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 .
Status of claims
Claims 1-3, 6-12 and 16 as filed on 8/15/2025 are currently pending and under examination in the instant office action.
Claim Rejections - 35 USC § 112
Indefinite
Claims 1-3, 6-12 and 16 as amended 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.
Claims 1, 12 and 16 as amended are rendered indefinite by the newly inserted phrase “maintaining a constant concentration of spirulina in the subject”. It is unclear what is regarded as “concentration of spirulina in the subject” in the lack of definitions in the specification. Spirulina is not a probiotic microorganism and is not a live probiotic microorganism to definite its presence in the subject in CFU amounts either in gut or in feces of the subject. The amount of spirulina as a whole component cannot be measured in the subject. No specific component of spirulina is described in the as-filed specification as to be maintained on some specific level in the body of subject. Thus, the metes and bound of the claims cannot be determined.
.
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.
Claims 2 and 8-11 as amended are 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.
Claims 2 and 8-11 depend on claim 1, wherein the claim 1 limits amount of spirulina dose, number of doses and intervals between doses but claim 2 and 8-11 describe dose, number of doses and intervals between doses in indefinite terms, thereby, they extend the limitations of claim 1 to indefinite (unlimited) amounts, numbers and intervals.
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.
New Matter
Claims 1-3, 6-12 and 16 as amended 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.
Insertion of the limitation “maintaining a constant concentration of spirulina in the subject” in the claims 1,12 and 16 has no support in the as-filed specification. The insertion of this limitation is a new concept because it neither has literal support in the as-filed specification by way of a generic disclosure, nor are there specific examples of the newly insertion limitation that would show possession of the concept of the “maintaining a constant concentration of spirulina in the subject”.
There is no description in as-filed specification what is monitored for determining “concentration of spirulina in the subject”. Spirulina is not a probiotic microorganism and is not a live probiotic microorganism to definite its presence in the subject in CFU amounts either in gut or in feces of the subject. No specific component of spirulina is described in the as-filed specification as to be monitored and maintained on some specific level in the body of subject.
There is no sufficient support for the newly inserted limitation. This is a matter of written description, not a question of what one of skill in the art would or would not have known. The material within the four corners of the as-filed specification must lead to the generic concept. If it does not, the material is new matter. Declarations and new references cannot demonstrate the possession of a concept after the fact. Thus, the insertion of the phrase “maintaining a constant concentration of spirulina in the subject” is considered to be the insertion of new matter for the above reasons.
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.
Claims 1, 2, 6-12 and 16 as amended are rejected under 35 U.S.C. 103 as being unpatentable over US 10,646,523 (Migliaccio et al) in the light of evidence by Nowicka-Krawczyk et al (Scientific Reports. 2019, 9, 964, pages 1-11).
US 10,646,523 (Migliaccio et al) teaches a method for treating inflammatory pathologies (or enhancing immune system), eye-related ailments or macular degeneration pathologies (see entire document including abstract); wherein the method comprises administering a therapeutically effective composition comprising spirulina (abstract, col. 4, lines 12-31; col. 6, lines 50; examples 1-2). The spirulina-containing composition is provided by a predefined administration schedule (col.10, lines 10-30; examples). In particular, the spirulina-containing formulation contains 2600 mg of spirulina (col. 10, lines 67) and/or 2200 mg (col. 11, line 65). The composition is provided as 2-4 doses daily (col. 10, line 12), depends on body weight (col. 10, lines 14-16) and schedule of meals of the subject (col. 6, lines 5-6). The cited document acknowledges healing and/or improvement of subjects under treatment with spirulina (col. 12, lines 17-18 and lines 22-23). The “spirulina” of the US 10,646,523 (Migliaccio et al) is a common name for alga belonging to the species of Arthrospora and Limnospora including Limnospora fusiformis, Arthrospora platensis, Arthrospora maxima, etc as evidenced by Nowicka-Krawczyk et al (see page 1).
Thus, although the cited US 10,646,523 (Migliaccio et al) does not explicitly describe administration of spirulina-based formulation 5-6 times daily with intervals 90-240 min between doses, it teaches that doses are modified depending on subject body weight (col. 10, lines 10-16) and in the course of treatment (examples). Most importantly is that the cited US 10,646,523 (Migliaccio et al) recognizes the same total daily dose of the spirulina-based formulation as in the claimed method.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to modify administration protocol of spirulina-containing formulations with regard to frequencies of taking the formulation through the day and intervals between uptakes with a reasonable expectation of success in enhancing immune system and treating age-related ailments including macular degeneration because the cited US 10,646,523 (Migliaccio et al) recognizes the same total daily dose of the spirulina-based formulation and further teaches and suggests that daily doses are modified depending on subject body weight, during the course of treatment and schedule of meals. Thus, it would be obvious for one of skill in the art to optimize daily doses and their schedule depending on a subject general state of health, severity of condition and life style.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Claims 1-3, 6-12 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over US 10,646,523 (Migliaccio et al) in the light of evidence by Nowicka-Krawczyk et al (Scientific Reports. 2019, 9, 964, pages 1-11) as applied to claims 1, 2, 6-12 and 16 above, and further in view of US 8,747,915 (Giampapa).
