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 .
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 limitation(s) is/are:
gut diameter module in claim 4 – drawn to element 106 which includes software (0035, 0066 published spec).
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.
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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Claim 1 recites “determine a geometric variable or a biomechanical response variable that corresponds to a characteristic of the soft tissue.”
Under the first of the two-prong inquiry of step 2A for evaluating 101, this limitation is considered a mental process because the “determine” function when given its broadest reasonable interpretation may be performed in the user’s mind or using pen and paper, e.g. the user can mentally calculate the geometric variable or biomechanical response variable.
Under the second of the two-prong inquiry of step 2A, this judicial exception is not integrated into a practical application because there are no limitations that indicate improvements to the functioning of a computer or to the technology/technical field; effecting a particular treatment or prophylaxis for a disease/condition; applying the judicial exception with a particular machine (the control unit and sensor are recited with such generality that they are not considered a particular machine); effecting a transformation or reduction of a particular article to a different state/thing; applying the judicial exception in a meaningful way beyond generally linking to a particular technological environment. There are no limitations referring to any practical output or application in the claims.
Since the second of the two-prong inquiry of step 2A is not satisfied, the claim is then evaluated under step 2B.
Under step 2B for evaluating 101, the claim(s) does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the other limitations present do not impose meaningful limits on the abstract idea. The catheter, pump, pressure transducer, and control system recited are well-known, routine, and conventional structures within the art and thus merely provide data gathering that constitute insignificant pre-solution activity. Thus, they do not add significantly more to the abstract idea.
The control system “configured to coordinate pressure data from the catheter with diameter data from a series of diameter measurements of the soft tissue region” has also been recited with such generality that it does not constitute a special machine to perform the abstract idea that amounts to significantly more.
Claims 2-12 only further add details to the above abstract ideas or add structure that do not add meaningfully more to the abstract idea. Additionally, real-time readout of the data as recited in Claim 7 merely constitutes insignificant post-solution activity. Claim 12 presents an additional abstract idea that may be considered a mental concept and/or a mathematical concept, which is not significantly more per the above.
Claim 13 recites “calculating a stress versus strain curve from the pressure and diameter data of the soft tissue lumen; calculating the gut stiffness index from the slope of the stress versus strain curve.”
Under the first of the two-prong inquiry of step 2A for evaluating 101, these limitations are considered a mental process or a mathematical concept because the “calculating” step when given its broadest reasonable interpretation may be performed in the user’s mind or using pen and paper, e.g. the user can mentally calculate the stress versus strain curve and the gut stiffness index from the slope of said stress vs. strain curve.
Under the second of the two-prong inquiry of step 2A, this judicial exception is not integrated into a practical application because there are no limitations that indicate improvements to the functioning of a computer or to the technology/technical field; effecting a particular treatment or prophylaxis for a disease/condition; applying the judicial exception with a particular machine (the control unit and sensor are recited with such generality that they are not considered a particular machine); effecting a transformation or reduction of a particular article to a different state/thing; applying the judicial exception in a meaningful way beyond generally linking to a particular technological environment. There are no limitations referring to any practical output or application in the claims.
Since the second of the two-prong inquiry of step 2A is not satisfied, the claim is then evaluated under step 2B.
Under step 2B for evaluating 101, the claim(s) does not include additional steps that are sufficient to amount to significantly more than the judicial exception because the other steps present do not impose meaningful limits on the abstract idea. The steps of inserting the catheter, inflating the catheter, inflating the soft tissue, and recording the pressure and diameter data are well-known, routine, and conventional steps within the art that provide data gathering that constitute insignificant pre-solution activity. Thus, they do not add significantly more to the abstract idea. Additionally, the step of generating a report of the gut stiffness index merely amounts to insignificant post-solution activity. Thus, they do not add significantly more to the abstract idea.
Claims 14-16 add additional abstract ideas and therefore do not meaningfully limit the abstract ideas in Claim 13.
Claim 17 recites “calculating circumferential stress for each data point using the pressure measurements in the first series of data points and the corresponding diameter measurements in the second series of data points; calculating circumferential strain for each data point using the diameter measurements in the second series of data points.”
Under the first of the two-prong inquiry of step 2A for evaluating 101, these limitations are considered a mental process or a mathematical concept because the “calculating” step when given its broadest reasonable interpretation may be performed in the user’s mind or using pen and paper, e.g. the user can mentally calculate the circumferential stress and strain for each data point using the pressure/diameter measurements.
