DETAILED ACTION
This Office action is responsive to communications filed on 06/02/2026. Claims 1-9 have been amended. Claim 10 is canceled. Claims 11-14 are newly added. Presently, Claims 1-9 and 11-14 remain pending and are hereinafter examined on the merits.
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 .
Response to Arguments
Priority Translation filed on 06/02/2026 is accepted
Previous objections to the Abstract are withdrawn in view of the amendments filed on 06/02/2026.
Previous claim objections are withdrawn in view of the amendments filed on 06/02/2026.
Previous interpretations under 35 USC § 112(f) for the term “signaling means” is withdrawn in view of the amendments filed on 06/02/2026.
Previous rejections under 35 USC § 112(a) are withdrawn in view of the amendments filed on 06/02/2026.
Previous rejections under 35 USC § 112(b) are withdrawn in view of the amendments filed on 06/02/2026.
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The new grounds of rejection now relies on: Egorov (US 20210015451 A1) in view of Law et al (US 5762066 A) in view of Ratner et al (US 20180206971 A1).
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, invokes 35 USC § 112(f).
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 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 11-14 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 11:
line 3, “convex distal end”. It is unclear if this is referring to the same distal end as stated in line 3 of claim 1. The relational link between the convex distal end to the “distal end” is missing rendering the phrase indefinite. For examination purposes, the Examiner assumes its the same distal end as interpreted in claim 1. Appropriate correction is required.
Claim 12:
line 11, “a distal end”. It is unclear if this distal end refers to or is separate from the “distal end” defined in line 3. For examination purposes, the Examiner assumes it’s the same distal end (i.e., the distal end). Consistent claim language is required when referring to the same term. Appropriate correction is required.
Claim 13:
line 2, “convex distal end”. It is unclear if this is referring to the same distal end as interpreted above or another distal end. The relational link between the convex distal end to the “distal end” is missing rendering the phrase indefinite. For examination purposes, the Examiner assumes its the same distal end as interpreted in claim 12. Appropriate correction is required.
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 1, 3, 7, & 11 are rejected under 35 U.S.C. 103 as being unpatentable over Egorov (US 20210015451 A1) in view of Law et al (US 5762066 A) in view of Ratner et al (US 20180206971 A1).
Claim 1: Egorov discloses, An ultrasound system for carrying out rectal or vaginal examinations comprising: (¶Abstract)
an ultrasound rod probe (104/200) with a probe head rounded on a distal end (¶0054-0055, ¶0062. There is “a” distal end that is rounded. See FIG. 1, 2, 3a, 4a, 5a. Under the broadest reasonable interpretation an elongate probe with a tapered, rounded front portion/tip designed for atraumatic insertion constitutes as an ultrasound probe with a probe head rounded on a distal end.);
an ultrasound transducer (201, ¶0056) integrated within the probe head, (¶0018, ¶0054, ¶0056, ¶0057-0060, See FIG. 2)
wherein at least one pressure-sensitive element is attached to the probe head (¶0062, ‘pressure sensors on the angled probe tip 304 and 306 may be used to create the tactile image 309. These sensors 304 and 307 may be configured to measure the tactile feedback from the vaginal walls for up to about 13 mm deformation per side from the vaginal canal 305.’ See FIG. 3a where 304, 306, 307 are physically attached to the probe head.) and configured to deform when a pressure acting between the at least one pressure-sensitive element and a biological vessel wall exceeds a pressure threshold, (The probe is designed to deform to the vaginal wall, ¶0062: “The vaginal probe 200 may be designed to deform the vaginal walls in an orthogonal direction and away from each other as shown by arrows 303 and 307 from the vaginal canal 305 during the vaginal probe insertion. The linear motion of the vaginal probe, in this case, may be translated into vaginal tissue deformation in a definitive manner, as only the pressure sensors on the angled probe tip 304 and 306 may be used to create the tactile image 309. These sensors 304 and 307 may be configured to measure the tactile feedback from the vaginal walls for up to about 13 mm deformation per side from the vaginal canal 305.” while the tactile sensors acquire tactical pressure images showing the deformation, ¶0008. ¶0063, during insertion, the operator advances the probe to follow the insertion angle that “offers/offering the least resistance” along the vaginal canal. The operator does this while observing the acquired tactile pressure images in real-time. The probe finds an equilibrium of opposing forces as it advances. This least resistance feedback constitutes as the operators indicator of a physical resistance threshold, allowing them to adjust the angle and safely advance the probe without exceeding safe pressure limits.)
