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 Objections
Claim 17 is objected to because of the following informalities:
Claim 17, line 2: in “a sensor device”, the recitation of “sensor” 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:
“Sensing element” in claim 1 because it uses a generic placeholder (i.e., “element”) that is coupled with functional language (i.e., “sensing”) without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
The element is being interpreted to correspond to element 106 as depicted in Fig. 1B 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 3-5, 14, and 17-20 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.
The terms “about” in claims 3-5 and 19 and “substantially” in claim 17 are relative terms which render the claims indefinite. The terms are not defined by the claims, the specification does not provide a standard for ascertaining the requisite degrees, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Paragraph [0051] of the published application indicates that “in any disclosed embodiment, the terms ‘substantially,’ ‘approximately,’ and ‘about’ may be substituted with ‘within [a percentage] of’ what is specified, where the percentage includes 0.1, 1, 5, and 10 percent.” However, the recitation does not clearly provide a standard for ascertaining what the percentage is. Specifically, the inclusion of 0.1, 1, 5, and 10 percents is not a clear indication of what the percentage should be, and one of ordinary skill would not be reasonably apprised of what percentage should be used. The Examiner suggests deleting the terms.
Claim 14 recites “at least two legs that… are configured to allow free movement of the sensor head relative to the sensor body” in lines 1-3, which is unclear in light of the specification. The claim language indicates that the legs allow unconstrained movement of the sensor head. Fig. 1B of the specification depicts legs 110a, 110b which engage with a cavity of a sensor base 102. However, the legs 110a, 110b of Fig. 1B prevent movement in rotational and lateral directions. Therefore, it is unclear whether the at least two legs are configured to allow free (i.e., unconstrained) movement of the sensor head relative to the sensor head or not. For the purposes of examination, the recitation will be interpreted to be “at least two legs that… are configured to allow movement of the sensor head relative to the sensor body and along a longitudinal axis of the sensor body”.
Claim 17 recites “tissue” in line 1 and “a target tissue” in line 3. Additionally, claim 17 recites “a reaction force” in lines 1 and 6. It is unclear whether the respective recitations are the same as, related to, or different from each other. If they are the same, consistent terminology should be used. If they are different or related, the relationship between the two should be made clear. For the purposes of examination, (A) the recitation of “tissue” in line 1 will be interpreted to be “a target tissue”, (B) the recitation of “a target tissue” in line 3 will be interpreted to be “the target tissue”, and (C) the recitation of “a reaction force” in line 6 will be interpreted to be “the reaction force”.
Claim 20 recites “the precision of the sensor is greater than 87%” in line 1. There is insufficient antecedent basis for this limitation in the claim because the claim does not previously recite a precision. Additionally, the precision does not appear to be single inherent component of the device. Paragraph [0097] of the published application discloses the sensor having a plurality of precisions, which makes would make it unclear which of the plurality of precisions is being referred. For the purposes of examination, the recitation will be interpreted to be “a precision of the sensor is at least 87%”.
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, 3, and 7-18 are rejected under 35 U.S.C. 103 as being unpatentable over 2021/0267456 A1 (Shiakolas) (cited by Applicant) in view of US 2010/0024574 A1 (Werthschutzky).
With regards to claim 1, Shiakolas teaches a device for tissue evaluation (¶ [0020] discloses a device comprising a manipulator having a force sensor that can be pressed against tissues within the bladder to measure a reaction force of the tissues for purposes of assessing the health of the bladder), the device comprising:
a sensor housing (Figs. 1-2 and 8 depict a sensor 14; Fig. 8 and ¶ [0027] depict a housing comprising a sensor head 90, beam clamp 88, and sensor body 84) comprising:
a sensor head configured to engage with a target tissue (Fig. 8 and ¶¶ [0027]-[0029] depict a sensor head 90 configured to be in direct contact with any desired tissue within the bladder), and
a sensor body (Fig. 8 and ¶¶ [0027]-[0028] depict a body 84); and
a sensing element disposed within the sensor housing (Fig. 8 and ¶¶ [0027]-[0029] depict a beam 86 including one or more strain gauges disposed within the cavity 96 of the body 84), wherein the device is configured to measure a reaction force of the target tissue when the sensor head is pressed against the target tissue (¶ [0029] discloses calculating the reaction force of the tissue).
