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 .
Priority
Examiner acknowledges that, according to the Filing receipt received 08/27/2024, that the instant application 18/799,812 filed 08/09/2024 is a continuation of PCT/IB2024/057711 filed 08/08/2024, which claims foreign priority of IN202311054017 filed 08/11/2023.
Acknowledgment is made of applicant's claim for foreign priority. It is noted, however, that applicant has not filed a certified copy of the IN202311054017 application as required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statements filed on 08/09/2024 and 11/15/2024 are in compliance with the provisions of 37 CFR 1.97 and have been considered in full. A signed copy of list of references cited from the IDS is included with this Office Action.
Specification
The disclosure is objected to because of the following informalities:
p. 14, “Formula III or a thereof” should read “Formula III or a salt thereof”;
p. 35, "Annalize" should read "Analyze";
p. 45, Example 12, “asan” should read “as an”;
The structures in the reaction schemes depicted in the specification are inconsistent as to their stereochemistry. For example, Scheme 1 (p. 32) depicts a Formula III and Formula IV reacting to form a compound of Formula II, which is reacted with oxone to form Formula I (see below).
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However, the stereochemistry of Formula IV would not result in the stereochemistry of Formula I as an end product, wherein the Formula IV depicted above would yield a compound of Formula I wherein the methyl would be a dash rather than a wedge. The same deficiency occurs in Scheme 3 (p. 33) regarding Formula IV. Example 1 (p. 35), additionally, depicts the preparation of the below compound of Formula X by reacting (1S)-1-(4-pyrdinyl) ethanol with Pd/C.
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However, the above structure cannot be obtained with (1S)-1-(4-pyrdinyl) ethanol as the starting material, as the end product would be (1S)-1-(4-piperidinyl) ethanol rather than (1R)-1-(4-piperidinyl) ethanol. As Examiner cannot point to each and every location where the depicted stereochemistry of each compound is incorrect, Examiner recommends that Applicant review the specification to ensure that the stereochemistry of each compound is accurate and results in the correct end products.
Appropriate correction is required.
The use of the terms "Welch Materials, Inc." and "X-Bridge", which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 6, 9-10 and 14-15 are objected to because of the following informalities:
Claim 6: “formula X” should read “Formula X”;
Claim 9: in step (c), “of compound of Formula I” should read “of the compound of Formula I”;
Claim 10: “claims 8” should read “claim 8”;
Claim 14: the claim depicts the structure of Formula F but only recites that the compound is substantially free of one or more of “Formulas A, B, C, D, and E”;
Claim 15: “characterized by a particle size distribution wherein” should read “characterized by a particle size distribution of”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1 and 6-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 8-9 recite “the desired isomer of the compound of Formula I”. This limitation lacks antecedent basis. Additionally, it is unclear what isomer of Formula I is considered “the desired isomer”. Claim 10 does not clarify the limitation at issue and is also rejected.
Claim 6 depicts the following structures of Formula XI and X.
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Formula XI is reacted with a reducing agent to obtain Formula X, which is then reacted with Formula IX-a to form Formula IV which has the below structure.
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The compound of Formula X would not result in formation of a compound of Formula IV with the above stereochemistry. Namely, reaction of Formula X with Formula IX-a would be expected to form a compound of Formula IV wherein the methyl is a dash rather than a wedge. It is unclear how one would arrive at the above compound of Formula IV with the depicted starting materials. Claim 7 is rejected for not clarifying the limitations at issue. For the purposes of examination, Examiner has interpreted Formula XI and Formula X as the (R) isomers, rather than the (S) isomers, which would result in the above Formula IV.
Claim 9 recites “the chiral acid salt of the compound of Formula I”. This limitation lacks antecedent basis.
Claim 11 recites “the reaction mass”. This limitation lacks antecedent basis.
Claim 11 recites “the purified compound of Formula I”. This limitation lacks antecedent basis.
Claim 12 recites “the one or more solvents”. This limitation lacks antecedent basis.
