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 amendments to the claims and specification submitted on 9/23/24 have been entered.
Claims 1, 4, 6, 19, 22, 28-30, 37, 40, 42 and 58 are examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/23/24 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Objections
Specification
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 for the reason(s) set forth below. The specification is objected to because paragraph 35 recites, the amino acid sequence CGGG does not contain a specific SEQ ID NO:.
Applicants must comply with sequence rules in order to be considered a complete response to this Office Action.
Claims interpretation
The instant claims recite several optional limitations which are not examined on the merits. A summary of the rejected claims are presented below in each rejection.
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, 4, 6, 19, 22, 28-30, 37, 40, 42 and 58 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.
Claims 1 and 37 recite, “about” more than once. The specification states that “about” is to be interpreted as “Generally, the term "about" includes an amount that would be expected to be within experimental error.” [see paragraph 43] However, the metes and bounds of “expected to be within experimental error” are unclear and therefore the metes and bounds of “about” are also unclear. Experimental error will vary with each “experiment” making the limitation of “about” a moving target to one of ordinary skill in the art. Claims 4, 6, 19, 22, 28-30, 40, 42 and 58 are also rejected because they depend from this claim but do not remedy this deficiency.
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 4 and 40 recites the broad recitation “the plant virus is from the genus Bromovirus, Comovirus, or Tymovirus”, and the claim also recites “wherein the plant virus is Cowpea chlorotic mottle virus (CCMV), Cowpea mosaic virus (CPMV), or Phsalis mottle virus (PhMV)” 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.
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 6 and 42 recites the broad recitation “wherein the VLP comprises a capsid protein”, and the claim also recites “optionally a modified capsid protein, further optionally from CCMV, CPMV, PhMV or a combination thereof” 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 28 recites, “administering to the subject a formulation of claim 1.” However, only one formulation is mentioned in claim 1 and therefore, the recitation of “a formulation of claim 1” is unclear as to which formulation claim 28 is referring to. It is suggested that claim 28 be amended to recite, “administering to the subject the formulation of claim 1.”
Claim 30 recites, “an effective amount of a VLP derived from a plant virus…”. However, the recitation of “a VLP derived from a plant virus” is indefinite because this suggests that a VLP derived from a plant virus other than that of claim 28, which depends from claim 1, is to be used in the method of claim 30. It is suggested that claim 30 be amended to recite, “an effective amount of the VLP derived from a plant virus…”
Claim 29 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of different illnesses is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: the grouping of claim 29 includes distinct illnesses, such as cancer, allergy and a pathogenic infection.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claims interpretation
The instant claims recite several optional limitations which are not examined on the merits. A summary of the rejected claims are presented below in the following rejection.
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, 6, 19, 22, 28-30, 37, 40, 42 and 58 are rejected under 35 U.S.C. 102a1 as being anticipated by Steinmetz et al. (US PGPub 2020/0283738).
The claimed invention is drawn to a formulation comprising a virus-like particle (VLP) derived from a plant virus from the genus Bromovirus, Comovirus or Tymovirus. The VLP comprises a capsid protein and the formulation comprises a plurality of VLPs. The composition comprising the formulation and a carrier and a kit comprising the formulation and instructions for use.
The claimed invention is also drawn to a method of treating a disease (cancer) in a subject by administering to the subject an effective amount of the formulation of plant virus VLPs from the genus Bromovirus, Comovirus or Tymovirus.
The claimed invention is also drawn to a method of formulating the VLP by admixing a VLP derived from a plant virus.
