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 .
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 1-2, 4-6, and 11-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-6 of U.S. Patent No. 11744600 . Claims 1-2, 4-6 and 11-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-6 of U.S. Patent No. 10702292. Although the claims at issue are not identical, they are not patentably distinct from each other because all limitations in the current claims can be found in the patented claims, as shown in the chart below.
Current claim #
1
2
4
5
6
11
12
13
Corresponding claim # in 11744600
3, 6
3, 6
3
6
3, 6
3
6
3, 6
Current claim #
1
2
4
5
6
11
12
13
Corresponding claim # in 10702292
3-6
3-6
3, 4
5, 6
6
3, 4
5, 6
6
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.
Claims 1-2, 4, 6-11, 13-20, and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Tiedtke et al. (US 20040153109 A1), hereinafter after referred to as “Tiedtke” in view of Pratt et al. (US 20150094673 A1), hereinafter referred to as “Pratt”.
Regarding Claim 1, Tiedtke teaches a system for real time monitoring of catheter aspiration (see Abstract; Figure 3), comprising:
a pressure sensor (414) configured for placement in fluid communication with a lumen (return lumen 438) which at least partially includes an aspiration lumen of a catheter (lumen of catheter 402), the aspiration lumen configured to couple to a vacuum source (440);
a processor coupled to the pressure sensor (electronic signal evaluation circuit 442, see Figure 3) and configured for measuring deviations in fluid pressure (the pressure sensor 414 measures the pressure drop over the hydraulic resistance. The measured pressure varies as a function of flow resistance of the fluid in the flow path of the catheter, see Paragraph [0020]-[0022]; it is understood the evaluation device collects data from sensor 414); and
a communicator coupled to the processor (an acoustic signal generator 446, see Figure 3) and configured to generate a continuous signal which is proportional to measured fluid pressure (the acoustic signal generator 446 generates tones or noises that the user can hear, depending on the information, see Paragraph [0021]), the continuous signal provided by a non-visual source (acoustic signal generator 446).
However, Tiedtke does not explicitly disclose an aspiration lumen; the aspiration lumen configured to couple to a vacuum source; and the communicator configured to generate a continuous signal which is proportional to measured fluid pressure.
Pratt teaches a reduced-pressure therapy system (see Abstract) an aspiration lumen (tubing 412 and 410); the aspiration lumen configured to couple to a vacuum source (coupled to reduce pressure pump 402, see Figure 4); and the communicator (LED 508) configured to generate a continuous signal which is proportional to measured fluid pressure (the LED 508 may be communicatively coupled to the pressure sensor 504 to receive a signal from the pressure sensor 504 in response to an applied pressure, see Paragraph [0082]).
Tiedtke and Pratt are analogous art because both teach a system for real time monitoring of a catheter.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the lumen and the communicator of Tiedtke and further include an aspiration lumen configured to couple to a vacuum source and wherein the communicator generates a continuous signal which is proportional to measured fluid pressure, as taught by Pratt. Pratt teaches an aspiration lumen coupled to a vacuum can provide negative pressure which is beneficial for reducing pressure in proximity to a tissue site can augment and accelerate growth of new tissue at the tissue site (see Paragraph [0003]). Pratt also teaches the communicator may provide a generic visual feedback as to whether reduced-pressure therapy is being effectively administered using a wall-suction source (see Paragraph [0116]).
Regarding Claim 2, Tiedtke teaches a system for real time monitoring of catheter aspiration (see Abstract; Figure 3), comprising:
a pressure sensor (414) configured for placement in fluid communication with an lumen (return lumen 438) of a catheter (catheter 402),
a processor coupled to the pressure sensor (electronic signal evaluation circuit 442, see Figure 3) and configured for measuring variations in fluid pressure (the pressure sensor 414 measures the pressure drop over the hydraulic resistance. The measured pressure varies as a function of flow resistance of the fluid in the flow path of the catheter, see Paragraph [0020]-[0022]; it is understood the evaluation device collects data from sensor 414); and
a communicator coupled to the processor (an acoustic signal generator 446, see Figure 3) and configured to generate a signal which varies proportionally as a result of variation in fluid pressure (the acoustic signal generator 446 generates tones or noises that the user can hear, depending on the information, see Paragraph [0021]), the signal provided by a non-visual source (acoustic signal generator 446).
