8/2024Notice 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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/28/2024 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 15 is objected to because of the following informalities:
Claim 15 recites "A compounds"; "compounds" should be singular.
Appropriate correction is required.
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.
Claim 8 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
The claim does not fall within at least one of the four categories of patent eligible subject matter because claim 8 recites “use" of a product per se, and therefore it does not fall within at least one of the four categories of patent eligible subject matter. "Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 "). In Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967). See MPEP 2173.05(q).
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 7-10, 13 and 16 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 7 and 8 recite “at least one compound of formula (I) and/or a composition according to claim 6” and “one or more compounds of formula (I) and/or of a composition according to claim 6” respectively. Reference to formula (I) can ambiguously be interpreted as reference to formula (I) of another claim without clarity as to which claim is being references, or as a reference to the specification. Reference without specifying another claim makes the metes and bounds of a compound of formula (I) unclear because it is unclear whether the variables are as defined in claim 1 or in another claim such as claim 2. If the recitation is interpreted as a reference to the specification, where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table in claims “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). See MPEP 2173.05(s). Referring to formula (I) in the specification is therefore indefinite.
Claim 8 recites “use” of a product. Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986). See MPEP 2173.05(q). Accordingly, the instant “use” claim is indefinite because it recites use of a product without setting forth any active steps defining how the use is practiced, leaving the metes and bounds of the claim unclear.
Claims 9 and 10 recite “may be prepared”. It is unclear if the step(s) that follow this phrase are claim limitations, e.g. whether the claim requires the performance of said step(s), or if the phrase is merely a statement that said step(s) could be performed.
Regarding claim 10, the phrase "e.g." renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 10 and 13 recite “preferably”. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language denoted by the term “preferably” is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 16 recites CAS numbers. Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table in claims “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). See MPEP 2173.05(s). In this case, the claims refer to CAS numbers, however, the practical and accepted way to refer to chemical compounds is by name or structure (See, e.g., 2173.05(t)).
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.
Claim(s) 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAPlus Registry Number: RN 2387380-11-0 [Database Registry Chemical Abstracts Service, Columbus, Ohio, Accession No. RN 2387380-11-0, Entered STN: 02 Dec 2019].
The structure of CAPlus RN 2387380-11-0 is
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which reads on a compound of formula (29) of claim 16 wherein Y is
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146
94
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; X1 is chloro; A1 is CH; R7L is amino; and R7M is H. Note that the compound is a tautomer of a compound of formula (29) at the amidine substituent; formula (29) is explicitly drawn to wherein the hydroxy-bound nitrogen has a double bond. However, the specification at Para. [0214] recites “Where a compound can be present in two or more tautomer forms in equilibrium, reference to the compound by means of one tautomeric description is to be considered to include all tautomer forms.” Accordingly, said tautomeric form is encompassed by formula (29) of claim 16.
Registry number RN 517894-99-4 is available as prior art as of 02 Dec 2019, the day it was indexed into the CAplus database.
See MPEP 2128: ELECTRONIC PUBLICATIONS AS PRIOR ART Status as a "Printed Publication" An electronic publication, including an on-line database or Internet publication, is considered to be a “printed publication” within the meaning of 35 U.S.C. 102(a) and (b) provided the publication was accessible to persons concerned with the art to which the document relates. See In re Wyer, 655 F.2d 221, 227, 210 USPQ 790, 795 (CCPA 1981) Since this date represents the date that each compound entered the CAPlus database on STN, this represents the date that each compound was made accessible to the public.
The aforementioned compounds anticipate the instantly claimed compounds: It is further noted that for the purposes of determining if a reference is a “printed publication” for the purposes of 102(b), MPEP 2128 states the following:
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880
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where “prior art disclosures…on an on-line database are considered to be publicly available as of the date the item was publicly posted.” Since each of the database entries above lists the date that each compound was entered into the on-line database, the compounds were made publicly available as of that date in each citation, and the claims are anticipated.
Allowable Subject Matter
Claims 1-15 are allowable over the prior art. The closest prior art is WO2020127780A1 which teaches compounds of formula (I) (claims 1-7) and processes for preparing and using and intermediates thereof (claims 8-16). The primary difference between the prior art compounds and those instantly claimed is the presence of the -O- linker in the prior art versus the sulfide/sulfoxide/sulfone linkers in the instant claims connecting Q to the adjoining heterocycle. Each embodiment of the prior art requires O in said position and there is nothing to suggest modifying said position, particularly in view of all of the other variables a PHOSITA would have been motivated to modify based upon the disclosure of variable positions and preferred embodiments thereof. Accordingly, substituting the -O- with a sulfide/sulfoxide/sulfone would not have been obvious to a PHOSITA and instant claims 1-15 are both novel and nonobvious in view of the prior art.
Conclusion
Claims 7-10, 13 and 16 are rejected.
Claim 15 is objected to.
Claims 1-6, 11-12 and 14 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JED A KUCHARCZK whose telephone number is (571)270-5206. The examiner can normally be reached Mon-Fri 7:30 to 5.
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/JED A KUCHARCZK/ Examiner, Art Unit 1623
/VALERIE RODRIGUEZ-GARCIA/ Primary Examiner, Art Unit 1621
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