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 .
Information Disclosure Statement
The information disclosure statements (IDS) filed 04/25/2023 and 12/10/2025 have been considered and the references therein are of record.
Claim Objections
Claim 15 is objected to because of the following informalities: contains a grammatical error, reciting, “wherein the IL-15/IL-15Ra complex a fusion protein comprising”; “is” should be inserted. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 2 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.
Regarding claims 2, 6, 9, 10, and 12-15, the term "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. Furthermore, regarding claim 14, 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). The claim is 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.
Regarding claim 10, the phrase “at least about” is a relative term which renders the claim indefinite. The term “at least about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claim 11 is rejected due to dependency on claim 10.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claims recite the natural phenomenon of the naturally occurring protein complex, This judicial exception is not integrated into a practical application because the claims only require the naturally occurring complex. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the intended use of the Claims 2-15 are rejected under 35 U.S.C. 101 due to dependency on claim 1.
Claims 10-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. Claims 10-11 recite inherent biological properties of the IL-15/IL-15Ra complex treatment: reduction in tumor size and activation of the innate immune response mediated by NK cells. This judicial exception is not integrated into a practical application because the claims simply recite inherent biological properties of the IL-15/IL-15Ra complex treatment. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims simply recite inherent biological properties of the IL-15/IL-15Ra complex treatment. Claims 12-15 are rejected under 35 U.S.C. 101 due to dependency on claims 10-11.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-14 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Lewis et al., 2018 (WO 2018134784 A1).
The instant claims are drawn to an IL-15/IL-15Ra complex for cancer treatment.
The instant claims recite the phrase “for use” which renders what follows the phrase as statements of intended use. The claim language encompassed by a statement of intended use does not hold patentable weight if it does not impart structure to the product being claimed. Claims 1-15 are interpreted as product claims. The intended use language of claims 1-14 recites the function of the IL-15/IL-15Ra complex as a cancer treatment, which does not impart structure to the 15/IL-15Ra complex and is therefore nonlimiting. In contrast, the intended use language of claim 15 does impart structure to the IL-15/IL-15Ra complex by specifying sequences (SEQ ID NO: 4, 6, and 9) and is therefore limiting.
Lewis teaches the IL-15/IL-15Ra complex (abstract) and therefore anticipates claims 1-14.
In the interest of compact prosecution, Examiner will also address the intended use in claims 1-14, which is anticipated by Lewis et al., 2018 (WO 2018134784 A1).
The intended use recited in claims 1-14 is drawn to using an IL-15/IL-15Ra complex in the treatment of squamous cell carcinoma in patients that are resistant or refractory to at least one immune checkpoint inhibitor treatment. The complex is intended to be used with or without a PD-1 antagonist. Also, the complex is intended to be administered according to a cyclical administration regimen.
Lewis teaches an IL-15/IL-15Ra complex (page 12) for use in treatment of non-small-cell lung cancer with squamous histology in a human patient (page 13, 1st paragraph) with or without being administered in combination with a PD-1 antagonist (pages 14-15, last paragraph of page 14 through 1st paragraph of page 15; Lewis claim 1) that the patient is resistant or refractory to (page 3-4, last paragraph of page 3 through 2nd paragraph of page 4; page 5, last paragraph) as required in instant claims 1-9. Lewis teaches that this treatment results in at least a 30% size reduction in the tumor and that it is mediated by the NK cells of the innate immune response as required in instant claims 10-11 (page 31, 1st paragraph; page 50, 4th paragraph). Lewis teaches subcutaneously administering a dose of the IL-15/IL-15Rα complex to a subject at a frequency of once per day on consecutive days for 2 days a week and repeating this weekly regimen 2 or more times and then teaches no administration of the IL-15/IL-15Rα complex for a second period of time as required in instant claims 12-13 (Lewis page 7). Lewis teaches a dose of the IL-15/IL-15Rα complex which is 0.1 μg/kg to 10 μg/kg as required in instant claim 14 (Lewis page 7). Therefore, Lewis anticipates the intended use recited in claims 1-14.
Claim Rejections - 35 USC § 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Lewis et al., 2018 (WO 2018134784 A1) as applied to claims 1-14 above and in further view of Morisseau et al., 2012 (WO2012175222-A1) (see IDS Document and instant PTO-892).
Claim 15 is drawn to an IL-15/IL-15Ra complex where the human IL-15Ra sushi domain comprises the sequence of SEQ ID NO:6, the human IL-15 comprises the sequence of SEQ ID NO: 4, and the IL- 15/IL-15Ra complex as a whole is the sequence of SEQ ID NO: 9.
While Lewis teaches the IL-15/IL-15Ra complex as applied to claims 1-14 above, Lewis does not teach specific sequences for the complex.
