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 .
Priority
The present application is a continuation of U.S. Patent Application No. 17/660,081, filed April 21, 2022, now U.S. Patent No. 12,053,201, which is a continuation of U.S. Patent Application No.16/121,489, filed September 4, 2018, now U.S. Patent No. 11,337,719, which is a continuation of U.S. Patent Application No. 14/244,452, filed April 3, 2014, now U.S. Patent No. 10,098,656, which claims the benefit of U.S. Provisional Application No. 61/808,197, filed April 3, 2013.
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 11 recites the limitation "the working channel" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. For examination purpose this limitation has been interpreted as “a working channel.” Appropriate correction is required.
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.
Claim(s) 1-8 and 13-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aljuri et al. (US 2011/0184391, hereinafter “Aljuri”).
Referring to claim 1, Aljuri discloses an apparatus to enucleate at least a portion of a prostate of a patient, the prostate comprising a capsule and an inner layer of prostate tissue (FIGS. 1-2D, 9a-10c and 15-18), the apparatus comprising:
a probe to advance at least partially into the patient, the probe configured to provide a water jet to resect a urethra of the patient at a first location and a second location to separate the capsule from the inner layer of prostate tissue to enucleate the at least a portion of the prostate (para. [0082]: “At step 801, the device is positioned and anchored in the urethra, as described above. At step 802, the device is configured to discharge a fluid stream of sufficient force to resect and penetrate the urethral wall. At step 803, after the fluid stream has penetrated the urethral wall, the fluid stream is adjusted to a level that selectively resects the desired prostate tissue while leaving intra-prostate blood vessels, capsules, and other non-glandular tissue substantially undamaged.”);
wherein the apparatus is configured to provide the water jet comprising a visible entrainment region of cavitations (the jet stream of Aljuri inherently be visible to user’s eye), and wherein at least one of a pressure and a flow rate of liquid through the probe is adjustable to adjust the length of the visible entrainment region; wherein the apparatus is adjustable to decrease a distance from the orifice to a tip of the visible entrainment region subsequent to cutting the urethra ([0068]: “When using a fluid stream to resect tissue, selective tissue resection may be accomplished by varying one or more parameters of the fluid stream, such as the pressure within a nozzle or other fluid delivery element, or the flow rate of the fluid in the stream, so that it resects some tissue compositions while leaving other tissue compositions substantially undamaged.” [0078]: “At step 701, various fluid parameters such as the pressure of the fluid source, shape of the fluid stream, etc., are configured to resect a specific tissue type, such as glandular prostate tissue. By configuring the fluid parameters one can control fluid force, rate of resection, treatment time, area of tissue to be resected, etc., in order to achieve controlled and selective resection” Aljuri is silent about controlling a distance from the orifice to a tip of the visible entrainment region, however, one of ordinary skill in the art will understand that the distance from the orifice of the fluid delivery element to the tip of the visible entrainment region (the bubbles at the end of the fluid jet) is directly related to the pressure and volume of the fluid. Thus, controlling the pressure and volume also controls the distance from the orifice to a tip of the visible entrainment region); and
wherein the apparatus is configured to image the visible entrainment region of the water jet, and wherein the apparatus is adjustable to adjust the length of the visible entrainment region based on a said obtained image of the visible entrainment region (para. [0139] discloses “Optionally, the treatment may be visualized by providing visualization elements within the expanded working space WS. Such visualization elements may comprise endoscopic cameras or other suitable visualization elements. In one embodiment, the visualization elements may be disposed on the elongate element 310 or on the carrier tube 380. In another embodiment, the visualization elements may be separately inserted into the working space WS..” Based on the disclosure in paragraphs [0068], [0078] and [0139] examiner contends that one of ordinary skill in the art will understand that the intensity and the distance of the entrainment region of the water jet can be seen by the user and can be controlled by the controller).
