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 .
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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on September 18, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 7 is objected to because of the following informalities:
In claim 7, the phrase “key-shaped slot a sidewall” (line 12) should read - - key-shaped slot in a sidewall - -.
Appropriate correction is required.
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.
Claim 4 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.
Claim 4 recites the limitation of materials which are bendable with a “modest exertion of manually-applied force” in line 3. Such limitation is indefinite because the claim does not provide sufficient details to indicate what constitutes a “modest” exertion of manually-applied force. Furthermore, the Specification does not provide some standard for measuring the degree of exertion to determine whether such exertion is “modest” or not. Therefore, claim 4 is indefinite. For examination purposes, claim 4 is interpreted as reciting materials which are bendable with a manually-applied force.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 15 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 15 depends from claim 1 and recites the end effector is “permanently affixed to the extension” in lines 1-2. However, claim 1 recites an end effector “releasably couplable to the second end of the extension” in line 20. Thus, claim 15 appears to fail to include a “releasably couplable” end effector, as recited in claim 1, by reciting the end effector being “permanently affixed” to the extension.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-3, 5-13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Moore (U.S. Patent No. 2790437) in view of Marlow et al. (U.S. Patent No. 55368606; hereinafter “Marlow”).
Regarding claim 1, Moore discloses a forceps system (Figs. 1-2) , comprising:
a handle (11), with proximal (15) and distal (17) handgrip sections pivotably coupled to one another at a pivot axis (21), a coupler structure (annotated Fig. 2 below) disposed at an end of the proximal handgrip section, a biasing element (22) mechanically disposed between the proximal and distal handgrip sections, such that proximal and distal handgrip sections are biased pivotably away from one another (Fig. 2; col. 2, ll. 45-48), the proximal handgrip section having a first end comprising a gripping portion and a second end opposite the first end comprising a coupling structure (34), the distal handgrip section having a first end comprising a gripping portion and a second end opposite the first end comprising a coupling structure (30), the pivot axis connecting the proximal and distal handgrip sections between their respective gripping portions and coupling structures, such that pivoting movement of the gripping portions of the proximal and distal handgrip sections toward one another against the biasing element corresponds to pivoting movement of the coupling structures of the proximal and distal handgrip sections away from one another (col. 2, ll. 41-59);
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an extension (12; annotated Fig. 1 below), having a longitudinal axis, a first end (42) releasably couplable to the coupling structures of the proximal and distal handgrip portions (Figs. 2 and 6), and a second end having a connector disposed thereon; and
an end effector coupled to the second end of the extension.
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Moore discloses the invention substantially as claimed, except for the end effector releasably couplable to the second end of the extension.
Marlow, a reference in the forceps device field of endeavor, teaches configuring an extension (56) and end effector (14) so that the end effector is releasably couplable to the second end of the extension (Fig. 3; col. 4, ln. 4 – col. 5, ln. 13) to allow the end effector to be disposable and allow for different end tools to be attachable the extension to perform different procedures.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention configure the extension and end effector such that the end effector is releasably couplable to the second end of the extension, in view of Marlow, in order to allow for disposal of a soiled end effector and allow another end effector to be used for a procedure.
Regarding claim 2, the modified device discloses the system further comprising the end effector including a first jaw (52) and a second jaw (54), wherein at least one of the first and second jaws is pivotable about a pivot axis extending substantially perpendicular to the extension longitudinal axis (Moore Fig. 1; col. 3, ll. 56-67),
the handle, extension, and end effector in an operably coupled state, the biasing element prompting the first and second jaws toward an open configuration (Moore col. 2, ll. 45-48), the open configuration of the jaws corresponding to a released configuration of the handle (Moore Fig. 1), a closed configuration of the jaws corresponding to a gripped configuration of the proximal and distal handgrip portions, wherein the proximal and distal handgrip portions pivoted toward one another against the biasing element (Moore col. 4, ll. 3-20).
Regarding claim 3, the modified device discloses the system further comprising the extension and end effector fabricated from materials which enable the extension and end effector to be fabricated in a sterile state (Moore col. 4, ll. 18-34), but which enable the extension and end effector to be at least one of discarded or recycled after use (body entering portion (12) and end effector of Moore are capable of being discarded or recycled because Moore does not disclose any structure that would prevent discarding or recycling them).
Regarding claim 5, the modified device discloses wherein the extension comprises a core (38) surrounded by a sheath (37), the core and sheath being axially relatively movable, the core releasably couplable to the proximal handgrip portion and the sheath releasably couplable to the distal handgrip portion (Moore Figs. 2 and 6; col. 3, ll. 29-42).
Regarding claim 6, the modified device discloses wherein the coupling structure (34) of the proximal handgrip portion comprises a hollow tubular region having an externally-threaded surface (Moore Figs. 5-6; col. 2, ll. 65-70) ; and
the core releasably couplable to the proximal handgrip portion via an internally-threaded collar (45) that is rotatably coupled to, but axially-fixed in relation to, the first end of the extension (Moore Fig. 6; col. 3, ll. 35-42).
