DETAILED ACTION
The following Office Action is in response to the Amendment filed on December 15, 2025. Claims 1 and 3-20 are currently pending.
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
Concerning the “Claim Interpretation” section on page 8 of the Applicant’s Response filed on December 15, 2025, the applicant requests the examiner identify the claim and element for which 35 U.S.C. §112(f) is invoked. However, the examiner was merely setting forth that no limitations are being interpreted under 35 U.S.C. §112(f) given no “means for” language was used.
Concerning the “Title” section on page 8 of the Applicant’s Response filed on December 15, 2025, the applicant requests reconsideration of the objection to the title of the application, arguing that the title precisely matches the subject in the preamble of each claim. However, the examiner asserts that the matching of the preamble does not necessarily meet the standards of a descriptive title. As stated in MPEP 606.01, a descriptive title is necessary for informative value in indexing, classifying, and searching etc. If a satisfactory title is not supplied by the application, the examiner may, at the time of allowance, change the title by examiner’s amendment. Therefore, the objection to the title stands.
Concerning the “Section 112(b) – claim 17” section on page 8 of the Applicant’s Response filed on December 15, 2025, the applicant’s arguments have been fully considered, and they are persuasive. The amendment to claim 17 to address the issue of antecedent basis has obviated the necessity of the rejection. Therefore, the rejection of claim 17 under 35 U.S.C. §112(b) is withdrawn.
Concerning the “Section 103 – claims 1, 3, 4, 7-9, 11, 13, 15, and 18: Claims 1, 3, 4, 7-9, 11, and 13” section on pages 8-9 of the Applicant’s Response filed on December 15, 2025, the applicant’s arguments have been fully considered, but they are not persuasive. The applicant argues that the combination of the Skubitz and Schulte references does not teach the newly added limitation of “each jaw of said pair of arms is offset from the working end of the corresponding arm of said pair of arms such that the jaws of said pair of jaws are farther apart than the cooperative faces of the working ends of the pair of arms”. However, the examiner asserts that the Skubitz reference shows that the concave inner surfaces of the jaws, with the midline of both the inner and outer surfaces of the jaws, are offset from the working end of the corresponding arms (Figure 8A; 38), therein defining each jaw as being offset from the working end of the corresponding arm. Therefore, the rejections of the claims under 35 U.S.C. §103 stand.
Concerning the “Section 103 – claims 1, 3, 4, 7-9, 11, 13, 15, and 18: Claim 15” section on pages 9-10 of the Applicant’s Response filed on December 15, 2025, the applicant’s arguments have been fully considered, but they are not persuasive. As discussed above with respect to claim 1, the combination of the Skubitz and Schulte references does teach the limitation of “each jaw of said pair of arms is offset from the working end of the corresponding arm of said pair of arms such that the jaws of said pair of jaws are farther apart than the cooperative faces of the working ends of the pair of arms”. Therefore, the rejection of the claim 15 under 35 U.S.C. §103 stands.
Concerning the “Section 103 – claims 1, 3, 4, 7-9, 11, 13, 15, and 18: Claim 18” section on pages 9-10 of the Applicant’s Response filed on December 15, 2025, the applicant’s arguments have been fully considered, but they are not persuasive. The applicant argues that the combination of the Skubtiz and Schulte references does not teach the limitation of “a guide comprising a hollow cylindrical tube”, arguing that the Schulte reference merely teaches grips comprising C-shaped clips. However, the examiner asserts that the shape of the C-shaped clips may be interpreted as having a tubular profile, and wherein said tubular profile is hollow (Figure 8; clips 140ab are shaped as hollow cylinders with a longitudinal slot running down the side), therein allowing said clips to be interpreted as hollow cylindrical tubes. Therefore, the rejection of claim 18 under 35 U.S.C. §103 stands.
Concerning the “Section 103 – claims 5, 10, 12, 16, and 18” section on page 11 of the Applicant’s Response filed on December 15, 2025, the applicant’s arguments have been fully considered, but they are not persuasive. The applicant argues that the Ahmad reference does not cure the deficiencies of the Skubitz and Schulte combination. However, the examiner asserts that the Skubitz and Schulte combination is not deficient in any teachings with regards to the independent claims as discussed above. Therefore, the rejections of the claims under 35 U.S.C. §103 stand.
Concerning the “Section 103 – claims 6 and 17” section on page 11 of the Applicant’s Response filed on December 15, 2025, the applicant’s arguments have been fully considered, but they are not persuasive. The applicant argues that the Nanda reference does not cure the deficiencies of the Skubitz and Schulte combination. However, the examiner asserts that the Skubitz and Schulte combination is not deficient in any teachings with regards to the independent claims as discussed above. Therefore, the rejections of the claims under 35 U.S.C. §103 stand.
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.
