DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The preliminary amendment to the claims filed 22 May 2025 has been entered. Claim(s) 1-14 has/have been canceled. New claim(s) 15-34 has/have been added, and is/are pending.
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 ("BRI") 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 BRI 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(I), claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f):
(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). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) 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). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) 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), 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), 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) 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 limitation(s) is/are: "connection member" of the limitation "the pressure sensor is connected by a connection member" (i.e., a connection member for connecting the pressure sensor) in claim(s) 33.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f), it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If Applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f), Applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) (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).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of pre-AIA 35 U.S.C. 112, first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of pre-AIA 35 U.S.C. 112, second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 33 and claims dependent thereon is/are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding claim 33 and claims dependent thereon, as noted above, "connection member" of the limitation "the pressure sensor is connected by a connection member" has been interpreted to invoke 35 U.S.C. 112(f). While "connection member" is repeated in the specification as filed (pg. 4, lines 3-5, "The sensors 7 are connected by connection members 71 in the sensor lumen 4 to a sensor connector 72, for instance an RJ45 connector, at the proximal outer end of the sensor lumen 4"), Applicant fails to disclose the structure of said member, such that the definiteness requirement is not met. See MPEP 2181.
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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 15-18, 20, 26-29 and 31-34 are rejected under 35 U.S.C. 103 as being unpatentable over US 6,259,938 B1 (Zarychta) in view of EP 0694284 A1 (Abrahams), US 2011/0144516 A1 (Fisher), WO 2012/052924 A1 (Sverdlik) and US 5,284,138 A (Kujawski).
Regarding claims 15-16, 18, 26-28 and 31-32, Zarychta discloses and/or suggests a catheter comprising:
a tube (Abstract, combined monitoring catheter and feeding tube) having a proximal end (e.g., Fig. 1A, end having connectors 44, 46, etc.) and a distal end (e.g., Fig. 1A end having guide line 72),
wherein the distal end of the tube is arranged to be inserted into an internal region of the esophagus of a patient (Abstract; col. 1, lines 9-17; etc.),
wherein the tube is provided with a plurality of pressure transducers distributed along the length of the tube, said pressure transducers including at least one pressure transducer for measuring a pressure in the internal region of the esophagus of the patient, wherein the at least one pressure transducer is in direct communication with the internal region of the esophagus of the patient (Abstract, pair of pressure detecting mechanisms that measure the pressures within the patient at separate locations, such as esophageal and gastric pressures; col. 5, lines 20-29, electronic pressure sensor(s) provided in place of the one or more pressure ports, e.g., 36 and 38; col. 11, lines 28-32, additional pressure detecting mechanisms for measuring the patient's internal pressures at further locations; etc.),
wherein the catheter is an esophageal pressure measurement catheter (Abstract),
wherein the tube comprises a feeding lumen for transporting liquid food, medication and/or gastric acid to and/or from the stomach of a patient (Fig. 2, second catheter 84, or lumen thereof, which may comprise a feeding tube/lumen, e.g., col. 8, lines 13-32).
Zarychta discloses the tube comprises a pressure lumen for each pressure detecting mechanism (e.g., lumens 40 and 42), and further discloses the pressure detecting mechanisms may comprise electronic pressure sensors provided along the tube (i.e., in place of ports 36, 38) so as to be in direct communication with in the internal region of the esophagus of the patient, rather than fluid-filled lumens coupled to external pressure transducers (col. 4, line 66 - col. 5, line 29), but does not expressly disclose the pressure transducer(s) is provided in a wall of the tube at the disclosed pressure port locations (e.g., corresponding to each of the esophagus, stomach, etc.).
Abrahams discloses a catheter (e.g., Fig. 2) comprising a tube (comprising catheter parts 10a, 12a) having a proximal end (left side of figure) and a distal end (right side of figure), wherein the distal end of the tube is arranged to be inserted into an internal region of the esophagus of a patient (e.g., col. 10, lines 19-47); a plurality of pressure transducers (pressure sensors 22a, 25), including at least one pressure transducer for measuring a pressure in the internal region of the esophagus of the patient (second pressure sensor 25 for measuring the pressure inside the esophagus), wherein the at least one pressure transducer is provided in a wall of the tube (see Fig. 2) so as to be in direct communication with the internal region of the esophagus of the patient (col. 10, lines 19-47, where second pressure sensor 25 is positioned inside the esophagus); and a pressure transducer lumen for accommodating a connection for the at least one pressure transducer (col. 9, lines 50-55, conductors 17 extend from the pressure sensor 25 through the wall of the catheter part 12a or through a separate lumen to connect the pressure sensor 25 to a coupling 19).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Zarychta with each pressure transducer being provided in a wall of the tube at the disclosed location(s) (e.g., locations of ports 36, 38, etc.), such that a pressure transducer is provided in the wall of the tube so as to be in direct communication with the internal region of the esophagus of the patient, and the tube comprising a respective pressure transducer lumen for accommodating a connection for each pressure transducer as disclosed/suggested by Abrahams as a simple substitution of one known, suitable means/method for detecting pressure in an internal region at a desired location of the patient (esophagus, stomach, etc.) and communicating detected pressure outside of the patient (e.g., electronic pressure sensor provided along the tube with connection provided within a lumen of tube) for another (e.g., fluid-filled lumens coupled to external pressure transducers) to yield no more than predictable results. See MPEP 2143(I)(B).