However, Tiedtke does not explicitly disclose an aspiration lumen; the aspiration lumen configured to couple to a vacuum source; and the communicator configured to generate a continuous signal which is proportional to measured fluid pressure.
Pratt teaches a reduced-pressure therapy system (see Abstract) an aspiration lumen (tubing 412 and 410); the aspiration lumen configured to couple to a vacuum source (coupled to reduce pressure pump 402, see Figure 4); and the communicator (LED 508) configured to generate a continuous signal which is proportional to measured fluid pressure (the LED 508 may be communicatively coupled to the pressure sensor 504 to receive a signal from the pressure sensor 504 in response to an applied pressure, see Paragraph [0082]).
Tiedtke and Pratt are analogous art because both teach a system for real time monitoring of a catheter.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the lumen and the communicator of Tiedtke and further include an aspiration lumen configured to couple to a vacuum source and wherein the communicator generates a continuous signal which is proportional to measured fluid pressure, as taught by Pratt. Pratt teaches an aspiration lumen coupled to a vacuum can provide negative pressure which is beneficial for reducing pressure in proximity to a tissue site can augment and accelerate growth of new tissue at the tissue site (see Paragraph [0003]). Pratt also teaches the communicator may provide a generic visual feedback as to whether reduced-pressure therapy is being effectively administered using a wall-suction source (see Paragraph [0116]).
Regarding Claim 4, Tiedtke and Pratt teaches all of the limitations, as discussed above in claim 1, and Tiedtke further teaches wherein the continuous signal is provided by an audible source (the acoustic signal generator 446 generates tones or noises that the user can hear, depending on the information, see Paragraph [0021]).
Regarding Claim 5, Tiedtke teaches all of the limitations as discussed above in claim 1. However, Tiedtke does not explicitly disclose wherein the continuous signal is provided by a tactile source.
Pratt teaches an apparatuses for providing feedback for reduced-pressure therapy (see Abstract) comprising a pressure sensor (504) coupled to a processor (printed circuit board 502); a communicator coupled to the processor and configured to generate a continuous signal which varies proportionally as a result of variation in fluid pressure (feedback system (500) having a signal interface may be an auditory device or a tactile device, such as a moving protrusion, see Paragraph [0080]; The feedback system may further include an indicator communicatively coupled to the printed circuit board and the pressure sensor, and may be configured to indicate a status of the control pressure, see Paragraph [0007]), wherein the continuous signal is provided by a tactile source (a tactile device, such as a moving protrusion, see Paragraph [0080]).
Tiedtke and Pratt are analogous art because both teach a monitoring device for providing feedback to user.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the audio communicator device of Tiedtke and replace it with a tactile communicator device of Pratt. Pratt teaches the devices and systems described herein may provide feedback to an operator on leak conditions, feedback to an operator on blockage conditions, and feedback to an operator on canister full conditions (see Paragraph [0117]).
Regarding Claim 6, Tiedtke and Pratt teaches all of the limitations, as discussed above in claim 1, and Tiedtke further teaches wherein the communicator comprises an audio speaker, a piezoelectric, a heater, or a vibrator (the acoustic signal generator 446 generates tones or noises that the user can hear, depending on the information, see Paragraph [0021]).
Regarding Claim 7, Tiedtke and Pratt teaches all of the limitations, as discussed above in claim 1, and Tiedtke further teaches wherein an amplitude of the continuous signal is proportional to the measured fluid pressure (the measured pressure varies as a function of flow resistance of the fluid in the flow path of the catheter, see Paragraph [0020]).
