DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
118a in Fig. 1
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1-19 are objected to because of the following informalities:
Claim 1, line 2: “labor, without rupturing the amniotic sac, comprising” should be replaced with –labor without rupturing the amniotic sac, wherein the system comprises–;
Claims 2-5: “A system as in Claim” in the preamble should be replaced with –The system of claim–;
Claim 6, line 3: the comma before “having a proximal end” should be deleted;
Claim 6, line 5: “caried” should be replaced with –carried–;
Claims 7-19: “A catheter as in Claim” in the preamble should be replaced with –The catheter of claim–;
Claim 7, lines 1-2: “body, spaced proximally of the uttering balloon” should be replaced with “body, wherein the vaginal balloon is spaced proximally from the uterine balloon”;
Claim 9, line 1: “SpO2” should be replaced with –oxygen saturation (SpO2)–;
Claim 13, line 2: “the support” should be replaced with –the electronic component support–;
Claim 14, line 1: “PPG” should be replaced with –photoplethysmography (PPG)–; and
Claim 15, line 1: the comma in front of “for measuring” should be deleted.
Appropriate correction is required.
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:
“Pressure-sensing module” in claim 20 because it uses a generic placeholder (module) that is coupled with functional language (pressure-sensing) without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
“Pressure-sensing module” is being interpreted to the an enclosure having a first chamber in fluid communication with the conduit, the first chamber including a pressure-sensing membrane in communication with a sensor, as indicated in ¶ [0100] of the published application, and equivalents thereof.
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 § 112
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 35 U.S.C. 112 (pre-AIA ), 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.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “the amniotic sac” in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the recitation will be interpreted to be “an amniotic sac”.
Claim 1 recites “the catheter including: a distal end…; a uterine balloon…; a uterine balloon inflation port…; a uterine balloon sensing port…; a uterine balloon pressure sensor…” in lines 3-10. Due to the formatting (i.e., the lack of further indents that indicate what is included in the catheter), it is unclear whether the catheter also includes the uterine balloon, uterine balloon inflation port, uterine balloon sensing port, and uterine balloon pressure sensor are parts of the catheter. If the catheter includes all of the above elements, (A) each of the elements should be further indented and (B) “A system” in line 1 should be replaced with “An apparatus”. If only “a distal end” is a part of the catheter, the Examiner suggests deleting the colon after “including” in line 3 and deleting the line break between lines 3 and 4.
Claim 1 recites “a uterine balloon situated substantially at the distal end” in line 5. The term “substantially at the distal end” is a relative term which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In this case, it is unclear when something starts/stops being considered to be “substantially at the distal end”. Claim 20 recites a similar limitation, so it is rejected on similar grounds.
Claim 1 recites “the distal end of the catheter adapted to be placed at least partially inside a lower segment of a uterus of the patient” in lines 5-6. Claim 1 also recites “a distal end adapted to be placed at least partially inside a cervix of a patient” in line 4. Due the variations in terminology, it is unclear if these recitations of the distal end are the same as, related to, or different from each other. For the purposes of examination, the recitation in lines 5-6 will be interpreted to be “the distal end of the catheter, wherein the uterine balloon is adapted to be placed at least partially inside a lower segment of a uterine cavity of the patient”. Claim 20 recites a similar limitation, so it is rejected on similar grounds.
Claim 1 recites “the proximal end” in line 7. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the recitation will be interpreted to be “a proximal end”.
Claims 2-5 are rejected by virtue of their dependence from claim 1.
Claim 6 recites “An integrated pressure and fetal heart rate monitoring cervical ripening catheter” in line 1. However, it is unclear how the pressure monitoring, the fetal heart rate monitoring, and/or the cervical ripening is performed by the catheter because there are no components or configurations for performing the limitations. For the purposes of examination, the recitations of “pressure and fetal heart rate monitoring cervical ripening” will not be given patentable weight.
Claim 6 recites “at least one working channel extending therethrough” in lines 3-4. However, due to the grammatical structure of the claim, it is unclear what “therethrough” refers to. For the purposes of examination, the working channel will be interpreted to extend through the catheter.
Claim 6 recites “and having at least one emitter and at least one sensor” in lines 6-7. Due to the grammatical structure, it is unclear what the limitation modifies. For the purposes of examination, the recitation will be interpreted to be “wherein the electronic component support has at least one emitter and at least one sensor”.
Claims 7-20 are rejected by virtue of their dependence from claim 6.
