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 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 1-12 and 18 and 21-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 is rejected because “said initial ‘on’ condition” and “the divergence voltage setpoint” lack proper antecedent basis. Claim 1 is also rejected because it is unclear what a “sizeable blood vessel is” and how the user knows the device is not above one. Moreover, such limitations appear to be method steps and Applicant is reminded apparatus claims cover what a device is, not what a device does (MPEP 2144). Claim 1 is also rejected because it is unclear if “an indication” (line 24) and “an indication” (line 28) is the “on” condition indicator. Claim 1 is also rejected because it is unclear if “a divergence voltage setpoint” (lines 27-28) is the same divergence voltage setpoint previously set forth in line 20. Claim 18 is rejected because it is unclear what area of the user does not include blood vessels. Claim 18 is rejected because it is unclear if the indicating condition is a result of the device being over an area with no blood vessels. Claim 21 is rejected because it is unclear if the step of adjusting is the same adjustment of Claim 18 or a different adjustment. Claim 21 is also rejected because it is unclear what “adjusting” is being referred to in lines 5-6. Claim 21 is also rejected because it is unclear if the device is above a blood vessel when the adjusting changes the indicating.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 4, 7-8, 11-12 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2008/0147147 to Griffiths et al. “Griffiths” in view of U.S. Publication No. 2017/0172423 to Banet et al. “Banet”, U.S. Publication No. 2020/0232850 to Takaoka et al. “Takaoka” or U.S. Publication No. 2020/0291564 to O’Malley et al. “O’Malley”, either Griffiths, Banet and Takaoka or Griffiths, Banet and O’Malley in further view of U.S. Publication No. 2017/0156665 to Miller et al. “Miller”.
As for Claim 1, 4, 7, 12 and 22, Griffiths discloses a portable vein-locating or vein visualizing device comprising a housing having a top and bottom portion (Figs. 1-2, 5-6 and corresponding descriptions) an individual infrared (IR) light emitter adapted to emit IR light from the bottom portion of the housing to the patient and an individual IR light receiver adapted to receive backscattered IR light emitted by the IR light emitter (Paragraph [0010]). As for the movement, Griffiths makes it clear that the device is used to scan the patient’s skin until the vein finder provides an indication (Paragraph [0033]). Scanning would include moving the device in its broadest reasonable interpretation. Examiner notes that Griffiths makes it clear that the device can include a single infrared source and detector pair or a single source and an array of detectors or an array of sources and array of detectors (Paragraph [0010]) all of which read on an “individual infrared light emitter” and an “individual infrared red light receiver” in its broadest reasonable interpretation. In other words, an array of emitters and receivers include an individual emitter and an individual receiver in its broadest reasonable interpretation. The emitted and received IR light would correspond to voltages in its broadest reasonable interpretation. Nonetheless, U.S. Publication No. 2020/0118679 to Burman et al. is cited as evidence to disclose IR light sources emit light based on a voltage applied to the source (Paragraph [0038]) and where IR detectors paired with respective light sources generate a voltage as an output signal which is proportional to the IR light absorbed by the detector (Paragraph [0040]). Griffith’s handheld vessel locator would include a battery or portable power source in order to power the portable unit in its broadest reasonable interpretation (Fig. 7). However, it is not clear if the LEDs provide an initial indication when the device is powered on.
Banet teaches from within a similar field of endeavor with respect to physiological sensing devices (Abstract; Paragraph [0001]) where an LED is used as a simple user interface and can radiate different colors of the visible spectrum and blink them at different frequencies to indicate when the sensor is turned on, making a measurement, charging, running low on power, completed with a measurement, etc. (Paragraph [0074]).
Accordingly, one skilled in the art would have been motivated to have modified the LEDs in Griffiths to radiate with distinct colors or patterns when the device is first powered on, making measurements, completed with measurements or any other device status pertinent to the user in order to provide a simple user interface to convey device states. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Regarding the divergence voltage and setpoint, while Griffiths detects the presence of a vessel when the detector picks up “less reflected energy” (Paragraph [0028]) or when the detector shows “the most signal change” (Paragraph [0033]), Griffiths does not expressly disclose detecting the vessel when a divergence voltage is less than a divergence voltage set point as claimed.
Takaoka teaches from within a similar field of endeavor with respect to systems and methods to analyze detected sensor data where a divergence value between reference data and measured data is calculated and compared with a threshold to indicate an abnormality in the data (Paragraph [0112]).
