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 .
Response to Amendment
As of the reply filed 7/21/2026, claims 1-3, 5, and 7-9 are pending. Claims 4, 6, and 10-19 are cancelled. Claims 1, 3, and 8 have been amended.
Response to Arguments
Applicant’s arguments with respect to the combination of Barnes et al. and Berger (see pages 5-6 of Remarks) have been considered but are not persuasive.
Applicant argues that “the combination of Barnes and Berger ‘963 cannot be made, as doing so would directly eradicate the primary purpose of Berger ‘963- i.e. to avoid cutting the transverse carpal ligament” (see page 5 of Remarks), but the Examiner respectfully disagrees. The combination as proposed would modify the base reference, Barnes et al., to simply and predictably incorporate the pressure monitoring as taught by Berger. Although Berger teaches a dilation carpal tunnel procedure, rather than the cutting of the ligament as disclosed by the Barnes et al. reference, the Examiner argues that providing the pressure monitoring of Berger in the method of Barnes et al. would still simply allow the surgeon to monitor the fluid pressure within the balloons as the device is placed and moved along the carpal tunnel of a patient. The combination as proposed does not combine the cutting/dilation procedures of each reference.
In response to applicant's argument that Berger is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, the Berger reference is analogous art due to its use of a balloon catheter in a carpal tunnel procedure, regardless of whether it cuts or stretches the ligament in question.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitations are: “inflation mechanism” in claims 1 and 8.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The limitation “inflation mechanism” is being interpreted to cover:
PP [0050]: “the inflation device 288 is a bellows 288 that includes a body 290 and a spring-biased plunger 292 with a distal end 292a and a proximal end 292b. The body 290 is shown as a transparent feature to illustrate interior detail. The spring-biased plunger 292 is pivotally coupled to the balloon activation lever 216. When the balloon activation lever 216 is depressed, the plunger 292 moves towards distal end 292a. When the balloon activation lever 216 is released, the spring-bias of the plunger 292 moves the plunger 292 toward proximal end 292b”
PP [0051]: “In other embodiments, the inflation device 288 can be in the form of a syringe with a piston or plunger or the like. Alternatively, the inflation device 288 can be any desired device known in the art that holds inflation material and both pushes inflation material out of the inflation device 288 and pulls inflation material back into the inflation device 288”
And equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Barnes et al. (US PGPub 2016/0081710 A1) in view of Berger (US Patent No. 5,179,963).
With respect to claim 1, Barnes et al. discloses a method of performing carpal tunnel release procedure on a hand (abstract), the method comprising:
advancing a soft tissue cutting device (200 in Fig. 14) into the hand (PP [0125]: “The distal end 214 includes a shaft 220 that inserts into the carpal tunnel region”), the soft tissue cutting device (200) comprising;
a handle (see unmarked shaft 220 in Fig. 14 coupled to handle 212) comprising an inflation mechanism (218);
a shaft (220) extending from a proximal end attached to the handle (212) to a distal end and comprising an opening (226 in Fig. 15) on a top surface of the shaft (220, 214 is the distal end of shaft 220);
a hook shaped blade (228, see hook-shaped working end 246 in Fig. 17) slidably disposed along the top surface of the shaft (220, 214 is the distal end of shaft 220, PP [0129]: “The blade shaft 244 engages with a blade activation assembly 222 to move the blade 228 forward and backward”) and configured to extend through the opening (226 in Figs. 15-16, see blade extending through unmarked opening in Figs. 23-26);
two balloons (234a-b) coupled with two sides of the shaft (see distal end 214 of shaft 220 in Fig. 16 coupled with two balloons 234a-b) at or near the distal end; and
tubing (286a-b in Fig. 15) extending from the two balloons (234a-b), through the shaft (220, 214 is the distal end of shaft 220), to the inflation mechanism (218) in the handle (212, PP [0141]: “The inflation assembly 218 includes the first balloon 234a, a first conduit 286a, the second balloon 234b, a second conduit 286b, and an inflation device 288”, PP [0142]: “The first conduit 286a connects the first balloon 234a to the inflation device 288. Likewise, the second conduit 286b connects the second balloon 236b to the inflation device 288”);
positioning the distal end of the shaft (214 of 220) at or near a carpal tunnel (see PP [0125]);
inflating the two balloons (234a-b) via the inflation mechanism (218) to cause the balloons (234a-b) to expand and create a safe zone in the carpal tunnel region (PP [0153]: “In certain embodiments, the handle also houses the syringe. In such cases, the syringe includes an actuator or control positioned outside of the handle that controls functions of the syringe. For example, the control can be a lever, slider button, push button and/or clamp. In some cases, the control is another slider button positioned on an external surface of the handle. The slider button can be coupled to a plunger to control movement of the plunger. In some cases, the slider button is directly connected to the plunger. In other cases, the control is a clamp. In such cases, the clamp can be coupled to a plunger to control movement of the plunger. When an operator desires to inflate the balloons, he or she slides the slider button forward (or compresses the clamp) to push the plunger and push fluid from the barrel into a piping arrangement”, PP [0137]: “The balloons can be positioned anywhere about the shaft 220 such that they expand the safe zone of the carpal tunnel region”, see also PP [0141-0142]);
moving the hook shaped blade (246 in Figs. 17-24) out of the opening in the top surface of the shaft (see opening 264 in Fig. 22) between the two balloons and proximally along the shaft (see Figs. 23-26, the blade moves up and out of the opening in Figs. 23-24, and proximally from Figs. 25-26) to cut a transverse carpal ligament in the hand (PP [0152]: “Once the blade pin 256 reaches the proximal guideway end 268, the transverse carpal ligament is cut and the device 200 is in the second inactive position”); and
removing the soft tissue cutting device (200) from the hand (PP [0152]: “The cutting edge 254 is fully housed and protected within the shaft 220 and the device 200 can be safely removed from the body”, the carpal tunnel ligament is in the hand, removal of the device is removal of the device from the hand).
However, Barnes et al. fails to disclose a handle comprising a pressure gauge and measuring a first pressure in the two balloons via the pressure gauge in the handle. Barnes et al. further fails to specifically disclose depressing a lever on the handle to activate a bellows in the handle, wherein the bellows comprises a spring-based plunger coupled with the lever.
In the same field of carpal tunnel procedures (abstract), Berger teaches a carpal tunnel treatment device (see Fig. 2) including a balloon (26 in Fig. 3) and a pressure gauge (30 in Fig. 2) on a handle of the device (see Fig. 2) coupled with the balloon via tubing (see 34 in Fig. 2), and further teaches measuring a first pressure (col. 6, lines 39-41: “A balloon catheter 24 is attached to the pressure monitor 30 and syringe 32. Initial pressure reading is taken of the carpal tunnel”) via the pressure gauge (30).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Barnes et al. method to incorporate the teachings of Berger and include measuring a first pressure in the two balloons via a pressure gauge in the handle. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have constituted the use of a known technique (the incorporation of a pressure gauge into the handle of a carpal ligament release device comprising balloons) to a known device (the device of Barnes et al.) ready for improvement to yield predictable results. The combination as proposed would simply allow the surgeon to monitor the fluid pressure within the balloons as the device is placed and moved along the carpal tunnel of a patient to ensure proper release of the transverse carpal ligament (Berger claim 7: “injecting a fluid into said balloon catheter and serially inflating and deflating said catheter while intermittantly moving it along said carpal tunnel from distal to proximal end and continuously monitoring the pressure therein thereby stretching the transverse carpal ligament”) and would not alter the main operating principle of the Barnes et al. device.
