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 .
Claims 5, 6, 8, 9, 11, 12, 14, 15, 17, 21, 24, 25, 27, 28, 30 have been canceled. Claims 31-34 have been added. Claims 1-4, 7, 10, 13, 16, 18-20, 22, 23, 26, 29, 31-34 are pending.
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.
Enablement
Claims 16, 18-20, 22, 23, 26, 29, 31-34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for administering a composition comprising a replication defective HSV1 particle comprising a genome comprising a nucleotide encoding collagen to a subject, does not reasonably provide enablement for obtaining a therapeutic effect against any “dermatological signs of aging”, doing so in any subject other than mammals, doing so via any route of administration, or an HSV encoding collagen and fibronectin, elastin, lumican, vitronectin, vitronectin receptor, laminin, neuromodulator, or fibrillin (claims 31, 32). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make/use the invention commensurate in scope with these claims.
The specification does not enable administering HSV encoding collagen to any subject such that a therapeutic effect against any “dermatological signs of aging” is obtained, doing so in any subject other than mammals, or doing so via any route of administration.
Claim 16 is drawn to diminishing a dermatological sign of aging using a composition comprising: (a) a herpes virus comprising a recombinant herpes virus genome, wherein the recombinant herpes virus genome comprises a collagen protein; and (b) an excipient.
The claim encompasses any herpes virus including HSV1, HSV2, VZV, EBV, HCMV, HHV-6A, HHV-6B, HHV-7, HHV-8….
It appears the claim is attempting to say the virus encodes a collagen protein but does not encode collagen alpha-1 (VII) chain (COL7).
The claim encompasses obtaining any therapeutic effect against any “dermatological signs of aging”, doing so in any subject including insects, fish, amphibians, reptiles, birds, and mammals, or doing so via any route of administration including intramuscular, intravitreally, orally, etc. (claim 19).
The claim encompasses any therapeutic effect including “treatment, reduction, and/or prevention of fine lines and/or wrinkles; (b) reduction of skin pore size; (c) improvement in skin thickness, plumpness, and/or tautness; (d) improvement in skin smoothness, suppleness, and/or softness; (e) improvement in skin tone, radiance, and/or clarity; (f) improvement in procollagen and/or collagen production; (g) improvement in skin texture and or promotion of retexturization; (h) improvement in appearance of skin contours; (i) restoration of skin luster and/or brightness; (j) improvement of skin appearance decreased by aging and/or menopause; (k) improvement in skin moisturization; (1) increase in skin elasticity and/or resiliency; (m) treatment, reduction, and/or prevention or skin sagging; (n) improvement in skin firmness; (o) reduction of pigment spots, mottled skin, and/or scars; (p) improvement of optical properties of skin by light diffraction or reflection; or (q) any combinations thereof” (claim 33).
The specification does not correlate performing the method in a mammal to any insects, fish, amphibians, reptiles, birds, and mammals, or doing so via any route of administration including intramuscular, intravitreally, orally, etc. (claim 19). The specification does not teach obtaining any therapeutic in skin effect via any route of administration as broadly encompassed by claim 16. The specification does not teach obtaining any therapeutic effect listed in claim 33. The specification does not teach any HSV encoding collagen and fibronectin, elastin, lumican, vitronectin, vitronectin receptor, laminin, neuromodulator, or fibrillin (claims 31, 32) or how to use such a vector in the treatment of skin.
Given the lack of guidance in the specification taken with the art at the time of filing, it would have required those of skill undue experimentation to determine how to perform the method of claim 16, to arrive at the products in claims 31 and 32, or to use the product in claims 31 and used in the method of claim 32.
Written Description
Claims 16, 18-20, 22, 23, 26, 29, 31-34 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 specification lacks written description for administering HSV encoding collagen to any subject such that a therapeutic effect against any “dermatological signs of aging” is obtained, doing so in any subject other than mammals, or doing so via any route of administration.
Claim 16 is drawn to diminishing a dermatological sign of aging using a composition comprising: (a) a herpes virus comprising a recombinant herpes virus genome, wherein the recombinant herpes virus genome comprises a collagen protein; and (b) an excipient.
The claim encompasses any herpes virus including HSV1, HSV2, VZV, EBV, HCMV, HHV-6A, HHV-6B, HHV-7, HHV-8….
It appears the claim is attempting to say the virus encodes a collagen protein but does not encode collagen alpha-1 (VII) chain (COL7).
The claim encompasses obtaining any therapeutic effect against any “dermatological signs of aging”, doing so in any subject including insects, fish, amphibians, reptiles, birds, and mammals, or doing so via any route of administration including intramuscular, intravitreally, orally, etc. (claim 19).
