DETAILED ACTION
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 .
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.
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Claims 1-2, 4-5, 9-10, and 12-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-5, 9-10, and 12-20 of U.S. Patent No. 10,155,108. Although the claims at issue are not identical, they are not patentably distinct from each other because of the below rejections.
In reference to claim 1, Ackermann discloses a method of tear production in a subject, comprising: positioning a probe in contact with the nasal mucosa of the subject; and delivering a stimulus via the probe to produce tears [e.g. claim 1].
In reference to claim 2, Ackermann discloses further comprising positioning a second probe in contact with the nasal mucosa of the subject [e.g. claim 2].
In reference to claim 4, Ackermann discloses wherein the stimulus is a biphasic symmetric pulse waveform [e.g. claim 4].
In reference to claim 5, Ackermann discloses wherein the stimulus is pulsed [e.g. claim 5].
In reference to claim 9, Ackermann discloses wherein the stimulus is delivered for a 5 minute period, and wherein the Schirmer score over the 5 minute period is at least 3 mm greater than a basal Schrimer score of the patient [e.g. claim 9].
In reference to claim 10, Ackermann discloses a method of improving ocular health in a patient, comprising: positioning a probe in a nasal cavity of the patient; and delivering stimulation to the nasal tissue of the patient via the probe at least once daily during a treatment period comprising at least 2 days to improve the ocular health of the patient, wherein improved ocular health is measured by one or more of decreased dry eye symptoms, decreased ocular surface staining, or increased tear production [e.g. claim 10].
In reference to claim 12, Ackermann discloses wherein improved ocular health is measured by decreased dry eye symptoms as measured by the Ocular Surface Disease Index, and wherein the Ocular Surface Disease Index decreases by at least 10% within the treatment period, wherein the treatment period comprises 7 days [e.g. claim 12].
In reference to claim 13, Ackermann discloses wherein improved ocular health is measured by decreased dry eye symptoms as measured by the Ocular Surface Disease Index, and wherein the Ocular Surface Disease Index decreases by at least 40% within the treatment period, wherein the treatment period comprises 90 days [e.g. claim 13].
In reference to claim 14, Ackermann discloses wherein the Ocular Surface Disease Index decreases by at least 50% within the treatment period [e.g. claim 14].
In reference to claim 15, Ackermann discloses wherein improved ocular health is measured by decreased ocular surface staining as measured by corneal staining, and wherein corneal staining decreases by at least 10% within the treatment period, wherein the treatment period comprises 7 days [e.g. claim 15].
In reference to claim 16, Ackermann discloses wherein improved ocular health is measured by decreased ocular surface staining as measured by corneal staining, and wherein corneal staining decreases by at least 60% within the treatment period, wherein the treatment period comprises 90 days [e.g. claim 16].
In reference to claim 17, Ackermann discloses wherein improved ocular health is measured by decreased ocular surface staining as measured by conjunctival staining, and wherein conjunctival staining decreases by at least 5% within the treatment period, wherein the treatment period comprises 7 days [e.g. claim 17].
In reference to claim 18, Ackermann discloses wherein improved ocular health is measured by decreased ocular surface staining as measured by conjunctival staining, and wherein conjunctival staining decreases by at least 30% within the treatment period, wherein the treatment period comprises 90 days [e.g. claim 18].
In reference to claim 19, Ackermann discloses wherein conjunctival staining decreases by at least 40% within the treatment period [e.g. claim 19].
In reference to claim 20, Ackermann discloses wherein improved ocular health is measured by increased tear production as measured by increased basal tear production, and wherein basal tear production increases by at least 1 mm on the Schirmer Tear Test within the treatment period, wherein the treatment period comprises 7 days [e.g. claim 20].
Claims 3, 7, and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,155,108 in view of U.S. Patent Application Publication No 2012/0323227 granted to Wolf et al (hereinafter “Wolf”). U.S. Pat ‘108 discloses a method of tear production but fails to describe where the stimulation is electrical or mechanical and comprises at least one electrode. Wolf describes a method to treat nasal airways and discloses the use of electrodes for providing electrical stimulation [e.g. 0026] and where the stimulation may also be mechanical [e.g. 0088]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of U.S. Pat ‘108 to include electrical or mechanical stimulation as taught by Wolf, since such a modification would provide the predictable results of having two methods of tear production.
Allowable Subject Matter
Claims 6 and 8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NADIA AHMAD MAHMOOD whose telephone number is (571)270-3975. The examiner can normally be reached Monday-Friday 8am-4pm.
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/NADIA A MAHMOOD/Primary Examiner, Art Unit 3796