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 .
Response to Arguments
Applicant’s amendments have overcome the previously applied rejections with respect to Teletronics, Li and Bornzin (2014/0172034).
Applicant's arguments filed 1/9/2026 regarding the Drawing objections have been fully considered but they are not persuasive. The “pacing device” that is released from a pacing catheter (see claims 44 and 45) and the two pacing devices connected together (claim 47) are not shown in Fig. 5A-E or Fig. 2 as cited by Applicant. Fig. 5A-E show a fixation element and not a pacing device as claimed. Fig. 2 shows two electrodes on a lead and not the second pacing device that is separately deliverable from a first pacing device (as clearly implied by the language “further comprising introducing a second pacing device to the heart”). Applicant’s specification clearly indicates that for the two “pacing device” embodiment, these “pacing devices” are envisioned as “pellets” and not electrodes as argued (par. [0083, 0087]). Even, for the sake of argument one were to say the ”pacing devices” could be electrodes (which contradicts the scope set forth in the specification), this interpretation would not make sense within the scope of the claim in that the second electrode of Fig. 2 would not require a second step of insertion as set forth in Claim 47 and instead would be introduced to the heart with a first electrode since they are formed on the same structure. They are not separately insertable through a introducer. The objection is maintained.
Applicant’s arguments regarding the rejection of Claim 4 as being anticipated by Zhang et al. (US Patent 7,890,188) have been considered and are not persuasive. Applicant argues Zhang does not disclose that the lead is straightened during implantation via the guiding catheter or stylet. The Examiner respectfully disagrees. The concept of delivering the lead through a stylet that would revert to its pre-biased shape once implanted and the stylet removed is disclosed in Claim 1. If the pre-biased electrode were not delivered in a straightened configuration, then the lead would fixate within the stylet, lumen and would not be capable of being delivered. The purpose of the bias is to cause passive fixation. The concept of having a delivery state of pre-biased elements is well-known and well-established and a skilled artisan would readily understand the straightened profile the lead of Zhang would obtain during delivery, especially given the reduced diameter of delivery catheters/stylets as compared to the diameter of the vasculature of the patient. See Carlson et al. (2013/0231727), par. [0027]; Carlson et al. (2013/0184801), Fig, 2, 3; Hiel, Jr. et al. (US Patent 5,397,342), col. 9, lines 29-34 are but a few examples of this common, well-known and well-understood practice of compressing implantable devices so they can easily pass though the vasculature and an insertion cannula to their final implantation location without snagging or otherwise affixing to an improper location. The rejection with respect to Zhang is maintained. The other rejections have been modified to address the newly amended claim language.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “pacing device” that is released from a pacing catheter (see claims 44 and 45); the two pacing devices connected together (claim 47) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 44, 45, 47, 49 and 50 are 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.
Applicant has amended claim 1 in such a manner that claims 44, 45, 47, 49 and 50 contain combinations of features not supported by the originally field specification. Paragraph [0087] of the specification is the only part of the detailed description that mentions the two pacing device embodiment (i.e. the two pellets), which states: “Although certain examples have been described herein as bipolar, any of the pacing systems described herein may be configured in a quadripolar configuration. For example, the system may be include two pacing devices (e.g., two pellets) with a first pacing device to pace the atrium and a second pacing device to pace the ventricle. The first pacing device may be connected to the second pacing device, for example by a wire. Each of the pacing devices may be affixed using any of the concepts described herein.” Nothing in this disclosure discloses how the pellets provide pacing in conjunction with a catheter particularly with a catheter that is shaped “when a distal tip of the pacing catheter is in a right ventricle outflow tract f the heart”. The drawings, as noted previously, do not provide an illustration of a two pellet embodiment as claimed and the combination of claims as originally filed did not recite the currently amended features in conjunction with the two pellet embodiment. It appears applicant is combining embodiments in a manner not clearly set forth in the originally filed disclosure.
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 44, 45, 47, 49 and 50 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.
Applicant’s amendment to Claim 1 creates combined features in claims 44, 45, 47, 49 and 50 that do not clearly set forth the claimed invention. Particularly, Claim 1 states a pacing catheter is shaped in the right ventricular outflow tract of the heart and has an electrode for applying pacing pulses to the wall of the heart. Claim 44 then states a pacing device is release from the pacing catheter. It is unclear if this pacing device is the distal portion of the catheter for pacing the heart or some other structure. Applicant’s arguments contradict the specification wherein Applicant argues the pacing device is an electrode on the catheter whereas the specification states the pacing device is a pellet separate from the pacing catheter. The metes and bounds of the claim are unclear. Claims 45, 47, 49 and 50 are rejected due to their dependence on indefinite Claim 44.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 5 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Zhang et al. (US Patent 7,890,188).
