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
The present application claims priority to the applications, EP21197914.1 and PCT/EP2022/076180, with the effective filing dates of 21 Sept 2021 and 21 Sept 2022.
Claim Status
This Office Action is in response to Applicant’s Response to Restriction filed, 3 June 2026.
Applicant’s election without traverse of Group I (claims 1-3) and
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and ischemic stroke in the reply filed 3 June 2026 is acknowledged.
Claims 1-3, 5, and 7-23 are pending.
Claims 5 and 7-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group (Group II: 5, 7-13, and 16-23; Group III: claims 14-15), there being no allowable generic or linking claim.
Claims 1-3 are under consideration in the instant office action.
Information Disclosure Statement
The Information Disclosure Statements filed on 20 Mar 2024 and 19 Aug 2025 and the references cited therein have been considered, unless indicated otherwise.
Claim Interpretation
Claim 1 recites a compound according to general structure (I) or a pharmaceutically acceptable carrier, solvate, enantiomer, or hydrate thereof. As written, claim 1 specifies a list of alternatives. Further, the specification defines a carrier as “a diluent, adjuvant, excipient, or vehicle with which the therapeutic is administered” ([0068]). Thus, there is no limit on the identity of a pharmaceutically acceptable carrier, and claim 1 does not require a compound of structure (I). Similarly, claim 3 does not require a compound of structure (I).
Claim Objections
1. Claim 2 is objected to because of the following informalities: lack of conjunction to separate the options. Claim 2 recites the compound is selected from the group consisting of:
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,
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,
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,
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,
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, but claim 2 does not specify a conjunction (i.e. “and” or “or”).
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.
2. Claim 1-3 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.
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). In the present instance, claim 1 recites the broad recitation E is CH2, C=O, or CH(C1-5 alkyl), F is CH2, C=O, or CH(C1-5 alkyl), and J is CH2 or C=O, and the claim also recites E is preferably CH2, F is preferably CH2, and J is preferably CH2, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 2-3 depend upon claim 1, do not rectify the indefiniteness of claim 1, and thus incorporate by dependency the indefiniteness of claim 1. Accordingly, claims 2-3 are similarly rejected.
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.
3. Claims 1 and 3 are rejected under 35 U.S.C. 101, because the claimed invention is directed to a natural product without significantly more as evidenced by Wikipedia 1 (“Water,” Wikipedia, 2026, <en.wikipedia.org/wiki/Water>, accessed 24 June 2026), Wikipedia 2 (“Lactose,” Wikipedia, Mar 2020, <web.archive.org/web/20200313174813/en.wikipedia.org/wiki/Lactose#Applications#Applications>, accessed 24 June 2026), and JW (“8 Types of Water Recognized by the FDA”, JW Consulting Engineers, 2018, <jwconsultingengineers.com/post/2018/08/16/8-types-of-water-recognized-by-the-fda>, accessed 24 June 2026).
Claim 1 recites a compound according to general structure (I) or a pharmaceutically acceptable carrier, solvate, enantiomer, or hydrate thereof. Thus, the instant claims are drawn to a product, which is a statutory category of matter (Step 1: Yes).
Claims 1 and 3 are drawn to a judicial exception of a natural product, more specifically, a compound according to general structure (I) or a pharmaceutically acceptable carrier, solvate, enantiomer, or hydrate thereof. Due to the alternative, claims 1 and 3 are also drawn to a judicial exception of a natural product, more specifically, a pharmaceutically acceptable carrier ([0068]), such as water or lactose, which are natural products as evidenced by Wikipedia 1 (page 1, paragraph 1) and Wikipedia 2 (page 3, paragraph 6). Further, claim 3 specifies that the composition of claim 1 and at least one pharmaceutically acceptable excipient, which water is an excipient as evidenced by JW (page 1, paragraph 1). Thus, claim 1 and dependent claim 3 are directed toward a naturally-occurring product (Step 2A, Prong 1: Yes). This judicial exception is not integrated into a practical application, because the carrier of claims 1 and 3 is not used to provide a particular treatment or prophylaxis for a disease or medical condition. Further, the claimed invention does not apply or use the judicial exception in a meaningful way and there is no inventive concept in the claims. A naturally-occurring product, or a combination of natural-occurring products, is not novel when the combination does not change the structure, function, or properties of the naturally-occurring components (see MPEP 2106.05(h)). Thus, claims 1 and 3 do not recite any additional elements that integrate the exception into a practical application (Step 2A, Prong 2: No).
Claims 1 and 3 are drawn to a judicial exception and do not recite any additional elements that amount to significantly more than the judicial exception. The discovery of a naturally-occurring product does not amount to significantly more: (Roslin, 750 F.3d at 1337, 110 USPQ2d at 1671-72). See MPEP § 2106.04(c)(II)(A) and 2106.04(c)(II)(C)(2). (Step 2B: No).
Accordingly, claims 1 and 3 do not constitute patent eligible subject matter under 35 U.S.C. § 101.