Alternatively, O’Malley teaches from within a similar field of endeavor with respect to devices for analyzing sensor data where if measured data is greater than a reference value by at least a threshold amount a condition may be identified (Paragraph [0013]). O’Malley explains that the threshold may define a tolerance margin specifying when a deviation from the reference value is considered a “meaningful divergence” indicating an abnormality (e.g. problem) (Paragraph [0013]).
Accordingly, one skilled in the art would have been motivated to have modified the vessel detection scheme used by Griffiths to incorporate conventional data processing techniques as described by Takaoka and O’Malley such as determining a divergence value and comparing it to a threshold in order to determine a meaningful difference in the detected IR data and thus, improve the accuracy of vessel detection. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
As for adjusting the divergence voltage setpoint with a potentiometer, Miller teaches from within a similar field of endeavor with respect to physiological measurement systems and methods where a potentiometer is used to control the set point of a circuit (Paragraph [0078]).
Accordingly, one skilled in the art would have been motivated to have utilized a potentiometer as described by Miller to easily make adjustments to the vessel locating system’s sensitivity (e.g. divergence voltage setpoint value) described by Griffiths and Takaoka/O’Malley. Such a modification merely involves combining prior art techniques to yield predictable results (MPEP 2143). Examiner notes that one skilled in the art would have been motivated to have adjusted the device settings at any point during examination including when the device is not over sizeable blood vessels.
Regarding Claim 8, Griffiths discloses where the device includes LED indicators to indicate when the device has located the vessel (e.g. is over the vessel) with various lighting configurations such as changing intensity (Paragraph [0029]).
Regarding Claim 11, Griffiths discloses wherein the system includes a visible light LED to illuminate the patient’s skin (Paragraph [0030]).
Claim(s) 2-3, 5-6 and 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Griffiths, Banet, Takaoka/O’Malley and Miller as applied to claims 1 and 18 above, and further in view of U.S. Publication No. 2019/0076070 to Nogueira et al. “Nogueira”.
Regarding Claims 2-3, 5-6 and 9, Griffiths, Banet, Takaoka/O’Malley and Miller disclose a vessel locating device as described above utilizing circuitry but fail to specify using a comparator as claimed.
Nogueira teaches from within a similar field of endeavor with respect to utilizing sensors to determine physiological data (Abstract) where a comparator circuit it utilized with programmable hysteresis (Paragraphs [0422] and [0508]).
Accordingly, one skilled in the art would have been motivated to have modified the circuity described by Griffiths, Banet, Takaoka/O’Malley and Miller to use a comparator with an adjustable threshold via programmable hysteresis as described by Nogueira in order to customize detection parameters. Such a modification merely involves combining prior art techniques to yield predictable results (MPEP 2143).
With respect to Claim 10, Griffith’s handheld vessel locator would include a battery or portable power source in order to power the portable unit in its broadest reasonable interpretation (Fig. 7). In addition, Nogueira teaches use of a battery (Paragraph [0193]) and a voltage regulator (Paragraph [0197]).
Claim(s) 13-14, 17-18 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Griffiths, Takaoka/O’Malley and Miller.
As for Claims 13, 18 and 21, Griffiths discloses a portable vein-locating or vein visualizing device comprising a housing having a top and bottom portion (Figs. 1-2, 5-6 and corresponding descriptions) an individual infrared (IR) light emitter adapted to emit IR light from the bottom portion of the housing to the patient and an individual IR light receiver adapted to receive backscattered IR light emitted by the IR light emitter (Paragraph [0010]). As for the movement, Griffiths makes it clear that the device is used to scan the patient’s skin until the vein finder provides an indication (Paragraph [0033]). Scanning would include moving the device in its broadest reasonable interpretation. Examiner notes that Griffiths makes it clear that the device can include a single infrared source and detector pair or a single source and an array of detectors or an array of sources and array of detectors (Paragraph [0010]) all of which read on an “individual infrared light emitter” and an “individual infrared red light receiver” in its broadest reasonable interpretation. In other words, an array of emitters and receivers include an individual emitter and an individual receiver in its broadest reasonable interpretation. The emitted and received IR light would correspond to voltages in its broadest reasonable interpretation. Nonetheless, U.S. Publication No. 2020/0118679 to Burman et al. is cited as evidence to disclose IR light sources emit light based on a voltage applied to the source (Paragraph [0038]) and where IR detectors paired with respective light sources generate a voltage as an output signal which is proportional to the IR light absorbed by the detector (Paragraph [0040]).
However, while Griffiths detects the presence of a vessel when the detector picks up “less reflected energy” (Paragraph [0028]) or when the detector shows “the most signal change” (Paragraph [0033]), Griffiths does not expressly disclose detecting the vessel when a divergence voltage is less than a divergence voltage set point as claimed. Griffiths also does not specify using an adjustment wheel (e.g. potentiometer).