Claim Rejections - 35 USC § 112(d)
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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 depends upon claim 13, which has not yet been recited. Per 35 U.S.C. 112(d), “a claim in dependent form shall contain a reference to a claim previously set forth…”. Since claim 12 does not depend upon a claim previously set forth, it is considered to be in improper dependent form. Additionally, claim 12 recites “the process according to claim 13”, while claim 13 is directed toward a compound. As such claim 12 does not incorporate the limitations of the claim from which it depends. For the purposes of examination, claim 12 has been interpreted as if it depends from claim 11.
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 § 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 (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 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.
Claim(s) 1-5 and 14 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Patil et al. (US 2020/0317661 A1; IDS filed 11/15/2024).
Patil et al. discloses a process for preparing the compound below, which is identical to instantly claimed Formula I (p. 69).
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Patil et al. discloses that the process comprises reacting the following compounds 53 and 41, to obtain the compound 54, wherein in the below compounds X is a leaving group (chloro) and n is 0 (p. 68).
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Patil et al. additionally teaches converting the methylthio of compound 54 to methylsulfonyl as below (p. 69).
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Patil et al. discloses isolating compound 1086 by extracting with ethyl acetate, concentrating the organic layer, and purifying the compound via silica gel column chromatography (p. 69, par. [0507]).
Patil et al. further discloses preparing the above compound 41 via the below reaction scheme (p. 64-65).
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The above scheme is identical to that of claim 3 wherein the acetyl halide in step (a) is acetyl chloride, the solvent and halogenating agent in step (b) are dioxane and bromine respectively, and the leaving group X is bromo.
Regarding claim 14, one of ordinary skill in the art would expect the compound of Patil et al. to be substantially free of at least Formula C, as the compound 41 of Patil et al. is substituted by chloro instead of bromo. As such, Formula C is not an intermediate in the scheme of Patil et al.
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.
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.
Claim(s) 6-7, 9, 11-13, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patil et al. (US 2020/0317661 A1; IDS filed 11/15/2024) as applied to claims 1-5 and 14 above, and further in view of Barba et al. (WO 2011/147951 A1; IDS filed 11/15/2024).
Patil et al. discloses as above.
However, Patil et al. does not disclose a process of preparing Formula IV comprising reacting a compound of Formula XI with a reducing agent to give a compound of Formula X, reacting the compound of Formula X with a compound of Formula IX-a in the presence of a solvent, and obtaining a compound of Formula IV. Patil et al. does not disclose a process for purifying the compound of Formula I. Patil et al. does not disclose a compound of Formula I with the purity of claim 13 or the particle dispersion of claim 15. These limitations are obvious over Patil et al. in view of Barba et al.
Patil et al. discloses the formation of 1-(piperidin-4-yl) ethanol hydrochloride from piperidine-4-carboxylic acid (p. 65-67, Steps 5-10) and reacting 1-(piperidin-4-yl) ethanol hydrochloride with 2-chloro-5-ethylpyrimidine to obtain the below compound 50 (p. 67, Step 11).
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Patil et al. discloses the below reaction scheme to afford a compound identical to Formula IV (p. 67-68).
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Barba et al. discloses GPR119 agonists and a method of making (R)-1-piperidin-4-ylethanol acetate, as below (p. 68).
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Barba et al. discloses that the method comprises reacting (R)-1-pyridin-4-yl-ethanol with platinum oxide to yield the above compound (p. 68, lines 23-30).
Barba et al. additionally teaches methods of purifying a synthesized GPR119 agonist comprising heating a solution of the compound in at least one solvent (acetonitrile), heating the solution to about 80oC, cooling the solution and filtering, adding one or more solvents (acetonitrile and water), and concentrating and drying the resulting residue before isolating the compound via gel chromatography (par. [0096]).
