Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/3/25 has been entered.
Claims 1-10, 15-16, 20, 24-26, 28, 32-33, and 37 are pending. Applicant's election without traverse of Group Ill and the species described below in the reply filed on 12/03/2024 remains in effect.
The elected species are:
polypeptide consisting of amino acids at positions corresponding to positions 1 to 200 according to SEQ ID NO: 1;
CDON polypeptide fragment comprising SEQ ID NO: 2 that binds to an anti-CDON antibody; AND
pancreatic tumor.
Claims 1-10, 15-16, 28, 32-33, and 37 are withdrawn as being drawn to an unelected species/invention. Claims 20 and 24-26 are under examination.
Withdrawn Rejections
The enablement rejection is withdrawn.
Maintained Rejections
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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 or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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.
Claims 20 and 24-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 20 and 24-26 are drawn to a method of forming a complex by contacting a sample with an antibody. The antibody is claimed and described solely by its method of making (“obtained by”) and a function. Further, this “obtained by” language clearly indicates the antibody is being claimed as a product-by-process with no relevant structural limitations. Claims 24-26 depend from claim 20 but do not add any additional limitations to the antibody.
The specification discloses the production of a polyclonal anti-CDON antibody that comprises immunizing two rabbits with a polypeptide comprising an N-terminal CDON sequence SEQ ID NO: 2 and another two rabbits with a polypeptide comprising a C-terminal CDON sequence SEQ ID NO: 3 wherein SEQ ID NO: 2 consists of amino acids 142-159 and SEQ ID NO:3 consists of amino acids 1271-1287. The specification further discloses that the rabbits were further immunized with boosters on days 14, 28, and 42 with serum samples collected from each rabbit after 35, 56, and 58 days post- immunization. Antibodies were then purified from serum and examined via SDS-PAGE and immunohistochemistry for reactivity against xenograft tissue (pages 82-83, all of Example 15). Data is provided in the figures for binding, though it is noted that the black and white images of staining are difficult to interpret.
While the process to obtain these antibodies may be described, a product-by-process composition is determined on the basis of the structure, not the process (MPEP 2113). The past tense “obtained” clearly indicates this is not a method step of the claimed process but rather claiming the product (antibody) by the process it was made. While 2113 is generally concerned with the application of prior art, it is informative because “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself”; considerations under §112 are material to patentability and so the resulting antibody—not only the process—must be considered for description.
There is insufficient written description in the specification as-filed of the genus of anti-CDON antibodies that specifically binds to a CDON polypeptide consisting of SEQ ID NOs: 2 or 3 even if claimed by their preparation method.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. However, a showing of possession alone does not cure the lack of a written description. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). For example, it is now well accepted that a satisfactory description may be found in originally-filed claims or any other portion of the originally-filed specification. See In re Koller, 613 F.2d 819, 204 USPQ 702 (CCPA 1980); In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973); In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). However, that does not mean that all originally-filed claims have adequate written support. The specification must still be examined to assess whether an originally-filed claim has adequate support in the written disclosure and/or the drawings. An applicant shows that the inventor was in possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was “ready for patenting” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the inventor was in possession of the claimed invention. See MPEP 2163. Yet, none of these are adequately shown.
Here, Applicant has claimed any polyclonal anti-CDON antibody population that specifically binds to certain CDON polypeptides that might be generated by the claimed process as well as all those antibodies that bind the same polypeptides generated by any process (product-by-process; MPEP 2113). The specification discloses working examples of undisclosed antibodies purified from mice that were injected with a polypeptide comprising an N-terminal CDON sequence SEQ ID NO: 2 and another comprising a C-terminal CDON sequence SEQ ID NO: 3, wherein SEQ ID NO: 2 consists of amino acids 142-159 and SEQ ID NO: 3 consists of amino acids 1271-1287. This, at best, is a description of that particular population of antibodies though it is noted no structural information, formulas, or distinguishing characteristics other than the hoped-for function are provided. However, as explained previously and discussed below, immunization with an antigen is not expected to generate the same population of polyclonal antibodies yet the claims encompass all antibodies produced by the process as well as those with the same functions produced by other processes.
