DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Claims included in the prosecution are claims 1-8, 10-19 and 21-30.
Applicants' arguments, filed 08/24/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 § 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.
1. Claims 1-8, 10-12, 14-17, 19, 21 and 24-29 are rejected under 35 U.S.C. 103 as being unpatentable over Sumiko (JP 2020-180088 A, Nov. 5, 2020) in view of Shimpo et al. (CN 1271985 C, Aug. 30, 2006) (hereinafter Shimpo) and Yokozuka et al. (JP H07258036, Oct. 9, 1995) (hereinafter Yokozuka).
Sumiko discloses a skin external preparation containing (A) and (B). (A) is one or more selected from boron nitride, barium sulfate, acylamino acid powder, glittering powder, spherical silica, spherical calcium carbonate, spherical cellulose, spherical starch, spherical modified starch, and spherical silk (abstract). Examples of acyl amino acid powder include acyl lysine (page 4 of translation, first paragraph). When the acyl amino acid powder is blended, the content is preferably 0.01% by mass or more and 15% by mass or less (page 4 of translation, second paragraph). The glittering powder may be plate-shaped cellulose (page 4 of translation, third paragraph). When the glittering powder is blended, the content is preferably 0.01% by mass or more and 80% by mass or less (page 4 of translation, fourth paragraph). Spherical cellulose, spherical starch, and spherical silica are spherical powders (page 4 of translation, fifth paragraph). When the spherical powder is blended, the content is preferably 0.1 to 40% by mass (page 4 of translation, sixth paragraph). Spherical silica preferably has an average particle size of 1 to 50 µm (page 4 of translation, seventh paragraph). The spherical cellulose may be crystalline cellulose (page 4 of translation, last paragraph). The spherical powder may be surface-treated with a hydrophobizing agent. Examples of the hydrophobizing agents include N-lauoryl-L-lysine (i.e., (D) lysine or a salt thereof) (page 5 of translation, fourth paragraph). The external preparation for skin can be produced by a usual production method. The dosage form of the external preparation may be a loose type external preparation for powdered skin (page 5 of translation, last paragraph).
Sumiko differs from the instant claims insofar as not disclosing wherein the acyl lysine has a median diameter of a volume-based distribution of 9 µm or less.
However, Shimpo discloses a powder cosmetic composition comprising component (A), wherein component (A) has a volume average particle diameter of more than 0.1 microns to less than 2 microns (abstract). Component (A) may an inorganic micro-powder or organic micro-powder (page 2 of translation, seventh paragraph). If the volume average particle diameter is less than 0.1 microns, the feeling in use is not good and pores and small wrinkles are not reduced. If the volume average particle diameter is more than 2 microns, pores and small wrinkles are not reduced (page 2 of translation, last paragraph – page 3 of translation, first paragraph). N-lauroyl-L-lysine is an organic powder (page 3 of translation, fourth paragraph).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the acyl lysine of Sumiko to have a volume average particle diameter of more than 0.1 microns to less than 2 microns motivated by the desire to provide the powder of Sumiko with good feeling in use and the property of reducing pores and small wrinkles as taught by Shimpo.
The combined teachings of Sumiko and Shimpo do not teach wherein the composition comprises 50 to 80% spherical silica; 5 to 40% spherical cellulose and 55 to 90% spherical starch; or 60 to 95% spherical cellulose..
However, Yokozuka discloses a solid powder cosmetic containing spherical powder in an amount of 50% by weight or more, a water-soluble polymer, and an oil component. The solid powder cosmetic has a smooth and non-greasy feeling in use and is excellent in impact resistance (¶ [0004]).
As discussed above, Sumiko discloses wherein spherical silica, spherical cellulose, and spherical starch are spherical powders and wherein the composition may be a powder. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated 50% or more spherical silica, spherical cellulose, and/or spherical starch, water-soluble polymer, and an oil component into the composition of Sumiko motivated by the desire to formulate a powder cosmetic that has a smooth and non-greasy feeling in use and is excellent in impact resistance as taught by Yokozuka. One of ordinary skill in the art would have had a reasonable expectation of success since Sumiko teaches on page 4 of the translation that more than 40% does not negatively affect the elongation desired.
In regards to the water repellant time recited in instant claims 2, 3, 26 and 28, the instant specification discloses in Table 2-2 on page 26 wherein when the median diameter of the volume-based distribution of acyllysine is 9 µm or less, the composition has a water repellant time with 30% ethanol or 35% ethanol of 38 minutes, 43 minutes or 60 minutes or more. Therefore, since it would have been obvious to one of ordinary skill in the art to have formulated the acyl lysine of Sumiko to have a volume average particle diameter of more than 0.1 microns to less than 2 microns, the composition of the prior art necessarily has the claimed water repellant time.
2. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Sumiko (JP 2020-180088 A, Nov. 5, 2020) in view of Shimpo et al. (CN 1271985 C, Aug. 30, 2006) (hereinafter Shimpo), Yokozuka et al. (JP H07258036, Oct. 9, 1995) (hereinafter Yokozuka), and further in view of Nakanishi et al. (JP-H 07206640 A, Aug, 8, 1995) (hereinafter Nakanishi).
The teachings of Sumiko, Shimpo, and Yokozuka are discussed above. Sumiko, Shimpo, and Yokozuka do not teach the amount of N-lauoryl-L-lysine (i.e., (D) lysine or a salt thereof).
However, Nakanishi discloses a cosmetic obtained by blending a spherical silica having the surface treated with platy L-lauroyl-L-lysine (abstract). The amount of N-lauroyl-L-lysine used for the surface treatment of the spherical silica is preferably 0.05 to 50% by weight (page 4 of translation, first paragraph).
Sumiko discloses N-lauoryl-L-lysine as a surface-treatment agent. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated 0.05 to 50% N-lauoryl-L-lysine into the composition of Sumiko since this is a known and effective amount of N-lauoryl-L-lysine for use as a surface treatment agent as taught by Nakanishi.
3. Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Sumiko (JP 2020-180088 A, Nov. 5, 2020) in view of Shimpo et al. (CN 1271985 C, Aug. 30, 2006) (hereinafter Shimpo), Yokozuka et al. (JP H07258036, Oct. 9, 1995) (hereinafter Yokozuka), and further in view of Hobo et al. (JP 2019104935 A, Jun. 27, 2019) (hereinafter Hobo).
The teachings of Sumiko, Shimpo, and Yokozuka are discussed above. Sumiko, Shimpoand Yokozuka do not teach wherein the acyl lysine has a bulk density of 0.38 g/mL or less.
However, Hobo discloses a powder of hyaluronic acid and/or salt thereof with a loose bulk density of 0.30-0.50 g/cm3. By setting the loose bulk density in this range, the gaps between the powder particles can be narrowed and the amount of water vapor absorbed can be reduced. As a result, the handleability of the powder is secured (page 3 of translation, penultimate paragraph).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated acyl lysine with a loose bulk density of 0.30-0.50 g/cm3 into the powder composition of Sumiko motivated by the desire to formulate the powder composition with effective handleability as taught by Hobo.
4. Claims 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Sumiko (JP 2020-180088 A, Nov. 5, 2020) in view of Shimpo et al. (CN 1271985 C, Aug. 30, 2006) (hereinafter Shimpo), Yokozuka et al. (JP H07258036, Oct. 9, 1995) (hereinafter Yokozuka), and further in view of Li et al. (CN 104095239 A, Oct. 15, 2014) (hereinafter Li).
The teachings of Sumiko, Shimpo, and Yokozuka are discussed above. Sumiko, Shimpo, and Yokozuka do not teach wherein the composition is produced by dry mixing for 120 minutes or less.
However, Li discloses adding materials to a mixer and dry mixing for 15-20 minutes to produce a loose powder (abstract).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have dry mixed the components of Sumiko for 15-20 minutes since the composition of Sumiko is a powder and this is a known and effective method of producing powders as taught by Li.
5. Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Sumiko (JP 2020-180088 A, Nov. 5, 2020) in view of Ide (JP 2018162227A, Oct. 18, 2018) and Yokozuka et al. (JP H07258036, Oct. 9, 1995) (hereinafter Yokozuka).
Sumiko discloses a skin external preparation containing (A) and (B). (A) is one or more selected from boron nitride, barium sulfate, acylamino acid powder, glittering powder, spherical silica, spherical calcium carbonate, spherical cellulose, spherical starch, spherical modified starch, and spherical silk (abstract). Examples of acyl amino acid powder include acyl lysine (page 4 of translation, first paragraph). When the acyl amino acid powder is blended, the content is preferably 0.01% by mass or more and 15% by mass or less (page 4 of translation, second paragraph). The glittering powder may be plate-shaped cellulose (page 4 of translation, third paragraph). When the glittering powder is blended, the content is preferably 0.01% by mass or more and 80% by mass or less (page 4 of translation, fourth paragraph). Spherical cellulose, spherical starch, and spherical silica are spherical powders (page 4 of translation, fifth paragraph). When the spherical powder is blended, the content is preferably 0.1 to 40% by mass (page 4 of translation, sixth paragraph). Spherical silica preferably has an average particle size of 1 to 50 µm (page 4 of translation, seventh paragraph). The spherical cellulose may be crystalline cellulose (page 4 of translation, last paragraph). The spherical powder may be surface-treated with a hydrophobizing agent. Examples of the hydrophobizing agents include N-lauoryl-L-lysine (i.e., (D) lysine or a salt thereof) (page 5 of translation, fourth paragraph). The external preparation for skin can be produced by a usual production method. The dosage form of the external preparation may be a loose type external preparation for powdered skin (page 5 of translation, last paragraph).
