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 .
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.
Claims 1-20 are 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 1 states “a cannula gasket disposed within the flange of the outer tube and defining a plurality of apertures each in alignment with one of the tool path, the scope path, and the insufflation channel” where the “each in alignment with one of the tool path, the scope path, and the insufflation channel” is indefinite. The problem with the language is that a minimum of two apertures is claimed (a plurality being more than one), and there are three paths. How would two holes be in alignment with the three paths? Also, is each hole in alignment with one path? For example, would the holes be stacked so that three holes align with the scope path and no holes align with the other two paths? The Examiner assumes this is not the case. The Examiner assumes that there is one hole for each path (a tool path aperture, a scope path aperture, and an insufflation path aperture) and the tool path aperture is aligned with the tool path, the scope path aperture with the scope path, and the insufflation path aperture with the insufflation path. Appropriate correction is required.
Claim 9 states “wherein the filter chamber defines a vent opening through which filter exhaust gases can flow to the atmosphere.” The Examiner does not know what “filter exhaust gases” is intended to mean. Is this “filtered” exhaust gases or just exhaust gases? The Examiner assumes that the vent is in such a position that gases that have already been filtered are able to exit the through the vent opening. Appropriate correction is required.
The term “small” in claim 10 is a relative term which renders the claim indefinite. The term “small” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term “small” renders the size of the tube indefinite. First, “small” is a relative term. Second, the claim does not indicate which dimension is small. This could be diameter, length, or some other dimension. Appropriate correction is required.
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, 10-11, 15, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Dejima (US 2016/0022121) in view of Wilk (US 2006/0241344).
Regarding Claim 1, Dejima discloses:
A cannula device for a vessel harvesting system, comprising:
a handle (see Fig. 13 showing the proximal-most portion of the device near numeral 160); and
a cannula assembly extending distally from the handle, the cannula assembly comprising:
an outer tube (102) having a flange (see Fig. 13 showing the proximal part of 102 including 104); and
at least one insert (118) extending within the outer tube and defining:
a tool path (128) configured to receive a surgical tool therethrough;
a scope path (132) configured to receive a surgical scope therethrough;
a cannula gasket (160) disposed within the flange of the outer tube (see Fig. 13 showing 160 within the flange 104) and defining a plurality of apertures (168/170) each in alignment with one of the tool path and the scope path (see Paragraphs 0136-0137, the tool and scope are inserted through the openings 168/170 into the insert 118, see Fig. 7 for example).
Dejima does not explicitly disclose an insufflation channel and an insufflation tube extending from the handle through the cannula gasket and the insufflation channel. Wilk teaches including an insufflation channel and tube (see Fig. 1 showing 36 extend through channel 22) for providing gas to the cavity (see Paragraph 0029). 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 modify Dejima’s device to include Wilk’s insufflation channel and tube. Such a modification provides a means for delivering gas to the cavity as is known in the art.
Regarding Claim 10, Dejima as modified does not specifically disclose wherein the insufflation tube comprises: a small tube configured for connection to a gas source; and a hypotube partially inserted into a distal end of the small tube. Making components separable is well-known and obvious (see MPEP 2144.04.V.C). Applicant has provided no criticality to there being two tubes instead of one. In fact, Applicant states that one continuous tubing section can be used. Therefore, the Examiner asserts that a person having ordinary skill in the art before the effective filing date of the claimed invention would have considered it obvious to use two tubes as claimed. Such a modification is a simple means of extending a tube, and a person having ordinary skill in the art would have had a reasonable expectation of success in that the modification is simple using two tubes instead of one.
Regarding Claim 11, Dejima as modified further discloses wherein the handle comprises a tool guide channel (see proximal end of 108 in Fig. 13) for guiding the surgical tool into the tool path of the cannula assembly (see Paragraph 0105).
Regarding Claim 15, Dejima as modified further discloses an endoscope (10) extending within the scope channel (see Fig. 7), wherein the scope is moveable between a retracted position in which a distal end of the scope is recessed within the cannula assembly, and an extended position in which the distal end of the scope protrudes from the cannula assembly (extended position is shown in Fig. 7, the retracted position is achieved when the scope is inserted into the channel).
Regarding Claim 18, Dejima as modified further discloses wherein the handle comprises at least two sections that form an interference fit with the cannula assembly (see Fig. 13 showing the handle (the proximal-most piece in the picture, fitting around the flange; the handle includes a proximal section and a distal section; the Examiner notes that the claim requires the handle to form an interference fit with the cannula assembly and not the at least two sections to form an interference fit with one another; furthermore, using two halves that come together into one piece is well-known in the art and in manufacturing when making components).
