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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/6/2026 has been entered.
Election/Restrictions
The rejections of record are maintained below.
Applicant’s election without traverse of Group I in the reply filed on 9/18/2025 is acknowledged.
Claims 13-37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/18/2025.
Priority
This application claims priority to US provisional application 63/564,880. There is also a related US application 19/079,370, and PCT/US25/19871.
This application finds support from the US provisional application. Therefore, the effective filing date is 3/13/2024.
Response to Arguments
Applicants’ claim amendments and Remarks of 3/9/2026 are acknowledged and have been considered.
The obviousness rejections made in the Final are withdrawn because upon further consideration, the cited references do not teach how an artisan would arrive at the synergistic mixture.
Applicants remarks with Examiner's reply are summarized below:
Applicants submit that there is a functional difference between the composition of the instant application and the formulation in Pelikaan. Decanoic acid appears in Example 1 of Pelikaan as a lipid phase component as a passive formulation component used to create oil droplets for sustained release rather than being a claimed active ingredient. Instant app. uses this as an active ingredient. Applicants submit that the therapeutic approaches and claimed benefits of are fundamentally different.
Applicants statements are arguing a functional difference (which is intended use). Nothing precludes the use as claimed.
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Chemical properties are inherent to their compounds. See MPEP 2112 (II). Products of identical chemical composition cannot have mutually exclusive properties. A chemical composition, ezetimibe, and its properties, reducing mesangial expansion, are inseparable. See MPEP 2112.01 (II).
Additionally, the instant claims use the open ended language of comprising. A combination of Pelikaan's composition and Zhou's composition meet the limitation of the both compounds of the instant claims.
Applicants submit that there would be no reasonable expectation of success. Applicants submit that Zhou teaches away from using lactate in a combination because Zhou investigates as a standalone therapy.
Examiner disagrees. There is no explicit teaching in Zhou limiting lactate to a standalone therapy. In general, the artisan would have found it obvious to combine two treatments used for the same purpose via in Re Kerkhoven.
Applicants submit that the additive effects of lactate, dexamethasone, and decanoic acid are highly unpredictable.
Examiner cannot take this statement without supporting data.
The double patenting rejection is withdrawn for the reason Examiner withdraws the obviousness rejection above.
Response to Amendment
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 1-12 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.
Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: (1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
The nature of the invention: The nature of the invention pertains to a pharmaceutical composition of dexamethasone, decanoic acid, and lactate.
The breadth of the claims: The breadth of the claims is drawn to a pharmaceutical composition of a synergistic mixture of dexamethasone, decanoic acid, and lactate.
The predictability or unpredictability of the art: Calzetta (Calzetta et al., “Drug-Drug Interactions and Synergy from Pharmacological Models to Clinical Applications”, American Society for Pharmacology and Experimental therapeutics, November 2024) discloses that the prediction of the additive effect represents the cornerstone in determining synergy (section IV). Table 1 describes that if both drugs are effective then a greater than zero-interaction is synergy. Identifying synergy is complex and unpredictable (page 1170).
The amount of direction or guidance presented: Identifying synergy requires trial and error testing. Trial and error testing is not guidance or a direction to find synergy. Examiner reviewed the instant Specification. No guidance is presented in the Instant Specification on how to arrive at the synergistic mixture. Applicants do not show any data or evidence that the composition of the claims had been tested.
The presence or absence of working examples: No working examples are shown in the Instant Specification. Applicants do not show any data or evidence that the composition of the claims had been tested. Applicants do not provide guidance for how the instant composition would attain synergy. Lack of a working example is a factor to be considered, especially in a case involving an unpredictable art. See MPEP § 2164.02.
The quantity of experimentation necessary: The quantity of experimentation would be “undue” because of the amount of time and resources needed to experimentally prove that the instant composition has synergy.
For the reasons above, especially the lack of a working example or guidance from the specification, a person of ordinary skill in the art would have to engage in undue experimentation to create a pharmaceutical composition comprising a synergistic mixture, with no assurance of success.
Thus, claims 1-12 are rejected as lacking enablement.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GILLIAN A HUTTER whose telephone number is (571)272-6323. The examiner can normally be reached M-F 7:30-5.
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/G.A.H./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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