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 .
Claim Status
Applicant’s amendments received 12JAN2026 are acknowledged.
Claims 1-12 and 26-103 have been canceled.
Claims 13-19, 21, and 24 have been amended.
Claims 104-119 are new.
Claims 13-25 and 104-119 are pending and examined on the merits in the instant application (i.e., Claim(s) 13 and 106 is/are independent).
Priority
The present application is a 371 National Stage of PCT International Application No. PCT/US2020/048708, filed 31AUG2020, which claims the benefit of
US Provisional Patent Application No. 62/894749, filed 31AUG2019;
US Provisional Patent Application No. 62/896382, filed 05SEP2019; and
US Provisional Patent Application No. 62/933735, filed 11NOV2019.
Applicant’s claim for the benefit of prior-filed application is acknowledged.
Drawings
Applicant’s arguments, see p 8, Objections section, filed 12JAN2026, with respect to objections to the drawings for minor informalities have been fully considered and said objections to the drawings have been withdrawn in view of new drawings filed as part of said response.
Specification
Applicant’s arguments, see p 8, Objections section, filed 12JAN2026, with respect to objections to the specification for minor informalities have been fully considered and said objections to the specification have been withdrawn in view of amendments to the specification filed as part of said response.
Withdrawn Rejections
Indefiniteness
Applicant’s arguments, see p 8, Rejections under 35 USC §112(b) section, filed 12JAN2026, with respect to the rejection(s) of claim(s) 13-25 under 35 USC §112(b) have been fully considered and said rejections of claim(s) 13-25 have been withdrawn in view of the claim amendments filed as part of said response.
Dependency
Applicant’s arguments, see p 9, Rejections under 35 USC §112(d) section, filed 12JAN2026, with respect to the rejection(s) of claim(s) 21 under 35 USC §112(b) have been fully considered and said rejections of claim(s) 21 have been withdrawn in view of the claim amendments filed as part of said response.
Scope of Enablement
Applicant’s arguments, see p 9, Rejections under 35 USC §112(a) section, filed 12JAN2026, with respect to the rejection(s) of claim(s) 13-25 under 35 USC §112(a) - enablement have been fully considered and said rejections of claim(s) 13-25 have been withdrawn in view of the claim amendments filed as part of said response.
Claim Objections
Claims 14-16, and 107-110 are objected to because of the following informalities:
Claims 14-15, omits “wherein” between “…claim 13,” and “the antibody….” in line 1 of each claim.
Claim 14, contains a typographical error, “is” should be removed from the end of line 1 of the claim.
Claim 16, should be corrected to: …encoded by heavy and light chain variable region…” in line 2 of the claim.
Claims 107-108, omits “wherein” between “…claim 106,” and “the antibody….” in line 1 of each claim.
Claim 109, should be corrected to: …encoded by heavy and light chain variable region…” in line 2 of the claim.
Claim 110, omits an “or” between “… 150, respectively” and “SEQ ID NOs: 131 and 132,….” in line 3 of the claim.
Appropriate correction is required.
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 15-16, 22, and 108-109 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.
Claims 15-16 and 108-109 recite the limitation "….is encoded by the heavy and light chain variable region sequences…" in lines 1-2 of the claims. In this instance, claims 15-16 and 108-109 are dependent on claims 13 and 106, respectively, and neither independent claim recites that the antibody or antibody fragment comprises heavy and light chain variable regions. Therefore there is insufficient antecedent basis for this limitation in the claim. See Examiner suggestion below to obviate the rejection.
Claim 22 recites the limitation "administered" in line 2. Claim 13, upon which claim 22 is dependent does not recite a step of administration. Therefore there is insufficient antecedent basis for this limitation in the claim. By changing “administered” to “delivered” would obviate this rejection.
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.
Applicant’s claim amendments received as part of the 12JAN2026 response have necessitated the following new grounds of rejection.
