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 arguments, filed 05/23/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112(b) or pre-AIA 2nd ¶
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.
Claim 44 stands 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.
With regards to claim 44, the claim recites “citric acid/citrate buffer”, and it is unclear if the compounds are intended to be included together or as alternatives. For purposes of examination, the elements are interpreted as alternatives.
Response to Arguments
Applicants assert the skilled artisan understands from the term “citric acid/citrate buffer” as referring to a buffer comprising both citric acid and its corresponding base (citrate) salt, and that this term refers to a single entity (buffer) and the skilled artisan understands that citric acid and citrate are both present at chemical equilibrium.
This argument is not persuasive. While citric acid and citrate buffer can be included as a mixture, Examiner respectfully disagrees that the skilled artisan knows that “citric acid/citrate buffer” must refer to a single buffer of the combination of citric acid and citrate buffer, where “/” generally indicates an alternative or choice between two or more options. Adding to the lack of clarity is the instant specification, where pg. 8 recites that citric acid and sodium citrate can be used as alternative pH adjusters.
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.
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 33-35, 38, 39, 42, 44, and 46-53, stand rejected under 35 U.S.C. 103 as being unpatentable over Patzold et al (US 20190314428 A1), in view of Panzieri et al (US 20110081401 A1), as evidenced by Khardori et al (“Cutibacterium (Propionibacterium) Infections”, 2024) and ATMAN (“Ethylhexyl Cocoate”, retrieved 2024).
Patzold et al teach skin care compositions for topical administration comprising freeze dried (lyophilized) live Propionibacterium acnes (P. acnes) (aka Cutibacterium acnes, C. acnes, as evidenced by Khardori et al) (abs, ¶ 163). The compositions may further comprise a thickener at a concentration from about 1-5% (¶ 8), and may be less than 1% or more than 5% (¶ 134). Conventional pharmaceutical carriers and additives may be used (¶ 124), such as vitamins or antioxidants (¶ 148). The compositions may include emollients, such as coconut oil (contains ethylhexyl cocoate, as evidenced by ATMAN) (¶ 142); ethyl alcohol (ethanol) (¶ 124); and buffers such as citrate buffer in order to help stabilize the pH (¶¶ 130, 131). The P. acnes is selected from SLST type D1, H1, H2, H3, K1, K2, K4, K6, K9, and L1 (¶ 13), and specifically C3 and/or K8, and in some embodiments further comprises A5 and/or F4 (¶¶ 5, 6). The strains are in a concentration of at least 5% of the composition each (¶ 9), or 104-109 CFU/ml (¶ 11). The compositions may be in the form of a gel, cream, ointment, or lotion (¶¶ 12, 124). The compositions are capable of treating or preventing a condition selected from: acne, oily skin, progressive macular hypomelanosis, dandruff, atopic eczema, atopic dermatitis, and rosacea; improving the appearance of the skin and/or maintaining healthy skin in a subject (¶¶ 14-17); or modulating sebum production (¶ 93).
Patzold et al does not teach one or both of Chondrus crispus extract and hydroxypropyl starch phosphate.
Panzieri et al teaches Chondrus crispus extract was known to be used as a thickener in cosmetic products because it contains polysaccharides with structuring properties, so it can enhance viscosity and stability (¶ 10) and may be used in combination with other skin care ingredients (e.g., emollients, emulsifiers, etc.) to improve appearance of the skin (¶¶ 42, 79-82). In various embodiments, Chondrus crispus extract was included at 2 wt % (ex. 1, 2, table 1, claims 6, 7).
With regards to claim 33, it would have been obvious to include known thickeners used in cosmetic compositions, such as Chondrus crispus extract, which was known to enhance viscosity and stability of cosmetic products, and can be used in combination with other skin care ingredients, as taught by Panzieri et al.
Regarding the specific strains of claims 33, 46, and 47, it would have been obvious at least one strain of C. acnes comprising SLST strains such as C3 and/or K8, and further comprising A5 and/or F4, as taught by Patzold et al.
With regards to claim 34 and 35, where Patzold et al teaches thickeners from 1-5%, and Panzieri et al teaches Chondrus crispus extract at 2 wt%, it would have been obvious to include Chondrus crispus extract at 2 wt%, falling within the claimed range.
With regards to claim 38, where the inclusion of Chondrus crispus extract as the only thickener is made obvious above, the limitation is met.
With regards to claim 39, it would have been obvious to include coconut oil (contains ethylhexyl cocoate), an emollient taught to be suitable by Patzold et al.
With regards to claim 42, it would have been obvious to include ethanol, a suitable component taught by Patzold et al.
