CHAPTER V PATENT SPECIFICATION AND CLAIMS

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1 CHAPTER V PATENT SPECIFICATION AND CLAIMS This chapter deals with the specification and claiming requirements of patent applications. Patents are granted with a significant involvement of the patent office. The stage where the patent office processes the invention is called patent prosecution. This is the stage where the patent application is filed. This chapter deals with the requirements in the patent application. It is notable that the statutory requirements for a patent application are compounded by the patent office rules. As always, the American patent system is the most complex in the world. This chapter looks at the basic necessities of statutory requirements of the patent application. The first area of discussion will be specification. Specification is discussed in section 112. This section discusses specification, written description, claims and other requirements of for patent prosecution. SPECIFICATION Section 112 (1) discusses patent specification. (1) The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. This section specifically states that the application shall contain the following: a) written description with a detail of the manner of making and the process of making b) to enable a person skilled in the art to make and to use the invention c) setting for the best mode contemplated by the inventor to carry out the invention. Each of these are very complex and technical requirements. WRITTEN DESCRIPTION The purpose and function of the written description requirement have changed over time. All United States patent statutes have required a "description" of the applicant's invention. The Patent Act of 1790 required the grantee of a patent to deliver to the Secretary of State: a specification in writing, containing a description... of the thing or things by him... invented or discovered... which specification shall be so particular,... as not only to distinguish the invention or discovery from other things before known and used, but also to enable a workman or other

2 person skilled in the art... to make, construct or use the same, to the end that the public may have the full benefit thereof, after the expiration of the patent term... During this time the written description provided notice to the public of the scope of exclusive rights asserted by an inventor. Through the written description, the public was to be "put in possession" of the boundaries of a patentee's asserted monopoly. Today, that role is played by claims, single-sentence statements that must "particularly [point] out and distinctly [claim] the subject matter which the applicant regards as his invention." The written description requirement in its current form no longer focuses on putting the public "in possession" of the claimed invention in the sense of fulfilling a notice requirement. Rather, written description now asks whether the inventor was "in possession" of the claimed invention as of a particular date. Now written description is a statutory descriptor for the general concept of "support" for claims not filed in an original application. It ensures that the inventor would be limited to claiming that which was identified as within the scope of her invention at the time of filing the original application. Today, the written description, rather than notifying the public at the time of patent issuance of the asserted scope of the patentee's property right, serves as a manifestation of what was within the scope of the patentee's inventive contribution as of his filing date. Thus, the written description requirement takes a "snapshot" view of the inventor's contribution based on the disclosure in her specification as originally filed, and asks whether that "snapshot" reasonably conveys to persons of ordinary skill that any subsequently-claimed subject matter was truly and fairly part of that contribution. The written description requirement can be satisfied in any manner sufficient to convey possession by the inventor. It provides whether the inventor had actually invented the claimed subject matter as of the application filing date. In gist, this requirement essentially states that the Specification shall have a detailed written description that embody all the elements of the invention. There are instances (discussed below in the case) where although the claims have been accepted, patents have been rejected because of inadequate written description. Written descriptions are mechanisms to ensure that inventors do not change the gist of the invention while filing claim amendments or while filing complete specifications. The American system also allows filing of provisional or complete specifications like in the Indian system under

3 Section 111 of the patent statute. Now the written description provides an outline of the invention when the application is first made. This ensures that inventors do not claim a wider or a completely different invention either when filing the complete specifications or when filing claim amendments. A written description need not always be in writing. In some cases, even drawings have been accepted as a sufficient requirement of written description. This requirement was laid down in the case of Vas-Cath v. Mahurkar (935 F 2d 1555). The issue in this case was whether mere drawings could provide the written description. The court stated that the purpose of the "written description" requirement was broader than to merely explain how to "make and use" the invention. The applicant had to also convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the "written description" inquiry, whatever is now claimed. A fairly uniform standard for determining compliance with the written description requirement is that although the applicant does not have to describe exactly the subject matter claimed, the description must clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter. Drawings alone may provide a "written description" of an invention as required by section 112. While the district court and the Federal circuit agreed that drawings could provide the written description, the district court did not believe that the drawings in the instant case sufficiently described the invention. The court was concerned that though the drawing showed the invention it did not detail out what was novel or important about the invention. The Federal Circuit found the district court's concern with "what the invention is" misplaced, and its requirement that the 'drawings "describe what is novel or important" legal error. It stated that there is "no legally recognizable or protected 'essential' element, 'gist' or 'heart' of the invention in a combination patent." The invention in this case not only claims the features of the invention but a combination of those features. That combination invention is what the drawings show. The court held that in this case what was eventually patented was exactly what the pictures show. Similarly, with reference to biotechnology patents, the written description requirement has a much higher standard. Here the court has clarified that written description needs to be clear, detailed and discuss specific aspects of the invention. This requirement is best discussed in the case of Regents of the University Of California v. Eli Lilly (119 F 3d 1559). The Science:

4 The patents in suit relate to recombinant DNA technology and, more specifically, to recombinant plasmids and microorganisms that produce human insulin, a protein involved in the regulation of sugar metabolism. A person unable to produce insulin is afflicted with diabetes. Prior to the development of recombinant techniques for the production of human insulin, diabetic patients were treated with injections of animal insulin, which often caused allergic reactions. Human insulin produced by recombinant methods is less likely to produce such reactions. It consists of two separate amino acid chains, a 21-amino acid A chain and a 30-amino acid B chain, which are linked only by disulfide bonds. Healthy people produce insulin in vivo via the terminal enzymatic cleavage of preproinsulin (PPI) to yield proinsulin (PI), a single amino acid chain consisting of the A and B chains, linked by a sequence of additional amino acids that positions the A and B chains so that the disulfide bonds are readily formed. The PI is then further cleaved to liberate the linking sequence and yield insulin. The Issue: Plaintiffs in this case had two patents for the manufacture of insulin. They claimed that Eli Lilly infringed on the patent by using the same manufacturing process for insulin. Eli lilly claimed that the patent was unenforceable because of failure to adequately describe the invention. The court held for the company. It stated that, to fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention. Thus, an applicant complies with the written description requirement by describing the invention, with all its claimed limitations, not that which makes it obvious, and by using such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention. An adequate written description of a DNA requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention. Accordingly, an adequate written description of a DNA requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it; what is required is a description of the DNA itself. The court looked at Claim 5 of the patent specification, which described the cdna encoding human insulin. Claim 5 is directed to a recombinant procaryotic microorganism modified so that it contains "a nucleotide sequence having the structure of the reverse transcript of an mrna of a [human], which mrna encodes insulin." Thus, the definition of the claimed microorganism is one that requires human insulin-encoding cdna. The patent describes a method of obtaining this cdna by means of a constructive example. This example, however, provides only a general method for obtaining the human cdna (it incorporates by reference the method used to obtain the rat cdna) along with the amino acid sequences of human insulin A and B chains. Whether or not it provides an enabling disclosure, it does not

5 provide a written description of the cdna encoding human insulin, which is necessary to provide a written description of the subject matter of claim 5. The court held that the name cdna is not itself a written description of that DNA; it conveys no distinguishing information concerning its identity. While there was an example in the specification that provided a process for obtaining human insulin-encoding cdna, there was no further information in the patent pertaining to that cdna's relevant structural or physical characteristics; in other words, it thus did not describe human insulin cdna. Describing a method of preparing a cdna or even describing the protein that the cdna encodes, as the example does, does not necessarily describe the cdna itself. No sequence information indicating which nucleotides constitute human cdna appears in the patent, as appears for rat cdna in an example of the patent. Accordingly, the specification does not provide a written description of the invention of claim 5. A claim to a specific DNA is not made obvious by mere knowledge of a desired protein sequence and methods for generating the DNA that encodes that protein. A prior art disclosure of the amino acid sequence of a protein does not necessarily render particular DNA molecules encoding the protein obvious because the redundancy of the genetic code permits one to hypothesize an enormous number of DNA sequences coding for the protein. Thus, a fortiori, a description that does not render a claimed invention obvious does not sufficiently describe that invention for purposes of 112. Because the specification provided only a general method of producing human insulin cdna and a description of the human insulin A and B chain amino acid sequences that cdna encodes, it did not provide a written description of human insulin cdna. OBJECTIVE DISCLOSURES The second part of 112 (1) discusses that specification should enable one skilled in the art. Thus this requirement is called the enablement requirement. This essentially means that there needs to be specific details in the invention that will enable other people in the future by looking at the application to make and to use the invention. Again, the ability of the enablement aspect of the specification to educate on the necessities of MAKING and USING the invention is the crux of enablement. These two requirements are called as the objective disclosure requirements. They are so known because the details of how to make and use should be done objectively so that in the future the public are enabled to perform the invention. The rationale is that in return for the monopoly rights, the patentee teaches the public to make and use the invention after the monopoly period is over. Each of the enablement requirements is discussed in the following paragraphs.

