DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/20/2025 has been entered.
Priority
This application is a continuation of U.S. Application 15/601,297 filed on 05/22/2017 which is a divisional of U.S. Application 14/146,066 filed on 01/02/2014 which claims priority to U.S. Provisional Application filed on 01/03/2013.
Claim Status
Claims 1-29, 31-32 and 47-55 are cancelled at the Applicant’s request. Claims 30 and 46 are currently amended, and the Applicant notes that no new matter is added. Claim 33 is previously presented. Claims 34-39 are original. Claims 40-45 are withdrawn for being directed to a nonelected invention as noted in the Office action of 05/28/2024.
Thus, claims 30, 33-39 and 46 are pending and are under examination.
Withdrawn Objections and Rejections
The previous objection to claims 30 and 46, regarding informalities, is withdrawn in light of Applicant’s amendments of claims.
The previous rejection of claim 31 under 35 U.S.C. 112 (pre-AIA ), second paragraph, regarding improper Markush grouping of alternatives, is withdrawn in light of Applicant’s cancellation of the claim.
The previous rejection of claim 46 under 35 U.S.C. 112 (pre-AIA ), second paragraph, regarding improper Markush grouping of alternatives, is withdrawn in light of Applicant’s amendments of the claim.
The previous rejection of claims 30, 33-39 and 46 under pre-AIA 35 U.S.C. 103(a), regarding obviousness, is withdrawn in light of Applicant’s amendments of claims.
The previous rejection of claim 31 under pre-AIA 35 U.S.C. 103(a), regarding obviousness, is withdrawn in light of Applicant’s cancellation of the claim.
New Objections and Rejections
Claim Objections
Applicant is advised that should claim 34 be found allowable, claim 36 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112(pre-AIA ), First Paragraph
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 30, 33-39 and 46 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 claims contain 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.
The claims are drawn to the use of antibodies. The analyte to which the antibodies bind to are already drawn to vastly diverse and unrelated protein species, e.g., cytokines, factors, chemokines or immunological proteins. And the proteins are also drawn to different animal species. Therefore, the claims encompass the use of antibodies to widely varying and unrelated antibody species. The antibodies are also drawn to a wide range of different animal species. Consequently, the claims are drawn to a widely diverse scope of antibodies.
Claims 30, 33-39 and 46 are genus claims in that they use the transitional phrase “comprising” and, therefore, allow for the presence of further species in addition to those specified in the claims. Claims 33-39 and 46 are each directed to a subgenus of claim 30.
Claim 30 comprises qualified detection and capture antibodies specific for widely varying analytes of different origin (i.e., animal species). The specification does not describe a common structure or function among the widely varying species such that its function could be correlated to specific structure by the binding of the detection and capture antibodies. And the specification only recites spotting the antibodies on different wells (Page 6, Table 2, “Spot Pattern Configuration Per Panel”). The specification further teaches how to prepare the antibody solutions without any description of the structure of such antibodies (Pages 17-18, Panels 1-5).
Claim 33 comprises qualified detection and capture antibodies specific for one of three groups of human analytes with widely varying species of (i) IFN-gamma, IL-1beta, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, and TNF alpha; (ii) GM-CSF, IL-1 alpha, IL-5, IL-7, IL-12/IL-23 p40, IL-15, IL-16, IL-17A, TNF-beta, and VEGF-A or (iii) Eotaxin, MIP-1 alpha, Eotaxin-3, TARC, IP-10, MIP-1 beta, IL-8, MCP-1, MDC, and MCP-4. The specification does not describe a common structure or function among the widely varying species such that its function could be correlated to specific structure by the binding of the detection and capture antibodies. And the specification only recites spotting the antibodies on different wells (Page 6, Table 2, “Spot Pattern Configuration Per Panel”). The specification further teaches how to prepare the antibody solutions without any description of the structure of such antibodies (Pages 17-18, “Panels 1-3”). Thus, the specification is just reciting spotting antibodies to widely diverse and unrelated species without any description about the structure of the spotted antibodies or the species to which the antibodies are directed to.
