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 .
Priority
This application was filed 9/15/2023. This application claims benefit to U.S. Provisional Application Serial Number 63/405,101, filed 9/09/2022; however, the instant application was filed 12 months and 6 days after the provisional application, i.e., after the expiration of the provisional application. The application data sheet filed on the filing date of the instant application, 9/15/2023, lists the filing date of 63/405,101 as 9/15/2022; however, the filing receipt of 63/405,101 shows that 63/405,101 was actually filed 9/9/2022. The instant application was filed after the 12-month expiration date of the 63/405,101 provisional application; hence, the effective filing date of the instant claims is the filing date of the instant application - 9/15/2023. Claims 1-19 are pending and have been examined on the merits.
Information Disclosure Statement
No information disclosure statement has been received for this application.
Drawings
The drawings are objected to because the singular view is labeled “Figure 1”.
37 CFR 1.84(u)(1) states “The different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation "FIG." Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation "FIG." must not appear.” (Emphasis added). Thus, the singular view in the application should be labeled “Figure” not “Figure 1”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 2-5, 7, 11, 13-14 and 17-18 are objected to because of the following informalities:
Claim 2 recites “wherein the predefined administration schedule comprising number of dosages of the formulation and gap between the dosages along with the dosage amount” should be “wherein the predefined administration schedule comprises a number of dosages of the formulation, a gap between the dosages and the dosage amount” to be grammatically correct. Appropriate correction is required.
Claim 3 recites “wherein the formulation comprising” should be “wherein the formulation comprises” to be grammatically correct. Appropriate correction is required.
Claim 4 recites “2000 mg-4000 mg per day” which should be “2000 - 4000 mg per day” to conform with proper numerator-unit of measure nomenclature. Appropriate correction is required.
Claim 5 recites “The method of claim 1, comprising administering number of dosages” which should be “The method of claim 1, comprising administering a number of dosages” to be grammatically correct. Appropriate correction is required.
Claim 7 recites “of Limnospira fusiformis, Limnospira indica, Limnospira maxima, Arthrospira platensis, Arthrospira erdosensis, Arthrospira jenneri, Arthrospira fusiformis, Arthrospira indica, and Arthrospira maxima” which should be “of Limnospira fusiformis, Limnospira indica, Limnospira maxima, Arthrospira platensis, Arthrospira erdosensis, Arthrospira jenneri, Arthrospira fusiformis, Arthrospira indica, and Arthrospira maxima” to be grammatically correct because Latin taxonomical names are italicized. Appropriate correction is required.
Claim 11 recites “wherein number of dosages in a day/week varies as compared to that of the next day/week” which should be “wherein a number of dosages in a day/week varies as compared to a number of dosages of the next day/week” to be grammatically correct. Appropriate correction is required.
Claim 13 recites “administered to the subject in a unit dosage form in the range of 2000 mg-4000 mg per day and number of dosages thereof in the range of 4-6 doses per day” which should be “administered to the subject in a unit dosage form in the range of 2000 - 4000 mg per day and a number of dosages thereof in the range of 4-6 doses per day” to be grammatically correct and to conform with proper numerator-unit of measure nomenclature. Appropriate correction is required.
Claim 14 recites “2000 mg-4000 mg per day” which should be “2000 - 4000 mg per day” to conform with proper numerator-unit of measure nomenclature. Appropriate correction is required.
Claim 17 recites “administered to the subject in a unit dosage form in the range of 2000 mg-4000 mg per day and number of dosages thereof in the range of 4-6 doses per day” which should be “administered to the subject in a unit dosage form in the range of 2000 - 4000 mg per day and a number of dosages thereof in the range of 4-6 doses per day” to be grammatically correct and to conform with proper numerator-unit of measure nomenclature. Appropriate correction is required.
Claim 18 recites “2000 mg-4000 mg per day” which should be “2000 - 4000 mg per day” to conform with proper numerator-unit of measure nomenclature. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 3-4, 8-10, 13-14 and 17-18 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.
