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
Claims 1-2 and 4-5 are objected to because of the following informalities:
In claims 1 and 5, line 1, “the follicles” should read “follicles”.
In claims 1 and 5, line 1, “the thickness” should read “a thickness”.
In claim 1, line 4, and claim 5, line 6, “the hand of a subject” should read “a hand of the subject”.
In claim 1, line 6, and claim 5, line 8, “the inner volume” should read “an inner volume”.
In Claim 2, the “A device” should read “The device” and the claim should end with “.”.
In claim 4, “claim 1” should read “claim 2” because the depth-limiting element is recited in claim 2.
In claim 5, para. i), line 2, “a subject” should read “the subject”.
In claim 5, para. ii), line 2, “a user” should read “the subject” or the “subject” should be changed to the “user” in the entire claim.
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:
“communication elements adapted to …” in claim 5. Interpreted as electronic components for a wireless or wired connection (Applicant’s specification: p. 7, 2nd para.).
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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 this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5 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 pre-AIA the applicant regards as the invention.
Claims 1 and 5 recite "the lowest point” in lines 5 and 7, respectively. This recitation is ambiguous because it is unclear which direction is a direction from high to low. For examination purposes, Examiner of record takes this to be a saddle point.
Claims dependent upon the rejected claims above, but not directly addressed, are also rejected because they inherit the indefiniteness of the claim(s) they respectively depend upon.
Claim Rejections - 35 USC § 103
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.
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.
Claims 1 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Ridge (US 20230139828), hereinafter Ridge, in view of Robbins et al (US 20230054353), hereinafter Robbins.
Regarding claim 1, Ridge teaches a device (100) adapted to monitor the follicles and to assess the thickness of the endometrium of a subject (401) (“to fully automate part of the IVF process—Measure follicle and the Endometrium” [0056]; “the MLS is taught how to: [0104] Measure the thickness of the endometrium.”)(“The model shown here enables reliable, real-time detection of the follicles and in addition provides measurements of the endometrium and other features identified in the pelvic area to optimize conception and inform the user at what stage of the menstrual cycle they are at as measured by the size of the follicles.” [0109]; Figs. 8 and 11-12), comprising:
a) an elongated member (101-102) having a tip (111) that houses an ultrasound probe (107) (“The probe 100 also includes an image capture assembly which includes a piezo crystal array 107 and a battery-powered radio frequency transceiver. The piezo crystal array 107 is coupled to the distal end of the shaft 105 and has an axis aligned with the longitudinal axis 115." [0031]. “FIG. 3 is an exploded view of the endocavitary probe of FIG. 1. The main body 101-102 of the probe may … be constructed in a plurality of parts and has an acoustic insulator and plastic covering, as required by regulation.” [0034]; Figs. 1 and 3).
Ridge does not explicitly teach an ergonomic grip adapted to be held in the hand of a subject, said grip having a concave portion, the lowest point of which is located on an imaginary projection of the inner volume of said elongated member.
However, in the ultrasound imaging systems field of endeavor, Robbins discloses ultrasound finger probe and methods thereof, which is analogous art. Robbins teaches an ergonomic grip (110) adapted to be held in the hand of a subject (“grasping the ultrasound probe 40” [0169]; Figs. 3A-D), said grip having a concave portion (118) (“the concave grip surface 118” 0169]; Figs. 3A-D), the lowest point of which (one of the saddle points of 118) is located on an imaginary projection of the inner volume of said elongated member (44) (the inner volume of “head 44” [0111]) (“FIGS. 3A-3D depict various features of the ultrasound probe 40 including the head 44 thereof, in accordance with one embodiment. As shown, the ultrasound probe 40 includes a body 102 defining lateral surfaces 102A and end surfaces 102B, with the head 44 of the ultrasound probe defining a distal end of the ultrasound-probe body. A lens 108 is disposed at the distal end of the ultrasound probe body 102 and is configured to enable passage therethrough of ultrasonic signals.” [0111]; “The method also includes a grasping step of grasping the ultrasound probe 40. The grasping step includes placing at least one of an index finger or a middle finger on the concave grip surface 118 of the finger-grip portion 110 of the ultrasound probe 40” [0169]; Figs. 3A-D).
