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 .
Priority
The instant application (filed on 02/03/2025) is a non-provisional application filed under 35 USC 111(a). Acknowledgment is made of Applicant's claim for domestic priority based on provisional application 63/549,797 (filed 02/05/2024). Instant claims 1-20 are adequately supported in 63/549,797 for those claims to receive an effective filing date of 02/05/2024.
Election/Restriction
Applicant’s election of Species A1 without traverse in the reply filed on 07/29/2026 is acknowledged. Applicant identifies claims 1, 4, 7-15, and 17-20 as generic to the species identified by the Examiner and claim 2 as reading specifically on elected Species A1. Therefore, claims 3, 5-6, and 16 are withdrawn as being directed to unelected species.
Status of Claims
Claims 1-20 are currently pending. Claims 1-2, 4, 7-15, and 17-20 are under examination while claims 3, 5-6, and 16 are withdrawn as pertaining to unelected species.
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 4, 7, 17, and 19-20 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 4: The limitation “wherein the at least one male connection element is part of the first strain relief” renders claim 4 indefinite because it is unclear whether the at least one male connector is part of the cuff body or lead body. Claim 1 discloses “the first cuff body comprising an exterior surface, an interior surface, and at least one first male connection element.” Based on the disclosure, it is unclear how the at least one male connection elements on the cuff body can be simultaneously present on the lead body.
The specification at page 20, lines 1-8 states:
In at least some embodiments, as shown in FIG. 3B, conjoining is accomplished by directly conjoining one cuff with another cuff, such as by using mating features on the cuffs. In other embodiments, conjoining is accomplished, at least in part, with a mating feature on the strain reliefs (e.g., strain reliefs 172 and 182 of FIG. 3B). For instance, in at least some embodiments, the strain reliefs of the cuff leads have complementary male connection element(s) and female connection element(s). In at least some embodiments, conjoining is accomplished based on features on the lead body rather than or in addition to features on the cuff body.
This passage discloses either male/female connections between the cuffs or male/female connections between the leads, but not any associations between the male connection element on the cuff and the strain relief element on the lead. The clarity of the claim would benefit from reconciling the male connection element on the cuff with its claimed inclusion on the strain relief on the lead.
This limitation is currently being interpreted as the cuff connection (facilitated by the male connection element on the cuff) contributing to the strain relief function.
Claim 7: The limitation “wherein the first cuff body further comprises at least one first female connection element and the second cuff body further comprises at least one second male connection element configured to receive the at least one first female connection element to conjoin the first cuff body to the second cuff body” is indefinite because it is unclear how the male connection element would receive the female connection element. The reverse with the female connection element receiving the male connection element would enhance the clarity of the claim.
Claim 17: The limitation “wherein the second cuff lead further comprises at least one third connection element coupled to the second cuff body of the second distal attachment portion of the second lead body, the cuff lead arrangement further comprising” in indefinite for two reasons:
The second cuff lead comprising “at least one third connection element” is inconsistent with the naming conventions used for the rest of the claims where the number (first, second, third) corresponds to the cuff lead on which the feature is located. The clarity of the claim would benefit from the connection element on the second cuff lead being “second.”
The “second cuff body of the second distal attachment of the second lead body” refers to separate cuff body and lead body components. The statement may have been intended to be “second cuff body or the second distal attachment of the second lead body.”
Claim 19: The limitation “a method of electrically stimulating a patient using the electrical stimulation system of claim 14” lacks an antecedent basis for the electrical stimulation system because claim 14 is a cuff lead arrangement for electrical stimulation of a nerve. It is unclear if the “electrical stimulation system” is supposed to be a reference to claim 18.
Claim 20: The limitations “a plurality of first stimulation emitters disposed on the interior surface of the first cuff body” and “a plurality of second stimulation emitters disposed on the interior surface of the second cuff body” lack an antecedent basis for the interior surfaces of the cuff bodies.
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 1-2, 4, 9, 12-15, and 17-20 are rejected under U.S.C 103 as being unpatentable over Bolea (US 2008/0103407 A1) in view of Dillon (US 2021/0346671 A1).