Regarding claim 3, claim 3 recites “The method of claim 1, wherein the formulation comprising 86% spirulina, a type of blue-green algae, 5% chlorella, 7% bilberry extract, and 2% fucoxanthin” which is indefinite because it is unclear whether “a type of blue-green algae” is an ingredient of the formulation in addition to 86% spirulina, 5% chlorella, 7% bilberry extract, and 2% fucoxanthin or whether “a type of blue-green algae” is an unnecessary adjectival phrase describing spirulina. This rejection can be overcome by removing the phrase “a type of blue-green algae”.
Regarding claim 4, claim 4 recites “The method of claim 1, comprising providing the formulation in a unit dosage form in the range of 2000 mg-4000 mg per day” which appears to limit the amount of the formulation in a single dose, i.e., unit dosage, to 2000 - 4000 mg; however, claim 5 recites “The method of claim 1, comprising administering number of dosages of the formulation in the range of 4-6 doses per day with a gap between two doses in a time range of 90-240 minutes” which necessitates that the unit dosage form is administered at least 4 times per day. Hence, it is unclear whether the claims in combination are reciting administering 2000 - 4000 mg of the formulation, i.e., unit dosage amount, 4-6 times per day, i.e. the daily administration of 8000 - 24000 mg of the formulation or whether the limitation “in the range of 2000 mg-4000 mg” does not apply to the unit dosage form at all; hence, claim 4 is rejected under 35 U.S.C. 112(b) as being indefinite.
Claim 8 recites the limitation "the gap between two doses" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 8 depends from claim 2 which depends from claim 1 and neither claim 1, claim 2 nor claim 8 recites a gap between two doses; hence, the limitation lacks antecedent basis; therefore, claim 8 is rejected under 35 U.S.C. 112(b) as being indefinite.
Claim 9 recites the limitation "the gap between any two doses" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 9 depends from claim 2 which depends from claim 1 and neither claim 1, claim 2 nor claim 9 recites a gap between any two doses; hence, the limitation lacks antecedent basis; therefore, claim 9 is rejected under 35 U.S.C. 112(b) as being indefinite.
Claim 9 recites the limitation "the gap between any other doses" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 9 depends from claim 2 which depends from claim 1 and neither claim 1, claim 2 nor claim 9 recites a gap between any other doses; hence, the limitation lacks antecedent basis; therefore, claim 9 is rejected under 35 U.S.C. 112(b) as being indefinite.
Claim 10 recites the limitation "the gap between any two doses" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 10 depends from claim 2 which depends from claim 1 and neither claim 1, claim 2 nor claim 10 recites a gap between any two doses; hence, the limitation lacks antecedent basis; therefore, claim 10 is rejected under 35 U.S.C. 112(b) as being indefinite.
Regarding claim 13, claim 13 recites “The method of claim 12, wherein the formulation is administered to the subject in a unit dosage form in the range of 2000 mg-4000 mg per day and number of dosages thereof in the range of 4-6 doses per day with a gap of time in the range of 90-240 minutes between two dosages” which appears to limit the amount of the formulation in a single dose, i.e., unit dosage, to 2000 - 4000 mg; however, the claim also necessitates that the unit dosage form is administered at least 4 times per day. Hence, it is unclear whether the claim is reciting administering 2000 - 4000 mg of the formulation, i.e., unit dosage amount, 4-6 times per day, i.e. the daily administration of 8000 - 24000 mg of the formulation or whether the limitation “in the range of 2000 mg-4000 mg” does not apply to the unit dosage form at all; hence, claim 13 is rejected under 35 U.S.C. 112(b) as being indefinite.
Regarding claim 14, claim 14 recites “The method of claim 12, comprising providing the formulation in a unit dosage form in the range of 2000 mg-4000 mg per day” which appears to limit the amount of the formulation in a single dose, i.e., unit dosage, to 2000 - 4000 mg; however, claim 55 recites “The method of claim 12, comprising administering a number of dosages of the formulation in the range of 4-6 doses per day with a gap of time in the range of 90-240 minutes between two dosages” which necessitates that the unit dosage form is administered at least 4 times per day. Hence, it is unclear whether the claims in combination are reciting administering 2000 - 4000 mg of the formulation, i.e., unit dosage amount, 4-6 times per day, i.e. the daily administration of 8000 - 24000 mg of the formulation or whether the limitation “in the range of 2000 mg-4000 mg” does not apply to the unit dosage form at all; hence, claim 14 is rejected under 35 U.S.C. 112(b) as being indefinite.
