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 .
The amendment filed 04/27/2026 is acknowledged.
Withdrawn Objection(s) and Rejection(s)
The objections to the title and drawings are withdrawn.
The rejections under 35 USC 112, first paragraph for enablement, first paragraph for written description, and second paragraph for being indefinite are also withdrawn.
An updated search made the following rejection necessary:
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 5 , 6, 8 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2005/09715 A2 (Retmed), in view of U.S. Patent No. 7,674,247 (Fojtik).
Retmed discloses administering an effective amount of compounds which modulate the activity of mineralocorticoid receptors as a treatment of ophthalmic conditions (Abstract; page 8, paragraph 1). These compounds include hydrocortisone, methyl prednisolone, prednisolone, dexamethasone and fludrocortisone acetate at a concentration from about 0.1 ug/ml to about 40 mg/ml (page 29, paragraph 2 to page 33, paragraph 2; page 36, paragraph 2). The combination of fludrocortisone and triamcinolone acetonide is preferred (Page 38, paragraph 3). The formulations of Retmed may be in the form of solid dispersions or as solubilized preparations (page 52, paragraph 4). Carboxymethylcellulose is added at page 3, line 27 - 33.) Surfactant is added at page 5, lines 11-15. The combination of triamcinolone and fluconazole meets the requirement of at least one glucocorticoid, and at least one mineralocorticoid. No preservatives are disclosed by Retmed. As such, Retmed would allow one of ordinary skill in the medical arts to claim a treatment of a condition or disease with a reasonable expectation of beneficial therapeutic results.
Retmed lacks a teaching of administering it’s combination medicated composition through a double-barreled syringe capable of administering the separate medications simultaneously. Fojjtik specifically teaches a double-barreled syringe which is capable of simultaneously administering medications from both barrels. As such, it would have been able to administer the composition as claimed according to the teachings of Retmed. Further, it would have been well within the skill of the ordinary practitioner to administer the composition through a double-barreled syringe as taught by Fojtik. The instant claims would have therefore been obvious to one of ordinary skill in the art at the time of filing.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 5, 6, 8, and 9 are
rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Compositions administered through double-barreled compositions are separated in different barrels because mixing of the compositions may react or contaminate each other if placed in a single barrel. Applicant has not described why or how the components of the claimed composition should be separated. Clarification is requested.
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 5, 6, 8, and 9 are 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.
Applicant has claimed a double-barreled syringe as part of the administration of the claimed composition, but has not particularly pointed out how or why the composition is divided before injection takes place. Clarification is requested.
Conclusion
No claims are allowed.
Correspondence
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/CARLOS A AZPURU/ Primary Examiner, Art Unit 1617 caz
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