Artisans are well aware that knowledge of a given antigen (for instance CDON) provides no information concerning the sequence/structure of antibodies that bind the given antigen. For example, Briney et. al. (Nature 2019. 566:393-399; previously cited) teaches that “the diversity of naive antibody repertoire in humans is estimated to be at least 1012 unique antibodies” and that “the circulating B cell population samples only a small fraction of this diversity” (paragraph 1, lines 3-6). In other words, without complete structural information, consisting at least of both heavy and light chain CDRs 1, 2, and 3, an immune response to a single antigen can produce a vast array of unique antibody configurations. As such, there is insufficient support for the entire genus of anti-CDON antibody. Identifying an antibody simply on the basis of it binding to a given antigen rather than the specific sequence of the antibody in question is generally insufficient to prove sufficient written description. Adding the process by which this population of antibodies is to be obtained does not rectify the deficiency as this process would not be expected to produce the same antibodies and thus the antibodies remain undefined by any characteristic other than the desired function.
See MPEP §2163(I)(A) which states:
"The claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art recognized correlation or relationship between the structure of the invention and its function. A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” (emphasis added). Even where this method of obtaining is placed into the claims, the antibodies remain defined solely by their function and the method of obtaining. As discussed, there is no correlation between an antigen and the structure in an antibody that binds that antigen. Additionally, there is no described structure of the exemplified antibodies correlated to the breadth of the claims.
Claiming the research plan by which such antibodies will later be discovered does not satisfy the written description requirement and would provide protection for as-yet undiscovered and undescribed antibodies, rather than providing such protection to parties which actually invent such antibodies. Applicant’s claims exceed what was invented and merely represents a “wish or plan for obtaining the chemical invention claimed” (MPEP §2163(II)(A)(3)(a)). The specification discloses that Applicant produced a polyclonal sera with the claimed attributes (Example 15, p.82); however, the claims are not to a particular polyclonal sera produced by the claimed process, but rather to antibodies with specific functions obtained with an immunization/screening method. Thus, it is not that such antibodies resist definition by any other means but by product-by-process; rather, it is that Applicant was not in possession of a sufficient number of species representing the breadth of the genus now claimed nor does the specification convey to the skilled artisan that Applicant was in possession of the genus by way of identifying structural features responsible for the function. The Examiner reiterates that a function plus means of obtaining that compound is insufficient in the instant claims. The skilled artisan, provided with the process by which Applicant claims to produce the antibodies, cannot envisage the breadth of the claimed antibodies. The “process” in these claims is clearly a research plan to discover other species of the genus being claimed solely by a function, which is contrary to the requirements for written description. Further, the facts in Abbott labs v Sandoz did not use the process alone to define the product and there is a significant difference between claiming an antibody by the antigen it binds versus “Crystalline 7-[2-(2-a minothiazol-4-yl)-2-hydroxyiminoacetamido] -3-vinyl-3-cephem-4-carboxylic acid (syn isomer) which is obtainable by acidifying a solution containing 7-[2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-3-vinyl -3-cephem-4-carboxylic acid (syn isomer) at room temperature or under warming”. One of skill in the relevant art could immediately envisage one being in possession of a chemical described by a precise chemical name that describes every atom in the chemical while the “obtainable by” process steps further distinguished structural features in the form of crystal A vs crystal B for consideration of infringement/prior art. For reasons discussed above and previously, providing the artisan with the identity of an antigen, even when coupled with a method of making (process steps) does not allow the artisan to envisage the members of that genus and does not convey possession of that genus.
Further note the decision in Amgen v. Sanofi 2017, where the Court supported previous decisions (Centocor 2011; Abbvie 2014) that defining an antibody solely by what it binds does not satisfy the written description requirement, stating that this would allow patentees to “claim antibodies by describing something that is not the invention, i.e., the antigen”. This is reflected in MPEP §2163, which states:
[D]isclosure of an antigen fully characterized by its structure, formula, chemical name, physical properties, or deposit in a public depository does not, without more, provide an adequate written description of an antibody claimed by its binding affinity to that antigen, even when preparation of such an antibody is routine and conventional. See Amgen Inc. v. Sanofi, 872 F.3d 1367, 1378, 124 USPQ2d 1354, 1361 (Fed. Cir. 2017)(“knowledge of the chemical structure of an antigen [does not give] the required kind of structure-identifying information about the corresponding antibodies”); see also Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1351-52, 97 USPQ2d 1870, 1877 (Fed. Cir. 2011)(patent disclosed the antigen the claimed antibody was supposed to bind, but did not disclose any antibodies with the specific claimed properties)…
…See Eli Lilly, 119 F.3 at 1568, 43 USPQ2d at 1406 (Holding that description of a gene’s function will not enable claims to the gene “because it is only an indication of what the gene does, rather than what it is.”); see also Fiers, 984 F.2d at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991)). An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. See, e.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004).
