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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Claim Objections
Claims 1-13 are objected to because of the following informalities:
In each of claims 1-13, the preamble should read “A system…”, “The system…”, “A method…”, “The method….” as appropriate.
In Claim 1, four lines from the end, “o measuring” should have the “o” deleted.
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 1-13 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.
Regarding Claim 1, twelve lines from the end, the inclusion of preferable ranges is confusing because it is unclear if they are part of the claim or not. Applicant may delete “preferably between 10 and 60, more preferably between 20 and 45” to resolve the issue.
Further regarding claim 1, nine lines from the end, “or an array of two or more photodetectors” is redundant to the previous limitation “two or more photodetectors (44)”. It is adding confusion to the claim because it is unclear how it is different than the other given option.
Further regarding claim 1, six lines from the end, an “intelligence” is indefinite because this is not a term recognized to apply in the context of the invention and it is instead recognized to mean the abstract ability to acquire and apply knowledge and skills. The term “processor” is suggested to resolve the issue, consistent with the disclosure. During examination, it is assumed this is a processor, i.e. processing circuitry.
In claim 3, “and wherein the implantation depth (h) is determined with any one of the following expression (3) or (3a)…” does not limit the claim and adds confusion because the variable a2 appears to go unused. The formulas (3) and (3a) are simple mathematical contraction that can be obtained when a1 = a2 and a1 is substituted for a2. It is suggested to delete the limitation to resolve the issue.
Claim 4 is not understood. How can a1 be equal and different from a2? Claim 4 may be canceled to resolve the issue.
In Claim 9, two lines from the end “wherein N is preferably comprises between 3 and 8, more preferably between 4 and 6” is confusing because it is unclear if the preferable ranges are required by the claim. This limitation may be deleted to resolve the issue.
Again in claim 10, “intelligence” is a confusing term.
Claims 2, 5-8, 11-13 are rejected based on their dependency from a rejected claim.
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 1-6, 10-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: YES – Claim 1 recites a system for optically measuring an implantation depth of an active implantable medical device, and is therefore a device. Claim 11 recites a method for determining an implantation depth.
Step 2A, Prong 1, Judicial Exception: YES – The claim recites the limitation of “determining from the maxima distance (ds) the implantation depth (h) of the AIMD below the skin (3s) of the patient”. This limitation, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components and generic data collection components. That is, other than reciting “controller”, “two or more photodetectors (44) or an array of two or more photodetectors” nothing in the claim element precludes the step from practically being performed in the mind.
For example, but for the “controller” and “two or more photodetectors (44) or an array of two or more photodetectors” language, the claim encompasses a user simply observing two illuminated light points and measuring the distance between the observed light points in his/her mind. The mere nominal recitation of a generic controller and photodetectors does not take the claim limitation out of the mental processes grouping, since the photodetectors are analogous to the human eye for making observations in this instance. Thus, the claim recites a mental process.
Examiner notes that the AIMD is not part of the scope required by the claim. The claimed components, i.e. the external optical depth measuring device, must only be capable of use with the AIMD.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites additional elements: “photodetectors” located in the external optical depth measuring device in order to detect light. This amounts to mere data gathering, which is a form of insignificant extra-solution activity. “controller” to activate the light sources of the AIMD is a power-on function and is insignificant extra-solution activity to the depth determination function. The processing circuitry (“intelligence”) that performs the determining depth function is recited at a high level of generality and merely automates the depth determination function. The additional limitations are no more than mere instructions to apply the exception using generic computer components (“photodetectors”, “intelligence”, “controller”).
The combination of these additional elements is no more than mere instructions to apply the exception using a generic computer component (the processing circuitry “intelligence”). Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to the abstract idea.
In addition, claims 2, 3, 4 introduce additional abstract concepts of mathematics.
Claims 6 and 10 adds the component of an “external charger” but it is not tied to the abstract idea of determining depth and therefore does not impose any meaningful limit on practicing the abstract idea in the mind.
Claim 11 is found to be ineligible for the same reasoning as for claim 1.
However, claim 7 introduces an electrical circuit configured to vary and optimize the current fed to the primary coil based on the determined depth. This is found to be patent eligible, since it places meaningful limits on practicing the abstract idea. Claims 8 and 9 are eligible for their dependency on claim 7.