Regarding claim 7, the modified device discloses herein the coupling structure of the distal handgrip portion comprises a fork structure (annotated Fig. 2 of Moore below) there at, receivable within the hollow tubular region of the proximal handgrip portion, through a slot (20) in a sidewall thereto (Fig. 2; col. 2, ll. 41-45), for arcuate reciprocating movement therein, in response to gripping and release of the handle by an operator thereof;
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a pin (41) is coupled to the sheath of the extension (via coupling between rod (38) and tubular rod (37); Fig. 6), for axial movement therewith (ball (41) and tubular rod (37) are capable of axial movement together, such as during coupling of body entering portion (12) and handle (11));
a slider (27) is axially movable within the hollow tubular region and pivotably coupled to the fork structure (via slot (28); col. 2, ll. 53-59);
the pin having a key structure (defined by the shape of necked down portion (40) and ball (41); Fig. 6) at a proximal end thereof, receivable within a corresponding key-shaped recess (defined by socket (31) and slot (32); Figs. 3-6) in a distal end of the slider, through a similar key-shaped slot (35) a sidewall of the hollow tubular region (the shape of slot (35) is similar to the shape defined by socket (31) and slot (32) in that both shapes have similar dimension and extend longitudinally, so as to overlap; Fig. 6).
Regarding claim 8, the modified device discloses wherein the key-shaped (35) slot is located in the externally-threaded surface of the hollow tubular region (Moore Figs. 5-6; col. 2, ll. 65-70).
Regarding claim 9, the modified device discloses wherein the sheath (37; Moore Figs. 1-2) moves axially distally or proximally in response to the gripping portions of the proximal and distal handgrip sections being squeezed together or released (e.g., tubular rod (37) is capable of axial movement in response to proximal handle portion (15) moving toward distal handle portion (17), respectively.
Further, the modified device discloses wherein distal axial movement of the sheath, relative to the core, causing a pulling force to be exerted by the core on the jaws of the end effector prompting the jaws into a closed configuration (Marlow Figs. 4-5; col. 4, ll. 4-40) as part of configuring the sheath to be releasably coupled with the end effector in the modified device.
Regarding claim 10, the modified device discloses wherein the end effector is releasably coupled to the extension (Marlow Figs. 3-5; col. 4, ln. 4 – col. 5, ln. 13).
Regarding claim 11, the modified device discloses wherein the core, in turn, comprises a central tension member (38) slidably coupled relative to a surrounding tube (37; Moore Figs. 2 and 6; col. 3, ll. 29-42).
Regarding claim 12, the modified device discloses wherein the central tension member comprises one of a semi-rigid shaft (38; Moore col. 3, ll. 9-15), a wire, a braided cable.
Regarding claim 13, the modified device discloses wherein a proximal end (41) of the tension member is coupled to the internally-threaded collar(34; e.g. plunger (38) and sleeve (45) are coupled together via tubular rod (37); Moore Fig. 2), precluding relative axial movement therebetween (e.g., while forceps system is assembled and the gripping members (15, 17) are not being actuated, relative axial movement between ball (41) and sleeve (45) is precluded).
Regarding claim 15, the modified device discloses wherein the end effector is one of: permanently affixed to the extension (Moore Fig. 1); replaceably attachable to the extension to enable a variety of end effectors having different configurations to be employed with a single extension and handle (Marlow Figs. 6-8; col. 5, ll. 5-13).
Claims 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Moore in view of Marlow, as applied to claim 1 above, and further in view of Hahnen et al. (U.S. Patent No. 8043328; hereinafter “Hahnen”).
Regarding claim 4, the modified device discloses the invention substantially as claimed, except for at least one of the extension and end effector being fabricated from materials which are relatively stiff yet bendable with a modest exertion of manually-applied force, and shape-retaining once bent or formed into a desired configuration.
Hahnen, a reference in the medical end effector field of endeavor, teaches an extension (shaft; col. 15, ll. 35-55) fabricated from materials which are relatively stiff yet manually bendable and shape-retaining once bent or formed into a desired configuration (col. 15, ln. 35 – col. 18, ln.48) to provide an instrument with a desired configuration to treat a patient based on the medical procedure employed, the approach utilized in the procedure, and the area which is to be treated (col. 15, ll. 43-48).
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 at least one of the extension and end effector being fabricated from materials which are relatively stiff yet bendable with a modest exertion of manually-applied force, and shape-retaining once bent or formed into a desired configuration, in view of Hahnen, in order to provide the forceps system with a desired shape for positioning at and treatment of an area within a patient.
Regarding claim 14, the modified device discloses the invention substantially as claimed, except for the extension being configured to be bent from an original straight configuration into a desired shape and then restored to its original configuration, through at least two cycles of bending and restoration.
Hahnen, a reference in the medical end effector field of endeavor, teaches an extension (shaft; col. 15, ll. 35-55) configured to be bent from an original straight configuration into a desired shape (col. 15, ln. 35 – col. 18, ln.48).
Further, the materials taught by Hahnen are malleable so as to be manipulated into a desired configuration and are thus capable of being restored to an original configuration, through at least two cycles of bending and restoration (e.g., bending and then bending back to a previous configuration), to facilitate multiple uses of the forceps system in multiple medical procedures.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the extension to be bent from an original straight configuration into a desired shape and then restored to its original configuration, through at least two cycles of bending and restoration, to facilitate multiple uses of the forceps system in multiple medical procedures, in view of Hahnen, in order to provide the forceps system with a desired shape for positioning at and treatment of an area within a patient and allow for re-adjustment of the system as needed to position the system within a patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Bond et al. (U.S. Patent No. 5308358) disclosing surgical instrument including a detachable shaft and end effector (Figs.1-3); and
Palmer et al. (U.S. Patent No. 5782748) disclosing a surgical instrument including a detachable shaft and end effector (Figs. 1-15).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan A Hollm whose telephone number is (703)756-1514. The examiner can normally be reached Mon - Fri 8:30-5:30.
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/JONATHAN A HOLLM/Examiner, Art Unit 3771