Regarding claim 3, Barnes et al. as modified by the Berger patent further discloses measuring a second pressure in the two balloons after the transverse carpal ligament is cut (Berger patent col. 6, lines 39-53: “A balloon catheter 24 is attached to the pressure monitor 30 and syringe 32. Initial pressure reading is taken of the carpal tunnel. Sterile saline solution is then injected from syringe 32 into the catheter 24 via tube 34 and the distal dilatation bulb or balloon 26 of the catheter is expanded in the most distal portion of the carpal canal. The position of the radioopaque catheter and balloon is confirmed by either image intensification or radiographs. The carpal tunnel-plasty is performed by serially inflating and deflating the balloon catheter 24 intermittently along the course of the carpal tunnel from distal to proximal dilating and permanently stretching the transverse carpal ligament. Pressure measurements are taken throughout the procedure”, claim 1: “serially inflating and deflating said balloon catheter while intermittently moving it along the tunnel and continuously montioring the pressure therein”, the pressure gauge is connected to the balloons and measure the pressure therein, the combination as proposed would allow continuous pressure monitoring using the gauge as taught by Berger, therefore a second pressure would be measured after the carpal ligament is cut while the device is still inserted).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Barnes et al. (US PGPub 2016/0081710 A1) in view of Berger (US Patent No. 5,179,963), as applied to claim 1 above, and further in view of Berger (US PGPub 2010/0100114 A1).
Regarding claim 2, Barnes et al. as modified by the Berger patent fails to disclose using a visualization member on the distal end of the shaft to visualize at least one anatomical landmark, wherein the visualization member is selected from the group consisting of a camera, a light fiber, and an ultrasound transducer.
In the same field of carpal tunnel procedures (abstract), the Berger publication teaches a surgical instrument comprising a shaft (32 in Fig. 4) and a balloon (50), and further teaches using a visualization member (55 in Fig. 6) on the distal end of the shaft (32) to visualize at least one anatomical landmark, wherein the visualization member is selected from the group consisting of a camera, a light fiber, and an ultrasound transducer (PP [0049]: “Clearly depicted in FIG. 6 is the visualization lens 55 used in lieu of the closed tip 26 in an alternative embodiment. As shown here, the lens 55 is generally optically transparent wherein the expensive optics of an arthroscope or endoscope inserted into this otherwise inexpensive device will be protected while in use. Additionally, the optical properties of the generally convex cross section of the lens 55 results in a wider field of view regarding objects viewed therethrough. It is contemplated that the visualization lens 55 may be ground with additional refractive indeces as desired, for example, the lens 55 may be ground to provide a magnified view of tissues viewed therethrough”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the combination as proposed further in view of the Berger publication to incorporate a visualization member as claimed. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have constituted the use of a known technique (a distal lens for accommodating an endoscope or arthroscope to improve visualization in a carpal tunnel procedure) to improve a similar device (the Barnes et al. device) in the same way. The modification as proposed would not have altered the main operating principle of the Barnes et al. device, but would simply and predictably yield a more efficient procedure by enabling the surgeon to more accurately place the device and perform the carpal tunnel release as claimed.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Barnes et al. (US PGPub 2016/0081710 A1) in view of Berger (US Patent No. 5,179,963), as applied to claim 1 above, and further in view of Eschbach (US PGPub 2018/0256161 A1).
Regarding claim 5, since the combination as proposed uses an analog pressure gauge, Barnes et al. as modified by the Berger patent fails to disclose:
converting the first pressure and the second pressure into digital numerical data; and
providing the digital numerical data on a display on the handle
In the related field of surgical instruments with sensors to detect a characteristic of the surgical environment (abstract), Eschbach teaches a device (1 in Fig. 1) comprising a pressure sensor (PP [0049]: “The second sensor 66 of the end effector 46 is a pressure sensor or pressure measuring device”). Eschbach further teaches:
converting the sensor data into digital numerical data (PP [0052]: “In some embodiments, the display 20 (FIG. 1) may display ranges of numbers or various numeral outputs to display the measurements of first and second sensors 64, 66. In particular, the first, second, and third display sections 20a, 20b, 20c may display the number ranges 0 to 3, 0 to 5, 0 to 10, 0 to 100, or any other suitable range, to illustrate information about the tissue being grasped by the end effector 46”); and
providing the digital numerical data on a display (20 in Fig. 1) coupled with the device (1).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the combination of Barnes et al. and the Berger patent to incorporate the teachings of Eschbach and include converting measurements into numerical digits for display. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have constituted applying a known technique (the conversion of raw data into numerical digits for display purposes) to the known method of Barnes et al. and the Berger patent in order to yield predictable results (see MPEP 2143 I. D.), since incorporating these teachings would only enable the display of the sensor information and would not interfere with or change the operation of the device or method of the combination as proposed.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Barnes et al. (US PGPub 2016/0081710 A1) in view of Berger (US Patent No. 5,179,963), as applied to claim 1 above, and further in view of Wallace (US Patent No. 5,004,472).
Regarding claim 7, Barnes et al. as modified by the Berger patent fails to discloses:
inflating the two balloons before advancing the shaft into the hand; and
measuring a priming pressure in the two balloons to confirm the two balloons are inflated.
In the related field of balloon catheters (abstract), related in that this field is also concerned with pressurized balloons placed within a patient, Wallace teaches that “the balloon is typically inflated before the procedure to ensure the patency of the balloon and to check whether the balloon can withstand the desired pressure” (col. 2, lines 8-10).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the combination of Barnes et al., the Berger patent, and Barnes ‘21 to further incorporate the teachings of Wallace and include inflating the two balloons before advancing the shaft into the hand, and measuring a priming pressure in the two balloons to confirm that they are inflated (since the Berger patent teaches continuous pressure readings via the gauge as described, testing the balloons as taught by Wallace would include measuring this priming pressure when combined with the teachings of the Berger patent). One of ordinary skill in the art would have been motivated to perform this modification because doing so would have constituted the use of a known technique (inflating the balloons prior to the procedure before the device is inserted within a hand of a patient to test their patency at the desired pressure/inflation amount) to improve a similar device (the method of the combination as proposed) in the same way, since adding a method of inflating the balloons prior to their insertion into the patient merely serves to confirm their patency prior to the surgical procedure. Checking that the balloons can withstand the desired pressure would enhance the efficiency of the surgical procedure.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Barnes et al. (US PGPub 2016/0081710 A1) in view of Berger (US Patent No. 5,179,963) and Eschbach (US PGPub 2018/0256161 A1).