Steinmetz et al. teach a Tymovirus VLPs which can be administered together with a pharmaceutically acceptable carrier. The VLP can also be used to treat cancer, including prostate, breast or ovarian cancer. Furthermore, the Tymovirus virus can belong to the physalis mottle virus (PhMV) species. In some embodiments, the Tymovirus virus or VLPs have been PEGylated. [see paragraph 11] Steinmetz et al. further teach VLPs based on physalis mottle virus (PhMV) and their use for imaging and drug delivery. The VLPs of PhMV have 180 identical capsid proteins that form the VLP structure. [see paragraph 140] Steinmetz et al. therefore teach the method of formulation and a method of treating a disease, such as cancer. With regard to the kit of claim 58, Steinmetz et al. teach the structural requirements of the claimed kit and MPEP 2112.01 III (NONFUNCTIONAL PRINTED MATTER DOES NOT DISTINGUISH CLAIMED PRODUCT FROM OTHERWISE IDENTICAL PRIOR ART PRODUCT) provides guidance towards the limitation of “instructions for use”.
Therefore, the claimed invention is anticipated by Steinmetz et al.
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.
The claimed invention is drawn to a formulation comprising a virus-like particle (VLP) derived from a plant virus from the genus Bromovirus, Comovirus or Tymovirus. The VLP comprises a capsid protein and the formulation comprises a plurality of VLPs. The composition comprising the formulation and a carrier and a kit comprising the formulation and instructions for use.
The claimed invention is also drawn to a method of treating a disease (cancer) in a subject by administering to the subject an effective amount of the formulation of plant virus VLPs from the genus Bromovirus, Comovirus or Tymovirus.
The claimed invention is also drawn to a method of formulating the VLP by admixing a VLP derived from a plant virus.
Claims 1, 4, 6, 19, 22, 28-30, 37, 40, 42 and 58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 27, 32 and 36 of copending Application No. 17779484 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the invention of ‘484 is also drawn to a VLP of a plant virus, such as Cowpea chlorotic mottle virus, which would include capsid proteins of the virus and a plurality (more than one) VLPs, methods of administration for treating a disease and would also require formulating the VLP and a kit comprising the VLP.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, 6, 19, 22, 28-30, 37, 40, 42 and 58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 125 of copending Application No. 18271366 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the invention of ‘366 is also drawn to a methods of administration for treating a disease with VLP of a plant virus, such as Cowpea chlorotic mottle virus, which would include capsid proteins of the virus and a plurality (more than one) VLPs and would also require formulating the VLP.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, 6, 19, 22, 28-30, 37, 40, 42 and 58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 15 and 31 of copending Application No. 18554979 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the invention of ‘979 is also drawn to a VLP of a plant virus, such as Cowpea chlorotic mottle virus, methods of administration for treating a disease, which would include capsid proteins of the virus and a plurality (more than one) VLPs, methods of administration for treating a disease and would also require formulating the VLP and a kit comprising the VLP.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, 6, 19, 22, 28-30, 37, 40, 42 and 58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 21, 24 and 30 of copending Application No. 18708930 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the invention of ‘930 is also drawn to a VLP of a plant virus, such as Cowpea mosaic virus, methods of administration for treating a disease, which would include capsid proteins of the virus and a plurality (more than one) VLPs, methods of administration for treating a disease and would also require formulating the VLP.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, 6, 19, 22, 28-30, 37, 40, 42 and 58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 15, 18, 21 and 23 of copending Application No. 18862453 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the invention of ‘453 is also drawn to a VLP of a plant virus, such as Cowpea chlorotic mottle virus, methods of administration for treating a disease, which would include capsid proteins of the virus and a plurality (more than one) VLPs, methods of administration for treating a disease and would also require formulating the VLP and a kit comprising the VLP.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, 6, 19, 22, 28-30, 37, 40, 42 and 58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 12 and 21 of copending Application No. 19109518 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because distinct from each other because the invention of ‘518 is also drawn to a VLP of a plant virus, such as cytoplasmic type citrus leprosis, methods of administration for to a subject in need thereof, which would include capsid proteins of the virus and a plurality (more than one) VLPs, methods of administration for treating a disease and would also require formulating the VLP and a method of package an agent with the VLP.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN P BLUMEL whose telephone number is (571)272-4960. The examiner can normally be reached M-F 8-5 EST.
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/BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671
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