The claim encompasses any therapeutic effect including “treatment, reduction, and/or prevention of fine lines and/or wrinkles; (b) reduction of skin pore size; (c) improvement in skin thickness, plumpness, and/or tautness; (d) improvement in skin smoothness, suppleness, and/or softness; (e) improvement in skin tone, radiance, and/or clarity; (f) improvement in procollagen and/or collagen production; (g) improvement in skin texture and or promotion of retexturization; (h) improvement in appearance of skin contours; (i) restoration of skin luster and/or brightness; (j) improvement of skin appearance decreased by aging and/or menopause; (k) improvement in skin moisturization; (1) increase in skin elasticity and/or resiliency; (m) treatment, reduction, and/or prevention or skin sagging; (n) improvement in skin firmness; (o) reduction of pigment spots, mottled skin, and/or scars; (p) improvement of optical properties of skin by light diffraction or reflection; or (q) any combinations thereof” (claim 33).
The specification does not correlate performing the method in a mammal to any insects, fish, amphibians, reptiles, birds, and mammals, or doing so via any route of administration including intramuscular, intravitreally, orally, etc. (claim 19). The specification does not teach obtaining any therapeutic in skin effect via any route of administration as broadly encompassed by claim 16. The specification does not teach obtaining any therapeutic effect listed in claim 33.
Accordingly, the specification lacks written description for the method of claim 16.
The specification lacks written description for an HSV encoding collagen and fibronectin, elastin, lumican, vitronectin, vitronectin receptor, laminin, neuromodulator, or fibrillin (claim 31) or how to use such a vector in the treatment of skin (claim 32). The specification does not teach any HSV encoding collagen and fibronectin, elastin, lumican, vitronectin, vitronectin receptor, laminin, neuromodulator, or fibrillin or how to use such a vector in the treatment of skin. Accordingly, the specification lacks written description for the product in claim 31 or using it to treat skin as required in claim 32.
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, 7, 10, 13, 16, 18-20, 22, 23, 26, 29, 31-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,128,122. Although the claims at issue are not identical, they are not patentably distinct from each other because they both encompass HSV encoding collagen. The inactivated ICP4 in the claims of ‘122 is optional in the instant application (claim 23).
Claims 1-4, 7, 10, 13, 16, 18-20, 22, 23, 26, 29, 31-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10,786,438. Although the claims at issue are not identical, they are not patentably distinct from each other because they both encompass HSV encoding collagen. The inactivated ICP4 in the claims of ‘438 is optional in the instant application (claim 23).
Claims 1-4, 7, 10, 13, 16, 18-20, 22, 23, 26, 29, 31-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,155,016. Although the claims at issue are not identical, they are not patentably distinct from each other because they both encompass HSV encoding collagen. The inactivated ICP4 in the claims of ‘016 is optional in the instant application (claim 23).
Claims 1-4, 7, 10, 13, 16, 18-20, 22, 23, 26, 29, 31-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of U.S. Patent No. 9,877,990. Although the claims at issue are not identical, they are not patentably distinct from each other because they both encompass HSV encoding collagen. The inactivated ICP4 in the claims of ‘990 is optional in the instant application (claim 23).
Claims 1-4, 7, 10, 13, 16, 18-20, 22, 23, 26, 29, 31-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,185,564 in view of Krishnan (201702900866). Although the claims at issue are not identical, they are not patentably distinct from each other because they both encompass HSV encoding collagen. The inactivated ICP4 in the claims of ‘438 is optional in the instant application (claim 23).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 7, 10, 13, 16, 18-20, 22, 23, 26, 29, 31-34 are rejected under 35 U.S.C. 103 as being unpatentable over Krishnan (20170290866) in view of 20060172416; 20200375868; 2024067926; CA2151547.
Krishnan taught an HSV particle with a genome encoding COL7 combined with an excipient. Krishnan did not teach the genome encoded a collagen other than COL7 as required in claim 1.
However, vectors encoding non-COL7 collagen were well-known in the art as described by 20060172416 - retrovirus encoding COL1A2 (para 41); 20200375868 - AAV encoding COL3 (para 104); 2024067926 - retrovirus encoding COL7 (claim 1); CA2151547 – plasmid encoding COL2 (Fig. 11-14).
Thus, it would have been obvious to those of ordinary skill in the art at the time of filing to replace COL7 with any other collagen to express any other collagen in vitro. Those of ordinary skill in the art at the time of filing would have been motivated to replace COL7 with COL1, COL2, COL3,… to investigate the role of collagens in tissue maintenance in vitro. Those of ordinary skill in the art at the time of filing would have been motivated to use HSV particle rather than a retrovirus for protein expression because HSV was well-known to provide superior genetic carrying capacity, non-integrating episomal safety, and the ability to infect both dividing and non-dividing cells, notably excelling in neuronal tissue.
Krishnan taught the HSV was replication defective as in claim 2.
Krishnan taught the HSV was HSV1 as in claim 3.
