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 .
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1-5 and newly added Claims 9-20) and sub-species 1A, 2A, 3A, 4A, 5E, 6A, and 7A in the reply filed on 07/21/2026 is acknowledged.
Claims 6-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-5 and 9-20 are hereby considered pending and under examination.
Claim Interpretation
Regarding the claim limitation “actuator”, the term “actuator” is interpreted as any actuation device that would be similar in moving or controlling a mechanism such as slider 288 from the Applicant’s specification [0056]. This is because the term “actuator” may imply that an electrical, pneumatic, or hydraulic input is needed to produce a controlled force, torque, or displacement. However, the specifications mention an actuator “operable to selectively advance and retract the pin with respect to the carrier body” [0020]. Slider 288 is mentioned in the Applicant’s specifications to be capable of doing the actions required by the “actuator” [0056, 0067]. Therefore, the term “actuator” is interpreted to be any actuation device for moving or controlling a mechanism that is similar in function to slider 288.
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 2-4 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.
In re claim 2, the limitation “the actuator” lacks antecedent basis.
Appropriate correction is required.
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.
(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 1-4, 9, and 14-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boggs et al. (US 2018/0104481).
In re claim 1, Boggs discloses a system [0002], comprising:
an introducer tool (fig. 1: 100; [0162]) including a dilator portion (150; [0162]),
a carrier portion ([0041]: spacer is interpreted as a carrier portion), and
a release mechanism ([0014]: inner deployment mechanism and locking mechanism [0076] are interpreted as a release mechanism),
the dilator portion selectively engageable with the carrier portion ([0236]: spacers lock needles during insertion and enable deployment of the lead which means the dilator portion must selectively engage with the carrier portion); and
a lead (138; [0166]) including a lead body (fig. 1: body of 138) and an electrode structure (fig. 1: combination of 130 and 134),
the electrode structure including an active side (130) with an electrode disposed thereon [0165] and an inactive side (134) with an element disposed thereon ([0166]: 134 may comprise an uninsulated portion that is barbed),
wherein the introducer tool is configured to be temporarily inserted into a patient over a guidewire ([0056-0060]: needle assembly used to position deployment mechanism before the needle assembly is removed), and
wherein a portion of the release mechanism is selectively engageable with the element of the electrode structure to retain the electrode structure to the introducer tool [0076]: locking mechanism prevents additional electrode movement prior to final deployment).
In re claim 2, Boggs discloses wherein the release mechanism further includes a first release () configured to be coupleable to the carrier portion so as to prevent movement of the actuator and unintended separation of the dilator portion and the carrier portion ([0236]: spacers may be locked which is interpreted as a first release to prevent movement of an actuator and unintended separation of the dilator portion and the carrier portion; [0223]: various lead mechanisms may be used for actuating deployment of lead; [0236]: spacer used to control deployment of the lead).
In re claim 3, Boggs discloses wherein the release mechanism further includes a second release configured to be coupleable to the carrier portion so as to prevent movement of the actuator and unintended disengagement of the electrode structure ([0233-0234]: clip may be used to fix position of angle and rotation of introducer needle; [0203]: lock mechanism prevents deployment of the lead and therefore deployment of the electrode structure by only partially exposing the lead).
In re claim 4, Boggs discloses wherein the second release includes a retention clip configured for securing the lead body thereto ([0233]: clip used to fix position of the introducer needle which would fix position if the lead body).
In re claim 9, Boggs discloses wherein the element disposed on the inactive side of the electrode structure comprises a tissue-engagement structure *configured to engage tissue adjacent a blood vessel following implantation ([0166]: 134 comprises uninsulated portion that may be barbed and would engage tissue adjacent a blood vessel following implantation; [0169]: 134 may be released and embedded into tissue).
*Regarding the limitation, “configured to engage tissue adjacent a blood vessel following implantation”, Examiner asserts that the recited limitations are directed to functional language/intended use.
A recitation of the functional language of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional language, then it meets the claim.
In this case, the tissue-engagement structure need only be able to perform these functions in order to anticipate the claimed invention; see MPEP § 2114 (I) and In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432. Therefore, since the tissue-engagement structure has all of the necessary structure to engage tissue adjacent a blood vessel following implantation, it is therefore capable of and/or able to be configured to do the above limitations, see MPEP 2114 "[A]pparatus claims cover what a device is, not what a device does." See MPEP 2114.
In re claim 14, Boggs wherein
the active side of the electrode structure is configured to face the blood vessel ([0262]: introducer doesn’t contact blood vessels and instead penetrates tissue proximate to nerves, which would face a blood vessel instead of being inserted into the blood vessel) and
the inactive side is configured to face tissue surrounding the blood vessel when implanted ([0169]: 134 is embedded into tissue proximate to introducer system; [0262]).
