DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-17 and 33-36 are pending.
Priority
Instant application 18/742,035, filed 06/13/2024 claims priority as follows:
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Information Disclosure Statement
All references from IDS(s) received 07/02/2025 have been considered unless marked with a strikethrough.
Claim Objections
Claim 36 is objected to because of the following informalities: claim 36 contains a typographical error. Claim 36 sets forth a Markush group with “wherein the disease…is…” but should instead recite “wherein the disease…is selected from the group consisting of…”
Appropriate correction is required.
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.
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 1-16 and 35-36 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.
Claim 1 recites that R1 is OH or “optionally substituted ester”. The recitation of “optionally substituted ester” for R1 in claim 1 is indefinite. R1 is attached to a carbonyl carbon. If R1 is actually an ester (as recited), then the resulting moiety has the structure:
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or
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.
Neither of the above structures appears to be the intended structure. See, e.g., the compound of para. [0254] in the spec as an example of a compound having an “ester” moiety:
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In the above compound, R1 is an alkoxy group (-OCH2CH3). Calling R1 an “ester” is chemically ambiguous because it conflates the resulting functional group (ester) with the actual atoms comprising R1 (alkoxy), making it unclear what R1 actually is.
Therefore, claim 1 is indefinite. Claims 2-16 and 34-36 depend from claim 1 and carry forward the issue identified above. Therefore, these claims are also rejected as indefinite.
Clarification of the claim language is required.
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 17 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by KAWAMOTO (US 20070299086 A1; published 2007).
Kawamoto discloses the following compounds which anticipate claim 17:
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(page 26, [0261])
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(page 26, [0262]).
The first compound anticipates claim 17 when A is aryl, substituted with halo (chloro); R2a and R2b are each independently H; and R3a and R3b are each independently H. The second compound anticipates claim 17 when A is aryl, substituted with C1 alkyl (methyl); R2a and R2b are each independently H; and R3a and R3b are each independently H. See also the compounds in Table VIII on page 24 (Nos. 319-327).
Please note: the proviso in claim 17 requiring that at least one of R2a, R2b, R3a, and R3b is -OH:
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Does not apply to the following alternative limitation:
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The second limitation above allows R2a, R2b, R3a, and R3b in Formula (II) to each independently be H.
Therefore, claim 17 is anticipated by Kawamoto.
Claim Rejections - 35 USC § 103
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.
Claims 1-2, 16, 17, and 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over KAWAMOTO (US 20070299086 A1).
Kawamoto discloses compounds having the formula (page 24, [0250]-[0251]):
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Relevant compounds disclosed by Kawamoto include those in Table VIII (Nos. 265-345) and Table XIV ([0305], Nos. 559-576). See the following selection of exemplary compounds from Kawamoto which are closest to the claim 16 compound wherein ring A is
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:
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The sole difference between Kawamoto’s compounds and the claimed compounds is that the claimed compounds comprise one or two additional methylene (-CH2-) moieties between the amide nitrogen and ester carbonyl carbon. The claimed compounds are therefore homologs of Kawamoto’s compounds.
MPEP 2144.09, second paragraph, states, “Compounds which are position isomers or
homologs are generally of sufficiently close structural similarity that there is a presumed
expectation that such compounds possess similar properties.” In re Wilder, 563 F.2d 457, 195
USPQ 426 (CCPA 1977). The homolog is expected to be preparable by the same method and to
have generally the same properties. This expectation is then deemed the motivation for
preparing the homolog. This circumstance has arisen many times. See In re Schechter and
LaForge, 98 USPQ 144, 150, which states “a novel useful chemical compound which is homologous or isomeric with compounds of the prior art is unpatentable unless it possesses some
unobvious or unexpected beneficial property not possessed by the prior art compounds.” See In
re Wilder, 166 USPQ 545, 548. Note also In re Deuel 34 USPQ2d 1210, 1214 which states, “Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds … a known compound may suggest its analogs or
isomers, either geometric isomers (cis v. trans) or position isomers (e.g., ortho v. para).”