Regarding Claim 1, Bolea discloses a cuff lead arrangement for electrical stimulation of a nerve ([0038] – stimulation lead connected to a distal nerve cuff which carries the signal from the implantable neurostimulator), the cuff lead arrangement comprising:
• a first cuff lead (Fig. 20, [0085] – individual leads 62 attached to respective cuffs 200A-200C, for example 200A being a first cuff), comprising
a first cuff body configured to be disposed around at least a portion of the nerve (Fig. 20, [0085] - one of cuffs 200A-200C disposed around the nerve), the first cuff body comprising an exterior surface and an interior surface (Fig. 20 – the cuff bodies have an inner surface facing the nerve and an outer surface facing away from the nerve),
a plurality of first electrodes disposed on the interior surface of the first cuff body ([0085] – “Each of the cuffs 200A, 200B and 200C may include a cuff body 202 with one or more imbedded electrode contacts”),
a first lead body coupled to the first cuff body (Fig. 20, [0085] – individual leads 62 attached to respective cuffs 200A-200C), and
a plurality of first conductors electrically coupled to the first electrodes and extending along the first lead body ([0085] – independent lead bodies; [0086] – independent leads contain independent conductors in each lead which electrically connect with the electrode contacts); and
• a second cuff lead (Fig. 20, [0085] – individual leads 62 attached to respective cuffs 200A-200C, for example 200B being a second cuff), comprising
a second cuff body configured to be disposed around at least a portion of the nerve (Fig. 20, [0085] - one of cuffs 200A-200C disposed around the nerve), the second cuff body comprising an exterior surface and an interior surface (Fig. 20 – the cuff bodies have an inner surface facing the nerve and an outer surface facing away from the nerve),
a plurality of second electrodes disposed on the interior surface of the second cuff body ([0085] – “Each of the cuffs 200A, 200B and 200C may include a cuff body 202 with one or more imbedded electrode contacts”),
a second lead body coupled to the second cuff body (Fig. 20, [0085] – individual leads 62 attached to respective cuffs 200A-200C), and
a plurality of second conductors electrically coupled to the second electrodes and extending along the second lead body ([0085] – independent lead bodies; [0086] – independent leads contain independent conductors in each lead which electrically connect with the electrode contacts).
Bolea discloses the benefits of a multi-cuff placement of electrodes at separate locations around the nerve:
The series of independent cuffs 200A, 200B and 200C allows more selectivity in electrode placement to adjust for anatomical variation or multiple target stimulation sites, for example. Providing multiple independent lead bodies 62 allows for more options in routing and placement of the individual lead bodies 62 (e.g., alternate placement of lead body 62A) and also prevents tissue encapsulation around the lead bodies 62 from collectively affecting encapsulation of the nerve cuffs 200 ([0085]).
Bolea also stresses the use of a tether to prevent high levels of traction in a cuff due to movement of the lead by connecting either the lead or cuff to another nearby object within the implantation site ([0094-0095]). Bolea discloses a mechanical lock can be used to connect the lead and the cuff ([0087]), which demonstrates the mechanical union of lead/cuff components was contemplated by Bolea. Note a single cuff containing multiple electrodes with insulative strips to stimulate along the length of a nerve using a single lead is disclosed in another embodiment (Fig. 17, [0082]).
However, Bolea does not disclose (1) the first cuff lead including a first cuff comprising at least one first male connection element and (2) the second cuff lead including a second cuff comprising at least one second female connection element configured to receive the at least one first male connection element to conjoin the first cuff body to the second cuff body.
The tubing connector in Dillon would be considered “reasonably pertinent” (see MPEP 2141.01(a)1) to the claimed invention because there is a common problem to be solved where a quick and efficient connection of components, without causing undue stress on those components, is needed. Dillon teaches a connector for attaching tubular elements (Fig. 2, [0007]). Dillon teaches a male connector body 12 (Fig. 1A) with a first end 13 connected to a female connector body 15 (Fig. 1B) with front end 16 ([0014]). The first end 13 of the male connector body contains tab 19 and the front end 16 of the female connector body contains notch 20, where tab 19 locks with notch 20 to connect the two tubular segments (Fig. 2, [0015]). Dillon states: “In this manner, the tab 19 locks within the notch 20, such that the male connector body 12 is securely affixed to the female connector body 15 throughout use” ([0015]) and “in such embodiments, the tab 19 is maneuvered through the notch 20 to prevent the tab 19 from unintentionally disengaging during use ([0016]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the cuffs on independent leads in Bolea by incorporating the male and female tubular connectors in Dillon. This would have been obvious because both Bolea and Dillon discuss tubular-shaped elements and Dillon provides a solution/improvement by mechanically securing tubular bodies in their selected relative positions and resisting unintended displacement via separation. Therefore, a person of ordinary skill in the art would be motivated to improve the cuff arrangement in Bolea by incorporating the male and female tubular connectors in Dillon to lock the independent cuffs in a particular configuration (similar in theory to the one cuff/one lead design for multiple electrodes in Fig. 17) in Bolea.
Regarding Claim 2, the cuff lead arrangement according to Claim 1 is obvious over Bolea in view of Dillon, as indicated hereinabove. Bolea does not disclose wherein each of the at least one first male connection element comprises a connection finger and each of the at least one second female connection element comprises a slot configured to receive a portion of the connection finger to conjoin the first cuff body to the second cuff body.
