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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/13/25, 5/10/25, and 12/22/25 are being considered by the examiner.
Claim Objections
Claim 5 is objected to because of the following informalities: the limitation of “from the proximal end of the lead body to nerve cuff” is incorrect grammar. Applicant is encouraged to change the limitation to recite –from the proximal end of the lead body to the nerve cuff--. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: Applicant is encouraged to remove “)” from the claim in line 5. 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 7, 12, and 15 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 7 recites the limitation "the tubular member" in line 3. There is insufficient antecedent basis for this limitation in the claim. The Examiner notes that claim 7 does not depend from claim 2 which is the only other claim that recites “a tubular member.”
In claim 12, the limitation of “selected from group consisting of” seems unclear. It remains unclear what “a group” is referring to. Applicant is encouraged to change the limitation to recite “selected from the group consisting of” as stated in MPEP 2173.05(h). For the purpose of examination, the Examiner is interpreting the limitation to read “selected from the group consisting of.”
Claim 15 recites the limitation "the stylet" in line 3. There is insufficient antecedent basis for this limitation in the claim. The Examiner notes that claim 1 does not recite “a stylet,” which claim 15 depends from.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 5, 8-9, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Dearden (US 20220062629 filed on 9/1/21 as cited in the IDS) in view of Zarembo (US 20140188202 filed on 12/27/13 as cited in the IDS).
Regarding claim 1, Dearden teaches an electrode lead assembly, comprising: and an electrode lead including an elongate lead body having a proximal end and a distal end (claim 1-an electrode lead, comprising: an elongate lead body having a proximal end and a distal end), and a nerve cuff, associated with the distal end of the lead body, including a biologically compatible, elastic, electrically insulative cuff body that is configured to be circumferentially disposed around a nerve, has a pre-set furled state that defines an inner lumen and is movable to an unfurled state (¶6-the nerve cuff may include a biologically compatible, elastic, electrically insulative cuff body affixed to the distal end of the lead body, the cuff body being configured to be circumferentially disposed around a nerve, having a pre-set furled state that defines an inner lumen, and being movable to an unfurled state), and a plurality of electrically conductive contacts carried by the cuff body (¶6-electrically conductive contacts carried by the cuff body).
However, Dearden does not teach a nerve cuff straightener; and is configured to receive a portion of the nerve cuff straightener, wherein, when inserted into the nerve cuff, the portion of the nerve cuff straightener received by the nerve cuff moves the nerve cuff out of the pre-set furled state.
Zarembo relates to implantable stimulation devices and more specifically to cuffs and tools for implanting the cuffs around nerves and other targets (¶2). Zarembo further teaches the invention using the following steps:
a nerve cuff straightener (¶59-stiffener 1272; ¶33-a stiffener with a cuff; Figs. 12-14); and is configured to receive a portion of the nerve cuff straightener (¶60-the stiffener 1272 can extend laterally across the cuff 1208. The stiffener 1272 can extend over the entire width of the cuff 1208, the stiffener 1272 can additionally or alternatively be…embedded in the main body 1270; Figs. 12-14), wherein, when inserted into the nerve cuff, the portion of the nerve cuff straightener received by the nerve cuff moves the nerve cuff out of the pre-set furled state (¶33-use of a stiffener with a cuff; ¶59-pre-stressing of the materials of the main body 1270 can cause the edges 1274, 1276 of the cuff 1208 to curl inward as a sub-wrap. Stiffener 1272 (shown in FIGS. 12 and 14) can be provided along the outer tab 1236 to inhibit the edges 1274, 1276 from curling inward; ¶60-the stiffener 1272 can additionally or alternatively be…embedded in the main body 1270; Figs. 12-14; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)).
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 invention of Dearden to include a nerve cuff straightener; and is configured to receive a portion of the nerve cuff straightener, wherein, when inserted into the nerve cuff, the portion of the nerve cuff straightener received by the nerve cuff moves the nerve cuff out of the pre-set furled state of Zarembo in order to inhibit the edges of the cuff from curling inward (Zarembo, ¶59).
Regarding claim 2, the combination of Dearden and Zarembo teaches the electrode lead assembly claimed in claim 1, wherein the nerve cuff includes a tubular member that is configured to receive the portion of the nerve cuff straightener (Zarembo, ¶45-the first tubular member 146 can be encircled within the cuff 108; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)).
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 invention of Dearden to include wherein the nerve cuff includes a tubular member that is configured to receive the portion of the nerve cuff straightener of Zarembo in order to pull the first tubular member to uncurl the cuff (Zarembo, ¶4).
Regarding claim 5, the combination of Dearden and Zarembo teaches the electrode lead assembly claimed in claim 1, wherein the elongate lead body (Dearden, ¶6-elongate lead body) is configured to facilitate passage of the portion of the nerve cuff straightener (Zarembo, ¶59-stiffener 1272; ¶33-a stiffener with a cuff; Figs. 12-14) that is inserted into the nerve cuff from the proximal end of the lead body to nerve cuff (Dearden, ¶6-nerve cuff, proximal end of the lead body; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
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 invention of Dearden to include the nerve cuff straightener of Zarembo in order to inhibit the edges of the cuff from curling inward (Zarembo, ¶59).
Regarding claim 8, the combination of Dearden and Zarembo teaches the electrode lead assembly claimed in claim 1, wherein when inserted into the nerve cuff (Dearden, ¶6-the nerve cuff; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)), the portion of the nerve cuff straightener (Zarembo, ¶59-stiffener 1272; ¶33-a stiffener with a cuff; Figs. 12-14); moves the nerve cuff out of the pre-set furled state to an at least substantially straightened state (Dearden, ¶6-the cuff body being configured to be circumferentially disposed around a nerve, having a pre-set furled state that defines an inner lumen, and being movable to an unfurled state; ¶46-a flattened, unfurled state; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)).
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 invention of Dearden to include the portion of the nerve cuff straightener of Zarembo in order to inhibit the edges of the cuff from curling inward (Zarembo, ¶59).
Regarding claim 9, the combination of Dearden and Zarembo teaches the electrode lead assembly claimed in claim 1, wherein when inserted into the nerve cuff (Dearden, ¶6-the nerve cuff; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)), the portion of the nerve cuff straightener (Zarembo, ¶59-stiffener 1272; ¶33-a stiffener with a cuff; Figs. 12-14) moves the nerve cuff out of the pre-set furled state to a curved shape (Dearden, ¶46-the nerve cuff 102 is pre-set (or “pre-shaped”) to the furled (or “curled”) state, the nerve cuff 102 will return to the pre-shaped furled state when the force is removed; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)).
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 invention of Dearden to include the portion of the nerve cuff straightener of Zarembo in order to inhibit the edges of the cuff from curling inward (Zarembo, ¶59).
Regarding claim 16, the combination of Dearden and Zarembo teaches the electrode lead assembly claimed in claim 1, wherein the cuff body defines a length, a length direction, a width in the unfurled state that is greater than the length, and a width direction (Dearden, ¶6-the cuff body…being movable to an unfurled state and defining a length and a width in the unfurled state that is greater than the length, first and second relatively wide electrically conductive contacts carried by the cuff body that are spaced from one another in the length direction and that extend in the width direction); and the electrically conductive contacts comprise relatively long contacts that are spaced from one another in the width direction (Dearden, ¶6-electrically conductive contacts carried by the cuff body that are spaced from one another in the width direction; ¶47; Figs. 5-6).
Regarding claim 17, the combination of Dearden and Zarembo teaches the electrode lead assembly claimed in claim 1, wherein the cuff body defines a length, a length direction, a width in the unfurled state that is greater than the length, and a width direction (Dearden, ¶6-the cuff body…being movable to an unfurled state and defining a length and a width in the unfurled state that is greater than the length, first and second relatively wide electrically conductive contacts carried by the cuff body that are spaced from one another in the length direction and that extend in the width direction); and the electrically conductive contacts comprise first and second relatively wide electrically conductive contacts that are spaced from one another in the length direction and extend in the width direction to such an extent that they extend completely around the cuff body inner lumen when the cuff body is in the pre-set furled shape (Dearden, ¶6-first and second relatively wide electrically conductive contacts carried by the cuff body that are spaced from one another in the length direction and that extend in the width direction to such an extent that they extend completely around the cuff body inner lumen when the cuff body is in the pre-set furled shape) and a plurality of relatively narrow electrically conductive contacts that are spaced from one another in the width direction and are located between the first and second relatively wide electrically conductive contacts (Dearden, ¶6-a plurality of relatively narrow electrically conductive contacts carried by the cuff body that are spaced from one another in the width direction and are located between the first and second relatively wide electrically conductive contacts).
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Dearden in view of Zarembo as applied to claim 1 above, and further in view of Schmidt (US 20180117313 filed on 6/27/17 as cited in the IDS).
Regarding claim 3, the combination of Dearden and Zarembo teaches the electrode lead assembly claimed in claim 1. However, the combination of Dearden and Zarembo does not teach a port on the cuff body configured to facilitate passage of the portion of the nerve cuff straightener into the cuff body.
Schmidt teaches a port on the cuff body (Fig. 20-first enlarged cuff substrate 46a with a second elongated lead substrate portion 38b with a connection port on the left; ¶106) configured to facilitate passage of the portion of the nerve cuff straightener into the cuff body (Fig. 20; ¶106; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)).
Schmidt relates to implantable neurostimulation leads, and specifically relates to implantable nerve cuff electrodes that can be used to stimulate nerves (¶2).
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 invention of Dearden to include a port on the cuff body configured to facilitate passage of the portion of the nerve cuff straightener into the cuff body of Schmidt in order to expose portions of the electrically conductive traces to form four connector pads and four additional electrode pads (Schmidt, ¶107), and stimulate nerves (Schmidt, ¶2).
Regarding claim 4, the combination of Dearden, Zarembo, and Schmidt teaches the electrode lead assembly claimed in claim 3, wherein the port is offset from the elongate lead body (Schmidt, Fig. 20-first enlarged cuff substrate portion 46a has a second elongated lead substrate portion 38b with a connection port on the left that is offset from the first elongated lead substrate portion on the right; ¶106).
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 invention of Dearden to include wherein the port is offset from the elongate lead body of Schmidt in order to expose portions of the electrically conductive traces to form four connector pads and four additional electrode pads (Schmidt, ¶107), and stimulate nerves (Schmidt, ¶2).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Dearden in view of Zarembo as applied to claim 5 above, and further in view of Malinowski (US 20160059019 filed on 8/25/15).
Regarding claim 6, the combination of Dearden and Zarembo teaches the electrode lead assembly claimed in claim 5, and configured to facilitate passage of the portion of the nerve cuff straightener (Zarembo, ¶59-stiffener 1272; ¶33-a stiffener with a cuff; Figs. 12-14) that is inserted into the nerve cuff (Dearden, ¶6-nerve cuff, proximal end of the lead body; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
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 invention of Dearden to include the nerve cuff straightener of Zarembo in order to inhibit the edges of the cuff from curling inward (Zarembo, ¶59).
However, the combination of Dearden and Zarembo does not teach wherein the elongate lead body includes an internal lumen; and a lead connector, including an internal lumen, is on the proximal end of the elongate lead body.
Malinowski teaches wherein the elongate lead body includes an internal lumen (¶5-connector-contact assemblies are disposed in the connector lumen and are each configured and arranged to couple to a terminal of the lead or lead extension; ¶63-the conductive wires may be embedded in the non-conductive material of the lead or can be disposed in one or more lumens (not shown) extending along the lead; ¶100-lead lumen); and a lead connector, including an internal lumen, is on the proximal end of the elongate lead body (¶5-a connector lumen is defined in the connector housing and is configured and arranged for receiving a proximal portion of a lead or lead extension).
Malinowski s directed to the area of implantable electrical stimulation systems and methods of making and using the systems. The present invention is also directed to implantable electrical stimulation systems having connectors with improved connector contacts, as well as methods of making and using the connectors, connector contacts, and electrical stimulation systems (¶2).
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 invention of Dearden to include wherein the elongate lead body includes an internal lumen; and a lead connector, including an internal lumen, is on the proximal end of the elongate lead body of Malinowski in order to provide stimulation to nerves (Malinowski, ¶57; ¶130).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Dearden in view of Zarembo as applied to claim 5 above, and further in view of Bolea (US 20080103545 filed on 10/12/07 as cited in the IDS).
Regarding claim 7, the combination of Dearden and Zarembo teaches the electrode lead assembly claimed in claim 5. However, the combination of Dearden and Zarembo does not teach wherein the tubular member extends through the elongate lead body.
Bolea teaches wherein the tubular member extends through the elongate lead body (¶60-the lead body 62 may comprise a tubular jacket with electrical conductors 68 extending therein; ¶61-the tubular jacket of lead body 62).
Bolea relates to devices, systems and associated methods for treating sleeping disorders. More particularly, the inventions described herein relate to devices, systems and methods for treating obstructive sleep apnea (¶2).