Claims 13-25 and 104-119 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 and providing written description support for:
“A method of reducing the likelihood of infection of a subject at risk of contracting alphavirus, comprising delivering to said subject an antibody or antibody fragment comprising heavy and light chain variable regions comprising the heavy chain CDR sequences and the light chain CDR sequences, respectively of SEQ ID NOS: 364-366 and SEQ ID NOS: 553- 555, respectively, or SEQ ID NOS: 286-288 and SEQ ID NOS: 475-477, respectively.” (i.e., claim 13)
“The method of claim 13, wherein the heavy and the light chain variable region of the antibody or antibody fragment is encoded by the nucleic acid sequence comprising (95% identity to or 90% identity to) SEQ ID NOs: 75 and 76, respectively, or SEQ ID NOs: 23 and 24, respectively.” (i.e., claims 14-16)
“The method of claim 13, wherein the heavy and the light chain variable region of the antibody or antibody fragment comprises (90% identity to or 95% identity to) SEQ ID NOs: 210 and 202, respectively, or SEQ ID NOs: 149 and 150, respectively.” (i.e., claims 17-19)
“The method of claim 13, wherein said antibody is an IgG, IgA, IgM, polymeric IgA, or polymeric IgM antibody, or a recombinant IgG, IgA, IgM, polymeric IgA, or polymeric IgM antibody or IgG, IgA, IgM, polymeric IgA, or polymeric IgM antibody fragment comprising a mutated Fc portion comprising a LALA mutation, a N297 mutation, a GASD/ALIE mutation, a YTE mutation, an LS mutation, an enzymatic or chemical addition glycan modification, removal of glycans glycan modification or results from expression in a cell line engineered with a defined glycosylating pattern glycan modification.” (i.e., claims 21 and 105)
“The method of claim 13, wherein delivering the antibody or antibody fragment comprises administration of said antibody or antibody fragment to said subject.” (i.e., claim 24)
“The method of claim 13, wherein delivering the antibody or antibody fragment comprises administration of the RNA, DNA, or vector nucleic acid sequence which encodes said antibody or antibody fragment to said subject.” (i.e., claim 104)
“A method of treating a subject infected with alphavirus comprising delivering to said subject an antibody or antibody fragment comprising heavy and light chain variable regions comprising the heavy chain CDR sequences and the light chain CDR sequences, respectively of SEQ ID NOS: 364-366 and SEQ ID NOS: 553- 555, respectively, or SEQ ID NOS: 286-288 and SEQ ID NOS: 475-477, respectively,….” (i.e., claim 106)
“The method of claim 106, wherein the heavy and the light chain variable region of the antibody or antibody fragment is encoded by the nucleic acid sequence comprising (95% identity to or 90% identity to) SEQ ID NOs: 75 and 76, respectively, or SEQ ID NOs: 23 and 24, respectively,….” (i.e., claims 107-109)
“The method of claim 106, wherein the heavy and the light chain variable region amino acid sequences of the antibody or antibody fragment comprises (90% identity to or 95% identity to) SEQ ID NOs: 210 and 202, respectively, or SEQ ID NOs: 149 and 150, respectively,….” (i.e., claims 110-112)
“The method of claim 106, wherein said antibody is an IgG, IgA, IgM, polymeric IgA, or polymeric IgM antibody, or a recombinant IgG, IgA, IgM, polymeric IgA, or polymeric IgM antibody or IgG, IgA, IgM, polymeric IgA, or polymeric IgM antibody fragment comprising a mutated Fc portion comprising a LALA mutation, a N297 mutation, a GASD/ALIE mutation, a YTE mutation, an LS mutation, an enzymatic or chemical addition glycan modification, removal of glycans glycan modification or results from expression in a cell line engineered with a defined glycosylating pattern glycan modification.” (claims 114 and 119)
“The method of claim 106, wherein delivering the antibody or antibody fragment comprises administration of said antibody or antibody fragment to said subject.” (i.e., claim 116)
-AND-
“The method of claim 106, wherein delivering the antibody or antibody fragment comprises administration of the RNA, DNA, or vector nucleic acid sequence which encodes said antibody or antibody fragment to said subject.” (i.e., claim 118); does not reasonably provide enablement or support for more. Furthermore, claims 20, 22-23, 25, 113, 115, and 117 are also rejected since they depend on claims 13 or 106, but do not remedy this deficiency.
The use of the term “providing” in independent claims 13 and 106 and specifically in dependent claims 24, 104, 116, and 118 lack support from the specification. In this instance, the originally filed specification teaches that “delivering” comprises antibody or antibody fragment administration or genetic delivery with a RNA or DNA sequence or vector encoding the antibody or antibody fragment (p 9, lines 8-10) and does not teach “providing” the antibody or antibody fragment. Therefore, there is enablement and written description support for delivering, wherein delivering comprises administering the antibody or antibody fragment or wherein delivering comprises administering the RNA or DNA sequence or vector encoding said antibody or antibody fragment to said subject.
The omission of the antibody or antibody fragment “comprising a VH and VL region, comprising “the” HCDRs and “the” LCDRs of SEQ ID NOs:…” of claims 13 and 106 and the omission of “the” prior to VH and VL in claims 14-19 and 107-112 does not provide full enablement or written description support because the antibody or antibody fragments supported in the specification must comprise the full length sequence (e.g., in claims 13 and 106, one of the antibodies or antibody fragments must comprise the full length of all six sequences: GFSLSTSGMR, IDWDDDK, ARILPGYCSGGSCYYNYHFDY, NIGSKS, HDS, and QVWDSSSDPYV) with additional nucleotides or amino acid residues before and/or after said sequence.
In the instance of claims 21 and 114, the mutations to the Fc region claim functions rather than identifiable structures; however, the mutation structure limitations are recited in dependent claims 105 and 119, respectively. Therefore, by removing the functionality and claiming the actual mutations of the Fc region, claim 21 and 114 would be enabled and supported by the specification.
Allowable Subject Matter
Examiner notes that the antibodies or antibody fragments comprising the HCDRs and the LCDRs of SEQ ID NOS: 364-366 and SEQ ID NOS:553-555, respectively, or SEQ ID NOS: 286-288 and SEQ ID NOS: 475-477, respectively, or SEQ ID NOS: 259-261 and SEQ ID NOS:448-450, or SEQ ID NOS:355-357 and SEQ ID NOS: 544-546, or SEQ ID NOS: 346-348 and SEQ ID NOS: 535- 537, or SEQ ID NOS: 265-267 and SEQ ID NOS: 454-456 are free of the prior art and therefore methods of use would also be free of the art.
Conclusion
Claims 13-25 and 104-119 are not 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA L. HOPKINS whose telephone number is (703)756-4666. The examiner can normally be reached Mon-Thurs 6:00 AM to 4:00 PM EST.
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/SAMANTHA LAKE HOPKINS/Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641