6 HOW TO MAKE: This requirement is embodied in section 112 as the specification shall contain,.the manner and process of making. With clear, concise, and exact terms to enable any person skilled in the art.. to make.the invention. Genentech v. Nono Nordisck (108 F 3d 1361) Genentech obtained an injunction from the lower court against Novo Nordisk preventing Nono Nordisk from selling or importing its brand of recombinant human growth hormone (hgh). Genentech alleged that the hgh of Novo Nordisk infringed its inventions. Novo Nordisk challenged this injunction claming that Genentech s specification did not fulfill the enablement requirement of section 112 and was itself not valid. Regarding enablement, Novo argued that the patent was invalid because it does not contain sufficient detail concerning the practice of the claimed method. Novo argued that the mere generic statement of the possibility of cleavable fusion expression, was not an enabling disclosure commensurate in scope with the claim. Genentech argued that those skilled in the art of recombinant protein expression at the time of filing would have been able to use cleavable fusion expression to produce hgh without undue experimentation by using the specification along with methods and tools well known in the art. Therefore Genentech argued that the teaching in the specification enabled one skilled in the art to perform the invention and was sufficient. The issue before the court was whether the specification would have enabled a person having ordinary skill in the art at the time of filing to use cleavable fusion expression to make hgh without undue experimentation. There was no dispute that the portion of the specification chiefly relied upon by Genentech did not describe in any detail whatsoever how to make hgh using cleavable fusion expression. For example, no reaction conditions for the steps needed to produce hgh were provided; nor was there a description of any specific cleavable conjugate protein. The relevant portion of the specification merely described three (or perhaps four) applications for which cleavable fusion expression was generally well-suited and then named an enzyme that might be used as a cleavage agent (trypsin), along with sites at which it cleaves ("arg-arg or lys-lys, etc."). Thus, the specification did not describe a specific material to be cleaved or any reaction conditions under which cleavable fusion expression would work. Genentech's argument was that the knowledge of one skilled in the art was sufficient to provide all of the missing information and, more specifically, that the disclosure of a DNA

7 encoding hgh, when combined with prior art cleavable fusion expression techniques applied to non-human proteins, would enable the practice of the claimed method. In response to these arguments, Novo asserted that no one had been able to produce any human protein via cleavable fusion expression as of the application date. At the time of filing, trypsin and other like enzymes were used only to digest proteins, not to specifically and precisely cleave conjugate proteins to yield intact, useful proteins. Novo further argued that neither the specification nor the references cited by Genentech suggested a single amino acid sequence, out of the virtually infinite range of possibilities, that would yield hgh in a useful form when cleaved from the conjugate protein. The court observed that if as Genentech argued, one skilled in the art, armed only with what the patent specification disclosed (a DNA sequence encoding a human protein, in this case, hgh, and a single example of an enzyme and its cleavage site), could have used cleavable fusion expression to make a human protein without undue experimentation, it was remarkable that this method was not used to make any human protein for nearly a year or to make hgh for five years. DNAs encoding desirable human proteins were known at the time of filing (e.g., insulin, described in the British patent), and a great many researchers were attempting to produce human proteins using recombinant DNA technology. This failure of skilled scientists, who were supplied with the teachings that Genentech asserted were sufficient and who were clearly motivated to produce human proteins, indicates that producing hgh via cleavable fusion expression was not then within the skill of the art. The test for enablement: To be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. It stated that while every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention. The omission of minor details does not cause a specification to fail to meet the enablement requirement. However, when there is no disclosure of any specific starting material or of any of the conditions under which a process can be carried out, undue experimentation is required; there is a failure to meet the enablement requirement that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art. The court stressed that it was the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute

8 adequate enablement. In this case Genetech had failed to meet the enablement requirement and thus its patent was held invalid. HOW TO USE: The how to use requirement is embodied in section 112 as the specification shall contain,.the manner and process of using.with clear, concise, and exact terms to enable any person skilled in the art.. to use.the invention. In many cases, the appropriate use of the invention is straight forward. However, if the use of the invention is not provided properly, then there is a likely hood that the patent will be rejected. In Re Gardener, Roe and Willy (427 F 2d 786). Appellant filed application for pharmaceutical compositions that acted as antidepressants and for a method of producing antidepressant effects by internally administering compounds. None of the claims mentioned to whom the antidepressants were to be administered, and recommended dosages for each compound ranged broadly. The patent office rejected all claims on the grounds that the claims were not definite enough and that they did not disclose enough information to enable one skilled in the art to use the compounds, and so did not meet the requirements of section 112. The first problem with the specification was that there is not one specific embodiment of a contemplated host. While dosages were recited in the specification and in the claims, they were (1) not related to any host nor (2) are the dosages related to body weight of a host. The question was not one of obviousness, but a failure to "set forth the best mode contemplated". The specification called for dosage units of from about 10 mg. to about 150 mg., and from about 10 mg. to about 100 mg. of the active ingredient, respectively. It then called for administering "an effective amount". Appellants stated their invention was in the discovery of the antidepressant activity in a group of compounds. They were not claiming the compounds. In effect, by claiming pharmaceutical compositions "having antidepressant activity" and methods "of producing antidepressant activity" which consist in administering the compounds, they were claiming in terms of use. The burden is therefore on the appellant to disclose how to use, "in such full, clear, concise, and exact terms as to enable any person skilled in the art to use" their invention. The Patent Office took the position is that these generalizations were an insufficient disclosure of how to use and did not comply with the law. Appellants claimed they were sufficient because anyone skilled in the art would, first of all, assume the host to be an average adult human (at the same time keeping open the possibility of veterinary use). Moreover this was not the first antidepressant drug, and that doctors were generally given sufficient information on how to properly administer. The court nonetheless held that the disclosure of specific dosage units, ranging all the way from 10 mg. to 150 mg., did not

9 teach anyone anything about proper dosage. The only significant dosage disclosure was in the statement about daily dosage and even here this took the form of from 10 mg. to 450 mg., a range of from 1 to 45 times. The court felt that the dosage amount varied a lot and it seemed like the dosage was to be administered as taught by the specification, until an antidepressant effect was achieved especially within the broad daily dosage range of from about 10 mg. to about 450 mg. Since the specification was too broad and did not explain how the drug was to be used it, the patent office was right in rejecting a patent for the same. Another interesting case is that of the famous Rubick Cube - The enablement requirement had a very interesting turn in the case of the popular Rubik s cube Puzzle. Here the patent consisted of a toy. The toy was a cube puzzle divided into smaller cubes. Rotation of the sides of the cubes allowed to cube to be a pattern. The inventor claimed the a) cube puzzle, b) method for restoring a predetermined pattern of smaller cubes but did not describe the precise sequence of moves necessary to solve the puzzle. The court held that the patent specification was nonetheless not invalid since the patent provided a general approach for solving the puzzle in a way that the enablement requirement was satisfied. BEST MODE This essentially means that the inventor should reveal the best method of making the invention that is known to the inventor. The policy behind this is provision is inventors are vested with monopoly rights. In return they need to educated the public on the invention completely. CLAIMS NOTE: This section explains claims and their ambit for better understanding. Under no circumstance does this section prepare the reader to draft a claim. Claim drafting is a complex, technical and scientific exercise. It requires special courses in science as well as law before either a lawyer or a scientist can draft a claim. A course on claim drafting is a detailed, selfcontained course. No school in India provides this as such. In the United Stated lawyers are not qualified to draft a claim under THEY ARE EQUIPPED WITH A SCIENCE DEGREE. Claim drafting requires understanding of complex science and the ability to appreciate the complexity and distinguish it from prior art.

