DETAILED ACTION
Status of Application
The response filed 07/07/2025 has been received, entered and carefully considered. The response affects the instant application accordingly:
Claims 8, 11, 14, 19-22 have been amended.
Claim 13, 15-18 has been cancelled.
Claims 8-12, 14, 19-22 are pending in the case.
Claims 8-12, 14, 19-22 are present for examination.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s argument that the double patenting of over U.S. Patent No. 11339181 does not apply as there is not a common inventor/assignee is persuasive wherein the double patenting rejection is withdrawn.
All grounds not addressed in the action are withdrawn as a result of amendment.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 § 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 8-12, 14, 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Okigami et al. (U.S. Pat. Pub. 2016/0367556).
Due to the broad breath claimed as it does not define the patient population (i.e. “a patient in need thereof”) the following rejection applies.
Rejection:
Okigami et al. teach treating/ameliorate a VEGF eye condition with the administration of compound A
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which is 3-[(3S, 4R)-3-Methyl-6-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1,6-diazaspiro[3.4]octan-1-yl]-3-oxopropanenitrile (delgocitinib), claims the method of treatment with the compound by administration to an eye of the subject with examples include intravitreal administration, and teaches that the active can also be given by eye drop, from about 0.0001-0.1%; wherein the active step of compound administration as claimed would treat any dry eye present by the recited mechanism like tear secretion which would be present from the administration of the active as the activity/mechanism of action of the active flows naturally from its active step of administration as recited (Abstract, Examples 1-3, claims 1-9, [45, 63, 66] see full document specifically areas cited).
While Okigami et al. expressly does not expressly teach the exact claimed values for the compound
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in the ophthalmic composition, they do overlap as it can be in an eyedrop from about 0.0001-0.1% [45, 63, 66]; wherein even a slight overlap in ranges establishes a prima facie case of obviousness, as a means of optimizing within the taught range to attain the desired therapeutic profile and arrive at the overlapping values with a reasonable expectation of success absent evidence of criticality for the claimed values.
Response to Arguments:
Applicant's arguments filed 07/07/2025 are centered on the assertion that there are unexpected result in Tet Examples 1-3 and Figures 1-3 for a single administration of the claimed compound within the claimed concentration to significantly increase tear volume in normal aminal models and in the excised lacrimal gland rat model and Okigami does not teach or suggest a significant increase of tear production by the compound. This is fully considered but not persuasive. First the claims as written and addressed above do not recited the patient population (i.e. “a patient in need thereof”) wherein the claims as written are broad wherein the active step of compound administration as claimed would treat any dry eye present or present with tears by the recited mechanism like tear secretion which would be present from the administration of the active as the activity/mechanism of action of the active flows naturally from its active step of administration as recited. As for the assertion of unexpected results, the showing does not demonstrate criticality for the claimed range, but in fact that there is the mechanism of tear production at values outside the claimed range. Figure 5 may show some evidence of criticality for the statistical significant for treating dry eye (based on the lacrimal excision model) for repeated administration (4 times a day, versus the single administration asserted by Applicant) for 0.05% delgocitinib solution with the p<0.05 value and 0.2%% delgocitinib solution with the p<0.01 value against the PBS, and also helpful for a lower end of a range but does not address criticality for an upper end of a range, but the values of 0.05% delgocitinib solution and 0.2%% delgocitinib solution are not commensurate in scope with the claims as written.
Accordingly, the rejection stands.
Claims 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Kamiya et al. (WO 2018/117153).
Due to the broad breath claimed as it does not define the patient population (i.e. “a patient in need thereof”) the following rejection applies, but even as treated to a patient in need of treatment for dry eye (a keratoconjunctival epithelial disorder) the following rejection applies.
Rejection:
Kamiya et al. teaches treating/ameliorating dry eye with a therapeutic effective amount of the composition comprising a crystalline form of 3-[(3S, 4R)-3-Methyl-6-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1,6-diazaspiro[3.4]octan-1-yl]-3-oxopropanenitrile
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(claim 60 and 63); wherein the active step of compound administration as claimed would treat any dry eye present by the recited mechanism like tear secretion which would be present from the administration of the active as the activity/mechanism of action of the active flows naturally from its active step of administration as recited. The composition can be in various forms including drops and ointment, administration can be topical, and the compound can be about 0.1-100% of the composition (claims 51-53, [57-58, 98-99, 118], see full document specifically areas cited).
While Kamiya et al. does not recite the exact claimed values for the amount of the compound, they do overlap and even a slight overlap in ranges establishes a prima facie case of obviousness, as a means of optimizing within the taught range to attain the desired therapeutic profile and arrive at the overlapping values with a reasonable expectation of success absent evidence of criticality for the claimed values.
Response to Arguments:
Applicant's arguments filed 07/07/2025 are centered on the assertion that there are unexpected result in Tet Examples 1-3 and Figures 1-3 for a single administration of the claimed compound within the claimed concentration to significantly increase tear volume in normal aminal models and in the excised lacrimal gland rat model and Kamiya does not teach or suggest a significant increase of tear production by the compound. This is fully considered but not persuasive. First the claims as written and addressed above do not recited the patient population (i.e. “a patient in need thereof”) wherein the claims as written are broad wherein the active step of compound administration as claimed would treat any dry eye present or present with tears by the recited mechanism like tear secretion which would be present from the administration of the active as the activity/mechanism of action of the active flows naturally from its active step of administration as recited. Second, Kamiya teaches treating dry eye with the claimed compound wherein the mechanism of action like tear secretion would be present as the activity/mechanism of action of the active flows naturally from its active step of administration as recited as it is the same active also being used for the recited keratoconjunctival epithelial disorder (dry eye). As for the assertion of unexpected results, the showing does not demonstrate criticality for the claimed range, but in fact that there is the mechanism of tear production at values outside the claimed range (i.e. 0.0125%). Figure 5 may show some evidence of criticality for the statistical significance for treating dry eye (based on the lacrimal excision model) for repeated administration (4 times a day, versus the single administration asserted by Applicant) for 0.05% delgocitinib solution with the p<0.05 value and 0.2%% delgocitinib solution with the p<0.01 value against the PBS, and also helpful for a lower end of a range but does not address criticality for an upper end of a range, but the values of 0.05% delgocitinib solution and 0.2%% delgocitinib solution are not commensurate in scope with the claims as written.
Accordingly, the rejection stands.
Claims 14, 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Kamiya et al. (WO 2018/117153) as applied to claims 8-12 above, in view of Winfield (Ophthalmic products- Introduction).
Rejection:
The teachings of Kamiya et al. are addressed above.
Kamiya does not expressly teach the composition to be eyedrops but does teach the composition to be administered for treating dry eye, the composition to be in the form of drops and that the composition can be topical forms like ointments.
Winfield teaches that known forms for topical ophthalmic use (i.e. instillation, application) include eyedrops like solutions/suspensions, lotions, and ointments.
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the compound as an eyedrop to treat dry eye as suggested by Winfield and produce the claimed invention; as Kamiya teaches administration with topical forms for treating dry eye and it is prima facie obvious to deliver the active in a known conventional topical ophthalmic form like an eyedrop with a reasonable expectation of success.
Response to Arguments:
Applicant's arguments are those to Kamiya which are addressed above.
Accordingly, the rejection stands.
Conclusion
Claims 8-12, 14, 19-22 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