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 Objections
Claim 1 objected to because of the following informalities: “a second stimulation signal having a second stimulation signal” should be – a second stimulation signal—. 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 2-13 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.
Claim 2 recites “wherein upon detecting a stimulation of the heart in response to the electrical stimulation signal, determining whether the stimulation probe is touching the pericardium”. First, it is unclear if “a stimulation of the heart”, of claim 2, is the same as or different than “a first stimulation of the heart” or “a second stimulation of the heart”, as introduced in claim 1. Second, there is insufficient antecedent basis for the limitation "the electrical stimulation signal" in the claim, and further it is unclear if “the electrical stimulation signal” is the same as or different than the “a first stimulation signal” or “a second stimulation signal”, as introduced in claim 1. Third, there is insufficient antecedent basis for the limitation “the stimulation probe” in the claim. Claims 3-4 are rejected by virtue of its dependency on claim 2.
Claim 4 recites “the adjusted at least one of the amplitude and frequency of the electrical stimulation signal”. First, there is insufficient antecedent basis for the limitation " the adjusted at least one of the amplitude and frequency" in the claim; independent claim 1 introduces a first stimulation signal and a second stimulation signal but does not introduce “adjusted at least one of the amplitude and frequency”. Second, there is insufficient antecedent basis for the limitation "the electrical stimulation signal" in the claim, and further it is unclear if “the electrical stimulation signal” is the same as or different than the “a first stimulation signal” or “a second stimulation signal”, as introduced in claim 1.
Claim 5 recites “wherein the adjusting at least one of the selected amplitude and frequency includes lowering the amplitude”; there is insufficient antecedent basis for the limitation "the adjusting at least one of the selected amplitude and frequency " in the claim; independent claim 1 introduces a first stimulation signal and a second stimulation signal but does not introduce “adjusting at least one of the selected amplitude and frequency”.
Claim 6 recites the limitation " the stimulation probe " in line 1. There is insufficient antecedent basis for this limitation in the claim. Claims 7-8 are rejected by virtue of their dependency on claim 6.
Claim 9 recites the limitation " the stimulation probe " in line 1. There is insufficient antecedent basis for this limitation in the claim. For examination purposes the examiner is considering the stimulation probe to be the puncture device.
Claim 11 recites the limitation “wherein the stimulation probe includes an electrode configured in a monopolar mode”. First, there is insufficient antecedent basis for the limitation “the stimulation probe” in the claim. Second, it is unclear if the “an electrode”, of claim 11, is the same as or additional to the “an electrode”, as introduced in independent claim 1, which renders the claim indefinite; for examination purposes the examiner is considering the stimulation probe to be the puncture device and the electrode to be the same as introduced in claim 1.
Claim 12 recites “wherein the detecting the stimulation includes detecting the stimulation via a QRS wave of the heart”; it is unclear if “the stimulation”, of claim 12, is the same as or different than “a first stimulation of the heart” or “a second stimulation of the heart”, as introduced in claim 1, which renders the claim indefinite; the examiner is considering “the stimulation” to be -- the first stimulation and the second stimulation—.
Claim 13 recites “wherein the detecting the stimulation includes detecting the stimulation via determining changes in an electrogram signal”; it is unclear if “the stimulation”, of claim 12, is the same as or different than “a first stimulation of the heart” or “a second stimulation of the heart”, as introduced in claim 1, which renders the claim indefinite; the examiner is considering “the stimulation” to be -- the first stimulation and the second stimulation—.
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 1, 5, 9-11, & 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Balkovec et al. (WO2022013791A1; see attached foreign reference), hereinafter “Balkovec”, in view of Ludwig et al. (US 20180117336 A1), hereinafter “Ludwig”.
Regarding method claim 1, Balkovec discloses a method of epicardial access of a heart, the method comprising: providing a puncture device ([0023]; Figure 1—element 102) including a shaft having a proximal portion and a distal portion ([0023]; Figure 1—element 104), the distal portion including an electrode ([0023]; Figure 1—element 110); providing a first stimulation signal having a first amplitude and frequency having a first stimulation energy to the electrode ([0032]; Figures 3-5—element 110; once the electrode 110 is in contact with the pericardium 302 a stimulus signal can be delivered from the electrode 110 and to the heart 300 in order to contract the heart); advancing the electrode of the puncture device toward a pericardium of the heart by manipulating the proximal portion of the puncture device ([0031]; Figure 3—elements 102 & 302; the puncture device 102 is advanced through an introducer 122 towards the target location to contact the pericardium 302); detecting a first stimulation of the heart in response to the first stimulation signal ([0036]; an ECG monitoring system can be used to determine that the heart in contracted).