It would have been prima facie obvious for one of ordinary skill in the art to apply the method of Barba et al. to the method of Patil et al. by forming (R)-1-piperidin-4-ylethanol prior to reacting the (R)-1-piperidin-4-ylethanol with 2-chloro-5-ethylpyrimidine. One would have been motivated to do so, with reasonable expectation of success, as the method of Barba et al. would reduce the number of steps, and therefore intermediates, of the reaction scheme of Patil et al. in order to synthesize Formula IV and ultimately arrive at the desired isomer of Formula I.
It would have been prima facie obvious for one of ordinary skill in the art to apply the method of Barba et al. for purifying the compound of Patil et al. One would have been motivated to do so, with reasonable expectation of success, in order to further isolate the compound and remove impurities. Absent any unexpected or surprising results, it would be routine for one of ordinary skill in the art to purify a pharmaceutical compound.
Furthermore, regarding purity, when claiming a purer form of a known compound, it must be demonstrated that the purified material possesses properties and utilities not possessed by the unpurified material. Ex parte Reed, 1.35 U.S.P.Q. 34, 36 (P.O.B.A. 1961), on reconsideration. There exists a vast number of decisions holding that where the purification of an old product results in a mere change in degree in its properties, the purified form is unpatentable. Ex parte Windhaus, 15 USPQ 45 (POBA 1931); In re Ridgeway, 76 F.2d 602, 25 USPQ 202 (CCPA 1935); In re Merz, 97 F.2d 599, 38 USPQ
143 (CPA 1938); In re Macallum, 102 F.2d 614, 41 USPQ 146 (CCPA 1939); In re King, 107 F.2d 614, 4.3 USPQ 400 (CCPA 1939); Ex parte Sparhawk, 64 USPQ 339 (POBA 1345); In re Weilard, 154 F.2d 133. 69 USPQ 86 (CCPA 1946); In re Johnson, 94 F.2d 978, 37 USPQ 75 (CCPA 1938).
As no particular advantages have been disclosed regarding the instant invention, the claimed purified form of Formula I would be prima facie obvious over the compound of Patil et al., as it would be routine to optimize the purity of a compound with a known pharmaceutical utility. Similarly, selection of particle size is not a patentable modification in the absence of unobvious results. In re Rose, 105 U.S.P.Q. 237 (C.C.P.A. 1955). The particle sizes of instant claim 15 are, therefore, also considered to be prima facie obvious.
Claim(s) 8 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable Patil et al. (US 2020/0317661 A1; IDS filed 11/15/2024) as applied to claims 1-5 and 14 above, and further in view of Patil et al. (WO 2017/175066 A1; IDS filed 11/15/2024) (hereinafter, "Patil et al. (2017)").
Patil et al. discloses as above.
Patil et al. does not disclose a compound of Formula III wherein the leaving group is bromo, or separating the desired isomer of Formula I by chiral chromatography using a solvent. These limitations are obvious over Patil et al. in view of Patil et al. (2017).
Patil et al. discloses separation of diastereomers via chiral HPLC using ethyl acetate in hexane as eluent (par. [0500]).
Patil et al. (2017) discloses the following reaction scheme (p. 72-73) in the synthesis of a GPR119 agonist (Abstract).
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Notably, a compound identical to Formula III is reacted with a compound of Formula IV-a to obtain the above intermediate structure. The courts have additionally stated that halogens are equivalent substitutions for each other. Ex parte Wiseman, 98 USPQ 277 (1953). As such, it would be prima facie obvious for one of ordinary skill in the art to substitute the compound 41 of Patil et al., wherein the leaving group is chloro, with the above compound of Patil et al. (2017), wherein the leaving group is bromo. One would be motivated to do so, with reasonable expectation of success, as the two compounds would be expected to be functionally equivalent and have been shown to be effective intermediates in substantially analogous reaction schemes for synthesizing GPR119 compounds.
Additionally, one of ordinary skill in the art would find it prima facie obvious to apply a known method in the art (chiral separation via HPLC) in order to isolate diastereomers of Formula I, absent unexpected results.