As stated in claim 1, the proposed combination with Dillon yields a tubular male connector body 12 (Fig. 1A) with a first end 13 connected to a tubular female connector body 15 (Fig. 1B) with front end 16 ([0014]). The first end 13 of the male connector body contains tab 19 and the front end 16 of the female connector body contains notch 20, where tab 19 locks with notch 20 to connect the two tubular segments (Fig. 2, [0015]). The tab 19 is reasonable read as the claimed “connection finger” under the broadest reasonable interpretation. The instant specification does not define a necessary shape other than referencing what can best be interpreted as an example in Figures 3A-3B. The claim 2 language functionally requires the finger to be part of a male connection element and for a portion of the finger to be received in the female element (without providing further limitations regarding the dimensions or shape of the finger).
Regarding Claim 4, the cuff lead arrangement according to Claim 1 is obvious over Bolea in view of Dillon, as indicated hereinabove. Bolea discloses wherein the first cuff body further comprises a first strain relief extending along a portion of the first lead body wherein the first lead body is attached to the first cuff body (Fig. 5, [0049] – sigmoid shaped lead reduces strain imposed on the cuff when the lead is moved). However, Bolea does not disclose wherein the at least one male connection element is part of the first strain relief. Note it is unclear how the male connection element is structurally a part of the first strain relief on the lead body since the male connection element was previously defined as being on the cuff body - a structural element distinct from the lead body (see 112(a) and 112(b) rejections). This limitation is currently being interpreted as the cuff connection (facilitated by the male connection element on the cuff) contributing to the strain relief function.
As stated in claim 1, the proposed combination with Dillon yields a tubular male connector body 12 (Fig. 1A) with a first end 13 connected to a tubular female connector body 15 (Fig. 1B) with front end 16 ([0014]). The first end 13 of the male connector body contains tab 19 and the front end 16 of the female connector body contains notch 20, where tab 19 locks with notch 20 to connect the two tubular segments (Fig. 2, [0015]). Dillon [0015-0016] explains how the male and female connectors securely affix the tubular elements in place to prevent unintentional disengagement, which could be considered a form of strain relief in Bolea by securing the cuffs using this connection.
Regarding Claim 9, the cuff lead arrangement according to Claim 1 is obvious over Bolea in view of Dillon, as indicated hereinabove. Bolea discloses wherein the cuff lead arrangement further comprising
a third cuff lead (Fig. 20, [0085] – individual leads 62 attached to respective cuffs 200A-200C, for example 200C being a third cuff), comprising a third cuff body configured to be disposed around at least a portion of the nerve (Fig. 20, [0085] - one of cuffs 200A-200C disposed around the nerve, such as 200C), the third cuff body comprising an exterior surface and an interior surface (Fig. 20 – the cuff bodies have an inner surface facing the nerve and an outer surface facing away from the nerve),
a plurality of third electrodes disposed on the interior surface of the third cuff body (Fig. 20, [0085] – “Each of the cuffs 200A, 200B and 200C may include a cuff body 202 with one or more imbedded electrode contacts” which touch the nerve on the inner surface of the cuff),
a third lead body coupled to the third cuff body (Fig. 20, [0085] – individual leads 62 attached to respective cuffs 200A-200C; [0087] – a mechanical lock is used to connect the lead to the cuff), and
a plurality of third conductors electrically coupled to the third electrodes and extending along the third lead body ([0085] – independent lead bodies; [0086] – independent leads contain independent conductors in each lead which electrically connect with the electrode contacts).
However, Bolea does not disclose:
the second cuff body further comprises at least one second male connection element,
at least one third female connection element configured to receive the at least one second male connection element to conjoin the second cuff body to the third cuff body,
As stated in claim 1, the proposed combination with Dillon yields a tubular male connector body 12 (Fig. 1A) with a first end 13 connected to a tubular female connector body 15 (Fig. 1B) with front end 16 ([0014]). The first end 13 of the male connector body contains tab 19 and the front end 16 of the female connector body contains notch 20, where tab 19 locks with notch 20 to connect the two tubular segments (Fig. 2, [0015]).
It would have been obvious to a person of ordinary skill in the art to additionally provide the second and third cuff bodies of Bolea with the male and female connectors taught by Dillon to mechanically secure the third cuff in its relative relationship with the second cuff and resist unintended separation or displacement during use. Bolea discloses three cuffs and Dillon’s known connection between the second and third cuffs would predictably provide the same mechanical securing function as the connection between the first and second cuffs.
Regarding Claim 12, Bolea discloses an electrical stimulation system ([0038-0040] – neurostimulator system applying electrical stimulation) comprising:
• the cuff lead arrangement of claim 1 (see the rejection of claim 1 over Bolea in view of Dillon); and
• a control module ([0046] – the INS contains a microprocessor and memory for storing and processing stimulation algorithms) configured to receive a portion of the first lead body and to electrically couple to the first plurality of electrodes and to receive a portion of the second lead body and to electrically couple to the second plurality of electrodes ([0045] – the leads connect to the INS 50 via receptables in header 52, [0085] – leads are connected to electrodes within the cuffs), wherein the control module is configured to generate electrical stimulation signals for delivery through at least one of the first or second electrodes ([0046] – a stimulation signal is provided by INS 50 to stimulate the nerve under the cuffs positioned as described in [0085]).
