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 .
Notice of New Examiner
This case has been transferred to a new examiner for continued examination. Any further communications regarding this case may be directed to the contact information included in the conclusion of this office action.
Claim Status
Applicant’s remarks and amendments, filed 24 September 2025 in response to the non-final rejection mailed 24 March 2025, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 24 September 2025 replaces all prior versions and listings of the claims.
Claims 1 and 4-16 are pending. Claims 4-15 remain withdrawn. Claims 2 and 3 are canceled by Applicant’s amendment. Claim 16 is newly added. Claims 1 and 4 are amended. Claims 1 and 16 are being examined on the merits.
Response to Amendment
Any previous rejection or objection not mentioned herein is withdrawn.
Applicant’s arguments and amendments, on pages 6-8 of the reply filed 24 September 2025 with respect to the rejection of Claims 1-3 under 35 USC § 112(b) have been fully considered. The rejection of Claim 1 is withdrawn and the phrase “substantially free of alginates” is being interpreted broadly as any protein fraction of a water-soluble extract of Durvillaea antarctica which has had any amount of alginates removed. The rejections of Claims 2 and 3 are withdrawn due to cancellation of the claims and the rejection of Claim 1 has been withdrawn.
Applicant’s arguments and amendments, on page 9 of the reply filed 24 September 2025 with respect to the rejection of Claim 1 under 35 USC § 102(a)(1) have been fully considered. The rejection of Claim 1 is withdrawn due to amendment of the claim.
Claim Rejections - 35 USC § 112(a)
(as necessitated by amendment)
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.
Claim 16 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 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 inventors, at the time the application was filed, had possession of the claimed invention.
Claim 16 recites the limitation “wherein the alginate content is less than about 1% by weight,” however this limitation does not have support in the original disclosure. Neither express, implicit, nor inherent support for the above limitation can be found in the original disclosure. The original disclosure describes a water extract of Durvillaea antarctica which is treated with absolute ethanol to precipitate alginates, thus resulting in a composition which is substantially free of alginates. Neither the disclosure nor the claims, however, provide an objective definition of “substantially free” or a specific amount of alginates present in the composition aside from “substantially free” or “alginate-free,” which are both prepared using the same method (e.g., Example 1 referencing “substantially free” and Example 2 referencing the extract of Example 1 as “alginate-free”). While the 37 CFR § 1.132 declaration of Dr. David Contreras submitted on 24 September 2025 provides a subjective justification for a less than about 1% by weight limit for alginate content, neither the original disclosure nor claims provide a specific amount of alginates present in the claimed composition.
Claim Rejections - 35 USC § 101
(maintained)
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 and 16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1 and 16 are directed to a natural product (i.e., a law of nature/a natural phenomenon). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception – i.e., as drafted, the claims read upon a product of nature (i.e., a law of nature/a natural phenomenon) for the following reasons:
Claims 1 and 16 are drawn to a composition (for the intended use as having antiviral activity) formed entirely from natural ingredients (as disclosed on page 4 of the instant specification) including a water extract of the algae Durvillaea antarctica (and protein fractions thereof) and optionally a pharmaceutically acceptable carrier (such as water, e.g., page 7). The claimed composition is not markedly different from its naturally-occurring counterpart (e.g., the algae itself and proteins found therein) because there is no indication that the composition has any characteristics or properties that are different from the naturally-occurring counterpart (including the natural compounds found therein, such as proteins). The cited 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 additional elements. The stated antiviral activity is a requirement of the composition as a whole and not the extract itself, and in addition, both the water extract and protein fractions have antiviral activity (e.g., page 7).
Furthermore, the claims do not integrate the composition into a distinguishing practical application (for example, do not broadly or specifically recite dosage form(s) and the therapeutically-effective amounts of the material), but merely recites the natural materials themselves or a multiplicity of natural materials. While Claim 1 requires a broad range of concentrations for the protein fraction, there is no indication that the amounts claimed result in a markedly different characteristic for the composition as compared to components found in nature. Additionally, while Claim 16 requires a particular amount of alginates, there is no evidence that removing alginates materially changes the natural components and results in structural and/or functional differences.
Therefore, the claimed composition is not deemed to be markedly different from what exists in nature in terms of structural and/or functional differences. In other words, the claims do not set forth a marked difference in terms of structural and/or functional differences (properties and/or characteristics) as compared to the naturally-occurring counterpart (see, e.g., Diamond v. Chakrabarty, 447 U.S. 303(1980)). Please note that combining natural extracts (such as from two or more plants) does not remove the claims from reading upon a judicial selection (Funk Brothers Seed Col. V. Kalo Inoclulant Col. – 333 U.S. 127 (1948)) because, again, there is no evidence of a marked difference brought about by combining the instantly claimed herbal extracts. Please also note that modifying the concentration of the product/composition is not sufficient to remove the claimed composition from a judicial exception (see, e.g., Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107, 106 USPQ2d 1972 (2013)).
