DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Receipt and consideration of Applicant’s amended claim set and Applicant’s arguments/remarks submitted on January 9, 2026 are acknowledged.
All rejections/objections not explicitly maintained in the instant office action have been withdrawn per Applicant’s claim amendments and/or persuasive arguments. Applicant’s claim amendments have necessitated new grounds of rejections set forth below.
Status of the Claims
Claims 20-24 and 29 are pending and under consideration in this action. Claims 1-19, 25-28, and 30 are cancelled.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 9, 2026 has been entered.
Information Disclosure Statement
The information disclosure statement filed January 9, 2026 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language.
It has been placed in the application file, and all of the information referred to therein aside from those explicitly crossed out have been considered.
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 20 and 29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to naturally occurring products without significantly more.
Claim 20 is directed to an algal extract fraction product comprising one or more polar bioactive molecules extracted from a brown algae species having a molecular weight less than 1.0 kDa, and wherein the algal extract is desalted. Claim 29 is directed to an algal extract fraction prepared according to the method of claim 21, which is directed to a method of preparing an algal extract fractionated product, wherein the extract is prepared from brown algae species. The extractions are ultimately from a naturally occurring organism (i.e., brown algae species), and thus, the products resulting from the extraction are made up of compounds that are also naturally occurring (i.e., were naturally occurring within the brown algae species and merely isolated from the source). Furthermore, there is no indication in the instant Specification that the compounds in the claimed extract would result in any characteristics (structural, functional, or otherwise) that are different from their respective naturally occurring counterparts.
This judicial exception is not integrated into a practical application because the claims do not recite any meaningful elements to the naturally occurring compounds. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there is no indication in the specification that the claimed compositions of naturally occurring compounds have any characteristics (structural, functional, or otherwise) that are different from their respective naturally occurring counterparts.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 20 and 21 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 20 recites “wherein the algal extract fraction excludes at least: mannitol, a sulfated polysaccharide, and a laminarin.” While the application as originally filed appears to have support for excluding mannitol, a sulfated polysaccharide, and a laminarin (e.g., P.G. Pub., para.0052), the instant application does not appear to provide support for explicitly excluding more than the three claimed (i.e., at least mannitol, a sulfated polysaccharide, and a laminarin).
Claim 21 recites the step of “circulating a brown algae species extract with a pH less than or equal to 3.0.” (step (a)). The recitation of a pH range less than or equal to 3.0 raises the issue of new matter because the instant disclosure only provides support for circulation of a brown algae species extract with a pH value of 2.76, 2.42, and 2.92 (e.g., Examples 2-4 in Specification). The entire range of pH values of less than or equal to 3.0 is not accounted for in the instant disclosure, and thus, is considered new matter.
Claims 21-24 and 29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, for scope of enablement because the specification, while being enabling for producing filtrate fractions excluding a sulfated polysaccharide and a laminarin when a brown species extract or retentate is passed through an ultrafiltration membrane of about 1.0 kDa, does not reasonably provide enablement for producing filtrate fractions excluding mannitol when a brown species extract or retentate is passed through an ultrafiltration membrane with a molecular weight cutoff of about 1.0 kDa. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims.
An analysis based upon the most relevant Wands factors is set forth below.
To be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In Genentech Inc. v. Novo Nordisk 108 F.3d 1361, 1365, 42 USPQ2d 1001, 1004 (Fed. Cir. 1997); In re Wright 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993),. See also Amgen Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1212, 18 USPQ2d 1016, 1026 (Fed. Cir. 1991); In re Fisher 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). Further, in In re Wands 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) the court stated:
Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman (230 USPQ 546, 547 (Bd. Pat App Int 1986)). They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art and (8) the breadth of the claims.
The Nature of the Invention and Breadth of Claims
The instant claims are directed to a method of preparing an algal extract fractionated product, the method consisting of the steps of inter alia circulating a brown algae species extract with a pH less than or equal to 3.0 through an ultrafiltration membrane having a molecular weight cutoff of about 1.0 kDa creating a first filtrate fraction and a retentate; rinsing with water and recirculating the retentate to obtain one or more additional filtrate fractions, wherein the one or more additional filtrate fractions exclude mannitol, a sulfated polysaccharide, and a laminarin.
The complex nature of the claims is exacerbated by the breadth of the claims. The claims encompass a method of preparing filtrate fractions that exclude mannitol (which have a molecular weight of 182.2 Da) by circulating the extract and retentate through an ultrafiltration membrane having a molecular weight cutoff of about 1.0 kDa.
State of the Prior Art
As illustrative of the state of the art, the examiner cites NL 2009482 C2 (Hal et al) published 03/19/2014 (of record; cited in PTO-892 dated 04/11/2023). Hal recognizes that removal of laminarin from the aqueous extract of brown algae species by ultrafiltration (UF) over a membrane with a molecular weight cut-off of between 3.0 kDa and 200 Da ([0010-0012]) or more preferably between 1.0 kDa and 500 Da ([0026]) results in a UF retentate comprising laminarin, and a UF permeate comprising mannitol and optionally minerals ([0027]). As evidenced by the instant specification, mannitol has a molecular weight of 182.2 Da (instant specification [0050]). The lack of significant guidance from the specification or the prior art with regard to providing a mannitol-free algal extract fraction solely by circulating the algal species extract with a pH less than or equal to 3.0 through an ultrafiltration membrane having a molecular weight cutoff of about 1.0 kDa makes practicing the scope of the invention unpredictable.
