DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/09/2026 has been entered.
Status of the Application
Claims 1, 4, 6-9, 11-20 are pending, of which Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1, 4, 6-9 and 11 are under current examination.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained through the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 obviousnessor nonobviousness.
Claim(s) 1, 4, 6-9 are rejected under 35 U.S.C. 103(a) as being unpatentable over by Beumer (Cancer Chemotherapy and Pharmacology; 2008, 62: 457-464; published 11/15/2007) as evidenced by DiMartino (US 2004/0204339 A1).
Application Claims
Applicant claims an oral composition comprising decitabine and tetrahydrouridine (THU).
Determination of the scope and contents of the prior art
Beumer teaches that therapeutically important analogues, such as decitabine and other similar cytidine analogues cannot be given orally because of rapid catabolism by cytidine deaminase (CD) and THU (dose 300mg/m2, see page 463, col 1, paragraph 1) (orally available), which is a modulator of CD may be combined with decitabine and other similar cytidine analogues to make the composition oral, increase bioavailability by reducing catabolism by CD etc. (abstract, pages 457, 458, 460-463). Thus, the cited prior art teaches as well as provides a motivation to make a composition comprising decitabine and THU.
Ascertainment of the differences between the prior art and the claims
The differences between Beumer and the instant claims are:
Beumer fails to teach decitabine amount, form of composition as solid, capsule, coating etc.; effect of the composition and bioavailability; decitabine and THU are differentially located in the composition.
With regard to the difference of amount of decitabine in the composition- Since decitabine is a known drug with a known dosage (50mg/m2), safe in humans (as evidenced by DiMartino (paragraphs 38-40)), it would have been prima facie obvious to a person of ordinary skill in the art to have the dose of decitabine already proven as safe in humans. Since the amount is effective, it is effective to produce same plasma concentration in time period as in the instant claims. Thus, the cited prior art meets limitation of the instant claims.
With regard to the difference of form of composition as solid, capsule, coating etc.- Since both decitabine and THU are solids, it would have been prima facie obvious to a person of ordinary skill the art with a reasonable expectation of success that the composition may be made in the form of solid (without dissolving them in a carrier) as a capsule, tablet etc., with a coating useful in making tablets and capsules. Further, making a solid composition in a capsule or tablet with a coating is routinely practiced in the art. Thus, the cited prior art meets limitation of the instant claims.
With regard to the difference of effect of the composition and bioavailability - Since the cited prior art teaches same composition as in the instant claims, the resulting effects of such composition such as plasma concentration, treating blood disorder etc., is expected to be same and exerted by the composition of the cited prior art, whether recognized by the cited prior art or not. Additionally, as the cited prior art teaches same composition as in instant claims, the composition of the cited prior art must be capable of being useful for treating blood disorders of claim 4, treating malignancy of claim 6 and capable of being bioavailable same as in the instant claims 7 and 8. Further, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000).
With regard to the difference of differential location of decitabine and THU in the composition- Since each molecule occupies its own space, it would have been prima facie obvious to a person of ordinary skill in the art to that suggested combination has differentially located molecules of THU and decitabine in the composition. Thus, the cited prior art meets limitation of the instant claims.
Finding of prima facie obviousness rational and motivation
(MPEP 2142-2143)
To establish a prima facie case of obviousness, rationales that may support a conclusion of obviousness include: HYPERLINK "http://rdms-mpep-vip.uspto.gov/RDMS/detail/manual/MPEP/e8r9/d0e209553"
(A) Combining prior art elements according to known methods to yield predictable results; HYPERLINK "http://rdms-mpep-vip.uspto.gov/RDMS/detail/manual/MPEP/e8r9/d0e209557"(B) Simple substitution of one known element for another to obtain predictable results; HYPERLINK "http://rdms-mpep-vip.uspto.gov/RDMS/detail/manual/MPEP/e8r9/d0e209561"
(C) Use of known technique to improve similar devices (methods, or products) in the same way; HYPERLINK "http://rdms-mpep-vip.uspto.gov/RDMS/detail/manual/MPEP/e8r9/d0e209565"
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; HYPERLINK "http://rdms-mpep-vip.uspto.gov/RDMS/detail/manual/MPEP/e8r9/d0e209569"
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; HYPERLINK "http://rdms-mpep-vip.uspto.gov/RDMS/detail/manual/MPEP/e8r9/d0e209573"
(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; HYPERLINK "http://rdms-mpep-vip.uspto.gov/RDMS/detail/manual/MPEP/e8r9/d0e209577"
(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; and (MPEP § 2143).
In this case, Beumer teaches that therapeutically important analogues, such as decitabine and other similar cytidine analogues cannot be given orally because of rapid catabolism by cytidine deaminase (CD) and THU (dose 300mg/m2, see page 463, col 1, paragraph 1) (orally available), which is a modulator of CD may be combined with decitabine and other similar cytidine analogues to make the composition oral, increase bioavailability by reducing catabolism by CD etc.
Thus, with the guidance provided by Beumer, it would have been prima facie obvious to a person of ordinary skill in the art to make a composition comprising decitabine and THU as in the instant claims. Further, a person of ordinary skill in the art will be motivated to make such composition to prevent catabolism of decitabine to increase its bioavailability and oral availability as taught by the cited prior art.
Thus, the instantly claimed composition would have been prima facie obvious to one of ordinary skill in the art in view of Beumer’s teaching.
Double Patenting Rejection
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1, 4, 6-9 and 11 in the instant application are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11786543 B2; claims 1-8 of U.S. Patent No. 11096953 B2; claims 1-15 of U.S. Patent No. 10517884 B2; claims 1-18 of U.S. Patent No. 9895391 B2; claims 1-24 of U.S. Patent No. 9259469 B2 and claims 1-35 of U.S. Patent No. 9265785 B2 respectively, since the claims, if allowed, would improperly extend the “right to exclude" already granted in the patent.
The subject matter claimed in Claims 1, 4, 6-9 and 11, in the instant application is fully disclosed and is covered by claims 1-14 of U.S. Patent No. 11786543 B2; claims 1-8 of U.S. Patent No. 11096953 B2; claims 1-15 of U.S. Patent No. 10517884 B2; claims 1-18 of U.S. Patent No. 9895391 B2; claims 1-24 of U.S. Patent No. 9259469 B2 and claims 1-35 of U.S. Patent No. 9265785 B2, which are drawn to either composition or a method of using the composition, wherein the composition is same among instant claims and patents with a difference of wording.
However, the difference in wording does not constitute a patentable distinction because the claims in the present invention simply fall within the scope of the patents. For the foregoing reasons, the instantly claimed composition is made obvious.
Furthermore, there is no apparent reason why applicant was prevented from presenting claims corresponding to those of the instant application during prosecution of the application which matured into a patent. See also MPEP § 804.
Response to arguments
Applicant’s remarks and amendment, filed on 01/09/2026, have been fully considered but not found persuasive.
Applicant argument over 103 is moot in view of new rejection as set forth above.
Applicant didn’t provide any argument over the ODP rejection. Therefore, the rejection is maintained.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PANCHAM BAKSHI whose telephone number is (571)270-3463. The examiner can normally be reached M-Thu 7-4.30 EST.
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/PANCHAM BAKSHI/Primary Examiner, Art Unit 1623
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