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF' s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence.
Such is the case here. The newly characterized antigen has been disclosed and Applicant now lays claim to inventing the genus of all antibodies that bind that antigen and that might be generated by this claimed method, where the claimed immunization steps beyond the antigen itself are no more than routine, conventional means by which antibodies are generated and screened. This essentially claims an unknowable number of antibodies that currently do not exist but which might be generated in the future by others, yet claims those antibodies as the Applicant’s own invention. Adding the method of making to the claim itself does not avoid the deficiency of claiming antibodies solely by what they bind, i.e., by what they do rather than what they are. Importantly, this is not a previously well-known antigen nor are there any known antibodies with the claimed binding properties. Description of a known class defined by the function can, in some cases, be sufficient; however, where the antibodies and antigen were not described by the prior art, the description must be provided by the specification.
The claim is a process that uses a product (the antibody) where the product is claimed as a product-by-process, defining the antibody by a function and the process of making it. The MPEP normally disallows claiming a product by no more than a function and method of making, though it makes an exception to the written description requirement for product-by-process claims. Still, while free to use product-by-process claim construction and noting that disclosure of a method of making and the function may not be sufficient to support a product claim other than a product-by-process claim (MPEP §2163(II)(A)(3)(a)(i)), this does not mean a product-by-process claim automatically meets the written description requirement.
The claims are directed to a genus: all antibodies with the claimed functions produced by the claimed methods. As per MPEP §2163(II)(A)(3)(a)(ii), the written description requirement for a claimed genus may be satisfied through “sufficient description of a representative number of species” by meeting one of a-c in MPEP §2163(II)(A)(3)(a)(i). A “representative number of species means that the species which are adequately described are representative of the entire genus” (MPEP §2163(II)(A)(3)(a)(ii)). This same section also states “[f]or inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are ‘representative of the full variety or scope of the genus,’ or by the establishment of ‘a reasonable structure-function correlation’.”
For a product-by-process claim, the written description requirement may not be satisfied where it is not clear that the product is produced by that process (MPEP §2163(II)(A)(3)(a)(i)). “The product” in this case is the genus of all antibodies with the required properties.
For a species, MPEP §2163(II)(A)(3)(a)(i) sets forth three means for determining if that species meets the written description requirement (herein referred to as “criteria A”, “criteria B”, or “criteria C”). These criteria are reproduced below:
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It is appreciated that there are no claims currently directed to a single embodiment or species but rather all pending claims are directed to a genus of antibodies: all those produced by the claimed process. However, as claims drawn to a genus may be satisfied through sufficient description of a representative number of species (see above), the analysis is relevant.
Criteria A: the antibodies described by actual reduction to practice are those generated by the method described in the specification; see pages 82-83, all of Example 15. These antibodies are not described by sufficient structural characteristics. At most, this example provides reduction to practice of these specific populations of antibodies; however, without additional details, there is no way to determine if these antibodies represent the “structural diversity” of the genus required for these populations to “represent” the entire genus being claimed. Even though reduced to practice, the skilled artisan cannot envisage any salient structural features of these antibodies, e.g., the structures responsible for binding.
Criteria B: As discussed previously and above, there are no structural chemical formulas/structural information present in the specification as filed which would meet the criteria of “sufficiently detailed to show that applicant was in possession of the claimed invention as a whole”. The specification discloses certain antibodies were produced, though does not provide any relevant data regarding the structure of the binding regions (CDRs) of these antibodies.
Criteria C1: a complete description of the structure is not present as discussed above and previously.
