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 .
DETAILED ACTION
Priority and Status of the Claims
1. This application is a 371 of PCT/IN2023/050402 with a filing date 04/25/2013, which claims benefit of the foreign application INDIA IN202221024674 04/27/2022.
2. Amendment of claims 1-19 are pending in the application.
Information Disclosure Statement
3. The information Disclosure Statement filed on 10/25/2024 is acknowledged. However, the information disclosure statement filed on 10/25/2024 fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Moreover, the information disclosure statement filed on 7/2/2025 fails to comply with the provisions of 37 CFR 1.97(a) because it lacks the appropriate size fee set forth in 37 CFR 1.17(v). It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
Applicants are requested to file a new PTO/SB08 01-25 IDS form to the Office.
Claim Rejections - 35 USC § 112
4. 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.
Claims 1-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112, first
paragraph (pre-AIA ), because the specification does not reasonably provide
enablement of the instant “amino acid derivative” without limitation (i.e.,
no named moiety). 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 the invention
commensurate in scope with these claims.
ln In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining
whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first
paragraph, have been described. They are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or Iack thereof in the art,
4. the amount of direction or guidance present,
5. the presence or absence of working examples,
6. the breadth of the claims,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.
In the instant case:
The nature of the invention
The nature of the invention is a processes of making using “amino acid derivative” without limitation (i.e., no named moiety), see claims 1, 8, 10 and 17.
The state of the prior art and the predictability or Iack thereof in the art
The state of the prior art is Kitagawa et al. CAS: 156: 59318, 2011, it discloses a
Number of amino acid derivatives.
The amount of direction or guidance present and the presence or absence
of working examples
The only direction or guidance present in the instant specification is the description of a number of “amino acid derivative” of the instant glycine on page 9-10 of the specification. There is no data present in the instant specification for the “amino acid derivative” without limitation (i.e., no named moiety).
The breadth of the claims
The instant breadth of the rejected claims is broader than the disclosure,
specifically, the instant “amino acid derivative” is without limitation (i.e., no named moiety).
The quantity or experimentation needed and the Ievel of skill in the art
While the level of the skill in the chemical arts is high, it would require
undue experimentation of one of ordinary skill in the art to resolve any “amino acid derivative” without limitation. There is no guidance or working examples present for constitutional any “amino acid derivative” without limitation for the instant invention. Incorporation of the limitation of “amino acid derivative” supported by specification into claims 1, 8, 10 and 17 respectively would overcome this rejection.
5. 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 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.
Claim Rejections - 35 USC § 103
6. The following is a quotation of 35 U.S.C. 103(a) 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 non-obviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(f) or (g) prior art under 35 U.S.C. 103(a).
Claim 1 is rejected under 35 U.S.C. 103(a) as being obvious over Cravo
et al. US 8,742,103.
Applicants claim a process for the preparation of an imeglimin HCl compound
of formula (I), which process:
a) reacting a compound of formula (II),
PNG
media_image1.png
112
322
media_image1.png
Greyscale
with a compound of formula (III),
PNG
media_image2.png
94
254
media_image2.png
Greyscale
, in the presence of p-toulene sulphonic acid monohydrate under a suitable condition to obtain a racemic compound of formula (IV),
PNG
media_image3.png
200
362
media_image3.png
Greyscale
b) reacting the racemic compound of formula (IV) with a suitable chiral amino acid or its derivative in the presence of a base and a solvent to obtain R-imeglimin L-amino acid salt of compound of formula (V),
PNG
media_image4.png
352
458
media_image4.png
Greyscale
,
c) reacting the compound of formula (V) with hydrochloric acid in the presence of a solvent to obtain imeglimin hydrochloride of formula (I)
PNG
media_image5.png
220
310
media_image5.png
Greyscale
and
d) optionally purifying the imeglimin hydrochloride of formula (I) obtained in step (c) using an alcoholic solvent, see claim 1.
Determination of the scope and content of the prior art (MPEP §2141.01)
Cravo et al. ‘103 discloses a process of making a compound of formula (I), i.e.,
PNG
media_image6.png
278
356
media_image6.png
Greyscale
, wherein R3 and R4 are H, R1 and R2 are alkyl (ie., methyl) and R5 is alkyl (i.e., methyl) by reacting a compound of formula
PNG
media_image7.png
136
270
media_image7.png
Greyscale
with
PNG
media_image8.png
80
196
media_image8.png
Greyscale
to obtain
PNG
media_image9.png
160
290
media_image9.png
Greyscale
then with tartaric acid to obtain
PNG
media_image10.png
204
338
media_image10.png
Greyscale
or its tautomeric form, i.e.,
PNG
media_image11.png
202
232
media_image11.png
Greyscale
, see columns 3 and 7-10.
Determination of the difference between the prior art and the claims (MPEP §2141.02)
The difference between instant claims and Cravo et al. ‘103 is that the instant claims are embraced within the scope of Cravo et al. ‘103. It is noted that the instant claim is silent on the scope of amino acid derivatives.
Finding of prima facie obviousness-rational and motivation (MPEP §2142-2143)
One having ordinary skill in the art would find the claim 1 prima facie obvious because one would be motivated to employ processes of Cravo et al. ‘103 to obtain instant invention.
The motivation to make the claimed processes derived from the known processes of Cravo et al. ‘103 would possess similar yields to that which is claimed in the reference.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REI TSANG SHIAO whose telephone number is (571)272-0707. The examiner can normally be reached on 8:30 am-5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached on 571-272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
August 04, 2026
Prosecution Insights