Under the second of the two-prong inquiry of step 2A, this judicial exception is not integrated into a practical application because there are no limitations that indicate improvements to the functioning of a computer or to the technology/technical field; effecting a particular treatment or prophylaxis for a disease/condition; applying the judicial exception with a particular machine (the control unit and sensor are recited with such generality that they are not considered a particular machine); effecting a transformation or reduction of a particular article to a different state/thing; applying the judicial exception in a meaningful way beyond generally linking to a particular technological environment. There are no limitations referring to any practical output or application in the claims.
Since the second of the two-prong inquiry of step 2A is not satisfied, the claim is then evaluated under step 2B.
Under step 2B for evaluating 101, the claim(s) does not include additional steps that are sufficient to amount to significantly more than the judicial exception because the other steps present do not impose meaningful limits on the abstract idea. The steps of collecting pressure measurements and collecting diameter measurements are well-known, routine, and conventional steps within the art that provide data gathering that constitute insignificant pre-solution activity. Thus, they do not add significantly more to the abstract idea. Additionally, the step of outputting one or more of a geometric variable or a biomechanical response variable that characterizes the soft tissue as a report merely amounts to insignificant post-solution activity. Thus, they do not add significantly more to the abstract idea.
Claims 18-22 add additional abstract ideas and therefore do not meaningfully limit the abstract ideas in Claim 17.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 8-13, 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Gregersen et al (US Pub No. 20080027358 – cited by applicant) in view of Sarvazyan (US Pat No. 7947001 – cited by applicant).
In regard to Claim 1, Gregersen et al disclose a system for characterizing soft tissue, the system comprising:
a catheter configured to extend into a soft tissue region of an anatomical body (abst);
a pump for actuating inflation or deflation of the catheter – “the apparatus may also include an automated or manual pump… for inflation of the balloon” (0043);
a pressure transducer necessarily in communication with the pump, the pressure transducer configured to sense pressure within the catheter – “start recording of parameters such as pressures” (0107); and
a system in communication with: (1) the pump to activate the catheter within the soft tissue region of the anatomical body (abst), and (2) the pressure transducer to record a series of pressure measurements from the catheter – “start recording of parameters such as pressures” (0107),
wherein the system is configured to coordinate pressure data from the catheter – “the morphometric data and other data such as pressures and forces are used for computation of advanced mechanical parameters such as active-passive tension-strain analysis (FIG. 7), active-passive stress-strain analysis” (0041)
with diameter data from a series of diameter measurements of the soft tissue region – “The circumferential strain was calculated based on the average of circumference [which requires diameter data] in approximately the same 6 slices in both the stem and bending part of the rectum” (0059), “Morphometric parameters such… diameter, circumferences… and pressure are measured during inflation of a balloon” (0034),
wherein the control system is further configured to use at least one of the pressure measurements and the diameter measurements to determine a geometric variable or a biomechanical response variable that corresponds to a characteristic of the soft tissue – “the morphometric data and other data such as pressures and forces are used for computation of advanced mechanical parameters such as active-passive tension-strain analysis (FIG. 7), active-passive stress-strain analysis” (0041).
However, Gregersen et al do not expressly disclose the system using a control system to perform the functions above.
Sarvazyan teach that it is well-known in the art to provide an analogous device for characterizing tissue comprising a pressure sensor 14 as well as control system 16 to perform the similar functions of Gregersen et a – “Control unit of the apparatus 10 includes a controller 16 that manages operation of the pump 13 and the motion unit 15, as well as a processor 17 adapted to issue commands to the controller 16 and accept data from the pressure sensor 14 and other sources” (Col.5: 51-55).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Gregersen et al such that the functions are performed with a control system and includes a pressure sensor as taught by Sarvazyan to effectively perform the functions as desired and is well-known within the art.
2. Gregersen et al disclose the system of claim 1, wherein the geometric variable includes the diameter data – “Morphometric parameters such… diameter, circumferences… and pressure are measured during inflation of a balloon” (0034).
3. Gregersen et al disclose the system of claim 1, wherein the biomechanical response variable is a slope from a plot of stress measurements versus strain measurements – “slope of tension-strain relation” (0009),
the stress measurements calculated from pressure data and the diameter data –“subsequent evaluation of the circumferential wall tension” (0017), which requires diameter data to determine the circumference, and
the strain measurements calculated from the diameter data – “circumferential strain was calculated based on the average of circumference” (0059).