Criteria C2: There is insufficient correlation between structure and function. The structures of CDRs and binding target have already been discussed previously. Briefly, identification of an antigen provides no information regarding the antibodies which bind that antigen and identification of CDRs for one or even hundreds of antibodies does not inform the artisan as to the breadth of the genus given that disparate sequences may still share a binding target; see also Abbvie V Janssen 759 F.3d where a structural disclosure of over 200 antibodies was not sufficient to envisage possession of the genus of antibodies defined by their binding properties and Amgen v. Sanofi 2017 concluded that defining an antibody solely by what it binds does not satisfy the written description requirement, stating that this would allow patentees to “claim antibodies by describing something that is not the invention, i.e., the antigen”. Further, as discussed previously, simply immunizing an animal with an antigen will not necessarily produce antibodies with the claimed function nor produce the same antibodies obtained by Applicant. Clearly, one of ordinary skill would not understand the inventor to be in possession of the invention as broadly as claimed at the time of filing.
Thus, a written description analysis in keeping with MPEP §2163 would indicate that the individual species do not meet the written description requirement. However, even arguendo if the specific populations of antibodies produced in the disclosure met these criteria (such as by a potential biological deposit or simply by virtue of having been produced by Applicant), this is not “a representative number of species” to warrant a claim to the entire genus. To support written description for the breadth of the genus of all antibodies with the claimed properties, these species must be representative of the genus (MPEP §2163(II)(A)(3)(a)(ii)). As above, no structure of the antibodies is provided and so it cannot be determined if these antibodies represent the structural diversity within the genus. Further, a structural description of one antibody does not describe other antibodies with the same properties (Abbvie) The disclosure provides a function and an antigen (process of obtaining), which is not a description of any identifying structural feature of the antibody itself. Applicant adds immunization methods to create a product-by-process claim, yet these still amount to no more than “a wish or plan for obtaining the chemical invention claimed” (MPEP §2163(II)(A)(3)(a)). While product-by-process claims may allow for a narrow exception to this general rule it does not circumvent the written description entirely. The instant facts do not support the conclusion that the claims meet the criteria set forth in a written description analysis as it applies to product-by-process claims. Further, such product-by-process “exceptions” were settled when the “newly characterized antigen” exception was still part of the legal framework for determining compliance with the written description requirement. If an antigen and method of producing antibodies which bind that antigen do not meet the written description requirement (Amgen 2017), there is no basis for concluding that simply placing these limitations in the claim itself should meet the written description requirement when the same deficiencies exist in both scenarios.
Fiers (984 F.2d 1169), cited by the MPEP, expounds on this, noting that the statute is “to promote disclosure of inventions, not of research plans”. In this case, the specification discloses the method was practiced with a particular set of animals, immunized according to a specific schedule, harvesting the serum at specific times, and then screening those populations for the desired function. The analysis then must turn to whether or not the method as broadly as claimed—immunizing a rabbit according to any schedule—would produce the same products. This is clearly not the case. A polyclonal population by definition includes an array of antibodies with different structures and binding properties and the instant example is not characterized in any way which would represent the diversity of antibodies that might be produced. Even in rabbits and even using the same schedule as disclosed (but not claimed), rabbits other than the specific rabbits Applicant used will produce their own, distinct populations of antibodies rather than the ones obtained by Applicant. Thermo (form 892) states: “Antibody production is conceptually simple. However, because it depends upon such a complex biological system (immunity of a living organism), results are not entirely predictable. Individual animals—even those that are genetically identical—will respond uniquely to the same immunization scheme generating different suites of specific antibodies against an injected antigen.” While Thermo describes ways to increase the probability of obtaining useful antibodies, it is clear that these will not be the same antibodies produced from a different animal, even of the same species; the actual antibodies must be described, not a description of how the antibodies are made.
As such, the instant claims are far more like the “research plan” criticized in Fiers. The claim is directed to using any rabbit and any immunization method (limited only by the peptide used) to “hunt” for other antibodies with the required properties. Those antibodies were clearly not invented by Applicant nor would Applicant have possession of such antibodies. A claim to these yet-to-be discovered antibodies is contrary to the written description requirement.