With respect to claim 8, Barnes et al. discloses a method of performing carpal tunnel release procedure on a hand (abstract), the method comprising:
advancing a soft tissue cutting device (200 in Figs. 15-16) into the hand (PP [0125]: “The distal end 214 includes a shaft 220 that inserts into the carpal tunnel region”), the soft tissue cutting device (200) comprising;
a handle (see unmarked shaft in Fig. 14 coupled to handle 212) comprising an inflation mechanism (218);
a shaft (220) extending from a proximal end attached to the handle (212) to a distal end and comprising an opening (226 in Fig. 15) on a top surface of the shaft (220, 214 is the distal end of shaft 220);
a hook shaped blade (228, see hook-shaped working end 246 in Fig. 17) slidably disposed along the top surface of the shaft (220, 214 is the distal end of shaft 220, PP [0129]: “The blade shaft 244 engages with a blade activation assembly 222 to move the blade 228 forward and backward”) and configured to extend through the opening (226 in Figs. 15-16, see blade extending through unmarked opening in Figs. 23-26);
two balloons (234a-b) coupled with two sides of the shaft (see distal end 214 of shaft 220 in Fig. 16 coupled with two balloons 234a-b) at or near the distal end; and
tubing (286a-b in Fig. 15) extending from the two balloons (234a-b), through the shaft (220, 214 is the distal end of shaft 220), to the inflation mechanism (218) in the handle (212, PP [0141]: “The inflation assembly 218 includes the first balloon 234a, a first conduit 286a, the second balloon 234b, a second conduit 286b, and an inflation device 288”, PP [0142]: “The first conduit 286a connects the first balloon 234a to the inflation device 288. Likewise, the second conduit 286b connects the second balloon 236b to the inflation device 288”);
positioning the distal end (214) of the shaft (220) in a carpal tunnel region in the hand (see PP [0125]);
inflating the two balloons (234a-b) via the inflation mechanism (218) to cause the balloons (234a-b) to expand and create a safe zone in the carpal tunnel region (PP [0153]: “In certain embodiments, the handle also houses the syringe. In such cases, the syringe includes an actuator or control positioned outside of the handle that controls functions of the syringe. For example, the control can be a lever, slider button, push button and/or clamp. In some cases, the control is another slider button positioned on an external surface of the handle. The slider button can be coupled to a plunger to control movement of the plunger. In some cases, the slider button is directly connected to the plunger. In other cases, the control is a clamp. In such cases, the clamp can be coupled to a plunger to control movement of the plunger. When an operator desires to inflate the balloons, he or she slides the slider button forward (or compresses the clamp) to push the plunger and push fluid from the barrel into a piping arrangement”, PP [0137]: “The balloons can be positioned anywhere about the shaft 220 such that they expand the safe zone of the carpal tunnel region”, see also PP [0141-0142]);
moving the hook shaped blade (246 in Figs. 17-24) out of the opening in the top surface of the shaft (see opening 264 in Fig. 22) between the two balloons and proximally along the shaft (see Figs. 23-26, the blade moves up and out of the opening in Figs. 23-24, and proximally from Figs. 25-26) to cut a transverse carpal ligament in the hand (PP [0152]: “Once the blade pin 256 reaches the proximal guideway end 268, the transverse carpal ligament is cut and the device 200 is in the second inactive position”).
However, Barnes et al. fails to disclose measuring a first pressure in the two balloons via a pressure gauge in the handle coupled with the two balloons via tubing, or sensing a second pressure in the two balloons, using the pressure gauge. Barnes et al. further fails to disclose converting the first pressure and the second pressure into digital numeric data and providing the digital numerical data on a display on the handle.
In the same field of carpal tunnel procedures (abstract), Berger teaches a carpal tunnel treatment device (see Fig. 2) including a balloon (26 in Fig. 3) and a pressure gauge (30 in Fig. 2) on a handle of the device (see Fig. 2) coupled with the balloon via tubing (see 34 in Fig. 2), and further teaches measuring a first pressure (col. 6, lines 39-41: “A balloon catheter 24 is attached to the pressure monitor 30 and syringe 32. Initial pressure reading is taken of the carpal tunnel”) via the pressure gauge (30).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Barnes et al. method to incorporate the teachings of Berger and include measuring a first pressure in the two balloons via a pressure gauge in the handle. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have constituted the use of a known technique (the incorporation of a pressure gauge into the handle of a carpal ligament release device comprising balloons) to a known device (the device of Barnes et al.) ready for improvement to yield predictable results. The combination as proposed would simply allow the surgeon to monitor the fluid pressure within the balloons as the device is placed and moved along the carpal tunnel of a patient to ensure proper release of the transverse carpal ligament (Berger claim 7: “injecting a fluid into said balloon catheter and serially inflating and deflating said catheter while intermittantly moving it along said carpal tunnel from distal to proximal end and continuously monitoring the pressure therein thereby stretching the transverse carpal ligament”) and would not alter the main operating principle of the Barnes et al. device.
Barnes et al. as modified by Berger further fails to disclose converting the first pressure and the second pressure into digital numeric data and providing the digital numerical data on a display on the handle.
In the related field of surgical instruments with sensors to detect a characteristic of the surgical environment (abstract), Eschbach teaches a device (1 in Fig. 1) comprising a pressure sensor (PP [0049]: “The second sensor 66 of the end effector 46 is a pressure sensor or pressure measuring device”). Eschbach further teaches:
converting the sensor data into digital numerical data (PP [0052]: “In some embodiments, the display 20 (FIG. 1) may display ranges of numbers or various numeral outputs to display the measurements of first and second sensors 64, 66. In particular, the first, second, and third display sections 20a, 20b, 20c may display the number ranges 0 to 3, 0 to 5, 0 to 10, 0 to 100, or any other suitable range, to illustrate information about the tissue being grasped by the end effector 46”); and
providing the digital numerical data on a display (20 in Fig. 1) coupled with the device (1).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the combination of Barnes et al. and the Berger patent to incorporate the teachings of Eschbach and include converting measurements into numerical digits for display. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have constituted applying a known technique (the conversion of raw data into numerical digits for display purposes) to the known method of Barnes et al. and the Berger patent in order to yield predictable results (see MPEP 2143 I. D.), since incorporating these teachings would only enable the display of the sensor information and would not interfere with or change the operation of the device or method of the combination as proposed.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Barnes et al. (US PGPub 2016/0081710 A1) in view of Berger (US Patent No. 5,179,963) and Eschbach (US PGPub 2018/0256161 A1), as applied to claim 8 above, and further in view of Berger (US PGPub 2010/0100114 A1).
Regarding claim 9, Barnes et al. as modified by Berger and Eschbach fails to disclose visualizing an area within the hand using a visualization member on the distal end of the shaft.
In the same field of carpal tunnel procedures (abstract), the Berger publication teaches a surgical instrument comprising a shaft (32 in Fig. 4) and a balloon (50), and further teaches using a visualization member (55 in Fig. 6) on the distal end of the shaft (32) to visualize at least one anatomical landmark, wherein the visualization member is selected from the group consisting of a camera, a light fiber, and an ultrasound transducer (PP [0049]: “Clearly depicted in FIG. 6 is the visualization lens 55 used in lieu of the closed tip 26 in an alternative embodiment. As shown here, the lens 55 is generally optically transparent wherein the expensive optics of an arthroscope or endoscope inserted into this otherwise inexpensive device will be protected while in use. Additionally, the optical properties of the generally convex cross section of the lens 55 results in a wider field of view regarding objects viewed therethrough. It is contemplated that the visualization lens 55 may be ground with additional refractive indeces as desired, for example, the lens 55 may be ground to provide a magnified view of tissues viewed therethrough”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the combination of Barnes et al., the Berger patent, and Wallace further in view of the Berger publication to incorporate a visualization member as claimed. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have constituted the use of a known technique (a distal lens for accommodating an endoscope or arthroscope to improve visualization in a carpal tunnel procedure) to improve a similar device (the combination of Barnes et al. and the Berger patent) in the same way. The modification as proposed would not have altered the main operating principle of the Barnes et al. device, but would simply and predictably yield a more efficient procedure by enabling the surgeon to more accurately place the device and perform the carpal tunnel release as claimed.
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 and 3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,004,884 B2 (hereinafter known as the ‘884 patent) in view of Berger (US Patent No. 5,179,963) and Barnes et al. (US PGPub 2021/0085416 A1, hereinafter known as Barnes ’21).
