Traversing Art Rejections in Nanotechnology Patent Applications No Small Task

Traversing Art Rejections in Nanotechnology Patent Applications No Small Task Mark Williamson and James Carpenter Abstract Courts have long held that merely changing the scale of a prior art device does not create a patentable invention. However, nanoscale properties are governed by quantum mechanical interactions that do not exist on a macroscale. When viewed in this light, in some circumstances macroscale prior art may be inapplicable to nanoscale devices. Thus, the application of macroscale prior art in a rejection of a nanoscale invention creates unique issues during patent prosecution. Further, because of the seemingly random effects of quantum mechanical interactions, combining nanoscale prior art with other nanoscale prior art to show obviousness under Section 103 raises questions about whether such a combination would be apparent to a person of ordinary skill in the art. This article discusses anticipation and obviousness rejections of nanoscale inventions in depth, based on a review of granted patents and their prosecution histories. It also provides guidance for avoiding or minimizing rejections and for addressing them should they arise during prosecution. I. Introduction The field of nanotechnology is a relatively new and fast growing area. Because it is a pioneering area, broad prior art could, on its face, preclude patent protection of more developed inventions. Moreover, nanotechnology incorporates multiple disciplines, and examiners at the U.S. Patent and Trademark Office ( USPTO ) may not have extensive experience or education in both nanoscience and the various broader disciplines. While the USPTO has improved nanotechnology examination in recent years, such as by developing a nanotechnology patent classification, the prior art cited in many rejections may not be properly applied or even relevant. Nevertheless, with a Mark Williamson is Co Chair of the Nanotechnology Practice Group at the law firm of Fitzpatrick, Cella, Harper & Scinto in Washington, D.C. James Carpenter is an associate at the law firm of Fitzpatrick, Cella, Harper & Scinto in Washington, D.C. 131

working knowledge of certain aspects of patent law particularly applicable to nanotechnology and other emerging technologies, prior art rejections can be effectively overcome. This article serves as a guide on how to strategically respond to, or even preempt, common prior art issues raised in nanotechnology patent applications. Part II of this article provides a brief overview of the current state of 35 U.S.C. 102 and 103 rejections. Part III discusses the state of nanotechnology examination in the USPTO. Part IV analyzes frequent issues raised in prior art rejections in nanotechnology patent applications and offers practical suggestions on how to respond to or avoid these issues. II. Anticipation and Obviousness Rejections In order to reject a claim under 35 U.S.C. 102 as anticipated by a single prior art reference, each and every element set forth in the claim must be either expressly or inherently described in the reference. 1 Regarding obviousness, 35 U.S.C. 103 forbids issuance of a patent when the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. 2 To determine whether an invention is obvious under 35 U.S.C. 103, the USPTO uses guidelines based on two U.S. Supreme Court decisions. 3 In Graham v. John Deere Co., 4 the Court established four factors to determine obviousness: (i) the scope and content of the relevant prior art; (ii) the differences between the prior art and the claims at issue; (iii) the level of ordinary skill in the pertinent art; and (iv) secondary considerations such as commercial success, long felt but unsolved needs, and failure of others. 5 Based on the Graham factors, the Court of Appeals for the Federal Circuit (the Federal Circuit ) for years used the TSM test, which held that obviousness rejections needed some evidence of teaching, suggestion, or motivation to combine the relevant prior art. 6 Forty years after Graham, the Supreme Court again addressed the issue of obviousness in KSR Int l Co. v. Teleflex, Inc. 7 The Court found that the TSM test was rigid because it ignored that common sense teaches...that familiar items may have obvious uses beyond their primary purposes, and in many cases a person having ordinary skill in the art ( PHOSITA ) will be able to fit the teachings of multiple patents together like pieces of a puzzle, found that a PHOSITA is also a person of ordinary creativity, and revived the obvious to try standard. 8 Also, the Court reaffirmed principles based on its precedent that [t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. 9 1 Manual of Patent Examining Procedure (MPEP) 2131, available at http://www.uspto.gov/web/offices/pac/mpep/index.htm; Verdegaal Bros. v. Union Oil Co. of Cal., 814 F.2d 628, 631 (Fed. Cir. 1987). 2 Power One, Inc. v. Artesyn Technologies, Inc., 2010 U.S. App. LEXIS 6487, at *14 *15 (Fed. Cir. 2010). 3 MPEP 2141. 4 383 U.S. 1 (1966). 5 Id., at 17 18. 6 In re Kahn, 441 F.3d 977, 986 88 (Fed. Cir. 2006). 7 550 U.S. 398 (2007). 8 Id. 9 Id. at 416. 132