Claim 8 recites “comprising a first and second LED, and a photodetector” in line 1. Claim 6 recites “at least one emitter and at least one sensor in line 7. It is unclear how these elements are related to each other. The specification suggests that they are the same. For example, ¶ [0049] teaches a PPG which uses LED light sources and a photodetector while ¶ [0151] teaches a PPG catheter including at least one LED emitter. However, the claim language suggests that they are not the same. The Examiner suggests amending the recitation to be “wherein the at least one emitter comprises a first and second LED and the at least one sensor comprises a photodetector”.
Claim 9 recites “configured to generate data convertible in SpO2”, claim 10 recites “configured to generate data convertible into fetal heart rate”, and claim 11 recites “configured to generate data convertible into pH”. However, it is unclear how a catheter alone is configured to generate data. The Examiner suggests amending the claim to include an element (e.g., a processor or control unit) configured to convert data from the sensor into the SpO2/fetal heart rate/pH.
Claim 14 recites “proximal to the uterine balloon” in line 2. However, due to the grammatical structure of the claim, it is unclear what this limitation modifies. For the purposes of examination, the limitation will be interpreted to be “wherein the maternal PPG sensor is proximal to the uterine balloon”.
Claim 18 recites “the pressure sensing balloon extends between a proximal end and a distal end” in line 2, but it is not clear what the ends are components of. For the purposes of examination, the recitation will be interpreted to be “the pressure sensing balloon comprising a proximal end and a distal end”.
Claim 18 recites “the distal end” in line 2. Claim 6 recites “a distal end” of the elongate, flexible tubular body in line 3, and claim 18 recites “a distal end” of a pressure sensing balloon. It is unclear which of the distal ends is being referred to by the limitation of “the distal end” in line 2 of claim 18. For the purposes of examination, the recitation in line 2 of claim 18 will be interpreted to be “the distal of the pressure sensing balloon”.
Claim 20 recites “fetal heart rate monitoring cervical ripening catheter” in line 1. However, it is unclear how the fetal heart rate monitoring and the cervical ripening is performed by the catheter because there are no components or configurations for performing the limitations. For the purposes of examination, the recitation of “and fetal heart rate monitoring cervical ripening” will not be given patentable weight.
Claim 20, lines 15-17 recites “wherein the sensing port is configured to attach to a pressure-sensing module located extracorporeally from the patient a pressure sensor in fluid communication with the inflation port and in pressure sensing communication with the uterine balloon”, which is indefinite. Due to the grammatical structure, it is unclear how the pressure sensor is related to the pressure-sensing module. For the purposes of examination, the recitation of “a pressure sensor in fluid communication with the inflation port and in pressure sensing communication with the uterine balloon” will not be given patentable weight.
Claim 20 recites “the inflation port” in line 17. There is insufficient antecedent basis for this limitation in the claim because claim 20 does not previously recite an inflation port.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0310707 A1 (Ghodsian) (cited by Applicant).
With regards to claim 1, to the extent that it can be argued that all features taught by Ghodsian are not provided in a single embodiment, Ghodsian discloses a variety of alternative and additional embodiments that are provided in a variety of combinations so that the benefits of these various features can be utilized. It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the various features in the alternative and additional embodiments so as to derive the benefits of these features, as suggested by Ghodsian. See at least ¶¶ [0049]-[0053] of the Ghodsian.
The above combination of Ghodsian teaches or suggests a system for monitoring and measuring a change in intrauterine pressure during labor without rupturing the amniotic sac (Fig. 2 depicts an inflatable system 200; ¶ [0030] and Fig. 4 depict intrauterine pressure measurement without rupturing the amniotic sac), comprising: a catheter configured for manipulation by an operator (Fig. 2 depicts a catheter 210), the catheter including: a distal end adapted to be placed at least partially inside a cervix of a patient (Fig. 2 depicts a distal end 230, wherein at least a portion of the distal end is placed inside a cervix; Fig. 4 depicts a distal end of a catheter in the cervix); a uterine balloon situated substantially at the distal end of the catheter adapted to be placed at least partially inside a lower segment of a uterus of the patient (Fig. 2 and ¶ [0020] depict a uterine balloon 240; Fig. 4 depicts a uterine balloon 420 at least partially inside a lower segment of a uterus); a uterine balloon inflation port situated at the proximal end of the catheter (Fig. 2 and ¶ [0036] discloses a connection port 280 influid communication with uterine ballon 240 that may be connected to a pressure gauge 290 and a fluid pump 270); a uterine balloon sensing port situated at the proximal end of the catheter (¶ [0036] discloses that connection port 280 to uterine balloon 240 may even have a separate dedicated port for connecting to sensors and gauges); a uterine balloon pressure sensor in fluid communication with the inflation port and in pressure sensing communication with the uterine balloon (Fig. 2 and ¶ [0036] depict a pressure gauge 290 in fluid communication with the connection port 280 and in pressure sensing communication with the uterine balloon 240).
