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 .
Claims 1-9 are cancelled. A complete action on the merits of pending claims 10-28 appears herein.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 10-16, 20-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11-13, 15-18, 23, 25-28 of U.S. Patent No. 11,564,728. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims comprise overlapping subject matter with minor grammatical differences.
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) 10, 12-14, 22, and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brenneman (hereinafter “Brenneman944”) (US 2008/0171944 A1).
Regarding claim 10, Brenneman944 teaches a method for creating an anastomosis between first and second blood vessels, (Fig. 1-5) comprising:
identifying a procedural site for creating the anastomosis, (Par. [0048]) having adjacent first and second blood vessels; (Fig. 1-5)
creating an opening through a first blood vessel wall and an adjacent second blood vessel wall, (Par. [0052]: The needle is advanced from an artery to a vein, or from a vein to an artery.) the opening comprising a communicating opening between the first blood vessel and the second blood vessel; (Fig. 2-5, the opening at fistula site (111))
determining blood flow volume through the communicating opening; (Par. [0063]: prior to a complete retraction, a contrast medium injection can be used to assess blood flow through the fistula.) and
dilating the communicating opening if the determined blood flow volume is below a predetermined level. (Par [0063]: If flow is determined to be insufficient, subsequent procedures can be employed to change flow characteristics; Claim 69: the flow modification procedure includes dilating the fistula)
Regarding claim 12, Brenneman944 further teaches the dilating step after determining the blood flow volume is performed using an inflatable balloon. (Brenneman944: Par. [0063] and Claim 7)
Regarding claims 13 and 14, Brenneman944 further teaches a second step of determining the blood flow volume through the communicating opening after the dilating step; (Par. [0071]: A repeat parameter measurement is performed, wherein the parameter can be any heart or physiologic parameter; Par. [0047]: External ultrasound allows a user to visualize vessels, and perform measurements including determining blood flow rates) and a second step of dilating the communicating opening if the determined blood flow volume obtained during the second step of determining the blood flow volume is below the predetermined blood flow volume level. (Par. [0071]: A repeat parameter measurement is performed, and flow modifications repeated, until target values have been achieved; Claim 69: the flow modification procedure includes dilating the fistula)
Regarding claim 22, Brenneman944 further teaches the step of creating an opening is performed using a needle. (Par. [0052]: the needle is advanced from an artery to a vein, and can also be advanced from a vein to an artery. This forms an opening between the artery and vein)
Regarding claim 23, Brenneman944 further teaches a step of removing tissue to enlarge the communicating opening. (Par. [0056]: A debulking tool may be used to remove a portion of tissue as a method of enlarging the opening or flow path.)
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.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brenneman944 (US 2008/0171944 A1), as applied to claim 10 above, in view of Reu (hereinafter “Reu710”) (US 9,439,710 B2).
Regarding claim 11, Brenneman944 is silent regarding the predetermined blood flow volume level is approximately 500 ml/min.
Reu710, in a similar field of endeavor, teaches arteriovenous fistulas should achieve a flow rate of 500 ml/min or greater to promote vein maturation and growth. (Col. 2, Lines 22-25)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Brenneman944, as applied to claim 10 above, to incorporate the teachings of Reu710, and use 500 ml/min as the predetermined blood flow volume. Doing so would help in promoting vein maturation and growth after the procedure is complete, as suggested in Reu. (Col. 2, Lines 22-25)
Claim(s) 15 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brenneman944 (US 2008/0171944 A1), as applied to claim 10 above, in view of Brenneman (hereinafter “Brenneman452”) (US 2016/0058452 A1).
Regarding Claim 15, Brenneman944, as applied to claim 14 above, is silent regarding the second dilating step is performed using a larger dilator or longer dilation time than was used to perform the first dilating step.
Brenneman452, in a similar field of endeavor teaches the use of two dilation devices configured to dilate an arteriovenous fistula, with a second dilation device being configured to expand to a different diameter than a first dilation device. (Page 14, Par. [0148])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Brenneman944 as applied to claim 14 above, to incorporate the teachings of Brenneman452 and include a second dilator configured to expand to a different diameter than a first dilation device. Doing so would allow the user to dilate the fistula to different diameters as needed to ensure the blood flow rate through the fistula reaches a target value.
The combination of Brenneman944/Brenneman452, as discussed above, does not explicitly teach that the second dilation device is configured to expand to a diameter larger than that of the first dilation device.
