DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
2. The information disclosure statement (IDS) submitted on 10/30/23 was filed and entered. The submission is in compliance with the provisions of 37 CFR 1.97 and has been considered by the Examiner.
Election/Restrictions
3. Applicant’s election, without traverse, of Group I, in the reply filed on 01/29/26, is acknowledged.
Claim Status
4. The amendment, filed 01/29/26, has been entered. Claims 1-23 are pending. Claim 13 is amended. Claims 19-23 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/29/26. Claims 1-18 are under examination.
Claim Rejections - 35 USC § 112
5. 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.
6. Claims 1-18 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
The term “conserved” in claim 1, is a relative term which renders the claim indefinite. The term “conserved” is not defined by the claim, thus one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In other words, to what degree of conservation of any particular metabolic pathway would be included vs. excluded from the scope of the claim? Thus, clarification is required.
Further, claim 1 is indefinite based on the phrase “…metabolically priming” because it is unclear what the positively recited step requires. It is noted that the specification does not explicitly define this phrase and it is the Office’s position that one of ordinary skill in the art would not recognize what this encompasses. Thus, clarification is required.
The term “normal” in claims 4, 7, 9, 13, and 15, is a relative term which renders each claim indefinite. The term “normal” is not defined by the claim, thus one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In other words, what culture conditions (e.g. pH, temperature, oxygen, nutrients, salinity, etc.) would be considered “normal” and by whom? Further, it is unclear if the “normal” conditions are required to be the same before and after the irradiating or if the culturing conditions would be allowed to vary; and would the culturing conditions encompass specific metrics or would they vary over a range – and, if so, what range? Thus, the metes and bounds of these claims cannot be clearly ascertained because the “normal” conditions for skilled artisan (i.e. in one laboratory) would not necessarily be the same as that for any other artisans in any other laboratory, even for the same organisms. Accordingly, clarification is required to remove scope ambiguity.
With regards to claim 3, the limitation “…versus control on biomass yield” does not make sense; thus, clarification is required (i.e. there appear to be extra words, or missing words for the limitation).
Claims 8 and 12 are each indefinite because of the use of parentheses. Although parenthesis may be appropriate when defining an abbreviation or acronym, the inclusion of parentheses for phrases, raises uncertainty as to whether the feature in the parentheses is optional or always present. Thus, clarification is required to ascertain the metes and bounds of these claims. The Office suggests the use of commas or semicolons. Further, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 8 and 12 each recite several broad recitations of a phylum or a division (e.g. Haptophyta and/or Bigyra), and the same claims also recite additional limitations such as “mostly marine algae including coccoliths” and/or “including Thraustochytrids” which are each narrower statements of the broad limitations. The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Thus clarification and/or correction, throughout the entire list in claims 8 and 12 is required.
Other dependent claims do not clarify the issues identified above. Consequently, clarification is required to remove scope ambiguity and clearly ascertain the metes and bounds of these claims.
Claim Rejections - 35 USC § 101
7. 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.
8. Claims 1-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e. law of nature) without significantly more.
The claims recite A method of metabolic activation of an organism by irradiation, comprising: irradiating the organism with at least one of X-ray and gamma radiation that produces hormesis in the organism, the organism being at least one of a microalgae strain and an organism with conserved metabolic pathways; and metabolically priming the organism to produce a hormetic effect of at least one of a greater lipid yield, greater biomass yield, and greater metabolite yield under given conditions compared to untreated organisms of the same species when maintained under the same conditions; which encompasses the natural process of radiation hormesis, as evidenced by, for example, Macklis et al. 1991 (Radiation Hormesis; J Nucl Med 32:350-359) and Erofeeva 2022 (Environmental hormesis: From cell to ecosystem; Current Opinion in Environmental Science & Health; 29:100378). Therefore, although the claims are drawn to a statutory category (i.e. Step 1 of the subject matter eligibly analysis is yes), they also recite a natural phenomenon (Step 2A, prong 1, is yes).
This judicial exception is not integrated into a practical application because the claims amount to merely observing a natural phenomenon since there are no other positively recited steps and no required doses (e.g. encompasses naturally levels) of the radiation and both x-ray and gamma radiation are naturally occurring (i.e. from space via cosmic interactions); thus hormesis via radiation is the handiwork of nature, not the handiwork of man. Accordingly, Step 2A, prong 2, is no.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements in claims 1, 3, 6, 8, 10, 11, 12, 16, 17 and/or 18 that are not either judicial exceptions themselves (i.e. specifying the naturally occurring organism) or merely expressions of intended results (i.e. the result of the only positively recited method step of irradiating) because the only positively recited step is irradiation with x-ray or gamma rays with any dose for any length of time which encompasses naturally occurring conditions. With regards to “…cells in culture” in claim 2 and normal culturing conditions in claims 4, 5, 7, 9, 13, 14, and 15; it is noted that merely putting the naturally occurring organisms in a container does amount to significantly more that the judicial exception per se, because the natural process of radiation hormesis would still occur independent of the container. Further, these elements are not sufficient because they are recited at a high level of generality and are well-understood, routine, conventional activities already engaged in by the scientific community, as evidenced by, for example, Jeong 2017 (Effect of continuous exposure to low-dose-rate gamma irradiation on cell growth and lipid accumulation of marine microalgae; Aquacult Int 25:589-601) and Tale et al. 2018 (Effect of gamma irradiation on lipid accumulation and expression of regulatory genes involved in lipid biosynthesis in Chlorella sp.; J Appl Phycol 30:277-286) see art rejections below. Thus, taken alone, the additional elements do not amount to significantly more than the above identified judicial exceptions (i.e. the natural phenomenon of radiation hormesis). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Therefore, Step 2B is no.
