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
This office action is response to communication filed on 01/27/2026.
Election/Restriction
Applicant elected, without traverse, Group I and species: (A) anhydrous crystalline form D,
(B) suspension stirring method; (C) minoxidil; (D) androgenetic alopecia, in the reply filed on 01/27/2026.
Claims 1, 2, 10-12 read on the elected invention and species.
Claims 6-9 and 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected inventions. Claims 3-5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected species.
Claim Status
Claims 1-12 and 14 are pending.
Claims 3-9 and 14 are withdrawn.
Claims 1, 2, and 10-12 are currently under examination in this office action.
Priority
This instant application 18/551,444, filed on 09/20/2023, is a national stage 371 of PCT/CN2022/082274 filed 03/22/2022, which claims priority benefit of foreign application CHINA No. 202110310216.8 filed on 03/23/2021.
Acknowledgment is made of Applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy of CHINA No. 202110310216.8 in Chinese is filed on 09/20/2023, no English translation is included in the certified copy of CHINA No. 202110310216.8. Applicant’s right of foreign priority is not perfected due to lack of English translation thereof, the priority date of instant application is determined to be 03/22/2022, the filing date of PCT/CN2022/082274.
Information Disclosure Statement
The information disclosure statement dated 09/20/2023 fails to comply with 37 CFR 1.98(a)(3)(i) because they do not include a concise explanation of the relevance of each reference listed that is not in the English language as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information. To expedite the compact prosecution, the IDS has been placed in the application file, reference written in foreign language without English translation are only considered to the degree of English abstract or patent family of foreign patent if present by the examiner.
Claim Objections
Claims 1 is objected to because of the following informalities:
Claim 1 recites plural “compounds” should be singular compound.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because there are no legends indicating which crystalline form are referred to in Figures 1- 11 and they fail to clearly indicate values of characteristic peaks of XRPD spectrum in Figures 1, 4-6, 8, 10, 12-13 that are essential to characterize instantly claimed polymorphs/crystalline forms. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d).
Instant specification disclosed various crystalline forms of compound of Formula I and XRPD pattern thereof. Instant claim 2 recites limitation “ the XRPD pattern of the crystalline form D is substantially consistent with Fig. 1”. It is well recognized in the art that X-ray diffraction patterns may have different appearance due to artifacts and solvent, thus must be carefully evaluated for true new polymorphs. Without specifying the characteristic peak values, it’s not clear which peaks are characteristic XRPD pattern of instantly claimed crystalline Form D that differentiate Form D from other crystalline forms.
Figure 2, 7 and 9 comprise both TGA profile and DSC profile for crystalline forms (D, C or B ) of compound of Formula I without legend are confusing. TGA measures weight change (decomposition, desolvation) against temperature, while DSC measures heat flow (melting, polymorphic transitions).
Fig. 12 and 13 recite four different crystal form A, B, C, D. It’s not clear which crystal form is evaluated for suspension competition test at 90ºC, 4 hours, or 50ºC, 4hr.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
As disclosed by instant specification(See bridging para of page 1 and 2), compound of Formula I is a small molecule AR receptor with chemical name 4-[4,4-dimethyl-3-(6-methylpyridin-3-yl)- 5-oxo-2-thioxoimidazolidin-l-yl]-3-fluoro-2-methoxybenzonitrile.
According to PubChem database, compound of Formula I ( CAS# 1272719-08-0) is also known as faznolutamide, etc. (retrieved from https://pubchem.ncbi.nlm.nih.gov/compound/51002556).
Instant claims recite crystalline forms of compound of Formula I characterized by XRPD pattern, DSC and TGA profile. The limitation of peaks in X-ray powder diffraction pattern DSC and TGA profile are properties of the crystalline form which are inseparable from the product itself. Once the crystalline is obtained, XRPD, DSC and TGA profile of the crystalline form could be easily measured by a person of ordinary skilled in the art through routine method and general knowledge of crystallography. Claim 12 reciting intended use of instantly claimed polymorph and/ or the pharmaceutical composition thereof is improper multiple dependent claim and do not necessarily contribute to the structural limitation of the polymorph or pharmaceutical composition.
