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 .
Status of Claims
Claims 1-10, 12-19, 23, and 27 are pending in the instant application.
Claims 11, 20-22, 24-26, and 28-35 have been canceled.
Election/Restriction
This action is in response to an election from a restriction requirement filed September 24th, 2025. There are 20 claims pending and 19 claims under consideration. Claim 27 has been withdrawn as a claim directed to a non-elected invention. This is the first action on the merits.
Acknowledgement is made of Applicant’s election made in the reply received November 17th, 2025 without traverse of Group I, Claims 1-10, 12-19, and 23 and species election of BMX-010:
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as the single species of hydrophilic active ingredient.
Domestic Benefit
Acknowledgement is made of Applicant’s claim for domestic benefit based on the 63/349,793 provisional application filed June 7th, 2022. The instant claims are supported by this application, and will be evaluated with an effective filing date of June 7th, 2022.
Information Disclosure Statement
The Information Disclosure Statements received July 17th, 2023 and September 18th, 2023 have been fully considered by the examiner, except where marked with a strikethrough.
Drawings
Acknowledgement is made of the drawings received June 7th, 2023. These drawings are acceptable.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., “The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics.” Exemplification of a species could be illustrative of members of the class. For processes, the type of reaction, reagents and process conditions should be stated, generally illustrated by a single example unless variations are necessary.
The abstract of the disclosure is objected to because it is fewer than 50 words in length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 1-5, 7-10, 12-19, and 23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a composition comprising BMX-010 as a hydrophilic active ingredient, does not reasonably provide enablement for a composition comprising any hydrophilic active ingredient. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (1) The breadth of the claims, (2) The nature of the invention, (3) The state of the prior art, (4) The level of one of ordinary skill, (5) The level of predictability in the art, (6) The amount of direction provided by the inventor, (7) The existence of working examples and (8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Nature of the invention:
The invention is drawn to a composition comprising a hydrophilic active ingredient, a hydrophobic carrier, and an acid.
Breadth of the invention:
The scope of the claimed invention is very broad. The instant specification, at Paragraph 0059, defines hydrophilic active ingredient as “a compound that has a log P (logP) of less than 1 and that can provide a pharmacological activity, a direct effect on the treatment and/or prevention of a disease, disorder, and/or condition in and/or on a subject, and/or that can affect the structure and/or a function of the body of a subject.” This description is applicable to a myriad of compounds, both presently known, or to compounds that have not yet been discovered.
State of the prior art and predictability in the art:
The invention is directed toward medicine and is therefore physiological in nature. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F. 2d 833, 839, 166, USPQ 18, 24 (CCPA 1970).
In terms of the law, MPEP 2107.03 states “evidence of pharmacological or other biological activity of a compound will be relevant to an asserted therapeutic use if there is reasonable correlation between the activity in question and the asserted utility. Cross v. Iizuka, 753 F. 2d 1040, 224 USPQ 739 (Fed. Cir. 1985); In re Jolles, 628 F. 2d 1322, 206 USPQ 885 (CCPA 1980); Nelson v. Bowler, 626 F. 2d 853, 206 USPQ 881 (CCPA 1980).” If correlation is lacking, it cannot be relied upon, Ex parte Powers, 220 USPQ 924; Rey-Bellet and Spiegelberg v. Engelhardt v. Schindler, 181 USPQ 453; Knapp v. Anderson, 177 USPQ 688. Indeed, the correlation must have been established “at the time the tests were performed”, Hoffman v. Klaus, 9 USPQ2d 1657.
Level of ordinary skill in the art:
An ordinary artisan in the area of drug development would have experience in synthesizing chemical compounds for particular activities. The synthesis of new drug candidates, while complex, is routine in the art. The process of finding new drugs that have in vitro activity against a particular biological target (i.e., receptor, enzyme, etc.) is well known. Additionally, while high throughput screening assays can be employed, developing a therapeutic method, as claimed, prior to synthesizing and testing compounds is generally not well-known or routine, given the complexity of certain biological systems.
