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
Final Rejection
Claim Status
Claims 1-6 are currently pending investigation.
Priority Status
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Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d).
The certified copy has been filed in parent Application No. 17/598187, filed on 09/24/2021.
Information Disclosure Statement
All references have been considered in the one (1) IDS(s) filed 03/06/2026 unless marked with a strikethrough.
Examiner Responses to Arguments/Amendments
The issues raised in the Office Action, are addressed below:
I. Response to Double Patenting Rejection–
Claims 1-6 of U.S. Application No. 19/216,559 rejected on nonstatutory double patenting over Claims 1-3, 10, 12-13 of copending Application No. 17/598,187 (U.S. Patent No. 12,466,807).
The terminal disclaimer filed on 03/06/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of Application No. 17/598,187 (U.S. Patent No. 12,466,807) has been reviewed and is NOT accepted.
This application was filed on or after September 16, 2012. The person who signed the terminal disclaimer is not the applicant, the patentee or an attorney or agent of record. See 37 CFR 1.321(a) and (b).
The Double Patenting rejection is maintained.
II. Response to Claim Rejections under 35 USC § 112 –
In view of Applicant’s amendment, the 35 U.S.C. 112(a) rejection over Claim 4 is withdrawn.
III. Response to Declaration of Christopher Burns, Ph.D. under CFR 1.132 -
Examiner acknowledges Applicant submission of Declaration under 37 §1.132.
The declaration under 37 CFR 1.132 filed 03/06/2026 is insufficient to overcome the
rejections as set forth in the last Office action because:
As stated by the Inventor, “choosing and preparing a salt of a drug compound is an exercise in trial an error because the correct choice of salt is always dependent on the compound.” Examiner agrees.
While the act of creating a salt is routine, the specific physicochemical properties (solubility, stability, non-hygroscopicity) of a particular salt involves experimental screening, it is not deemed patentable because it requires effort. Identifying a specific salt form from a finite, known list of counterions (e.g., HCI, besylate, mesylate, tartrate) is routine optimization, especially when the resulting properties are predictable based on common pharmaceutical knowledge.
The combination of Holmes & Berge focused on the reasonable expectation of success and the predictability of the results, rather than the effort required. While the process might involve some routine experimentation, the outcome was not unpredictably superior. In that, the prior art suggests salt formation for improving solubility or stability. The fact that experimentation is required does not make the result non-obvious if the prior art provided a reasonable expectation of success and suggested the pathway taken
Though the Applicant claims superior stability, solubility, or bioavailability, these are the expected reasons for preparing a salt in the first place. The claimed properties (e.g., increased dissolution, reduced hygroscopicity) are the standard, predictable goals of salt screening. The results are not 'unexpected'—they are the desired and intended outcome of following established pharmaceutical practices.
In this, according to Pfizer Inc. v. Apotex Inc., 480 F.3d 1348 (Fed. Cir. 2007)) when the prior art teaches a method of creating salts and the resulting salt has characteristics expected from that salt type, the salt is obvious.
In this, Examiner does have questions for the Applicant over this specific API with the listed salts.
Is the evidence in the context of this specific API, was the salt ineffective or less optimal than the claimed compared to other salts of this API? Applicant has failed to provide comparative evidence showing the claimed salt has unexpectedly superior properties relative to other closely related salt forms of the same drug API.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
III. Response to Claim Rejections under 35 USC § 103 –
Applicant' s arguments, filed 03/06/2026, with respect to the claims have been fully considered and they are not persuasive for the following reason(s):
First, in response to applicant' s argument that there is no teaching, suggestion, or
motivation to combine the references, the examiner recognizes that obviousness may be
established by combining or modifying the teachings of the prior art to produce the claimed
invention where there is some teaching, suggestion, or motivation to do so found either in the
references themselves or in the knowledge generally available to one of ordinary skill in the art.
See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21
USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82
USPQ2d 1385 (2007).
In this case, the maintained rejection and the prior art is good for what it claims. In them,
the salts of fumarate, succinate and mesylate to reboxetine uses techniques to analyze purity, crystallinity and moisture-related compositions of material specification for pharmaceutical purposes; Differential Scanning Calorimetry (DSC) and Dynamic Vapor Sorption (DVS).
In response also to the statement above, the prior art reads on Claim 1 as it does state its intended use. Thus, the salts are relevant in regards to the prior art and claims. The purity obtained and the result interpretations (including the impurity) read on the claims.
In response to applicant's argument that the references fail to show certain features of the
invention, it is noted that the features upon which applicant relies (i.e., choosing and preparing a salt of a drug compound because the correct choice of salt always dependent on the compound)
is 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).
Therefore, the Applicant has not provided the criticality since there is reasonable expectation of success and the predictability of the results, rather than the effort required. While the process might involve some routine experimentation, the outcome is not unpredictably superior. In that, the prior art combination it is suggested salt formation for improving solubility or stability. The fact that experimentation is required does not make the result non-obvious if the prior art provided a reasonable expectation of success and suggested the pathway taken.
Though the Applicant claims superior stability, solubility, or bioavailability, these are the expected reasons for preparing a salt in the first place. The claimed properties (e.g., increased dissolution, reduced hygroscopicity) are the standard, predictable goals of salt screening. The results are not 'unexpected'—they are the desired and intended outcome of following established pharmaceutical practices.
