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 Status
The amendment of 08/07/2025 has been entered. Claims 1 and 4-17 are pending in this US patent application. Claims 5-8 and 13-17 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/18/2024.
Claims 1, 4, and 9-12 are currently under examination and were examined on their merits.
Withdrawn Rejections
All rejections of claim 3 set forth in the previous Office action are withdrawn in light of the amendment of 08/07/2025, which canceled claim 3.
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 1, 4, and 9-12 remain rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
The statutory categories of invention under 35 U.S.C. 101 are processes, machines, manufactures, and compositions of matter. However, certain members of these categories constitute judicial exceptions, i.e., the courts have determined that these entities are not patentable subject matter. These judicial exceptions include abstract ideas, laws of nature, and natural phenomena. The Office released guidance on January 7, 2019 for the examination of claims reciting natural products under 35 U.S.C. 101 in light of the recent Supreme Court decisions in Association for Molecular Pathology v. Myriad Genetics, Inc. (569 U.S. ___, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013)) and Mayo Collaborative Services v. Prometheus Laboratories (566 U.S. ___, 132 S. Ct. 1289, 101 USPQ2d 1961 (2012)). This guidance indicates that claims must pass an eligibility test to avoid rejection under 35 U.S.C. 101. Under this test, the product must (a) not be directed to a judicial exception or must (b) contain additional elements that amount to significantly more than the judicial exception itself.
‘Directed to a judicial exception’ analysis:
Prong One: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties. Non-limiting examples of characteristics that can determine the presence of a marked difference include biological or pharmacological functions or activities; chemical and physical properties; phenotype, including functional and structural characteristics; and structure and form, whether chemical, genetic, or physical.
Claim 1 recites a particular extract from a naturally-occurring seaweed that contains particular amounts of particular naturally-occurring fatty acids and particular amounts of other naturally-occurring eicosanoids. The instant disclosure does not establish that this extract has a particular property that is not present in the organism as a whole or that performing the extraction results in a marked difference in the structure of the naturally-occurring fatty acids and/or eicosanoids. As such, claim 1 recites a judicial exception.
Claim 4 further limits the amounts of the naturally-occurring ingredients in the extract obtained from a naturally-occurring seaweed. Changing the amount of a naturally-occurring compound in a composition does not result in a marked difference in structure or function absent evidence from Applicant, which has not been presented. As such, claim 4 recites a judicial exception.
Claims 9-12 further limit the naturally-occurring composition of claim 1 by including additional naturally-occurring ingredients. Applicant has not provided evidence that the inclusion of these additional natural ingredients results in a marked difference in structure or function in the composition containing only naturally-occurring ingredients. As such, claims 9-12 recite judicial exceptions.
Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
The claims do not recite additional elements that integrate the judicial exception into a practical application because the claims do not recite any elements that are not judicial exceptions.
‘Significantly more’ analysis:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not recite any elements that are not judicial exceptions.
Therefore, claims 1, 4, and 9-12 are directed to subject matter that is not patent-eligible and are rejected under 35 U.S.C. 101.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4, and 9-12 remain rejected under 35 U.S.C. 103 as being unpatentable over Honda et al., Marine Drugs 17: 96 (2019; published 02/02/2019; cited on the IDS filed 05/23/2022), in view of international patent application WO 2014/186913 filed by Bronfman et al., published 11/27/2014 (cited on the IDS filed 05/23/2022).
Please note: the page and paragraph numbers for the Bronfman reference correlate to the translated copy of the document attached to the previous Office action.
Honda teaches an oleoresin from Agarophyton chilensis that contains the compounds recited in instant claim 1, along with omega-3 fatty acids (see entire document, including abstract; page 2, Figure 1; page 4, Table 2; cf. claims 1, 4, and 9-12; the Examiner notes that the composition of Honda, which contains multiple nutrients, can be interpreted as a “nutraceutical composition”). When fractionating the oleoresin by HPLC, the neutral lipids eluted first and the free fatty acids eluted together in a single peak separate from the glycerolipids (page 3, Figure 2; cf. claim 1).
However, Honda does not teach the specific amounts of the fatty acids and eicosanoids recited in instant claims 1 and 3-4.
Bronfman teaches that an oleoresin from red algae has a high capacity to induce the transcriptional activity of PPARγ (see entire document, including page 1, paragraph 0003). The red alga is Gracilaria chilensis (page 2, paragraph 0006; the Examiner notes that Gracilaria chilensis is a synonym for Agarophyton chilensis, as instantly recited). The oily extract from Gracilaria chilensis has the ability to induce PPARγ, and the algae contain large amounts of acidic eicosanoids, including 8-HETE, that are oxidized derivatives of polyunsaturated fatty acids very similar to those produced in mammals, and so they may correspond to endogenous activators of PPARγ (page 4, paragraph 0011; cf. claim 1). The method of processing the algae once it has been washed, frozen, thawed, and dried determines the amount of PPARγ activation observed in the extract (page 7, paragraph 0026-0029). The algal extract had significant effects on blood glucose levels in mice (page 35, paragraph 0205) and on cerebral infarctions in mice (page 37, paragraph 0213).
