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 3/9/26 have been fully considered.
The panel decided that: a) prosecution should be reopened, and b) neither side was persuasive. The rationale provided consisted of the following three points:
i) Nau Jr. anticipates the claims,
ii) inoperability and teaching away should be presented as separate issues, as it relates to the examiner’s reference to MPEP 2123, and lastly,
iii) the BRI of the claims should be reconsidered, and new searches be conducted, in order to reduce issues before the Board.
As such, prosecution is reopened. The examiner withdraws the previous rejections, as not having met the preponderance of the evidence standard.
Nau Jr. is applied as directed. New grounds of rejection are applied, in light of reconsideration of the BRI and new art.
Allowable subject matter is also indicated below.
The Pre-Appeal Pilot Program is covered in detail in MPEP 1204.02.
Claim Rejections - 35 USC § 102
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 35, 38, and 41-43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2014/0066910 by Nau Jr.
Regarding Claim 35, Nau Jr. discloses a surgical tool for use in a surgical procedure (e.g. title, abstract, ¶¶ 3: endoscopic surgical forceps device 10 for sealing and cutting tissue), the surgical tool comprising:
a handle at a proximal end of the tool (e.g. ¶40, Fig. 1A: handle assembly 20);
an elongate shaft extending in a distal direction from the handle, the elongate shaft having proximal and distal portions (e.g. ¶41, Fig. 1A: shaft 12);
a tip, which is disposed at the distal portion of the shaft, the distal portion of the shaft being sized and shaped to be inserted into a subject during the surgical procedure and to contact tissue of the subject (e.g. title, abstract, ¶¶3,23,42, see annotated Fig. 1A: the tip is interpreted as the entire distal end past the shaft, including end effector assembly 100 having jaws 110 and 120, as well as the connecting elements having pin 19 that couple it to shaft 12. The device is endoscopic and the jaws of the tip are used to cut tissue by contact),
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Figure 1 Annotated Fig. 1A of Nau Jr.
wherein the tip comprises a mechanical cutting mechanism (this limitation which includes the generic placeholder “mechanism” and the function of “mechanical cutting” is not interpreted under 112f, because it is defined by the structure that follows) comprising a moving part (e.g. ¶42, Fig. 1B, Fig. 2A, Fig. 5A: jaws 110/120 are interpreted as the moving part) that (a) moves with respect to another part of the surgical tool by rotating about an axis, in order to cut tissue of the subject (e.g. ¶ 42: “One or both jaw members 110 and 120 are pivotable about a pin 19 and one or both are movable from a first position wherein jaw members 110 and 120 are spaced relative to another, to a second position wherein jaw members 110 and 120 are closed and cooperate to grasp tissue between the jaw members 110 and 120”, thus they rotate with respect to the shaft, with respect to the handle, with respect to the pin, and with respect to one another. The grasping motion of the jaws 110/120 of forceps 10 is capable of the intended use of “to cut tissue”, by, both, grasping the tissue and allowing the light energy to be transmitted into tissue via contact with tissue, thereby cutting it, see title, abstract, ¶¶ 3,7,10-12,44. Thus, the moving part of the forceps device 10 is capable of both grasping and cutting tissue, both required for the cutting operation, thus meeting the claimed intended use. Note that the claim does not limit the “another part of the surgical tool”, and does not require a blade. Also note that the entire tip and shaft are rotatable relative to the handle, see ¶ 41), and (b) is shaped to define a hollow cavity (e.g. ¶¶ 22, 69, Fig. 2A, 5A: the upper member of the jaws, 110, is hollow to allow the light to be reflected therein); and
an optical fiber configured to deliver laser energy into the hollow cavity of the moving part (e.g. ¶ 9,15,22,39,69: laser with optical fiber directs light into a hollow part of jaw 110), such that the moving part absorbs the laser energy and thermally conducts the absorbed energy to the tissue by contacting the tissue (e.g. ¶ 16, 18, 60, 70: jaw 120 is made of material that absorbs light and dissipates heat).
Regarding Claim 38, Nau Jr. teaches the surgical tool according to claim 35, further comprising a laser configured to generate the laser energy (e.g. ¶¶ 39, Fig. 1A: laser source 40).
Regarding Claim 41, Nau Jr. teaches the surgical tool according to claim 35, wherein the moving part of the mechanical cutting mechanism defines a distal-most end of the tip (e.g. as shown in Fig. 1A: the jaws 110/120 are the distal-most end of the tip).
Regarding Claim 42, Nau Jr. teaches the surgical tool according to claim 35, wherein the optical fiber is configured to deliver the laser energy to the tip such that the moving part of the mechanical cutting mechanism coagulates the tissue upon thermally conducting the absorbed energy to the tissue (the optical fiber is capable of delivering any laser energy transmitted to it. The intended use claimed attributes entirely to the fiber and not limiting the laser source in emitting any particular energy. Nevertheless, Nau Jr. does explicitly teach tissue sealing with the laser forceps device, see abstract).
Regarding Claim 43, Nau Jr. teaches the surgical tool according to claim 35, wherein the optical fiber is configured to deliver the laser energy to the tip such that the moving part of the mechanical cutting mechanism vaporizes the tissue upon thermally conducting the absorbed energy to the tissue (the optical fiber is capable of delivering any laser energy transmitted to it. The intended use claimed attributes entirely to the fiber and not limiting the laser source in emitting any particular energy. Nevertheless, Nau Jr. does explicitly teach tissue cutting with the laser forceps device, see title).
Claim 44 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 6,221,069 by Daikuzono.