The amount of direction provided and working examples:
Dependent Claim 3 limits the scope of the hydrophilic active ingredient by providing the structure of Formula I:
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Even with this limitation, the scope of compounds claimed is very broad, as this formula allows for a number of compounds generated from various definitions of the variables thereof.
Even in view of this further limitation, beginning at Page 43 of the instant specification, several examples are provided disclosing various compositions of the instant invention. In each of the examples, BMX-010, the elected species, is the hydrophilic active ingredient. No examples are provided demonstrating a composition of the instant invention with a hydrophilic active ingredient other than BMX-010.
Taken together, Applicant has sufficiently disclosed compositions in which BMX-010 is the hydrophilic active ingredient. These limited examples, however, are insufficient to guide a person having ordinary skill in the art to formulate a composition employing a different hydrophilic active ingredient, nor would it be readily understood based on the content of the instant disclosure the motivation for doing so.
Within the specification, “specific operative embodiments or examples of the invention must be set forth. Examples and description should be of sufficient scope as to justify the scope of the claims.” Markush claims must be provided with support in the disclosure for each member of the Markush group. Where the constitution and formula of a chemical compound is stated only as a probability or speculation, the disclosure is not sufficient to support claims identifying the compound by such composition or formula. See MPEP 608.01(p).
MPEP § 2164.01 (a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F. 2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here that Applicant is not enabled for compositions in which the hydrophilic active ingredient is anything other than BMX-010.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-6, 8, 12-18, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Crow et. al. (US 6,372,727; hereinafter referred to as Crow) in view of Batinic-Haberle et. al. (“Diverse functions of cationic Mn(III) N-substituted pyridylporphyrins, recognized as SOD mimics”, Free Radical Biology & Medicine, 2011; hereinafter referred to as Batinic-Haberle).
Crow teaches compositions comprising iron meso-substituted metalloporphyrins as the active ingredient. At Column 5, line 35, Crow teaches the active ingredient as compounds having the general structure:
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At Column 23, Lines 18-22, Crow teaches these iron porphyrins are regarded as SOD mimics.
At Column 7, Lines 60-65, Crow teaches the active ingredient may comprise anywhere from 0.001% to 10% w/w of the composition. While this range is broader than the range instantly recited, per MPEP 2144.05, I., “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).”
At Column 8, Second Paragraph, Crow teaches compositions comprising active ingredients above the formula in a variety of hydrophobic carriers including paraffin, natural oils including corn or olive oil, and further comprising fatty acids such as oleic acid.
At Column 6, Lines 66-67, Crow teaches the compositions are suitable as ointments.
While Crow is silent with respect to the amount of hydrophobic carrier and acid in the composition, these amounts would have been arrived at via routine optimization, as per MPEP 2144.05, II., A, “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”.
The prior art differs from the instantly claimed composition in that it teaches iron porphyrins as the active hydrophilic ingredient rather than the instantly elected BMX-010.
At Page 1039, Figure 4, Batinic-Haberle teaches BMX-010 as MnTE-2PyP5+ having the structure:
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.
At Page 1042, First Column, Third Paragraph, Batinic-Haberle teaches MnTE-2-PyP5+ as a SOD mimic. Therefore, MnTE-2-PyP5+ and the iron porphyrins taught by Crow were both known in the art at the time of filing to be SOD mimics. Applying KSR exemplary rationale B, it would have been prima facie to substitute the iron porphyrins taught by Crow for BMX-010, as instantly claimed to arrive at the claimed compositions. Doing so would have been practiced with reasonable expectation of success, as a person having ordinary skill in the art would reasonably expect the inclusion of SOD mimics not disclosed by Crow in the compositions taught by Crow would be suitable.
Conclusion
Claims 1-5, 7-10, 12-19, and 23 are rejected.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday.
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/D.J.B./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624