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 .
Acknowledgments and Claim Status
The Examiner acknowledges receipt of the amendment filed 8/19/2026 wherein claim 1 was amended and claims 2-7, 11-13, 15, 23, 24, 26, and 28 were canceled.
Note(s): Claims 1, 8-10, 14, 16-22, 25, 27, and 29-41 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/8/2026 has been entered.
Priority and Priority Document
This application is a 371 of PCT/CN2020/101424 filed 7/10/2020 which claims benefit to CHINA CN201910624609.9 filed 7/11/2019.
Note(s): The earliest effective filing date is 7/11/2019 because CN201910624609.9 fully supports the pending invention.
The Examiner acknowledges receipt of the certified document required by 37 CFR 1.55 filed 1/11/2022. In addition, the Examiner acknowledges receipt of the English translation of the priority document filed 8/26/2025.
Applicant’s Election
Once again, Applicant's election with traverse of Group I filed 4/3/2025 is acknowledged. The traversal is on the grounds that amended independent claim 1 reads on all the groups as they require the fusion protein of amended claim 1. This is found non-persuasive because lack of unity was shown for the claims that were presented for examination as detailed in the office action mailed 2/4/2025. A document (Wadia et al, Nature Medicine, 2004, Vol. 10, No. 3, pages 310-315) was made of record to illustrate that Applicant’s pending independent claim 1 at that time, the claim limitations were met. Thus, independent claim 1 was found to lack a special technical feature distinguished over the prior art. Hence, the restriction requirement was deemed proper and made FINAL.
Once again, in the response filed 4/3/2025, Applicant elected the following species for initial examination: cell penetrating peptide (Tat-derived peptide); pH-sensitive fusogenic peptide (INF7); furin recognition sequence (SEQ ID NO: 4); cathepsin L recognition sequence (SEQ ID NO: 6); specific binding sequence (leucine zipper peptide); and fusion protein (SEQ ID NO: 14). Group I comprises pending claims 1, 8, 9, 29-31, and 37-41.
Note(s): Initially, Applicant’s elected species was searched. No prior art was found to reject the claims. The search was extended over the full scope of Group I. While no prior art was found to reject the claims, Applicant must address and overcome the written description and double patenting rejections below.
Response to Applicant’s Amendment and/or Arguments
The Applicant's arguments and/or amendment filed 8/10/2026 to the rejection of claims 1, 8, 9, 29-31, and 37-41 made by the Examiner under 35 USC 112 first paragraph and/or double patenting have been fully considered and deemed persuasive-in-part for the reasons set forth below.
Double Patenting Rejection
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 1, 8, 9, 27, 31, and 37-41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, 13-15, 21, 26, 29, 32-35 of copending Application No. 17/758,234 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a fusion protein/polypeptide comprising furin, cathepsin L, a cell penetrating peptide, and a pH sensitive fusogenic peptide (see, for example, copending claims 1 and 15). Thus, the inventions disclose overlapping components.
Note(s): Copending SEQ ID No: 10 corresponds to pending SEQ ID No. 6.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
APPLICANT’S ASSERTIONS
In summary, Applicant has requested that the provisional rejection be held in abeyance until it is the last pending rejection and allowable subject matter is determined.
EXAMINER’S RESPONSE
Applicant’s request to hold the rejection is duly noted. The rejection is still deemed proper.
Written Description Rejection
The 112 first paragraph (written description rejection) is WITHDRAWN because Applicant amended the claims to overcome the rejection.
Rejoining of Claims
In order to advance prosecution, the allowable product of independent claim 1 was rejoined with the appropriate dependent claims (claims 10, 14, 16, 17, 21, 27, and 32-35) pursuant to the procedures set forth in MPEP 821.94(B) that fully encompass the scope of independent claim 1.
Claims 18-20, 22, 25, 29, and 36 were not rejoined with independent claim 1 as the scope of those claims exceeded that which is encompassed by independent claim 1.