While the TSM test was not overruled, it was held to be only one of many tests to determine obviousness. In response to 102 and 103 rejections, applicants often try to persuasively show that the examiner has not set forth a prima facie case of anticipation or obviousness, such as by demonstrating that the applied reference(s) does not disclose or suggest the features specifically purported by the examiner to be taught by the reference. If such a tack does not show potential or proves ineffective, various alternative strategies are available. For example, one can argue that the applied reference(s) is non enabling or non analogous. Should an examiner invoke the doctrine of inherency, the applicant can offer evidence that the allegedly inherent features are not necessarily in the prior art. In obviousness rejections, one can show that the examiner impermissibly engaged in a hindsight reconstruction of applicant s claimed invention. Further, secondary considerations under Graham can be offered as a rebuttal to obviousness rejections. The authors have analyzed the file histories of hundreds of nanotechnology patent applications, many of which were granted letters patents, and determined the types of art rejections that were raised most often. This paper summarizes those types of rejections, analyzes which strategies were successful in overcoming the rejections, and offers practical suggestions for responding to or avoiding these issues. III. Examination of Nanotechnology in the USPTO The USPTO has recognized the importance of nanotechnology in today s world and has taken steps to improve the quality of examination of nanotechnology patent applications. For example, the USPTO has utilized a Nanotechnology Customer Partnership to help identify sources of prior art and establish technical training programs for examiners. In addition to its complexity, another issue that raises difficulties in examination is that the field of nanotechnology is distinct from many other technology areas because nanotechnology encompasses many different disciplines. While a discrete nanotechnology examination group may not be feasible or desirable, the USPTO significantly aided the prior art search by creating a nanotechnology class, Class 977, containing 263 subclasses, to organize most nanotechnology subject matter in a logical manner. 10 Class 977 is a cross reference classification. Prior to issuance, a patent directed to nanotechnology is first assigned a main classification in an area related to its specific technology, and then assigned a secondary nanotechnology classification to provide a supplemental search resource. Even with the nanotechnology cross reference class, finding relevant prior art is still difficult. Though courts have long held that merely changing the scale of a prior art device does not create a patentable invention, 11 nanotechnology inventions are generally not simply a result of a change in scale. 12 Thus, much of the macroscale prior art is not necessarily applicable in nanotechnology applications. Complicating matters more, nanotechnology standards are only beginning to be developed and nanotechnology nomenclature is quite diverse. Therefore, nanotechnology properties and terms do not easily fit into the searchable databases of the USPTO. 10 See Class Definitions for Class 977 Nanotechnology, available at http://www.uspto.gov/web/patents/classification/uspc977/defs977.htm (last visited April 1, 2010). 11 See King Ventilating Co. v. St. James Ventilating Co., 26 F.2d 357, 359 (8th Cir. 1928) ( mere difference in dimension cannot add novelty to a claimed new product); In re Rose, 220 F.2d 459, 461, 463 (C.C.P.A. 1955) (limitations relating to size were not sufficient to distinguish over prior art); In re Rinehart, 531 F.2d 1048, 1053 (C.C.P.A. 1976) ( mere scaling up of a prior art process... would not establish patentability.... ); Gardner v. TEC Sys., Inc., 725 F.2d 1338, 1345 (Fed. Cir. 1984) (stating that a claimed device is not patentably di stinct from prior art that differs only in terms of relative dimensions). 12 Certain nanotech inventions are scale reductions of larger objects or devices. See, e.g., U.S. Patent No. 6,203,768 (filed Oct. 5, 1998) (issued Mar. 20, 2001) (describing the formation of zirconium oxide nanoparticles by milling larger particles and heat treating the result). 133

