DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant's amendment and remarks filed on 05/28/2026 are acknowledged.
Claims 32-48 are pending.
3. Applicant’s election of the invention of Group I in the reply filed on 05/28/2026 is acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
All presently pending claims are deemed to read on the elected invention.
4. Claim interpretation:
Claim 32 recites a fusion protein which “comprises an amino acid sequence that lacks at least one of” SEQ ID NO: 174 and SEQ ID NO: 175. This recitation does not limit the scope of the claim, because it stipulates only that there is a fragment (“an” amino acid sequence) “comprised” within the fusion protein that lacks SEQ ID NO: 174 and/or 175, even if the fusion protein contains these sequences outside of that fragment.
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.
6. Claims 32-48 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
(i) Claim 32 is indefinite in the recitation of “a” pembrolizumab. As one of skill in the art would be aware, “pembrolizumab” is a non-proprietary name which uniquely identifies a specific antibody, and therefore use of indefinite article “a” crates ambiguity as to the scope of the claim.
(ii) Claim 32 is further indefinite in the recitation of pembrolizumab or “binding fragment thereof,” because it is unclear whether it refers to an antigen binding, Fc receptor binding, complement binding, or some other fragment of the antibody.
(iii) Claim 32 is further indefinite as being in improper Markush format in reciting “at least one of” SEQ ID NO: 174 “or” SEQ ID NO: 175. The Office recommends the use of the phrase "selected from the group consisting of ..." with the use of the conjunction "and" rather than "or" in listing the species. See MPEP 803.02.
(iv) Claim 42 is indefinite in the recitation of the fusion protein of claim 32, “further” comprising an extracellular domain, because the fusion protein of claim 32 already comprises an extracellular domain, which is the “binding domain.”
(v) Claim 47 is indefinite in the recitation of a method of making “a cell.” The method comprises a step of transducing or transfecting “a cell” which already exists, and therefore it is unclear what is being “made.”
(vi) Claim 47 is indefinite because of the inconsistency between the preamble, which is directed to a method of preparing a population of cells that express “a” fusion protein (i.e. any fusion protein), and the method step, which utilizes the nucleic acid of claim 45 encoding a specific fusion protein.
(vii) Claims 33-48 are indefinite, because they encompass the indefinite limitations of the claim(s) on which they depend.
In view of the above, a person of ordinary skill in the art cannot unequivocally interpret the metes and bounds of the claims so as to understand how to avoid infringement. Applicant is reminded that any amendment must point to a basis in the specification so as not to add New Matter. See MPEP 714.02 and 2163.06.
7. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
8. Claims 32-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11697677 (cited on IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of US ‘677, which are directed to the same fusion protein as the instant claims.
Specifically, US ‘677 recites a fusion protein comprising
a pembrolizumab-binding domain comprising VL and VH of SEQ ID NOS: 158- and 160, respectively (claims 1-5),
a membrane-proximal fragment of CD28 of SEQ ID NO: 162 (claim 1),
a CD28 transmembrane domain of SEQ ID NO: 163 (claim 1),
a CD28 intracellular signaling domain of SEQ ID NO: 164 (claim 1),
a CD40 intracellular signaling domain of SEQ ID NO: 165 (claim 1), and
two linkers of SEQ ID NO: 159 and SEQ ID NO: 161 (claims 6 and 7).
As such, claims 1-7 of US ‘677 recite all structural features of the fusion protein recited in instant claims 32-34 and 37-44, thereby anticipating the instant claims.
Both VL-VH and VH-VL configurations would be at once envisaged by a person of skill in the art, being the only possible configurations. Also, the VL-VH configuration is exemplified in SEQ ID NOS: 166 and 167 recited in US ‘677 claims 8-14. Accordingly, instant claims 35 and 36 are anticipated by US ‘677 claims.
US ‘677 claims 15-25 recite nucleic acids encoding the fusion protein and cells expressing the fusion protein, which inherently include methods of making such cells, thereby anticipating instant claims 45-48.
9. Claims 32-48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending application USSN 18005330 (US PG Pub. No. 20230277670).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of USSN ‘330.
USSN ‘330 claim 11 recites engineered proteins
“Anti-ID3-VH-VL (A30633-pembro)-CD28TMD-CD28-CD40” and
“Anti-ID3-VL-VH (A30633-pembro)-CD28TMD-CD28-CD40.”
According to present specification at Table 7, these proteins are designated as clones pIB1101 and pIB1102, respectively. According to present specification as-filed at p. 11 (paragraph [0055] of US 20230331808), the amino acid sequence of pIB1102 is SEQ ID NO: 123, which comprise all of the structural elements the fusion protein recited in instant claims 32-44 (see SCORE).
SEQ ID NO: 123 also comprises instant SEQ ID NO: 174 and SEQ ID NO: 175. As pointed out in section 4 above, claim 32, as presently recited, does not exclude SEQ ID NO: 174 or SEQ ID NO: 175 from the claimed fusion protein. Accordingly, instant claims are anticipated by the claims of USSN ‘330, which also recite nucleic acids encoding the proteins and cells expressing the proteins (e.g. claims 32 and 34).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
10. The following copending US application shares a coinventor and/or an assignee with the present application, and discloses and/or claims subject matter similar to that of the present claims, but does not contain currently pending claims which would anticipate or make obvious the presently claimed invention:
USSN 18/323342 (US PG Pub. No. 20240058447).
11. Conclusion: no claim is allowed.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ILIA I OUSPENSKI whose telephone number is (571)272-2920. The examiner can normally be reached 9 AM - 5:30 PM.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644
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