Moreover, Kawamoto discloses a broad genus and contemplates a linking unit (L) comprising “one or more optionally substituted methylene units having the formula:
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wherein R8 and Rb are each independently hydrogen, C1-C6 linear or branched alkyl, or phenyl; and the index y is from 1 to 4” (page 7, [0155]). Kawamoto therefore provides a suggestion to prepare compounds having 1 to 4 linking carbon atoms between the amide nitrogen and carbonyl carbon.
Kawamoto’s compounds are disclosed as prolyl hydroxylase inhibitors (title, abstract). Therefore, compounds reading on instant claims 1-2, 16, and 17 and their utility as prolyl hydroxylase inhibitors would have been prima facie obvious before the effective filing date of the instant application. A skilled artisan would have been motivated to prepare a homolog of
Kawamoto’s compounds disclosed above with a reasonable expectation of success in obtaining compounds with utility for treating a disease mediated by PHD1 activity.
With respect to claims 35-36, Kawamoto teaches the application of the compounds for treating a disease or disorder including skeletal muscle and myocardial ischemia, stroke, coronary artery disease, peripheral vascular disease, coronary artery disease, and cancer (Kawamoto, claims 29-33). It would have therefore been prima facie obvious to apply the homologs prepared from Kawamoto’s compounds in a method for treating a disease mediated by PHD1 activity; wherein the disease is an ischemic reperfusion injury, cancer, atherosclerosis, and cardiovascular disease.
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.
18/041,490
Claims 1-9, 14, 16-17, and 35-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 10, 13-14, 16-17, 21-25, 29-30, 61-62, and 64 of copending Application No. 18/041,490.
The reference application recites compounds of Formula (I):
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The difference between the reference application’s compounds and the claimed compounds is that the claimed compounds comprise one or two additional methylene (-CH2-) moieties between the amide nitrogen and ester carbonyl carbon. The claimed compounds are therefore homologs of the reference application’s compounds.
MPEP 2144.09, second paragraph, states, “Compounds which are position isomers or
homologs are generally of sufficiently close structural similarity that there is a presumed
expectation that such compounds possess similar properties.” In re Wilder, 563 F.2d 457, 195
USPQ 426 (CCPA 1977). The homolog is expected to be preparable by the same method and to
have generally the same properties. This expectation is then deemed the motivation for
preparing the homolog. This circumstance has arisen many times. See In re Schechter and
LaForge, 98 USPQ 144, 150, which states “a novel useful chemical compound which is homologous or isomeric with compounds of the prior art is unpatentable unless it possesses some
unobvious or unexpected beneficial property not possessed by the prior art compounds.” See In
re Wilder, 166 USPQ 545, 548. Note also In re Deuel 34 USPQ2d 1210, 1214 which states, “Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds … a known compound may suggest its analogs or
isomers, either geometric isomers (cis v. trans) or position isomers (e.g., ortho v. para).”
The reference application’s compounds are disclosed as prolyl hydroxylase inhibitors (title, abstract). Therefore, compounds reading on instant claims 1-2, 16, and 17 and their utility as prolyl hydroxylase inhibitors would have been prima facie obvious before the effective filing date of the instant application. A skilled artisan would have been motivated to prepare a homolog of the reference application’s recited compounds with a reasonable expectation of success in obtaining compounds with utility for treating a disease mediated by PHD1 activity.
With respect to claims 35-36, the reference application discloses the application of the compounds for treating a disease or disorder reading on the instant claims (reference application, [0005]). It would have therefore been prima facie obvious to apply the homologs prepared from the reference application compounds in a method for treating a disease mediated by PHD1 activity; wherein the disease is an ischemic reperfusion injury, irritable bowel disease, cancer, liver disease, atherosclerosis, and cardiovascular disease.
This is a provisional nonstatutory double patenting rejection.