Regarding Claim 8, Tiedtke and Pratt teaches all of the limitations, as discussed above in claim 1, and Tiedtke further teaches wherein a frequency of the continuous signal is proportional to the measured fluid pressure (the measured pressure varies as a function of flow resistance of the fluid in the flow path of the catheter, see Paragraph [0020]).
Regarding Claim 9, Tiedtke and Pratt teaches all of the limitations, as discussed above in claim 1, and Tiedtke further teaches wherein the proportionality is direct proportionality (the measured pressure varies as a function of flow resistance of the fluid in the flow path of the catheter, see Paragraph [0020]).
Regarding Claim 10, Tiedtke and Pratt teaches all of the limitations, as discussed above in claim 1, and Tiedtke further teaches wherein the catheter further includes a high pressure injection lumen (430) having a proximal end (404) and a distal end (406) and extending from a proximal end of the catheter to a location adjacent a distal end of the aspiration lumen (see Figure 3); and at least one orifice at or near the distal end of the high pressure injection lumen (a path section 432 open to the outside surroundings on the distal end section 406 of the catheter, see Figure 3) and configured to allow high pressure liquid injected through the high pressure injection lumen to be released into the aspiration lumen (the pressurized fluid arrives at the distal end section 406 of catheter 402 in the form of a sharp fluid jet in the open path section 432, treats the vessel 12 there, for example, cuts or fragments the vascular constriction material 434 and then flows into the distal end 436 of the return channel 438 with entrainment of material 434 and then through the latter in the direction of arrow 418 to the proximal end section 404, see Paragraph [0020]).
Regarding Claim 11, Tiedtke and Pratt teaches all of the limitations, as discussed above in claim 2, and Tiedtke further teaches wherein the continuous signal is provided by an audible source (the acoustic signal generator 446 generates tones or noises that the user can hear, depending on the information, see Paragraph [0021]).
Regarding Claim 12, Tiedtke teaches all of the limitations as discussed above in claim 2. However, Tiedtke does not explicitly disclose wherein the continuous signal is provided by a tactile source.
Pratt teaches an apparatuses for providing feedback for reduced-pressure therapy (see Abstract) comprising a pressure sensor (504) coupled to a processor (printed circuit board 502); a communicator coupled to the processor and configured to generate a continuous signal which varies proportionally as a result of variation in fluid pressure (feedback system (500) having a signal interface may be an auditory device or a tactile device, such as a moving protrusion, see Paragraph [0080]; The feedback system may further include an indicator communicatively coupled to the printed circuit board and the pressure sensor, and may be configured to indicate a status of the control pressure, see Paragraph [0007]), wherein the continuous signal is provided by a tactile source (a tactile device, such as a moving protrusion, see Paragraph [0080]).
Tiedtke and Pratt are analogous art because both teach a monitoring device for providing feedback to user.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the audio communicator device of Tiedtke and replace it with a tactile communicator device of Pratt. Pratt teaches the devices and systems described herein may provide feedback to an operator on leak conditions, feedback to an operator on blockage conditions, and feedback to an operator on canister full conditions (see Paragraph [0117]).
Regarding Claim 13, Tiedtke and Pratt teaches all of the limitations, as discussed above in claim 2, and Tiedtke teaches wherein the communicator comprises an audio speaker, a piezoelectric, a heater, or a vibrator (the acoustic signal generator 446 generates tones or noises that the user can hear, depending on the information, see Paragraph [0021]).
Regarding Claim 14, Tiedtke and Pratt teaches all of the limitations, as discussed above in claim 2, and Tiedtke further teaches wherein an amplitude of the continuous signal is proportional to the measured fluid pressure (the measured pressure varies as a function of flow resistance of the fluid in the flow path of the catheter, see Paragraph [0020]).
Regarding Claim 15, Tiedtke and Pratt teaches all of the limitations, as discussed above in claim 2, and Tiedtke further teaches wherein a frequency of the continuous signal is proportional to the measured fluid pressure (the measured pressure varies as a function of flow resistance of the fluid in the flow path of the catheter, see Paragraph [0020]).