With regards to claim 2, Ghodsian further teaches or suggests a fetal heart rate sensor (¶ [0040] disclose that device 236 may be a fetal heart-beat sensor, which is capable of being used for fetal heart rate sensing).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0310707 A1 (Ghodsian) (cited by Applicant), as applied to claim 1 above, and in view of US 2018/0344250 A1 (McKinney) (Cited by Applicant).
With regards to claim 3, Ghodsian is silent with regards to comprising an oxygen saturation sensor. However, Ghodsian teaches that various sensors and other instruments may be used along with or as a part of the inflatable system to monitor cervical dilation, fetal well-being, and the woman's conditions (¶ [0020]).
In a device related to the problem of monitoring fetal and maternal parameters, McKinney discloses that catheters can include a pulse oximetry sensor for measuring oxygen saturation (¶ [0142]) along with uterine pressure (¶ [0066]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter of Ghodsian to incorporate a pulse oximetry sensor as taught by McKinney. The motivation would have been to provide a better diagnostic analysis of maternal or fetal parameters.
Claims 4-5 rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0310707 A1 (Ghodsian) (cited by Applicant), as applied to claim 1 above, and in view of US 2008/0139897 A1 (Ainsworth).
With regards to claim 4, the above combination is silent with regards to whether the catheter comprises an extruded catheter shaft.
In the same field of endeavor of balloon catheters, Ainsworth teaches a catheter comprising an extruded catheter shaft (Fig. 2 and ¶ [0045] discloses a tubular inner member 12 that is co-extruded). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter of Ghodsian such that it comprises a co-extruded tubular inner member as taught by Ainsworth. The motivation would have been to provide the inner tubular member with an exterior that has better fusion capabilities with the balloon while also having an interior with differing properties.
With regards to claim 5, the above combination teaches or suggests that the catheter shaft comprises a coextrusion at least under the uterine balloon (see the above 103 analysis with regards to the modification of Ghodsian in view of Ainsworth; see Fig. 2 and ¶ [0045] of Ainsworth which depicts the co-extruded tubular inner member 12 under at least the balloon 15).
Claims 6-10, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0310707 A1 (Ghodsian) (cited by Applicant) in view of US 2016/0270707 A1 (Atlee) (cited by Applicant).
With regards to claim 6, Ghodsian discloses an integrated pressure and fetal heart rate monitoring cervical ripening catheter (Fig. 2 and ¶ [0022] disclose an inflatable system 200. The Examiner notes that the recitation of “pressure and fetal heart rate monitoring cervical ripening” is not being given patentable weight in view of the 112b indefiniteness rejection above), comprising: an elongate, flexible tubular body, having a proximal end, a distal end, and at least one working channel extending therethrough (Fig. 2 and ¶ [0023] depict a catheter 210 comprising a proximal end 220, a distal end 230; ¶¶ [0022], [0026] discloses at least one conduit/tube inside the catheter 210; ¶ [0035] disclose a plurality of ports which are connected to working channels that extend through the catheter); at least one uterine balloon carried by the tubular body (Fig. 2 and ¶ [0022] depict a uterine balloon 240).
Although Ghodsian teaches sensors on the distal end of the tubular body (¶¶ [0017], [0041]), Ghodsian is silent with regards to an electronic component support mounted on the distal end of the tubular, and having at least one emitter and at least one sensor.
In a system related to the problem of mounting sensors in relation to a tubular body, Atlee discloses an electronic component support mounted on the distal end of the tubular body (Fig. 4 and ¶ [0041] disclose a molded sleeve which encircles probe tubing and contains a multiplicity of sensor elements for measuring physiological parameters), and having at least one emitter and at least one sensor (Fig. 4 and ¶¶ [0041]-[0042] disclose the sensors including LED’s and at least one sensor). It would have been obvious for one of ordinary sill in the art before the effective filing date of the claimed invention to have modified the catheter of Ghodsian, based on the teachings of Atlee, to incorporate an electronic component support mounted on the distal end of the tubular, and having at least one emitter and at least one sensor. The motivation would have been to mount more sensing elements on the catheter, thereby allowing for a better diagnostic analysis of maternal or fetal parameters.
With regards to claim 7, the above combination teaches or suggests a vaginal balloon on the tubular body spaced proximally from the uterine balloon (Fig. 2 of Ghodsian depicts a vaginal balloon 260 spaced proximally from the uterine balloon 240).
