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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/9/26 has been entered.
Status of the Claims
Claims 2 and 9-11 have been cancelled.
Claim 29 is new.
Claims 1, 3-8 and 12-29 are pending.
Claims 8, 22, 24 and 26 are withdrawn.
Claims 1, 3-7, 12-21, 23, 25 and 27-29 are presented for examination on the merits as they read on the elected species of fosaprepitant as the NK-1 antagonist, keratitis, as the cause of ocular pain. Traumatic ulcerations (Claim 25) has been included as the cause for ocular pain.
Withdrawn rejections
Applicant's amendments and arguments filed 2/9/26 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
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.
Claims 1, 3-7, 12-21, 23, 25 and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Gamache et al. (WO9814193) and Ferrari (WO 2013/004766) and Lacharriere et al. (US5730998; IDS filed 8/10/2020) and Nithya et al. (World Journal of Pharmaceutical Research 2014; 3(7):189-201).
This application currently names joint inventors. In considering patentability of the claims under 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 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103.
Applicant claims, for example:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a medical/pharmaceutical ophthalmologic research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from ophthalmologic treatment methods, ophthalmologic pharmaceuticals, ocular physiology and medicinal chemistry— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claim 1, Gamache et al. claim a “method for treating ocular pain, which comprises, administering to an affected eye an ophthalmic formulation comprising a pharmaceutically effective amount of a substance P antagonist.” (Claim 1). Thus, Gamache et al. teach that the artisan is aware that substance P antagonists are used in methods of treating ocular pain (Claim 1; page 3, lines 1-3) and the method does not include a treatment or prevention of corneal neovascularization or chemical burns. Gamache also teach that: “Substance P is a neuropeptide released by pain sensory neurons and is known to participate in the transmission of pain stimuli to the CNS. Substance Preceptor antagonists have been proposed as potential analgetic agents.” (Page 1, lines 29-32). Gamache et al. further teach that: “The cornea is highly inervated with sensory afferents which transmit pain stimuli to the CNS. Anything that stimulates these neurons, such as, surgical procedures, accidental trauma, dry eye, and various inflammatory conditions can elicit pain.” (Page 2, lines 24-26). Gamache et al. teach that conditions such as trauma, uveitis and conjunctivitis, which are an inflammation of the eye, can produce ocular pain (Page 2, line 26 through page 3, line 3).
Regarding claims 3, 4 and 15, Gamache et al. teach that the compound will normally be contained in the formulation in an amount of 0.05 to 2.0% by weight (Page 3, lines 28-30), which is a range of 0.5 mg/ml to 20 mg/ml.
Regarding claim 5 and 6, Gamache et al. teach administration of 1-3 drops of the formulation delivered to the eye 1-4 times a day according to the discretion of the skilled clinician (Page 3, line 30 through page 4, line 2). Thus, 1 drop of a 2.0% by weight solution to the eye is delivering 20 mg/ml of the compound which is within the range of 1-100 mg/ml.
Regarding claim 13, Gamache et al. teach topical application to the eye in the form of a solution (Page 3, lines 10-16, 27-28).
Regarding claim 14, Gamache et al. teach topical application of eye drops (Page 3, line 30 through page 4, line 2).
Regarding claims 16-19, as discussed above Gamache et al. suggest an amount a range of 0.5 mg/ml to 20 mg/ml and administration of 1-4 drops a day. Thus, in the embodiment of a 20 mg/ml concentration, then 2 drops would delivery 40 mg/ml and 3 drops would delivery 60 mg/ml which render obvious all the concentrations in between such as 30 mg/ml and 50 mg/ml.
Regarding claims 21 and 28, as discussed above Gamache et al. suggest an amount a range of 0.5 mg/ml to 20 mg/ml and administration of 1-4 drops a day, where 10 mg/ml is included in the range. Thus, administration of 1 drop of a 10 mg/ml solution for 1 day reads on the claim.
