DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
This application is a DIV of US Patent 11897885, which is a DIV of US Patent 11292795, which is a CON of US Patent 10807981, which is a CON of US Patent 10370377, which is a DIV of US Patent 9981966, which is a CON of US Patent 9896453, which is a CON of US Patent 9371325, which is a CON of US Patent 9199997, which is the national stage filing of PCT/JP2012/080769, filed 11/28/2012, and claims the benefit of foreign priority to JP2011-259662, filed 11/29/2011.
A certified translation of JP2011-259662 was submitted 10/29/2025 and is acknowledged.
Response to Amendments/Arguments
Applicant’s amendments and arguments filed 2/19/26 are acknowledged and have been entered. Any rejection and/or objection not specifically addressed below in original or modified form is herein withdrawn.
With regards to the 102(e) rejection, Applicant is correct that the certified translation was timely filed in response to a rejection and has been accepted as sufficient to overcome the 102(e) rejection. It is greatly appreciated that applicant has identified where support for the instant claims was found in the priority document.
With regards to the NSDP rejection over US 8557803, the terminal disclaimer filed on 2/19/26 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US 8557803 has been reviewed and is accepted. The terminal disclaimer has been recorded.
With regards to the Statutory Double Patenting rejection of claims 15-19 over claims 1 of ‘997, applicant argues that the subject matter is not identical, and therefore the non-statutory double patenting rejection is improper. Applicant highlights that claim 1 of ‘997 is to the compound HCl salt written out as: 6-Amino-9-[(3R)-1-(2-butynoyl)-3-pyrrolidinyl]-7-(4-phenoxyphenyl)-7,9-dihydro-8H-purin-8-one hydrochloride, while the instant claims are to the HCl salt of the compound, depicted as:
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, claimed as a product-by-process. Applicant argues the claims are not identical in subject matter.
Applicant’s arguments have been considered, but are not persuasive. The instant claims are at their heart a compound, specifically the HCl salt of the compound, and it is, contrary to applicant’s assertion, the same as that of ‘997. Considering all parts of the claim, the preamble "A pharmaceutical compound" does not create a patentable distinction for the purpose of avoiding same-invention double patenting, as the claim ultimately defines the same specific hydrochloride salt as the '997 patent, rather than a distinct composition or formulation, and recitation of “pharmaceutical” before “compound” does not change the compound in any appreciable manner. Further, as stated in MPEP 2113:
"Even 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)
Here, the product-by-process steps are not imparting any unique structure, as the claim is to the HCl salt of the compound, and not to a process of making the HCl salt, nor would one having the salt prepared by the process within the instant claims be able to distinguish it from the salt claimed in ‘997. Similarly, if the claims were to a composition comprising the HCl salt, the scope of the claims could be construed as distinct enough because the composition could contain additional elements, such as contaminants that are not found in a discrete “compound”; however, as drafted, and compared to the prior patent claims, there is no discernable distinction. Furthermore, even if the prior examiner was inadvertently using “prior art” instead of “prior patent claims”, the implication is the same- the prior patent contains- in the claims- the identical subject matter of the instant claims, even if worded, or presented differently. Accordingly, the rejection is maintained and restated below.
Claims 14-19 are pending and have been examined on the merits.
Claim Rejections - 35 USC § 112
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.
Claims 16-19 are 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.
While the claims are product-by-process, the claims are drawn to “A pharmaceutical compound”, and the steps recited do not limit the compound that is claimed in any discernable manner, and the steps do not impart any unique or identifying characteristic to “A pharmaceutical compound”, and as such the claims are not further limiting of claim 15. This is in contrast to a composition or method of making, where it could be conceived that the added steps add, or remove, impurities that may be present if not for those additional steps, however as the claims are to a compound, there is no distinction.
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.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 15-19 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of prior U.S. Patent No. 9199997 (IDS 12/23/26). This is a statutory double patenting rejection. The instant claims are to “A pharmaceutical compound” as the HCl salt and ‘997 is to the compound HCl salt.
The preamble "A pharmaceutical compound" also does not create a patentable distinction for the purpose of avoiding same-invention double patenting, as the claim ultimately defines the same specific hydrochloride salt as the '997 patent, rather than a distinct composition or formulation. As stated in MPEP 2113:
"Even 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)
Here, the product-by-process steps are not imparting any unique structure, as the claim is to the HCl salt of the compound, and not to a process of making the HCl salt, nor would one having the salt prepared by the process within the instant claims be able to distinguish it from the salt claimed in ‘997. Placing the claims side-by-side, the 6-Amino-9-[(3R)-1-(2-butynoyl)-3-pyrrolidinyl]-7-(4-phenoxyphenyl)-7,9-dihydro-8H-purin-8-one hydrochloride, while the instant claims are to the HCl salt of the compound, depicted as:
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, even when claimed as a product-by-process would be indistinguishable one from another.
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 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. 10487085 (IDS 10/29/25) in view of GOULD (P.L. Gould. Salt selection for basic drugs. Int. J. Pharm. 33 (1986) 201-217).
The instant claims are to the compound 6-Amino-9-[(3R)-1-(2-butynoyl)-3-pyrrolidinyl]-7-(4-phenoxyphenyl)-7,9-dihydro-8H-purin-8-one hydrochloride, depicted as:
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.
‘085 claims a pharmaceutical composition of the compound
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or a pharmaceutically acceptable salt thereof. ‘085 does not explicitly claim the HCl salt.
