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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/17/2025 has been entered.
Response to Amendment
As of the reply filed 12/17/2025, claims 1-5, 10, and 15 are pending. Claims 6-9 and 11-14 remain canceled. Claim 1 has been amended.
Response to Arguments
Applicant’s amendments to claim 1 have overcome the previously filed claim objections, therefore these claim objections are withdrawn.
Applicant's arguments filed 12/17/2025 have been fully considered but they are not persuasive.
With respect to Applicant’s argument regarding the previously filed rejection under 35 U.S.C. 112(a) that “para [0031] of the Specification explicitly provides direct support for the limitation indicated by the Office… that ‘[when] the lever 12 is in the first lever position shown in Figure 2A, the push rod 36 is in the first rod position in which the distal end 40 of the push rod 36 is disposed at a first distance from the distal end 22 of the shaft 18…’ [and] ’[i]n this position, the distal end 40 of the push rod 36 is remote from, and therefore not engaging, a ramp portion 42 of the needle assembly 24, as illustrated in Fig. 5B’” (see Remarks pages 5-6), the Examiner respectfully disagrees. The present specification recites that “the distal end of the push rod 36 is remote from, and therefore not engaging, a ramp portion 42” whereas claim 1 recites “when the push rod is in the first rod position, the distal end of the push rod does not contact the ramp portion”, which has a different meaning due to the difference in plain language. While the specification provides support for the rod being apart from the ramp portion, the present specification does not provide support for the push rod being entirely out of contact with the ramp portion. Merriam-Webster dictionary defines “contact” as “a union or junction of surfaces”, which includes a union of surfaces through intervening structures. Even if Fig. 5B showed a lack of contact between the distal end of the push rod (40 of rod 36), the distal end of the push rod and the ramp are contacting one another through other intervening structures of the device, such as the shaft 18 which can be seen in Fig. 5D to be contacting both the ramp (42) and the push rod (36), including its distal end (40). Fig. 5B, however, does not clearly show this lack of contact in the first position (see annotated Fig. 5B below).
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With respect to Applicant’s argument that “Green fails to disclose that the needle assembly is formed as a single, monolithic part” (see Remarks pages 7-8), the Examiner respectfully disagrees. The term “monolithic” is not defined by the present specification, therefore the dictionary definition “consisting of or comprising a single unit” (Merriam-Webster) is relied upon to interpret the broadest reasonable interpretation of the amended limitation. Since the needle assembly of Green et al. can be considered to be a single unit and since the present disclosure does not offer any special definitions for “monolithic”, Green et al. continues to read on the claim.
Lastly, the Applicant argues that “Green also fails to disclose or suggest that when the push rod displaces from the first rod position to the second rod position, the distal end of the push rod contacts a portion of the ramp portion of the first support arm such that the first needle arm is displaced to transition the needle assembly from the first open position into the second closed position, and when the push rod is in the first rod position, the distal end of the push rod does not contact the ramp portion of the first support arm” (see pages 8-9 of Remarks). The Examiner respectfully disagrees with this argument that “the Office is misinterpreting the claim language”, countering that “Though understanding the claim language may be aided by explanations contained in the written description, it is important not to import into a claim limitations that are not part of the claim” (see MPEP 2111.01 II.). The present claims do not recite the argued limitation wherein “the distal end of the push rod does not contact any part of the ramp portion”, nor does the specification provide adequate support for this language (see above argument over 112(a)). The prior, and present, interpretation of the “ramp portion” being only a proximal portion of the slot 212 shown in Figs. 24-25 of Green et al. is consistent with the present specification which provides the ramp portion as a part of the contiguous first support arm. The interpreted ramp portion of Green et al. is not the entirety of the slot 212 as alleged by the Applicant, but only a proximal portion such that the push rod 114 is no longer directly contacting the proximal end of the slot 212 as it rotates out of engagement with pin 24, which the push rod 114 was previously contacting the proximal end of the slot 212 via (see Figs. 24-25).