18/742,052
Claims 1-17 and 35-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7-17, 33-34, 38, and 42-44 of copending Application No. 18/742,052.
The reference application recites compounds of Formula (I):
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The reference application recites compounds which read on the instant claims. As a (non-exhaustive) example, the compound 49:
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reads on the instant claims when in Formula (I), A is
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; R2b and R2a are each H; n is 1; R3a is H; and R3b is C1 alkyl (methyl).
With respect to claims 35-36, the reference application recites (e.g. claims 33-34) a method for treating a disease mediated by PHD1 activity with compounds reading on the claims, wherein the disease is an ischemic reperfusion injury, irritable bowel disease, cancer, liver disease, atherosclerosis, and cardiovascular disease.
This is a provisional nonstatutory double patenting rejection.
US 7,811,595 B2
Claims 1-2, 16, 17, and 35-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. 7,811,595. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference patent recite compounds such as (claim 26):
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and
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.
The above compounds anticipate instant claim 17.
Additionally, the reference patent recites compounds such as (claim 26):
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.
The difference between the reference patent’s compounds and the claimed compounds is that the claimed compounds comprise one or two additional methylene (-CH2-) moieties between the amide nitrogen and ester carbonyl carbon. The claimed compounds are therefore homologs of the reference patent’s compounds.
MPEP 2144.09, second paragraph, states, “Compounds which are position isomers or
homologs are generally of sufficiently close structural similarity that there is a presumed
expectation that such compounds possess similar properties.” In re Wilder, 563 F.2d 457, 195
USPQ 426 (CCPA 1977). The homolog is expected to be preparable by the same method and to
have generally the same properties. This expectation is then deemed the motivation for
preparing the homolog. This circumstance has arisen many times. See In re Schechter and
LaForge, 98 USPQ 144, 150, which states “a novel useful chemical compound which is homologous or isomeric with compounds of the prior art is unpatentable unless it possesses some
unobvious or unexpected beneficial property not possessed by the prior art compounds.” See In
re Wilder, 166 USPQ 545, 548. Note also In re Deuel 34 USPQ2d 1210, 1214 which states, “Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds … a known compound may suggest its analogs or
isomers, either geometric isomers (cis v. trans) or position isomers (e.g., ortho v. para).”
The reference patent’s compounds are disclosed as prolyl hydroxylase inhibitors (title, abstract). Therefore, compounds reading on instant claims 1-2, 16, and 17 and their utility as prolyl hydroxylase inhibitors would have been prima facie obvious before the effective filing date of the instant application. A skilled artisan would have been motivated to prepare a homolog of the reference patent’s recited compounds with a reasonable expectation of success in obtaining compounds with utility for treating a disease mediated by PHD1 activity.
With respect to claims 35-36, the reference patent discloses the application of the compounds for treating a disease or disorder reading on the instant claims. It would have therefore been prima facie obvious to apply the homologs prepared from the reference application compounds in a method for treating a disease mediated by PHD1 activity; wherein the disease is an ischemic reperfusion injury, irritable bowel disease, cancer, liver disease, atherosclerosis, and cardiovascular disease.
US 8,323,671 B2
Claims 1-2, 16, 17, and 35-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-47 of U.S. Patent No. 8,323,671. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference patent recite compounds such as (claim 40):
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and
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.
The above compounds anticipate instant claim 17.
Additionally, the reference patent recites compounds such as (claim 26):
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.
The difference between the reference patent’s compounds and the claimed compounds is that the claimed compounds comprise one or two additional methylene (-CH2-) moieties between the amide nitrogen and ester carbonyl carbon. The claimed compounds are therefore homologs of the reference patent’s compounds.
