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 .
Applicant’s amendments filed 1/8/2026 have been entered.
Claims 28-37 and 40-47 are pending.
Claims 28-34 and 44-47 are withdrawn from consideration as they are directed to non-elected invention.
The outstanding rejections under 35 USC 102 and 103 are withdrawn in view of the amendments filed 1/8/2026.
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.
Claim(s) 35-37, 40-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over US2005/0009931 (‘931).
‘931 teaches a composition for treating infection and inflammation which comprises rifampicin as one of the anti-bacterial agent (see [0132]), buffering agents ([0195]), a carrier such as propylene glycol (see claim 49 for example). ‘931 teaches the composition can be formulated as eye drops, gel, or ointment (see [0095]). ‘931 teaches non-aqueous carrier as oils such as sesame oil (see [0193]).
‘931 does not expressly teach the composition can be used in treating the herein claimed conditions.
It would have been obvious one of ordinary skill in the art at the time of filing to formulate an eye drop rifampicin composition containing the herein claimed excipients.
One of ordinary skill in the art would have been motivated to formulate an eye drop rifampicin composition containing the herein claimed excipients since all of the excipients are known to be suitable to be the carrier for the rifampicin composition. Selecting well-known excipients for formulating the known dosage forms of rifampicin would be reasonably expected to be successful. Furthermore, the intended use of treating the herein claimed conditions does not lend patentable weight to the claims directed to composition.
Response to Arguments
Applicant’s arguments with respect to claim(s) 35-37, 40-43 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments with regard to the presence of the unexpected benefits according to the affidavit dated 1/8/2026, have been considered, but are not found persuasive. The examiner notes that it is applicant’s burden to demonstrate unexpected results over the prior art. See MPEP 716.02, also 716.02 (a) - (g). Furthermore, the unexpected results should be demonstrated with evidence that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance. Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). Moreover, evidence as to any unexpected benefits must be "clear and convincing" In re Lohr, 137 USPQ 548 (CCPA 1963), and be of a scope reasonably commensurate with the scope of the subject matter claimed, In re Linder, 173 USPQ 356 (CCPA 1972). There is no comparative data about what other isotonic components presented to show that indeed the herein claimed excipients are being critical to the unexpected benefit (stability) the composition possessed.
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 SAN MING R HUI whose telephone number is (571)272-0626. The examiner can normally be reached Mon - Fri 9:30-5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAN MING R HUI/Primary Examiner, Art Unit 1627
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