If the Applicant chooses to amend the instant claims, the Examiner recommends that Applicant consider the SCOTUS ruling that the additional steps should consist of more than well-understood, routine, conventional activity already engaged in by the scientific community. The Court has made clear that to transform an unpatentable judicial exception(s) into a patent-eligible application thereof, one must do more than simply state the exception while adding the words “apply it.” . Thus, based upon consideration of the relevant factors with respect to the claims as a whole, the claims are rejected as ineligible subject matter under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
9. 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.
10. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
11. Claims 1-10 and 12-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jeong 2017 (Effect of continuous exposure to low-dose-rate gamma irradiation on cell growth and lipid accumulation of marine microalgae; Aquacult Int 25:589-601).
Jeong teaches methods for enhancing biomass and lipid content in marine microalgae comprising irradiating cultures of the microalgae with low doses of gamma radiation (e.g. see abstract; page 591, Experimental procedure; and Figure 2; meeting limitations found in instant claims 1, 2, 6, and 16). Jeong provides explicit examples wherein Tetraselmis suecica (i.e. Chlorophyta) was cultured using autoclaved natural seawater supplemented with f/2 medium (i.e. “normal conditions”); grown through exponential and stationary growth phases; while being exposed to low-dose-rates of chronic radiation to produce a hermetic response; see page 592, Materials and Methods; Figures 1 and 2; and page 596, first paragraph of Discussion; meeting the broadest reasonable interpretations of limitations found in instant claims 1, 4, 5, 7, 8, 9, 12, 13, 14, and 15). Jeong reports results for significant increases in cell growth and biomass (i.e. biomass did not decrease relative to controls) with the highest cell densities documented at stationary phase; see page 593, Results; and page 596, Discussion; meeting limitations found in claims 1, 3, 5 and 16). Jeong reports results for significant increases in total lipid content (e.g. see Figures 4 and 5; and page 595, last section; meeting limitations found in instant claims 1 and 10).
Accordingly, Jeong anticipates the invention as claimed.
Claim Rejections - 35 USC § 102
12. Claims 1-4, 8-15 and 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tale et al. 2018 (Effect of gamma irradiation on lipid accumulation and expression of regulatory genes involved in lipid biosynthesis in Chlorella sp.; J Appl Phycol 30:277-286).
Tale teaches methods for increasing lipid accumulation in Chlorella sorokiniana (i.e. Chlorophyta) comprising culturing the microalgae in 250-mL Erlenmeyer flasks containing 100 mL BBM for a period of 4 weeks at 25°C with 12:12 h light and dark cycles with 5-min shaking at 100 rpm twice a day (i.e. “normal conditions”); wherein exponentially grown algal cultures (e.g. cell density approximately 5 x 105 cells mL-1) were directly exposed to gamma rays for a particular dose, taken out of irradiation chamber, and maintained as such for a period of 30 days (e.g. see abstract; and page 278, Material and methods; meeting limitations found in instant claims 1, 2, 4, 8, 9, 12, 13, 14, and 15). Tale reports that at day 3, post irradiation, there was hardly any growth suppression (i.e. biomass did not decrease relative to control; e.g. see page 280, Results, right column; meeting limitations found in instant claim 3). Tale reports an almost 100% increase in lipid content at 3 days post irradiation including the accumulation of cytoplasmic lipid droplets (e.g. see page 281, Results, left column; and Figure 2; and Figure S1; meeting limitations found in instant claims 1, 10, and 11). Tale demonstrated that the relative expression levels for ribulose-1,5-bisphosphate carboxylase/oxygenase, acetyl-CoA carboxylase (ACCase), and diacylglycerol acyl transferase (DGAT) genes increased under gamma exposure (e.g. see page 283; and Figures 4 and 5; also meeting limitations found in instant claims 10 and 11). Tale teaches that the major fatty acids detected including linoleic acid (e.g. see page 285, left column; and Tables 1 and 2; meeting limitations found in instant claims 17 and 18).
With regards to a-linoleic acid, in dependent claim 18, it is the Office’s position that this species within the genus of linoleic acid can be at once envisaged from the prior art because the species within this genus (i.e. alpha, ALA and gamma, GLA), are sufficiently limited and well delineated; see MPEP 2131.02(III) and In re Petering (wherein the courts determined that a reference describing a generic formula encompassing about 20 compounds was found to anticipate each of the 20 species without specifically naming them).
Accordingly, Tale anticipates the invention as claimed.
Conclusion
13. No claims are allowed.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY MAILLE LYONS whose telephone number is (571)272-2966. The examiner can normally be reached on Monday-Friday 8 am to 5 pm EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http: //www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dan Kolker can be reached on (571)-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARY MAILLE LYONS/Examiner, Art Unit 1645
February 23, 2026