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
This application claims benefit for foreign priority under 35 U.S.C. § 119(a)-(d) to a CON of PCT/EP2021/065873 06/14/2021, however the certified copy of priority document has not been received or made part of the file. Therefore, any priority claim to this document has not been perfected.
Status of Claims
Claims 1-2, 4-18, 25, 56, and 57 are currently pending in the application. Claims 3, 19-24, 26-55, and 58-64 were canceled previously.
Information Disclosure Statement
Receipt is acknowledged of Information Disclosure Statement (IDS), filed on 02/11/2025, which has been entered in the file.
Claim Rejections - 35 USC § 103
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) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negative by the manner in which the invention was made.
Claims 1-2, 4-18, 25, 56, and 57 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Gosselin et al (WO 2016/049414 A1, IDS) and further in view of Askin et al (WO 2013/173768 A1, IDS). Applicant claims a process for making hydroxylated cyclopentyl- pyrimidine compounds thereof.
Determination of the scope and content of the prior art (MPEP §2141.01)
Gosselin et al (WO 2016/049414) teaches a process for preparing cyclopentyl-pyrimidine piperazine compound utilizing analogous reagents and reaction conditions [such as,
PNG
media_image1.png
424
536
media_image1.png
Greyscale
, see Claim 1, page 58]. Askin et al (WO 2013/173768) also teaches a similar process for making hydroxylated cyclopentyl- pyrimidine compounds comprising cyclizing a compound of formula II (see abstract, claim 1, page 26 and whole reference).
Ascertainment of the difference between the prior art and the claims (MPEP §2141.02)
The difference between the process taught in the references and the claimed process herein lies merely in the variation of reagents and reaction conditions such as, the use of “continuous” flow reaction instead of ‘batch’ process of the prior art under specific set of reaction conditions in order to obtain the hydroxylated cyclopentyl-pyrimidine compounds for instantly claimed inventions. Further, the disclosure of Askin et al (WO 2013/173768) that teaches a similar process for making hydroxylated cyclopentyl-pyrimidine compound comprising a cyclization step reaction for a compound of formula II (see claim 1, page 26) that would easily place Applicants invention in possession of the public at the time of Applicants invention was filed. The differences between the instant claims and the prior art references are so negligible, that one of ordinary skill in the chemical arts would expect slight variations to be within the expected purview of 35 U.S.C. 103(a).
Finding of prima facie obviousness--rational and motivation (MPEP §2142-2413)
It is obvious to prepare compounds by an old method using analogous starting materials and determining the optimum reaction conditions in the absence of any unobvious or unexpected results. The only difference between the instantly claimed inventions and prior art is “continuous” flow reaction versus ‘batch’ process which is obvious absent a showing of criticality [In reDilnot, 319 F.2d 188, 138 USPQ 248 (CCPA 1963) (Claim directed to a method of producing a cementitious structure wherein a stable air foam is introduced into a slurry of cementitious material differed from the prior art only in requiring the addition of the foam to be continuous. The court held the claimed continuous operation would have been obvious in light of the batch process of the prior art), MPEP 2144.05]. The motivation to make the claimed process / method derives from the expectation that the use of analogous reactants / reagents and reaction conditions would have made similar yield of product. The selection of reaction conditions is more optimization by more modification of routine experimentation and within one skilled in the art (In re Aller, et al., 105 USPQ 233). Since there is an exemplary teaching in the prior art to obtain the instantly claimed process, it is obvious for those ordinary skilled in the chemical art with a reasonable expectation of success that such modification and optimization of reaction conditions would give process with similar rate of recovery. Therefore, in looking at the instantly claimed process as a whole, the claimed process would have been suggested to one skilled in the art and therefore, is obvious, absent evidence to the contrary.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Golam Shameem, Ph.D. whose telephone number is (571) 272-0706. The examiner can normally be reached on Monday-Thursday from 7:30 AM - 6:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks, Ph.D. can be reached at (571) 270-7682.
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://portal.uspto.gov/external/portal. Should you have questions about access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist, whose telephone number is (571) 272-1600.
/GOLAM M SHAMEEM/Primary Examiner, Art Unit 1621