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.
4. Claim(s) 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JW (“8 Types of Water Recognized by the FDA”, JW Consulting Engineers, 2018, <jwconsultingengineers.com/post/2018/08/16/8-types-of-water-recognized-by-the-fda>, accessed 24 June 2026).
JW teaches that water is an excipient (page 1, paragraph 1), which the specification defines a carrier as “a diluent, adjuvant, excipient, or vehicle with which the therapeutic is administered” ([0068]).
Regarding claim 1, JW teaches that water is an excipient (page 1, paragraph 1), which the specification defines a carrier as “a diluent, adjuvant, excipient, or vehicle with which the therapeutic is administered” ([0068]). Thus, JW teaches a pharmaceutically acceptable carrier.
Regarding claim 3, JW teaches that water is an excipient (page 1, paragraph 1).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
5. Claim(s) 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Schiemann (U.S. Patent No. 8,552,001, issued 8 Oct 2013; of record, see PTO-892 mailed 13 Apr 2026) in view of Lowe (“Sulfur, Your Pal. Mostly.” In the Pipeline, 2007, <https://www.science.org/content/blog-post/sulfur-your-pal-mostly>, accessed 31 Mar 2026; of record, see PTO-892 mailed 13 Apr 2026).
Schiemann teaches compounds that inhibit enzymes that regulate or modulate lysophosphatidic acid (LPA), such as autotaxin (column 1, lines 14-23 and 26-29). Schiemann teaches that it is desirable to lower the LPA level for treating tumor patients, because LPA plays a role in tumor cell proliferation and invasion thereof into neighboring tissue (column 1, lines 41-48; column 1, lines 49-50). Schiemann teaches that the compounds therein cause specific inhibition of the enzyme family of nucleotides pyrophosphatases and phosphodiesterases, in particular autotaxin (column 2, lines 53-56). Schiemann teaches Compound 1d,
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which does not fall into Formula (I) but significantly overlaps with Formula (I) (column 4, lines 19-25).
18/693,887 Formula (I) components
18/693,887 Formula (I)
Compound 1d (Schiemann)
E
CH2
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F
CH2
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J
CH2
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Regarding claim 1, Schiemann fails to teach a sulfone.
Lowe teaches that sulfones are metabolically stable with the reputation as rock-solid functional groups in drug discovery (page 1, paragraphs 1 and 4). Lowe teaches lessons regarding various sulfur-containing functional groups in drug discovery from an experienced medicinal chemist (page 1, paragraphs 1, 3, and 4). Lowe teaches sulfoxides are interestingly polar but frustratingly chiral and subject to both oxidation (to the sulfone) and reduction (to the sulfide) (page 1, paragraph 4). Lowe teaches that sulfoxides are accessible in not-appealing methods and that the several medicinal chemists prefer to avoid sulfoxides (page 1, paragraph 4).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to select the compound of Schiemann and the sulfone of Lowe to arrive at instant claim 1 (
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). One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Schiemann teaches compounds that inhibit enzymes that regulate or modulate lysophosphatidic acid (LPA), such as autotaxin,
-Schiemann teaches that it is desirable to lower the LPA level for treating tumor patients, because LPA plays a role in tumor cell proliferation and invasion thereof into neighboring tissue,
-Schiemann teaches that the compounds therein cause specific inhibition of the enzyme family of nucleotides pyrophosphatases and phosphodiesterases, in particular autotaxin,
-Schiemann teaches Compound 1d,
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which does not fall into Formula (I) but significantly overlaps with Formula (I),
-Lowe teaches lessons regarding various sulfur-containing functional groups in drug discovery from an experienced medicinal chemist,
-Lowe teaches sulfoxides are interestingly polar but frustratingly chiral and subject to both oxidation (to the sulfone) and reduction (to the sulfide),
-Lowe teaches that sulfoxides are accessible in not-appealing methods and that the several medicinal chemists prefer to avoid sulfoxides, and
-Lowe teaches that sulfones are metabolically stable with the reputation as rock-solid functional groups in drug discovery.
As such, an artisan having ordinary skill in the art would have been motivated to make such a selection to predictably arrive at a compound of formula (I):
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.
Regarding claim 2, Schiemann teaches Compound 1d:
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which does not fall into Formula (I) but significantly overlaps with Formula (I) (column 4, lines 19-25). Lowe teaches sulfones are metabolically stable with the reputation as rock-solid functional groups in drug discovery (page 1, paragraphs 1 and 4). Thus, the combination of Schiemann and Lowe teaches the compound,
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.
Regarding claim 3, Schiemann teaches pharmaceutical compositions of the compounds therein with a pharmaceutically acceptable excipient (column 1, lines 9-13; column 9, lines 45-49; column 10, lines 4-7).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Madeline M Dekarske whose telephone number is (571)272-1789. The examiner can normally be reached Monday - Thursday 10am - 4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached at 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MADELINE M. DEKARSKE/Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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