Takaoka teaches from within a similar field of endeavor with respect to systems and methods to analyze detected sensor data where a divergence value between reference data and measured data is calculated and compared with a threshold to indicate an abnormality in the data (Paragraph [0112]).
Alternatively, O’Malley teaches from within a similar field of endeavor with respect to devices for analyzing sensor data where if measured data is greater than a reference value by at least a threshold amount a condition may be identified (Paragraph [0013]). O’Malley explains that the threshold may define a tolerance margin specifying when a deviation from the reference value is considered a “meaningful divergence” indicating an abnormality (e.g. problem) (Paragraph [0013]).
Accordingly, one skilled in the art would have been motivated to have modified the vessel detection scheme used by Griffiths to incorporate conventional data processing techniques as described by Takaoka and O’Malley such as determining a divergence value and comparing it to a threshold in order to determine a meaningful difference in the detected IR data and thus, improve the accuracy of vessel detection. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Miller teaches from within a similar field of endeavor with respect to physiological measurement systems and methods where a potentiometer is used to control the set point of a circuit (Paragraph [0078]).
Accordingly, one skilled in the art would have been motivated to have utilized a potentiometer as described by Miller to easily make any adjustments (e.g. calibrate) to the vessel locating system’s sensitivity (e.g. divergence voltage setpoint value) described by Griffiths and Takaoka/O’Malley. Such a modification merely involves combining prior art techniques to yield predictable results (MPEP 2143). Examiner notes that one skilled in the art would have been motivated to have adjusted the device settings at any point during examination in order to locate the desired size blood vessels.
Regarding Claim 14, Griffiths discloses where the device includes LED indicators to indicate when the device has located the vessel (e.g. is over the vessel) (Paragraph [0029]).
Regarding Claim 17, Griffiths discloses wherein the system includes a visible light LED to illuminate the patient’s skin (Paragraph [0030]).
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Griffiths, Takaoka/O’Malley and Miller as applied to claim 13 above, and further in view of Nogueira.
Regarding Claim 15, Griffiths, Takaoka/O’Malley and Miller disclose a vessel locating device as described above utilizing circuitry but fail to specify using a comparator as claimed.
Nogueira teaches from within a similar field of endeavor with respect to utilizing sensors to determine physiological data (Abstract) where a comparator circuit it utilized with programmable hysteresis (Paragraphs [0422] and [0508]).
Accordingly, one skilled in the art would have been motivated to have modified the circuity described by Griffiths, Takaoka/O’Malley and Miller to use a comparator with an adjustable threshold via programmable hysteresis as described by Nogueira in order to customize detection parameters. Such a modification merely involves combining prior art techniques to yield predictable results (MPEP 2143).
As for Claim 16, Griffiths discloses where the device includes LED indicators to indicate when the device has located the vessel (e.g. is over the vessel) with various lighting configurations such as changing intensity (Paragraph [0029]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-18 and 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 12,220,255 Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed toward blood vessel locating devices including infrared emitters and receivers and configured to indicate the presences of a blood vessel based on a divergence voltage. The presently pending claims represent an obvious broadening of the allowed Claims. Examiner also notes any adjustment to the divergence set setpoint is considered to read on a calibration of the device in its broadest reasonable interpretation.
Response to Arguments
Applicant's arguments filed 11/13/2025 have been fully considered but are moot in view of the updated grounds of rejection necessitated by amendment. However, Examiner will address Applicant’s remarks which may still pertain to the current rejection. For example, Applicant argues Griffiths does not provide a teaching where a divergence value is to be manually adjusted based on readings taken by a device on a patient’s skin nor does Griffiths teach moving the device along a patient’s skin to locate a blood vessel. First, it must be noted In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As noted in the rejection above, one skilled in the art would have been motivated to have adjusted the device sensitivity at any point during examination in order to locate the desired size blood vessels. As for the movement, Griffiths makes it clear that the device is used to scan the patient’s skin until the vein finder provides an indication (Paragraph [0033]). Scanning would include moving the device in its broadest reasonable interpretation.
Double Patenting rejections have also been maintained. Applicant does not provide any additional arguments in the 11/13/2025 remarks.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Publication No. 2021/0052214 to Miyazaki which discloses a hand held blood vessel mapping device with a potentiometer used to adjust a device setting (Paragraph [0052]).
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 CHRISTOPHER L COOK whose telephone number is (571)270-7373. The examiner can normally be reached M-F approximately 8AM-5PM.
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/CHRISTOPHER L COOK/Primary Examiner, Art Unit 3797