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 .
Preliminary Amendment
1) Acknowledgment is made of Applicants’ preliminary amendment filed 07/20/2023.
Election
2) Acknowledgment is made of Applicants’ election filed 11/13/25 in response to the species election requirement mailed 09/22/25. Applicants have elected the active ingredient species of the Cyanobacterium of the genus spirulina-derived phycocyanin and said phytocyanin that is protease degraded; and the health food composition species, a food with a health claim and the food for a specified health use. Because Applicants did not distinctly and specifically point out the supposed errors in the species election requirement, the election has been treated as an election without traverse (M.P.E.P § 818.03(a)).
Status of Claims
3) Claims 3, 5, 6, 8 and 9 have been amended via the preliminary amendment filed 07/20/23.
New claims 10-20 have been added via the preliminary amendment filed 07/20/23.
Claims 1-20 are pending.
Claims 8, 9 and 18-20 are withdrawn from consideration as being directed to a non-elected species. See 37 CFR 1.142(b) and M.P.E.P § 821.03.
Claims 1-7 and 10-17 are examined on the merits.
Drawings
4) Acknowledgment is made of Applicants’ drawings filed 07/20/2023.
Information Disclosure Statements
5) Acknowledgment is made of Applicants’ information disclosure statements filed 07/20/23, 06/28/24, 06/02/25 and 06/28/24. Except for one of the IDSs filed 06/28/24 containing duplicate citations, the information referred to therein has been considered and a signed copy is attached to this Office Action.
Priority
6) The instant AIA application, filed 07/20/2023, is the national stage 371 application of PCT/JP2022/001882 filed 01/20/2022, which claims priority to application 2021-009348 filed 01/25/2021 in Japan. A certified copy of the foreign priority application is of record, but not a certified English translation of the same. Should Applicants desire to obtain the benefit of foreign priority under 35 U.S.C 119(a)-(d), a certified copy of the foreign priority application and a certified English translation thereof should be submitted under 37 CFR 1.55 in reply to this Office Action. Failure to do so may result in no benefit being accorded.
Double Patenting Rejection(s)
7) The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accomplished by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional, the reply must be complete. MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying:online/eterminal-disclaimer.
8) Claims 1-7 and 10-17 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting over claims 1-12 of the co-pending 18273779 application.
Although the conflicting claims are not identical, they are not patentably distinct from each other. The identified claims of the co-pending ‘779 application, drawn to a composition comprising as an effective component phycocyanin or a phycocyanin enzymatically degraded product, the latter obtained by enzyme action of protease, the composition being a health food composition, a food with a health claim, or a food for a specified health use read on and anticipate the instantly claimed composition.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
9) Claims 1, 3-7, 12, 13 and 15-17 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting over claims 1-4 and 7 of the co-pending 18008698 application.
Although the conflicting claims are not identical, they are not patentably distinct from each other. The identified claims of the co-pending ‘698 application, drawn to a composition containing a spirulina extract including one for oral use and a food or a drink containing said spirulina extract read on and anticipate instant claims since said spirulina extract is expected to contain the intrinsic phycocyanin element of spirulina.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
10) Claims 1, 3-7, 12, 13 and 15-17 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting over claims 1-6 of the co-pending 18273796 application.
Although the conflicting claims are not identical, they are not patentably distinct from each other. The identified claims of the co-pending ‘796 application, drawn to a food or beverage composition containing a blue-green algae powder read on and anticipate instant claims since said composition is expected to contain the intrinsic phycocyanin element of the Spirulina blue-green algae. As in In re Basell Pollolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008), the specification of the co-pending ‘796 application at section [0002] that defines the blue-green algae includes Spirulina that are known to contain phycocyanin which exerts various bioactivities indicating that such compositions were fully intended to fall within the meaning and coverage of the claims. Note that ‘[The specification] may be used to learn the meaning of terms and in interpreting the coverage of a claim’ [Emphasis added]. In re Basell Pollolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008).
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Rejection(s) under 35 U.S.C § 101
11) 35 U.S.C § 101 states:
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.
12) Claims 1-7 and 10-17 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.