While Zarychta as modified does not expressly disclose the tube is provided with at least one inflatable balloon adjacent to each pressure transducer, Zarychta discloses a conventional patient monitoring device having at least one inflatable balloon "surrounding" a pressure sensing port(s) of the device, wherein the balloon is inflated with a small volume of air to prevent blockage of said port(s) (col. 1, lines 44-57). Fisher discloses such blockage occurs as a result of contacting surrounding (esophageal, gastric, etc.) tissue(s) (e.g., ¶ [0021]). Sverdlik discloses/suggests a catheter (Fig. 15A, catheter 1222) comprising at least one component in direct communication with the internal region of a cavity, lumen, etc. into which the catheter is inserted (element 102); and at least one inflatable balloon adjacent to a side of the component, such as two inflatable balloons adjacent to and at each side of the component (balloons 2000), wherein the balloon(s) is configured to keep the component of the catheter a minimal distance from the cavity, lumen, etc. wall (throughout document). Sverdlik discloses the balloon(s) are coupled to the catheter "at an area proximal and/or distal to," i.e., adjacent to, the component in order to provide this function (pg. 31). Like the pressure port(s) detecting mechanism(s) discussed above, Kujawski discloses electronic pressure sensors in direct communication with an internal region of tissue (e.g., within a body lumen) of the patient, such as the pressure transducer(s) of Zarychta as modified above, should similarly be prevented from contacting nearby tissue walls in order to provide accurate and/or reliable pressure measurements (col. 1, line 56 - col. 2, line 27; col. 4, lines 31-40; etc.).
Since Zarychta discloses providing an inflatable balloon(s) proximate a pressure detecting mechanism is a suitable means for preventing inaccurate readings by the detecting mechanism resulting from contacting nearby tissue, and Kujawski discloses electronic pressure transducers configured for direct insertion into a body lumen of a patient, such as the pressure transducers of the catheter of Zarychta as modified above, should similarly be provided with means for preventing said transducers from contacting nearby tissue, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Zarychta with the tube being provided with an inflatable balloon(s) adjacent to each pressure transducer along the tube as disclosed/suggested by Zarychta and Sverdlik, such as two inflatable balloons adjacent to and at each side of each pressure transducer as disclosed/suggested by Sverdlik, such that the balloons, when inflated, act as a spacer to keep the wall of the esophagus away from the pressure transducer, in order to increase accuracy/reliability of a pressure measurement(s) obtained within the body lumen at each respective location (esophagus, stomach, etc.) by preventing a "wall effect" that may cause aberrant sensor values (Kujawski, col. 1, line 56 - col. 2, line 27; col. 4, lines 31-40).
Zarychta as modified does not expressly disclose a distance between an edge of the balloon and the center of the pressure transducer is less than 20 mm, less than 10 mm, or less than 7 mm. However, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the catheter of Zarychta with the distance between the edge of the balloon(s) and the center of the pressure transducer being less than 20, 10 or 7 mm because Applicant has not disclosed that the claimed distance(s) provides an advantage, is used for a particular purpose, or solves a stated problem. Therefore, as no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with the balloon(s) being "sufficiently close" to the respective pressure transducer as disclosed/suggested by Zarychta and Sverdlik because either arrangement facilitates maintaining a space between a respective pressure transducer and nearby tissue, as discussed above.
Alternatively/Additionally, Zarychta discloses the balloon "surrounds" the pressure detecting mechanism(s), i.e., is sufficiently close to the pressure detecting mechanism to prevent said mechanism from contacting nearby tissue. Additionally, Sverdlik discloses the balloon(s) are coupled to the catheter "at an area proximal and/or distal to" the component to provide the functionality of maintaining a distance between the component and tissue wall (pg. 31). Accordingly, Zarychta and Sverdlik disclose, or at least suggest, the proximity of the balloon (or edge thereof) to a respective pressure detecting mechanism (or center thereof) provides a quality that can be optimized, i.e., the ability of the balloon(s) to maintain a minimum distance between a component of the catheter and the lumen wall, or is a result-effective variable. See MPEP 2144.05. Accordingly, the specific claimed ranges of an edge of each balloon and the center of its respective pressure transducer being less than 20 mm, less than 10 mm, or less than 7 mm, would have been obvious because it has been held that the discovery of optimum and/or workable ranges by routine experimentation is not inventive. See MPEP 2144.05(II).
