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 .
Election/Restriction
The response filed on 4/29/26 to the restriction requirement of 1/29/26 has been received. Without traverse, Applicant has elected Group I and the following species: the combination of SEQ ID NO:77 (MK150) and SEQ ID NO:75 (MH8).
Claims 1 and 29-69 are pending.
Claims 31-46 are withdrawn from further consideration by the examiner under 37 CFR 1.142(b) as being drawn to a non-elected invention.
Claims 1, 29, 30, and 47-69 are currently under consideration.
Claim Objections
Claim 29 is objected to because of a typographical issue. The word “and” appears to be missing after part f) and before part g) of the claim. Proper 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 29, 30, and 47-69 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.
Claims 29-30 are rejected to because the metes-and-bounds of the claims are unclear. Parts a)-f) of claim 29 each recite a domain is “linked to” without reciting what each domain is linked to. In an effort to expedite prosecution, it is suggested all instances of “linked to” be deleted from parts a)-f) of claim 29.
Claims 47-52 are rejected because claims 47-48 both recite a “construct of any one of claims 1”. It is unclear what is meant by “claims (plural) 1”. The metes-and-bounds of the claims are unclear because it is unclear what is meant by a “construct of any one of claims 1”, as claim 1 is a single claim.
Claims 53-69 are rejected because claim 53 recites a “construct of any one of claims 1 or for increasing”. It is unclear what is meant by “claims (plural) 1”. The metes-and-bounds of the claims are unclear because it is unclear what is meant by a “construct of any one of claims 1”, as claim 1 is a single claim. Further, the metes-and-bounds of the claims are unclear because it is unclear as to what the/an alterative the “or” at the first line of claim 53 is referring.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 47-65, 67, and 68 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Fu et al (WO 2019/213517 A1; 11/7/19; 7/24/23 IDS).
Fu et al teaches IL15 construct comprising at least one IL15 molecule, at least one IL15 receptor domain, and at least one Fc region ([00118]-[00119] and claims 1-2, in particular). Fu et al further teaches the at least one Fc region is an IgG1 Fc region ([0066] and claim 10, in particular). Fu et al further teaches said construct wherein the IL15 receptor domain is an IL15Ra domain ([00121] and claim 4, in particular). Fu et al further teaches said construct further comprising at least one protease activatable moiety ([00132], [00136], and claims 14-17, in particular). Fu et al further teaches a pharmaceutical composition comprising such a construct and a pharmaceutically acceptable excipient, carrier, or diluent ([0152] and claim 31, in particular). Fu et al further teaches a homodimer or heterodimer comprising said IL15 construct (claims 21 and 31, in particular). Fu et al further teaches a method of treating cancer comprising administering the IL15 construct to subjects with a recited cancer and in combination with an additional therapy such as a chemotherapeutic (claims 32-38, in particular) or an immunotherapy ([0158], in particular). Fu et al further teaches such a chemotherapeutic includes those recited by the instant claims ([0164], in particular). Fu et al further teaches said method where the constructs are administered at doses of less than 10 mg/Kg body weight ([00208], in particular) and maintenance doses including 1 mg/kg ([00209], in particular). Fu et al further teaches said method where therapeutics, such as anti-PD-1 checkpoint inhibitors, are administered to the subjects ([0165], in particular).
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.
Claim(s) 1 and 47-68 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fu et al (WO 2019/213517 A1; 11/7/19) as applied to claims 1, 47-65, 67, and 68 above, and further in view of Alizadeh et al (Cancer Immunology Research, 2019, 7(5): 759-772).
Teachings of Fu et al are discussed above.
Fu et al does not specifically teach administering a cell therapy in addition to the IL15 construct. However, these deficiencies are made up in the teachings of Alizadeh et al.
Alizadeh et al teaches subjects with cancerous tumors are therapeutically administered CAR-T cell therapy and that IL15 has been shown to promote superior CAR-T cell antitumor responses (Abstract, in particular).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform the method of treating a subject with cancer comprising administering an IL15 construct of Fu et al wherein the subject is further administered an anti-cancer CAR-T therapy because Alizadeh et al teaches subjects with cancerous tumors are therapeutically administered CAR-T cell therapy and that IL15 has been shown to promote superior CAR-T cell antitumor responses (Abstract, in particular). This is an example of combining prior art elements according to known methods to yield predictable results See MPEP 2143. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
Claim Rejections - 35 USC § 103
Claim(s) 1, 47-65, and 67-69 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fu et al (WO 2019/213517 A1; 11/7/19) as applied to claims 1, 47-65, 67, and 68 above, and further in view of Deva et al (Annals of Oncology, 2018, 29(Supp 10): x24-x25).
Teachings of Fu et al are discussed above.
Fu et al does not specifically teach administering the anti-PD-1 checkpoint inhibitor Tislelizumab. However, these deficiencies are made up in the teachings of Deva et al.
Deva et al teaches subjects with cancerous tumors are therapeutically administered the anti-PD-1 checkpoint inhibitor Tislelizumab (Abstract, in particular).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform the method of treating a subject with cancer comprising administering an IL15 construct of Fu et al with an anti-PD-1 checkpoint inhibitor wherein the anti-PD-1 checkpoint inhibitor Tislelizumab because Deva et al teaches subjects with cancerous tumors are therapeutically administered the anti-PD-1 checkpoint inhibitor Tislelizumab (Abstract, in particular). Substituting the anti-PD-1 checkpoint inhibitor Tislelizumab of Deva et al in place of the anti-PD-1 checkpoint inhibitor of Fu et al is an example of a simple substitution of one known element for another to obtain predictable results. See MPEP 2143. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN E AEDER whose telephone number is (571)272-8787. The examiner can normally be reached M-F 9am-6pm ET.
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, Samira Jean-Louis can be reached at (571)270-3503. 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.
/SEAN E AEDER/ Primary Examiner, Art Unit 1642
Prosecution Insights