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 invention of Dearden to include wherein the tubular member extends through the elongate lead body of Bolea in order to improve durability (Bolea, ¶60) and for treating obstructive sleep apnea (Bolea, ¶2).
Claims 10 is rejected under 35 U.S.C. 103 as being unpatentable over Dearden in view of Zarembo as applied to claim 1 above, and further in view of Foster (US 20220370793 filed on 5/18/22).
Regarding claim 10, the combination of Dearden and Zarembo teaches the electrode lead assembly claimed in claim 1. However, the combination of Dearden and Zarembo does not teach wherein the nerve cuff straightener includes a stylet; and the portion of the nerve cuff straightener that is inserted into the nerve cuff comprises a portion of the stylet.
Foster teaches wherein the nerve cuff straightener includes a stylet (¶36-there may also be one or more lumens (not shown) that open at, or near, the proximal end of the lead body 106, for example, for inserting a stylet to facilitate placement of the lead body 106 within a body of a patient; ¶37-part of the lead body 106, coupled to cuff 150); and the portion of the nerve cuff straightener that is inserted into the nerve cuff comprises a portion of the stylet (MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987); Fig. 1; ¶36-37).
Foster is directed to the area of implantable electrical stimulation systems and methods of making and using the systems. The present disclosure is also directed to implantable electrical stimulation cuff devices, as well as methods of making and using the same (¶2).
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 invention of Dearden to include wherein the nerve cuff straightener includes a stylet; and the portion of the nerve cuff straightener that is inserted into the nerve cuff comprises a portion of the stylet of Foster in order to facilitate placement of the lead body (Foster, ¶36).
Claims 11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Dearden in view of Zarembo, and further in view of Foster as applied to claim 10 above, and further in view of Heptke (US 20090132042 filed on 10/17/08 as cited in the IDS).
Regarding claim 11, the combination of Dearden, Zarembo, and Foster teaches the electrode lead assembly claimed in claim 10. However, the combination of Dearden, Zarembo, and Foster does not teach wherein the stylet includes a first region with first straightening characteristics and a second region with second straightening characteristics that are different than the first straightening characteristics.
Heptke teaches wherein the stylet includes a first region with first straightening characteristics (¶26-the stylet 16 is preferably made from a stiff material such as metal, but may alternatively be made from any suitable material) and a second region with second straightening characteristics that are different than the first straightening characteristics (¶26-the stylet 16 may include a sharpened end adapted to penetrate the tissue and aid in the insertion of the stylet).
Heptke relates generally to the implantable device field, and more specifically to an implantable device including a resorbable carrier (¶3).
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 invention of Dearden to include wherein the stylet includes a first region with first straightening characteristics and a second region with second straightening characteristics that are different than the first straightening characteristics of Heptke in order to penetrate the tissue or other material and/or functions to provide structural support to the device during implantation of the device (Heptke, ¶26).
Regarding claim 13, the combination of Dearden, Zarembo, and Foster teaches the electrode lead assembly claimed in claim 10. However, the combination of Dearden, Zarembo, and Foster does not teach wherein the stylet is malleable.
Heptke teaches wherein the stylet is malleable (¶26-the stylet 16 is preferably made from a stiff material such as metal).
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 invention of Dearden to include wherein the stylet is malleable of Heptke in order to penetrate the tissue or other material, function to provide structural support to the device during implantation of the device, and be stiff (Heptke, ¶26).
Claims 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Dearden in view of Zarembo, and further in view of Foster as applied to claim 10 above, and further in view of Lacey (US 20140171961 filed on 12/6/13).
Regarding claim 12, the combination of Dearden, Zarembo, and Foster teaches the electrode lead assembly claimed in claim 10. However, the combination of Dearden, Zarembo, and Foster does not teach wherein the stylet defines a longitudinal axis and one or more cross-sections in directions perpendicular to the longitudinal axis with shapes selected from group consisting of a flat ribbon-like shape, a rectangular shape, a rounded rectangular shapes), and an oval shape.
Lacey teaches wherein the stylet defines a longitudinal axis and one or more cross-sections in directions perpendicular to the longitudinal axis with shapes selected from group consisting of a flat ribbon-like shape, a rectangular shape, a rounded rectangular shapes), and an oval shape (Fig. 10-stylet 1030 has a longitudinal axis; ¶84-the first end portion 1032 of the stylet 1030 has a cross-sectional profile, the first end portion 1032 may have a rectangular cross-section).
Lacey is directed to the area of implantable electrical stimulation systems and methods of making and using the systems. The present invention is also directed to an insertion tool suitable for facilitating implantation of paddle bodies of electrical stimulation leads, as well as methods of making and using the insertion tool, paddle bodies, leads, and electrical stimulation systems (¶2).
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 invention of Dearden to include wherein the stylet defines a longitudinal axis and one or more cross-sections in directions perpendicular to the longitudinal axis with shapes selected from group consisting of a flat ribbon-like shape, a rectangular shape, a rounded rectangular shapes), and an oval shape of Lacey in order to facilitate insertion of the insertion tool into the patient's body (Lacey, ¶46) and/or facilitate rotation of the stylet (Lacey, ¶54).
Regarding claim 14, the combination of Dearden, Zarembo, and Foster teaches the electrode lead assembly claimed in claim 10. However, the combination of Dearden, Zarembo, and Foster does not teach wherein the stylet defines a distal end and a proximal end; and the nerve cuff straightener includes a handle at the proximal end of the stylet.
Lacey teaches wherein the stylet defines a distal end and a proximal end (¶6-the stylet has a first end portion and an opposing second end portion, where the first end portion is the distal end and the opposing second end portion is the proximal end); and the nerve cuff straightener includes a handle at the proximal end of the stylet (¶6-the actuator handle to the second end portion of the stylet).
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 invention of Dearden to include wherein the stylet defines a distal end and a proximal end; and the nerve cuff straightener includes a handle at the proximal end of the stylet of Lacey in order to facilitate insertion of the insertion tool into the patient's body (Lacey, ¶46), where movement of the actuator handle along the actuator slit causes a corresponding movement of the stylet (Lacey, ¶6).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Dearden in view of Zarembo as applied to claim 1 above, and further in view of Heptke.
Regarding claim 15, the combination of Dearden and Zarembo teaches the electrode lead assembly claimed in claim 1. However, the combination of Dearden and Zarembo does not teach wherein the stylet comprises multiple stylets.
Heptke teaches wherein the stylet comprises multiple stylets (¶28-although omitted for conciseness, the preferred embodiments include every combination and permutation of the various carriers 10, the various electrical subsystems, the various connectors, the various stylets, and the various methods of use; ¶10-the implantable device is preferably designed to be implanted into the brain, spinal cord, peripheral nerve, muscle, or any other suitable anatomical location).
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 invention of Dearden to include wherein the stylet comprises multiple stylets of Heptke in order to penetrate the tissue or other material and/or functions to provide structural support to the device during implantation of the device (Heptke, ¶26).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
The Examiner notes that there are double patenting rejections for 6 different US Patents/Copending Applications. The rejections are listed in order for US 12654002, US 12350489, US 12296172, US 12194290, 18/985448, and 19/034472, respectively.
Claims 1-2, 5, and 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12654002 in view of Zarembo (US 20140188202).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12654002
Secondary Reference Zarembo (US 20140188202)
1
1, 7
Zarembo teaches a nerve cuff straightener (¶59-stiffener 1272; ¶33-a stiffener with a cuff; Figs. 12-14); and is configured to receive a portion of the nerve cuff straightener (¶60-the stiffener 1272 can extend laterally across the cuff 1208. The stiffener 1272 can extend over the entire width of the cuff 1208, the stiffener 1272 can additionally or alternatively be…embedded in the main body 1270; Figs. 12-14), wherein, when inserted into the nerve cuff, the portion of the nerve cuff straightener received by the nerve cuff moves the nerve cuff out of the pre-set furled state (¶33-use of a stiffener with a cuff; ¶59-pre-stressing of the materials of the main body 1270 can cause the edges 1274, 1276 of the cuff 1208 to curl inward as a sub-wrap. Stiffener 1272 (shown in FIGS. 12 and 14) can be provided along the outer tab 1236 to inhibit the edges 1274, 1276 from curling inward; ¶60-the stiffener 1272 can additionally or alternatively be…embedded in the main body 1270; Figs. 12-14; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). 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 invention of the US Patent to include a nerve cuff straightener; and is configured to receive a portion of the nerve cuff straightener, wherein, when inserted into the nerve cuff, the portion of the nerve cuff straightener received by the nerve cuff moves the nerve cuff out of the pre-set furled state of Zarembo in order to inhibit the edges of the cuff from curling inward (Zarembo, ¶59).
2
Zarembo teaches wherein the nerve cuff includes a tubular member that is configured to receive the portion of the nerve cuff straightener (Zarembo, ¶45-the first tubular member 146 can be encircled within the cuff 108; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). 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 invention of the US Patent to include wherein the nerve cuff includes a tubular member that is configured to receive the portion of the nerve cuff straightener of Zarembo in order to pull the first tubular member to uncurl the cuff (Zarembo, ¶4).
5
Zarembo teaches wherein the elongate lead body (Zarembo, ¶43-lead body 122) is configured to facilitate passage of the portion of the nerve cuff straightener (Zarembo, ¶59-stiffener 1272; ¶33-a stiffener with a cuff; Figs. 12-14) that is inserted into the nerve cuff from the proximal end of the lead body to nerve cuff (Zarembo, ¶38-cuff 108 wrapped around the nerve 104; ¶43-the lead body 122 can be attached to the cuff 108; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). 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 invention of the US Patent to include wherein the elongate lead body is configured to facilitate passage of the portion of the nerve cuff straightener that is inserted into the nerve cuff from the proximal end of the lead body to nerve cuff of Zarembo in order to inhibit the edges of the cuff from curling inward (Zarembo, ¶59).
8
Zarembo teaches wherein when inserted into the nerve cuff (Zarembo, ¶38- cuff 108 wrapped around the nerve 104; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)), the portion of the nerve cuff straightener (Zarembo, ¶59-stiffener 1272; ¶33-a stiffener with a cuff; Figs. 12-14); moves the nerve cuff out of the pre-set furled state to an at least substantially straightened state (Zarembo, ¶4-pull the first tubular member to uncurl the cuff; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). 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 invention of the US Patent to include wherein when inserted into the nerve cuff, the portion of the nerve cuff straightener moves the nerve cuff out of the pre-set furled state to an at least substantially straightened state of Zarembo in order to inhibit the edges of the cuff from curling inward (Zarembo, ¶59).
9
Zarembo teaches wherein when inserted into the nerve cuff (Zarembo, ¶38- cuff 108 wrapped around the nerve 104; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)), the portion of the nerve cuff straightener (Zarembo, ¶59-stiffener 1272; ¶33-a stiffener with a cuff; Figs. 12-14) moves the nerve cuff out of the pre-set furled state to a curved shape (Zarembo, ¶50-release the first elongate element 154 and allow the cuff 108 to curl around the nerve 104; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). 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 invention of the US Patent to include wherein when inserted into the nerve cuff, the portion of the nerve cuff straightener moves the nerve cuff out of the pre-set furled state to a curved shape of Zarembo in order to inhibit the edges of the cuff from curling inward (Zarembo, ¶59).
Claims 3-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12654002 in view of Zarembo and Schmidt (US 20180117313).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo and Schmidt as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12654002
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Schmidt (US 20180117313)
3
Schmidt teaches a port on the cuff body (Fig. 20-first enlarged cuff substrate 46a with a second elongated lead substrate portion 38b with a connection port on the left; ¶106) configured to facilitate passage of the portion of the nerve cuff straightener into the cuff body (Fig. 20; ¶106; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). 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 invention of Dearden to include a port on the cuff body configured to facilitate passage of the portion of the nerve cuff straightener into the cuff body of the US Patent in order to expose portions of the electrically conductive traces to form four connector pads and four additional electrode pads (Schmidt, ¶107), and stimulate nerves (Schmidt, ¶2).
4
Schmidt teaches wherein the port is offset from the elongate lead body (Schmidt, Fig. 20-first enlarged cuff substrate portion 46a has a second elongated lead substrate portion 38b with a connection port on the left that is offset from the first elongated lead substrate portion on the right; ¶106). 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 invention of Dearden to include wherein the port is offset from the elongate lead body of the US Patent in order to expose portions of the electrically conductive traces to form four connector pads and four additional electrode pads (Schmidt, ¶107), and stimulate nerves (Schmidt, ¶2).
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12654002 in view of Zarembo and Malinowski (US 20160059019).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo and Malinowski as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12654002
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Malinowski (US 20160059019)
6
Zarembo teaches configured to facilitate passage of the portion of the nerve cuff straightener (Zarembo, ¶59-stiffener 1272; ¶33-a stiffener with a cuff; Figs. 12-14) that is inserted into the nerve cuff ( Zarembo, ¶38-cuff 108 wrapped around the nerve 104; ¶43-the lead body 122 can be attached to the cuff 108; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). 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 invention of the US Patent to include being configured to facilitate passage of the portion of the nerve cuff straightener that is inserted into the nerve cuff of Zarembo in order to inhibit the edges of the cuff from curling inward (Zarembo, ¶59).
