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 .
DETAILED ACTION
Claims 5-6, 8, and 11-14 are pending. Claims 11-14 are withdrawn.
Response to Amendment
Applicant amended claim 5 and added new limitations of extraction method steps and “and at least one cosmetically acceptable additive selected from the group consisting of alcohol, surfactant, silicone oil, moisturizing agent, and stabilizer”.
Applicant amended claim 8 and added new limitations of extraction method steps and “at least one pharmaceutically acceptable excipient selected from the group
consisting of lactose, starch, cellulose, polyvinyl pyrrolidone, and magnesium stearate”.
Applicant deleted the limitations “consisting essentially of” and “unknown” in claims 5 and 8.
Claim Objections
Claims 5 and 8 are objected to because of the following informalities:
The phrase “extracting method” should be replaced with “extraction method”.
The phrase “ethanol aqueous solution” should be replaced with “aqueous ethanol solution”.
The term “impurity” should be replaced with “impurities”, and “being free” should be replaced with “is free”.
Appropriate correction is required.
New Rejection necessitated by the Amendment
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 5-6 and 8 remain 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.
Claims 5 and 8 recite the limitation “using an ethanol aqueous solution”. The claims are indefinite because it is not clear how the aqueous ethanol solution is used.
Claims 5 and 8 recite the limitation “a supernatant”. The claims are indefinite because it is not clear if the exopolysaccharide in a supernatant is the same as the precipitated exopolysaccharide in the previous steps. It is not clear where “a supernatant” is coming from.
Claims 5 and 8 recite the limitation “removing impurity from a precipitate”. The claims are indefinite because it is not clear if “a precipitate” refers to the precipitated exopolysaccharide in the previous steps or if it is a different precipitate.
Claim 6, which depends from claim 8, does not cure the indefiniteness and is also rejected.
Maintained Rejection
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 5-6 and 8 remain rejected under 35 U.S.C. 101 because the claimed invention is directed to natural product without significantly more.
Claims 5-6 recite a composition comprising a purified exopolysaccharide derived from a Deinococcus radiodurans BRD125 comprising arabinose, galactose, glucose and xylose wherein the exopolysaccharide comprises 9% by weight of arabinose, 10% by weight of galactose, 15% by weight of glucose, 18% by weight of xylose, and 48% by weight of other sugars, based on a weight of a total exopolysaccharide, and being free of fucose and rhamnose, and at least one cosmetically acceptable additive selected from the group consisting of alcohol, surfactant, moisturizing agent, and stabilizer. Applicant discloses the exopolysaccharide is produced from a naturally occurring microorganism Deinococcus radiodurans BRD125 strain ([88]). Alcohol is a naturally occurring product. Surfactant such as naturally occurring fatty acids, moisturizing agent such as aloe vera or honey, and stabilizer such as natural phospholipids, are naturally occurring components. Claim 8 recites “at least one pharmaceutically acceptable excipient selected from the group consisting of lactose, starch, cellulose, polyvinyl pyrrolidone, and magnesium stearate”. Lactose, starch, and cellulose are naturally occurring components. There is no markedly different characteristic of the recited products compared to their naturally occurring counterpart in its natural state (same structure or form, same biological and chemical properties), and combining them into the recited composition does not change any of their natural characteristics individually or in combination.
This judicial exception is not integrated into a practical application because formulating this natural product into a pharmaceutical formulation is nothing more than an attempt to generally link the product of nature to a particular technological environment. Rana et al. (International journal of biological macromolecules 157 (2020): 577-583, of record in Office Correspondence mailed on 01/27/2026) reports exopolysaccharides are used in the food industry, medical field, cosmetic products (page 577 right column, second para.). Therefore, composition comprising exopolysaccharide as cosmetic composition is well-understood, routine, conventional activity. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Response to Arguments
Applicant's arguments filed 04/07/2026 have been fully considered but they are not persuasive.
Applicant argues that the additional elements integrate the exception into a practical application and argues the claims recite non-naturally occurring additives/excipients.
In response to the argument, claim 5 recites “at least one cosmetically acceptable additive selected from the group consisting of alcohol, surfactant, silicone oil, moisturizing agent, and stabilizer”. While silicone oil is non-natural, alcohol is a natural product, and surfactant, moisturizing agent, and stabilizer encompass natural products such as naturally occurring fatty acids, aloe vera or honey, and natural phospholipids, respectively. Claim 8 recites non-natural components, polyvinyl pyrrolidone, and magnesium stearate. However the claim recites “at least one pharmaceutically acceptable excipient selected from the group consisting of lactose, starch, cellulose, polyvinyl pyrrolidone, and magnesium stearate”. Lactose, starch, and cellulose are naturally occurring components. There is no markedly different characteristic of the recited products compared to their naturally occurring counterpart in its natural state, and combining them into the recited composition does not change any of their natural characteristics individually or in combination.
Applicant argues that the extraction steps are not convention purification.
In response to the argument, claims 5-6 and 8 are drawn to a composition and not an extraction method. The extraction method limitation is a product by process limitation. See MPEP 2113. Determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. There is no indication in the specification that the extraction method alters the exopolysaccharide structure. The specification does not disclose the structure of the purified exopolysaccharide is different from its naturally occurring counterpart.
Applicant argues the prima facie case in incomplete. Applicant argues that without a proper identification of a naturally occurring counterpart having the same characteristics as the claimed exopolysaccharide, the Office's prima facie case is incomplete.
In response to the argument, the claims are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural product. The claims are not rejected based on prima facie case. The specification discloses the exopolysaccharide is produced from a naturally occurring microorganism Deinococcus radiodurans BRD125 strain ([88]). There is no indication that the claimed exopolysaccharide is different from the naturally occurring one. Furthermore, there is no indication that formulating the exopolysaccharide with alcohol, surfactant, moisturizing agent, stabilizer lactose, starch, or cellulose changes its characteristics.
Conclusion
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 MARY A CRUM whose telephone number is (571)272-1661. The examiner can normally be reached M-F 8:00-5:00 CT with alternate Fridays off.
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/MARY A CRUM/Examiner, Art Unit 1657
/THANE UNDERDAHL/Primary Examiner, Art Unit 1699
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