Regarding claim 17, claim 17 recites “The method of claim 16, wherein the formulation is administered to the subject in a unit dosage form in the range of 2000 mg-4000 mg per day and number of dosages thereof in the range of 4-6 doses per day with a gap of time in the range of 90-240 minutes between two dosages” which appears to limit the amount of the formulation in a single dose, i.e., unit dosage, to 2000 - 4000 mg; however, the claim also necessitates that the unit dosage form is administered at least 4 times per day. Hence, it is unclear whether the claim is reciting administering 2000 - 4000 mg of the formulation, i.e., unit dosage amount, 4-6 times per day, i.e. the daily administration of 8000 - 24000 mg of the formulation or whether the limitation “in the range of 2000 mg-4000 mg” does not apply to the unit dosage form at all; hence, claim 17 is rejected under 35 U.S.C. 112(b) as being indefinite.
Regarding claim 18, claim 18 recites “The method of claim 16, comprising providing the formulation in a unit dosage form in the range of 2000 mg-4000 mg per day” which appears to limit the amount of the formulation in a single dose, i.e., unit dosage, to 2000 - 4000 mg; however, claim 19 recites “The method of claim 16, comprising administering a number of dosages of the formulation in the range of 4-6 doses per day with a gap of time in the range of 90-240 minutes between two dosages” which necessitates that the unit dosage form is administered at least 4 times per day. Hence, it is unclear whether the claims in combination are reciting administering 2000 - 4000 mg of the formulation, i.e., unit dosage amount, 4-6 times per day, i.e. the daily administration of 8000 - 24000 mg of the formulation or whether the limitation “in the range of 2000 mg-4000 mg” does not apply to the unit dosage form at all; hence, claim 18 is rejected under 35 U.S.C. 112(b) as being indefinite.
Claim 8 recites “wherein the gap between two doses is of predetermined equal intervals” which is indefinite because it is unclear how “the gap” (singular) can be “of predetermined equal intervals” (plural), i.e., how can a singular gap be equal intervals; therefore, claim 8 is rejected under 35 U.S.C. 112(b) as being indefinite.
Claim 10 recites “wherein the gap between any two doses is of predetermined unequal intervals” which is indefinite because it is unclear how “the gap” (singular) can be “of predetermined unequal intervals” (plural), i.e., how can a singular gap be unequal intervals; therefore, claim 10 is rejected under 35 U.S.C. 112(b) as being indefinite.
Claim 10 recites “wherein one dose is administered in every fixed span of hour” which is indefinite because the metes and bounds of “every fixed span of hour” is unclear. The specification does not provide any definition of “every fixed span of hour” or any other indication of the metes and bounds of “every fixed span of hour”; therefore, claim 10 is rejected under 35 U.S.C. 112(b) as being indefinite.
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 1-19 are 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 claims contain 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 1 recites “A method for enhancing immune system functions in a subject, the method comprising providing a predefined administration schedule administering a spirulina or a spirulina-based formulation in a unit dosage form effective to enhance the immune system”. The inventor is not in possession of the claimed invention because simply providing a schedule will not enhance immune system function in a subject; hence, Applicant is not in possession of the claimed invention; therefore, claim 1 is rejected under 35 U.S.C. 112(a) for failing to comply with the written description requirement for not being in possession of the claimed invention. Claims 2-3, 6-9 and 11 do not provide method steps beyond providing the schedule and claim 4 simply provides the formulation in unit dosage form; hence, claims 2-4, 6-9 and 11 are rejected under 35 U.S.C. 112(a) for failing to comply with the written description requirement for not being in possession of the claimed invention.
Regarding claims 5 and 10, Applicant presents no evidence that administering the formulation according to the claimed administration schedule enhances immune system function in any subject or that administering the formulation according to the claimed administration schedule enhances immune system function greater than administration of spirulina or a spirulina-based formulation according to any other administration schedule and/or dosage; hence, Applicant is not in possession of the claimed invention; therefore, claims 5 and 10 are rejected under 35 U.S.C. 112(a) for failing to comply with the written description requirement for not being in possession of the claimed invention.
