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 .
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.
Claim 20 is 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.
Claim 20 recites the limitations “the non-transitory computer-readable medium”, “the processor”, “the display”, “the icon”, “the needle”, “the patient”, and “the target position”. There is insufficient antecedent basis for these limitations in the claim. For the purpose of continued examination, the examiner has interpreted claim 20 as being dependent on claim 19.
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 10-15, 19-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to nonstatutory subject matter of abstract ideas under the mental processes and mathematical concepts groupings, without significantly more.
The framework for establishing a prima facie case of lack of subject matter eligibility requires that the examiner determine: (1) Does the claim fall within the four categories of patent eligible subject
matter; (2a) Prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon and (2a) Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application; and (2b) Does the claim recite additional elements that amount of significantly more than the judicial exception.
Step (1)
The claimed invention in claims 10-15, 19-20 are directed to a system or a method, and thus, the claims fall under one of the four patent eligible categories.
Step (2a) Prong 1 (Judicial Exception)
Regarding claims 10-15, the recited steps are directed to mental processes of performing concepts in a human mind or by a human using a pen and paper and utilizing mathematical concepts (See MPEP 2106.05(a)(2) subsections (I) and (III)).
Independent claim 10 recites:
A method of guiding a needle comprising:
determining an ideal angle from an entry point of a needle of needle guide in a patient to a target position of the needle for treatment of the patient; and
displaying an icon on the needle guide that indicates a difference between a current angle of the needle guide and the ideal angle.
Under the broadest reasonable interpretation, these limitations require determining an ideal angle of entry of a needle into a patient, and displaying the difference between the current angle of entry and the ideal angle of entry. These limitations are processes that, as drafted, cover that which can be wholly performed in a person’s mind via a series of mental observations and judgments and utilizing mathematical concepts. In particular, a person can determine the ideal angle of entry for a needle, observe/measure the current angle of entry of a needle, then calculate/display the difference between the two. These are data gathering and processing steps (determining, finding the difference) that reflect mental processes and mathematical relationships/clinical decision rules.
Accordingly, claim 10 is directed to a judicial exception including one or more abstract ideas, specifically mental processes and mathematical concepts.
The dependent claims recite additional limitations for determining differences between the current needle position and the ideal needle position, including the current/ideal needle depth and other ways of displaying the data. These limitations also fall within the judicial exceptions of one or more mental processes and/or mathematical calculations.
Regarding claims 19-20, the recited steps are directed to mental processes of performing concepts in a human mind or by a human using a pen and paper and utilizing mathematical concepts (See MPEP 2106.05(a)(2) subsections (I) and (III)).
Independent claim 19 recites:
A non-transitory computer-readable medium including executable instructions that when executed by a processor cause the processor to perform the steps of:
determining a difference between an ideal angle that is an angle from an entry point of a needle of a needle guide in a patient to a target position of the needle for treatment of the patient; and
driving a display to display an icon on the needle guide that indicates a difference between a current angle of the needle guide and the ideal angle.
Under the broadest reasonable interpretation, these limitations require determining the difference between the ideal angle of entry and a target position, and displaying the difference between a current and ideal angle. These limitations are processes that, as drafted, cover that which can be wholly performed in a person’s mind via a series of mental observations and judgments and utilizing mathematical concepts. In particular, a person can determine the ideal angle of entry for a needle, observe/measure the current angle of entry of a needle, then calculate/display the difference between the two. A person can also similarly calculate/display the difference between an ideal angle of entry and a target point. These are data gathering and processing steps (determining, finding the difference) that reflect mental processes and mathematical relationships/clinical decision rules.
Accordingly, claim 19 is directed to a judicial exception including one or more abstract ideas, specifically mental processes and mathematical concepts.
The dependent claim 20 recites additional limitations for displaying data, including indicating a difference between a current and ideal depth of a needle. These limitations also fall within the judicial exceptions of one or more mental processes and/or mathematical calculations.
Step (2a) Prong 2 (Integration into a Practical Application)
This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (2) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. MPEP 2106.04(d).
For claims 10-15, 19-20, the judicial exception is not integrated into a practical application.
Regarding claim 10, the additional element of “displaying an icon on the needle guide that indicates a difference between a current angle of the needle guide and the ideal angle” is directed to outputting data to a generic needle guide. Merely outputting the result of the mathematical processing to generic hardware is “post-solution activity” and does not integrate the abstract idea. See Parker v. Flook, 437 U.S. 584, 590 (1978) (updating alarm limits after calculation is still abstract).
Claims 11-12, 14-15 further limit the abstract ideas of claim 10 without introducing any additional elements.
Claim 13 also recites the additional elements of “a gyroscope” and “an accelerometer,” but these additional elements merely define the field of use of the current claim. These additional elements do not practically integrate the judicial exception because these elements do not provide improvements to the technical field under MPEP 2106.05(a).
