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 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: “an irradiation unit configured to irradiate” interpreted as being a light in claim 1 ; “an imaging unit configured to capture an image” interpreted as being a camera in claims 1, 4, & 13; “a selection unit programmed to select” interpreted as being a processor in claims 1 & 10-12, and “a display unit configured to highlight” in claims 1-9.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim limitation “display unit” invokes 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. The display unit is described as both a projector projecting an iamge as well as a second light source highlighting the target site (Applicant Spec [0042]), the corresponding structure is unclear in view of the claims. 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.
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.
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.
Claims 1-5, 9-10, & 13-14 are rejected under 35 U.S.C. 102(a) as being anticipated by Yada et al (JP2006102360A; hereinafter referred to as Yada).
Regarding Claim 1, Yada discloses A blood vessel visualization device for visualizing a blood vessel of a living body (“A biological information presentation apparatus capable of accurately and quickly confirming biological feature information such as the position and direction of a blood vessel with a simple operation” [Abstract], the blood vessel visualization device comprising:
an irradiation unit configured to irradiate a target site of the living body with light having a wavelength capable of passing through an inside of the living body (“ The biological information presentation apparatus according to the present invention presents biological feature information as an image, and illuminates illumination light having a predetermined wavelength for photographing the feature information onto the biological body, and photographs the biological body” [Pg. 3];
an imaging unit configured to capture an image of the target site irradiated with the light (“Imaging means for acquiring biometric captured image information, image processing means for detecting the feature information based on the biometric captured image information, and converting the detected feature information into imaged projection image information, and the projection Projecting means for projecting a projected image based on image information onto the surface of the living body.” [Pg. 3];
a selection unit programmed to select, using the image of the target site captured by the imaging unit, a puncturing blood vessel site optimal for puncturing from among a plurality of the blood vessels (“in the biological information presentation device according to the present invention, the feature information generated by the feature extraction unit is a position shape of a blood vessel, a blood vessel branch point, a position of an image of a special sticker attached to a living body, or an optimum puncture region.” [Pg. 4]);
and a display unit configured to highlight at least one of the puncturing blood vessel site or a puncture position based on the puncturing blood vessel site on the target site (“The optimal puncture region extracted in this manner may be superimposed on the blood vessel emphasized image information stored in the blood vessel emphasized image storage unit 803 and projected onto the arm 109, for example.” [Pg. 12]).
Regarding Claim 2, Yada discloses further comprising: a puncturing blood vessel image generation unit that generates a puncturing blood vessel image obtained by visualizing the puncturing blood vessel site using the image (“in the biological information presentation device according to the present invention, the feature information generated by the feature extraction unit is a position shape of a blood vessel, a blood vessel branch point, a position of an image of a special sticker attached to a living body, or an optimum puncture region.” [Pg. 4]),
wherein: the display unit highlights the puncturing blood vessel image on the target site (“The optimal puncture region extracted in this manner may be superimposed on the blood vessel emphasized image information stored in the blood vessel emphasized image storage unit 803 and projected onto the arm 109, for example.” [Pg. 12]).
Regarding Claim 3, Yada discloses the display unit is configured to irradiate the puncture position based on the puncturing blood vessel site in the target site with a light beam (“The optimal puncture region extracted in this manner may be superimposed on the blood vessel emphasized image information stored in the blood vessel emphasized image storage unit 803 and projected onto the arm 109, for example.” [Pg. 12]).
Regarding Claim 4, Yada discloses further comprising: an entire blood vessel image generation unit programmed to generate an entire blood vessel image obtained by visualizing a plurality of the blood vessels existing inside the target site based on the image captured by the imaging unit (“ An image 601 shown in FIG. 6A is a near-infrared image or a visible image corresponding to the biometric image information 413, and blood vessels 603, 604, and 605 are shown. Based on this information, the blood vessel boundary is detected by the method described in FIG. 5, and blood vessel pattern information is generated.” [Pg. 11]),
wherein: the display unit is configured to display the entire blood vessel image on the target site and subsequently perform the highlighting (“The optimal puncture region extracted in this manner may be superimposed on the blood vessel emphasized image information stored in the blood vessel emphasized image storage unit 803 and projected onto the arm 109, for example.” [Pg. 12]).