Claim 12 recites “A method for reversing age-related macular degeneration in a subject, the method comprising providing a predefined administration schedule for administering a spirulina or a spirulina-based formulation in a unit dosage form effective to reverse the age-related macular degeneration in the subject”. The inventor is not in possession of the claimed invention because simply providing a schedule will not reverse age-related macular degeneration in a subject; hence, Applicant is not in possession of the claimed invention; therefore, claim 12 is rejected under 35 U.S.C. 112(a) for failing to comply with the written description requirement for not being in possession of the claimed invention. Claim 14 simply provides the formulation in unit dosage form; hence, claims 12 and 14 are rejected under 35 U.S.C. 112(a) for failing to comply with the written description requirement for not being in possession of the claimed invention.
Regarding claims 13 and 15, Applicant presents no evidence that administering the formulation according to the claimed administration schedule reverses age-related macular degeneration in any subject or that administering the formulation according to the claimed administration schedule reverses age-related macular degeneration greater than administration of spirulina or a spirulina-based formulation according to any other administration schedule and/or dosage; hence, Applicant is not in possession of the claimed invention; therefore, claims 13 and 15 are rejected under 35 U.S.C. 112(a) for failing to comply with the written description requirement for not being in possession of the claimed invention.
Claim 16 recites “A method for curing eye-related ailments, the method comprising providing a predefined administration schedule for administering a spirulina or a spirulina-based formulation in a unit dosage form effective to cure eye-related ailments”. The inventor is not in possession of the claimed invention because simply providing a schedule will not cure eye-related ailments; hence, Applicant is not in possession of the claimed invention; therefore, claim 16 is rejected under 35 U.S.C. 112(a) for failing to comply with the written description requirement for not being in possession of the claimed invention. Claim 18 simply provides the formulation in unit dosage form; hence, claims 16 and 18 are rejected under 35 U.S.C. 112(a) for failing to comply with the written description requirement for not being in possession of the claimed invention.
Regarding claims 17 and 19, Applicant presents no evidence that administering the formulation according to the claimed administration schedule cures eye-related ailments in any subject or that administering the formulation according to the claimed administration schedule cures eye-related ailments greater than administration of spirulina or a spirulina-based formulation according to any other administration schedule and/or dosage; hence, Applicant is not in possession of the claimed invention; therefore, claims 17 and 19 are rejected under 35 U.S.C. 112(a) for failing to comply with the written description requirement for not being in possession of the claimed 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 1-4, 6-9, 11-12, 14, 16 and 18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea, a judicial exception, without significantly more.
Independent claims 1, 12 and 16 are drawn to methods comprising providing a predefined administration schedule for administering a spirulina or a spirulina-based formulation in a unit dosage form which constitutes an abstract idea, specifically the subgrouping of abstract ideas of managing personal behavior or relationships or interactions between people which includes following rules or instructions (see MPEP 2106.04(a)(2)(II)(C)). Providing a predefined administration schedule for administering a spirulina or a spirulina-based formulation in a unit dosage form constitutes providing rules of instructions to the subject. This judicial exception is not integrated into a practical application because claims 1, 12 and 16 do not recite any active method step other than providing the predefined administration schedule for administering a spirulina or a spirulina-based formulation in a unit dosage form. Claims 2-4, 6-9, 11-12, 14, 16 and 18 do not recite method steps comprising a practical application; thus, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The first question in the subject matter eligibility determination (MPEP 2106.03- is “Is the claim to a process, machine, manufacture or composition of matter?” (Step 1)
Yes, claims 1-4, 6-9, 11-12, 14, 16 and 18 are drawn to methods, i.e., a process.
The second question (Step 2A, prong 1) in the subject matter eligibility determination asks “Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea (judicially recognized exceptions)?"
Yes, claims 1-4, 6-9, 11-12, 14, 16 and 18 are drawn to processes comprising an abstract idea - managing personal behavior or relationships or interactions between people which includes following rules or instructions. Providing a predefined administration schedule for administering a spirulina or a spirulina-based formulation in a unit dosage form constitutes providing rules of instructions to the subject.
