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 the Claims
Claims 1, 2, 12, 13, 19, 20, 23, 25, 28, 32, 35, 45, 48, 49, 52, 57, 63-65, 71, 73, 86, 88, 92, 95, 105, 108-113, 118, 119, 139, 142, 144, 152-156, 177, and 178 are pending.
Claims 19, 64, 65, 71, 73, 86, 88, 92, 95, 105, 108-113, 118, 119, 139, 142, 144, 152-156, 177, and 178 are withdrawn (see election/restriction below).
Priority
Applicant’s claim for benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application is a national stage entry of and claims priority to Application Serial No. PCT/US21/46048, filed 8/14/2021; and further claims priority to PRO application number 63/065,810, filed 08/14/2020.
Information Disclosure Statement
All references from IDS(s) received on 03/31/2025 have been considered unless marked with a strikethrough.
Election/Restrictions
Applicant’s election of Group I without traverse in the reply filed on 4/20/2026 is acknowledged. Claims 64, 65, 71, 73, 86, 88, 92, 95, 105, 108-113, 118, 119, 139, 142, 144, 152-156, 177, and 178 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method of making.
Applicant’s election of lenalidomide as the active pharmaceutical ingredient, a co-former of nicotinamide, and a second active ingredient of nicotinamide without traverse in the reply filed on 4/20/2026 is acknowledged. Claim 19 is withdrawn as not reading on the elected species.
Claims 1, 2, 12, 13, 20, 23, 25, 28, 32, 35, 45, 48, 49, 52, 57, 63 will be examined on their merits.
Anticipatory art was found on the elected species. Any limitations not found in the anticipatory art are also rejected using an obviousness-type rejection. See 102/103 analysis below.
Claim Rejections - 35 USC § 112
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 1 and 35 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 term “derivative” in claim 1 and 35 is a relative term which renders the claim indefinite. The term “derivative” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The Specification does not define the word derivative it only provides an example where the example leads to two interpretations, a functional derivative such as nicotinamide as a derivative of vitamin or a structural derivative such as mefenamic acid. Since there is no definition within the Specification, the Examiner interprets it through its broadest reasonable interpretation. Therefore, since there are no definitive terms or boundaries to what can constitute as a derivative, the Examiner can only assume the derivatives can span as broad as to any compound that would act like afenamic acid or any structural derivatization of a vitamin.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 12, 13, 20, 23, 25, 28, 32, 35, 45, 52, 57, 63 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Shanghai University (CN105837556A; Published 10/26/2018).
Shanghai University teaches a preparation method which would result in a composition comprising lenalidomide and nicotinamide co-crystal, where lenalidomide is used as a pharmaceutical active ingredient, and nicotinamide is used as a co-crystal former (Claim 1), as required by Claims 1, 2, 12, 13, 20, 23, 25, 28, 32, 35, and 45.
Shanghai University also teaches the molar ratio or lenalidomide and nicotinamide to be 1:1 (Claim 1) which falls within the range required by instant claim 52.
Finally, Shanghai University teaches the composition to be grinded, pressed in a mold and into tablet formation, as required by instant claims 57 and 63.
Therefore, Shanghai University anticipates the limitations of instant claims 1, 2, 12, 13, 20, 23, 25, 28, 32, 35, 45, 52, 57, 63.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 12, 13, 20, 23, 25, 28, 32, 35, 45, 48-49, 52, 57, 63 are rejected under 35 U.S.C. 103 as being unpatentable over Shanghai University (CN105837556A; Published 10/26/2018) in further view of Gomathi, T. et al. (Int J Pharm. 2014 Jul 1;468(1-2):214-22; “Gomathi”) and Matat, M. et al. (Carbohydrate Polymers 95 (2013) 241– 251; “Matat”).
Shanghai University teaches a preparation method which would result in a composition comprising lenalidomide and nicotinamide co-crystal, where lenalidomide is used as a pharmaceutical active ingredient, and nicotinamide is used as a co-crystal former (Claim 1), as required by Claims 1, 2, 12, 13, 20, 23, 25, 28, 32, 35, and 45.
Shanghai University also teaches the molar ratio or lenalidomide and nicotinamide to be 1:1 (Claim 1) which falls within the range required by instant claim 52.
Finally, Shanghai University teaches the composition to be grinded, pressed in a mold and into tablet formation, as required by instant claims 57 and 63.
Shanghai university fails to teach where the composition further comprises a pharmaceutical excipient, or that the pharmaceutical excipient would be a thermoplastic polymer, as required by instant claims 48-49.
Gomathi teaches that encapsulation of lenalidomide with controlled polymeric pharmaceutical excipient, chitosan nanoparticles (CS-NPs) is a method used to improve bioavailability and to reduce under as well as overloading of hydrophobic and sparingly soluble drug lenalidomide towards cancer cells (Abstract). Further, Matet teaches that chitosan can be plasticized and used in several applications, such as biomedical and biopharmaceutical applications, where chitosan can be used for the development of controlled release drug delivery systems (Introduction, para. 1).
Therefore, with respect to instant claims 48-49, it would be obvious to a person skilled in the art to modify a known pharmaceutical composition with polymeric pharmaceutical excipient especially if that excipient is known to improve the drug delivery properties of the active ingredient in the composition.
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Applying KSR example rationale (A), it would have been prima facie obvious to extract the pharmaceutical composition of lenalidomide, as taught by Shanghai University, and modify it with polymeric pharmaceutical excipient, such as chitosan, as taught by Gomathi, especially if that excipient is known to improve the drug delivery properties of the active ingredient in the composition, as taught by Gomathi and Matet. Therefore, claims 1, 2, 12, 13, 20, 23, 25, 28, 32, 35, 45, 48-49, 52, 57, 63 would be obvious to a person skilled in the art at the time.
Conclusion
Claims 1, 2, 12, 13, 20, 23, 25, 28, 32, 35, 45, 48-49, 52, 57, 63 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLA MARIA BAUER whose telephone number is (703)756-1269. The examiner can normally be reached Monday-Friday 7:30-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clint Brooks can be reached at (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.M.B./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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