Regarding claim 29, Gamache et al. teach making ophthalmic compositions by incorporating the substance P antagonist into various types of ophthalmic formulations containing the polymeric species hydroxymethylcellulose, hydroxyethylcellulose, hydroxypropylmethylcellulose, methylcellulose, polyvinylpyrrolidone and Carbopol-940 (a crosslinked polyacrylic acid) (Page 3, lines 10-25), which implicitly chemically bind, such as hydrogen bonding, or physically entrap the substance P antagonist.
In summary, Gamache et al. teach the ordinary artisan in this art:
A method of treating ocular pain by administering to an affected eye an ophthalmic formulation comprising a pharmaceutically effective amount of a substance P antagonist (Claim 1);
Where the ocular pain can arise from surgical procedures, such as, photo refractive keratotomy (PRK), radial keratotomy, cataract extraction and irritating conditions, including, uveitis, conjunctivitis, dry eye, contact lens intolerance, and trauma (Page 3, lines 1-3);
An ophthalmic formulation is fully disclosed (Example 1); and
Directions for the ordinary artisan to topically (route of administration) deliver 1-3 drops of the formulation with 0.05 to 2.0 wt% of the compound (dosage) to the surface of the eye 1-4 times a day (therapeutic treatment window) (Page 3, lines 10-25 and 27 through page 4, line 2).
Accordingly, the disclosure of Gamache provides guidance regarding the dosage, formulation, route of administration, and therapeutic window of treatment of ocular pain with a substance P antagonist with a reasonable expectation of success.
Regarding claim 1, 12-12 and 29, Lacharriere et al. teach methods of treating ocular pain with a substance P antagonist (Abstract; claims 1-30) in combination with non-steroidal anti-inflammatory agents (Claim 22) and topically applied (Claim 24). Lacharriere et al. teach: “The application of compositions containing one or more substance P antagonists to the eyes or eyelids enables a marked decrease or even a complete disappearance of the ophthalmic pain, dysaesthetic sensations and pruritus to be obtained; a calming and soothing, preventive and curative effect on the eyes and eyelids is observed very quickly, and in any case much faster than with corticoids.” (Column 2, lines 32-38). Lacharriere et al. also teach addition of polymers such as HPMC, carbomer and acrylic copolymers (Page 5, lines 25-33), which would physically entrap or chemically bind with the active agent(s).
Regarding claims 1, 7, 13, 23, 25, and 27, Ferrari further teaches that fosaprepitant/aprepitant is a NK-1 antagonist (Claim 1 and 16) where the principal receptor for substance P is NK-1 (Page 3, lines 25-29; page 7, lines 15-20). Thus, fosaprepitant is a substance P antagonist. Ferrari also teaches that inflammatory condition (Claim 4), physical insult of the eye and bacterial infection, viral infection, Chlamydia trachomatis infection, infectious keratitis including herpes simplex keratitis, viral interstitial keratitis, infections caused by staphylococcus, streptococcus, Pseudomonas or microbial keratoconjunctivitis , Pseudomonas aeruginosa infection (claim 5) as well as fungal keratitis such as keratitis caused by Candida, Fusarium and Aspergillus spp and parasitic keratitis such as keratitis caused by Onchocerciasi (Page 6, lines 19-23) and traumatic disorders such as ulcerations (Page 6, lines 24-25). Ferrari teaches topical application to the eye (Claims 10, 25; Abstract).
Regarding claims 3, 5-7, 13 and 14, Ferrari teaches in Example 2 treating mice after caustication (i.e., burn, physical insult of the eye) with topical eyedrop administration of fosaprepitant in 0.9% NaCl solution, which is a pharmaceutically acceptable vehicle, at a concentration of 1mg/ml 5 times per day for 1 week with reduction of neovascularization and improved corneal transparency (Page 73 line 15-Page 74 line 5).
Regarding claim 12, Ferrari further teaches adding one or more further therapeutically active agents including antibiotics and antifungals (Abstract; claims 20-25; See also page 68, line 22 through page 70, line 22 naming analgesics, NSAIDs and other agents useful for treatment of conditions of the eye or after surgery to the eye), which are agents that is used following surgery to the eye to prevent infection and/or an agent useful in the prevention and/or treatment of the disease or condition that causes ocular sensitivity and/or ocular pain such as infection.
