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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 22 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 22 depends from claim 18, claim 18 recites that the second anionic surfactant is present in amounts of about 1% to about 5% by weight, but claim 22 recites that the second anionic surfactant is present in an amount of less than about 1% by weight which broadens the range of the surfactant claimed in claim 1 because less than about 1% is broader than about 1%.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 18-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 12083208 (‘208). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘208 claims a cleansing composition comprising a surfactant system comprising a first non-ionic surfactant in the claimed amounts, specifically the instantly claimed PEG-80 sorbitan laurate and a second non-ionic that his the claimed decyl glucoside the same amounts as instantly claimed, and an amphoteric surfactant, specifically a betaine in the same amounts that are instantly claimed, then a first anionic surfactant and a second anionic surfactant together in the same amounts which are instantly claimed and wherein the first and second anionic surfactant are the claimed sodium methyl cocoyl taurate and isethionate, and wherein the composition further comprises a polyquaternium, thickener, and preservative system, and pH adjuster that are instantly claimed and has the same properties that are instantly claimed (transmittance, skin mildness score, etc.). Thus, ‘208 claims compositions which anticipate the instant claims and as such one of ordinary skill in the art would conclude that the instant claims are anticipated by the claims of US Patent No. 12083208 (‘208).
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 18-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Molenda et al. (EP2532343A1, from IDS), and further in view of Roberts et al. (US3590122, from IDS), CN106176270 (from IDS), SpecialChem (https://cosmetics.specialchem.com/inci/peg-80-sorbitan-laurate, google cache date 01/23/15, from IDS) CN104825344 (‘344, abstract only (IDS)), Dalrymple et al. (US6525034, from IDS), and as evidenced by Russo et al. (US5478490, from IDS).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 18-21, 24, 28-29, Molenda teaches cleansing compositions having a pH preferably from 3 to 6.5, most preferably 4-5.5 which reads on the claimed range of about 3.5 to about 5.5 ([0077]), and wherein the viscosity is about 1500 to 10000mPa.s at 20°C which reads on the claimed range ([0080]), and wherein the composition comprises coco or decyl glucoside (nonionic surfactant) (claims 18-19), a betaine surfactant (amphoteric surfactant) (see entire document; examples; [0043]; [0028-0029]) (claims 18, 20), sodium cocoyl isethionate as an anionic surfactant (claims 18 and 21) ([0014-0016]; Claims 1-7; Examples), sodium methyl cocoyl taurate (claims 18 and 21) as a more preferred amino acid based anionic surfactant, a polyquaternium (claims 18 and 24) (conditioning agent) in amounts of 0.1-1.5% by weight which reads on the instantly claimed 0.1-0.3% (See [0056]), a thickener (in amounts of about 1-3.5 wt% in the examples) which reads on the instantly claimed range of about 1%, a preservative/preservative system in q.s. (amount which is sufficient), a pH adjuster, specifically citric acid (claims 18, 28-29) and wherein the composition is/can be free of sulfate surfactants as they teach examples which contain no sulfate surfactants (see entire document; e.g. [0018-0021]; [0007]; [0044]; [0046-0047]; [0056]; [0076-0077]; [0078-0080]; examples; Claims). Molenda further teaches wherein the thickener is an ethoxylated polyglyceryl ester with total ethoxy units in the range of 50-200 and fatty acyl chain length of 8 to 22 carbon atoms which would broadly include the instantly claimed PEG-200 hydrogenate glyceryl palmitate (claims 18 and 27) (see entire document; claims; examples; [0079]).
