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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-14 and 20) in the reply filed on 4/29/2026 is acknowledged.
Claims 15-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on Group I.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/30/2023 and 1/29/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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.
Claims 1-14 and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Regarding independent claim 1, the claim recites a series of steps. This is a process.
The claim recites receiving a captured medical image, identifying an object of interest, determining a drug injection position and plurality of electrode insertion positions based on a position and shape of the object of interest, defining a drug movement path based on the shape, and generating a current sequence to move the drug along a drug movement path, and outputting the current sequence information to a current source apparatus. The claim recites several abstract ideas. The claim recites "identifying" and "determining", “defining”, “generating” and “outputting” steps for detecting a position and shape of an object of interest. The limitations, as drafted, is a process that, under its broadest reasonable interpretation when read in light of the specification, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting "a current source apparatus", nothing in the claim element precludes the steps from practically being performed in the mind using observation, evaluation, judgment, and opinion. Such mental observations or evaluations fall within the "mental processes" grouping of abstract ideas. Accordingly, the claim recites abstract ideas. This judicial exception is not integrated into a practical application. In particular, the claim recites additional elements: "receiving" steps. These are data gathering steps. The hardware in these steps is recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea, that is no indication of improvement to any other technology or technical field, (see MPEP 2106.05(a)), or applying or by use of, a particular machine (see MPEP 2106.05(b)), or effecting a transformation (see MPEP 2106.05(c)), or applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment (see MPEP 2106.05(e)).
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processor to perform prompting and providing steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component or simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception (see MPEP 2106.05) cannot provide an inventive concept. Therefore, the claim is directed to an abstract idea and is not patent eligible.
The dependent claims are rejected by virtue of their dependency on the rejected independent claim. The dependent claims fail to cure the deficiencies of the independent claim.
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-13 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Scott (US 10,661,055).
In regard to claim 1, Scott discloses a method of controlling injection of a drug (see at least the Abstract), the method comprising: receiving a captured medical image of an object (see col. 7, line 17- col. 8, line 45); identifying an object of interest from the medical image (imaging is used to identify a tumor; see col. 7, line 17- col. 8, line 45); based on a position and a shape of the object of interest, determining a drug injection position where a drug is to be injected (see col. 7, lines 43- col. 8, line 45); based on the position and the shape of the object of interest, determining a plurality of electrode insertion positions where a plurality of electrodes (22) are to be inserted, respectively (see col. 7, line 17- col. 8, line 45), the plurality of electrodes being configured to supply a current to move the drug (see col. 4, lines 48-51); defining a drug movement path based on a shape of the identified object of interest (see col. 7, line 57- col. 8, line 45); generating current sequence information to move the drug along the drug movement path, the current sequence information defining a current to be applied over time to each of the plurality of electrode (see col. 7, lines 50-56, col. 8, line 46- col. 9, line 60); and outputting the current sequence information to a current source apparatus, the current source apparatus being configured to supply the current to the plurality of electrodes (see col. 7, line 17- col. 9, line 60).
In regard to claim 2, Scott discloses wherein the defining of the drug movement path comprises defining the drug movement path to move the drug along a surface of the object of interest or defining the drug movement path to move the drug into the object of interest (see cited portions above including “Ideally, electrodes are controllable individually or in groups. Ideally, all adjustable parameters are set to maximize the fundamental goal: to put as much drug into tumor tissue and as little drug into healthy tissue as possible.” and “Additionally, the tumor itself may not be modeled a sharp-edged. It may be desirable, for example, to aggressively target a portion of the perimeter of the tumor to minimize metastasis or growth into specific adjacent organs.” )
In regard to claim 3, Scott discloses wherein the object is a brain (see col. 9, lines 64-65), and a magnitude of the current supplied to the plurality of electrodes is defined as a 2 mA or less (see col. 10, lines 60-62).
In regard to claim 4, Scott discloses wherein the current sequence information comprises at least one of a current value of the current applied to each of the plurality of electrodes, a duty cycle, a total current application duration, and an on/off timing or a combination thereof (see col. 7, lines 31-35, col. 7, lines 50-52).
In regard to claim 5, Scott discloses wherein the generating of the current sequence information comprises determining the total current application duration based on a movement distance for which the drug moves along the drug movement path and the duty cycle (see col. 7, lines 31-35, col. 7, lines 50-56, col. 8, line 46- col. 9, line 60).
In regard to claim 6, Scott discloses wherein the generating of the current sequence information further comprises determining an on/off timing of each of the plurality of electrodes to move the drug along the drug movement path (see cited portions above and col. 9, lines 21-40).
In regard to claim 7, Scott discloses wherein the generating of the current sequence information further comprises: determining a movement speed of the drug based on the shape of the object of interest; and determining the duty cycle based on the movement speed of the drug (see col. 7, line 17- col. 9, line 60).
In regard to claim 8, Scott discloses wherein the determining of the movement speed of the drug comprises increasing the movement speed of the drug as electrical conductivity of the object of interest is lower (see col. 7, line 17- col. 9, line 60).
In regard to claim 9, Scott discloses wherein the injection of the drug is performed by inserting a drug injection apparatus (see Figs. 1 and 2)at the drug injection position in the object and injecting the drug from the drug injection apparatus into the object (via 26), and when the drug injection apparatus comprises an electrode (22), the drug injection position corresponds to one of the plurality of electrode insertion positions (see Fig. 2).
In regard to claim 10, Scott discloses, wherein the object of interest corresponds to a lesion or a tumor in the object (“Ideally, electrodes are controllable individually or in groups. Ideally, all adjustable parameters are set to maximize the fundamental goal: to put as much drug into tumor tissue and as little drug into healthy tissue as possible.”).
In regard to claim 11, Scott discloses wherein the medical image comprises at least one of a magnetic resonance imaging (MRI) image, a computed tomography (CT) image, an X-ray image, or an ultrasound image (see col. 8, lines 24-27).
In regard to claim 12, Scott discloses wherein the drug comprises at least one of polar molecules, ions, or particles (see col. 10, line 65- col. 12, line 45).
In regard to claim 13, Scott discloses wherein the drug comprises at least one of a tissue-specific adhesion functional group for the object of interest, a contrast agent, or a therapeutic agent (see col. 10, line 65- col. 12, line 45).
In regard to claim 20, Scott discloses a computer-readable recording medium having recorded thereon a program for executing, on a computer, the method of claim 1 (see rejection of claim 1).
Claim Rejections - 35 USC § 103
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) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Scott in view of Cosman (US 6,241,725).
In regard to claim 14, Scott fails to expressly disclose further comprising displaying, on the medical image, object-of-interest region information corresponding to the object of interest, information about the drug injection position, information about the plurality of electrode insertion positions, and information about the drug movement path.
In a similar art, Cosman discloses displaying (via 751), on the medical image, object-of-interest region information corresponding to the object of interest (753), information about the drug injection position, information about the plurality of electrode insertion positions (761), and information about the drug movement path (see Fig. 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Scott with the display features of Cosman to provide a visual representation of the surgical procedure to help planning and navigation of the electrodes in the procedure.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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