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 .
Final Rejection
The Status of Claims:
Claims 24-25, 37, 39-41, 44-46, 49-57 are pending.
Claims 24-25, 37, 39-41, 44-46, 49-57 are rejected.
IDS
The IDS filed on 7/31/26 were reviewed by the examiner.
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
The rejection of Claims 26-27 and 48 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn due to the modification of the claims.
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Regarding the rejection for the term” solvate”, the rejection of Claims 24-29, 37, 39,41-48 under 35 U.S.C. 112, first paragraph, is withdrawn.
However, in view of the revised claim 37, another 112, first paragraph rejection regarding the term “solvate ” is necessary in the following:
Claim 37 is rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for making salts of the claimed compounds, does not reasonably provide enablement for making solvates of the claimed compounds. The specification does not enable any person skilled in the art of synthetic organic chemistry to make the invention commensurate in scope with these claims. “The factors to be considered [in making an enablement rejection] have been summarized as a) the quantity of experimentation necessary, b) the amount of direction or guidance presented, c) the presence or absence of working examples, d) the nature of the invention, e) the state of the prior art, f) the relative skill of those in that art, g) the predictability or unpredictability of the art, h) and the breadth of the claims”, In re Rainer, 146 USPQ 218 (1965); In re Colianni, 195 USPQ 150, Ex parte Formal, 230 USPQ 546. In the present case the important factors leading to a conclusion of undue experimentation are the absence of any working example of a formed solvate, the lack of predictability in the art, and the broad scope of the claims.
c) There is no working example of any hydrate or solvate formed. The claims are drawn to solvates, yet the numerous examples presented all failed to produce a solvate. These cannot be simply willed into existence. As was stated in Morton International Inc. v. Cardinal Chemical Co., 28 USPQ2d 1190 “The specification purports to teach, with over fifty examples, the preparation of the claimed compounds with the required connectivity. However ... there is no evidence that such compounds exist... the examples of the '881 patent do not produce the postulated compounds... there is ... no evidence that such compounds even exist.” The same circumstance appears to be true here. There is no evidence that solvates of these compounds actually exist; if they did, they would have formed. Hence, applicants must show that solvates can be made, or limit the claims accordingly.
g) The state of the art is that is not predictable whether solvates will form or what their composition will be. In the language of the physical chemist, a solvate of organic molecule is an interstitial solid solution. This phrase is defined in the second paragraph on page 358 of West (Solid State Chemistry). West, Anthony R., "Solid State Chemistry and its Applications, Wiley, New York, 1988, pages 358 & 365. The solvent molecule is a species introduced into the crystal and no part of the organic host molecule is left out or replaced. In the first paragraph on page 365, West (Solid State Chemistry) says, “it is not usually possible to predict whether solid solutions will form, or if they do form what is their compositional extent". Thus, in the absence of experimentation one cannot predict if a particular solvent will solvate any particular crystal. One cannot predict the stoichiometery of the formed solvate, i.e. if one, two, or a half a molecule of solvent added per molecule of host. In the same paragraph on page 365 West (Solid State Chemistry) explains that it is possible to make meta-stable non-equilibrium solvates, further clouding what Applicants mean by the word solvate. Compared with polymorphs, there is an additional degree of freedom to solvates, which means a different solvent or even the moisture of the air that might change the stabile region of the solvate.
h) The breadth of the claims includes all of the hundreds of thousands of compounds of formula *** as well as the presently unknown list of solvents embraced by the term "solvate". Thus, the scope is broad.
MPEP 2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here. Thus, undue experimentation will be required to practice Applicants' invention.
Regarding the rejection for the term” preventing”, the rejection of Claims 41 and 48 under 35 U.S.C. 112, first paragraph, is withdrawn.
Regarding and 48 under 35 U.S.C. 112, first paragraph, is withdrawn.
Claim Rejections - 35 USC § 103
Applicants’ arguments filed 6/26/2026 have been fully considered, but they are not
Persuasive at this time.
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.