Regarding Claim 5, Yada discloses the display unit is configured to stop display of the entire blood vessel image when performing the highlighting (“The optimal puncture region extracted in this manner may be superimposed on the blood vessel emphasized image information stored in the blood vessel emphasized image storage unit 803 and projected onto the arm 109, for example.” [Pg. 12]).
Regarding Claim 9, Yada discloses comprising: a motion detection unit configured to detect a motion vector of the living body based on the image, wherein: the display unit is configured to use the motion vector to perform the highlighting following a motion of the living body (“When the living body moves or shakes, in the near-infrared image captured at the next time, the positions of the blood vessels 701 and 702 move to the blood vessels 711 and 712, respectively, and similarly, the blood vessel branch point 703 moves to the blood vessel branch point 713. The special seal image itself also moves from the special seal image 704 to the special seal image 714. Similarly, when the feature extraction unit 801 detects the pixel position of the special seal image 714 or the blood vessel branch point 713 in the captured image region 700, the feature extraction unit 801 stores the special seal image 714 stored in the near infrared feature information first storage unit 805. After the pixel position of the seal image 704 or the blood vessel branch point 703 is stored in the near infrared feature information second storage unit 810, the pixel position of the special seal image 714 or the blood vessel branch point 713 is stored in the near infrared feature information first memory. The data is stored in the means 805. Next, the misalignment detection unit 808 detects the special seal from the position of the special seal image 704 based on the information stored in the near infrared feature information first storage unit 805 and the near infrared feature information second storage unit 810. A vector to the position of the image 714 or a vector from the position of the blood vessel branch point 703 to the position of the blood vessel branch point 713 is calculated. For example, if the position of the blood vessel branch point 713 is shifted by 50 pixels in the horizontal left direction and 20 pixels in the vertical downward direction with respect to the position of the blood vessel branch point 703, the positional shift vector is (−50, +20). The position shift vector detected in this way is used for correcting the blood vessel emphasized image information stored in the blood vessel emphasized image storage unit 803. That is, the image correction unit 809 uses the blood vessel enhancement image information obtained by shifting the blood vessel enhancement image information stored in the blood vessel enhancement image storage unit 803 by the position shift vector as the blood vessel enhancement image information after motion correction. It is updated and stored in the image storage means 803 and transferred to the projection means 404 as projection image information 414.” [Pg. 11-12]).
Regarding Claim 10, Yada discloses the selection unit is programmed to acquire at least one or more parameters of straightness, length, thickness, depth, and extension direction of a plurality of blood vessel sites of the target site based on the image, and to select a blood vessel site of which the acquired parameter is equal to or greater than a threshold as the puncturing blood vessel site (“The feature extraction unit 801 generates feature information by extracting features of the biometric image information 413 input from the imaging unit. As will be described in detail later, as feature information, blood vessel pattern information related to a blood vessel route and a blood vessel branch point, optimal puncture region information that means a high linearity and thick region in the blood vessel pattern information, and affixed to the arm Special seal position information is included. “ [Pg. 8], “Next, in order to extract a region suitable for puncture, a plurality of points with high linearity of the dotted line connecting the center positions are extracted as sublists from each blood vessel list, and the average of the thickness of the blood vessels in each sublist N sub-lists (N is a natural number) are selected in order from the largest value. The area specified by the sublist selected in this way is set as an area suitable for puncture. In this example, two sublists are selected as the optimum puncture areas 611 and 612.” [Pg. 12]).
