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 .
Election/Restrictions
Applicant’s election of Group I in the reply filed on 6/30/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The species election of SEQ ID# 4 and HBB is acknowledged.
Applicant requests confirmation of status of claims 2 and 13. Claim 13 is included in the elected group and claim 2 is not as it is drawn to the second group.
Claims 2, 34 (not drawn to elected HBB but in listed in Group I), 73, 119, and 123 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions or species, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4, 9, 11, 13, 16, 21, 24, 27, 28, 30, 48-49, 57-58, 63, 65-68, 71-72, 127, and 130 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims require variants (for claim 1 (and those dependent on claim 1) genotypic variants and for claim 63 (and 65-67) VP2 variants) and mutations with functions including affinity, specificity, and tropism.
The specification does not teach the genus of variants or functional mutations commensurate with the scope of the claims.
The Court has indicated in Amgen Inc vs Sanofi (2017-1480, Fed Cir, 2017) that the disclosure of a well characterized antigen is insufficient for an adequate written description of the antibody that binds the antigen. The Court stated that “an adequate written description must contain enough information about the actual makeup of the claim products – a precise definition such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other material,” which may be present in “function “terminology “when the art has established a correlation between structure and function” (page 17, 1st paragraph). The Court went on to indicate that knowledge of the chemical structure of an antigen does not tell you anything about the structure of the antibody (Id).
The guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, § 1 "Written Description" Requirement make clear that if a claimed genus does not show actual reduction to practice for a representative number of species, then the Requirement may be alternatively met by reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the Applicant was in possession of the genus (Federal Register, Vol. 66, No. 4, pages 1099-1111, Fri. January 5, 2001, see especially page 1106 column 3).
The specification does not provide adequate written description of the claimed invention. The legal standard for sufficiency of a patent's (or a specification's) written description is whether that description "reasonably conveys to the artisan that the inventor had possession at that time of the. . .claimed subject matter", Vas-Cath, Inc. V. Mahurkar, 19 USPQ2d 1111 (Fed. Cir. 1991). In the instant case, the specification does not convey to the artisan that the Applicant had possession at the time of invention of the claimed invention, the genus of variants or functional mutations.
The Federal Circuit addressed the application of the written description requirement to DNA-related inventions in University of California v. Eli Lilly and Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997). The court stated that “[a] written description of an invention involving a chemical genus, like a description of a chemical species, requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials.” Id. At 1567, 43 USPQ2d at 1405. The court concluded that “naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material.” Id.
The Federal Circuit clarified that a molecule can be adequately described without disclosing its complete structure. See Enzo Biochem, Inc. V. Gen-Probe Inc., 296 F.3d 1316, 63 USPQ2d 1609 (Fed. Cir. 2002). The Enzo court adopted the standard that the written description requirement can be met by “show[ing] that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics ....i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. “ Id. At 1324, 63 USPQ2d at 1613 (emphasis omitted, bracketed material in original).
Furthermore The Board in Ex Parte Kubin found that the written description of 35 USC 112 was not met, stating that
Without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“definition by function … does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is”).
The Board in Ex Parte Kubin further stated on page 16 that
Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895.
The court in In re Alonso (Fed. Cir. 2008) citing In re Enzo, Enzo, 323 F.3d at 969 stated that
[F]or purposes of satisfying the written description requirement, it is not enough merely to disclose a method of making and identifying compounds capable of being used to practice the claimed invention.
In this case, the specification does not appear to describe the genus of variants or functional mutations and thus does not satisfy either the Lilly nor Enzo standards.
Thus, the specification does not appear to describe the genus of variants or functional mutations. There are insufficient structural features common to all members of the genus. The Board in Kubin indicated that possession may not be shown by merely describing how to obtain possession of members of the claimed genus. The mutations are claimed by function, the ability to have certain functions. However, the specification does not disclose sufficient information on the structural function relationship to identify the claimed genus of autoantibodies. One of ordinary skill in the art would not be able to identify the broad claimed genus of variants or functional mutations.
Thus, the specification does not provide an adequate written description of the genus of variants or functional mutations that is required to practice the claimed invention. Applicants have not described the genus of variants or functional mutations sufficiently to show they had possession of the claimed genus. Since the disclosure fails to provide sufficient relevant identifying characteristics, and because the genus is highly variant, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus as broadly claimed.
Claims 1, 4, 9, 11, 13, 16, 21, 24, 27, 28, 30, 48-49, 57-58, 63, 65-68, 71-72, 127, and 130 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The claims are drawn to treating and preventing any disease including any type of cancer and products used to treat or prevent and diseases that can be treated or prevented with HBB as the heterologous nucleic acid.
The art recognizes that it is very unpredictable to treat cancer with immunotherapy. MD Becker Partners (2010 Cancer Vaccine Therapies: Failures and Future Opportunities7 April 2010 (printed 4/19/13) 8 pages) point out there are very few immunotherapies for cancer and that 12 product candidates for active immunotherapy have failed in trials (first paragraph page 3) and no active immunotherapeutic agents are approved for treatment (second paragraph page
3).