Step 2A, prong 2 asks does the claim recite additional elements that integrate the judicial exception into a practical application?
Regarding claims 1-4, 6-9, 11-12, 14, 16 and 18, no, the claims do not integrate the judicial exception into a practical application because the claims do not recite any practical steps to be taken upon the provision of the predefined administration schedule.
The final question (Step 2B) in the subject matter eligibility determination to be asked is “Does the claim recite additional elements that amount to significantly more than the judicial exception?”
No, claims 1-4, 6-9, 11-12, 14, 16 and 18 do not recite additional elements that amount to significantly more than the judicial exception.
Accordingly, claims 1-4, 6-9, 11-12, 14, 16 and 18 do not amount to significantly more than the judicial exceptions and are not patent eligible.
Thus, claims 1-4, 6-9, 11-12, 14, 16 and 18 are rejected under U.S.C. 101 as not being drawn to patent eligible subject matter.
Claim Rejections - 35 USC § 103
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.
Claims 1-2, 4-6 and 8-19 are rejected under 35 U.S.C. 103 as being unpatentable over Migliaccio et al., US 10646523 (cite A, attached PTO-892; herein “Migliaccio”).
Migliaccio teaches a method of preventing and/or treating tissue hyperactivation states and inflammatory pathologies (Abst.; col. 4, ll. 9-12; col. 6, ll. 21-23), i.e., enhancing immune system functions in a subject, comprising administering a spirulina or a spirulina-based formulation in a unit dosage form according to a predefined administration schedule wherein the schedule can be the daily administration of 4 doses per day (col. 10, ll. 10-16) wherein the dose can be a tablet, i.e. in a unit dosage form, comprising 800 mg of spirulina (col. 10, ll. 31-33), i.e., 3200 mg spirulina per day; therefore, claims 1-2, 4 and 6 are prima facie obvious.
Migliaccio does not specifically teach when the 4 doses per day are to be taken; however, a person of ordinary skill in the art at the time of filing would have found it obvious to space the 4 doses out during their awake hours (16 hours for a schedule with 8 hours of sleep) which could conveniently be every 4 hours (16 h / 4 = 4 h or 240 minutes); therefore, claims 5 and 8 are prima facie obvious.
Regarding claim 9, the gap between the first dose of the day and the last dose of the day is necessarily more than that of the gap between any other doses in a day; therefore, claim 9 is prima facie obvious.
Regarding claim 10, the gap between any two doses could be of a predetermined unequal interval due to the schedule of the subject, such as adjusting the schedule so that a dose occurs when they eat lunch, to conform with a work schedule, etc.; therefore, claim 10 is prima facie obvious.
Regarding claim 11, Migliaccio teaches reducing the daily total amount of spirulina administered in a tapering format (col. 12, ll. 50-56); hence, a person of ordinary skill in the art at the time of filing would have found it obvious to practice the method of Migliaccio wherein the number of dosages in a day/week varies as compared to that of the next day/week; therefore, claim 11 is prima facie obvious.
Regarding claims 12 and 16, Migliaccio teaches a method of preventing and/or treating ophthalmic pathologies, particularly macular degeneration (Abst.; col. 6, ll. 25-27), which Migliaccio clarifies is senile macular degeneration (Example 2, col. 11, l. 36 -col. 12, ll. 27), i.e., age-related macular degeneration, comprising administering a spirulina or a spirulina-based formulation in a unit dosage form according to a predefined administration schedule wherein the schedule can be the daily administration of 4 doses per day (col. 10, ll. 10-16) wherein the dose can be a tablet, i.e. in a unit dosage form, comprising 800 mg of spirulina (col. 10, ll. 31-33); therefore, claims 12 and 14 are prima facie obvious.
Migliaccio does not specifically teach when the 4 doses per day are to be taken; however, a person of ordinary skill in the art at the time of filing would have found it obvious to space the 4 doses out during their awake hours (16 hours for a schedule with 8 hours of sleep) which could conveniently be every 4 hours (240 minutes); therefore, claims 13 and 15 are prima facie obvious.