In view of the revised claims and the addition of the new claims the rejection of Claims 24-29, 37, 39-48 under 35 U.S.C. 103 as being unpatentable over Takasu et al (EP 3299028 A1) in view of Bridle et al (WO2012/122629) and Andrews et al (WO 2007045844 A1) is maintained with reasons of record filed on 1/30/2023 has been changed to the rejection of Claims 24-25, 37, 39-41, 44-46, 49-57 under 35 U.S.C. 103 as being unpatentable over Takasu et al (EP 3299028 A1) in view of Bridle et al (WO2012/122629) and Andrews et al (WO 2007045844 A1) is maintained with reasons of record filed on 1/30/2023
Applicants’ Argument
Applicants argue the following issues:
The Examiner has rejected claims 24-29, 37, and 39-48 under 35 U.S.C. § 103 as obvious over Takasu et al. (EP 3299028 Al) in view of Bridle et al. (WO 2012/122629) and Andrews et al. (WO 2007/045844 Al). The Examiner relies on Takasu for a combination of a WT1 antigen peptide vaccine and an immunomodulator (allegedly CXD-101/AZD-9468) for treating or preventing cancer; on Bridle for co-administration of a histone deacetylase inhibitor with a vaccine including viral and bacterial antigens; and on Andrews for the specific benzamide HDAC inhibitor N-(2- aminophenyl)-4-(1-[(1,3-dimethyl-1H-pyrazol-4-yl)methyl]piperidin-4-yl)benzamide (CXD-101) and its dosage range. The Examiner concludes it would have been obvious to combine these teachings with a reasonable expectation of success. Applicant respectfully disagrees.
Without acquiescing to the rejection and solely to advance prosecution, each of the independent claims has been amended to recite that N-(2-aminophenyl)-4-(1-[(1,3-dimethyl-1H- pyrazol-4-yl)methyl]piperidin-4-yl)benzamide, or a pharmaceutically acceptable salt thereof, is administered at a dosage of 0.1 mg to 40 mg per day.
The Examiner asserts that the dosage limitation, which was present in now-cancelled claims 27 and 47, is obvious in view of the cited prior art. The Examiner relies on Andrews (WO 2007/045844 Al) to teach the recited daily dosage range. Applicant respectfully disagrees. Andrews does not teach or suggest the daily dosage range recited in amended independent claims 24, 37, and 41. Taking an average adult weight of 70 to 85 kg and applying the disclosure of Andrews would provide a minimum adult daily dose of 70 mg (based on the lowest dose taught in Andrews of 1 mg/kg/day). In contrast, the present claims recite a daily dosage of 0.1 to 40 mg/day. Neither of the cited references, whether considered alone or in combination, teaches or suggests the daily dosage range recited in the amended claims. Accordingly, even if one of ordinary skill in the art had been motivated to combine the cited references, that person would not thereby have been led to the daily dosage range recited in the amended claims nor have any reason to choose the claimed dose range. Furthermore, one of ordinary skill in the art would not have had a reasonable expectation of success at least because the now claimed dose range is approximately half of the dose range disclosed in the cited combination of references.
In view of the foregoing, the instant claims are not obvious over the combination of Takasu, Bridle, and Andrews, and Applicant respectfully requests reconsideration and withdrawal of this rejection.
Regarding applicants’ arguments, the Examiner has noted applicants’ arguments. However, although the prior art does not specify a daily dosage of 0.1 to 40 mg/day, Andrews et al generally does teach that a unit dose form such as a tablet or capsule will usually contain, for example 1-250 mg of active ingredient. Preferably a daily dose in the range of 1-50 mg/kg is employed. Furthermore, the daily dose will necessarily be varied depending upon the host treated, the particular route of administration, and the severity of the illness being treated (see page 27, line 27 to page 28, line 3). If the patient were a small child of 5 years old with an average weight about 18 kg instead of an average adult weight of 70 to 85 kg, the dosage can be adjusted to 18 mg per day.
Therefore, if one of ordinary skilled in the art had to formulate a pharmaceutical product comprising an immunomodulator (allegedly CXD-101/AZD-9468) and vaccine or treat a disease related to an immune response for the small child of 5 years old with an average weight about 18 kg by using a pharmaceutical product comprising an immunomodulator (allegedly CXD-101/AZD-9468) and vaccine, it would have been incorporate the teachings of Bridle Bridle’s vaccine therapy containing a histone deacetylase inhibitor in combination with Andrews et al’s specific compound of N-(2-aminophenyl)-4-{1-[(1,3-dimethyl-l H-pyrazol-5-yl)methyl]piperidin-4- yl}benzamide compound as a histone deacetylase inhibitor into Takasu et al method in the absence of an unexpected result.
Thus, the prior art is still relevant to the claimed invention.
Therefore, applicants’ arguments are not persuasive.
Conclusion
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 TAYLOR V OH whose telephone number is (571)272-0689. The examiner can normally be reached 8:00-5:00.
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/TAYLOR V OH/Primary Examiner, Art Unit 1625 8/25/2026
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