Instant claims 1, 2, 5 and 11 are directed to a composition comprising a phycocyanin or enzymatically degraded or protease degraded phycocyanin as an active ingredient. Claims 3, 4, 10, 12 and 13 are directed to a composition wherein the phycocyanin is derived from a Cyanobacterium or a Cyanobacterium of the genus Spirulina. Such a product is one of the statutory categories of invention (Step: 1: YES). The composition of the dependent claims 6, 7 and 14-17 as a whole is required to be a food composition. Both phycocyanin and phycocyanin-containing Spirulina are naturally occurring products. For instance, phycocyanin from a Cyanobacterium or Spirulina is recognized in the art as a naturally occurring product having innumerable natural properties and multiple uses including as a food, pharmaceutical and neutraceutical having innumerable natural properties and multiple uses including as a food, pharmaceutical and neutraceutical. See Abstract; at least first full paragraph under section 7 on page 6; 5th full sentence of 1st full paragraph of page 2; and 2nd full paragraph under section 4 on page 6 of Athiyappan et al. Food and Humanity 2: 100235, pages 1-19, 2024. Phycocyanin is recognized in the art as a natural fluorophore and as a natural substance that alleviates insulin resistance and enhancer of insulin sensitivity. See 1st sentence of last full paragraph of page 13; and the last sentence of the paragraph bridging pages 12 and 13 of Athiyappan et al. Athiyappan et al. further teach that the extracted phycocyanin has abundant natural properties including antioxidant, anti-microbial, anti-cancer and anti-anaemic properties and bioactivity in it. See Abstract; 5th full sentence of 1st full paragraph of page 2; 2nd full sentence of the paragraph bridging pages 11 and 12; and 4th full sentence in right column of page 1. The enzymatically degraded phycocyanin is obtained by degrading the proteins, the saccharides and the like of the Spirulina., i.e., rendered isolated or purified. See 2nd paragraph under section [0035] of Applicants’ specification. This does not change the structural or functional characteristics of the phycocyanin. The phycocyanin-containing Spirulina itself has served as a food source in Mexico or as a dietary supplement. See 1st full paragraph under the section ‘Introduction’ on page 1 of Athiyappan et al. The claims are therefore directed to a naturally occurring judicial exception (Step 2: prong 1). Judicial exceptions include all natural products including those derived from natural sources such as naturally occurring phycocyanin and its cyanobacterial or Spirulina source, and other substances found in or derived therefrom, or from nature. This is the case regardless of whether particular words such as ‘isolated’, ‘purified’, ‘recombinant’, or ‘synthetic’ are recited in the claim(s). All the properties of the claimed phycocyanin such as improving memory learning function and/or cognitive function or suppressing deterioration thereof represent the inherent qualities, properties or characteristics inseparable from said naturally occurring product and therefore are a handiwork of nature. Note that “….. patents cannot issue for the discovery of phenomena of nature”. Le Roy v. Tatham, 14 How. 156, 175. Next, the claims as a whole are analyzed to determine whether any additional element, or a combination of elements, is sufficient to ensure that the claims amount to significantly more than the exceptions. There are no additional features in the claims that would either integrate the judicial exception (Step 2: prong 2) or add significantly more under Step 2B. The claims are subject matter ineligible as they are directed to judicial exception(s) without significantly more.
The rationale for this determination is formed in view of the 2019 PEG, the 2015 Update of the 2014 Interim Guidance on Patent Subject Matter Eligibility (79 FR 4618) (hereafter Interim Eligibility Guidance) dated 16 December 2014, the Life Sciences Examples issued in May 2016, and in view of Myriad v Ambry, CAFC 2014-1361, -1366, 17 December 2014. The unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (March 20, 2012). The unpatentability of natural products was confirmed by the U.S. Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U. S. (June13, 2013).
Rejection(s) under 35 U.S.C § 112(b) or (Pre-AIA ), Second Paragraph
13) 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.
.
14) Claims 1-7 and 10-17 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 inventor or a joint inventor, or for the pre-AIA the Applicant regards as the invention.
(a) Claim 1 is ambiguous and indefinite in the limitation ‘at least one kind selected from’. It is unclear what does it refer to or encompass. One of ordinary skill in the art cannot understand in an unambiguous way that which is being claimed.
(b) The dependent claim 5 is ambiguous, confusing and indefinite in the limitation “composition according to claim 1 ...... 4,”. It is unclear whether claim 5 depends from claim 4 or claim 1. Without a proper claim dependency, one cannot ascertain the metes and bounds of the claim.
(c) Claims 2-7 and 10-17, which depend directly or indirectly from claim 1, are also rejected as being indefinite due to the indefiniteness identified supra in the base claim.
Notice Re Prior Art Available under Both Pre-AIA and 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 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.
Rejection(s) under 35 U.S.C § 102
15) 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
16) Claims 1-5 and 10-13 are rejected under 35 U.S.C § 102(a)(1) as being anticipated by TW 201443075 A (Original; and Machine Translation, pages 1-14, 2014).
The page numbers and claims indicated in the rejection below refer to those in the machine translated document.
TW 201443075 A disclosed a composition comprising a purified, enzymolysis product of Spirulina phycocyanin and PBS. Said product was a proteinase-degraded Spirulina phycocyanin. See Abstract; paragraph bridging pages 1 and 2; page 3; last four paragraphs of page 12; and claims. The preamble claim limitations “for improving memory learning function ....” in claim 1 merely represent the intended use of the claimed composition. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and wherein the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951). Any disclosure of the same product in the prior art is anticipatory to the claims and is considered to be also suitable for the recited intended use.
