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 .
Priority
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Examiner Notes
Claims filed on 10/30/2024 are not the most recent claims by date in the file wrapper. It appears the original claims were filed on 04/23/2025, dated after the aforementioned 10/30/2024 claim set. The claim set filed on 10/30/2024 including the amendments are hereinafter examined on the merits.
Abstract
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because “Described is an” in line 1 is a phrase which can be implied. Correction is required. See MPEP § 608.01(b).
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 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) 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):
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f), is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f), is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) except as otherwise indicated in an Office action. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) because the claim limitations use a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are:
The nonce term “pressure-sensitive element” that senses deformation is used in claim(s) 1, 3, 5, 6, 7, invokes 35 USC § 112(f).
The term, “signaling means” that generates an optical, acoustic and/or haptically perceptible signal, invoked 35 USC § 112(f). Upon review of the specification there does not appear to set forth a corresponding structure for the claimed, “signaling means”.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) they 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 these limitations interpreted under 35 U.S.C. 112(f) applicant may: (1) amend the claim limitations to avoid them being interpreted under 35 U.S.C. 112(f) (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f).
Please note that for the purposes of this examination the phrase “pressure-sensitive element” is being interpreted to include generic pressure sensor, or gel cushion or elastomer nipple as described in Paragraphs [¶0021-0022, ¶0028] in the specification as performing the claimed function, and equivalents thereof.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
As discussed above, the claim limitations below are interpreted under 35 U.S.C. 112 (f).
Claim 10, “signaling means”
In the specification, at least ¶0022 & ¶0034, mention the term. The drawings do not provide any further detail. However, one of ordinary skill in the art would not understand the specification, the drawing and the original claims to disclose any particular structure that achieves the disclosed functionality.
These limitations fail to comply with the written description requirement as the limitations are unbound functional imitations which cover all ways of performing the respective functions and inventor has not provided sufficient disclosure to show possession of such an invention. The limitations therefore fails to comply with the written description requirement. See MPEP 2181.II.A.
The dependent claims of the above rejected claims are rejected due to their dependency.
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 1-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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:
Lines 5-6, “when a pressure acting between the pressure-sensitive element and the object is exceeded”, renders the claim indefinite. It is unclear what constitutes as exceeding of a pressure act between the two elements. In view of the specification ¶0018 describes, ‘at least one pressure-sensitive element is attached to the probe head, which element undergoes deformation in response to mechanical contact with an object when a pressure acting between the pressure-sensitive element and the object is exceeded.’ It is unclear, if there are technical steps for determining if the pressure has been exceeded or if the claimed scope is directed to an intrinsic determination when the element undergoes deformation. Furthermore, it is unclear what is meant by a pressure acting between the pressure-sensitive element and the object is exceeded because the claim does not identify a reference value, threshold, or comparator relative to which the pressure is evaluated. Hence, for examination purposes, the Examiner assumes, deformation itself is the indicator that the pressure has been exceeded (i.e., a threshold defined by the physical material properties of the pressure-sensitive element rather than a specific numerical value). Appropriate correction is required.
Claim 4:
Line 2, “elastomeric condom-like covering”. It is unclear what constitutes as a “elastomeric condom-like covering”. For examination purposes, the Examiner assumes an elastomeric condom covering. Appropriate correction is required.
Claim 8:
Line 3, “the manner”. There is insufficient antecedent basis for this limitation in the claim, as required by MPEP 2173.05(e). Accordingly, proper antecedent basis is required. In addition, it is unclear what constitutes as “designed in the manner of a web-like” in the context of the claim. For examination purposes, the Examiner assumes a web. Appropriate correction is required.
Line 3, “web-like”. It is unclear what constitutes as “web-like”. For examination purposes, the Examiner assumes surface texture. Appropriate correction is required.
Claim 10:
The following claim limitations invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph:
Claim 10: the limitations of “signaling means”. For examination purposes, the Examiner assumes a central processing unit (CPU) as a “signaling means”.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
The dependent claims of the above rejected claims are rejected due to their dependency.
Claim Objections
The following claims are objected to because of the following informalities and should recite:
Claim 1, “An ultrasound system for carrying out rectal or vaginal examinations comprising:
an ultrasound rod probe a distal end;
[[an]] ultrasound transducer is integrated within the probe head,
wherein at least one pressure-sensitive element is attached to the probe head[[,]] an object [[is]] exceeds a desired threshold
Claim 4, “wherein an elastomeric condom-like covering is provided [[which]] enclose[[es]]ing at least the probe head.”