Zarychta as modified does not expressly disclose the balloon is inflatable to a diameter of between 7-18 mm, or between 10-15 mm. However, each of Zarychta, Fisher and Sverdlik discloses/suggests the diameter to which the balloon is inflated provides a quality that can be optimized (i.e., preventing contact of the mechanism with nearby tissue by providing sufficient spacing), such that the specific claimed ranges of the balloon(s) being inflatable to a diameter of between 7-18 mm, or between 10-15 mm, would have been obvious because it has been held that the discovery of optimum or workable ranges by routine experimentation is not inventive. See MPEP 2144.05(II).
Alternatively/Additionally, Sverdlik discloses the balloon(s) is inflatable to a diameter of between 7-18 mm, or 10-15 mm (pg. 20, lines 7-13, where distance 1702, which corresponds substantially to a diameter of the balloon(s), as illustrated in Fig. 15A, is maintained between element 102 and wall 1226, wherein said distance may be at least 10 mm, or another smaller, intermediate or larger distance). Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Zarychta with two balloons sufficiently proximate/adjacent (e.g., within 20 mm, for the reasons discussed above) at each side of the pressure transducer(s), wherein the balloons are inflatable to a diameter of between 7-18 mm, or 10-15 mm, as disclosed/suggested by Sverdlik in order to maintain a minimum of at least the above-noted distances (e.g., between 7-18 mm, etc.) between each pressure transducer and nearby tissue (Sverdlik, pg. 2, lines 2-4), thereby preventing contact therebetween, and increasing accuracy/reliability of pressure measurements, as discussed above.
Regarding claim 17, Zarychta as modified discloses/suggests the tube comprises a balloon inflation lumen for transporting a fluid to the at least one inflatable balloon (Zarychta, col. 1, lines 44-57, Sverdlik, pg. 31, lines 14-19, etc., means through which balloon is inflated and/or deflated).
Regarding claims 20 and 29, Zarychta as modified discloses/suggests the length of the tube is at least 80 cm, or at least 95 cm (col. 4, lines 40-45, length of approximately 120 cm).
Regarding claim 33, Zarychta discloses and/or suggests a catheter comprising:
a tube (Abstract, combined monitoring catheter and feeding tube) having a proximal end (e.g., Fig. 1A, end having connectors 44, 46, etc.) and a distal end (e.g., Fig. 1A end having guide line 72),
wherein the distal end of the tube is arranged to be inserted into an internal region of the esophagus of a patient (Abstract; col. 1, lines 9-17; etc.),
wherein the tube is provided with a plurality of pressure transducers distributed along the length of the tube, said pressure transducers including at least one pressure transducer for measuring a pressure in the internal region of the esophagus of the patient, wherein the at least one pressure transducer is in direct communication with the internal region of the esophagus of the patient (Abstract, pair of pressure detecting mechanisms that measure the pressures within the patient at separate locations, such as esophageal and gastric pressures; col. 5, lines 20-29, electronic pressure sensor(s) provided in place of the one or more pressure ports, e.g., 36 and 38; col. 11, lines 28-32, additional pressure detecting mechanisms for measuring the patient's internal pressures at further locations; etc.),
wherein the catheter is an esophageal pressure measurement catheter (Abstract),
wherein the tube comprises a feeding lumen for transporting liquid food, medication and/or gastric acid to and/or from the stomach of a patient (Fig. 2, second catheter 84, or lumen thereof, which may comprise a feeding tube/lumen, e.g., col. 8, lines 13-32).
Zarychta discloses the tube comprises a pressure lumen for each pressure detecting mechanism (e.g., lumens 40 and 42), and further discloses the pressure detecting mechanisms may comprise electronic pressure sensors provided along the tube (i.e., in place of ports 36, 38) so as to be in direct communication with in the internal region of the esophagus of the patient, rather than fluid-filled lumens coupled to external pressure transducers (col. 4, line 66 - col. 5, line 29), but does not expressly disclose the pressure transducer(s) is provided in a wall of the tube at the disclosed pressure port locations (e.g., corresponding to each of the esophagus, stomach, etc.).
