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 .
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.
Election/Restrictions
Applicant’s election of a thioketal-containing composition as the thiol or selenium species and an anionic linker, reading on claims 1, 6-8, 11 and 13-14, in the response dated 7/20/2026, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
Claims 2-5, 9-10, and 12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim.
Claim Status
Claims 1-14 are pending.
Claims 2-5, 9-10, and 12 are withdrawn.
Claims 1, 6-8, 11, and 13-14 are examined on the merits in this prosecution.
CLAIM REJECTIONS
Indefiniteness Rejections
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.
Claims 1, 6-8, 11, and 13-14 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claims 1 and 13 recite the term “biomaterial.” However, the term is not defined in the specification or the claims, and the metes and bounds of the limitation are unclear. See MPEP 2173.02(III)(B). The term “biomaterial” is recited in claim 13 as including polymeric coatings, hydrogels, and nanoparticles, but these elements are not necessarily materials with a biological function, and it is unclear whether polymeric coatings, hydrogels, and nanoparticles that do not have a biological function are within the scope of the claim.
For the purposes of this examination, any element that may have a biological function is considered a “biomaterial.”
Furthermore, claim 1 is confusing in that it is unclear what process is being claimed, what the individual steps are recited by the method, and what step requires the presence of an acid catalyst.
Obviousness Rejection
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 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.
1. Claims 1, 6, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Xu (“ROS-Responsive Polyprodrug Nanoparticles for Triggered Drug Delivery and Effective Cancer Therapy,” Adv. Mater. 2017, 29, 1700141), in view of Wilson (“Mercaptans From Thioketals: Cyclododecyl Mercaptan,” Organic Syntheses, Coll. Vol. 7, p. 124 (1990); Vol. 61, p .74 (1983)).
It is noted that the Supporting Information accompanying this prior art is considered part of the teaching of the Xu publication for the purposes the Obviousness Rejection.
Xu teaches a method of incorporating one or more linkers into a biomaterial comprising at least one ketone by reacting a linker-containing material (including a thioketal) with the biomaterial in the presence of an acid catalyst.
Xu teaches the following synthetic method; the transformation of the ketal to the thioketal to yield diacetate 2 is catalyzed by p-toluenesulfonic acid (Supplementary Material, pg 15) :
Scheme S1:
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745
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In compound 2, the biomaterial is the acetate group, a compound with known immunomodulatory properties.
Xu does not teach a ketone unit, but rather an equivalent, 2,2-dimethoxypropane.
Wilson teaches the missing element of Xu.
Wilson teaches thioketals can be prepared from ketones by the reaction of the ketone with 2 equivalents of thiol (as one equivalent of a dithiol) in a reaction catalyzed by p-toluenesulfonic acid (first page, figure).
The skilled artisan would have expected success in substituting Wilson's ketone, or acetone, for the 2,2 dimethoxypropane in Xu’s method because Wilson teaches a method of forming a thioketal from a ketone and two equivalents of thiol utilizing p-toluenesulfonic acid as the acid catalyst and Wilson teaches the method is general (see pg 3, Table 1) and may utilize the lower boiling solvent benzene (Note 3).
CONCLUSION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P COHEN whose telephone number is (571)270-7402. The examiner can normally be reached on M-Th 8:30-5:30; F 9-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup, can be reached on (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL P COHEN/Primary Examiner, Art Unit 1612