Regarding Claim 13, Yada discloses a blood vessel visualization method for visualizing a blood vessel of a living body (“A biological information presentation apparatus capable of accurately and quickly confirming biological feature information such as the position and direction of a blood vessel with a simple operation” [Abstract], the blood vessel visualization method comprising:
irradiating a target site of the living body with light having a wavelength capable of passing through an inside of the living body (“ The biological information presentation apparatus according to the present invention presents biological feature information as an image, and illuminates illumination light having a predetermined wavelength for photographing the feature information onto the biological body, and photographs the biological body” [Pg. 3];
capturing an image of the target site irradiated with the light (“Imaging means for acquiring biometric captured image information, image processing means for detecting the feature information based on the biometric captured image information, and converting the detected feature information into imaged projection image information, and the projection Projecting means for projecting a projected image based on image information onto the surface of the living body.” [Pg. 3];
using an image of the target site captured by the imaging unit, a puncturing blood vessel site optimal for puncturing from among a plurality of the blood vessels (“in the biological information presentation device according to the present invention, the feature information generated by the feature extraction unit is a position shape of a blood vessel, a blood vessel branch point, a position of an image of a special sticker attached to a living body, or an optimum puncture region.” [Pg. 4]);
and highlighting at least one of the puncturing blood vessel site or a puncture position based on the puncturing blood vessel site on the target site (“The optimal puncture region extracted in this manner may be superimposed on the blood vessel emphasized image information stored in the blood vessel emphasized image storage unit 803 and projected onto the arm 109, for example.” [Pg. 12]).
Regarding Claim 14, Yada discloses a blood vessel visualization device for visualizing a blood vessel of a living body (“A biological information presentation apparatus capable of accurately and quickly confirming biological feature information such as the position and direction of a blood vessel with a simple operation” [Abstract], the blood vessel visualization device comprising:
a first light source configured to irradiate a target site of the living body with light having a wavelength capable of passing through an inside of the living body (“ The biological information presentation apparatus according to the present invention presents biological feature information as an image, and illuminates illumination light having a predetermined wavelength for photographing the feature information onto the biological body, and photographs the biological body” [Pg. 3];
an camera configured to capture an image of the target site irradiated with the light (“Imaging means for acquiring biometric captured image information, image processing means for detecting the feature information based on the biometric captured image information, and converting the detected feature information into imaged projection image information, and the projection Projecting means for projecting a projected image based on image information onto the surface of the living body.” [Pg. 3];
a processor programmed to select, using the image of the target site captured by the imaging unit, a puncturing blood vessel site optimal for puncturing from among a plurality of the blood vessels (“in the biological information presentation device according to the present invention, the feature information generated by the feature extraction unit is a position shape of a blood vessel, a blood vessel branch point, a position of an image of a special sticker attached to a living body, or an optimum puncture region.” [Pg. 4]);
and at least one of a projector configured to highlight the puncturing blood vessel site on the target site, or a second light source configured to highlight a puncture position based on the puncturing blood vessel site on the target site (“The optimal puncture region extracted in this manner may be superimposed on the blood vessel emphasized image information stored in the blood vessel emphasized image storage unit 803 and projected onto the arm 109, for example.” [Pg. 12]).
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 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.
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Yada in view of Marcotte et al (US20060173351A1; hereinafter referred to as Marcotte).
Regarding Claim 6, Yada discloses all limitations noted above except that the display unit is configured to end the highlighting when a predetermined period of time elapses after the highlighting is performed.
However, in a similar field of endeavor, Marcotte teaches a needle insertion system and method. The insertion system includes an imaging system and a needle [Abstract]
Marcotte also teaches that the display unit is configured to end the highlighting when a predetermined period of time elapses after the highlighting is performed (“Once the target blood vessel is located, the user looks downward from display 40 to view catheter 300 in his/her visual field. Utilizing either his/her naked eye or the IR-enhanced image that appears on display 40, the user aligns catheter 300 above and parallel to the target blood vessel and pierces skin surface 225 with needle tip 330. The user, by utilizing either his/her naked eye or the enhanced image appearing on display 40, pierces skin surface 225 with needle tip 360 and introduces the catheter 300 into the target blood vessel… The user advances catheter 300 into the target blood vessel, until a sufficient depth has been reached, after which catheter needle 350 and catheter body 380 are withdrawn, which leaves cannula 310 remaining in the target blood vessel. Cannula 310 is secured in place, and the procedure completed using standard medical practices.” [0076]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Yada as outlined above with the display unit is configured to end the highlighting when a predetermined period of time elapses after the highlighting is performed as taught by Marcotte, because it allows for medical practitioners to locate and gain access to subsurface blood vessels, and insure proper insertion [0010].
