DETAILED ACTION
This office action is in response to applicant’s filing September 14, 2026.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
Claims 1-20 are pending in the instant application. Acknowledgement is made of Applicant's amendments filed September 14, 2026. Acknowledgement is made of Applicant's amendment of claims 3-11; and addition of new claims 12-20.
Election of Species
Applicant’s election without traverse of a formulation species comprising a α2-receptor agonist, brimonidine, in the reply filed on September 14, 2026 is acknowledged.
Claims 4, 6-11, 13, and 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 14, 2026.
Claims 1-3, 5, 12, and 14 are presently under examination as they relate to the elected species: brimonidine.
Priority
The present application is a Continuation of US Application No. 17/358,883 filed on June 25, 2021, which is a Continuation of US Application No. 16/578,679 filed on September 23, 2019, which is a Continuation of US Application No. 15/132,768 filed on April 19, 2016, which is a Continuation of US Application No. 13/939,381 filed on July 11, 2013, which claims benefit of US Provisional Application No. 61/671,219 filed on July 13, 2012.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 3, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner, except where marked with a strikethrough.
Duplicate Claims
Applicant is advised that should claims 1, 3, and 5 be found allowable, claims 2, 12, and 14 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-3, 5, 12, and 14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Prasanna et al (US 2008/0045545 A1, cited in the IDS filed April 3, 2024) in view of Hagihara et al (WO 2010/113957, cited in the IDS filed April 3, 2024).
WO 2010/113957 (Hagihara) is the PCT counterpart to US 2012/0190852 (Hagihara). WO 2010/113957 has a 102(a)(1) date as a result of its October 7, 2010 publication date. Because WO 2010/113957 and US 2012/0190852 appear to have identical disclosures, and because the WO document was published in Japanese language designating the United States, the US 2012/0190852, which is the National Stage entry of WO 2010/113957, is being used as a translation of WO 2010/113957. As such, any reference hereinafter to column and line numbers will be based upon the US publication, but should be interpreted as referring to the corresponding disclosure of the aforementioned WO counterpart.
Regarding claims 1-3, 5, 12, and 14, Prasanna teaches a pharmaceutical composition containing EP2 agonists for lowering intraocular pressure and thereby treating glaucoma (abstract); an EP2 agonist for lowering intraocular pressure is the compound depicted as Compound 1 below ([0144 and claims 7 and 9]):
Compound 1
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Compound 1 is structurally similar to the instantly claimed compound, isopropyl (6-{[4-(pyrazol-1-yl)benzyl](pyridin-3-ylsulfonyl) aminomethyl}pyridin-2-ylamino)acetate, depicted as Claimed compound below:
Claimed Compound
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Compound 1 differs from the instantly claimed compound in positions denoted by dashed circles labeled A and B. In particular, Compound 1 does not contain an N in position A and contains an NH (amino) moiety at position B instead of an O (oxygen) moiety at position B. Moreover, Prasanna et al teach EP2 agonist compounds are administered alone or in combination with one or more other EP2 agonist compounds or in combination with one or more other drugs (or as any combination thereof) including a alpha2-adrenergic receptor
agonist such as brimonidine (Alphagan); generally, such drugs and/or combinations thereof will be administered as a formulation in association with one or more pharmaceutically acceptable excipients [0108]. Thus, Prasanna teaches a composition for treating glaucoma or for lowering intraocular pressure comprising a structurally similar EP2 agonist and brimonidine.
Prasanna does not explicitly teach the EP2 agonist is the claimed compound, isopropyl (6-{[4-(pyrazol-1-yl)benzyl](pyridin-3-ylsulfonyl) aminomethyl}pyridin-2-ylamino)acetate.
However, Hagihara teaches a medical composition for the treatment or prophylaxis of glaucoma which comprises Compound 1473, isopropyl (6-{[4-(pyrazol-1-yl)benzyl](pyridin-3-ylsulfonyl) aminomethyl}pyridin-2-ylamino)acetate (claims 1 and 18) and Compound 1473 is exemplified as a most preferred EP2 agonist compound ([0391] and [0420]).
Since Prasanna teaches a composition for treating glaucoma or for lowering intraocular pressure comprising a structurally similar EP2 agonist and brimonidine, and since Hagihara teaches Compound 1473 is an EP2 agonist for treating glaucoma and lowering intraocular pressure, at the time of the invention it would have been prima facie obvious for a person of ordinary skill in the art to substitute one functional equivalence (any EP2 agonist) for another (Compound 1473) with an expectation of success, since the prior art establishes that both function in similar manner, thus resulting in the practice of claims 1-3, 5, 12, and 14, with a reasonable expectation of success.
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 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 1-3 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 9,339,496 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The previously granted claims are directed to a composition for treating glaucoma or ocular hypertension comprising the claimed compound and the therapeutic drug for glaucoma or ocular hypertension, timolol. Thus, the composition of the previously granted claims would anticipate the instantly claimed composition.
Claims 1-3 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,974,994 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The previously granted claims are directed to a composition for treating glaucoma or ocular hypertension comprising the claimed compound and the therapeutic drug for glaucoma or ocular hypertension, timolol. Thus, the composition of the previously granted claims would anticipate the instantly claimed composition.
Conclusion
Claims 1-3, 5, 12, and 14 are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm, Monday - Thursday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Rayna Rodriguez/ Primary Examiner, Art Unit 1628
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