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 (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.
Claim Objections
Claim 1 objected to because of the following informalities:
“the outer member” in lines 3 and 10 should be written “the elongate outer member”
“the inner member” in lines 5-8 and 11-12 should be written “the elongate inner member”
Appropriate correction is required.
Claim 2 objected to because of the following informalities:
“the inner member” in lines 2-3 should be written “the elongate inner member”
Appropriate correction is required.
Claim 4 objected to because of the following informalities:
“the distal end the inner member” in line 2 should be written “the distal end of the elongate inner member”
Appropriate correction is required.
Claim 5 objected to because of the following informalities:
“the inner member” in line 1 should be written “the elongate inner member”
“the outer member” in lines 1-2 should be written “the elongate outer member”
Appropriate correction is required.
Claim 6 objected to because of the following informalities:
“the inner member” in line 2 should be written “the elongate inner member”
Appropriate correction is required.
Claim 7 objected to because of the following informalities:
“the inner member” in line 2 should be written “the elongate inner member”
“the outer member” in line 2 should be written “the elongate outer member”
Appropriate correction is required.
Claim 8 objected to because of the following informalities:
“the outer member” in line 4 should be written “the elongate outer member”
Appropriate correction is required.
Claim 10 objected to because of the following informalities:
“the inner member” in line 2 should be written “the elongate inner member”
Appropriate correction is required.
Claim 11 objected to because of the following informalities:
“the inner member” in lines 3 and 5 should be written “the elongate inner member”
Appropriate correction is required.
Claim 13 objected to because of the following informalities:
“the inner member” in line 2 should be written “the elongate inner member”
Appropriate correction is required.
Claim 14 objected to because of the following informalities:
“the inner member” in line 2 should be written “the elongate inner member”
“the outer member” in line 2 should be written “the elongate outer member”
Appropriate correction is required.
Claim 17 objected to because of the following informalities:
“the inner member” in line 2 should be written “the elongate inner member”
“the outer member” in line 2 should be written “the elongate outer member”
Appropriate correction is required.
Claim 19 objected to because of the following informalities:
“the outer member” in lines 3, 10, and 12 should be written “the elongate outer member”
“the inner member” in lines 5-8 and 11 should be written “the elongate inner member”
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.
Claims 2-7, 9, and 11-13 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 2 recites the limitation "the second lumen" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitations "an elongate outer member" in line 2 and “the elongate outer member” in line 3. It is unclear whether these limitations are meant to be interpreted as the elongate outer member recited in claim 1, or a different elongate outer member.
Claims 4-6 are rejected as being dependent upon a rejected base claim.
Claim 7 and Claim 14 are written as the same claim, including the same language. Therefore, it is unclear whether these claims are meant to be interpreted as different claims or not.
Claim 9 and Claim 15 are written as the same claim, including the same language. Therefore, it is unclear whether these claims are meant to be interpreted as different claims or not.
Claim 11 recites the limitation "the ceramic insulator" in lines 1-4. There is insufficient antecedent basis for this limitation in the claim. However, a ceramic insulator is recited in claim 10. Therefore, claim 11 is interpreted as being dependent upon claim 10.
Claim 12 recites the limitation "the ceramic insulator opening" in line 2. There is insufficient antecedent basis for this limitation in the claim. However, a ceramic insulator opening is recited in claim 11. Therefore, claim 12 is interpreted as being dependent upon claim 11.
Claim 12 also recites the limitation "the electrode" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the ceramic insulator" in line 1. There is insufficient antecedent basis for this limitation in the claim. However, a ceramic insulator is recited in claim 10. Therefore, claim 13 is interpreted as being dependent upon claim 10.
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.
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.
Claim(s) 1, 7-8, 14, 16-17, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rubin et al., (US 20090270894; hereinafter Rubin) in view of Smith et al., (US 20130172918; hereinafter Smith).