Regarding Claim 13, Bolea discloses a method of electrically stimulating a patient (Claim 1) using the electrical stimulation system of claim 12 (see the rejection of claim 12 over Bolea in view of Dillon), the method comprising:
providing the cuff lead arrangement implanted within the patient (Fig. 20, [0038], [0085] – the cuffs are implanted over a nerve within the body);
generating electrical stimulation signals by the control module ([0046] – the INS contains a microprocessor and memory for storing and processing stimulation algorithms); and
delivering the electrical stimulation signals from the control module to the patient using at least one of the first or second electrodes ([0046] – a stimulation signal is provided by INS 50 to stimulate the nerve under the cuffs positioned as described in [0085]).
Regarding Claim 14, Bolea discloses a cuff lead arrangement for electrical stimulation of a nerve ([0038] – stimulation lead is connected to a distal nerve cuff which carries the signal from the implantable neurostimulator), the cuff lead arrangement comprising:
• a first cuff lead (Fig. 20, [0085] – individual leads 62 attached to respective cuffs 200A-200C, for example 200A being a first cuff), comprising
a first cuff body configured to be disposed around at least a portion of the nerve (Fig. 20, [0085] - one of cuffs 200A-200C disposed around the nerve, such as 200A),
a plurality of first electrodes disposed on an interior surface of the first cuff body (Fig. 20, [0085] – “Each of the cuffs 200A, 200B and 200C may include a cuff body 202 with one or more imbedded electrode contacts” which touch the nerve on the inner surface of the cuff),
a first lead body comprising a first distal attachment portion directly attached to the first cuff body (Fig. 20, [0085] – individual leads 62 attached to respective cuffs 200A-200C; [0087] – a mechanical lock is used to connect the distal lead to the cuff),
a plurality of first conductors electrically coupled to the first electrodes and extending along the first lead body ([0085] – independent lead bodies; [0086] – independent leads contain independent conductors in each lead which electrically connect with the electrode contacts),
• a second cuff lead (Fig. 20, [0085] – individual leads 62 attached to respective cuffs 200A-200C, for example 200B being a second cuff), comprising
a second cuff body configured to be disposed around at least a portion of the nerve (Fig. 20, [0085] - one of cuffs 200A-200C disposed around the nerve, such as 200B),
a plurality of second electrodes disposed on an interior surface of the second cuff body (Fig. 20, [0085] – “Each of the cuffs 200A, 200B and 200C may include a cuff body 202 with one or more imbedded electrode contacts” which touch the nerve on the inner surface of the cuff),
a second lead body comprising a second distal attachment portion directly attached to the second cuff body (Fig. 20, [0085] – individual leads 62 attached to respective cuffs 200A-200C; [0087] – a mechanical lock is used to connect the distal lead to the cuff),
a plurality of second conductors electrically coupled to the second electrodes and extending along the second lead body ([0085] – independent lead bodies; [0086] – independent leads contain independent conductors in each lead which electrically connect with the electrode contacts).
Bolea discloses the benefits of a multi-cuff placement of electrodes at separate and physiologically significant locations around the nerve ([0085]). Bolea also stresses the use of a tether to prevent high levels of traction in a cuff due to movement of the lead by connecting either the lead or cuff to another nearby object within the implantation site ([0094-0095]). Bolea discloses a mechanical lock can be used to connect the lead and the cuff ([0087]), which demonstrates the mechanical union of lead/cuff components was contemplated by Bolea. Note a single cuff containing multiple electrodes with insulative strips to stimulate along the length of a nerve using a single lead is disclosed in another embodiment (Fig. 17, [0082]).
However, Bolea does not disclose:
at least one first connection element coupled to the first cuff body or the first distal attachment portion of the first lead body; and
at least one second connection element coupled to the second cuff body or the second distal attachment portion of the second lead body, wherein the at least one second connection element is configured to be attached to the at least one first connection element to conjoin the first cuff lead to the second cuff lead.