With regards to claim 44, it would have been obvious to include a buffer, such as citrate buffer, in order to help stabilize the pH, as taught by Patzold et al.
With regards to claims 48 and 49, it would have been obvious to include the C. acnes strain in a concentration of at least 5% of the composition each, and in an amount from 104-109 CFU/ml, as taught by Patzold et al. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
With regards to claim 50, it would have been obvious to formulate the composition in the form of a gel, cream, ointment, or lotion, as taught by Patzold et al.
With regards to claims 51 and 52, where Patzold et al teaches the compositions are capable of treating and/or preventing a condition selected from acne, oily skin, progressive macular hypomelanosis, dandruff, atopic eczema, atopic dermatitis, and rosacea, improving the appearance of the skin and/or maintaining healthy skin in a subject, or modulating sebum production, the intended use limitations are met.
Regarding new claim 53, where the skin care composition made obvious above comprises freeze dried live C. acnes bacteria strains as instantly claimed, and Chondrus crispus extract, it appears the skin care composition would be inherently be capable of meeting the intended use limitation of maintaining healthy skin of a subject, as instantly claimed.
Response to Arguments
First, Applicants assert the specific thickeners in the instant claims are surprisingly compatible with C. acnes strains, where the claimed thickeners do not significantly interfere with C. acnes bacteria, and in some cases, provide an increased viability and replication capacity. Applicants assert the thickeners do not interfere with the reactivation of specific lyophilized or spray-dried C. acnes strains to any undesirable extent. Second, Applicants assert Panzieri et al are not concerned with compositions comprising live bacteria and do not relate to manipulating the skin microbiome. Rather, Applicants assert the product of Panzieri et al are completely different from Patzold et al and argue a skilled artisan would not have considered Panzieri et al when trying to find thickeners that do not interfere with C. acnes strains. Third, Applicants assert that even if Panzieri et al would have been considered, the skilled artisan would not have motivation to use Chondrus crispus extract as a thickener because Panzieri et al lacks and specific teaching regarding advantages of using Chondrus crispus extract, let alone in combination with live bacteria. Fourth, Applicants assert the selection would be based on improper hindsight.
First, this argument is not persuasive. Applicants assert improved compatibility of the instantly claimed thickeners with C. acnes strains, however, from the instant embodiments shown if fig. 1 and fig. 2, these thickeners do not appear to have improved compatibility compared to other thickeners and control. Formulations 1-4, 9, and 10 used Chondrus crispus extract, Formulation 6 used hydroxypropyl starch phosphate, and the other formulations used thickeners such as hydroxyethyl cellulose, carbomer, and hyaluronic acid, however, looking at figs. 2 and 3, formulations using Chondrus crispus extract and hydroxypropyl starch phosphate did not have significant advantages over other formulations. This is further supported by the instant specification where it is recited that all of the tested thickeners were acceptable with no negative influence of ingredients on bacteria reactivation (see example 2). Based on these results and contrary to Applicants’ assertion, there does not appear to be a proper showing of improved compatibility of the claimed thickeners, compared to any of the other tested thickeners. Even arguendo, only C. acnes strains C3 and K8 were tested, and the data presented in the instant examples cannot be extended to include the entire claimed range of strains, where it is not clear how the different thickeners would impact other strains. Additionally, while Chondrus crispus extract is tested in the instant examples, it appears that where Chondrus crispus extract is a plant extract, Chondrus crispus extract can vary in its composition and properties such as due to extraction methods, etc., and the instant specification does not recite the exact Chondrus crispus extract used.
Second, this argument is not persuasive. Panzieri et al was relied upon for simply teaching known thickeners used in cosmetic products that can be used on the skin, where Chondrus crispus extract was known to enhance viscosity and stability of formulations. While Panzieri et al does not specifically teach embodiments with live bacterial strains, both are directed to cosmetic compositions that can be applied to the skin, and it would have therefore been obvious to modify Patzold et al to include any known thickener suitable for cosmetic compositions. The motivation to select Chondrus crispus extract can be different than the motivation Applicants want, and still arrive at the claimed composition. Further, there do not appear to be any teachings or suggestions in Patzold et al or Panzieri et al that suggest that Chondrus crispus extract would interfere with C. acnes strains and not be suitable for use in the compositions made obvious above by Patzold et al and Panzieri et al, and Patzold et al teach thickeners can be included.