Abrahams discloses a catheter (e.g., Fig. 2) comprising a tube (comprising catheter parts 10a, 12a) having a proximal end (left side of figure) and a distal end (right side of figure), wherein the distal end of the tube is arranged to be inserted into an internal region of the esophagus of a patient (e.g., col. 10, lines 19-47); a plurality of pressure transducers (pressure sensors 22a, 25), including at least one pressure transducer for measuring a pressure in the internal region of the esophagus of the patient (second pressure sensor 25 for measuring the pressure inside the esophagus), wherein the at least one pressure transducer is provided in a wall of the tube (see Fig. 2) so as to be in direct communication with the internal region of the esophagus of the patient (col. 10, lines 19-47, where second pressure sensor 25 is positioned inside the esophagus); and a pressure transducer lumen for accommodating a connection member connected to the pressure transducer (col. 9, lines 50-55, conductors 17 extend from the pressure sensor 25 through the wall of the catheter part 12a or through a separate lumen to connect the pressure sensor 25 to a coupling 19).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Zarychta with each pressure transducer being provided in a wall of the tube at the disclosed location(s) (e.g., locations of ports 36, 38, etc.), such that a pressure transducer is provided in the wall of the tube so as to be in direct communication with the internal region of the esophagus of the patient, and the tube comprising a respective pressure transducer lumen for accommodating a connection for each pressure transducer as disclosed/suggested by Abrahams as a simple substitution of one known, suitable means/method for detecting pressure in an internal region at a desired location of the patient (esophagus, stomach, etc.) and communicating detected pressure outside of the patient (e.g., electronic pressure sensor provided along the tube with connection provided within a lumen of tube) for another (e.g., fluid-filled lumens coupled to external pressure transducers) to yield no more than predictable results. See MPEP 2143(I)(B).
While Zarychta as modified does not expressly disclose the tube is provided with at least one inflatable balloon adjacent to each pressure transducer, Zarychta discloses a conventional patient monitoring device having at least one inflatable balloon "surrounding" a pressure sensing port(s) of the device, wherein the balloon is inflated with a small volume of air to prevent blockage of said port(s) (col. 1, lines 44-57). Fisher discloses such blockage occurs as a result of contacting surrounding (esophageal, gastric, etc.) tissue(s) (e.g., ¶ [0021]). Sverdlik discloses/suggests a catheter (Fig. 15A, catheter 1222) comprising at least one component in direct communication with the internal region of a cavity, lumen, etc. into which the catheter is inserted (element 102); and at least one inflatable balloon adjacent to a side of the component, such as two inflatable balloons adjacent to and at each side of the component (balloons 2000), wherein the balloon(s) is configured to keep the component of the catheter a minimal distance from the cavity, lumen, etc. wall (throughout document). Sverdlik discloses the balloon(s) are coupled to the catheter "at an area proximal and/or distal to," i.e., adjacent to, the component in order to provide this function (pg. 31). Like the pressure port(s) detecting mechanism(s) discussed above, Kujawski discloses electronic pressure sensors in direct communication with an internal region of tissue (e.g., within a body lumen) of the patient, such as the pressure transducer(s) of Zarychta as modified above, should similarly be prevented from contacting nearby tissue walls in order to provide accurate and/or reliable pressure measurements (col. 1, line 56 - col. 2, line 27; col. 4, lines 31-40; etc.). One of ordinary skill in the art would readily appreciate that a balloon provided on a catheter/tube is typically inflated/deflated via a lumen in the tube for transporting a fluid to and/or from the at least one inflatable balloon (Zarychta, col. 1, lines 44-57, Sverdlik, pg. 31, lines 14-19, etc., means through which balloon is inflated and/or deflated). Alternatively/Additionally, Abrahams more expressly discloses a tube comprising a dedicated balloon inflation lumen for transporting a fluid to the at least one inflatable balloon (Fig. 4, col. 13, lines 36-51, through the second catheter part 80 extends a separate lumen from a coupling 85 at the proximal end until an opening in the wall of the catheter such, that in case from the coupling 85 a fluidum is pressed into this lumen the balloon 84 will be inflated. By sucking off the fluidum the balloon 84 will be deflated).
Since Zarychta discloses providing an inflatable balloon(s) proximate a pressure detecting mechanism is a suitable means for preventing inaccurate readings by the detecting mechanism resulting from contacting nearby tissue, and Kujawski discloses electronic pressure transducers configured for direct insertion into a body lumen of a patient, such as the pressure transducers of the catheter of Zarychta as modified above, should similarly be provided with means for preventing said transducers from contacting nearby tissue, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Zarychta with the tube being provided with an inflatable balloon(s) adjacent to each pressure transducer along the tube as disclosed/suggested by Zarychta and Sverdlik, such as two inflatable balloons adjacent to and at each side of each pressure transducer as disclosed/suggested by Sverdlik, such that the balloons, when inflated, act as a spacer to keep the wall of the esophagus away from the pressure transducer; and a balloon inflation lumen, different from the pressure transducer lumen, for transporting a fluid to the balloon(s) as disclosed/suggested by Abrahams, in order to enable increasing the accuracy/reliability of a pressure measurement(s) obtained within the body lumen at each respective location (esophagus, stomach, etc.) by permitting inflation of the balloon(s) to prevent a "wall effect" that may cause aberrant sensor values (Kujawski, col. 1, line 56 - col. 2, line 27; col. 4, lines 31-40).
