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 .
Status of the Claims
Claims 1, 32, 37, 39, 43, 45, 47-49, 61-62, 74, 84-86, 88, 94, and 100-102 are currently pending.
Claims 1, 37, 43, 74, 84-86, 88, 94, 100, and 101 have been amended.
Claims 62 and 102 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 2-31, 33-36, 38, 40-42, 44, 46, 50-60, 63-73, 75-83, 87, 89-93, and 95-99 have been cancelled.
Claims 1, 32, 37, 39, 43, 45, 47-49, 61, 74, 84-86, 88, 94, and 100 have been considered on the merits.
Withdrawn Rejections
The rejections made under 35 U.S.C. 112(b) have been withdrawn in light of the amendments submitted on 10/29/2025.
The rejections made onto claims 14, 18, 37, 70-73, 77-81, 83-83, 87, 89-93, and 95-99 are withdrawn in light of the amendments submitted on 10/29/2025.
New and Maintained Rejections Necessitated by Amendment
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, 32, 37, 39, 43, 45, 47-49, 61, 74, 84-86, 88, 94, and 100 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 claim(s) contains 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.
Claim 1 recites the limitation “a first nucleic acid sequence comprising SEQ ID NO: 179, or a variant thereof that hybridizes under stringent hybridization conditions to the complement of SEQ ID NO: 179, wherein any substitution relative to SEQ ID NO: 179 occur outside of the region corresponding to SEQ ID NO: 72”. The specification describes the nucleic acids of SEQ ID NOs: 179 but does not teach “a variant thereof that hybridizes under stringent conditions to the complement” thereof. The concept of any non-naturally occurring variant able to hybridize under stringent conditions to SEQ ID NO: 179, as recited in claim 1, lacks written description other than the nucleic acid sequence that is 100% identical to SEQ ID NO: 179. It is noted that claims encompass nucleic acid molecule the complementary strand of which hybridizes under stringent hybridization showing contemplated biological activity. Thus, for example a sequence of 25, 50 to100 base pairs from the SEQ ID NO 179 or a fragment thereof will hybridize with the target sequence, however if it does not contain the essential motifs that are required for contemplated biological activity, such a sequence will hybridize to plurality of sequence embraced by the variant, but will not be functional and show contemplated biological activity. Although the claim language includes the phrase “wherein any substitution relative to SEQ ID NO: 179 occur outside of the region corresponding to SEQ ID NO: 72”, this phrase does not require that the sequence which corresponds to SEQ ID NO: 72 is included in the variant of SEQ ID NO: 179 which is able to hybridize under stringent conditions to SEQ ID NO: 179. As currently claimed, a fragment of SEQ ID NO: 179 which corresponds to nucleic acid positions 1-82 or positions 106-210 of SEQ ID NO: 179 would meet the limitations of a “variant thereof that hybridizes under stringent hybridization conditions to the complement of SEQ ID NO: 179”, however this variant would not need to include SEQ ID NO: 72. Additionally, the specification does not appear to correlate SEQ ID NO: 179 to any other nucleic acid variants that hybridizes under stringent hybridization conditions to the complement of SEQ ID NO: 179 and contains SEQ ID NO: 72, which is a region which requires conservation to have a polynucleotide with the same structural and functional characteristics of SEQ ID NO: 179. Accordingly, the concept lacks written description other than SEQ ID NO: 179.
Claim 1 recites the limitation “a second nucleic acid sequence comprising SEQ ID NO: 180, or a variant thereof that hybridizes under stringent hybridization conditions to the complement of SEQ ID NO: 180, wherein any substitution relative to SEQ ID NO: 180 occur outside of the region corresponding to SEQ ID NO: 74”. The specification describes the nucleic acids of SEQ ID NOs: 180 but does not teach “a variant thereof that hybridizes under stringent conditions to the complement” thereof. The concept of any non-naturally occurring variant able to hybridize under stringent conditions to SEQ ID NO: 180, as recited in claim 1, lacks written description other than the nucleic acid sequence that is 100% identical to SEQ ID NO: 180. Although the claim language includes the phrase “wherein any substitution relative to SEQ ID NO: 180 occur outside of the region corresponding to SEQ ID NO: 74”, this phrase does not require that the sequence which corresponds to SEQ ID NO: 74 is included in the variant of SEQ ID NO: 180 which is able to hybridize under stringent conditions to SEQ ID NO: 180. As currently claimed, a fragment of SEQ ID NO: 180 which corresponds to nucleic acid positions 1-102 or positions 125-186 of SEQ ID NO: 180 would meet the limitations of a “variant thereof that hybridizes under stringent hybridization conditions to the complement of SEQ ID NO: 180”, however this variant would not need to include SEQ ID NO: 74. Additionally, the specification does not appear to correlate SEQ ID NO: 180 to any other nucleic acid variants that hybridizes under stringent hybridization conditions to the complement of SEQ ID NO: 180 and contains SEQ ID NO: 74, which is a region which requires conservation to have a polynucleotide with the same structural and functional characteristics of SEQ ID NO: 180. Accordingly, the concept lacks written description other than SEQ ID NO: 180.