The tubing connector in Dillon would be considered “reasonably pertinent” (see MPEP 2141.01(a)1) to the claimed invention because Dillon teaches a connector for attaching tubular elements ([0007]) where such tubular elements can be interpreted as taking the shape of cuffs (see Fig. 2). Dillon teaches a male connector body 12 (Fig. 1A) with a first end 13 connected to a female connector body 15 (Fig. 1B) with front end 16 ([0014]). The first end 13 of the male connector body contains tab 19 and the front end 16 of the female connector body contains notch 20, where tab 19 locks with notch 20 to connect the two tubular segments (Fig. 2, [0015]). Dillon states: “In this manner, the tab 19 locks within the notch 20, such that the male connector body 12 is securely affixed to the female connector body 15 throughout use” ([0015]) and “in such embodiments, the tab 19 is maneuvered through the notch 20 to prevent the tab 19 from unintentionally disengaging during use ([0016]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the cuffs on independent leads in Bolea by incorporating the male and female tubular connectors in Dillon. This would have been obvious because both Bolea and Dillon discuss tubular-shaped elements and Dillon provides a solution/improvement by mechanically securing tubular bodies in their selected relative positions and resisting unintended displacement via separation. Therefore, a person of ordinary skill in the art would be motivated to improve the cuff arrangement in Bolea by incorporating the male and female tubular connectors in Dillon to lock the independent cuffs in a particular configuration (similar in theory to the one cuff/one lead design for multiple electrodes in Fig. 17) in Bolea.
Regarding Claim 15, the cuff lead arrangement according to Claim 14 is obvious over Bolea in view of Dillon, as indicated hereinabove. Bolea does not disclose wherein the at least one first connection element and the at least one second connection element comprise at least one of: a tongue-and- groove arrangement, a screw arrangement, a bolt arrangement, a thread-and-elbow arrangement, a pin-and-slot arrangement, a connection-finger-and-slot arrangement, or a sliding arrangement.
As stated in claim 14, the proposed combination with Dillon yields a tubular male connector body 12 (Fig. 1A) with a first end 13 connected to a tubular female connector body 15 (Fig. 1B) with front end 16 ([0014]). The first end 13 of the male connector body contains tab 19 and the front end 16 of the female connector body contains notch 20, where tab 19 locks with notch 20 to connect the two tubular segments (Fig. 2, [0015]). The tab 19 is reasonable read as the claimed “connection finger” under the broadest reasonable interpretation. The instant specification does not define a necessary shape other than referencing what can best be interpreted as an example in Figures 3A-3B. The claim 2 language functionally requires the finger to be part of a male connection element and for a portion of the finger to be received in the female element (without providing further limitations regarding the dimensions or shape of the finger).
Regarding Claim 17, the cuff lead arrangement according to Claim 14 is obvious over Bolea in view of Dillon, as indicated hereinabove. Bolea discloses wherein, the cuff lead arrangement further comprising
• a third cuff lead (Fig. 20, [0085] – individual leads 62 attached to respective cuffs 200A-200C, for example 200C being a third cuff), comprising
a third cuff body configured to be disposed around at least a portion of the nerve (Fig. 20, [0085] - one of cuffs 200A-200C disposed around the nerve, such as 200C),
a plurality of third electrodes disposed on an interior surface of the third cuff body (Fig. 20, [0085] – “Each of the cuffs 200A, 200B and 200C may include a cuff body 202 with one or more imbedded electrode contacts” which touch the nerve on the inner surface of the cuff),
a third lead body comprising a third distal attachment portion directly attached to the third cuff body (Fig. 20, [0085] – individual leads 62 attached to respective cuffs 200A-200C; [0087] – a mechanical lock is used to connect the lead to the cuff),
a plurality of third conductors electrically coupled to the third electrodes and extending along the third lead body ([0085] – independent lead bodies; [0086] – independent leads contain independent conductors in each lead which electrically connect with the electrode contacts).
However, Bolea does not disclose:
the second cuff lead further comprises at least one third connection element coupled to the second cuff body of the second distal attachment portion of the second lead body (see 112(b) rejection, it is difficult to interpret what this limitation requires)
at least one third connection element coupled to the third cuff body or the third distal attachment portion of the third lead body, wherein the at least one third connection element is configured to be attached to the at least one second connection element to conjoin the second cuff lead to the third cuff lead.
As stated in claim 14, the proposed combination with Dillon yields a tubular male connector body 12 (Fig. 1A) with a first end 13 connected to a tubular female connector body 15 (Fig. 1B) with front end 16 ([0014]). The first end 13 of the male connector body contains tab 19 and the front end 16 of the female connector body contains notch 20, where tab 19 locks with notch 20 to connect the two tubular segments (Fig. 2, [0015]).
It would have been obvious to a person of ordinary skill in the art to additionally provide the second and third cuff bodies of Bolea with the male and female connectors taught by Dillon to mechanically secure the third cuff in its relative relationship with the second cuff and resist unintended separation or displacement during use. Bolea discloses three cuffs and Dillon’s known connection between the second and third cuffs would predictably provide the same mechanical securing function as the connection between the first and second cuffs.
