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 .
Election/Restrictions
Applicant’s election without traverse of Group II (claims 15-21 in the reply filed on June 30th, 2026 is acknowledged. Claims 10-14 and 22-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
The requirement is still deemed proper and therefore made FINAL.
Applicant’s election of Species C (claim 18) in the reply filed on June 30th, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the election requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 16 and 17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Claims 15 and 18-21 are pending and were examined on the merits.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The priority date is October 20th, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on September 20th, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement filed April 11th, 2025 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the title of Other Document 23 "New Health Function Nutrients Included in Edible Microalgae: Hitherto Unknown Physical Health-Promoting Nutrients Made Clear" does not match the title of the corresponding document included in the file wrapper : "New Health-Promoting Nutrients Found in Edible Microalgae Unveiling Nutrients with Previously Unknown Health-Regulating Functions". It has been placed in the application file, but the information referred to therein has not been considered as to the merits for the lined-through document. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a). All documents not lined through have been considered.
The information disclosure statement (IDS) submitted on December 16th, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings were received on April 18th, 2024. These drawings are acceptable.
Specification
The disclosure is objected to because of the following informalities: page 26 line 15 recites the term "Thermo Fischer", which should be changed to "Thermo Fisher" for correct spelling.
Appropriate correction is required.
The use of the terms Shimadzu, Agilent, J&W, GL Sciences, Thermo Fischer (registered as Thermo Fisher), Exactive, and Sigma (registered as Millipore Sigma and Sigma-Aldrich), each of which is a trade name or a mark used in commerce, has been noted in this application. Each term should be accompanied by the generic terminology; furthermore, each term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 15 is objected to because of the following informalities: the . Appropriate correction is required.
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 15, 18, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16, 19-21, 24-26, 29-31, 34, and 35 of copending Application No. 19/116526 (reference application, document US 20260060952 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because of the overlapping subject matter discussed below.
Instant claims 15, 18, and 19; and reference claims 16, 19-21, 24-26, 29-31, 34, and 35; recite a method comprising administering to a subject in need thereof, a first triglyceride represented by the following formula (I):
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wherein R1, R2 and R3 each denotes a saturated fatty acid residue, at least one of which is a pentadecanoic acid residue (instant claim 15; reference claims 16, 21, 26, and 31); wherein, in the first triglyceride, Ri, R2 and R3 all denote pentadecanoic acid residues, wherein the method further comprises administering a second triglyceride, which is also represented by the formula (I), and wherein, in the second triglyceride, any two of Ri, R2 and R3 are pentadecanoic acid residues and another is a myristic acid residue or a palmitic acid residue (instant claim 18; reference claims 19, 24, 29, and 34); wherein at least the first triglyceride is derived from algae of the genus Aurantiochytrium or Schizochytrium (instant claim 19; reference claims 20, 25, 30, and 35).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 15 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-8 of U.S. Patent No. 12485103 (reference document). Although the claims at issue are not identical, they are not patentably distinct from each other because of the overlapping subject matter discussed below.
Instant claims 15 and 18; and reference claims 6-8; recite a method comprising administering to a subject in need thereof, a first triglyceride represented by the following formula (I):
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wherein R1, R2 and R3 each denotes a saturated fatty acid residue, at least one of which is a pentadecanoic acid residue (instant claim 15; reference claims 6-8); wherein, in the first triglyceride, Ri, R2 and R3 all denote pentadecanoic acid residues, wherein the method further comprises administering a second triglyceride, which is also represented by the formula (I), and wherein, in the second triglyceride, any two of Ri, R2 and R3 are pentadecanoic acid residues and another is a myristic acid residue or a palmitic acid residue (instant claims 18, reference claims 6-8).
Claim 15 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of copending Application No. US 20260076933 A1 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the overlapping subject matter as discussed below.
Instant claim 15 and reference claim 1-3 recite a method comprising administering to a subject in need thereof, a first triglyceride represented by the following formula (I):
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wherein R1, R2 and R3 each denotes a saturated fatty acid residue, at least one of which is a pentadecanoic acid residue (instant claim 15; reference claims 1-3).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 15 and 18-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: the steps of administerin To overcome indefiniteness, the applicant may recite the route(s) of administration, such as oral administration. Claim 18 should explicitly recite administering to a subject in need thereof, to define the subject receiving the administration of the second triglyceride.