Balkovec does not disclose providing a second stimulation signal having a second stimulation signal having a second amplitude and frequency having a second stimulation energy to the electrode; and detecting a second stimulation of the heart in response to the second stimulation signal, based on the electrode contacting the epicardium of the heart; wherein the first stimulation energy is greater than the second stimulation energy.
Ludwig teaches method comprising: providing a first stimulation signal having a first amplitude and frequency having a first stimulation energy to the electrode; and providing a second stimulation signal having a second stimulation signal having a second amplitude and frequency having a second stimulation energy to the electrode; and detecting a second stimulation of the heart in response to the second stimulation signal, based on the electrode contacting the epicardium of the heart; wherein the first stimulation energy is greater than the second stimulation energy ([0048]; the device delivers pacing pulses to capture the heart; if the pacing energy fails to capture the heart the pacing energy may be decreased by decreasing the voltage of pulse width).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the method of providing stimulation energy, as disclosed by Balkovec, to include providing a second stimulation signal having a second amplitude and frequency having a second stimulation energy to the electrode and detecting a second stimulation of the heart in response to the second stimulation signal, wherein the first stimulation energy is greater than the second stimulation energy, as taught by Ludwig, as both references and the claimed invention are directed toward methods for contracting the heart. As disclosed by Balkovec, the system is configured to deliver a stimulus signal to contract the heart ([0032]). As disclosed by Ludwig, rather than always pacing at a predetermined pacing energy, which may cause the device to expend unnecessary energy if the pacing energy if the pacing energy fails to capture the heart, the medical device instead may be configured to deliver the pacing pulses at a controllable energy level, such that the pacing energy may be decreased or increased ([0048]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of providing stimulation energy, as disclosed by Balkovec, to include providing a second stimulation signal having a second amplitude and frequency having a second stimulation energy to the electrode and detecting a second stimulation of the heart in response to the second stimulation signal, wherein the first stimulation energy is greater than the second stimulation energy, as taught by Ludwig, as such a modification would allow for providing a second stimulation signal that is controllable to capture the heart if the first stimulation signal failed to capture the heart.
Regarding method claim 5, as best understood in view of the 112(b) rejection above, Balkovec in view of Ludwig disclose all of the limitations of claim 1, as described above.
Ludwig further teaches wherein the adjusting at least one of the selected amplitude and frequency includes lowering the amplitude ([0048]).
Regarding method claims 9-10, as best understood in view of the 112(b) rejection above, Balkovec in view of Ludwig disclose all of the limitations of claim 1, as described above.
Balkovec further teaches wherein the stimulation probe includes a delivery sheath (claim 9) ([0031]; Figure 3—element 122); wherein the delivery sheath includes an electrode (claim 10) ([0035]).
Regarding method claim 11, as best understood in view of the 112(b) rejection above, Balkovec in view of Ludwig disclose all of the limitations of claim 1, as described above.
Balkovec further teaches wherein the stimulation probe includes an electrode configured in a monopolar mode ([0033]; Figures 1 & 2—element 110).
Regarding method claim 13, as best understood in view of the 112(b) rejection above, Balkovec in view of Ludwig disclose all of the limitations of claim 1, as described above.
Balkovec further teaches wherein the detecting the stimulation includes detecting the stimulation via determining changes in an electrogram signal ([0036]).
Regarding method claim 14, Balkovec in view of Ludwig disclose all of the limitations of claim 1, as described above.
Balkovec further teaches wherein the puncture device is a radio-frequency (RF) crossing device ([0033]).
Regarding claim 15, Balkovec discloses a system to access an epicardium of a heart, the system comprising: a stimulation probe ([0023]; Figure 1—element 102) configured to advance toward a pericardium ([0031]) and configured to provide an electrical stimulation signal of a selected amplitude and frequency ([0032]; Figures 3-5—element 110; once the electrode 110 is in contact with the pericardium 302 a stimulus signal can be delivered from the electrode 110 and to the heart 300 in order to contract the heart).