An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. See, e.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004) (The patent at issue claimed a method of selectively inhibiting PGHS-2 activity by administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product; however, the patent did not disclose any compounds that can be used in the claimed methods. While there was a description of assays for screening compounds to identify those that inhibit the expression or activity of the PGHS-2 gene product, there was no disclosure of which peptides, polynucleotides, and small organic molecules selectively inhibit PGHS-2. Replacing “inhibits PGHS-2 activity” with the instantly claimed antibody function leads to the conclusion that—as per the Courts—the compounds are required to practice the method and so the specification must meet the written description requirement of such compounds. The court held that “[w]ithout such disclosure, the claimed methods cannot be said to have been described.” The decision in Rochester is on point to the instant analysis. In that same case, the Court stated “Pfizer points out that the district court found that the '850 patent does not disclose the structure or physical properties of any of the compounds required to practice the claimed methods, and that the structure of such compounds cannot be deduced from any known structure-function correlation. Pfizer agrees with the district court that the '850 patent discloses nothing more than a hoped-for function for an as-yet-to-be-discovered compound, and a research plan for trying to find it.” While it is appreciated that Applicant has produced some polyclonal antibodies with the desired function, these antibodies are not described in a way which would meet the written description requirement as there is no identifying structural features and no biological deposit of those antibodies, while the specification is generally directed to methods of obtaining the antibodies, not use of existing ones. In other words, a new method of using old antibodies need not necessarily describe those antibodies as they were already well known (MPEP §2163(II)(A)(2)). In contrast, the instant claims include novel, undiscovered antibodies and so the antibodies must be sufficiently described in order to meet the requirements of §112, first paragraph, even for a method of use.
Further, even arguendo if the specific antibodies of the specification meet the written description requirement, these antibodies do not describe other polyclonal antibodies from other rabbits, or produced by the myriad ways one might generate antibodies with these functions where the only limitation is the peptide is used to “immunize” a rabbit in some way. The antibodies are claimed by a method that may or may not generate the desired antibodies and, in either case, is not a description of the compounds themselves representative of the breadth that is now claimed.
Dependent claims do not offer any additional structure to define the claimed antibodies and are deficient for the same reasons.
In summary, MPEP §2163(I)(A) states “A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence”, which, as a product-by-process claim, is exactly what is being claimed: a biomolecule sequence (genus of antibodies) described only by a functional characteristic (binding) accompanied by a method of obtaining the claimed sequence (process). The antibodies are not described by relevant structural features and use the process steps to further distinguish that structure but rather the antibodies are claimed by a function and method for finding more.
The claims encompass all possible antibodies with the required function, additionally defined by their method of making. However, the specification does not describe any structural feature of such antibodies responsible for that function and a description of the antigen is not a description of the antibodies which bind that antigen. Further, while Applicant is free to construct a claim as a product-by-process, the claim must nevertheless meet the written description requirement and the instantly claimed process does not meet that burden for the reasons articulated above. While the instant claims are method claims, Amgen makes clear that there is no special written description requirement for a particular class of compounds and the same written description requirement applies, while the Court in Rochester (358 F.3d 916) clearly noted that decisions in composition of matter cases apply to methods.
Therefore, claims 20 and 24-26 do not meet the written description requirement.
Claims 20 and 24-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
There are many factors considered when determining if the disclosure satisfies the enablement requirement and whether any necessary experimentation is undue. These factors include, but are not limited to: 1) nature of the invention, 2) breadth of claims, 3) amount of direction or guidance by the inventor, 4) relative skill of those in the art, 5) level of predictability in the art, 6) state of the prior art, 7) existence of working examples, and 8) quantity of the experimentation needed to make or use the invention. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The nature of the invention is one of preparing a complex between an antibody and material found in a tissue or cell sample from a mammal suspected of having pancreatic or ovarian cancer.
The breadth of the claims encompasses use of an antibody claimed solely by the method of its making and a desired function. This immunization method encompasses any animal according to any inoculation schedule. No information regarding the structure required for this binding, e.g., the CDRs, is provided.
The amount of direction or guidance by Applicant is a description of one particular immunization method performed in rabbits. These antibodies are not described via structural information so no guidance regarding any potential structure/function correlation is provided.
While the relative skill in the art is high, predictability is low. Immunization of animals from the same species—rabbits in this case—would not be expected to produce the same polyclonal antibodies that Applicant produced. Thermo states: “Antibody production is conceptually simple. However, because it depends upon such a complex biological system (immunity of a living organism), results are not entirely predictable. Individual animals—even those that are genetically identical—will respond uniquely to the same immunization scheme generating different suites of specific antibodies against an injected antigen.” While Thermo describes ways to increase the probability of obtaining useful antibodies, it is clear that these will not be the same antibodies produced from a different animal, even of the same species. While absolute predictability is not a requirement under §112(a), this rationale highlights the fact that the claimed method requires others to invent the antibody, where Applicant lays claim to the use of that newly invented antibody before the antibody even exists. Moreover, this is not a well-known class of antibodies; there are no prior art antibodies with the same function and so even if Applicant created a polyclonal serum that contained the required antibodies, the claim covers all antibodies produced by all immunization schemes in rabbits using the antigen, which is significantly broader and would require extensive trial-and-error to create new antibodies which are structurally distinct from Applicant’s.
