DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 20 March 2026 has been entered in light of the RCE filed 31 March 2026.
Notice of 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 .
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 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.
Response to Arguments
Claim 1 was amended to recite a third arm such that the first and second arms are parallel or substantially parallel in at least a portion. A third arm was previously recited in claim 9.
Claim 9 was not rejected under DaSilva’714 because DaSilva’714 does not disclose a third arm. Therefore, the amendment to claim 1 overcomes DaSilva’714.
Claim 9 was previously rejected under Little’424. However, claim 1 now recites the first and second arms are parallel or substantially parallel in at least a portion. The first and second arms (75 and 56, respectively) are not parallel in at least a portion. Therefore, the amendment to claim 1 overcomes the rejection under Little’424.
However, upon further search and consideration, a new rejection follows below.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 5-7, 9-10, 22, 33 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Gruger (US Patent 104,018).
Claim 1: Gruger’018 discloses a surgical device (Figure 2) capable of cutting a percutaneous implant, the surgical device comprising:
a proximal end (towards r) and a distal end (towards A)
wherein the proximal end comprises a handle (r can be grasped);
wherein the distal end comprises a first arm (a), a second arm (a’), and a first cutting element (labeled in the annotated copy of Figure 1 below)) fixedly coupled with the first arm and the second arm and comprising a sharpened surface (distal end of blade is sharp) disposed at least partially between the first arm and the second arm (Figure 1); and
wherein the sharpened surface has a first end adjacent to the first arm, a second end adjacent to the second arm, and a middle section proximal to the first end and distal to the second end (Figure 1);
wherein at least a portion of at least one of the first arm and the second arm is distal to the first cutting element to prevent or inhibit the first cutting element from cutting tissue adjacent to the percutaneous implant during use of the surgical device to cut the percutaneous implant (Figure 1);
a third arm (A) disposed between the first arm and the second arm, wherein at least a portion of the first cutting element is disposed between the first arm and the third arm (Figure 1);
a second cutting element (see annotated copy of Figure 1 below), wherein at least a portion of the second cutting element is disposed between the second arm and the third arm (Figure 1);
wherein at least a portion of the first arm is parallel or substantially parallel to at least a portion of the second arm (Figure 1 shows the first and second arms are substantially parallel at their tips); and
wherein the third arm is configured for insertion into an opening in the percutaneous implant such that the first cutting element and the second cutting element simultaneously or substantially simultaneously create, respectively, a first cut and a second cut in the percutaneous implant when the surgical device is advanced distally relative to the percutaneous implant (note: the implant is introduced functionally in claim 1 and is not considered a positively recited element of the invention. Arms A is capable of fitting into the lumen of an implant since implants come in many shapes and sizes.)
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Claim 2: Gruger’018 discloses the first cutting element (see annotated copy of Figure 1 above) comprises a first blade (column 1 identifies a knife blade B]).
Claim 3: Gruger’018 discloses the first blade extends at least partially between an inner surface of the first arm (a) and an inner surface of the third arm (A) (Figure 1).
Claim 5: Gruger’018 discloses the third arm (A) has a width or diameter that is less than a width or diameter opening in the percutaneous implant (note: the implant is introduced functionally in claim 1 and is not considered a positively recited element of the invention. Arms A is capable of fitting into the lumen of an implant since implants come in many shapes and sizes).
Claim 6: Gruger’018 discloses at least a portion of the first arm is spaced from at least a portion of the third arm by a first distance (Figures 1), the first distance being larger than a wall thickness of at least a portion of the percutaneous implant to be cut by the surgical device (note: the implant is introduced functionally in claim 1 and is not considered a positively recited element of the invention. Arms a, A are spaced such that one of the arms is capable of fitting into the lumen of an implant since implants come in many wall thicknesses and sizes.)
Claim 7: Gruger’018 discloses the position of the first cutting element is fixed with respect to the first arm and the third arm during use of the surgical device to cut the percutaneous implant (Figure 1; note: the implant is introduced functionally in claim 1 and is not considered a positively recited element of the invention. To function or cut, Gruger’018’s blade does not move – see Figures 5 and 6).
Claim 9: Gruger’018 discloses the third arm (A) having a proximal end and a distal end (end surface of A – i.e. end of A towards the top of the page with respect the figure), the proximal end of the third arm being disposed between the first arm and the second arm (Figure 1), and the distal end of the third arm being distal to at least one of the first arm and the second arm (Figure 1).
Claim 10: Gruger’018 discloses the third arm (A) has an opening permitting a guidewire to pass through at least the third arm (see arrow in annotated copy of Figure 2 below).
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Claim 22: Gruger’018 discloses a first guide surface (see annotated copy of Figure 1 below) proximal to at least a portion of the first cutting element (at least a portion of this surface is proximal to the cutting element – see Figure 1) and configured to guide at least a first portion of the percutaneous implant cut by the first cutting element in a first direction generally away from a longitudinal axis of the surgical device during use of the surgical device (slope of the surface is capable of guiding an implant radially outward from the longitudinal axis of the device as the cutting element is moved); and
a second guide surface (see annotated copy of Figure 1 below) proximal to at least a portion of the second cutting element (at least a portion of this surface is proximal to the cutting element – see Figure 1) and configured to guide at least a second portion of the percutaneous implant cut by the second cutting element in a second direction generally away from the longitudinal axis of the surgical device during use of the surgical device (slope of the surface is capable of guiding an implant radially outward from the longitudinal axis of the device as the cutting element is moved).
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Claim 33: The percutaneous implant is not a positively recited element of the invention. Because Gruger’018 discloses the claimed structure, it is considered to be capable of cutting a PEG tube, RIG tube, or a gastrostomy tube. See MPEP 2114 Section II.
Claim 48: Gruger’018 discloses a longitudinal axis passing through the proximal end and the distal end Figure 1), wherein each portion of the sharpened surface between the first arm and the second arm is non-perpendicular with respect to the longitudinal axis (Figure 1).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSEY BACHMAN whose telephone number is (571)272-6208. The examiner can normally be reached Monday-Friday 9am-5pm and alternating Fridays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached on 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Lindsey Bachman
/L.B./Examiner, Art Unit 3771 22 June 2026
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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