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 .
Status of the Claims
Claims 1-6 and 10-15 have been cancelled in a previous communication
Claims 7-9 and 16-21 are pending. Claims 7-9 stand withdrawn with traverse.
Claims 16-21 are under current examination.
All rejections not reiterated have been withdrawn.
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 16-21 are rejected under 35 U.S.C. 103 as being unpatentable over Levin (US 2012/0064135; publication date: 03/15/2012; cited in the IDS filed 07/12/2023) and Dluzneski (US 6,699,403; issue date: 07/20/2004; cited in the IDS filed 07/12/2023) in view of Poigny et al. (US 2013/0108568; publication date: 05/02/2013).
With regard to claims 16, 19, 20, and 21, Levin discloses a benzoyl peroxide composition and pharmaceutical or cosmetic formulations for topical administration containing the same (title). The benzoyl peroxide has a particle size distribution of 0.1 to 150 microns (this range overlaps with the limitations recited in the instant claims, see MPEP 2144.05), and is coated with a fatty substance (abstract). Levin discloses further that benzoyl peroxide particle size is important because this range allows for more thorough dispersal through the product and benzoyl peroxide particles in this size range more easily enter the pores (0017). Additionally, the end product does not have a gritty feel, increasing patient compliance (0017).
Levin does not disclose coating the benzoyl peroxide with the claimed multivalent fatty acid salts.
Dluzneski, which solves the problem of coating organic peroxides with a water insoluble fatty coating, discloses solid particles of organic peroxide particles having a coating formed by converting a water soluble metallic soap to a water insoluble salt of a metallic soap by reaction with a polyvalent metal ion. The insoluble soap precipitates in the form of a coating over the peroxide particle (abstract). The soap is a C4 to C30 carboxylic acid (i.e. a fatty acid) salt with a monovalent metal ion (abstract) and specifically may be e.g. palmitic, stearic, behenic, capric caprylic, etc. (col 3, lines 55-65) and specifically, arachidonic (i.e. an omega-6 fatty acid) or docosahexaenoic acid (i.e. an omega-3 fatty acid; col 3, line 62) that precipitate over the organic peroxide as insoluble salts with polyvalent metals including calcium, magnesium, and aluminum (col 4, lines 50-60). The coated organic peroxide particles are easy to disperse, show exceptional resistance to degradation, and the metallic soap adds lubricity to the particles (col 5, lines 15-25).
Poigny discloses that ricinoleic acid is a C18 fatty acid.
It would have been prima facie obvious so use coat benzoyl peroxide particles with the claimed polyvalent metal salts of fatty acids and taught by Dluzneski as the coated benzoyl peroxide in Levin’s formulation because this merely represents combining prior art elements according to known techniques to yield predictable results. See MPEP 2143(I)(A).
It would have been prima facie obvious to use ricinoleic acid because one having ordinary skill in the art would have recognized ricinoleic acid to be a member of the genus C4 to C30 carboxylic acids (i.e. fatty acids) disclosed by Dluzneski. See MPEP 2144.07.
With regard to claim 16, as noted above, Levin discloses a topical formulation for application to skin.
With regard to claims 16-18, the composition may be a cream, gel, or lotion (0017) and may contain other ingredients including emollients, emulsifiers, fragrances, and antioxidants (0090).
Response to Arguments
Applicant's arguments filed 12/11/2025 have been fully considered but they are not persuasive.
On page 5, Applicant argues that Levin’s particle size refers to the D90 not the D50 particle size and that the inventors have discovered that a reduction in inflammation can be achieved by reducing the particle size of the peroxide and by encapsulating the fine particles in fatty acid salts that have beneficial impacts on the skin. Applicant argues that the reduced particle size increases efficacy by enabling the peroxide particles to effectively penetrate pores of the skin and be more thoroughly dispersed in a carrier making distribution across skin easier. Applicant argues that there was no motivation in Levin that would motivate one to select the claimed D50 particle size range to achieve the above effect.
The argument that Levin discloses a range for D90 whereas the instant claims require a size distribution for D50 is not persuasive because a D90 value indicates that 90 percent of particles are smaller than the value, and D50 indicates that 50% of the particles are smaller than the recited value. If 90% of a population of particles falls below a certain value, then 50% of the particles would necessarily also fall below that same value. Moreover, Levin discloses a broad range of from 0.1 to 150 microns and this range in D90 necessarily embraces the same range for D50, as explained above. The range overlaps with the range recited in the instant claims and this is sufficient to establish a prima facie case of obviousness regarding this limitation (MPEP 2144.05(I)). Additionally, regarding the argument that Levin discloses a range for D90 and the instant claims require a range in D50, Levin points out the particle size of the benzoyl peroxide, which would indicate to one of ordinary skill that this is an important parameter in the composition. It would have been obvious to the skilled artisan as of the instant effective filing date to explore the effect of particle size on the efficacy of the composition. The artisan of ordinary skill in this art would have had an advanced degree in biological sciences and would have been inclined to experiment; see MPEP 2144.05(II), citing Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."). See also Perfect Web, which discussed the role of common sense in the determination of obviousness. The district court had cited KSR for the proposition that "[a] person of ordinary skill is also a person of ordinary creativity, not an automaton," and found that "the final step [of the claimed invention] is merely the logical result of common sense application of the maxim ‘try, try again.’" In affirming the district court, the Federal Circuit undertook an extended discussion of common sense as it has been applied to the obviousness inquiry, both before and since the KSR decision.
