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 .
Priority
This application is a CON of PCT/JP2021/025389 (07/06/2021)
and claims foreign priority to PCTJP2020027266 (07/13/2020).
New 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.
Claims 1-7 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Applicant amended the claims to include the following language:
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allegedly supported by the original filing at [0013]. The specification does not clearly define how the “wavelength is determined based on an infrared absorption spectrum … and a dissolution rate”. In addition, one of ordinary skill in the art would not understand how to perform the setting and determined steps because the language is unclear as to how a wavelength is based on the particular claim elements. Furthermore, the language is vague with respect to what is required in order to within the scope of the claims. Thus, the language renders indefinite the claim and those that depend therefrom. See MPEP 2173.02.
Applying the BRI as per MPEP 2173.06, the above cited language is interpreted as “wherein the target wavelength is any wavelength that results in crystallization”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yuyama et al. (Cryst. Growth Des. 2012, 12, 2427−2434).
Yuyama teaches the selective crystallization of glycine polymorphs by infrared irradiation at 1064 nm wavelength using an apparatus (Abstract, Fig. 1, p. 2427-28).
Regarding claim 2, Yuyama teaches glycine has a plurality of forms (p. 2427).
Regarding claim 4, Yuyama teaches infrared irradiation at 1064 nm wavelength.
Response to Remarks - 35 USC § 102
Applicant amended the claims and argues that “Yuyama does not disclose or suggest this process step as part of the method for the selective crystallization of glycine polymorphs by infrared irradiation at 1064 nm wavelength”.
Yuyama teaches analysis of the “photon absorption of glycine molecules” that resulted in spontaneous crystallization (p. 2431; Fig. 4) and the rate of polymorph formation depended upon the laser irradiation (p. 2428: “The laser irradiation always provides only one single crystal, and it can be ascribed to be either α- or γ-form. The preparation rate of the two polymorphs strongly depends on laser polarization, and in particular, almost absolute polymorph control is achieved in the unsaturated solution.”). Thus, the prior art does teach that the target wavelength was selected due to absorption spectrum and dissolution (inverse of formation) rate. Furthermore, under the BRI detailed above, the target wavelength resulted in crystallization and thus anticipates the claim.
Applicant’s argument is not persuasive and the rejection is maintained.
Amended Claim Rejections - 35 USC § 103
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.
Claims 1-6 and newly presented claim 7 are rejected under 35 U.S.C. 103 as being unpatentable over Piran et al. (US20100317702) in view of Niwa et al. (US20190194101).
Piran teaches techniques for crystallization febuxostat into multiple polymorphic forms using steps comprising dissolving, heating, and evaporating at various temperatures (Forms F1-F14). Piran teaches examples 1-23 using various solvent, temperatures, and concentrations to produce the various polymorphic forms. Piran does not teach use of an infrared radiation apparatus in the manner claimed.
Niwa teaches the apparatus of the claims (Figs. 3-4 are the nearly the same as instant application Figs 1-2) used to selectively crystallize polymorphic forms of organic compounds ([0032]) using a target wavelength ([0033]) and temperature ([0010]-[0011], [0046]-[0048]). Niwa teaches the apparatus is useful for crystallizing pharmaceuticals ([0032]). One of ordinary skill in the art would have reasonably considered combining the teaching of Piran to use known heaters in the art, particularly ones described for the same purpose of crystallizing polymorphic pharmaceuticals. One of ordinary skill in the art would have had a reasonable expectation of success and combine the teachings using a known device to achieve the same result to arrive at the claimed invention with a reasonable expectation of success.
Regarding new claim 7, the Niwa apparatus appears to be identical to that of the instant application Figs. 1-2 (instant specification refers to the same as MIM type at [0023] “The infrared heater 10 is an example of a metamaterial emitter of the MIM type”). Thus, one of ordinary skill in the art would have used the same apparatus and arrive at the claimed invention.
With each of the claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art in the same field of endeavor. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed with a reasonable expectation of success.
Response to Remarks - 35 USC § 103
Applicant amended the claims and argues that the “combination of Piran in view of Niwa does not teach or suggest the feature of amended claim 1 “wherein the target wavelength is determined … “.
This argument is not persuasive because Piran suggests crystallization techniques such as disclosed by Niwa, including the selection of a wavelength based on infrared absorption (Abstract; claims 1-4) and the rate of formation (inverse of dissolution) of the crystal ([0022]-[0023]; [0067]: “ecrystallization of p-aminobenzoic acid is suppressed, so that 1,4-dibromobenzene can be crystallized preferentially.”). Thus, the prior art does teach and suggest that the target wavelength was selected due to absorption spectrum and dissolution (inverse of formation) rate. Furthermore, under the BRI detailed above, the target wavelength resulted in crystallization and thus anticipates the claim.
Applicant’s argument is not persuasive and the rejection is maintained.
Amended Double Patenting
Claims 1-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-6 of copending Application No. 18147198 (reference application) in view Piran et al. (US20100317702) in view of Niwa et al. (US20190194101). Although the claims at issue are not identical, they are not patentably distinct from each other because as detailed in the 35 USC 103 rejection supra and incorporated herein. Furthermore, the reference application claims a similar method only differing by “a specific concentration” which one of ordinary skill in the art would know was a results effective variable and is routinely optimized as demonstrated by the teaching of the various form in Piran.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6 and new claim 7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of copending Application No. 18147229 (reference application) in view Piran et al. (US20100317702) in view of Niwa et al. (US20190194101). Although the claims at issue are not identical, they are not patentably distinct from each other because as detailed in the 35 USC 103 rejection supra and incorporated herein. Furthermore, the reference application claims a similar method only differing by precipitating from solution which one of ordinary skill in the art would know was a results effective variable and is routinely optimized as demonstrated by the teaching of the various form in Piran.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6 and new claim 7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of copending Application No. 19050247 (reference application) in view Piran et al. (US20100317702) in view of Niwa et al. (US20190194101). Although the claims at issue are not identical, they are not patentably distinct from each other because as detailed in the 35 USC 103 rejection supra and incorporated herein. Furthermore, the reference application claims a similar method only differing by “a specific concentration” which one of ordinary skill in the art would know was a results effective variable and is routinely optimized as demonstrated by the teaching of the various form in Piran.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Remarks - Double Patenting
Applicant requested the rejections be held in abeyance.
As Applicant did not persuasively argue withdrawal of the rejections, these rejections are maintained.
Conclusion
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626