While Honda does not teach the specific amounts of the compounds recited in the compositions of claims 1 and 4, the instantly recited amounts would be within the realm of routine experimentation. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[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 re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05 part II A. It would have been obvious to one of ordinary skill in the art at the time Applicants' invention was made to determine all operable and optimal concentrations of all fatty acids and eicosanoids in the extract because the concentrations of lipids in an algal lipid extract that has pharmaceutical effects are art-recognized, result-effective variables known to affect the pharmaceutical efficacy of the extract, which would have been optimized in the pharmaceutical art to provide the desired level of efficacy. The Examiner notes that Honda establishes a method of separating out the various components of the extract using HPLC and that Bronfman discusses the means of processing the algae to result in higher levels of eicosanoids that affect PPARγ transcription, and so one of ordinary skill in the art would have the means of optimizing the concentrations of various components in the extract based on the cited references.
Therefore, claims 1, 4, and 9-12 are rendered obvious by Honda in view of Bronfman and are rejected under 35 U.S.C. 103.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation…103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions……the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
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 was 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.
Response to Arguments
Applicant has traversed the above rejection of the claims under 35 U.S.C. 101. Applicant states that “Extract B,” a highly specific embodiment that falls within the scope of the instantly claimed extract, is not directly obtainable from nature but can only be obtained through multiple steps of purification, separation, stabilization, and formulation (remarks, pages 6-9 and 11). This argument has been fully considered but has not been found persuasive.
The Examiner first notes that the instant claims are not drawn to Extract B. Rather, Extract B represents a single, highly specific embodiment that falls within the scope of the instant claims but does not represent the entire scope of the instantly claimed extract. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The Examiner further notes that every component of the instantly recited composition is a naturally occurring molecule. As such, it does not matter if non-naturally-occurring methods are used to obtain an extract with the particular concentrations of ingredients recited in the instant claims. Unless a markedly different property in structure or function can be demonstrated, or unless Applicant’s claims integrate the judicial exception into a practical application, any claim directed to a combination of naturally-occurring ingredients that does not require any non-naturally-occurring ingredients is a judicial exception.
Applicant states that Extract B is markedly different because it shows a lipid profile not found in any natural sample, including the presence of DHA and optimized ratios of omega-6 to omega-3 fatty acids, which Applicant states cannot be reached through “standard or single-step extraction processes.” Applicant states that the lipid profiles of the prior art extracts are different from the lipid profiles of the instantly claimed extract (remarks, pages 9-10). This argument has been fully considered but has not been found persuasive.
The Examiner first notes that, as discussed above, the instant claims are not drawn to Extract B. The Examiner further notes that, as discussed above and in the previous Office action, markedly different characteristics can be expressed as the product’s structure, function, and/or other properties. Non-limiting examples of characteristics that can determine the presence of a marked difference include biological or pharmacological functions or activities; chemical and physical properties; phenotype, including functional and structural characteristics; and structure and form, whether chemical, genetic, or physical. Importantly, as discussed above and in the previous Office action, differences in concentration do not qualify as marked differences. As noted above, every recited ingredient of the instantly claimed extract is a natural product. As such, Applicant must demonstrate a marked difference in structure or function (i.e., not simply any difference, such as a difference in concentration) for the claimed composition to be distinct from a judicial exception.
Applicant states that Extract B has a markedly different function than Extract A or other prior art extracts (remarks, pages 10-11). This argument has been fully considered but has not been found persuasive.
The Examiner notes that, as discussed above, the instant claims are significantly broader than Extract B. Applicant has provided no evidence that the allegedly different functions found for Extract B would be observed over the entire scope of the composition of the instant claims, which are recited using open-ended “comprising” language. As such, even if, arguendo, Applicant’s assertions regarding the properties of Extract B are persuasive, they are moot as they apply only to a single embodiment of a much broader claim.
Applicant has traversed the above rejection of the claims under 35 U.S.C. 103 as being unpatentable over Honda in view of Bronfman. Applicant states that, contrary to the extracts of Honda and Bronfman, glycerolipids are absent or are minor constituents of Extract B, which Applicant states is the instantly claimed composition. Applicant states that the extract of the cited art is Extract A, which Applicant states is different from Extract B. Applicant states that Extract B has different properties than Extract A of Bronfman or the extract of Honda (remarks, pages 12-14). These arguments have been fully considered but have not been found persuasive.
The Examiner notes that, as discussed above and in the previous Office action, Honda discloses the separation of the glycerolipids from the free fatty acids (see Honda, page 3, Figure 2), and so Honda clearly teaches an extract of free fatty acids in which glycerolipids are absent or are minor constituents, contrary to Applicant’s assertion. The Examiner notes that the instant claims are not drawn to Extract B, contrary to Applicant’s assertion. The Examiner further notes that the cited art renders obvious the instantly recited composition for the reasons discussed above and in the previous Office action; regardless of whether the extract rendered obvious by the art is “Extract A,” “Extract B,” or any other extract, it falls within the scope of the instantly claimed extract. Regarding the properties of Extract B, the Examiner notes the instant claims are significantly broader than Extract B. Applicant has provided no evidence that the allegedly different functions found for Extract B would be observed over the entire scope of the composition of the instant claims, which are recited using open-ended “comprising” language. As such, even if, arguendo, Applicant’s assertions regarding the properties of Extract B are persuasive, they are not commensurate in scope with the instantly claimed extract.
Applicant states that the method of obtaining the instantly recited extract is different from the method recited in the cited art and that the instant method results in different concentrations of various components and different properties (remarks, pages 15-17). This argument has been fully considered but has not been found persuasive because the instant claims are drawn to a composition, not to a method.
Therefore, the Examiner has maintained the rejections presented above.
Conclusion
No claims are allowed.
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 Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Monday-Friday, 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau, can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Erin M. Bowers/Primary Examiner, Art Unit 1653 12/03/2025