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 1-5, 10, and 15 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 1 recites the limitation “when the push rod is in the first rod position, the distal end of the push rod does not contact the ramp portion of the first support arm” on page 3, lines 21-23. There is inadequate support for this limitation in the present Specification. In the Remarks filed 5/21/2025, Applicant states that “Non-limiting examples of support for the further amendments to independent claim 1 can be found in Figs. 5B to 5D” (see page 6), however these figures fail to provide support for amended claim 1. Fig. 5B shows the push rod (36) and the ramp portion (42) of the first support arm (56) in contact with one another, and Fig. 5D further shows the distal end (40) of the push rod (36) still in contact with the ramp portion (42). . The present specification recites that “the distal end of the push rod 36 is remote from, and therefore not engaging, a ramp portion 42” whereas claim 1 recites “when the push rod is in the first rod position, the distal end of the push rod does not contact the ramp portion”, which has a different meaning due to the difference in plain language. While the specification provides support for the rod being apart from the ramp portion, the present specification does not provide support for the push rod being entirely out of contact with the ramp portion. Merriam-Webster dictionary defines “contact” as “a union or junction of surfaces”, which includes a union of surfaces through intervening structures. Even if Fig. 5B showed a lack of contact between the distal end of the push rod (40 of rod 36), the distal end of the push rod and the ramp are contacting one another through other intervening structures of the device, such as the shaft 18 which can be seen in Fig. 5D to be contacting both the ramp (42) and the push rod (36), including its distal end (40).
Claims 2-5, 10, and 15 inherit the deficiencies of claim 1 and are also rejected.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the limitation “wherein when the push rod displaces from the first rod position to the second rod position, the distal end of the push rod contacts a portion of the ramp portion of the first support arm such that the first needle arm is displaced to transition the needle assembly from the first open position into the second closed position, and when the push rod is in the first rod position, the distal end of the push rod does not contact the ramp portion of the first support arm” (emphasis added) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 1-3, 5, 10, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Green et al. (US Patent No. 5,476,479).
With respect to claim 1, Green et al. discloses a device (see 10 in Fig. 2) comprising:
a housing portion (body of 10) having a grip portion (16) adapted to be grasped by a hand of a user (16 is stationary and can be grasped by a user);
a lever (14) pivotably coupled to a first portion of the housing portion (14 is coupled to the body of 10, see unmarked pivot point in Fig. 2), the lever (14) configured to be pivoted between a first lever position and a second lever position (14 is the pivoting handle);
a shaft (22 in Fig. 2) extending along a shaft axis from a proximal end to a distal end, wherein the proximal end of the shaft (22) is coupled to a second portion of the housing portion (22 connects to 18);
a push rod (24) extending along a push rod axis from a proximal end to a distal end, wherein at least a portion of the push rod (24) extends through an interior portion of the shaft (see 24 within 22 in Fig. 2, see also analogous push rod 114 in Figs. 24-26, col. 12, lines 59-65: “Note that the present novel jaw structure is described in the context of a surgical instrument in accordance with the embodiment of FIG. 15 discussed hereinabove. However, the jaw structure of the present invention may be equally incorporated into other surgical instrument configurations including the alternative embodiments discussed herein”), wherein the proximal end of the push rod (24) is coupled to a portion of the lever (14) such that when the lever (14) is in the first lever position, the push rod (24) is in a first rod position, and when the lever (14) is in the second lever position, the push rod (24) is in a second rod position (col. 9, lines 24-29: “Upon movement of pivoting handle 14, inner rod 24 reciprocates within tube member 22 to operate a tool mechanism provided at the distal end of the instrument 10. This tool mechanism (not shown) may comprise a surgical implement, such as scissors, graspers, forceps, retractors and the like”); and
a needle assembly (200 in Fig. 26, col. 12, lines 59-65: “Note that the present novel jaw structure is described in the context of a surgical instrument in accordance with the embodiment of FIG. 15 discussed hereinabove. However, the jaw structure of the present invention may be equally incorporated into other surgical instrument configurations including the alternative embodiments discussed herein”) coupled to the shaft (22 in Fig. 2, see also analogous shaft 112 in Figs. 24-26) at or adjacent to the distal end of the shaft (22 in Fig. 2, see also analogous shaft 112 in Figs. 24-26), the needle assembly (200) comprising:
a first needle arm (first 206) and a second needle arm (opposite 206), wherein the first needle arm (first 206) and the second needle arm (opposite 206) are displaceable between a first open position and a second closed position, wherein the distal end of the push rod (24 in Fig. 2, see also analogous push rod 114 in Figs. 24-26) contacts a portion of the needle assembly (200) when translating from the first rod position to the second rod position, and wherein the distal end of the push rod (24 in Fig. 2, see also analogous push rod 114 in Figs. 24-26) contacting the portion of the needle assembly (200) displaces at least one of the first needle arm and the second needle arm to transition the needle assembly (200) from the first open position into the second closed position (col. 14, lines 9-13: “Links 244 of opposing jaws 230 are connected to coaxial inner rod member 114 at pin 246, and serve to drive the jaws 230 between an open and closed position as the rod member 114 is moved coaxially with respect to outer tube member 112”, see Fig. 25), the first needle arm (first 206 in Fig. 26, col. 12, lines 59-65: “Note that the present novel jaw structure is described in the context of a surgical instrument in accordance with the embodiment of FIG. 15 discussed hereinabove. However, the jaw structure of the present invention may be equally incorporated into other surgical instrument configurations including the alternative embodiments discussed herein”) extends from a distal end to a proximal end along a first needle arm axis, and the proximal end of the first needle arm (206) is disposed adjacent to or at the distal end of the shaft (22 in Fig. 2, see analogous shaft 112 in Figs. 24-26), and wherein the second needle arm (opposite 206) extends from a distal end to a proximal end along a second needle arm axis, and the proximal end of the second needle arm (opposite 206) is disposed adjacent to or at the distal end of the shaft (22 in Fig. 2, see analogous shaft 112 in Figs. 24-26);
a first support arm (202 associated with first 206 in Figs. 24-26) having a proximal end and a distal end that extends along a first support arm axis, wherein the distal end of the first support arm (202 associated with first 206) is coupled to the proximal end of the first needle arm (206) such that the first support arm axis generally extends along the first needle arm axis (see Figs. 24-25); wherein the first support arm (first 202) includes a ramp portion (distal part of 212 can be considered a ramp portion since it’s a diagonal/ramped camming slot that contacts 114 via pin 24), and the ramp portion (proximal half of 212 is a ramp portion since it’s a diagonal/ramped camming slot) includes a surface (a proximal half of the interior surface of 212) on the first support arm (first 202) that extends from a first point proximal to the distal end of the first support arm (first 202) to a second point distal to the proximal end of the first support arm (first 202, col. 12, lines 57-58: “a diagonal camming slot 212 formed in the proximal portion 202”, see Figs. 24-25);
a second support arm (opposite 202 associated with opposite 206) having a proximal end and a distal end that extends along a second support arm axis, wherein the distal end of the second support arm (opposite 202 associated with opposite 206) is coupled to the proximal end of second needle arm (216) such that the second support arm axis generally extends along the second needle arm axis (see Figs. 24-25), wherein the first support arm and the second support arm (202) are disposed within the interior portion of the shaft (22 in Fig. 2, see Figs. 24-26, 202 are within the distal end of analogous shaft 112); and
a hub portion (distal end of shaft 22 in Fig. 2, see analogous shaft 112 including portion with 210 and 24 in Fig. 24), wherein the proximal end of the first support arm (first 202) is coupled to a first portion of a hub portion (distal end of 112 including portion with 210 and 24) and the proximal end of the second support arm (opposite 202) is coupled to a second portion of the hub portion (distal end of 112 including portion with 210 and 24), and the hub portion (distal end of 112 including portion with 210 and 24) extends substantially normal to the shaft axis (distal end of 112 with slot and pins extends normal to the axis running through 112 because it has width) such that a gap exists between the first support arm and the second support arm (202) when the needle assembly (200) is in the first open position (see Fig. 25 for open position, 202 are spread axially apart);
wherein when the push rod (24 in Fig. 2, see analogous push rod 114 in Figs. 24-25) displaces from the first rod position to the second rod position (see Figs. 24-25), the distal end of the push rod (114) contacts a portion of the ramp portion (proximal half of 212 is a ramp portion since it’s a diagonal/ramped camming slot, proximal part of 212 contacts 114 in Fig. 24) of the first support arm (first 202) such that the first needle arm (first 206) is displaced to transition the needle assembly (200) from the first open position into the second closed position (see Figs. 24-25), and when the push rod (114) is in the first rod position, the distal end of the push rod (114) does not contact the ramp portion (proximal half of 212 is a ramp portion since it’s a diagonal/ramped camming slot, proximal part of 212 rotates out of contact with 114 in Fig. 25) of the first support rod (first 202); and
wherein the needle assembly (200) is formed as a single, monolithic part (see Figs. 24-25, Merriam-Webster defines “unitary” as “of or relating to a unit” or “having the character of a unit”, the needle assembly can be considered a unitary part because it includes 204, 210, 202, and 24, which the needle assembly unit is comprised of).