The state of the prior art/quantity of experimentation is such that description of an antigen is in no way sufficient to describe the antibody binding that antigen. For enablement, the state of the art is such that different animals—even those of the same species—will produce different populations of antibodies. Further, immunization with the claimed peptide will not necessarily produce the required antibodies in every animal. The amount of work required is extensive, involving multiple animals, multiple species, and testing multiple different immunization schedules, harvesting at various time points, and repeated testing of the collected samples for other to determine if the correct antibodies were produced. Essentially, Applicant has set forth a research plan for others to follow to create these antibodies while simultaneously laying claim to those antibodies invented by others. As noted in the allowable subject matter section, these antibodies are wholly unknown to the art and so this is not considered “auxiliary” or a well-known class of antibodies.
See the decision in Rasmusson v. SmithKline 413 F.3d 1318, 1325 (Fed. Cir. 2005) which stated:
“Thus, at the end of the day, the specification, even read in the light of the knowledge of those skilled in the art, does no more than state a hypothesis and propose testing to determine the accuracy of that hypothesis. That is not sufficient. [Citation omitted.] ‘If mere plausibility were the test for enablement under §112, applicants could obtain patent rights to “inventions” consisting of little more than respectable guesses as to the likelihood of their success. When one of the guesses later proved true, the “inventor” would be rewarded the spoils instead of the party who demonstrated that the method actually worked.’”
The standard of an enabling disclosure is not the ability to make and test if the invention worked but one of the ability to make and use with a reasonable expectation of success.
"[T]o be enabling, the specification.., must teach those skilled in the art how to make and use the full scope of the claimed invention without 'undue experimentation.'" Wright, 999 F.2d at 1561, 27 USPQ2d at 1513 (emphasis added), quoted in Genentech, Inc. v. Novo Nordisk, A/S, 108 F.3d 1361, 1365, 42 USPQ2d 1001, 1004 (Fed. Cir. 1997). Thus, "there must be sufficient disclosure, either through illustrative examples or terminology, to teach those of ordinary skill how to make and how to use the invention as broadly as it is claimed." In re Vaeck, 947 F.2d 488, 496 & n. 23, 20 USPQ2d 1438, 1445 & n. 23 (Fed. Cir. 1991), quoted in Enzo Biochem, Inc. v. Calgene, lnc., 188 F.3d 1362, 1372, 52 USPQ2d 1129, 1138 (Fed. Cir. 1999).
Here, while the specification and claims generally disclose a method of making the antibodies, the instant claim is not a method of making. Rather, it is a method of preparing a complex using a polyclonal antibody population where the antibodies themselves must already exist (“obtained”). If the genus of such antibodies does not exist—and as discussed it appears Applicant’s disclosure of a population is the only known population existing at the time of filing—then it falls to others to make and test such antibodies, effectively claiming antibodies that must first be invented by others. This is not consonant with the enablement requirement.
"Patent protection is granted in return for an enabling disclosure..., not for vague intimations of general ideas that may or may not be workable." Genentech, 108 F.3d at 1365, 42 USPQ2d at 1005. "Tossing out the mere germ of an idea does not constitute enabling disclosure. 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 [skilled in the art] to understand and carry out the invention." Id. at 1366, 42 USPQ2d at 1005 (emphasis added). While the claimed method using antibodies with the claimed functions is expected to work, creating those antibodies amounts to a significant inventive effort on its own that requires undue experimentation to produce.
Finally, it must be emphasized that even the antibody population generated by Applicant is not in the public possession. Even following the claimed method, even down to the particulars in the specification, would not be reasonably expected to produce the same antibody population. Applicant has not described the structure of those antibodies in the disclosure nor has Applicant provided an enabling biological deposit. Based on the disclosure, no such antibodies are available to others for practicing the method. As the antibodies are required to practice the claimed method, the method as a whole is not enabled.
Therefore, claims 20 and 24-26 are not enabled.