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 2 and 10-12 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.
Claim 2 recites anhydrous crystalline Form D of compound of Formula I, which meets at least one of the following conditions: I. an XRPD pattern comprising peaks at 5.3 ± 0.2,…; II) TGA profile showing a weight loss of about 1.6 % at 150±1°C... ; III) DSC profile showing heat absorption at 167±1°C....Claim 2 recites multiple “preferably”, e.g. “preferably, the XRPD pattern of the crystalline form D further comprises peaks...” “further preferably, the XRPD pattern of the crystalline form D is substantially consistent with Fig. 1”, “preferably, the TGA profile of the crystalline form D is substantially consistent with FIG. 2”, “preferably, the DSC profile of crystalline form D is substantially consistent with FIG. 2.”
First, the phrase “preferably” is indefinite. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). It’s not clearly whether the narrower limitation following “preferably” is required limitation. An ordinary skilled in the art would not know what’s the intended scope of claim 2.
Second, the term “substantially” is indefinite. It’s not clear to what extent the XRPD pattern of the crystalline form D is considered as substantially consistent with Fig. 1. It is well recognized in the art that X-ray diffraction patterns may have different appearance due to artifacts/solvents, thus the small differences in X-ray diffraction must be carefully evaluated for true new crystalline forms/ polymorphs. There are many peaks in XRPD of crystalline form D of compound of Formula I. Without specifying the peak value, it is unclear what thresholds of peak are used to determine whether a XRPD pattern is characteristic as “substantially consistent with Fig. 1”. It’s not clear which peaks or combinations thereof are characteristic XRPD pattern to determine the structure of instantly claimed crystalline form D and how to differentiate crystalline form D from other crystalline forms of compound of Formula I. It’s also not clear to what extent the DSA and/or TGA profile of crystalline form D is substantially consistent with FIG. 2. As stated in MPEP § 2173.05(s): “Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted)”.
Further, differential scanning calorimeter (DSC) and TGA profile are thermal analytic techniques that do not directly determine or define the structure of crystalline forms. For polymorph, DSC is primary for detecting phase transitions/melting points, while TGA distinguishes between hydrated/solvated forms (weight loss) and anhydrous polymorphs (no weight loss). In absence of XRPD peak or other crystallographic characterization technique, DSC, TGA profile alone, or in combination
could not be used to identify structural limitation of unique crystalline form. For example, the TGA profile of instantly disclosed crystalline form C and D are similar with weight loss of about 1.6% at 150ºC. As such, “at least one of the following conditions” encompassing characterization of crystalline form D by DSC, TGA profile alone, or in combination do not clearly define crystalline form D and the scope of claim 2. The limitations of claim 2 do not clearly set forth the metes and bounds of the patent protection desired.
Claim 10 recites “a pharmaceutical composition comprising the anhydrous polymorph according to claim 1 and preferably, in the pharmaceutical composition, the weight percentage of the anhydrous polymorph is 1.0 %-99.0 %”. It’s not clearly whether the weight limitation following “preferably” is required limitation. An ordinary skilled in the art would not know what’s the intended scope of claim 10.
Claim 11 recites a pharmaceutical composition further comprises a second functional component; preferably, the second functional component is selected from any one or more of minoxidil, deuterated ruxolitinib (CTP-543), botulinum toxin, clascoterone (CB-03-01), finasteride, and latanoprost. It’s not clear what component is considered as “functional component” . It’ not clear if the recited other component (e.g. minoxidil) following “preferably” are required or not. An ordinary skilled in the art would not know what’s the intended scope of claim 11.