Claim(s) 1, 3-4, 7-9, 11, 13, 15, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Skubitz et al. (US 2015/0230813, hereinafter Skubitz) in view of Schulte et al. (US 2013/0268041, hereinafter Schulte).
Concerning claim 1, the Skubitz et al. prior art reference teaches a surgical instrument (Figures 1-8b; 10) for positioning a paddle electrode having opposite side edges extending between a leading edge and a trailing edge opposite the leading edge (Figure 5; 60), the paddle electrode having leads extending from the trailing edge (Figure 5; 68), said instrument comprising: a pair of flexibly resilient arms (Figure 3; 24, 34) operatively coupled at a user end of each arm of said pair of arms (Figure 3; 15), each arm of said pair of arms extending longitudinally along a rearward section from the corresponding user end (See OA Figure 1 below; annotated Figure 5) to an intermediate section extending obliquely upward relative to the rearward section (See OA Figure 1 below; annotated Figure 5) to a forward section extending downward relative to the intermediate section toward a working end opposite the corresponding user end (See OA Figure 1 below; annotated Figure 5), each arm of said pair of arms having a cooperative face facing the other arm of said pair of arms and an outer face facing opposite said cooperative face; a jaw formed adjacent to the working end of each arm of said pair of arms adapted to engage a selected side edge of the paddle electrode when gripping the paddle electrode (Figure 1; 37, 37); wherein the jaws of said pair of arms are separated by a gap (Figure 1; 27, 37) that is larger than a distance between the opposite side edges of the paddle electrode when said pair of arms are unflexed, depending on the specific size of the specific paddle electrode, each jaw of said pair of arms being offset from the working end of the corresponding arm of said pair of arms such that the jaws of said pair of jaws are father apart than the cooperative faces of the working ends of the pair of arms (Figure 8; concave inner surfaces of the jaws 38 are offset from the working end of the corresponding arms 320, 330, therein defining each jaw as being offset from the working end of the corresponding arm); said pair of arms is capable of being flexed to reduce the gap separating the jaws of said pair of arms with the side edges of the paddle electrode to grip the paddle electrode ([¶ 0027, 0040]); and said pair of arms is sufficiently resilient to return said pair of arms to a released configuration in which the gap separating the jaws of said pair of arms is larger than the distance between the opposite side edges of the paddle electrode ([¶ 0041]), but does not specifically teach a guide located along the forward section of each arm of the pair of arms adapted to receive a selected lead of the leads of the paddle electrode when the jaws of said arms of said pair of arms are gripping the paddle electrode.
However, the Schulte reference teaches a surgical instrument for positioning a paddle electrode, therein being in the same field of endeavor as the Skubitz reference, wherein the Schulte reference teaches an arm of the instrument (Figure 8; 136) including a guide adapted to receive a lead of the paddle electrode ([¶ 0043]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the guide of the Schulte reference be located along the forward section of each arm of the pair of arms of the Skubitz reference and adapted to receive a selected lead of the leads of the paddle electrode when the jaws of said arms of said pair of arms are gripping the paddle electrode to prevent the leads of the paddle electrode of the Skubitz reference from interfering with the implantation procedure (Schulte; [¶ 0043]).
Concerning claim 3, the combination of the Skubitz and Schulte references as discussed above teaches the surgical instrument as set forth in claim 1, wherein the Skubitz reference further teaches the gap by which the jaws of said pair of arms being separated being larger than a space between the working ends of the arms of said pair of arms (Figure 1; 38).
Concerning claim 4, the combination of the Skubitz and Schulte references as discussed above teaches the surgical instrument as set forth in claim 1, wherein the Skubitz reference further teaches each jaw having a groove facing the jaw of the outer arm of said pair of arms (Figure 1; 38).
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OA Figure 1
Concerning claim 7, the combination of the Skubitz and Schulte references as discussed above teaches the surgical instrument as set forth in claim 1, wherein the Skubitz reference further teaches each jaw having a concave face facing the jaw of the other arm of said pair of arms (Figure 1; 38).
Concerning claims 8 and 9, the combination of the Skubitz and Schulte references as discussed above teaches the surgical instrument as set forth in claim 1, wherein the Skubitz reference further teaches a seat formed on the outer face of each arm of said pair of arms adapted to grasp and manipulate the instrument (OA Figure 1; flat outer surface of intermediate section may be defined as a seat given an users finger may sit on said portion), wherein the seat is located on the intermediate section on each arm of said pair of arms (a seat may be defined as any place where something may be seated).
Concerning claim 11, the combination of the Skubitz and Schulte references as discussed above teaches the surgical instrument as set forth in claim 1, wherein the Schulte reference further teaches the guide comprising a hollow tube (Figure 8; 140ab, guide may be interpreted as a hollow tube with a longitudinal slot running through a side), which in the combination is mounted on the forward section of the corresponding arm of said pair of arms.
