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 .
Claims Accounting
Applicant' s arguments, filed 12/24/2025, have been fully considered.
The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 12/24/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-2, 4-5, 8-12, and 18-20 have been amended.
Claims 1-20 are the current claims hereby under examination.
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 11-20 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.
Regarding claim 11, claim 1 recites “allowing” in a number of method steps. For example, in line 11, the claim recites “allowing the processor to detect the sensor head being removed from contact…”. It is unclear the limitations that “allowing” is imparting on the claim. Allowing for may be interpreted as permitting an action to occur, however this does not reasonably define the scope of the claims. In the case of “allowing the processor to detect the sensor head being removed from contact”, it is unclear the limitations this phrase adds to the claim, as it is unclear if the method steps that “allowing” is modifying must occur. There is no previously claimed structure or method that may prevent the processor from detecting the sensor head being removed from contact, therefore it is unclear how allowing for this action adds a meaningful limitation.
For the purposes of examination, all instances of “allowing” are interpreted as definitively performing the proceeding claim limitations. For example, “allowing the processor to detect the sensor head being removed from contact” is interpreted as “the processor to detects the sensor head being removed from contact”.
Other locations of this indefinite language include claim 11, (lines 16, 19, 22, and 25).
All claims not explicitly addressed above are rejected under 35 U.S.C. 112(b) are rejected by virtue of their dependency on a rejected base claim.
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.
Claims 1-3, 6-7, 11-13, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Publication 2014/0046152 by Bechtel et al. – previously cited (hereinafter “Bechtel”) in view of US Patent Publication 2017/0119313 by Helvick et al. – previously cited (hereinafter “Helvick”) in view of US Patent 10,716,499 by Freeman – previously cited (hereinafter “Freeman”).
Regarding claim 1, Bechtel teaches a method comprising: providing an oximetry system (tissue oximetry device 100); providing for the oximetry system to contact a first tissue of a patient (oximetry probe 100 is in contact with tissue [0120]); providing the oximetry system to make a plurality of first oximetry readings of the first tissue (a plurality of oxygen saturation values can be made and repeated [0092]); and providing for the oximetry system to display a value for the average on a display of the system unit (“Two or more measurements, such as three measurements, of the oxygen saturation value can be averaged by control processor 200 for display on display 125.” [0092]).
Bechtel does not teach providing for the oximetry system to be removed from contact from the first tissue; providing for the oximetry system to detect being removed from contact from the first tissue. Bechtel does, however, teach a pressure sensor that can sense if the pressure between the probe tip and the tissue is in range to produce a valid tissue oximetry measurement ([0251]).
Helvick teaches a system where a proximity sensor is used to determine whether contact is made between the sensor device and tissue. If contact is established, measurements start and when contact stops, the measurements stop. This method determines when to start and stop measurements, improving the reliability of the system output and system longevity ([0005]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method of Bechtel to include providing for the oximetry system to be removed from contact from the first tissue and allowing for the oximetry system to detect being removed from contact from the first tissue, to improve the reliability of the system output and system longevity, as taught by Helvick ([0005]). It is noted that in the combination of Bechtel and Helvick, the pressure sensor can be selected as the proximity sensor to perform the step of detecting contact with the tissue.
The combination of Bechtel and Helvick does not teach providing the oximetry system to store a value in a memory of the oximetry system one of the first oximetry readings based on the oximetry system detecting being removed from contact from the first tissue; providing for the oximetry system to contact a second tissue of a patient; providing for the oximetry system to make a plurality of second oximetry readings of the second tissue; providing for the oximetry system to be removed from contact from the second tissue; providing for the oximetry system to detect being removed from contact from the second tissue; providing for retrieving from the memory by the oximetry system the one of the first oximetry readings based on the oximetry system detecting being removed from contact from the second tissue; providing the oximetry system to generate an average of the value for the one of the first oximetry readings and a value for one of the second oximetry readings based on the oximetry system detecting being removed from contact from the second tissue.