Zarychta as modified does not expressly disclose a distance between an edge of the balloon and the center of the pressure transducer is less than 20 mm, less than 10 mm, or less than 7 mm. However, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the catheter of Zarychta with the distance between the edge of the balloon(s) and the center of the pressure transducer being less than 20, 10 or 7 mm because Applicant has not disclosed that the claimed distance(s) provides an advantage, is used for a particular purpose, or solves a stated problem. Therefore, as no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with the balloon(s) being "sufficiently close" to the respective pressure transducer as disclosed/suggested by Zarychta and Sverdlik because either arrangement facilitates maintaining a space between a respective pressure transducer and nearby tissue, as discussed above.
Alternatively/Additionally, Zarychta discloses the balloon "surrounds" the pressure detecting mechanism(s), i.e., is sufficiently close to the pressure detecting mechanism to prevent said mechanism from contacting nearby tissue. Additionally, Sverdlik discloses the balloon(s) are coupled to the catheter "at an area proximal and/or distal to" the component to provide the functionality of maintaining a distance between the component and tissue wall (pg. 31). Accordingly, Zarychta and Sverdlik disclose, or at least suggest, the proximity of the balloon (or edge thereof) to a respective pressure detecting mechanism (or center thereof) provides a quality that can be optimized, i.e., the ability of the balloon(s) to maintain a minimum distance between a component of the catheter and the lumen wall, or is a result-effective variable. See MPEP 2144.05. Accordingly, the specific claimed ranges of an edge of each balloon and the center of its respective pressure transducer being less than 20 mm, less than 10 mm, or less than 7 mm, would have been obvious because it has been held that the discovery of optimum and/or workable ranges by routine experimentation is not inventive. See MPEP 2144.05(II).
Zarychta as modified does not expressly disclose the balloon is inflatable to a diameter of between 7-18 mm, or between 10-15 mm. However, each of Zarychta, Fisher and Sverdlik discloses/suggests the diameter to which the balloon is inflated provides a quality that can be optimized (i.e., preventing contact of the mechanism with nearby tissue by providing sufficient spacing), such that the specific claimed ranges of the balloon(s) being inflatable to a diameter of between 7-18 mm, or between 10-15 mm, would have been obvious because it has been held that the discovery of optimum or workable ranges by routine experimentation is not inventive. See MPEP 2144.05(II).
Alternatively/Additionally, Sverdlik discloses the balloon(s) is inflatable to a diameter of between 7-18 mm, or 10-15 mm (pg. 20, lines 7-13, where distance 1702, which corresponds substantially to a diameter of the balloon(s), as illustrated in Fig. 15A, is maintained between element 102 and wall 1226, wherein said distance may be at least 10 mm, or another smaller, intermediate or larger distance). Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Zarychta with two balloons sufficiently proximate/adjacent (e.g., within 20 mm, for the reasons discussed above) at each side of the pressure transducer(s), wherein the balloons are inflatable to a diameter of between 7-18 mm, or 10-15 mm, as disclosed/suggested by Sverdlik in order to maintain a minimum of at least the above-noted distances (e.g., between 7-18 mm, etc.) between each pressure transducer and nearby tissue (Sverdlik, pg. 2, lines 2-4), thereby preventing contact therebetween, and increasing accuracy/reliability of pressure measurements, as discussed above.
Regarding claim 34, Zarychta discloses and/or suggests a catheter comprising:
a tube (Abstract, combined monitoring catheter and feeding tube) having a proximal end (e.g., Fig. 1A, end having connectors 44, 46, etc.) and a distal end (e.g., Fig. 1A end having guide line 72),
wherein the distal end of the tube is arranged to be inserted into an internal region of the esophagus of a patient (Abstract; col. 1, lines 9-17; etc.),
wherein the tube is provided with a plurality of pressure transducers distributed along the length of the tube, said pressure transducers including at least one pressure transducer for measuring a pressure in the internal region of the esophagus of the patient, wherein the at least one pressure transducer is in direct communication with the internal region of the esophagus of the patient (Abstract, pair of pressure detecting mechanisms that measure the pressures within the patient at separate locations, such as esophageal and gastric pressures; col. 5, lines 20-29, electronic pressure sensor(s) provided in place of the one or more pressure ports, e.g., 36 and 38; col. 11, lines 28-32, additional pressure detecting mechanisms for measuring the patient's internal pressures at further locations; etc.),
wherein the catheter is an esophageal pressure measurement catheter (Abstract),
wherein the tube comprises a feeding lumen for transporting liquid food, medication and/or gastric acid to and/or from the stomach of a patient (Fig. 2, second catheter 84, or lumen thereof, which may comprise a feeding tube/lumen, e.g., col. 8, lines 13-32).
Zarychta discloses the tube comprises a pressure lumen for each pressure detecting mechanism (e.g., lumens 40 and 42), and further discloses the pressure detecting mechanisms may comprise electronic pressure sensors provided along the tube (i.e., in place of ports 36, 38) so as to be in direct communication with in the internal region of the esophagus of the patient, rather than fluid-filled lumens coupled to external pressure transducers (col. 4, line 66 - col. 5, line 29), but does not expressly disclose the pressure transducer(s) is provided in a wall of the tube at the disclosed pressure port locations (e.g., corresponding to each of the esophagus, stomach, etc.).
