DETAILED ACTION
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. Applicant’s Request for Continued Examination received on 07 May 2026, Amendment and Arguments/Remarks received on 07 April 2026 have been entered. Claims 1, 3-18, and 20 were previously pending in the application. Claim 11 has been newly cancelled by Applicant, and no new claims have been added. Claims 1, 3-10, 12-18, and 20 are currently pending in the application. Claims 1, 16, 17, and 18 are independent claims.
The following election of species remains in effect in the instant application:
4)c. costimulatory factor: OX40.
Claims 4-7 and 12 remain withdrawn from consideration as being directed to a nonelected species.
Claims 1, 3, 8-10, 13-18, and 20 are currently pending and under examination in the instant application. An action on the merits follows.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Priority
The present application is a 35 U.S.C. 371 national stage filing of International Application No. PCT/US20/24674, filed 25 March 2020, which claims priority to U.S. Provisional Application No. 62/823,215, filed 25 March 2019.
Thus, the earliest possible priority for the instant application is 25 March 2019.
Claim Objections
Amended claim 10 is newly objected to because of the following informalities: claim 10 recites, “of any one of claim 1”, which appears to be a typographical error for “of claim 1” in that claim 1 is singular and so has no alternative options from which to select “any one of”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The rejection of amended, previously presented, and original claims 1, 3, 8-10, 13-18, and 20 under 35 U.S.C. 112(b) as failing to particularly point out and distinctly claim the subject matter which the inventor(s) regards as the invention for independent claims 1 and 18 reciting, “wherein the engineered RPS27A 5’UTR sequence comprises SEQ ID NO: 82, SEQ ID NO: 83, or SEQ ID NO: 84” in lines 6-7 and 8-9, respectively, is withdrawn in view of Applicant’s amendments to the claims.
Original claim 9 is newly 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 9 recites, “wherein the co-stimulatory molecule is selected from” followed by a list of co-stimulatory molecules connected by the linking word “or”, which is indefinite because it is unclear which co-stimulatory molecules are being selected from and whether the list is an open or closed list. As such, the metes and bounds of the claim cannot be determined.
Claim Interpretation
Applicant amended claims 1 and 18 to recite, “wherein the engineered 5’ UTR is a sequence according to SEQ ID NO: 82, SEQ ID NO: 83, or SEQ ID NO: 84” in lines 3-5 of claim 1 and lines 4-5. The limitation “is a sequence” has been afforded its broadest reasonable interpretation to encompass wherein the engineered 5’UTR is a fragment having at least two and up to all of the nucleotides comprised within the sequences of SEQ ID NO: 82, SEQ ID NO: 83, or SEQ ID NO: 84.
If Applicant intends to limit the engineered 5’ UTR to only full-length sequences according to SEQ ID NO: 82, SEQ ID NO: 83, or SEQ ID NO: 84, Examiner suggests amending independent claims 1 and 18 to recite “wherein the engineered 5’ UTR sequence is selected from the group consisting of the sequences according to SEQ ID NO: 82, SEQ ID NO: 83, and SEQ ID NO: 84”.
Similarly, claim 10 has been amended to recite, “wherein the RPS27A 3’UTR sequence is a sequence according to one selected from the group consisting of SEQ ID NO: 24, SEQ ID NO: 25, SEQ ID NO: 26, SEQ ID NO: 87, SEQ ID NO: 89, and SEQ ID NO: 91” in lines 1-2. The limitation “is a sequence” has been afforded its broadest reasonable interpretation to encompass wherein the RPS27A 3’UTR sequence is a fragment having at least two and up to all of the nucleotides comprised within the sequences of SEQ ID NO: 24, SEQ ID NO: 25, SEQ ID NO: 26, SEQ ID NO: 87, SEQ ID NO: 89, and SEQ ID NO: 91.
If Applicant intends to limit the RPS27A 3’UTR sequence to only full-length sequences according to SEQ ID NO: 24, SEQ ID NO: 25, SEQ ID NO: 26, SEQ ID NO: 87, SEQ ID NO: 89, and SEQ ID NO: 91, Examiner suggests amending claim 10 to recite “wherein the RPS27A 3’UTR sequence is selected from the group consisting of the sequences according to SEQ ID NO: 24, SEQ ID NO: 25, SEQ ID NO: 26, SEQ ID NO: 87, SEQ ID NO: 89, and SEQ ID NO: 91”.
Claim Rejections - 35 USC § 112(a)- Written Description
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.
Amended, previously presented and new claims 1, 3, 8-10, 13-18, and 20 are newly 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 applicant is reminded that an amendment to the claims or the addition of a new claim must be supported by the description of the invention in the application as filed. In re Wright, 866 F.2d 422, 9 USPQ2d 1649 (Fed. Cir. 1989). New or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972).
Applicant amended claims 1 and 18 to recite, “wherein the engineered 5’ UTR is a sequence according to SEQ ID NO: 82, SEQ ID NO: 83, or SEQ ID NO: 84” in lines 3-5 of claim 1 and lines 4-5. The limitation “is a sequence” has been afforded its broadest reasonable interpretation to encompass wherein the engineered 5’UTR is a fragment having at least two and up to all of the nucleotides comprised within the sequences of SEQ ID NO: 82, SEQ ID NO: 83, or SEQ ID NO: 84. However, the instant disclosure does not provide any teachings, explicitly or implicitly, to support this new limitation.