Regarding claim 14, Ferrari teaches that: “The composition may be formulated in any liquid form suitable for topical application such as eye-drops” (Page 60 line 1-11).
Regarding claims 4 and 15-21, Ferrari teaches that NK-1 antagonist like fosaprepitant can be in topical composition from 0.01-50%w/v of NK-1 antagonist, specifically 0.1%w/v (0.1%w/v =0.1g/100ml=1mg/ml), 1%w/v (1%w/v =1g/100ml=10mg/ml), 2% w/v (2%w/v =2g/100ml=20mg/ml), 40%w/v, 50%w/v (50%w/v =50g/100ml=500mg/ml), 5% w/v (5%w/v =5g/100ml=50mg/ml) of NK-1 antagonist (Page 67, lines 6-25), thus embracing approximately 10 mg/mL and at least- 20 mg/mL, 30 mg/mL, 40 mg/mL, 50 mg/mL, 60 mg/mL and 100 mg/mL. Ferrari teach that the dosage can be given once or several times per day; and for one or more weeks including more than 8 weeks (Page 67, line 26 through page 68, lines 1-4). The NK-1 antagonist can be administered as the sole active and in combination with other actives including non-steroidal anti-inflammatory agents (NSAIDS) (Page 68, lines 22-24).
Regarding claims 5, 6, 12, 21 and 28, Ferrari further teaches that immediately after sodium hydroxide caustication, which is a traumatic an alkali burn disorder, daily topical administration of fosaprepitant 4 times per day for 1 week (Example 2, page 73, lines 20-24).
Regarding claims 23, 25 and 27, Ferrari further teaches concurrent treatment of infectious keratitis including viral and bacterial infections such as herpes simplex virus (claims 4-5). Herpes zoster is also disclosed as well as bacterial keratitis such as keratitis caused by infection with Pseudomonas (e.g., Pseudomonas Aeruginosa), Chlamydia trachomatis, Treponema pallidum), fungal keratitis such as keratitis caused by Candida, Fusarium and Aspergillus spp and parasitic keratitis such as keratitis caused by Onchocerciasi and traumatic ulcerations (Page 6, lines 19-25).
Regarding claims 23 and 27, Nithya et al. teach that keratitis is inflammation of the cornea caused by bacteria, fungi and virus (Abstract) with symptoms of pain (Page 190, Symptoms of keratitis).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
Gamache et al. does not expressly teach treating ocular pain caused by infectious keratitis and the infectious keratitis is viral keratitis, bacterial keratitis, fungal keratitis or parasitic keratitis or ulcerations to the eye by administering fosaprepitant at a concentration of at least 1 mg/ml, 1-100 mg/ml or at least 100 mg/ml and the claimed concentrations in between for the time periods claimed and wherein the fosaprepitant is chemically bound to or physically entrapped by a pharmaceutically compatible polymer. This deficiency in Gamache et al. is cured by the teachings of Ferrari, Lacharriere et al. and Nithya et al.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform the method of Gamache et al. and treat ocular pain caused by infectious keratitis and the infectious keratitis is viral keratitis, bacterial keratitis, fungal keratitis or parasitic keratitis or ulcerations to the eye by administering the substance P antagonist fosaprepitant, alone or chemically bound to or physically entrapped by a pharmaceutically compatible polymer, in the concentrations and time periods claimed, as suggested by Ferrari and Nithya et al., and produce the instant invention. One of ordinary skill in the art would have been motivated to do this because of the following rational. The art of Gamache et al. established treatment of ocular pain by administering a substance P antagonist that can be chemically bound or physically entrapped by a pharmaceutically compatible polymer. The art of Gamache et al. expressly teaches in claim 1: “A method for treating ocular pain, which comprises, administering to an affected eye an ophthalmic formulation comprising a pharmaceutically effective amount of a substance P antagonist” without including a treatment or prevention of corneal neovascularization. It is established by Ferrari that fosaprepitant is a substance P antagonist and therefore useful in the method of Gamache et al. of treating ocular pain. The method of Ferrari is also taught to reduce inflammation of the eye (Claim 9) and includes dosages of fosaprepitant to 100 mg/ml as well as dosage regimens. Nithya et al. teach that keratitis is a painful inflammatory condition where: “The pain may be mild to severe depending on the cause and extent of the inflammation” (Page 190, Symptoms of keratitis) and the method of Gamache et al. is open to the treatment of other conditions that cause ocular pain and includes conditions considered to cause trauma (Page 3, line 3 of Gamache et al.) which includes ulcerations as suggested by Ferrari. Therefore, it is obvious to treat a painful inflammatory condition such as keratitis, no matter whether it is bacterial, viral, fungal