Regarding Claim 18, Bolea discloses an electrical stimulation system ([0038-0040] – neurostimulator system applying electrical stimulation), comprising:
• the cuff lead arrangement of claim 14 (see the rejection of claim 14 over Bolea in view of Dillon); and
• a control module ([0046] – the INS contains a microprocessor and memory for storing and processing stimulation algorithms) configured to receive a portion of the first lead body and to electrically couple to the plurality of first electrodes and to receive a portion of the second lead body and to electrically couple to the plurality of second electrodes ([0045] – the leads connect to the INS 50 via receptables in header 52, [0085] – leads are connected to electrodes within the cuffs), wherein the control module is configured to generate electrical stimulation signals for delivery through at least one of the first or second electrodes ([0046] – a stimulation signal is provided by INS 50 to stimulate the nerve under the cuffs positioned as described in [0085]).
Regarding Claim 19, Bolea discloses a method of electrically stimulating a patient (Claim 1) using the electrical stimulation system of claim 14 (see the rejection of claim 14 over Bolea in view of Dillon), the method comprising:
providing the cuff lead arrangement implanted within the patient (Fig. 20, [0038], [0085] – the cuffs are implanted over a nerve within the body);
generating electrical stimulation signals by the control module ([0046] – the INS contains a microprocessor and memory for storing and processing stimulation algorithms); and
delivering the electrical stimulation signals from the control module to the patient using at least one of the first or second electrodes ([0046] – a stimulation signal is provided by INS 50 to stimulate the nerve under the cuffs positioned as described in [0085]).
Regarding Claim 20, Bolea discloses a cuff lead arrangement for electrical stimulation of a nerve ([0038] – stimulation lead is connected to a distal nerve cuff which carries the signal from the implantable neurostimulator), the cuff lead arrangement comprising:
• a first cuff lead (Fig. 20, [0085] – individual leads 62 attached to respective cuffs 200A-200C, for example 200A being a first cuff), comprising
a first cuff body configured to be disposed around at least a portion of the nerve (Fig. 20, [0085] - one of cuffs 200A-200C disposed around the nerve, such as 200A),
a plurality of first stimulation emitters disposed on the interior surface of the first cuff body (Fig. 20, [0085] – “Each of the cuffs 200A, 200B and 200C may include a cuff body 202 with one or more imbedded electrode contacts” which touch the nerve on the inner surface of the cuff),
a first lead body comprising a first distal attachment portion directly attached to the first cuff body (Fig. 20, [0085] – individual leads 62 attached to respective cuffs 200A-200C; [0087] – a mechanical lock is used to connect the distal lead to the cuff)
a plurality of first conductors operatively coupled to the first stimulation emitters and extending along the first lead body ([0085] – independent lead bodies; [0086] – independent leads contain independent conductors in each lead which electrically connect with the electrode contacts), and
• a second cuff lead (Fig. 20, [0085] – individual leads 62 attached to respective cuffs 200A-200C, for example 200B being a second cuff), comprising
a second cuff body configured to be disposed around at least a portion of the nerve (Fig. 20, [0085] - one of cuffs 200A-200C disposed around the nerve, such as 200B),
a plurality of second stimulation emitters disposed on the interior surface of the second cuff body (Fig. 20, [0085] – “Each of the cuffs 200A, 200B and 200C may include a cuff body 202 with one or more imbedded electrode contacts” which touch the nerve on the inner surface of the cuff),
a second lead body comprising a second distal attachment portion directly attached to the second cuff body (Fig. 20, [0085] – individual leads 62 attached to respective cuffs 200A-200C; [0087] – a mechanical lock is used to connect the distal lead to the cuff),
a plurality of second conductors operatively coupled to the second stimulation emitters and extending along the second lead body ([0085] – independent lead bodies; [0086] – independent leads contain independent conductors in each lead which electrically connect with the electrode contacts).
Bolea discloses the benefits of a multi-cuff placement of electrodes at separate and physiologically significant locations around the nerve ([0085]). Bolea also stresses the use of a tether to prevent high levels of traction in a cuff due to movement of the lead by connecting either the lead or cuff to another nearby object within the implantation site ([0094-0095]). Bolea discloses a mechanical lock can be used to connect the lead and the cuff ([0087]), which demonstrates the mechanical union of lead/cuff components was contemplated by Bolea. Note a single cuff containing multiple electrodes with insulative strips to stimulate along the length of a nerve using a single lead is disclosed in another embodiment (Fig. 17, [0082]).
However, Bolea does not disclose:
- at least one first connection element coupled to the first cuff body or the first distal attachment portion of the first lead body; and
- at least one second connection element coupled to the second cuff body or the second distal attachment portion of the second lead body, wherein the at least one second connection element is configured to be attached to the at least one first connection element to conjoin the first cuff lead to the second cuff lead.