Malinowski teaches wherein the elongate lead body includes an internal lumen (¶5-connector-contact assemblies are disposed in the connector lumen and are each configured and arranged to couple to a terminal of the lead or lead extension; ¶63-the conductive wires may be embedded in the non-conductive material of the lead or can be disposed in one or more lumens (not shown) extending along the lead; ¶100-lead lumen); and a lead connector, including an internal lumen, is on the proximal end of the elongate lead body (¶5-a connector lumen is defined in the connector housing and is configured and arranged for receiving a proximal portion of a lead or lead extension). 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 invention of the US Patent to include wherein the elongate lead body includes an internal lumen; and a lead connector, including an internal lumen, is on the proximal end of the elongate lead body of Malinowski in order to provide stimulation to nerves (Malinowski, ¶57; ¶130).
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12654002 in view of Zarembo and Bolea (US 20080103545).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo and Bolea as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12654002
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Bolea (US 20080103545)
7
Bolea teaches wherein the tubular member extends through the elongate lead body (¶60-the lead body 62 may comprise a tubular jacket with electrical conductors 68 extending therein; ¶61-the tubular jacket of lead body 62). 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 invention of the US Patent to include wherein the tubular member extends through the elongate lead body of Bolea in order to improve durability (Bolea, ¶60) and for treating obstructive sleep apnea (Bolea, ¶2).
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12654002 in view of Zarembo and Foster (US 20220370793).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo and Foster as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12654002
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Foster (US 20220370793)
7
Foster teaches wherein the nerve cuff straightener includes a stylet (¶36-there may also be one or more lumens (not shown) that open at, or near, the proximal end of the lead body 106, for example, for inserting a stylet to facilitate placement of the lead body 106 within a body of a patient; ¶37-part of the lead body 106, coupled to cuff 150); and the portion of the nerve cuff straightener that is inserted into the nerve cuff comprises a portion of the stylet (MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987); Fig. 1; ¶36-37). 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 invention of the US Patent to include wherein the nerve cuff straightener includes a stylet; and the portion of the nerve cuff straightener that is inserted into the nerve cuff comprises a portion of the stylet of Foster in order to facilitate placement of the lead body (Foster, ¶36).
Claims 11 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12654002 in view of Zarembo, Foster, and Heptke (US 20090132042).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo, Foster, and Heptke as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12654002
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Foster (US 20220370793)
Secondary Reference Heptke (US 20090132042)
11
Heptke teaches wherein the stylet includes a first region with first straightening characteristics (¶26-the stylet 16 is preferably made from a stiff material such as metal, but may alternatively be made from any suitable material) and a second region with second straightening characteristics that are different than the first straightening characteristics (¶26-the stylet 16 may include a sharpened end adapted to penetrate the tissue and aid in the insertion of the stylet). 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 invention of the US Patent to include wherein the stylet includes a first region with first straightening characteristics and a second region with second straightening characteristics that are different than the first straightening characteristics of Heptke in order to penetrate the tissue or other material and/or functions to provide structural support to the device during implantation of the device (Heptke, ¶26).
13
Heptke teaches wherein the stylet is malleable (¶26-the stylet 16 is preferably made from a stiff material such as metal). 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 invention of the US Patent to include wherein the stylet is malleable of Heptke in order to penetrate the tissue or other material, function to provide structural support to the device during implantation of the device, and be stiff (Heptke, ¶26).
Claims 12 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12654002 in view of Zarembo, Foster, and Lacey (US 20140171961).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo, Foster, and Lacey as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12654002
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Foster (US 20220370793)
Secondary Reference Lacey (US 20140171961)
12
Lacey teaches wherein the stylet defines a longitudinal axis and one or more cross-sections in directions perpendicular to the longitudinal axis with shapes selected from group consisting of a flat ribbon-like shape, a rectangular shape, a rounded rectangular shapes), and an oval shape (Fig. 10-stylet 1030 has a longitudinal axis; ¶84-the first end portion 1032 of the stylet 1030 has a cross-sectional profile, the first end portion 1032 may have a rectangular cross-section). 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 invention of the US Patent to include wherein the stylet defines a longitudinal axis and one or more cross-sections in directions perpendicular to the longitudinal axis with shapes selected from group consisting of a flat ribbon-like shape, a rectangular shape, a rounded rectangular shapes), and an oval shape of Lacey in order to facilitate insertion of the insertion tool into the patient's body (Lacey, ¶46) and/or facilitate rotation of the stylet (Lacey, ¶54).
14
Lacey teaches wherein the stylet defines a distal end and a proximal end (¶6-the stylet has a first end portion and an opposing second end portion, where the first end portion is the distal end and the opposing second end portion is the proximal end); and the nerve cuff straightener includes a handle at the proximal end of the stylet (¶6-the actuator handle to the second end portion of the stylet). 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 invention of the US Patent to include wherein the stylet defines a distal end and a proximal end; and the nerve cuff straightener includes a handle at the proximal end of the stylet of Lacey in order to facilitate insertion of the insertion tool into the patient's body (Lacey, ¶46), where movement of the actuator handle along the actuator slit causes a corresponding movement of the stylet (Lacey, ¶6).
Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12654002 in view of Zarembo and Heptke.
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo and Heptke as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12654002
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Heptke
15
Heptke teaches wherein the stylet comprises multiple stylets (¶28-although omitted for conciseness, the preferred embodiments include every combination and permutation of the various carriers 10, the various electrical subsystems, the various connectors, the various stylets, and the various methods of use; ¶10-the implantable device is preferably designed to be implanted into the brain, spinal cord, peripheral nerve, muscle, or any other suitable anatomical location). 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 invention of the US Patent to include wherein the stylet comprises multiple stylets of Heptke in order to penetrate the tissue or other material and/or functions to provide structural support to the device during implantation of the device (Heptke, ¶26).
Claims 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12654002 in view of Zarembo and Dearden (US 20220062629).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo and Dearden as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12654002
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Foster (US 20220370793)
Secondary Reference Dearden (US 20220062629)
16
1, 7
Dearden teaches wherein the cuff body defines a length, a length direction, a width in the unfurled state that is greater than the length, and a width direction (Dearden, ¶6-the cuff body…being movable to an unfurled state and defining a length and a width in the unfurled state that is greater than the length, first and second relatively wide electrically conductive contacts carried by the cuff body that are spaced from one another in the length direction and that extend in the width direction); and the electrically conductive contacts comprise relatively long contacts that are spaced from one another in the width direction (Dearden, ¶6-electrically conductive contacts carried by the cuff body that are spaced from one another in the width direction; ¶47; Figs. 5-6). 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 invention of the US Patent to include wherein the cuff body defines a length, a length direction, a width in the unfurled state that is greater than the length, and a width direction; and the electrically conductive contacts comprise relatively long contacts that are spaced from one another in the width direction of Dearden in order to treat obstructive sleep apnea (Dearden, ¶2).
17
1, 7
Dearden teaches wherein the cuff body defines a length, a length direction, a width in the unfurled state that is greater than the length, and a width direction (Dearden, ¶6-the cuff body…being movable to an unfurled state and defining a length and a width in the unfurled state that is greater than the length, first and second relatively wide electrically conductive contacts carried by the cuff body that are spaced from one another in the length direction and that extend in the width direction); and the electrically conductive contacts comprise first and second relatively wide electrically conductive contacts that are spaced from one another in the length direction and extend in the width direction to such an extent that they extend completely around the cuff body inner lumen when the cuff body is in the pre-set furled shape (Dearden, ¶6-first and second relatively wide electrically conductive contacts carried by the cuff body that are spaced from one another in the length direction and that extend in the width direction to such an extent that they extend completely around the cuff body inner lumen when the cuff body is in the pre-set furled shape) and a plurality of relatively narrow electrically conductive contacts that are spaced from one another in the width direction and are located between the first and second relatively wide electrically conductive contacts (Dearden, ¶6-a plurality of relatively narrow electrically conductive contacts carried by the cuff body that are spaced from one another in the width direction and are located between the first and second relatively wide electrically conductive contacts). 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 invention of the US Patent to include wherein the cuff body defines a length, a length direction, a width in the unfurled state that is greater than the length, and a width direction; and the electrically conductive contacts comprise first and second relatively wide electrically conductive contacts that are spaced from one another in the length direction and extend in the width direction to such an extent that they extend completely around the cuff body inner lumen when the cuff body is in the pre-set furled shape and a plurality of relatively narrow electrically conductive contacts that are spaced from one another in the width direction and are located between the first and second relatively wide electrically conductive contacts of Dearden in order to treat obstructive sleep apnea (Dearden, ¶2).
Claims 1-2, 5, 8-9, and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 12350489 in view of Zarembo (US 20140188202).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12350489
Secondary Reference Zarembo (US 20140188202)
1
1
Zarembo teaches a nerve cuff straightener (¶59-stiffener 1272; ¶33-a stiffener with a cuff; Figs. 12-14); and is configured to receive a portion of the nerve cuff straightener (¶60-the stiffener 1272 can extend laterally across the cuff 1208. The stiffener 1272 can extend over the entire width of the cuff 1208, the stiffener 1272 can additionally or alternatively be…embedded in the main body 1270; Figs. 12-14), wherein, when inserted into the nerve cuff, the portion of the nerve cuff straightener received by the nerve cuff moves the nerve cuff out of the pre-set furled state (¶33-use of a stiffener with a cuff; ¶59-pre-stressing of the materials of the main body 1270 can cause the edges 1274, 1276 of the cuff 1208 to curl inward as a sub-wrap. Stiffener 1272 (shown in FIGS. 12 and 14) can be provided along the outer tab 1236 to inhibit the edges 1274, 1276 from curling inward; ¶60-the stiffener 1272 can additionally or alternatively be…embedded in the main body 1270; Figs. 12-14; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). 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 invention of the US Patent to include a nerve cuff straightener; and is configured to receive a portion of the nerve cuff straightener, wherein, when inserted into the nerve cuff, the portion of the nerve cuff straightener received by the nerve cuff moves the nerve cuff out of the pre-set furled state of Zarembo in order to inhibit the edges of the cuff from curling inward (Zarembo, ¶59).
2
Zarembo teaches wherein the nerve cuff includes a tubular member that is configured to receive the portion of the nerve cuff straightener (Zarembo, ¶45-the first tubular member 146 can be encircled within the cuff 108; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). 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 invention of the US Patent to include wherein the nerve cuff includes a tubular member that is configured to receive the portion of the nerve cuff straightener of Zarembo in order to pull the first tubular member to uncurl the cuff (Zarembo, ¶4).
5
Zarembo teaches wherein the elongate lead body (Zarembo, ¶43-lead body 122) is configured to facilitate passage of the portion of the nerve cuff straightener (Zarembo, ¶59-stiffener 1272; ¶33-a stiffener with a cuff; Figs. 12-14) that is inserted into the nerve cuff from the proximal end of the lead body to nerve cuff (Zarembo, ¶38-cuff 108 wrapped around the nerve 104; ¶43-the lead body 122 can be attached to the cuff 108; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). 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 invention of the US Patent to include wherein the elongate lead body is configured to facilitate passage of the portion of the nerve cuff straightener that is inserted into the nerve cuff from the proximal end of the lead body to nerve cuff of Zarembo in order to inhibit the edges of the cuff from curling inward (Zarembo, ¶59).
8
Zarembo teaches wherein when inserted into the nerve cuff (Zarembo, ¶38- cuff 108 wrapped around the nerve 104; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)), the portion of the nerve cuff straightener (Zarembo, ¶59-stiffener 1272; ¶33-a stiffener with a cuff; Figs. 12-14); moves the nerve cuff out of the pre-set furled state to an at least substantially straightened state (Zarembo, ¶4-pull the first tubular member to uncurl the cuff; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). 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 invention of the US Patent to include wherein when inserted into the nerve cuff, the portion of the nerve cuff straightener moves the nerve cuff out of the pre-set furled state to an at least substantially straightened state of Zarembo in order to inhibit the edges of the cuff from curling inward (Zarembo, ¶59).
9
Zarembo teaches wherein when inserted into the nerve cuff (Zarembo, ¶38- cuff 108 wrapped around the nerve 104; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)), the portion of the nerve cuff straightener (Zarembo, ¶59-stiffener 1272; ¶33-a stiffener with a cuff; Figs. 12-14) moves the nerve cuff out of the pre-set furled state to a curved shape (Zarembo, ¶50-release the first elongate element 154 and allow the cuff 108 to curl around the nerve 104; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). 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 invention of the US Patent to include wherein when inserted into the nerve cuff, the portion of the nerve cuff straightener moves the nerve cuff out of the pre-set furled state to a curved shape of Zarembo in order to inhibit the edges of the cuff from curling inward (Zarembo, ¶59).