Similarly, claim 34 and 36 comprise qualified detection and capture antibodies specific for human analytes with widely varying species of IFN-gamma, IL-1 beta, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, and TNF alpha. The specification does not describe a common structure or function among the widely varying such that its function could be correlated to specific structure by the binding of the detection and capture antibodies. And the specification only recites spotting the antibodies on different wells (Page 6, Table 2, “Spot Pattern Configuration Per Panel”). The specification further teaches how to prepare the antibody solutions without any description of the structure of such antibodies (Pages 17, Panel 1).
Claim 35 is even broader because it comprises qualified detection and capture antibodies specific for mouse analytes without any count of the analytes. The specification does not describe a common structure or function among the widely varying species such that its function could be correlated to specific structure by the binding of the detection and capture antibodies. And the specification only recites spotting the antibodies on different wells (Page 6, Table 2, “Spot Pattern Configuration Per Panel”).
Claim 37 comprises qualified detection and capture antibodies specific for human analytes with widely varying species of GM-CSF, IL-1 alpha, IL-5, IL-7, IL-12/IL-23 p40, IL-15, IL-16, IL-17A, TNF-beta, and VEGF-A. The specification does not describe a common structure or function among the widely varying species such that its function could be correlated to specific structure by the binding of the detection and capture antibodies. And the specification only recites spotting the antibodies on different wells (Page 6, Table 2, “Spot Pattern Configuration Per Panel”). The specification further teaches how to prepare the antibody solutions without any description of the structure of such antibodies (Pages 17, Panel 2).
Claim 38 comprises qualified detection and capture antibodies specific for human analytes with widely varying species of Eotaxin, MIP-1 alpha, Eotaxin-3, TARC, IP-10, MIP-1 beta, IL-8, MCP-1, MDC, and MCP-4. The specification does not describe a common structure or function among the widely varying species such that its function could be correlated to specific structure by the binding of the detection and capture antibodies. And the specification only recites spotting the antibodies on different wells (Page 6, Table 2, “Spot Pattern Configuration Per Panel”). The specification further teaches how to prepare the antibody solutions without any description of the structure of such antibodies (Pages 17-18, Panel 3).
Claim 39 is even broader because it comprises qualified detection and capture antibodies specific for mouse analytes without any count of the analytes. The specification does not describe a common structure or function among the widely varying species such that its function could be correlated to specific structure by the binding of the detection and capture antibodies. And the specification only recites spotting the antibodies on different wells (Page 6, Table 2, “Spot Pattern Configuration Per Panel”)
Claim 46 comprises qualified detection and capture antibodies specific for human analytes with widely varying species of interferon (IFN)-gamma, interleukin (IL)-1 beta, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, and tumor necrosis factor (TNF-alpha). The specification does not describe a common structure or function among the widely varying species such that its function could be correlated to specific structure by the binding of the detection and capture antibodies. And the specification only recites spotting the antibodies on different wells (Page 6, Table 2, “Spot Pattern Configuration Per Panel”). The specification further teaches how to prepare the antibody solutions without any description of the structure of such antibodies (Pages 17, Panel 1).
The level of knowledge and skill in the art does not allow those skilled in the art to
structurally envisage or recognize a common structure or function among the widely varying species. Therefore, those skilled in the art would have recognized that the specification’s description of the human analytes would not have put the applicant in possession of the antibodies that are directed to the widely varying species at the time of filing. Thus, the specification does not describe sufficiently detailed, relevant characteristics to show that the applicant was in possession of the claimed antibodies that are directed to the widely varying species.
In addition, there is functional language to these antibodies( i.e., (a) average intraplate coefficient of variability (CV) of < 10%; (b) maximum intraplate CV of < 13%; (c) average uniformity metric of < 25%; (d) maximum uniformity metric of < 37%; (e) CV of intraplate averages of < 18%; (f) lower signal boundary of > 1500; and (g) upper signal boundary of < 106 ). The specification does not describe any physical or chemical properties of the antibodies that would possess such functional limitation. The specification only recites the functional language without any description of the physical or chemical properties of antibodies with such properties (Page 3, first paragraph; page 14, Table 3(a), “Plate Metrics”).
