DETAILED ACTION
Status of Application
The response filed 02/06/2026 has been received, entered and carefully considered. The response affects the instant application accordingly:
Claims 25, 35-36 have been amended.
Claims 1, 26-30, 41-43 has been cancelled.
Applicant had previously elected the disease species to be retinal blood vessel occlusion and the compound to be 3-amino-1-(3-(cyclohexylmethoxy)phenyl)propan-1-ol
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, which was expanded to include age-related macular degeneration and Stargardt’s macular dystrophy (as it is a type of macular degeneration); and the “non-retinoid compound” is expanded to include those in U.S. Pat. Pub. 2009/0062353 to address the broad breath previously claimed in claim 1. The claims as amended are to (R) 3-amino-1-(3-(cyclohexylmethoxy)phenyl)propan-1-ol
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(emixustat) and retinal blood vessel occlusion.
Claims 25, 35-36 are pending in the case.
Claims 25, 35-36 are present for examination.
The present application is being examined under the pre-AIA first to invent provisions.
All grounds not addressed in the action are withdrawn or moot as a result of amendment.
New grounds of rejection are set forth in the current office action as a result of amendment.
New Grounds of Rejection
Due to the amendment of the claims the new grounds of rejection are applied:
Claim Rejections - 35 USC § 103
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 of this title, 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.
Claims 25, 35-36 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Scott et al. (WO 2009/045479).
Rejection:
Scott el al. teaches and claims treating an ophthalmic condition including retinal blood vessel occlusion with the administration of compounds of Formula A including 3-amino-1-(3-(cyclohexylmethoxy)phenyl)propan-1-ol
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(racemic mixture of R form
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and S form
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) which is claimed (abstract, claims 38 and 40 and 61, Examples 4, 28-29, see full document specifically areas cited). Scott et al. also teach the modes of administration to include topical eye drops at doses like about 1mg to about 25mg per single dose; injections like about 0.1 to about 10mg; and oral administration from 1.0-1000mg at 1-4x or more/day ([369,371, 375-376, 380-381], see full document specifically areas cited).
While Scott et al. does not expressly teach the exact claimed values for the amount of the active, it does embrace them (i.e. eyedrops about 1mg to about 25mg per dose); wherein it would have been prima facie obvious to one of ordinary skill in the art at the time the claimed invention was made to optimize within the taught range and arrive at the claimed amounts with a reasonable expectation of success, as is not inventive to discover the optimum or workable ranges by routine experimentation when the general conditions of a claim are disclosed in the prior art; absent evidence of criticality for the claimed amounts. The effects of administering the composition are tied to the compound and its administration. When the compound is administered as claimed, the effects of the compound would be the same such as the electroretinogram response and the therapeutic profile as they are the direct result of the compound and its administration as it is the same compound being given for the same condition which is met by the art wherein the resulting properties and effect are the same as any component that materially affect the compound/composition and its resulting properties/effects would have to be present in the claim to be commensurate in scope and the specification addresses that a non-retinoid compound administered in any fashion would be expected ot have this effect..
Response to Arguments:
Applicant's arguments center on the assertion that amended claim 25 is not obvious as the selection of the compound for the treatment of retinal blood vessel occlusion at the claimed dose ranges is not taught in Scott et al. (WO 2009). This is fully considered but not persuasive as addressed above, Scott et al. does teach and claim treating retinal blood vessel occlusion with the administration of compounds of Formula A which include 3-amino-1-(3-(cyclohexylmethoxy)phenyl)propan-1-ol
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which is the racemic mixture of R form
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and S form and is claimed; with doses that embrace the claimed values wherein optimization of the dose within the taught range to arrive at the claimed values to attain the desired therapeutic profile is prima facie obvious with a reasonable expectation of success absent evidence of criticality for the claimed values which has not been presented.
Accordingly, the rejection stands.
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 25, 35-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 7982071.