However, it has been held that an “obvious to try” rationale when choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success is a support for a conclusion of obviousness which is consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham, if the following findings can be established: (1) a finding that at the time of the invention, there had been a recognized problem or need in the art, which may include a design need or market pressure to solve a problem; (2) a finding that there had been a finite number of identified, predictable potential solutions to the recognized need or problem; (3) a finding that one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success; and (4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness. See MPEP § 2143(I)(E).
In the instant case, and as per (1), the flow rate through an arteriovenous fistula needs to be at least 500 ml/min in order to promote vein maturation and growth (Please see evidentiary reference Reu710 (US 9,439,710 B2): Col. 2, Lines 22-25). As per (2), one of ordinary skill in the art would recognize that the differing diameter of the second dilation device can only be selected from the following options: (A) wherein the diameter of the second dilation device is larger than a diameter of a first dilation device; or (B) wherein the diameter of the second dilation device is smaller than a diameter of a first dilation device. As per (3), one of ordinary skill in the art would recognize that modifying the prior art based on the finite number of predictable solutions outlined herein can be done without changing the principles of operation of the prior art, and without changing the intended purpose of the prior art. As such, one of ordinary skill in the art would have a reasonable expectation of success when modifying the prior art. As per (4), a dilation device with a larger diameter would allow for the fistula to be dilated to a larger degree, and would result in a larger flow rate through the fistula. If dilating the fistula with a first, smaller diameter dilation device produces a flow volume through the fistula that’s below a target flow volume, dilating the fistula to a larger degree with a second, larger diameter dilation device will allow for a greater flow volume through the fistula.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of the combination of Brenneman944/Brenneman452, as applied to claim 15 above, and to have modified them by having the second dilation step be performed using a larger dilator than was used to perform the first dilating step, as a matter of trying a finite number of predictable solutions, in order to achieve the target blood flow volume through the fistula.
Regarding claim 20, Brenneman944, as applied to claim 10 above, is silent regarding a step of dilating the first blood vessel before the step of creating an opening.
Brenneman452, in a similar field of endeavor, teaches pre-dilating a vein prior to an introducer being placed into said vein. (Par. [0148])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Brenneman944, as applied to claim 10 above, to incorporate the step of pre-dilating a first blood vessel before the catheter apparatus (10) is inserted into the first blood vessel and the communicating opening is created as taught by Brenneman452. Doing so would provide for more space within the vessel for the catheter apparatus (10) to maneuver, and minimize the risk of damaging the vessel walls during transit to the target treatment area.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brenneman944 (US 2008/0171944 A1), in view of Brenneman452 (US 2016/0058452 A1), as applied to claim 20 above, and further in view of Consigny (US 2016/0000985 A1).
Regarding Claim 21, the combination of Brenneman944/Brenneman452, as applied to claim 20 above, is silent regarding the dilating step is performed using one of a brachial plexus block (BPB), an axillary block, or a vasodilator drug.
Consigny, in a similar field of endeavor, teaches the use of a vasodilator drug to promote venous dilation. (Page 2, Par. [0023])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Brenneman944/Brenneman452, as applied to claim 20 above, to incorporate the teachings of Consigny, and use of a vasodilator drug to dilate the blood vessel before creating the opening. Doing so would be a simple substitution of one dilation mechanism for another for the predictable result of dilating a first blood vessel.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brenneman944 (US 2008/0171944 A1), as applied to claim 10 above, in view of Rios (US 2014/0107642 A1).
Regarding Claim 16, Brenneman944, as applied to claim 10 above, is silent regarding a step of evaluating secondary outflow vessels downstream from the communicating opening for suitability of use as a future dialysis access point creating a flow restriction in one of the secondary outflow vessels.
Rios, in a similar field of endeavor, teaches evaluating secondary outflow vessels downstream from the communicating opening for suitability of use as a future dialysis access point (Par. [0021]: Outflow vessels are evaluated, and a vein is selected from the outflow vessels that has a flow rate suitable for dialysis access.) creating a flow restriction in one of the secondary outflow vessels. (Par. [0021]: The vein is then cannulated to provide vascular access. Depending on which vein is selected, flow from the fistula into the basilic vein or the cephalic vein is reduced.)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Brenneman944, as applied to claim 10 above, to incorporate the teachings of Rios, and evaluate secondary outflow vessels downstream from the communicating opening for suitability of use as a future dialysis access point, and to create a flow restriction in one of the secondary outflow vessels. Doing so would allow for the formation of a safe and effective dialysis access point, as suggested in Rios. (Par. [0021])
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brenneman944 (US 2008/0171944 A1), as applied to claim 10 above, in view of Kellerman (hereinafter “Kellerman959”) (US 2011/0306959 A1).