Concerning claim 13, the combination of the Skubitz and Schulte references as discussed above teaches the surgical instrument as set forth in claim 11, wherein the Schulte reference further teaches each hollow tube being cylindrical having a centerline extending to the distal end of the shaft (Figure 8; clip 140ab defines a tubular profile which is hollow, therein allowing it to be interpreted as a hollow cylindrical tube), which in the combination would correspond to the forward section of the corresponding arm of said pair of arms.
Concerning claim 15, the Skubitz et al. prior art reference teaches a surgical instrument (Figures 1-5; 10) for positioning a paddle electrode having opposite side edges extending between a leading edge and a trailing edge opposite the leading edge (Figure 5; 60), the paddle electrode having leads extending from the trailing edge (Figure 5; 68), said instrument comprising: a pair of flexibly resilient arms (Figure 3; 24, 34) operatively coupled at a user end of each arm of said pair of arms (Figure 3; 15), each arm of said pair of arms extending to a working end opposite the corresponding user end, each arm of said par of arms having a cooperative face facing the other arm of said pair of arms and an outer face facing opposite said cooperative face; a jaw formed at and offset from the working end of each arm of said pair of arms (Figure 1; 27, 37), each said jaw having a concave face facing the jaw of the outer arm of said pair of arms and a groove extending across said concave face, the width of said groove being adapted to receive a paddle electrode side edge (Figure 1; 38 | [¶ 0043]), wherein: the jaws of said pair of arms are separated by a gap that is larger than a distance between the opposite side edges of the paddle electrode when the pair of arms is unflexed, depending on the specific size of the specific paddle electrode, each jaw of said pair of arms being offset from the working end of the corresponding arm of said pair of arms such that the jaws of said pair of jaws are father apart than the cooperative faces of the working ends of the pair of arms (Figure 8; concave inner surfaces of the jaws 38 are offset from the working end of the corresponding arms 320, 330, therein defining each jaw as being offset from the working end of the corresponding arm); said pair of arms is capable of being flexed to reduce the gap separating the jaws of said pair of arms with the side edges of the paddle electrode to grip the paddle electrode ([¶ 0027, 0040]); and said pair of arms is sufficiently resilient to return said pair of arms to a released configuration in which the gap separating the jaws of said pair of arms is larger than the distance between the opposite side edges of the paddle electrode ([¶ 0041]), but it does not specifically teach a guide located along each arm of the pair of arms adapted to receive a selected lead of the leads of the paddle electrode when the jaws of said arms of said pair of arms are gripping the paddle electrode.
However, the Schulte reference teaches a surgical instrument for positioning a paddle electrode, therein being in the same field of endeavor as the Skubitz reference, wherein the Schulte reference teaches an arm of the instrument (Figure 8; 136) including a guide adapted to receive a lead of the paddle electrode ([¶ 0043]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the guide of the Schulte reference be located on each arm of the pair of arms of the Skubitz reference and adapted to receive a selected lead of the leads of the paddle electrode when the jaws of said arms of said pair of arms are gripping the paddle electrode to prevent the leads of the paddle electrode of the Skubitz reference from interfering with the implantation procedure (Schulte; [¶ 0043]).
Concerning claim 18, the Skubitz et al. prior art reference teaches a surgical instrument (Figures 1-5; 10) for positioning a paddle electrode having opposite side edges extending between a leading edge and a trailing edge opposite the leading edge (Figure 5; 60), the paddle electrode having leads extending from the trailing edge (Figure 5; 68), said instrument comprising: a pair of flexibly resilient arms (Figure 3; 24, 34) operatively coupled at a user end of each arm of said pair of arms (Figure 3; 15), each arm of said pair of arms extending to a working end opposite the corresponding user end, each arm of said par of arms having a cooperative face facing the other arm of said pair of arms and an outer face facing opposite said cooperative face; a jaw formed at and offset from the working end of each arm of said pair of arms (Figure 1; 27, 37), each said jaw having a concave face facing the jaw of the outer arm of said pair of arms (Figure 1; 38), wherein: the jaws of said pair of arms are separated by a gap that is larger than a distance between the opposite side edges of the paddle electrode when the pair of arms is unflexed, depending on the specific size of the specific paddle electrode, said pair of arms is capable of being flexed to reduce the gap separating the jaws of said pair of arms with the side edges of the paddle electrode to grip the paddle electrode ([¶ 0027, 0040]); and said pair of arms is sufficiently resilient to return said pair of arms to a released configuration in which the gap separating the jaws of said pair of arms is larger than the distance between the opposite side edges of the paddle electrode ([¶ 0041]), but it does not specifically teach a guide located along the forward section of each arm of the pair of arms adapted to receive a selected lead of the leads of the paddle electrode when the jaws of said arms of said pair of arms are gripping the paddle electrode.