Regarding Claim 16, Tiedtke and Pratt teaches all of the limitations, as discussed above in claim 2, and Tiedtke further teaches wherein the proportionality is direct proportionality (the measured pressure varies as a function of flow resistance of the fluid in the flow path of the catheter, see Paragraph [0020]).
Regarding Claim 17, Tiedtke and Pratt teaches all of the limitations, as discussed above in claim 2, and Tiedtke further teaches wherein the catheter further includes a high pressure injection lumen (430) having a proximal end (404) and a distal end (406) and extending from a proximal end of the catheter to a location adjacent a distal end of the aspiration lumen (see Figure 3); and at least one orifice at or near the distal end of the high pressure injection lumen (a path section 432 open to the outside surroundings on the distal end section 406 of the catheter, see Figure 3) and configured to allow high pressure liquid injected through the high pressure injection lumen to be released into the aspiration lumen (the pressurized fluid arrives at the distal end section 406 of catheter 402 in the form of a sharp fluid jet in the open path section 432, treats the vessel 12 there, for example, cuts or fragments the vascular constriction material 434 and then flows into the distal end 436 of the return channel 438 with entrainment of material 434 and then through the latter in the direction of arrow 418 to the proximal end section 404, see Paragraph [0020]).
Regarding Claim 18, Tiedtke teaches a system for real time monitoring of thrombus aspiration (see Abstract; Figure 3), comprising:
a pressure sensor (414) configured for placement in fluid communication with an lumen (return lumen 438) of a catheter (catheter 402) and configured to measure pressure within the lumen to characterize flow of blood and/or thrombus within the lumen (the pressure sensor 414 measures the pressure drop over the hydraulic resistance. The measured pressure varies as a function of flow resistance of the fluid in the flow path of the catheter, see Paragraph [0020]-[0022]; it is understood the evaluation device collects data from sensor 414), the aspiration lumen configured to couple to a vacuum source (440);
a processor coupled to the pressure sensor (electronic signal evaluation circuit 442, see Figure 3) and configured for measuring fluid pressure (it is understood the evaluation device collects data from sensor 414); and
a communicator coupled to the processor to receive output therefrom (an optical display device 444 and/or to an acoustic signal generator 446, see Figure 3), and configured to generate a signal that is not a pseudo-continuous analog (the acoustic signal generator 446 generates tones or noises that the user can hear, depending on the information, see Paragraph [0021]), of which a physical property is proportional to measured fluid pressure and of which a physical property can be sensed real- time by a user for characterizing fluid pressure (the optical display device 444 shows the user of catheter 402 the aforementioned information; the acoustic signal generator 446 generates tones or noises that the user can hear, depending on the information, see Paragraph [0021]).
However, Tiedtke does not explicitly disclose an aspiration lumen; the aspiration lumen configured to couple to a vacuum source; and the communicator configured to generate a continuous signal which is proportional to measured fluid pressure.
Pratt teaches a reduced-pressure therapy system (see Abstract) an aspiration lumen (tubing 412 and 410); the aspiration lumen configured to couple to a vacuum source (coupled to reduce pressure pump 402, see Figure 4); and the communicator (LED 508) configured to generate a continuous signal which is proportional to measured fluid pressure (the LED 508 may be communicatively coupled to the pressure sensor 504 to receive a signal from the pressure sensor 504 in response to an applied pressure, see Paragraph [0082]).
Tiedtke and Pratt are analogous art because both teach a system for real time monitoring of a catheter.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the lumen and the communicator of Tiedtke and further include an aspiration lumen configured to couple to a vacuum source and wherein the communicator generates a continuous signal which is proportional to measured fluid pressure, as taught by Pratt. Pratt teaches an aspiration lumen coupled to a vacuum can provide negative pressure which is beneficial for reducing pressure in proximity to a tissue site can augment and accelerate growth of new tissue at the tissue site (see Paragraph [0003]). Pratt also teaches the communicator may provide a generic visual feedback as to whether reduced-pressure therapy is being effectively administered using a wall-suction source (see Paragraph [0116]).
