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 compound IIb-18 in the reply filed on 2026 January 16 is acknowledged. In light of the elected species, a search encompassing this compound has been conducted. In query L6, nodes 7, 8, and 9 represent any non-H element and node 19 represents any heteroatom. In addition to the query below, a search of the examined claims is limited to the prior art cited. In light of the search scope, claims 1, 2, 5, 6, 8, 11, 14, 15, 18-20, and 23 are examined on the merits.
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Claims 3, 4, 12, 13, 16, 17, 21, and 22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2026 January 16.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 2023 March 10, 2024 March 6, and 2025 April 2 were submitted in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1, 2, 5, 6, 8, 11, 14, 15, 18-20, and 23 are objected to because of the following informalities.
In claim 1, the phrase “mixtures thereof” should be written as “a mixture thereof” to be consistent with a compound or the alternative forms recited.
In claims 1, 2, 5, 6, 8, 11, 14, 15, 18-20, and 23, each variable should be recited on its own line, which will make the claim more readable [see MPEP CFR 1.75(i)]. Dependent claims of claim 1 are objected to because they depend on claim 1.
In claim 1, if the text in parentheses has the same definition as recited in the specification, it is not needed. This issues applies to the text “amino (NH2), aminocarbonyl (H2NCO)”. Based on a specification readthrough, each group is limited to an NH2 or H2NCO respectively. Consequently the text “amino (NH2), aminocarbonyl (H2NCO)” should be written as --amino, aminocarbonyl--.
In claim 1, the text “-C(RfRg-“ should be written as -- -C(RfRg)- -- so the parentheses are closed.
In claims 2, 5, 14, and 23, the text “the definitions of n, E … in claim 1;” is extraneous because the variables are assumed to have the same definitions as parent claim 1 unless they are further limited.
In claim 4, the text “G1” should be written --G1--.
Appropriate correction is required.
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 8, 14, 15, 18-20, and 23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification is enabling for treating diabetes with a compound of formula Ib or IIb and non-enabling for the prevention of diabetes with a compound of formula Ib or IIb. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or 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.
Consideration of the relevant factors sufficient to establish a prima facie case for lack of enablement is set forth herein below:
The nature of the invention and (2) the breadth of the claims:
The claims are drawn to treatment or prevention of diabetes with a compound of formula Ib or IIb. Thus, the claims taken together with the specification imply a compound of formula Ib or IIb can treat or prevent diabetes.
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The state of the prior art and (4) the predictability or unpredictability of the art:
LI (Lancet, 2008, 371, 1783-1789) describes that the prevalence of diabetes can be reduced but not prevented (page 1787, column 1, paragraph 2 to page 1789, column 1, paragraph 1).
The relative skill of those in the art:
Those of relative skill in the art are those with level of skill of the authors of the references cited to support the examiner’s position (MD’s, PhD’s, or those with advanced degrees and the requisite experience in treatment or prevention of diabetes).
The amount of direction or guidance presented and the presence or absence of working examples:
The specification has provided guidance for treatment of diabetes (table 4, pages 81-82).
The specification does not provide guidance for the prevention of diabetes.
The quantity of experimentation necessary:
Considering the state of the art as discussed by the references above, particularly with regards to prevention of diabetes with a compound of formula Ib or IIb and the high unpredictability in the art as evidenced therein, and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims.
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 1, 2, 5, 6, 8, 11, 14, 15, 18-20, and 23 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.
In claim 1, the term “mixtures thereof” is unclear due its relationship to the rest of the alternative forms. Does “mixtures thereof” refer to combinations of two or more combinations of a cis-trans isomer, enantiomer, diastereomer, racemate, tautomer, solvate, hydrate, or a pharmaceutically acceptable salt? Alternatively does “mixtures thereof” refer to any mixture containing a compound of formula Ib?
In claim 2, the same issue as “mixtures thereof” of claim 1 applies to “mixture thereof”.
Claim 4 recites the limitation “G1”. There is insufficient antecedent basis for this limitation in the claim because parent claim 1 recites variable G1.
In claims 15, 17-20, and 22, and 23, applicants have not defined what a “related metabolic syndrome” is relative to diabetes. Neither the specification nor the claims recite metes and bounds with respect to this term (specification, pages 8, lines 17-20).
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.
Claim(s) 1, 2, 6, 8, 11, 15, 19, 20, and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by SHI (WO 2011/159297, published 2011 December 22, cited in IDS). Shi describes examples 2-35, 39-57 and 61, 62, and 65-67 (page 178, line 7 to page 201, line 15). In these compounds, examined variables X5-X7, Z, Z1, Y1, n, L1, L2, E, G, R1-R3, R5, R5b, and R6 are the following groups: Z is O; variables Y1-(Y)m-Z1 form an O-C(Me)2-ethylene group, O-ethylene group, an OC(Me)2CH2, an OCH2OCH2 group, or an O[CHMe)2 group; L1-L2 is a CH2-O or a CH2-NH group; E is H or F; R1, R2, and R3 represent (F, F, H), (H, H, H), (Me, H, H), (F, H, H), (CF3, H, H), (Cl, H, H), (Cl, Cl, H), (OMe, H, H), (H, H, Cl), (H, H, OMe), (H, H, Me), (H, H, Cl), (H, H, F), (OMe, H, Br), and (H, H, CF3); G1-R4 is CH; C(R5)(R5a) is CH2 or CHMe R6 is CO2H. In examples 19, 22, 24, 27, 31, and 35 variables R5 and R5a form a cyclopropyl ring. Compositions and method of usage are described (page 65, paragraph [0195] to page 80, paragraph [0247]). Diabetes can be treated (page 65, paragraph [0195]).
Allowable Subject Matter
Claims 1, 2, 5, 6, 8, 11, 14, 15, 18-20, and 23 are not allowed.
The following is a statement of reasons for the indication of allowable subject matter: SHI (WO 2010/080537, published 2010 July 15) describes example 262 (page 221, lines 5-11). This compound does not anticipate or render obvious a compound of the elected group because E----G cannot form an O-CH=CH group.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOBLE E JARRELL whose telephone number is (571)272-9077. The examiner can normally be reached 9:00 AM to 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NOBLE E JARRELL/Primary Examiner, Art Unit 1699