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 .
DETAILED ACTION
1. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/20/26 has been entered.
2. The terminal disclaimer filed on 2/20/26 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent granted on application serial no. 17/790,711 has been reviewed and is NOT accepted for the following reason(s). The applicant spelling is incorrect: The applicant cited on the TD should be cited exactly as cited on the ADS form, in its entirety. Please correct and submit the TD. No fee is required.
3. Applicant is reminded of Applicant's election without traverse of Group I and species of SEQ ID NO: 2, HLA-A*0201, monomer, placeholder peptide MHC-I complex, no peptide of interest is contacted and no further moiety is attached in Applicant’s amendment and response filed 9/6/23. Examination had been previously extended to include H-2Dd and SEQ ID NO: 4, and on HLA-A*02:01 and the “gTAX/HLAA*” placeholder peptide (which is SEQ ID NO: 40), as well as H-2Ld and QL9. Upon consideration of the prior art, examination is presently being extended to all recited species.
Claims 1, 12, 15, 16, 27, 30, 34, 35, 37, 43, 44 and 46 are presently being examined.
4. Applicant is reminded that the prior rejection of record of claims 1, 12, 15,16, 27, 30, 34, 35, 37, 43, 44 and 46 as rejected under 35 U.S.C. 102(a)(2) as being anticipated by US20230059548 A1 was withdrawn in view of Applicant’s statement pursuant to 35 U.S.C. 102(b)(2)(C) filed 3/31/2025.
5. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
6. For the purpose of prior art, the filing date of instant claims is deemed to be the filing date of provisional application 63/011,221, i.e., 4/16/20, as provisional application 62/957,040 does not support the claimed limitations of the instant application. The said provisional application 62/957,040 does not provide support for biotinylation prior to contact with [dipeptides] and chaperone, the QL9 peptide, the AcLLFGYPVYV peptide, or for contacting the plurality of p*MHC I complexes with the TAPBPR, multimer backbones and peptides of interest in one step.
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 § 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.
8. Claims 1, 12, 15, 16, 27, 30, 34, 37, 43, 44 and 46 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 99-109 and 111-118 of copending Application No. 17/790,711 in view of Kalergis et al (JM, 2000, 234: 61-70, of record) and Khan et al (J. Immunol. 2000, IDS reference), as evidenced by an admission in the instant specification at [00129].
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Court rulings have been quite clear that ONLY DIVISIONAL applications are entitled to the shield from double patenting under 35 USC 121. Indeed, in AMGEN INC v. HOFFMANN LA ROCHE LTD GMBH LA (Nos. 2009-1020, 2009-1096) the court discusses this issue at length and states:
Turning to the legislative history, the court observed that a House Report also referred specifically to “divisional application[s].” Id. Notably absent from the legislative history, in the court's view, was a suggestion “that the safe-harbor provision was, or needed to be, directed at anything but divisional applications.” Id. at 1361. From there, the court “conclude^] that the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications.” Id. at 1362. Accordingly, the court decided that the § 121 safe harbor did not apply to the patent before it, which issued from a continuation-in-part application. Id.
We are persuaded by the reasoning in Pfizer that the § 121 safe harbor provision does not protect continuation applications or patents descending from only continuation applications. The statute on its face applies only to divisional applications, and a continuation application, like a continuation-in-part application, is not a divisional application.
Given that Applicant chose to file the ‘711 case as a separate unrelated application, not as a DIV of the instant application, the instant rejection has been set forth.
Claim interpretation: The instant claims recite the open transitional phrase “comprising” opening the claimed method to encompass other non-recited method steps and/or ingredients. The instant specification does not disclose a limiting definition for “placeholder peptide(s)”, but generally discusses that the MHC I complexes formed with placeholder peptides are “peptide receptive” for peptide exchange using TAPBPR (with or without a dipeptide (e.g., [0010], [0030],[0047],[0057]). The specification at [0075] discloses (In a non-limiting fashion) that suitable placeholder peptides can include, for example, modified versions of peptides known to bind to the particular MHC class I allele included in the peptide receptive MHC-I complex, and having lower affinity than the wild type peptide. The specification discloses that streptavidin is an example of a multimer backbone ([0040]).
Claims 99-109 and 111-118 of 17/790,711 are drawn to a method of purifying a peptide of interest that binds an MHC class I molecule, the method comprising contacting a precursor/”placeholder” peptide-MHC I complex comprising a MHC class I heavy chain, a b2m and a precursor peptide with a molecular chaperone such as TAPBPR, thereby forming a peptide receptive MHC I complex, including wherein the molecular chaperone is at a ratio of less than 1:1 (including the ratios recited in instant claims) and affixing the peptide receptive MHC complex (i.e., the placeholder MHC-I complex) to a solid substrate, and including wherein the heavy chain or b2m is biotinylated and the solid substrate comprises a biotin binding protein, and/or wherein the solid substrate comprises a molecular barcode. The claims of 17/790,711 also recite a step of contacting the peptide receptive MHC I/placeholder peptide complex with a plurality of peptides of interest, thereby forming a peptide of interest/MHC I complexes.
Although the claims of ‘711 do not recite how the precursor peptide/MHC I complex is made, they do recite the components, and so it would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to have incubated the MHC class I heavy chain, b2m and precursor peptide in order to form the said complex.
