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 .
Applicant’s preliminary amendment filed 3/18/2025, is acknowledged. Claims 1-94 are canceled. Claims 95-114 are new and pending.
Claim Objections
Claims 103 and 113 are objected to because of the following informalities: The claims have typographical errors including extra commas and/or spaces. 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.
Claim 113 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.
Regarding claim 113, the phrase "e.g.," renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 95-114 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of Patent No. 11,344,628 (“the ‘628 patent”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the ‘628 patent recite the inclusion of liposomal composition comprising a polyglutamated antifolate encapsulated by a liposome, wherein the polyglutamated antifolate including polyglutamated pralatrexate comprises at least 4 glutamate residues linked by alpha carboxyl group linkages and wherein the liposome does not contain a targeting moiety having specific affinity for a surface antigen on a target cell. Meanwhile, the instant claims require at least 3-12 glutamyl groups of the polyglutamated pralatrexate having alpha carboxyl group linkages.” As such, the claims of the ‘628 patent read upon the instantly recited composition.
Claims 95-114 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of Patent No. 11,779,584 (“the ‘584 patent”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the ‘584 patent recite the inclusion of a liposomal composition comprising a polyglutamated pemetrexed (PMX) comprising 4, 5, or 6 glutamyl groups in D-form that have an alpha carboxy group linkage. Although the claims indicate PMX, one of ordinary skill in the art would have known PMX and pralatrexate to be obvious antifolate alternatives. As such, the claims of the ‘584 patent read upon the instantly recited composition.
Claims 95-114 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20, 27-41, 43 and 45-47 of Patent No. 11,730,738 (“the ‘738 patent”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the ‘738 patent recite the inclusion of liposomal composition comprising an alpha polyglutamated pralatrexate encapsulated by a liposome, wherein the polyglutamated antifolate including polyglutamated pralatrexate comprises four or more glutamyl groups having an alpha carboxyl group linkage. Meanwhile, the instant claims require at least 3-12 glutamyl group of the polyglutamated pralatrexate having alpha carboxyl group linkages.” As such, the claims of the ‘738 patent read upon the instantly recited composition.
Claims 95-114 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21, 28-38, 40-42 and 44 of Patent No. 12,213,981 (“the ‘981 patent”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the ‘981 patent recite the inclusion of liposomal composition comprising an alpha polyglutamated pralatrexate encapsulated by a liposome, wherein at least only glutamyl group of the polyglutamated pralatrexate has at least one glutamyl group of the polyglutamated pralatrexate has an alpha carboxyl group linkage. Meanwhile, the instant claims require at least 3-12 glutamyl group of the polyglutamated pralatrexate having alpha carboxyl group linkages.” As such, the claims of the ‘981 patent read upon the instantly recited composition.
Claims 95-114 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24, 31-40, 42-45, 47-48 and 50-52 of Patent No. 12,076,402 (“the ‘402 patent”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘402 patent recite the inclusion of a liposomal composition comprising an alpha polyglutamated antifolate encapsulated by a liposome, wherein the polyglutamated antifolate comprises at least 4 glutamate residues and wherein at least 2 of the glutamate residues contain an alpha carboxyl group linkage and are in the L-form or D-form. Meanwhile, the instant claims require at least 3-12 glutamyl group of the polyglutamated pralatrexate having alpha carboxyl group linkages.” As such, the claims of the ‘402 patent read upon the instantly recited composition.
Claims 95-114 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of Patent No. 12,178,882 (“the ‘882 patent”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the ‘882 patent recite the inclusion of a pegylated liposomal composition comprising a polyglutamated pemetrexed (PMX) wherein the PMX comprise at least 3 glutamate residues linked by alpha linkages. Meanwhile, the instant claims require at least 3-12 glutamyl group of the polyglutamated pralatrexate having alpha carboxyl group linkages.” Although the ‘882 claims indicate PMX, one of ordinary skill in the art would have known PMX and pralatrexate to be obvious antifolate alternatives.
Claims 95-114 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 13-17, 19-20 and 22-24 of Patent No. 12,433,893 (“the ‘893 patent”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the ‘893 patent recite the inclusion of a pegylated liposomal composition comprising a polyglutamated pemetrexed (PMX) wherein the PMX comprise 2-10 glutamyl groups in the D-form that have an alpha carboxyl group linkage. Although the claims indicate PMX, one of ordinary skill in the art would have known PMX and pralatrexate to be obvious antifolate alternatives. Meanwhile, the instant claims require at least 3-12 glutamyl group of the polyglutamated pralatrexate having alpha carboxyl group linkages.” Although the ‘893 claims indicate PMX, one of ordinary skill in the art would have known PMX and pralatrexate to be obvious antifolate alternatives.
COMMENTS/NOTES
It should be noted that no prior art is cited against the instant invention. In particular, the claims are distinguished over the prior art of record because the prior art neither anticipates nor renders obvious compounds of claim 1. The closest art is Applicant’s own work which is cited in the double patenting rejections above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S CABRAL whose telephone number is (571)270-3769. The examiner can normally be reached M-F 8 am - 5 pm.
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/ROBERT S CABRAL/Primary Examiner, Art Unit 1614
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