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 1-19 are pending and under current examination.
Claim Objections
Claim 19 objected to because of the following informalities: Claim 19 recites “wherein the composition includes” in line 5. The examiner recommends amending the claim to recite “comprises” in place of “includes”. Although in this instance, “includes” is interpreted as a transitional phrase rather than preceding exemplary language, the consistency of the claims would be improved by the suggested amendment. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, line 3 recites “a thickening system including”. The word “including” in this instance renders the claim indefinite because it is unclear whether that substances that follow are required or merely exemplary.
The term “substantial leakage” in claim 1 is a relative term which renders the claim indefinite. The term “substantial leakage” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention in terms of the amount of leakage that would be acceptable in compositions falling within the scope of the claims.
Claim 2 recites “pigments based on bismuth oxychloride” in line 4. The phrase “based on” renders the claim indefinite because it is unclear the extent to which a substance must resemble bismuth oxychloride in order to fall within the scope of the claim.
Claim 1 requires the thickening system to be present in an amount sufficient to cause the cosmetic composition to be retained within a rollerball cartridge assembly without substantial leakage; however, the viscosity (which reflects the amount and identity of thickening agents in the composition) required to retain a composition within a rollerball cartridge is contingent on specific features of the cartridge that vary among different cartridges (see e.g. Roberts US 20090257971, claim 14, which indicates that the clearance between the rotatable ball and the container housing carrying the rotatable ball affects the retention of composition, depending on viscosity). Because the parameter of the rollerball in claim 1 are not defined, the requisite viscosity is also undefined and the claim is indefinite.
The phrase “may be” and the parentheses in claim 5, line 4 render the claim indefinite because it is unclear whether the phrase within the parentheses and following the word “may be” is required or merely exemplary.
The parentheses in claim 9, line 4 render the claim indefinite because it is unclear whether the phrase within the parentheses is required or merely exemplary.
The term “substantial leakage” in claim 13 is a relative term which renders the claim indefinite. The term “substantial leakage” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention in terms of the amount of leakage that would be acceptable in compositions falling within the scope of the claims.
Claim 19, line 7 recites “a thickening system including”. The word “including” in this instance renders the claim indefinite because it is unclear whether that substances that follow are required or merely exemplary.
Claim 19 requires the thickening system to be present in an amount sufficient to cause the cosmetic composition to be retained within a rollerball cartridge assembly without substantial leakage; however, the viscosity (which reflects the amount and identity of thickening agents in the composition) required to retain a composition within a rollerball cartridge is contingent on specific features of the cartridge that vary among different cartridges (see e.g. Roberts US 20090257971, claim 14, which indicates that the clearance between the rotatable ball and the container housing carrying the rotatable ball affects the retention of composition, depending on viscosity). Because the parameter of the rollerball in claim 1 are not defined, the requisite viscosity is also undefined and the claim is indefinite.
The term “substantial leakage” in claim 19 is a relative term which renders the claim indefinite. The term “substantial leakage” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention in terms of the amount of leakage that would be acceptable in compositions falling within the scope of the claims.
Claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the indefiniteness concerns outlined above.
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.
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Breyfogle (US20130195783; publication date: 08/01/2013) in view of Roberts US 20090257971; publication date: 10/15/2009) and further in view of Banowski et al (WO 9637184; publication date: 01/23/1997, citing the English machine translation).
With regard to claims 1 and 19, Breyfogle discloses a personal care composition for reducing wrinkles on skin (0001) in the form of a water gel (abstract). The composition comprises thickening agents selected from a group that contains synthetic polymers as well as various natural polysaccharides (0070): “Thickening agents which can be used in the present invention include, but are not limited to, cross-linked polyacrylates such as Carbopol™ (Goodrich); polyacrylate copolymers such as SepiMAX ZEN (Seppic, Inc.); modified acrylate copolymers such as Sepiplus S (Seppic, Inc.) polymeric carboxylates including modified and unmodified starches, polysaccharide gums such as xanthan gum (e.g. CP Kelco's Keltrol CGT and Keltrol T630, Jungbunzlauer's Xanthan Gum), dehydroxanthan gum (e.g. Amaze XT from AkzoNobel), gallactomanan ((Solagum Tara from Seppic), and cellulose derivatives (e.g. Natrosol 250). Gums may also include, but are not limited to, crosslinked-xanthan gum, hydroxypropyl xanthan gum, undecylenoyl xanthan gum, deacetylated xanthan gum, guar gum, cellulose gum, carrageenan, hydroxylpropyl methyl cellulose, and sodium carboxymethyl chitin. It would have been prima facie obvious to combine any of the above thickening agents, including a combination of synthetic polymers and polysaccharides because each are taught for the purpose of thickening the composition (see MPEP 2144.06).