Claim 12 recites “The anhydrous polymorph according to claim 1 or the pharmaceutical composition according to claim 10 for use in the prevention, alleviation and/or treatment of a disease or condition associated with androgen receptor activity; preferably, the disease or condition associated with androgen receptor activity is selected from the group consisting of prostate cancer, benign prostatic hyperplasia, acne, hirsutism, excess sebum and androgenetic alopecia”. Claim 12 is improper multiple dependent claim and it’s not clear if the subject matter of claim 12 is the polymorph of compound of Formula I or the pharmaceutical composition. Further, the intended use of instantly claimed polymorph and/ or the pharmaceutical composition thereof do not impart any further physical or otherwise material characteristic to the polymorph or composition. As stated in MPEP 2173.05: “Notwithstanding the permissible instances, the use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear”. The phrase “preferably” is also indefinite. It’s not clearly whether the narrower limitation following “preferably” is required limitation.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 12 reciting “The anhydrous polymorph according to claim 1 or the pharmaceutical composition according to claim 10 for use...” is improper multiple dependent claim. It’s not clear if the subject matter of claim 12 is the polymorph of compound of Formula I or the pharmaceutical composition. Further, the intended use of the polymorph or pharmaceutical composition do not impart any further physical or otherwise material characteristic to the polymorph of claim 1 or pharmaceutical composition of claim 10. As such, claim 12 fails to further limit claim 1 or claim 10.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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.
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, 2 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Tong et al. (US 8,809,550 B2, hereafter “Tong’550”, corresponding to US20120172406A1), in view of Peddy et al. (US20150239848A1).
Tong’550 teaches thioimidazolidinone compound of Formula I to Formula IV, as androgen receptor antagonist, preparation thereof, pharmaceutical compositions comprising aforementioned thioimidazolidinone and method for treating androgen receptor-associated diseases or disorders (e.g. prostate cancer, androgenic alopecia, benign prostatic hypertrophy, etc.) (See abstract; Col.2, lines 10-65; Col. 15, lines 11-24; Examples 1-32, claims 1-16 ).
Regarding compound of Formula I, Tong’550 explicitly teaches Example 20 ( See Col. 74, claims 8 and 18 ) that is instantly claimed compound of Formula I.
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Tong’550 teaches compound of Formula I might be crystalline product prepared from crystallization under different conditions (solvent, temperature, etc. fast or slow cooling during crystallizations, etc.) and may exist as one or a combination of polymorphs, characterized by solid probe NMR spectroscopy, IR spectroscopy, differential scanning calorimetry, powder X-ray diffractogram and/or other techniques ( See Col 38, lines 6-20). Tong’550 teaches it is often desirable to slow the absorption of the drug in order to prolong the effect of a drug, which may be accomplished by the use of crystalline( See Col. 41, lines 8-14).
Regarding pharmaceutical composition limitation of claim 10 -12, Tong’550 teaches pharmaceutical composition /medicament comprising compound of Formula I and pharmaceutical excipients, and further comprise one or more additional therapeutic agents ( See Col. 38, lines 30-49; Col. 39 and 40; claims 12-13). Tong’550 teaches androgen receptor antagonist activity (See Col. 84, Table 1 and 2) and in-vivo activity in mouse model (0.2% and 1% concentration) for hair growth (See Col.85, lines 50-55). A skilled artisan would have known to explore effective amount of compound of Formula I in the pharmaceutical composition. Where 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. MPEP 2144.05.
Regarding medicament limitation of instant claim 11, Tong’550 teaches compositions further comprise one or more additional therapeutic agents and combination therapy for treating androgen receptor-associated diseases or disorders, e.g. inhibitors of oncogenic kinases, e.g. VEGF, mTOR, EGFR, SRC and PI3K, cancer chemotherapy agents such as taxanes, etoposide, estramustine phosphate, and doxorubicin, etc.(See Col. 44, lines 1-18).
