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 1 in the reply filed on April 16, 2026 is acknowledged. Currently claims 1-11 and 23-34 are pending in this application.
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 1-11 and 23-34 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the abstract idea of a non-transitory memory configured to store specific data and one or more processor adapted to access the memory and execute the instructions programmed to perform a method on that data without significantly more.
Step 1:
Claims 1-11 recite a method and thus falls into a statutory category.
Claim 23-34 recite a non-transitory computer readable medium and thus falls into a statutory category.
Step 2A, Prong 1
Claim 1 recites the following abstract ideas:
receiving information . . . ;
estimating . . . first interactions of the electrodes with respect to the first cells;
estimating . . . second interactions of the electrodes with respect to the second cells; and
generating . . . values of electrical parameters . . . .
All of these limitations, at the broadest reasonable interpretation, cover a method of organizing human activity and mental process. See MPEP 2106.04(a)(2)II and III.
All of the above steps can be performed by a human. For example, a trained Otolaryngologist can receive X-ray or electrical field data, use their personal knowledge of cochlear anatomy to make rudimentary estimations of how first and second cells will react to electroporation from the desired electrodes, and then write down values of electrical parameters configured to be provided to the plurality of electrodes to electroporate to the first cells while not damaging the second cells (for example, avoiding extreme stimulation of all electrodes at max values).The claims as filed do not require precision in the values obtained, just that they electroporate first cells while not damaging second cells. Examiner also notes that the claim does not require any limitations for actually collecting implantable device data or applying electrical parameters, but merely only receives data and generates parameters.
As such, the claims are directed towards an abstract idea.
Step 2A, Prong 2
The claims do not include additional elements that integrate the abstract idea into a practical application. The following elements do not add meaningful limitation to the abstract idea.
The “non-transitory computer readable storage medium” of claim 23 is recited at a high level of generality, i.e. as generic circuitry, performing a generic computer function of processing and displaying data. This generic processor limitation is no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additionally limitation does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Step 2B
As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than mere instructions to apply the exception using a generic computer components is not found to integrate a judicial exception into a practical application. The same analysis applies here in 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial except into a practical application at Step 2A or provide an inventive concept in Step 2B.
Under 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field. The specification does not provide any indication that the computer readable storage medium is anything other than a generic, off-the-shelf computer component. Court decisions cited in MPEP 2106.05(d)(II) indicate that computer-implemented processes not to be significantly more than an abstract idea (and thus ineligible) where the claim as a whole amounts to nothing more than generic computer functions merely used to implement an abstract idea, such as an idea that could be done by a human analog (i.e., by hand or by merely thinking). Accordingly, the generic computer functions merely are being used to implement an abstract idea is well-understood, routine, conventional activity.
For these reasons, there is no inventive concept in the claim and thus it is ineligible.
Dependent claims 2-3 and 25-26 further limit the areas of the body where the responses are estimated, but do not further apply any stimulation or collect a response.
Dependent claims 4-8 and 27-30 further limit the type of information received, all of which can be received by a human.
Dependent claims 9 and 31 further provides a feedback signal indicative of the position or orientation of the device during implantation which can be a human looking at a real time fluoroscopy image and narrating the position.
Dependent claims 10 and 32-33 further evaluating a suitability for electroporation during implantation, which can be done by a human looking at the location of the device.
Dependent claims 11 and 34 further includes accessing electrical parameter ranges which can be done on a piece of paper and generating the values based on the ranges, which can also be done by a human.
Dependent claim 24 further instructs the computer system to apply the values calculated previously. The limitation does not integrate the judicial exception into a practical application. This is not an example of applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. Instead, this "performing/treating" step is an example of generally linking the use of a judicial exception to a particular field of use, which is an example of a limitation that the courts have found to not integrate a judicial exception into a practical application [MPEP 2106.04(d)(I) and 2106.05(h)].
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, 4-11, 23-24, 27-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Neal (US 2011/0106221).
Regarding claims 1 and 23, Neal discloses the claimed method including (e.g. Example 1; [0085] – [0117]:
receiving information regarding a position and/or an orientation of an implantable device relative to a body portion of a recipient during and/or after implantation of at least a portion of the device on and/or into the body portion, the device comprising a plurality of electrodes configured to apply electroporation to first cells of the body portion while not damaging second cells of the body portion (e.g. image acquisition as described in [0085] – [0102] and placement of electrodes as described in [0104])
estimating, in response at least in part to the information, first interactions of the electrodes with respect to the first cells (e.g. simulation of electric field distributions as disclosed in [0105] – [0110] which will disclose both where is stimulated and where is not stimulated);
estimating, in response at least in part to the information, second interactions of the electrodes with respect to the second cells (e.g. simulation of electric field distributions as disclosed in [0105] – [0110] which will disclose both where is stimulated and where is not stimulated including avoiding unacceptable effects on untargeted regions as disclosed in [0111]); and
generating, in response at least in part to the estimated first interactions and the estimated second interactions, values of electrical parameters configured to be provided to the plurality of electrodes to electroporate to the first cells while not damaging the second cells (e.g. choosing of desired parameters through an optimization process as disclosed in [0113]).