Claim 5, line 3, “the elastomeric condom covering
Claim 6: Line 3, “the elastomeric condom covering
Claim 7, “wherein the at least one pressure-sensitive element has an elastic-modulus (E-modulus) ing to a biological vessel wall.”
Claim 8, “wherein the elastomer nipple is designed in the manner of a web-like, flexible extension [[which]] project[[s]]ing distally beyond the probe head.”
Claim 9, “3 centimeters (cm)”.
Claim 10, “wherein the pressure sensor is connected to a signaling means arranged on the proximal side of the ultrasound rod probe, signaling means capable of generating an optical, acoustic and/or haptically perceptible signal.”
Appropriate correction is needed.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, & 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Egorov (US20200022674A1).
Claim 1: An arrangement with an ultrasound rod probe for carrying out rectal or vaginal examinations with a probe head rounded on the distal side, at least in which an ultrasound transducer is integrated, wherein at least one pressure-sensitive element is attached to the probe head, which is subject to deformation by mechanical contact with an object when a pressure acting between the pressure-sensitive element and the object is exceeded. (FIG. 1 – vaginal 104 examination. FIG. 3, the probe head is indeed rounded on the distal side. ¶0053, Claim 1, ¶0044-0049 – The cervix probe comprises a shaft and a head integrating an ultrasound transducer alongside a sensor array. The tactile sensor is a sensor capable of measuring pressure. ¶0012, ¶0018, ¶0044-0049, ¶0071-0073 – The tactile sensors are used to acquire stress (i.e., pressure) data during this mechanical deformation. Additionally, note; the probe head may be covered with an elastic medical grade silicone layer that undergoes reversible deformations to transmit the stress from the tissue to the tactile sensors located underneath it, ¶0033.)
Regarding the limitations of claim 1 “for carrying out rectal or vaginal examinations" directed to the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Therefore, as taught, the invention Johnson is capable of performing the functions as set forth by applicant. Also, see MPEP 2114.
Claim 2: Egorov discloses all the elements above in claim 1, Egorov discloses, wherein the at least one pressure-sensitive element is one of the following elements: pressure sensor, gel cushion, elastomer nipple. (¶0044-0049, ¶0052, ¶0060 – tactile sensors capable of measuring an applied force averaged per sensor area or pressure. The tractile sensors are configured to acquire stress data in the form of pressure data, (i.e., the tractile sensors constitute as a pressure sensor)).
Claim 3: Egorov discloses all the elements above in claim 1, Egorov discloses, wherein the at least one pressure-sensitive element is integrated in or on the probe head. (FIG. 2 – element 202, FIG. 3 – element 305.)
Claim 10: Egorov discloses all the elements above in claim 2, Egorov discloses, wherein the pressure sensor is connected to a signaling means arranged on the proximal side of the ultrasound rod probe, which is capable of generating an optical, acoustic and/or haptically perceptible signal. (¶¶0032, claim 9, -the tractile sensor and the ultrasound transducer are operably connected to an external unit and a data processor (i.e., which would be arranged on a proximal side of the ultrasound rod probe) since this data processor receives the stress and strain from its connection to the probe. The claim does not specify how the signaling means is arranged on the proximal side of the ultrasound rod probe. The claim does not specify any specify structural limitation that further defined “arranged on”. Accordingly, Egorov discloses the required claim limitation. The device software is configured to allow real-time observations of the applied stress levels. The display functions is an optically perceptible signal, see ¶0054-0055.)
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 4-6 & 8 are rejected under 35 U.S.C. 103 as being unpatentable over Egorov (US20200022674A1), as applied to claim 1 and claim 2, respectively, in further view of Poncy et al (US 4593699 A).
Claim 4: Egorov discloses all the elements above in claim 1, Egorov fails to disclose: wherein an elastomeric condom-like covering is provided which encloses at least the probe head.
However, Poncy in the context of sterile covers for intraoperative ultrasonic devices discloses, wherein an elastomeric condom-like covering is provided which encloses at least the probe head. (FIG. 1-5, [Col. 1 l.55-61], ‘The sterile cover includes a flexible sleeve which can cover at least a portion of a connecting cable and all but a distal end of a transducer probe, and a flexible sheath that fits over a portion of the sleeve and covers at least the distal end of the probe.’; [Col 4 l.51-56], ‘The tip 30 of the sheath is nipple shaped in order to receive the distal end 14 of the probe. The sheath should be flexible and sterilizable, and is preferably composed of an elastomer to provide the snug fit with the probe.’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the ultrasound rod probe of Egorov to include a elastomeric condom-like cover which encloses at least the probe head as taught by Poncy. The motivation to do this yield predictable results such as providing a flexible and sterilizable cover to prevent contamination, as suggested by Poncy [Col 3-4].