Tong’550 is silent about anhydrous polymorph of compound of Formula I characterized by the XRPD pattern or DSC or TGA profile. However, instantly claimed peaks in X-ray powder diffraction pattern, DSC profile and DSC profile are properties of the crystalline form which are inseparable from the product itself. It is well known practice for a skilled artisan to explore crystalline/polymorph/solid state form of active compound for purpose of stability, solubility and bioavailability etc. as taught by Tong’550. Once the crystalline is obtained, XRPD, DSC and TGA of the crystalline form could be easily measured by a person of ordinary skilled in the art through routine method and general knowledge of crystallization.
Peddy teaches crystalline and amorphous form of enzalutamide, process for preparing the polymorphs, and compositions comprising aforementioned polymorphs( See abstract, [0001]-[0003], [0006]-[0017], Examples 1-31, claims 1-15). Peddy teaches enzalutamide, 4-(3-(4-cyano-3-(trifluoromethyl)phenyl)-5,5-dimethyl-4-oxo-2-thioxoimidazolidin-1-yl)-2-fluoro-N-methylbenzamide, having following structure, is an oral, once-daily androgen receptor signaling inhibitor used for the potential treatment of prostate cancer (See [0002]-[0003]). It’s noted enzalutamide is very similar to instant compound of Formula I(i.e. faznolutamide), except phenyl ring vs pyridine.
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Regarding polymorph of enzalutamide, Peddy teaches preparation of various polymorph forms (e.g. R1 , R2, amorphous form , etc.) and characterization thereof, e.g. X-ray diffraction pattern (See Experiment 1-31, Figures 1-4 ). Peddy teaches variety of crystallization conditions/techniques, e.g. different solvent, temperature, crystallization by cooling or adding antisolvent, etc. (See [0033]-[0089], claim 5). Peddy teaches benefit /advantage of polymorphic forms for a pharmaceutically acceptable dosage form with a targeted release profile or other desired characteristics(See [0005]).
Regarding the XRPD peaks recited in instant claim 2, Peddy teaches XRPD pattern of enzalutamide Form R1 characterized by powder X-ray diffraction (PXRD) pattern having one or more peaks at about 12.3±0.2, 13.1±0.2, 15.0±0.2, and 17.5±0.2 degrees 2-theta, and further comprises 9.8±0.2, 13.5±0.2, 14.3±0.2, 16.7±0.2, 18.9±0.2, 21.1±0.2, 21.8±0.2, 22.8±0.2 and 24.4±0.2 degrees 2-theta (See [0006]-[0007], [0030]-[0031], Figure 1). Peddy also teaches the XRPD pattern of enzalutamide Form R2 characterized by powder X-ray diffraction (PXRD), having one or more peaks at about 4.8±0.2, 11.3±0.2 and 20.2±0.2 degrees 2-theta , and further comprises 9.7±0.2, 14.5±0.2, 15.6±0.2, 16.9±0.2 and 25.5±0.2 degrees 2-theta (See Figure 2, [0012]-[0013], claims 8 and 15).
It's noted XRPD peaks of Peddy enzalutamide Form R1 and/or form R2 are very similar to instant claimed XRPD peaks (±5-10%). It is well recognized in the art that X-ray diffraction patterns may have different appearance(e.g. peak locations, intensities, and/or presence) due to artifacts and solvent. One of skilled in the art would have known XRPD data might not produce exactly the same peaks even for the same crystalline form/p due to instrumental variation, sample preparation, scientific error, etc. As such, enzalutamide polymorph having XRPD characteristic peaks significantly similar to instantly claimed peaks is considered as read on instant claimed XRPD peaks/pattern.
Regarding pharmaceutical composition limitation of instant claims 10, Peddy teaches pharmaceutical composition(e.g. solid dispersion) comprising enzalutamide, with one or more pharmaceutically acceptable excipients (See [0021], [0073], [0090]-).
Peddy teaches polymorphic forms are characterized by scattering techniques ( e.g. X-ray powder diffraction pattern) , by spectroscopic methods(e.g.13C nuclear magnetic resonance spectroscopy) and by thermal techniques, e.g., differential scanning calorimetry or differential thermal analysis (See [0092]). Peddy is silent about specific DSC and TGA profile of enzalutamide. However, DSC and TGA profiles are properties of the crystalline/polymorph which are inseparable from the product itself. Once the crystalline form/polymorph is obtained, DSC and TGA profile of the crystalline form could be easily measured by a person of ordinary skilled in the art through routine method and general knowledge of crystallography.
