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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08 May 2026 has been entered.
MATTER OF RECORD
Newly submitted claims 27-30 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Applicant has received an action on the merits for the originally presented invention, which is a fusion protein. See the Restriction requirement (21 April 2025) and the Election of Group I (18 July 2025).
The instant claims are drawn to an isolated nucleic acid encoding the therapeutic fusion protein, a viral vector comprising the isolated nucleic acid, a cloning or expression vector comprising the isolated nucleic acid and a recombinant host cell comprising the cloning or expression vector.
Since Applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 27-30 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
However, the Examiner has joined newly submitted claim 31 (a pharmaceutical composition comprising the therapeutic fusion protein and at least one pharmaceutically acceptable carrier) to Group I.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should Applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Status of Application, Amendments and/or Claims
The amendment and Applicant’s arguments, filed 08 May 2026, have been entered in full. Claims 1-25 are canceled. Claims 27-30 are withdrawn from consideration as being drawn to a non-elected invention. Claim 26 is amended. New claim 31 is added. Claims 26 and 31 are under examination.
Information Disclosure Statement
The information disclosure statement(s) (IDS) (filed 5/8/2026 and 5/21/2026) were received and comply with the provisions of 37 CFR §§1.97, 1.98 and MPEP § 609. They have been placed in the application file and the information referred to therein has been considered as to the merits.
Withdrawn Objections And/Or Rejections
The rejection to claims 1 and 22-25 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), First paragraph, Written description, as set forth at pages 3-6 the previous Office Action (09 February 2026), is withdrawn in view of the amendment (08 May 2026).
The objections to claims 22, 23 and 25, as set forth at page 6 the previous Office Action (09 February 2026), are withdrawn in view of the amendment (08 May 2026).
The rejection to claims 1 and 22-25 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as set forth at page 7 the previous Office Action (09 February 2026), is withdrawn in view of the amendment (08 May 2026).
The rejection to claims 22-25 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), First paragraph, Written description, New Matter, as set forth at pages 7-11 the previous Office Action (09 February 2026), is withdrawn in view of the amendment (08 May 2026).
Double Patenting
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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 26 (and new claim 31) remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 18 of copending Application No. 17/640,291 (reference application).
The basis for this rejection is set forth at pages 11-15 of the previous Office Action (09 February 2026).
APPLICANT’S ARGUMENTS: Applicant argues that the rejection is moot in view of present claim 26, which is directed to a therapeutic fusion protein comprising the amino acid sequence set forth in SEQ ID NO: 73, wherein the therapeutic fusion protein does not comprise the C2 domain having the amino acid sequence set forth in SEQ ID NO: 143. Applicant argues that the cited claims of the reference application encompass fusion proteins comprising the C2 domain, whereas the present claims are expressly limited to fusion proteins lacking the C2 domain. Applicant maintains that accordingly, the presently claimed fusion proteins are distinct from the cited claims in the reference application.
Applicant’s arguments have been fully considered but are not found persuasive for the following reasons:
1. The specification teaches SEQ ID NO:73 as a fusion protein that does not comprise the C2 domain. The Examiner directs Applicant’s attention to the published publication of the instant application. The specification teaches therapeutic fusion protein FP135, also named herein FP261 as (EGF-HSA-C1 SEQ ID No: 73)(see paragraphs 0047-0050, and 0052).
2. Instant claim 26 recites that the therapeutic fusion protein comprises the amino acid sequence set forth in SEQ ID NO:73.
Claim limitations “comprising” and “comprises” read on open claim language. In the instant case, this means that the therapeutic fusion protein comprises the amino acid sequence set forth in SEQ ID NO:73 AND additional amino acid sequences.
3. The claims of copending Application No. 17/640,291 teach a therapeutic fusion protein (SEQ ID NO:48) that is 100% identical to instant SEQ ID NO:73. See the previous Office Action (09 February 2026, see page 14 and Sequence Search Result B, Result number 2, at pages 22-24).
Instant SEQ ID NO:73 has 783 amino acid residues. SEQ ID NO:48 from copending Application No. 17/640,291 has 941 amino acid residues.
Amending instant claim 26 to recite, “..wherein the therapeutic fusion protein consists of the amino acid sequence set forth in SEQ ID NO: 73”, would obviate the Double Patent Rejection.
NEW CLAIM REJECTIONS/OBJECTIONS
Claim Rejections-35 USC § 112(a) or 35 U.S.C. 112 (pre-AIA ), First paragraph, Written description, New Matter
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 26 and 31 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. This is a New Matter Rejection.
The specification as originally filed does not provide support for the invention as now claimed: “..wherein the therapeutic fusion protein does not comprise the C2 domain having the amino acid sequence set forth in SEQ ID NO:143”
Applicant's amendment, filed 08 May 2026, asserts that no new matter has been added and directs support to page 103 of the application as filed.
The Examiner does not see Written Support for “..wherein the therapeutic fusion protein does not comprise the C2 domain having the amino acid sequence set forth in SEQ ID NO:143”.
The specification as filed does not provide a written description or set forth the metes and bounds of this "limitation". It is not expressly asserted, nor does it flow naturally from the specification.
The instant claims now recite limitations which were not disclosed in the specification as filed, and now change the scope of the instant disclosure as-filed.
Applicant is required to cancel the new matter in the response to this Office action. Alternatively, Applicant is invited to provide specific written support for the "limitations" indicated above or rely upon the limitations set forth in the specification as filed.
Possible Allowable Subject Matter
Claims 26 and 31 would be allowed, if claim 26 was amended to recite
“A therapeutic fusion protein wherein the therapeutic fusion protein consists of the amino acid sequence set forth in SEQ ID NO: 73” or alternatively, “A therapeutic fusion protein consisting of the amino acid sequence set forth in SEQ ID NO: 73”.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REGINA M DEBERRY whose telephone number is (571)272-0882. The examiner can normally be reached M-F 9:00-6:30 pm (alt Fri).
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/R.M.D/Examiner, Art Unit 1647 5/19/2026
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647
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