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 .
Election/Restrictions
The rejection of record is 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Claims 13-37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim.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 7/8/2026 are acknowledged and have been considered.
Any rejection and/or objection not specifically addressed or modified below is herein withdrawn.
In regard to the enablement rejection, this rejection is maintained. Applicants have amended claim 1 to include the limitation “for treating osteoarthritis”. Examiner points out that this is a 3-comonent mixture that now has an intended use (i.e. “for treating osteoarthritis”). Applicants remarks are summarized below:
Applicants submit that the specification provides sufficient guidance, direction and working examples that demonstrate the synergistic effects of the claimed three-component composition in treating osteoarthritis.
Examiner has reviewed claims 14 and 35, and is unsure. Table 3 summarizes this information (in the specification) by showing superior improvement with a “++”, improvement with a “+” and did not show improvement with a “-“.
Applicants state that regarding inflammatory markers, the combination resulted in statistically significantly lower serum TNF-A, IL-1B, and IL- compared to saline controls.
Although Applicants state there is synergy and the combination resulted in a statistically significantly lower serum TNF-A, IL-1B, and IL- compared to saline controls, Examiner cannot determine what “+” and “++” stands for in terms of statistical significance (i.e. a p-value or other equivalent) in order to determine if this statement is supported and if synergy exists for the instant combination. Applicant’s Arguments cannot take the place of evidence. See MPEP 716.01C.
Applicants submit that the specification has an abundance of in vitro evidence supporting synergy of the claim components.
Examiner agrees that there are in vitro examples. After a review of the specification, Examiner cannot determine is the proposed synergy is synergy or an additive effect.
Though Applicant states that unexpected results have been achieved, the instant specification does not provide any unexpected or surprising results. The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Examples of attorney statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor. See MPEP 716.01(c).
Additionally, the three components each have very broad concentration ranges and with synergy being an unpredictable phenomenon (see Calzetta page 1170 below), there is no way to know which 3-way combination will have a synergistic effect for treating osteoarthritis.
No invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients, In re Sussman, 1943 C.D. 518. Applicants invention is predicated on an unexpected result (i.e. synergism/synergistic mixture, which is an unpredictable phenomenon) that is highly dependent upon specific proportions and/or amounts of particular ingredients. Any mixture of the components embraced by the claims which does not exhibit an unexpected result (e.g., synergism) is therefore ipso facto unpatentable.
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.
THIS ACTION IS MADE FINAL. 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 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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