Referring to claim 2, Aljuri discloses the apparatus of claim 1, wherein the probe is configured to advance into the patient with one or more of open surgical access, percutaneous access or urethral access (FIGS. 2A-2C shows the probe is configured to advance into the patient with via urethral access).
Referring to claim 3, Aljuri discloses the apparatus of claim 1, wherein the probe is configured to provide the water jet to the first location situated near a bladder neck of the urethra and the second location situated near a verumontanum and toward the bladder neck from the verumontanum (FIGS. 4-7 and 15. Para. [0061]: “As shown in FIG. 4, an exemplary energy delivery region 20 can be formed by a high pressure nozzle 200 which is carried on a delivery tube 380 which is disposed within the shaft 12. Carrier tube 380 may be axially translated as shown by arrow 204 and/or rotated as shown by arrow 206 so that the fluid stream 208 emanating from the nozzle 200 can be scanned or rastered over all or a selected portion of the urethra within the prostate.” FIG. 2C shows the water jet is positioned near a bladder neck. Furthemore, Aljuri discloses the device can be moved within urethra to locate the water jet (para. [0030])).
Referring to claim 4, Aljuri discloses the apparatus of claim 1, wherein the probe is configured to resect the urethra with a plurality of resections extending between the first location and the second location and wherein the plurality of resections extend from the urethra to the capsule (paras. [0030], [0078], [0081]-[0082]; para. [0030]: “[0030] Positioning of the pressurized fluid source will typically comprise advancing a probe into the urethra, directing the pressurized fluid through a fluid delivery element (such as a nozzle or plurality of nozzles) which is movably mounted on the probe, and moving the fluid delivery element relative to the probe to scan the fluid stream over the wall.”).
Referring to claim 5, Aljuri discloses the apparatus of claim 1, wherein an energy of the water jet is adjustable to separate the capsule from the inner layer of prostate tissue and inhibit resection of the capsule and blood vessels. (paras. [0078], [0081]-[0082])
Referring to claim 6, Aljuri discloses the apparatus of claim 1, wherein the water jet comprises a divergent stream (para. [0026]; FIGS. 10a and 10c; para. [0047]: “FIG. 10a illustrates a columnar fluid stream and a diverging fluid stream.”).
Referring to claim 7, Aljuri discloses the apparatus of claim 1, wherein an energy of the water jet is adjustable based on a said obtained image of the entrainment region of the water jet when the probe has been inserted at least partially into the urethra (FIGS. 16-17 show a working space is created between the tissue and orifice 320. Thus, the visual device will allow the user to see the entrainment region of the water jet and to adjust an energy of the water jet by changing pressure and/or volume of water injected into the nozzle).
Referring to claim 8, Aljuri discloses the apparatus of claim 1, wherein the water jet is adjustable to a first amount of energy to resect the urethra at the first location and the second location and a second amount of energy to separate the outer capsule of the prostate from the inner layer of prostate tissue (Para. [0082]: “At step 801, the device is positioned and anchored in the urethra, as described above. At step 802, the device is configured to discharge a fluid stream of sufficient force to resect and penetrate the urethral wall. At step 803, after the fluid stream has penetrated the urethral wall, the fluid stream is adjusted to a level that selectively resects the desired prostate tissue while leaving intra-prostate blood vessels, capsules, and other non-glandular tissue substantially undamaged.” Para. [0068]: “When using a fluid stream to resect tissue, selective tissue resection may be accomplished by varying one or more parameters of the fluid stream, such as the pressure within a nozzle or other fluid delivery element, or the flow rate of the fluid in the stream, so that it resects some tissue compositions while leaving other tissue compositions substantially undamaged.”).
Referring to claim 13, Aljuri discloses the apparatus of claim 1, further comprising an endoscope to view the water jet. (para. [0139] discloses “Optionally, the treatment may be visualized by providing visualization elements within the expanded working space WS. Such visualization elements may comprise endoscopic cameras or other suitable visualization elements. In one embodiment, the visualization elements may be disposed on the elongate element 310 or on the carrier tube 380.” (emphasis added)).