With regards to claim 8, the above combination teaches or suggests a first and second LED, and a photodetector (Fig. 4 and ¶¶ [0042]-[0043] of Atlee disclose LED’s and a photodetector for pulse oximetry).
With regards to claim 9, the above combination teaches or suggest generating data convertible into SpO2 (Fig. 4 and ¶¶ [0042]-[0043] of Atlee disclose LED’s and a photodetector for pulse oximetry).
With regards to claim 10, the above combination teaches or suggests generating data convertible into fetal heart rate (¶ [0040] of Ghodsian discloses sensor for sensing fetal heart-beat).
With regards to claim 13, the above combination teaches or suggests that the working channel extends distally through the support (Fig. 4 and ¶ [0041] of Atlee disclose a molded sleeve which encircles probe tubing. The Examiner notes that the above combination of Ghodsian in view of Atlee results in the working channels of Ghodsian extending through the support of Atlee).
With regards to claim 15, the above combination teaches or suggests a pressure sensor for measuring pressure in the uterine balloon (¶ [0036] of Ghodsian discloses a pressure gauge 290 for monitoring pressure of the uterine balloon 240).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Ghodsian in view of Atlee, as applied to claim 6 above, and further in view of US 2008/0245371 A1 (Gruber) (Cited by Applicant).
With regards to claim 11, the above combination is silent with regards to a configuration for generating data convertible into pH.
In the same field of endeavor of analyzing the uterus, Gruber teaches that elongate shafts may carry pH sensors (¶ [0084] depicts functional elements mounted to shafts or other components of the device, wherein the functional elements include pH sensors). It would have been obvious for one of ordinary sill in the art before the effective filing date of the claimed invention to have modified the above combination of Ghodsian in view of Atlee to incorporate a pH sensor as taught by Gruber. The motivation would have been to provide better diagnostic analysis of maternal or fetal parameters.
With regards to claim 12, the above combination is silent with regards to comprising at least one ultrasound transducer carried by the electronic component support
In the same field of endeavor of analyzing the uterus, Gruber teaches that elongate shafts may carry at least one ultrasound transducer(¶ [0084] depicts functional elements mounted to shafts or other components of the device, wherein the functional elements include ultrasound crystals). It would have been obvious for one of ordinary sill in the art before the effective filing date of the claimed invention to have modified the electronic component support of the above combination of Ghodsian in view of Atlee to incorporate at least one ultrasound transducer sensor as taught by Gruber. The motivation would have been to provide better diagnostic analysis of maternal or fetal parameters.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Ghodsian in view of Atlee, as applied to claim 6 above, and further in view of McKinney
With regards to claim 14, the above combination is silent with regards to a maternal PPG sensor on the tubular body proximal to the uterine balloon.
In a device related to the problem of monitoring fetal and maternal parameters, McKinney discloses a pulse oximeter located either proximal or distal to the pressure balloon for monitoring oxygen saturation (¶ [0142] a pulse oximeter is a PPG sensor). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination of Ghodsian in view of Atlee, based on the teachings of McKinney to incorporate a maternal PPG sensor on the tubular body proximal to the uterine balloon. The motivation would have been to provide better diagnostic analysis of maternal or fetal parameters.
Claims 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Ghodsian in view of Atlee, as applied to claim 15 above, and further in view of McKinney
With regards to claim 16, the above combination is silent with regards to the pressure sensor comprising a pressure sensing balloon.
In the same field of endeavor of monitoring uterine pressure, McKinney discloses a pressure sensor comprising a pressure sensor balloon of measuring pressure in a uterine balloon (¶ [0100] and Fig. 15 discloses measuring pressures of an outer balloon 142 by using an inner balloon 143). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure sensing configuration of Ghodsian in view of Atlee with that of McKinney. Because both configurations are capable of being used for measuring pressure of a balloon, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
With regards to claim 17, the above combination teaches or suggests that the pressure sensing balloon is in pressure sensing communication with the uterine balloon (¶ [0100] of McKinney).
With regards to claim 18, the above combination teaches or suggests the pressure sensing balloon extends between a proximal end and a distal end (Fig. 15 of McKinney depicts inner balloon 143 having distal and proximal ends), and the distal end is distal to a proximal end of the uterine balloon (Fig. 15 of McKinney depicts the distal end of the inner balloon 143 being distal to the proximal end of outer balloon 142).