Additionally, regarding the limitations, “wherein
the active side of the electrode structure is configured to face the blood vessel and
the inactive side is configured to face tissue surrounding the blood vessel when implanted”,
Examiner asserts that the recited limitations are directed to functional language/intended use.
A recitation of the functional language of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional language, then it meets the claim.
In this case, the active side of the electrode and the inactive side need only be able to perform these functions in order to anticipate the claimed invention; see MPEP § 2114 (I) and In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432. Therefore, since the active side of the electrode and the inactive side have all of the necessary structure to face the blood vessel and face tissue surrounding the blood vessel when implanted, respectively, they are therefore capable of and/or able to be configured to do the above limitations, see MPEP 2114 "[A]pparatus claims cover what a device is, not what a device does." See MPEP 2114.
In re claim 15, Boggs wherein the tissue-engagement structure is configured to maintain the position of the electrode structure relative to the blood vessel ([0264]: distal anchor enables position to be maintained).
Additionally, regarding the limitation, “wherein the tissue-engagement structure is configured to maintain the position of the electrode structure relative to the blood vessel” Examiner asserts that the recited limitation is directed to functional language/intended use.
A recitation of the functional language of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional language, then it meets the claim.
In this case, the tissue-engagement structure need only be able to perform these functions in order to anticipate the claimed invention; see MPEP § 2114 (I) and In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432. Therefore, since the tissue-engagement structure has all of the necessary structure to configured to maintain the position of the electrode structure relative to the blood vessel, it is therefore capable of and/or able to be configured to do the above limitations, see MPEP 2114 "[A]pparatus claims cover what a device is, not what a device does." See MPEP 2114.
In re claim 16, regarding the limitation, “wherein the blood vessel comprises a carotid artery”, Examiner asserts that the recited limitation is directed to functional language/intended use.
A recitation of the functional language of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional language, then it meets the claim.
In this case, the system need only be able to perform these functions in order to anticipate the claimed invention; see MPEP § 2114 (I) and In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432. Therefore, since the system has all of the necessary structure to provide wherein the blood vessel comprises a carotid artery, it is therefore capable of and/or able to be configured to do the above limitations, see MPEP 2114 "[A]pparatus claims cover what a device is, not what a device does." See MPEP 2114.
In re claim 17, regarding the limitation, “wherein the electrode structure is configured to be implanted adjacent a carotid sinus or an aortic arch”, Examiner asserts that the recited limitation is directed to functional language/intended use.
A recitation of the functional language of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional language, then it meets the claim.
In this case, the electrode structure need only be able to perform these functions in order to anticipate the claimed invention; see MPEP § 2114 (I) and In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432. Therefore, since the electrode structure has all of the necessary structure to be implanted adjacent a carotid sinus or an aortic arch, it is therefore capable of and/or able to be configured to do the above limitations, see MPEP 2114 "[A]pparatus claims cover what a device is, not what a device does." See MPEP 2114.
In re claim 18, Boggs wherein the electrode structure further comprises a barbed suture coupled to the element disposed on the inactive side of the electrode structure ([0043]: electrode on inactive side may include fixation helix which is interpreted as a barbed suture since it is a sharp projection).
In re claim 19, regarding the limitation, “wherein the barbed suture is configured to maintain the position of the electrode structure along a length of a carotid artery following implantation”, Examiner asserts that the recited limitation is directed to functional language/intended use.
A recitation of the functional language of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional language, then it meets the claim.
In this case, the barbed suture need only be able to perform these functions in order to anticipate the claimed invention; see MPEP § 2114 (I) and In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432. Therefore, since the barbed suture has all of the necessary structure to maintain the position of the electrode structure along a length of a carotid artery following implantation, it is therefore capable of and/or able to be configured to do the above limitations, see MPEP 2114 "[A]pparatus claims cover what a device is, not what a device does." See MPEP 2114.
In re claim 20, regarding the limitation, “wherein the barbed suture and the tissue-engagement structure collectively maintain the position of the electrode structure without suturing the electrode structure directly to the blood vessel”, Examiner asserts that the recited limitation is directed to functional language/intended use.
A recitation of the functional language of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional language, then it meets the claim.
In this case, the barbed suture and the tissue-engagement structure need only be able to perform these functions in order to anticipate the claimed invention; see MPEP § 2114 (I) and In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432. Therefore, since the barbed suture and the tissue-engagement structure have all of the necessary structure to collectively maintain the position of the electrode structure without suturing the electrode structure directly to the blood vessel, they are therefore capable of and/or able to be configured to do the above limitations, see MPEP 2114 "[A]pparatus claims cover what a device is, not what a device does." See MPEP 2114.
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Boggs et al. (US 2018/0104481) in view of Ware et al. (US 2011/0160824).