With respect to claim 1, the ‘884 patent discloses a method of performing carpal tunnel release procedure on a hand (claim 1, lines 51-52), the method comprising:
advancing a soft tissue cutting device into the hand (claim 1, lines 53-54), the soft tissue cutting device comprising;
a handle comprising an inflation mechanism (claim 1, line 57, see lines 48-64 for inflation mechanism);
a shaft extending from a proximal end attached to the handle to a distal end (claim 1, lines 53 and 57) and comprising an opening on a top surface of the shaft (claim 1, lines 65-67);
a blade slidably disposed along the top surface of the shaft and configured to extend through the opening (claim 1, lines 65-67);
two balloons coupled with two sides of the shaft at or near the distal end (claim 1, lines 58-60); and
tubing extending from the two balloons, through the shaft, to the inflation mechanism in the handle (claim 1, lines 57-64);
positioning the distal end of the shaft in a carpal tunnel region in the hand (claim 1, lines 53-54);
inflating the two balloons via the inflation mechanism to cause the balloons to expand and create a safe zone in the carpal tunnel region (claim 1, lines 57-60);
moving the blade out of the opening in an upper surface of the shaft between the two balloons and proximally along the shaft to cut a transverse carpal ligament in the hand (claim 1, lines 65-66); and
removing the soft tissue cutting device from the hand (claim 1, col. 13, line 4).
However, the ‘884 patent is silent on the handle comprising a pressure gauge, measuring a first pressure in the two balloons via the pressure gauge in the handle, and further fails to explicitly disclose a hook shaped blade.
In the same field of carpal tunnel procedures (abstract), Berger teaches a carpal tunnel device (see Fig. 2) including a balloon (26 in Fig. 3) and a gauge (30 in Fig. 2) on a handle of the device (see Fig. 2) coupled with the balloon via tubing (see 34 in Fig. 2), and further teaches measuring a first pressure (col. 6, lines 39-41: “A balloon catheter 24 is attached to the pressure monitor 30 and syringe 32. Initial pressure reading is taken of the carpal tunnel”) via the pressure gauge (30).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the method of the ‘884 patent to incorporate the teachings of Berger and include measuring a first pressure in the two balloons via a pressure gauge in the handle coupled with the two balloons via tubing. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have constituted the use of a known technique (the incorporation of a pressure gauge into the handle of a device comprising balloons) to a known device (the device of the ‘884 patent) ready for improvement to yield predictable results. The combination as proposed would simply allow the surgeon to monitor the fluid pressure within the balloons as the device is placed and moved along the carpal tunnel of a patient and would not alter the main operating principle of the device of the ‘884 patent.
However, the combination of the ‘884 patent and Berger further fails to disclose a hook shaped blade.
In the same field of carpal tunnel release (abstract), Barnes ’21 teaches a soft tissue cutting device (200 in Fig. 5) comprising a handle (unmarked right end of 200 proximal to 220 and comprising 216), a shaft (220) comprising balloons (202). Barnes ’21 further teaches a hook shaped blade (PP [0045]: “the blade working end 246 is configured as a hook and configured to cut a transverse carpal ligament”) translatable within the shaft (220).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have further modified the ‘884 patent and Berger combination according to the teachings of Barnes ’21 to include the hook-shaped blade as claimed. One of ordinary skill in the art would have been motivated to specifically modify the blade of the ‘884 patent to be hook-shaped since it has been held that the variations in shape were a matter of choice and only involves routine skill in the art (see MPEP 2144.04, see In re Dailey, 357 F.2d 669, 149 USPQ (CCPA 1966)).
Regarding claim 3, the ‘884 patent as modified by the Berger patent and Barnes ‘21 further discloses measuring a second pressure within the carpal tunnel after the transverse carpal ligament is cut (Berger patent claim 1: “serially inflating and deflating said balloon catheter while intermittently moving it along the tunnel and continuously montioring the pressure therein”, the combination as proposed would allow continuous pressure monitoring using the gauge as taught by Berger, meaning a second pressure would be measured after the carpal ligament is cut while the device is still inserted).
Claims 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,004,884 B2 (hereinafter known as the ‘884 patent) in view of Berger (US Patent No. 5,179,963) and Barnes et al. (US PGPub 2021/0085416 A1, hereinafter known as Barnes ’21), as applied to claim 1 above, and further in view of Berger (US PGPub 2010/0100114 A1).
Regarding claim 2, the ‘884 patent as modified by the Berger patent and Barnes ’21 fails to disclose using a visualization member on the distal end of the shaft to visualize at least one anatomical landmark, wherein the visualization member is selected from the group consisting of a camera, a light fiber, and an ultrasound transducer.
In the same field of carpal tunnel procedures (abstract), the Berger publication teaches a surgical instrument comprising a shaft (32 in Fig. 4) and a balloon (50), and further teaches using a visualization member (55 in Fig. 6) on the distal end of the shaft (32) to visualize at least one anatomical landmark, wherein the visualization member is selected from the group consisting of a camera, a light fiber, and an ultrasound transducer (PP [0049]: “Clearly depicted in FIG. 6 is the visualization lens 55 used in lieu of the closed tip 26 in an alternative embodiment. As shown here, the lens 55 is generally optically transparent wherein the expensive optics of an arthroscope or endoscope inserted into this otherwise inexpensive device will be protected while in use. Additionally, the optical properties of the generally convex cross section of the lens 55 results in a wider field of view regarding objects viewed therethrough. It is contemplated that the visualization lens 55 may be ground with additional refractive indeces as desired, for example, the lens 55 may be ground to provide a magnified view of tissues viewed therethrough”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the combination of the ‘884 patent, Berger, and Barnes ’21 further in view of the Berger publication to incorporate a visualization member as claimed. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have constituted the use of a known technique (a distal lens for accommodating an endoscope or arthroscope to improve visualization in a carpal tunnel procedure) to improve a similar device (the combination of the ‘884 patent, Berger, and Barnes ‘21) in the same way, since providing an avenue for direct visualization would simply yield a more efficient procedure by enabling the surgeon to more accurately place the device and perform the carpal tunnel release as claimed.
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,004,884 B2 (hereinafter known as the ‘884 patent) in view of Berger (US Patent No. 5,179,963) and Barnes et al. (US PGPub 2021/0085416 A1, hereinafter known as Barnes ’21), as applied to claim 1 above, and further in view of Eschbach (US PGPub 2018/0256161 A1).
Regarding claim 5, the ‘884 patent as modified by Berger and Barnes ’21 fails to disclose the method further including:
converting the first pressure and the second pressure into digital numerical data; and
providing the digital numerical data on a display on the handle.
In the related field of surgical instruments with sensors to detect a characteristic of the surgical environment (abstract), Eschbach teaches a device (1 in Fig. 1) comprising a pressure sensor (PP [0049]: “The second sensor 66 of the end effector 46 is a pressure sensor or pressure measuring device”). Eschbach further teaches:
converting the sensor data into digital numerical data (PP [0052]: “In some embodiments, the display 20 (FIG. 1) may display ranges of numbers or various numeral outputs to display the measurements of first and second sensors 64, 66. In particular, the first, second, and third display sections 20a, 20b, 20c may display the number ranges 0 to 3, 0 to 5, 0 to 10, 0 to 100, or any other suitable range, to illustrate information about the tissue being grasped by the end effector 46”); and
providing the digital numerical data on a display (20 in Fig. 1) coupled with the device (1).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the combination of the ‘884 patent, Berger, and Barnes ’21 to incorporate the teachings of Eschbach and include converting measurements into numerical digits for display. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have constituted applying a known technique (the conversion of raw data into numerical digits for display purposes) to the known method of the ‘884 patent in order to yield predictable results (see MPEP 2143 I. D.), since incorporating these teachings would only enable the display of the sensor information and would not interfere with or change the operation of the device or method of the combination as proposed.
