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 .
Reopening of Prosecution After Appeal Brief
In view of the appeal brief filed on 10/29/25, PROSECUTION IS HEREBY REOPENED. New Grounds of rejection are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/FEREYDOUN G SAJJADI/ Supervisory Patent Examiner, Art Unit 1699
Response to Applicant’s Arguments and Amendments
In the response submitted by the Applicant the following 35 U.S.C § 103 (a) rejections are withdrawn:
Claims 19, 21-28, 30, 31, 33, and 36-38 were rejected under 35 U.S.C. 103 as being unpatentable over Myntti et al. (WO 2007/134055) in view of Lichter et al. (WO 2010/011605) in light of support by Mehta et al. (Otolaryngology, 2005).
Claim 20 were rejected under 35 U.S.C. 103 as being unpatentable over Myntti et al. (WO 2007/134055) and Lichter et al. (WO 2010/011605) as applied to claims 19, 21-28, 30, 31, and 33 above, and further in view of Pellico (WO 2008/070387).
Claim 34 were rejected under 35 U.S.C. 103 as being unpatentable over Lichter et al. (WO 2010/011605).
Claim 35 were rejected under 35 U.S.C. 103 as being unpatentable over Lichter et al. (WO 2010/011605) as applied to claim 34 above, and further in view of Pellico (WO 2008/070387)
The following 35 U.S.C. 112 rejections are withdrawn:
Claims 19-28, 30, 31, and 33-38 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The following Double Patenting rejections are withdrawn:
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11090369. Claims 1-18 were cancelled on 7/25/24.
The Applicant’s arguments in the Appeal Brief against the 35 USC 112 rejection were persuasive and necessitated the above withdrawals. The Prior Art Rejections were removed since while Myntti et al. (WO 2007/134055) discloses the amount of organic acid, specifically citric acid, they do not disclose the low effective solute concentration (ESC) claimed. While Lichter et al. (WO 2010/011605) does disclose a composition comprising the low ESC, they do not clearly disclose the amount of citric acid, nor do they disclose that citric acid as a critical ingredient. Lichter et al. also discloses 14-21% by weight of surfactant as an active ingredient in their compositions (Lichter [0026]). Such weights are expressly excluded by Myntti et al. Therefore the motivation to combine Lichter et al. and Myntti et al. is lacking while both are drawn to treating otitis media, both compositions use different approaches in the amount of citric acid and Lichter et al. relies on high concentrations of surfactant.
Rejoinder of Claims
Claims 29 and 32 were previously withdrawn in the Election of Species response on 11/11/24. Since they now depend from an allowable independent claim, they are rejoined.
New Rejections
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 19-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11090369. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets disclose a composition comprising:
a) a solvent component comprising water and at least 2% of DMSO or ethanol;
b) a solute component comprising citric acid, 0-1% of an anionic surfactant, a buffer, and at least 0.005 wt% (50 ppm) of lysozyme.
Both compositions are at a pH of 6-8 and an osmolarity of no more than 200 mOsm/L.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 29 is rejoined and is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is a method of treating the middle or inner ear of an animal by introducing the claimed composition into the ear cavity of the animal. However claim 29 applies the composition to the tympanic membrane, which reads on the external surface in the external auditory canal, which is neither the middle or inner ear cavity. Therefore it is unclear how claim 29 limits claim 1 since applying the composition to the outer surface of the tympanic membrane is treating a different area than the middle or inner ear.
Request for Interview
The Examiner believes an interview would be useful in progressing this case/allowable subject matter is present in this invention. The Applicant is encourage to contact Thane Underdahl at (303) 297-4299 to discuss the claims/claim amendments to place this case in condition for allowance prior to replying to this Office Action.
In response to this office action the applicant should specifically point out the support for any amendments made to the disclosure, including the claims (MPEP 714.02 and 2163.06).
CONTACT INFORMATION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THANE E UNDERDAHL whose telephone number is (303) 297-4299. The examiner can normally be reached Monday through Thursday, M-F 8-5 MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311.The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THANE UNDERDAHL/Primary Examiner, Art Unit 1699