Regarding Claim 24, Brenneman944, as applied to claim 10 above, teaches applying energy to the fistula (tissue surrounding the communicating opening), wherein the energy is selected from a group consisting of “electrical energy such as radiofrequency or microwave energy; cryogenic energy; heat; radiation; and combinations thereof” (Claim 17)
Brenneman944, as applied to claim 17 above, does not explicitly teach that applying heat to the fistula seals or welds the tissue.
Kellerman959, in an analogous device, teaches using a heating member to form an aperture between two vessels and weld the edges of the aperture to create an arteriovenous fistula. (Par. [0022]: “applying energy to a heating member on one of the distal member and the elongate member to cut and form the aperture, and to weld the edges thereof in order to create a desired fistula between the two vessels”)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Brenneman944, as applied to claim 10 above, to incorporate the use of heat to weld tissue, as taught by Kellerman959 for the predictable result of forming an arteriovenous fistula.
Claim(s) 10 is rejected again under 35 U.S.C. 103, along with claim 25, as being unpatentable over Kellerman (hereinafter “Kellerman998”) (US 2013/0281998 A1) in view of Bender (US 7,794,471 B1) in view of Reu (hereinafter “Reu561”) (US 2014/0142561 A1), in view of Brenneman944 (US 2008/0171944 A1).
Regarding claims 10 and 25, Kellerman998 teaches a method for creating an anastomosis between first and second blood vessels, (abstract) comprising:
identifying a procedural site for creating the anastomosis, having adjacent first and second blood vessels; (Fig. 3-7: A user would identify the procedural site at least before navigating to the treatment zone and affecting tissue at least in that they have to select/choose the vessels and treatment zone.)
advancing a catheter (Fig. 1, Char. 510: device) having a proximal portion and a distal portion over a guidewire to the procedural site; (Par. [0044])
advancing the distal catheter portion (Fig. 5, Char. 518 and 516) through the opening into the second blood vessel; (Fig. 5: Distal tip (518) and shaft (516) are advanced over guidewire (34) and into the second blood vessel)
retracting the distal portion so that a proximal face thereon contacts tissue on the second blood vessel wall; (Fig. 6-7 and Par. [0047]-[0048])
contacting tissue on the first blood vessel wall with a distal face on the proximal portion, thereby capturing tissue between the proximal and distal faces; (Fig. 6-7: The distal face of outer tube (512) contacts tissue on first blood vessel (26) and the proximal face of tip (518) contacts tissue on the second blood vessel (28), capturing tissue therebetween)
applying energy to a heating surface on one of the proximal and distal faces to heat the captured tissue (Claim 22) to a prescribed temperature; (Claim 23 and Par. [0015]: The heat energy is controlled at a known temperature ranging from between about 150-300C) and
creating an opening through a first blood vessel wall and an adjacent second blood vessel wall, (Fig. 3-7 and Claim 22) the opening comprising a communicating opening between the first blood vessel and the second blood vessel; (Claim 22)
Kellerman998, as applied to claims 10 and 25 above, is silent regarding measuring a distance between the proximal and distal faces to thereby determine a thickness of the tissue captured between the proximal and distal faces; releasing and recapturing the tissue if the determined thickness of the captured tissue is not within a predetermined range; stopping the application of energy to the heating surface when a measured distance between the distal and proximal faces reaches a desired level; determining blood flow volume through the communicating opening; and dilating the communicating opening if the determined blood flow volume is below a predetermined level.
