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 .
Priority
It is noted that US provisional application 63/281,361, which applicants claim benefit to, does not provide support for independent claims 1 and 15 limitation: “thereby resulting in at least about a 20% reduction in tumor size as compared to an untreated tumor and/or in at least about a 20% inhibition in tumor growth as compared to an untreated tumor”; and therefore, the US effective filing date is 11/18/22.
Claim Rejections - 35 USC § 102/103
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 1-3, 8-19, 23-27 and 32-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Kmiec (US 2020/0370047; published: 11/26/20; in IDS dated 6/17/25).
Kmiec is directed to gene knockout of nrf2 for treatment of cancer (Title).
With regards to independent claims 1 and 15, Kmiec teaches a method of treating cancer comprising administering a pharmaceutical composition comprising: a DNA sequence encoding a guide RNA that is complementary to a target domain from an NRF2 gene in the subject; and a nucleic acid sequence encoding a Clustered Regularly Interspaced Short Palindromic Repeat (CRISPR)-associated endonuclease [Abstract]. Kmiec teaches that in certain embodiments, the cancer is a solid tumor [0054]. Kmiec teaches that the pharmaceutical composition is administered in an amount sufficient to reduce tumor growth relative to a tumor that is not treated with the pharmaceutical composition, wherein the reduction in tumor growth is at least, for example by 20% [0105]. Kmiec also teaches a method of reducing NRF2 expression or activity in a cell comprising introducing into the cell (a) one or more DNA sequence(s) encoding a guide RNA (gRNA) that is complementary to a target sequence in the NRF2 gene and (b) a nucleic acid sequence encoding a Clustered Regularly Interspaced Short Palindromic Repeat (CRISPR)-associated endonuclease, whereby the gRNA hybridizes to the NRF2 gene and the CRISPR-associated endonuclease cleaves the NRF2 gene, and wherein NRF2 expression or activity is reduced in the cell relative to a cell in which the one or more DNA sequences encoding the gRNA and the nucleic acid sequence encoding the CRISPR-associated nuclease are not introduced [0096]. With regards to the claimed administration, Kmiec teaches that the nucleic acid sequences can be delivered to an appropriate cell of a subject, e.g., a cancer cell [0092]. When one of ordinary skill in the art might be able to envisage the claimed species from a prior art reference that discloses a genus with a limited number of species, but does not specifically disclose by name the claimed species, the examiner may be able to justify a rejection under 35 U.S.C. § 102. MPEP 2131.02(III) and 2144.08; See: In re Schaumann, 197 USPQ 5 (CCPA 1978).
With regards to instant claims 2-3 and 16-17, Kmiec teaches wherein the one or more gRNAs comprise a trans-activated small RNA (tracrRNA) and a CRISPR RNA (crRNA) and in other embodiments, the one or more gRNAs are one or more single guide RNAs [0006].
With regards to instant claims 8-9, and 18-19, Kmiec teaches that in some embodiments, the CRISPR-associated endonuclease is a class 2 CRISPR-associated endonuclease, and in some embodiments, the class 2 CRISPR-associated endonuclease is Cas9 or Cas12a [0006].
With regards to instant claims 10 and 23, Kmiec teaches that a ribonucleoprotein (RNP) complex comprising the aforementioned gRNA and a Clustered Regularly Interspaced Short Palindromic Repeat (CRISPR)-associated endonuclease [0013].
With regards to instant claims 11 and 24, Kmiec teaches that one or more vectors driving expression of one or more elements of a CRISPR system are introduced into a host cell such that the presence and/or expression of the elements of the CRISPR system direct formation of a CRISPR complex at one or more target sites [0050].
With regards to instant claims 12-13 and 25-26, Kmiec teaches that a vector can comprise the aforementioned DNA sequence, wherein the vector is an adeno-associated virus (AAV) vector [0016].
With regards to instant claims 14 and 27, Kmiec teaches wherein the compositions are used for treatment of various types of solid tumors, or example breast cancer, bladder cancer, colon and rectal cancer, endometrial cancer, kidney (renal cell) cancer, lung cancer, melanoma, pancreatic cancer, prostate cancer, thyroid cancer, skin cancer, bone cancer, brain cancer, cervical cancer, liver cancer, stomach cancer, mouth and oral cancers, neuroblastoma, testicular cancer, uterine cancer, thyroid cancer, head and neck, kidney, lung, non-small cell lung, melanoma, mesothelioma, ovary, sarcoma, stomach, uterus and medulloblastoma, and vulvar cancer. In certain embodiments, solid tumors include breast cancer, including triple negative breast cancer. In certain embodiments, skin cancer includes melanoma, squamous cell carcinoma, cutaneous T-cell lymphoma (CTCL) [0110].