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 Egorov is capable of performing the functions as set forth by applicant. Also, see MPEP 2114.
Egorov fails to disclose:
wherein as a result of deforming, the at least one pressure-sensitive element is configured to push the ultrasound rod probe away from the biological vessel wall, and
However, Law in the context of ultrasound transvaginal and/or transrectal probes discloses: wherein as a result of deforming, the at least one pressure-sensitive element is configured to push the ultrasound rod probe away from the biological vessel wall,
Law teaches a flexible elastic membrane sheath covering the distal end of the probe housing, (elastic membrane 8), [Col 3. l.35-39], ‘flexible elastic membrane sheath covers a distal end of the probe housing, extending over the open window’. Law teaches that the expansion (i.e., deformation) of the elastic membrane under fluid pressure is configured to “the pressure of the coupling fluid acts to expand membrane 8 primarily at window 92, to displace any tissue where protruding tissues would otherwise pose a risk.”, [Col. 16 l.21-23]. This means the deforming elastic element directly pushes the adjacent tissue (i.e., the object/the biological vessel wall) away from the probe’s window to protect the internal movement parts. Because the deforming elastic membrane pushes outward against the adjacent tissue to displace it, Newton’s third law dictates that the tissue exerts an opposite force back onto the membrane and the probe assembly. Physically, this reaction force acts to push the probe housing away from the tissue.
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 pressure-sensitive element of Egorov to incorporate the teachings of Law for the advantage of providing an improve system being able to displace tissue from the imaging window for the transducer to scan and rotate safely, as suggested by Law, [Col. 16 l.30-31].
Regarding the limitations of claim 1 “before mechanically induced damage occurs to the biological vessel wall" 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 modified Egorov is capable of performing the functions as set forth by applicant. Also, see MPEP 2114.
Egorov fails to disclose: wherein the at least one pressure-sensitive element has an elastic modulus (E-modulus) smaller than an E-modulus which corresponds to the biological vessel wall.
However, Ratner in the context of elastomer materials designed to go inside body discloses, an elastomer material that has an elastic modulus (E-modulus) smaller than an E-modulus which corresponds to the biological vessel wall. (¶0005, ‘graft comprising a compliant, elastomeric polymeric graft wall’, ¶0053, ‘As the material becomes more and more elastic, the Young's Modulus decreases. As shown in FIG. 4, materials with a range of Young's Modulus span from twice of that of the native artery to half of it can be obtained by varying the molar ratio of the soft segments to hard segments in the polyurethane polymer.’; Having a modulus that is half that native artery means its elastic modulus is smaller than that of the biological vessel wall. In addition, ¶0053, ‘if the vascular graft becomes more rigid after implantation, initial elasticity of the vascular graft can be fine-tuned, e.g., be more elastic than native blood vessels to compensate this change.’. Higher elasticity corresponds to lower Young Modulus, so the material has a smaller elastic modulus (E-modulus) than the biological vessel.)
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 material of the at least one pressure sensitive of modified Egorov to comprise the elastomer material of Ratner that has an elastic modulus (E-modulus) smaller than an E-modulus which corresponds to the biological vessel wall. The motivation to do this yield predictable results such as to prevent vessel damage as suggested by Ratner, ¶0003.
Claim 3: Modified 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. (See FIG. 1, 2, 3a, 4a, 5a.)