Claim 5: Modified Egorov discloses all the elements above in claim 4, Egorov discloses t wherein the at least one pressure-sensitive element is integrated in or on the probe head, (FIG. 2 – 202, FIG. 3 – 305)
Egorov fails to disclose: wherein the at least one pressure-sensitive element is integrated into the cover.
However, Poncy is relied upon above disclose, the elastomeric condom-like covering which encloses at least the probe head. (FIG. 1-5, [Col. 1 l.55-61], ‘The sterile cover includes a flexible sleeve which can cover at least a portion of a connecting cable and all but a distal end of a transducer probe, and a flexible sheath that fits over a portion of the sleeve and covers at least the distal end of the probe.’; [Col 4 l.51-56], ‘The tip 30 of the sheath is nipple shaped in order to receive the distal end 14 of the probe. The sheath should be flexible and sterilizable, and is preferably composed of an elastomer to provide the snug fit with the probe.’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the ultrasound rod probe of modified Egorov to include the elastomeric condom-like cover which encloses at least the probe head as taught by Poncy. The motivation to do this yield predictable results such as providing a flexible and sterilizable cover to prevent contamination, as suggested by Poncy [Col 3-4]. The modified combination would disclose wherein the at least one pressure-sensitive element is integrated into the cover.
Claim 6: Modified Egorov discloses all the elements above in claim 4, Egorov discloses: wherein the at least one pressure-sensitive element is arranged in or on the probe head (FIG. 2 – 202, FIG. 3 – 305)
Egorov fails to disclose: wherein the at least one pressure-sensitive element is arranged between the probe head and the coating.
However, Poncy is relied upon above disclose, the elastomeric condom-like covering which encloses at least the probe head. (FIG. 1-5, [Col. 1 l.55-61], ‘The sterile cover includes a flexible sleeve which can cover at least a portion of a connecting cable and all but a distal end of a transducer probe, and a flexible sheath that fits over a portion of the sleeve and covers at least the distal end of the probe.’; [Col 4 l.51-56], ‘The tip 30 of the sheath is nipple shaped in order to receive the distal end 14 of the probe. The sheath should be flexible and sterilizable, and is preferably composed of an elastomer to provide the snug fit with the probe.’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the ultrasound rod probe of modified Egorov to include the elastomeric condom-like cover which encloses at least the probe head as taught by Poncy. The motivation to do this yield predictable results such as providing a flexible and sterilizable cover to prevent contamination, as suggested by Poncy [Col 3-4]. The modified combination would disclose wherein the at least one pressure-sensitive element is arranged between the probe head and the coating.
Claim 8: Egorov discloses all the elements above in claim 2, Egorov fails to disclose: wherein the elastomer nipple is designed in the manner of a web-like, flexible extension which projects distally beyond the probe head.
However, Poncy in the context of sterile covers for intraoperative ultrasonic devices discloses, elastomer nipple is designed in the manner of a web-like, flexible extension which projects distally beyond the probe head. (FIG. 1-5, [Col. 1 l.55-61], ‘The sterile cover includes a flexible sleeve which can cover at least a portion of a connecting cable and all but a distal end of a transducer probe, and a flexible sheath that fits over a portion of the sleeve and covers at least the distal end of the probe.’; [Col 4 l.51-56], ‘The tip 30 of the sheath is nipple shaped in order to receive the distal end 14 of the probe. The sheath should be flexible and sterilizable, and is preferably composed of an elastomer to provide the snug fit with the probe.’ -FIG. 3-4 depicts a textured surface of the elastomer nipple which projects distally beyond the probe head)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the device of Egorov to include an elastomer nipple designed in the manner of a web-like, flexible extension which projects distally beyond the probe head as taught by Poncy. The motivation to do this yield predictable results such as providing a flexible and sterilizable cover to prevent contamination, as suggested by Poncy [Col 3-4].
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Egorov (US20200022674A1) in view of Poncy et al (US 4593699 A), as applied to claim 8, in further view of Stolk (US 5088178 A).
Claim 9: Egorov discloses all the elements above in claim 8, Egorov fails to disclose: wherein the elastomer nipple has a rounded distal end and a length of up to 3 cm projecting distally beyond the probe head.