However, the Schulte reference teaches a surgical instrument for positioning a paddle electrode, therein being in the same field of endeavor as the Skubitz reference, wherein the Schulte reference teaches an arm of the instrument (Figure 8; 136) including a guide adapted to receive a lead of the paddle electrode ([¶ 0043]), the guide comprising a hollow tube (Figure 8; clip 140ab defines a tubular profile with a longitudinal slot running down the side, the tubular profile being hollow, therein allowing it to be interpreted as a hollow cylindrical tube) adjacent to the working end of the arm, said hollow cylindrical tube extending along a centerline of the arm and having an interior diameter sized to receive at least one lead of said paddle electrode lead ([¶ 0043]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the guide of the Schulte reference be located adjacent the working end of each arm of the pair of arms of the Skubitz reference and adapted to receive a selected lead of the leads of the paddle electrode when the jaws of said arms of said pair of arms are gripping the paddle parade to prevent the leads of the paddle electrode of the Skubitz reference from interfering with the implantation procedure (Schulte; [¶ 0043]).
Claim(s) 5, 10, 12, 16, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Skubitz et al. (US 2015/0230813, hereinafter Skubitz) in view of Schulte et al. (US 2013/0268041, hereinafter Schulte) as applied to claims 1, 3-4, 7-9, 11, 13, 15, and 18 and further in view of Ahmad et al. (US 2017/0333714, hereinafter Ahmad).
Concerning claims 5 and 16, the combination of the Skubitz and Schulte references as discussed above teaches the surgical instrument as set forth in claims 4 and 15, but does not teach the width of each groove.
However, the Skubitz reference teaches that the groove is sized to receive a surface of a paddle lead body (Skubiz; [¶ 0029]), while the Ahmad reference teaches a paddle lead body which may have a thickness of about 3 mm (Ahmad; [¶ 0038]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the groove of the Skubitz and Schulte combination have a width of 3 mm given said width is the size of a known paddle electrode (Ahmad; [¶ 0038]).
Concerning claim 10, the combination of the Skubitz and Schulte references as discussed above teaches the surgical instrument as set forth in claim 9, wherein the pair of arms are capable of being flexed using a conventional pressure applied to the seats to reduce the gap separating the jaws of said pair of arms, but does not specifically teach a gap width.
However, the Skubitz reference teaches that the gap is intended to be sized to receive a paddle lead body, while Ahmad reference teaches a paddle lead body which may have a width of 10 mm (Ahmad; [¶ 0038]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the gap of the Skubitz and Schulte combination be capable of reducing to a width of 10 mm given said width is the width of a known paddle electrode (Ahmad; [¶ 0038]).
Concerning claims 12 and 19, the combination of the Skubitz and Schulte references as discussed above teaches the surgical instrument as set forth in claims 11 and 18, but does not teach the minimum interior width of the hollow tube.
However, the Schulte reference teaches that the hollow tube is sized to receive the lead body (Schulte; [¶ 0043]), while the Ahmad reference teaches a paddle electrode which may have a lead body with a diameter of 3 mm (Ahmad; [¶ 0038]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the tube of the Skubitz and Schulte combination have a minimum interior width of 3 mm given said width is the size of a known lead body for a paddle electrode (Ahmad; [¶ 0038]).
Claim(s) 6 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Skubitz et al. (US 2015/0230813, hereinafter Skubitz) in view of Schulte et al. (US 2013/0268041, hereinafter Schulte) as applied to claims 1, 3-4, 7-9, 11, 13, and 18 and further in view of Nanda et al. (US 2020/0078032, hereinafter Nanda).
Concerning claims 6 and 17, the combination of the Skubitz and Schulte references as discussed above teaches the surgical instrument as set forth in claims 4 and 16, wherein each said groove may be defined as a first groove, but does not specifically teach each jaw having a plurality of parallel grooves including said first groove facing the jaw of the other arm of said pair of arms.
However, Nanda reference teaches a forceps device having a similar structure to that of the Skubitz and Schulte combination, wherein the Nanda reference teaches the forceps having jaws at the working end of the forceps (Figure 1; 110, 112), wherein the jaw may have a concave groove (Figure 2; 118) and may further include a plurality of parallel grooves (Figure 3; 127).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have each jaw of the Skubitz and Schulte combination include a plurality of parallel grooves in addition to the first groove as in the Nanda reference to provide anti-slip elements on the inner jaw surfaces (Nanda; [¶ 0027]).
Allowable Subject Matter
Claims 14 and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN TRUYEN TON whose telephone number is (571)270-5122. The examiner can normally be reached Monday - Friday; EST 10:00 AM - 6:30 PM.
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/MARTIN T TON/Examiner, Art Unit 3771 3/6/2026