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,004,884 B2 (hereinafter known as the ‘884 patent) in view of Berger (US Patent No. 5,179,963) and Barnes et al. (US PGPub 2021/0085416 A1, hereinafter known as Barnes ’21), as applied to claim 1 above, and further in view of Wallace (US Patent No. 5,004,472).
Regarding claim 7, the ‘884 patent as modified by Berger and Barnes ’21 fails to disclose:
inflating the two balloons before advancing the shaft into the hand; and
measuring a priming pressure in the two balloons to confirm the two balloons are inflated.
In the related field of balloon catheters (abstract), related in that this field is also concerned with pressurized balloons placed within a patient, Wallace teaches that “the balloon is typically inflated before the procedure to ensure the patency of the balloon and to check whether the balloon can withstand the desired pressure” (col. 2, lines 8-10).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the combination of the ‘884 patent, the Berger patent, and Barnes ‘21 to further incorporate the teachings of Wallace and include inflating the two balloons before advancing the shaft into the hand, and measuring a priming pressure in the two balloons to confirm that they are inflated (since the Berger patent teaches continuous pressure readings via the gauge as described, testing the balloons as taught by Wallace would include measuring this priming pressure when combined with the teachings of the Berger patent). One of ordinary skill in the art would have been motivated to perform this modification because doing so would have constituted the use of a known technique (inflating the balloons prior to the procedure before the device is inserted within a hand of a patient to test their patency at the desired pressure/inflation amount) to improve a similar device (the method of the combination as proposed) in the same way, since adding a method of inflating the balloons prior to their insertion into the patient merely serves to confirm their patency prior to the surgical procedure. Checking that the balloons can withstand the desired pressure would enhance the efficiency of the surgical procedure, and would not alter the main operating principle of the ‘884 patent since testing the balloons would not interfere with the surgical procedure itself.
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,004,884 B2 (hereinafter known as the ‘884 patent) in view of Berger (US Patent No. 5,179,963), Barnes et al. (US PGPub 2021/0085416 A1, hereinafter known as Barnes ’21), and Eschbach (US PGPub 2018/0256161 A1).
With respect to claim 8, the ‘884 patent discloses a method of performing carpal tunnel release procedure on a hand (claim 1, lines 51-52), the method comprising:
advancing a soft tissue cutting device into the hand (claim 1, lines 53-54), the soft tissue cutting device comprising;
a handle comprising an inflation mechanism (claim 1, line 57, see lines 48-64 for inflation mechanism);
a shaft extending from a proximal end attached to the handle to a distal end (claim 1, lines 53 and 57) and comprising an opening on a top surface of the shaft (claim 1, lines 65-67);
a blade slidably disposed along the top surface of the shaft and configured to extend through the opening (claim 1, lines 65-67);
two balloons coupled with two sides of the shaft at or near the distal end (claim 1, lines 58-60); and
tubing extending from the two balloons, through the shaft, to the inflation mechanism in the handle (claim 1, lines 57-64);
positioning the distal end of the shaft in a carpal tunnel region in the hand (claim 1, lines 53-54);
inflating the two balloons via the inflation mechanism to cause the balloons to expand and create a safe zone in the carpal tunnel region (claim 1, lines 57-60); and
moving the blade out of the opening in an upper surface of the shaft between the two balloons and proximally along the shaft to cut a transverse carpal ligament in the hand (claim 1, lines 65-66).
However, the ‘884 patent is silent on measuring a first pressure in the two balloons via a pressure gauge in the handle coupled with the two balloons via tubing, sensing a second pressure in the two balloons, using the pressure gauge, and further fails to explicitly disclose a hook shaped blade. Additionally, the ‘884 patent fails to disclose converting the first pressure and the second pressure into digital numerical data and providing the digital numerical data on a display on the handle.
In the same field of carpal tunnel procedures (abstract), Berger teaches a carpal tunnel device (see Fig. 2) including a balloon (26 in Fig. 3) and a gauge (30 in Fig. 2) on a handle of the device (see Fig. 2) coupled with the balloon via tubing (see 34 in Fig. 2), and further teaches measuring a first pressure (col. 6, lines 39-41: “A balloon catheter 24 is attached to the pressure monitor 30 and syringe 32. Initial pressure reading is taken of the carpal tunnel”) via the pressure gauge (30). Berger additionally teaches sensing measuring a second pressure within the two balloons (claim 1: “serially inflating and deflating said balloon catheter while intermittently moving it along the tunnel and continuously montioring the pressure therein”, the combination as proposed would allow continuous pressure monitoring using the gauge as taught by Berger, meaning a second pressure would be sensed).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the method of the ‘884 patent to incorporate the teachings of Berger and include measuring a first pressure in the two balloons via a pressure gauge in the handle coupled with the two balloons via tubing. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have constituted the use of a known technique (the incorporation of a pressure gauge into the handle of a device comprising balloons) to a known device (the device of the ‘884 patent) ready for improvement to yield predictable results since the combination as proposed would simply allow the surgeon to monitor the fluid pressure within the balloons as the device is placed and moved along the carpal tunnel of a patient and would not alter the main operating principle of the device of the ‘884 patent which also aims to ensure carpal tunnel release.
However, the combination of the ‘884 patent and Berger further fails to disclose a hook shaped blade, converting the first pressure and the second pressure into digital numerical data, and providing the digital numerical data on a display on the handle.
In the same field of carpal tunnel release (abstract), Barnes ’21 teaches a soft tissue cutting device (200 in Fig. 5) comprising a handle (unmarked right end of 200 proximal to 220 and comprising 216), a shaft (220) comprising balloons (202), wherein the balloons (202) are inflated by depressing a lever (216) on the handle (unmarked right end of 200 proximal to 220 and comprising 216) to activate a bellows (288) in the handle (PP [0050]: “the inflation device 288 is a bellows that includes a body 290 and a spring-biased plunger 292 with a distal end 292a and a proximal end 292b. The body 290 is shown as a transparent feature to illustrate interior detail. The spring-biased plunger 292 is pivotally coupled to the balloon activation lever 216. When the balloon activation lever 216 is depressed, the plunger 292 moves towards distal end 292a. When the balloon activation lever 216 is released, the spring-bias of the plunger 292 moves the plunger 292 toward proximal end 292b”), wherein the bellows (288) comprises a spring-based plunger (292) coupled with the lever (216, see PP [0050] cited above). Barnes ’21 further teaches a hook shaped blade (PP [0045]: “the blade working end 246 is configured as a hook and configured to cut a transverse carpal ligament”) translatable within the shaft (220).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have further modified the ‘884 patent and Berger combination according to the teachings of Barnes ’21 to include the hook-shaped blade as claimed. One of ordinary skill in the art would have been motivated to specifically modify the blade of the ‘884 patent to be hook-shaped since it has been held that the variations in shape were a matter of choice and only involves routine skill in the art (see MPEP 2144.04, see In re Dailey, 357 F.2d 669, 149 USPQ (CCPA 1966)).
However, the combination of the ‘884 patent, Berger, and Barnes ’21 further fails to disclose converting the first pressure and the second pressure into digital numerical data and providing the digital numerical data on a display on the handle.