Shiakolas is silent regarding whether the reaction force of the target tissue is measured as a function of time.
In the same field of endeavor of in vivo force detection (¶ [0010] of Werthschutzky discloses detection of a force in an elongated medical device such as a catheter), Werthschutzky teaches a force is measured as a function of time (¶ [0053] discloses the detection of the force vector thereby becomes time-discrete and an adaptation of the overall system comprising sensor, power and signal lines and electronic unit has to be adapted to the required frequency resolution of the application in order to ensure a quasi-continuous representation of the force vector; also see Fig. 7). 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 measurement of the reaction force of Shiakolas to incorporate that it is measured as a function of time as taught by Werthschutzky. The motivation would have been to provide a quasi-continuous representation of the force vector (¶ [0053] of Werthschutzky), and/or to provide a more complete diagnostic analysis of the patient.
With regards to claim 3, Shiakolas further teaches the sensor housing has an outer diameter of less than or equal to about 3.5 mm (¶ [0022] depicts the device 10 being passed through a guide tube that has an outer diameter no greater than 3.5 mm, which indicates that the sensor housing must have an outer diameter less than 3.5 mm).
With regards to claim 7, Shiakolas further teaches the sensor head has a hemispherical surface for engaging with the target tissue (Fig. 8 depicts the sensor head 90 having a hemispherical surface).
With regards to claim 8, Shiakolas further teaches a strain gauge in operable communication with the sensing element (¶ [0028] discloses the beam includes one or more strain gauges that are fixedly attached to the beam 86).
With regards to claim 9, the above combination is silent regarding whether the sensing element has a first end and a second end, wherein the first end is curved.
In the same field of endeavor of in vivo force detection (¶ [0010] of Werthschutzky discloses detection of a force in an elongated medical device such as a catheter), Werthschutzky teaches a sensing element has a first end and a second end, wherein the first end is curved (Fig. 3 depicts a base body 101 having a top end and a bottom end, wherein the top end has a curved cutout). 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 sensing element of the above combination to incorporate that the sensing element has a first end and a second end, wherein the first end is curved as taught by Werthschutzky. Because both sensing elements are capable of being used for detecting forces (¶ [0037] of Werthschutzky; ¶¶ [0027]-[0029] of Shiakolas), it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
With regards to claim 10, the above combination teaches or suggests the sensor head comprises a load transmitter configured to engage with the sensing element (¶ [0028] and Fig. 8 of Shiakolas discloses a protrusion 100 configured to engage the beam 86).
With regards to claim 11, the above combination teaches or suggests the load transmitter is configured to contact the top end of the sensing element (Fig. 8 of Shiakolas depicts a protrusion 100 being located to engage with the top side of the beam 86).
The above combination is silent regarding whether the load transmitter is configured to contact the first end.
In the same field of endeavor of in vivo force detection (¶ [0010] of Werthschutzky discloses detection of a force in an elongated medical device such as a catheter), Werthschutzky teaches that the first end of the sensing element is configured to receive forces and contact with load transmitters (¶ [0037] and Fig. 3 depicts forces Fz can be introduced via the end face 104). 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, based on the teachings of Werthschutzky, to incorporate that the load transmitter is configured to contact the first end. The motivation would have been to allow for the determination of compressive forces, thereby providing a more complete diagnostic analysis.
With regards to claim 12, Shiakolas further teaches the sensing element is fixedly attached to the sensor body (¶ [0027] discloses the beam clamp 88 is configured to securely clamp the ends of the beam 86 to the ledges 98 so that the beam cannot shift during use of the device 10).
With regards to claim 13, the above combination teaches or suggests the sensor head flexes the sensing element when the sensor head receives an applied force from the target tissue (¶ [0028] depicts the protrusion 100 causes deformation of the beam; ¶ [0037] of Werthschutzky depicts flexure of the base body 101 caused by the force Fz ).
