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 § 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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) the mental process of receiving data to detect for an evoked response signal and determining whether a target tissue has been captured based on the evoked response signal. This judicial exception is not integrated into a practical application because a biostimulator comprising a housing containing an electronics compartment; a fixation element coupled to the housing; an attachment feature coupled to the housing; a low-polarization coating on one or more of the fixation element or the attachment feature, wherein the low-polarization coating effectively enlarges a surface area of the fixation element or the attachment feature is a pre-solution activity of used to detect the evoked response signals. The addition of a transport system including a catheter having a distal end in claim 9 does not integrate the abstract into a practical application as it is part of the pre-solution activity of getting the stimulator in a location to collect the data. Regarding the processor, the claimed method and system merely implements the above-identified abstract idea using rules (e.g., computer instructions) executed by a computer (e.g., processor as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because a biostimulator comprising a housing containing an electronics compartment; a fixation element coupled to the housing; an attachment feature coupled to the housing; a low-polarization coating on one or more of the fixation element or the attachment feature, wherein the low-polarization coating effectively enlarges a surface area of the fixation element or the attachment feature is a pre-solution activity of used to detect the evoked response signals. Demmer et al (US Patent 10,441,796) in Figure 2A illustrates a housing (150) with fixation elements (166) and an attachment feature (162-158) and in Column 7 lines 41-46 discloses a low-polarization coating on the attachment feature (162). Cho et al (US Publication 2017/0105635) discloses in Figure 2A a housing (14) with fixation elements (41) and an attachment feature (22 and 46) and in Paragraph [0045] discloses a low-polarization coating on the attachment feature (22). Klimovitch et al (US Publication 2018/0236249) discloses a housing (202) with fixation elements (205) and an attachment feature (bottom of the figure, 108b down towards “Fig. 3”) and Paragraph [0070] discloses a low-polarization coating on the attachment feature (108b). Regarding the transport system including a catheter having a distal end. Demmer et al (US Patent 10,441,796) discloses a delivery tool 158 with catheter in Column 8 lines 15-20 and Figure 2B. Cho et al (US Publication 2017/0105635) discloses a delivery tool 300 with catheter 302. Klimovitch et al (US Publication 2018/0236249) in Paragraph [0071] discloses the using a catheter to rotate the housing into heart tissue. Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications). The processor is a generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93. Therefore the claims do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself. The examiner notes that the claims recite the device as a biostimulator, but do not require a structure to generate stimulation. Also the detection of an evoked response signal requires the delivery of electrical stimulation to evoke a response in light of the disclosure (e.g. Paragraph [0005]). However, a pulse generator is part of the pre-solution activity to generate the evoked response. In addition, Demmer et al (US Patent 10,441,796) discloses a pulse generator within the housing in Figure 3, Element 202. Cho et al (US Publication 2017/0105635) discloses a pulse generator 602 within the housing. Klimovitch et al (US Publication 2018/0236249) discloses a pulse generator 116. The limitations of claims 5 and 13 describing the attachment figures are illustrated by the attachment features described in Demmer et al; Cho et al; and Klimovitch et al and are not sufficient to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself
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, 4, 9, 12, and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sheldon et al (US Publication 2016/0250480).
Referring to Claims 1 and 17, Sheldon et al teaches a method/biostimulator comprising: a housing containing an electronics compartment (e.g. Figure 2A, Element 150); a fixation element coupled to the housing (e.g. Figure 2A, Element 166); an attachment feature coupled to the housing (e.g. Figure 2A, Element 158 to 162); a low-polarization coating on one or more of the fixation element or the attachment feature, wherein the low-polarization coating effectively enlarges a surface area of the fixation element or the attachment feature (e.g. Paragraph [0033] discloses a low polarizing coating on the electrode 162); one or more processors in the electronics compartment (e.g. Figure 3, Element 206), wherein the one or more processors are configured to: detect an evoked response signal between the low-polarization coating and one or more of a cathode or an anode of the biostimulator, and determine whether a target tissue has been captured based on the evoked response signal (e.g. Paragraphs [0047]-[0048] discloses the control module 206 sets a pulse amplitude and/or pulse width of pacing pulses delivered by pulse generator 202 according to a capture threshold determined during a capture threshold search. Control module 206 executes a capture threshold search by controlling pulse generator 202 to deliver pacing pulses at decreasing pacing output, for example decreasing pacing pulse amplitude for a given pulse width, until an electrical evoked response is not sensed).