Regarding Claim 44, Daikuzono discloses a surgical tool for use in a surgical procedure (e.g. abstract: miniaturized surgical tool for use with an endoscope), the surgical tool comprising:
a handle at a proximal end of the tool (e.g. 5:50-59, 10:25-45, Fig. 1,16: the tool is a handpiece 1 with actuating switch 9 for pulling with a hand; all embodiments of the tip are used with the handpiece 1, see 13:19-20,14:27-34);
an elongate shaft extending in a distal direction from the handle, the elongate shaft having proximal and distal portions (e.g. 5:60-67, Fig. 6: hollow tube 22 is a shaft that extends from the handpiece 1);
a tip, which is disposed at the distal portion of the shaft, the distal portion of the shaft being sized and shaped to be inserted into a subject during the surgical procedure and to contact tissue of the subject (e.g. 5:60-67, Fig. 6: end portion 24),
wherein the tip comprises a mechanical cutting mechanism comprising a moving part that (a) moves with respect to another part of the surgical tool in order to cut tissue of the subject, and (b) is shaped to define a hollow cavity and (c) comprises a mechanical cutting blade indirectly coupled to the other part of the surgical tool (e.g. 10:24-45, Fig. 20, 21: inner moving cutter blade 30 moves forward and with respect to the handpiece 1 and the distal end of the tip, via switch 9 in the handle, in order to cut a blood vessel, and it is coupled to the tip and the entire instrument; Also note that Daikuzono teaches dual blades in Fig. 33, on both sides of the cutting mechanism); and
an optical fiber configured to deliver laser energy into the hollow cavity of the moving part (e.g. 15:30-35, Fig. 37,38: in one variation of the movable cutting member 30, the fiber 50 is within a hollow cavity in movable member 30 and “surrounded by a frame” and “side windows”) such that the moving part absorbs the laser energy and thermally conducts the absorbed energy to the tissue by contacting the tissue (e.g. 3:34-40, 7:31-49: the moving portion 30/30F of the cutting tip absorbs heat from the laser fiber 50 inserted in the hollow portion of moving part 30).
Daikuzono also discloses that the mechanical cutting blade of the moving part is coupled to the other part of the surgical tool at a mechanical joint (e.g. 8:55-67, 9:34-54, Fig. 1-2, and Fig. 16: the reciprocating hook 30 is indirectly coupled to link member 10a of the surgical tool via a mechanical joint, with a pin 12c; It is noted here that: a) the “other part of the surgical tool” can be any part of the tool, b) “coupled to” include indirect coupling, and c) and that the “mechanical joint” is any type of a mechanical connection between parts).
Regarding Claim 47, Daikuzono teaches the surgical tool according to claim 44, further comprising a laser configured to generate the laser energy (e.g. 8:1-7: Nd-YAG laser).
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 37 is rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0066910 by Nau Jr., as applied to Claim 35, in view of US 6,039,729 by Durville.
Regarding Claim 37, Nau Jr. teaches the surgical tool according to claim 35, yet does not explicitly disclose wherein the moving part of the mechanical cutting mechanism comprises metal.
However, Durville teaches an analogous fiber laser treatment tool which utilizes metal to absorb laser energy and convert it to heat, in various applications including cauterization, hemostasis, and dissection (e.g. 4:6-23). Therefore, it would have been prima facie obvious to phosita to utilize metal in the light absorbing element of the jaws of a device according to the teachings of Nau Jr., as taught by Durville, as: a) the selection of a known material based upon its suitability for the intended use is a design consideration within the skill of the art (In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)), and b) this would predictable absorb laser energy and emit heat.
Claims 46 is rejected under 35 U.S.C. 103 as being unpatentable over Daikuzono, as applied to Claim 44, in view of US 4209017 by Shaw.
Regarding Claim 46, Daikuzono discloses the surgical tool according to claim 44, yet does not disclose wherein the tip is configured to prevent the laser energy from leaving the tip and directly irradiating the tissue.
Daikuzono teaches that the moving part 30F has a cavity with side “windows” which “may not be open but be closed” (15:30-35, Fig. 37-38), albeit it is not explicitly taught that the blade with the enclosed cavity would necessarily prevent the laser energy from escaping the blade. Shaw teaches an analogous laser blade for cutting and hemostasis, wherein the blade includes a cavity therein which reflects the laser energy so that it is directed to the blade portion of the device, where it absorbed and converted to heat (abstract, 2:27-67, 5:13-30, Fig. 2,3-4: fibers 33 transmit laser energy to a cavity 9 where non-transmissive reflection directs the energy to a radiation-absorbing layer, where the light energy is converted to heat, which, in turn, heats cutting edge 17). The radiant energy emitted by the laser is “contained within the blade”, thus is prevented from leaving the tip of the blade (abstract, 2:27-41). 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 incorporate a closed non-transmissive/reflective cavity in the moving blade of a device according to the teachings of Daikuzono, as taught by Shaw, as this would: a) predictably heat the blade, as taught by Shaw, and b) prevent energy loss and maintain a suitable operating temperature throughout the blade, as all of the laser energy is converted to heat distributed “throughout the blade”, as suggested by Shaw (e.g. 2:28-34,58-64), the blade being the one part of the instrument that effects the intended treatment.
Allowable Subject Matter
Claims 39-40, 45 and 48 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANOLIS Y PAHAKIS whose telephone number is (571)272-7179. The examiner can normally be reached M-F 9-5, EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CARL LAYNO can be reached at (571)272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MANOLIS PAHAKIS/ Examiner, Art Unit 3796
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