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 .
The preliminary amendment filed on 3/22/2024 is acknowledged. Claims 3-6 are amended. Claims 3-6 are pending and are currently under examination.
Information Disclosure Statement
The information disclosure statement filed on 5/23/2024 has been considered. A signed copy is enclosed. The lined-through document was not considered because no English language translation was provided.
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 1-6 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 pre-AIA the applicant regards as the invention.
Claim 1 is indefinite because a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011). The instant claim is drawn to a medicament comprising two components. However, said medicament then requires treatment steps. As a medicament is a discrete object, it is not clear how it can also be the steps of administration and application of light. Furthermore, a medicament, as a discrete object, cannot comprise a conjugate and talaporfin, porfimer, or verteporfin and at the same time have these items not be delivered at the same time. To do this, the items would have to be separate and thus, not a medicament.
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.
Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hamakubo et al (US Patent Application Publication 2020/0147233, 5/14/2020).
The instant claims are drawn to a medicament comprising a conjugate of a binding substance and cytotoxin and talaporfin sodium, porfimer sodium, or verteporfin. It is noted that the claims require various method steps. As noted above in the rejection under 35 USC 112b, a medicament cannot be a product while also being method steps. Therefore, in the interests of compact prosecution, the instant claims are being examined for art purposes as the medicament itself.
Hamakubo et al disclose methods where an immunotoxin conjugate comprising a cytotoxin bound to an antibody finding to ROBO1 is contacted with tumor cells, followed by administration of a photosensitizer followed by irradiation of the tumor cells (see abstract). The cytotoxin can be saporin or gelonin (see paragraph 0038). The photosensitizer can be talaporfin sodium (see paragraph 0038). The tumor cells can be head and neck cancer cells, among others (see paragraph 0038).
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 1-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-38 of copending Application No. 17913578 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
The instant claims are drawn to a medicament comprising a conjugate of a binding substance and cytotoxin and talaporfin sodium, porfimer sodium, or verteporfin. It is noted that the claims require various method steps. As noted above in the rejection under 35 USC 112b, a medicament cannot be a product while also being method steps. Therefore, in the interests of compact prosecution, the instant claims are being examined for art purposes as the medicament itself.
The copending claims are drawn to methods of killing tumor cells by contacting a conjugate of a binding substance and cytotoxin and talaporfin sodium, porfimer sodium, or verteporfin with tumor cells, followed by contacting the cells with talaporfin sodium, porfimer sodium or verteporfin. The conjugate has, as a cytotoxin, saporin, gelonin, or pseudomonas exotoxin and can comprise an antibody, Ab fragment, ligand, or peptide. The tumor cells include the cells recited in instant claim 4 and the cancers are those recited in instant claim 5. The cells are irradiated at 650nm.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-5, 7-8, and 11-12 of copending Application No. 17916642 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
The copending claims are drawn to medicaments and methods of killing tumor cells by contacting a conjugate of a binding substance and cytotoxin and talaporfin sodium, porfimer sodium, or verteporfin with tumor cells, followed by contacting the cells with talaporfin sodium, porfimer sodium or verteporfin. The conjugate has, as a cytotoxin, saporin, gelonin, or pseudomonas exotoxin and can comprise an antibody, Ab fragment, ligand, or peptide. The tumor cells include the cells recited in instant claim 4 and the cancers are those recited in instant claim 5. The cells are irradiated at a wavelength effective for activating the photosensitizer, which, for the recited photosensitizers, is 600-800nm.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian J Gangle whose telephone number is (571)272-1181. The examiner can normally be reached M-F, 9-6:30.
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/BRIAN GANGLE/Primary Examiner, Art Unit 1645