Freeman teaches a system capable of collecting a plurality of oximetry measurements from areas or volumes of tissue or body fluid. Collecting a plurality of oximetry measurements throughout the area or volume (two or more locations), the method allows for calculations to be performed to arrive at comparative, blended, or computed values (e.g., average values) (Col 12, lines 57-67).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method taught by the combination of Bechtel and Helvick to include providing for the oximetry system to contact a second tissue of a patient; providing for the oximetry system to make a plurality of second oximetry readings of the second tissue, providing for the oximetry system to be removed from contact from the second tissue, providing for the oximetry system to detect being removed from contact from the second tissue, as collecting pluralities of measurements can enable comparative, blended, or computed values over an area or volume, as taught by Freeman (Col 12, lines 57-67). It is noted that in this combination of Bechtel, Helvick, and Freeman, the average values can only be computed if at least one measurement from the first location is stored in a memory, and is then retrieved to calculate the average. Therefore, the combination of Bechtel, Helvick, and Freeman also teaches providing the oximetry system to store a value in a memory of the system unit one of the first oximetry readings based on the system unit detecting being removed from contact from the first tissue; providing for retrieving from the memory by the oximetry system the one of the first oximetry readings based on the oximetry system detecting being removed from contact from the second tissue; providing the oximetry system to generate an average of the value for the one of the first oximetry readings and a value for one of the second oximetry readings based on the system unit detecting being removed from contact from the second tissue.
Regarding claim 2, the combination of Bechtel, Helvick, and Freeman teach the method of claim 1, wherein the first and second tissues are different tissue locations of a patient (to measure an average over a volume (as taught by Freeman (Col 12, lines 57-67)), the first tissue and second tissue measured would be in different locations).
Regarding claim 3, the combination of Bechtel, Helvick, and Freeman teach the method of claim 1, wherein the first and second tissues are the same tissue of a patient (to measure an average over an area the size of the probe tip (as taught by Freeman (Col 12, lines 57-67)), the first tissue and second tissue measured could be the same location).
Regarding claim 6, the combination of Bechtel, Helvick, and Freeman teach the method of claim 1, wherein the oximetry system is a tissue oximeter (Bechtel; in an implementation, the device is a tissue oximeter [0010]).
Regarding claim 7, the combination of Bechtel, Helvick, and Freeman teach the method of claim 6, wherein the oximetry device is a laparoscopic oximeter (Bechtel; “In one application of tissue oximetry probe 100, the tissue oximetry probe can be used by a physician for a laparoscope procedure to measure the oxygen saturation of tissues within a patient.” [0270]).
Regarding claim 11, Bechtel teaches a method comprising: providing a housing of an oximetry device (enclosure of tissue oximetry system [0011]); providing a processor housed by the housing (printed circuit board includes a processor within the enclosure [0011]); providing a memory housed by the housing coupled to the processor (printed circuit board includes a memory coupled to the processor within the enclosure [0011]); providing a display, housed by the housing and visible from an exterior of the housing, coupled to the processor (“The enclosure includes a display, coupled to the processor where the display is visible from an exterior side of the enclosure.” [0011]); and providing a sensor head (sensor head 250 and probe tip 300), housed by the housing and visible from an exterior of the housing (tip portion of housing 105 holds the sensor head and probe tip [0108]), comprising at least a first source structure and at least a first detector structure (probe tip includes at least first, second, and third sensor openings which includes at least a light source and two light detectors [0011-0012), providing for the oximetry system to contact first tissue of a patient (oximetry probe 100 is in contact with tissue [0120]); make a plurality of first oximetry readings of the first tissue using the sensor head, (a plurality of oxygen saturation values can be made and repeated [0092]); and allowing the processor to control the display to display the value for the average (“Two or more measurements, such as three measurements, of the oxygen saturation value can be averaged by control processor 200 for display on display 125.” [0092]).