When examiners do find seemingly applicable prior art references, these references often do not explicitly describe all of the claimed features. In some cases, examiners may distort what is taught by the prior art or improperly modify the disclosed teachings. Discussed below are some of the more common issues raised in nanotechnology 102 and 103 rejections and suggestions on how they can be addressed or avoided. IV. Common Issues Raised in Nanotechnology Art Rejections The examiner bears the initial burden of factually supporting any prima facie conclusion of anticipation or obviousness. 13 As noted above, to support a rejection under 35 U.S.C. 102 as anticipated by a single prior art reference, each and every element set forth in the claim must be either expressly or inherently described in the reference. 14 Supporting a rejection under 35 U.S.C. 103 requires clear articulation of the reason(s) why the claimed invention would have been obvious. 15 The U.S. Supreme Court in KSR Int l Co. noted that the analysis supporting an obviousness rejection should be made explicit, and agreed with the Federal Circuit that rejections on obviousness cannot be sustained with mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness. 16 When analyzing 102 and 103 rejections, applicants should first ensure that a prima facie case of anticipation or obviousness has been established. Namely, applicant should ensure that all of the elements of the claimed invention are present in the reference(s) and, in the case of an obviousness rejection, that there is explicit reasoning for modifying or combining the reference(s). An anticipatory or obviousness rejection can be readily overcome if it can be shown that even one claimed element is not described in, or would not have been obvious from, the prior art. For example, in one nanotechnology patent application, an applicant was able to overcome an anticipatory reference by demonstrating that it failed to clearly disclose one of the claimed elements, a transistor. 17 If a prima facie case of anticipation or obviousness appears to have been established, a more detailed analysis is necessary to determine whether other aspects of the rejection can be traversed. Several possible issues for traversal are discussed in detail below. 1. Macroscale Prior Art Based on MPEP 2144.04 IV (A), examiners may rely on a macroscale prior art reference to reject claims directed to a nanoscale invention. However, the USPTO has held that there is no per se rule of obviousness based merely on a change in size of the prior art. Obviousness must be determined on a case by case basis and the examiner must establish that a reduction in size would have been obvious in each particular case. 18 13 MPEP 2131; MPEP 2142. 14 MPEP 2131. 15 MPEP 2142. 16 KSR Int l Co., 550 U.S. at 418, quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). See also Ex parte Schiffelers, Appeal No. 2009 006666 (B.P.A.I. 2009) (an example of a nanotechnology patent application where the examiner gave articulated reasoning for combining references). 17 U.S. Patent No. 7,312,155 (filed Apr. 7, 2004) (issued Dec. 25, 2007). 18 See Ex parte Nguyen, Appeal No. 2009 006509 (B.P.A.I. 2009). 134

A recent USPTO Board of Patent Appeals and Interferences ( BPAI ) decision highlights what an examiner must demonstrate to establish a prima facie case of obviousness based on reducing the size of a prior art reference to the nanoscale. In Ex parte Nguyen, the invention related to a process for making liquid nano carbon having an average particle size of less than 30 nanometers. Among other rejections, the examiner rejected certain claims under 35 U.S.C. 102 and 103 over the Belmont reference. 19 The BPAI found that the Belmont reference taught the size of particles to be no larger than about 2 microns with the desirability of making the particles as small as possible, optimally 1 micron and below. Citing MPEP 2144.04 IV (A), the examiner argued changes in size do not impart patentability and to reduce the size of the particles in the Belmont reference to the nanoscale would have been obvious. The BPAI disagreed with the examiner, stating that Belmont s teaching of a preferred size less than 1 micron... does not establish that those of ordinary skill in the art were capable of achieving the much smaller 30 nanometer particle sizes.... 