One of ordinary skill in the art would have been motivated to do this and with a reasonable expectation of success in doing so, as it was well known in the art to recombinantly make these said components and mix them in vitro to form such a complex, as is taught for example by Morozov et al (PNAS, 2016: E1006-E1015, doi/10.1073/pnas.1519894113, IDS reference), while other precursor peptides were known in the art as is taught for example by Khan et al that is also cited above in this office action.
Instant dependent claim 44 is included in this rejection because streptavidin was a commonly known in the art to be a strong binding partner for biotin before the filing date of the claimed invention, as is evidenced for example by Kalergis et al* (2000, of record), and the claims of ‘711 recite that the solid substrate comprises a biotin binding protein, and so it would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to have used any suitable biotin binding partner such as streptavidin in the method recited in the claims of ‘711 in order to associate the biotinylated MHC I/peptide complexes into higher order multimers for increased valency.
*Kalergis et al teach that a powerful approach for the detection of MHC/peptide specific T cells has been made possible by the engineering of soluble tetrameric MHC/peptide complexes consisting of biotinylated MHC/peptide molecules bound to fluorescent labeled streptavidin (see entire reference, especially abstract).
In addition, although the claims of 17/790,711 recite that the MHC-I is HLA-A:02, they do not recite that the HLA-A:02 is HLA-A*02:01 and that the placeholder peptide is LFGYPVYV.
Khan et al teach that HLA-A2 can form a complex with Tax 8 peptide LFGYPVYV, which is an N-terminally truncated version of the wild type Tax 9 peptide LLFGYPVYV. Khan et al teach the Tax 8 peptide is much less stable with a Tm at 16 degrees C (e.g., abstract). Khan et al teach that the stability of the HLA-A2/Tax 8 complex is markedly reduced as expected for loss of the conserved interactions at the N-terminal peptide binding site, but that the structure of the complex is remarkably similar with water molecules substituting for some of the peptide interactions in the binding site (sentence before the materials and methods section). Khan et al teach forming complexes of the Tax 8 peptide and HLA-A2 by contacting recombinantly produced HLA-A2 heavy chain, b2m and Tax 8 peptide (materials and methods at the first sentence). (See entire reference.)
The admission in the instant specification at [00129] is that the gTax peptide (recited in instant dependent claims consists of the sequence LFGYPVYV (i.e., the same as is taught by Khan et al).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to have used the destabilizing Tax 8 peptide taught by Khan et al in the method recited in the claims of 17/790,711.
One of ordinary skill in the art would have been motivated to do this in order to provide a complex of HLA-A2 with a less stable peptide that is more receptive to peptide exchange due to its lower Tm value, and with a reasonable expectation of success in doing so, as Khan et al teach that this Tax 8 peptide does form complexes with HLA-A2 while having significantly lower Tm and without significantly changing the structure of the complex.
Claims 1, 12, 15, 16, 27, 30, 34, 37, 43, 44 and 46 are directed to an invention not patentably distinct from claims 99-109 and 111-118 of commonly assigned 17/790,711, as enunciated supra.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned 17/790,711, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
The Examiner note Applicant’s comment that a terminal disclaimer has been presently filed over the ‘711 application. However, as indicated above at item #2 of this office action, the said terminal disclaimer has been disapproved for the reasons stated above.
9. Applicant is reminded that Applicants response filed 3/31/25 has overcome the prior rejection of record of claims 1, 12, 15, 16, 27, 30, 34, 37, 43, 44 and 46 on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,814,420 (of record) in view of US20230059548 A1.
Applicant has stated on page of the said response that the subject matter disclosed in US 20230059548 and the presently claimed invention of US application no. 17/141,096, not later than the effective filing date of the claimed invention, were subject to an obligation of assignment to the Regents of the University of California.
10. Applicant is reminded that Applicants response filed 3/31/25 has overcome the prior rejection of record of claims 1, 12, 15, 16, 27, 30, 34, 37, 44 and 46 as provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-81 of copending Application No. 18/482,755 in view of US20230059548 A1.
Applicant has stated on page of the said response that the subject matter disclosed in US 20230059548 and the presently claimed invention of US application no. 17/141,096, not later than the effective filing date of the claimed invention, were subject to an obligation of assignment to the Regents of the University of California.
11. Applicant is reminded that the prior rejection of record of claims 1-3, 12, 15-18, 26, 27, 30, 34, 37, 44 and 46 as provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-10, 12-18 and 20-26 of copending Application No. 17/233,407 in view of Kalergis et al (JM, 2000, 234: 61-70, of record) had been withdrawn as Applicant had amended the instant claims to recite particular MHC class I molecules that are not recited in the claims of 17/233,407. In addition, Applicant had canceled claims 2, 3, 18 and 26.
12. Claim 35 is allowed. Claims 1, 12, 15, 16, 27, 30, 34, 37, 43, 44 and 46 are rejected.
13. All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIANNE DIBRINO whose telephone number is (571)272-0842. The examiner can normally be reached on M, T, Th, F.
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If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, MISOOK YU can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Marianne DiBrino/
Marianne DiBrino, Ph.D.
Patent Examiner
Group 1640
Technology Center 1600
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641