Bechtel does not teach wherein when the sensor head contacts first tissue of a patient, the processor controls the oximetry device, when the sensor head is removed from contact with the first tissue of the patient, allowing the processor to detect the sensor head being removed from contact from the first tissue. Bechtel does, however, teach a pressure sensor that can sense if the pressure between the probe tip and the tissue is in range to produce a valid tissue oximetry measurement ([0251]).
Helvick teaches a system where a proximity sensor is used to determine whether contact is made between the sensor device and tissue. If contact is established, measurements start and when contact stops, the measurements stop. This method determines when to start and stop measurements, improving the reliability of the system output and system longevity ([0005]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method of Bechtel to include when the sensor head contacts first tissue of a patient, the processor controls the oximetry device, when the sensor head is removed from contact with the first tissue of the patient, allowing the processor to detect the sensor head being removed from contact from the first tissue, to improve the reliability of the system output and system longevity, as taught by Helvick ([0005]). It is noted that in the combination of Bechtel and Helvick, the pressure sensor can be selected as the proximity sensor to perform the step of detecting contact with the tissue.
The combination of Bechtel and Helvick does not teach storing a value in a memory of one of the first oximetry readings based on the processor detecting the sensor head being removed from contact from the first tissue, when the sensor head of the oximetry device contacts a second tissue of the patient, allowing the processor to control the oximetry device to make a plurality of second oximetry readings of the second tissue, when the sensor head of the oximetry device is removed from contact from the second tissue, allowing the processor to detect the sensor head being removed from contact from the second tissue and retrieves from the memory the one of the first oximetry readings based on the sensor head being removed from contact from the second tissue, allowing the processor to generate an average of the value for the one of the first oximetry readings and a value for one of the second oximetry readings based on the device unit detecting being removed from contact from the second tissue.
Freeman teaches a system capable of collecting a pluralities of oximetry measurements from areas or volumes of tissue or body fluid. Collecting a pluralities of oximetry measurements throughout the area or volume (two or more locations), the method allows for calculations to be performed to arrive at comparative, blended, or computed values (e.g., average values) (Col 12, lines 57-67).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method taught by the combination of Bechtel and Helvick to include when the sensor head of the oximetry device contacts a second tissue of the patient, allowing the processor to control the oximetry device to make a plurality of second oximetry readings of the second tissue, when the sensor head of the oximetry device is removed from contact from the second tissue, allowing the processor to detect the sensor head being removed from contact from the second tissue, as collecting pluralities of measurements can enable comparative, blended, or computed values over an area or volume, as taught by Freeman (Col 12, lines 57-67). It is noted that in this combination of Bechtel, Helvick, and Freeman, the average values can only be computed if at least one measurement from the first location is stored in a memory, and is then retrieved to calculate the average. Therefore, the combination of Bechtel, Helvick, and Freeman also teaches storing a value in a memory of one of the first oximetry readings based on the processor detecting the sensor head being removed from contact from the first tissue, and retrieves from the memory the one of the first oximetry readings based on the sensor head being removed from contact from the second tissue, allowing the processor to generate an average of the value for the one of the first oximetry readings and a value for one of the second oximetry readings based on the device unit detecting being removed from contact from the second tissue.
Regarding claim 12, the combination of Bechtel, Helvick, and Freeman teach the method of claim 11, wherein the first and second tissues are different tissue locations of a patient (to measure an average over a volume (as taught by Freeman (Col 12, lines 57-67)), the first tissue and second tissue measured would be in different locations).
Regarding claim 13, the combination of Bechtel, Helvick, and Freeman teach the method of claim 11, wherein the first and second tissues are different tissue of a patient (to measure an average over an area the size of the probe tip (as taught by Freeman (Col 12, lines 57-67)), the first tissue and second tissue measured could be the same location).