In the related field of surgical instruments with sensors to detect a characteristic of the surgical environment (abstract), Eschbach teaches a device (1 in Fig. 1) comprising a pressure sensor (PP [0049]: “The second sensor 66 of the end effector 46 is a pressure sensor or pressure measuring device”). Eschbach further teaches:
converting the sensor data into digital numerical data (PP [0052]: “In some embodiments, the display 20 (FIG. 1) may display ranges of numbers or various numeral outputs to display the measurements of first and second sensors 64, 66. In particular, the first, second, and third display sections 20a, 20b, 20c may display the number ranges 0 to 3, 0 to 5, 0 to 10, 0 to 100, or any other suitable range, to illustrate information about the tissue being grasped by the end effector 46”); and
providing the digital numerical data on a display (20 in Fig. 1) coupled with the device (1).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the combination as proposed to incorporate the teachings of Eschbach and include converting measurements into numerical digits for display. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have constituted applying a known technique (the conversion of raw data into numerical digits for display purposes) to the known method of Barnes et al. and the Berger patent in order to yield predictable results (see MPEP 2143 I. D.), since incorporating these teachings would only enable the display of the sensor information and would not interfere with or change the operation of the device or method of the combination as proposed.
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,004,884 B2 (hereinafter known as the ‘884 patent) in view of Berger (US Patent No. 5,179,963), Barnes et al. (US PGPub 2021/0085416 A1, hereinafter known as Barnes ’21), and Eschbach (US PGPub 2018/0256161 A1) as applied to claim 8 above, and further in view of Berger (US PGPub 2010/0100114 A1).
Regarding claim 9, the ‘884 patent as modified by the Berger patent, Barnes ’21, and Eschbach fails to disclose visualizing an area within the hand using a visualization member on the distal end of the shaft.
In the same field of carpal tunnel procedures (abstract), the Berger publication teaches a surgical instrument comprising a shaft (32 in Fig. 4) and a balloon (50), and further teaches using a visualization member (55 in Fig. 6) on the distal end of the shaft (32) to visualize at least one anatomical landmark, wherein the visualization member is selected from the group consisting of a camera, a light fiber, and an ultrasound transducer (PP [0049]: “Clearly depicted in FIG. 6 is the visualization lens 55 used in lieu of the closed tip 26 in an alternative embodiment. As shown here, the lens 55 is generally optically transparent wherein the expensive optics of an arthroscope or endoscope inserted into this otherwise inexpensive device will be protected while in use. Additionally, the optical properties of the generally convex cross section of the lens 55 results in a wider field of view regarding objects viewed therethrough. It is contemplated that the visualization lens 55 may be ground with additional refractive indeces as desired, for example, the lens 55 may be ground to provide a magnified view of tissues viewed therethrough”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the combination of the ‘884 patent, Berger, Barnes ’21, and Eschbach further in view of the Berger publication to incorporate a visualization member as claimed. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have constituted the use of a known technique (a distal lens for accommodating an endoscope or arthroscope to improve visualization in a carpal tunnel procedure) to improve a similar device (the combination of the ‘884 patent, Berger, Barnes ’21, and Eschbach) in the same way, since providing an avenue for direct visualization would simply yield a more efficient procedure by enabling the surgeon to more accurately place the device and perform the carpal tunnel release as claimed.
Claims 1 and 3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,336,732 B2 (hereinafter known as the ‘732 patent) in view of Berger (US Patent No. 5,179,963) and Barnes et al. (US PGPub 2021/0085416 A1, hereinafter known as Barnes ’21).
With respect to claim 1, the ‘732 patent discloses a method of performing carpal tunnel release procedure on a hand (claim 1, lines 51-52), the method comprising:
advancing a soft tissue cutting device into the hand (claim 1, lines 53-54), the soft tissue cutting device comprising;
a handle comprising an inflation mechanism (claim 1, line 57, see lines 55-64 for inflation mechanism);
a shaft extending from a proximal end attached to the handle to a distal end (claim 1, lines 53-56) and comprising an opening on a top surface of the shaft (claim 1, line 61);
a blade slidably disposed along the top surface of the shaft and configured to extend through the opening (claim 1, lines 61-64);
two balloons coupled with two sides of the shaft at or near the distal end (claim 1, lines 58-60); and
tubing extending from the two balloons, through the shaft, to the inflation mechanism in the handle (claim 1, lines 55-60);
positioning the distal end of the shaft in a carpal tunnel region in the hand (claim 1, lines 53-54);
inflating the two balloons via the inflation mechanism to cause the balloons to expand and create a safe zone in the carpal tunnel region (claim 1, lines 57-60);
moving the blade out of the opening in an upper surface of the shaft between the two balloons and proximally along the shaft to cut a transverse carpal ligament in the hand (claim 1, lines 61-62); and
removing the soft tissue cutting device from the hand (claim 1, lines 66-67).
However, the ‘732 patent is silent on measuring a first pressure in the two balloons via a pressure gauge in the handle coupled with the two balloons via tubing, and further fails to explicitly disclose a hook shaped blade.
In the same field of carpal tunnel procedures (abstract), Berger teaches a carpal tunnel device (see Fig. 2) including a balloon (26 in Fig. 3) and a gauge (30 in Fig. 2) on a handle of the device (see Fig. 2) coupled with the balloon via tubing (see 34 in Fig. 2), and further teaches measuring a first pressure (col. 6, lines 39-41: “A balloon catheter 24 is attached to the pressure monitor 30 and syringe 32. Initial pressure reading is taken of the carpal tunnel”) via the pressure gauge (30).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the method of the ‘732 patent to incorporate the teachings of Berger and include measuring a first pressure in the two balloons via a pressure gauge in the handle coupled with the two balloons via tubing. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have constituted the use of a known technique (the incorporation of a pressure gauge into the handle of a device comprising balloons) to a known device (the device of the ‘884 patent) ready for improvement to yield predictable results. The combination as proposed would simply allow the surgeon to monitor the fluid pressure within the balloons as the device is placed and moved along the carpal tunnel of a patient and would not alter the main operating principle of the device of the ‘732 patent.
However, the combination of the ‘732 patent and Berger further fails to disclose wherein the bellows comprises a spring-based plunger coupled with the lever, and further fails to explicitly disclose a hook shaped blade.
In the same field of carpal tunnel release (abstract), Barnes ’21 teaches a soft tissue cutting device (200 in Fig. 5) comprising a handle (unmarked right end of 200 proximal to 220 and comprising 216), a shaft (220) comprising balloons (202), wherein the balloons (202) are inflated by depressing a lever (216) on the handle (unmarked right end of 200 proximal to 220 and comprising 216) to activate a bellows (288) in the handle (PP [0050]: “the inflation device 288 is a bellows that includes a body 290 and a spring-biased plunger 292 with a distal end 292a and a proximal end 292b. The body 290 is shown as a transparent feature to illustrate interior detail. The spring-biased plunger 292 is pivotally coupled to the balloon activation lever 216. When the balloon activation lever 216 is depressed, the plunger 292 moves towards distal end 292a. When the balloon activation lever 216 is released, the spring-bias of the plunger 292 moves the plunger 292 toward proximal end 292b”), wherein the bellows (288) comprises a spring-based plunger (292) coupled with the lever (216, see PP [0050] cited above). Barnes ’21 further teaches a hook shaped blade (PP [0045]: “the blade working end 246 is configured as a hook and configured to cut a transverse carpal ligament”) translatable within the shaft (220).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have further modified the ‘732 patent and Berger combination according to the teachings of Barnes ’21 to include the lever, bellows, and spring-based plunger balloon inflation mechanism as claimed, in addition to the hook-shaped blade as claimed. One of ordinary skill in the art would have been motivated to perform this modification because doing so constitutes applying a known technique (the handle mechanism of Barnes ’21) to improve a similar carpal tunnel device and method in the same way. The combination as proposed would not alter the main operating principle of the ‘732 patent and Berger combination, since Barnes ’21 also teaches a device and method for performing surgery on a carpal tunnel of a patient (PP [0054]: “the device 200 can be safely inserted into a carpal tunnel region”), but would simply provide an alternate actuation mechanism in order to achieve inflation of the balloons on the shaft of the device of the ‘732 patent. One of ordinary skill in the art would have been motivated to specifically modify the blade of the ‘732 patent to be hook-shaped since it has been held that the variations in shape were a matter of choice and only involves routine skill in the art (see MPEP 2144.04, see In re Dailey, 357 F.2d 669, 149 USPQ (CCPA 1966)).