Allowable Subject Matter
Claims 20 and 24-26 are allowable over the prior art. The examiner did not discover any art that would fairly suggest the existence of antibodies that specifically bind either SEQ ID NO:2 or SEQ ID NO: 3 as claimed. While a product-by-process claim allows for art teaching a substantially identical product, and while there is art regarding antibodies binding CDON as previously set forth, there is no evidence to suggest these antibodies bind these specific peptides. As there are other residues in CDON to bind, neither could it be concluded that the antibodies possess this property inherently.
Response to Arguments
Applicant's arguments filed 10/3/25 have been fully considered but they are not persuasive.
Applicant argues the instant specification “provides a step-by-step protocol for generating these polyclonal antibodies in rabbits” (remarks 10/3/25 p.9). This is not persuasive because an argument that the specification discloses one potential method of making within the breadth of the claimed “immunizing a rabbit” is precisely the point criticized by MPEP §2163(I)(A) and the associated case law when stating “a biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence” (emphasis added).
Applicant argues that this “detailed” production protocol provides the necessary “distinguishing identifying characteristics” to demonstrate possession of the antibodies. This is not persuasive because the MPEP makes clear that a description of how something is made and the desired function is not a description of the thing itself. The production protocol describes what the antibody will bind, but provides no distinguishing characteristics of the antibody itself other than this desired function.
Applicant argues that a polyclonal antibody preparation is “an inherently complex mixture of antibody species”, which the Examiner agrees with. This inherent complexity forms part of the basis of the rejection as even following the same protocol disclosed but not claimed, there is virtually no chance that the skilled artisan would generate the same antibodies as Applicant. While Applicant argues the claims are enabled (addressed below), this does not cure the written description deficiency as “one cannot describe what one has not conceived” (Fiddes). While Applicant may have discovered the value of antibodies targeting the claimed antigens, those antibodies cannot be claimed by the antigen alone as this is not a description of the invention (the antibodies).
Applicant argues that the concern regarding the claims being no more than a research plan to hunt for other antibodies is overcome because the amended claim is “directed to a method that uses a specific, well-defined reagent: a polyclonal antibody preparation obtained from a rabbit immunized with the claimed peptides. This reagent is fully described and enabled by the specification”.
This is not persuasive. Whether the claim is enabled is not an argument that the claims meet the written description requirement. While Applicant argues the reagent is “fully described”, Applicant does not point to a single structural description nor any other distinguishing characteristic other than “a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence” and “a method of obtaining the claimed sequence”. The antibodies (polyclonal serum) are claimed by their function and, as set forth above, that function does not correlate to any specific structure, e.g., highly structurally diverse antibodies may share the same binding function. Thus, the reagent is not “fully described” as argued as the description is by function alone; the method of making is not a description of the antibody itself. The argument that a description of the method of making rises to the level of a “well-defined reagent” is not persuasive because the MPEP and cited case law above directly address this situation: a method of making plus a hoped-for function is not a sufficient description of the reagent. As Rochester makes clear the reagent used in the method must be sufficiently described, the facts support the conclusion that the instant claims fail to meet the written description requirement. The reagent is not described in any way other than by function and the method of making, which is not sufficient as detailed above.
Finally, Applicant is reminded that Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, makes clear that the written description provision of 35 U.S.C. § 112 is severable from its enablement provision (see page 1115). An argument that the claimed method of making is enabled, or even that the claim as a whole is enabled, does not address a written description rejection. The skilled artisan cannot envision the detailed chemical structure of the encompassed genus of polypeptides, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. While Applicant may have generated a polyclonal serum and while others may be able to make their own polyclonal serum, this is not a description of the unknowable variation within the genus of the “inherently complex” polyclonal sera which may be produced nor of the antibodies contained within that serum.
The Examiner notes Applicant’s request for an interview filed 10/3/25. However, no specific issue to be discussed is provided but rather urges discussion of any outstanding issues. For the written description rejection, the issues and arguments advanced by the Examiner are substantively the same and so Applicant has generally already responded to the rejection of record. An interview to restate the position of the Examiner is not deemed likely to further advance prosecution and therefore the interview request is denied. Upon reviewing the Office Action, Applicant is welcome to contact the Examiner for an interview.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM M WEIDNER whose telephone number is (571)272-3045. The examiner can normally be reached M-T 9-18; W-R 9-15.
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/Adam Weidner/ Primary Examiner, Art Unit 1675