While such preparation of a mannitol-free algal extract fraction using solely the steps recited in the method claims may be possible under strictly controlled laboratory conditions, as a practical matter it would be unpredictable or unclear how a mannitol-free algal extract product can be produced from purely following the claimed steps.
Guidance/Working Examples
There does not appear to be any working examples or guidance towards filtrate fractions that exclude mannitol when passed through an ultrafiltration membrane having a molecular weight cutoff of about 1.0 kDa.
To the obtain the “one or more additional filtrate fractions” as recited in the instant claim 21, the retentate of step (a) is rinsed with water and recirculated. The ultrafiltration membrane used, as evidenced by step (a) of claim 21, is a membrane having a molecular weight cutoff of about 1.0 kDa. The instant Specification disclose that “[t]he retentate is rinsed several times to remove the major portion of molecules with a molecular weight smaller than the cutoff of the membrane. The ultra-filtrates contain molecules having a molecular weight smaller than that of the cutoff membrane” (P.G. Pub., para.0063). Mannitol has a molecular weight of 182.2 Da (P.G. Pub., para.0049). Thus, as mannitol has a molecular weight smaller than of the cutoff membrane, there is not a predictable way to generate algal extract ultrafiltrates that exclude mannitol from the ultrafiltrates by running through an ultrafiltration membrane with a molecular weight cutoff of about 1.0 kDa, and only performing the explicitly recited steps of claim 21. Accordingly, the instant claims do not comply with the enablement requirement because to practice the invention as claimed, a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
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 20-24 and 29 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 20 recites that the algal extract fraction “excludes at least: mannitol, a sulfated polysaccharide, and a laminarin.” The phrase “at least” indicates a floor of the minimum things excluded from the extract fraction. The limitation renders the claim indefinite because it is unclear what else is intended be excluded.
With regards to Claim 21, the claim is indefinite because the claim essentially uses both narrow and broad limitations. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since 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 case, the last paragraph of claim 21 recites “wherein the ultrafiltration membrane has a molecular weight cutoff such that the one or more additional filtrate fractions excludes mannitol.” The only earlier mention of an “ultrafiltration membrane” is in step (a), which recites circulation through “an ultrafiltration membrane having a molecular weight cutoff of about 1.0 kDa.”
The molecular weight of mannitol, however, is about 180.2 Da, and thus, would be captured in any filtrate fractions resulting from a pass through of the ultrafiltration membrane. Step (c), for example, appears to be directed to another pass through of retentate through the ultrafiltration membrane (recirculating the retentate). As evidenced by the instant Specification, “[t]he retentate is rinsed several times to remove the major portion of molecules with a molecular weight smaller than the cutoff of the membrane. The ultra-filtrates contain molecules with a molecular weight smaller than that of the cutoff membrane” (P.G. Pub., para.0063). As mannitol has a molecular weight smaller than the claimed ultrafiltration membrane, it will always be found in the filtrate fractions resulting from circulation through an ultrafiltration membrane having a molecular weight cutoff of about 1.0 kDa.
Thus, it is unclear what the required molecular weight cutoff is for the ultrafiltration membrane as step (a) requires the molecular weight cutoff to be about 1.0 kDa, and the end of the claim requires a molecular weight cutoff “such that the one or more additional filtrate fractions excludes mannitol” (i.e., less than 180.2 Da). Claims 22-24 and 29 are subsequently rejected as they incorporate the limitation discussed above and do not remedy the issue discussed above.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 22 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 22 depends from claim 21, which recites the transitional phrase “consisting of” with regards to the method, indicating the exclusion of any unrecited steps. Claim 22 fails to further limit the subject matter of the claim upon which it depends from as it broadens the scope of claim 21 by including an additional step that would be excluded by the closed transitional phrase of claim 21.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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.
Claim 20 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Parys et al., (Parys) (Phytochemistry; published 2010).
Parys discloses that to explore the therapeutic potential of phlorotannins in detail, pure compounds were isolated during the current study from the extract of Fucus vesiculosus. Among the phlorotannins isolated was trifucotriphlorethol A, which is a polar bioactive molecule (a strong radical scavenger) with a molecular weight of 870.7 Da (abstract; p.221, Introduction, para.1).
The isolated compound reads on “an algal extract fraction product” as it is a product of a Fucus vesiculosus extract (i.e., the compound was isolated from said extract). Furthermore, the instant claim 20 is directed to a product, and there appears to be no structural difference between the claimed product and the product of the prior art (i.e., trifucotriphlorethol A isolated from the Fucus vesiculosus extract), as the prior art product is a polar bioactive molecule extracted from Fucus vesiculosus having a molecular weight less than 1.0 kDa, does not contain mannitol, a sulfated polysaccharide, or laminarin, and does not contain any salt.
Response to Arguments
Applicant's arguments filed December 8, 2025 have been fully considered. In light of Applicant’s claim amendment, new rejections are set forth above.
Conclusion
Claims 20-24 and 29 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MONICA A. SHIN whose telephone number is (571)272-7138. The examiner can normally be reached Monday-Friday (9:00AM-5:00PM EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MONICA A SHIN/Primary Examiner, Art Unit 1616
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