Balkovec does not disclose a controller coupled to the to the stimulation probe, the controller configured to provide the electrical stimulation signal of the selected amplitude and frequency to the stimulation probe and adjust at least one of the selected amplitude and frequency of the electrical stimulation signal based on a detected stimulation of the heart in response to the electrical stimulation signal.
Ludwig teaches a system configured to provide an electrical stimulation signal of a selected amplitude and frequency, comprising a controller, the controller configured to provide the electrical stimulation signal of the selected amplitude and frequency to the stimulation probe and adjust at least one of the selected amplitude and frequency of the electrical stimulation signal based on a detected stimulation of the heart in response to the electrical stimulation signal ([0048]; the delivers controllable pacing pulses to capture the heart; if the pacing energy fails to capture the heart the pacing energy may be decreased by decreasing the voltage of pulse width).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the system for providing stimulation energy, as disclosed by Balkovec, to include a controller configured to provide the electrical stimulation signal of the selected amplitude and frequency to the stimulation probe and adjust at least one of the selected amplitude and frequency of the electrical stimulation signal based on a detected stimulation of the heart in response to the electrical stimulation signal, as taught by Ludwig, as both references and the claimed invention are directed toward systems for contracting the heart. As disclosed by Balkovec, the system is configured to deliver a stimulus signal to contract the heart ([0032]). As disclosed by Ludwig, rather than always pacing at a predetermined pacing energy, which may cause the device to expend unnecessary energy if the pacing energy if the pacing energy fails to capture the heart, the medical device instead may be configured to deliver the pacing pulses at a controllable energy level, such that the pacing energy may be decreased or increased ([0048]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, the system for providing stimulation energy, as disclosed by Balkovec, to include a controller configured to provide the electrical stimulation signal of the selected amplitude and frequency to the stimulation probe and adjust at least one of the selected amplitude and frequency of the electrical stimulation signal based on a detected stimulation of the heart in response to the electrical stimulation signal, as taught by Ludwig, as such a modification would provide for a stimulation signal that is controllable to capture the heart if a previous stimulation signal failed to capture the heart.
Regarding claim 16, Balkovec in view of Ludwig disclose all of the limitations of claim 15, as described above.
Ludwig further teaches wherein the adjusting at least one of the selected amplitude and frequency includes lowering the amplitude ([0048]).
Regarding claim 17, Balkovec discloses a system to access an epicardium of a heart, the system comprising: a puncture device ([0023]; Figure 1—element 102) including a shaft having a proximal portion and a distal portion ([0023]; Figure 1—element 104), the distal portion including an electrode ([0023]; Figure 1—element 110), the puncture device configured to advance toward a pericardium of the heart by manipulating the proximal portion of the puncture device ([0031]); configured to provide a first stimulation signal having a first amplitude and frequency having a first stimulation energy to the electrode, detect a first stimulation of the heart in response to the first stimulation signal.
Balkovec does not disclose a controller coupled to the puncture device, the controller configured to: provide the first stimulation signal; provide a second stimulation signal having a second stimulation signal having a second amplitude and frequency having a second stimulation energy to the electrode, and detect a second stimulation of the heart in response to the second stimulation signal, based on the electrode contacting the epicardium of the heart; wherein the first stimulation energy is greater than the second stimulation energy.
Ludwig teaches a system configured to provide a first stimulation signal, comprising a controller coupled to the puncture device, the controller configured to: provide the first stimulation signal; provide a second stimulation signal having a second stimulation signal having a second amplitude and frequency having a second stimulation energy to the electrode, and detect a second stimulation of the heart in response to the second stimulation signal, based on the electrode contacting the epicardium of the heart; wherein the first stimulation energy is greater than the second stimulation energy([0048]; the device delivers controllable pacing pulses to capture the heart; if the pacing energy fails to capture the heart the pacing energy may be decreased by decreasing the voltage of pulse width).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the system for providing stimulation energy, as disclosed by Balkovec, to include a controller configured to: provide the first stimulation signal; provide a second stimulation signal having a second stimulation signal having a second amplitude and frequency having a second stimulation energy to the electrode, as taught by Ludwig, as both references and the claimed invention are directed toward systems for contracting the heart. As disclosed by Balkovec, the system is configured to deliver a stimulus signal to contract the heart ([0032]). As disclosed by Ludwig, rather than always pacing at a predetermined pacing energy, which may cause the device to expend unnecessary energy if the pacing energy if the pacing energy fails to capture the heart, the medical device instead may be configured to deliver the pacing pulses at a controllable energy level, such that the pacing energy may be decreased or increased ([0048]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, the system for providing stimulation energy, as disclosed by Balkovec, to include a controller configured to: provide the first stimulation signal; provide a second stimulation signal having a second stimulation signal having a second amplitude and frequency having a second stimulation energy to the electrode, as taught by Ludwig, as such a modification would provide for a stimulation signal that is controllable to capture the heart if a previous stimulation signal failed to capture the heart.