or parasitic keratitis or ulcerative trauma to the eye, with the method of combined references by applying fosaprepitant in the concentrations claimed topically to the eye with a reasonable expectation of reducing inflammation and reducing ocular pain. See MPEP 2143.02(II): Obviousness does not require absolute predictability, however, at least some degree of predictability is required. Evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness. In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). In re O'Farrell, 853 F.2d 894, 903, 7 USPQ2d 1673, 1681 (Fed. Cir. 1988). Especially when Lacharriere et al. teach: “application of compositions containing one or more substance P antagonists to the eyes or eyelids enables a marked decrease or even a complete disappearance of the ophthalmic pain”. Thus, there is a reasonable expectation of success in topically applying a substance P antagonists, such as fosaprepitant, and treating ocular pain.
Determination of the proper dosage amount and days of treatment is determined by the artisan in this art to achieve the desired therapeutic benefit. Thus, the dosage ranges and treatment periods are obvious in the absence of unexpected results.
Gamache et al. does not expressly teach a method of treating ocular pain further comprising administering an agent selected from the group consisting of: an anaesthetic agent, a non-steroidal anti-inflammatory agent, an analgesic agent, an agent useful in the treatment of the disease or condition that causes the ocular pain, and an agent that is used following surgery to the eye. This deficiency in Gamache et al. is cured by the teachings of Ferrari, Lacharriere et al. and Nithya et al.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform the method of Gamache et al. and treat ocular pain further comprising administering an agent selected from the group consisting of: an anaesthetic agent, a non-steroidal anti-inflammatory agent, an analgesic agent, an agent useful in the treatment of the disease or condition that causes the ocular pain, and an agent that is used following surgery to the eye, as suggested by Ferrari, Lacharriere et al. and Nithya et al., and produce the instant invention. One of ordinary skill in the art would have been motivated to do this because of the following rational. The method of Gamache et al. is open to the inclusion of other steps and elements and is open to other conditions that cause ocular pain. As established above, infectious keratitis in a painful inflammatory condition. It would be obvious to administer other antimicrobial agents to treat the infection and/or anti-inflammatory drugs and/or anaesthetic/analgesic agents to assist with the control of pain. Especially when Ferrari teaches the artisan to combine the method of claim 7 with one or more therapeutic agents (Claim 20) that can be antibacterial (Claim 22) or anti-viral (Claim 23) or analgesic or anti-inflammatory (Page 68, lines 20-25) and Lacharriere et al. also teaches combination with antiseptic, anti-allergic, anaesthetic, antiviral and non-steroidal anti-inflammatory agents (Claim 21). Accordingly, in view of the combined references the ordinary artisan would employ the claimed agents in the method of Gamache et al. for at least an additive effect in treating the ocular pain caused by keratitis or ulcerations with a reasonable expectation of success.
The test for obviousness is "what the combined teachings of the references would have suggested to those of ordinary skill in the art." In re Keller, 642 F.2d 4I3, 425 (CCPA I98I) (MPEP 2145(III)). In the present case, the combined references render obvious each and every limitation claimed. “In the consideration of references, the question is, could one skilled in the art with the references before him make the combination of elements here claimed without exercise of the inventive faculty,” In re Goepfrich, 136 F.2d 918, 920 (C.C.P.A. 1943). In the Examiner’s reasoned analysis with evidentiary support that answer is yes. All that is required to show obviousness is that the applicant "make his claimed invention merely by applying knowledge clearly present in the prior art. Section 103 requires us to presume full knowledge by the inventor of the prior art in the field of his endeavor." In re Winslow, 365 F.2d 1017, 1020, 53 C.C.P.A. 1574, 1578 (1966). Application of Sheckler, 438 F.2d 999, 1001 (C.C.P.A. 1971). Thus, does Applicant make their claimed invention merely by applying knowledge clearly present in the prior art. Under that test, Applicant fails. No commercial success is claimed, nor is any other factor indicating non-obviousness shown to exist.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments:
Applicant’s arguments filed 2/9/26 have been carefully considered but are not persuasive.