Abrahams discloses a catheter (e.g., Fig. 2) comprising a tube (comprising catheter parts 10a, 12a) having a proximal end (left side of figure) and a distal end (right side of figure), wherein the distal end of the tube is arranged to be inserted into an internal region of the esophagus of a patient (e.g., col. 10, lines 19-47); a plurality of pressure transducers (pressure sensors 22a, 25), including at least one pressure transducer for measuring a pressure in the internal region of the esophagus of the patient (second pressure sensor 25 for measuring the pressure inside the esophagus), wherein the at least one pressure transducer is provided in a wall of the tube (see Fig. 2) so as to be in direct communication with the internal region of the esophagus of the patient (col. 10, lines 19-47, where second pressure sensor 25 is positioned inside the esophagus); and a pressure transducer lumen for accommodating a connection for the at least one pressure transducer (col. 9, lines 50-55, conductors 17 extend from the pressure sensor 25 through the wall of the catheter part 12a or through a separate lumen to connect the pressure sensor 25 to a coupling 19).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Zarychta with each pressure transducer being provided in a wall of the tube at the disclosed location(s) (e.g., locations of ports 36, 38, etc.), such that a pressure transducer is provided in the wall of the tube so as to be in direct communication with the internal region of the esophagus of the patient, and the tube comprising a respective pressure transducer lumen for accommodating a connection for each pressure transducer as disclosed/suggested by Abrahams as a simple substitution of one known, suitable means/method for detecting pressure in an internal region at a desired location of the patient (esophagus, stomach, etc.) and communicating detected pressure outside of the patient (e.g., electronic pressure sensor provided along the tube with connection provided within a lumen of tube) for another (e.g., fluid-filled lumens coupled to external pressure transducers) to yield no more than predictable results. See MPEP 2143(I)(B).
Zarychta as modified does not disclose the tube is provided with a spacer to keep the wall of the esophagus away from the pressure transducer arranged adjacent to the at least one pressure transducer. However, Zarychta as modified discloses a conventional patient monitoring device having at least one inflatable balloon "surrounding" a pressure sensing port(s) of the device, wherein the balloon is inflated with a small volume of air to prevent blockage of said port(s) (col. 1, lines 44-57). Fisher discloses such blockage occurs as a result of contacting surrounding (esophageal, gastric, etc.) tissue(s) (e.g., ¶ [0021]). Sverdlik discloses/suggests a catheter (Fig. 15A, catheter 1222) comprising at least one component in direct communication with the internal region of a cavity, lumen, etc. into which the catheter is inserted (element 102); and at least one spacer, such as an inflatable balloon, adjacent to a side of the component (e.g., balloons 2000), wherein the spacer is configured to keep the wall(s) of surrounding tissue(s) away from the component (throughout document). Sverdlik discloses the balloon(s) are coupled to the catheter "at an area proximal and/or distal to," i.e., adjacent to, the component in order to provide this function (pg. 31). Like the pressure port(s) detecting mechanism(s) discussed above, Kujawski discloses electronic pressure sensors in direct communication with an internal region of tissue (e.g., within a body lumen) of the patient, such as the pressure transducer(s) of Zarychta as modified above, should similarly be prevented from contacting nearby tissue walls in order to provide accurate and/or reliable pressure measurements (col. 1, line 56 - col. 2, line 27; col. 4, lines 31-40; etc.).
Since Zarychta discloses providing an inflatable balloon(s) proximate a pressure detecting mechanism is a suitable means for preventing inaccurate readings by the detecting mechanism resulting from contacting nearby tissue, and Kujawski discloses electronic pressure transducers configured for direct insertion into a body lumen of a patient, such as the pressure transducers of the catheter of Zarychta as modified above, should similarly be provided with means for preventing said transducers from contacting nearby tissue, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Zarychta with the tube being provided with a spacer, such as an inflatable balloon(s), arranged adjacent to the at least one pressure transducer as disclosed/suggested by Zarychta and Sverdlik, to keep the wall of the esophagus away from the pressure transducer in order to increase accuracy/reliability of a pressure measurement(s) obtained within the body lumen at each respective location (esophagus, stomach, etc.) by preventing a "wall effect" that may cause aberrant sensor values (Kujawski, col. 1, line 56 - col. 2, line 27; col. 4, lines 31-40).
Claim(s) 17, 19 and 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zarychta in view of Abrahams, Fisher, Sverdlik, and Kujawski as applied to claim(s) 15 above, and further in view of US 2001/0053920 A1 (Shaker).