With regards to claim 14, Shiakolas further teaches the sensor head comprises at least two legs that engage with an inside guideway cavity of the sensor body and are configured to allow free movement of the sensor head relative to the sensor body (Fig. 8 and ¶ [0028] depict two tangs 106 that extend through 88 and 84 via passages and allow movement of the head 90 along a longitudinal axis of the sensor 14).
With regards to claim 15, Shiakolas further teaches the device further comprises a biocompatible protective sheath or covering (¶ [0022] depict tube 16 and the links 18-22 are generally cylindrical and are made of a suitable rigid, biocompatible material, such as stainless steel or a suitable polymer material).
With regards to claim 16, Shiakolas further teaches the sensing element generates a signal corresponding to the reaction force of the target tissue (¶ [0029] discloses the strain within the beam 86 can be measured by the one or more sensor elements, which provide data (e.g., strain data) that can be used to calculate the reaction force of the tissue).
With regards to claim 17, the above combination teaches or suggests a method for measuring a reaction force of tissue (¶ [0029] of Shiakolas teaches a method for using the device 10), the method comprising: inserting a sensor device according to claim 1 into a body such that the sensor head is substantially perpendicular to and in contact with a target tissue (¶ [0029] of Shiakolas discloses inserting the device 10 through the urethra into the bladder, wherein the head 90 can be controllably pressed against the tissue, preferably while in an orientation perpendicular to the tissue); receiving an applied force from the target tissue against the sensor head (¶ [0029] of Shiakolas discloses the head 90 can be controllably pressed against the tissue, preferably while in an orientation perpendicular to the tissue, and the reaction force of the tissue can be determined); causing the sensing element to deform in response to a displacement of the sensor head (¶ [0029] of Shiakolas teaches that when the head 90 is pressed against the tissue, the head is urged inward against the beam 86 so as to deform it, wherein the strain within the beam 86 can be measured by the one or more sensor elements, which provide data (e.g., strain data) that can be used to calculate the reaction force of the tissue); and generating one or more signals corresponding to a reaction force of the target tissue (¶ [0029] of Shiakolas discloses generation of strain data).
With regards to claim 18, the above combination teaches or suggests the one or more signals are generated by a strain gauge attached to the sensing element (¶ [0029] of Shiakolas one or more sensor elements provide data (e.g., strain data); ¶ [0028] of Shiakolas teaches the sensing elements are one or more strain gauges).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over 2021/0267456 A1 (Shiakolas) (cited by Applicant) in view of US 2010/0024574 A1 (Werthschutzky), as applied to claim 1 above, and further in view of US 2017/0196478 A1 (Hunter).
With regards to claim 2, Shiakolas is silent regarding whether at least one of the sensor head and the sensor body are fabricated by an additive manufacturing process.
In a system relevant to the problem of manufacturing medical devices, Hunter teaches at least one of the sensor and a sensor support are fabricated by an additive manufacturing process (¶ [0136] of Hunter teaches at least one of a sensor and a support for the sensor using a 3D printing techniques, wherein the 3D printing technique may be an additive manufacturing technique). 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, based on the teachings of Shiakolas, to incorporate that at least one of the sensor and a sensor support are fabricated by an additive manufacturing process. The motivation would have been to improve the ease of manufacturing the sensor device.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over 2021/0267456 A1 (Shiakolas) (cited by Applicant) in view of US 2010/0024574 A1 (Werthschutzky), as applied to claim 1 above, and further in view of US 2016/0310006 A1 (Aguero Villarreal)
With regards to claim 4, the above combination is silent regarding whether the device is configured to operate under an applied force of up to about 1.2 N.