The tubing connector in Dillon would be considered “reasonably pertinent” (see MPEP 2141.01(a)1) to the claimed invention because Dillon teaches a connector for attaching tubular elements ([0007]) where such tubular elements can be interpreted as taking the shape of cuffs (see Fig. 2). Dillon teaches a male connector body 12 (Fig. 1A) with a first end 13 connected to a female connector body 15 (Fig. 1B) with front end 16 ([0014]). The first end 13 of the male connector body contains tab 19 and the front end 16 of the female connector body contains notch 20, where tab 19 locks with notch 20 to connect the two tubular segments (Fig. 2, [0015]). Dillon states: “In this manner, the tab 19 locks within the notch 20, such that the male connector body 12 is securely affixed to the female connector body 15 throughout use” ([0015]) and “in such embodiments, the tab 19 is maneuvered through the notch 20 to prevent the tab 19 from unintentionally disengaging during use ([0016]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the cuffs on independent leads in Bolea by incorporating the male and female tubular connectors in Dillon. This would have been obvious because both Bolea and Dillon discuss tubular-shaped elements and Dillon provides a solution/improvement by mechanically securing tubular bodies in their selected relative positions and resisting unintended displacement via separation. Therefore, a person of ordinary skill in the art would be motivated to improve the cuff arrangement in Bolea by incorporating the male and female tubular connectors in Dillon to lock the independent cuffs in a particular configuration (similar in theory to the one cuff/one lead design for multiple electrodes in Fig. 17) in Bolea.
Claim 7 is rejected under U.S.C 103 as being unpatentable over Bolea (US 2008/0103407 A1) in view of Dillon (US 2021/0346671 A1) and Brugger (US 2019/0078714 A1).
Regarding Claim 7, the cuff lead arrangement according to Claim 1 is obvious over Bolea in view of Dillon, as indicated hereinabove. Bolea does not disclose wherein the first cuff body further comprises at least one first female connection element and the second cuff body further comprises at least one second male connection element configured to receive the at least one first female connection element to conjoin the first cuff body to the second cuff body.
As stated in claim 1, the proposed combination with Dillon yields a tubular male connector body 12 (Fig. 1A) with a first end 13 connected to a tubular female connector body 15 (Fig. 1B) with front end 16 ([0014]). The first end 13 of the male connector body contains tab 19 and the front end 16 of the female connector body contains notch 20, where tab 19 locks with notch 20 to connect the two tubular segments (Fig. 2, [0015]). However, only one connection with an interlocking tab and notch is taught by Dillon.
The tubing connector in Brugger would be considered “reasonably pertinent” (see MPEP 2141.01(a)1) to the claimed invention because there is common problem to be solved where a quick and efficient connection of components, without causing undue stress on the components, is needed. Brugger teaches a connector for attaching tubular elements ([0069]). Brugger teaches a tubing connector with both male and female sides where the hermaphroditic coupling allows for a stronger connection than having only one male or female connector ([0054]). Hermaphroditic coupling designs also have the advantage of each connector being identical (containing both a male and a female connector) rather than explicitly one male or female connector ([0054-0055]). Hermaphroditic couplers allow for more streamlined and cheaper production in that only one mold is necessary since the couplers are identical ([0055]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Bolea and Dillon by incorporating tubing connectors with separate male and female sides to couple together in Brugger. This would have been obvious because both Bolea/Dillon and Brugger discuss tubular elements and Brugger provides a solution/improvement of a hermaphroditic coupling with distinct male and female sides of a connector to improve the fit of the tubing connection and create identical connection elements (which eases production and limits costs by only requiring the development of one type of part). Therefore, a person of ordinary skill in the art would be motivated to improve the cuff arrangement in the combination of Bolea and Dillon by incorporating tubing connectors with separate male and female sides to couple together in Brugger to create male (tab) and female (notch) sides on each tubing connection in Dillon to connect the independent cuffs in Bolea.
Claim 8 is rejected under U.S.C 103 as being unpatentable over Bolea (US 2008/0103407 A1) in view of Dillon (US 2021/0346671 A1) and Derkacz (US 2018/0305986 A1).
Regarding Claim 8, the cuff lead arrangement according to Claim 1 is obvious over Bolea in view of Dillon, as indicated hereinabove. Bolea does not disclose wherein the first cuff body comprises a plurality of the first male connection elements and the second cuff body comprises a plurality of the second female connection elements configured to receive the first male connection elements to conjoin the first cuff body to the second cuff body.
As stated in claim 1, the proposed combination with Dillon yields a tubular male connector body 12 (Fig. 1A) with a first end 13 connected to a tubular female connector body 15 (Fig. 1B) with front end 16 ([0014]). The first end 13 of the male connector body contains tab 19 and the front end 16 of the female connector body contains notch 20, where tab 19 locks with notch 20 to connect the two tubular segments (Fig. 2, [0015]). However, only one connection with an interlocking tab and notch is taught by Dillon.