Regarding claim 17, Zarychta as modified discloses/suggests the limitations of claim 15, as discussed above. Specifically, Zarychta as modified discloses a balloon provided on the tube is inflated, which one of ordinary skill in the art would readily appreciate is normally or typically achieved via an inflation lumen. Alternatively/Additionally, Shaker more expressly discloses a catheter (10) comprising a tube (12) including a balloon inflation lumen for transporting a fluid to the at least one inflatable balloon (¶ [0014]), such that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Zarychta with the tube comprising a balloon inflation lumen for transporting a fluid to the at least one inflatable balloon as disclosed/suggested by Shaker as a simple substitution of one known, suitable means/method for selectively inflating and/or deflating the balloon(s) (Shaker, ¶ [0026]) for another to yield no more than predictable results. See MPEP 2143(I)(B).
Regarding claims 19 and 23, Zarychta as modified discloses/suggests the limitations of claim 15, as discussed above, but does not expressly disclose the balloon has a spherical shape, or the balloon has a cylindrical shape with a substantially rectangular longitudinal cross section, or the balloon is made of urethane, PET and/or nylon. However, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the catheter of Zarychta with the above-noted features because Applicant has not disclosed that the balloon shape and/or material provides an advantage, is used for a particular purpose, or solves a stated problem. Rather, Applicant merely states the claimed shape(s) and/or material(s) are "preferable" (pg. 2, lines 3-6), but provides no indication as to why said shape(s) and/or material(s) is/are preferred. Therefore, as no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with any suitable balloon shape and/or material as suggested by Zarychta as modified because either arrangement facilitates maintaining a space between a respective pressure transducer and nearby tissue, as discussed above.
Alternatively/Additionally, Shaker discloses/suggests a comparable device including at least one balloon, wherein the balloon has a spherical shape (e.g., Fig. 1, balloon 28), or has a cylindrical shape with a substantially rectangular longitudinal cross section (e.g., Fig. 1, balloon 30), and wherein the balloon(s) is made of urethane, PET and/or nylon (e.g., ¶ [0027] balloon(s) may be made of PET). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Zarychta with the balloon(s) having a spherical shape, or a cylindrical shape with a substantially rectangular longitudinal cross section, and being made of PET as disclosed/suggested by Shaker as a simple substitution of one known, suitable catheter balloon shape and/or material for another to yield no more than predictable results. See MPEP 2143(I)(B).
Regarding claim 22, Zarychta as modified discloses and/or suggests the limitations of claim 15, disclosing the pressure transducer(s) may comprise an electronic pressure sensor(s) configured to be in direct communication with the internal region of respective body lumen(s) of the patient, as discussed above. Zarychta as modified does not expressly teach the pressure transducer(s) is a solid-state pressure sensor/transducer. Shaker discloses/suggests a catheter and, similar to Zarychta, discloses a pressure detecting mechanism thereof may comprise a pressure port and fluid-perfused lumen in communication therewith, or an electronic pressure sensor positioned along the length of the catheter, such as a strain gauge transducer with solid-state circuitry (e.g., ¶ [0029]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Zarychta with each pressure transducer being a solid-state pressure transducer as disclosed/suggested by Shaker as a simple substitution of one known, suitable electronic pressure sensor/transducer capable of being positioned along the length of a catheter for direct insertion into a patient for sensing pressure for another to yield no more than predictable results. See MPEP 2143(I)(B).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zarychta in view of Abrahams, Fisher, Sverdlik, and Kujawski as applied to claim(s) 15 above, and further in view of US 4,214,593 A (Imbruce).
Regarding claim 21, Zarychta as modified discloses/suggests the limitations of claim 15, as discussed above, and further discloses the diameter of the monitoring catheter forming the tube is between 2 mm and 6 mm (col. 4, lines 40-45, body member 32 may be 7 or 8 French (an outside diameter in a range of 2.3-2.7 mm)). Zarychta as modified does not disclose the entire tube (e.g., combined monitoring catheter and feeding tube) has a diameter between 2 mm and 6 mm.
Fisher discloses a single tube with a plurality of lumens can be used for gastric feeding, and monitoring pressure at multiple locations (e.g., ¶ [0025]). Accordingly, particularly in embodiments in which the monitoring catheter does not comprise a pair of electrodes (e.g., col. 3, lines 1-7, monitoring catheter may include a pair of electrodes "and/or" a pair of pressure detecting mechanisms, thereby contemplating embodiments with only the pressure detecting mechanisms), one of ordinary skill in the art would readily appreciate an existing lumen (e.g., 54) may be utilized for a different purpose. Alternatively/Additionally, Imbruce discloses catheter (monitoring device 2), comprising a tube (tube 10), wherein the diameter of the tube is between 2 and 6 mm (col. 3, lines 61-64, 14 FR (approximately 4.7 mm) size tube 10), wherein the catheter comprises a feeding lumen for transporting liquid food, medication and/or gastric acid to and/or from the stomach of a patient (major lumen 12) and at least one pressure lumen (Abstract, secondary lumen) to enable continuous pressure measurements without interruption of the function of tube (Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Zarychta with the tube consisting only of the 7-8 FR monitoring catheter, wherein said tube comprises a feeding lumen for transporting liquid food, medication and/or gastric acid to and/or from the stomach of a patient (e.g., using a lumen of the monitoring catheter for transporting liquid food, medication and/or gastric acid to and/or from the stomach of a patient) as disclosed/suggested by Fisher, or with the tube consisting only of a 14 FR monitoring catheter capable of simultaneous feeding and sensing functions as disclosed and/or suggested by Imbruce, such that the diameter of the tube is 2-6 mm, in order to simplify insertion of the device by only requiring a single insertion procedure (as opposed to first inserting a feeding tube, then inserting the monitoring catheter, as described by Zarychta, e.g., col. 7, lines 36-53).
