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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/27/2026 has been entered.
Claim Status
Claims 12-14 and 16-26 are pending.
Claim 12 is currently amended.
Claims 1-11, 15, and 27-56 were cancelled.
Claim 16 is withdrawn as directed to a non-elected species. Dated 1/28/2021
Claims 12-14 and 17-26 have been examined.
Priority
This application is a CON of 16/166,984 10/22/2018 PAT 10538558
This application is a DIV of 12/895,454 09/30/2010 PAT 10138276
16/166,984 has PRO 61/247,033 09/30/2009
Modified Rejection
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 13-14, 17-24, and 26 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.
The specification failed to provide a representative number of class I peptide inhibitor sequences to support the entire genus of the peptide formula in claim 12.
PNG
media_image1.png
90
492
media_image1.png
Greyscale
The original claim dated 12/18/2019 disclosed class I of TCR peptide inhibitor C1 comprising Y5 as shown follows, but the general disclosure of Y5 comprising four amino acid residues independently selected from Leu, Ile, Thr, and Pro in any order does not support the specific tetrapeptide sequence of Leu-Leu-Thr-Ile (SEQ ID NO: 104), Ile-Pro-Tur-Leu (SEQ ID NO: 100), Ile-Leu-Tur-Leu (SEQ ID NO: 101), Thr-Pro-Thr-Leu (SEQ ID NO: 102), and Ile-Pro-Leu-Leu (SEQ ID NO: 103) in the instant claim 12. The introduction of claim changes which involve narrowing the claims by introducing elements or limitations which are not supported by the as-filed disclosure is a violation of the written description requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996). See MPEP 2163.05 (B)(II).
PNG
media_image2.png
472
732
media_image2.png
Greyscale
PNG
media_image3.png
430
588
media_image3.png
Greyscale
Applicant failed to establish correlation of a peptide sequence and class I peptide inhibitor. Applicant disclosed individual class I peptide inhibitor sequences of SEQ ID Nos: 1-26, but not the derivative peptide sequences created by domain swap of Y5 as well as other insertions, deletions, and substitutions in all possible positions in the claimed peptide formula. Fig 5 shows class I peptide inhibitor is distinct from class II and class III with respect to peptide sequence and structure, demonstrating the design of class I peptide inhibitor different from class II and III peptide inhibitors. Furthermore, the tetrapeptide domain sequence (Y5 position) between two positive charged amino acids in class I peptide inhibitor also depends on the N-terminal and C-terminal peptide flanking sequences as proline or threonine is not a conservative substitution of leucine or isoleucine evidenced by STN CAS Registry 2008 as shown follows. A representative sequence alignment of the elected species of SEQ ID NO: 96 in comparison to SEQ ID NO: 10 shows poor structural similarity of 29.6%.
PNG
media_image4.png
150
616
media_image4.png
Greyscale
Without establishing a correlation between a peptide sequence and the function of class I peptide inhibitor, the specification failed to satisfy written description requirements.
Claims 13-14, 17-24, and 26 are rejected as depending on claim 12.
The rejection may be overcome by distinctly claiming the peptide sequences with specified SEQ ID NOs.
Applicant’s Arguments
Claims 12-14 And 17-26 Comply With The Written Description Requirement for the reasons as follows:
Claim 12 Does Not Contain New Matter because Y5 amino acid substitutions have representative species disclosed in Table 2 (Remarks, p6, last para to p7, para 1-3).
The Specification Is Sufficient for the reasons as follows:
A Representative Number Of Species Are Described because the amendment to fix typographical error in claim 12 overcomes the rejection (Remarks, p7, last two para).
The Specification Describes A Correlation Between Structure & Function.
All Y5 embodiments are exemplified by SEQ ID NO:s 1-25 as presented in Table 2 and Applicant's describe binding region having a six amino acid sequence derived from amino acid sequences of fusion and other protein regions of various viruses according to Sigalov Declaration 3 (Remarks, p8, whole page).
Applicant’s specification provides more than sufficient written description. It is not the Y5 amino add sequence order that provides function, but its length (e.g., four amino acids). Applicant's Specification pg 55 [141] (emphasis added). As such, a four amino acid peptide flanked by a single positively charged amino acids is a common structural element that represents the entire species (Remarks, p9, para 2-4).
Applicant's Specification pg 32 [073] (emphasis added); See also, The Sigalov Declaration 4. The above examples of written description, alone, establishes a correlation between the structure and function of the presently claimed Class I inhibitor peptides. Written description is also present which identifies specific an1ino acid substitutions and their biological purpose for all the other positions . Applicant's Specification pg70 [171] (emphasis added). The Y3, Y7 - Y9 amino acid substitutions are supported by written description disclosing that these are not arbitrarily selected or based upon trial & error, but adhere to rational design requirements of amino acid addition and/or substitution that improve biological activity of the naturally occurring core peptide (e.g., SEQ ID NO: 10) (Remarks, p9, last two para to p10, para 1-2).
The guideline peptide inhibitor design has been described in US 20090075899 and incorporated by reference; thus, the instant specification satisfies written description requirements (Remarks, p10, para 3-5).
According to Sigalov Declaration, applicant used computer for designing and predicting peptide sequences and the experimental data show SEQ ID NO: 17 superior to TCR inhibition efficacy as compared to either SEQ ID NO: 14 or SEQ ID NO: 10 (Remarks, p11, whole page).