Regarding claims 18-19, 22-23, Molenda also teaches wherein their cleansing compositions comprise 1-15% by weight of the cleansing composition are the isethionate (second anionic surfactant) which reads on the instantly claimed range of about 1 wt% to about 2.5% by weight based on the total weight of the composition that is instantly claimed and the range of less than about 1 wt% claimed in claim 22, and Molenda teaches wherein 3 to 7.5% by weight of the cleansing composition is the betaine which reads on the claimed range of about 1.2 to about 10.5 wt% of the amphoteric surfactant, and wherein the taurate (first anionic surfactant) is present in amounts of 1-15% by weight and which reads on the claimed ratios of about 1:1 of the first anionic surfactant and the second anionic surfactant as claimed when the amounts are optimized, and wherein 1-10% by weight of the cleansing compositions is the glucoside, e.g. decyl glucoside (See [0013]; [0014-0016]; [0017-0021]; [0028-0030]; [0031-0032]).
Ascertainment of the difference between prior art and the claims
(MPEP 2141.02)
Regarding claims 18-29, Molenda does not teach that the cleansing composition has a skin mildness score of IL-1α release less than about 150 pg/mL or wherein the composition has a transmittance greater than 40.000 as measured by UV spectroscopy at 800 nm wavelength and glass cuvette with 10 cm of cell path or wherein the non-ionic surfactant is specifically PEG-80 sorbitan laurate. However, it would have been obvious to one of ordinary skill in the art to add PEG-80 sorbitan laurate to the composition of Molenda and expect to achieve a skin mildness score that falls within the claimed range and a transmittance which falls within the claimed range because SpecialChem teaches that PEG-80 sorbitan laurate, also known liposorb L-80 (claim 19) has been used in cleansing products, specifically facial washes to improve mildness and clarity which would improve the transmittance which could be optimized to the claimed range because if the composition is clear/has high clarity then it would have the high transmittance instantly claimed as mild/low irritation shampoos are desired to be clear as is evidenced by Russo (See Col. 1, ln. 11-21).
Regarding claims 18 and 26, Molenda also does not teach wherein the preservative/preservative system comprises sodium benzoate or benzoic acid and is present in amounts of about 0.5%. However, this deficiency in Molenda is addressed by Roberts and CN10617270.
Roberts teaches that it was known to add sodium benzoate as a preservative to cleansing formulations to prevent mold growth (see Col. 6, In. 9-11).
CN106176270 teaches that it was known to add benzoic acid to mild cleansing/shampoo formulations in amounts of 0.1-0.5% by weight (see abstract; claims 1-2).
Regarding claims 18 and 27, Molenda also does not teach wherein the thickener is specifically PEG-200 hydrogenated glyceryl palmitate. However, this deficiency in Molenda is addressed by Dalrymple.
Dalrymple teaches that it was known in the art to use PEG-200 hydrogenated glyceryl palmitate in clear compositions to be used for personal care products, e.g. shampoo/conditioner, body wash, face cleanser, e.g. all of which read on the claimed cleansing composition (see Formulation A; Formulation K).
Regarding claims 18, 19, Molenda also does not teach wherein the nonionic surfactant comprises a laurate, more specifically PEG-80 sorbitan laurate, even more specifically 0.5-2%wt based on the total composition of PEG-80 sorbitan laurate. However, this deficiency in Molenda is addressed by SpecialChem and ‘344.
SpecialChem teaches that PEG-80 sorbitan laurate, also known liposorb L-80 has been used in cleansing products, specifically facial washes to improve mildness and clarity (See skin care formulation with LiposorbL-80 at bottom of page; see also Liposorb L-80 entry in the table).
‘344 teaches that it was known in the art to use PEG-80 sorbitan laurate in cleansing compositions in amounts of 2-8% which reads on the instantly claimed amounts of about 0.5-2% (See abstract).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art to add the claimed PEG-80 sorbitan laurate to the formulation of Molenda in order to develop a composition having the claimed skin mildness score of IL-1α release less than about 150 pg/mL or wherein the composition has a transmittance greater than 40.000% as measured by UV as are instantly claimed because SpecialChem teaches that PEG-80 sorbitan laurate, also known liposorb L-80 has been used in cleansing products, specifically facial washes to improve mildness and clarity and it was already known to use the PEG-80 sorbitan laurate in the claimed/disclosed amounts as is taught by ‘344 because Russo teaches that it is desired that mild/less irritating shampoos are clear, e.g. have transmittance greater than 40 as instantly claimed.