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zarychta in view of Abrahams, Fisher, Sverdlik, and Kujawski as applied to claim(s) 15 above; or alternatively, over Zarychta in view of Abrahams, Fisher, Sverdlik, and Kujawski as applied to claim 16 above, and further in view of US 2012/0071912 A1 (Campbell).
Regarding claim 24, Zarychta as modified discloses/suggests the limitations of claim 15, as discussed above, but does not expressly disclose the wall thickness of the balloon, i.e., does not teach the wall thickness of the balloon is between 0.01 mm and 0.06 mm. However, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the catheter of Zarychta with the above-noted balloon wall thickness because Applicant has not disclosed that any specific balloon wall thickness (or range of thicknesses) provides an advantage, is used for a particular purpose, or solves a stated problem. Rather, the application as filed merely indicates the claimed wall thickness(es) is "preferable" (pg. 2, lines 6-7), but provides no indication as to why said wall thickness(es) are preferred. Therefore, as no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with any suitable balloon wall thickness as disclosed/suggested by Zarychta as modified because either arrangement facilitates maintaining a space between a respective pressure transducer and nearby tissue, as discussed above.
Alternatively/Additionally, Campbell discloses a catheter comprising an inflatable balloon wherein the wall thickness of the balloon is between 0.01 mm and 0.06 mm (¶ [0051] wall thickness can range from less than about 0.01 mm to about 5 mm, e.g., about 0.02 mm). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Zarychta with the wall thickness of the balloon being between 0.01 mm and 0.06 mm (e.g., 0.02 mm) as disclosed/suggested by Campbell as a simple substitution of one known, suitable balloon wall thickness for another to yield no more than predictable results. See MPEP 2143(I)(B).
Claim(s) 25 and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zarychta in view of Abrahams, Fisher, Sverdlik, and Kujawski as applied to claim(s) 15 above, and further in view of US 2012/0234434 A1 (Woodruff).
Regarding claims 25 and 30, Zarychta as modified discloses/suggests the limitations of claim 15, as discussed above, but does not expressly disclose the balloon has a leg on either side for fixating the balloon on the tube.
Woodruff discloses a catheter (catheter 200) comprising a tube (shaft 202) and an inflatable balloon (balloon 240), wherein the balloon has a leg on either side for fixating the balloon on the tube (Fig. 4, end bases 420; ¶ [0045]; etc.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Zarychta with the balloon having a leg on either side for fixating the balloon on the tube as disclosed/suggested by Woodruff in order to facilitate permanently securing the balloon to the tube (Woodruff, ¶ [0045]).
Zarychta as modified does not expressly disclose the length of each of said legs is less than 7 mm in axial direction. However, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the catheter of Zarychta with the length of each leg being less than 7 mm in an axial direction because Applicant has not disclosed that the claimed leg length (or leg length range) provides an advantage, is used for a particular purpose, or solves a stated problem. Rather, the application as filed merely indicates the claimed length(s) is "preferable" (pg. 2, lines 6-7), but provides no indication as to why said wall thickness(es) are preferred. Therefore, as no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with any suitable leg length(s) that enable the pressure transducer to be sufficiently close to or "surrounded by" the inflatable portion of the balloon (e.g., within 20 mm thereof) as disclosed/suggested by Zarychta as modified because either arrangement facilitates maintaining a space between a respective pressure transducer and nearby tissue, as discussed above.
Alternatively/Additionally, Woodruff discloses the length of each of said legs is less than 7 mm, or 5 mm in the axial direction (e.g., ¶ [0038] each end base 420 has a length LBB of approximately 0.043 inch, i.e., approximately 1 mm), such that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Zarychta with the length of each of said legs being less than 7 or 5 mm in axial the direction as disclosed/suggested by Woodruff as a simple substitution of one known, suitable balloon leg length for securely affixing an inflatable balloon to a tube for another to yield no more than predictable results. See MPEP 2143(I)(B).
Conclusion
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/Meredith Weare/Primary Examiner, Art Unit 3791
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