17
1
Claims 3-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 12350489 in view of Zarembo and Schmidt (US 20180117313).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo and Schmidt as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12350489
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Schmidt (US 20180117313)
3
Schmidt teaches a port on the cuff body (Fig. 20-first enlarged cuff substrate 46a with a second elongated lead substrate portion 38b with a connection port on the left; ¶106) configured to facilitate passage of the portion of the nerve cuff straightener into the cuff body (Fig. 20; ¶106; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). 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 invention of Dearden to include a port on the cuff body configured to facilitate passage of the portion of the nerve cuff straightener into the cuff body of the US Patent in order to expose portions of the electrically conductive traces to form four connector pads and four additional electrode pads (Schmidt, ¶107), and stimulate nerves (Schmidt, ¶2).
4
Schmidt teaches wherein the port is offset from the elongate lead body (Schmidt, Fig. 20-first enlarged cuff substrate portion 46a has a second elongated lead substrate portion 38b with a connection port on the left that is offset from the first elongated lead substrate portion on the right; ¶106). 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 invention of Dearden to include wherein the port is offset from the elongate lead body of the US Patent in order to expose portions of the electrically conductive traces to form four connector pads and four additional electrode pads (Schmidt, ¶107), and stimulate nerves (Schmidt, ¶2).
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 12350489 in view of Zarembo and Malinowski (US 20160059019).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo and Malinowski as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12350489
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Malinowski (US 20160059019)
6
Malinowski teaches wherein the elongate lead body includes an internal lumen (¶5-connector-contact assemblies are disposed in the connector lumen and are each configured and arranged to couple to a terminal of the lead or lead extension; ¶63-the conductive wires may be embedded in the non-conductive material of the lead or can be disposed in one or more lumens (not shown) extending along the lead; ¶100-lead lumen); and a lead connector, including an internal lumen, is on the proximal end of the elongate lead body (¶5-a connector lumen is defined in the connector housing and is configured and arranged for receiving a proximal portion of a lead or lead extension). 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 invention of the US Patent to include wherein the elongate lead body includes an internal lumen; and a lead connector, including an internal lumen, is on the proximal end of the elongate lead body of Malinowski in order to provide stimulation to nerves (Malinowski, ¶57; ¶130).
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 12350489 in view of Zarembo and Bolea (US 20080103545).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo and Bolea as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12350489
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Bolea (US 20080103545)
7
Bolea teaches wherein the tubular member extends through the elongate lead body (¶60-the lead body 62 may comprise a tubular jacket with electrical conductors 68 extending therein; ¶61-the tubular jacket of lead body 62). 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 invention of the US Patent to include wherein the tubular member extends through the elongate lead body of Bolea in order to improve durability (Bolea, ¶60) and for treating obstructive sleep apnea (Bolea, ¶2).
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 12350489 in view of Zarembo and Foster (US 20220370793).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo and Foster as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12350489
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Foster (US 20220370793)
10
Foster teaches wherein the nerve cuff straightener includes a stylet (¶36-there may also be one or more lumens (not shown) that open at, or near, the proximal end of the lead body 106, for example, for inserting a stylet to facilitate placement of the lead body 106 within a body of a patient; ¶37-part of the lead body 106, coupled to cuff 150); and the portion of the nerve cuff straightener that is inserted into the nerve cuff comprises a portion of the stylet (MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987); Fig. 1; ¶36-37). 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 invention of the US Patent to include wherein the nerve cuff straightener includes a stylet; and the portion of the nerve cuff straightener that is inserted into the nerve cuff comprises a portion of the stylet of Foster in order to facilitate placement of the lead body (Foster, ¶36).
Claims 11 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 12350489 in view of Zarembo, Foster, and Heptke (US 20090132042).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo, Foster, and Heptke as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12350489
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Foster (US 20220370793)
Secondary Reference Heptke (US 20090132042)
11
Heptke teaches wherein the stylet includes a first region with first straightening characteristics (¶26-the stylet 16 is preferably made from a stiff material such as metal, but may alternatively be made from any suitable material) and a second region with second straightening characteristics that are different than the first straightening characteristics (¶26-the stylet 16 may include a sharpened end adapted to penetrate the tissue and aid in the insertion of the stylet). 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 invention of the US Patent to include wherein the stylet includes a first region with first straightening characteristics and a second region with second straightening characteristics that are different than the first straightening characteristics of Heptke in order to penetrate the tissue or other material and/or functions to provide structural support to the device during implantation of the device (Heptke, ¶26).
13
Heptke teaches wherein the stylet is malleable (¶26-the stylet 16 is preferably made from a stiff material such as metal). 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 invention of the US Patent to include wherein the stylet is malleable of Heptke in order to penetrate the tissue or other material, function to provide structural support to the device during implantation of the device, and be stiff (Heptke, ¶26).
Claims 12 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 12350489 in view of Zarembo, Foster, and Lacey (US 20140171961).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo, Foster, and Lacey as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12350489
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Foster (US 20220370793)
Secondary Reference Lacey (US 20140171961)
12
Lacey teaches wherein the stylet defines a longitudinal axis and one or more cross-sections in directions perpendicular to the longitudinal axis with shapes selected from group consisting of a flat ribbon-like shape, a rectangular shape, a rounded rectangular shapes), and an oval shape (Fig. 10-stylet 1030 has a longitudinal axis; ¶84-the first end portion 1032 of the stylet 1030 has a cross-sectional profile, the first end portion 1032 may have a rectangular cross-section). 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 invention of the US Patent to include wherein the stylet defines a longitudinal axis and one or more cross-sections in directions perpendicular to the longitudinal axis with shapes selected from group consisting of a flat ribbon-like shape, a rectangular shape, a rounded rectangular shapes), and an oval shape of Lacey in order to facilitate insertion of the insertion tool into the patient's body (Lacey, ¶46) and/or facilitate rotation of the stylet (Lacey, ¶54).
14
Lacey teaches wherein the stylet defines a distal end and a proximal end (¶6-the stylet has a first end portion and an opposing second end portion, where the first end portion is the distal end and the opposing second end portion is the proximal end); and the nerve cuff straightener includes a handle at the proximal end of the stylet (¶6-the actuator handle to the second end portion of the stylet). 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 invention of the US Patent to include wherein the stylet defines a distal end and a proximal end; and the nerve cuff straightener includes a handle at the proximal end of the stylet of Lacey in order to facilitate insertion of the insertion tool into the patient's body (Lacey, ¶46), where movement of the actuator handle along the actuator slit causes a corresponding movement of the stylet (Lacey, ¶6).
Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 12350489 in view of Zarembo and Heptke.
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo and Heptke as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12350489
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Heptke
15
Heptke teaches wherein the stylet comprises multiple stylets (¶28-although omitted for conciseness, the preferred embodiments include every combination and permutation of the various carriers 10, the various electrical subsystems, the various connectors, the various stylets, and the various methods of use; ¶10-the implantable device is preferably designed to be implanted into the brain, spinal cord, peripheral nerve, muscle, or any other suitable anatomical location). 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 invention of the US Patent to include wherein the stylet comprises multiple stylets of Heptke in order to penetrate the tissue or other material and/or functions to provide structural support to the device during implantation of the device (Heptke, ¶26).
Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 12350489 in view of Zarembo and Dearden (US 20220062629).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo and Dearden as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12350489
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Dearden (US 20220062629)
16
1
Dearden teaches the electrically conductive contacts comprise relatively long contacts that are spaced from one another in the width direction (Dearden, ¶6-electrically conductive contacts carried by the cuff body that are spaced from one another in the width direction; ¶47; Figs. 5-6). 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 invention of the US Patent to include the electrically conductive contacts comprise relatively long contacts that are spaced from one another in the width direction of Dearden in order to treat obstructive sleep apnea (Dearden, ¶2).
Claims 1-2, 5, and 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12296172 in view of Zarembo (US 20140188202).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12296172
Secondary Reference Zarembo (US 20140188202)
1
1
Zarembo teaches a nerve cuff straightener (¶59-stiffener 1272; ¶33-a stiffener with a cuff; Figs. 12-14); and is configured to receive a portion of the nerve cuff straightener (¶60-the stiffener 1272 can extend laterally across the cuff 1208. The stiffener 1272 can extend over the entire width of the cuff 1208, the stiffener 1272 can additionally or alternatively be…embedded in the main body 1270; Figs. 12-14), wherein, when inserted into the nerve cuff, the portion of the nerve cuff straightener received by the nerve cuff moves the nerve cuff out of the pre-set furled state (¶33-use of a stiffener with a cuff; ¶59-pre-stressing of the materials of the main body 1270 can cause the edges 1274, 1276 of the cuff 1208 to curl inward as a sub-wrap. Stiffener 1272 (shown in FIGS. 12 and 14) can be provided along the outer tab 1236 to inhibit the edges 1274, 1276 from curling inward; ¶60-the stiffener 1272 can additionally or alternatively be…embedded in the main body 1270; Figs. 12-14; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). 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 invention of the US Patent to include a nerve cuff straightener; and is configured to receive a portion of the nerve cuff straightener, wherein, when inserted into the nerve cuff, the portion of the nerve cuff straightener received by the nerve cuff moves the nerve cuff out of the pre-set furled state of Zarembo in order to inhibit the edges of the cuff from curling inward (Zarembo, ¶59).
2
Zarembo teaches wherein the nerve cuff includes a tubular member that is configured to receive the portion of the nerve cuff straightener (Zarembo, ¶45-the first tubular member 146 can be encircled within the cuff 108; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). 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 invention of the US Patent to include wherein the nerve cuff includes a tubular member that is configured to receive the portion of the nerve cuff straightener of Zarembo in order to pull the first tubular member to uncurl the cuff (Zarembo, ¶4).
5
Zarembo teaches wherein the elongate lead body (Zarembo, ¶43-lead body 122) is configured to facilitate passage of the portion of the nerve cuff straightener (Zarembo, ¶59-stiffener 1272; ¶33-a stiffener with a cuff; Figs. 12-14) that is inserted into the nerve cuff from the proximal end of the lead body to nerve cuff (Zarembo, ¶38-cuff 108 wrapped around the nerve 104; ¶43-the lead body 122 can be attached to the cuff 108; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). 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 invention of the US Patent to include wherein the elongate lead body is configured to facilitate passage of the portion of the nerve cuff straightener that is inserted into the nerve cuff from the proximal end of the lead body to nerve cuff of Zarembo in order to inhibit the edges of the cuff from curling inward (Zarembo, ¶59).
8
Zarembo teaches wherein when inserted into the nerve cuff (Zarembo, ¶38- cuff 108 wrapped around the nerve 104; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)), the portion of the nerve cuff straightener (Zarembo, ¶59-stiffener 1272; ¶33-a stiffener with a cuff; Figs. 12-14); moves the nerve cuff out of the pre-set furled state to an at least substantially straightened state (Zarembo, ¶4-pull the first tubular member to uncurl the cuff; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). 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 invention of the US Patent to include wherein when inserted into the nerve cuff, the portion of the nerve cuff straightener moves the nerve cuff out of the pre-set furled state to an at least substantially straightened state of Zarembo in order to inhibit the edges of the cuff from curling inward (Zarembo, ¶59).
9
Zarembo teaches wherein when inserted into the nerve cuff (Zarembo, ¶38- cuff 108 wrapped around the nerve 104; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)), the portion of the nerve cuff straightener (Zarembo, ¶59-stiffener 1272; ¶33-a stiffener with a cuff; Figs. 12-14) moves the nerve cuff out of the pre-set furled state to a curved shape (Zarembo, ¶50-release the first elongate element 154 and allow the cuff 108 to curl around the nerve 104; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). 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 invention of the US Patent to include wherein when inserted into the nerve cuff, the portion of the nerve cuff straightener moves the nerve cuff out of the pre-set furled state to a curved shape of Zarembo in order to inhibit the edges of the cuff from curling inward (Zarembo, ¶59).
Claims 3-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12296172 in view of Zarembo and Schmidt (US 20180117313).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo and Schmidt as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12296172
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Schmidt (US 20180117313)
3
Schmidt teaches a port on the cuff body (Fig. 20-first enlarged cuff substrate 46a with a second elongated lead substrate portion 38b with a connection port on the left; ¶106) configured to facilitate passage of the portion of the nerve cuff straightener into the cuff body (Fig. 20; ¶106; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). 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 invention of Dearden to include a port on the cuff body configured to facilitate passage of the portion of the nerve cuff straightener into the cuff body of the US Patent in order to expose portions of the electrically conductive traces to form four connector pads and four additional electrode pads (Schmidt, ¶107), and stimulate nerves (Schmidt, ¶2).
