DETAILED ACTION
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 .
Information Disclosure Statement
An information disclosure statement was filed 04/25/2023.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 5-19 in the reply filed on 10/27/2025 is acknowledged.
Clarification was made during a telephonic interview on 10/30/2025 with Mr Ludomir A. Budzyn since Group I, does not coincide with the claims indicated for election.
Applicant’s election without traverse is of Group II, claims 5-9, is acknowledged.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Drawings
The drawings are objected to because Figures 1 and 2 are not clear and can not be read clearly. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 5-9 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) determined that factors which enable an invention. These are:
(A) The breadth of the claims;
The instant claims set out a treatment of a disease or condition or a predisposition thereto.
(B) The nature of the invention;
The method is claimed for treatment and prevention of a wide range of diseases or conditions
(C) The state of the prior art;
The method of using fludrocortisone acetate and triamcinolone acetonide is new.
(D) The level of one of ordinary skill;
The ordinary practitioner is either a PhD or medical practitioner
(E) The level of predictability in the art;
As with any condition or disease, treatment and/or prevention must be evaluated in a painstaking, case by case basis..
(F) The amount of direction provided by the inventor;
No direction is given as to treatment protocols, dosage or frequency.
(G) The existence of working examples;
There are no working examples on the treatment or prevention of any disease or condition of any patients.
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Because each patient response is unique to the condition or disease, each one must be evaluated by carefully step by step as to dosage, frequency, patient reaction, and efficacy. This involves painstaking, undue experimentation to determine what is efficacious, what if any side effects such as skin irritation, and frequency of administration.
The claim for treatment and/or prevention of general diseases or conditions is not enabled by the original specification.
Claims 5-9 a 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.
The term “predisposition” is not defined clearly. 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 5-9 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.
The claims are indefinite in the use of the word ”including”. The metes and bounds of the claimed bioactives are indefinite, since it is not particularly pointed out what other bioactives may be included in the powder . Correction is requested.
The term “predisposition” is indefinite since each disease or condition would entail a different predisposition.
The claims are also indefinite in that claims set out a dry powder for injection through a syringe. Administration of powders through a syringe would not function as claimed. This is particularly true of claim 18 which sets out different particle sizes for the bioactive. Clarification is requested.
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).
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 mineralcorticoid. 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. The instant claims would have been obvious to one of ordinary skill in the art at the time of filing.
Conclusion
No claims are allowed.
US Patent No. 11,701,368 is cited as the parent to this application, and is directed to a composition.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARLOS A AZPURU whose telephone number is (571)272-0588. The examiner can normally be reached 9 am- 3 pm, 4 pm-8pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CARLOS A AZPURU/Primary Examiner, Art Unit 1617 caz