8. Gregersen et al disclose the system of claim 1, wherein the soft tissue region is characterized in vivo – “Development of balloon distension protocols is useful in order to correlate biomechanics, motor control and visceral non-pain and pain perception in the visceral organs, in particular in the gastrointestinal tract in vivo” (0017).
9. Gregersen et al disclose the system of claim 1, wherein the catheter is a water-filled balloon catheter – “circulating tempered water in the balloon of a probe” (0075).
10. Gregersen et al disclose the system of claim 1, wherein the soft tissue region is a gut including a large intestine and a small intestine, which is included in the gastrointestinal tract – “Development of balloon distension protocols is useful in order to correlate biomechanics, motor control and visceral non-pain and pain perception in the visceral organs, in particular in the gastrointestinal tract in vivo” (0017).
11. Gregersen et al disclose the system of claim 1, wherein the soft tissue region includes one or more of a jejunum, an ileum, or a colon, which is included in the gastrointestinal tract – “Development of balloon distension protocols is useful in order to correlate biomechanics, motor control and visceral non-pain and pain perception in the visceral organs, in particular in the gastrointestinal tract in vivo” (0017).
12. Gregersen et al disclose the system of claim 1, wherein the control system is further configured to calculate a stress versus strain curve from the pressure and diameter data – “slope of tension-strain relation” (0009) and generate a gut stiffness index from the slope of the stress versus strain curve – “stiffness (slope of tension-strain relation) to be computed” (0009).
In regard to Claim 13, Gregersen et al disclose a method of obtaining a gut stiffness index for a soft tissue region, the method comprising:
inserting a catheter into an anatomical space having a soft tissue region – “steps of introducing from an exteriorly accessible opening of a bodily hollow system a catheter into the hollow system, the catheter being provided with one or more inflatable balloons” (abst);
inflating the catheter within the anatomical space – “subsequently inflating at least one of the balloons in the hollow internal organ at least until the balloon abuts an inner wall of the hollow system“ (abst);
inflating a soft tissue lumen within the soft tissue region by contacting the soft tissue lumen with the catheter – “subsequently inflating at least one of the balloons in the hollow internal organ at least until the balloon abuts an inner wall of the hollow system” (abst);
recording corresponding pressure data – “ start recording of parameters such as pressures and sensory data” (0107) and
diameter data of the soft tissue lumen – “Morphometric parameters such… diameter, circumferences… and pressure are measured during inflation of a balloon” (0034);
calculating a stress versus strain curve from the pressure and diameter data of the soft tissue lumen – “slope of tension-strain relation” (0009);
calculating the gut stiffness index from the slope of the stress versus strain curve – “ stiffness (slope of tension-strain relation) to be computed” (0009).
However, Gregersen et al do not expressly disclose generating a report including the gut stiffness index.
Sarvazyan teach that it is well-known in the art to provide an analogous device for characterizing tissue comprising pressure sensor 14 and a display 18 used for “presentation of results” which constitute generating a report (Col.5: 54-55).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Gregersen et al such that it includes generating a report including the gut stiffness index already taught by Gregersen et al as taught by Sarvazyan to effectively convey the results to the user.
In regard to Claim 17, Gregersen disclose a method of characterizing soft tissue at a soft tissue region within a gut, the method comprising:
collecting pressure measurements from the soft tissue region for a length of time to provide a first series of data points – “start recording of parameters such as pressures and sensory data” (0107);
collecting diameter measurements of the gut at the soft tissue region for the length of time to provide a second series of data points – “Morphometric parameters such… diameter, circumferences… and pressure are measured during inflation of a balloon” (0034);
calculating circumferential stress for each data point using the pressure measurements in the first series of data points and the corresponding diameter measurements in the second series of data points;
calculating circumferential strain for each data point using the diameter measurements in the second series of data points – “circumferential strain was calculated based on the average of circumference in approximately the same 6 slices” (0059); and
calculating one or more of a geometric variable or a biomechanical response variable that characterizes the soft tissue – “the morphometric data and other data such as pressures and forces are used for computation of advanced mechanical parameters such as active-passive tension-strain analysis (FIG. 7), active-passive stress-strain analysis” (0041).
However, Gregersen et al do not expressly disclose outputting a report of the variables.
Sarvazyan teach that it is well-known in the art to provide an analogous device for characterizing tissue comprising a pressure sensor 14 and a display 18 used for “presentation of results” which constitute generating a report (Col.5: 54-55).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Gregersen et al such that it includes outputting a report of the variables already taught by Gregersen et al as taught by Sarvazyan to effectively convey the results to the user.
