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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/10/2025 has been entered.
Response to Arguments
Applicant's arguments filed 03/10/2025 regarding the amendments to the claims have been fully considered but they are not persuasive. As is cited below, Meade teaches the newly amended limitations regarding the structural organization of the valve/port system and the placement of the biasing element in light of the said structural organization.
However, upon further consideration, Claim 8 is now rejected under U.S.C. 103 in view of Meade and Sapienza, to better address the surgical stapling limitations of the claim.
Newly added Claim 50 is rejected under U.S.C. 103 in view of Meade and Moll.
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 1-2, 4-5, and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent 5499998 awarded to Meade, hereinafter Meade.
Regarding Claim 1, Meade teaches a surgical device (abstract) comprising: an outer sleeve (Fig. 13, outer sleeve 18), comprising: an inner wall (Fig. 13, taper portion of wall of port 40, Col. 14, Lines 58-59, “syringe having a luer taper which matches the luer taper of the port 40 is inserted into the port 40”), a port (port 40), and a housing within the port (washer 160), the port extending through the inner wall of the outer sleeve (Col. 14, Lines 42-45, “a plastic washer 160 comprises a tapered through hole 166 which serves as a valve seat against the poppet 168. The washer 168 is welded by known means to a shoulder 165”); and a valve disposed at least partially within the outer sleeve (Fig. 13, poppet valve 168), the valve comprising: a shoulder portion positioned radially inward from the inner wall of the outer sleeve (shoulder 165, Fig. 13), an engagement portion configured to selectively engage the port of the outer sleeve, the engagement portion of the valve movable relative to the outer sleeve from an occluding position where the engagement portion forms a fluid-tight seal with the port to an open position where at least a portion of the engagement portion is spaced from the port (Col. 14, Lines 47-55, “The spring 170 rests on the outer diameter of the sleeve 18 and is slightly compressed by the poppet 168 and washer 165 to force the poppet 168 against the valve seat 166. The poppet 168 so biased by the spring 170 prevents fluids within the interior of sleeve 18 from migrating up into the port 40 and out of the instrument 10. At the same time, the poppet 41 allows fluid to be introduced into the interior of sleeve 18 via the port 40”), and a biasing element (coil spring 170) disposed between the engagement portion of the valve and the shoulder portion of the valve (Fig. 13), wherein the biasing element is configured to urge the engagement portion of the valve radially outward and into the occluding position (Col. 14, Lines 60-63, “The pressure of the cleaning fluid within the port 40 forces the poppet 168 out of the hole 166 against the bias force of the spring 170”).
Regarding Claim 2, Meade teaches the surgical device according to Claim 1, wherein the valve is biased into the occluding position (Col. 14, Lines 47-55, “The spring 170 rests on the outer diameter of the sleeve 18 and is slightly compressed by the poppet 168 and washer 165 to force the poppet 168 against the valve seat 166. The poppet 168 so biased by the spring 170 prevents fluids within the interior of sleeve 18 from migrating up into the port 40 and out of the instrument 10. At the same time, the poppet 41 allows fluid to be introduced into the interior of sleeve 18 via the port 40”).
Regarding Claim 4, Meade teaches the surgical device according to Claim 1, wherein the biasing element is compression spring (spring 170).
Regarding Claim 5, Meade teaches the surgical device according to Claim 1, wherein the valve includes a body portion (poppet 168), the biasing element disposed about the body portion of the valve (Fig. 13).
Regarding Claim 7, Meade teaches the surgical device according to Claim 1, further including a second valve (spring-loaded retaining knob 60) configured to selectively engage a second port (port 17) of the outer sleeve (Col. 5 Line 66-Col. 6 Line 6, “The tool assembly 12 is retained within the port 17 of the handle 14 by engagement of the tapered end 63 of the spring-loaded retaining knob 60 with the retention groove 62 fixedly coupled to the outer sleeve 18”).
Regarding Claim 9, Meade teaches the method according to Claim 8, further comprising biasing the engagement portion of the valve into the occluding position (Col. 14, Lines 47-55, “The spring 170 rests on the outer diameter of the sleeve 18 and is slightly compressed by the poppet 168 and washer 165 to force the poppet 168 against the valve seat 166. The poppet 168 so biased by the spring 170 prevents fluids within the interior of sleeve 18 from migrating up into the port 40 and out of the instrument 10. At the same time, the poppet 41 allows fluid to be introduced into the interior of sleeve 18 via the port 40”).
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 8 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent 5499998 awarded to Meade, hereinafter Meade, as applied to the claims above, and further in view of U.S. Patent Publication 20160143641 awarded to Sapienza, hereinafter Sapienza.
