Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
This office action is a response to Applicant’s amendments/remarks after non-final rejection filed 1/23/2026.
As filed, claims 243-253, 255-257, and 259-261 are pending; and claims 1-242, 254, and 258 are cancelled.
Response to Amendments/Remarks
Applicant’s amendments/remarks, filed 1/23/2026, with respect to claims 243-253, 255-257, and 259-261, have been fully considered and are entered. The status for each rejection in the previous Office Action is set out below.
The § 112(b) indefinite rejection of claims 243-253, 255, and 256 is withdrawn per amendments.
The nonstatutory obviousness-type double patenting (ODP) rejections of claims 243-253, 255-257, and 259-261 by conflicting U.S. Patent No. 11,390,627 and 10,202,396 is maintained because the Applicant’s remarks are not persuasive. According to paragraph 0070 of the instant specification, an O-protecting group for instant variable R1 encompasses methyl, based on non-patent literature titled “Protective Groups in Organic Synthesis”, hereinafter Greene. Methyl in combination with the -O- forms a methyl ether, which is a known protecting group for hydroxyl group. For the reasons stated above, in addition to the rationale set forth in the rejection of the previous office action, the ODP rejections are maintained.
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(Greene, pg. 708)
The claim objection of claims 243 and 257 is withdrawn per amendments.
Claim Interpretation
With regards to the preamble phrases in claims 243-253, 255-257, and 259-261, such as “A reaction product" or “The reaction product”, the Examiner does not finds that the abovementioned phrases accorded patentable weight for prior art purpose, under the guidance of MPEP 2111.02 (I) and (II), because such phrases do not limit the structure of instant formula (V) and (III), and they are simply reciting an intended use for the structure of instant formula (V) and (III).
In addition, the Examiner finds that the phrases, “A reaction product" or “The reaction product”, is synonymous as any composition or reaction mixture because there are already two components, such as compound of instant formula (V) and (III), that are explicitly recited in the claims.
The Examiner finds the claim construction of claim 257 as a product by process limitation. In other words, the patentability of the instantly claimed reaction product is based on the compound of instant formula (V) and the compound of instant formula (III) themselves, and not their method of preparation.
Nonstatutory Double Patenting
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. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); 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) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
The instant claims are drawn to a reaction product, which is a solid precipitate of a compound of instant formula (V) and a compound of instant formula (III).
Claims 243-253, 255-257, and 259-261 are rejected on the ground of nonstatutory obviousness-type double patenting (ODP) as being unpatentable over the conflicting claims of the following U.S. patents or co-pending applications. See Table below.
If the conflicting claims are in a co-pending application, then the rejection is a provisional ODP rejection because the conflicting claims have not in fact been patented.
Co-pending Application No./ U.S. Patent No.
Conflicting Claims
Provisional ODP
(Yes or No)
11,390,627
1-12
No
10,202,396
1-29
No
The analysis employed for an obviousness-type double patenting rejection parallels the analysis for a determination of obviousness under 35 U.S.C. § 103. See MPEP 804; In re Braat, 937 F.2d 589, 19 USPQ 2d 1290 (Fed. Cir. 1991); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985). For this reason, the factual inquires set forth in Graham v. John Deere Co., 383 U.S. 1, USPQ 459 (1966) are employed herein.
The Graham v. Deere inquires are summarized as follows: (A) Determining the scope and contents of the patent claim relative to a claim in the application at issue; (B) Ascertaining the differences between the scope and content of the patent claim as determined in (A) and the claim in the application at issue; (C) Determine the level of ordinary skill in the pertinent art; and, (D) Evaluate any objective indicia of nonobviousness.
(A) Determining the scope and contents of the patent claim relative to a claim in the application at issue – The conflicting claims of the abovementioned U.S. patents are drawn to a composition comprising a compound of instant formula (V) and (III) in a solid, hydrate form; and/or drawn to a method of making the abovementioned composition.
(B) Ascertaining the differences between the scope and content of the patent claim as determined in (A) and the claim in the application at issue - The conflicting claims of the abovementioned U.S. patents did not described the abovementioned composition as a reaction product; the composition has an overlapping amount of the compound of instant formula (III); and/or described the abovementioned composition in a method of making-type claims.
(C) Determine the level of ordinary skill in the pertinent art - the level of ordinary skill in the art may be found by inquiring into: (1) the type of problems encountered in the art; (2) prior art solutions to those problems; (3) the rapidity with which innovations are made; (4) the sophistication of the technology; and (5) the education level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 855, 962 (Fed. Cir. 1986). All of those factors may not be present in every case, and one or more of them may predominate. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983).
Based on the typical education level of active workers in the field of organic chemistry, as well as the high degree of sophistication required to solve problems encountered in the art, the Examiner finds that a person of ordinary skill in the art would have at least a college degree in the field related to medicine, chemistry, and/or the pharmaceutical art and at least four years of work experience, i.e. a masters or doctorate level scientist/clinician.
(D) Evaluate any objective indicia of nonobviousness - none
Conclusion - Although the conflicting claims are not identical, one of ordinary skill in the art would recognize that they are not patentably distinct from each other because they are drawn to the same compounds in the same composition having the same utilities (e.g. API intermediate, etc.). As a result, an infringer of a patent issuing from the instant claims would also be an infringer of the conflicting claims of the abovementioned U.S. patents.
The Examiner, according to the guidance in MPEP 2144.05(I)-(II), finds that a prima facie case of obviousness exists where the instantly claimed amount overlapped with the abovementioned U.S. patents or do not overlap with the abovementioned U.S. patents but are merely close. In addition, the Examiner does not find the abovementioned amount of instant formula (III) as result-effective variable because the Applicant fails to demonstrate this parameter to impart any unexpected or novel aspect to the instant reaction product (i.e. no comparative example). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05. Accordingly, this parameter is viewed as routine experimentation to optimize the instant reaction product, and not a patentable distinction.
The unpredictable nature of the chemical arts generally allows an assertion of similarity to be rebutted by a sufficient demonstration of nonobviousness that employs secondary considerations of objective indicia. In this case, there are no indicia of nonobviousness shown to provide evidence that composition of the abovementioned U.S. patents is excluded as the instant reaction product of the instant application. Absent indicia of nonobviousness, the Examiner finds that one of ordinary skill in the art would consider the instant reaction product and that of the conflicting claims of the abovementioned U.S. patents to be equally effective in their objective.
This rejection is in agreement with the judicially created doctrine grounded in public policy 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.
Conclusion
Claims 243-253, 255-257, and 259-261 are rejected.
Claims 1-242, 254, and 258 are cancelled.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PO-CHIH CHEN whose telephone number is (571)270-7243. The examiner can normally be reached Monday - Friday 10:00 am to 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PO-CHIH CHEN/Primary Examiner, Art Unit 1621
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