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 09/01/2023 and is a 371 of PCT/ES2021/070235 (04/09/221) which claims foreign priority to PCTES2020070234 (04/09/2020). Claims 1-17 are before the Examiner.
Claim Rejections - 35 USC § 112
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 1-17 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 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(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
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There are many factors to be considered when determining whether the Written Description requirement are (1) level of skill and knowledge in the art, (2) partial structure, (3) physical and/or chemical properties, (4) functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the (5) method of making the claimed invention.
In the instant case, the claims are drawn to compositions of the following formula:
(1) Level of skill and knowledge in the art:
(2) Partial structure:
(3) Physical and/or chemical properties:
(4) Functional Characteristics:
(5) Method of making the claimed invention:
A stated supra, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that claims 1-17 are generic, with respect to all possible compounds encompassed by the claims by the use of “a derivative, a prodrug or a solvate thereof” of melatonin outside melatonin or a compound of formula (I). The possible structural variations are limitless to any class of compound represented in a Markush structure that does not contain or possess a common core structure. The claims lack written description because there is no disclosure of a correlation between function and structure of the compounds beyond compounds disclosed in the examples in the specification of melatonin or a compound of formula (I). While having written description for the compound of melatonin or formula (I), there is insufficient description of a common core structure that would allow one of skill in the art to practice the invention as claimed for “a derivative, a prodrug or solvate thereof”.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed.Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”)
Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
It is suggested that the claims be limited to melatonin or a compound of formula (I) as described in the specification.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McCarty US PGPub 20100119601. McCarty teaches the use of melatonin in a pharmaceutical composition with polyethylene glycol and propylene glycol and glycerin to treat human diseases. Paragraph 10 teaches melatonin in a pharmaceutical composition. Paragraph 13 teaches the pharmaceutical composition has polyethylene glycol and propylene glycol. Paragraph 23 teaches melatonin therapy is used in humans in need of melatonin therapy. Paragraph 30 teaches an amount of melatonin of 0.01mg – 3.0 mg/kg/day. Paragraph 46 teaches that melatonin therapy treats immunity issues in humans. This fully encompasses the instant claims.
Claims 1-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wo2015144965. WO teaches the use of melatonin along with PEG (polyethylene glycol) and PE (propylene glycol) in a composition to treat infection and inflammation. Claim 1 teaches the use of a melatonin with PEG and PE as a pharmaceutical composition. Claim 3 specifically teaches that the amount of melatonin is 0.1mg – 30mg per day. Claim 12 teaches the treatment of infection and inflammation among other conditions. This anticipates the instant claims.
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.
Claims 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over USGPGub20100119601 (McCarty) and WO2015144965 in view of Camp. Both McCarty and WO teach the composition of melatonin with PEG and PG. Both teach melatonin treating infection. Camp teaches specifically that SARS and Cov-2 can be treated by a melatonin composition. It would have been obvious to one of ordinary skill in the art at the time of the invention to treat SARS or Cov-2 with the composition of McCarty and WO with the reasonable expectation of getting treatment of SARS or COv-2. Rationale: Both McCarty and WO teach the use of a melatonin and PEG and PG to treat infection. Camp teaches melatonin treats SARS and Cov-2.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D MARGARET M SEAMAN whose telephone number is (571)272-0694. The examiner can normally be reached M-F 8am-4pm Eastern.
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/D MARGARET M SEAMAN/Primary Examiner, Art Unit 1625