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
Claims 1-34 are pending in the application. Claims 1, 3/1, 4/1, 5/1, 25, 31 and 33 are rejected. Claims 2, 3/2, 4/2, 5/2, 6-24, 26-30, 32 and 34 are objected to.
NOTE: Claims 3-5 are multiple dependent and not all embodiments are subject to the same objections or rejections. The different embodiments are defined according to MPEP 608.01(n)(I)(F), e.g. the embodiment of claim 3 dependent upon claim 1 is referred to as “3/1” and the embodiment of claim 3 dependent upon claim 2 is referred to as “3/2,” etc.
Priority
This application is a 35 U.S.C. 371 National Stage Filing of International Application No. PCT/GB2022/050552, filed March 2nd, 2022, which claims priority under 35 U.S.C. 119(a-d) to GB2103008.5, filed March 3rd, 2021.
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statement(s) filed on October 30th, 2024 and September 5th, 2024.
Claim Objections
Claims 6-24, 26-30, 32 and 34 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claims have not been further treated on the merits.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 31 and 33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim Scope (MPEP 2163(II)(A)(1)
MPEP 2163 outlines the methodology for determining adequacy of written description. MPEP 2163(II)(A)(1) instructs “For Each Claim, Determine What the Claim as a Whole Covers”.
The instant claims are directed to “A HCN2 inhibitor for use in the treatment of” tinnitus or a related condition or migraine. The “for use in” language is considered an intended use that does not structurally limit the scope of compounds embraced by the claims. Within claim 31 and 33, no particular structure is required so long as the material is an HCN2 inhibitor.
The instant specification does not contain a strict definition for “HCN2 inhibitor” in terms of minimal properties. For instance, page 13 of the specification recites the following:
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Therefore, utility in any particular disease is not required to be considered an HCN2 inhibitor, and it would appear only a non-zero level of inhibition is required.
For the reasons above, the scope of “HCN2 inhibitor” as used in the instant rejected claims is defined by property as opposed to any particular structure.
Disclosed Support (MPEP 2163(II)(A)(2))
MPEP 2163(II)(A)(2) instructs “Review the Entire Application to Understand How Applicant Provides Support for the Claimed Invention Including Each Element and/or Step”. The specification generally discusses the field of HCN receptors on pages 3-6 and states the following on page 6:
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The statement above implies that (as of the instant filing) the structural attributes yielding HCN2 inhibitors were not fully elucidated.
Regarding particular embodiments of HCN2 inhibitors, the specification provides the following general description on page 10:
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Various structural definitions, subgeneric structures and species falling within the generic structures are provided on pages 24-75. The specification provides synthetic examples on pages 87-246 where the various synthetic examples correspond to the generic structure of instant claim 1. The specification provides biological testing beginning on page 247.
The disclosed examples that are purported to have the instantly recited property are limited to the generic structure of claim 1.
As further noted in MPEP 2163(II)(A)(2), “Such a review is conducted from the standpoint of one of ordinary skill in the art at the time the application was filed (see, e.g., Wang Labs., Inc. v. Toshiba Corp., 993 F.2d 858, 865, 26 USPQ2d 1767, 1774 (Fed. Cir. 1993)) and should include a determination of the field of the invention and the level of skill and knowledge in the art.” In this situation, a person of ordinary skill in the art would have been familiar the existence of certain HCN inhibitors, such as the following disclosure on page of U.S. Patent PGPub No. 2015/0025062 A1 by Karakossian et al.:
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U.S. Patent PGPub No. 2023/0140818 A1 by Khoo et al. similarly discloses HCN inhibitors and notes on page 16 (paragraph [0186]): “In addition to HCN4, Ivabradine can inhibit HCN1, HCN2 and HCN3 with IC50 value of between 1.5 μM and 4.5 μM.” where ivabradine has the following structure:
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As discussed above, the instant claims do not require any particular level of HCN2 inhibition. Bartels et al. (U.S. Patent PGPub No. 2022/0306607 A1) discloses compounds of the following formula:
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Despite being designed as HCN1 inhibitors, Bartels et al. demonstrate that compounds within the genus still inhibit HCN2 on page 16.
Between the instantly disclosed compounds, ivabradine and compounds of Bartels et al., a person having ordinary skill in the art would recognize that substantially varied structures can affect HCN receptors. Accordingly, the combined disclosure of the instant specification and knowledge of in art is much narrower than the instant claims given the known structural variability among compounds that can possess the instantly claimed property and the lack of detailed disclosures in the specification related to structures that (out of all possible compounds) would be HCN2 inhibitors.
Determination of Sufficient Support (MPEP 2163(II)(A)(3))
MPEP 2163(II)(A)(3) instructs “Determine Whether There is Sufficient Written Description to Inform a Skilled Artisan That Inventor was in Possession of the Claimed Invention as a Whole at the Time the Application Was Filed”. This section of the MPEP further provides the following guidance:
Possession may be shown in many ways. For example, possession may be shown by describing an actual reduction to practice of the claimed invention. Possession may also be shown by a clear depiction of the invention in detailed drawings or in structural chemical formulas which permit a person skilled in the art to clearly recognize that inventor had possession of the claimed invention. An adequate written description of the invention may be shown by any description of sufficient, relevant, identifying characteristics so long as a person skilled in the art would recognize that the inventor had possession of the claimed invention.
