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 Claims
1. This application is a CIP of PCT/US2021/056799 10/27/2021, , which claims benefit of the provisional application 63106456 10/28/2020.
2. Claims 1-15 are pending in the application.
3. 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
4. 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 12-15 are rejected under 35 U.S.C. 103(a) as being obvious over
Brown et al. US 2006/0045894 A1, and Perrine et al. US 6,011,000.
Applicants claim a process of preparing a pharmaceutical composition for the
treatment of a urea cycle disorder, comprising mixing a cinnamein and /or cinnamic acid
compound together with a pharmaceutically acceptable carrier or excipient, see claim
12. Dependent claims 13 further limit the scope of processes, i.e., specific disorders.
Applicants claim a process of preparing a pharmaceutical composition for the
treatment of glycine encephalopathy, comprising mixing a cinnamein and /or cinnamic
acid compound together with a pharmaceutically acceptable carrier or excipient, see
claim 14. Dependent claims 15 further limit the scope of processes, i.e., specific
formulations.
Determination of the scope and content of the prior art (MPEP §2141.01)
Brown et al. ‘894 discloses a pharmaceutical composition comprising benzyl
cinnamate (i.e., cinnamein) and a pharmaceutical acceptable carrier, see claim 1 and 5 in column 4.
Perrine et al. ‘000 discloses a pharmaceutical composition comprising cinnamic acid and a pharmaceutical acceptable carrier, see columns 19 and 23. It is noted that a process of preparing a pharmaceutical composition by mixing active ingredients (i.e., cinnamein and/or cinnamic acid) with a pharmaceutical acceptable carrier is a preparation routine in the pharmaceutical industry. .
Determination of the difference between the prior art and the claims (MPEP §2141.02)
The difference between instant claims and Brown et al. ‘894 and Perrine et al. ‘000 is that the instant claims are embraced within the scope of Brown et al. ‘894 and Perrine et al. ‘000.
Finding of prima facie obviousness-rational and motivation (MPEP §2142-2143)
One having ordinary skill in the art would find the claims 12-15 prima facie obvious because one would be motivated to employ the compositions and processes of Brown et al. ‘894 and Perrine et al. ‘000 to obtain instant invention.
The motivation to make the claimed processes and compositions derived from the known processes and compositions of Brown et al. ‘894 and Perrine et al. ‘000 would possess similar yields or activity to that which is claimed in the reference.
Double Patenting
5. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. See In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-11 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1 of Pahan’s co-pending application No. 17/433,730. Although the conflicting claims are not identical, they are not patentably distinct from each other and reasons are as follows.
Applicant claim a method for inhibiting the progression of a urea cycle disorder comprising administering to a patient in need thereof an effective amount of a pharmaceutical composition comprising cinnamein and/or cinnamic acid, see claim 1. Dependent claims 2-6 further limit the scope of methods, i.e., specific disorder and administration strategy.
Applicants claim a method for treating glycine encephalopathy comprising administering to a patient in need thereof an effective amount of a pharmaceutical composition comprising cinnamein and /or cinnamic acid, see claim 7. Dependent claims 8-11 further limit the scope of methods, i.e., specific dose and administration strategy.
Pahan’s ‘730 claims a method for treating glycine encephalopathy, comprising: administering to a human patient in need thereof a therapeutically effective amount of a pharmaceutical composition comprising cinnamic acid, wherein the human patient is less than three years old, wherein treating results in an increase in cognitive function in the human patient compared to an untreated human patient.
The difference between instant claims and Pahan’s ‘730 is that the instant claims are embraced within the scope of Pahan’s ‘730.
One having ordinary skill in the art would find the claims 1-11 prima facie obvious because one would be motivated to employ the methods of use of Pahan’s ‘730 to obtain instant invention.
The motivation to make the claimed methods of use derived from the known methods of use of Pahan’s ‘730 would possess similar activity to that which is claimed in the reference.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claim Objections
Claims 13 and 15 are objected to because of the following informalities:
Claim 13 shall be amended as a process claim. The term “any of claims 1 to 14” shall be amended as a term “any one of claims 1 to 14”. Correction is required.
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.
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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.
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1629
October 20, 2025