Regarding Claim 7, Yada discloses all limitations noted above except that an image recognition unit programmed to recognize a position of a puncture needle based on the image, wherein: the display unit is configured to end the highlighting of the puncturing blood vessel site when the recognized puncture needle comes into contact with the puncturing blood vessel site or the puncture position.
However, in a similar field of endeavor, Marcotte teaches that an image recognition unit programmed to recognize a position of a puncture needle based on the image, wherein: the display unit is configured to end the highlighting of the puncturing blood vessel site when the recognized puncture needle comes into contact with the puncturing blood vessel site or the puncture position (“Once the target blood vessel is located, the user looks downward from display 40 to view catheter 300 in his/her visual field. Utilizing either his/her naked eye or the IR-enhanced image that appears on display 40, the user aligns catheter 300 above and parallel to the target blood vessel and pierces skin surface 225 with needle tip 330. The user, by utilizing either his/her naked eye or the enhanced image appearing on display 40, pierces skin surface 225 with needle tip 360 and introduces the catheter 300 into the target blood vessel…the position and travel path of catheter needle 350 is clearly visible to the user on display 40, which allows the user to guide its depth and travel path more accurately… The user advances catheter 300 into the target blood vessel, until a sufficient depth has been reached, after which catheter needle 350 and catheter body 380 are withdrawn, which leaves cannula 310 remaining in the target blood vessel. Cannula 310 is secured in place, and the procedure completed using standard medical practices.” [0076]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Yada as outlined above with an image recognition unit programmed to recognize a position of a puncture needle based on the image, wherein: the display unit is configured to end the highlighting of the puncturing blood vessel site when the recognized puncture needle comes into contact with the puncturing blood vessel site or the puncture position as taught by Marcotte, because it allows for medical practitioners to locate and gain access to subsurface blood vessels, and insure proper insertion [0010].
Regarding Claim 8, Yada discloses all limitations noted above except that the display unit is configured to initially highlight at least the puncturing blood vessel site, and subsequently end the highlighting of the puncturing blood vessel site and begin or continue highlighting the puncture position.
However, in a similar field of endeavor, Marcotte teaches that the display unit is configured to initially highlight at least the puncturing blood vessel site, and subsequently end the highlighting of the puncturing blood vessel site and begin or continue highlighting the puncture position (“Once the target blood vessel is located, the user looks downward from display 40 to view catheter 300 in his/her visual field. Utilizing either his/her naked eye or the IR-enhanced image that appears on display 40, the user aligns catheter 300 above and parallel to the target blood vessel and pierces skin surface 225 with needle tip 330. The user, by utilizing either his/her naked eye or the enhanced image appearing on display 40, pierces skin surface 225 with needle tip 360 and introduces the catheter 300 into the target blood vessel…the position and travel path of catheter needle 350 is clearly visible to the user on display 40, which allows the user to guide its depth and travel path more accurately… The user advances catheter 300 into the target blood vessel, until a sufficient depth has been reached, after which catheter needle 350 and catheter body 380 are withdrawn, which leaves cannula 310 remaining in the target blood vessel. Cannula 310 is secured in place, and the procedure completed using standard medical practices.” [0076]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Yada as outlined above with the display unit is configured to initially highlight at least the puncturing blood vessel site, and subsequently end the highlighting of the puncturing blood vessel site and begin or continue highlighting the puncture position as taught by Marcotte, because it allows for medical practitioners to locate and gain access to subsurface blood vessels, and insure proper insertion [0010].