• Therefore, Applicant’s argument is not persuasive.
IV. Maintained Rejections –
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6 of U.S. Application No. 19/216,559 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-3, 10, 12-13 of copending Application No. 17/598,187 (U.S. Patent No. 12,466,807).
Although the claims at issue are not identical, they are not patentably distinct from each other because: Formula (I) teaches the exact structure in both Applications. The Instant Application also teaches overlapping method of treating a proliferative disease using the tartrate salt of Claim 1, as well as the pharmaceutical composition and oral administration of Formula (I).
It therefore would be prima facie obvious to arrive at the instantly claimed compounds because structurally similar compounds are expected to have similar properties. In the matter of the Instant Application and the co-pending referenced Application, the exact structure of the claims of the ‘187 application (U.S. Patent No. 12,466,807) teaches overlapping Formula (I) and further suggests the pharmaceutical composition and oral administration of said compound.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Joint Inventors
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over IP Holmes, et al in US 9,174,946 B2 (pub’d 11/03/2015; hereinafter “Patent’946”) over SM Berge, et al. in “Pharmaceutical Salts” (pub’d 01/1977; hereinafter “Berge”) as evidenced by PubChem (CAS RN: 1393653-34-3).
With respect to Claims 1-3, Patent’946 teaches a compound of formula I as seen below:
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The prior art, Patent’946, continues teaching the genus of 2,4,5-substituted pyrimidines (Ex. 3A, col. 49, lns. 43-53; identical structure, as evidenced by PubChem 1393653-34-3) that inhibit Focal Adhesion Kinase (FAK), also known as protein tyrosine kinase 2 (PTK2), and the corresponding salt of the active compound, for example, a pharmaceutically-acceptable salt (col. 29, lns. 5-31). FAK is a non-receptor tyrosine kinase that mediates signals from both trans-membrane integrins and growth factor receptors (col. 1, lns. 30-37). Patent’946 teaches the compounds crystallize within the genus (col. 37, lns. 40-45), in which Example 3A falls within. This also signifies the prior art structure of Patent’946 is capable of performing the intended use, and as such, meets the claim.
Claims 2-3: These are limitations relating to the properties of a generic tartrate salt, so if the salt is obvious the properties would flow from the structure.
MPEP 2112.01. II.:
“A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
With respect to Claim 3, Patent’946 teaches the separation of the compounds (col. 59, lns. 45-67; dried phase separation cartridge, separation by chromatography, extraction, etc…) found in the crude product to yield pure crystals (col. 37, lns. 40-45) of desired product, which suggests one can optimize crystallization referring to separation, as the examples set in the genus (col. 9, lns. 40-46).
Claim 4: Patent’946 discloses a “method of treating a proliferative disease using the tartrate salt of claim 1, wherein the proliferative disease is cancer.” (col. 4, lns. 20-25; a compound which is a selective FAK inhibitor would enable the targeting of specific biological pathways, without any potential issues caused by the inhibition of any targets, such as other protein kinases. Accordingly, compounds that selectively inhibit FAK would be useful for the treatment of proliferative diseases, such as cancer).
Claims 5-6: wherein said pharmaceutical composition comprising a tartrate salt is suitable for oral administration (col. 28, lns. 50-55; col. 29, lns. 45-50).
With respect to Claim 1, although the prior art, Patent’946 fails to teach the tartrate salt (col. 10, lns. 5-25) as the pharmaceutically acceptable salt; it is mentioned in the Specification of Patent’946 that “it may be convenient or desirable to prepare, purify, and/or handle a corresponding salt of the active compound, for example, a pharmaceutically-acceptable salt. Examples of pharmaceutically acceptable salts are discussed in Berge et al. J. Pharm. Sci., 66, 1-19 (1977; col. 9, lns. 50-55).”
Berg teaches that there are a finite number of common pharmaceutically acceptable salts to choose from. Berge teaches the list of FDA approved commercially marketed salts in Table 1 and that tartrate anion salt forms is one of the FDA approved commercially marketed salt forms to formulate an active pharmaceutical ingredient. Berge additionally states several benefits and considerations by formulating different active pharmaceutical ingredients into salt form, including chemical, biological, physical and economical properties of the active pharmaceutical agent (pg. 1, col. 1, para. 1; pg. 2, able 1).
It would have been prima facie obvious at the time of the invention to formulate the compound, as seen with Formula I, in a tartrate salt form (in view of the teachings of Patent’946 and Berg) in order to arrive at the instantly claimed species. One of ordinary skill in the art would have utilized the pharmaceutically acceptable tartrate salt to elicit the advantages disclosed by Patent’946 and Berg.
In doing so, a reasonable expectation of success is likely because (1) Patent’946 teaches that the claimed compound can be formulated as a pharmaceutically acceptable salt coupled with the knowledge that (2) the tartrate acid salt form is one of the most preferred salt species for formulating medicinal compounds due to the corresponding physiological benefits and ease of synthesis as taught by Patent’946 and Berg.
Conclusions
Claims 1-6 are rejected.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Josmalen M. Ramos-Lewis whose telephone number is (571)272-0084. The examiner can normally be reached M-F 9:00-5:30 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, Clinton A. Brooks can be reached on (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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Josmalen M. Ramos-Lewis, Ph.D.
Patent Examiner
Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
Prosecution Insights