Bender, in a similar field of endeavor, teaches determining the thickness of vessel walls when selecting a location (area) for creating an anastomosis; (Col. 22, Lines 7-40) and repositioning to a different point at a location (area) of the procedural site (the limitation “location of the procedural site,” given broadest reasonable interpretation, could be interpreted as referring to any anatomic structure that can be considered as involved in the procedure. (e.g. portions of a blood vessel, Specific blood vessels, the entire circulatory system, the patient’s abdomen or any limbs, the patient’s entire body, etc.)) upon determining that the thickness of the vessels walls is not within a predetermined range. (Col. 22, Lines 28-33: The operator can select a different location for anastomosis based on the determined thickness; One of ordinary skill in the art would recognize that the term “location” used in Bender could refer to a different point along the target blood vessel as well as a different vessel entirely; There would be some form of cutoff between a range of thicknesses deemed “appropriate” and at least one range of thicknesses deemed “inappropriate.”)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Kellerman998, as applied to claims 10 and 25 above, to incorporate the teachings of Bender, and measure the thickness of the captured tissue, before applying energy to said tissue, to determine and if the current positioning of the catheter (510) of Kellerman998 is appropriate for forming an anastomosis; and if it is determined that the current positioning is not appropriate, to reposition and recapture tissue at a different point within the same location (area) of tissue targeted for treatment. Doing so would allow for a safer procedure, as the risk of forming an anastomosis at inappropriate positions would be minimized.
The combination of Kellerman998/Bender, as applied to claims 10 and 25 above, is silent regarding stopping the application of energy to the heating surface when a measured distance between the distal and proximal faces reaches a desired level; determining blood flow volume through the communicating opening; and dilating the communicating opening if the determined blood flow volume is below a predetermined level.
Reu561, in an analogous device, teaches determining the thickness of a tissue captured between a distal heating assembly (Fig. 1, Char. 4: distal heating assembly) and a proximal heating assembly (Fig. 1, Char. 2: proximal heating assembly) of an anastomosis forming device (Fig. 1, Char. 1: device) by measuring the position of the distal heating assembly before, during and after the procedure. (Par. [0063])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Kellerman998/Bender, as applied to claims 10 and 25 above, to incorporate the teachings of Reu561, and measure a distance between the proximal and distal faces before, during and after the procedure, and to determine the tissue thickness by measuring the distance between the proximal and distal faces. Measuring the distance between the proximal and distal faces would provide the user with more information regarding the progress of the procedure, and can be related to the rate of tissue desiccation, cutting and welding, as suggested in Reu561. (Par. [0063]) Determining the tissue thickness by measuring the distance between the proximal and distal faces would be a simple substitution of one position measurement method for another, for the predictable result of determining a tissue thickness, and would allow for the tissue thickness and the procedure’s progress to be easily monitored by a user.
The combination of Kellerman998/Bender/Reu561, as applied to claims 10 and 25 above, is silent regarding stopping the application of energy to the heating surface when a monitored distance between the distal and proximal faces reaches a desired level; and determining blood flow volume through the communicating opening; and dilating the communicating opening if the determined blood flow volume is below a predetermined level.
However, Kellerman998 teaches that distal tip is fully retracted, such that the heating elements (520 and 522) on the distal tip and outer tube contact each other in order to ensure a complete cut and capture of the vessel tissue to be removed. (Fig. 1, 7, and 11, and Par. [0048])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified to modify the combination of Kellerman998/Bender/Reu561, as applied to claims 10 and 25 above, and stop the application of energy when the distal tip is fully retracted, such that the distal and proximal faces contact each other, and the procedure is complete. Doing so would allow for the anastomosis forming device to be safely removed from the patient without the risk of accidentally applying energy to tissue, and would allow for the procedure to be more energy efficient as energy would only be applied when said energy is used to affect tissue.
The combination of Kellerman998/Bender/Reu561, as applied to claims 10 and 25 above, is silent regarding determining blood flow volume through the communicating opening; and dilating the communicating opening if the determined blood flow volume is below a predetermined level.
Brennemen944, in a similar field of endeavor, teaches determining blood flow volume through the communicating opening; (Par. [0063]: prior to a complete retraction, a contrast medium injection can be used to assess blood flow through the fistula.) and dilating the communicating opening if the determined blood flow volume is below a predetermined level. (Par [0063]: If flow is determined to be insufficient, subsequent procedures can be employed to change flow characteristics; Claim 69: the flow modification procedure includes dilating the fistula)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Kellerman998/Bender/Reu561, as applied to claims 10 and 25 above, to incorporate the teachings of Brennemen944, and determine blood flow volume through the communicating opening; and dilate the communicating opening if the determined blood flow volume is below a predetermined level. Doing so would ensure the proper blood flow rate through the communicating opening is achieved, as suggested in Brennemen944. (Par. [0063])
Claim(s) 26 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Kellerman998 (US 2013/0281998 A1) in view of Bender (US 7,794,471 B1) in view of Reu561 (US 2014/0142561 A1), in view of Brenneman944 (US 2008/0171944 A1), as applied to claim 25 above, and further in view of Requarth (US 2012/0197061 A1).
