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 .
Information Disclosure Statements
The information disclosure statements (IDSs) filed November 24, 2025 and November 26, 2025 have been entered and the references cited therein have been considered by the examiner. However, on both IDSs, for all of the cited U.S. Patent Application Publications, the entries add an extra "0" after the year and then truncate the last digit. For example, on the IDS filed November 24, 2025, Cite No. 1, it should be 20200289747 instead of “20200028974. To rectify the situation and to complete the record, the examiner has added all of the mis-cited references to a PTO-892 form. In addition, on the November 26, 2025 IDS, the examiner has lined through the incorrect citations for the two references utilized in the rejections below (Cohen; U.S. Patent Application Publication No. 2022/0273359 and McKenna et al.; U.S. Patent Application Publication No. 2014/0243733) in order to avoid future publications issues.
Preliminary Amendment
Applicant’s preliminary amendment, filed November 26, 2025, has been entered. Accordingly, the status of the claims is as follows: Claims 1, 10 and 11 are amended; claims 2-9 remain as originally presented and claim 12 is canceled.
Election/Restrictions
As noted in applicant’s December 12, 2025 response to the requirement for restriction/election mailed on November 24, 2025, applicant’s preliminary amendment, filed November 26, 2025, crossed in the mail with the requirement for restriction/election. The preliminary amendment amends the claims so that the claims are drawn to a single invention. Accordingly, the requirement for restriction/election is hereby withdrawn.
Claim Objections
Claims 3 and 6 are objected to because of the following informalities: In claim 3, line 3, “continues” should be “continuous”. In claim 6, line 2, “vain” should be “vein.” Appropriate correction is required.
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 6-9 and 11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 6, the phrase “the conductive part” lacks proper antecedent basis in either independent claim 1 (from which claim 6 depends) or claim 6 itself.
In claim 7, the phrase “cancer cells try to engulf them” is vague and ambiguous. “Them” is undefined and thus it cannot be determined what applicant is intending to claim. In addition, the phrase “be ready for cell interaction when exposed to induction heat” is undefined (what does “be ready” mean?).
In claims 8 and 9, “the inserted part” lacks proper antecedent basis in either independent claim 1 (from which claims 8 and 9 depend) or claim 8 or 9 itself. Furthermore, in claim 9, the phrase “compounded materials capable of at least one of the disclosed treatment options” is not specific enough to properly identify what applicant intends to claim and the following phrase “e.g., inductive heating and/or radiation and/or time release drug delivery on one or more combinations” does not further identify the “disclosed treatment options.” Furthermore, the use of the term “and/or” renders the claim vague and indefinite as the metes and bounds of the claim cannot be determined.
In claim 11, the phrase “the method device” is vague and ambiguous.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 7 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 7 appears to be claiming cancer cells, which are human organisms excluded from the scope of patentable subject matter.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5, 8 and 9 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Cohen (U.S. Patent Application Publication No. 2022/0273359).
In regard to claims 1 and 9, Cohen teaches a method for introducing a treatment object into a cancerous tumor (see paras. 0002 and 0006) by using an injector 10 (surgical tool) that places treatment bodies 12, 14 into a tumor (see Figs. 10A and 10E and para. 0223). The injector 10 includes a needle tip 16 that would perform a puncture or incision (see Fig. 10E and para. 0227). Cohen also teaches the use of an endoscope provide with or attached to injector 10 to help with precise location on the tumor (see para. 0231). The treatment bodies 12, 14 are ejected from the injector 10 and placed precisely where intended within a tumor of interest (see para. 0225). Cohen also teach that the injector can be withdrawn from the patient’s body leaving the treatment object within the patient’s body (see para. 0245). In regard to claims 2 and 3, Cohen teaches that the treatment body picks up heating by induction (see para. 0213) and the induction powered treatment may contain a predetermined amount of a substance for killing the tumor placed in the hollow in the treatment object where the substance may be inductively powered to release the substance into the tumor (see para. 0265). The amount of the substance may be selected according to the size of the tumor or in an amount in accordance with the specific tumor the treatment object is intended for (see para. 0265). Thus, the treatment is both contactless and personalized. With further respect to claim 3, Cohen also teaches melting an envelope surrounding the treatment object to release the medication to treat the tumor, which would comprise a slow-release drug delivery (see paras. 0272 and 0162). In regard to claim 4, Cohen teaches that the treatment object may comprise a radioactive material and provide a particular radiation dose (see paras. 0183 and 0131). With further respect to claim 1 and in regard to claim 5, Cohen teaches that a tank section 703 that can be filled with a sample of a tumor to take a biopsy while delivering the part (see para. 0167). Removal of tissue via a biopsy would naturally create a cavity in a tumor. In regard to claim 8, Cohen teaches that the treatment object may decompose after awhile in the body into harmless substances (see para. 0214).
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 (i.e., changing from AIA to pre-AIA ) 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, 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.
Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cohen (U.S. Patent Application Publication No. 2022/0273359) in view of McKenna et al. (U.S. Patent Application Publication No. 2014/0243733).
In regard to claim 6, Cohen is silent as to the treatment bodies 12, 14 being coated with a bait targeted at cancer cells. However, McKenna et al. teach the use of a coating of carbodilimide conjugated polyethylene glycol-iron oxide-impregnated dextran deposited on a nano-particle to make it attractive to human breast cancer cells (see para. 0144). McKenna et al. thus demonstrate that the use of a bait coating on part to make it more attractive to cancer cells is well known in the art. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to apply the bait coating of McKenna et al. to the treatment bodies 12, 14 of Cohen in order to make the treatment bodies 12, 14 more attractive to cancer cells. In regard to claim 7, see paras. 0070 and 0151 of McKenna et al.
Claim(s) 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cohen (U.S. Patent Application Publication No. 2022/0273359) in view of Sadaka et al. (PCT Publication No. WO 2023/086899).
In regard to claim 10, Cohen is silent as to the structural makeup of injector 10 (although Figure 10A does show a plunger). However, Sadaka et al. teach a biopsy tool 100 comprised of a cannula 102 and a stylet 104 where the distal end of cannula 102 includes a cutting surface 116 for shearing off a portion of a target tissue (see Figs. 2A-2D and para. 0037). Stylet 104 includes a notch 140 for collection of tissue (see Fig. 2E and para. 0047). Sadaka et al. thus demonstrate that a tool used for a biopsy with an inner stylet and a notch for collection of tissue is well known and desirable in the art in order to effectively capture the excised tissue. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the device of Cohen with the inner stylet and notch taught by Sadaka et al. in order to equip the device with a more effective tissue capturing structure. In regard to claim 11, see the above rejection for claim 1.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BEVERLY MEINDL FLANAGAN whose telephone number is (571)272-4766. The examiner can normally be reached Mon-Fri 7:30AM to 5:00PM.
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/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794