Referring to Claims 4 and 12, Sheldon et al teaches the claimed invention, wherein the low-polarization coating is on the attachment feature (e.g. Paragraph [0033] and element 162).
Referring to Claim 9, Sheldon et al teaches a biostimulator system, comprising: a transport system including a catheter having a distal end (e.g. Paragraph [0031] discloses distal end 102 of stimulator 100 is the leading end as it advances through delivery tool, such as, a catheter); a biostimulator (e.g. Figure 2A, Element 100) coupled to the distal end and including: a housing containing an electronics compartment (e.g. Figure 2A, Element 150); a fixation element coupled to the housing (e.g. Figure 2A, Element 166); an attachment feature coupled to the housing (e.g. Figure 2A, Element 158 to 162); a low-polarization coating on one or more of the fixation element or the attachment feature, wherein the low-polarization coating effectively enlarges a surface area of the fixation element or the attachment feature (e.g. Paragraph [0033] discloses a low polarizing coating on the electrode 162); one or more processors in the electronics compartment (e.g. Figure 3, Element 206), wherein the one or more processors are configured to: detect an evoked response signal between the low-polarization coating and one or more of a cathode or an anode of the biostimulator, and determine whether a target tissue has been captured based on the evoked response signal (e.g. Paragraphs [0047]-[0048] discloses the control module 206 sets a pulse amplitude and/or pulse width of pacing pulses delivered by pulse generator 202 according to a capture threshold determined during a capture threshold search. Control module 206 executes a capture threshold search by controlling pulse generator 202 to deliver pacing pulses at decreasing pacing output, for example decreasing pacing pulse amplitude for a given pulse width, until an electrical evoked response is not sensed).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2-3, and 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sheldon et al (US Publication 2016/0250480) in view of Sommer et al (US Publication 2006/0122682).
Referring to Claims 2 and 10, Sheldon et al teaches the claimed invention, wherein the attachment feature is the anode, and it is used in combination with a cathode on the distal end of the device. However, Sheldon et al does not explicitly disclose wherein the fixation element is the cathode.
Sommer et al teaches that it is known to use an active fixation element at the distal end as set forth in Figure 2 to provide improved reliable electrodes that maintain the distal end electrode in contact with the endocardium or within the myocardium (e.g. Paragraph [0004]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Sheldon et al, with an active fixation element at the distal end as taught by Sommer et al, since such a modification would provide improved reliable electrodes that maintain the distal end electrode in contact with the endocardium or within the myocardium.
Referring to Claims 3 and 11, Sheldon et al teaches the claimed invention, except wherein the low-polarization coating is on the fixation element.
Sommer et al teaches that it is known to use an active fixation element with a low-polarization coating as set forth in Paragraphs [0076]-[0077] to provide a surface texture that enhances the characteristics of the tissue-electrode interface to decrease post pulse delivery polarization and stabilizes impedance changes (e.g. Paragraph [0068]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Sheldon et al, with an active fixation element with a low-polarization coating as taught by Sommer et al, since such a modification would provide the predictable results of a surface texture that enhances the characteristics of the tissue-electrode interface to decrease post pulse delivery polarization and stabilizes impedance changes.
Claim(s) 5 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sheldon et al (US Publication 2016/0250480) in view of Maile et al (US Publication 2019/0054304).
Referring to Claims 5 and 13, Sheldon et al teaches the claimed invention, teaches a stem between a base and a button (e.g. Figure 2A). However, Sheldon et al does not explicitly disclose wherein the attachment feature includes a stem having an annular stem wall extending around an internal cavity, wherein the stem extends between a base and a button, wherein the button includes a proximal button face having a face port extending into the internal cavity, and wherein the button includes an exterior surface and an interior surface around the internal cavity.