Regarding claim 1, Rubin (Figures 1-7) discloses a medical device (10) comprising: an elongate inner member (18) disposed at least partially within an elongate outer member (16) defining an outer lumen (93) along a longitudinal axis of the outer member (16) and a lateral fluid port (31) at the elongate outer member (16), the lateral fluid port (31) in fluid communication with the outer lumen (16), wherein the inner member (18) defines an inner lumen (64) along a longitudinal axis of the inner member (18), wherein: the inner member (18) comprises a first passage (45) on a distal end portion (44) of the inner member (18) in fluid communication with the inner lumen (64) and a second passage (47) configurable to be in at least partial alignment with the lateral fluid port (31) of the outer member (16) to provide fluid communication between the lateral fluid port (31) and the inner lumen (64); and an end effector (24) at a distal end of the inner member (18), ([0024]-[0028], [0033]).
Rubin fails to disclose that the lateral fluid port is a lateral suction port. However, Smith (Figure 5) discloses a medical device (500) in which a lateral fluid port (512) is configured as a combined suction and irrigation port ([0081]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Rubin to include the lateral fluid port configured as a combined suction and irrigation port, as taught by Smith, since the modification would provide suction in addition to the irrigation disclosed by Rubin without the need to incorporate separate suction and irrigation ports (Smith; [0081]), reducing the bulk of the device when including suction capabilities for treatment.
Regarding claim 7, Rubin (Figures 1-7) further discloses a working channel (93) located between an inner surface of the outer member (16) and an outer surface of the inner member (18), the working channel being (93) in fluid communication with the lateral port (31), ([0024]-[0028], [0033]).
Regarding claim 8, Rubin (Figures 1-7) discloses wherein the second passage (47) is disposed more proximal than the first passage (45), and a length between the first passage (45) and the second passage (47) is more than a length between a distal end of the outer member (16) and the lateral port (31), ([0024]-[0028], [0033]).
Regarding claim 14, Rubin (Figures 1-7) further discloses a working channel (93) located between an inner surface of the outer member (16) and an outer surface of the inner member (18), the working channel being (93) in fluid communication with the lateral port (31), ([0024]-[0028], [0033]).
Regarding claim 16, Rubin (Figures 1-7) further discloses a seal (52) disposed more proximal than the second passage (47), ([0024]-[0028], [0032]-[0033]).
Regarding claim 17, Rubin (Figures 1-7) further discloses a seal (49) disposed between an outer surface of the inner member (18) and an inner surface of the outer member (16) and more proximal than the second passage (47), ([0024]-[0028], [0032]-[0033]).
Regarding claim 19, Rubin (Figures 1-7) discloses a medical device (10) comprising: an elongate inner member (18) disposed at least partially within an elongate outer member (16) defining an outer lumen (lumen defining the open channel within outer member 16) along a longitudinal axis of the outer member (16) and a lateral fluid port (31) at the elongate outer member (16), the lateral fluid port (31) in fluid communication with the outer lumen (93), wherein the inner member (18) defines a inner lumen (64) along a longitudinal axis of the inner member (18), wherein: the inner member (18) comprises a first passage (45) on a distal end (44) portion of the inner member (18) in fluid communication with the inner lumen (64) and a second passage (47) configurable to be in at least partial alignment with the lateral fluid port (31) of the outer member (16) to provide fluid communication between the lateral fluid port (31) and the inner lumen (64); and a working channel (93) disposed between an inner surface of the outer lumen (lumen defining the open channel within outer member 16) and an outer surface of the inner lumen (64), the working channel being in fluid communication with the fluid port (31), ([0024]-[0028], [0033]).