Regarding claim 3, the ‘732 patent as modified by the Berger patent and Barnes ‘21 further discloses measuring a second pressure in the two balloons after the transverse carpal ligament is cut (Berger patent claim 1: “serially inflating and deflating said balloon catheter while intermittently moving it along the tunnel and continuously montioring the pressure therein”, the combination as proposed would allow continuous pressure monitoring using the gauge as taught by Berger, meaning a second pressure would be measured after the carpal ligament is cut while the device is still inserted).
Claims 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,336,732 B2 (hereinafter known as the ‘732 patent) in view of Berger (US Patent No. 5,179,963) and Barnes et al. (US PGPub 2021/0085416 A1, hereinafter known as Barnes ’21), as applied to claim 1 above, and further in view of Berger (US PGPub 2010/0100114 A1).
Regarding claim 2, the ‘732 patent as modified by the Berger patent and Barnes ’21 fails to disclose using a visualization member on the distal end of the shaft to visualize at least one anatomical landmark, wherein the visualization member is selected from the group consisting of a camera, a light fiber, and an ultrasound transducer.
In the same field of carpal tunnel procedures (abstract), the Berger publication teaches a surgical instrument comprising a shaft (32 in Fig. 4) and a balloon (50), and further teaches using a visualization member (55 in Fig. 6) on the distal end of the shaft (32) to visualize at least one anatomical landmark, wherein the visualization member is selected from the group consisting of a camera, a light fiber, and an ultrasound transducer (PP [0049]: “Clearly depicted in FIG. 6 is the visualization lens 55 used in lieu of the closed tip 26 in an alternative embodiment. As shown here, the lens 55 is generally optically transparent wherein the expensive optics of an arthroscope or endoscope inserted into this otherwise inexpensive device will be protected while in use. Additionally, the optical properties of the generally convex cross section of the lens 55 results in a wider field of view regarding objects viewed therethrough. It is contemplated that the visualization lens 55 may be ground with additional refractive indeces as desired, for example, the lens 55 may be ground to provide a magnified view of tissues viewed therethrough”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the combination of the ‘732 patent, Berger, and Barnes ’21 further in view of the Berger publication to incorporate a visualization member as claimed. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have constituted the use of a known technique (a distal lens for accommodating an endoscope or arthroscope to improve visualization in a carpal tunnel procedure) to improve a similar device (the combination of the ‘732 patent, Berger, and Barnes ‘21) in the same way, since providing an avenue for direct visualization would simply yield a more efficient procedure by enabling the surgeon to more accurately place the device and perform the carpal tunnel release as claimed.
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,336,732 B2 (hereinafter known as the ‘732 patent) in view of Berger (US Patent No. 5,179,963) and Barnes et al. (US PGPub 2021/0085416 A1, hereinafter known as Barnes ’21), as applied to claim 1 above, and further in view of Eschbach (US PGPub 2018/0256161 A1).
Regarding claim 5, the ‘732 patent as modified by Berger and Barnes ’21 fails to disclose the method further including:
converting the first pressure and the second pressure into digital numerical data; and
providing the digital numerical data on a display on the handle.
In the related field of surgical instruments with sensors to detect a characteristic of the surgical environment (abstract), Eschbach teaches a device (1 in Fig. 1) comprising a pressure sensor (PP [0049]: “The second sensor 66 of the end effector 46 is a pressure sensor or pressure measuring device”). Eschbach further teaches:
converting the sensor data into digital numerical data (PP [0052]: “In some embodiments, the display 20 (FIG. 1) may display ranges of numbers or various numeral outputs to display the measurements of first and second sensors 64, 66. In particular, the first, second, and third display sections 20a, 20b, 20c may display the number ranges 0 to 3, 0 to 5, 0 to 10, 0 to 100, or any other suitable range, to illustrate information about the tissue being grasped by the end effector 46”); and
providing the digital numerical data on a display (20 in Fig. 1) coupled with the device (1).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the combination of the ‘732 patent, Berger, and Barnes ’21 to incorporate the teachings of Eschbach and include converting measurements into numerical digits for display. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have constituted applying a known technique (the conversion of raw data into numerical digits for display purposes) to the known method of the ‘732 patent in order to yield predictable results (see MPEP 2143 I. D.), since incorporating these teachings would only enable the display of the sensor information and would not interfere with or change the operation of the device or method of the combination as proposed.
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,336,732 B2 (hereinafter known as the ‘732 patent) in view of Berger (US Patent No. 5,179,963) and Barnes et al. (US PGPub 2021/0085416 A1, hereinafter known as Barnes ’21), as applied to claim 1 above, and further in view of Wallace (US Patent No. 5,004,472).
Regarding claim 7, the ‘732 patent as modified by Berger and Barnes ’21 fails to discloses:
inflating the two balloons before advancing the shaft into the hand; and
measuring a priming pressure in the two balloons to confirm the two balloons are inflated.
In the related field of balloon catheters (abstract), related in that this field is also concerned with pressurized balloons placed within a patient, Wallace teaches that “the balloon is typically inflated before the procedure to ensure the patency of the balloon and to check whether the balloon can withstand the desired pressure” (col. 2, lines 8-10).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the combination of the ‘732 patent, the Berger patent, and Barnes ‘21 to further incorporate the teachings of Wallace and include inflating the two balloons before advancing the shaft into the hand, and measuring a priming pressure in the two balloons to confirm that they are inflated (since the Berger patent teaches continuous pressure readings via the gauge as described, testing the balloons as taught by Wallace would include measuring this priming pressure when combined with the teachings of the Berger patent). One of ordinary skill in the art would have been motivated to perform this modification because doing so would have constituted the use of a known technique (inflating the balloons prior to the procedure before the device is inserted within a hand of a patient to test their patency at the desired pressure/inflation amount) to improve a similar device (the method of the combination as proposed) in the same way, since adding a method of inflating the balloons prior to their insertion into the patient merely serves to confirm their patency prior to the surgical procedure. Checking that the balloons can withstand the desired pressure would enhance the efficiency of the surgical procedure, and would not alter the main operating principle of the ‘732 patent since testing the balloons would not interfere with the surgical procedure itself.
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,336,732 B2 (hereinafter known as the ‘732 patent) in view of Berger (US Patent No. 5,179,963), Barnes et al. (US PGPub 2021/0085416 A1, hereinafter known as Barnes ’21), and Eschbach (US PGPub 2018/0256161 A1).
With respect to claim 8, the ‘732 patent discloses a method of performing carpal tunnel release procedure on a hand (claim 1, lines 51-52), the method comprising:
advancing a soft tissue cutting device into the hand (claim 1, lines 53-54), the soft tissue cutting device comprising;
a handle comprising an inflation mechanism (claim 1, line 57, see lines 55-64 for inflation mechanism);
a shaft extending from a proximal end attached to the handle to a distal end (claim 1, lines 53-56) and comprising an opening on a top surface of the shaft (claim 1, line 61);
a blade slidably disposed along the top surface of the shaft and configured to extend through the opening (claim 1, lines 61-64);
two balloons coupled with two sides of the shaft at or near the distal end (claim 1, lines 58-60); and
tubing extending from the two balloons, through the shaft, to the inflation mechanism in the handle (claim 1, lines 55-60);
positioning the distal end of the shaft in a carpal tunnel region in the hand (claim 1, lines 53-54);
inflating the two balloons via the inflation mechanism to cause the balloons to expand and create a safe zone in the carpal tunnel region (claim 1, lines 57-60);
moving the blade out of the opening in an upper surface of the shaft between the two balloons and proximally along the shaft to cut a transverse carpal ligament in the hand (claim 1, lines 61-62).