4
Schmidt teaches wherein the port is offset from the elongate lead body (Schmidt, Fig. 20-first enlarged cuff substrate portion 46a has a second elongated lead substrate portion 38b with a connection port on the left that is offset from the first elongated lead substrate portion on the right; ¶106). 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 invention of Dearden to include wherein the port is offset from the elongate lead body of the US Patent in order to expose portions of the electrically conductive traces to form four connector pads and four additional electrode pads (Schmidt, ¶107), and stimulate nerves (Schmidt, ¶2).
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12296172 in view of Zarembo and Malinowski (US 20160059019).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo and Malinowski as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12296172
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Malinowski (US 20160059019)
6
Zarembo teaches configured to facilitate passage of the portion of the nerve cuff straightener (Zarembo, ¶59-stiffener 1272; ¶33-a stiffener with a cuff; Figs. 12-14) that is inserted into the nerve cuff ( Zarembo, ¶38-cuff 108 wrapped around the nerve 104; ¶43-the lead body 122 can be attached to the cuff 108; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). 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 invention of the US Patent to include being configured to facilitate passage of the portion of the nerve cuff straightener that is inserted into the nerve cuff of Zarembo in order to inhibit the edges of the cuff from curling inward (Zarembo, ¶59).
Malinowski teaches wherein the elongate lead body includes an internal lumen (¶5-connector-contact assemblies are disposed in the connector lumen and are each configured and arranged to couple to a terminal of the lead or lead extension; ¶63-the conductive wires may be embedded in the non-conductive material of the lead or can be disposed in one or more lumens (not shown) extending along the lead; ¶100-lead lumen); and a lead connector, including an internal lumen, is on the proximal end of the elongate lead body (¶5-a connector lumen is defined in the connector housing and is configured and arranged for receiving a proximal portion of a lead or lead extension). 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 invention of the US Patent to include wherein the elongate lead body includes an internal lumen; and a lead connector, including an internal lumen, is on the proximal end of the elongate lead body of Malinowski in order to provide stimulation to nerves (Malinowski, ¶57; ¶130).
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12296172 in view of Zarembo and Bolea (US 20080103545).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo and Bolea as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12296172
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Bolea (US 20080103545)
7
Bolea teaches wherein the tubular member extends through the elongate lead body (¶60-the lead body 62 may comprise a tubular jacket with electrical conductors 68 extending therein; ¶61-the tubular jacket of lead body 62). 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 invention of the US Patent to include wherein the tubular member extends through the elongate lead body of Bolea in order to improve durability (Bolea, ¶60) and for treating obstructive sleep apnea (Bolea, ¶2).
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12296172 in view of Zarembo and Foster (US 20220370793).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo and Foster as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12296172
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Foster (US 20220370793)
10
Foster teaches wherein the nerve cuff straightener includes a stylet (¶36-there may also be one or more lumens (not shown) that open at, or near, the proximal end of the lead body 106, for example, for inserting a stylet to facilitate placement of the lead body 106 within a body of a patient; ¶37-part of the lead body 106, coupled to cuff 150); and the portion of the nerve cuff straightener that is inserted into the nerve cuff comprises a portion of the stylet (MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987); Fig. 1; ¶36-37). 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 invention of the US Patent to include wherein the nerve cuff straightener includes a stylet; and the portion of the nerve cuff straightener that is inserted into the nerve cuff comprises a portion of the stylet of Foster in order to facilitate placement of the lead body (Foster, ¶36).
Claims 11 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12296172 in view of Zarembo, Foster, and Heptke.
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo, Foster, and Heptke as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12296172
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Foster (US 20220370793)
Secondary Reference Heptke (US 20090132042)
11
Heptke teaches wherein the stylet includes a first region with first straightening characteristics (¶26-the stylet 16 is preferably made from a stiff material such as metal, but may alternatively be made from any suitable material) and a second region with second straightening characteristics that are different than the first straightening characteristics (¶26-the stylet 16 may include a sharpened end adapted to penetrate the tissue and aid in the insertion of the stylet). 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 invention of the US Patent to include wherein the stylet includes a first region with first straightening characteristics and a second region with second straightening characteristics that are different than the first straightening characteristics of Heptke in order to penetrate the tissue or other material and/or functions to provide structural support to the device during implantation of the device (Heptke, ¶26).
13
Heptke teaches wherein the stylet is malleable (¶26-the stylet 16 is preferably made from a stiff material such as metal). 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 invention of the US Patent to include wherein the stylet is malleable of Heptke in order to penetrate the tissue or other material, function to provide structural support to the device during implantation of the device, and be stiff (Heptke, ¶26).
Claims 12 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12296172 in view of Zarembo, Foster, and Lacey (US 20140171961).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo, Foster, and Lacey as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12296172
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Foster (US 20220370793)
Secondary Reference Lacey (US 20140171961)
12
Lacey teaches wherein the stylet defines a longitudinal axis and one or more cross-sections in directions perpendicular to the longitudinal axis with shapes selected from group consisting of a flat ribbon-like shape, a rectangular shape, a rounded rectangular shapes), and an oval shape (Fig. 10-stylet 1030 has a longitudinal axis; ¶84-the first end portion 1032 of the stylet 1030 has a cross-sectional profile, the first end portion 1032 may have a rectangular cross-section). 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 invention of the US Patent to include wherein the stylet defines a longitudinal axis and one or more cross-sections in directions perpendicular to the longitudinal axis with shapes selected from group consisting of a flat ribbon-like shape, a rectangular shape, a rounded rectangular shapes), and an oval shape of Lacey in order to facilitate insertion of the insertion tool into the patient's body (Lacey, ¶46) and/or facilitate rotation of the stylet (Lacey, ¶54).
14
Lacey teaches wherein the stylet defines a distal end and a proximal end (¶6-the stylet has a first end portion and an opposing second end portion, where the first end portion is the distal end and the opposing second end portion is the proximal end); and the nerve cuff straightener includes a handle at the proximal end of the stylet (¶6-the actuator handle to the second end portion of the stylet). 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 invention of the US Patent to include wherein the stylet defines a distal end and a proximal end; and the nerve cuff straightener includes a handle at the proximal end of the stylet of Lacey in order to facilitate insertion of the insertion tool into the patient's body (Lacey, ¶46), where movement of the actuator handle along the actuator slit causes a corresponding movement of the stylet (Lacey, ¶6).
Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12296172 in view of Zarembo and Heptke.
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo and Heptke as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12296172
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Heptke
15
Heptke teaches wherein the stylet comprises multiple stylets (¶28-although omitted for conciseness, the preferred embodiments include every combination and permutation of the various carriers 10, the various electrical subsystems, the various connectors, the various stylets, and the various methods of use; ¶10-the implantable device is preferably designed to be implanted into the brain, spinal cord, peripheral nerve, muscle, or any other suitable anatomical location). 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 invention of the US Patent to include wherein the stylet comprises multiple stylets of Heptke in order to penetrate the tissue or other material and/or functions to provide structural support to the device during implantation of the device (Heptke, ¶26).
Claims 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12296172 in view of Zarembo and Dearden (US 20220062629).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo and Dearden as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12296172
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Dearden (US 20220062629)
16
Dearden teaches the electrically conductive contacts comprise relatively long contacts that are spaced from one another in the width direction (Dearden, ¶6-electrically conductive contacts carried by the cuff body that are spaced from one another in the width direction; ¶47; Figs. 5-6). 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 invention of the US Patent to include the electrically conductive contacts comprise relatively long contacts that are spaced from one another in the width direction of Dearden in order to treat obstructive sleep apnea (Dearden, ¶2).
17
Dearden teaches extend in the width direction to such an extent that they extend completely around the cuff body inner lumen when the cuff body is in the pre-set furled shape (Dearden, ¶6-first and second relatively wide electrically conductive contacts carried by the cuff body that are spaced from one another in the length direction and that extend in the width direction to such an extent that they extend completely around the cuff body inner lumen when the cuff body is in the pre-set furled shape) and a plurality of relatively narrow electrically conductive contacts that are spaced from one another in the width direction (Dearden, ¶6-a plurality of relatively narrow electrically conductive contacts carried by the cuff body that are spaced from one another in the width direction and are located between the first and second relatively wide electrically conductive contacts). 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 invention of the US Patent to include extending in the width direction to such an extent that they extend completely around the cuff body inner lumen when the cuff body is in the pre-set furled shape and a plurality of relatively narrow electrically conductive contacts that are spaced from one another in the width direction of Dearden in order to treat obstructive sleep apnea (Dearden, ¶2).
Claims 1-2, 5, and 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12194290 in view of Zarembo (US 20140188202).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12194290
Secondary Reference Zarembo (US 20140188202)
1
1
Zarembo teaches is configured to receive a portion of the nerve cuff straightener (¶60-the stiffener 1272 can extend laterally across the cuff 1208. The stiffener 1272 can extend over the entire width of the cuff 1208, the stiffener 1272 can additionally or alternatively be…embedded in the main body 1270; Figs. 12-14), wherein, when inserted into the nerve cuff, the portion of the nerve cuff straightener received by the nerve cuff moves the nerve cuff out of the pre-set furled state (¶33-use of a stiffener with a cuff; ¶59-pre-stressing of the materials of the main body 1270 can cause the edges 1274, 1276 of the cuff 1208 to curl inward as a sub-wrap. Stiffener 1272 (shown in FIGS. 12 and 14) can be provided along the outer tab 1236 to inhibit the edges 1274, 1276 from curling inward; ¶60-the stiffener 1272 can additionally or alternatively be…embedded in the main body 1270; Figs. 12-14; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). 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 invention of the US Patent to include is configured to receive a portion of the nerve cuff straightener, wherein, when inserted into the nerve cuff, the portion of the nerve cuff straightener received by the nerve cuff moves the nerve cuff out of the pre-set furled state of Zarembo in order to inhibit the edges of the cuff from curling inward (Zarembo, ¶59).
2
Zarembo teaches wherein the nerve cuff includes a tubular member that is configured to receive the portion of the nerve cuff straightener (Zarembo, ¶45-the first tubular member 146 can be encircled within the cuff 108; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). 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 invention of the US Patent to include wherein the nerve cuff includes a tubular member that is configured to receive the portion of the nerve cuff straightener of Zarembo in order to pull the first tubular member to uncurl the cuff (Zarembo, ¶4).
5
Zarembo teaches wherein the elongate lead body (Zarembo, ¶43-lead body 122) is configured to facilitate passage of the portion of the nerve cuff straightener (Zarembo, ¶59-stiffener 1272; ¶33-a stiffener with a cuff; Figs. 12-14) that is inserted into the nerve cuff from the proximal end of the lead body to nerve cuff (Zarembo, ¶38-cuff 108 wrapped around the nerve 104; ¶43-the lead body 122 can be attached to the cuff 108; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). 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 invention of the US Patent to include wherein the elongate lead body is configured to facilitate passage of the portion of the nerve cuff straightener that is inserted into the nerve cuff from the proximal end of the lead body to nerve cuff of Zarembo in order to inhibit the edges of the cuff from curling inward (Zarembo, ¶59).
8
Zarembo teaches wherein when inserted into the nerve cuff (Zarembo, ¶38- cuff 108 wrapped around the nerve 104; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)), the portion of the nerve cuff straightener (Zarembo, ¶59-stiffener 1272; ¶33-a stiffener with a cuff; Figs. 12-14); moves the nerve cuff out of the pre-set furled state to an at least substantially straightened state (Zarembo, ¶4-pull the first tubular member to uncurl the cuff; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). 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 invention of the US Patent to include wherein when inserted into the nerve cuff, the portion of the nerve cuff straightener moves the nerve cuff out of the pre-set furled state to an at least substantially straightened state of Zarembo in order to inhibit the edges of the cuff from curling inward (Zarembo, ¶59).
9
Zarembo teaches wherein when inserted into the nerve cuff (Zarembo, ¶38- cuff 108 wrapped around the nerve 104; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)), the portion of the nerve cuff straightener (Zarembo, ¶59-stiffener 1272; ¶33-a stiffener with a cuff; Figs. 12-14) moves the nerve cuff out of the pre-set furled state to a curved shape (Zarembo, ¶50-release the first elongate element 154 and allow the cuff 108 to curl around the nerve 104; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). 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 invention of the US Patent to include wherein when inserted into the nerve cuff, the portion of the nerve cuff straightener moves the nerve cuff out of the pre-set furled state to a curved shape of Zarembo in order to inhibit the edges of the cuff from curling inward (Zarembo, ¶59).
Claims 3-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12194290 in view of Zarembo and Schmidt (US 20180117313).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo and Schmidt as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12194290
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Schmidt (US 20180117313)
3
Schmidt teaches a port on the cuff body (Fig. 20-first enlarged cuff substrate 46a with a second elongated lead substrate portion 38b with a connection port on the left; ¶106) configured to facilitate passage of the portion of the nerve cuff straightener into the cuff body (Fig. 20; ¶106; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). 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 invention of Dearden to include a port on the cuff body configured to facilitate passage of the portion of the nerve cuff straightener into the cuff body of the US Patent in order to expose portions of the electrically conductive traces to form four connector pads and four additional electrode pads (Schmidt, ¶107), and stimulate nerves (Schmidt, ¶2).