On page 6 of remarks, Applicant continues the argument that Gamache does not base his treatment of ocular pain with a substance P antagonist on any experimental data and thus there would have been no motivation or reasonable expectation of success to achieve Gamache's treatment of ocular pain with Ferrari's fosaprepitant. It is Applicant’s position that: “In view of the unpredictable nature of pharmaceutical research, a person of ordinary skill in the art would not have had a reasonable expectation of achieving the claimed treatment of ocular pain with fosaprepitant (and other compounds) based on Gamache that offers no experimental validation for its assertions.” The Examiner strongly disagrees. As asserted by the Examiner previously,
“As noted in the interview summary filed 7/18/25: “The specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970). Allergan, Inc. v. Sandoz Inc., 796 F.3d 1293, 1310, 115 USPQ2d 2012, 2023 (Fed. Cir. 2015) ( "Only a sufficient description enabling a person of ordinary skill in the art to carry out an invention is needed.").” In the present case, the prior art of Gamache teaches:
A method of treating ocular pain by administering to an affected eye an ophthalmic formulation comprising a pharmaceutically effective amount of a substance P antagonist (Claim 1);
Where the ocular pain can arise from surgical procedures, such as, photo refractive keratotomy (PRK), radial keratotomy, cataract extraction and irritating conditions, including, uveitis, conjunctivitis, dry eye, contact lens intolerance, and trauma (Page 3, lines 1-3);
An ophthalmic formulation is fully disclosed (Example 1); and
Directions for the ordinary artisan to topically (route of administration) deliver 1-3 drops of the formulation with 0.05 to 2.0 wt% of the compound (dosage) to the surface of the eye 1-4 times a day (therapeutic treatment window) (Page 3, lines 10-25 and 27 through page 4, line 2).
Consequently, the disclosure of Gamache answers the Declarants critical questions regarding the dosage, formulation, route of administration, and therapeutic window of treatment. It is not material to the examination of the pending claims if CP99,994 was actually approved for the purpose of treating ocular pain. Similarly, a substantial research program does not equate to undue experimentation. It is more than sufficient that the disclosure of Gamache establishes methods of treating ocular pain by administration of a substance P antagonist, which renders obvious other substance P antagonists for that purpose. Especially when Gamache discusses prior art disclosures teaching NK1 receptor antagonists for treating pain (Page 1, lines 35-38), NK3 receptor antagonists to treat ophthalmic diseases, inflammation of the eye and pain (Page 2, lines 1-10; page 3, lines 5-8). Since there is considerable direction and guidance in the specification and the skill level is that of a medical/pharmaceutical ophthalmologic research scientist, with knowledge of ophthalmologic treatment methods, ophthalmologic pharmaceuticals, ocular physiology and medicinal chemistry and all the methods needed to practice the method were well-known, then the only reasonable conclusion is that the method of Gamache is enabled and it would not require undue experimentation to practice the method of Gamache. Applicant is reminded that the expectation of success need only be reasonable and not guaranteed. See MPEP 2143.02(II): Obviousness does not require absolute predictability, however, at least some degree of predictability is required. Such is the present case. The Examiner notes for the record that in 1996 De Lacharriere et al. (FR2728169) applied a substance P antagonist to the eye to treat pruritis and ocular or palpebral dysesthesia (Abstract; claims 1-13) and report: “The application of compositions containing one or more antagonists of substance P to the eyes or the eyelids makes it possible to obtain a marked reduction or even complete disappearance of the dysesthetic sensations and ophthalmic pruritus; we notice very quickly, and in any event much more quickly than with corticoids, a calming and soothing, preventive and curative effect on eyes and eyelids.” (Page 4 of 10). The term “dysesthetic sensation” is interpreted to be an abnormal/unpleasant feeling such as pain and De Lacharriere et al. was aware that substance P is involved in the transmission of pain. (Page 3 of 10) Accordingly, the ordinary artisan is aware that application of substance P antagonists to the eye “very quickly” provides “a calming and soothing” effect on the eyes to reduce or eve completely disappear dysesthetic (painful) sensations. It is then predictable to apply a substance P antagonist to the eye and expect a rapid calming and soothing effect on the eye.”
