DETAILED ACTION
Status of Application
The response filed 04/29/2026 has been received, entered and carefully considered. The response affects the instant application accordingly:
Claims 25-29 have been cancelled.
Claims 10-23 are pending in the case.
Claims 10-14, 16-20, 22-23 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 .
All grounds not addressed in the action are withdrawn as a result of amendment.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.
Election/Restrictions
Applicant’s election without traverse of Group I and the species election for the active to be an α1-adrenergic receptor inhibitor with the specific election for tamsulosin as the α1-adrenergic receptor inhibitor and oral administration as the mode of administration in the reply filed on 04/29/2026 is acknowledged. Upon review the election for the specific α1-adrenergic receptor inhibitor is withdrawn.
Claims 15, 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species.
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 10, 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nelms et al. (U.S. Pat. Pub. 2021/0130338).
Rejection:
Nelms et al. teaches and claims treating ocular inflammatory disorders like dry eye with an effective amount of doxazosin (claims 44-45, see full document specifically areas cited; doxazosin is an α1 adrenergic receptor inhibitor known to inhibit α1a receptors as evidenced by Bansal [39]-WO 2009/026584).
All the critical elements are taught by the cited reference and thus the claims are anticipated.
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 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Nelms et al. (U.S. Pat. Pub. 2021/0130338) as applied to claims 10, 18-19.
Rejection:
Nelms et al. teaches and claims treating ocular inflammatory disorders like dry eye with an effective amount of doxazosin (claims 44-45). Nelms et al. also teaches that the active can be administered in forms like tablets and capsules and liquids for oral administration [156-159]. The daily dose is from about 0.01mg/kg-100mg/kg ([170], see fully document specifically areas cited).
While Nelms et al. does not expressly teach the exact claimed values for the dose (1-100mg/kg) they are embraced by the taught range (0.01-100mg/kg); wherein it would be prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to optimize within the taught range to arrive at the desired therapeutic dose/profile with a reasonable expectation of success absent evidence of critically for the claimed values.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Nelms et al. (U.S. Pat. Pub. 2021/0130338 as applied to claims 10, 18-19, in view of Bansal (WO 2009/026584) and Rolando et al. (The Ocular Surface and Tear Film and Their Dysfunction in Dry Eye Discase).
Rejection:
The teachings of Nelms et al. are addressed above.
Nelms et al. does not expressly teach the inclusion of tamsulosin but does teach the treatment of dry eye with doxazosin.
Bansal teaches treatment of inflammatory conditions like rheumatoid arthritis and systemic lupus erythematosus with α1a adrenergic receptor antagonists/inhibitors such as prazonsin, doxazosin and tamsulosin (claim 16, [39, 43]); and that treatment is defined to include inhibiting and/or relieving symptoms associated with inflammation [29, 31].
Rolando et al. teaches that dry eye is known to be present in certain autoimmune (inflammatory) disorders including rheumatoid arthritis and lupus erythematosus (Systemic Diseases).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate tamsulosin for the treatment of dry eye as suggested by Bansal and Rolando et al. and produce the claimed invention; as it is prima facie obvious to incorporate an additional α1a adrenergic receptor antagonist for its additive effect as Rolando et al. teaches that dry eye is a symptom in conditions like rheumatoid arthritis and lupus erythematosus and Bansal teaches that α1a adrenergic receptor antagonists like tamsulosin are useful for treating rheumatoid arthritis and lupus erythematosus and treatment includes its symptoms like dry eye with a reasonable expectation of success.
Claims 11-13, 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Nelms et al. (U.S. Pat. Pub. 2021/0130338 as applied to claims 10, 18-19, in view of Rolando et al. (The Ocular Surface and Tear Film and Their Dysfunction in Dry Eye Discase).
Rejection:
The teachings of Nelms et al. are addressed above including treating ocular inflammatory disorders like dry eye with an effective amount of doxazosin (claims 44-45). Nelms et al. also teaches that the active can be administered in forms like tablets and capsules and liquids for oral administration [156-159] and eyedrop forms [162]. The daily dose is from about 0.01mg/kg-100mg/kg [170].
Wherein while Nelms et al. does not expressly teach the exact claimed values for the dose (1-100mg/kg), they are embraced by the taught range (0.01-100mg/kg); wherein it would be prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to optimize within the taught range to arrive at the desired therapeutic dose/profile with a reasonable expectation of success absent evidence of critically for the claimed values.
Nelms et al. does not expressly recite the type of dry eye but does recite the treatment of dry eye.