Regarding claims 4-5 and 27-28, Neal additionally discloses wherein the information comprises one or more values selected from electrical computed tomography values (e.g. tomography CT as disclosed in [0086]).
Regarding claims 6 and 29, Neal additionally discloses wherein at least some of the imaging data comprises pre-operative imaging data (e.g. image acquisition occurs before electrode placement).
Regarding claim 7, Neal additionally discloses wherein the information further comprises fluoroscopy data (e.g. fluoroptic thermometer as disclosed in [0178]).
Regarding claim 8 and 30, Neal additionally discloses wherein at least some of the information is generated by the device during implantation of the portion of the device on and/or into the body portion (e.g. data collected during electrode implantation).
Regarding claims 9 and 31, Neal additionally discloses generating a feedback signal indicative of the position and/or orientation of the device during the implantation and providing, in real-time, the feedback signal to an operator of an insertion system being used to implant the device and/or to an automated implantation system performing the implantation (e.g. electrode placement as disclosed in [0105] – [0110]).
Regarding claims 10 and 32, Neal additionally discloses evaluating a suitability for electroporation of the position and/or orientation of the device relative to the body portion and communicating the evaluation, in real-time during implantation of the device on and/or into the body portion, to either an operator of an electroporation system or to an automated electroporation system (e.g. iterative optimization process as described in [0112] – [0114]).
Regarding claim 11, Neal additionally discloses wherein generating the values of electrical parameters comprises: accessing at least one first predetermined range of electrical parameter values sufficient to electroporate the first cells; accessing at least one second predetermined range of electrical parameter values insufficient to damage the second cells; and generating the values of electrical parameters in response at least in part to the at least one first predetermined range of electrical parameter values and the at least one second predetermined range of electrical parameter values (e.g. use of all data to make the graphs as shown in Figures 1 – 11).
Regarding claim 24, Neal additionally discloses wherein the computer program further instructs the computer system to use the plurality of electrodes to apply electroporation using the values of electrical parameters so as to electroporate the first cells while not damaging the second cells of the body portion (e.g. implementation of the desire protocol as disclosed in [0115] – [0117]).
Regarding claim 33, Neal additionally discloses wherein the computer program further instructs the computer system to access anatomical model data of the body portion and to perform said estimating the first interactions and said estimating the second interactions in response at least in part to the anatomical model data (e.g. reconstructed body data as disclosed in [0090].
Regarding claim 34, Neal additionally discloses wherein the computer program further instructs the computer system to use the plurality of electrodes to electroporate the first cells using a first set of electrical signals and to stimulate neurons of the body portion using a second set of electrical signals (e.g, two sets of electrode signals as shown in Figures 11A, 14B, and 16B).
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.
Claims 2-3 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Neal in view of Lehmann (US 2019/0351220.
Regarding claims 2 and 25, Neal discloses that it was well known in the art to apply electroporation to the body but does not expressly disclose wherein the first cells and the second cells are located within a cochlea of the recipient. Lehmann discloses that it was well known in the art to apply electroporation to apply stimulation to the cochlea (e.g. Abstract). It would have been obvious to one having ordinary skill in the art to include the electroporation of Neal in the cochlear implant of Lehmann in order to provide the system with the predictable results of a reliable means of applying the correct stimulation to the body.
Regarding claims 3 and 26, Neal and Lehmann disclose the claimed invention but do not disclose expressly wherein the first cells comprise mesenchymal cells lining a scala tympani and/or a basilar membrane of the cochlea and the second cells comprise hair cells of the cochlea. It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the stimulation location as taught by Lehman with the desired locations, because Applicant has not disclosed that such locations provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the stimulation as taught by Lehmann, because it provides reliable stimulation and since it appears to be an arbitrary design consideration which fails to patentably distinguish over the prior art. Therefore, it would have been an obvious matter of design choice to modify Neal and Lehmann to obtain the invention as specified in the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amanda K Hulbert whose telephone number is (571)270-1912. The examiner can normally be reached Monday - Friday 9:00-5:00.
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/Amanda K Hulbert/ Primary Examiner, Art Unit 3792
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