Regarding Claims 1, 4 and 5, Zhang discloses advancing a pacing catheter into the heart if a first configuration (a pre-bent/pre-biased configuration); inserting a stylet into the catheter to straighten the catheter during implantation; and then removing the stylet to place the catheter in a ventricular outflow tract so that the pre-curve of the lead passively affixes in the ventricular outflow tract. (Claim 1; Fig. 1; the Examiner notes the pe-curved shaped is assumed within the right ventricle outflow tract once implanted in the tract). Lastly, Zhang discloses applying pacing energy to the lead while the distal tip of the catheter is in the ventricular outflow tract (col. 2, lines 35-47).
Claims 10-12 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Bornzin et al. (U.S. Patent 5,643,338).
Regarding Claims 10 and 11 (and the features incorporated by the amended features of Claim 1 which changes the scope of claims 10 and 11 and creates a new combination of features not previously claimed), Bornzin discloses advancing a pacing catheter into a right ventricular outflow tract of a heart with a shaping element (e.g. a stylet 44), wherein during implantation the catheter takes a first, straightened configuration. When the catheter is placed within the RVOT, the stylet is removed and the catheter assumes its pre-formed shape in the RVOT for passive fixation (see Fig. 1, 7A; col. 9, lines 30-65). Once implanted the RVOT, an electrode on the lead is used to apply electrical pulses to the wall of the heart (col. 3, lines 24-30). Lastly, Bornzin discloses that a passive fixation element 94 that can be formed in the portion of the catheter in the atrium (col. 6, line 44-col. 7, line 10) and further discloses that this passive fixation could be replaced with an active fixation device (col. 5, lines 57-65). Either way, Bornzin discloses fixation elements in the atrium.
In regard to Claim 12, Bornzin discloses fixation element 94 can provide electrical pulses to the atrium (col. 3, line 65-col. 4, line 10).
Claim Rejections - 35 USC § 103
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 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.
Claims 2, 3 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Pedersen et al. (2018/0353751) in view of Zhang et al. (US Patent 7,890,188).
Regarding Claims 2 and 3 (and the features incorporated by the amended features of Claim 1 which changes the scope of claims 2 and 3 and creates a new combination of features not previously claimed), Pedersen discloses a method of delivering a temporary pacing lead into a heart chamber comprising advancing a pacing catheter 80 to the heart (Abstract) in a first configuration (the procedure starts with a pacing catheter having a first radius of curvature); inserting a stylet 230 into the catheter that causes the pacing catheter to assume a shape having a larger radius of curvature than the first configuration (par. [0097, 0125]); and delivering electrical stimulation to the temporary pacing lead once in place (the purpose of implanting the temporary pacing lead is to provide temporary pacing from a pulse generators, see par. [0003, 0012]). Pedersen discloses various stylets having different shapes/configurations can be selected to be used with the catheter (par. [0113-0118, 0125]). Pederson is silent regarding the implantation site where the lead is shaped is a right ventricle outflow tract of the heart. However, Zhang discloses implanting and affixing the lead within a right ventricle outflow tract of the heart for the purpose of effectively treating arrhythmias via a common implant location without causing trauma to the heart (col. 1, lines 13-30, col. 3, lines 27-42) as well as allowing accurate measure of blood outflow of the heart (col. 3, lines 60-65). Therefore 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 device in the Pederson reference to include biasing the lead within a ventricular outflow tract, as taught and suggested by Zhang, for the purpose of effectively treating arrhythmias via a common implant location without causing trauma to the heart as well as allowing for accurate blood outflow measures.
With regard to Claim 6, Pedersen discloses a method of delivering a temporary pacing lead into a heart chamber comprising advancing a pacing catheter 80 to the heart (Abstract) in a first configuration (the procedure starts with a pacing catheter having a first radius of curvature); inserting a stylet 230 into the catheter that causes the pacing catheter to assume a shape having a larger radius of curvature than the first configuration (par. [0097, 0125]); and delivering electrical stimulation to the temporary pacing lead once in place (the purpose of implanting the temporary pacing lead is to provide temporary pacing from a pulse generators, see par. [0003, 0012]). Pedersen discloses various stylets having different shapes/configurations can be selected to be used with the catheter (par. [0113-0118, 0125]). Pedersen discloses removing the pacing stylet used to implant the temporary pacing lead (in which the second configuration is obtained); inserting a removal stylet and removing the pacing catheter with the removal stylet (par. [0125]). Pederson is silent regarding the implantation site where the lead is shaped is a right ventricle outflow tract of the heart. However, Zhang discloses implanting and affixing the lead within a right ventricle outflow tract of the heart for the purpose of effectively treating arrhythmias via a common implant location without causing trauma to the heart (col. 1, lines 13-30, col. 3, lines 27-42) as well as allowing accurate measure of blood outflow of the heart (col. 3, lines 60-65). Therefore 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 device in the Pederson reference to include biasing the lead within a ventricular outflow tract, as taught and suggested by Zhang, for the purpose of effectively treating arrhythmias via a common implant location without causing trauma to the heart as well as allowing for accurate blood outflow measures.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Pedersen et al. (2018/0353751) in view of Zhang et al. (US Patent 7,890,188), further in view of Ventura et al. (2008/0015625).