10 Claims represent the limitation of a patent. Claims are defined in the Patent Act, 1952 (of the United States) in 112 (2) to (6). Section 112 (2) states that the specification ends with one or more claims. Section 112 (2) to (6) reads as follows: (2) The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. (3) A claim may be written in independent or, if the nature of the case admits, in dependent or multiple dependent form. (4) Subject to the following paragraph, a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. (5) A claim in multiple dependent form shall contain a reference, in the alternative only, to more than one claim previously set forth and then specify a further limitation of the subject matter claimed. A multiple dependent claim shall not serve as a basis for any other multiple dependent claim. A multiple claim shall be construed to incorporate by reference all the limitations of the particular claim in relation to which it is being considered. (6) An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The claims limit the extent of the patent. This means that claims ensure that the inventor does not define his patent in very broad terms. For example, let us assume that the invention is a simple box for storing a few items. If the inventor simply describes his invention as a box, then nobody else will be able to invent another box for storage or even other purposes. This first description will prohibit a second inventor with a box that keeps food items cool inside from patenting because it will also fall into the category of a box. Therefore claims are used to avoid such broad and all encompassing definitions. Thus claims are limitations of the patent. Claims can be expressed in several ways there are functional claims, structural claims, means plus functional claims, product by process claims, dependent claims, Jepson claims and so on. In reality the sophistication of the claim drafting mechanism represents the sophistication of the patent system. Claims from the main pith and substance of patenting. Patent prosecution depends on claims drafting and interpretation.

11 The following attempts to describe in simple terms each of the types of claims and the reason for including such claims. Functional Claims: A functional claim defines the patent by its function. For example, a box would be defined as a mechanism used for the purposes of storage.. and so on. This way, boxes useful for purposes other than for storage will still be eligible for a patent. Structural claims: These claims limit the patent by its structural features. For example, a box is defined as a structure with four corners and flat surface facilitating the closing.. and so on. This way other boxes that are probably not round in shape can still be patented. Means plus function claim: This mechanism describes the means performing a particular function. For example, in the case of the box in question, let us assume that the box has a special lock that makes closing and opening easier. The top flap is the means facilitating the locking of the box. This means performs of the function of locking of the box. Given the above, the means plus function claims are likely to read as a means to facilitate the sealing of the upper body.. Note that in the above case, the inventor can patent the box (by structural or functional language) and the lid with a means plus function language separately. Also, if the box is already protected by a patent by another inventor, the second inventor can merely patent the lock mechanism. This way, different box manufacturers can seek to incorporate the lock and thus the inventor gets his royalty. Again, this ensures that some one else with some o1ther new means (even if it is to facilitate the same function) will still be eligible to patent the new invention embodying a different means to carry on the same function. Product by process claims: This mechanism describes the product by the process of making the product. The patent vests on the product made from that process. This way, the same product made by another process will be eligible for a new patent. For example, in the case of the box, assuming that the box is made from using a process of combining X and Y to derive some kind of plastic material. Another box made for the same purpose, for performing the same function will be eligible for a patent if made by a different

12 process. (earlier the court used to construe that product was patented and therefore even if the process is changed, the same product cannot be patented. That has been overruled in the case of Atlantic Thermoplastics. Although there are several dissents to this case, it has not been overruled. Jepson claims are essentially improvement patents. These claims are used when the invention is an improvement over a previous patent. But these claims are more closely surveyed by the patent office to ensure that they are not merely frivolous claims. Importantly, claims so drafted should adhere to the rule in section 12 (2). Essentially, claims should particularly point out and distinctly claim the subject matter that the applicant regards as his invention. This is to ensure that each inventor who wants to get patent protection has well marked boundaries around the property of the invention. This enables other inventors to know which information is already another inventor s property and which is available for exploitation. This feature is called the claim definiteness.