Respectfully, Applicant’s argument was not persuasive previously and is not persuasive now.
On page 7 of remarks, Applicant cites a pubmed article and wikipedia page for teaching lanepitant as failing to show therapeutic results for osteoarthritis. Those references were not provided and the Examiner has attached the pubmed article to this Office Action. Goldstein et al. teach that orally administered lanepitant was ineffective at treating osteoarthritis pain (Page 425, 3rd paragraph). However, in the present case Gamache et al. teach topical administration directly to the eye. Consequently, Goldstein et al. is directed to treating a different pain by a different route of administration and is not relevant to the instantly applied rejection. Applicant’s arguments are not persuasive.
On page 7 of remarks, Applicant asserts that: “the Office Action does not present any reasons or evidence to support that pain is a predictable condition, while cancer is not.” The OSI Pharmaceutical, LLC v. Apotex Inc. case determined that cancer was unpredictable and it is common sense that trauma inflicted upon the eye will predictably cause pain. See Jacobs, DS. (Curr Ophthalmol Rep 2017;5:271-275): “People with ocular pain typically present or are referred to ophthalmologists or optometrists for evaluation. When there is recent trauma or surgery, or signs of an infectious or inflammatory process, treatment of the underlying process or pathologic
abnormality usually results in resolution of pain. These situations represent physiologic or nociceptive pain. Such pain associated with surgery, injury, infection, or inflammation at the front of the eye is typically treated with topical steroid, topical NSAID, systemic NSAID, lubricant ointment, gel or drops, bandage contact lens, or a few doses of oral opiate or topical anesthetic.” (Page 271, Introduction 1st paragraph). Applicant’s argument is not persuasive.
On page 8 of remarks, Applicant cited Pinter et al. as being attached as Appendix 1, but no such Appendix 1 was found in the submission filed 2/9/26. The Examiner has attached Pinter et al. with this Office Action. Simply because some drug companies failed to bring a drug to market, does not distract from the fact that the art teaches and suggests substance P antagonists for the treatment of ocular pain. The Pinter et al. article also teaches that: “GR205171 also relieved mechanical hyperalgesia in CFA-induced arthritis in the rat, and it could inhibit joint swelling in animal models of neuropathic pain (Page 6, right column NK1 receptor antagonists 3rd paragraph); NK1 receptor antagonist L-703,606 was able to reduce arthritic pain (Page 6, right column NK1 receptor antagonists 4th paragraph) and that Nk1 antagonists “exerted antihyperalgetic effects in some animal models of inflammation and neuropathic pain (Page 7, right column 3rd paragraph). So, there are teachings of pain treatment with NK1 antagonists, thereby providing a reasonable expectation of success, and Applicant’s arguments are not persuasive. Furthermore, Lacharriere et al. provide further support for a reasonable expectation of success in treating ocular pain by topical administration of a substance P antagonist. The balance of evidence favors obviousness for the claimed method.
On page 8 of remarks, Applicant cites Rosenthal et al., but did not make the reference of record, and attempts to make the correlation that ocular pain and dental pain are transmitted through the trigeminal ganglion and that Pinter et al. teach that aprepitant was not effective in treating dental pain. However, NK1 antagonist CP-99994 had significant analgesic effect in molar extraction. In any case, ocular pain is under examination; not dental pain. The Examiner’s position remains unchanged in that it would not require any undue experimentation to arrive at the claimed method. Respectfully, none of Applicant’s arguments are persuasive.
Conclusion
No claims are allowed.
The Examiner suggests proceeding to the Board of Appeals.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613