The composition may further comprise pigments such as titanium oxide coated mica (i.e. a pearlescent pigment; 0047). It would have been prima facie obvious to include titanium oxide coated mica in the composition as a means to impart a color to the cosmetic, and choice of titanium oxide coated mica would have been merely a matter of aesthetic preference.
The composition does not require emulsifiers as it is either an emulsion or an aqueous gel.
With regard to the limitation requiring the thickening system to be present in an amount sufficient to cause the cosmetic composition to be retained within a rollerball cartridge assembly without substantial leakage, Breyfogle teaches rollerball applicators as one option to deliver the composition to the skin (0093) but does not disclose any particular amount of thickening agent to achieve retention in the rollerball device.
Roberts, in the analogous art of personal care compositions delivered by rollerball, teaches that the clearance between the rotatable ball and the container housing carrying the rotatable ball determines retention of the composition and prevents leaking and that this is contingent on viscosity of the composition (specifically claim 14 recites “the clearance between the rotatable ball and the container housing carrying the rotatable ball is sufficient small to prevent the less than 800 centipoises antiperspirant composition from leaking therepast.”)
Banowski, in the analogous art of personal care compositions delivered by rollerball, “For use in rollerball application containers, the viscosity should preferably be in the range from 500 to 1000 [m ^ Pa-s] at 20 ° C, which may be achieved by adding water-soluble thickeners, e.g. of natural microbial or synthetic water-soluble polymers such as e.g. water-soluble starch, guar, xanthan gum, hydroxyethyl cellulose, hydroxypropyl starch, polyacrylamide, polyvinylpyrrolidone, polyvinyl alcohol or jittery polyacrylates (e.g. of the Carbopol (R) type) can be achieved.”
Thus, one having ordinary skill would have recognized that the viscosity of a composition contributes to its retention in rollerball applicators, that viscosity can be adjusted by adding comparable thickeners to those taught by Breyfogle, and a target range in viscosity for rollerball compositions thickened by synthetic or natural water soluble polymers is from 500 – 1000 mPa.s. It would have been prima facie obvious to one of ordinary skill at the time the instant invention was filed to optimize the concentration of the thickeners in Breyfogle’s composition in order to prevent leakage from a rollerball applicator because this would have been routine optimization of an art-recognized parameter. See MPEP 2144.05.
With regard to claim 2, as noted above, the composition may contain the pearlescent pigment titanium oxide coated mica (0047).
With regard to claims 3 and 4, the pigment powder, which includes the titanium oxide coated mica, may be present in amounts ranging from about 5 to about45% of the composition (0046). This range overlaps with the range recited in instant claims 3 and 4 as the value “about 5” is considered to embrace “about 4.8%”.
With regard to claims 5, 8, and 9, as noted above, the thickening agent may be Carbopol, which is a trademark for carbomer as well as various gums (e.g. xanthan) and celluloses.
With regard to claims 6, 7, 10 12-14 and 18, the Breyfogle teaches a range in thickening polymer of up to 15% (0069), and Banowski teaches a target range for viscosity for rollerball delivery. The examiner considers it a matter of routine for one of ordinary skill to determine optimal amounts of the polymers known to increase viscosity in order to achieve a target viscosity of the composition for Breyfogle’s embodiment delivered in a rollerball cartridge. See MPEP 2144.05.