Regarding claim 16, the combination of Bechtel, Helvick, and Freeman teach the method of claim 11, wherein the oximetry device is a tissue oximeter (Bechtel; in an implementation, the device is a tissue oximeter [0010]).
Regarding claim 17, the combination of Bechtel, Helvick, and Freeman teach the method of claim 16, wherein the oximetry device is a laparoscopic oximeter (Bechtel; “In one application of tissue oximetry probe 100, the tissue oximetry probe can be used by a physician for a laparoscope procedure to measure the oxygen saturation of tissues within a patient.” [0270]).
Claims 4-5 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Bechtel in view of Helvick in view of Freeman, as applied to claims 1 and 11, in view of US Patent Publication 2018/0279939 by Madsen et al. – previously cited (hereinafter “Madsen”).
Regarding claim 4, the combination of Bechtel, Helvick and Freeman teaches the method of claim 1, but does not teach wherein the stored value is a value for a second to last one of the first oximetry readings taken by the oximetry system prior to the system unit detecting being removed from contact from the first tissue.
Madsen teaches a system that collects physiological signals from a subject. The system clips, or removes, data at the end of a dataset to remove the effects of transients ([0047, 0068]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method taught by Bechtel, Helvick, and Freeman so that the stored value is a value for a second to last one of the first oximetry readings taken by the oximetry system prior to the system unit detecting being removed from contact from the first tissue, to remove the effects of transients, as taught by Madsen ([0047, 0068]).
Regarding claim 5, the combination of Bechtel, Helvick and Freeman teaches the method of claim 1, but does not teach wherein the stored value is a value for a second to last one of the second oximetry readings taken by the oximetry system prior to the system unit detecting being removed from contact from the first tissue.
Madsen teaches a system that collects physiological signals from a subject. The system clips, or removes, data at the end of a dataset to remove the effects of transients ([0047, 0068]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method taught by Bechtel, Helvick, and Freeman so that the stored value is a value for a second to last one of the second oximetry readings taken by the oximetry system prior to the system unit detecting being removed from contact from the first tissue, to remove the effects of transients, as taught by Madsen ([0047, 0068]).
Regarding claim 14, the combination of Bechtel, Helvick and Freeman teaches the method of claim 11, but does not teach wherein the stored value is a value for a second to last one of the first oximetry readings taken by the oximetry device prior to the device unit being removed from contact from the first tissue.
Madsen teaches a system that collects physiological signals from a subject. The system clips, or removes, data at the end of a dataset to remove the effects of transients ([0047, 0068]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method taught by Bechtel, Helvick, and Freeman so that the stored value is a value for a second to last one of the first oximetry readings taken by the oximetry device prior to the device unit being removed from contact from the first tissue, to remove the effects of transients, as taught by Madsen ([0047, 0068]).
Regarding claim 15, the combination of Bechtel, Helvick and Freeman teaches the method of claim 11, but does not teach wherein the stored value is a value for a second to last one of the second oximetry readings taken by the oximetry device prior to the device unit being removed from contact from the first tissue.
Madsen teaches a system that collects physiological signals from a subject. The system clips, or removes, data at the end of a dataset to remove the effects of transients ([0047, 0068]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method taught by Bechtel, Helvick, and Freeman so that the stored value is a value for a second to last one of the second oximetry readings taken by the oximetry device prior to the device being removed from contact from the first tissue, to remove the effects of transients, as taught by Madsen ([0047, 0068]).
Claims 8-10 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Bechtel in view of Helvick in view of Freeman, as applied to claims 1 and 11, in view of US Patent Publication 2013/012010 by Cauwels et al. – previously cited (hereinafter “Cauwels”).
Regarding claim 8, the combination of Bechtel, Helvick and Freeman teaches the method of claim 1, but does not teach providing for a start of a first new averaging when the oximetry system is rotated about a horizontal axis by a predetermined first number of degrees, wherein the first new averaging comprises resetting the display and initiating a first new averaging.