MPEP 2144.09, second paragraph, states, “Compounds which are position isomers or
homologs are generally of sufficiently close structural similarity that there is a presumed
expectation that such compounds possess similar properties.” In re Wilder, 563 F.2d 457, 195
USPQ 426 (CCPA 1977). The homolog is expected to be preparable by the same method and to
have generally the same properties. This expectation is then deemed the motivation for
preparing the homolog. This circumstance has arisen many times. See In re Schechter and
LaForge, 98 USPQ 144, 150, which states “a novel useful chemical compound which is homologous or isomeric with compounds of the prior art is unpatentable unless it possesses some
unobvious or unexpected beneficial property not possessed by the prior art compounds.” See In
re Wilder, 166 USPQ 545, 548. Note also In re Deuel 34 USPQ2d 1210, 1214 which states, “Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds … a known compound may suggest its analogs or
isomers, either geometric isomers (cis v. trans) or position isomers (e.g., ortho v. para).”
The reference patent’s compounds are disclosed as prolyl hydroxylase inhibitors (title, abstract). Therefore, compounds reading on instant claims 1-2, 16, and 17 and their utility as prolyl hydroxylase inhibitors would have been prima facie obvious before the effective filing date of the instant application. A skilled artisan would have been motivated to prepare a homolog of the reference patent’s recited compounds with a reasonable expectation of success in obtaining compounds with utility for treating a disease mediated by PHD1 activity.
With respect to claims 35-36, the reference patent discloses the application of the compounds for treating a disease or disorder reading on the instant claims. It would have therefore been prima facie obvious to apply the homologs prepared from the reference application compounds in a method for treating a disease mediated by PHD1 activity; wherein the disease is an ischemic reperfusion injury, irritable bowel disease, cancer, liver disease, atherosclerosis, and cardiovascular disease.
US 8,343,952 B2
Claims 1-2, 16, 17, and 35-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. 8,343,952. The reference patent recites compounds such as (claim 27):
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and
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The difference between the reference patent’s compounds and the claimed compounds is that the claimed compounds comprise one or two additional methylene (-CH2-) moieties between the amide nitrogen and ester carbonyl carbon. The claimed compounds are therefore homologs of the reference patent’s compounds.
MPEP 2144.09, second paragraph, states, “Compounds which are position isomers or
homologs are generally of sufficiently close structural similarity that there is a presumed
expectation that such compounds possess similar properties.” In re Wilder, 563 F.2d 457, 195
USPQ 426 (CCPA 1977). The homolog is expected to be preparable by the same method and to
have generally the same properties. This expectation is then deemed the motivation for
preparing the homolog. This circumstance has arisen many times. See In re Schechter and
LaForge, 98 USPQ 144, 150, which states “a novel useful chemical compound which is homologous or isomeric with compounds of the prior art is unpatentable unless it possesses some
unobvious or unexpected beneficial property not possessed by the prior art compounds.” See In
re Wilder, 166 USPQ 545, 548. Note also In re Deuel 34 USPQ2d 1210, 1214 which states, “Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds … a known compound may suggest its analogs or
isomers, either geometric isomers (cis v. trans) or position isomers (e.g., ortho v. para).”
The reference patent’s compounds are disclosed as prolyl hydroxylase inhibitors (title, abstract). Therefore, compounds reading on instant claims 1-2, 16, and 17 and their utility as prolyl hydroxylase inhibitors would have been prima facie obvious before the effective filing date of the instant application. A skilled artisan would have been motivated to prepare a homolog of the reference patent’s recited compounds with a reasonable expectation of success in obtaining compounds with utility for treating a disease mediated by PHD1 activity.
With respect to claims 35-36, the reference patent discloses the application of the compounds for treating a disease or disorder reading on the instant claims. It would have therefore been prima facie obvious to apply the homologs prepared from the reference application compounds in a method for treating a disease mediated by PHD1 activity; wherein the disease is an ischemic reperfusion injury, irritable bowel disease, cancer, liver disease, atherosclerosis, and cardiovascular disease.
Allowable Subject Matter
Claims 33-34 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
Claims 1-17 and 35-36 are rejected. Claims 33-34 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kyle Nottingham whose telephone number is (571)270-0640. The examiner can normally be reached M-F from 10:00 am - 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.N./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
Prosecution Insights