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 .
DETAILED ACTION
Applicant’s amendment in the reply filed on 3/26/26 is acknowledged, with the cancellation of Claims 9-11; and the additional newly added Claim 23. Claims 1-8, and 12-23 are pending. Claims 1-8, and 12-23 are examined on the merits.
Any rejection that is not reiterated is hereby withdrawn.
Claim Rejections –35 USC § 112, 1st New Matter
The following is a quotation of the first paragraph of 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.
Claim 23 is newly rejected under 35 U.S.C. 112, 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. This is a new matter rejection.
This is a new rejection necessitated by the Applicant’s amendment filed on 3/26/26.
Claim 23 recites “The method of claim 1, wherein the compound is 2-monopentadecanoin”. However, the specification fails to provide any support regarding the description of “2-monopentadecanoin”. Therefore, it is not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, Applicant had possession of the “2-monopentadecanoin” in the invention. Thus, the subject matter of “2-monopentadecanoin” is a new matter that needs to be cancelled.
Claim Rejections –35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an 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.
Claims 1-8, and 12-22 remain rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Chang et al (WO 2017211274 A1).
This rejection is maintained for reasons of record set forth in the Office Action mailed out on 12/2/25, repeated below, slightly altered to take into consideration Applicant’s amendment filed on 3/26/26. Applicants’ arguments filed have been fully considered but they are not deemed to be persuasive.
Chang et al teach the compounds of formula (I), in particular tripentadecanoin contained in ophioglossum (see claims 23-26) (thus claim 8 is met), for the treatment and/ or prevention of neurodegenerative diseases (thus claims 17 is met), retinal or optic nerve degenerative diseases, demyelinating diseases, neuromuscular disorders and muscular dystrophy (thus muscle weakness, thus claims 14 and 15 are met), brain (thus claims 12 and 13 are met) or spinal cord nerve injury, cranial nerve disorders, or seizures (thus claim 16 is met), amyloid deposit related diseases, chronic diseases selected from the group consisting of kidney diseases, diabetes and asthma (thus claim 13 is met), and for the use of anti-aging or life-span prolongation and improving brain function (see claim 7), like encephalitis caused by or related to Zika virus (see claim 10) (thus claim 9 is met, thus claim 19 is met). The dosage of the compound is from 1 µg (microgram)/day to 50 mg/day (see claim 21) (thus claims 1-5 are met, thus claim 22 is met).
Chang et al teach a further embodiment of the invention relates to the compound according to any one of embodiments (1) to (17) for the use in the treatment and/or prevention of the diseases and conditions of embodiments (19) to (27), wherein the treatment dosage is from 1 mg/day to 1000 mg/day. In a further embodiment, the treatment dosage is from 1 mg/day to 1000 mg/day. The lower limits are for instance 1 mg/day, 5 mg/day, 10 mg/day, 20 mg/day, 25 mg/day or 50 mg/day. The upper limits are for instance 1000 mg/day, 900 mg/day, 800 mg/day, 750 mg/day, 700 mg/day, 600 mg/day, 500 mg/day, 250 mg/day, 200 mg/day. It is to be understood that each upper limit can be combined with each lower limit. In a preferred embodiment, the dosage is from 10 mg/day to 200 mg/day (page 21, 3rd paragraph from the bottom) (thus exactly the same as the dosage in the specification, page 16, 2nd paragraph from the bottom).
Chang et al teach a metabolite or prodrug of the compound of formula (I) according to claim 4, wherein the metabolite or prodrug is HOC(O)C12-alkyl, HOC(O)C-14-alkyl (thus claims, HOC(O)C-16-alkyl, HOC(O)C18-alkyl or HOC(O)C20-alkyl for the manufacture of a medicament for humans and/or animals (see claim 6).
Chang et al teach the use of the compound of the formula (I) according to any one of claims 1 to 6 for the manufacture of a medicament for the treatment and/or prevention of neurodegenerative diseases, retinal or optic nerve degenerative diseases, demyelinating diseases, neuromuscular disorders and muscular dystrophy, brain or spinal cord nerve injury, cranial nerve disorders, or seizures, amyloid deposit related diseases, chronic diseases selected from the group consisting of kidney diseases, diabetes and asthma, and for the use of antiaging or life-span prolongation and improving brain function (see claim 7) (thus claim 6 is met).
Chang et al teach a pharmaceutical composition for the use in the treatment and/or prevention of the diseases and conditions of claims 7 to 14, wherein the composition contains the compound of claims 1 to 6 and a pharmaceutically acceptable carrier (see claim 16) (thus claim 7 is met).
Regarding claims 20 and 21, since the claimed compound is being administered to the claimed subject at the claimed dosage, it is the inherent mechanism that the compound of formula I is going to perform the claimed designated function, which is to upregulate expression of neuroglobin, and inhibit apoptosis of neuron cells (thus claims 20 and 21 are met).
Regarding claim 1, since the claimed compound is being administered to the claimed subject at the claimed dosage, it is inherent that the compound of formula I is going to perform the claimed designated function, which is to prevent the viral infection disease caused by SARS-CoV-2, SARS-CoV-1, or MERS, no matter the cited reference teaches it or not.
Therefore, the reference is deemed to anticipate the instant claim above.
Applicant argues that “Nowhere does Chang teach treatment of symptoms of a neurological complication of a viral infection disease in which the viral infection disease is caused by SARS-CoV-2, SARS-CoV-1, or MERS, as required by amended claim 1” (page 6, 4th paragraph).
This is not found persuasive. Regarding claim 1, since the claimed compound is being administered to the claimed subject at the claimed dosage, it is inherent that the compound of formula I is going to perform the claimed designated function, which is to prevent the viral infection disease caused by SARS-CoV-2, SARS-CoV-1, or MERS, no matter the cited reference teaches it or not.
Applicant's arguments have been fully considered but they are not persuasive, and therefore the rejections in the record are maintained.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QIUWEN MI whose telephone number is (571)272-5984. The examiner can normally be reached on Monday-Friday 8:30 am to 5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached on 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Qiuwen Mi/
Primary Examiner, Art Unit 1655
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