Third, this argument is not persuasive. Panzieri et al teach Chondrus crispus extract was a known to enhance the viscosity and stability of cosmetic formulations, which provides motivation for the skilled artisan to specifically select Chondrus crispus extract, in addition to the teachings that it was a known thickeners used in cosmetic compositions that can be applied to the skin. As discussed above, while Panzieri et al may not teach embodiments comprising live bacteria strains, the motivation to select Chondrus crispus extract can be different than the motivation Applicants want, and still arrive at the claimed composition. There appears to be no teachings or suggestions in Patzold et al or Panzieri et al that suggest that Chondrus crispus extract would interfere with C. acnes strains and not be suitable for use in the compositions made obvious above by Patzold et al and Panzieri et al.
Fourth, this argument is not persuasive. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). It would have been obvious for the skilled artisan to modify Patzold et al with the known thickeners of Panzieri et al, for the same reasons discussed above, relying only on knowledge within the level of ordinary skill at the time of the claimed invention was made, as well as the teachings of Patzold et al and Panzieri et al.
Claims 33, 36-39, 42, 44, and 46-53, stand rejected under 35 U.S.C. 103 as being unpatentable over Patzold et al (US 20190314428 A1), in view of Lockhead (Cosmetic Nanotechnology, 2007, ch 1, pp 3-56), and Robert (US 20180085297 A1).
Patzold et al are discussed above but do not teach hydroxypropyl starch phosphate.
Lockhead teaches hydroxypropyl starch phosphate is naturally derived nonionic thickener and is used to fulfill several roles in skin care products, such as emulsion stability, improved sensory quality and viscosity build (table 2, pg 28). The starch polymer gives body to formulations and leaves the skin feeling soft and is compatible with most skin care ingredients (pg 28).
Lockhead does not teach the amount of thickener.
Robert teaches it was known to include thickeners from 0.1 to 20 wt% of skin care compositions that can be used to treat acne, improve the appearance of the skin, etc. (abs, ¶ 50).
Regarding claim 33, it would have been obvious to include known thickeners used in skin care products, such as hydroxypropyl starch phosphate, where hydroxyl starch phosphate provides emulsion stability, improved sensory quality, viscosity build, and leaves the skin feeling soft, as taught by Lockhead, and where Patzold et al teaches thickeners are included.
Regarding the specific strains of claims 33, 46, and 47, it would have been obvious at least one strain of C. acnes comprising SLST strains such as C3 and/or K8, and further comprising A5 and/or F4, as taught by Patzold et al.
With regards to claims 36 and 37, it would have been obvious to include hydroxypropyl starch phosphate to those amounts suitable for thickeners, such as from 0.1 to 20 wt%, as taught by Robert, overlapping the claimed ranges. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
With regards to claim 39, it would have been obvious to include coconut oil (contains ethylhexyl cocoate), an emollient taught to be suitable by Patzold et al.
With regards to claim 42, it would have been obvious to include ethanol, a suitable component taught by Patzold et al.
With regards to claim 44, it would have been obvious to include a buffer, such as citrate buffer, in order to help stabilize the pH, as taught by Patzold et al.
With regards to claims 48 and 49, it would have been obvious to include the C. acnes strain in a concentration of at least 5% of the composition each, and in an amount from 104-109 CFU/ml, as taught by Patzold et al, for the same reasons discussed above.
With regards to claim 50, it would have been obvious to formulate the composition in the form of a gel, cream, ointment, or lotion, as taught by Patzold et al.
With regards to claims 51 and 52, where Patzold et al teaches the compositions are capable of treating and/or preventing a condition selected from acne, oily skin, progressive macular hypomelanosis, dandruff, atopic eczema, atopic dermatitis, and rosacea, improving the appearance of the skin and/or maintaining healthy skin in a subject, or modulating sebum production, the intended use limitations are met.
Regarding new claim 53, where the skin care composition made obvious above comprises freeze dried live C. acnes bacteria strains as instantly claimed, and hydroxypropyl starch phosphate, it appears the skin care composition would be inherently be capable of meeting the intended use limitation of maintaining healthy skin of a subject, as instantly claimed.
Response to Arguments
First, Applicants assert Lockhead fails to point out that hydroxypropyl starch phosphate is a particularly advantageous thickener, let alone teach or suggest that hydroxypropyl starch phosphate being disclosed as a nonionic thickener. Applicants assert the reference fails to teach that it is suitable for maintaining the viability of lyophilized and/or spray dried live bacteria. Accordingly, Applicants assert there is no reason a skilled artisan would consider using hydroxypropyl starch phosphate as a thickener. Second, Applicants assert even if Lockhead was considered, there is no motivation to use hydroxypropyl starch phosphate in combination with the live bacteria because Lockhead lacks specific teaching regarding technical advantages of using hydroxypropyl starch phosphate, let alone in combination with live bacteria. Third, Applicants assert the selection would be based on improper hindsight.
