DETAILED ACTION
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 .
Response to Amendment
Claims 1-3, 12, 17, and 20 have been amended as requested in the amendment filed on 28 October 2025. Following the amendment, claims 1-20 are pending in the instant application.
Claims 5-11 and 13-20 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions without traverse in the reply filed on 20 June 2025.
Claims 1-4 and 12 are examined upon their merits.
Claim Objections (New)
Claims 5-11 and 13-20 are objected to because of the following informalities: These claims lack a proper Status Identifier as set forth in 37 CFR 1.121(c). The current status of all of the claims in the application, including any previously canceled or withdrawn claims, must be given. Status is indicated in a parenthetical expression following the claim number by one of the following status identifiers: (original), (currently amended), (previously presented), (canceled), (withdrawn), (new), or (not entered). Appropriate correction is required.
Withdrawn Claim Rejections:
As currently amended, the rejections of Claims 3 and 12 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn.
The rejection of Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Xie and Wang, 2011 and Valsanen et al., 2006; and SHBC online publication 2016. The combination of references fails to teach the second antibody id an antigen-binding fragment and linked to a second nano-microsphere via a spacer arm molecule. Nor was there anything to teach or suggest this feature in the art prior to filing. Therefore the rejection is withdrawn.
Claim Rejections - 35 USC § 112
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 1-4 and 12 stand as 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, for reasons of record in the previous Office action.
In Remarks filed 28 October 2025, Applicant traverses the rejection on the grounds that the instant disclosure provides more written description than what Amgen found as insufficient. Applicant asserts, unlike Amgen, the specification teaches the second antibody does not bind the antigen in free status but binds the complex formed by the first antibody and said antigen. Applicant asserts the negative limitation adds specificity beyond what is disclosed in Amgen (Remarks pg. 12, third and fourth full paragraphs). Applicant further asserts there is structure-to-function correlation, specifically, that the second antibody preferably having a smaller molecular weight, linked to nanomicrospheres via a spacer arm because “it is not recommended to use a complete monoclonal antibody …due to its relatively large molecular weight” (citing pg. 5 of Specification). Lastly, Applicant asserts the working examples demonstrate an actual reduction to practice (Example 1, pages 11-14); and Example 4 shows a larger antibody cannot get access to the epitope due to steric hindrance. Therefore, Applicant asserts, “the inventors actually made antibodies meeting the claimed criteria and understood which features were significant” (Remarks pg. 13) Lastly, applicant asserts the claims are not directed to antibodies per se and specific CDR sequences are not required because a person of ordinary skill can obtain such antibodies using conventional hybridoma technology.
While all of these arguments have been reviewed in full, they are not persuasive to overcome the rejection because the claims read upon a genus of anti-human fPSA antibody, and a genus of second antibodies. Contrary to Applicant’s assertions the specification merely sets forth preferred embodiments of not using a complete monoclonal antibody due to its relatively large molecular weight; the claims, however, encompass complete antibodies. Therefore, information regarding the preferable molecular weight of the anti-fPSA antibody does not provide enough information to adequately describe the claimed genus as a whole. The only information pertaining to the full genus encompassed by the first antibody is that it binds to the antigen fPSA. The courts have held that "knowledge of the chemical structure of an antigen [does not give] the required kind of structure-identifying information about the corresponding antibodies". The courts have further stated, the formation of an intact antigen-binding site generally requires the association of the complete heavy and light chain variable regions of a given antibody, each of which consists of three CDRs which provide the majority of the contact residues for the binding of the antibody to its target epitope. The amino acid sequences and conformations of each of the heavy and light chain CDRs are critical in maintaining the antigen binding specificity and affinity which is characteristic of the parent immunoglobulin. It is expected that all of the heavy and light chain CDRs in their proper order and in the context of framework sequences which maintain their required conformation, are required in order to produce a protein having antigen-binding function and that proper association of heavy and light chain variable regions is required in order to form functional antigen binding sites (Amgen v. Sanofi, 872 F.3d 1367, Fed. Cir. 2017). Further, there is no written description for the second antibody other than it “does not bind to human fPSA, but binds to the complex formed by the first antibody and human fPSA …and…is linked to a second nano-microsphere via a spacer arm”.
The examiner maintains the position that the instant claims fail to meet the requirements for disclosure because the antibodies are described solely by the antigen to which they do or do not bind. Therefore, the rejection of Claims 1-4 and 12 is maintained.
Claims 1-4 and 12 stand as 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, for reasons of record.
On pages 14-15 of Remarks (Id), Applicant argues, “The invention requires only identifying functional antibodies to practice the kit – not enabling millions of possible antibody variants”.
In AMGEN INC. ET AL. v. SANOFI ET AL. (No. 21-757, decided May 18, 2023), the Supreme Court held that Amgen was not enabled for “the entire genus” of antibodies that (1) “bind to specific amino acid residues on PCSK9,” and (2) “block PCSK9 from binding to [LDL receptors]” (872 F. 3d 1367, 1372) even though Amgen identified the amino acid sequences of 26 antibodies that perform these two functions. Applicant asserts, “Unlike Amgen, where the specification merely described trial-and-error methods, the specification here discloses targeted preparation strategies”.
While all of these arguments have been reviewed, in full, they are not persuasive to overcome the rejection. Amgen not only described trial and error methods, the inventors identified the amino acid sequences of 26 antibodies that perform the claimed functions and the SCOTUS found this insufficient to describe the full genus of antibodies encompassed by the claims. Additionally, the Court said antibody science remains unpredictable, and scientists cannot always accurately predict exactly how trading even one amino acid for another will affect an antibody’s structure and function.
The examiner maintains that a skilled artisan would have to make multiple antibodies that fulfill the binding/not binding requirements, for each of the two antibodies, in order to enable the invention. This amount of experimentation goes beyond what is considered “a reasonable degree of experimentation” and constitutes undue further experimentation in order to enable the method for the breadth of what is claimed. This rejection may be obviated by limiting the invention to those specific antibodies taught by the specification. Claims 1-4 and 12 are rejected under 35 U.S.C. 112(a).
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STACEY NEE MACFARLANE whose telephone number is (571)270-3057. The examiner can normally be reached M-F 7:30-5 (EST) & Sat. A.M..
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/STACEY N MACFARLANE/Examiner, Art Unit 1675
/KIMBERLY BALLARD/Primary Examiner, Art Unit 1675