Therefore, based on Robbins’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Ridge to employ an ergonomic grip adapted to be held in the hand of a subject, said grip having a concave portion, the lowest point of which is located on an imaginary projection of the inner volume of said elongated member, as taught by Robbins, in order to facilitate ultrasonic measurements and imaging of the target tissue.
Regarding claim 5, Ridge teaches a system for monitoring the follicles and assessing the thickness of the endometrium of a subject (401) (“Measure follicle and the Endometrium” [0056] “Box B—The application running on the computing device works as the communication method between the endocavitary probe 100 and the server 500 and tells the user 401 how to work the endocavitary probe.” [0082]; Figs. 8, 10, and 13), comprising:
i) a device (100) adapted to monitor the follicles and to assess the thickness of the endometrium of a subject (“to fully automate part of the IVF process—Measure follicle and the Endometrium” [0056]; “the MLS is taught how to: [0104] Measure the thickness of the endometrium.”)(“The model shown here enables reliable, real-time detection of the follicles and in addition provides measurements of the endometrium and other features identified in the pelvic area to optimize conception and inform the user at what stage of the menstrual cycle they are at as measured by the size of the follicles.” [0109]; Figs. 11-12), comprising:
A) an elongated member (101-102) having a tip (111) that houses an ultrasound probe (107) (“The probe 100 also includes an image capture assembly which includes a piezo crystal array 107 and a battery-powered radio frequency transceiver. The piezo crystal array 107 is coupled to the distal end of the shaft 105 and has an axis aligned with the longitudinal axis 115." [0031]. “FIG. 3 is an exploded view of the endocavitary probe of FIG. 1. The main body 101-102 of the probe may … be constructed in a plurality of parts and has an acoustic insulator and plastic covering, as required by regulation.” [0034]; Figs. 1 and 3);
ii) a smart device (406) (“a smartphone” [0030]) adapted to display to a user (401) information relative to the operation of the device (“Box B—The application running on the computing device works as the communication method between the endocavitary probe 100 and the server 500 and tells the user 401 how to work the endocavitary probe.” [0082]; “a computer with associated display capable of executing the process steps” [0120]; Box B; Fig. 8); and
iii) communication elements adapted to perform communication and transfer of data between the device and the smart device (“cause the computing device to receive the image data from the image capture assembly” [0007]. “Block 400—Connectivity. This is the interface/communication between the user 401a and the endocavitary probe (Tv-DAP) 100 using a designed app and/or webpage 402 that can be downloaded on a computing device 406 or any device with internet connection. Once uploaded, the remote self-operated endocavitary Tv-DAP, when turned on with the “on/off” switch, automatically connects with the computing device 406… If the image is being pre-processed 403 by the Tv-DAP 100 then the pre-processed images automatically upload 405 to the mobile device 406” [0111]; Figs. 8, 10, and 13).
Ridge does not explicitly teach an ergonomic grip adapted to be held in the hand of a subject, said grip having a concave portion, the lowest point of which is located on an imaginary projection of the inner volume of said elongated member.
However, in the ultrasound imaging systems field of endeavor, Robbins discloses ultrasound finger probe and methods thereof, which is analogous art. Robbins teaches an ergonomic grip (110) adapted to be held in the hand of a subject (“grasping the ultrasound probe 40” [0169]; Figs. 3A-D), said grip having a concave portion (118) (“the concave grip surface 118” 0169]; Figs. 3A-D), the lowest point of which (one of the saddle points of 118) is located on an imaginary projection of the inner volume of said elongated member (44) (the inner volume of “head 44” [0111]) (“FIGS. 3A-3D depict various features of the ultrasound probe 40 including the head 44 thereof, in accordance with one embodiment. As shown, the ultrasound probe 40 includes a body 102 defining lateral surfaces 102A and end surfaces 102B, with the head 44 of the ultrasound probe defining a distal end of the ultrasound-probe body. A lens 108 is disposed at the distal end of the ultrasound probe body 102 and is configured to enable passage therethrough of ultrasonic signals.” [0111]; “The method also includes a grasping step of grasping the ultrasound probe 40. The grasping step includes placing at least one of an index finger or a middle finger on the concave grip surface 118 of the finger-grip portion 110 of the ultrasound probe 40” [0169]; Figs. 3A-D).
