DETAILED ACTION
The following is a Non-Final Office Action on the merits.
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 .
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 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/3/2025 has been entered.
Response to Amendment
Acknowledgment is made to the amendment received 11/3/2025.
Applicant’s amendments are sufficient to overcome the claim objection set forth in the previous office action.
The Examiner notes that support is provided for the amendments to the claims, and particularly that as the stimulus signal is delivered, the heart contracts, and thus, the shaft deflects between the first and second profiles (Fig. 3-4).
Claim Objections
Claim 1 is objected to because of the following informalities: amend “and to penetrate into pericardial space between the pericardium and myocardium” to -and to penetrate into pericardial space between the pericardium and myocardium with the electrode- in ll. 12-13. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: amend “exhibits” to -is configured to exhibit- in ll. 11. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: amend “to delivery” to -to the delivery- in ll. 12, 13 & 15. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: amend “connect to the RF generator to receive” to -connected to the RF generator and configured to receive- in ll. 14-15. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: amend “and penetrate into a pericardial space between the pericardium and myocardium” to -and penetrate into a pericardial space between the pericardium and myocardium with the electrode- in ll. 16-17. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: amend “at least partially returns to the biased” to -to at least partially return to the- in ll. 20. Appropriate correction is required.
Claim Interpretation
The Examiner notes that claims 1 & 15 recite the phrase “a second deflection profile…that is lesser than the first deflection profile”. Under BRI, this is taken to be a deflection profile from the biased straight configuration that is less deflected from the biased straight deflection profile.
The Examiner notes that last limitation reciting “following puncture” and “after penetration” in claim 15 corresponds to the previous limitation of “the electrode connected to the RF generator [configured] to receive and deliver RF energy…to puncture…and penetrate- in ll. 14-17.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 11 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 11 recites the limitation “the stimulus signal is delivered from the introducer to the heart”; however, claim 1, upon which claim 11 depends, recites the limitations “an electrode of a medical device, the electrode located at a distal end of an elongate shaft…delivering, with the electrode, a stimulus signal…delivering radiofrequency energy from the electrode…advancing the elongate shaft into the pericardial space”. Thus, the electrode on the elongate shaft is the electrode that both stimulates and penetrates the pericardium. There is no support in the originally filed disclosure for the “electrode” to be both on the elongate shaft and the introducer to deliver the stimulus signal.
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 11 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 11 recites the limitation “the stimulus signal is delivered from the introducer to the heart”; however, claim 1, upon which claim 11 depends, recites the limitations “an electrode of a medical device, the electrode located at a distal end of an elongate shaft…delivering, with the electrode, a stimulus signal…delivering radiofrequency energy from the electrode…advancing the elongate shaft into the pericardial space”. It is unclear how “the electrode” that delivers the stimulus signal can be both on the elongate shaft of the medical device and an introducer at the same time. For purposes of examination, claim 11 will be interpreted as -the stimulus signal is delivered from a second electrode on the introducer-.
Allowable Subject Matter
Claims 1, 3-7 & 12-18 are allowed. As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
The following is a statement of reasons for the indication of allowable subject matter: the prior art, neither alone nor in combination, teaches a method or medical system comprising a pulse generator that delivers a stimulus signal from an electrode on an elongate shaft to a pericardium of a heart to induce contraction and transient standstill of the heart and an RF generator that delivers RF energy to the same electrode to puncture and perforate the pericardium.
The closest prior art is regarded as: Davies et al. (2014/0228841, previously cited) teaches puncturing a pericardium while the heart is in a contracted state, but fails to disclose simulating the heart to induce contraction and transient standstill of the heart, where puncturing at an angled approach improves safety. Davies et al. (2016/0066989, previously cited) teaches a biased shaft profile with respect to pericardial puncture devices. Hissong et al. (2017/0296217, previously cited) teach delivering a stimulus signal to force controlled intermittent asystole (CIA) to control or inhibit motion associated with cardiac contraction such that a relatively stationary volume of cardiac tissue may be targeted with energy, but fail to disclose inducing contraction and transient standstill of the heart as CIA occurs when the heart is in a relaxed/non-contracted state. Hossainy (2016/0184595) teaches flexible device movement that mirrors motion of the pericardium. Altman et al. (2002/0019623) teach temporary pacing to provide electrical stimuli to allow ventricular contraction to be controlled where pacing wires are placed epicardially at either ventricular apex (), but the control is to restart contraction after a transient conduction block ([0141], [0146]; Fig. 9A-B). The prior art, neither alone nor in combination, teach stimulating to induce contraction and transient standstill and deliver energy with the same electrode.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAYMI E DELLA whose telephone number is (571)270-1429. The examiner can normally be reached on M-Th 6:00 am - 4:45 pm.
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, Joanne Rodden can be reached on (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794