First, this argument is not persuasive. For the same reasons discussed above, Applicants do not appear to have shown hydroxypropyl starch phosphate is a particularly advantageous thickener. Lockhead teaches hydroxypropyl starch phosphate as a naturally derived nonionic thickener that was known to be used in skin care products, in order to improve sensory quality and viscosity build. Further, Lockhead teaches hydroxypropyl starch phosphate improves stability, sensory quality, and leaves the skin feeling soft. While Lockhead may not teach embodiments comprising live bacteria strains, the motivation to select hydroxypropyl starch phosphate can be different than the motivation Applicants want, and still arrive at the same composition. Here, the motivation was to modify Patzold et al with known thickeners used in skin care compositions, in order to impart the above taught benefits to the composition/skin, and where Patzold et al teach thickeners can be included. There appears to be no teachings or suggestions in Patzold et al or Lockhead that suggest that hydroxypropyl starch phosphate would interfere with C. acnes strains and not be suitable for use in the compositions made obvious above by Patzold et al and Lockhead.
Second, this argument is not persuasive. As discussed above, Applicants do not appear to have shown hydroxypropyl starch phosphate is a particularly advantageous thickener for the instantly claimed combination. Lockhead teaches hydroxypropyl starch phosphate was known to have the above taught benefits to skin care compositions, which provides motivation for the skilled artisan to specifically select hydroxypropyl starch phosphate, and where Patzold et al teach thickeners can be included. As discussed above, while Lockhead may not teach embodiments comprising live bacteria strains, the motivation to select hydroxypropyl starch phosphate can be different than the motivation Applicants want, and still arrive at the claimed composition. There appears to be no teachings or suggestions in Patzold et al or Lockhead that suggest that hydroxypropyl starch phosphate would interfere with C. acnes strains and not be suitable for use in the compositions made obvious above by Patzold et al and Lockhead.
Third, this argument is not persuasive. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). It would have been obvious for the skilled artisan to modify Patzold et al with the known thickeners of Lockhead, for the same reasons discussed above, relying only on knowledge within the level of ordinary skill at the time of the claimed invention was made, as well as the teachings of Patzold et al and Lockhead.
Claims 39, 40, and 41, stand rejected under 35 U.S.C. 103 as being unpatentable over Patzold et al (US 20190314428 A1), in view of Panzieri et al (US 20110081401 A1), and further in view of Borchers et al (WO 2016173824 A1, cited from English translation).
Patzold et al and Panzieri et al are discussed above but do not teach distarch phosphate and/or tapioca starch, nor tocopherol and/or tocopheryl acetate.
Borchers et al teach topical skin care compositions with dermatological, or pharmaceutical, components such as dicaprylyl carbonate, Chondrus crispus extract, tapioca starch, tocopherol and tocopheryl acetate, ethanol, etc. (pg 6 example). Tapioca starch further improves the sensory effects of the composition and improves dispersibility (pg 4 ¶¶ 5-7).
It would have been obvious to include tapioca starch, where tapioca starch was known to improve the sensory effect and dispersibility of the composition, and where it is a known component used in skin care compositions than can be used in combination with Chondrus crispus extract, as taught by Borchers et al.
It would have been obvious to include dicaprylyl carbonate, tocopherol, and tocopheryl acetate to the compositions of Patzold et al, where they are known components use in skin care compositions, and were known to be used in combination with Chondrus crispus extract, as taught by Borchers et al.
Response to Arguments
Applicants assert Borchers et al fail to cure the noted deficiencies of Patzold et al and Panzieri et al set forth above.
This argument is not persuasive. The claims stand rejected for the same reasons above and of record.
Claims 39, 41, and 43, stand rejected under 35 U.S.C. 103 as being unpatentable over Patzold et al (US 20190314428 A1), in view of Panzieri et al (US 20110081401 A1), and further in view of Stadler et al (DE 10-2008062398 A1)
While Patzold et al teach ethylhexyl cocoate above, additional motivation for including the component is also provided by Stadler et al as cited below. Patzold et al and Panzieri et al are discussed above but do not teach tocopherol and/or tocopheryl acetate, nor PEG-40 hydrogenated castor oil.
Stadler et al teach an improved emulsion thickening system for cosmetic and dermatological compositions comprising one or more of tocopherol (i.e., vitamin E) and tocopheryl acetate (¶ 155). The composition further comprises PEG-40 hydrogenated castor oil (taught as an emulsifier) (¶ 14), where the emulsifiers add stability to the composition (¶¶ 3 and 10). The composition also comprises at least one emollient, such as ethylhexyl cocoate and/or dicaprylyl carbonate (¶ 20). The emollients in the composition are included to make the skin supple and smooth (¶ 19).