Similarly, Claim 12 is found eligible. Claim 13 is eligible based on its dependency from claim 12.
As such, claims 7, 8, 9, 12, 13 are found to be eligible at Step 2A.
Step 2B, Inventive Concept: No - 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 component and generic data collection components. The same analysis applies here in 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B. Under the 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B. Here, the initial light activation and collection functions were considered to be extra-solution activity in Step 2A, and thus it is re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field. The specification teaches generic photodetectors as the collections means, not specialized photodetectors. The specification also cites related prior art that utilizes photodetectors in an external implant charger in the same context, e.g. par. 0070, WO2017202455. As such, it is reasonable to conclude the data collecting step using photodetectors and external charging hardware is well-understood, routine, conventional activity. For these reasons, there is no inventive concept in claims 1, 2, 3, 4, 5, 6, 10, 11, and thus they are ineligible.
Allowable Subject Matter
Claims 7, 8, 9, 12, 13 include allowable subject matter and would be allowable if rewritten in independent form and to overcome the USC 112 issues specified above. The following is a statement of reasons for the indication of allowable subject matter: The prior art does not teach or suggest the subject matter in each of Claims 7 and 12, including determining an implantation depth of an AIMD based on distance between first and second maxima of projected light beams from the AIMD at the skin surface and optimizing the current fed to an AIMD coil to optimize a power transfer efficiency between an external charger coil and the AIMD coil as a function of the determined implantation depth, in combination with intervening limitations. One of ordinary skill in the art would recognize that the advantage of such an optimization would permit steady power transfer, regardless of the variable implant depth, which is advantageous for prolonging battery life and minimizing heat accumulation during charging.
In particular, US 20150077050 to Van Funderburk teaches an inductive charger for implants wherein photodetectors are utilized to communicate alignment information between the external charger and the implant, as in Figure 13. The intensity of the light transmitted from the implant to the skin surface is measured and used to adjust and optimize the current fed to the implant. While Van Funderburk discusses the depth is initially inferred and associated with a baseline intensity value (par. 0095). Then as measured intensity changes due to depth changing, the current is also changed to compensate. However, the measured intensity varies not only from depth, but from a mix of misalignment and depth (e.g. Figure 14B, 14C). Van Funderburk does not measure depth value based on two maxima (a spatial intensity distribution) as in the claimed invention and cannot actually quantify depth. Van Funderburk is utilizing a different mode of operation than the claimed invention to optimize the power transfer.
US 10507330 to Doguet teaches alignment of an external charger with an implant based on measured optical signals. Similar to the claimed invention, Doguet teaches measurement of an intensity distribution of the projected light onto the skin surface (e.g. Figure 1). However, this information is not used to assess depth information. Rather, it is used to assess alignment over the implant.
US 8425488 to Clifford teaches using angled beam light projections onto a tissue membrane in order to assess the depth of the implant/device due to distance between the perceived light projections (Figure 33). However, this methodology is used to optimize the depth of the implant/device by converging the projected beams to achieve the desired depth. It is not used to optimize charging current of an external device. Combining such a technique of Clifford for the purpose of external implant charging as in the claimed invention (e.g. claims 7, 12) would be impermissible hindsight.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 20150100109, US 9339660 to Feldman teach optical alignment of an external charging device but operate in a different mode than the claimed invention. US 9435830, US 20140203823 to Joshi teach determining distance between an external charging device and an implant using current measurements, not projected optical signals. US 20050075699, US 7286880 to Olson, US 20220149671, US 12088125 to Sama, US 20100217353 to Forsell, US 20100137948, 20160114173, 20180272141, 9227075, 10010717, 10737103 to Aghassia, US 20170340243 to Jain, US 20190168004 to Doguet, US 4014346 to Brownlee teach externally charging and optimizing power transfer to an implant.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANGELA MARIE HOFFA whose telephone number is (571)270-7408. The examiner can normally be reached Monday - Friday 9:30 am - 6:00 pm.
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ANGELA M. HOFFA
Primary Examiner
Art Unit 3799
/Angela M Hoffa/ Primary Examiner, Art Unit 3799