However, the ‘732 patent is silent on measuring a first pressure in the two balloons via a pressure gauge in the handle coupled with the two balloons via tubing, sensing a second pressure in the two balloons, using the pressure gauge, and further fails to explicitly disclose a hook shaped blade. Additionally, the ‘732 patent fails to disclose converting the first pressure and the second pressure into digital numerical data and providing the digital numerical data on a display on the handle.
In the same field of carpal tunnel procedures (abstract), Berger teaches a carpal tunnel device (see Fig. 2) including a balloon (26 in Fig. 3) and a gauge (30 in Fig. 2) on a handle of the device (see Fig. 2) coupled with the balloon via tubing (see 34 in Fig. 2), and further teaches measuring a first pressure (col. 6, lines 39-41: “A balloon catheter 24 is attached to the pressure monitor 30 and syringe 32. Initial pressure reading is taken of the carpal tunnel”) via the pressure gauge (30). Berger additionally teaches sensing measuring a second pressure within the two balloons (claim 1: “serially inflating and deflating said balloon catheter while intermittently moving it along the tunnel and continuously montioring the pressure therein”, the combination as proposed would allow continuous pressure monitoring using the gauge as taught by Berger, meaning a second pressure would be sensed).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the method of the ‘732 patent to incorporate the teachings of Berger and include measuring a first pressure in the two balloons via a pressure gauge in the handle coupled with the two balloons via tubing. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have constituted the use of a known technique (the incorporation of a pressure gauge into the handle of a device comprising balloons) to a known device (the device of the ‘884 patent) ready for improvement to yield predictable results since the combination as proposed would simply allow the surgeon to monitor the fluid pressure within the balloons as the device is placed and moved along the carpal tunnel of a patient and would not alter the main operating principle of the device of the ‘884 patent which also aims to ensure carpal tunnel release.
However, the combination of the ‘884 patent and Berger further fails to disclose a hook shaped blade, converting the first pressure and the second pressure into digital numerical data, and providing the digital numerical data on a display on the handle.
In the same field of carpal tunnel release (abstract), Barnes ’21 teaches a soft tissue cutting device (200 in Fig. 5) comprising a handle (unmarked right end of 200 proximal to 220 and comprising 216), a shaft (220) comprising balloons (202), wherein the balloons (202) are inflated by depressing a lever (216) on the handle (unmarked right end of 200 proximal to 220 and comprising 216) to activate a bellows (288) in the handle (PP [0050]: “the inflation device 288 is a bellows that includes a body 290 and a spring-biased plunger 292 with a distal end 292a and a proximal end 292b. The body 290 is shown as a transparent feature to illustrate interior detail. The spring-biased plunger 292 is pivotally coupled to the balloon activation lever 216. When the balloon activation lever 216 is depressed, the plunger 292 moves towards distal end 292a. When the balloon activation lever 216 is released, the spring-bias of the plunger 292 moves the plunger 292 toward proximal end 292b”), wherein the bellows (288) comprises a spring-based plunger (292) coupled with the lever (216, see PP [0050] cited above). Barnes ’21 further teaches a hook shaped blade (PP [0045]: “the blade working end 246 is configured as a hook and configured to cut a transverse carpal ligament”) translatable within the shaft (220).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have further modified the ‘732 patent and Berger combination according to the teachings of Barnes ’21 to include the hook-shaped blade as claimed. One of ordinary skill in the art would have been motivated to specifically modify the blade of the ‘732 patent to be hook-shaped since it has been held that the variations in shape were a matter of choice and only involves routine skill in the art (see MPEP 2144.04, see In re Dailey, 357 F.2d 669, 149 USPQ (CCPA 1966)).
However, the combination of the ‘732 patent, Berger, and Barnes ’21 further fails to disclose converting the first pressure and the second pressure into digital numerical data and providing the digital numerical data on a display on the handle.
In the related field of surgical instruments with sensors to detect a characteristic of the surgical environment (abstract), Eschbach teaches a device (1 in Fig. 1) comprising a pressure sensor (PP [0049]: “The second sensor 66 of the end effector 46 is a pressure sensor or pressure measuring device”). Eschbach further teaches:
converting the sensor data into digital numerical data (PP [0052]: “In some embodiments, the display 20 (FIG. 1) may display ranges of numbers or various numeral outputs to display the measurements of first and second sensors 64, 66. In particular, the first, second, and third display sections 20a, 20b, 20c may display the number ranges 0 to 3, 0 to 5, 0 to 10, 0 to 100, or any other suitable range, to illustrate information about the tissue being grasped by the end effector 46”); and
providing the digital numerical data on a display (20 in Fig. 1) coupled with the device (1).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the combination as proposed to incorporate the teachings of Eschbach and include converting measurements into numerical digits for display. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have constituted applying a known technique (the conversion of raw data into numerical digits for display purposes) to the known method of Barnes et al. and the Berger patent in order to yield predictable results (see MPEP 2143 I. D.), since incorporating these teachings would only enable the display of the sensor information and would not interfere with or change the operation of the device or method of the combination as proposed.
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,336,732 B2 (hereinafter known as the ‘732 patent) in view of Berger (US Patent No. 5,179,963), Barnes et al. (US PGPub 2021/0085416 A1, hereinafter known as Barnes ’21), and Eschbach (US PGPub 2018/0256161 A1) as applied to claim 8 above, and further in view of Berger (US PGPub 2010/0100114 A1).
Regarding claim 9, the ‘732 patent as modified by the Berger patent, Barnes ’21, and Eschbach fails to disclose visualizing an area within the hand using a visualization member on the distal end of the shaft.
In the same field of carpal tunnel procedures (abstract), the Berger publication teaches a surgical instrument comprising a shaft (32 in Fig. 4) and a balloon (50), and further teaches using a visualization member (55 in Fig. 6) on the distal end of the shaft (32) to visualize at least one anatomical landmark, wherein the visualization member is selected from the group consisting of a camera, a light fiber, and an ultrasound transducer (PP [0049]: “Clearly depicted in FIG. 6 is the visualization lens 55 used in lieu of the closed tip 26 in an alternative embodiment. As shown here, the lens 55 is generally optically transparent wherein the expensive optics of an arthroscope or endoscope inserted into this otherwise inexpensive device will be protected while in use. Additionally, the optical properties of the generally convex cross section of the lens 55 results in a wider field of view regarding objects viewed therethrough. It is contemplated that the visualization lens 55 may be ground with additional refractive indeces as desired, for example, the lens 55 may be ground to provide a magnified view of tissues viewed therethrough”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the combination of the ‘732 patent, Berger, Barnes ’21, and Eschbach further in view of the Berger publication to incorporate a visualization member as claimed. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have constituted the use of a known technique (a distal lens for accommodating an endoscope or arthroscope to improve visualization in a carpal tunnel procedure) to improve a similar device (the combination of the ‘732 patent, Berger, Barnes ’21, and Eschbach) in the same way, since providing an avenue for direct visualization would simply yield a more efficient procedure by enabling the surgeon to more accurately place the device and perform the carpal tunnel release as claimed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771
/MOHAMED G GABR/Primary Examiner, Art Unit 3771
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