Applicant’s declaration shows how to design and optimize the peptide inhibitor binding to the targeted receptor; thus, the specification satisfy written description requirements.
Response to Arguments
Applicant's arguments filed 3/27/2026 have been fully considered but they are not persuasive for the reasons as follows.
PNG
media_image4.png
150
616
media_image4.png
Greyscale
Applicant’s argument (A) is not persuasive because the introduction of claim changes which involve narrowing the claims by introducing elements or limitations which are not supported by the as-filed disclosure is a violation of the written description requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996). See MPEP 2163.05 (B)(II). SEQ ID NOs: 1-25 in Table 2 only represent the individual peptide sequences as they are (NOT the entire genus of the peptide formula in claim 12) evidenced by a representative sequence alignment comparison the elected SEQ ID NO: 96 to SEQ ID NO: 10 as shown follows.
Applicant’s argument (B)1 is not persuasive because fixing typographical error in claim 12 is insufficient to overcome other reasons of 112(a) rejection. The introduction of claim changes which involve narrowing the claims by introducing elements or limitations which are not supported by the as-filed disclosure is a violation of the written description requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. The original specification disclosed a tetrapeptide sequence independently selected from [LITP] in any order, neither explicitly teaching not inherent teaching the specific tetrapeptide of Y5 position as claimed..
Applicant’s argument (B)2(i) is not persuasive because SEQ ID NOs: 1-25 only represent the individual peptide sequences as they are not the entire genus of the peptide formula in claim 12. See response to argument (A) above. Sigalov Declaration 3 describes certain peptides fail to inhibit TCR in vitro; such kind arguments do not demonstrate the amendment to claim 12 without sufficient written description requirements.
Applicant’s argument (B)2(ii) is not persuasive because p55 [141] references to Fig 5 which shows specific class I inhibitor peptide sequences SEQ ID NO: 6, 76, and 78 as shown follows and the limited disclosure is insufficient to support the entire genus of the peptide formula in claim 12.
PNG
media_image5.png
104
726
media_image5.png
Greyscale
Applicant’s argument (B)2(iii) is not persuasive because pg 32 [073] discloses a general difference inhibitor peptide design among class I, II, and III, but does not teach or suggest the entire genus of the peptide formula in claim 12 or the amendment to claim 12. Specification pg70 [171] is general description for conjugating at least one polyarginine and/or polylysine to an inhibitory peptide for binding to the transmembrane membrane of a targeted receptor. The disclosure of polyarginine and polylysine does not support Y1 as a single arginine or Y2 as a single lysine in claim 12.
PNG
media_image6.png
294
954
media_image6.png
Greyscale
Applicant’s argument (B)2(iv) is not persuasive because US 20090075899 as argued by applicant neither explicitly nor inherently teach the peptide formula in claim 12. Fig 11 of US 20090075899 shows a general compound formula as shown follows. The compound formula did not explicitly nor inherently teach the instant peptide formula such as the tetrapeptide sequences of Y5 position in the instant claim 12. Even though the general compound formula of Fig 11 may be able to “create” a tetrapeptide of Y5 as claimed by selecting/swapping/combining the amino acids listed in each domain, one of ordinary skill in the art would not recognize the general compound formula of Fig 11 explicitly or inherently teaches the instant peptide formula. See MPEP 2163.05 (B)(II).
Applicant’s argument (B)2(v) is not persuasive because (a) the examiner is focusing on whether the peptide sequences of the peptide formula have sufficient support in the SPEC and a human can also design a peptide sequence and validate the peptide activity through a functional assay. The applicant appears to argue unexpected result, a better activity compared to a reference peptide, but this type of argument does not apply to insufficient written description under 112(a).
Applicant’s argument (B)2(vi) is not persuasive because Applicant’s declaration are describing a peptide inhibitor design and mechanism of the inhibitor peptide. Applicant’s declaration does not change the fact that the specific tetrapeptide sequences at the Y5 position lacks of support support by the original specification of a tetrapeptide sequence independently selected from [LITP] in any order. Thus, claim 12 is rejected for lack of sufficient written description. See the response to arguments above. The rejections are unlikely to be overcome by verbal arguments of peptide inhibitor design because the rejections are not based on prior art references. Thus, the examiner suggests distinctly claiming the peptide inhibitor sequences with SEQ ID NOs supported by the disclosure to overcome 112(a) rejection.
Maintained Rejection
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 25 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. At least the peptide SEQ ID NO 17 as claimed do not read on the peptide formula at position 9 in claim 12. The examiner also found many other peptide sequences in claim 25 do NOT read on the peptide formula in claim 12 either. Appropriate correction is required.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Examiner Note:
The closest prior art references Sigalov (WO 2008/0762675 A2, previously cited 05/10/2021) disclosed a lipid-peptide conjugate formula (Fig 11), but did not teach the elected peptide species of SEQ ID NO: 96.
Allowable Subject Matter
The elected species of SEQ ID NO: 96 is allowable as the examiner did not find a prior art teaching the peptide sequence of SEQ ID NO: 96.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIA-HAI LEE whose telephone number is (571)270-1691. The examiner can normally be reached Mon-Fri from 9:00 AM to 6:00 PM.
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, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.L/Examiner, Art Unit 1658
09-June-2026
/Melissa L Fisher/ Supervisory Patent Examiner, Art Unit 1658
Prosecution Insights