4
Schmidt teaches wherein the port is offset from the elongate lead body (Schmidt, Fig. 20-first enlarged cuff substrate portion 46a has a second elongated lead substrate portion 38b with a connection port on the left that is offset from the first elongated lead substrate portion on the right; ¶106). 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 invention of Dearden to include wherein the port is offset from the elongate lead body of the US Patent in order to expose portions of the electrically conductive traces to form four connector pads and four additional electrode pads (Schmidt, ¶107), and stimulate nerves (Schmidt, ¶2).
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12194290 in view of Zarembo and Malinowski (US 20160059019).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo and Malinowski as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12194290
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Malinowski (US 20160059019)
6
Zarembo teaches configured to facilitate passage of the portion of the nerve cuff straightener (Zarembo, ¶59-stiffener 1272; ¶33-a stiffener with a cuff; Figs. 12-14) that is inserted into the nerve cuff ( Zarembo, ¶38-cuff 108 wrapped around the nerve 104; ¶43-the lead body 122 can be attached to the cuff 108; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). 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 invention of the US Patent to include being configured to facilitate passage of the portion of the nerve cuff straightener that is inserted into the nerve cuff of Zarembo in order to inhibit the edges of the cuff from curling inward (Zarembo, ¶59).
Malinowski teaches wherein the elongate lead body includes an internal lumen (¶5-connector-contact assemblies are disposed in the connector lumen and are each configured and arranged to couple to a terminal of the lead or lead extension; ¶63-the conductive wires may be embedded in the non-conductive material of the lead or can be disposed in one or more lumens (not shown) extending along the lead; ¶100-lead lumen); and a lead connector, including an internal lumen, is on the proximal end of the elongate lead body (¶5-a connector lumen is defined in the connector housing and is configured and arranged for receiving a proximal portion of a lead or lead extension). 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 invention of the US Patent to include wherein the elongate lead body includes an internal lumen; and a lead connector, including an internal lumen, is on the proximal end of the elongate lead body of Malinowski in order to provide stimulation to nerves (Malinowski, ¶57; ¶130).
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12194290 in view of Zarembo and Bolea (US 20080103545).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo and Bolea as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12194290
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Bolea (US 20080103545)
7
Bolea teaches wherein the tubular member extends through the elongate lead body (¶60-the lead body 62 may comprise a tubular jacket with electrical conductors 68 extending therein; ¶61-the tubular jacket of lead body 62). 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 invention of the US Patent to include wherein the tubular member extends through the elongate lead body of Bolea in order to improve durability (Bolea, ¶60) and for treating obstructive sleep apnea (Bolea, ¶2).
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12194290 in view of Zarembo and Foster (US 20220370793).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo and Foster as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12194290
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Foster (US 20220370793)
10
Foster teaches wherein the nerve cuff straightener includes a stylet (¶36-there may also be one or more lumens (not shown) that open at, or near, the proximal end of the lead body 106, for example, for inserting a stylet to facilitate placement of the lead body 106 within a body of a patient; ¶37-part of the lead body 106, coupled to cuff 150); and the portion of the nerve cuff straightener that is inserted into the nerve cuff comprises a portion of the stylet (MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987); Fig. 1; ¶36-37). 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 invention of the US Patent to include wherein the nerve cuff straightener includes a stylet; and the portion of the nerve cuff straightener that is inserted into the nerve cuff comprises a portion of the stylet of Foster in order to facilitate placement of the lead body (Foster, ¶36).
Claims 11 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12194290 in view of Zarembo, Foster, and Heptke (US 20090132042).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo, Foster, and Heptke as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12194290
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Foster (US 20220370793)
Secondary Reference Heptke (US 20090132042)
11
Heptke teaches wherein the stylet includes a first region with first straightening characteristics (¶26-the stylet 16 is preferably made from a stiff material such as metal, but may alternatively be made from any suitable material) and a second region with second straightening characteristics that are different than the first straightening characteristics (¶26-the stylet 16 may include a sharpened end adapted to penetrate the tissue and aid in the insertion of the stylet). 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 invention of the US Patent to include wherein the stylet includes a first region with first straightening characteristics and a second region with second straightening characteristics that are different than the first straightening characteristics of Heptke in order to penetrate the tissue or other material and/or functions to provide structural support to the device during implantation of the device (Heptke, ¶26).
13
Heptke teaches wherein the stylet is malleable (¶26-the stylet 16 is preferably made from a stiff material such as metal). 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 invention of the US Patent to include wherein the stylet is malleable of Heptke in order to penetrate the tissue or other material, function to provide structural support to the device during implantation of the device, and be stiff (Heptke, ¶26).
Claims 12 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12194290 in view of Zarembo, Foster, and Lacey (US 20140171961).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo, Foster, and Lacey as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12194290
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Foster (US 20220370793)
Secondary Reference Lacey (US 20140171961)
12
Lacey teaches wherein the stylet defines a longitudinal axis and one or more cross-sections in directions perpendicular to the longitudinal axis with shapes selected from group consisting of a flat ribbon-like shape, a rectangular shape, a rounded rectangular shapes), and an oval shape (Fig. 10-stylet 1030 has a longitudinal axis; ¶84-the first end portion 1032 of the stylet 1030 has a cross-sectional profile, the first end portion 1032 may have a rectangular cross-section). 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 invention of the US Patent to include wherein the stylet defines a longitudinal axis and one or more cross-sections in directions perpendicular to the longitudinal axis with shapes selected from group consisting of a flat ribbon-like shape, a rectangular shape, a rounded rectangular shapes), and an oval shape of Lacey in order to facilitate insertion of the insertion tool into the patient's body (Lacey, ¶46) and/or facilitate rotation of the stylet (Lacey, ¶54).
14
Lacey teaches wherein the stylet defines a distal end and a proximal end (¶6-the stylet has a first end portion and an opposing second end portion, where the first end portion is the distal end and the opposing second end portion is the proximal end); and the nerve cuff straightener includes a handle at the proximal end of the stylet (¶6-the actuator handle to the second end portion of the stylet). 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 invention of the US Patent to include wherein the stylet defines a distal end and a proximal end; and the nerve cuff straightener includes a handle at the proximal end of the stylet of Lacey in order to facilitate insertion of the insertion tool into the patient's body (Lacey, ¶46), where movement of the actuator handle along the actuator slit causes a corresponding movement of the stylet (Lacey, ¶6).
Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12194290 in view of Zarembo and Heptke.
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo and Heptke as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12194290
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Heptke
15
Heptke teaches wherein the stylet comprises multiple stylets (¶28-although omitted for conciseness, the preferred embodiments include every combination and permutation of the various carriers 10, the various electrical subsystems, the various connectors, the various stylets, and the various methods of use; ¶10-the implantable device is preferably designed to be implanted into the brain, spinal cord, peripheral nerve, muscle, or any other suitable anatomical location). 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 invention of the US Patent to include wherein the stylet comprises multiple stylets of Heptke in order to penetrate the tissue or other material and/or functions to provide structural support to the device during implantation of the device (Heptke, ¶26).
Claims 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12194290 in view of Zarembo and Dearden (US 20220062629).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo and Dearden as shown below.
Claims of the Present Application (19/019360)
Claims of US Patent No. 12194290
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Dearden (US 20220062629)
16
1
Dearden teaches the electrically conductive contacts comprise relatively long contacts that are spaced from one another in the width direction (Dearden, ¶6-electrically conductive contacts carried by the cuff body that are spaced from one another in the width direction; ¶47; Figs. 5-6). 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 invention of the US Patent to include the electrically conductive contacts comprise relatively long contacts that are spaced from one another in the width direction of Dearden in order to treat obstructive sleep apnea (Dearden, ¶2).
17
1
Dearden teaches the electrically conductive contacts comprise first and second relatively wide electrically conductive contacts that are spaced from one another in the length direction and extend in the width direction to such an extent that they extend completely around the cuff body inner lumen when the cuff body is in the pre-set furled shape (Dearden, ¶6-first and second relatively wide electrically conductive contacts carried by the cuff body that are spaced from one another in the length direction and that extend in the width direction to such an extent that they extend completely around the cuff body inner lumen when the cuff body is in the pre-set furled shape) and a plurality of relatively narrow electrically conductive contacts that are spaced from one another in the width direction and are located between the first and second relatively wide electrically conductive contacts (Dearden, ¶6-a plurality of relatively narrow electrically conductive contacts carried by the cuff body that are spaced from one another in the width direction and are located between the first and second relatively wide electrically conductive contacts). 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 invention of the US Patent to include the electrically conductive contacts comprise first and second relatively wide electrically conductive contacts that are spaced from one another in the length direction and extend in the width direction to such an extent that they extend completely around the cuff body inner lumen when the cuff body is in the pre-set furled shape and a plurality of relatively narrow electrically conductive contacts that are spaced from one another in the width direction and are located between the first and second relatively wide electrically conductive contacts of Dearden in order to treat obstructive sleep apnea (Dearden, ¶2).
Claims 1-2, 5, 8-9, and 16-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 18/985448 in view of Dearden (US 20220062629) and Zarembo (US 20140188202).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Dearden and Zarembo as shown below.
Claims of the Present Application (19/019360)
Claims US 18/985448
Secondary Reference Dearden (US 20220062629)
Secondary Reference Zarembo (US 20140188202)
1
1, 2-4
Dearden teaches a nerve cuff, associated with the distal end of the lead body, including a biologically compatible, elastic, electrically insulative cuff body (¶6-the nerve cuff may include a biologically compatible, elastic, electrically insulative cuff body affixed to the distal end of the lead body, the cuff body being configured to be circumferentially disposed around a nerve, having a pre-set furled state that defines an inner lumen, and being movable to an unfurled state) and a plurality of electrically conductive contacts carried by the cuff body (¶6-electrically conductive contacts carried by the cuff body). 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 invention of the copending application to include a nerve cuff, associated with the distal end of the lead body, including a biologically compatible, elastic, electrically insulative cuff body and a plurality of electrically conductive contacts carried by the cuff body of Dearden in order to treat obstructive sleep apnea (Dearden, ¶2).
Zarembo teaches is configured to receive a portion of the nerve cuff straightener (¶60-the stiffener 1272 can extend laterally across the cuff 1208. The stiffener 1272 can extend over the entire width of the cuff 1208, the stiffener 1272 can additionally or alternatively be…embedded in the main body 1270; Figs. 12-14), wherein, when inserted into the nerve cuff, the portion of the nerve cuff straightener received by the nerve cuff moves the nerve cuff out of the pre-set furled state (¶33-use of a stiffener with a cuff; ¶59-pre-stressing of the materials of the main body 1270 can cause the edges 1274, 1276 of the cuff 1208 to curl inward as a sub-wrap. Stiffener 1272 (shown in FIGS. 12 and 14) can be provided along the outer tab 1236 to inhibit the edges 1274, 1276 from curling inward; ¶60-the stiffener 1272 can additionally or alternatively be…embedded in the main body 1270; Figs. 12-14; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). 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 invention of the copending application to include is configured to receive a portion of the nerve cuff straightener, wherein, when inserted into the nerve cuff, the portion of the nerve cuff straightener received by the nerve cuff moves the nerve cuff out of the pre-set furled state of Zarembo in order to inhibit the edges of the cuff from curling inward (Zarembo, ¶59).
2
Zarembo teaches wherein the nerve cuff includes a tubular member that is configured to receive the portion of the nerve cuff straightener (Zarembo, ¶45-the first tubular member 146 can be encircled within the cuff 108; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). 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 invention of the copending application to include wherein the nerve cuff includes a tubular member that is configured to receive the portion of the nerve cuff straightener of Zarembo in order to pull the first tubular member to uncurl the cuff (Zarembo, ¶4).
5
Zarembo teaches wherein the elongate lead body (Zarembo, ¶43-lead body 122) is configured to facilitate passage of the portion of the nerve cuff straightener (Zarembo, ¶59-stiffener 1272; ¶33-a stiffener with a cuff; Figs. 12-14) that is inserted into the nerve cuff from the proximal end of the lead body to nerve cuff (Zarembo, ¶38-cuff 108 wrapped around the nerve 104; ¶43-the lead body 122 can be attached to the cuff 108; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). 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 invention of the copending application to include wherein the elongate lead body is configured to facilitate passage of the portion of the nerve cuff straightener that is inserted into the nerve cuff from the proximal end of the lead body to nerve cuff of Zarembo in order to inhibit the edges of the cuff from curling inward (Zarembo, ¶59).