Claim 1 recites the limitation “a variable light chain (VL) domain comprising SEQ ID NO: 387, or a conservatively substituted variant thereof having at least 90% identity to SEQ ID NO: 387, wherein the percent sequence identity is calculated over the framework regions only”. Claim 1 also recites the limitation “a variable heavy chain (VH) domain comprising SEQ ID NO: 349, or a conservatively substituted variant thereof having at least 90% identity to SEQ ID NO: 349, wherein the percent sequence identity is calculated over the framework regions only”. The specification describes the nucleic acids of SEQ ID NO: 387 and 349 but does not teach “a conservatively substituted variant thereof”. The concept of any non-naturally occurring polynucleotide having greater than 90% identity to SEQ ID NO: 387 and 349, as recited in claim 1, lacks written description other than nucleic acid sequences that are 100% identical to SEQ ID NO: 387 and 349. The specification does not appear to correlate SEQ ID NO: 387 and/or 349 to any other nucleic acids having at least 90% identity that still encode a polynucleotide with the same structural and functional characteristics of SEQ ID NO: 387 and 349. In reference to the Variable heavy and light chains, the specification states only that “The Vh and VL regions have a similar general structure, with each region comprising four framework regions, whose sequences are relatively conserved” ([0099]). The specification and the art at the time of filing do not teach variants of SEQ ID NO: 387 and/or 349. Accordingly, the concept lacks written description other than SEQ ID NO: 387 and 349. It cannot be readily envisioned which 10% can be altered and still retain structure and function.
Claims 84-86 further limit the sequences represented by SEQ ID NOs: 387 and 349 by reciting that the sequences are least 95%, at least 98%, and at least 99% sequence identity with SEQ ID NO: 387 and 349 listed in the claim. The specification describes the nucleic acid of SEQ ID NO: 387 and 349 but does not teach a portion thereof. The concept of any non-naturally occurring amino acid sequence having greater than 80%/90%/98%/99% identity to SEQ ID NO: 387 and 349, as recited in claims 84-86, lacks written description other than nucleic acid sequences that are 100% identical to SEQ ID NO: 387 and 349. The specification does not appear to correlate SEQ ID NO: 387 and 349 to any other nucleic acids having at least 80%/90%/98%/99% identity that still encode a polynucleotide with the same structural and functional characteristics of the listed SEQ ID NO: 387 and 349. The specification and the art at the time of filing do not teach variants of SEQ ID NO: 387 and 349. Accordingly, the concept lacks written description other than SEQ ID NO: 387 and 349. It cannot be readily envisioned which 10%/5%/2%/1% can be altered and still retain structure and function.
The claimed invention as a whole is not adequately described if the claims require essential or critical elements that are not adequately described in the specification and that is not conventional in the art as of applicants effective filing date. Possession may be shown by actual reduction to practice, clear depiction of the invention in a detailed drawing, or by describing the invention with sufficient relevant identifying characteristics such that a person skilled in the art would recognize that the inventor had possession of the claimed invention. Pfaff v. Wells Electronics, Inc., 48 USPQ2d 1641,1646 (1998).
With the exception of the sequence referred to above, the skilled artisan cannot envision the detailed chemical structure of the encompassed polynucleotides or polypeptides, and therefore conception is not achieved until reduction to practice has occurred regardless of the complexity or simplicity of the method of isolation. The skilled artisan cannot envision the detailed chemical structure of the encompassed nucleic acid molecules and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. 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 nucleic acid 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.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483.
In Fiddes, claims directed to mammalian FGF' s were found to be unpatentable due to lack of written
description for that broad class. The specification provided only the bovine sequence.