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 15 and 18-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for decreasing limited endoplasmic reticulum (ER) stress (the test drug has no statistically significant effect above a certain concentration of the ER-stressor tunicamycin, per Table 2), does not reasonably provide enablement for improving or preventing the progression of any neurodegenerative disease. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
(1) The nature of the invention and (2) the breadth of the claims:
The claims are drawn to a method of improving or preventing progression of a neurodegenerative disease by administering a triglyceride composition to a subject in need thereof as recited in claims 15 and 18-21. Thus, the claims taken together with the specification imply that the method recited in instant independent claim 15 and dependent claims 18-21 improves or prevents the progression of any neurodegenerative disease, this method comprising administering to a subject in need thereof a first triglyceride comprising at least one pentadecanoic acid residue (Claim 15); the first triglyceride comprising three pentadecanoic acid residues, and the method further comprising administering a second triglyceride wherein any two of the fatty acid residues in the second triglyceride are pentadecanoic acid residues and another is a myristic acid residue or a palmitic acid residue (claim 18); the first triglyceride is derived from algae of the genus Aurantiochytrium or Schizochytrium (claim 19); the neurodegenerative disease is dementia (claim 20); the method ameliorates or prevents progression of at least one symptom selected the group consisting of forgetfulness, impaired comprehension, impaired judgment, memory impairment, disorientation, executive dysfunction, loss of speech, loss of action, and loss of cognition (claim 21).
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
Henry et al. (J. Agric. Food Chem. 2002, 50, 2231-2234) recites myristic acid, pentadecanoic acid, and palmitic acid having antioxidant activity, evaluated by analysis of model liposome oxidation using fluorescence spectroscopy (Experimental Procedures, Results paragraphs 1 and 2, Figure 1). This antioxidant activity suggests that administering a triglyceride comprising these fatty acids (hydrolyzed upon organismal digestion) would help protect the lipid membranes of cells from oxidative damage; therefore, inhibiting neurodegenerative disease resulting from oxidative damage to the lipid components of cells. However, this suggestion does not reasonably extend to improving or preventing progression of neurodegenerative diseases resulting from other causes such as injury or protein aggregation.
Dong (WO 2019052629 A1); Foreign Patent Document C on the IDS received on September 20th, 2024; recites adding different fatty acids to mouse primary cortical neurons, challenging the neurons with amyloid-β-oligomers 48 hours later, and investigating cell viability 24 hours later using MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) (Example I-6). Pentadecanoic acid provided partial neuroprotection at 0.01 μM (21.9) and 0.1 μM (14.0%); the effects of myristic and palmitic acid were not studied in this example. Dong enables administering pentadecanoic acid for partially inhibiting neurodegenerative diseases resulting from amyloid-β-oligomers. However, Dong does not enable this method improving or preventing progression of neurodegenerative disease resulting from other causes such as oxidative damage, injury, vascular lesions, or exposure to heavy metals.
Sasaki et al. (Front. Cell Dev. Biol. 2021, 8, 600575); Other Document 4 on the IDS received on September 20th, 2024; investigated the effects of ethanol extract of Aurantiochytrium (EEA) and a derivative, the n-Hexane layer of EEA (HEEA) on amyloid-β-stimulated SH-SY5Y cells and senescence-accelerated mouse-prone 8 (SAMP8) mice, a non-transgenic strain with accelerated aging and AD-like memory loss for evaluation of spatial learning and memory using the Morris water maze test (Abstract). Sasaki et al. recites the following effects of EEA and HEEA on neural health and cognitive function:
"Pretreatment of SH-SY5Y cells with EEA or the squalene-rich fraction of EEA, HEEA, ameliorated amyloid-β-induced cytotoxicity. Interestingly, only EEA-treated cells showed a significant increase in cell metabolism and intracellular adenosine triphosphate production. Moreover, EEA treatment significantly increased the number of neurospheres, whereas HEEA treatment significantly increased the number of β-III-tubulin+ young neurons and GFAP+ astrocytes. SAMP8 mice were given 50 mg/kg EEA or HEEA orally for 30 days. EEA and HEEA decreased escape latency in the Morris water maze in SAMP8 mice, indicating improved memory. To detect stem cells and newborn neurons, we administered BrdU for 9 days and measured BrdU+ cells in the dentate gyrus, a neurogenic stem cell niche of the hippocampus. In SAMP8 mice, EEA rapidly and significantly increased the number of BrdU+GFAP+ stem cells and their progeny, BrdU+NeuN+ mature neurons" (Abstract).