With regard to claim 11, one having ordinary skill, e.g. a Ph.D. in cosmetic formulations science, would have recognized the need to consider uniformity of the composition over time for consistent effect on application to the skin, and would have also optimized the stability of the suspension of pigment particles accordingly be taking into consideration the proportion of the particle relative to the thickening agents that increase viscosity.
With regard to claims 15 and 16, the composition can be formulated as a gel (0043), therefore the examiner considers the disclosure to embrace gelling amounts of thickening agent; the composition contains from about 10 to 98% water (i.e. a solvent, claim 1) and can contain polyhydric alcohols (a solvent; 0040); and as noted above, can contain pearlescent pigments such as titanium oxide coated mica.
With regard to claim 17, the composition can contain skin active agents (page 5).
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 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 5626853 in view of Breyfogle (US20130195783; publication date: 08/01/2013) in view of Roberts US 20090257971; publication date: 10/15/2009) and further in view of Banowski et al (WO 9637184; publication date: 01/23/1997, citing the English machine translation).
Inter alia the claims of the ‘853 patent embrace a gel composition having viscosity from 0.1 – 10 Pa, containing polysaccharide and acrylic hydrophilic polymers as well as a pigment. The ‘853 invention does not require emulsifiers.
The claims of the cited patent do not recite a limitation requiring the pigments to be pearlescent or expressly describe the polymers as being present in an amount sufficient to cause the cosmetic composition to be retained within a rollerball cartridge assembly without leakage.
Breyfogle teach inclusion of pearlescent pigments such as titanium oxide coated mica (0047).
It would have been prima facie obvious to use a pearlescent pigment such as titanium oxide coated mica in the ‘853 composition because this would merely have been combining known prior art elements according to known techniques to yield predictable results (MPEP 2143(A)).
Breyfogle discloses that gel cosmetic compositions may be delivered via a rollerball assembly (0093).
Roberts, in the analogous art of personal care compositions delivered by rollerball, teaches that the clearance between the rotatable ball and the container housing carrying the rotatable ball determines retention of the composition and prevents leaking and that this is contingent on viscosity of the composition (specifically claim 14 recites “the clearance between the rotatable ball and the container housing carrying the rotatable ball is sufficient small to prevent the less than 800 centipoises antiperspirant composition from leaking therepast.”)
Banowski, in the analogous art of personal care compositions delivered by rollerball, “For use in rollerball application containers, the viscosity should preferably be in the range from 500 to 1000 [m ^ Pa-s] at 20 ° C, which may be achieved by adding water-soluble thickeners, e.g. of natural microbial or synthetic water-soluble polymers such as e.g. water-soluble starch, guar, xanthan gum, hydroxyethyl cellulose, hydroxypropyl starch, polyacrylamide, polyvinylpyrrolidone, polyvinyl alcohol or jittery polyacrylates (e.g. of the Carbopol (R) type) can be achieved.”
Thus, one having ordinary skill would have recognized that the viscosity of a composition contributes to its retention in rollerball applicators, that viscosity can be adjusted by adding comparable thickeners to those delimited in the ‘853 patent, and a target range in viscosity for rollerball compositions thickened by synthetic or natural water soluble polymers is from 500 – 1000 mPa.s.
It would have been prima facie obvious to one of ordinary skill at the time the instant invention was filed to optimize the concentration of the thickeners in the composition embraced by the ‘853 patent in order to prevent leakage from a rollerball applicator because this would have been routine optimization of an art-recognized parameter. See MPEP 2144.05.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11129789 in view of Breyfogle (US20130195783; publication date: 08/01/2013) in view of Roberts US 20090257971; publication date: 10/15/2009) and further in view of Banowski et al (WO 9637184; publication date: 01/23/1997, citing the English machine translation).
Inter alia the claims of the ‘789 patent embrace a cosmetic composition comprising ammonium polyacyloyldimethyl taurate and xanthan gum and a pearlescent pigment including micas. The claims of the ‘789 patent do not require an emulsifier.
The claims of the ‘789 patent do not mention the thickening agents being present in an amount sufficient to cause the cosmetic composition to be retained within a rollerball cartridge assembly without leakage.
