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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous office action has been withdrawn pursuant to 37 CFR 1.114.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 17 March 2026 has been entered.
The Request for Continued Examination filed has been considered. The following information has been made of record in the RCE filed for the instant application:
1. Claims 1-34 have been canceled.
2. New Claims 35-55 have been added.
3. Remarks drawn to rejections under 35 USC 102(a)(1) and 103.
Claims 35-55 are pending in the case.
The rejection of Claim(s) 1 and 23-24 under 35 U.S.C. 102(a)(1) as being anticipated by Mazzio et al (US 2010/0209388 A1; of record), and the rejection of Claim(s) 1, 16-22 and 25-34 under 35 U.S.C. 103 as being unpatentable over Mazzio et al (US 2010/0209388 A1; of record) in view of Wyatt et al (Cell Mol. Life Sci, 2009, 66, 788-799; of record) and further in view of Ajnai et al (Journal of Experimental and Clinical Medicine, 2014, 6(6), 172-178; of record) have been rendered moot by cancelation.
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.
Claim(s) 35-55 are rejected under 35 U.S.C. 103 as being unpatentable over Mazzio et al (US 2010/0209388 A1; of record and newly cited in this rejection) in view of Wyatt et al (Cell Mol. Life Sci, 2009, 66, 788-799; of record and newly cited in this rejection) and further in view of Ajnai et al (Journal of Experimental and Clinical Medicine, 2014, 6(6), 172-178; of record and newly cited in this rejection) and Arevalo et al (Analytical Chemistry, 2014, 86, 10223-10230; newly cited).
Mazzio teaches the use of a composition which can have FAD as a component, in a method of treating cancer in humans (paras 0032, 0038; method and active agent recited in claim 35). The cancers treated are skin, breast, colon, kidney, blood, lymph, stomach, gastrointestinal, ovary, prostate, liver, lung, gallbladder, pancreas, etc. (para 0058; cancers as in claim 36). Mazzio teaches various routes of administration of the composition including parenteral route (para 0060; as in claim 47). In view of the teaching of Mazzio regarding the various routes of administration as in para 0060, it would be obvious to one of ordinary skill in the art to make the composition suitable for intra-vesical and intra-urethral administration as in claim 49. Mazzio teaches that a therapeutically effective amount is defined as an amount of the active agent of its invention, administered to a human at a dose such that the treatment can bring about halting of tumor growth (para 0061). In view of this one of ordinary skill in the art can determine the therapeutically effective amount of FAD as in claim 35, and can also arrive at the dosages recited in claims 37-39. The artisan can adjust the dosage in order that FAD has a plasma concentration as in claim 55.
Mazzio does not expressly teach treating some of the cancers recited in claim 36 and the limitations of claims 40-47.
Wyatt et al teaches that 5-fluorouracil is used to manage solid tumors including colorectal breast cancers, head, neck, ovary, pancreas, stomach etc. (Abstract, Introduction). This tells one of ordinary skill in the art that 5-fluorouracil can further be used as an additional active agent in combination with FAD in the method of Mazzio (active agent as in claim 40).
Ajnai et al teaches that gold nanoparticles have been used as nanobiomaterials for drug delivery. Gold nanoparticle conjugated drugs have a high perfusion rate in targeting tumor foci (page 172, Introduction; page 173, part 3; limitation of claims 42-43 and 47). Polyethylene glycol is used as a nanocarrier surface coating (as in claims 42 and 47). Ajnai also teaches conjugation of active agent to PEG coated GNPs (page 173, part 4 through page 175; limitation of claims 41-42). According to Ajnai, oxaliplatin, an anticancer drug, conjugated to PEG GNPs display higher rate of penetration to the nucleus of lung cancer cells, resulting in greater cytotoxicity compared to oxaliplatin alone (page 175, part 5, see lines 38-41 of that para). This means that FAD can also be covalently bound to PEG and also to GNP as in claims 44-46. In view of the teachings of Ajnai and Mazzio, one of ordinary skill in the art will use the carriers as in claim 42 for FAD, and also use FAD covalently bound to PEG and gold atom as in claim 45 and FAD bonded to gold atoms by coordination bonding and bonded to PEG by covalent bonding as in claim 46 since Ajnai teaches conjugation of active agents for treating cancer to both gold and PEG including encapsulation as claimed in claims 45-46. The artisan would also have a reasonable expectation of success in treating all the other cancers recited in claim 36 in view of Mazzio, Wyatt and Ajnai et al. It would be obvious to the artisan to administer FAD as the sole active ingredient in the claimed method as in claims 50-54 since from Mazzio’s teachings it can be seen that FAD is an active agent in a method of treating cancer. The artisan would choose FAD as a sole active ingredient since Mazzio teaches that recent studies show that riboflavin is protective against carcinogenesis and a deficiency, pre-empts cervical dysplasia and cancer, an effect reversed by high intake of riboflavin in both humans and animals (para 0011, lines 11-15).
Arevalo et al teaches the structural formula of FAD. It is seen that FAD has the riboflavin moiety attached to the flavin dinucleotide. In view of this teaching of Arevalo and that of Mazzio one of ordinary skill in the art would choose FAD as an active agent, including choosing it as the sole active agent in a method of treating cancer as in claims 35 and 50-54, since it has the riboflavin moiety on it and Mazzio teaches that riboflavin is protective against carcinogenesis.
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary 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."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, FAD is used as an active agent for treating various cancers, and gold nanoparticles and PEG have been used as carriers to conjugate anticancer agents for drug delivery. 5-fluorouracil is also an active agent that is used for treating many cancers. Thus, it is obvious to arrive at the claimed invention in view of the combined teachings of the prior art.
Thus, the claimed invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art.
The artisan would be motivated to use the claimed carriers with FAD since such a combination is taught as being very effective and provide better therapeutic outcome (Ajnai: page 175, part 5). The artisan would also substitute the other polymers recited in claims 42 and 47 in order to look for biopolymer conjugates that have high perfusion rate as suggested by Ajnai. The artisan would also use FAD as the active agent in view of Mazzio and Arevalo. In addition, the use of just FAD and the other claimed ingredients will also reduce the cost of the method.
Response to Applicants’ Remarks
In view of the amendment the rejection under 35 USC 103 as set forth above is made of record.
Conclusion
1. Claims 35-55 are rejected.
2. Claims 1-34 have been canceled.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GANAPATHY KRISHNAN whose telephone number is (571)272-0654. The examiner can normally be reached M-F 8.30am-5pm.
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/GANAPATHY KRISHNAN/Primary Examiner, Art Unit 1693