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 Claims 11-14 are withdrawn.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/24/2025 has been entered.
Claim Objections
Claims 5 and 8 are objected to because of the following informalities: Deinococcus radiodurans should be italicized.
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 5-6 and 8 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.
Claims 5 and 8 are indefinite because they recite “an exopolysaccharide consisting essentially of” in line 5, and further recite “the exopolysaccharide comprises” in line 6. The term “consisting essential of” is narrower in scope than “comprising”. This language creates uncertainty in the scope of the claims.
Claims 5 and 8 recite the limitation “unknown sugars”. The claim is indefinite and lacks clarity because it is not clear what sugar needs to be present. A person of ordinary skill in the art would not understand the metes and bounds of the claim. Applicant may consider amending the claim and replace “other unknown sugars” with “other sugars”.
Claim 6, which depends from claim 5, does not cure the deficiency and is also rejected.
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 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural product without significantly more.
The claims recite a composition comprising an exopolysaccharide derived from a Deinococcus radiodurans BRD125 consisting essentially of 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 unknown sugars, based on a weight of a total exopolysaccharide, and being free of fucose and rhamnose. Applicant discloses the exopolysaccharide is produced from a naturally occurring microorganism Deinococcus radiodurans BRD125 strain ([88]).
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) 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 10/24/2025 have been fully considered but they are not persuasive.
Applicant argues Deinococcus radiodurans BRD125 is not naturally occurring, and was created through human intervention: gamma irradiation of soil samples (5 kGy) to induce mutations, followed by artificial selection for enhanced EPS production. Applicant argues the claimed EPS is a human-engineered product obtained via a deliberate process, has a unique sugar profile, arabinose, galactose, glucose, and xylose in specific ratios, that is not found in wild-type Deinococcus strains, contains no fucose or rhamnose, which sets it apart from naturally occurring counterparts, and exhibits superior antioxidant activity.
In response to the argument, the specification discloses the radiation was used to isolate the radiation resistant microorganism from soil sample ([79]). The specification does not disclose the strain was mutated due to the radiation. Applicant discloses Deinococcus radiodurans survives radiation conditions because the DNA repair system of the strain is superior to cells of other organisms ([2]). Applicant does not compare Deinococcus radiodurans BRD125 and its exopolysaccharide before and after irradiation. There is no indication in the specification that purification of the EPS alters its structure compared to non-purified EPS. Applicant may consider amending the claim to recite unnatural components such as some of the those recited in para. [49] of the specification in order to obviate the rejection.
Conclusion
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