Rolando et al. teaches that dry eye is known to be classified as aqueous layer deficiency or evaporative deficiency but the clinical presentation is often a mix of the two (Aqueous Layer Alteration-1st paragraph). Rolando et al. also teaches that dry eye is known to be present in certain autoimmune (inflammatory) disorders including rheumatoid arthritis and lupus erythematosus (Systemic Diseases).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to treat aqueous layer deficiency dry eye as suggested by Rolando et al. and produce the claimed invention; as it is prima facie obvious to treat any of the various forms of dry eye including aqueous layer deficiency dry eye which is often present in the clinical presentation as a mix of the two presentations with a reasonable expectation of success.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Nelms et al. (U.S. Pat. Pub. 2021/0130338) in view of Rolando et al. (The Ocular Surface and Tear Film and Their Dysfunction in Dry Eye Discase as applied to claims 11-13, 16-17, in view of Bansal (WO 2009/026584).
Rejection:
The teachings of Nelms et al. in view of Rolando et al. are addressed above including that dry eye is known to be present in certain autoimmune (inflammatory) disorders including rheumatoid arthritis and lupus erythematosus (Systemic Diseases).
Nelms et al. in view of Rolando et al. does not expressly teach the inclusion of the α1 adrenergic receptor inhibitor tamsulosin.
Bansal. teaches that α1 adrenergic receptor inhibitors like tamsulosin are useful in treating inflammatory conditions like rheumatoid arthritis and systemic lupus erythematosus (claim 16, [39, 43]); and treatment is defined to include inhibiting and/or relieving symptoms associated with inflammation [29, 31].
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate tamsulosin for the treatment of dry eye as suggested by Bansal and produce the claimed invention; as it is prima facie obvious to incorporate an additional active like tamsulosin for its additive effect as Bansal teaches that α1a adrenergic receptor antagonists like tamsulosin are useful for treating inflammatory conditions like rheumatoid arthritis and lupus erythematosus and treatment includes symptoms like dry eye as seen by Rolando et al. with a reasonable expectation of success.
Claims 10-14, 16-20, 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Bansal (WO 2009/026584) in view of Rolando et al. (The Ocular Surface and Tear Film and Their Dysfunction in Dry Eye Discase).
Rejection:
Bansal teaches treatment of inflammatory conditions like rheumatoid arthritis and systemic lupus erythematosus with α1a adrenergic receptor antagonists/inhibitors such as prazonsin, doxazosin and tamsulosin (claims 1-2, 8-10, 14, 16-18, 21, 23-25, 28, 31, [39, 43]). Modes of administration include oral and forms like tablets, capsules and solutions; with the dose of the α1 adrenergic receptor antagonist is from about 0.001-100mg/kg (claims 7, 14, 21, 28; [13-14, 46-47]). Treatment is also defined to include inhibiting and/or relieving symptoms associated with inflammation ([29, 31], see full document specifically areas cited).
While Bansal does not expressly teach the exact claimed values for the dose (1-100mg/kg), they are embraced by the taught range (0.001-100mg/kg); wherein it would be prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to optimize within the taught range to arrive at the desired therapeutic dose/profile with a reasonable expectation of success absent evidence of critically for the claimed values.
Bansal does not expressly teach treating dry eye but does teach treating inflammatory conditions like rheumatoid arthritis and systemic lupus erythematosus with α1a adrenergic receptor antagonists/inhibitors such as prazonsin, doxazosin and tamsulosin; and that treatment includes inhibiting and/or relieving symptoms associated with the inflammation.
Rolando et al. teaches that dry eye is known to be present in certain autoimmune (inflammatory) disorders including rheumatoid arthritis and lupus erythematosus (Systemic Diseases); and that dry eye is known to be classified as aqueous layer deficiency or evaporative deficiency but the clinical presentation is often a mix of the two (Aqueous Layer Alteration-1st paragraph).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to treat the dry eye symptoms of rheumatoid arthritis and lupus erythematosus such as aqueous layer deficiency dry eye as suggested by Rolando et al. and produce the claimed invention; as it is prima facie obvious to treat the known symptoms of rheumatoid arthritis and lupus erythematosus while treating the disease as Bansal teaches treating the conditions and its symptoms with a reasonable expectation of success. It is also prima facie obvious to treat any of the various forms of dry eye including aqueous layer deficiency dry eye which is often present in the clinical presentation as a mix of the two presentations with a reasonable expectation of success.
Conclusion
Claims 10-14, 16-20, 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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