However, Sasaki et al. did not identify pentadecanoic acid, myristic acid, or palmitic acid, or as active components of EEA or HEEA which resulted in the improved neural health or cognitive function of mice. Moreover, Sasaki did not study models of all types of neurodegenerative disease.
Scott and Barrett (Expert Rev Neurother. 2007, 7 (4), 407–422) recite different types of dementia, not all of which are related to amyloid-β protein accumulation, or have an obvious etiology in oxidative damage to the lipid components of cells. Regarding Alzheimer' disease:
"Pathologically, AD [Alzheimer's disease] is associated with the accumulation of neuritic plaques (NPs) and NFTs in the brain. What triggers these events is unclear. NPs are probably the result of abnormal metabolism of amyloid-β 40 and amyloid-β 42 leading to its accumulation, while NFTs are formed from hyperphosphorylated tau protein [30]" (Scott and Barrett, Syndromic classification, Mild cognitive impairment, Alzheimer's disease).
Regarding Lewy Body dementia:
"Lewy body disease is second only to AD in prevalence. DLB may be more prevalent in men [204] … Insoluble α-synuclein aggregations are a major component of Lewy bodies (LBs) –the key pathological feature of DLB. LBs are identified as round, eosinophilic inclusions that are surrounded by white halos on microscopic examination. LBs are seen in cortical and subcortical regions of affected individuals" (Scott and Barrett, Syndromic classification, Dementia syndromes associated with parkinsonism, Dementia with Lewy Bodies).
When describing vascular dementia, Scott and Barrett recite "individuals should demonstrate some causal relationship between dementia and cerebrovascular disease such as a recent stroke (generally within 3 months) … Suspected cases should have evidence on brain imaging suggesting one or more infarcts, and/or extensive periventricular ischemic white-matter disease" (Scott and Barrett, Syndromic classification, Vascular dementia). When describing fronto-temporal dementia syndromes, Scott and Barrett recite "Fronto–temporal dementias (FTD) arise from degeneration of the frontal and temporal lobes without evidence of the classic pathology seen in AD (e.g., amyloid plaques and NFTs) [39]. Although the pathophysiology is not fully understood, FTD interestingly shows serotonergic deficits with relative sparing of acetylcholine function [40,201]" (Scott and Barrett, Syndromic classification, Fronto–temporal dementia syndromes).
Since the treatment of any neurodegenerative disease by administering pentadecanoic acid, remains largely unsolved, means for improving or preventing the progression of any neurodegenerative disease by administering a triglyceride comprising at least one pentadecanoic acid residue is highly unpredictable.
(5) The relative skill of those in the art:
The relative skill of those in the art is high. Henry et al. and Dong suggest that pentadecanoic acid is useful for inhibiting oxidative damage (Henry et al.) and damage from amyloid-β-oligomers in cortical nervous tissue (Dong).
Accordingly, one would have turned to the instant disclosure for additional direction and guidance.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The specification has provided extracting pentadecanoic acid triglycerides from the algae genus Aurantiochytrium (Production Example 1); and improved mouse hippocampal neuron cell viability as a result of treatment with a pentadecanoic acid triglyceride, when the cells are exposed to certain concentrations of the endoplasmic reticulum stressor tunicamycin up to 5 μg/mL (Example 1). However, the specification does not provide improving mouse hippocampal neuron cell viability at any concentration under any condition of neuronal endoplasmic reticulum stress; moreover, the specification does not provide improving or preventing the progression of any neurodegenerative disease.
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed by Henry et al., Dong, Sasaki et al., and Scott and Barrett and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to a method of improving or preventing progression of any neurodegenerative disease by administering a triglyceride composition to a subject in need thereof as recited in claims 15 and 18-21.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert F Spaine whose telephone number is (571)272-9099. The examiner can normally be reached 8:00 AM - 4:00 PM United States Eastern Time, Monday-Friday.
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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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