Claim 7: Modified Egorov discloses all the elements above in claim 1, Egorov discloses, wherein the biological vessel wall is an intestinal wall (¶0013, FIG. 1).
Claim 11: Modified Egorov discloses all the elements above in claim 1, Egorov discloses, wherein the distal end is configured to be inserted first into an orifice of a patient, and wherein the probe head comprises a convex distal end in a cross-sectional plane extending along a longitudinal axis of the ultrasound rod probe through a center of a surface of the distal end. (See FIG. 3a highlighted below)
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Claims 2, 4-6 & 8 are rejected under 35 U.S.C. 103 as being unpatentable over Egorov (US 20210015451 A1) in view of Law et al (US 5762066 A) in view of Ratner et al (US 20180206971 A1), as applied to claim 1, in further view of Poncy et al (US 4593699 A).
Claim 2: Modified Egorov discloses all the elements above in claim 1, Egorov discloses, wherein the at least one pressure-sensitive element (¶0062, ‘pressure sensors on the angled probe tip 304 and 306 may be used to create the tactile image 309. These sensors 304 and 307 may be configured to measure the tactile feedback from the vaginal walls for up to about 13 mm deformation per side from the vaginal canal 305.’ See FIG. 3a where 304, 306, 307 are physically attached to the probe head.) In addition Egorov discloses, 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.
Egorov fails to disclose that the at least one pressure-sensitive element comprises a gel cushion or an elastomer nipple.
However, Poncy in the context of sterile covers for intraoperative ultrasonic devices discloses, an ultrasound probe rode comprises an elastomer nipple. (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.’) Poncy teaches that tip of the ultrasound probe rod comprises “The sheath 18 is designed to fit snugly around the probe and preferably to extend a short distance behind the probe, to thus cover a portion of the cable, as best depicted in FIG. 5(b). It has a closed end and an open end, and the closed end is shaped to mate with the tapered shape 40 of the probe. 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.”. The probe itself is tapered shaped that mates with the sheath that it nipple shaped composed of an elastomer nipple, thereby defining a elastomer nipple.)
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 modified Egorov to comprise the elastomer nipple 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 of Poncey elastomer nipple with the pressure-sensitive element of modified Egorov would disclose the elastomer nipple.
Claim 4: Modified Egorov discloses all the elements above in claim 1, Egorov fails to disclose: wherein an elastomeric condom 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 enclosing 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 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 wherein the at least one pressure-sensitive element is integrated in or on the probe head, (See FIG. 1, 2, 3a, 4a, 5a.)
Egorov fails to disclose that the at least one pressure-sensitive element is integrated into the elastomeric condom covering.
However, Poncy is relied upon above disclose, the elastomeric condom 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 probe head that includes the at least pressure-sensitive element 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 elastomeric condom covering.
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 (See FIG. 1, 2, 3a, 4a, 5a.)
Egorov fails to disclose that the at least one pressure-sensitive element is arranged between the probe head and the elastomeric condom covering.
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 elastomeric condom covering.
Claim 8: Modified Egorov discloses all the elements above in claim 2, Egorov fails to disclose: wherein the elastomer nipple comprises a flexible extension projecting distally beyond the probe head.
However, Poncy in the context of sterile covers for intraoperative ultrasonic devices discloses, wherein the elastomer nipple comprises a flexible extension 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 to comprises a flexible extension 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].
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Egorov (US 20210015451 A1) in view of Law et al (US 5762066 A) in view of Ratner et al (US 20180206971 A1) in view of Poncy et al (US 4593699 A), as applied to claim 8, in further view of Stolk (US 5088178 A).
Claim 9: Modified 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 centimeters (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 centimeters (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 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Egorov (US 20210015451 A1) in view of Law et al (US 5762066 A) in view of Poncy et al (US 4593699 A).
