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 .
Election/Restrictions
Newly submitted claims 32-36 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
I. Claim 16 drawn to product.
II. Claim 32-36, drawn to method of treating viral disease.
The inventions are independent or distinct, each from the other because:
Inventions 1 and 2 are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the extract may be used in a different method such as a method of providing a nutritional supplement.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 32-36 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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 16 is 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.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claims are directed to a product; thus, the answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites to a product of nature. In this case, applicant’s claim recites a composition comprising Chlorella or an extract thereof for treatment of a viral disease caused by coronavirus and formulated for local administration. Thus, the claim recites a product of nature. MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”.
In this case, Applicant’s claim recites a composition comprising Chlorella or an extract thereof (and/or a compound derivable from eukaryotic microalgae) which is a judicial exception and is not markedly different characteristics with the naturally occurring counterparts. If one considers the “composition is formulated for local administration,” this may be any carrier including water which is also a judicial exception. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, the claims are directed a composition comprising Chlorella or an extract thereof. The intended use recitation for the “treatment of a viral disease…” and ‘for local administration…” however, MPEP § 2106.04(d)(2) specifically states that a claim is only directed to “an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the ‘treatment or prophylaxis’ consideration.” Therefore, applicant’s intended use is not sufficient to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception and the claims does not recite additional elements. If one considers the “composition is formulated for local administration,” this may be any carrier including water which is also a judicial exception.
Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
Response to Arguments
Applicant argues that the instant claims different from a naturally occurring Chlorella or extract thereof since the instant composition is formulated for local administration to the respiratory pathway. Applicant argues this specialized formulation enables the use of Chlorella or extract in a way natural Chlorella cannot.
Applicant's arguments filed 3/2/2026 have been fully considered but they are not persuasive. The instant claims do not recite any specific formulation, i.e. excipients, carriers in a way to distinguish the instant claims from its natural counterpart. Applicant The instant claims read on Chlorella in water, both of which are judicial exceptions. The intended use does not recite any particular structure to distinguish it from Chlorella in water and therefore the rejection is maintained.
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(s) 16 is rejected under 35 U.S.C. 102(a)(1) as being anticipated Alam, et al., “Algae-Derived Bioactive Molecules for the Potential Treatment of SARS-CoV-2”, Molecules, 26(8), 2134 (2021).
The instant claim is directed to a composition comprising Chlorella or an extract thereof. The recitation “for treatment of a viral disease…” and “wherein the composition is formulated for local administration…” (i.e., in some embodiments, SARS caused by a SARS-associated virus such as coronavirus) (see instant claims 16-31). Note for the treatment of recitation and the wherein clause are intended use.
Alam, et al, teaches algae-derived bioactive molecules and/or compounds (reading on extract) have been used for many years and teaches the use for applications including pharmaceutical applications. Alam et al., teaches algae-derived bioactive molecules tested for their potential treatment of SARS-CoV-2, teaching some specific algae-derived molecules can be used to produce antibodies and vaccines to treat the COVID-19 disease (Abstract)
Alam, et al. discloses Cholorella vulgaris contains containing sulfated polyusaccharides (reads on extract thereof) in treating HIV (e.g. blockage of reverse transcriptase) (see Table 1/page 2). Table 5 and 6 teach studies of extracts from Chlorella among other algae exhibit antioxidant effect against respiratory viruses. Alam teaches ”These bioactive agents have been evaluated and exploited as microbiota-based therapeutic agents, immunomodulators, glycan therapeutic agents, and antioxidants for their biotherapeutics in preventing and treating SARS-CoV-2.”
Consequently, the claim is anticipated by the reference. The instant claims do not recite any concentrations or excipients. Therefore, since the prior art teaches a composition comprising Chlorella (or extract), the pharmaceutical application thereof, the prior art teaches the same composition as claimed and therefore the prior art would be capable of performing the intended use and the wherein clause (the composition is capable of being locally administered). See MPEP 2111.02 and 2111.04
Response to Arguments
Applicant argues that the instant claims are directed to the “treatment of a viral disease caused by SARS-CoV-2.”
Applicant's arguments filed 3/2/2026 have been fully considered but they are not persuasive. As acknowledged by applicant, Alam teaches Chlorella and algae derived bioactives including polysaccharides, vitamins and carotene. Thus, the art teaches a composition comprising Chlorella or an extract. Regarding the intended use, if the intended use results in a structural difference between the claimed invention and the prior art. If so, the recitation serves to limit the claim. See MPEP 2111.02, In instant case, the claims structurally only recite Chlorella or extract. The instant claims do not recite any specific formulation, i.e. excipients, carriers or concentrations. Therefore, since the prior art discloses the invention as structurally claimed, it is capable of performing the intended use. In the interest of compact prosecution and should applicant intend to amend the claims, applicant should also note Alam teaches “These bioactive agents have been evaluated and exploited as microbiota-based therapeutic agents, immunomodulators, glycan therapeutic agents, and antioxidants for their biotherapeutics in preventing and treating SARS-CoV-2.”
Conclusion
No claims 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 SHARMILA G. LANDAU whose telephone number is (571)272-0614. The examiner can normally be reached Monday-Friday 7-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Michener can be reached at 571-272-1424. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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