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 .
Election/Restrictions
Applicant's election with traverse of Group II, claims 6-10 and SEQ ID NO: 8 in the reply filed on 1/13/2025 is acknowledged. The traversal is on the ground(s) that there is no search burden. This is not found persuasive because different inventions require different considerations and different rejections.
The requirement is still deemed proper and is therefore made FINAL.
Claims 6-10 are under consideration in the instant Office Action.
Withdrawn Objections
The objections to the figures and specification over sequence identifiers is withdrawn in view of the newly submitted specification and figures on 11/7/2025.
New Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 112
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 6-10 are 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.
Newly amended claim 6 uses the transitional term “having”. This term is problematic because it is not immediately clear whether open or closed claim language is intended, Crystal Semiconductor Corp. v. TriTech Microelectronics Int’l Inc., 246 F.3d 1336, 1348, 57 USPQ2d 1953, 1959 (Fed. Cir. 2001) (term “having” in transitional phrase "does not create a presumption that the body of the claim is open"); Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1573, 43 USPQ2d 1398, 1410 (Fed. Cir. 1997) (in the context of a cDNA having a sequence coding for human PI, the term “having” still permitted inclusion of other moieties), see MPEP 2111.03. Applicant is encouraged to use transitional phrases “comprising of” or “consisting of” to define the scope of a claim with respect to what unrecited additional components, if any, are excluded from the scope of the claims. Using the correct transitional phrase would clarify exactly what the limitations are requiring as limitation or what is explicitly excluded. Dependent claim 7-10 are included in this rejection since they all depend from claim 6 and therefore, suffers from the same issue.
Modified Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Diamond US2015/0126390 (4/1/2025, PTO-892) in view of Derisbourg et al., 2015 (4/1/2025, PTO-892) and Dorfel et al., 2015 (4/1/2025, PTO-892).
The instant claims are towards a method making antibodies that specifically bind N alpha acetylation of Met11 Tau protein fragment encompassing SEQ ID NO:8. Due to the new claim language of “having” the amino acid sequence is not limited to the amino acids set forth SEQ ID NO: 8.
Diamond teaches method of producing tau antibodies. Diamond teaches methods of generating monoclonal antibodies against tau proteins by isolating and purifying tau protein fragments and mixing the protein fragments with an adjuvant and injecting the mixture into laboratory animals that encompass non-human mammals like mice (see paragraphs 53-54 and 56) as required in instant claims 6 and 9-10. Diamond teaches sacrificing the animal, retrieving their spleen and mixing with myeloma cells to produce hybridoma that secretes anti-tau antibodies (see paragraph 54) as required in instant claim 6. Diamond teaches screening the antibodies produced by hybridoma to confirm that the antibodies bind the desired target protein epitopes (see paragraph 55) as required in instant claims 7-8, While Diamond teaches the methods of producing tau antibodies, Diamond does not teach the specific N alpha acetylation of Met11 Tau protein fragment as required in the instant claims.
Derisbourg teaches that Tau protein is a central player in Alzheimer’s disease and related tauopathies and that abnormal post-translational modifications like truncations are involved in the pathological process. Derisbourg teaches identifying the precise cleavage sited of several truncated Tau fragments including N-terminal Met11 truncation (see abstract and page 1) as required in instant claim 6. Derisbourg teaches that truncation is another post-translational modification that have an etiological role tau pathology. Derisbourg teaches the tau fragment of instant SEQ ID NO:8 in Table 1 (page 4) as now required in instant claim 6 but fails to teach the N alpha acetylation of Met11 of the tau protein but teaches N alpha acetylation of Ala2 of the tau protein. Derisbourg teaches N alpha acetylation of Ala2 of the tau protein is found in both normal and AD brains (see parg2, 1st column, bottom of 2nd column). Derisbourg teaches that these tau fragments, including Met11 tau fragment, have effects on the protein phosphorylation (see page 2, 2nd column, 1st paragraph). Derisbourg teaches that producing specific antibodies to the newly identified N-terminal truncations would be necessary to achieve their goal of quantifying and determining if these truncations are disease-related (see page 5, 2nd column and page 6).
Dorfel teaches N-terminal alpha acetylation (NTA) is one of the most abundant eukaryotic protein modifications and that this modulation is involved in protein-protein interaction, protein stability, protein function and protein targeting to specific cellular compartments (see abstract and page 103, 1st column). Dorfel does not teach tau fragments or methods of making antibodies.
It would have been prima facie obvious to the person of ordinary skill in the art to arrive at the claimed invention from the disclosures of Diamond, Derisbourg, and Dorfel. The person of ordinary skill in the art would have been motivated to make and use the invention as claimed because Diamond teaches that there methods of making tau antibodies and one of ordinary skill in the art would be motivated to use the known tau fragments taught by Derisbourg and produce antibodies against these fragments with different modifications including N alpha acetylation of Met11 tau since Derisbourg already teaches naturally occurring N alpha acetylation of tau fragments, such as Ala2 tau fragment. One of ordinary skill would be interest in producing tau antibodies that are able to differentiate between potential N alpha acetylation tau fragments and non N alpha acetylation tau fragments since this type of protein modification is very common in eukaryotic proteins and have been shown to be present in disease states as set forth by Derisbourg, and Dorfel. Therefore, the person of ordinary skill in the art would have had a reasonable expectation of success based on the cumulative disclosures of these prior art references.
Response to Arguments
Applicant's arguments filed 11/7/2025 have been fully considered but they are not persuasive. Applicant argues that the newly amended claim 6 that now specifically requires SEQ ID NO: 8 is not obvious because the claim is limited to the MEDHAGTYGLG peptide and lacks the DR amino acids of the MEDHAGTYGLGDR peptide taught by Derisbourg. This is not found persuasive since the claim language does not limit the SEQ ID NO:8 to only those specific amino acids as set forth above in the new 112 indefinite rejection. Therefore, this is not found persuasive.
Further, even if the SEQ ID NO: 8 of the instant claims are limited to the explicit amino acid sequence that would exclude DR amino acids, this would not be found persuasive because the prior art clearly already discloses that these specific peptide sequences of the tau protein is a desired target of interest and that one of ordinary skill in the art would be motivated and capable of determining the best antigen to produce antibodies that bind this specific target. However, that fact does not avoid a finding of prima facie obviousness in light of the overlap of the claimed range. “Selecting a narrow range from within a somewhat broader range disclosed in a prior art reference is no less obvious than identifying a range that simply overlaps a disclosed range.” In re Peterson, 315 F.3d at 1329—30.
Therefore, the argument is not found persuasive and the rejections are maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to AURORA M. FONTAINHAS whose telephone number is 571-272-2952. The examiner can normally be reached on Monday - Friday (8AM - 4PM).
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/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675