Rubin fails to disclose that the lateral fluid port is a lateral suction port. However, Smith (Figure 5) discloses a medical device (500) in which a lateral fluid port (512) is configured as a combined suction and irrigation port ([0081]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Rubin to include the lateral fluid port configured as a combined suction and irrigation port, as taught by Smith, since the modification would provide suction in addition to the irrigation disclosed by Rubin without the need to incorporate separate suction and irrigation ports (Smith; [0081]), reducing the bulk of the device when including suction capabilities for treatment.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rubin/Smith, as applied to claim 1 above, and further in view of Flom et al., (US 5830214; hereinafter Flom).
Regarding claim 2, Rubin (Figures 1-7) further discloses wherein the first passage (45) comprising a front opening at a distal end (44) of the inner member (18), ([0027]), but fails to disclose a side opening on a side wall of the inner member at the distal end portion in fluid communication with the second lumen. However, Flom (Figures 1-2A) teaches a medical device comprising a side opening (8) on a side wall of an inner member (4) at the distal end portion in fluid communication with a second lumen (14), (Col. 4, lines 40-45 and 60-65). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Rubin/Smith to include a side opening on a side wall of the inner member at the distal end portion in fluid communication with the second lumen, as taught by Flom, because the modification would enhance the evacuation of fluids from the target area (Flom; Col. 5, lines 55-60).
Claim(s) 3-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rubin/Smith, as applied to claim 1 above, and further in view of Shalon et al., (US 20100137891; hereinafter Shalon).
Regarding claims 3-6, Rubin (Figures 1-7) further teaches an elongate outer member (16), but Rubin/Smith fails to teach a camera at a distal end of the elongate outer member, further comprising an alignment marker located at the distal end the inner member, the alignment marker being alignable with the second passage and positionable in a field of view of the camera, wherein the inner member is slidable relative to the outer member between a retracted position and an extended position. However, Shalon (Figure 3b) teaches a medical device comprising an elongate outer member (60) and a camera (72) at a distal end of the elongate outer member (60), further comprising an alignment marker (84) located at a distal end of an inner member (64), the alignment marker (84) being alignable as desired and positionable in a field of view of the camera (72), wherein the inner member (64) is slidable relative to the outer member (60) between a retracted position and an extended position ([0111]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Rubin/Smith to include a camera at a distal end of the elongate outer member, further comprising an alignment marker located at the distal end the inner member, the alignment marker being alignable as desired and positionable in a field of view of the camera, wherein the inner member is slidable relative to the outer member between a retracted position and an extended position, as taught by Shalon, because the modification would enable desired positioning and alignment of the different parts of the device during use (Shalon; [0111]). Furthermore, since the base device is concerned with the alignment of the different passages of the device, the alignment marker of the modified device would be alignable with the second passage.
Claim(s) 9 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rubin/Smith, as applied to claim 1 above, and further in view of Goble et al., (US 6090106; hereinafter Goble).
Regarding claim 9, Rubin/Smith teaches the medical device of claim 1, but fails to teach wherein the end effector is a helical electrode defining helical loops adjacently spaced apart from each other to allow fluid flow therebetween. However, Goble (Figure 6) teaches a medical device in which the end effector (51) is a helical electrode defining helical loops adjacently spaced apart from each other to allow fluid flow therebetween (Col. 15, lines 4-19). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Rubin/Smith to include the end effector configured as a helical electrode defining helical loops adjacently spaced apart from each other to allow fluid flow therebetween, as taught by Goble, because the modification would provide active cutting using the active electrode, wherein the helical shape of the electrode would enable a low power threshold (Goble; Col. 15, lines 4-19).
Regarding claim 15, the medical device of claim 1, wherein the end effector is a helical electrode defining helical loops adjacently spaced apart from each other to allow fluid flow therebetween. However, Goble (Figure 6) teaches a medical device in which the end effector (51) is a helical electrode defining helical loops adjacently spaced apart from each other to allow fluid flow therebetween (Col. 15, lines 4-19). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Rubin/Smith to include the end effector configured as a helical electrode defining helical loops adjacently spaced apart from each other to allow fluid flow therebetween, as taught by Goble, because the modification would provide active cutting using the active electrode, wherein the helical shape of the electrode would enable a low power threshold (Goble; Col. 15, lines 4-19).