Thus, when the relevant factors are analyzed, they weigh against a significant difference between the claimed invention and a judicial exception. Therefore, the claimed invention is not considered to be patent eligible subject matter.
Claim Rejections - 35 USC § 103
(grounds modified as necessitated by amendment)
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.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Matsuhiro et al. (Hydrobiologia, 1996, 77-81) in view of Wang et al. (J Zheijan Uni, 2008, 969-976).
The instant claim is as of record, drawn to a composition with antiviral activity comprising 0.05-50 mg/mL of a protein fraction of a water-soluble extract of Durvillaea antarctica which is free of alginates and optionally comprises a pharmaceutically acceptable carrier or vehicle.
Matsuhiro et al. teach an extract of Durvillaea antarctica which is obtained using water and dissolvable in water (Matsuhiro et al., Extraction, pg. 78) and the sulfated fucose-containing polysaccharide fraction comprises 0.14% protein (broadly, a water-soluble extract which comprises protein is a protein fraction; Matsuhiro et al., Results and discussion, pg. 79). This fraction had antiviral activity at a concentration of 100 μg/mL, or 0.1 mg/mL in distilled water (pharmaceutically acceptable carrier; Matsuhiro et al., Table 3, pg. 80), and alginic acid (alginate) was precipitated out (substantially free; Matsuhiro et al., Results and discussion, pg. 79).
While Matsuhiro et al. do not explicitly teach a protein-only fraction with a specific protein concentration of 0.05-50 mg/mL, a skilled artisan would be motivated to try different fractions of seaweed extracts as antiviral agents based upon the teachings of Wang et al., which discloses that various water extracts of seaweeds have antiviral activities (Wang et al., Table 1, pg. 972; Table 2, pg. 973) and that various fractions of Hydroclathrus clathratus have varying effects against herpes viruses (Wang et al., Table 5, pg. 973). It was therefore known in the art prior to the effective filing date of the instant application that not only does Durvillaea antarctica have antiviral effects, but also that different fractions of extracts from seaweeds have varying antiviral efficacies. A skilled artisan would therefore be motivated to try different fractions and concentrations of Durvillaea antarctica to arrive at the specifically claimed composition with antiviral activity with a reasonable expectation of success.
Response to Arguments
Applicant's arguments filed 24 September 2025 have been fully considered but they are not persuasive.
Regarding the rejection of Claims 1-3 under 35 USC § 101, applicant argues that the claimed protein fraction differs from the naturally occurring algae and from any simple aqueous extract in both composition and function and integrate the fraction into a practical application by reciting its use in therapeutic compositions for treatment or prevention of Alphaherpesvirinae infections. This argument is not persuasive, however, because absent evidence to the contrary, the proteins found in the protein fraction of the extract are not markedly different from the proteins found naturally in Durvillaea antarctica. The creation of an extract only partitions and concentrates the molecules which are naturally found in the algae. Therefore, the claimed composition is not markedly different from its naturally-occurring counterpart (e.g., the algae itself and proteins found therein) because there is no indication that the composition has any characteristics or properties that are different from the naturally-occurring counterpart (including the natural compounds found therein, such as proteins).
The claimed antiviral activity is a requirement of the composition as a whole and not the extract itself, and in addition, both the water extract and protein fractions have antiviral activity (e.g., instant specification, page 7). Additionally, the use of the composition in therapeutic compositions for treatment or prevention of Alphaherpesvirinae infections is not recited in the instant claims.
Regarding Matsuhiro et al., applicant argues that the protein fraction is tied to specific antiviral activity and that this specific protein fraction is not taught by Matsuhiro et al. and the composition of Matsuhiro et al. does not find meaningful antiviral activity and thus does not meet the instant claims. Firstly, it is noted that Matsuhiro et al. are not relied upon for the teaching of the specific protein concentration, and instead a skilled artisan would be motivated to test different fractions of Durvillaea antarctica for antiviral activity based upon the teachings of Wang et al., and in doing so could reasonably expect to arrive at the instantly claimed invention. Additionally, the instant claims are drawn to a composition which has any amount of antiviral activity and does not require any specific amount of antiviral activity relative to different fractions of the extract or the algae itself. Instead, the claims are drawn to a composition with any amount of antiviral activity which also comprises a water-soluble extract of Durvillaea antarctica that contains proteins which may be present in a broad range.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., potent and selective antiviral activity; specific EC50 values; reduction of severity and durations of HSV-1 lesions; specific preparation methods; enriched protein fractions; stable water-soluble extract) are not recited in the rejected claim(s). 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).
Conclusion
No claim are currently 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 JENNIFER L CAIN whose telephone number is (703)756-1318. The examiner can normally be reached M-Th 5:00am to 5:00pm 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, Anand Desai can be reached at (571)272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655
Prosecution Insights