In the same field of endeavor of monitoring tissue using force sensors, Aguero Villarreal teaches a device configured to operate under an applied force of up to about 1.2 N (¶ [0060] discloses a sensor for measuring forces including 1.2 N). The ability to operate under specific applied forces would depend up the factors of the desired sensitivity of the device. As such, the ability to operate under specific applied forces is a results-effective variable that would have been optimized through routine experimentation based on the desired sensitivity. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to select the ability to operate under specific applied forces, using the teachings of Aguero Villarreal as a starting point, so as to obtain the desired sensitivity. In view of the above, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the device of the above combination to incorporate that it is configured to operate under an applied force of up to about 1.2 N. See MPEP 2144.05 (II) (A).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over 2021/0267456 A1 (Shiakolas) (cited by Applicant) in view of US 2010/0024574 A1 (Werthschutzky), as applied to claim 1 above, and further in view of US 2016/0184041 A1 (Gafford).
With regards to claim 5, the above combination is silent regarding whether the device has a resolution of about 20 mN.
In a system relevant to the problem of detecting loads accurately, Gafford teaches a device has a resolution of about 20 mN (¶¶ [0157], [0180] depict a force resolution of 20 mN). The resolution would depend up the factors of the desired sensitivity of the device. As such, the resolution is a results-effective variable that would have been optimized through routine experimentation based on the desired sensitivity. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to select the resolution, using the teachings of Gafford as a starting point, so as to obtain the desired sensitivity. In view of the above, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the device of the above combination to incorporate that it has a resolution of about 20 mN. See MPEP 2144.05 (II) (A).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over 2021/0267456 A1 (Shiakolas) (cited by Applicant) in view of US 2010/0024574 A1 (Werthschutzky), as applied to claim 1 above, and further in view of US 2017/0363487 A1 (Kuribayashi).
With regards to claim 6, the above combination is silent regarding whether the device has a safety factor of at least 3.5.
In a system relevant to the problem of detecting loads, Kuribayashi teaches a device has a safety factor of at least 3.5 (¶ [0004] discloses a material for strain detection having a safety factor of 5). The safety factor would depend up the factors of the desired safety and operational parameters of the device. As such, the safety factor is a results-effective variable that would have been optimized through routine experimentation based on the desired safety and operational parameters of the device. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to select the safety factor, using the teachings of Kuribayashi as a starting point, so as to obtain the desired safety and operational parameters of the device. In view of the above, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the device of the above combination to incorporate that it has a safety factor of at least 3.5. See MPEP 2144.05 (II) (A).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over 2021/0267456 A1 (Shiakolas) (cited by Applicant) in view of US 2010/0024574 A1 (Werthschutzky), as applied to claim 17 above, and further in view of US 2014/0206953 A1 (Valdastri).
With regards to claim 19, the above combination is silent regarding whether the maximum accuracy error level of the sensor is about 3%.
In a system relevant to the problem of detecting loads, Valdastri teaches maximum accuracy error level of the sensor is about 3% (¶ [0052] discloses a maximum relative error below 3%). The maximum accuracy error level would depend up the factors of the desired accuracy of the device. As such, the maximum accuracy error level is a results-effective variable that would have been optimized through routine experimentation based on the desired accuracy of the device. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to select the maximum accuracy error level, using the teachings of Valdastri as a starting point, so as to obtain the desired accuracy of the device. In view of the above, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the device of the above combination to incorporate that it has a maximum accuracy error level of about 3%. See MPEP 2144.05 (II) (A).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over 2021/0267456 A1 (Shiakolas) (cited by Applicant) in view of US 2010/0024574 A1 (Werthschutzky), as applied to claim 17 above, and further in view of CN 102066928 A (Shih) (paragraph references are made with regards to the attached translation).
With regards to claim 20, the above combination is silent regarding whether the precision of the sensor is greater than 87%.
In a system relevant to the problem of detecting loads, Shih teaches a precision of greater than 87% (¶¶ [0211], [0215], [0218] disclose precisions of 93%). The precision would depend up the factors of the desired accuracy of the device. As such, the precision is a results-effective variable that would have been optimized through routine experimentation based on the desired accuracy of the device. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to select the precision, using the teachings of Shih as a starting point, so as to obtain the desired accuracy of the device. In view of the above, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the device of the above combination to incorporate that the precision of the sensor is greater than 87%. See MPEP 2144.05 (II) (A).
Conclusion
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/S.C.K./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791