Morisseau teaches the IL- 15/IL-15Ra complex (SEQ ID NO: 17) with an identical sequence to instant SEQ ID NO: 9, which encompasses SEQ ID NO: 4 and 6. The alignment data between Morisseau SEQ ID NO: 17 and instant SEQ ID NO: 9 is shown below. SEQ ID NO: 4 has an identical alignment spanning from position 3 to position 63 in the diagram below. SEQ ID NO: 6 has identical alignment spanning from position 98 to position 211 in the diagram below.
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It would have been prima facie obvious to arrive at the claimed invention from the disclosure of Lewis and Morisseau. A person having ordinary skill in the art would have been motivated to make and use the invention as claimed because a person of ordinary skill would have been motivated to use the sequence of Morisseau to synthesis the IL- 15/IL-15Ra complex as disclosed by Lewis. A person having ordinary skill in the art would have had a reasonable expectation of success based on the cumulative disclosure of the prior art references.
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 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of co-pending Application No. 18/033,524. Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims recite an IL-15/IL-15Ra complex for use in the treatment of squamous cell carcinoma in a human patient who’s resistant or refractory to at least one immune checkpoint inhibitor treatment (claim 1). The dependent claims recite specific species of squamous cell carcinoma, not co-administering an immune checkpoint inhibitor such as a PD-1 antagonist, co-administering an immune checkpoint inhibitor such as a PD-1 antagonist, tumor reduction, activation of the innate immune response mediated by NK cells, a cyclical administration regimen, specific dosages of the complex, specific sequences of the complex, and that the patient is resistant or refractory to a PD-1 antagonist (claims 2-15).
The co-pending claims recite an IL-15/IL-15Ra complex for use in the treatment of non-melanoma skin cancer in a human patient whose non-melanoma skin cancer is skin squamous cell carcinoma (claim 1). The dependent claims recite that the patient is resistant or refractory to at least one immune checkpoint inhibitor treatment including a PD-1 antagonist, not co-administering an immune checkpoint inhibitor such as a PD-1 antagonist, co-administering an immune checkpoint inhibitor such as a PD-1 antagonist, tumor reduction, activation of the innate immune response mediated by NK cells, a cyclical administration regimen, specific dosages of the complex, and specific sequences of the complex (claims 2-15).
Instant claim 1 recites the genus of squamous cell carcinoma and instant claim 2 recites a species of this genus, non-melanoma skin cancer. Co-pending claim 1 also recites non-melanoma skin cancer. Therefore, the instant claims encompass the co-pending claim. Further, claims 3-15 are identical between applications. Also, SEQ ID NO: 4, 6, 9 of the instant claims share identical sequence identity to SEQ ID NO: 4, 6, 9 of the co-pending claims. Therefore, claims 1-15 are rejected as being unpatentable over co-pending Application No. 18/033,524. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 42-53 of co-pending Application No. 17/612,432. Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claims 1-15 are recited above.
The co-pending claims recite a method of treating or managing cancer or infectious diseases comprising administering an interleukin-2/interleukin-15 receptor beta gamma (IL-2/IL-15Rby) agonist to a human patient using a cyclical administration regimen, where the IL-2/IL- 15Rby agonist is an IL-15/IL-15Ra complex (claim 41). The dependent claims recite specific days of administering the complex, specific dosages, injection methods, injection routines, specific sequences, and co-administration of a therapeutic antibody. The co-pending application does not specify that the patient is resistant or refractory to at least one immune checkpoint inhibitor treatment.
As instant claims 1, 12-14 recite a specific species (the IL-15/IL-15Ra complex) of the generic genus (an IL-2/IL-15Rby agonist) recited in co-pending claims 42-47 and cyclical administration regimes for the treatment of cancer, the instant claims anticipate the co-pending claims. Further, co-pending claim 42 specifies the IL-2/IL-15Rby agonist as the IL-15/IL-15Ra complex. Also, the specific administration methods and injection regimes of co-pending claims 45-47 are encompassed by the generic cyclical administration regime of instant claims 1, 12-14. Instant claims 4-9 are not patentably distinct from co-pending claims 51-53 because the instant claims encompass all immune checkpoint inhibitors administered alongside the IL-15/IL-15Ra complex, which encompasses the specific immune checkpoint inhibitors, anti-PD-1 and anti-Nectin 4, recited in the co-pending claims. Instant claims 10-11 are inherently encompassed by co-pending claims 42, 48 because tumor reduction and the activation of the innate immune response mediated by NK cells are inherent properties of IL-15/IL-15Ra complex treatment. Also, SEQ ID NO: 4, 6, 9 of instant claim 15 share identical sequence identity to SEQ ID NO: 4, 6, 9 of co-pending claim 50. Therefore, claims 1-15 are rejected as being unpatentable over co-pending Application No. 17/612,432. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH CESARE whose telephone number is (571)272-6908. The examiner can normally be reached Monday - Friday .
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/JOSEPH D. CESARE/Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675