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 .
Claim Status
Applicant’s claim amendments filed 20 February 2025 are acknowledged.
Claims 1-17 are pending.
Claims 16 & 17 are new.
No claims are cancelled.
Claims 2-10 are amended.
Claims 12-15 are withdrawn.
Claims 1-11, 16 & 17 are under consideration.
Examination is to the extent of the following species:
What the Particle Comprises-cellulose;
At least one lipophilic antioxidant-tocopherol;
What the composition further comprises-oil; -and-
Goal/Intention-protecting skin by reducing or controlling peroxidation of unsaturated lipids
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file. The effective filing date is 26 April 2019 due to the priority document being in the English language.
Withdrawn Objections/Rejections
The objection to claims 2-7 is withdrawn due to amendments which recite “the (a) particle(s)”.
The objection to claim 3 is withdrawn due to amendments to recite the word “to” for a ratio rather than “/”.
The rejection of claims 8-10 under 35 USC 112(b)-lack of antecedent basis is withdrawn due to amendments which recite "(b) lipophilic antioxidant(s)”.
New & Maintained Rejections
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.
Claims 1-8, 10 & 11 are rejected under 35 U.S.C. 103 as being unpatentable over Dumousseaux (EP 2939653; Published: 11/04/2015; previously cited).
With regard to claim 1 (a) & 4, Dumousseaux teaches a core “made of particle(s) having a high wet point and being optionally porous”. With regard to claim 1 (a), 2, 3, 5 & 6, Dumousseaux teaches Cellulobeads USF [i.e. a polysaccharide] as the encapsulated particle which the “wet point for oil is 296.0 ml/100 g, wet point for water is 400.8 ml/100 g, the ratio of the wet point for water/the wet point for oil is 1.4) with a particle size of 4 µm” [0186]. With regard to claim 7, Dumousseaux in their claim 11 teaches the microcapsule used in the invention comprises preferably between 40 and 75% by weight comprises of the particles/core and in their claim 36 teaches the composition comprises between 2 and 10% by weight of the microcapsules; as such the composition comprises particles in an amount of 0.8-7.5%, including 1.5% and 4% which falls within the recited range [Math: 40% * 2% =0.8%; 75% *10% =7.5%; 40% * 10% = 4%; 75% * 2%=1.5%]. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). With regard to claim 1 (b), 8, & 10, Dumousseaux teaches the composition of their invention may comprise at least one active agent chosen from cosmetic active agents including antiwrinkle agents which may be tocopherol with the content of active agents is from 0.001% to 20% by weight, preferably from 0.01% to 10% by weight, and more preferably from 0.01% to 5% by weight”([0505]- [0508]). With regard to claim 11, Dumousseaux teaches the compositions of their invention may be anhydrous and in their claim 38 teaches the composition comprises least one additional non encapsulated cosmetic ingredient(s) selected from volatile and non-volatile silicon or hydrocarbon oils [0292].
While there is not a single example comprising each of the claimed components, the porous particle/core constituents (i.e. cellulose polymer/Cellulobeads USF), lipophilic antioxidant/tocopherol, and oil components are included among short lists of reagents. It would have been obvious to one of ordinary skill in the art at the time of the instant invention to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results.
With regard to the recited amounts of lipophilic antioxidant and particle in the composition; the wet point for oil; the wet point for water; the ratio of the wet point for water/the wet point for oil; and the number average primary particle size of the particle, Dumousseaux teaches these parameters with values which fall within or overlap with 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. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Dumousseaux as applied to claims 1-8, 10 & 11 above, and further in view of Ganceviciene (Published: 2012; previously cited).
The teachings of Dumousseaux is described above. Dumousseaux teaches a composition comprising tocopherol as an anti-wrinkle agent.
Dumousseaux does not teach the species of tocopherol.
In the same field of invention of skin anti-aging, Ganceviciene teaches α-tocopherol is “used as a component of skin products…It acts by smoothing the skin and increasing the ability of the stratum corneum to maintain its humidity, to accelerate the epithelialization, and contribute to photoprotection of the skin” (i.e. α-tocopherol smooths the skin/is an anti-wrinkle product; pg. 310, col. 1).
The Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
Here, at least rationale (G) may be employed in which it would have been prima facie obvious to the ordinary skilled artisan at the time of filing to have modified Dumousseaux’s composition by substituting Dumousseaux’s generically taught tocopherol with Ganceviciene’s α-tocopherol because Dumousseaux’s tocopherol is for anti-wrinkling and α-tocopherol smooths the skin (i.e. anti-wrinkle) and accelerates epithelialization (i.e. anti-wrinkle). The ordinary skilled artisan would have been motivated to do so, with an expectation of success in order to select a species of tocopherol which has anti-wrinkle properties.
Claims 1, 3-6, 8-11, 16 & 17 are rejected under 35 U.S.C. 103 as being unpatentable over Baschong (US 2009/0156563; Published: 06/18/2009).