With regards to instant claims 32-33, Kmiec teaches wherein the method further comprises administering one or more chemotherapeutic agents to the subject [0019].
Therefore, by teaching all the limitations of claims 1-3, 8-19, 23-27 and 32-33, Kmiec anticipates the instant invention as claimed.
Alternatively, with regards to the claims 1 and 15 administration limitation of “intratumorally or peritumorally”, Kmiec teaches that the nucleic acid sequences can be delivered to an appropriate cell of a subject, e.g., a cancer cell [0092]. It is clear that the administration of the abovementioned composition to the subject produces a result wherein the active agents are “delivered” to the cancer cell, but Kmiec does not specifically teach that such administration is intratumorally or peritumorally. It is noted that Kmiec discloses multiple routes of administration including pulmonary, topically, ocularly, orally and parenterally and the purpose of the method of Kmiec is to inhibit tumor growth and/or reduce tumor size. Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art to modify the method of Kmiec by specifically administering its composition intratumorally or peritumorally in order to provide an effective amount of active agents at the site of action.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Thus, the claimed invention was prima facie obvious before the effective filing date of the claimed invention.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-3, 8-19, 23-27 and 32-33 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-30 of copending Application No. 19/170,388.
With regards to copending claims 1-20: although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to the same method of reducing NRF2 expression in a cell (e.g., cancer cell such as pancreatic cancer cell) comprising intratumorally (e.g., introducing into the cell) (a) one or more DNA sequences encoding a gRNA (tracrRNA, crRNA, single gRNA) and (b) a nucleic acid sequence encoding a CRISPR-associated endonuclease (e.g., cas9 or Cas12a), whereby the gRNA hybridizes to the NRF2 gene and the CRISPR-associated endonuclease cleaves the NRF2 gene, and further comprising the step of introducing into the cancer cell one or more chemotherapeutic agents. It is noted that the copending method represents a species (with regards to the “one or more DNA sequences encoding a gRNA comprising sequence set forth in any one of SEQ ID NO: 3-74”; and the species of “one or more chemotherapeutic agent”) within the scope of the instantly claimed genus. It has been held that a generic invention is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29 USPQ2d 2010 (Fed. Cor. 1993). Thus, the instant claims and the application claims are obvious variants.
With regards to copending claims 21-30: although the conflicting claims are not identical, they are not patentably distinct from each other because both claim sets are drawn to the same composition and method of using thereof. The difference is that copending claims are directed to the composition, whereas the instant claims are directed to the method of reducing NRF2 expression in a cancer cell of a solid tumor and a method of treating a solid tumor comprising intratumorally or peritumorally administering to a subject in need thereof a therapeutically effective amount of the composition. However, the specification of ‘388 teaches the same method. Attention is directed MPEP 804 (II)(B)(2)(a) which states: In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003). Thus, the instant claims and the application claims are obvious variants.
Claims 1-3, 8-19, 23-27 and 32-33 are directed to an invention not patentably distinct from claims 1-30 of commonly assigned 19/170,388. See above rejection.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned 19/170,388, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
This is a provisional nonstatutory double patenting rejection.
Claims 1-3, 8-19, 23-27 and 32-33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of copending Application No. 18/835,913 in view of Kmiec (US 2020/0370047; published: 11/26/20; in IDS dated 6/17/25). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to the same method of reducing a cancer gene (e.g., NRF2) expression in a cell (e.g., cancer cell such as breast cancer cell) comprising administering (e.g., introducing into the cell) (a) one or more DNA sequences encoding a gRNA (tracrRNA, crRNA, single gRNA) and (b) a nucleic acid sequence encoding a CRISPR-associated endonuclease (e.g., cas9 or Cas12a), whereby the gRNA hybridizes to the NRF2 gene and the CRISPR-associated endonuclease cleaves the NRF2 gene, and further comprising the step of introducing into the cancer cell one or more chemotherapeutic agents. The difference is that the instant claims require intratumoral or peritumoral administration and specifically to treat solid tumor; however, such was specifically taught by Kmiec and therefore one of ordinary skill in the art would start with the method of ‘913 and would have found it obvious in view of the teachings of Kmiec to specifically treat solid tumors intra- or prei-tumorally with the abovementioned composition in order to reduce NRF2 expression and/or treat the tumor. Thus, the instant claims and the application claims are obvious variants.
Claims 1-3, 8-19, 23-27 and 32-33 are directed to an invention not patentably distinct from claims 1-27 of commonly assigned 18/835,913. See rejection above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned 18/835,913, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GENEVIEVE S ALLEY whose telephone number is (571)270-1111. The examiner can normally be reached Monday-Friday 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached at 571-272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GENEVIEVE S ALLEY/Primary Examiner, Art Unit 1617