Regarding claim 18, Balkovec in view of Ludwig disclose all of the limitations of claim 17, as described above.
Balkovec further discloses wherein the puncture device is one of a radio-frequency (RF) crossing device and a needle configured to pierce the pericardium ([0028]; RF device; the examiner notes the rest are in the alternative).
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Balkovec in view of Ludwig and Visram et al. (US 20050159738 A1), hereinafter “Visram”.
Regarding method claims 2-4, as best understood in view of the 112(b) rejection above, Balkovec in view of Ludwig disclose all of the limitations of claim 1, as described above.
Balkovec further discloses wherein if the stimulation probe is touching the pericardium, piercing the pericardium (claim 3) ([0033] & [0036]; when the heart is in the contracted state RF energy is delivered to puncture the pericardium); the stimulation probe providing the adjusted at least one of the amplitude and frequency of the electrical stimulation signal (claim 4) (see above rejection of claim 1).
Balkovec does not disclose wherein upon detecting a stimulation of the heart in response to the electrical stimulation signal, determining whether the stimulation probe is touching the pericardium (claim 2); wherein if the stimulation probe is not touching the pericardium, further advancing the stimulation probe toward the pericardium (claim 4).
Visram teaches a method of detecting a stimulation of the heart, wherein upon detecting a stimulation of the heart, determining whether the stimulation probe is touching the pericardium (claim 2); wherein if the stimulation probe is not touching the pericardium, further advancing the stimulation probe toward the pericardium (claim 4) ([0059]-[0063]; the position of the device may be determined my monitoring ECG tracings; if the position of the device is not in a desired position the device may be repositioned).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the detecting a stimulation of the heart, as disclosed by Balkovec, to include determining whether the stimulation probe is touching the pericardium, as taught by Visram, as both references and the claimed invention are directed toward methods of puncturing cardiac tissue and ECG monitoring. As disclosed by Balkovec, the detecting a stimulation of the heart may include ECG monitoring ([0036]). As disclosed by Visram, ECG monitoring may be used to determine if the puncture device is in the desired position or needs to be repositioned ([0059]-[0063]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the detecting a stimulation of the heart, as disclosed by Balkovec, to include determining whether the stimulation probe is touching the pericardium, as taught by Visram, as such a modification would provide feedback to a user as to whether or not the puncture device is in contact with target tissue or if the puncture device needs to be repositioned.
Claims 6-8 & 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Balkovec in view of Ludwig and Allen et al. (US 20160206338 A1), hereinafter “Allen”.
Regarding claims 6-8, as best understood in view of the 112(b) rejection above, Balkovec in view of Ludwig disclose all of the limitations of claim 1, as described above.
Balkovec does not disclose wherein the stimulation probe includes a needle configured to pierce the pericardium (claim 6); wherein the needle is a Tuohy needle (claim 7); wherein the needle is included in a micropuncture needle set (claim 8).
Allen teaches a method of epicardial access comprising a puncture device, wherein the stimulation probe includes a needle configured to pierce the pericardium (claim 6); wherein the needle is a Tuohy needle (claim 7); wherein the needle is included in a micropuncture needle set (claim 8) ([0004]; surgical methods to create an opening in the pericardium can be performed with commercially available Tuohy needle or 21G Micropuncture needle kits).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the puncture device, as disclosed by Balkovec, to include a Tuohy needle or a micropuncture needle set, as taught by Allen, as both references and the claimed invention are directed toward methods of epicardial access. As disclosed by Balkovec, methods of creating a pericardial puncture can be performed with an RF apparatus ([0022]). As disclosed by Allen, methods of creating an opening in the pericardium can be performed with a commercially available Tuohy needle or a Micropuncture needle kit ([0004]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the puncture device, as disclosed by Balkovec, to include a Tuohy needle or a micropuncture needle set, as taught by Allen, as such a modification would provide for a suitable and known puncture device in the art that produces the predictable result of puncturing the pericardium.