With regard to claims 1(a), 4, 5, 6, 16 & 17, Baschong teaches several particulate skin care delivery systems which include microsponge technology which are water-swellable particles made of cellulose having a myriad interconnecting voids within a non collapsible structures (i.e. porous particles of cellulose/polysaccharide polymer; [0109] & [0125]). With regard to claims 16 & 17, Baschong teaches the active ingredients “such as antioxidants… may be integrated in [the] cosmetically or dermatologically acceptable carrier system” (emphasis added; i.e. the particles and the antioxidant are accessible to each other and the antioxidant is absorbed by the carrier; [0109]). With regard to claims 1(a) & 3, the instant specification discloses at pg. 6, ll. 40 to pg. 7, ll. 1-4, that “ [i]t is more preferable that the (a) particle comprises at least one polysaccharide…Cellulose and its derivatives are preferable. Cellulose is more preferable” (i.e. “the particle has a wet point for oil…a wet point for water… the ratio of the wet point for water to the wet point for oil is 5 or less”). These properties are inherent to the chemical which is cellulose. "Products of identical chemical composition can not have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). With regard claims 1(b), 8 & 9, Baschong teaches the lipophilic antioxidant/active agent may be antioxidants “preferably selected from the group containing” tocopherol (α, γ, γ, δ isomers)” ([0078]-[0080]). More broadly, with regard to claim 10, Baschong teaches the concentration range for the antioxidants, which include tocopherol, is from 0.001 % to 10% [0078]. With regard to claim 11, Baschong teaches end-product formulations which include emulsions in the form of W/O, O/W, O/W/O, and W/O/W (i.e. containing at least one oil or water; [0054]-[0055]).
While there is not a single example comprising each of the claimed components, the porous cellulose particle/core constituents (i.e. cellulose polymer), lipophilic antioxidant/tocopherol, oil components and water components are included among short lists of reagents. It would have been obvious to one of ordinary skill in the art at the time of the instant invention to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results.
With regard to the recited amounts of lipophilic antioxidant in the composition; the wet point for oil; the wet point for water; and the ratio of the wet point for water/the wet point for oil; Baschong teaches these parameters with values which fall within or overlap with 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. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Response to Arguments
In the traverse of the rejection of claims 1-8, 10, and 11 under 35 U.S.C. 103 over Dumousseaux, Applicant summaries the rejection (reply, pg. 7-8). Applicant argues there is no reason or motivation in Dumousseaux to combine "Cellulobeads USF" and "tocopherol" and Dumousseaux discloses no specific examples containing both of them (reply, pg. 8).
This is not persuasive. Dumousseaux teaches Cellulobeads to be as suitable for being the encapsulated particle. Dumousseaux teaches tocopherol to be a suitable anti-wrinkle agent. A person of ordinary skill in the art would be motivated to use these together because Dumousseaux teaches these are suitable reagents for formulating the compositions of their invention.
With regard to Applicant’s arguments that Dumousseaux does not exemplify a composition having both Cellulobeads and tocopherol, exemplification is not the standard for obviousness. It is well-established that a reference is prior art for all that it teaches to a skilled artisan, not merely its preferred
embodiments. Beckman Instruments, Inc. v. LKB Produkter AB, 892 F.2d 1547, 1551 (Fed. Cir. 1989).
Applicant argues that synergism is present with the claimed combination of cellulose beads and tocopherol in terms reducing the hydroperoxide concentration that was not present in the combinations of: a) cellulose beads + glutathione and b) cellulose beads + ascorbic acid (reply, pg. 8-10). Applicant argues since Dumousseaux teaches ascorbic acid, tocopherol, and glutathione interchangeably it could be expected that they all provide comparable results, but contrary to expectations, the combination of cellulose beads + tocopherol gave “significantly greater” results (reply, pg. 10-11).
This is not persuasive. Synergism is commonly defined as the effect of two or more agents working in combination that is greater than the expected additive effect of said agents. Applicant evaluated the effect of cellulose beads + tocopherol, tocopherol alone, cellulose beads + glutathione, and cellulose beads + ascorbic acids. Applicant failed to assess the effect of cellulose beads alone, as such we are unable to conclude their effect on hydroperoxide concentration and whether the combination of cellulose beads + tocopherol is indeed a greater than additive effect.
Next, while Applicant alleges significance in the hydroperoxide concentrations with cellulose beads + tocopherol as compared to cellulose beads + glutathione, or cellulose beads + ascorbic acids, no statistical tests appear to have been performed. What does a concentration of 4 µM as compared to 8 µM and 9 µM? Are the differences in these three values statistically significant? Were they of practical significance? The evidence relied upon should establish “that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.” Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength “are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration.”); Ex parte C, 27 USPQ2d 1492 (Bd. Pat. App. & Inter. 1992). Notably, to establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960) (see MPEP 716.02).