The tubing connector in Derkacz would be considered “reasonably pertinent” (see MPEP 2141.01(a)1) to the claimed invention because there is common problem to be solved where a quick and efficient connection of components, without causing undue stress on the components, is needed. Derkacz teaches a connector for attaching tubular elements (Fig. 2, Abstract). Derkacz teaches a male connector 200 (Figure 8) on one end of tubing section 10 and a female connector 100 (Figure 2) on the opposite end of tubing section 10 to facilitate a connection between different tubing sections ([0032]). Male connector 200 contains multiple threaded apertures and connection ribs around the circumference of the male connector which mate with the multiple connection apertures and positioning slots of the female connector 100 ([0043-0044]). The rationale behind this type of connector is to provide a modular connection between flexible tubing segments where:
The female connector 100 and the male connector 200 are designed to apply forces in a uniform manner around an end 20 of the tubing section 10 and allow axial preloading of the female connector 100 and male connector 200 to prevent deformation of the end 20 of the tubing section 10 and movement of the female connector 100 and male connector 200 relative to the tubing section 10. [0033]
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Bolea and Dillon by incorporating the male/female tubing connectors with multiple engagement points in Derkacz. This would have been obvious because both Bolea/Dillon and Derkacz discuss connecting tubular elements and Derkacz provides a solution/improvement by creating multiple engagement points (compared to Dillon’s single engagement point with the tab and notch) around the radial ends of the tube to create more uniform/distributed forces to prevent deformation of the tubing and reduce movement within the male/female connection. Therefore, a person of ordinary skill in the art would be motivated to improve the cuff arrangement in the combination in Bolea and Dillon by incorporating the male/female tubing connectors with multiple engagement points in Derkacz to create multiple instances of the tab and notch connection in Dillon spread radially over the ends of the independent cuffs in Bolea.
Claims 10-11 are rejected under U.S.C 103 as being unpatentable over Bolea (US 2008/0103407 A1) in view of Dillon (US 2021/0346671 A1) and Subramanian (US 2022/0226641 A1).
Regarding Claim 10, the cuff lead arrangement according to Claim 1 is obvious over Bolea in view of Dillon, as indicated hereinabove. Bolea discloses cuffs 200A, 200B, and 200C may contain one or more electrodes ([0085]), but does not discuss the relative orientation of the electrodes between cuffs. Therefore, Bolea does not explicitly disclose wherein the first electrodes are disposed in a first arrangement on the interior surface of the first cuff lead and the second electrodes are disposed in the first arrangement on the interior surface of the second cuff lead.
Subramanian, in the same field of endeavor of an electrical stimulation cuff (Abstract), teaches a cuff body 352 with electrodes disposed on the interior surface of the cuff body and arranged in two sets (containing potentially hundreds of electrodes) in rings around the inner circumference of the cuff body (Figs. 3-6, [0050]). The electrode set configurations can be either aligned (as in having the same configuration) or staggered/unaligned based on the desired spatial pattern for stimulation along the length of the cuff ([0050]). The electrodes can selectively stimulate particular nerve fibers based on the positioning of the electrodes ([0049]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Bolea and Dillon by incorporating the distinct sets of similarly arranged electrodes along the length of the cuff in Subramanian. This would have been obvious because both Bolea and Subramanian discuss nerve cuffs providing electrical stimulation and Subramanian provides a solution/improvement of aligned longitudinal electrodes to provide a particular spatial electrical field for nerve fiber activation. Therefore, a person of ordinary skill in the art would be motivated to improve the multiple cuffs with independent leads positioned along a nerve in Bolea by incorporating the sets of similarly arranged longitudinal electrodes in Subramanian so that electrodes would have the same configuration when the cuffs of Bolea are attached using the mechanism in Dillon.
Regarding Claim 11, the cuff lead arrangement according to Claim 10 is obvious over Bolea in view of Dillon and Subramanian, as indicated hereinabove. Bolea discloses cuffs 200A, 200B, and 200C may contain one or more electrodes ([0085]), but does not discuss the relative orientation of the electrodes between cuffs. Therefore, Bolea does not explicitly disclose wherein, when conjoined, the second electrodes in the first arrangement are rotationally offset from the first electrodes in the first arrangement.
As stated in claim 10, the proposed combination with Subramanian yields a cuff body 352 with electrodes disposed on the interior surface of the cuff body and arranged in two sets (containing potentially hundreds of electrodes) in rings around the inner circumference of the cuff body (Figs. 3-6, [0050]). The electrode set configurations can be either aligned or staggered/unaligned based on the desired spatial pattern for stimulation along the length of the cuff ([0050]). The electrodes can selectively stimulate particular nerve fibers based on the positioning of the electrodes ([0049]). A person of ordinary skill in the art would be motivated to improve the multiple cuffs with independent leads positioned along a nerve in Bolea by incorporating the offset longitudinal electrodes in Subramanian (to provide a particular spatial electrical field for nerve fiber activation) so that electrode sets are not aligned when the cuffs of Bolea are attached using the mechanism in Dillon.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Benjamin Schmitt, whose telephone number is 703-756-1345. The examiner can normally be reached on Monday-Friday from 9:00 am to 5:00 pm.
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/Benjamin A. Schmitt/
Examiner
Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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