20 The BPAI further reasoned that applicant s specification taught that there were a limited number of ways to achieve the claimed particle size and the examiner failed to provide evidence that a PHOSITA would have be en capable of achieving that size. 21 If a prima facie case of obviousness has been established with regard to macroscale prior art, an applicant can also argue secondary considerations for patentability. Since many nanotechnology inventions exploit unique nanoscale properties that may not be present at the macroscale, unexpected results may be particularly pertinent in arguing patentability over macroscale prior art. Unexpected results, as well as other secondary considerations, will be discussed in more detail in a later section. When confronted with a rejection based on a macroscale prior art reference, the applicant should analyze the rejection fully and determine whether the examiner has provided detailed reasoning as to how a PHOSITA would be capable of achieving a size reduction to the nanoscale. Any such reasoning that is conclusory or unreasonable should be traversed. If feasible, evidence of secondary considerations, such as unexpected results, should also be presented, if not already set forth in the specification. Macroscale prior art can also be traversed for other reasons including, for example, the reference would be non enabling at the nanoscale, which will be discussed in the next section. 2. Use of Non Enabling References An allegedly anticipating reference must provide an enabling disclosure of the subject matter relied on by the examiner. 22 That is, even if the claimed invention is disclosed in a prior art reference, that disclosure will not suffice as prior art if it is not enabling. 23 A reference contains an enabling disclosure if the public was in possession of the claimed invention before the date of invention. 24 In other words, if a PHOSITA could have combined the reference s description of the invention with his or her own knowledge to make and use the claimed invention, the reference is sufficiently enabling. Underlying this possession test is the requirement that the prior art reference must teach a PHOSITA to make or carry out the claimed 19 U.S. Patent No. 5,630,868 (filed Dec. 14, 1995) (issued May 20, 1997). 20 Nguyen, at 10 11. 21 Id. 22 MPEP 2121.01; See also MPEP 2164 (discussing the enablement requirement). 23 In re Donohue, 766 F.2d 531, 533 (Fed. Cir. 1985). 24 MPEP 2121.01. 135

invention without undue experimentation. 25 Thus, an applicant should scrutinize any prior art reference applied in a rejection to determine whether it is enabling for the subject matter relied on by the examiner. When the applied reference is non enabling, the rejection should be readily overcome. Non patent prior art, in particular, should be scrutinized for enablement. These non patent publications are often written by experts in their respective fields for the purpose of disclosing observations and facts, not to enable a PHOSITA to make and use the invention. Some of these publications may not disclose enough to enable another scientist to reproduce the observations. Once an examiner has asserted a reference in an anticipatory or an obviousness rejection, 26 the applicant has the burden to rebut by way of evidence in the original specification or presented later, such as in an affidavit or declaration under 37 CFR 1.132. 27 A reference is presumed operable until facts are provided rebutting the presumption of operability. 28 Arguments of counsel cannot take the place of factually supported objective evidence in the specification or elsewhere. 29 Evidence showing that attempts to prepare a compound were unsuccessful before the date of invention has been found to adequately show inoperability. 30 However, the fact that an author or inventor of the prior art did not attempt to make the disclosed compound, without more, is insufficient to overcome a rejection. 31 For example, in In re Hoeksema, 32 a claim to a compound was rejected over a patent that disclosed compounds similar in structure to those claimed and a process of making such compounds. The applicant responded with an affidavit by an expert, which stated that there was no indication in the patent that the process disclosed could be used to produce the claimed compound and that he did not believe that the process disclosed in the patent could be adapted to the production of the claimed compound. The court held that the facts stated in the affidavit were legally sufficient to overcome the rejection and that applicant need not show that all known processes are incapable of producing the claimed compound because such a showing would be practically impossible. 33 In one particular nanotechnology patent application, applicants submitted three declarations to explain how the nanotechnology in the applied patent functioned and to show that it did not enable 25 Ela n Pharm., Inc. v. Mayo Found. For Med. Educ. & Research, 346 F.3d 1051, 1054 (Fed. Cir. 2003). 26 See MPEP 2121.01(II); See also Symbol Techs. Inc. v. Opticon Inc., 935 F.2d 1569, 1578 (Fed. Cir. 1991) ( a non enabling reference may qualify as prior art for the purpose of determining obviousness under 35 U.S.C. 103 ). 27 MPEP 2145. 28 In re Sasse, 629 F.2d 675, 681 (C.C.P.A. 1980). 29 In re Huang, 100 F.3d 135, 139 40 (Fed. Cir. 1996). 