Maia, et al. teach “Prostate cancer is the second most common malignant neoplasm in men worldwide and the fifth cause of cancer-related death. Although multiple new agents have been approved for metastatic castration resistant prostate cancer over the last decade, it is still an incurable disease. New strategies to improve cancer control are needed and agents targeting the immune system have shown encouraging results in many tumor types. Despite being attractive for immunotherapies due to the expression of various tumor associated antigens, the microenvironment in prostate cancer is relatively immunosuppressive and may be responsible for the failures of various agents targeting the immune system in this disease. To date, sipuleucel-T is the only immunotherapy that has shown significant clinical efficacy in this setting, although the high cost and potential trial flaws have precluded its widespread incorporation into clinical practice. Issues with patient selection and trial design may have contributed to the multiple failures of immunotherapy in prostate cancer and provides an opportunity to tailor future studies to evaluate these agents more accurately. We have reviewed all the completed immune therapy trials in prostate cancer and highlight important considerations for the next generation of clinical trials.” (abstract, Maia, et al., Critical Reviews in Oncology/Hematology, Vol 113, Pages 292-303, ISSN 1040-8428 year-2017)
Thus, while being a needed therapy, there are many issues with successful treatment of prostate cancer and success has been very limited.
Burke teaches that virotherapy has been used to treat bladder cancer and has yielded mixed results (abstract, Burke Cytokine and Growth Factors Review Vol 21, pages 99-102. 2010). Adenovirus expressing antigen (section 2) have had limited success.
Thus, there is unpredictability in the treatment of bladder cancer with viruses.
Butt et al. (Molecular Therapy, Volume 33, Issue 5, Pages 2154-2171, 2025) teach that there are a range of genotypes that cause the condition,
Thus, the art recognizes the problems in treating sickle cell and other HBB related diseases. [gene therapy approaches] have improved the lives of many patients, achieving a durable and comprehensive cure for all remains challenging, and direct correction of HBB and its translation from the laboratory to the clinic presents ongoing limitations, with challenges involved in achieving robust mutation-correction efficiency [and] off-target effects (abstract). And concluding- While these innovations are collectively pushing the boundaries of HBB correction, allowing for greater precision and efficiency in correcting mutations, testing their efficacy in more complex biological systems is crucial. Particularly, large-animal models are needed to assess whether these modifications can facilitate long-term stem cell engraftment without compromising the stemness or function of the edited cells. Such models will provide more accurate insights into the long-term stability and therapeutic potential of edited stem cells, as well as any potential off-target effects or unforeseen complications that may arise in a more physiologically relevant environment. (page 2165).
Thus, the treatments using HBB are still not certain or guaranteed to work and more testing is required.
The specification provides no detail on treatments with HBB that treat or prevent disease.
The specification provides no detail on treatments that treat or prevent disease cancer.
Thus, without additional guidance in the specification, it would require undue experimentation to make and use the claimed invention.
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 13 and 63 as well as 65-67 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
For claim 13, without a comparison sequence it is not clear what is 60% identical to the nucleic acid sequence in a target cell.
For claim 63, reference to UniProt number is unclear as the sequence with the number may change and thus it is not clear as to what is required. This is not fixed in claims 65-67.
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.
Claim(s) 1, 4, and 9 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Samulski et al. (US 20190382452).
For claim 1, Samulski et al. teach a recombinant virion comprising (1) at least one capsid protein or a variant thereof (a recombinant parvovirus particle comprising the capsid protein Para. [0127]), of a protoparvovirus (the parvovirus employed may be a protoparvovirus Para. [0105]): and (2) a nucleic acid, wherein the nucleic acid comprises a heterologous nucleic acid (the virus vectors may be used to deliver any heterologous nucleic acid sequence of interest; Para. [0151]).
For claim 4, Samulski et al. teach the recombinant virion of claim 1, wherein the protoparvovirus is canine parvovirus (Para 56).
For claim 9, Samulski et al. teach the recombinant virion of claim 1, wherein the capsid comprises a capsid protein, and the art recognizes capsid proteins as VP1 and VP2.
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.
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Samulski et al (20190382452) as applied to claims 1, 4, and 9 above, and further in view of David et al. (10080798).
Samulski et al. is discussed above.
Samulski et al. do not teach SEQ ID# 4.
David et al. teach a canine parvovirus capsid protein of SEQ ID# 1 that is 98% identical to SEQ ID# 4.
One of ordinary skill in the art would be able to choose from art known sequences of the same protein and have the expectation of success knowing that they are both canine parvovirus capsid proteins.
Thus, it would have been prima facie obvious before the effective filing date to change the canine parvovirus capsid and have the expectation of success.
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, 4, 9, 11, 16, 21, 24, 27, 48-49, 57-58, 63, 68, 71-72, 127, and 130 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-13, 17 and 19-20 of U.S. Patent No. 12383615. Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to similar virions with protoparvovirus capsid and heterologous nucleic acid.
For claims 1, 4, 9, and 11, patent claim 12 recites a virions with protoparvovirus capsid and heterologous nucleic acid and with SEQ ID#s 104 and 107. Both SEQ ID#s 104 and 107 are at least 98% identical to instant SEQ ID# 4.
For claims 16, 21, 24, 27, 48-49, 57-58, the construct can have an ITR, is DNA non-coding and regulatory sequences, a promoter, and encodes coding and or non-coding RNA, the virion comprises cap and rep, and the virion is autonomously replicating` (claim 20).
For claim 63, the patent SEQ ID# 104 is 100% identical to instant SEQ ID# 27.
For claim 68, the virion can contain a heterologous peptide tag (patent claim 13).
For claim 71, the composition can be a pharmaceutical composition (patent claim 17). Carrier and or diluent are routine in the art of pharmaceutical compositions.
For claim 72, the patent claim 19 recites administering the virion to treat or prevent.
For claims 127 and 130, patent claim 20 is drawn to a method of making the virion.
Thus, the claims are obvious over the claims of the patent.
Conclusion
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MYRON G. HILL
Examiner
Art Unit 1671
/M.G.H/Examiner, Art Unit 1671
/Shanon A. Foley/Primary Examiner, Art Unit 1671