In this situation and as discussed above, Applicant has disclosed a generic formula but the disclosure is limited in scope relative to the claims (which are not limited by structure) and does not demonstrate that Applicant was in possession of the structural attributes across the full genus that would possess the instantly recited property. MPEP 2163 (II)(A)(3)(a)(ii) discusses support for a generic claim as follows:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above).
The same section notes the following:
Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the inventor was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." Such correlations may be established "by the inventor as described in the specification," or they may be "known in the art at the time of the filing date." See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014)
In this situation, Applicant has failed to provide “disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus.” As discussed above, the evidence in the specification along with knowledge in the art would not convince a person of skill that Applicant has demonstrated possession of the genus of HCN2 inhibitors. The same rationale applies to the “representative number” analysis where Applicant has not demonstrated “the necessary common attributes or features possessed by the members of the genus in view of the species disclosed”. The genus supported by the disclosure is substantially narrower than the rejected claims and would correspond to a structure of instant claim 1 or known HCN2 inhibitors like ivabradine.
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.
Claim 25 is 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.
Claim 25 is rejected because it refers to Table 1 of the instant specification. A claim should particularly point out and distinctly claim the subject matter which the applicant regards as his invention and, under modern claim practice, stand alone to define the invention. MPEP 2173.05(s) states “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)”
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.
Claim(s) 1, 3/1, 4/1, 5/1, 31 and 33 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by U.S. Patent PGPub No. 2013/0023566 A1 by Grove.
The prior art teaches the following compounds on pages 12 and 13 in either free or tartrate salt form:
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The compounds are embraced by instant formula (I) where R1 is H, m is 1, R2 is C1 alkyl, A is O, n is 0, R4-R6 are hydrogen, X1 is CR7, R7 is H, and p is 0. Regarding the definition of R2, the instant specification defines “C1-6 alkyl” on page 14 (paragraph [0048]) where the groups can be optionally substituted. Therefore (contrary to the definition of R1 that indicates the permissible substituents for an alkyl group), the broadest reasonable interpretation of R2 consistent with the specification is that substitution (by oxo, amino and/or alkoxy groups) is permitted. Furthermore, R2 is depicted with a variable point of attachment that would appear to permit its presence on any hydrogen atom position of the ring including the instance where R1 is hydrogen. The compounds are embraced by instnat claims 1, 3/1, 4/1 and 5/1. Regarding instant claims 31 and 33, MPEP 2112.01(II) notes: ‘"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable.’ The instant specification discloses on page 10 (paragraph [0038]) that compounds of the invention are HCN2 inhibitors. Furthermore, the limitations regarding “for use” are considered intended uses that do not structurally limit the claims.
Further regarding isntant claims 31 and 33, the prior art teaches compounds of formula (A) and (B) excluded from claim 1 by provision on page 10 and 11 of the prior art as compounds 15a and 15b. The specification discloses on page 10 (paragraph [0038]) that these compounds are HCN2 inhibitors. Furthermore, the limitations regarding “for use” are considered intended uses that do not structurally limit the claims.
Claim(s) 31 and 33 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Patent PGPub No. 2023/0140818 A1 by Khoo et al.
Khoo et al. teaches on page 16 (paragraph [0186]): “In addition to HCN4, Ivabradine can inhibit HCN1, HCN2 and HCN3 with IC50 value of between 1.5 μM and 4.5 μM.” In claims 31 and 33, the limitations regarding “for use” are considered intended uses that do not structurally distinguish from the prior art since ivabradine possesses the property of an HCN2 inhibitor.
Claim(s) 31 and 33 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Patent PGPub No. 2022/0306607 A1 by Bartels et al.
Bartels et al. disclose compounds of the following formula:
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Despite being designed as HCN1 inhibitors, Bartels et al. demonstrate that compounds within the genus still inhibit HCN2 on page 16. See, at least, example No’s. 4 and 29 in paragraph [0266]. In claims 31 and 33, the limitations regarding “for use” are considered intended uses that do not structurally distinguish from the prior art. Furthermore, the instant claims do not require any particular minimum level of “inhibition” of HCN2.
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.
Claim 33 is provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 29 of copending Application No. 18/279,796 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Claim 33 is provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 37 of copending Application No. 18/279,801 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 31 and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of copending Application No. 18/279,796 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending case case recite HCN2 inhibitors (see, for instance, claim 30 of the copending case) and where the instantly claimed limitations regarding “for use” are considered intended uses that do not structurally limit the scope of the HCN2 inhibitor.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 31 and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-38 of copending Application No. 18/279,801 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending case recite HCN2 inhibitors (see, for instance, claim 38 of the copending case) and where the instantly claimed limitations regarding “for use” are considered intended uses that do not structurally limit the scope of the HCN2 inhibitor.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 2, 3/2, 4/2 and 5/2 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626