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 .
Current Status of 17/905,918
This office action is made second non-final due to the enablement rejection below.
The rejections of record have been withdrawn below.
The claims of 2/18/2026 (claims 1-3, 6, 11, 14) were examined in this Office Action.
The Markush search has been extended to another compound of formula I.
Information Disclosure Statement
The information disclosure statement (IDS), submitted on 2/18/2026, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicants’ claim amendments and Remarks of 2/18/2026 are acknowledged and have been considered.
Any rejection and/or objection not specifically addressed or modified below is herein withdrawn.
Claims 8, 10, 12, and 13 have been canceled.
In regard to the 103 rejection, this rejection is withdrawn. Applications remarks with Examiner’s reply are summarized below:
The scope of claims 1 and 14 is narrowed to the combination of a compound of formula I and one of the following evogliptin, sitagliptin, elafibranor, dapagliflozin, metformin, and volgibose.
Applicants submit that the instant combination is synergistic and unexpected.
Applicants submit the results of examples 1-5 from the specification, which show the fasting and non-fasting blood glucose levels and plasma triglycerides levels.
With regards to the synergistic effects of the compounds, it is noted that the features upon which applicant relies (i.e., a synergistic effect) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The data only supports the combination of one compound (compound 1) and evogliptin, sitagliptin, elafibranor, dapgliflozin, metformin and voglibose, but not the breadth of compounds of formula I and not all the diseases covered by the claims.
While this rejection is withdrawn, there are other obviousness rejections to be made.
Response to Amendment
Specification
The title of the invention is not descriptive. The title needs to change to remove prevention. A new title is required that is clearly indicative of the invention to which the claims are directed.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 is written so that it appears that formula 1 is voglibose. Examiner suggest moving the formula 1 after where it is recited in the claim language.
Additionally, Claim 1 recites limitations A and B, which can be more concisely written. For example, A is an oxadiazole substituted with a C1-6.
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 1-3, 6, 8, 10-11, and 14 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: (1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
The nature of the invention: The nature of the invention pertains a composition and a method of treating or preventing diabetes or at least one disease selected from metabolic diseases associated therewith.
The breadth of the claims: The breadth of the claims is drawn to a composition (and method of using) of formula I and evogliptin, sitagliptin, elafibranor, dapgliflozin, glimepiride, metformin, and voglibose.
The predictability or unpredictability of the art: Blue Cross (referenced in PTO-892) discloses that there is no effective method for reliably preventing diabetes.
The amount of direction or guidance presented: No guidance is presented in the Instant Specification on how to prevent diabetes or other metabolic diseases with the instant combinations. Applicants do not show any data or evidence that the composition of the claims had been tested for this purpose.
The presence or absence of working examples: No working examples are shown in the Instant Specification for preventing diabetes and other metabolic diseases. Applicants do not show any data or evidence that the composition of the claims had been tested for preventing. Applicants do not provide guidance for how the instant composition would be work preventively. Applications also do not have any data or experiments showing how the instant composition would work as a hangover cure. Lack of a working example is a factor to be considered, especially in a case involving an unpredictable art. See MPEP § 2164.02.
The quantity of experimentation necessary: The quantity of experimentation would be “undue” because of the amount of time and resources needed to experimentally find the amounts of the instant combination needed to prevent diabetes.
The artisan would not be able to anticipate the amount of the instant combination in order to prevent diabetes without undue experimentation, absent working examples from Applicants or the art. Preventing diabetes is unpredictable.
Moreover, the lack of a working example is noteworthy. There are no teachings or guidance in the specification which would lessen the amount of experimentation to a reasonable amount. Additionally, a person of ordinary skill in the art would have to engage in undue experimentation to create an effective diabetes preventative, with no assurance of success.
Thus, Claims 1-3, 6, 8, 10-11, and 14 are rejected as lacking enablement.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 14 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 14 cannot depend from claim 1 because the structure of formula I is not in claim 14. Applicants need to move the structure of formula I into claim 14 for it to be complete. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-3, 8, 10-11, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over DONG (WO2016068453A1, cited in the IDS of 09/13/2022) and in view of GREEN (Green et al., “Effect of Sitagliptin on cardiovascular Outcomes in Type 2 Diabetes”, The New England Journal of Medicine, July 15, 2016).
DONG teaches a pharmaceutical composition containing a compound of formula I (Compound in Example 3 on page 31, 33, and 58) (paragraphs [0001 and 0007])), depicted below
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. This teaches the compounds from claims 1-3, 11, and 14.
DONG teaches these compounds have GPR119 agonistic activity and is used for treating type 2 diabetes (page 1 technical field and background art).
DONG does not teach Sitagliptin.
GREEN teaches that Sitagliptin is used to treat type 2 diabetes (title and abstract). This helps teach claim 8, 10, 11, and 14.
It is prima facie obvious to combine one type 2 diabetes treatment compound with another in order to form a composition to be used for the very same purpose (treating type 2 diabetes). In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP 2144.06(I). This teaches claims 1-3, 8, 10, and 14.
Note, the phrase “for preventing or treating diabetes or at least one disease selected from metabolic diseases associated therewith” from claim 1 and similar phrase in claim 11 are interpreted as intended use. Nothing precludes the use as claimed. Furthermore, there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Chemical properties are inherent to their compounds. See MPEP 2112 (II). Products of identical chemical composition can not have mutually exclusive properties. This teaches claim 11.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GILLIAN A HUTTER whose telephone number is (571)272-6323. The examiner can normally be reached M-F 7:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/G.A.H./ Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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