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 .
Response to Amendment and Argument
The response filed on 2/10/26 has been entered.
Applicant’s arguments filed 2/10/26 have been fully considered but they are not deemed to be persuasive.
Claims 23-35 are pending in this office action. Claims 1-22 have been canceled.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 33-35 provides for the use of nanocluster but, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Additionally, the intended use is given no patentable weight as it should be noted that “a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone”. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951)
Necessitated Claim Rejections - 35 USC § 103by amendment
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) 23-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Durmaz et al. (WO 2019/177558) in view of Ma et al. (nanoscale Research Letters (2018)13:332) and Xu et al. ACS; Applied Materials & Interfaces 2020: 12, 3032-41) published 12/23/2019 and Rehman (development of Histotripsy…Thesis From Applicant’s IDS submission).
With regards to instant claim 23, Durmaz teaches nanodroplet- (see pg 1, lines 21+) comprising a guest host molecule a cyclodextrin, (i.e., beta cyclodextrin (see pg 4, lines 6+) wherein the guest molecule is selected from C3-C8 perfluorocarbon (see pg 4, lines 1-10) wherein the C3-C8 perfluorocarbon is a perfluorohexane (as required by instant claims 23, see pg 4, lines 20+) functionalize targeting agent (see pg. 4, lines 6-10, as required by instant claim 24), wherein the targeting agent is an antibody (see pg 6, lines 19-20, as required by instant claims 29-30), with at least one excipient (see claim 28, as requires by instant claim 32), a histoctripsy (see abstract, as required by instant claims 33) wherein the nanodroplet comprises a contrasting agent (see pg. 5, lines 24+, as required by instant claim 34) in the treatment of cancer (see pg 8, lines 10+, as required by instant claim 35).
However fails to teach the nanodroplets are nanocore clusters and that the nanocore clusters is of at least three nanocones. However, the nanocone cluster and the nanodroplets have the same composition and therefore it is reasonable that these droplets form clusters since the reference teaches droplets, that means plural of droplet form can be cluster
Ma teaches nanocones can result in 6-8 cones aggregating together forming nanocore cluster (see para. above Characterizations, rt. Col. as required by instant claim 26). Therefore it would have been obvious to form nanocore cluster by substituting Durmaz nanodroplets with Ma’s nanocore clusters with a reasonable expectation of success.
Rehman teaches host molecule that is beta-cyclodextrin with a cone line structure (see pg 24-25), a guest molecule perfluoroheptane with at least six carbon to form inclusion complex to form clusters as histotripsy agent in the treatment of cancer. Therefore it is reasonable that one of ordinary skill in the art would have been motivated to expand the teachings of Durmaz to include Rehman to result in the instant claimed invention as the formation of the nanocone clusters is prepared the same, when one looks at the specification as a dictionary.
Although the combined references failed to teach the percentage at which the cyclodextrin is modified, these percentages are within the purview of the skilled artisan to determine based on the reactive sites of the cyclodextrin as a variable that achieves a recognized result and, therefore, the determination of the optimum or workable percentage range would have been well within the practice of routine experimentation by the skilled artisan.
Xu teaches amino-functionalized beta-cyclodextrin, therefore it is reasonable to one of ordinary skill in the art to use a beta-cyclodextrin that has been modified (as required by instant claims 5).
It would have been obvious to one of ordinary skill in the art to have expand the teaching of Durmaz to include the teachings of Ma, Xu and Rehman to form a nanocore cluster to result in the instant claimed invention with a reasonable expectation of success because the combination of the references makes it obvious to do so.
Applicant argues that the Durmaz publication reference in the Official Action, is a prior patent application filed by the present Applicant and represents an earlier stage of the research of the present inventor. At the time that the Durmaz publication was prepared, the Applicant was not aware that the structures formed were "clusters". In this earlier publication, a perfluorocarbon inclusion complex of cyclodextrins was obtained. In other words, it was a single inclusion complex, not a clustered assembly of multiple inclusion complexes around a perfluorocarbon core.
In response, Applicant’s argument have been carefully considered but found unpersuasive because the newly added reference would have resulted in the instant claimed invention when combined. When the specification of the instant application is taken into consideration the process of making the nanoclusters is the same taught by Rehman. Thus Applicant’s argument is found unpersuasive.
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached M-F 9am-6pm.
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/SHIRLEY V GEMBEH/ Primary Examiner, Art Unit 1615 3/9/26
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