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 .
Priority
The instant application was filed 12 February 2024 and is the national stage entry of PCT/US/22/38489 filed 27 July 2022. The Applicant claims priority to provisional application 63/232,760 filed 13 August 2021. The effective filing date of the instant application is 13 August 2021.
Claim Objections
Claims 1, 3-5, 11, 12, and 16 are objected to because of the following informalities:
Claims 1, 11, 12 recite “the low substituted carboxymethyl cellulose has an average degree of substitution (DS) per anhydroglucose unit is in the range of from about…” The Applicant is encouraged to omit “is” and amend the claim to, for example, “the low substituted carboxymethyl cellulose has an average degree of carboxymethyl substitution (DS) per anhydroglucose unit in the range of from about…” Appropriate correction is required.
Claims 3 and 5 recite “alginic acid based polymers,,” with an extra comma. Claim 5 also has two periods at the end of the claim. Appropriate correction is required.
Claim 4 has an extra space before the period. Appropriate correction is required.
Claim 16 recites “jojoba oil almond oil” with a missing comma between the two oils. Claim 16 also recites “olive oil.” with a period right after instead of a comma and extra periods after eucalyptus, castor, and thyme. 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 10, 17 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 10 recites a list of formulations concluding the list with “and” instead of “or.” The metes and bounds of the limitation cannot be determined because it is unclear if all of the listed formulations are required or optional. The Applicant should clarify through using “or” instead if the formulations and properties are optional.
Claim 17 recites “silicone fluids (oils).” The parenthetical recitation renders the claim indefinite because it is unclear whether the limitations in the parenthesis are part of the claimed invention or describing an example of preference. The parenthetical recitation is also not an exact synonym for “fluids.” See MPEP 2173.05(d).
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Konno et al. (US 2012/0207689 A1), Dijk et al. (US 2008/0071077 A1), CMC document (2021), Anton Paar (2020), and Nouryon (2020).
Konno teaches a hair care composition (abs; entire teaching) that may comprise CMC as a semi-synthetic macromolecule (para. 48) in an amount of 5% (Table 14), wax (para. 59), water (para. 123), coconut oil (para. 60), silicones and dimethicones (para. 67), and additives, such as magnesium stearate, in an amount of 1% (paras. 58, 88, Table 1), addressing claims 10, 15-17, and partially claims 1 and 11. The formulation may be gels, creams, and emulsions (para. 122), addressing claims 9 and 14. Other ingredients include xanthan gum (para. 47), acrylate polymers and copolymers (para. 49), modified starch (para. 44), cationized guar gum derivatives (para. 103), and thickeners (para. 17), addressing claims 3-5, 13, and 20. The composition may be used impart hair smoothness (para. 311), addressing claim 18. The pH of the composition may be in the range of 7-12 (para. 33), addressing claim 19.
Konno does not specifically teach using low-substituted CMC in claims 1, 2, 11, and 12, CMC as a dry powder in claim 6, a combination of the ingredients in claims 1 and 11, or the viscosity and molecular weight in claims 7 and 8.
Dijk teaches that CMC with a degree of substitution of at least 0.6 (para. 26) is suited for hair care products, such as shampoo (para. 11).
Nouryon teaches that CMC is typically used as a dry powder (pg. 23).
In regards to selecting the combination of CMC, water, and polymers “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Konno teaches a hair care composition that may comprise CMC, whereas the claimed invention is directed towards a composition comprising low-substituted CMC, at least one personal care additive, and water Since Konno teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
Since Konno does not specifically teach using low-substituted CMC in claims 1, 2, 11, and 12 or CMC as a dry powder in claim 6, one of ordinary skill in the art would have been motivated to use Dijk’s teaching of low-substituted CMC with a DS of around 0.6 and Nouryon’s teaching of CMC as a dry powder with a reasonable expectation of success. Dijk teaches that CMC with a DS of at least 0.6 is preferably suited for hair care products. A skilled artisan would have recognized the benefit of adding lower-substituted CMC to Konno’s composition, especially because the CMC document that lower-substituted CMC is more thixotropic (pg. 2) and Anton Paar teaches that thixotropic formulations are better for hair care products (pg. 1). Additionally, since Nouryon teaches that CMC is typically used as a dry powder, it is obvious to a skilled artisan that the CMC used in Konno’s could also be used as a dry powder.
Regarding the amount of additives in claim 11, Dijk also teaches mineral oil and wheat germ oil in amounts of 4% and 2%, respectively (Examples 4 and 6). Additionally, in regards to the viscosity and molecular weight in claims 7 and 8, Dijk teaches a viscosity of over 12,000 mpa.s in a 1% aqueous solution (para. 33) with a DP of 6500 and DS of 0.75. However, Dijk specifically teaches a DS of at least 0.6 (para. 26). Therefore, the molecular weight of CMC with a DS of 0.6 and DP of 6500 may be expected to be around 1,365,000 Daltons (MW = DP x (162+80(DS)) (Nouryon, pg. 10). That being said and in lieu of objective evidence of unexpected results, the amounts, viscosity, and molecular weight can be viewed as a variable that achieves the recognized result of successfully making the low-substituted CMC composition, which a skilled artisan would have been easily motivated to modify and adjust. The optimum or workable range of amounts, viscosity, and molecular weight can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Applicants provide no evidence of any secondary consideration such as unexpected results that would render the optimized viscosity and molecular weight as nonobvious.
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 1-18, 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12, 16-18 of copending Application No. 18/554,337 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 16 recite low-substituted CMC, at least one additive, and water with a degree of substitution of 0.5 to about 0.7, which correspond to instant claims 1, 2, 11, and 12. Claims 2-4 include polymers that are similar to instant claims 3-5 and 13. Claim 5 recites CMC as a powder, which corresponds to instant claim 6. Claims 6 and 7 recite the same viscosity and molecular weight ranges as instant claims 7 and 8. Claims 9 and 17 recite an emulsion formulation and instant claim 9 recites an emulsion formulation. Claim 10 recites a gel, body lotion, cream, etc., which corresponds to instant claim 14. Claim 11 recites imparting certain properties to the consumer, which corresponds to instant claim 18. Claim 12 recites a hair care product, shampoo, conditioner, etc., which corresponds to instant claim 10. Claim 18 recites additives, which corresponds to additives similar to instant claims 15-17 and 20.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613