Regarding claim 26, the combination of Kellerman998/Bender/Reu561/Brennemen944, as applied to claim 25 above, is silent regarding the predetermined range of the thickness of the captured tissue is 0.1mm – 0.6 mm.
Requarth, in a similar field of endeavor, teaches forming an anastomosis in tissue less than 1 cm thick. (Par. [0067]; Absent a statement of criticality and unexpected results, the overlapping range of 0-1cm is interpreted as reading on the claimed range of 0.1-0.6mm.)
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the combination of Kellerman998/Bender/Reu561/Brennemen944, as applied to claim 25 above, to incorporate the teachings of Requarth, and configure the predetermined range of thickness to be 0.1mm-0.6mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 27, the combination of Kellerman998/Bender/Reu561/Brennemen944, as applied to claim 26 above, teaches the desired level is reached when the distal and proximal faces are in contact with one another. (Kellerman998: Fig. 1, 7, and 11, and Par. [0048]: the cut and capture of vessel tissue is complete when the heating elements on the distal tip and outer tube contact each other)
Claim(s) 28 is rejected under 35 U.S.C. 103 as being unpatentable over Kellerman998 (US 2013/0281998 A1) in view of Bender (US 7,794,471 B1) in view of Reu561 (US 2014/0142561 A1), in view of Brenneman944 (US 2008/0171944 A1), as applied to claim 10 above, and further in view of Turner (US 2011/0118723 A1).
Regarding claim 28, the combination of Kellerman998/Bender/Reu561/Brennemen944, as applied to claim 10 above, teaches a step of advancing a sheath (Kellerman998: Fig. 4-5, Char. 516: shaft; Shaft (516) would be considered a sheath, at least in that it contains a central lumen configured to receive guidewire (34)) having a dilator (Kellerman998: Fig. 4-5: The tapered, distal most portion of tip (518)) to the procedural site over a guidewire prior to the catheter advancing step, (Kellerman998: Par. [0044]: The catheter 510 is advanced further into the patient, tracking over the guidewire 34, until the tapered dilating distal tip 518 comes into contact with the selected anastomosis site; Par. [0046]: moving the distal tip (518) into contact with the selected anastomosis site occurs before moving the proximal surface (518a) into contact with the wall of first vessel (26))
The sheath advancing step comprising rotating the sheath as it is advanced over the guidewire to reduce friction thereon. (Kellerman998: Par. [0044]-[0045]: the distal tip (518) and/or system can be rotated to reduce friction.)
The combination of Kellerman998/Bender/Reu561/Brennemen944, as applied to claim 10 above, is silent regarding the rotation of the sheath causing the release of any tissue that may be caught between the guidewire and the sheath.
Turner, in a similar field of endeavor, teaches rotating an electrosurgical applicator releases tissue sticking to said applicator, thereby permitting removal of said applicator. (Par. [0073])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Kellerman998/Bender/Reu561/Brennemen944, as applied to claim 10 above, to incorporate the teachings of Turner, and rotate the sheath in order to release of any tissue that may be caught between the guidewire and the sheath. Doing so would minimize the risk of unintentional damage to the patient caused by tissue sticking to the device (510) of Kellerman998, and would provide for easy movement of the distal tip (518) and shaft (516) of Kellerman998, as suggested in Turner. (Par. [0073])
Allowable Subject Matter
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Claims 17 and 18 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 and if a terminal disclaimer is filed for commonly assigned U.S. Patent No. 11,564,728.
Claim 19 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 17, the prior art of record does not explicitly teach all of the limitations of claim 10 and further teach “wherein said identifying an anatomical location comprises identifying a location where a distance between the first blood vessel and the second blood vessel is approximately 2 mm or less, which can be accessed from the deep communicating (perforating) vein (DCV), and from which at least one superficial outflow vessel has a diameter of at least 2 mm.”
Claims 18 and 19 would be allowable due to their respective dependencies on claim 17.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS SHEA BORSCH whose telephone number is (571)272-5681. The examiner can normally be reached Monday-Thursday 7:30AM-5:30PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at 3032974276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/N.S.B./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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