Regarding claim 19, the additional element of “driving a display to display an icon on the needle guide that indicates a difference between a current angle of the needle guide and the ideal angle” is directed to outputting data to a generic needle guide. Merely outputting the result of the mathematical processing to generic hardware is “post-solution activity” and does not integrate the abstract idea. See Parker v. Flook, 437 U.S. 584, 590 (1978) (updating alarm limits after calculation is still abstract).
Claim 20 further limits the abstract ideas of claim 19 without introducing any additional elements.
Claim 19 also recites the additional element of a “processor,” but these additional elements merely define the field of use of the current claim. These additional elements do not practically integrate the judicial exception because these elements do not provide improvements to the functioning of a computer or to any the technical field under MPEP 2106.05(a). Furthermore, when the claims, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it is still in the mental processes grouping unless the claim limitation cannot practically be performed in the mind. Likewise, performance of a claim limitation using generic computer components does not preclude the claim limitation from being in the mathematical concepts grouping or the certain methods of organizing human activity grouping.
Step (2b) (Inventive Concept)
The claims also do 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 judicial exception into a practical application, the additional elements of a needle guide, gyroscope, accelerometer, and processor in the field of needle guiding methods are well-understood, routine and conventional activities previously known in the industry as indicated in the following references:
Xu et al. (US Pre-Grant Publication 2020/0197099) teaches a needle guide ([0069] instrument tracker 100 has a needle guide), gyroscope (130), an accelerometer (132), and processor (34).
Lampotang et al. (US Pre-Grant Publication 2022/0133284) teaches a needle guide (guidance application 220, needle guide [0039]), gyroscope [0048], an accelerometer [0048], and processor ([0155], the computing device 115 has processor circuit).
Accordingly, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Claims 10-15, 19-20 are thus rejected under 35 USC 101 for reciting patent-ineligible subject matter- abstract ideas.
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)(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.
Claims 1-8, 10-13, 15-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xu et al. (US Pre-Grant Publication 2020/0197099), hereinafter ‘Xu’.
Regarding claim 1, Xu teaches a needle guide device ([0069], instrument tracker 100 (Fig. 4) has a needle guide), further comprising:
a needle ([0041], instrument 20 (Fig. 4) can be a needle);
a controller (controller 106 (Fig. 12)); and
a display driven by the controller ([0050], display device 26 (Fig. 4)) and configured to indicate a difference between an ideal angle and a current angle of the needle (angular orientation information 48, Fig. 4) (divergence 56, Fig. 7).
Regarding claim 2, Xu teaches the device according to claim 1, further comprising:
wherein the needle is replaceable ([0070], device can be clipped onto any needle).
Regarding claim 3, Xu teaches the device according to claim 1, further comprising:
wherein the display indicates the current angle (Fig. 7, instrument 20) ([0048], angular orientation information 48 of instrument 20, Fig. 7).
Regarding claim 4, Xu teaches the device according to claim 1, further comprising:
wherein the current angle is based on data from a gyroscope (gyroscope 130) of the needle guide device [0064].
Regarding claim 5, Xu teaches the device according to claim 1, further comprising:
wherein the difference between the ideal angle and the current angle is based on data from a gyroscope (gyroscope 130, Fig. 12) and an accelerometer (accelerometer 132, Fig. 12) of the needle guide device [0064].
Regarding claim 6, Xu teaches the device according to claim 1, further comprising:
wherein the display is further configured to indicate a distance between a current position of the needle and a target position (region of interest 14, Fig. 7) (position information 46, Fig. 4) (divergence 56, Fig. 7).
Regarding claim 7, Xu teaches the device according to claim 1, further comprising:
a distance measurer to determine a distance between a current position of the needle and a target position ([0050], position information 46 can be determined from magnetometer 134, Fig. 12) (Figs. 22B, 22C, alignment to target position).
Regarding claim 8, Xu teaches the device according to claim 6, further comprising:
wherein the distance between the current position of the needle and the target position is based on data from a distance sensor of the needle guide device ([0050], position information 46 can be determined from magnetometer 134, Fig. 12).
Regarding claim 10, Xu teaches a method of guiding a needle ([0041], instrument 20 can be a needle) [0098], the method further comprising:
determining an ideal angle from an entry point (entry point 44, Fig. 4) of a needle of needle guide in a patient ([0069], instrument tracker 100 has a needle guide) to a target position (region of interest 14, Fig. 7) of the needle for treatment of the patient (angular orientation information 48, Fig. 4); and
displaying (display 26, Fig. 4) an icon on the needle guide that indicates a difference between a current angle of the needle guide and the ideal angle (divergence 56, Fig. 7).
Regarding claim 11, Xu teaches the method according to claim 10, further comprising:
determining a difference between an ideal depth to the target position and the current depth of the needle [0053, insertion depth] (Figs. 22B, 22C, alignment to target position), [0095].