Claim(s) 10-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rubin/Smith, as applied to claim 1 above, and further in view of Woloszko et al., (US 20030216725; hereinafter Woloszko).
Regarding claims 10-12, Rubin/Smith teaches the medical device of claim 1, but fails to disclose a ceramic insulator coupled to the inner member to separate the inner member from the end effector, wherein the end effector is located on the ceramic insulator and the end effector includes fluid inflow ports permitting fluid inflow through the end effector and into the inner lumen defined by the inner member and wherein the ceramic insulator defines a ceramic insulator opening in fluid communication with the inner lumen in the inner member, further wherein the electrode includes a grill spanning across the ceramic insulator opening. However, Woloszko (Figures 23A-23C) teaches a medical device (2100) in which a ceramic insulator (2108) is coupled to an inner member (2102) to separate the inner member (2102) from an end effector (2110), wherein the end effector (2110) is located on the ceramic insulator (2108) and the end effector (2110) includes fluid inflow ports (spaces between electrodes 2110 directing fluid into aspiration channel 2142 through element 2140) permitting fluid inflow through the end effector (2110) and into an inner lumen (2142) defined by the inner member (2102) and wherein the ceramic insulator (2108) defines a ceramic insulator opening (2140) in fluid communication with the inner lumen (2142) in the inner member (2102), further wherein the electrode (2110) includes a grill spanning across the ceramic insulator opening (2140), ([0172]-[0175]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the double tubular member configuration disclosed by Rubin, comprising tube 18 surrounding tube 14 which has end effector 24, with a single tubular member configuration taught by Woloszko, comprising only one tube 2102 which has end effector 2110 attached to the distal end of the one tube 2102 through ceramic insulator 2108, since both configurations perform the same function of providing an access shaft with an end effector located at the distal end of the device, and it has been held that substituting parts of an invention involves only routine skill in the art. MPEP 2144.06 (II)(B). Furthermore, reducing the double tubular member configuration disclosed by Rubin with a single tubular member configuration taught by Woloszko would reduce the bulk of the device.
Regarding claim 13, Rubin/Smith/Woloszko further teaches wherein the ceramic insulator (Woloszko; 2108) includes an inflow port (Woloszko; 2140) in fluid communication with the inner lumen (2142) defined by the inner member (Woloszko; 2102), (Woloszko; [0172]-[0175]).
Claim(s) 18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rubin/Smith, as applied to claims 1 and 19 above, and further in view of Hall et al., (US 20110282270; hereinafter Hall).
Regarding claim 18, Rubin (Figures 1-7) discloses a method for processing an instrument for surgery in accordance with the medical device of claim 1, but fails to disclose sterilizing the medical device; and storing the medical device in a sterile container. However, Hall teaches a method for processing an instrument for surgery, the method comprising sterilizing the medical device and storing the medical device in a sterile container ([0067]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Rubin/Smith to include the steps of sterilizing the medical device and storing the medical device in a sterile container, as taught by Hall, because the modification would provide a sterilized and safe medical device for use in treatment as desired (Hall; [0067]).
Regarding claim 20, Rubin (Figures 1-7) discloses a method for processing an instrument for surgery in accordance with the medical device of claim 19, but fails to disclose sterilizing the medical device; and storing the medical device in a sterile container. However, Hall teaches a method for processing an instrument for surgery, the method comprising sterilizing the medical device and storing the medical device in a sterile container ([0067]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Rubin/Smith to include the steps of sterilizing the medical device and storing the medical device in a sterile container, as taught by Hall, because the modification would provide a sterilized and safe medical device for use in treatment as desired (Hall; [0067]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE PREMRAJ whose telephone number is (571)272-8013. The examiner can normally be reached Monday - Friday: 8:00 AM - 5:00 PM.
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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794