Referring to claim 14, Aljuri discloses the apparatus of claim 1, wherein: the probe comprises carrier tube and a carrier (para. [0104] discloses “Optionally, when the elongate element 310 is introduced through the urethra, the elongate element 310 may be covered by a sheath or other cover (not shown). When fully covered with the sheath, the window is protected so that it reduces scraping and injury to the urethra as the elongate element 310 is advanced. Once in place, the sheath is retracted, exposing the window. The carrier tube 380 may then be rotated and advanced and/or retracted so that the fluid is delivered through the fluid delivery element 320.); or the apparatus further comprises a bag to receive the water jet.” (emphasis added)).
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.
Claim(s) 9 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aljuri et al..
Referring to claim 9, Aljuri discloses the apparatus of claim 1, wherein a first orifice of a first probe is configured to provide the water jet to resect the urethra and to separate the capsule from the inner layer of prostate tissue (para. [0082]: “At step 801, the device is positioned and anchored in the urethra, as described above. At step 802, the device is configured to discharge a fluid stream of sufficient force to resect and penetrate the urethral wall. At step 803, after the fluid stream has penetrated the urethral wall, the fluid stream is adjusted to a level that selectively resects the desired prostate tissue while leaving intra-prostate blood vessels, capsules, and other non-glandular tissue substantially undamaged.”). Aljuri fails to disclose a second probe to provide a second orifice to provide the water jet to separate the capsule from the inner layer of prostate tissue.
Referring again to claim 9, however, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. (In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960)). It would have been obvious to one of ordinary skill in the art, before the effective filling date of the application, to have modified the apparatus of Aljuri to have a first probe for resecting the urethra and a second probe for separating the capsule from the inner layer of prostate tissue because Aljuri discloses the parameters of the fluid jet for resecting urethra is different from the parameters of the fluid jet for separate the capsule from the inner layer of prostate tissue.
Referring to claim 11, Aljuri discloses the apparatus of claim 1, wherein the probe comprises sealed conduits to allow for sheath ports to be used to transmit flow or pressure of varying fluids within or parallel to the working channel. (FIG. 15, which is reproduced below, shows the probe include at least two parallel working channels. Therefore, it would have been obvious to provides several ports at the proximal end of the probe for coupling the ports to fluid sources for transmitting fluids to the channels).
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Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aljuri et al. in view of Kleyman et al. (US 2012/0157784, hereinafter “Kleyman”).
Referring to claim 12, Kleyman discloses the apparatus of claim 1, and the device can be inserted through an existing body tissue or stomach (para. [0033]). Kleyman fails to disclose the device further comprising a percutaneous access port to receive the probe and the endoscope.
Referring again to claim 12, however, Kleyman discloses advantage of endoscopic surgery includes reduced trauma, reduced blood loss, minimal scarring, minimized infection and reduced recovery time is well known in the art (para. [0005]). Endoscopic surgery can be performed percutaneously through one or more small incision or portals formed in the patient’s body or through a bodily orifice. Kleyman further discloses that providing one access port that allow insertion of multiple instrument simultaneously would further reduce the number of incisions for access port, thereby, further reduce trauma to patient (FIG. 1; para. [0028]). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the application, to have provided one single access port to allow the surgeon to utilize the device of Aljuri, which includes the probe and endoscopic camera ((para. [0139] discloses “Optionally, the treatment may be visualized by providing visualization elements within the expanded working space WS. Such visualization elements may comprise endoscopic cameras or other suitable visualization elements.” (emphasis added)), to perform endoscopic surgery inside patient’s stomach, therefore, reduced trauma, reduced blood loss, and reduced recovery time to the patient.
Allowable Subject Matter
Claim 10 is 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TUAN V NGUYEN whose telephone number is (571)272-5962. The examiner can normally be reached Monday - Friday 8:30 AM - 5:30 PM.
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/TUAN V NGUYEN/Primary Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771