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 .
Amended claims 10, 15, (8/3/2026), previously pending claims 16-17, and 19, and new claims 35-36, (8/3/2026), are pending and under consideration by the Examiner.
Claim 14 is withdrawn from further consideration by the Examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1-9, 11-13, 18, and 20-34 are canceled.
3. The following previous rejections and objections are withdrawn in light of applicants amendments filed on 8/3/2026:
(i) the rejection of claims 10, 15-17, 19 under 35 U.S.C. 112(b).
Applicant's arguments with respect to the above claims have been considered and are persuasive in-part . The new grounds of rejection over claims 10, 15-17, 19, and 35-36 are recited below.
Claim Rejections - 35 USC § 112, first paragraph, scope of enablement
4. 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.
4a. Claims 10, 15-17, 19, and 35-36 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method for inhibiting Tau aggregates in cardiac tissue of a subject with heart failure comprising administration of an anti-Tau monoclonal antibody TOMA of monoclonal antibody clone (TOMA-1) that specifically recognizes oligomeric forms of Tau protein, does not reasonably provide enablement for a method as recited in claim 10. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
This rejection is maintained for reasons of record set forth at pages 3-12 of the previous action dated 5/22/2026.
Applicant argues that claim 10 has been amended to recite the subject matter the Action indicates as enabled. However, contrary to Applicant’s arguments, the specification delimits the instant method to administering a specific Tau antibody for inhibiting Tau aggregation in a subject with heart failure, HF (see page 28). However, with respect to claim 10, as recited, what is claimed in the instant invention broadly encompasses a method of administering "all" Tau antibodies, the claim recites only function, no structure is recited. The specification is non-enabling for a method of administering these unlimited and unidentified number of antibodies, which are encompassed by the scope of the claims, because claim 10, for example, is a single means claim (M.P.E.P. 2164.08(a)). Therefore, it would require undue experimentation to determine which Tau antibodies would be encompassed by the scope of the method claims. Applicant has not taught how to make and use the claimed genus of “Tau antibody” with respect to the heavy chain variable region and the light chain variable region or the three CDR’s in the heavy chain variable region and the three CDRs in the light chain variable region. Some antibodies can be agonistic while some antibodies can be antagonistic and inhibit the function of the protein depending on the binding site of the antibody on the protein. The disclosure of a single TOMA is clearly insufficient support under the first paragraph of 35 U.S.C. 112 for claims, which encompass a method of administering every and all Tau antibodies, including variants of such. Given the breadth of claim 10 in light of the predictability of the art as determined by the number of working examples, the level of skill of the artisan, and the guidance provided in the instant specification and the prior art of record, it would require undue experimentation for one of skill in the art to practice the claimed invention.
Claim Rejections - 35 USC § 112, first paragraph, written description
4b. Claims 10, 15-17, 19, and 35-36, are rejected under 35 U.S.C. 112, first paragraph, as containing 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(s), at the time the application was filed, had possession of the claimed invention.
This rejection is maintained for reasons of record set forth at pages 12-14 of the previous action dated 5/22/2026.
Applicant argues that with respect to "which" antibody is to be administered, Applicant submits that any antibody to Tau would be understood to provide the requisite functionality of amended claim 10, namely, inhibiting Tau aggregates, there is no reason to believe that this functionality would not be sufficient to achieve the claim's stated goal, many anti-Tau antibodies are known and those of skill in the art are aware of such and further would not question that they would perform as described in the Examples presented. However, contrary to Applicant’s arguments, the instant claims only recite function without the recitation of structure. To provide adequate written description and 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, and any combination thereof. In this case, the only factor present in the claim that is sufficiently disclosed is a recitation of a desired activity. The specification does not identify any particular portion of the structure, nor does it provide a disclosure of structure/function correlation for the claimed antibody. The distinguishing characteristics of the claimed genus for the “Tau antibody” with respect to the heavy chain variable region and the light chain variable region or the three CDR’s in the heavy chain variable region and the three CDRs in the light chain variable region have not been described. Some antibodies can be agonistic while some antibodies can be antagonistic and inhibit the function of the protein depending on the binding site of the antibody on the protein. Accordingly, the specification does not provide adequate written description of the claimed genus of “Tau antibody”.