30 In re Wiggins, 488 F.2d 538, 179 USPQ 421 (C.C.P.A. 1971) (attempts to make the compounds using the prior art methods were all unsuccessful). 31 In re Donohue, 766 F.2d 531 (Fed. Cir. 1985) (In this case, the examiner rejected a claim under 35 U.S.C. 102(b) over a publication, which disclosed the claimed compound, in combination with two patents teaching a general process of making the particular class of compounds. The applicant submitted an affidavit stating that the authors of the publication had not actually synthesized the compound. The court held that the fact that the publication s author did not synthesize the disclosed compound was immaterial to the question of operability of the reference. The patents were evidence that synthesis methods were well known.). 32 399 F.2d 269 (C.C.P.A. 1968). 33 Id. at 274 75. 136

a PHOSITA to make and use the claimed invention. While the examiner in that case was not persuaded by the first declaration, subsequent declarations, along with counsel s explanation, showed that the applied reference required undue experimentation and taught away from the claimed invention. This led to the withdrawal of the 102 rejection and to the application s eventual allowance. 34 In another nanotechnology application, applicants successfully argued that a reference did not place the invention in the possession of the public because it failed to provide a method of producing. 35 In nanotechnology applications, applicants should analyze each prior art reference to determine whether a PHOSITA could make the claimed subject matter without undue experimentation. This is particularly applicable to non patent prior art, where enablement standards are not required. When a prior art reference appears to be non enabling, applicants should provide fact specific arguments that highlight the claimed features not disclosed by the reference, discuss the significance of these features with respect to the claims, and explain why these features require undue experimentation. An affidavit or declaration from an expert in the field would be particularly effective. 3. Lack of Inherency Patents, published applications, and non patent references rarely disclose all the underlying scientific principles and knowledge of a PHOSITA in their disclosures. References often rely on a PHOSITA s background knowledge as a basis of or supplement to their disclosures. Examiners, when rejecting claims, can use this inherent knowledge, and applicants should be prepared to distinguish knowledge actually inherent in a disclosure from knowledge that would not be attributed to a PHOSITA. In the USPTO, the doctrine of inherency allows an examiner to cite prior art that is relatively close to the claimed invention, posit that the prior art inherently or necessarily possesses the claimed property, and reject the claims. 36 If challenged, an examiner must offer reasoning or examples supporting a reliance on inherency. 37 Such reasoning and/or support require a basis in fact (evidence) and/or reasoning tending to show that an allegedly inherent feature necessarily flows from the teachings of the applied art. 38 Only after providing this support does the burden to rebut a claim rejection based on inherency shift to an applicant. 39 For much prior art applied in nanotechnology applications, however, an examiner s inherency argument may be legally insufficient to establish a valid prima facie case because nanoscale properties may not be present at larger scales. Fundamental and non obvious differences may exist between macroscale and nanoscale models. Matter behaves uniquely at the nanoscale level. For example, when a nanoscale invention is reduced beyond a critical size, its electron structure, conductivity, reactivity, melting temperature, mechanical properties, etc., may significantly differ from that of its macroscale counterpart. On the other hand, nanotechnology applicants must be aware that if the nanotechnology properties are simply a newly discovered understanding of how a 34 U.S. Patent No. 7,399,429 (filed May 10, 2005) (issued Jul. 15, 2008). 35 U.S. Patent No. 7,563,507 (filed Aug. 18, 2003) (issued Jul. 21, 2009). 36 MPEP 2112. See Ex parte Levy, 17 U.S.P.Q. 2d 1461, 1464 65 (B.P.A.I. 1990) (examiner asserted that a property which is not explicitly shown in the prior art is nonetheless present); See also In re Napier, 55 F.3d 610, 613 (Fed. Cir. 1995). 37 MPEP 2112 (IV). 38 Id., citing Ex parte Levy, 17 U.S.P.Q. 2d at 1464. 39 MPEP 2112 (V); MPEP 2112.01(I). 137