Maile et al teaches that it is known to use the attachment feature includes a stem (1164) having an annular stem wall extending around an internal cavity (1166), wherein the stem extends between a base (1156) and a button (1160), wherein the button includes a proximal button face having a face port extending into the internal cavity, and wherein the button includes an exterior surface and an interior surface around the internal cavity (1168) as set forth in Figure 14 to provide a simple substitution of one known technique for another which provides more surface area for gripping the housing for insertion and removal. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Sheldon et al, with the attachment feature includes a stem having an annular stem wall extending around an internal cavity, wherein the stem extends between a base and a button, wherein the button includes a proximal button face having a face port extending into the internal cavity, and wherein the button includes an exterior surface and an interior surface around the internal cavity as taught by Maile et al, since such a modification would provide the predictable results of a simple substitution of one known technique for another which provides more surface area for gripping the housing for insertion and removal.
Claim(s) 6-7, 14-15, and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sheldon et al (US Publication 2016/0250480) in view of Bradley (US Publication 2003/0153957).
Referring to Claims 6, 14 and 18, Sheldon et al teaches the claimed invention, except wherein determining whether the target tissue has been captured includes: differentiating the evoked response signal to determine a differentiated evoked response signal, and comparing the differentiated evoked response signal to a predetermined threshold.
Bradley teaches that it is known to use an algorithm to differentiate the evoked response from the polarization signal and comparing the differentiated signal to a predetermined threshold as set forth in Paragraph [0014] to provide improved determination of an evoked response by differentiating from a polarization signal with similar morphology and polarity to evoked response signals. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system/method as taught by Sheldon et al, with wherein determining whether the target tissue has been captured includes: differentiating the evoked response signal to determine a differentiated evoked response signal, and comparing the differentiated evoked response signal to a predetermined threshold as taught by Bradley, since such a modification would provide the predictable results of improved determination of an evoked response by differentiating from a polarization signal with similar morphology and polarity to evoked response signals.
Referring to Claims 7, 15, and 19, Sheldon et al teaches the claimed invention, except wherein determining whether the target tissue has been captured includes: integrating the evoked response signal to determine an integrated evoked response signal, and comparing the integrated evoked response signal to a predetermined threshold.
Bradley teaches that it is known to use an algorithm to integrate the evoked response signal and compare to a threshold as set forth in Paragraph [0014] to provide improved determination of an evoked response by differentiating from a polarization signal with similar morphology and polarity to evoked response signals. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system/method as taught by Sheldon et al, with wherein determining whether the target tissue has been captured includes: integrating the evoked response signal to determine an integrated evoked response signal, and comparing the integrated evoked response signal to a predetermined threshold as taught by Bradley, since such a modification would provide the predictable results of improved determination of an evoked response by differentiating from a polarization signal with similar morphology and polarity to evoked response signals.
Claim(s) 8, 16, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sheldon et al (US Publication 2016/0250480) in view of Hudson (US Publication 2006/0136003).
Referring to Claims 8, 16 and 20, Sheldon et al teaches the claimed invention, except wherein determining whether the target tissue has been captured includes: filtering the evoked response signal to determine a filtered evoked response signal, and comparing the filtered evoked response signal to a predetermined threshold.
Hudson teaches that it is known to use determining whether the target tissue has been captured includes: filtering the evoked response signal to determine a filtered evoked response signal, and comparing the filtered evoked response signal to a predetermined threshold as set forth in Paragraph [0036]-[0042] to provide a simple substitution of one known technique for another to determine the presence of capture. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system/method as taught by Sheldon et al, with determining whether the target tissue has been captured includes: filtering the evoked response signal to determine a filtered evoked response signal, and comparing the filtered evoked response signal to a predetermined threshold as taught by Hudson, since such a modification would provide the predictable results of a simple substitution of one known technique for another to determine the presence of capture.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
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/William J Levicky/Primary Examiner, Art Unit 3796
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