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 .
Claim Status
Claims 3 and 13 are cancelled. Claims 1-2, 4-12, and 14-22 as filed on 19 April 2024 are pending and under examination.
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.
Claims 1-2, 4-5, 14-16, and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Biel (WO 2017031367 A1) (PTO-892).
Regarding claims 1-2, 4, and 16, Biel teaches a composition for the treatment of cancer comprising a complex of IR700 conjugated to an antibody (abstract) including antibodies that bind cell surface markers of diseases including cancer ([0167]). Biel teaches combining with an immune modulating agent ([0393]) and further teaches immune modulating agents include adjuvants including TLR9 agonists ([0415]) including CPG-ODN which is a type-K CpG oligodeoxynucleotide ([0415]).
Regarding claim 5, a complex would include non-covalent association of the nucleic acid ligand for TLR9 with polysaccharide as supported by the instant specification ([0059]). Biel teaches IR700 with tumor-targeting molecules including a polysaccharide (claim 266) and the combination with an immune modulator which includes nucleic acid agonists for TLR9 which are nucleic acid based (claims 209, 107-108, and [0415]). Biel teaches the administration of the IR700 conjugated molecule and immune modulator can be administered together, sequentially, or intermittently ([0262], [0264], [0319])
Regarding claims 14-15, Biel teaches intravenous administration ([0007], [0269], [0270], [0348]).
Regarding claims 18-19, Biel teaches pharmaceutical compositions comprising the photosensitive molecule complex and adjuvants of their methods of treatment ([0262]-[0263]).
Claims 1-2, 11, 17-18, and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Garcia-Guzman (WO 2018156815 A1) (PTO-892).
Regarding claims 1-2, 11, 17, and 22, Garcia-Guzman teaches conjugates that comprise IR700 and an antibody that binds a cell surface marker including markers for cancer ([0018], [0038]-[0039]), claims 1 and 45-48). Garcia-Guzman teaches the treatment of multiple conditions including cancer (abstract). Garcia-Guzman teaches immune modulating agents administered with the conjugates and teaches the immune modulating agent binds STING (claims 34-35), as required by claims 11, 17, and 22).
Regarding claim 18, Garcia-Guzman teaches pharmaceutical compositions comprising the IR700 comprising conjugate and immune modulating agents ([0038]).
Claim Rejections - 35 USC § 103
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.
Claims 1, 4-10, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Biel (WO 2017031367 A1) (PTO-892) and Ishii (WO 2015041318 A1) (PTO-892).
Regarding claims 1-2, and 4, Biel teaches a composition for the treatment of cancer comprising a complex of IR700 conjugated to an antibody (abstract) including antibodies that bind cell surface markers of diseases including cancer ([0167]). Biel teaches combining with an immune modulating agent ([0393]) and further teaches immune modulating agents include adjuvants including TLR9 agonists ([0415]) including CPG-ODN which is a type-K CpG oligodeoxynucleotide ([0415]).
Biel does not teach the humanized type-K CpG oligodeoxynucleotide of instant SEQ ID NO: 9 or the synthetic strand of polydeoxyadenylic acid or the polysaccharides of ß-glucan or lentinan.
These deficiencies are filled by Ishii.
Regarding claims 4-10 and 19-20, Ishii teaches SEQ ID NO: 2 and 9-11 which matches instant SEQ ID NO: 1. Ishii teaches SEQ ID NO: 2 is a novel K-type CpG ODN for use with the ß-glucan polysaccharide lentinan. Ishii teaches it is effective as an immunostimulatory agent (page 3 in par 2). Ishii teaches the humanized K-type CpG ODN contains polydeoxyadenylic acid (page 3 in par 4 labeled [1] in the translated document). Ishii teaches a pharmaceutical composition comprising the compositions of the inventions (page 8 in par 1).
Ishii teaches the use of the compositions of its invention for use in treatment of cancer (page 8 in par 6).
It would have been obvious at the time the application was filed to substitute the type-K CpG oligodeoxynucleotide of Biel with the type-K CpG oligodeoxynucleotide of Ishii in a composition comprising polydeoxyadenylic acid and polysaccharides including ß-glucan of lentinan. First, it would have been prima facie obvious to substitute generic type-K CpG with the species of Ishii that matches instant SEQ ID NO: 1. Second, one of skill in the art would have been motivated by the teaching of Ishii that the type-K CpG oligodeoxynucleotide with polydeoxyadenylic acid and lentinan by their teaching of improved immunostimulatory activity. There would have been a reasonable expectation of success as it is a substitution of a generic for a species of type-K CpG oligodeoxynucleotide that Ishii teaches is effective in the cancer patients Biel is teaching.
Claims 1 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Garcia-Guzman (WO 2018156815 A1) (PTO-892) and Fisher (WO 2019014391 A1) (PTO-892).
Regarding claim 1, Garcia-Guzman teaches conjugates that comprise IR700 and an antibody that binds a cell surface marker including markers for cancer ([0018], [0038]-[0039]), claims 1 and 45-48). Garcia-Guzman teaches the treatment of multiple conditions including cancer (abstract). Garcia-Guzman teaches immune modulating agents administered with the conjugates and teaches the immune modulating agent binds STING (claims 34-35).
Garcia-Guzman does not teach the immune modulating agent that binds STING is cGAMP.
This deficiency is filed by Fisher.
Fisher teaches immune modulators that bind STING including cGAMP (claims 1-7) and further teaches its use in methods of treating cancer (abstract and claims 74-77).
It would have been obvious at the time the application was filed to substitute the generic STING binding immune modulator of Garcia-Guzman with the STING binding immune modulator of cGAMP taught by Figher. It would have been prima facie obvious at the time the application was filed to substitute the generic STING binding immune modulator of Garcia-Guzman with the specific STING binding immunomodulator of cGAMP taught by Fisher. There would have been a reasonable expectation of success as Garcia-Guzman and Fisher both teach STING binding immunomodulators for use in methods of treating cancer.
Conclusion
No claims allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRANCESCA EDGINGTON-GIORDANO whose telephone number is (571)272-8232. The examiner can normally be reached Mon - Fri 8:00 - 5:00.
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, Julie Wu can be reached at 571-272-5205. 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.
/F.E./Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643
Prosecution Insights