As taught by Gould, monoprotic hydrochlorides have historically been “by far the most frequent (40%) choice of the available anionic salt-forming species.” (page 203, also see Table 1). This prevalence is attributed to their simple availability, physiological compatibility, and the general understanding that they often provide the maximum obtainable concentration for a given amine, thereby facilitating absorption (throughout). Given this strong precedent, the selection of a hydrochloride salt is a standard and expected practice in drug development. Gould states, “Thus, there is clear precedent, and an overwhelming argument on many grounds to immediately progress to the hydrochloride salt and evaluate other forms only if problems with the hydrochloride emerge.” (page 203).
Here, the compound of ‘085 has a basic amine group, and would choose the HCl salt as the first choice of a pharmaceutical salt, as Gould provides that it is the primary choice for making pharmaceutical salts of basic drugs. Further, hydrochloride salts are frequently chosen due to their simple availability, physiological suitability, and clear precedent in drug development, often providing the maximum obtainable drug concentration and ensuring absorption for basic drugs (e.g. pages 203 and 209) and there is an “overwhelming argument” to “immediately progress to the hydrochloride salt” (page 203). Given that ‘085 teaches the compound and broadly “a pharmaceutically acceptable salt,” there would be a strong expectation of success in preparing the hydrochloride salt, as it is recognized as “by far the most frequent (40%) choice” and a standard starting point for salt selection (page 203).
Claims 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, and 7 of U.S. Patent No. 8940725 (IDS 12/26/23) in view of GOULD.
The instant claims and teachings of Gould are presented above.
‘725 claims the compound 6-Amino-9-[1-(2-butynoyl)-3-pyrrolidinyl]-7-(4-phenoxyphenyl)-7,9-dihydro-8H-purin-8-one hydrochloride (compound (7) of the claim), “or an optical isomer thereof or their mixture.” The claims are further to a pharmaceutical composition comprising the compound or optical isomer thereof, or a salt, solvate, on N-oxide thereof. ‘725 does not explicitly claim the (3R) form, nor does it claim the HCl salt.
With regards to the (3R) isomer, ‘725 embraces all stereoisomers, and because there are so few isomers- (3R) and (3S), one could at once envisage all isomers and the combination, including the instant (3R) isomer. With regards to the salt, as above, the compound of ‘725 has a basic amine group, and would choose the HCl salt as the first choice of a pharmaceutical salt, as Gould provides that it is the primary choice for making pharmaceutical salts of basic drugs. Further, hydrochloride salts are frequently chosen due to their simple availability, physiological suitability, and clear precedent in drug development, often providing the maximum obtainable drug concentration and ensuring absorption for basic drugs (e.g. pages 203 and 209) and there is an “overwhelming argument” to “immediately progress to the hydrochloride salt” (page 203). Given that ‘725 teaches the compound and broadly “a pharmaceutically acceptable salt,” there would be a strong expectation of success in preparing the hydrochloride salt, as it is recognized as “by far the most frequent (40%) choice” and a standard starting point for salt selection (page 203).
Claims 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 9926322 (IDS 10/29/25) in view of GOULD.
The instant claims and teachings of Gould are presented above.
‘322 claims the method of treating diseases via administration of 6-Amino-9-[(3R)-1-(2-butynoyl)-3-pyrrolidinyl]-7-(4-phenoxyphenyl)-7,9-dihydro-8H-purin-8-one, or a salt thereof. Gould does not teach the HCl salt. Though drawn to a method, ‘322 is of a different lineage than the instant application, and not a result of a restriction, such that to practice the method of ‘322, one necessarily must be in possession of the compound.
As taught by Gould, monoprotic hydrochlorides have historically been “by far the most frequent (40%) choice of the available anionic salt-forming species.” (page 203, also see Table 1). This prevalence is attributed to their simple availability, physiological compatibility, and the general understanding that they often provide the maximum obtainable concentration for a given amine, thereby facilitating absorption (throughout). Given this strong precedent, the selection of a hydrochloride salt is a standard and expected practice in drug development. Gould states, “Thus, there is clear precedent, and an overwhelming argument on many grounds to immediately progress to the hydrochloride salt and evaluate other forms only if problems with the hydrochloride emerge.” (page 203).
Here, the compound of ‘322 has a basic amine group, and would choose the HCl salt as the first choice of a pharmaceutical salt, as Gould provides that it is the primary choice for making pharmaceutical salts of basic drugs. Further, hydrochloride salts are frequently chosen due to their simple availability, physiological suitability, and clear precedent in drug development, often providing the maximum obtainable drug concentration and ensuring absorption for basic drugs (e.g. pages 203 and 209) and there is an “overwhelming argument” to “immediately progress to the hydrochloride salt” (page 203). Given that ‘085 teaches the compound and broadly “a pharmaceutically acceptable salt,” there would be a strong expectation of success in preparing the hydrochloride salt, as it is recognized as “by far the most frequent (40%) choice” and a standard starting point for salt selection (page 203).
Allowable Subject Matter
Claim 14 is allowable. In light of the certified translation of the priority document, the outstanding 102(e) rejection was withdrawn, and the reference no longer is applicable. It is noted that claim 14 could be shortened to remove the redundant preamble.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew D Kosar whose telephone number is (571)272-0913. The examiner can normally be reached Monday-Friday, 7am-3:30pm.
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/Andrew D Kosar/ Supervisory Patent Examiner, Art Unit 1625
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