The level of knowledge and skill in the art does not allow those skilled in the art to
structurally envisage or recognize those antibodies that would meet the claim limitations.
The specification does not describe any physical or chemical properties of the antibodies that
would be expected to be shared by members of the claimed genus. The level of knowledge and skill in the art does not allow those skilled in the art to structurally envisage or recognize which antibody would meet both the structural and functional limitations of the broad claims.
It is known that these proteins themselves are widely varying in function and structure and
tend to have different protein sequences and binding affinities to antibodies with unpredictable functions. Because the structure of the species within the claimed genus would be expected to vary unpredictably from the structure of the single, described subgenus, the specification has not shown a “representative number” of species within the claimed genus.
To provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. Applicant is directed to MPEP § 2163 for guidelines on compliance with the written description requirement.
Here, the specification has not described a reasonable number of widely varying species that have the function of being capable of binding to generic detection and capture antibodies, i.e., the required starting materials for the claim, but rather has presented the public with an idea of how to perform an assay that might identify some of the widely varying species that fall within the scope of the claim. Of course, depending on what antibodies are used in the screening assay, it may well identify none. The Court of Appeals for the Federal Circuit addressed claims of this sort in great detail in University of Rochester v. G.D. Searle and Co. (69 USPQ 2nd 1886, CAFC 2004). In Rochester, the Federal Circuit upheld the district court's ruling that patent claims which recited administration of compounds not disclosed, but rather to be identified in a screening assay, were invalid on their face. Because claim 30 (the broadest claim) recites kits that comprise widely varying species that are capable of binding to any generic antibody that is qualified by the claim, and the specification only provides evidence that these widely varying species can perhaps bind detection and capture antibodies, the specification does not disclose a structure/function correlation.
Functionally defined genus claims can be inherently vulnerable to invalidity challenge for
lack of written description support, especially in technology fields that are highly unpredictable,
where it is difficult to establish a correlation between structure and function for the whole genus or
to predict what would be covered by the functionally claimed genus. Abbvie Deutschland GMBH & Co. v. Janssen Biotech, Inc. (759 F.3d 1285 (Fed. Cir. 2014). “When a patent claims a genus using functional language to define a desired result, the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus." Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005).
Consequently, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus of widely varying species that would meet the limitations of the claims of the instant application.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111 (Fed. Cir. 1991), clearly states that “applicant must 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.” (See page 1117). The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116).
In the instant case, the skilled artisan cannot envision any structure function correlation for the widely varying species having the function required by the claim, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of identification. 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 antibody 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 (Fed. Cir. 1991). Therefore, claims 30, 33-39 and 46 of the instant application does not meet the written description requirement.
Moreover, the specification does not disclose the structure of the claimed antibodies and fails to disclose which region of the antibodies is responsible for the functions claimed. In the absence of a known or disclosed correlation between structure and function, claims which encompass variants defined by their function are generally not considered described.
Applicant is directed to MPEP § 2163 for guidelines on compliance with the written description requirement. Here, the Applicant has not described a reasonable number of members of the genus of antibodies that can bind to widely varying species, i.e., the required starting materials for the claims, but rather has presented the public with an idea of how to perform an assay that might identify some species that fall within the scope of the claim. Of course, depending on what antibodies are used in the screening assay, it may well identify none. The Court of Appeals for the Federal Circuit addressed claims of this sort in great detail in University of Rochester v. G.D. Searle and Co. (69 USPQ 2nd 1886, CAFC 2004) as recited above.
The specification provides three examples on reagent preparation, assay protocol and panel verification (see Examples 1-3 in the specification on pages 16-69 respectively). The specification does not describe the structure of the full genus of antibodies responsible for each of the functions claimed. The Federal Circuit has clarified Written Description as it applies to antibodies in the recent decision Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017). The Federal Circuit explained in Amgen that when an antibody is claimed, 35 U.S.C. 112(a) (or pre-AIA first paragraph) requires adequate written description of the antibody itself. Amgen, 872 F.3d at 1378-79. The Amgen court expressly stated that the so-called “newly characterized antigen” test, which had been based on an example in USPTO-issued training materials and was noted in dicta in several earlier Federal Circuit decisions, should not be used in determining whether there is adequate written description under 35 U.S.C. 112(a) for a claim drawn to an antibody. Citing its decision in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., the court also stressed that the “newly characterized antigen” test could not stand because it contradicted the quid pro quo of the patent system whereby one must describe an invention in order to obtain a patent. Amgen, 872 F.3d at 1378-79, quoting Ariad, 598 F.3d 1336, 1345 (Fed. Cir. 2010). In view of the Amgen decision, adequate written description of an antigen alone is not considered adequate written description of a claimed antibody to that antigen, even when preparation of such an antibody is routine and conventional.