Regarding claim 12, Xu teaches the method according to claim 10, further comprising:
wherein the icon indicates a difference between a current depth of the needle and an ideal depth of the needle to the target position (Figs. 22B, 22C) (divergence 56, Fig. 7).
Regarding claim 13, Xu teaches the method according to claim 10, further comprising:
wherein the current angle is determined based on data from a gyroscope (gyroscope 130, Fig. 12) and an accelerometer (accelerometer 132, Fig. 12) of the needle guide [0064].
Regarding claim 15, Xu teaches the method according to claim 12, further comprising:
wherein the icon changes size to indicate the difference between the current depth and the ideal depth (Fig 7, Fig. 8, corrective adjustment 58, divergence 56 shrinks as correction is made, [0047]-[0048]).
Regarding claim 16, Xu teaches a needle guide system (claim 17) comprising:
the needle guide according to claim 1 ([0069], instrument tracker 100 has a needle guide) ([0041, instrument 20 can be a needle) (controller 106, display device 26, angular orientation information 48, divergence 56, Figs. 4, 7, 12); and
a computer in communication with the needle guide and capable of determining the ideal angle (predetermined insertion path 42, Fig. 4) and transmitting the ideal angle to the needle guide ([0075], computer device).
Regarding claim 17, Xu teaches the system according to claim 16, further comprising:
wherein the computer ([0075], computer device) is further capable of determining an ideal depth of a needle of the needle guide between an entry point (entry point 44, Fig. 4) of a needle of the needle guide in a patient to a target position (region of interest 14, Fig. 3) of the needle for treatment ([0040], intervention procedures) of the patient ([0053], insertion depth) (Figs. 22B, 22C, alignment to target position).
Regarding claim 18, Xu teaches the system according to claim 16, further comprising:
a distance measurer to determine a distance between a current position of the needle and a target position of the needle for treatment of the patient ([0050], position information 46 can be determined from magnetometer 134, Fig. 12) (Figs. 22B, 22C, alignment to target position).
Regarding claim 19, Xu teaches a non-transitory computer-readable medium [0008] further comprising:
executable instructions that when executed by a processor (processor 34, Fig. 3) cause the processor to perform the steps of:
determining a difference between an ideal angle that is an angle from an entry point (entry point 44, Fig. 3) of a needle of a needle guide in a patient to a target position (region of interest 14, Fig. 3) of the needle for treatment of the patient (angular orientation information 48, Fig. 4); and
and driving a display (display 26, Fig. 4) to display an icon on the needle guide that indicates a difference between a current angle of the needle guide and the ideal angle (divergence 56, Fig. 7).
Regarding claim 20, Xu teaches a non-transitory computer-readable medium [0008] further comprising:
causing the processor to drive the display to display the icon to indicate a difference between a current depth of the needle in the patient and an ideal depth of the needle to the target position ([0053], insertion depth) (Figs. 22B, 22C, alignment to target position).
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.
Claims 9, 14 are rejected under 35 U.S.C. 103 as being unpatentable over Xu et al. (US Pre-Grant Publication 2020/0197099) in view of Lampotang et al. (US Pre-Grant Publication 2022/0133284), hereinafter ‘Lampotang’.
Regarding claim 9, Xu teaches the device according to claim 1, further comprising:
wherein the display indicates the ideal angle as an icon (predetermined insertion path 42, Fig. 4).
Xu does not teach the current angle being displayed as a reticle.
Lampotang teaches a biopsy guidance and tracking system (Fig. 1), further comprising:
wherein the display indicates the current angle as a reticle (Fig. 14, needle guide exit) ([0067], needle guide exit moves as probe moves).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Xu to incorporate the teachings of Lampotang to include the current angle displayed as a reticle. Doing so would provide a cognitive aid to the user during insertion of a needle, as recognized by Lampotang [0068].
Regarding claim 14, Xu teaches the method according to claim 10, but does not teach that the current angle is displayed as a reticle.
Lampotang teaches a biopsy guidance and tracking method (claim 11), further comprising:
wherein the current angle is displayed as a reticle (Fig. 14, needle guide exit) ([0067], needle guide exit moves as probe moves).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Xu to incorporate the teachings of Lampotang to include the current angle displayed as a reticle. Doing so would provide a cognitive aid to the user during insertion of a needle, as recognized by Lampotang [0068].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Yilmaz et al. (US Pre-Grant Publication 2016/0143693) teaches a system for performing navigation-assisted medical procedures.
Black et al. (US Pre-Grant Publication 2021/0161612) teaches a holographic needle guide system.
Green et al. (US Pre-Grant Publication 2013/0197357) teaches a system for providing guidance for placement of medical devices.
Shepherd et al. (US Pre-Grant Publication 2018/0303559) teaches a position guidance device for attachment to a medical device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH L OKONAK whose telephone number is (571)272-1594. The examiner can normally be reached Monday-Friday 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.L.O./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792