DETAILED ACTION
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 .
Priority
Acknowledgments are made that this application claims the priority to the following:
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Information Disclosure Statement
Filed information disclosure statements (IDS) comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, they have been placed in the application file and the information therein has been considered as to the merits.
Response to Restriction
Applicant's response to restriction requirement and election of group I corresponding to claims 12, 14 and 17 with traverse in the reply filed on 07/09/2026 is acknowledged.
Examiner also acknowledges applicants response to election of species and providing a single species for the claimed variables.
Applicants traversal of restriction is on the grounds that the common technical features in all the herein amended independent claims, in particular the azido-modified targeting ligand, contribute to the unity of the invention across all the amended claims, and that it should not be an undue burden to examine all the pending claims as amended in the present application.
Amended claims are still lack of unity of invention, since the claimed product is obvious over the cited art [see 103 rejection below].
With regard to ‘undue burden to examine all the pending claims as amended’, the search strategy for product is different from that of method claims. The product search is based on the on the registry numbers or structure or names of the compounds etc., whereas the search of method claims requires additional key words or subject matter, which is a serious burden. Even if the product is allowable, the method claims are not necessarily be allowable, because the method claims will be analyzed in view of 112 issues, which requires an additional search.
Accordingly, claims 19-30 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
The claims 12, 14 and 17 are examined on merits in this office action.
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.
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.
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 12, 14 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Hammond (US2012/0130045A1) in view of Bradshaw (US2016/0257961A1) and Hari (Bioorganic & Medicinal Chemistry, 2013, 21, 5583-5588; see applicants filed IDS dated 10/19/2023) .
For claim 12:
Hammond teaches a biomolecule-polymer conjugate formed by an alkyne modified siRNA and azide containing PEG [see 0011-0012, 0039-0043].
Difference is that Hammond is silent on applicants specific product, which is produced from the recited reactants.
The above difference is cured with the following art and the logical outcome from their teachings:
Bradshaw teaches the following:
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[see PSMA monovalent azide in page 118], which is identical to applicants azido-modified targeting ligand.
Hari teaches propargyl-modified small nucleic acid [see Schemes 1-3]. It appears that Hari silent on alkyne group on 3’ terminal oligonucleotide. However, Hari provided enough guidance to make propargyl-modified small nucleic acids, and so, a skilled person in the art would make 3’ terminal propargyl modification with a reasonable expectation of success. In fact, applicants specification already acknowledged that their process of making 3’ terminal oligonucleotide from the teachings of Hari.
From the above reactants, from Bradshaw and Hari, a conjugate can be formed through click chemistry, which reads applicants claimed subject matter.
In other words, if the reactants in the teachings of Hammond are replaced with the reactants of Bradshaw and Hari, then applicants conjugate is expected.
A combination of prior art references is only proper if a person of ordinary skill in the art (POSA) at the time of the invention, faced with the same problem, would have been motivated to combine their teachings with a reasonable expectation of success. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Here, the technical fields and problems addressed by the references are not distinct from that of the present claimed invention.
For claim 14:
It is the property of targeting ligand, since targeting ligand is identical in both cases, and so, this property is expected. Further, Bradshaw described applicants targeting ligand as PSMA [see page 118].
For claim 17:
In the teachings of Hammond, the biomolecule [see 0039-0041] is interpreted as a desired nucleic acid since the generic teaching is applicable to different types of nucleic acids.
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants individual reactants, were known in the prior art, and one skilled person in the art could have combined the elements as claimed by known relationships, with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art.
The USPTO has provided rationale for determining obviousness. MPEP § 2143 sets forth some rationales that were established in KSR International Co. v Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007). 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 BIRCH, STEWART, KOLASCH & BIRCH, LLPJWB/thd 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.
In this case, at least (a), (b) and (e) of above are applicable.
The motivation to combine the art can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. See MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited reference and to make the instantly claimed conjugate with a reasonable expectation of success.
The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. In re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983). In the instant case, click chemistry and its advantages are well known in the art. Further, applicants individual reactants are also known, and therefore, a conjugate is expected from these reactants.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUDHAKAR KATAKAM whose telephone number is (571)272-9929. The examiner can normally be reached 8:30 am to 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658
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