It also would have been obvious to optimize the amount of each of the claimed surfactants as taught by Molenda and the combined references to fall within the claimed ranges and to include the claimed PEG-80 sorbitan laurate in optimized amounts to form the composition having the claimed properties because Molenda teaches the claimed amounts of surfactants and the claimed ratios of anionic surfactants and it was known to add PEG-80 sorbitan laurate to increase mildness and clarity and it was known to form mild/less irritating shampoos as clear shampoos, e.g. having the claimed transmittance as is evidenced by Russo. One of ordinary skill in the art would have been motivated to do this in order to form new mild/less irritating shampoos which have good clarity especially since all of the claimed components were known in the art to be used in the claimed amounts to formulate shampoos, specifically less irritating high clarity shampoos which is the same problems being solved by the claimed cleansing composition. Further, it was known, “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 reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
It also would have been obvious to one of ordinary skill in the art to use the specifically claimed thickener PEG-200 hydrogenated glyceryl palmitate in the formulation of Molenda in order to develop the instantly claimed formulation because Dalrymple teaches that it was known in the art to use PEG-200 hydrogenated glyceryl palmitate in clear compositions. Thus, it is already known to be a useful thickener for forming clear cleansing compositions and would be an obvious choice for one of ordinary skill in the art to substitute the thickener of Molenda for the instantly claimed PEG-200 hydrogenated glyceryl palmitate in order to form clear cleansing compositions.
It also would have been obvious to one of ordinary skill in the art to select sodium benzoate as the preservative to use in the formulation of Molenda in order to develop the instantly claimed composition because Roberts teaches that it was known to add sodium benzoate as a preservative to cleansing formulations to prevent mold growth.
It also would have been obvious to one of ordinary skill in the art to optimize the amounts of anionic surfactant, specifically isethionate to fall within the claimed range of 0.4-2.25 wt% because it was known in the art to limit/minimize the amounts of anionic surfactant present in mild shampoo formulations to the extent feasible as is evidenced by Russo (see Col. 3, ln.
63-67) and Molenda specifically teaches wherein the range of the isethionate and/or anionic surfactant present in the composition significantly overlaps the claimed range as they teach using 1-15% of the anionic surfactant. Thus, it would have been obvious to one of ordinary skill in the art to optimize the amount of anionic surfactant to the lower end of the claimed range as taught by Molenda, e.g. about 1 to about 2.25 wt% because it was known in the art to limit the amount of anionic surfactants when forming a mild composition as is taught and evidenced by Russo and Molenda specifically teaches that ranges which overlap those instantly claimed are useful in their invention. “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). "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Further, one of ordinary skill in the art would have been motivated to optimize the ranges of concentrations/amounts and ratios of the instantly claimed components which are taught by the prior art to be used in overlapping amounts, etc. as discussed above in order to form new mild/less irritating shampoos which have good clarity especially since all of the claimed components were known in the art to be used in the claimed amounts to formulate shampoos, specifically less irritating high clarity shampoos which is the same problems being solved by the claimed cleansing composition. Further, it was known, “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 reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In the instant case it was already known in the art to use PEG-80 sorbitan laurate in amounts which overlap those instantly claimed, e.g. from 0.5-2% by weight in mild cleansing compositions for use in children/babies.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the above claims would have been obvious to one of ordinary skill in the art within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Molenda et al. (EP2532343A1, from IDS), and further in view of Roberts et al. (US3590122, from IDS), CN106176270 (from IDS), SpecialChem (https://cosmetics.specialchem.com/inci/peg-80-sorbitan-laurate, google cache date 01/23/15, from IDS), CN104825344 (‘344, abstract only from IDS), Dalrymple et al. (US6525034, from IDS), and as evidenced by Russo et al. (US5478490, from IDS) as applied to claims 18-29 above and further in view of DE102006034533 (‘533, from IDS).