Breyfogle discloses that cosmetic compositions having comparable thickening agents may be delivered via a rollerball assembly (0093).
Roberts, in the analogous art of personal care compositions delivered by rollerball, teaches that the clearance between the rotatable ball and the container housing carrying the rotatable ball determines retention of the composition and prevents leaking and that this is contingent on viscosity of the composition (specifically claim 14 recites “the clearance between the rotatable ball and the container housing carrying the rotatable ball is sufficient small to prevent the less than 800 centipoises antiperspirant composition from leaking therepast.”)
Banowski, in the analogous art of personal care compositions delivered by rollerball, “For use in rollerball application containers, the viscosity should preferably be in the range from 500 to 1000 [m ^ Pa-s] at 20 ° C, which may be achieved by adding water-soluble thickeners, e.g. of natural microbial or synthetic water-soluble polymers such as e.g. water-soluble starch, guar, xanthan gum, hydroxyethyl cellulose, hydroxypropyl starch, polyacrylamide, polyvinylpyrrolidone, polyvinyl alcohol or jittery polyacrylates (e.g. of the Carbopol (R) type) can be achieved.”
Thus, one having ordinary skill would have recognized that the viscosity of a composition contributes to its retention in rollerball applicators, that viscosity can be adjusted by adding comparable thickeners to those delimited in the ‘789 patent, and a target range in viscosity for rollerball compositions thickened by synthetic or natural water soluble polymers is from 500 – 1000 mPa.s.
It would have been prima facie obvious to one of ordinary skill at the time the instant invention was filed to optimize the concentration of the thickeners in the composition embraced by the ‘789 patent in order to prevent leakage from a rollerball applicator because this would have been routine optimization of an art-recognized parameter. See MPEP 2144.05.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18499498 in view of Breyfogle (US20130195783; publication date: 08/01/2013) in view of Roberts US 20090257971; publication date: 10/15/2009) and further in view of Banowski et al (WO 9637184; publication date: 01/23/1997, citing the English machine translation).
Inter alia the claims of the ‘498 application embrace a gelling solution comprising a crosslinked polyacrylic thickener and a hyaluronate in combination with a pearlescent agent. The claims of the ‘498 application do not require an emulsifier.
The claims of the ‘498 application do not mention the thickening agents being present in an amount sufficient to cause the cosmetic composition to be retained within a rollerball cartridge assembly without leakage.
Breyfogle discloses that cosmetic compositions having comparable thickening agents may be delivered via a rollerball assembly (0093).
Roberts, in the analogous art of personal care compositions delivered by rollerball, teaches that the clearance between the rotatable ball and the container housing carrying the rotatable ball determines retention of the composition and prevents leaking and that this is contingent on viscosity of the composition (specifically claim 14 recites “the clearance between the rotatable ball and the container housing carrying the rotatable ball is sufficient small to prevent the less than 800 centipoises antiperspirant composition from leaking therepast.”)
Banowski, in the analogous art of personal care compositions delivered by rollerball, “For use in rollerball application containers, the viscosity should preferably be in the range from 500 to 1000 [m ^ Pa-s] at 20 ° C, which may be achieved by adding water-soluble thickeners, e.g. of natural microbial or synthetic water-soluble polymers such as e.g. water-soluble starch, guar, xanthan gum, hydroxyethyl cellulose, hydroxypropyl starch, polyacrylamide, polyvinylpyrrolidone, polyvinyl alcohol or jittery polyacrylates (e.g. of the Carbopol (R) type) can be achieved.”
Thus, one having ordinary skill would have recognized that the viscosity of a composition contributes to its retention in rollerball applicators, that viscosity can be adjusted by adding comparable thickeners to those delimited in the ‘498 application, and a target range in viscosity for rollerball compositions thickened by synthetic or natural water soluble polymers is from 500 – 1000 mPa.s.
It would have been prima facie obvious to one of ordinary skill at the time the instant invention was filed to optimize the concentration of the thickeners in the composition embraced by the ‘498 application in order to prevent leakage from a rollerball applicator because this would have been routine optimization of an art-recognized parameter. See MPEP 2144.05.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
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
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