8
Zarembo teaches wherein when inserted into the nerve cuff (Zarembo, ¶38- cuff 108 wrapped around the nerve 104; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)), the portion of the nerve cuff straightener (Zarembo, ¶59-stiffener 1272; ¶33-a stiffener with a cuff; Figs. 12-14); moves the nerve cuff out of the pre-set furled state to an at least substantially straightened state (Zarembo, ¶4-pull the first tubular member to uncurl the cuff; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). 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 invention of the copending application to include wherein when inserted into the nerve cuff, the portion of the nerve cuff straightener moves the nerve cuff out of the pre-set furled state to an at least substantially straightened state of Zarembo in order to inhibit the edges of the cuff from curling inward (Zarembo, ¶59).
9
Zarembo teaches wherein when inserted into the nerve cuff (Zarembo, ¶38- cuff 108 wrapped around the nerve 104; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)), the portion of the nerve cuff straightener (Zarembo, ¶59-stiffener 1272; ¶33-a stiffener with a cuff; Figs. 12-14) moves the nerve cuff out of the pre-set furled state to a curved shape (Zarembo, ¶50-release the first elongate element 154 and allow the cuff 108 to curl around the nerve 104; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). 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 invention of the copending application to include wherein when inserted into the nerve cuff, the portion of the nerve cuff straightener moves the nerve cuff out of the pre-set furled state to a curved shape of Zarembo in order to inhibit the edges of the cuff from curling inward (Zarembo, ¶59).
16
Dearden teaches wherein the cuff body defines a length, a length direction, a width in the unfurled state that is greater than the length, and a width direction (Dearden, ¶6-the cuff body…being movable to an unfurled state and defining a length and a width in the unfurled state that is greater than the length, first and second relatively wide electrically conductive contacts carried by the cuff body that are spaced from one another in the length direction and that extend in the width direction); and the electrically conductive contacts comprise relatively long contacts that are spaced from one another in the width direction (Dearden, ¶6-electrically conductive contacts carried by the cuff body that are spaced from one another in the width direction; ¶47; Figs. 5-6). 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 invention of the copending application to include wherein the cuff body defines a length, a length direction, a width in the unfurled state that is greater than the length, and a width direction; and the electrically conductive contacts comprise relatively long contacts that are spaced from one another in the width direction of Dearden in order to treat obstructive sleep apnea (Dearden, ¶2).
17
Dearden teaches wherein the cuff body defines a length, a length direction, a width in the unfurled state that is greater than the length, and a width direction (Dearden, ¶6-the cuff body…being movable to an unfurled state and defining a length and a width in the unfurled state that is greater than the length, first and second relatively wide electrically conductive contacts carried by the cuff body that are spaced from one another in the length direction and that extend in the width direction); and the electrically conductive contacts comprise first and second relatively wide electrically conductive contacts that are spaced from one another in the length direction and extend in the width direction to such an extent that they extend completely around the cuff body inner lumen when the cuff body is in the pre-set furled shape (Dearden, ¶6-first and second relatively wide electrically conductive contacts carried by the cuff body that are spaced from one another in the length direction and that extend in the width direction to such an extent that they extend completely around the cuff body inner lumen when the cuff body is in the pre-set furled shape) and a plurality of relatively narrow electrically conductive contacts that are spaced from one another in the width direction and are located between the first and second relatively wide electrically conductive contacts (Dearden, ¶6-a plurality of relatively narrow electrically conductive contacts carried by the cuff body that are spaced from one another in the width direction and are located between the first and second relatively wide electrically conductive contacts). 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 invention of the copending application to include wherein the cuff body defines a length, a length direction, a width in the unfurled state that is greater than the length, and a width direction; and the electrically conductive contacts comprise first and second relatively wide electrically conductive contacts that are spaced from one another in the length direction and extend in the width direction to such an extent that they extend completely around the cuff body inner lumen when the cuff body is in the pre-set furled shape and a plurality of relatively narrow electrically conductive contacts that are spaced from one another in the width direction and are located between the first and second relatively wide electrically conductive contacts of Dearden in order to treat obstructive sleep apnea (Dearden, ¶2).
Claims 3-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 18/985448 in view of Dearden, Zarembo, and Schmidt (US 20180117313).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Dearden, Zarembo, and Schmidt as shown below.
Claims of the Present Application (19/019360)
Claims US 18/985448
Secondary Reference Dearden (US 20220062629)
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Schmidt (US 20180117313)
3
Schmidt teaches a port on the cuff body (Fig. 20-first enlarged cuff substrate 46a with a second elongated lead substrate portion 38b with a connection port on the left; ¶106) configured to facilitate passage of the portion of the nerve cuff straightener into the cuff body (Fig. 20; ¶106; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). 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 invention of Dearden to include a port on the cuff body configured to facilitate passage of the portion of the nerve cuff straightener into the cuff body of the copending application in order to expose portions of the electrically conductive traces to form four connector pads and four additional electrode pads (Schmidt, ¶107), and stimulate nerves (Schmidt, ¶2).
4
Schmidt teaches wherein the port is offset from the elongate lead body (Schmidt, Fig. 20-first enlarged cuff substrate portion 46a has a second elongated lead substrate portion 38b with a connection port on the left that is offset from the first elongated lead substrate portion on the right; ¶106). 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 invention of Dearden to include wherein the port is offset from the elongate lead body of the copending application in order to expose portions of the electrically conductive traces to form four connector pads and four additional electrode pads (Schmidt, ¶107), and stimulate nerves (Schmidt, ¶2).
Claim 6 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 18/985448 in view of Dearden, Zarembo, and Malinowski (US 20160059019).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Dearden, Zarembo, and Maslinowski as shown below.
Claims of the Present Application (19/019360)
Claims US 18/985448
Secondary Reference Dearden (US 20220062629)
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Malinowski (US 20160059019)
6
Zarembo teaches configured to facilitate passage of the portion of the nerve cuff straightener (Zarembo, ¶59-stiffener 1272; ¶33-a stiffener with a cuff; Figs. 12-14) that is inserted into the nerve cuff ( Zarembo, ¶38-cuff 108 wrapped around the nerve 104; ¶43-the lead body 122 can be attached to the cuff 108; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). 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 invention of the copending application to include being configured to facilitate passage of the portion of the nerve cuff straightener that is inserted into the nerve cuff of Zarembo in order to inhibit the edges of the cuff from curling inward (Zarembo, ¶59).
Malinowski teaches wherein the elongate lead body includes an internal lumen (¶5-connector-contact assemblies are disposed in the connector lumen and are each configured and arranged to couple to a terminal of the lead or lead extension; ¶63-the conductive wires may be embedded in the non-conductive material of the lead or can be disposed in one or more lumens (not shown) extending along the lead; ¶100-lead lumen); and a lead connector, including an internal lumen, is on the proximal end of the elongate lead body (¶5-a connector lumen is defined in the connector housing and is configured and arranged for receiving a proximal portion of a lead or lead extension). 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 invention of the copending application to include wherein the elongate lead body includes an internal lumen; and a lead connector, including an internal lumen, is on the proximal end of the elongate lead body of Malinowski in order to provide stimulation to nerves (Malinowski, ¶57; ¶130).
Claim 7 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 18/985448 in view of Dearden, Zarembo, and Bolea (US 20080103545).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Dearden, Zarembo, and Bolea as shown below.
Claims of the Present Application (19/019360)
Claims US 18/985448
Secondary Reference Dearden (US 20220062629)
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Bolea (US 20080103545)
7
Bolea teaches wherein the tubular member extends through the elongate lead body (¶60-the lead body 62 may comprise a tubular jacket with electrical conductors 68 extending therein; ¶61-the tubular jacket of lead body 62). 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 invention of the copending application to include wherein the tubular member extends through the elongate lead body of Bolea in order to improve durability (Bolea, ¶60) and for treating obstructive sleep apnea (Bolea, ¶2).
Claim 10 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 18/985448 in view of Dearden, Zarembo, and Foster (US 20220370793).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Dearden, Zarembo, and Foster as shown below.
Claims of the Present Application (19/019360)
Claims US 18/985448
Secondary Reference Dearden (US 20220062629)
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Foster (US 20220370793)
10
Foster teaches wherein the nerve cuff straightener includes a stylet (¶36-there may also be one or more lumens (not shown) that open at, or near, the proximal end of the lead body 106, for example, for inserting a stylet to facilitate placement of the lead body 106 within a body of a patient; ¶37-part of the lead body 106, coupled to cuff 150); and the portion of the nerve cuff straightener that is inserted into the nerve cuff comprises a portion of the stylet (MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987); Fig. 1; ¶36-37). 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 invention of the copending application include wherein the nerve cuff straightener includes a stylet; and the portion of the nerve cuff straightener that is inserted into the nerve cuff comprises a portion of the stylet of Foster in order to facilitate placement of the lead body (Foster, ¶36).
Claims 11 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 18/985448 in view of Dearden, Zarembo, Foster, and Heptke (US 20090132042).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Dearden, Zarembo, Foster, and Heptke as shown below.
Claims of the Present Application (19/019360)
Claims US 18/985448
Secondary Reference Dearden (US 20220062629)
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Foster (US 20220370793)
Secondary Reference Heptke (US 20090132042)
11
Heptke teaches wherein the stylet includes a first region with first straightening characteristics (¶26-the stylet 16 is preferably made from a stiff material such as metal, but may alternatively be made from any suitable material) and a second region with second straightening characteristics that are different than the first straightening characteristics (¶26-the stylet 16 may include a sharpened end adapted to penetrate the tissue and aid in the insertion of the stylet). 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 invention of the copending application to include wherein the stylet includes a first region with first straightening characteristics and a second region with second straightening characteristics that are different than the first straightening characteristics of Heptke in order to penetrate the tissue or other material and/or functions to provide structural support to the device during implantation of the device (Heptke, ¶26).
13
Heptke teaches wherein the stylet is malleable (¶26-the stylet 16 is preferably made from a stiff material such as metal). 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 invention of the copending application to include wherein the stylet is malleable of Heptke in order to penetrate the tissue or other material, function to provide structural support to the device during implantation of the device, and be stiff (Heptke, ¶26).
Claims 12 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 18/985448 in view of Dearden, Zarembo, Foster, and Lacey (US 20140171961).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Dearden, Zarembo, Foster, and Lacey as shown below.
Claims of the Present Application (19/019360)
Claims US 18/985448
Secondary Reference Dearden (US 20220062629)
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Foster (US 20220370793)
Secondary Reference Lacey (US 20140171961)
12
Lacey teaches wherein the stylet defines a longitudinal axis and one or more cross-sections in directions perpendicular to the longitudinal axis with shapes selected from group consisting of a flat ribbon-like shape, a rectangular shape, a rounded rectangular shapes), and an oval shape (Fig. 10-stylet 1030 has a longitudinal axis; ¶84-the first end portion 1032 of the stylet 1030 has a cross-sectional profile, the first end portion 1032 may have a rectangular cross-section). 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 invention of the copending application to include wherein the stylet defines a longitudinal axis and one or more cross-sections in directions perpendicular to the longitudinal axis with shapes selected from group consisting of a flat ribbon-like shape, a rectangular shape, a rounded rectangular shapes), and an oval shape of Lacey in order to facilitate insertion of the insertion tool into the patient's body (Lacey, ¶46) and/or facilitate rotation of the stylet (Lacey, ¶54).
14
Lacey teaches wherein the stylet defines a distal end and a proximal end (¶6-the stylet has a first end portion and an opposing second end portion, where the first end portion is the distal end and the opposing second end portion is the proximal end); and the nerve cuff straightener includes a handle at the proximal end of the stylet (¶6-the actuator handle to the second end portion of the stylet). 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 invention of the copending application to include wherein the stylet defines a distal end and a proximal end; and the nerve cuff straightener includes a handle at the proximal end of the stylet of Lacey in order to facilitate insertion of the insertion tool into the patient's body (Lacey, ¶46), where movement of the actuator handle along the actuator slit causes a corresponding movement of the stylet (Lacey, ¶6).
Claim 15 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 18/985448 in view of Dearden, Zarembo, and Heptke.
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Dearden, Zarembo, and Heptke as shown below.
Claims of the Present Application (19/019360)
Claims US 18/985448
Secondary Reference Dearden (US 20220062629)
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Heptke
15
Heptke teaches wherein the stylet comprises multiple stylets (¶28-although omitted for conciseness, the preferred embodiments include every combination and permutation of the various carriers 10, the various electrical subsystems, the various connectors, the various stylets, and the various methods of use; ¶10-the implantable device is preferably designed to be implanted into the brain, spinal cord, peripheral nerve, muscle, or any other suitable anatomical location). 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 invention of the copending application to include wherein the stylet comprises multiple stylets of Heptke in order to penetrate the tissue or other material and/or functions to provide structural support to the device during implantation of the device (Heptke, ¶26).
Claims 1-2, 5, 8-9, and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 19/034472 in view of Zarembo (US 20140188202).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo as shown below.