In view of the above considerations one of skill in the art would not recognize that applicant was in possession of the necessary common features or attributes possessed by any member of the genus of
the SEQ ID NOs encompassed by the claims. Therefore, only the exact SEQ ID NOs, but not the full breadth of the claims meet the written description provision of 35 U.S.C. §112, first paragraph. University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that “to fulfill the written
description requirement, a patent specification must describe an invention and do so in sufficient detail
that one skilled in the art can clearly conclude “the inventor invented the claimed invention”.
Subject Matter Free of Art
Claim 1 contains subject matter which is free of the prior art because SEQ ID NOs 179 did not return any results in which substitutions relative to SEQ ID NO: 179 occurred outside of the region corresponding to SEQ ID NO: 72. Additionally, SEQ ID NO: 180 180 did not return any results in which substitutions of SEQ ID NO: 180 occurred outside of the region corresponding to SEQ ID NO: 74.
Claim 74 contains subject matter which is free of the art because SEQ ID NO: 267, did not return any results with 100% identity.
Response to Arguments
Applicant's arguments filed 10/29/2025 have been fully considered but they are not persuasive.
Applicant argues for a request for rejoinder for claims 62 and 102 which are directed to a process of use of the elected invention (Remarks, pg. 6, last para). Please see the election/restriction requirement by original presentation presented in the previous office action.
Applicant argues the currently amended claims recite a polynucleotide comprising a first and second nucleic acid sequence which hybridizes under stringent conditions to the complement of the sequence and any substitutions relative to the references sequences are required to occur only outside the region corresponding to SEQ ID NOs: 72 and 74. (pg. 7, last two para).
In response, this argument is not found persuasive. Although the claim language includes the phrase “wherein any substitution relative to SEQ ID NO: 179 occur outside of the region corresponding to SEQ ID NO: 72”, this phrase does not require that the sequence which corresponds to SEQ ID NO: 72 is included in the variant of SEQ ID NO: 179 which is able to hybridize under stringent conditions to SEQ ID NO: 179. As currently claimed, a fragment of SEQ ID NO: 179 which corresponds to nucleic acid positions 1-82 or positions 106-210 of SEQ ID NO: 179 would meet the limitations of a “variant thereof that hybridizes under stringent hybridization conditions to the complement of SEQ ID NO: 179”, however this variant would not need to include SEQ ID NO: 72. Additionally, the claim language includes the phrase “wherein any substitution relative to SEQ ID NO: 180 occur outside of the region corresponding to SEQ ID NO: 74”, this phrase does not require that the sequence which corresponds to SEQ ID NO: 74 is included in the variant of SEQ ID NO: 180 which is able to hybridize under stringent conditions to SEQ ID NO: 180. As currently claimed, a fragment of SEQ ID NO: 180 which corresponds to nucleic acid positions 1-102 or positions 125-186 of SEQ ID NO: 180 would meet the limitations of a “variant thereof that hybridizes under stringent hybridization conditions to the complement of SEQ ID NO: 180”, however this variant would not need to include SEQ ID NO: 74. Therefore, the argument is not found persuasive.
Applicant argues the currently amended claims also recite a CAR comprising VL and VH domains that are 90% identical to SEQ ID NOs: 387 and 349, respectively, with percent identity calculated over the framework regions only, and requiring explicitly defined sequences for the CDRs of the antigen-binding domains, which renders the claim allowable. Applicant argues that the 90% identity threshold would only permit at most 10-11 substitutions in the framework region of the VL and VH domains (pg. 8, last two para).
This is not found persuasive because the specification does not appear to correlate SEQ ID NO: 387 and/or 349 to any other nucleic acids having at least 90% identity that still encode a polynucleotide with the same structural and functional characteristics of SEQ ID NO: 387 and 349. In reference to the Variable heavy and light chains, the specification states only that “The Vh and VL regions have a similar general structure, with each region comprising four framework regions, whose sequences are relatively conserved” ([0099]). The specification and the art at the time of filing do not teach variants of SEQ ID NO: 387 and/or 349. Accordingly, the concept lacks written description other than SEQ ID NO: 387 and 349. It cannot be readily envisioned which 10% can be altered and still retain structure and function. Therefore, the argument is not found persuasive.
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.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONSTANTINA E STAVROU whose telephone number is (571)272-9899. The examiner can normally be reached M-F 8:00-5:00.
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CONSTANTINA E. STAVROU
Examiner
Art Unit 1632
/ANOOP K SINGH/Primary Examiner, Art Unit 1632