Claim 12: Egorov discloses, An ultrasound system for carrying out rectal or vaginal examinations comprising: (¶Abstract)
an ultrasound rod probe (104/200) with a probe head rounded on a distal end (¶0054-0055, ¶0062. There is “a” distal end that is rounded. See FIG. 1, 2, 3a, 4a, 5a. Under the broadest reasonable interpretation an elongate probe with a tapered, rounded front portion/tip designed for atraumatic insertion constitutes as an ultrasound probe with a probe head rounded on a distal end.);
an ultrasound transducer (201, ¶0056) integrated within the probe head, (¶0018, ¶0054, ¶0056, ¶0057-0060, See FIG. 2)
wherein a pressure-sensitive element is attached to the probe head (¶0062, ‘pressure sensors on the angled probe tip 304 and 306 may be used to create the tactile image 309. These sensors 304 and 307 may be configured to measure the tactile feedback from the vaginal walls for up to about 13 mm deformation per side from the vaginal canal 305.’ See FIG. 3a where 304, 306, 307 are physically attached to the probe head.) and configured to deform when a pressure acting between the distal shaped element and an object exceeds a pressure threshold, (The probe is designed to deform to the vaginal wall, ¶0062: “The vaginal probe 200 may be designed to deform the vaginal walls in an orthogonal direction and away from each other as shown by arrows 303 and 307 from the vaginal canal 305 during the vaginal probe insertion. The linear motion of the vaginal probe, in this case, may be translated into vaginal tissue deformation in a definitive manner, as only the pressure sensors on the angled probe tip 304 and 306 may be used to create the tactile image 309. These sensors 304 and 307 may be configured to measure the tactile feedback from the vaginal walls for up to about 13 mm deformation per side from the vaginal canal 305.” while the tactile sensors acquire tactical pressure images showing the deformation, ¶0008. ¶0063, during insertion, the operator advances the probe to follow the insertion angle that “offers/offering the least resistance” along the vaginal canal. The operator does this while observing the acquired tactile pressure images in real-time. The probe finds an equilibrium of opposing forces as it advances. This least resistance feedback constitutes as the operators indicator of a physical resistance threshold, allowing them to adjust the angle and safely advance the probe without exceeding safe pressure limits.)
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 Egorov is capable of performing the functions as set forth by applicant. Also, see MPEP 2114.
Egorov fails to disclose:
wherein as a result of deforming, the pressure-sensitive element is configured to push the ultrasound rod probe away from the, and
However, Law in the context of ultrasound transvaginal and/or transrectal probes discloses: wherein as a result of deforming, the pressure-sensitive element is configured to push the ultrasound rod probe away from the object, and
Law teaches a flexible elastic membrane sheath covering the distal end of the probe housing, (elastic membrane 8), [Col 3. l.35-39], ‘flexible elastic membrane sheath covers a distal end of the probe housing, extending over the open window’. Law teaches that the expansion (i.e., deformation) of the elastic membrane under fluid pressure is configured to “the pressure of the coupling fluid acts to expand membrane 8 primarily at window 92, to displace any tissue where protruding tissues would otherwise pose a risk.”, [Col. 16 l.21-23]. This means the deforming elastic element directly pushes the adjacent tissue (i.e., the object/the biological vessel wall) away from the probe’s window to protect the internal movement parts. Because the deforming elastic membrane pushes outward against the adjacent tissue to displace it, Newton’s third law dictates that the tissue exerts an opposite force back onto the membrane and the probe assembly. Physically, this reaction force acts to push the probe housing away from the tissue.
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 pressure-sensitive element of Egorov to incorporate the teachings of Law for the advantage of providing an improve system being able to displace tissue from the imaging window for the transducer to scan and rotate safely, as suggested by Law, [Col. 16 l.30-31].
Regarding the limitations of claim 1 “before mechanically induced damage occurs to object" 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 modified Egorov is capable of performing the functions as set forth by applicant. Also, see MPEP 2114.