Regarding claims 12 and 16, Migliaccio teaches a method of preventing and/or treating ophthalmic pathologies, particularly macular degeneration (Abst.; col. 6, ll. 25-27), which Migliaccio clarifies is senile macular degeneration (Example 2, col. 11, l. 36 -col. 12, ll. 27), i.e., age-related macular degeneration, comprising administering a spirulina or a spirulina-based formulation in a unit dosage form according to a predefined administration schedule wherein the schedule can be the daily administration of 4 doses per day (col. 10, ll. 10-16) wherein the dose can be a tablet, i.e. in a unit dosage form, comprising 800 mg of spirulina (col. 10, ll. 31-33); therefore, claims 12, 14, 16 and 18 are prima facie obvious.
Migliaccio does not specifically teach when the 4 doses per day are to be taken; however, a person of ordinary skill in the art at the time of filing would have found it obvious to space the 4 doses out during their awake hours (16 hours for a schedule with 8 hours of sleep) which could conveniently be every 4 hours (240 minutes); therefore, claims 13, 15, 17 and 19 are prima facie obvious.
Claims 1-2 and 4-19 are rejected under 35 U.S.C. 103 as being unpatentable over Migliaccio in view of Nowicka-Krawczyk et al., 2019 (cite U, attached PTO-892; herein “Nowicka-Krawczyk”).
The discussion of Migliaccio regarding claims 1-2, 4-6 and 8-19 set forth in the rejection above is incorporated herein.
Migliaccio discloses that the spirulina in their formulation is the commercially available spirulina marketed as a dietary supplement or superfood (col. 4, ll. 13-31).
Nowicka-Krawczyk discloses that commercially marketed spirulina touted as a food supplement is, in actuality, cyanobacteria of the genera Arthrospira or Limnospira (Abst.; p. 1, ¶1-2; p. 8, full ¶4-6); hence, a person of ordinary skill in the art at the time of filing would have found it obvious that the spirulina in the formulations of Migliaccio comprises Limnospira fusiformis, Limnospira indica, Limnospira maxima, Arthrospira platensis, Arthrospira erdosensis, Arthrospira jenneri, Arthrospira fusiformis, Arthrospira indica, and/or Arthrospira maxima; therefore, claim 7 is prima facie obvious.
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Migliaccio in view of Nowicka-Krawczyk and Giampapa et al., US 8747915 (cite B, attached PTO-892; herein “Giampapa”).
The discussion of Migliaccio and Nowicka-Krawczyk regarding claims 1-2 and 4-19 set forth in the rejection above is incorporated herein.
Migliaccio does not specifically recite a formulation comprising spirulina, chlorella, bilberry extract, and fucoxanthin; however, a person of ordinary skill in the art at the time of filing would have found it obvious for the formulations of Migliaccio to additionally comprise chlorella, bilberry extract, and fucoxanthin in view of the disclosure of Giampapa.
Giampapa discloses supplement compositions having anti-inflammatory properties (col. 7, ll. 3-7), i.e., enhance immune system functions, comprising bilberry fruit extract (Abst.; col. 2, ll. 1-2, 59-60; Tables 1 and 3), fucoxanthin (Tables 1-4), chlorella (col. 3, ll. 9-14; Tables 1-4) and spirulina (col. 3, ll. 9-14; Tables 1-4).
Hence, it would have been obvious to one of ordinary skill in the art at the time of filing to produce a composition comprising the combination of Migliaccio’s formulation and Giampapa’s formulation based upon the teachings of the cited references and the common knowledge in the field. The claimed composition appears to be merely a combination of known constituent ingredients and it would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to combine the instant ingredients for their known benefit since each is well known in the art for the same purpose and for the following reasons: In KSR int'l Co. v. Teleflex inc., 550 U.S. 398 (2007), the Supreme Court reaffirmed "the conclusion that when a patent 'simply arranges old elements with each performing the same function it had been known to perform' and yields no more than one would expect from such an arrangement, the combination is obvious." Id. at 417 (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273,282 (1976)). The Supreme Court also emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is ... a person of ordinary creativity, not an automaton."). The Supreme Court thus implicitly endorsed the principle, stated in In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980) (citations omitted), that: It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art. The adjustment of particular conventional working conditions (e.g., altering the relative proportions of combined ingredients based upon desired effect(s) and adding commonly-employed nutraceutical/pharmaceutical additives, carriers, vitamins, minerals etc.) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
The instant claims, in the range of proportions where no unexpected results are observed, would have been obvious to one of ordinary skill having the above cited references before him/her; hence, claim 3 is prima facie obvious.