Regarding Claim 20, Dejima as modified further discloses wherein the at least one insert comprises a first insert (124) and a second insert (126), wherein the tool path and the scope path are defined between the first insert and the second insert. The Examiner also notes that making components separable is well-known and obvious (see MPEP 2144.04.V.C). Here, because the insert has two portions (first and second inserts 124/126), making these separable allows for inserts with different sizes or for different functions to be combined as desired by the user. Also, the ability to remove one or the other allows for the replacement of one as needed if it becomes damaged. For at least these reasons, Dejima reads on the claim and/or renders the limitations obvious.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Dejima (US 2016/0022121) and Wilk (US 2006/0241344), as applied to claim 1 above, and further in view of Sekine et al. (US 2005/0119524).
Dejima and Wilk disclose the invention substantially as claimed as stated above. They do not explicitly disclose wherein the at least one insert further defines an exhaust channel, wherein the cannula gasket further defines an exhaust aperture in alignment with the exhaust channel. Sekine teaches in a similar introduction device using an exhaust tube (124) and channel (122; see Fig. 30) for venting gas as is known in the art. 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 modify Dejima’s device to include Sekine’s exhaust tubes and channel. Extending Sekine’s tube and channel through Dejima’s gasket ensures the body cavity remains sealed until the user decides to vent the gas. The exhaust mechanism allows the user to vent gas as desired during the procedure.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Dejima (US 2016/0022121) and Wilk (US 2006/0241344), as applied to claim 1 above, and further in view of Jones (US 5,386,817).
Dejima and Wilk disclose the invention substantially as claimed as stated above. They do not explicitly disclose wherein the at least one insert further defines a scope wash channel configured to receive a scope wash tube therethrough, wherein the cannula gasket further defines a scope wash aperture in alignment with the scope wash channel. Jones teaches using tubes 90A/90B to wash the lens of an endoscope. 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 modify Dejima’s device to include Jones’s wash tube and channel. Extending Jones’s tube and channel through Dejima’s gasket ensures the body cavity remains sealed during the procedure. The washing mechanism allows the user to clean the endoscope lens as needed.
Allowable Subject Matter
Claims 2-3, 5-8, 12-14, 16, and 19 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim 2 requires columns that interface with the insert to create a gap between the outer tube and distal face of the gasket. This was not found in the prior art and, given Dejima’s configuration, the Examiner does not see how or why a person having ordinary skill in the art would modify the reference to include such a feature.
Claim 3 requires the gasket to have a tapered sidewall to form a fluid-tight seal around an internal perimeter of the flange. Dejima’s gasket is circular and the location of the gasket within the flange is also circular. A tapered gasket as claimed would not work in Dejima’s device as there would be a gap between the gasket and the flange. Modifying the reference to include this feature would provide no benefit and would require structural changes to both the flange and the gasket. While tapered seals may be known in the art, there is no reason to use one here.
Claim 5 includes details about a filter assembly. Filters related to vented gases are known in the art for obvious reasons. Venting gas that may be contaminated into the surgical arena would be unwise. That being said, the prior art does not disclose the claimed assembly with the filter assembly being contained within the handle, the claimed inlet tube, the filter housing, and the particulate filter. Adding a filter would be obvious, but the claim is narrower than simply including a filter, and the particulars of the assembly were not found such that it would be obvious to modify Dejima to include them.
Claims 6-9 depend from claim 5 and also overcome the prior art.
Claim 12 requires a rib that terminates proximally of the cannula assembly. Dejima does not include such a rib, and the Examiner found no reference that would render this feature obvious. Dejimag’s proximal ports are designed to seal around the inserted tool or scope such that including a rib would interfere with this purpose. Therefore, the Examiner does not consider modifying the reference to include a rib to be obvious.
Claims 13-14 depend from claim 12 and also overcome the prior art.
Claim 16 requires a proximal bell wherein a proximal end of the scope is positioned within the bell. Dejima includes a proximal bell-like portion, but the Examiner has already considered that to be the handle. Including another bell would be redundant and without a purpose. A person having ordinary skill in the art would have no reason to do such a thing other than Applicant’s own disclosure, which is the definition of impermissible hindsight.
Claim 19 requires first and second surfaces that engage the flange as claimed. No portion of Dejima’s handle engages the proximal face of the flange. The Examiner does not see how Dejima would even be modified for this to happen. Therefore, the claim is not considered obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY JAY NEAL whose telephone number is (313)446-4878. The examiner can normally be reached Mon-Fri 7:30-5:30.
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/TIMOTHY J NEAL/ Primary Examiner, Art Unit 3795