Cauwels teaches a device such that movement, can be interpreted as a sensed gesture and used as an input to control the device ([0135]). Different inputs signals may be configured to be sensed when the device is rotated by a predetermined amount ([0125, 0136]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method taught by Bechtel, Helvick, and Freeman to include allowing for a start of a first new averaging when the oximetry system is rotated about a horizontal axis by a predetermined number of degrees, as taught by Cauwels.
It is noted that the method step of taking oximetry measurements (starting a first new averaging) is a primary function of the oximetry device provided by the combination of Bechtel, Helvick, and Freeman of claim 11, therefore using a gesture as an input gesture to activate this function is combing known prior art elements to yield predictable results. See MPEP 2143-I-A. It is further noted that this new averaging would include displaying a new average (e.g., resetting the display and initiating a new average.
Regarding claim 9, the combination of Bechtel, Helvick, Freeman, and Cauwels teaches the method of claim 8, but does not teach providing for the display of the oximetry system to reset the display of the average when the oximetry system is rotated about a horizontal axis by the predetermined first number of degrees.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method taught by Bechtel, Helvick, Freeman, and Cauwels to include allowing for the display of the oximetry system to reset the display of the average when the oximetry system is rotated about a horizontal axis by the predetermined first number of degrees, as taught by Cauwels.
It is noted that the method step of updating the display is a function of the oximetry device provided by the combination of Bechtel, Helvick, and Freeman of claim 11 (Bechtel; [0093]), therefore using a gesture as an input gesture to activate this function is combing known prior art elements to yield predictable results. See MPEP 2143-I-A.
Regarding claim 10, the combination of Bechtel, Helvick, Freeman, and Cauwels teaches the method of claim 8, but does not teach providing for the oximetry system to prevent the oximetry system from a start of a second new averaging when the oximetry system is rotated within a predetermined second number of degrees from the predetermined first number of degrees after the oximetry system is rotated by the predetermined first number of degrees, wherein the second new averaging comprises resetting the display and initiating a second new average.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method taught by Bechtel, Helvick, Freeman, and Cauwels to include providing for the oximetry system to prevent the oximetry system from a start of a second new averaging when the oximetry system is rotated within a predetermined second number of degrees from the predetermined first number of degrees after the oximetry system is rotated by the predetermined first number of degrees, wherein the second new averaging comprises resetting the display and initiating a second new average.
It is noted that the method step of not collecting data when the oximetry device does not satisfy predetermined conditions (i.e., is in contact with the tissue) is provided by the combination of Bechtel, Helvick, and Freeman of claim 11 (Bechtel; [0093]), therefore using a gesture as an input gesture to activate this function is combing known prior art elements to yield predictable results. See MPEP 2143-I-A. It is further noted that a new averaging would be a function of the combination of Bechtel, Helvick and Freeman, therefore the combination would comprise using a gesture to prevent the collection of data, which comprises functions disclosed by Bechtel and Cauwels.
Regarding claim 18, the combination of Bechtel, Helvick and Freeman teaches the method of claim 11, but does not teach wherein when the oximetry device is rotated about a horizontal axis by a predetermined first number of degrees, providing the processor to control the oximetry device to start a first new averaging of oximetry readings, wherein providing for the start of the first new averaging comprises the resetting of the display of the value for the average and initiating a first new average.
Cauwels teaches a device such that movement, can be interpreted as a sensed gesture and used as an input to control the device ([0135]). Different inputs signals may be configured to be sensed when the device is rotated by a predetermined amount ([0125, 0136]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method taught by Bechtel, Helvick, and Freeman to about a horizontal axis by a predetermined first number of degrees, providing the processor to control the oximetry device to start a first new averaging of oximetry readings, wherein providing for the start of the first new averaging comprises the resetting of the display of the value for the average and initiating a first new average.
