DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 3/6/2026 have been fully considered but they are not persuasive. Applicant argues on page 8 under the Remarks, “Yu's anchoring ring 46 is located "on the lateral side of the paddle body 44 near the proximal end." Yu paragraph [0049]; Fig. 4B. Yu's ring 46 extends from the lateral edge of the paddle body. The lateral edge is the narrow peripheral boundary of the paddle; it is not a surface of the paddle body. The first surface and second surface, as recited in amended claim 1, are the two broad faces of the curved body. Yu's ring 46 does not extend from either face. It extends from the edge between the faces.”
The Examiner respectfully disagrees. First, in Claim 1 Applicant claims “a curved body comprising a first and second surface” and does not provide any details regarding the location of said surfaces. Therefore, in the argument provided by Applicant, the lateral surface from which the ring 46 extends can be considered “the first surface”. The ring 46 has a base that is part of that surface and the apex of the ring extends away from that surface. This is a different surface than the front surface to which the electrodes are attached. Yu therefore still reads on the claim.
Additionally, due to the lack of established boundaries of the first and second surfaces in Claim 1, it could be argued the back and side of the paddle lead form a first surface and the front face of the lead forms the second surface. In this interpretation, the ring still extends from the first surface and the electrical conductors (electrodes) are on the second surface as claimed. This applies to new claim 18.
Lastly, even if the first surface is claimed as the back of the paddle and the second surface is claimed as the front of the paddle in Claim 1, the ring on the side of the paddle would still extend away from the first surface in that the ring projects laterally away from the first surface. Nothing in the claim requires the ring to have its base on any particular surface and only requires the extension direction of the anchor to be away from the first surface.
The rejection of Claims 1-13 is maintained.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a securement member” in claims 1, 7 and 9.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. For the purposes of examination, the “securement member” will be interpreted as “a cinchable tie”; a “surgical suture” and equivalents thereof as set forth in claims 8 and 13 of the originally filed claims and par. [0006] of the originally filed disclosure.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 18 and 22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 18 includes “an electrical conductor disposed on the second surface of the curved body” and then includes “an inductive electrical element embedded in or mounted on the curved body, the inductive electrical element configured to receive an inductive electrical current from a stimulator device”. Therefore, Applicant is claiming in a singles lead both a wired form of energy delivery and a wireless form of energy delivery. However, Applicant’s originally field disclosure describes these as two distinct embodiments and not two embodiments combined to form a single invention; “In some embodiments, the implant can have an electrode/conductor associated therewith. The electrode/conductor can be associated with a stimulator device. The stimulator device can include a neurostimulator. In one embodiment, the implant and stimulator device can be electrically and communicatively coupled via a wired connection. In another example, the implant and stimulator device can be coupled wirelessly through an inductive means. (emphasis added)” (par. [0022] of PGPUB 2023/0285749 (the publication of the present application). The Examiner suggests amending the claim to either pursue the wired stimulation embodiment or the wireless stimulation embodiment and not both.
The combination of Claims 1 and 22 contain the same issue.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 23 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The term “generally” in claim 23 is a relative term which renders the claim indefinite. The term “generally” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear to what degree a shape has to resemble a polygon to be considered a “generally polygonal shape”.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-13 and 19 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Yu (PGPUB 2016/0166828).
Regarding Claims 1, 7-9, 12, 13 and 19 , Yu discloses a paddle lead body 44 having a curvature (Fig. 4b; par. [0045] indicates any of the paddle embodiments can have a curved shape); a rigid anchor member 46 having an aperture and monolithically formed with the curved body and extending, orthogonally away from the curved body (par. [0047]; Fig. 4B); and a securement member such as a suture configured to loop through the aperture. Yu further discloses, an electrical conductor 20 associated with the curved body (Fig. 4B; par. [0003]) and a stimulator device 22 coupled to the electrical conductor 20 (par. [0003, 0083]; Fig. 1). In one interpretation of the first and second surfaces, the lateral surface from which the ring 46 extends can be considered “the first surface”. The ring 46 has a base that is part of that surface and the apex of the ring extends away from that surface. This is a different surface than the front surface to which the electrodes are attached. In another interpretation, the back and side of the paddle lead form a first surface and the front face of the lead forms the second surface. In this interpretation, the ring still extends from the first surface and the electrical conductors (electrodes) are on the second surface as claimed. Lastly, even if the first surface is interpreted as the back of the paddle and the second surface is interpreted as the front of the paddle in Claim 1, the ring on the side of the paddle would still extend away from the first surface in that the ring projects laterally away from the first surface. Nothing in the claim requires the ring to have its base on any particular surface and only requires the extension direction of the anchor to be away from the first surface. Specifically in terms of Claims 7 and 12 , the Examiner notes the functional recitation of “looped through the aperture of the anchor member and is adapted to loop around the posterior tubercle and/or the posterior arches of the cervical vertebra…” are intended use limitations that fail to further define the structure of the claimed invention. The Examiner note a suture is capable of being tired around the claimed anatomical locations in the manner claimed.
Regarding Claim 3, Yu discloses a stimulator device 22 coupled to the electrical conductor 20 (par. [0003, 0083]; Fig. 1).