Egorov fails to disclose that the distal shaped element is an elastomer nipple & wherein elastomer nipple widens from a distal end of the elastomer nipple towards a proximal end of the elastomer nipple adjacent to the probe head.
However, Poncy in the context of sterile covers for intraoperative ultrasonic devices discloses, an elastomer nipple that widens from a distal end of the elastomer nipple towards a proximal end of the elastomer nipple adjacent to the probe head. (FIG. 1-5 – the elastomer nipple widens from a distal end of the elastomer nipple towards a proximal end of the elastomer nipple adjacent to the probe head, [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.’) Poncy teaches that tip of the ultrasound probe rod comprises “The sheath 18 is designed to fit snugly around the probe and preferably to extend a short distance behind the probe, to thus cover a portion of the cable, as best depicted in FIG. 5(b). It has a closed end and an open end, and the closed end is shaped to mate with the tapered shape 40 of the probe. 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.”. The probe itself is tapered shaped that mates with the sheath that it nipple shaped composed of an elastomer nipple, thereby defining a elastomer nipple.)
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 modified Egorov to comprise an elastomer nipple 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 of Poncey elastomer nipple with the pressure-sensitive element of modified Egorov would disclose the elastomer nipple.
Claim 13: Modified Egorov discloses all the elements above in claim 12, Egorov discloses, wherein the probe head comprises a convex distal end in a cross-sectional plane extending along a longitudinal axis of the ultrasound rod probe. (See FIG. 3a highlighted below)
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Claim 14: Modified Egorov discloses all the elements above in claim 12, Egorov discloses, the probe head;
Egorov fails to disclose: wherein a width of the proximal end of the elastomer nipple is approximately the same as a width of the distal end of the probe head.
However, Poncy in the context of sterile covers for intraoperative ultrasonic devices discloses, an elastomer nipple that widens from a distal end of the elastomer nipple towards a proximal end of the elastomer nipple adjacent to the probe head. (FIG. 1-5 – the elastomer nipple widens from a distal end of the elastomer nipple towards a proximal end of the elastomer nipple adjacent to the probe head, [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.’) Poncy teaches that tip of the ultrasound probe rod comprises “The sheath 18 is designed to fit snugly around the probe and preferably to extend a short distance behind the probe, to thus cover a portion of the cable, as best depicted in FIG. 5(b). It has a closed end and an open end, and the closed end is shaped to mate with the tapered shape 40 of the probe. 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.”. The probe itself is tapered shaped that mates with the sheath that it nipple shaped composed of an elastomer nipple, thereby defining a elastomer nipple.) See FIG. 4 below; under the broadest reasonable interpretation, the width of the proximal end of the elastomer nipple is approximately the same as a width of the distal end of the probe head; in addition, it takes the same shape of the probe to provide a snug fit.
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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 modified Egorov to comprise an elastomer nipple 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 of Poncey elastomer nipple with the pressure-sensitive element of modified Egorov would disclose the elastomer nipple.
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 width proximal end of the elastomer nipple of modified Egorov to approximately the same as a width of the distal end of 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].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Egorov (US 20200022674 A1) Egorov discloses, An ultrasound system for carrying out rectal or vaginal examinations comprising: an ultrasound rod probe with a probe head rounded on a distal end; an ultrasound transducer integrated within the probe head, wherein at least one pressure-sensitive element is attached to the probe head and configured to deform when a pressure acting between the at least one pressure-sensitive element and a biological vessel wall exceeds a pressure threshold, (FIG. 1 – vaginal 104 examination. FIG. 3, under the broadest reasonable interpretation, the probe head is indeed rounded on “a” distal end. ¶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.)
Chong et al (Vascular Pressure-Flow Measurement Using CB-PDMS Flexible Strain Sensor. IEEE Trans Biomed Circuits Syst. 2019 Dec;13). Chong in the context of pressure sensors in the body discloses, wherein the at least one pressure sensitive element has an elastic modulus (E-modulus) smaller than an E-modulus which corresponds to the 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.)
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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