Regarding claim 2, Green et al. further discloses wherein the push rod (24 in Fig. 2) translates along the push rod axis from the first rod position to the second rod position when the lever (14) is pivoted from the first lever position to the second lever position (col. 9, lines 24-29: “Upon movement of pivoting handle 14, inner rod 24 reciprocates within tube member 22 to operate a tool mechanism provided at the distal end of the instrument 10. This tool mechanism (not shown) may comprise a surgical implement, such as scissors, graspers, forceps, retractors and the like”).
Regarding claim 3, Green et al. further discloses wherein the proximal end of the push rod (24 in Fig. 2) includes a ball-shaped end (see annotated Fig. 2 below) and the portion of the lever (14) includes a socket (see annotated Fig. 2 below) that is configured to rotatably receive the ball-shaped end of the push rod such that the push rod (24) is configured to rotate about the push rod axis relative to the lever (14 is rotatable around the unmarked pivot, therefore it is able to rotate relative to the axis of the push rod 24 and the inverse is also true).
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Regarding claim 5, Green et al. further discloses wherein the shaft (22 in Fig. 2) is rotatably coupled to the second portion of the housing portion (body of 10) such that the shaft (22) is configured to rotate about the shaft axis relative to the second portion of the housing portion (col. 9, lines 29-31: “A rotation knob 26 may be provided which rotates body assembly 20 to orient the tool mechanism at various angles to the longitudinal axis”, 20 includes 22, therefore 22 can rotate relative to the body of 10 when 26 in Fig. 1 is actuated).
Regarding claim 10, Green et al. further discloses wherein the lever (14 in Fig. 2) further comprises a ratchet member (30) having a plurality of teeth and the device (10) further comprising a locking mechanism (see Fig. 3), the locking mechanism comprising:
an elongated lock lever (36) pivotably coupled to a portion of the housing portion (body of 10);
a pawl arm (32) coupled to a portion of the lock lever (36), the pawl arm (32) having an end portion that extends beyond a bottom surface of the lock lever (36, 32 extends below the edge of 36), wherein the lock lever (36) is configured to be pivoted between an engaged position to a disengaged position (36 pivots around 38),
wherein in the engaged position, the end portion of the pawl arm (32) engages one of the plurality of teeth of the ratchet member (30) to maintain the lever in a desired position (col. 9, lines 44-46: “Rack member 30 comprises a plurality of indentations or notches which accepts pawl member 32 to hold pivoting handle 14 in place”), and
in the disengaged position, the end portion of the pawl arm (32) does not engage one of the plurality of teeth of the ratchet member (col. 9, lines 50-54: “a trigger member 36 is provided which, when depressed by the user in the direction of arrow A in FIG. 3, causes the ratchet mechanism 28 to pivot about pivot point 38 in the direction of arrow B to disengage pawl member 32 from rack member 30”).
Regarding claim 15, Green et al. further discloses wherein the shaft axis is linear (see axis of 22 in Fig. 2, see also comparable shaft 112 in Fig. 26, the axis of shaft 112 is linear).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Green et al. (US Patent No. 5,476,479) as applied to claim 1 above, and further in view of Kaercher et al. (PGPub US 2013/0172859 A1).
Regarding claims 4 and 14, Green et al. fails to disclose wherein at least a portion of the shaft is flexible such that at least a portion of the shaft axis is non-linear.
In the same field of surgical grasping tools (abstract), Kaercher et al. teaches a device (10 in Fig. 1) comprising a housing (20) and a shaft (30), wherein the shaft (30) comprises a push rod (50) extending therethrough for controlling at least one jaw (44) of an end effector (40). Kaercher et al. further teaches wherein at least a portion of the shaft (30) is flexible such that at least a portion of the shaft axis is non-linear (PP [0067]: “The shaft 30 is rigid or flexible, straight or curved”).
One of ordinary skill in the art would have been motivated to perform this modification because it involves the use of a known technique (a flexible shaft on a surgical device) to improve a similar device in the same way. The device of Kaercher et al. is a comparable device to that of Green et al. because it is a pistol grip tool comprising an end effector actuatable via a push rod translating within an exterior shaft, therefore one of ordinary skill in the art could have applied the same flexible shaft as discussed within the Kaercher et al. reference to the Green et al. device and the results would have been predictable.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bridget E. Rabaglia whose telephone number is (571)272-2908. The examiner can normally be reached Monday - Thursday, 7am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached on (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771
/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771