Claims 1-5 and 10-13 are anticipated by TW 201443075 A.
17) Claims 1-7 and 10-17 are rejected under 35 U.S.C § 102(a)(1) as being anticipated by KR 102101988 B1 (Original; & Machine Translation, pages 1/10 to 10/10, 05/12/2020) (KR ‘988).
The page numbers and Experiments indicated in the rejection below refer to those in the machine translated document.
KR ‘988 disclosed a solution or a powder (i.e., a composition) comprising an enzymatic hydrolysate of Spirulina (i.e., a cyanobacterium) with a high phycocyanin content, wherein a proteolytic enzyme or protease was used in hydrolysis. KR ‘988 taught phycocyanin as an agent widely used in foods such as dairy (i.e., health food), jelly, chewing gum etc. See Abstract; Title; Experiments 1 and 3; two full paragraphs above the section “Result”; the section entitled ‘Spirulina Enzyme Treatment’; last full paragraph of page 3/10; and page 2/10 including 5th full paragraph therein. The preamble claim limitations “for improving memory learning function ....” in claim 1 merely represent the intended use of the claimed composition. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and wherein the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951). Any disclosure of the same product in the prior art is anticipatory to the claims and is considered to be also suitable for the recited intended use.
Claims 1-7 and 10-17 are anticipated by KR ‘988.
18) Claims 1, 3-7, 12, 13 and 15-17 are rejected under 35 U.S.C § 102(a)(1) as being anticipated by CN 105309968 A (Original; & Machine Translation, pages 1-9, 02/10/2016) (CN ‘968) as evidenced by Athiyappan et al. (Food and Humanity 2: 100235, pages 1-19, 2024).
The page numbers and Examples indicated in the rejection below refer to those in the machine translated document.
CN ‘968 disclosed a spirulina health drink or beverage or juice comprising a spirulina enzymatic hydrolysate or powder. CN ‘968 taught that spirulina is nutrients-rich and is the best nutritional food that no other natural food can match. CN ‘968 taught that spirulina contains a variety of physiologically active substances and is used widely in medicine, health care, food additives and feed additives. See entire document including pages 1-4; and Examples. That phycocyanin is intrinsically comprised within spirulina is inherent from the disclosure of CN ‘968 in light of what has been well known in the art. For instance, Athiyappan et al. taught that phycocyanin is abundant in Spirulina. See at least the first sentence of Abstract. The preamble claim limitations “for improving memory learning function ....” in claim 1 merely represent the intended use of the claimed composition. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and wherein the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951). Any disclosure of the same product in the prior art is anticipatory to the claims and is considered to be also suitable for the recited intended use.
Claims 1, 3-7, 12, 13 and 15-17 are anticipated by CN ‘968. The reference of Athiyappan et al. is not used as a secondary reference in combination with CN ‘968, but rather is used to show that every element of the claimed subject matter is disclosed by CN ‘968 with the unrecited limitation(s) being inherent as evidenced by the state of the art. See In re Samour 197 USPQ (CCPA 1978).
19) Claims 1, 3-7, 12, 13 and 15-17 are rejected under 35 U.S.C § 102(a)(2) as being anticipated by US 20220112235 A1 (Applicants’ IDS).
US 20220112235 A1 disclosed a solution (i.e., composition) comprising enzymatically degraded, purified phycocyanin obtained from Spirulina, a cyanobacterium. The prior art phycocyanin is used in solid and liquid foods, particularly in beverages. See claims 23, 22, 21, 12 and 13; and sections [0022], [0026] and [0090]. The preamble claim limitations “for improving memory learning function ....” in claim 1 merely represent the intended use of the claimed composition. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and wherein the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951). Any disclosure of the same product in the prior art is anticipatory to the claims and is considered to be also suitable for the recited intended use.
Claims 1, 3-7, 12, 13 and 15-17 are anticipated by US 20220112235 A1.
Conclusion
20) No claims are allowed.
Correspondence
21) Any inquiry concerning this communication or earlier communications from the Examiner should be directed to S. Devi, Ph.D., whose telephone number is (571) 272-0854. A message may be left on the Examiner’s voice mail system. The Examiner is on a flexible work schedule, however she can normally be reached Monday to Friday from 8.00 a.m. to 4.00 p.m. (EST). If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's Supervisor, Daniel E. Kolker, can be reached at (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned (571) 273-8300.
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/S. DEVI/
S. Devi, Ph.D.Primary Examiner
Art Unit 1645
January, 2026