Lastly the data are not commensurate with the scope of the claims. Claim 1 is generic to the (a) at least one particle, (b) at least one lipophilic antioxidant, and their amounts. Applicant evaluated only one specific particle (i.e. cellulose beads) in one specific amount and one specific lipophilic antioxidant (tocopherol) in one specific amount. "[O]bjective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980).
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 1-11, 16 & 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims, 1, 4, 6 & 9 of U.S. Patent No. 11,020,338 (hereinafter ‘338 patent) in view of Dumousseaux (EP 2939653; Published: 11/04/2015; hereinafter Dumousseaux ) and Ganceviciene (Published: 2012). Both the instant claims and the 338’ claims are drawn to a porous cellulose particle and it may be in a composition comprising a physiological acceptable medium. The size of particle is from about 2 to about 7 microns. The ’338 recites the ratio of the wet point for water to the wet point for oil is about 5 or less. The ‘338 does not teach the wet point for oil value, the wet point for water value, at least one lipophilic antioxidant, the species of lipophilic antioxidant, the amount of particle in the composition or that the composition comprises at least one oil. Dumousseaux teaches the species of cellulose particles/Cellulobeads USF, their wet point for water and oil, the percent amount of the cellulose particles/Cellulobeads USF for inclusion in the composition, inclusion of tocopherol as an antiwrinkling agent and its amount, and inclusion of oils as described above. The teachings of Ganceviciene are described above with α-tocopherol taught to be an anti-wrinkling reagent. Here it would have been prima facie obvious to adjust the wet point for oil and the wet point of water of the ‘338 particle as taught by Dumousseaux because Dumousseaux and the ‘338 are directed to porous cellulose particles/cellulose USF beads and it is obvious to modify similar compositions in the same way. It would have been prima facie obvious at the time of filing to add these modified cellulose particles to a composition comprising oil and α -tocopherol as suggested by the combined teachings of Dumousseaux and Ganceviciene because porous cellulose beads are added to such compositions to absorb oil. The ordinary skilled artisan would have been motivated to do so, with an expectation of success in order to supply an oil absorbent composition which has anti-wrinkling properties. With regard to the wet point for oil, the wet point for water, the ratio of the wet point for water to the wet point for oil, the primary particle size, the amount of particles in the composition, and the amount of lipophilic antioxidant in the composition, the combined teachings of the ‘338 patent, Dumousseaux and Ganceviciene teach these parameters with values that overlap or fall within 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. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claims 1-11, 16 & 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 & 7-9 of U.S. Patent No. 11,622,923 (hereinafter ‘923 patent) in view of Dumousseaux (EP 2939653; Published: 11/04/2015; hereinafter Dumousseaux) and Ganceviciene (Published: 2012). The instant claims and the ‘923 patent claims are drawn to an emulsion (i.e. oil and water containing composition) comprising particles. The ‘923 patent teaches particle is porous cellulose having a wet point for oil of at last 25 ml/100 g , a wet point for water of at least 50 mg/ 100 g, and the ratio of the wet point for water/wet point for oil of less than or equal to 5. The ‘923 recites the amount of particles present in the emulsion comprise 0.1 to about 10% by weight. The ‘923 does not teach inclusion of a lipophilic antioxidant, its amount or species the tocopherol; or the size of the particle. The teachings of Dumousseaux are described above with regard to particle size, inclusion of tocopherol as an anti-wrinkling agent and its amount. The teachings of Ganceviciene are described above in relation to α -tocopherol being an antiwrinkling agent. It would have been obvious to the ordinary artisan at the time of filing to have modified the ‘923 composition by adjusting the size of the cellulose particle to be 4 µm and adding an antiwrinkle agent which may be α -tocopherol in an amount more preferably from 0.01% to 5% by weight as suggested by Dumousseaux and Ganceviciene because the ‘923 are drawn to porous cellulose particles and compositions comprising them and it is obvious to modify similar compositions in the same way. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to provide a composition with oil absorbent and anti-wrinkling properties. With regard to the wet point for oil, the wet point for water, the ratio of the wet point for water to the wet point for oil, the primary particle size, the amount of particles in the composition, and the amount of lipophilic antioxidant in the composition, the combined teachings of the ‘923 patent, Dumousseaux and Ganceviciene teach these parameters with values that overlap or fall within 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. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Response to Arguments
Applicant request the nonstatutory double patenting rejections be held in abeyance until the time such allowable subject matter is indicated (reply, pg. 12-13).
Applicants' request is acknowledged, however, a request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an OBJECTION or REQUIREMENTS AS TO FORM (see MPEP 37 CFR 1.111(b) and 714.02). Thus, the double patenting rejections are maintained as no action regarding these rejections has been taken by applicants at this time.
Conclusion
No claims are allowed.
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 LORI K MATTISON whose telephone number is (571)270-5866. The examiner can normally be reached 9-7 (M-F).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David J Blanchard can be reached at 5712720827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LORI K MATTISON/ Examiner, Art Unit 1619
/NICOLE P BABSON/ Primary Examiner, Art Unit 1619
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