DETAILED ACTION
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 .
Status of Claims
Currently, claims 1-20 remain pending in the instant application and under consideration herein.
Response to Remarks
Applicant’s remarks and amendments filed June 23, 2026 have been entered and are considered herein. All rejections and objections not explicitly maintained herein are withdrawn. The rejections below constitute the full set of rejections being applied to the instant claims.
With respect to the rejection of claims 1-20 under 35 USC 102, Applicants traverse the rejection on several grounds, each of which has been considered but was not found persuasive to overcome the rejection.
Applicants first contend that the instant application distinguishes between XRPD polymorph analysis of a sample (Fig. 1D) and “single crystal X-Ray Diffraction” (SXRD) where XRPD confirms the presence of a single drug form and SXRD observes the repeating unit space in the crystalline lattice. This is not persuasive because both XRPD and SXRD rely on the same technology and technique for measurement. A particular polymorphic form will necessarily have a characteristic X-Ray diffraction pattern as the technique itself relies upon specific identifying characteristics of unique lattice structure in order to create the pattern.
Thus, although Huang does not explicitly specify that “crystal form B” is a single crystal form, it is necessarily the same as that tested to produce the characteristic X-Ray diffraction pattern recited for the claimed invention, as it is not possible for distinct crystal structures to produced identical X-Ray Diffraction patterns. The examiner disagrees with the notion that disclosure of an identical XRPD pattern is simply consistent with any crystalline sorafenib phase, because a crystal form different from that of the instant claims will necessarily produce a distinct XRPD pattern.
As an additional matter, the instantly claimed method utilizes open transitional language (“comprising”) such that nothing precludes the use of additional crystal polymorphs in the claimed composition. Accordingly, even if the prior art taught more than one polymorph in the composition, which the examiner does not concede, the broadest reasonable interpretation of the claim language would encompass this feature. Further, the art’s identification of the crystalline product as “crystal form B” of sorafenib itself indicates a single crystalline form of the compound. According to MPEP 2112(V), "[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same." In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). Since the prior art provides sufficient evidence that the disclosed product is the same as that required by the claims (i.e. identical XRPD peaks identifying the same crystal lattice structure) and Applicant has provided no rebuttal evidence to the contrary, the anticipation rejection is proper and maintained herein.
Claim Rejections - 35 USC § 102
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.
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.
Claims 1-20 is rejected under 102(a)(1) as anticipated by CN109422676 (“the ‘676 publication”), as evidenced by the machine translation of the same document.
The prior art teaches the compound sorafenib, chemical name 4-{4-[3-(4-chloro-3-trifluoromethylphenyl) acyl urea]phenoxy}pyridine-2-carboxamide, which is identical to the compound recited in the instant claims. The prior art further discloses that sorafenib blocks the formation of tumor angiogenesis. The reference goes on to teach crystallization of sorafenib into crystal form B, which has characteristic absorption peak 2θ values are located at 11.3±0.2θ, 12.5±0.2θ, 14.5±0.2θ, 15.1±0.2θ, 18.0±0.2θ, 18.6±0.2θ, 22.4±0.2θ, 22.9±0.2θ, 23.5±0.2θ, 24.3±0.2θ, 24.7±0.2θ, 25.2±0.2θ, 25.6±0.2θ, 29.5±0.2θ. The prior art crystal form includes all characteristic peaks recited in instant claims 2, 13 and 20, indicating that the crystal structures are the same.
With respect to claims 5-8 and 19, it is noted that the limitations reciting the conditions of crystallization are interpreted as product-by-process limitations, reciting only the process conditions for obtaining the recited crystal form. MPEP 2113 provides the following guidance: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.). Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffmann-La Roche Ltd., 580 F.3d 1340, 1370 n. 14, 92 USPQ2d 1289, 1312, n. 14 (Fed. Cir. 2009). The facts here are similar to those in Amgen above since the prior art and instantly claimed process for crystallizing both yield the same crystal form, as evidenced by their identical XRPD characteristic peaks.
With respect to the limitations of dependent claim 3-4, 8-12, 14-18 and 20, "Products of identical chemical composition can not have mutually exclusive properties" (MPEP 2112.01(II)). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure as that recited in the claim, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)). Even if that property (i.e. particle size, hydrophobicity, injectability) is not disclosed in the prior art, if the chemical structure is identical, the art need not recognize every property of the compound in order to render it unpatentable. In accordance with MPEP 2112, “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Since the prior art teaches all required features of the instantly claimed invention, the claims are anticipated.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alicia L. Otton whose telephone number is (571)270-7683. The examiner can normally be reached on Monday - Thursday, 8:00-6:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Fereydoun Sajjadi can be reached on 571-272-0699. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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.
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/ALICIA L OTTON/Primary Examiner, Art Unit 1699
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