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 .
DETAILED ACTION
Claims 1-20 are pending in the instant application and are examined on the merits herein.
Priority
The application claims benefit to provisional application US 63/458815 filed on 4/12/2023.
Information Disclosure Statement
The information disclosure statements (IDS) dated 3/25/2025 comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted. Accordingly, the IDS documents have been placed in the application file and the information therein has been considered as to the merits.
Claim Objection
Claim 7, 8 and 17-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 13 is objected to for the following informalities: The recitation “R1 is H or ; Rb is OH or ; and Rc is H or ;” contains “or” statements lacking necessary members of a group. It appears the intent was to recite, ““R1 is H; Rb is OH; and Rc is H;”. Appropriate correction is required.
Claim 16 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 13. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 706.03(k).
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 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 of this title, 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.
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.
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 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, 9-12, 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Caputo et al. (IT TO20020722A1, 2004, PTO-892).
Caputo et al. discloses a compound of formula (I): (Claims 1, 2, 6-9, 11; p. 10)
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132
318
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,
where BASE is cytosine, uracil, 7-deazaguanine or 7-deazaadenosine;
Y is
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110
172
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, where W1, W2 and W3 may be H or OH;
L1 is a linear (C1-C20) alkyl group, which may be saturated or unsaturated, such as -CH2CH2- or -CH2CH2CH2-, or is -CH2-NH-C(O)CH2CH2-; and
Z is OH, methoxy, ethoxy, chloroethoxy, cyanoethoxy, t-butoxy or phenoxy.
Caputo exemplifies the following compound: (Example 2)
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206
443
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.
It is noted that the exemplified compound of Caputo is excluded from instant claim scope due to the negative proviso.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the exemplified compound of Caputo by substituting the hydroxy group in the terminal carboxyl group with any one of a methoxy, ethoxy, or t-butoxy group, thereby arriving at the invention where R3 may be a (C1-C6) alkyl group. It would be further obvious that the C(O)-CH2CH2-COOH group of Caputo could be substituted with a C(O)-CH=CH-COOH group. One would be motivated to modify the exemplified compound of Caputo in this manner because Caputo suggests that the Z group may be selected from the group consisting of OH, methoxy, ethoxy, chloroethoxy, cyanoethoxy, t-butoxy or phenoxy; and Caputo suggests that the L1 group may be a saturated or unsaturated (C1-C20) alkyl group.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claims 13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Caputo et al. (IT TO20020722A1, 2004, PTO-892), in view of Truffert et al. (US 2015/0141490, PTO-892).
The disclosure of Caputo is referenced as discussed above. Caputo does not teach a pharmaceutical composition.
Truffert et al. discloses pharmaceutical compositions comprising nucleoside analogs and a pharmaceutically acceptable carrier. (Claim 38)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention the Caputo could have been modified such that the compound of formula (I) was formulated into a pharmaceutical composition comprising and a pharmaceutically acceptable carrier, thereby arriving at the instant invention. One would be motivated to modify Caputo in this way because Caputo is directed to nucleoside analogs for therapeutic use and Truffert discloses that it is well-established in the art of therapeutic nucleoside analogs to incorporate them into pharmaceutical compositions comprising pharmaceutically acceptable carriers. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at ___, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached on (571) 270-5341. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center and the Private Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from Patent Center or Private PAIR. Status information for unpublished applications is available through Patent Center and Private PAIR to authorized users only. Should you have questions about access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/DALE R MILLER/Primary Examiner, Art Unit 1693
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