With regards to claim 19, the above combination teaches or suggests the pressure sensing balloon being carried by a tubular shaft (Fig. 15 of McKinney depicts the inner balloon 143 being carried by a tubular shaft).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Ghodsian in view of US 5,951,497 A (Wallace) (Cited by Applicant)
With regards to claim 20, to the extent that it can be argued that all features taught by Ghodsian are not provided in a single embodiment, Ghodsian discloses a variety of alternative and additional embodiments that are provided in a variety of combinations so that the benefits of these various features can be utilized. It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the various features in the alternative and additional embodiments so as to derive the benefits of these features, as suggested by Ghodsian. See at least ¶¶ [0049]-[0053] of the Ghodsian.
The above combination of Ghodsian teaches or suggests an integrated pressure and fetal heart rate monitoring cervical ripening catheter (Fig. 2 depicts an inflatable system 200; ¶ [0017] discloses balloons of the inflatable system are for ripening the cervix; ¶ [0036] discloses a pressure gauge for monitoring pressure), comprising: a catheter (Fig. 2 depicts a catheter 210) having a proximal end (Fig. 2 depicts a proximal end 220), a distal end (Fig. 2 depicts a distal end 230), and at least one working channel extending therethrough (Fig. 2 and ¶ [0039] depict at least one additional conduit/tube having at least one opening 235 to the uterus for inserting a device 236 into the uterus, wherein 236 may be operated as a plunger-like device having a handle at the proximal end 220), the distal end adapted to be placed at least partially inside a cervix of a patient (Fig. 2 depicts a distal end 230, wherein at least a portion of the distal end is configured to be placed inside a cervix; Fig. 4 depicts a distal end of a catheter in the cervix); a uterine balloon situated substantially at the distal end of the catheter adapted to be placed at least partially inside a lower segment of a uterus of the patient (Fig. 2 and ¶ [0020] depict a uterine balloon 240 at distal end 230; Fig. 4 depicts a uterine balloon 420 at least partially inside a lower segment of a uterus); a sensing port situated at the proximal end of the catheter in fluid communication with the uterine balloon (Fig. 2 and ¶ [0036] depict the conduit/tube connecting connection port 280 to uterine balloon 240 may even have a separate dedicated port for connecting to sensors and gauges); wherein the uterine balloon is configured to be filled by introducing a first fluid through an inflation port (Fig. 2 and ¶ [0036] depicts a fluid pump 270 introducing a fluid through a port 280); wherein the at least one working channel is configured to accommodate a sensing probe as the sensing probe is advanced through the distal end of the at least one working channel (Fig. 2 and ¶ [0039] depict at least one additional conduit/tube having at least one opening 235 to the uterus for inserting a device 236 into the uterus, wherein 236 may be operated as a plunger-like device having a handle at the proximal end 220; ¶ [0039] discloses withdrawing the device 236, which indicates that the device 236 is capable of being advanced through the conduit/tube; ¶ [0040] discloses device 236 may be a sensor); and a pressure sensor in fluid communication with the inflation port and in pressure sensing communication with the uterine balloon (¶ [0036] and Fig. 2 depict connection port in communication with pressure gauge 290).
Ghodsian is silent regarding whether the sensing port is configured to attach to a pressure-sensing module located extracorporeally from the patient
In light of the interpretation under 35 U.S.C. §112(f), “pressure-sensing module” is being interpreted to the an enclosure having a first chamber in fluid communication with the conduit, the first chamber including a pressure-sensing membrane in communication with a sensor, as indicated in ¶ [0100] of the published application, and equivalents thereof.
In a system relevant to the problem of monitoring pressure of a catheter lumen, Wallace teaches a sensing port configured to attach to a pressure-sensing module located extracorporeally from the patient (Figs. 5-6 and Col. 12, lines 3-67 depict a male connector 72 of the IUP catheter 10 connected to a female connector 98 of a coupling 96, wherein enclosure 100 is in fluid connection lumen 64 of tube 30, which is connected to balloon 42, the enclosure 100 including a pressure sensor 102 comprising deformable diaphragm 120 in communication with a pressure transducer). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the separate dedicated port for connecting to sensors and gauges of ¶ [0036] of Ghodsian to incorporate that it is configured to be attached to a pressure-sensing module located extracorporeally from the patient as taught by Wallace. Because a pressure sensor attached to a port connected to a pump (Fig. 2 of Ghodsian) and attached to a separate port (Figs. 5-6 of Wallace) are capable of determine pressure applied to a balloon (Col. 13, lines 50-62 of Wallace; ¶ [0036] of Ghodsian), it would have been the simple substitution of one known equivalent element for another to obtain predictable results. Additionally or alternatively, the motivation would have been to allow for the connection ports to accommodate different pressure sensors, thereby improving the ease of use of the device.
Conclusion
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/S.C.K./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791