Krishnan taught the HSV was had an inactivated ICP4 gene as in claim 4.
The secondary references taught COL1, COL2, COL3 as required in claim 7.
Krishnan taught the HSV also encoded a selection marker as encompassed by claim 10.
The HSV of Krishnan was in a pharmaceutically acceptable carrier which is “suitable for intradermal or superficial injection” as required in claim 13.
Krishnan taught using a vector encoding collagen to improve skin which is equivalent to claim 16.
Krishnan taught the subject was human as required in claim 18.
Krishnan taught the route of administration was topical, subcutaneous, intradermal as required in claim 19.
Krishnan taught the route of administration was intradermal as required in claim 20.
Krishnan taught the HSV was HSV1 as in claim 22.
Krishnan taught the HSV was had an inactivated ICP4 gene as in claim 23.
The secondary references taught COL1, COL2, COL3 as required in claim 26.
Krishnan taught the HSV also encoded a selection marker as encompassed by claim 29.
Thus, Applicants' claimed invention as a whole is prima facie obvious in the absence of evidence to the contrary.
Claims 1, 3, 7, 10, 13, 16, 18, 19, 20, 22, 26 are rejected under 35 U.S.C. 103 as being unpatentable over Kolattukudy (20140341877) in view of 20060172416; 20200375868; 2024067926; CA2151547.
Kolattukudy taught using HSV1 comprising a protein of interest (para 63). Kolattukudy did not teach using non-COL7 collagen as the protein.
However, expressing non-COL7 collagen using vectors was well-known: 20060172416 - retrovirus encoding COL1A2 (para 41); 20200375868 - AAV encoding COL3 (para 104); 2024067926 - retrovirus encoding COL7 (claim 1); CA2151547 - plasmid encoding COL2 (Fig. 11-14).
Thus, it would have been obvious to those of ordinary skill in the art at the time of filing to express a protein of interest using HSV1 described by Kolattukudy using non-COL7 collagen as the protein described by 20060172416; 20200375868; 2024067926; CA2151547. Those of ordinary skill in the art at the time of filing would have been motivated to express a non-COL7 collagen instead of the proteins contemplated by Kolattukudy to investigate the role of non-COL7 collagen in human tissue in vitro.
Kolattukudy used HSV1 (para 63) as required in claim 3.
20060172416; 20200375868; 2024067926; CA2151547 taught some of the collagens listed in claim 7.
The HSV is suitable for injection as required in claim 13 because it is in a pharmaceutically acceptable carrier (para 63).
Kolattukudy used HSV1 to treat skin disorders (claim 1; title) as required in claim 16.
Kolattukudy taught the subject was human (para 9, 14) as required in claim 18.
Kolattukudy taught intradermal and other routes of administration as encompassed by claim 19 and 20 (para 17, 49, 53, 56).
Kolattukudy used HSV1 (para 63) as required in claim 22.
20060172416; 20200375868; 2024067926; CA2151547 taught some of the collagens listed in claim 26.
Thus, Applicants' claimed invention as a whole is prima facie obvious in the absence of evidence to the contrary.
Claims 16, 18-20, 22, 23, 26, 29, 31-34 are rejected under 35 U.S.C. 103 as being unpatentable over Kolattukudy (20140341877) in view of Krishnan (20170290866).
Kolattukudy taught using HSV1 comprising a protein of interest to improve skin (para 63; claim 1). Kolattukudy did not teach using COL7 collagen as the protein as encompassed by claim 16.
However, Krishnan taught an HSV particle with a genome encoding COL7 combined with an excipient for treating skin wounds.
Thus, it would have been obvious to those of ordinary skill in the art at the time of filing to express a protein of interest using HSV1 described by Kolattukudy using COL7 as the protein described by Krishnan. Those of ordinary skill in the art at the time of filing would have been motivated to express COL7 instead of the proteins contemplated by Kolattukudy for healing wounds in human tissue as taught by Krishnan.
Krishnan taught the subject was human as required in claim 18.
Krishnan taught the route of administration was topical, subcutaneous, intradermal as required in claim 19.
Krishnan taught the route of administration was intradermal as required in claim 20.
Krishnan taught the HSV was HSV1 as in claim 22.
Krishnan taught the HSV was had an inactivated ICP4 gene as in claim 23.
The secondary references taught COL1, COL2, COL3 as required in claim 26.
Krishnan taught the HSV also encoded a selection marker as encompassed by claim 29.
Thus, Applicants' claimed invention as a whole is prima facie obvious in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
Inquiry concerning this communication or earlier communications from the examiner should be directed to Michael C. Wilson who can normally be reached at the office on Monday through Friday from 9:30 am to 6:00 pm at 571-272-0738.
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Michael C. Wilson
/MICHAEL C WILSON/
Primary Examiner, Art Unit 1638
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