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Yada in view of Breteau et al (US20230293827A1; hereinafter referred to as Breteau).
Regarding Claim 11, Yada discloses all limitations noted above except that the selection unit is programmed to: change and re-select the threshold in a case where there are multiple selected puncturing blood vessel sites of which the acquired parameter is equal to or greater than a threshold, and change and re-select the threshold in a case where there is no selected puncturing blood vessel site of which the acquired parameter is equal to or greater than the threshold.
However, in a similar field of endeavor, Breteau teaches a method for determining at least one optimal insertion segment in a limb of a patient for inserting a needle into a vein of the patient,
Breteau also teaches that the selection unit is programmed to: change and re-select the threshold in a case where there are multiple selected puncturing blood vessel sites of which the acquired parameter is equal to or greater than a threshold, and change and re-select the threshold in a case where there is no selected puncturing blood vessel site of which the acquired parameter is equal to or greater than the threshold (“the predetermined classification parameters for classifying the insertion segments are selected from one or more parameters from the following list: the location of the segment with respect to a known pattern of positions of blood vessels on the part of the body of the patient; the average density of all of the points of the blood vessel included within contours of the blood vessel corresponding to the segment, calculated on the vascular profile map; the length of the segment; the depth of the blood vessel in the segment; the diameter of the blood vessel in the segment; the orientation of the segment; the presence or absence of irregularities on the skin on the insertion segment; a preference of the patient; a previous insertion history for the same patient. the classification of the insertion segments depends on one or more parameters, optionally weighted, so as to provide optimised determination of the optimal insertion segment, in particular for maximising the chances of success of insertion of the needle and for limiting as well as possible the safety risks.” [0037-0047])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Yada as outlined above with that the selection unit is programmed to: change and re-select the threshold in a case where there are multiple selected puncturing blood vessel sites of which the acquired parameter is equal to or greater than a threshold, and change and re-select the threshold in a case where there is no selected puncturing blood vessel site of which the acquired parameter is equal to or greater than the threshold as taught by Breteau, because it would maximise the chances of success of insertion of the needle and for limiting as well as possible the safety risks [0047].
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Yada in view of Peng et al (CN 112022346 A; hereinafter referred to as Peng).
Regarding Claim 12, Yada discloses all limitations noted above except a machine learning model programmed to use the image as input data and to output, as output data, puncture success rates of a plurality of blood vessel sites of the target site shown in the image, wherein: the selection unit is programmed to select a blood vessel site having a puncture success rate higher than a threshold as the puncturing blood vessel site.
However, in a similar field of endeavor, Peng teaches a control method of a fully automatic venipuncture identification [Technical Field]
Peng also teaches a machine learning model programmed to use the image as input data and to output, as output data, puncture success rates of a plurality of blood vessel sites of the target site shown in the image, wherein: the selection unit is programmed to select a blood vessel site having a puncture success rate higher than a threshold as the puncturing blood vessel site (“The monocular near-infrared camera continuously obtains the two-dimensional near-infrared image of the target, and scores the blood vessels identified in the two-dimensional infrared image through the image neural network, and takes the vein with the highest score as the target blood vessel… Score the blood vessel segmentation map based on Bayes' theorem, which regards the probability of simultaneous occurrence of independent events as the product of the respective occurrence probabilities of the two events” [Summary of the Invention])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Yada as outlined above with a machine learning model programmed to use the image as input data and to output, as output data, puncture success rates of a plurality of blood vessel sites of the target site shown in the image, wherein: the selection unit is programmed to select a blood vessel site having a puncture success rate higher than a threshold as the puncturing blood vessel site as taught by Peng, because it would significantly improving the safety of the puncture process [Summary of the Invention].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN MALDONADO whose telephone number is 703-756-1421. The examiner can normally be reached 8:00 am-4:00 pm PST M-Th Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at
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/Steven Maldonado/
Patent Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797