18. Gregersen et al disclose the method of claim 17, wherein the geometric variable is an outer diameter of the gut at the soft tissue region, i.e. circumferential (0017, 0059).
19. The method of claim 17, wherein the biomechanical response is a gut stiffness index calculated from a stress versus strain plot (0009) of the circumferential stress and the circumferential strain – “stiffness (slope of tension-strain relation) to be computed” (0009).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Gregersen et al (US Pub No. 20080027358 – cited by applicant) in view of Sarvazyan (US Pat No. 7947001 – cited by applicant), further in view of Yang (CN 110327046).
Gregersen et al in combination with Sarvazyan disclose the invention above including
the soft tissue region is a gut – “Development of balloon distension protocols is useful in order to correlate biomechanics, motor control and visceral non-pain and pain perception in the visceral organs, in particular in the gastrointestinal tract in vivo” (0017), wherein the diameter measurements of the diameter data is the outer diameter of the gut, i.e. circumferential (0017, 0059), citations in Gregersen et al.
Gregersen et al also disclose imaging used as well – “In a preferred embodiment the bag inflation is combined with imaging technology (0013, 0033, 0053) as well as detection of the gut edges using a gut diameter module – “The inner and outer contours of the rectal wall were identified for each cross-sectional image by semi-automatic edge detection based on greyscale threshold” (0054), all considered a part of the gut diameter module.
However, Gregersen et al in combination with Sarvazyan do not expressly disclose the gut diameter module includes a camera.
Yang teach that it is well-known in the art to provide an analogous gut identification module that uses a camera (abst). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Gregersen et al in combination with Sarvazyan such that the gut diameter module of Gregersen et al includes a camera as taught by Yang as an equally as effective imaging means already included in Gregersen et al.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Gregersen et al (US Pub No. 20080027358 – cited by applicant) in view of Sarvazyan (US Pat No. 7947001 – cited by applicant), further in view of Sandrin et al (US Pub No. 20210052250).
Gregersen et al in combination with Sarvazyan disclose the invention above but not expressly disclose the control system includes a real-time readout of the pressure data and the diameter data, wherein the real-time readout of the pressure data and the diameter data occurs at a frequency between 1.4 Hz and 3 Hz.
It is noted that applicant does not appear to provide any criticality toward the frequency of the real-time readout of the pressure and diameter data as solving a particular problem, conferring a specific advantage, or providing a desired result other than being a possible frequency.
Sandrin et al teach that it is well-known in the art to provide analogous device comprising a real-time readout of about 3 Hz – “the method according to the invention further includes a step of displaying in real time the real time positioning indicator; the refresh rate of the display is for example greater than or equal to 5 Hz” (0052).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Gregersen et al in combination with Sarvazyan such that it includes a real-time readout of the pressure data and the diameter data, wherein the real-time readout of the pressure data and the diameter data occurs at a frequency between 1.4 Hz and 3 Hz as suggested by Sandrin et al as an effective refresh rate for the display of said pressure data and diameter data.
Claims 16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Gregersen et al (US Pub No. 20080027358 – cited by applicant) in view of Sarvazyan (US Pat No. 7947001 – cited by applicant), further in view of Zhao et al, “Bowel stiffness associated with histopathologic scoring of stenosis in patients with Crohn's disease,” Acta Biomaterialia, August 2021 (cited by applicant).
Gregersen et al in combination with Sarvazyan disclose the method further using at least one of the pressure and the diameter data to determine a geometric variable or a biomechanical response variable that corresponds to a characteristic of the soft tissue (0034, 0041) but do not expressly disclose the report related to gut pathology or wherein the gut stiffness index positively correlates to one or more of: a level of gut fibrosis, severity of mucosa damage to the gut, or infiltration of immune cells.
Zhao et al teach that it is well-known in the art stiffness of the bowel is associated with gut pathology such as intestinal stenosis, which is considered a type of damage to the gut (see Abstract).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Gregersen et al in combination with Sarvazyan such that the report is related to gut pathology or wherein the gut stiffness index positively correlates to one or more of: a level of gut fibrosis, severity of mucosa damage to the gut, or infiltration of immune cells as suggested by Zhao et al because stiffness in the gut as taught by Gregersen et al (0009) is associated with such.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Huong Q NGUYEN whose telephone number is (571)272-8340. The examiner can normally be reached 10 am - 6 pm.
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/H.Q.N/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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