However, Poncy is relied upon above disclose, elastomer nipple has a rounded distal end and a length projecting distally beyond the probe head. (FIG. 1-5, [Col. 1 l.55-61], ‘The sterile cover includes a flexible sleeve which can cover at least a portion of a connecting cable and all but a distal end of a transducer probe, and a flexible sheath that fits over a portion of the sleeve and covers at least the distal end of the probe.’; [Col 4 l.51-56], ‘The tip 30 of the sheath is nipple shaped in order to receive the distal end 14 of the probe. The sheath should be flexible and sterilizable, and is preferably composed of an elastomer to provide the snug fit with the probe.’ -FIG. 3-4 depicts a textured surface of the elastomer nipple which projects distally beyond the probe head)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the elastomer nipple of modified Egorov such that it has a rounded distal end and a length projecting distally beyond the probe head as taught by Poncy. The motivation to do this yield predictable results such as providing a flexible and sterilizable cover to prevent contamination, as suggested by Poncy [Col 3-4].
Egorov in view of Poncy fail to disclose the length of up to 3.5 cm.
However, Stolk in the context of ultrasonic endoscope discloses, a distal tip of an ultrasound probe of up to 35 mm (i.e., 3.5 cm), FIG. 1.
Therefore, it would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the size of the distal tip of the ultrasound probe of modified Egorov to be 3.5 cm as taught by Stolk. The motivation to do this yield predictable results such as provide a suitable dimension for a distal ultrasound probe tip. The modified combination would disclose elastomer nipple has a rounded distal end and a length of up to 3.5 cm projecting distally beyond the probe head.
In regards to the feature of, “of up to 3 cm”, such a feature is consider a design choice based on
following consideration.
The device of modified Egorov discloses, the elastomer nipple has a rounded distal end and a length of up to 3.5 cm projecting distally beyond the probe head. It appears the device of modified Egorov would operate equally well such that the size of the length is up to 3 cm because it has been held that “In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955) (Claims directed to a lumber package "of appreciable size and weight requiring handling by a lift truck" were held unpatentable over prior art lumber packages which could be lifted by hand because limitations relating to the size of the package were not sufficient to patentably distinguish over the prior art.); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) ("mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability in a claim to an old process so scaled." 531 F.2d at 1053, 189 USPQ at 148.). In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.”, see MPEP 2144.04 – A. Changes in Size/Proportion. Further, the applicant places no criticality on the claimed feature. One of ordinary skill in the art would be able to obtain such a configuration through routine experimentation.
Claims 7 is rejected under 35 U.S.C. 103 as being unpatentable over Egorov (US20200022674A1), as applied to claim 1, in further view of Chong et al (Vascular Pressure-Flow Measurement Using CB-PDMS Flexible Strain Sensor. IEEE Trans Biomed Circuits Syst. 2019 Dec;13).
Claim 7: Egorov discloses all the elements above in claim 1, Egorov fails to disclose: wherein the at least one pressure sensitive element has an E-modulus which is smaller than an E-modulus which corresponds to a biological vessel wall.
However, Chong in the context of pressure sensors in the body discloses, wherein the at least one pressure sensitive element has an E-modulus which is smaller than an E-modulus which corresponds to a biological vessel wall. ([Abstract/pg. 1], ‘we have developed a new type of thin, flexible pulsation sensor (FPS) which is wrapped around a graft to monitor blood pressure and flow. The FPS uses carbon black (CB) nanoparticles dispersed in polydimethylsiloxane (PDMS) as a piezoresistive sensor layer, which was encapsulated within structural PDMS layers and connected to stainless steel interconnect leads. Because the FPS is more flexible than natural arteries, veins, and synthetic vascular grafts, it can be wrapped around target conduits at the time of surgery and remain implanted for long-term monitoring.’; [Conclusion/pg 12], ‘Because CB-PDMS composites have large strain ranges and elastic moduli lower than natural blood vessels’, see page 4 – regarding the sensors measurement under mechanical deformation to accurately and indirectly measure the pressure inside the vessel. Hence the FPS sensor is indeed a pressure sensitive element.)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the at least one pressure sensitive element of Egorov such that it has an E-modulus which is smaller than an E-modulus which corresponds to a biological vessel wall as taught by Chong for the advantage of providing an improved apparatus being able to remain implanted without constriction of the vessel during surgery, as suggested by Chong, pg. 3.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicholas Robinson whose telephone number is (571)272-9019. The examiner can normally be reached M-F 9:00AM-5:00PM EST.
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/N.A.R./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798