New claim 35 recites “….wherein the antibody or antibody fragment comprises a LALA, LALA-PG, N297, GASD/ALIE, DHS, YTE or LS mutation”. However, Applicant has failed to describe any other antibody other than the Tau (TOMA) antibody recited on page 28, lines 14-17, of the specification. The mutations recited in claim 35 are all Fc region modifications in IgG antibodies, designed to reduce or eliminate immune effector functions such as ADCC, ADCP, and CDC. The N297 mutation is located in the CH3 domain and disrupts C1q binding, while the LALA mutation is located near the CH2-CH3 interface. In the absence of a specific Tau antibody recited in the claims, there is no written description of the antibody to be administered with these Fc mutations.
New claim 36 recites “….wherein the antibody or antibody fragment comprises an enzymatic or chemical addition or removal of glycans or is expressed in a cell line engineered with a defined glycosylating pattern”. However, some antibodies have functional activity when glycosylated while other antibodies have functional activity when deglycosylated. There is no written description provided in the instant specification for which Tau antibody is functionally active when glycosylated or deglycosylated. Therefore, the full breadth of the claims fails to meet the written description provision of 35 U.S.C. §112, first paragraph. In the instant case, for example, Applicants have failed to describe which Tau antibody is to be administered in independent method claim 10 together with the imitations recited in new claims 35-36. Similarly, Applicants have failed to describe administering “a Tau antibody”, other than TOMA, which has the desirable property for reducing Tau aggregates in cardiac tissue of a subject with heart failure recited in claim 10. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision.
Claim Rejections - 35 U.S.C. § 112(b)
5. 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.
5a. Claims 10, 15-17, 19, and 35-36, 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 pre-AIA the applicant regards as the invention.
Claim 10 remains vague and indefinite because it is unclear whether the Tau antibody administered is "effective" in treating the claimed heart disease. Appropriate correction of the claim is requested to obviate this rejection.
Claim 17, line 2, remains vague and indefinite because it recites the limitation “antibody….is administered multiple times” and there is no upper limit on the number of times the antibody is administered. Is the antibody administered five times, ten times, are more than that? Applicant argues that this is not an issue of indefiniteness - "multiple" means more than one. This is exactly why the claim is indefinite because it encompasses administered five times, ten times, or even 15 times. The metes and bounds of the claim are unclear.
Claim 19 remains rejected as containing a non-elected invention (See Requirement for Restriction dated 11/19/2025) and election of Group II (claims 10, 15-17, 19) without traverse on 1/14/2026. Applicant argues that this non-elected subject matter can be rejoined, its retention would be appropriate to avoid the case passing to issue without the opportunity for such a rejoinder. However, these limitations for “genetic delivery with an RNA or DNA sequence or vector encoding the antibody or antibody fragment” will not be examined and not be rejoined in the instant application. Applicants are required to delete this non-elected subject matter from the claim to obviate this rejection.
New claim 35 is improper because every claim must begin with a capital letter and end with a period. Claim 35 begins with a capital letter but does not end in a period. Appropriate correction is required. See MPEP § 608.01(m). See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995).
Claim 36 is vague and indefinite because it recites “the method of claim 15, wherein the antibody or antibody fragment comprises an enzymatic or chemical addition or removal of glycans or is expressed in a cell line engineered with a defined glycosylating pattern”. However, claim 15 is silent with respect to a specific antibody and it is unclear whether the antibody claimed with have functional activity when it is glycosylated or aglycosylated.
Claims 14, 15, 16, are rejected as vague and indefinite insofar as they depend on the above rejected claims for their limitations.
Conclusion
No claims are allowed.
Claims 10, 15-17, 19, and 35-36 are rejected.
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.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PREMA MARIA MERTZ whose telephone number is (571)272-0876. The examiner can normally be reached on Monday to Thursday from 7:30am to 6:00pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, VANESSA FORD, can be reached at telephone number 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PREMA M MERTZ/ Primary Examiner, Art Unit 1674
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