Determination of the scope and content of the prior art
(MPEP 2141.01)
The combined references together teach the cleansing composition of claims 18-29 as is discussed above and incorporated herein.
Molenda also teaches wherein their cleansing compositions comprise 1-15%, more preferably 2-12%, by weight of the cleansing composition are the isethionate, and Molenda teaches wherein 3 to 7.5% by weight of the cleansing composition is the betaine which reads on the claimed about 3-5% by weight of the cleansing composition, and wherein the taurate/sodium methyl cocoyl taurate is present in amounts of 1-15% by weight which reads on the instantly claimed about 1% to about 2.5%, and wherein 1-10% by weight of the cleansing compositions is the glucoside/decyl glucoside, which reads on the instantly claimed about 1% to about 5%, and about 2.9% by weight of decyl glucoside claimed in claim 30 (See entire document; e.g. [0013]; [0014-0016]; [0017-0021]; [0028-0030]; [0031-0032]).
Ascertainment of the difference between prior art and the claims
(MPEP 2141.02)
Regarding claim 30, The combined references also does not teach wherein the nonionic surfactant comprises a laurate, more specifically PEG-80 sorbitan laurate in amounts of about 0.7% by weight based on the total composition of PEG-80 sorbitan laurate. However, this deficiency in the combined references is addressed by ‘533.
‘533 teaches that it was known in the art to use PEG-80 sorbitan laurate in mild cleansing compositions in amounts of about 0.5-2% which reads on the instantly claimed amounts of about amounts of about 0.5-2% and about 0.7% by weight that are instantly claimed (See table 13 for mild baby shampoo, pg. 19/22).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art to add the claimed PEG-80 sorbitan laurate to the formulation of Molenda in order to develop a composition having the claimed skin mildness score of IL-1α release less than about 150 pg/mL or wherein the composition has a transmittance greater than 40.000% as measured by UV as are instantly claimed because SpecialChem teaches that PEG-80 sorbitan laurate, also known liposorb L-80 has been used in cleansing products, specifically facial washes to improve mildness and clarity and it was already known to use the PEG-80 sorbitan laurate in the claimed/disclosed amounts as is taught by ‘344 and ‘533 and further because Russo teaches that it is desired that mild/less irritating shampoos are clear, e.g. have transmittance greater than 40 as instantly claimed.
It also would have been obvious to optimize the amounts of each of the surfactants in Molenda and the preservatives, thickeners, conditioning agents, etc. to fall within the claimed ranges and to include the claimed PEG-80 sorbitan laurate in the claimed amounts to form the composition having the claimed properties because Molenda teaches the mild cleaning compositions having overlapping amounts of the same second non-ionic, amphoteric, and anionic surfactants that are instantly claimed and overlapping amounts of the same conditioning agents and overlapping amounts of thickener(s), preservatives as discussed above and it was known to add PEG-80 sorbitan laurate to increase mildness and clarity and it was known to form mild/less irritating shampoos as clear shampoos, e.g. having the claimed transmittance as is evidenced by Russo. One of ordinary skill in the art would have been motivated to optimize the ranges of the instantly claimed components which are taught by the prior art to be used in overlapping amounts, etc. as discussed above in order to form new mild/less irritating shampoos which have good clarity especially since all of the claimed components were known in the art to be used in the claimed amounts to formulate shampoos, specifically less irritating high clarity shampoos which is the same problems being solved by the claimed cleansing composition. Further, it was known, “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 reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In the instant case it was already known in the art to use PEG-80 sorbitan laurate in amounts which overlap those instantly claimed, e.g. from 0.5-2% by weight in mild cleansing compositions for use in children/babies.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin E Hirt whose telephone number is (571)270-1077. The examiner can normally be reached 10:30-7:30 ET M-F.
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/ERIN E HIRT/Primary Examiner, Art Unit 1616
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