The patented claims are directed to the compound
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and its isomer
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The claims of the patent do not teach the specific utility of its use in conditions like retinal blood vessel occlusion as recited in the instant claims. However it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to arrive at this utility because the patent disclosure teaches this utility (e.g. Col. 19 line 30-35, Col. 20 line 63-67) and its effective amount (i.e. about 1mg to about 25mg); wherein there are certain instances when the disclosure of the earlier patent may be used in the obviousness type double patenting analysis. The specification can be used as a dictionary to learn the meaning of a term in the patent claim and portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent; as the patented compounds must have a utility. As the patent discloses the utility for retinal blood vessel occlusion for these compounds in the known modalities, the nonstatutory obviousness double patenting exists between the patent and the instant claims. It would also be prima facie obvious to optimize within the disclosed effective amount for this utility to attain the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed values. The effects of administering the composition are tied to the compound and its administration. When the compound is administered as claimed, the effects of the compound would be the same such as the electroretinogram response and the therapeutic profile as they are the direct result of the compound and its administration as it is the same compound being given for the same condition which is met by the claim wherein the resulting properties and effect are the same as any component that materially affect the compound/composition and its resulting properties/effects would have to be present in the claim to be commensurate in scope and the specification addresses that a non-retinoid compound administered in any fashion would be expected ot have this effect.
Response to Arguments:
Applicant request the rejection be held in abeyance. There is no terminal disclaimer.
Accordingly, the rejection stands.
Claims 25, 35-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-8 of U.S. Patent No. 8981153.
The patented claims are directed to the formula containing compound
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and its isomer
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The claims of the patent do not teach the specific utility of its use in conditions like retinal blood vessel occlusion as recited in the instant claims. However it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to arrive at this utility because the patent disclosure teaches this utility (e.g. Col. 19 line 30-35, Col. 20 line 63-67) and its effective amount (i.e. about 1mg to about 25mg); wherein there are certain instances when the disclosure of the earlier patent may be used in the obviousness type double patenting analysis. The specification can be used as a dictionary to learn the meaning of a term in the patent claim and portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent; as the patented compounds must have a utility. As the patent discloses the utility for retinal blood vessel occlusion for these compounds in the known modalities, the nonstatutory obviousness double patenting exists between the patent and the instant claims. It would also be prima facie obvious to optimize within the disclosed effective amount for this utility to attain the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed values. The effects of administering the composition are tied to the compound and its administration. When the compound is administered as claimed, the effects of the compound would be the same such as the electroretinogram response and the therapeutic profile as they are the direct result of the compound and its administration as it is the same compound being given for the same condition which is met by the claim wherein the resulting properties and effect are the same as any component that materially affect the compound/composition and its resulting properties/effects would have to be present in the claim to be commensurate in scope and the specification addresses that a non-retinoid compound administered in any fashion would be expected ot have this effect.
Response to Arguments:
Applicant request the rejection be held in abeyance. There is no terminal disclaimer.
Accordingly, the rejection stands.
Claims 25, 35-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 65-76 of copending Application No. 18/379142.
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims are directed to treating some of the same claimed diseases (i.e. retinal vein/artery occlusion, retinal blood vessel occlusion) with the same compound and its stereoisomers wherein they are obvious. The copending claims also recite the same dose amounts and therein obvious over the instant claims. The effects of administering the composition are tied to the compound and its administration. When the compound is administered as claimed, the effects of the compound would be the same such as the electroretinogram response and the therapeutic profile as they are the direct result of the compound and its administration as it is the same compound being given for the same condition which is met by the claim wherein the resulting properties and effect are the same as any component that materially affect the compound/composition and its resulting properties/effects would have to be present in the claim to be commensurate in scope.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments:
Applicant request the rejection be held in abeyance. There is no terminal disclaimer.
Accordingly, the rejection stands.
Conclusion
Claims 25, 35-36 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GIGI GEORGIANA HUANG whose telephone number is (571)272-9073. The examiner can normally be reached Monday-Thursday 9:00-5:00pm.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613
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