It would have been prima facie obvious to one of the ordinary skilled in the art before the effective filing date of instant invention to explore crystalline forms/polymorph of Compound of formula I (i.e. faznolutamide) taught by Tong’550, based on the teaching of enzalutamide crystalline forms taught by Peddy, together with experimentation/ optimization based on general knowledge of crystallization and pharmaceutical formulation, and arrive at instantly claimed invention with reasonable expectation of success.
It is common practice for the skilled artisan in the art to explore crystalline forms/polymorph of active compound for purpose of stability, solubility/dissolution and bioavailability, etc.. A skilled artisan would be motivated to combine the teachings of Tong’550 and Peddy because both teachings are associated with thioimidazolidinone androgen receptor antagonist. Both Tong’550 and Peddy teach the benefit of crystalline forms/polymorph, e.g. slow absorption/prolonged effect, etc.. The combined teachings of Tong’550 and Peddy, together with experimentation/ optimization based on general knowledge of crystalline/polymorph and pharmaceutical formulation, would provide crystalline forms of Compound of formula I (i.e. faznolutamide) with benefit/advantage (e.g. desirable solubility/dissolution profile, etc.) for treating disease/disorder associated with androgen receptor antagonist (e.g. alopecia, prostate cancer, etc.).
One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the combined teachings of prior art and optimization based on general knowledge of crystalline/polymorph and androgen receptor antagonist formulation. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art before the effective filing date of instant invention, as evidenced by the references, especially in the absence of evidence to the contrary.
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, 2 and 10-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 12, 15 and 18 of U.S. Patent No. 8,809,550 B2 in view of Peddy et al. (US20150239848A1).
Reference claims are directed to thioimidazolidinone compounds wherein refence claim 8 explicitly recites instant claimed compound of Formula I ( See Col.88 ). Reference claim 12 recites the pharmaceutically composition comprising the compound and carrier which read on instant claim 10.
Reference claims are silent about polymorph of compound of Formula I and XRPD pattern thereof. It is well known practice for the skilled artisan in the art to explore different crystalline form for purpose of stability, solubility and bioavailability etc. Instantly claimed anhydrous polymorph is only a crystalline form of compound of formula I. The limitation of XRPD pattern, DSC and TGA profile are properties of the crystalline form which are inseparable from the product itself.
The collective teachings of Peddy is elaborated in preceding 103 rejection and applied as before. Peddy teaches polymorph of enzalutamide which is very similar to instant compound of Formula I.
It would be prima facie obvious for a POSA to further explore polymorph of compound of Formula I taught by reference claims together with Peddy’s teaching for desired stability/dissolution profile of compound of Formula I. As stated in MPEP 2144.05, " It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.".
The instant application shares at least one common inventor and applicant with the reference patent. Further, the instant application is not related to the reference application thus no 35 USC 121 shield exists. See MPEP 804.01.
Conclusion
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
1. Hsu et al. Oncotarget, 2014 Apr 30;5(8):2187-97. doi: 10.18632/oncotarget.1886, Minoxidil may suppress androgen receptor-related functions. (Hsu teaches minoxidil has been used for more than two decades to treat androgenetic alopecia (AGA), and further teaches the mechanism of minoxidil on androgen receptor, e g, interfered with AR-peptide, AR-coregulator, and AR N/C-terminal interactions, as well as AR protein stability (See whole article, Introduction/Discussion). Hsu concludes minoxidil could be used to treat cancer and other androgen-AR pathway-related diseases).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIYUAN MOU whose telephone number is (571)270-1791. The examiner can normally be reached Mon-Fri 9:00-5:30.
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/LIYUAN MOU/Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628