The specification recites:
“In some embodiments, the engineered 5’UTR sequence is selected from the group comprising SEQ ID NO: 12, SEQ ID NO: 13, SEQ ID NO: 14, SEQ ID NO: 15, SEQ ID NO: 16, SEQ ID NO: 17, SEQ ID NO: 18, SEQ ID NO: 19, SEQ ID NO: 20, SEQ ID NO: 21, SEQ ID NO: 22, SEQ ID NO: 23, SEQ ID NO: 81, SEQ ID NO: 82, SEQ ID NO: 83, SEQ ID NO: 84, SEQ ID NO: 85, or SEQ ID NO: 86.” [page 4, 20, 21];
“In some embodiments, the RPS27A 5'UTR sequence comprises SEQ ID NO: 84” [page 19, 21];
“In some embodiments, the engineered 5'UTR sequence is SEQ ID NO: 82. In some embodiments, the engineered 5'UTR sequence is SEQ ID NO: 83. In some embodiments, the engineered 5'UTR sequence is SEQ ID NO: 84.” [page 21];
“In some embodiments, the engineered 5'UTR sequence is selected from the group comprising a nucleic acid sequence at least 60% (for example, at least 60%, at least 65%, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 95%, at least 96%, at least 97%, at least 98%, at least 99%) identical to SEQ ID NO: 12, SEQ ID NO: 13, SEQ ID NO: 14, SEQ ID NO: 15, SEQ ID NO: 16, SEQ ID NO: 17, SEQ ID NO: 18, SEQ ID NO: 19, SEQ ID NO: 20, SEQ ID NO: 21, SEQ ID NO: 22, SEQ ID NO: 23, SEQ ID NO: 81, SEQ ID NO: 82, SEQ ID NO: 83, SEQ ID NO: 84, SEQ ID NO: 85, or SEQ ID NO: 86.” [page 21];
“In some embodiments, the engineered 5'UTR sequence comprises SEQ ID NO: 82” [page 21]; and
“In some embodiments, the engineered 5'UTR sequence comprises SEQ ID NO: 83” [page 21].
Additionally, the examples of the specification teach the use of full length 5’UTR-25 (SEQ ID NO: 82), 5’UTR-26 (SEQ ID NO: 83), or full length 5’UTR-27 (SEQ ID NO: 82) [Example 7, 8, Figure 7, 8].
Therefore, the specification teaches that the engineered 5’ UTR is a sequence which is or comprises the full-length sequence of SEQ ID NO: 82, 83, or 84 or which is at least 60% identical to the sequence of SEQ ID NO: 82, 83, or 84. By reciting that the 5’ UTR sequence is selected from the group comprising a nucleic acid sequence at least 60% identical to SEQ ID NO: 82, 83, or 84, the specification is requiring a nucleic acid sequence which is at least 60% of the length of the sequences according to SEQ ID NO: 82, 83, or 84. None of the working examples disclose using fragments of the sequences according to SEQ ID NO: 82, SEQ ID NO: 83, or SEQ ID NO: 84.
The specification does not teach wherein the engineered 5’UTR is a fragment having at least two nucleotides comprised within the sequences of SEQ ID NO: 82, SEQ ID NO: 83, or SEQ ID NO: 84.
The drawings present data associated with 5’UTR-25, 5’UTR-26, and 5’UTR-27 [Figures 7,8], but do not provide any teachings for using a fragment of the sequences according to SEQ ID NO: 82, SEQ ID NO: 83, or SEQ ID NO: 84.
Therefore, the disclosure does not provide support for the limitation newly recited in independent claims 1 and 18 of “wherein the engineered 5’ UTR is a sequence according to SEQ ID NO: 82, SEQ ID NO: 83, or SEQ ID NO: 84”, and the limitation is new matter.
Claim Rejections - 35 USC § 103
The rejection of amended, previously presented, and original claims 1, 3, 8-10, 13-18, and 20 under 35 U.S.C. 103 as being unpatentable over Enenkel et al. (US20080131969A1, published 05 June 2008); in view of Stewart et al. (US10953033B2, published 23 March 2021 with priority to U.S. provisional Application Nos. 62/676,688 filed 25 May 2018 and 62/599,547 filed 15 December 2017); Kunert (2018, Adoptive T cell Therapy Against Solid Tumors: Success Requires Safe TCRs and Countering Immune Evasion. [Doctoral Thesis, Erasmus University Rotterdam]. Erasmus Universiteit Rotterdam (EUR), published 04 April 2018); and Thess (US20170029847A1, published 2 February 2017), is withdrawn.
Applicant amended claims 1 and 18 to recite, “wherein the engineered 5’ UTR is a sequence according to SEQ ID NO: 82, SEQ ID NO: 83, or SEQ ID NO: 84” in lines 3-5 of claim 1 and lines 4-5. The limitation “is a sequence” has been afforded its broadest reasonable interpretation to encompass wherein the engineered 5’UTR is a fragment having at least two and up to all of the nucleotides comprised within the sequences of SEQ ID NO: 82, SEQ ID NO: 83, or SEQ ID NO: 84. Although Enenkel teaches a 5’ UTR sequence in Figure 3 comprising sequences having at least two nucleotides comprised within the sequences of SEQ ID NO: 82, SEQ ID NO: 83, or SEQ ID NO: 84 (including GGC, AGA, or AAG of SEQ ID NO: 84), Enenkel does not teach that any of those fragments is the full length 5’ UTR.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dr. KATIE L PENNINGTON whose telephone number is (703)756-4622. The examiner can normally be reached M-Th 8:30 am - 5:30 pm, Friday 8:30 am - 12:30 pm CT.
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DR. KATIE L. PENNINGTON
Examiner
Art Unit 1634
/KATIE L PENNINGTON/Examiner, Art Unit 1634
Dr. A.M.S. Wehbé
/ANNE MARIE S WEHBE/Primary Examiner, Art Unit 1634
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