With regard to Claims 4, 5 and 10, the designation “horizontally” and “vertically” depend on how the device is oriented in the body and what frame of reference is considered horizontal and vertical. The paddle lead of Yu is capable of being implanted in any orientation within the body and therefore is capable of extending vertically, such as a direction parallel the cervical spinal column or horizontally, a direction transverse the cervical spinal column.
In regards to Claims 6 and 11, for the sake of art interpretation, the Examiner is taking the stance that this is an intended use limitation. The prior art need only be capable of the claimed function to anticipate the claim. The Examiner contends that the anchor member 46 is of such size that it is capable of contact the posterior tubercle and/or posterior arches of the cervical vertebrae.
Regarding Claims 9, 12 and 13, Yu discloses a paddle lead body 44 having a curvature (Fig. 4b; par. [0045] indicates any of the paddle embodiments can have a curved shape); a rigid anchor member 46 having an aperture and monolithically formed with the curved body and extending, orthogonally away from the curved body (par. [0047]; Fig. 4B); and a securement member such as a suture configured to loop through the aperture. Yu further discloses, an electrical conductor 20 associated with the curved body (Fig. 4B; par. [0003]) and a stimulator device 22 coupled to the electrical conductor 20 (par. [0003, 0083]; Fig. 1).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Raines (US Patent 9,084,882) in view of Yu (PGPUB 2016/0166828).
Regarding Claim 18, Raines discloses a paddle lead having a first surface (top surface that extends to lateral side of the paddle) and a second surface (the back of the paddle) inductive electrical elements (wire 602 around bobbin 502); and electrical conductors 1402 disposed on a second surface of the paddle, i.e. the back of the paddle (see Fig. 14; col. 11, lines 20-30). Raines discloses circular anchor members for suturing the paddle lead in place (see holes in Fig. 12). Raines fails to explicitly disclose the suture; ails to disclose curving the paddle lead body and fails to disclose the anchor member monolithically formed as a single piece with the curved body and extending orthogonally from the first surface of the curved body. However, Yu in the same field of endeavor of paddle leads for stimulation discloses a paddle lead body 44 having a curvature (Fig. 4b; par. [0045] indicates any of the paddle embodiments can have a curved shape); a rigid anchor member 46 having an aperture and monolithically formed with the curved body and extending, orthogonally away from the curved body, specifically a lateral side of the curved body which would equate to the region of Raines defined as part of the first surface (par. [0047]; Fig. 4B); and a securement member such as a suture configured to loop through the aperture. The curvature provides the benefit of allowing the lead to conform to the target stimulation site thus improving electrical contact (par. [0045]). The anchor member 46 as disclosed provides the benefit of promoting improved anchoring to the tissue site (par. [0047]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Raines reference to include a curved body; an anchor member extending laterally away from the first surface; and a suture, as taught and suggested by Yu, for the purpose of allowing the lead to conform to the target stimulation site thus improving electrical contact and promoting improved anchoring to the tissue site .
Claims 18 and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Yu (PGPUB 2016/0166828) in view of Raines (US Patent 9,084,882).
Regarding Claims 18 and 22, Yu discloses a paddle lead body 44 having a curvature (Fig. 4b; par. [0045] indicates any of the paddle embodiments can have a curved shape); a rigid anchor member 46 having an aperture and monolithically formed with the curved body and extending, orthogonally away from the curved body (par. [0047]; Fig. 4B); and a securement member such as a suture configured to loop through the aperture. Yu further discloses, an electrical conductor 20 associated with the curved body (Fig. 4B; par. [0003]) and a stimulator device 22 coupled to the electrical conductor 20 (par. [0003, 0083]; Fig. 1). The Examiner notes the back and side of the paddle lead form a first surface and the front face of the lead forms the second surface. In this interpretation, the ring extends from the first surface and the electrical conductors (electrodes) are on the second surface as claimed. Yu is silent regarding the incorporation of an inductive electrical element. However, Raines, in the same field of endeavor of paddle leads, discloses incorporating an inductor (a wire 602 coiled around bobbin 502 (Fig. 6) for the purpose of providing MRI compatibility of the lead. The language “configured to receive an inductive electrical current from a stimulator device” is intended use and the coil is capable of receiving inductive electrical current from a source of power, such as an MRI machine which provides electromagnetic stimuli. This configuration would also be capable of receiving energy from other devices such as nerve stimulators as long as the frequency of the energy is tuned to the coil. Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Yu reference to include an inductive electrical element, as taught and suggested by Raines, for the purpose of providing MRI protection.
Regarding Claims 20 and 21, Yu discloses all of the claimed invention except for a dielectric material. However, Raines discloses incorporating a dielectric material (e.g. a n insulative material) between the electrodes for the purpose of electrically isolating the electrodes from one another (col. 6, lines 9-24). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Yu reference to include a dielectric material, as taught and suggested by Raines, for the purpose of electrically isolating the electrodes from one another.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Yu (PGPUB 2016/0166828) in view of Jordan (2004/0243208). Yu discloses all of the claimed invention except for forming the lead in a generally polygonal shape having two tapered lateral edges. However, Jordan, in the same field of endeavor of paddle leads, discloses tapering two lateral edges to form a general polygonal shape for the purpose of preventing abrasion of tissue (par. [0034]; Fig. 1). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Yu reference to include two tapered lateral edges, as taught and suggested by Jordan, for the purpose of preventing abrasion of tissue.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ALLEN PORTER/Primary Examiner, Art Unit 3796
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