previously described patent or non patent publication worked, the discovery itself may not support patentability because it is an inherent aspect of the prior art. 40 Nevertheless, rejections based on inherency are being raised in nanotechnology applications. 41 However, since a basis in fact and technical reasoning is required to support an inherency argument, a failure to provide such evidence or rationale, if challenged, precludes reliance on this doctrine. In Ex parte Nguyen, the patent applicant challenged the examiner s assertion that carbon particles as small as 30 nanometers were inherent in the Belmont reference, which did not explicitly state such. 42 The BPAI reasoned that statements in applicant s specification supported the opposite conclusion and reversed the anticipation rejection. 43 When an inherency rejection is raised, nanotechnology applicants should analyze the prior art reference and determine whether the allegedly inherent feature would actually be present at the nanoscale. Any conclusory assertions raised in a rejection without any reasoned support for a reliance on inherency should be challenged. 4. Non Analogous Art As discussed above, Class 977 is a cross reference classification covering a diverse range of nanotechnology. Thus, when nanotechnology claims are rejected under 103, some cited references may not appear to be pertinent to the claimed invention. According to the USPTO, scope of the relevant prior art for purposes of evaluating obviousness under 35 U.S.C. 103 extends to all analogous arts. 44 An examiner must determine what is analogous prior art for the purpose of analyzing the obviousness of the subject matter at issue. 45 A reference in a field different from that of applicant s endeavor may be reasonably pertinent if it is one which, because of the matter with which it deals, logically would have commended itself to an inventor s attention in considering his or her invention as a whole. 46 Under the correct analysis, any need or problem known in the field of endeavor at the time of the invention and addressed by the reference can provide a reason for combining the elements in the manner claimed. 47 A reference is reasonably pertinent if, even though it may be in a different field from that of the inventor s endeavor, it is one which, because of the matter with which it deals, logically would have commended itself to an inventor s attention in considering his or her 40 See In re Oelrich, 666 F.2d 578, 580 81 (C.C.P.A. 1981); In re Geisler, 116 F.3d 1465, 1468 (Fed. Cir. 1997); Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999) (holding that the discovery of a previously unappreciated property of prior art, or of a scientific explanation for the prior art s functioning, does not render the old invention patentably new). 41 See U.S. Patent No. 7,393,410 (filed Apr. 26, 2005) (issued Jul. 1, 2008) (an examiner used a single reference, which disclosed a variety of processes that were already known in the art, and stated that this single reference inherently implied another very well known process); See also U.S. Patent No. 7,655,942 (filed Mar. 16, 2005) (issued Feb. 2, 2010) (an examiner argued that quantum dots will inherently have a doping effect on the insulator.... ). 42 Ex parte Nguyen, at 10. 43 Id. 44 MPEP 1504.03 (I)(A). 45 MPEP 2141.01(a)(I). 46 Id. 47 KSR Int l Co., 550 U.S. at 420. 138

problem. 48 If it can be shown that the respective fields of endeavor are sufficiently remote, a finding of non analogous art can be supported. 49 Applicants have raised the issue of non analogous prior art to traverse obviousness rejections in several nanotechnology applications, mostly without success. In one case, the examiner simply stated that the references were reasonably cross referenced in subclass 977/773, nanoparticles. 50 In another, even though the prior art references pre date the 977 classification, the argument was deemed insufficient because the references were considered reasonably pertinent by the examiner. 51 In still another application, an applicant argued that chemical vapor sensors were nonanalogous art to the field of light bulbs. 52 The examiner replied that it was generally recognized that nanotechnology would improve or replace conventional electrical or optical devices, including the carbon nano tubes of the claimed invention. 53 In an appeal brief, the applicant argued, among other things, that a PHOSITA would not turn to the field of chemical vapors to learn how to make light bulbs. 54 Although the rejection was withdrawn, it is unclear how much weight the examiner gave the argument regar ding non analogous prior art. 55 Notwithstanding the apparent lack of success of arguing non analogous prior art in the nanotechnology arts in recent years, such an argument should not be dismissed without careful consideration. Even if a prior art reference is classified in Class 977, one should keep in mind that the class is very broad, and diverse and persuasive arguments can be made that the reference is so remote as to be in a separate field of endeavor and would not have commended itself to an inventor s attention. 