Sumiko differs from the instant claims insofar as not disclosing wherein the acyl lysine has a median diameter of a volume-based distribution of 2.2 to 9 µm.
However, Ide discloses a solid cosmetic comprising (B) a powder component including a component (B1) spherical powder (abstract). Suitable (B1) include N-acyl lysine (page 8 of 14 of translation). The average particle diameter of the spherical powder of the component (B1) may be 5 to 60 µm from the viewpoint of preventing caking. The average particle diameter of the powder can be measured as a volume average particle diameter (page 7 of 14 of translation).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the acyl lysine of Sumiko to have a volume average particle diameter of 5 to 60 µm motivated by the desire to prevent caking as taught by Ide.
The combined teachings of Sumiko and Ide do not teach wherein the composition comprises 50 to 80% silica.
However, Yokozuka discloses a solid powder cosmetic containing spherical powder in an amount of 50% by weight or more, a water-soluble polymer, and an oil component. The solid powder cosmetic has a smooth and non-greasy feeling in use and is excellent in impact resistance (¶ [0004]).
As discussed above, Sumiko discloses wherein spherical silica is a spherical powder and wherein the composition may be a powder. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated 50% or more spherical silica, water-soluble polymer, and an oil component into the composition of Sumiko motivated by the desire to formulate a powder cosmetic that has a smooth and non-greasy feeling in use and is excellent in impact resistance as taught by Yokozuka. One of ordinary skill in the art would have had a reasonable expectation of success since Sumiko teaches on page 4 of the translation that more than 40% does not negatively affect the elongation desired.
Response to Arguments
Applicant argues that there is no teaching or suggestion from the combination of Sumiko and Shimpo of a spherical silica having an average particle diameter of 3 to 20 µm.
The Examiner does not find Applicant’s argument to be persuasive. Sumiko discloses on page 4 of the translation, seventh paragraph wherein the spherical silica preferably has an average particle size of 1 to 50 µm. Therefore, the claimed particle size for spherical silica would have been obvious and Applicant’s argument is unpersuasive.
Applicant argues that in view of the results of the Declaration, it would not be expected from the combined teachings of Sumiko, Shimpo, and the other prior art references that the powder composition of claims 24, 26, and 28 would show unexpected improvements in sensory evaluation when the content of starch is in a range of 55 to 90% by mass, or in the powder composition of claims 25, 27, and 29 wherein the content of the cellulose is 60 to 95% by mass.
The Examiner does not find Applicant’s argument to be persuasive. Applicant is arguing that the claimed ranges of starch and cellulose are unexpected. However, Applicant has not shown wherein the claimed ranges of starch and cellulose are unexpected. Example 6-8, which is representative of claims 24, 26, and 28, comprises 55% starch. Applicant claims starch in a range of 55 to 90%. 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. See MPEP 716.02(d)(II). Applicant has not established wherein a composition comprising up to 90% starch would achieve the same sensory evaluation as a composition comprising 55% starch. Furthermore, regarding claims 25, 27 and 29, Comparative Example B differs from the claims not only in the amount of spherical cellulose, but in the amount of acyllysine as well. The claims recite 2 to 40% acyllysine and 60 to 95% cellulose. Comparative Example B comprises 60% acyllysine and 40% cellulose. It is unclear whether the poor sensory evaluation of Comparative Example B is from the amount of acyllysine or from the amount of cellulose. Thus, Applicant has not shown wherein the claimed range of cellulose is unexpected. As such, Applicant’s argument is unpersuasive.
Response to Declaration
Declarant’s argument has been addressed above.
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 1-8, 10-19 and 21-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/894,071 (reference application) in view of Sumiko (JP 2020-180088 A, Nov. 5, 2020) and Yokozuka et al. (JP H07258036, Oct. 9, 1995) (hereinafter Yokozuka). The pending claims differ from the copending claims insofar as reciting 50 to 80% silica or 55 to 90% starch.
However, Yokozuka discloses a solid powder cosmetic containing spherical powder in an amount of 50% by weight or more, a water-soluble polymer, and an oil component. The solid powder cosmetic has a smooth and non-greasy feeling in use and is excellent in impact resistance (¶ [0004]).
Sumiko discloses wherein spherical starch and spherical silica are spherical powders (page 4 of translation, fifth paragraph).
Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated 50% or more spherical silica or spherical starch into the composition of the pending claims motivated by the desire to formulate a powder cosmetic that has a smooth and non-greasy feeling in use and is excellent in impact resistance as taught by Yokozuka and Sumiko.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant argues that the present claims are distinguished over Sumiko and Yokozuka for the reasons given above.
The Examiner submits that Applicant’s arguments above are unpersuasive. Therefore, the rejection is maintained.
Conclusion
Claims 1-8, 10-19 and 21-30 are rejected.
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 TRACY LIU whose telephone number is (571)270-5115. The examiner can normally be reached Mon-Fri 9 am - 5 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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/TRACY LIU/Primary Examiner, Art Unit 1614
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