With regards to claim 39, it would have been obvious to include ethylhexyl cocoate and/or dicaprylyl carbonate to the composition of Patzold et al, where the emollients function to make skin supple and smooth, as taught by Stadler et al, and where Patzold et al already teaches coconut oil (contains ethylhexyl cocoate) can be included.
With regards to claim 41, it would have been obvious to include known antioxidants to the composition of Patzold et al, such as tocopherol and tocopheryl acetate, where both are directed to skin compositions comprising antioxidants.
With regards to claim 43, it would have been obvious to include PEG-40 hydrogenated castor oil to the composition of Patzold et al, where PEG-40 hydrogenated castor oil was taught to adds stability to cosmetic and dermatological compositions, as taught by Stadler et al.
Response to Arguments
Applicants assert Stadler et al fail to cure the noted deficiencies of Patzold et al and Panzieri et al set forth above.
This argument is not persuasive. The claims stand rejected for the same reasons above and of record.
Statutory Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 41 is provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 40 of copending Application No. 17/754,431 (reference application), hereinafter referred to as ‘431. This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
The claims of ‘431 disclose a skin care composition comprising (a) lyophilized and/or spray dried live bacteria of at least one strain of cutibacterium acnes (C. acnes) single-locus sequence typing (SLST) type strain selected from D1, A5, C1, C3, H1, H2, H3, K1, K2, K4, K6, K8, K9, L1, and F4; and (b) one or both of tocopherol and tocopheryl acetate as an antioxidant (claim 33). The composition of claim 33 further comprises Chondrus crispus extract and/or hydroxypropyl starch phosphate as thickener (claim 40).
Response to Arguments
Applicants assert due to the claim amendments to the instant claims, the rejection is moot.
This argument is not persuasive. The claims of ‘431 were newly amended to include the specific strains in the independent claim, therefore, claim 40 of ‘431 is the same invention of instant claim 41.
Nonstatutory 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 33-44 and 46-53 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 17/754,426 (reference application), hereinafter referred to as ‘426, in view of Robert (US 20180085297 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘426 disclose a skin care composition, wherein the composition is suitable for topical application to the skin. The composition comprises lyophilized and/or spray dried live bacteria of at least one strain of Cutibacterium acnes (C. acnes); and one or more of: dicaprylyl carbonate and/or ethylhexyl cocoate as an emollient; Chondrus crispus extract and/or hydroxypropyl starch phosphate as a thickener; distarch phosphate and/or tapioca starch as a filler; tocopherol and/or tocopherol acetate as an antioxidant; one or more of ethanol, phenoxyethanol, caprylyl glycol, methylpropanediol as a preservative; and PEG-40 hydrogenated castor oil as a solubilizer (claim 33). The hydroxypropyl starch phosphate is included from 0.05 to 10.0 wt%, preferably 0.5 to 7.5 wt% (claim 5). The composition further comprises at least one of single-locus sequencing typing (SLST) type strains D1, A5, C1, C3, H1, H2, H3, K1, K2, K4, K8, K9, L1, and F4 (claims 45-47). The composition is present in the form of at least one of a gel, a cream, an ointment or a lotion (claim 50). The composition is capable of treating or preventing one or more of acne, oily skin, progressive macular hypomelanosis, dandruff, atopic eczema, atopic dermatitis, and rosacea in a subject (claim 51) or of improving an appearance of skin of a subject and/or of modulating a sebum production of skin cells of a subject and/or of maintaining healthy skin of a subject (claim 52).
‘426 does not disclose the amount of Chondrus crispus extract.
It would have been obvious to include the above listed thickeners in amounts known to be suitable for skin compositions such as 0.1-20 wt%, as taught by Robert above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The following also stand rejected in view of Robert (US 20180085297 A1) for the same reasons:
Copending application No. 17/754,427
Copending application No. 17/754,426
Copending application No. 17/754,430
Copending application No. 17/754,431
Copending application No. 17/754,432
Copending application No. 17/754,433
Response to Arguments
Applicants request that these provisional rejections be held in abeyance until an agreement regarding allowable claims has been reached.
Applicants’ request is acknowledged. The claims stand rejected for the same reasons above and of record.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA A ATKINSON whose telephone number is (571)270-0877. The examiner can normally be reached M-F: 9:00 AM - 5:00 PM + Flex.
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/JOSHUA A ATKINSON/Examiner, Art Unit 1612
/MARIANNE C SEIDEL/Primary Examiner, Art Unit 1600