The cited US 10,646,523 (Migliaccio et al) as above.
The cited US 10,646,523 (Migliaccio et al) is silent about incorporation of chlorella, bilberry and fucoxanthin together with to spirulina into therapeutic composition.
However, prior art teaches incorporation of chlorella, bilberry and fucoxanthin together with to spirulina into therapeutic composition for management of age-related ailments. For example: see dietary supplement of US 8,747,915 (Giampapa) at table 1, col. 4, lines 31, 40-44).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to add chlorella, bilberry and fucoxanthin to the spirulina-containing therapeutic composition of US 10,646,523 (Migliaccio et al) with a reasonable expectation of success in treating in enhancing immune system and treating age-related ailments including macular degeneration because spirulina-containing therapeutic composition has been known and used for enhancing immune system and treating age-related ailments including macular degeneration ( US 10,646,523 (Migliaccio et al) ) and because spirulina together with chlorella, bilberry and fucoxanthin has been used in the therapeutic compositions for management of age-related ailments (US 8,747,915 (Giampapa)). Thus, the claimed combination of the art recognized of art recognized beneficial ingredients for multifunctional age-related management is an obvious combination.
Therefore, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Response to Arguments
Applicant's arguments filed 8/1/5/2025 have been fully considered but they are not all found persuasive.
The rejection of claims under 35 U.S.C. 101 has been withdrawn in view of amendment to the claims limiting population under admisnitriaotn of spirulina to a specific subject(s) in new of enhancing immune system, reversing and treating age-related macular degeneration and eye-related ailments.
The rejection of claims under 35 U.S.C. 102 (a) (1) as being anticipated by US 10,646,523 (Migliaccio et al) in the light of evidence by Nowicka-Krawczyk et al (Scientific Reports. 2019, 9, 964, pages 1-11) has been withdrawn because the cited US 10,646,523 (Migliaccio et al) does not explicitly disclose administration of spirulina-based formulation 5-6 times daily with intervals 90-240 min between doses.
With regard to claim rejection under 35 USC § 103 Applicants argue that the cited US 10,646,523 (Migliaccio et al) teaches 2-4 doses per day but not 5-6 doses per day with intervals 9-240 min as in the claimed method and that the cited US 10,646,523 (Migliaccio et al) teaches administration of a formulation comprising spirulina and PEA as a synergistic combination, thus, one of skill in the art would not come to the reasonable conclusion to successfully treat diseases (response pages 10-11).
The arguments are not found persuasive.
The claimed formulation is a spirulina-based formulation which is open to incorporation of additional components and the amount of spirulina for the total daily dose is the same as claimed and as taught by disclosed by the cited US 10,646,523 (Migliaccio et al) such as 2000-4000 mg and 2200-2600 mg respectively. Moreover, the cited US 10,646,523 (Migliaccio et al) discloses that even when spirulina was administered as a sole active ingredient, it provided for improvement in conditions of patients with age-related macular degeneration (example 2).
Although the cited US 10,646,523 (Migliaccio et al) does not explicitly describe administration of spirulina-based formulation 5-6 times daily with intervals 90-240 min between doses but 2-4 times daily, it teaches that doses are modified depending on subject body weight (col. 10, lines 10-16) and in the course of treatment (examples); and that intervals are/could be adjusted depending of schedule of meals through the day depending. Most importantly is that the cited US 10,646,523 (Migliaccio et al) recognizes the same total daily dose of the spirulina-based formulation as in the claimed method for treating eye-associated diseased including macular degeneration. Thus, it would be obvious for one of skill in the art to optimize schedule of daily doses depending on a subject general state of health, severity of condition and life style.
No claims are allowed.
Conclusion
THIS ACTION IS MADE FINAL. 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 VERA AFREMOVA whose telephone number is (571)272-0914. The examiner can normally be reached Monday-Friday: 8.30am-5pm EST.
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.
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.
Vera Afremova
September 11, 2025
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653