Regarding claims 18-19, Balkovec in view of Ludwig disclose all of the limitations of claim 17, as described above.
Balkovec does not disclose wherein the puncture device is one of a needle configured to pierce the pericardium (claim 18); wherein the needle is one of a Tuohy needle and a micropuncture needle set (claim 19).
Allen teaches a system epicardial access comprising a puncture device, wherein the puncture device is one of a needle configured to pierce the pericardium (claim 18); wherein the needle is a Tuohy needle (claim 7); wherein the needle is one of a Tuohy needle and a micropuncture needle set (claim 19) ([0004]; surgical methods to create an opening in the pericardium can be performed with commercially available Tuohy needle or 21G Micropuncture needle kits).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the puncture device, as disclosed by Balkovec, to include a Tuohy needle or a micropuncture needle set, as taught by Allen, as both references and the claimed invention are directed toward systems for epicardial access. As disclosed by Balkovec, the system can create a pericardial puncture via with a RF apparatus ([0022]). As disclosed by Allen, the system can create an opening in the pericardium with a commercially available Tuohy needle or a Micropuncture needle kit ([0004]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the puncture device, as disclosed by Balkovec, to include a Tuohy needle or a micropuncture needle set, as taught by Allen, as such a modification would provide for a suitable and known puncture device in the art for puncturing the pericardium.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Balkovec in view of Ludwig and Sullivan et al. (US 20080269818 A1), hereinafter “Sullivan”.
Regarding claim 12, Balkovec in view of Ludwig disclose all of the limitations of claim 1, as described above.
Balkovec does not disclose wherein the detecting the stimulation includes detecting the stimulation via a QRS wave of the heart.
Sullivan teaches a method of providing a stimulation and detecting the stimulation, wherein the detecting the stimulation includes detecting the stimulation via a QRS wave of the heart ([0060]).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify detecting the stimulation, as disclosed by Balkovec, to include wherein the detecting the stimulation includes detecting the stimulation via a QRS wave of the heart, as taught by Sullivan, as both references and the claimed invention are directed toward methods of epicardial access. As disclosed by Balkovec, ECG monitoring can be used to determine when the heart is in the contracted state ([0036]). As disclosed by Sullivan, ECG monitoring can be used to verify whether the applied pulse captures the heart, if the applied pulse is captured by the heart such would result in an evoked QRS complex which can be used to verify the heart is being captured ([0060]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify detecting the stimulation, as disclosed by Balkovec, to include wherein the detecting the stimulation includes detecting the stimulation via a QRS wave of the heart, as taught by Sullivan, as such a modification would provide for a suitable and known monitoring to produce the predictable result of determining when the heart is contracted.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Balkovec in view of Ludwig and Alhumaid (US 20140088417 A1), hereinafter “Alhumaid”.
Regarding claim 20, Balkovec in view of Ludwig disclose all of the limitations of claim 17, as described above.
Balkovec does not disclose wherein the controller is further configured to generate a visualization on a display.
Alhumaid teaches a system for epicardial access ([0005]) comprising a controller, wherein the controller is further configured to generate a visualization on a display ([0107], [0110], & [0111]).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the system, as disclosed by Balkovec, to include wherein the controller is further configured to generate a visualization on a display, as taught by Alhumaid, as both references and the claimed invention are directed toward systems for epicardial access and ECG monitoring. As disclosed by Alhumaid, the controller may include a display, such that ECG data may be displayed for accessing the pericardial space ([0110]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system, as disclosed by Balkovec, to include wherein the controller is further configured to generate a visualization on a display, as taught by Alhumaid, as such a modification would allow for the ECG data to be displayed to a user such that the user can access the pericardial space.
Conclusion
Accordingly, claims 1-20 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARINA D TEMPLETON whose telephone number is (571)272-7683. The examiner can normally be reached M-F 8:00am to 5:00pm EST.
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/M.D.T./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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