The restriction requirement as set forth in the Office action mailed on 2/4/2025 is hereby WITHDRAWN. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
NEW GROUNDS OF REJECTION
112 Second Paragraph Rejections
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 8-10, 14, 16, 17, 21, and 32-35 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.
Claim 8: The claim as written is ambiguous because the claim is outside the scope of the sequences of independent claim 1.
Claims 9, 10, 14, 16, 17, and 21: The claims are ambiguous because it is unclear what specific binding sequence Applicant is referring to that allows another molecule to specifically bind thereto. In addition, according to MPEP 2173.05(p), a claim directed to both a product and method steps for using such product is indefinite. In particular, the claim is indefinite because while the claim initially sets forth a product, the claim limitation is not directed to the product, but rather to actions involving the product which creates confusion as to when direct infringement occurs. Specifically, it is unclear whether infringement occurs when one has the actual product binding occurs to enable another molecule to bind thereto (see claims 9, 10, 14, 16, 17, and 21).
Claim 21: The claim is ambiguous because it is unclear what limitations Applicant is referencing that are suitable conditions for encoding. In addition, it is unclear what vector and nucleotide sequence encoding the fusion protein or complex that Applicant is referring to in claim 21.
Claims 32-35: The claim is ambiguous because of the phrase ‘characterized by one or more of the following’. Did Applicant intend to write, ‘selected from one of the following’ to clearly set forth the subgrouping? The phrase "characterized by..." renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention.
Claim 32: The claim is ambiguous because it is unclear what chemical compound Applicant is referring to. In addition, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, the claim recites the broad recitation recites ‘chemical compound’, and the claim also recites ‘nucleic acid, peptide, protein, carbohydrate, and lipid’ which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 34 and 35: The claims are confusing for the following reasons. (1) The phrase "such that" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). (2) Did Applicant intend to insert ‘or’ at the end of line 7? (3) Furthermore, the claims are ambiguous because according to MPEP 2173.05(p), a claim directed to both a product and method steps for using such product is indefinite. In particular, the claim is indefinite because while the claim initially sets forth a product, the claim limitation is not directed to the product, but rather to actions involving the product which creates confusion as to when direct infringement occurs. Specifically, it is unclear whether infringement occurs when the complementary peptide is able to for a heterodimer (see line 5).
Withdrawn Claims
Claims 18-20, 22, 25, 29, 30, and 36 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Comments/Notes
In regard to claim 14 (lines 3-4), Applicant is respectfully reminded that the recitation that an element is ‘capable of’ performing a function is not a positive limitation but only requires the ability to so perform that function. Thus, such terminology does not constitute a limitation in any patentable sense (In re Hutchison, 69 USPQ 138).
It should be noted that no prior art is cited against the pending invention. However, Applicant needs to address and overcome the double patenting and 112 rejections above. Specifically, the prior art neither anticipates nor renders obvious the particular fusion protein component arrangement from the N-terminus to C-terminus. The closest art is Wadia et al (Nature Medicine, 2004, Vol. 10, No. 3, pages 310-315) which was previously cited in a 103 rejection. The rejection was overcome as detailed in the response filed 8/19/2025.
In the art it is recognized that the order of a fusion protein is critical because it affect a protein’s function, expression level, and folding, for example. See Sino Biological, 2007-2025, https://www.sinobiological.com/resource/protein-review/fusion-protein, pages 1-15.
Conclusion
Claims 1, 8-10, 14, 16, 17, 21, 27, 31-35, and 37-41 are rejected; claims 18-20, 22, 25, 29, 30, and 36 are withdrawn.
Future Correspondences
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D L Jones whose telephone number is (571)272-0617. The examiner can normally be reached M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael G. Hartley can be reached at (571)272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D. L. Jones/
Primary Patent Examiner
Art Unit 1618
September 19, 2026
Prosecution Insights