5. Impermissible Use of Hindsight Because of the fast paced nature of nanotechnology, what may be considered old knowledge may actually have been a relatively recent development. Over 90% of the 5,288 PUBLISHED PATENT APPLICATIONS CROSS referenced in Class 977 were filed after 2005. Because nanotechnology is developing so rapidly, applicants should be cognizant of what is considered to be the level of ordinary skill in the art at the time of the invention. The statutory language, at the time of the invention, prevents examiners from rejecting claims based on post invention date innovations and knowledge. Indeed, courts have made it clear that a fact finder should be aware of the distortion caused by hindsight bias and must be cautious of arguments reliant upon ex post reasoning. 56 48 In re Clay, 966 F.2d 656, 659 (Fed. Cir. 2002); In re Wood, 599 F.2d 1032 (C.C.P.A. 1979). 49 See Litton Systems, Inc. v. Honeywell, Inc., 87 F.3d 1559 (Fed. Cir. 1996), remanded, 520 U.S. 1111 (1997), aff d in part, rev d in part, vacated in part & remanded, 140 F.3d 1499 (Fed. Cir. 1998), petition for reh g denied & suggestion for reh g en banc declined, 145 F.3d 1472 (Fed. Cir. 1998) (In a non nanotechnology case, the Federal Circuit found that a jury could have reasonably found that a reference was not analogous art because the fields of space vehicle propulsion and ring laser gyroscopes were remote from one another and, at best, distant cousins. Further, the Federal Circuit held that a PHOSITA in ring laser gyroscopes at the time of the invention would not find space vehicle propulsion pertinent.). 50 U.S. Patent No. 7,173,313 (filed Mar. 8, 2004) (issued Feb. 6, 2007). 51 U.S. Patent No. 7,655,942 (filed Mar. 16, 2005) (issued Feb. 2, 2010). 52 53 Id. 54 Id. U.S. Patent No. 7,622,314 (filed May 5, 2006) (issued Nov. 24, 2009). 55 Id. 56 KSR Int l. Co., 550 U.S. at 421. 139

The USPTO has made it clear that hindsight cannot be the sole basis for an examiner s proposed modification of a prior art reference. An examiner must give a reasoned explanation and solid evidence that hindsight reconstruction in view of an applicant s disclosure is not the sole basis for his or her conclusion regarding the obviousness to modify or combine the references when an applicant challenges the examiner s reasoning. To reach a proper determination under 35 U.S.C. 103, the examiner must step backward in time and into the shoes worn by the hypothetical PHOSITA when the invention was unknown and just before it was made. 57 In view of all the factual information, an examiner must then make a determination as to whether the claimed invention as a whole would have been obvious at that time to that person. Knowledge of applicant s disclosure must be put aside in reaching this determination, yet kept in mind in order to determine the differences, conduct the search, and evaluate the subject matter as a whole. Impermissible hindsight must be avoided and the legal conclusion must be reached on the basis of the facts gleaned from the prior art. 58 Additionally, the USPTO has warned examiners that the tendency to resort to hindsight based upon applicant s disclosure is often difficult to avoid due to the very nature of the examination process. 59 In one nanotechnology example, an examiner, using a reference that was silent on a particular limitation, argued that a PHOSITA would have known to make a tapered shape on an interconnection. Applicant s argued that the examiner was attributing knowledge to a PHOSITA of the invention s disclosure. 60 The examiner allowed the case, indicating that applicants arguments were considered and found persuasive. An applicant should analyze an examiner s reasoning for a combination or modification of prior art in an obviousness rejection, determine whether such reasoning was derived directly from applicant s disclosure or a post invention date source, and if so, argue the impropriety of the combination or modification. Because of the fast paced nature of nanotechnology, an applicant should be aware that much of what is disclosed in his or her application may be new knowledge, and therefore cannot be used by in an examiner s rejection. 6. Secondary Considerations of Non Obviousness Even if a prima facie case of obviousness has been established by an examiner, secondary considerations can serve as relevant indicia of obviousness or nonobviousness and may be utilized to give light to the circumstances surrounding the origin of the subject matter to be patented. 61 In Graham, the Supreme Court offered three examples of secondary considerations, namely, commercial success, long felt but unsolved need, and the failure of others. 62 Other secondary considerations acknowledged by the Federal Circuit include unexpected results, whether the prior art teaches away from the invention, whether others have copied the invention, whether the invention has received industry acclamation, and subsequent independent invention. 63 In KSR 57 58 Id. MPEP 2142. 59 Id. 60 U.S. Patent No. 7,659,631 (filed Oct. 12, 2006) (issued Feb. 9, 2010). 61 Graham, 383 U.S. at 17 18. 62 Id. 63 See, e.g., Ecolochem, Inc. v. S. Cal. Edison Co., 227 F.3d 1361 (Fed. Cir. 2000), cert. denied, 532 U.S. 974 (2001). 140