In re claim 5, Boggs fails to disclose
wherein the release mechanism includes a movable pin and an actuator,
the actuator operable to selectively advance and retract the pin with respect to the carrier body, and
wherein the pin is selectively engageable with the element of the electrode structure to retain the electrode structure to the introducer tool.
Ware teaches an analogous system for implanting electrical leads [0006] and teaches
wherein a release mechanism [0007] includes
a movable pin [0007] and
an actuator ([0007]: knob can selectively engage or disengage a terminal pin),
the actuator operable to selectively advance and retract the pin with respect to a carrier body ([0007] carrier body is interpreted as main body which is coupled to the terminal pin that actuates the know), and
wherein the pin is selectively engageable with the element of an electrode structure [0043] to retain the electrode structure to the introducer tool ([0007]: pin selectively engages fixation helix; [0043]: helix may be a distal tip electrode).
Ware further teaches that the knob can be used to selectively allow a physician to engage a fixation helix [0007] and allows for selective implantation [0023].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the system taught by Boggs, to provide wherein the release mechanism includes a movable pin and an actuator, the actuator operable to selectively advance and retract the pin with respect to the carrier body, and wherein the pin is selectively engageable with the element of the electrode structure to retain the electrode structure to the introducer tool, as taught by Ware, because doing so allows a physician to selectively engage a fixation helix and provides selective implantation.
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Boggs et al. (US 2018/0104481) in view of Spreigl et al. (US 6,161,029).
In re claim 10, Boggs fails to disclose wherein the tissue-engagement structure comprises a mesh.
Spreigl teaches an analogous system for implanting a lead in a coronary sinus (Col. 1, lines 5-13) and teaches
wherein a tissue-engagement structure (Col. 14, lines 1-12: stent engages with vessel wall; Col. 11, 37-50) comprises a mesh (Col. 12, line 66- Col. 13, line 16: retention stent 230 may comprise of a wire mesh),
wherein the mesh is arranged in a bundled configuration while an electrode structure is retained to an introducer tool (Col. 12, line 59- Col. 13, line 16: retention stent 230 may be compressed to a compressed state diameter during delivery before it’s ejected from an introducer and the retention stent 230 is coupled to a tubular electrode support; Col. 5, lines 52-64), and
wherein the mesh is configured to be exposed from the bundled configuration following release of the electrode structure from the introducer tool (Col. 12, line 59- Col. 13, line 16: retention stent self-expands when ejected from introducer lumen; Col. 13, lines 49-67: mesh stent expands to normal shape and lead delivery mechanism is withdrawn; Col. 1, lines 25-37: lead contains electrodes).
Spreigl further teaches that a self-expanding retention stent doesn’t require externally applied force to expand it (Col. 12, lines 59-66), and that a mesh retention stent may be used in a cardiac implantation site (Col. 13, lines 18-23).
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the system taught by Boggs, to provide wherein the tissue-engagement structure comprises a mesh, wherein the mesh is arranged in a bundled configuration while the electrode structure is retained to the introducer tool, and wherein the mesh is configured to be exposed from the bundled configuration following release of the electrode structure from the introducer tool, as taught by Spreigl, because a self-expanding retention stent doesn’t require externally applied force to expand it and also because a mesh retention stent may be used in a cardiac implantation site.
In re claim 11, regarding the limitation, “wherein the mesh is arranged in a bundled configuration while the electrode structure is retained to the introducer tool”, see the proposed combination yielded in re claim 10 above.
In re claim 12, regarding the limitation, “wherein the mesh is configured to be exposed from the bundled configuration following release of the electrode structure from the introducer tool”, see the proposed combination yielded in re claim 10 above.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Boggs et al. (US 2018/0104481) in view of Spreigl et al. (US 6,161,029) in view of Rizk et al. (US 2019/0314130).
In re claim 13, the proposed combination fails to yield wherein the mesh comprises a self-fixating mesh having a plurality of gripping barbs configured to engage bodily tissue.
Rizk teaches an analogous implantation device [0002] and teaches wherein a mesh [0068] comprises a self-fixating mesh ([0068]: self-anchoring mesh) having a plurality of gripping barbs configured to engage bodily tissue ([0068]: self-anchoring mesh may comprise of barb like surfaces that engage with tissue).
Rizk further teaches that the self-anchoring mesh may be used to engage an implant [0068] with a patient’s tissue [0068] through a self-fixating system [0068].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the system yielded by the proposed combination, to provide wherein the mesh comprises a self-fixating mesh having a plurality of gripping barbs configured to engage bodily tissue, as taught by Rizk, because the self-anchoring mesh may be used to engage the implant with a patient’s tissue through a self-fixating system.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Pianca (US 2018/0021569) discloses an introducer [0008] including a reinforced mesh to reduce kinking [00008].
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUMAISA R BAIG whose telephone number is (571)270-0175. The examiner can normally be reached Mon-Fri: 8am- 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUMAISA RASHID BAIG/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