Regarding Claim 8, Meade teaches a method of cleaning a jaw-based medical instrument (Col. 8, Lines 3-12, “The tool assembly 12 can also be provided with a cleaning port 40 in the rotating knob 42. This port 40 allows for the introduction of cleaning fluid into the tool assembly 12. A syringe full of cleaning fluid (not shown) may be inserted into the port 40. The cleaning fluid is then introduced via the port 40 into the interior of the tool assembly 12 between the inner rod 16 and the inside surface of the sleeve 18. The cleaning port 40 includes a valve 41 which permits the cleaning fluid to enter the tool assembly and prevents fluids within the tool assembly from escaping”), comprising: biasing the engagement portion of the valve into the occluding position (Col. 14, Lines 47-55, “The spring 170 rests on the outer diameter of the sleeve 18 and is slightly compressed by the poppet 168 and washer 165 to force the poppet 168 against the valve seat 166. The poppet 168 so biased by the spring 170 prevents fluids within the interior of sleeve 18 from migrating up into the port 40 and out of the instrument 10. At the same time, the poppet 41 allows fluid to be introduced into the interior of sleeve 18 via the port 40”) that is disposed between a shoulder portion (shoulder 165, Fig. 13) positioned radially inward from the inner wall (Fig. 13, taper portion of wall of port 40, Col. 14, Lines 58-59, “syringe having a luer taper which matches the luer taper of the port 40 is inserted into the port 40”) of the outer sleeve ( Fig. 13), moving an engagement portion of a valve radially inward with respect to an inner wall of an outer sleeve of an extension assembly of the medical instrument from an occluding position where the engagement portion forms a fluid-tight seal with a part that extends radially inward with respect to the inner wall and extends through the inner wall (Col. 14, Lines 47-55, “The spring 170 rests on the outer diameter of the sleeve 18 and is slightly compressed by the poppet 168 and washer 165 to force the poppet 168 against the valve seat 166. The poppet 168 so biased by the spring 170 prevents fluids within the interior of sleeve 18 from migrating up into the port 40 and out of the instrument 10. At the same time, the poppet 41 allows fluid to be introduced into the interior of sleeve 18 via the port 40”) to an open position where at least a portion of the engagement portion is spaced from the port (Col. 14, Lines 60-63, “The pressure of the cleaning fluid within the port 40 forces the poppet 168 out of the hole 166 against the bias force of the spring 170”); inserting fluid through the port in the outer sleeve of the extension assembly of the medical stapling instrument, moving the fluid out of the medical instrument, and maintaining the engagement portion of the valve in the open position after a majority of the fluid has moved out of the medical stapling instrument (Col. 14, Line 57 to Col. 15, Line 2, “To clean the interior of the sleeve 18 and the inner rod 16, a syringe having a luer taper which matches the luer taper of the port 40 is inserted into the port 40. The plunger of the syringe is depressed to introduce fluid into the port 40. The pressure of the cleaning fluid within the port 40 forces the poppet 168 out of the hole 166 against the bias force of the spring 170. With the poppet out of the hole 166, the cleaning fluid passes from port 40 into chamber 164 then through hole 162 and into the interior of sleeve 18. The cleaning fluid then flows through the space 13 between the inner rod 16 and the outer sleeve 18 and out the distal end of the tool assembly 12 near the jaw assembly 66, thus cleaning the tool assembly 12 for the next use”). Meade does not teach wherein the jaw assembly is a stapling device.
However, Sapienza teaches a jaw based surgical device that uses the jaws as a stapling device (Para. 0004) that uses a luer cleaning systems to sterilize the device (Para. 0043-0044).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Meade by Sapienza, i.e. by having the jaw structure of Meade be a jaw-based stapling system, for the predictable purpose of simply substituting one known jaw-based end effector with another.
Regarding Claims 10 and 11, Meade modified by Sapienza makes obvious the method according to Claim 10. Meade does not teach wherein the method further comprises moving an engagement portion of a second valve radially inward relative to a second port of the outer sleeve of the medical stapling instrument from an occluding position where the engagement portion of the second valve forms a fluid-tight seal with the second port, to an open position where at least a portion of the engagement portion of the second valve is spaced from the second port, further comprising maintaining the engagement portion of the second valve in the open position while inserting fluid through the port in the outer tube of the medical stapling instrument. However, as taught above, Meade teaches the usage of a single valve performing these steps.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Meade, i.e. by adding a duplicate valve of port 40, as merely duplicating parts has been deemed to not provide patentable significance unless it provides a new and unexpected result (see MPEP 2144.04(IV)(B), “In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) (Claims at issue were directed to a water-tight masonry structure wherein a water seal of flexible material fills the joints which form between adjacent pours of concrete. The claimed water seal has a "web" which lies in the joint, and a plurality of "ribs" projecting outwardly from each side of the web into one of the adjacent concrete slabs. The prior art disclosed a flexible water stop for preventing passage of water between masses of concrete in the shape of a plus sign (+). Although the reference did not disclose a plurality of ribs, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.).”)
Claim 50 is rejected under 35 U.S.C. 103 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent 5499998 awarded to Meade, hereinafter Meade, as applied to the claims above, and further in view of U.S. Patent 461710 awarded to Moll, hereinafter Moll.
Regarding Claim 50, Meade teaches the surgical device of Claim 1. Meade does not teach wherein the engagement portion selectively engages the port of the outer sleeve by contacting the inner wall of the outer sleeve.
However, in the art of surgical devices (abstract, title), Moll teaches the usage of a spring-biased valve (coil spring 156) with an engagement portion contacting the inner wall of the outer sleeve (grip 112) of the port (Fig. 8) to stabilize the valve in the port (Col. 5, Lines 11-23, “The other end of the valve body has a cylindrical extension 148 that serves in combination with stop 150 to limit the axial movement of the valve in the cavity. Stop 150 has a cylindrical body 152 that aligns axially with extension 148 and a head defined by a pair of axially spaced circumferential collars 154 one of which abuts one end wall of the cavity 126 and the other of which abuts the exterior surface of the grip end wall. A coil spring 156 is received around extension 148 and stop body 152 with its ends seated, respectively, against the inner surface of the inner stop collar 154 and one end of the valve body. Spring 156 serves to bias the valve body axially”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Meade by Moll, i.e. by using the engagement portion in the valve of Moll in the valve of Meade, for the predictable purpose of stabilizing the valve of Meade the same way as in the valve in Moll.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jess Mullins whose telephone number is (571)-272-8977. The examiner can normally be reached between the hours of 9:00 a.m. to 5:00 p.m. PST M-F.
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/JLM/
Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792