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 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 10,954,229 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 5 of the ‘229 patent is directed toward a process of preparing the below compound.
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The process of preparing comprises the following steps.
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As in the above 102 rejection over Patil et al., the claims of the ‘229 patent are narrower in scope than, and therefore anticipate, the claimed invention.
Claims 13-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,752,622 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 1 of the ‘622 patent is directed toward the following compound.
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Regarding purity, when claiming a purer form of a known compound, it must be demonstrated that the purified material possesses properties and utilities not possessed by the unpurified material. Ex parte Reed, 1.35 U.S.P.Q. 34, 36 (P.O.B.A. 1961), on reconsideration. There exists a vast number of decisions holding that where the purification of an old product results in a mere change in degree in its properties, the purified form is unpatentable. Ex parte Windhaus, 15 USPQ 45 (POBA 1931); In re Ridgeway, 76 F.2d 602, 25 USPQ 202 (CCPA 1935); In re Merz, 97 F.2d 599, 38 USPQ
143 (CPA 1938); In re Macallum, 102 F.2d 614, 41 USPQ 146 (CCPA 1939); In re King, 107 F.2d 614, 4.3 USPQ 400 (CCPA 1939); Ex parte Sparhawk, 64 USPQ 339 (POBA 1345); In re Weilard, 154 F.2d 133. 69 USPQ 86 (CCPA 1946); In re Johnson, 94 F.2d 978, 37 USPQ 75 (CCPA 1938).
As no particular advantages have been disclosed regarding the instant invention, the claimed purified form of Formula I and forms absent any particular impurities would be prima facie obvious over the compound of the ‘622 patent, as it would be routine to optimize the purity of a compound with a known pharmaceutical utility. Similarly, selection of particle size is not a patentable modification in the absence of unobvious results. In re Rose, 105 U.S.P.Q. 237 (C.C.P.A. 1955). The particle sizes of instant claim 15 are, therefore, also considered to be prima facie obvious.
Claims 13-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 13 of U.S. Patent No. 10,208,030 B2 (cited in IDS filed 08/09/2024). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 1 of the ‘030 patent is directed toward a compound of formula (I), wherein claim 13 is directed toward particular species of formula (I) including the following compound.
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Regarding purity, when claiming a purer form of a known compound, it must be demonstrated that the purified material possesses properties and utilities not possessed by the unpurified material. Ex parte Reed, 1.35 U.S.P.Q. 34, 36 (P.O.B.A. 1961), on reconsideration. There exists a vast number of decisions holding that where the purification of an old product results in a mere change in degree in its properties, the purified form is unpatentable. Ex parte Windhaus, 15 USPQ 45 (POBA 1931); In re Ridgeway, 76 F.2d 602, 25 USPQ 202 (CCPA 1935); In re Merz, 97 F.2d 599, 38 USPQ
143 (CPA 1938); In re Macallum, 102 F.2d 614, 41 USPQ 146 (CCPA 1939); In re King, 107 F.2d 614, 4.3 USPQ 400 (CCPA 1939); Ex parte Sparhawk, 64 USPQ 339 (POBA 1345); In re Weilard, 154 F.2d 133. 69 USPQ 86 (CCPA 1946); In re Johnson, 94 F.2d 978, 37 USPQ 75 (CCPA 1938).
As no particular advantages have been disclosed regarding the instant invention, the claimed purified form of Formula I and forms absent any particular impurities would be prima facie obvious over the compound of the ‘622 patent, as it would be routine to optimize the purity of a compound with a known pharmaceutical utility. Similarly, selection of particle size is not a patentable modification in the absence of unobvious results. In re Rose, 105 U.S.P.Q. 237 (C.C.P.A. 1955). The particle sizes of instant claim 15 are, therefore, also considered to be prima facie obvious.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADELINE E BRAUN whose telephone number is (703)756-4533. The examiner can normally be reached M-F 8:30am-5:00pm ET.
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/MADELINE E BRAUN/Examiner, Art Unit 1624 08/13/2026
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