With regard to Applicant’s discussion of the benefits of the instant invention, insomuch as this may be an assertion of unexpected results, please refer to MPEP 716.02(b) which details the burden on Applicant to establish that results in a side-by-side comparison to the closest prior art are unexpected and significant. Specifically, Applicant must establish that differences in results are in fact unexpected and unobvious and are of both practical and statistical significance. Additionally, evidence of unexpected properties must be commensurate in scope with the claims.
In the instant case, the finding that particle size results in better skin penetration and improved dispersibility in a vehicle does not suffice to overcome the obviousness rejection because these properties, while beneficial, would not have been unexpected to one of ordinary skill. The relationships between size of a particle and its dispersibility and skin penetration were well known in the art as of the instant effective filing date. With regard to the expectations possessed by the ordinarily skilled artisan, please see for example Spengler (US 20060204469) who states “ benefits for nanoemulsions: efficient delivery of skin care actives [0007] due to small particle size, can penetrate through rough skin surface (0005-0006) and Chen (US 20070196415) who states “The appropriate particle size and density for such compacted material will facilitate dispersion in the depot vehicle and result in the desired beneficial agent release rate”. Importantly, no data has been made of record showing an improvement over the closest prior art, Levin. Thus, at this point in prosecution, there is no unexpected improvement over the closest prior art established on the record. Applicant is reminded that there also must be a nexus between the unexpected property and the difference between the prior art and the instant invention, as claimed.
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 16-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1-22 of U.S. Patent No. 6,674,612 (cited in the IDS filed 07/12/2023);
claims 1-12 of U.S. Patent No. 6,843,935 (cited in the IDS filed 07/12/2023); and
claims 1-9 of U.S. Patent No. 6,699,403 (cited in the IDS filed 07/12/2023)
in view of Levin (US 2012/0064135; publication date: 03/15/2012; cited in the IDS filed 07/12/2023) and further in view of Poigny et al. (US 2013/0108568; publication date: 05/02/2013).
With regard to claims 16 and 19-21, the claims of the ‘612, ‘935, and ‘403 patents embrace solid particles having a core comprising an organic peroxide and a polymer, the core having disposed thereon a coating comprising at least one water insoluble primary metallic soap comprising a polyvalent metal salt of a C4 to C30 carboxylic acid, wherein the polyvalent metal soap is inter alia calcium stearate, magnesium stearate aluminum stearate, or wherein the C4 to C30 carboxylic acid is selected from inter alia docosahexaenoic acid (an omega-3 fatty acid), or arachidonic acid. The claims of the ‘612, ‘935, and ‘403 patents also embrace a method of making the above benzoyl peroxide particle coated with water insoluble multivalent metal salts of fatty acids.
The ‘612, ‘935, and ‘403 patents do not recite that the organic peroxide is benzoyl peroxide and do not claim the D50 of 10 microns or less required by the instant claims.
Levin discloses a benzoyl peroxide composition and pharmaceutical or cosmetic formulations for topical administration containing the same (title). The benzoyl peroxide has a particle size distribution of 0.1 to 150, preferably 10 to 15 microns, and is coated with a fatty substance (abstract). Levin discloses further that benzoyl peroxide particle size is important because this range allows for more thorough dispersal through the product and benzoyl peroxide particles in this size range more easily enter the pores (0017). Additionally, the end product does not have a gritty feel, increasing patient compliance (0017).
It would have been prima facie obvious so use coat benzoyl peroxide particles with the claimed polyvalent metal salts of fatty acids and taught by the ‘612, ‘935, and ‘403 patents to use as the coated benzoyl peroxide in Levin’s formulation because this merely represents combining prior art elements according to known techniques to yield predictable results. See MPEP 2143(I)(A).
The ‘612, ‘935, and ‘403 patents do not recite and Levin does not disclose the claimed fatty acid salts.
Poigny discloses that ricinoleic acid is a C18 fatty acid.
It would have been prima facie obvious to use ricinoleic acid because one having ordinary skill in the art would have recognized ricinoleic acid to be a member of the genus C4 to C30 carboxylic acids (i.e. fatty acids) disclosed by Dluzneski. See MPEP 2144.07.
With regard to claims 16, as noted above, Levin discloses a topical formulation for application to skin.
With regard to claims 17 and 18, the composition may be a cream, gel, or lotion (0017) and may contain other ingredients including emollients, emulsifiers, fragrances, and antioxidants (0090).
Response to Arguments
Applicant's arguments filed 12/11/2025 have been fully considered but they are not persuasive. On page 6, Applicant argues that none of the cited patents alone or in view of Levin teaches or suggests the claimed invention for the reasons discussed in the previous pages in traversal of the obviousness rejection.
This is not persuasive for the reasons discussed in the Response to Arguments section following the obviousness rejection.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 KATHERINE PEEBLES whose telephone number is (571)272-6247. The examiner can normally be reached Monday through Friday: 9 am to 3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE PEEBLES/ Primary Examiner, Art Unit 1617