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 response to restriction letter of 8/18/26 is acknowledged. Applicant elected Group I (claims 1-3, 6-8, 10-13 and 26-29) without traverse.
Claims 4-5, 9, 19-25 are canceled.
Claims 14-18 and 30 are hereby withdrawn as drawn to non-elected invention.
Specification
The disclosure is objected to for reciting hyperlink language (see for example, page 15, last line). Applicant is advised to delete hyperlink language everywhere in the disclosure in compliance with 37 CFR section 1.57(d).
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 8, 11, 12, and 28 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 8, 11-12 and 28 refer to the term “preferably” which is indefinite as it fails to specify if the “preferable species” in each claim is the only limiting feature in each respective claim or whether the” preferable species” is among all the members of each respective genus claimed.
Claim 8 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. In claim 8, applicant recites a range within a range, which is improper.
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.
Claim(s) 1, 3, 6-8, 10-13 and 26-29 are rejected under 35 U.S.C. U.S.C. 103 as obvious over Li et al., “Li” (US 2022/0257646, 8/2022) in view of current pharmaceutical formulation preparation techniques.
Said publication in [0028-0029] discloses the following:
[0028] Provided herein are methods of treating or preventing a skin condition, preventing and/or slowing skin aging, and/or maintaining healthy skin. In some aspects, the methods relate to treating or preventing a skin disease in a subject, comprising administering a composition disclosed herein to the subject.
[0029] Compositions described herein comprise iron and/or cobalt. The compositions disclosed herein may further comprise one or more strains of P. acnes (wherein P. Acnes is a synonym for Cutibacterium acnes of this invention), see Li [0004]. The P. acnes strain may be a strain associated with healthy skin. The P. acnes strain may be RT1, RT2, RT3, or RT6 strain of P. acnes such as RT4, RT5, RT7, RT8, RT9 or RT10 strains. The composition may comprise P. granulosum, P. avidum, P. humerusii. Compositions disclosed herein may comprise an antibiotic (e.g., an antibiotic that does not target P. granulosum, P. avidum, P. humerusii, or an RT1, RT2, RT3, or RT6 strain of P. acnes). Compositions may contain two or more, three or more, four or more, five or more, six or more, seven or more, eight or more, nine or more, or ten or more strains of P. acnes (e.g., an RT1, RT2, RT3, or RT6 strain of P. acnes), P. granulosum, P. avidum, and/or P. humerusii.
It should be noted that according to publicly available databases (see attached), RT1-2 strains mentioned above, are specific types of C. acnes SLST type A1 strain.
In [0039] according to Li, the pharmaceutical compositions of its invention may be in gel or cream form.
In [0049], Li teaches that its topical formulation(s) or compositions may comprise PEG-40 stearate, which is an ester of PEG and a C18 fatty acid.
Said publication neither teaches the relative weight of PEG-40 stearate relative to the weight of the skin composition nor teaches the amount of bacterial strain in CFU/ml, units to be used in its formulation.
Current pharmaceutical preparation techniques teach typical amounts of emulsifiers and bacterial colonies, which may be used in preparing formulations for effective topical administration.
Before the effective filing of this application, it would have been obvious to one of ordinary skill in the art to start with the skin care composition comprising C. acnes cells and PEG-40 emulsifier of Li and formulate it in proper amounts of each of said ingredients for topical administration and treating ageing/diseased skin, according to current pharmaceutical formulation preparation techniques.
One of skill in the art is motivated to start with the skin composition and ingredients of Li and prepare therefrom a pharmaceutical formulation for topical administration in the form of gel or cream because such products are very convenient and effective to apply to diseased or aging skin of the subject.
Finally, one of ordinary skills in the art has a reasonable expectation of success in preparing a pharmaceutical composition (formulation) of the skin composition of Li according to current pharmaceutical formulation preparation techniques because such procedures have been fully established in the art tens and tens years, before the effective filing of this application,
Applicant is reminded that the attachment mentioned above is not a part of this rejection but is merely provided to show the knowledge of prior art about different strains of C. acnes.
Claim 2 is rejected under 35 U.S.C. U.S.C. 103 as obvious over Lood R. “Lood” (US2022/0000762, 1/2022, cited in the IDS).
Lood in its abstract teaches the use of compositions comprising a live C. acnes strain secreting RoxP (radical oxygenase of Propionibacterium acnes) and compositions comprising RoxP or a biologically active variant or fragment thereof for treating or preventing oxidative stress-associated skin diseases or for preventing or reducing skin ageing.
In [0091] according to Lood, the bacterial strains of C. acnes may be freeze-dried and in [0203, ] Lood mentions kits comprising freeze dried live bacteria which may be mixed with other ingredients to prepare its skin treating compositions.
In [0197] PEG-40 stearate is listed among the emulsifiers which may be used in compositions of Lood.
Again here, before the effective filing of this application, it would have been obvious to start with C. acnes freeze dried strains of Lood and mix them with emulsifiers (namely PEG-40 stearate), antibiotics and other ingredients taught by Lood and prepare a topical gel (see [0079] of Lood) according to current pharmaceutical formulation preparation techniques to apply to the diseased or ageing skin of the subject.
One of skill in the art is motivated to start with the skin composition of Lood and prepare therefrom a pharmaceutical formulation for topical administration in the form of gel because such gel product is very convenient and effective to apply to diseased or aging skin of the subject, leading to subject’s recovery or amelioration.
Finally, one of ordinary skills in the art has a reasonable expectation of success in preparing a pharmaceutical formulation of the skin composition of Lood according to current pharmaceutical formulation preparation techniques because such procedures have been fully established in the art tens and tens years, before the effective filing of this application.
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 asbecause ofctivities 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.
Claim s 1-3, 6-8, 10-13, 26-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 33 of copending Application No. 17/754,427. Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of instant claims embraces the scope of claims in said copending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2-3, 6-8, 10-13, 26-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and claim 1 of copending Application No. 19/297,624 and 19/535,449, respectively. Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of instant claims overlaps with the scope of claim in each of said copending applications.
The rejections above are all provisional nonstatutory double patenting rejections because the patentably indistinct claims in said applications have not in fact been patented.
Claims 1-3, 6-8, 10-13, 26-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 12-15 of U.S. Patent No. 2,409,129. Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of instant claims overlaps with the scope of claim in said copending application.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARYAM MONSHIPOURI whose telephone number is (571)272-0932. The examiner can normally be reached full-flex.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie L Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARYAM MONSHIPOURI/Primary Examiner, Art Unit 1651
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