While generically the structure of antibodies is known, the structure of the presently recited antibodies can vary substantially within the above given claimed recitations. As noted in Amgen, knowledge that an antibody binds to a particular epitope on an antigen tells one nothing at all about
the structure of the antibody, wherein “instead of analogizing the antibody-antigen relationship to a
‘key in a lock,’ it [is] more apt to analogize it to a lock and ‘a ring with a million keys on it.” (Internal
citations omitted). The relevant antibody art confirms this quandary, indicating that “knowledge of
an epitope or antigen used to generate a monoclonal antibody is insufficient for making the original
antibody available, even if suitable in vitro test systems for screening are used.” See p. 8, lines 3-5 of
WO 2009/033743 A1. Therefore, those of skill in the art would not accept that the inventor had
been in possession of the full genus of antibodies in the present claims. Functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description support, especially in technology fields that are highly unpredictable, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus. Abbvie Deutschland GMBH & Co. v. Janssen Biotech, Inc. (759 F.3d 1285 (Fed. Cir. 2014). “When a patent claims a genus using functional language to define a desired result, the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus." Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005). Here, the administered antibody is claimed only by function, i.e., the antibody binds to widely varying species.
Consequently, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus of antibodies nor guidance as to which of the myriad of molecules encompassed by the claimed antibodies would meet the limitations of the claims. Further, given the well-known high level of polymorphism of immunoglobulins and antibodies, the skilled artisan would not have recognized that the Applicant was in possession of the vast repertoire of antibodies encompassed by the claimed invention.
As stated above, Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111 (Fed. Cir. 1991), clearly states that “applicant must 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.” (See page 1117). The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116).
The skilled artisan cannot envision the detailed chemical structure of the genus of claimed antibodies to be used in the instant method, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of identification. 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 antibody 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 (Fed. Cir. 1991). Therefore, the instant claims do not meet the written description provision of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph.
Claim Rejections - 35 USC § 112(pre-AIA ), Second Paragraph
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
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.
Claims 30, 33-39 and 46 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “bacterial” in claims 30 and 46 is a term which renders the claim indefinite because it is not clear if “bacterial” is for the origin of the recombinant protein A and protein G or for the production method (i.e., bacterial expression system). The term “bacterial” is not defined by the claim, the specification does not provide a definition for the term “bacterial”, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The term “qualified” in the phrase “qualified detection and capture antibodies” in claims 30, 33-39 and 46 is a term which renders the claims indefinite because it is not clear if “qualified” is for the binding, the origin of the antibodies or something else. The term “qualified” is not defined by the claim, the specification does not provide a definition for the term “qualified”, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Response to Arguments
Applicant’s arguments, see Remarks of Applicant’s Reply to Office action of 05/21/2025, filed 11/20/2025, with respect to the rejection of claims 30, 33-39 and 46 under pre-AIA 35 U.S.C. 103(a), regarding obviousness, have been fully considered and are persuasive in light of Applicant’s amendments of claims. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection of claims 30, 33-39 and 46 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, is made in view of Applicant’s amendments.
The Examiner objected to the abbreviation of “protein A/G” in claims 30 and 46 in the Office action of 05/21/2025. The Examiner further suggested to the Applicant to replace “protein A/G” with “recombinant protein A/G”. However, the Applicant added the term “bacterial” to the claims without any definition in the specification.
Thus, claims 30, 33-39 and 46 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.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OMAR RAMADAN whose telephone number is (571)270-0754. The examiner can normally be reached Monday-Friday 8:30 am - 5:00 pm.
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/OMAR RAMADAN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678