Double Patenting
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . 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 accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See 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 website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-12 and 16 of copending Application No. 18/985909 (reference application; herein “’909”).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of ‘909 recites a method for enhancing immune system functions in a subject in need thereof, the method comprising: maintaining a constant concentration of spirulina in the subject by administering to the subject a spirulina or spirulina-based formulation in a unit dosage form according to an administration schedule comprising a total daily dose of 2000 mg to 4000 mg of spirulina wherein the total daily dose is administered in 5 to 6 separate doses with a time interval of 90 to 240 minutes between each consecutive dose; therefore, instant claims 1 and 4-5 are prima facie obvious.
Claim 2 of ‘909 recites the method of claim 1, wherein the administration schedule comprising number of dosages of the formulation and time interval between the dosages along with the dosage amount; therefore, instant claim 2 is prima facie obvious.
Claim 3 of ‘909 recites the method of claim 1, wherein the formulation comprising 86% spirulina, a type of blue-green algae, 5% chlorella, 7% bilberry extract, and 2% fucoxanthin; therefore, instant claim 3 is prima facie obvious.
Claim 6 of ‘909 recites the method of claim 1, comprising enhancing healing and reducing inflammation in the subject; therefore, instant claim 6 is prima facie obvious.
Claim 7 of ‘909 recites the method of claim 1, wherein the spirulina is selected from one or more of species consisting of Limnospira fusiformis, Limnospira indica, Limnospira maxima, Arthrospira platensis, Arthrospira erdosensis, Arthrospira jenneri, Arthrospira fusiformis, Arthrospira indica, and Arthrospira maxima alone or combinations thereof; therefore, instant claim 7 is prima facie obvious.
Claim 8 of ‘909 recites the method of claim 2, wherein the time interval between two doses is of predetermined equal time intervals; therefore, instant claim 8 is prima facie obvious.
Claim 9 of ‘909 recites the method of claim 2, wherein one time interval between two consecutive doses administered within the day is longer than all other time intervals between any other consecutive doses administered within the same day; therefore, instant claim 9 is prima facie obvious.
Claim 10 of ‘909 recites the method of claim 2, wherein the time intervals between consecutive doses are unequal; therefore, instant claim 10 is prima facie obvious.
Claim 11 of ‘909 recites the method of claim 2, wherein number of dosages in a day/week varies as compared to that of the next day/week; therefore, instant claim 11 is prima facie obvious.
Claim 12 of ‘909 recites a method for reversing age-related macular degeneration in a subject in need thereof, the method comprising: maintaining a constant concentration of spirulina in the subject by administering, to the subject, a spirulina or spirulina-based formulation in a unit dosage form according to an administration schedule comprising a total daily dose of 2000 mg to 4000 mg of spirulina, wherein the total daily dose is administered in 5 to 6 separate doses with a time interval of 90 to 240 minutes between each consecutive dose; therefore, instant claims 12-15 are prima facie obvious.
Claim 16 of ‘909 recites a method for curing eye-related ailments in a subject in need thereof, the method comprising: maintaining a constant concentration of spirulina in the subject by administering, to the subject, a spirulina or spirulina-based formulation in a unit dosage form according to an administration schedule comprising a total daily dose of 2000 mg to 4000 mg of spirulina wherein the total daily dose is administered in 5 to 6 separate doses with a time interval of 90 to 240 minutes between each consecutive dose; therefore, instant claims 16-19 are prima facie obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Trent R Clarke whose telephone number is (571)272-2904. The examiner can normally be reached M-F 10-7 MST.
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, Melenie Gordon can be reached at 571-272-8037. 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.
/TRENT R CLARKE/ Examiner, Art Unit 1651
/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651