It is noted that the method step of taking oximetry measurements (starting a first new averaging) is a primary function of the oximetry device provided by the combination of Bechtel, Helvick, and Freeman of claim 11, therefore using a gesture as an input gesture to activate this function is combing known prior art elements to yield predictable results. See MPEP 2143-I-A. It is further noted that this new averaging would include displaying a new average (e.g., resetting the display and initiating a new average.
Regarding claim 19, the combination of Bechtel, Helvick, Freeman, and Cauwels teaches the method of claim 18, but does not teach wherein when the oximetry device is rotated about a horizontal axis by the predetermined first number of degrees, providing the processor to remove oximetry information displayed on the display.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method taught by Bechtel, Helvick, Freeman, and Cauwels such that when the oximetry device is rotated about a horizontal axis by the predetermined first number of degrees, providing the processor to remove oximetry information displayed on the display, as taught by Cauwels.
It is noted that the method step of updating the display is a function of the oximetry device provided by the combination of Bechtel, Helvick, and Freeman of claim 11 (Bechtel; [0093]), therefore using a gesture as an input gesture to activate this function is combing known prior art elements to yield predictable results. See MPEP 2143-I-A. It is noted that to display a new average of the data, the current data (e.g., oximetry information) would have to be removed.
Regarding claim 20, the combination of Bechtel, Helvick, Freeman, and Cauwels teaches the method of claim 18, but does not teach wherein when the oximetry device is rotated within a predetermined second number of degrees from the predetermined first number of degrees after the oximetry device is rotated by the first number of degrees, providing the processor to control the oximetry device to prevent a start of a second new averaging, wherein providing for preventing the start of a second new averaging comprises not resetting the display of the value for the average and not initiating a second new average.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method taught by Bechtel, Helvick, Freeman, and Cauwels wherein when the oximetry device is rotated within a predetermined second number of degrees from the predetermined first number of degrees after the oximetry device is rotated by the first number of degrees, providing the processor to control the oximetry device to prevent a start of a second new averaging, wherein providing for preventing the start of a second new averaging comprises not resetting the display of the value for the average and not initiating a second new average.
It is noted that the method step of not collecting data when the oximetry device does not satisfy predetermined conditions (i.e., is in contact with the tissue) is provided by the combination of Bechtel, Helvick, and Freeman of claim 11 (Bechtel; [0093]), therefore using a gesture as an input gesture to activate this function is combing known prior art elements to yield predictable results. See MPEP 2143-I-A. It is further noted that a new averaging would be a function of the combination of Bechtel, Helvick and Freeman, therefore the combination would comprise using a gesture to prevent the collection of data, which comprises functions disclosed by Bechtel and Cauwels.
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 1-20 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-23 of copending Application No. 18/047627 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the two applications are parallel, such that one in possession of the claimed structures of the claims of the copending application, when operated in their intended manner, would necessarily perform the method steps of the pending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments, filed 12/24/2025 have been fully considered.
The amendments to claims 1, 8, and 11 overcome the objections of record.
The amendments to the claims overcome the rejections under 35 U.S.C. 112(b) of claims 1-10. The amendments to the claims do not overcome the rejection of claims 11-20.
The amendments to the claims do not alter the scope of the claims sufficiently enough to overcome the provisional Double Patenting rejection of record.
Applicant’s arguments regarding the rejection of claim 1 under 35 U.S.C. 103 is acknowledged. Applicant’s arguments regarding the lack of prima facie obviousness rejection of claim 1 is not found persuasive. The rejection of claim 1 of record in the Non-Final Office action mailed on 06/26/2025, and reiterated in the present Office action provides explicit reasoning for why combining the references. Regarding the passage indicated by Applicant, the rejection recites “as collecting pluralities of measurements can enable comparative, blended, or computed values over an area or volume, as taught by Freeman (Col 12, lines 57-67)”. The benefit of these values is that they provide a measure of the physiological variables throughout an area of interest, thereby providing a more comprehensive understanding of the physiological variable.
Conclusion
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.
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/NELSON ALEXANDER GLOVER/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791