Therefore, based on Robbins’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Ridge to employ an ergonomic grip adapted to be held in the hand of a subject, said grip having a concave portion, the lowest point of which is located on an imaginary projection of the inner volume of said elongated member, as taught by Robbins, in order to facilitate ultrasonic measurements and imaging of the target tissue.
Claims 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Ridge and Robbins as applied to claim 1, and further in view of Sakamoto et al (US 5971929), hereinafter Sakamoto.
Regarding claim 2, Ridge modified by Robbins teaches the device according to claim 1.
Ridge as modified by Robbins does not teach a depth-limiting element.
However, in the devices and systems for ultrasound imaging field of endeavor, Sakamoto discloses a stopper mechanism for endoscopically inserting ultrasound probe, which is analogous art. Sakamoto teaches a depth-limiting element (“a stopper”) (“The ultrasound scanner head can be fixed at the fore end of the endoscopic insertion instrument by providing a rubber ring or other stopper member around a flexible cord portion behind the ultrasound scanner head in such a way it functions as a stopper for the scanner head by frictional contact with inner surfaces of the endoscopic biopsy channel” Col. 3, l. 66 – Col. 4, l. 5).
Therefore, based on Sakamoto’ teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the combined invention of Ridge and Robbins to employ a depth-limiting element, as taught by Sakamoto, in order to restrict movement of the device during imaging thereby improving ultrasound image quality.
Regarding claim 4, Ridge modified by Robbins and Sakamoto teaches the device according to claim 2.
Ridge as modified by Robbins does not teach that the depth-limiting element comprises an elastomeric friction-generating layer.
However, in the devices and systems for ultrasound imaging field of endeavor, Sakamoto discloses a stopper mechanism for endoscopically inserting ultrasound probe, which is analogous art. Sakamoto teaches that the depth-limiting element comprises an elastomeric friction-generating layer (“a rubber ring ”) (“The ultrasound scanner head can be fixed at the fore end of the endoscopic insertion instrument by providing a rubber ring or other stopper member around a flexible cord portion behind the ultrasound scanner head in such a way it functions as a stopper for the scanner head by frictional contact with inner surfaces of the endoscopic biopsy channel” Col. 3, l. 66 – Col. 4, l. 5).
Therefore, based on Sakamoto’ teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the combined invention of Ridge and Robbins to employ the depth-limiting element that comprises an elastomeric friction-generating layer, as taught by Sakamoto, in order to restrict movement of the device during imaging thereby improving ultrasound image quality.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Ridge, Robbins, and Sakamoto as applied to claim 2, and further in view of Berner et al (DE 3636691), hereinafter Berner.
Regarding claim 3, Ridge modified by Robbins and Sakamoto teaches the device according to claim 2.
Ridge as modified by Robbins and Sakamoto does not teach two partial rings hinged together, and a clamp suitable to connect them.
However, in the mechanical assemblies field of endeavor, Berner discloses a gripper coupling for a robot, which is analogous art. Berner teaches two partial rings (11) hinged together, and a clamp (13) suitable to connect them (“A robot arm (1) and a gripper (2) are provided, at the mutually confronting end faces, with circumferential conical clamping shoulders which are gripped by hollow-conical side legs of a clamp (3). The clamp is pressed together by a tangential clamping screw (18), with the result that the two end faces are firmly pressed against one another.” Abstract. “Fig. 3 shows a hinge-like connection between two part rings 11 of the clamp … The two partial rings 11 have recesses 12 at the mutually facing ends, into which a clamp-like connecting piece 13 engages from the inside. The recesses 12 are kept so wide that the two partial rings 11 are pivotable against each other. By inserting the connecting piece 13 from the inside, it is secured in its position.”; p. 3, 6th para.).
Therefore, based on Berner’ teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the combined invention of Ridge, Robbins, and Sakamoto to employ two partial rings hinged together, and a clamp suitable to connect them, as taught by Berner, in order to facilitate a secure connection between the grip and the elongated member thereby improving ultrasound image quality.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXEI BYKHOVSKI whose telephone number is (571)270-1556. The examiner can normally be reached on Monday-Friday: 8:30am - 5:00pm.
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/ALEXEI BYKHOVSKI/
Primary Examiner, Art Unit 3798
Prosecution Insights