Claims of the Present Application (19/019360)
Claims of 19/034472
Secondary Reference Zarembo (US 20140188202)
1
1
Zarembo teaches is configured to receive a portion of the nerve cuff straightener (¶60-the stiffener 1272 can extend laterally across the cuff 1208. The stiffener 1272 can extend over the entire width of the cuff 1208, the stiffener 1272 can additionally or alternatively be…embedded in the main body 1270; Figs. 12-14), wherein, when inserted into the nerve cuff, the portion of the nerve cuff straightener received by the nerve cuff moves the nerve cuff out of the pre-set furled state (¶33-use of a stiffener with a cuff; ¶59-pre-stressing of the materials of the main body 1270 can cause the edges 1274, 1276 of the cuff 1208 to curl inward as a sub-wrap. Stiffener 1272 (shown in FIGS. 12 and 14) can be provided along the outer tab 1236 to inhibit the edges 1274, 1276 from curling inward; ¶60-the stiffener 1272 can additionally or alternatively be…embedded in the main body 1270; Figs. 12-14; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). 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 invention of the copending application to include is configured to receive a portion of the nerve cuff straightener, wherein, when inserted into the nerve cuff, the portion of the nerve cuff straightener received by the nerve cuff moves the nerve cuff out of the pre-set furled state of Zarembo in order to inhibit the edges of the cuff from curling inward (Zarembo, ¶59).
2
Zarembo teaches wherein the nerve cuff includes a tubular member that is configured to receive the portion of the nerve cuff straightener (Zarembo, ¶45-the first tubular member 146 can be encircled within the cuff 108; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). 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 invention of the copending application to include wherein the nerve cuff includes a tubular member that is configured to receive the portion of the nerve cuff straightener of Zarembo in order to pull the first tubular member to uncurl the cuff (Zarembo, ¶4).
5
Zarembo teaches wherein the elongate lead body (Zarembo, ¶43-lead body 122) is configured to facilitate passage of the portion of the nerve cuff straightener (Zarembo, ¶59-stiffener 1272; ¶33-a stiffener with a cuff; Figs. 12-14) that is inserted into the nerve cuff from the proximal end of the lead body to nerve cuff (Zarembo, ¶38-cuff 108 wrapped around the nerve 104; ¶43-the lead body 122 can be attached to the cuff 108; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). 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 invention of the copending application to include wherein the elongate lead body is configured to facilitate passage of the portion of the nerve cuff straightener that is inserted into the nerve cuff from the proximal end of the lead body to nerve cuff of Zarembo in order to inhibit the edges of the cuff from curling inward (Zarembo, ¶59).
8
Zarembo teaches wherein when inserted into the nerve cuff (Zarembo, ¶38- cuff 108 wrapped around the nerve 104; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)), the portion of the nerve cuff straightener (Zarembo, ¶59-stiffener 1272; ¶33-a stiffener with a cuff; Figs. 12-14); moves the nerve cuff out of the pre-set furled state to an at least substantially straightened state (Zarembo, ¶4-pull the first tubular member to uncurl the cuff; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). 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 invention of the copending application to include wherein when inserted into the nerve cuff, the portion of the nerve cuff straightener moves the nerve cuff out of the pre-set furled state to an at least substantially straightened state of Zarembo in order to inhibit the edges of the cuff from curling inward (Zarembo, ¶59).
9
Zarembo teaches wherein when inserted into the nerve cuff (Zarembo, ¶38- cuff 108 wrapped around the nerve 104; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)), the portion of the nerve cuff straightener (Zarembo, ¶59-stiffener 1272; ¶33-a stiffener with a cuff; Figs. 12-14) moves the nerve cuff out of the pre-set furled state to a curved shape (Zarembo, ¶50-release the first elongate element 154 and allow the cuff 108 to curl around the nerve 104; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). 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 invention of the copending application to include wherein when inserted into the nerve cuff, the portion of the nerve cuff straightener moves the nerve cuff out of the pre-set furled state to a curved shape of Zarembo in order to inhibit the edges of the cuff from curling inward (Zarembo, ¶59).
17
1, 12
Claims 3-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 19/034472 in view of Zarembo and Schmidt (US 20180117313).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo and Schmidt as shown below.
Claims of the Present Application (19/019360)
Claims of 19/034472
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Schmidt (US 20180117313)
3
Schmidt teaches a port on the cuff body (Fig. 20-first enlarged cuff substrate 46a with a second elongated lead substrate portion 38b with a connection port on the left; ¶106) configured to facilitate passage of the portion of the nerve cuff straightener into the cuff body (Fig. 20; ¶106; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). 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 invention of Dearden to include a port on the cuff body configured to facilitate passage of the portion of the nerve cuff straightener into the cuff body of the copending application in order to expose portions of the electrically conductive traces to form four connector pads and four additional electrode pads (Schmidt, ¶107), and stimulate nerves (Schmidt, ¶2).
4
Schmidt teaches wherein the port is offset from the elongate lead body (Schmidt, Fig. 20-first enlarged cuff substrate portion 46a has a second elongated lead substrate portion 38b with a connection port on the left that is offset from the first elongated lead substrate portion on the right; ¶106). 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 invention of Dearden to include wherein the port is offset from the elongate lead body of the copending application in order to expose portions of the electrically conductive traces to form four connector pads and four additional electrode pads (Schmidt, ¶107), and stimulate nerves (Schmidt, ¶2).
Claim 6 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 19/034472 in view of Zarembo and Malinowski (US 20160059019).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo and Malinowski as shown below.
Claims of the Present Application (19/019360)
Claims of 19/034472
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Malinowski (US 20160059019)
6
Zarembo teaches configured to facilitate passage of the portion of the nerve cuff straightener (Zarembo, ¶59-stiffener 1272; ¶33-a stiffener with a cuff; Figs. 12-14) that is inserted into the nerve cuff ( Zarembo, ¶38-cuff 108 wrapped around the nerve 104; ¶43-the lead body 122 can be attached to the cuff 108; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). 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 invention of the copending application to include being configured to facilitate passage of the portion of the nerve cuff straightener that is inserted into the nerve cuff of Zarembo in order to inhibit the edges of the cuff from curling inward (Zarembo, ¶59).
Malinowski teaches wherein the elongate lead body includes an internal lumen (¶5-connector-contact assemblies are disposed in the connector lumen and are each configured and arranged to couple to a terminal of the lead or lead extension; ¶63-the conductive wires may be embedded in the non-conductive material of the lead or can be disposed in one or more lumens (not shown) extending along the lead; ¶100-lead lumen); and a lead connector, including an internal lumen, is on the proximal end of the elongate lead body (¶5-a connector lumen is defined in the connector housing and is configured and arranged for receiving a proximal portion of a lead or lead extension). 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 invention of the copending application to include wherein the elongate lead body includes an internal lumen; and a lead connector, including an internal lumen, is on the proximal end of the elongate lead body of Malinowski in order to provide stimulation to nerves (Malinowski, ¶57; ¶130).
Claim 7 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 19/034472 in view of Zarembo and Bolea (US 20080103545).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo and Bolea as shown below.
Claims of the Present Application (19/019360)
Claims of 19/034472
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Bolea (US 20080103545)
7
Bolea teaches wherein the tubular member extends through the elongate lead body (¶60-the lead body 62 may comprise a tubular jacket with electrical conductors 68 extending therein; ¶61-the tubular jacket of lead body 62). 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 invention of the copending application to include wherein the tubular member extends through the elongate lead body of Bolea in order to improve durability (Bolea, ¶60) and for treating obstructive sleep apnea (Bolea, ¶2).
Claim 10 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 19/034472 in view of Zarembo and Foster (US 20220370793).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo and Foster as shown below.
Claims of the Present Application (19/019360)
Claims of 19/034472
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Foster (US 20220370793)
10
Foster teaches wherein the nerve cuff straightener includes a stylet (¶36-there may also be one or more lumens (not shown) that open at, or near, the proximal end of the lead body 106, for example, for inserting a stylet to facilitate placement of the lead body 106 within a body of a patient; ¶37-part of the lead body 106, coupled to cuff 150); and the portion of the nerve cuff straightener that is inserted into the nerve cuff comprises a portion of the stylet (MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987); Fig. 1; ¶36-37). 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 invention of the copending application include wherein the nerve cuff straightener includes a stylet; and the portion of the nerve cuff straightener that is inserted into the nerve cuff comprises a portion of the stylet of Foster in order to facilitate placement of the lead body (Foster, ¶36).
Claims 11 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 19/034472 in view of Zarembo, Foster, and Heptke (US 20090132042).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo, Foster, and Heptke as shown below.
Claims of the Present Application (19/019360)
Claims of 19/034472
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Foster (US 20220370793)
Secondary Reference Heptke (US 20090132042)
11
Heptke teaches wherein the stylet includes a first region with first straightening characteristics (¶26-the stylet 16 is preferably made from a stiff material such as metal, but may alternatively be made from any suitable material) and a second region with second straightening characteristics that are different than the first straightening characteristics (¶26-the stylet 16 may include a sharpened end adapted to penetrate the tissue and aid in the insertion of the stylet). 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 invention of the copending application to include wherein the stylet includes a first region with first straightening characteristics and a second region with second straightening characteristics that are different than the first straightening characteristics of Heptke in order to penetrate the tissue or other material and/or functions to provide structural support to the device during implantation of the device (Heptke, ¶26).
13
Heptke teaches wherein the stylet is malleable (¶26-the stylet 16 is preferably made from a stiff material such as metal). 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 invention of the copending application to include wherein the stylet is malleable of Heptke in order to penetrate the tissue or other material, function to provide structural support to the device during implantation of the device, and be stiff (Heptke, ¶26).
Claims 12 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 19/034472 in view of Zarembo, Foster, and Lacey (US 20140171961).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo, Foster, and Lacey as shown below.
Claims of the Present Application (19/019360)
Claims of 19/034472
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Foster (US 20220370793)
Secondary Reference Lacey (US 20140171961)
12
Lacey teaches wherein the stylet defines a longitudinal axis and one or more cross-sections in directions perpendicular to the longitudinal axis with shapes selected from group consisting of a flat ribbon-like shape, a rectangular shape, a rounded rectangular shapes), and an oval shape (Fig. 10-stylet 1030 has a longitudinal axis; ¶84-the first end portion 1032 of the stylet 1030 has a cross-sectional profile, the first end portion 1032 may have a rectangular cross-section). 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 invention of the copending application to include wherein the stylet defines a longitudinal axis and one or more cross-sections in directions perpendicular to the longitudinal axis with shapes selected from group consisting of a flat ribbon-like shape, a rectangular shape, a rounded rectangular shapes), and an oval shape of Lacey in order to facilitate insertion of the insertion tool into the patient's body (Lacey, ¶46) and/or facilitate rotation of the stylet (Lacey, ¶54).
14
Lacey teaches wherein the stylet defines a distal end and a proximal end (¶6-the stylet has a first end portion and an opposing second end portion, where the first end portion is the distal end and the opposing second end portion is the proximal end); and the nerve cuff straightener includes a handle at the proximal end of the stylet (¶6-the actuator handle to the second end portion of the stylet). 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 invention of the copending application to include wherein the stylet defines a distal end and a proximal end; and the nerve cuff straightener includes a handle at the proximal end of the stylet of Lacey in order to facilitate insertion of the insertion tool into the patient's body (Lacey, ¶46), where movement of the actuator handle along the actuator slit causes a corresponding movement of the stylet (Lacey, ¶6).
Claim 15 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 19/034472 in view of Zarembo and Heptke.
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo and Heptke as shown below.
Claims of the Present Application (19/019360)
Claims of 19/034472
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Heptke
15
Heptke teaches wherein the stylet comprises multiple stylets (¶28-although omitted for conciseness, the preferred embodiments include every combination and permutation of the various carriers 10, the various electrical subsystems, the various connectors, the various stylets, and the various methods of use; ¶10-the implantable device is preferably designed to be implanted into the brain, spinal cord, peripheral nerve, muscle, or any other suitable anatomical location). 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 invention of the copending application to include wherein the stylet comprises multiple stylets of Heptke in order to penetrate the tissue or other material and/or functions to provide structural support to the device during implantation of the device (Heptke, ¶26).
Claim 16 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 19/034472 in view of Zarembo and Dearden (US 20220062629).
This is a nonstatutory double patenting rejection. 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 invention of the U.S. Patent to include the subject matter in Zarembo and Dearden as shown below.
Claims of the Present Application (19/019360)
Claims of 19/034472
Secondary Reference Zarembo (US 20140188202)
Secondary Reference Dearden (US 20220062629)
16
1, 12
Dearden teaches the electrically conductive contacts comprise relatively long contacts that are spaced from one another in the width direction (Dearden, ¶6-electrically conductive contacts carried by the cuff body that are spaced from one another in the width direction; ¶47; Figs. 5-6). 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 invention of the copending application to include the electrically conductive contacts comprise relatively long contacts that are spaced from one another in the width direction of Dearden in order to treat obstructive sleep apnea (Dearden, ¶2).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20220218988: (¶1-an electrical stimulation system for improving sleep disordered breathing is provided).
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/LAURA HODGE/Examiner, Art Unit 3792
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