DETAILED ACTION
Status of Application
The response filed 08/13/2026 has been received, entered and carefully considered. The response affects the instant application accordingly:
Claims 1-3, 10, 15 have been amended.
Claim 9 has been cancelled.
Applicant had previously elected Group I with the species election of the ocular condition to be corneal neovascularization with the specific condition of inflammation caused by contact lens use, the species election of pDC activator (neuropeptide receptor agonist to be THIQ which is a melanocortin-4 receptor activator (((3R)-N-[(2R)-3-(4- chlorophenyl)-1-[4-cyclohexyl4-(1,24-tazo-1-ylmethyl)piperidin-1-y]-1-oxopropan-2-yl1,2,3,4- tetrahydroisoquinoline-3-carboxamide), and the route of administration to be directly to the eye with the specific means of subconjunctival injection; which was expanded to include the corneal neovascular condition of dry eye and neovascularization/inflammation associated with a corneal transplant and its rejection, the species of melanocortin-4 receptor agonist is expanded to include bremelanotide (also activates melanocortin-4 receptor, nonselective), the species for the route of administration is expanded to topical to the eye (i.e. eyedrops).
Claims 1-8, 10-26 are pending.
Claims 4-8, 13-14, 20-21, 24-26 are withdrawn being drawn to a non-elected subject matter
Claims 1-3, 10-12, 15-19, 22-23 are present for examination at this time.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
All grounds not addressed in the action are withdrawn or withdrawn as a result of amendment.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 § 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.
Claims 1-3, 10-12, 15-19, 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dodd et al. (WO 2009/120656).
It is noted that there is no recitation for the specific patient population (i.e. a patient in need thereof) wherein the administration of the melanocortin agonist like the claimed bremelanotide would inherently address any corneal neovascularization/inflammation from dry eye, dry eye from contact lens wear, or corneal transplant/rejection and its rejection that would be present.
Rejection:
Dodd et al. teaches and claims treating a mammalian subject with an ocular inflammatory disease with the administration of a melanocortin agonist (claim 1). The melanocortin agonist claimed is Ac-Nle-cyclo(- Asp-His-D-Phe-Arg-Trp-Lys)-OH which is also known as bremelanotide (claim 6, Page 4 line 13-17) and administered to the eye by eyedrops (claims 10-11). It is known to be an agonist for melanocortin-4 receptor (MC4-R), melanocortin-1 receptor (MC1-R), melanocortin-2 receptor (MC2-R), melanocortin-3 receptor (MC3-R), and melanocortin-5 receptor (MC5-R, Page 8 line 5-13). The ocular inflammatory disease treated includes the claimed neovascular conditions of dry eye, dry eye from contact lenses, corneal transplant and its rejection – wherein it is treating the claimed conditions (claims 7-8, 19-21, instant claim 3, instant specification Page 12-13 and Page 22 instant example 4); additionally it would also inherently treat the conditions if present as the instant claims do not recite a specific patient population. As the same recited neuropeptide receptor activator is administered to a subject, the effects of active being administered such as increasing angiostatic neuropeptide expression like endostatin from activating the neuropeptide receptors on pDCs in the eye are inherently present, as “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342,1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
An inherent feature need not be recognized at the time of the invention.
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. The fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention.
All the critical elements are taught by the cited reference and thus the claims are anticipated.
Response to Arguments:
Applicant's arguments are centered on the assertion that the claim has been amended to be to an ocular disease or condition characterized by neovascularization and Dodd only describes a mammalian subject with an ocular inflammatory disease with the administration of a melanocortin agonist, not to treating neovascularization in a subject.
This is fully considered but not persuasive.
First, the claims do not recite for the specific patient population (i.e. a patient in need thereof) wherein the administration of the melanocortin agonist like the claimed bremelanotide would inherently address any corneal neovascularization/inflammation from dry eye, dry eye from contact lens wear, or corneal transplant/rejection and its rejection that would be present.
Second, the prior art does expressly teach and claim treating these conditions (i.e. dry eye, dry eye from contact lens wear, or corneal transplant/rejection and its rejection) which the instant specification addresses to be corneal neovascular conditions wherein Dodd et al. expressly teaches and claims the treatment of with the administration of a melanocortin agonist (claim 1) including the claimed Ac-Nle-cyclo(- Asp-His-D-Phe-Arg-Trp-Lys)-OH which is also known as bremelanotide (claim 6, Page 4 line 13-17, also instantly claimed) and administered to the eye by eyedrops (claims 10-11). It is known to be an agonist for melanocortin-4 receptor.
Accordingly, the rejection stands.
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.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Dodd et al. (WO 2009/120656) as applied to claims 1-3, 10-12, 15-19, 22 above.
Rejection:
The teaching of Dodd et al. are addressed above, including the teaching and claimed treatment/use of ophthalmic medicament containing bremelanotide of a patient with an ocular inflammatory disease like dry eye. Dodd teaches and defines the term “patient” to a mammalian individual and the primary application involve human patients (claims, Page 5 line 18-22).
While Dodd et al. does not expressly claim the patient to be human, Dodd et al. does expressly teach that the primary application involves human patients wherein it would be prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the treatment to a human patient as expressly taught by Dodd et al. with a reasonable expectation of success.
Response to Arguments:
Applicant's arguments are to those presented for Dodd et al. which are addressed above.
Accordingly, the rejection stands.
Conclusion
Claims 1-3, 10-12, 15-19, 22-23 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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