Regarding Claim 19, Tiedtke and Pratt teaches all of the limitations, as discussed above in claim 18, and Tiedtke further teaches wherein the continuous signal is provided by a visual source (optical display device 444).
Regarding Claim 20, Tiedtke and Pratt teaches all of the limitations, as discussed above in claim 18, and Tiedtke further teaches wherein the continuous signal is provided by an audible source (the acoustic signal generator 446 generates tones or noises that the user can hear, depending on the information, see Paragraph [0021]).
Regarding Claim 21, Tiedtke teaches all of the limitations as discussed above in claim 18. However, Tiedtke does not explicitly disclose wherein the continuous signal is provided by a tactile source.
Pratt teaches an apparatuses for providing feedback for reduced-pressure therapy (see Abstract) comprising a pressure sensor (504) coupled to a processor (printed circuit board 502); a communicator coupled to the processor and configured to generate a continuous signal which varies proportionally as a result of variation in fluid pressure (feedback system (500) having a signal interface may be an auditory device or a tactile device, such as a moving protrusion, see Paragraph [0080]; The feedback system may further include an indicator communicatively coupled to the printed circuit board and the pressure sensor, and may be configured to indicate a status of the control pressure, see Paragraph [0007]), wherein the continuous signal is provided by a tactile source (a tactile device, such as a moving protrusion, see Paragraph [0080]).
Tiedtke and Pratt are analogous art because both teach a monitoring device for providing feedback to user.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the communicator device of Tiedtke and replace it with a tactile communicator device of Pratt. Pratt teaches the devices and systems described herein may provide feedback to an operator on leak conditions, feedback to an operator on blockage conditions, and feedback to an operator on canister full conditions (see Paragraph [0117]).
Regarding Claim 22, Tiedtke and Pratt teaches all of the limitations, as discussed above in claim 18, and Tiedtke further teaches wherein the continuous signal is provided by a non-visual source (the pressure sensor 414 is connected via an electronic signal evaluation circuit 442 to the acoustic signal generator 446, see Paragraph [0021]).
Regarding Claim 23, Tiedtke and Pratt teaches all of the limitations, as discussed above in claim 2, and Tiedtke further teaches wherein the catheter further includes a high pressure injection lumen (430) having a proximal end (404) and a distal end (406) and extending from a proximal end of the catheter to a location adjacent a distal end of the aspiration lumen (see Figure 3); and at least one orifice at or near the distal end of the high pressure injection lumen (a path section 432 open to the outside surroundings on the distal end section 406 of the catheter, see Figure 3) and configured to allow high pressure liquid injected through the high pressure injection lumen to be released into the aspiration lumen (the pressurized fluid arrives at the distal end section 406 of catheter 402 in the form of a sharp fluid jet in the open path section 432, treats the vessel 12 there, for example, cuts or fragments the vascular constriction material 434 and then flows into the distal end 436 of the return channel 438 with entrainment of material 434 and then through the latter in the direction of arrow 418 to the proximal end section 404, see Paragraph [0020]).
Response to Arguments
Applicant states that the 102(a)(1) rejection over Tiedtke would fail to teach “an aspiration lumen; the aspiration lumen configured to couple to a vacuum source; and the communicator configured to generate a continuous signal which is proportional to measured fluid pressure”. The examiner agrees that Tiedtke alone does not read on these limitations. Accordingly, claims 1-2 and 18 are now rejected under 103 in view of Pratt (US 20150094673 A1). Accordingly, Applicant’s arguments with respect to claims 1-2 and 18 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC RASSAVONG whose telephone number is (408)918-7549. The examiner can normally be reached Monday - Friday 9:00am-5:30pm PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nicholas J. Weiss can be reached at (571)270-1775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC RASSAVONG/ (4/4/2026)Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
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