Regarding Claim 7, Pedersen and Zhang disclose a system for advancing a lead into the body that can use various stylets but does not disclose using a stylet and a guidewire. However, in the same field of endeavor of implantable device delivery, such as electrical stimulators (par. [0003]), Ventura discloses utilizing both stylets and guidewires in implanting a catheter for the purpose of allowing the device to more easily access and navigate body cavities or lumens (par. [0227]). Therefore 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 device in the Pedersen and Zhang combinaiton to include both stylets and guidewires, as taught and suggested by Ventura, for the purpose of allowing the device to more easily access and navigate body cavities or lumens.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Pedersen et al. (2018/0353751) in view of Zhang et al. (US Patent 7,890,188), further in view of Spotnitz et al. (2012/0097174). Pedersen and Zhang disclose all of the claimed invention except for transmitting a light from a sidewall of the pacing catheter. However, in the same field of endeavor of implanting a pacing lead, Spotnitz discloses incorporating a fiber optic source for emitting light in the tip of the lead for the purpose of assisting in lead positioning (par. [0055]). Therefore 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 device in the Pedersen and Zhang combination to include a visible light, as taught and suggested by Spotnitz, for the purpose of assisting in lead positioning.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Pedersen et al. (2018/0353751) in view of Zhang et al. (US Patent 7,890,188), further in view of Tockman et al. (2016/0121102). Pedersen disclose passively anchoring the lead within the heart/vasculature but fails to disclose the use of a balloon. However, Tockman, in the same field of endeavor of pacing lead placement, discloses balloons are well-known means that can be employed to provide anchoring of the lead within the body (par. [0075]). Therefore 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 device in the Pedersen and Zhang combination to include a balloon, as taught and suggested by Tockman, for the purpose of providing anchoring of the lead within the body.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Pedersen et al. (2018/0353751) in view of Zhang et al. (US Patent 7,890,188), further in view of Sabel (U.S. Patent 3,949,757). Pedersen discloses implanting a pacing lead into the heart of a patient but is silent regarding introducing the catheter through an access location to an antecubital vein. However, Sabel discloses that antecubital vein access for catheter insertion was a well-known procedure (col. 3, lines 17-20) before the effective filing date of the claimed invention and provides a minimally invasive approach to implantation. Therefore 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 device in the Pedersen and Zhang combination to include inserting the catheter at an access location in the antecubital vein, as taught and suggested by Sabel, for the purpose of providing a minimally invasive access for catheter insertion.
Claims 44, 45, 47, 49 and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Cho et al. (2017/0105635) in view of Zhang et al. (US Patent 7,890,188)
The Examiner notes the current rejection is made with the Examiner’s best understanding of the claimed invention in light of the 35 USC 112(a) and 112(b) rejection of the claims.
Regarding Claims 44, 49 and 50 (and the features incorporated by the amended features of Claim 1 which changes the scope of claims 44, 49 and 50 and creates a new combination of features not previously claimed), Cho discloses implanting first and second pacing devices through the atrium of the heart and into the right ventricle of the heart, wherein a first pacing device (electrodes 20, 22, see par. [0027]) can be release from a catheter 300 and positioned within an RVOT of a heart (Fig. 1, 5). The first pacing device, once positioned, can deliver electrical therapy to the RVOT (par. [0027]; Fig. 1.). Cho is silent regarding pre-biasing the pacing device in a right ventricle outflow tract of the heart. However, Zhang discloses implanting and passively affixing the lead with a pre-biased shape that achieve the shape once implanted within a right ventricle outflow tract of the heart for the purpose of effectively treating arrhythmias via a common implant location without causing trauma to the heart (col. 1, lines 13-30, col. 3, lines 27-42) as well as allowing accurate measure of blood outflow of the heart (col. 3, lines 60-65). Therefore 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 device in the Cho reference to include biasing the lead within a ventricular outflow tract, as taught and suggested by Zhang, for the purpose of effectively treating arrhythmias via a common implant location without causing trauma to the heart as well as allowing for accurate blood outflow measures.
In regard to Claim 45, Cho discloses the first pacing device 20,22 is within the right atrium when second pacing device 14 is released from the catheter 300 (Fig. 5).
Regarding Claim 47, Cho discloses a second pacing device 14 connected to first pacing device 20, 22 (Fig. 5).
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over Pedersen et al. (2018/0353751) in view of Zhang et al. (US Patent 7,890,188), further in view of Valeti et al. (2015/0105729). Pedersen and Zhang disclose all of the claimed invention except for an external magnet. However, in the same field of endeavor of catheter implantation, Valeti discloses incorporating a magnetic tip on the catheter and using an external magnet with that tip for the purpose of improving the steerability of the catheter during implantation (par. [0090]). Therefore 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 device in the Pedersen and Zhang combination to include an externa magnet, as taught and suggested by Valeti, for the purpose of improving the steerability of the catheter during implantation.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ALLEN PORTER/Primary Examiner, Art Unit 3796
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