DETAILED ACTION
1. The examiner of your application in the PTO has changed. To aid in correlating of any papers for this application, all further correspondence regarding this application should be directed to Hong Sang, Art Unit: 1646.
2. The finality of the previous Office action is withdrawn and prosecution on the merits continues.
Notice of Pre-AIA or AIA Status
3. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
4. The reply filed on 3/24/2026 is acknowledged and entered. Claims 1, 4-5, 7-8 and 12 are pending. Claims 2-3, 6, 9-11 are canceled. Claim 12 is withdrawn. Claims 1 and 12 have been amended.
5. Claims 1, 4-5 and 7-8 are under examination.
Priority
6. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
7. The information disclosure statement (IDS) submitted on 2/18/2026 has been considered by the examiner.
Rejections Withdrawn
8. The rejection of claims 1, 4-5, and 7-8 under 35 U.S.C. 102(a)(2) as being
anticipated by Hamakubo (US Publication 2020/0147233) is withdrawn in view of applicant’s statement under 35 U.S.C. 102(b)(2)(C).
9. The provisional rejection of claims 1, 4-5, and 7-8 on the ground of nonstatutory
double patenting as being unpatentable over claims 1-13 of copending Application No.
16/592,143; US2020/0147233 (reference application) as the copending application became abandoned on 5/15/2023.
New Grounds of Objection and Rejection
Abstract
10. The abstract is objected to for use of legal phraseology. The form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Claim Objections
11. Claim 4 is objected to for reciting “antibody fragment” because not all antibody fragment can bind a target antigen. The term “an antigen binding fragment of an antibody” should be used.
Claim Rejections - 35 USC § 112
12. 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.
13. Claim 7 is 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 7 is indefinite for reciting “Epidermal Growth Factor Receptor (EGFR, ERBB1, ERBB2, ERBB3, or ERBB4)”.
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). In the present instance, claim 7 recites the broad recitation “Epidermal Growth Factor Receptor”, and the claim also recites “EGFR, ERBB1, ERBB2, ERBB3, or ERBB4” which is the narrower statement of the range/limitation. The claim(s) are 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.
Claim Rejections - 35 USC § 103
14. 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.
15. Claims 1, 4-5 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Yip et al. (Molecular Pharmaceutics, 4(2): 241-251, 2007, IDS filed on 2/3/2023), in view of Baskaran et al. (Biomaterials Res. 22(25), pages 1-8, 2018) and Lustig et al. (Cancer, 98(8): 1767-1771, 2003).
Regarding claims 1, 4-5 and 7-8, Yip teaches a method for killing tumor cells by targeting EGFR expressing cancer cells (tumor cells) with immunotoxin cetuximab-saporin in combination with photochemical internalization (PCI), which used a photosensitizer TPPS2a (abstract). Yip teaches that PCI is based on the principles of photodynamic therapy (PDT), which is approved worldwide for different cancer indications (page 244, column 1, para 3). Yip teaches that colorectal cancer cells and head and neck cancer cells are EGFR expressing cancer cells (page 242, column 2, and 247, para 1).
Yip does not teach a medicament for treating EGFR expressing cancer comprising cetuximab-saporin, and talaporfin sodium or porfimer sodium.
Baskaran discloses that PDT induces tumor regressions and second generation photosensitizers such as Photofrin[Symbol font/0xE2] (Porfimer sodium) and Laserphyrin[Symbol font/0xE2] (Talaporfin) have been approved clinically (abstract and page 6, under subtitle Laserphyrin[Symbol font/0xE2]). Baskaran discloses that Talaporfin was approved in Japan in 2004 as a PDT for lung cancer, and was also employed for early head and neck cancer patients (page 6, under subtitle Laserphyrin[Symbol font/0xE2]). Baskaran discloses that Talaporfin PDT achieved better therapeutic response rate about 80% in over the year (page 6, under subtitle Laserphyrin[Symbol font/0xE2]). Talaporfin is going through the phase II trial for the treatment of colorectal neoplasms and liver metastasis (page 6, under subtitle Laserphyrin[Symbol font/0xE2]).
Lustig teaches phase I study of intertumoral photoactivation of talaporfin sodium with refractory solid tumors (abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of instant invention to have made a medicament comprising cetuximab-saporin, and talaporfin sodium or porfimer sodium for treating cancer in view of Yip, Baskaran and Lustig. One skilled in the art would have been motivated to do so because Yip teaches cetuximab-saporin can be combined with PDT or PCI for treating cancer, and Baskaran teaches that talaporfin and porfimer sodium are both second generation photosensitizers and have been approved clinically in treating various cancers.
"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960).
In the instant case, both cetuximab-saporin and talaporfin sodium or porfimer sodium were used in the art to treat cancer. Moreover, it was known in the art that drug combinations produce higher rates of objective response and longer survival than single agents because it combines two anti-cancer agents, each operating via a different mechanism of action, and as such it could solve problems arising in the clinic, such as the development of resistance to drugs, and a change in the antigenicity of the tumor cells that would render them unreactive with one antibody. One of ordinary skill in the art would have a reasonable expectation of success because each drug has been used successfully in treating cancer.
Double Patenting
16. 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.
17. Claims 1, 4-5 and 7-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-38 of copending Application No. 17/913,578 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 9-38 of copending Application No. 17/913,578 (reference application) disclose a method for killing tumor cells using Talaporfin Sodium, Porfimer Sodium or Verteporfin in combination with a conjugate of a substance that binds to a target on the surface of tumor cells and a cytotoxin,
wherein the substance is an antibody, a ligand, or a peptide, and the cytotoxin is saporin, gelonin, or Pseudomonas exotoxin, wherein the tumor cells express EGFR and are cancer cells of any one of head and neck cancer, lung cancer, liver cancer, colorectal cancer, skin cancer, esophageal cancer, stomach cancer, cervical cancer, endometrial cancer, mesothelioma, brain tumor, malignant melanoma, breast cancer, bile duct cancer, pancreatic cancer, ovarian cancer, kidney cancer, bladder cancer, prostate cancer, malignant lymphoma, and osteosarcoma.
Therefore, the claims of copending application disclose a medicament comprising the instantly recited drug components.
18. Claims 1, 4-5 and 7-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of copending Application No. 18/694,632 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1-6 of copending Application No. 18/694,632 (reference application) disclose a medicament for killing tumor cells, comprising: a conjugate of a substance that binds to a target substance on the surface of tumor cells and a cytotoxin; and Talaporfin Sodium, Porfimer Sodium or Verteporfin, wherein Talaporfin Sodium, wherein the substance that binds to a target substance on the surface of tumor cells is an antibody, an antibody fragment, a ligand, or a peptide, wherein the cytotoxin is saporin, gelonin, or Pseudomonas exotoxin, wherein the tumor cells are cells that express EGFR, and are cancer cells of any one of head and neck cancer, lung cancer, liver cancer, colorectal cancer, skin cancer, esophageal cancer, stomach cancer, cervical cancer, endometrial cancer, mesothelioma, brain tumor, malignant melanoma, breast cancer, bile duct cancer, pancreatic cancer, ovarian cancer, kidney cancer, bladder cancer, prostate cancer, malignant lymphoma, and osteosarcoma.
Therefore, the claims of copending application disclose every limitation of instant claims.
Conclusion
19. No claims are allowed.
20. Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG SANG whose telephone number is (571)272-8145. The examiner can normally be reached Monday-Friday 8am-5pm.
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/HONG SANG/Primary Examiner, Art Unit 1646
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