Int l Co., the Supreme Court reaffirmed the use of secondary considerations in obviousness determinations. 64 Unexpected results is a category of secondary considerations particularly pertinent to the nanotechnology field. In one BPAI appeal, a nanotechnology applicant argued unexpected results and submitted a declaration by the inventor to rebut an obviousness rejection. 65 The BPAI found, however, that there was no evidence of unexpected results; the results were interesting, not unexpected. 66 The BPAI also found that it was not established that the claimed subject matter was compared with the closest prior art. 67 When arguing unexpected results, an applicant should ensure the presented evidence meets with standards established by case law and outlined in the MPEP. In order to successfully make an unexpected results argument, an applicant must show that differences in properties between the claimed invention and the prior art differ to such a degree that the disparity is unexpected. 68 To establish unexpected results, the claimed subject matter must be compared with the closest prior art. 69 Further, the showing of unexpected results must be based on evidence, not argument or speculation. 70 As noted above, it is the applicant s responsibility to present evidence and arguments by way of the specification and/or an affidavit or declaration under 37 C.F.R. 1.132. Once such evidence is presented, applicants must establish a nexus between the unexpected results and the claimed invention, and the evidence should be commensurate in scope with the claimed invention. 71 Other secondary considerations can be offered to rebut an obviousness rejection. When arguing commercial success, the applicant must provide hard evidence to show that the claimed invention caused an article to be commercially successful. 72 When arguing long FELT NEED AND FAILURE OF OTHERS, an applicant must directly show that a need for the claimed invention has long existed and/or that others have failed where the claimed invention succeeded. 73 However, mere absence of the features prior to the claimed invention is insufficient. 74 With these secondary indicia, the claimed invention itself must demonstrably provide the commercial success, solve the long felt need, and/or succeed where others have failed before. When confronted with a strong prima facie case of obviousness, applicants should consider whether there is any factual support for secondary considerations of patentability. If such evidence 64 KSR Int l. Co., 550 U.S. at 421. 65 Ex parte Smith, Appeal No. 2006 2810 at pages 13 15 (B.P.A.I. 2006). 66 Id. 67 Id. 68 MPEP 716.02; See In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995) ( [A] patent applicant [may] rebut a prima facie case of obviousness [by] make a showing of unexpected results, i.e.,... some superior property or advantage that a person of ordinary skill in the relevant art would have found surprising or unexpected. ). 69 In re Burckel, 592 F.2d 1175 (C.C.P.A. 1979). 70 MPEP 2145; See In re Dillon, 919 F.2d 688, 692 93 (Fed. Cir. 1990). 71 MPEP 2145; See In re Mayne, 104 F.3d 1339, 1343 44 (Fed. Cir. 1997). 72 MPEP 2145. 73 Id. 74 MPEP 2144.05 (III); See also Iron Grip Barbell Co., Inc. v. USA Sports, Inc., 392 F.3d 1317, 1324 25 (Fed. Cir. 2004) (absent a showing of a long felt need or the failure of others, the mere passage of time without the claimed invention is not evidence of non obviousness). 141

can be readily provided before the application is filed, incorporating such into the specification may preclude such a rejection from even being raised, thereby avoiding any unnecessary estoppel. V. Conclusion Nanotechnology has been touted as the next technological revolution. Strong patents will be critical in exploiting this wave. Therefore, it is incumbent upon nanotechnology patent applicants to have full knowledge of issues that may be raised by the USPTO and how best to address, if not avoid, these issues. Preferably, potential prior art rejections should be anticipated before filing an application. Relevant prior art should be scrutinized and, where practical, evidence establishing the patentability of the claimed invention over the prior art should be incorporated into the specification. Should prior art rejections be raised during examination, applicants should determine their strongest arguments and, when responding, emphasize these arguments with factual support and expert opinion, if applicable. 142