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 § 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.
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.
Claim(s) 1, 2, 6, 15, 17, 18, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Satish et al. (US 20140128838 A1 – cited by Applicant), hereinafter Satish, in view of Williams et al. (US 20130245599 A1 – cited by Applicant), hereinafter Williams.
Regarding Claim 1, Satish teaches: A method of estimating blood loss with a system including a receptacle, a vacuum source, a camera, and a display, the method comprising (abstract; paragraph 0067):
continuously capturing images of the receptacle with the camera, wherein the images depict the fluids within the receptacle (paragraph 0027-0030);
evaluating the images to determine estimated blood component quantities in the fluids (paragraph 0019);
continuously monitoring a fluid level of the fluids within the receptacle (paragraph 0035);
updating a determined volume of fluids within the receptacle based on the monitored fluid level (paragraph 0035);
estimating the blood loss based on the evaluated images and the updated volume of fluids, wherein the estimated of blood loss is updated substantially in real-time (paragraph 0054-0055); and
displaying, on the display in real-time, the estimated blood loss (figure 9; paragraph 0054).
While Examiner believes that a vacuum source is implied as Satish mentions the use of a surgical suction canister, Satish does not explicitly mention directing suction from a vacuum source to suction fluid into the receptacle.
Williams teaches that it is well known in the art that a vacuum source is commonly used with a suction canister collect fluid (paragraph 0155). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method of Satish to include directing suction from a vacuum source to suction fluid into the receptacle to efficiently collect lost fluids.
Regarding Claim 2, Satish in view of Williams teaches: The method of claim 1, wherein the system further includes a fluid level sensor, wherein the step of continuously monitoring the fluid level is based fluid level signals from the fluid level sensor (paragraph 0035-0037).
Regarding Claim 6, Satish in view of Williams teach: The method of claim 1, further comprising estimating intermittent estimates of blood loss based on the estimated blood component quantities and corresponding intermittent volumes of fluids within the receptacle (figure 9).
Regarding Claim 15, Satish teaches: A method of estimating blood loss with a system including a receptacle, a vacuum source, a camera, and a display, the method comprising (abstract; paragraph 0067):
operating the system in a fill mode in which the receptacle is filled with a flow of fluids from a patient (paragraph 0019-0022);
capturing images of the receptacle with the camera with the system in the fill mode, wherein the images depict the fluids within the receptacle (paragraph 0019);
evaluating the images to update a determined intermittent estimated blood component quantity in the fluids (paragraph 0019);
estimating the blood loss based on the updated estimated blood component quantity and corresponding intermittent volumes of fluid within the receptacle (paragraph 0054-0055); and
displaying, on the display in real-time, the estimated blood loss (figure 9; paragraph 0054).
While Examiner believes that a vacuum source is implied as Satish mentions the use of a surgical suction canister, Satish does not explicitly mention directing suction from a vacuum source to suction fluid into the receptacle.
Williams teaches that it is well known in the art that a vacuum source is commonly used with a suction canister collect fluid (paragraph 0155). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method of Satish to include directing suction from a vacuum source to suction fluid into the receptacle to efficiently collect lost fluids.
Regarding Claim 17, Satish in view of Williams teaches: The method of claim 15, wherein the images are captured continuously (paragraph 0028).
Regarding Claim 18, Satish in view of Williams teach: The method of claim 15, wherein the images are captured at fixed timing increments or fixed volume increments (paragraph 0028).
Regarding Claim 20, Satish in view of Williams teaches: The method of claim 15, wherein the system further includes a fluid level sensor, the method further comprising monitoring the fluid level is based fluid level signals from the fluid level sensor to determine the intermittent volumes of fluid (paragraph 0035-0037).
Claim(s) 7-10, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Satish in view of Williams, further in view of Satish et al. (US 20130303870 A1 – cited by Applicant), hereinafter Satish’870.
Regarding Claim 7, Satish in view of Williams teach: The method of claim 1, further. While Satish mentions triggering the camera in any suitable way, Satish does not explicitly mention triggering the camera to capture the images based on the monitored fluid level.
Satish’870 teaches triggering the camera to capture the images based on the monitored fluid level (paragraph 0038; trigger image capture once volume threshold is detected). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the method to include triggering the camera to capture the images based on the monitored fluid level in order to preserve/conserve compute resources until actually needed.
Regarding Claim 8, Satish in view of Williams, further in view of Satish’870 teach: The method of claim 7, wherein the camera is triggered to capture the images at one of fixed timing increments, and fixed volume increments (Satish – paragraph 0028).
Regarding Claim 9, Satish teaches: A method of estimating blood loss with a system including a receptacle, a vacuum source, a camera, and a display, the method comprising (abstract; paragraph 0067):
continuously monitoring a fluid level of the fluids within the receptacle (paragraph 0035);
evaluating the images to determine estimated blood component quantities in the fluids (paragraph 0019);
updating a determined volume of fluids within the receptacle based on the monitored fluid level (paragraph 0035);
estimating the blood loss based on the evaluated images and the updated volume of fluids, wherein the estimated blood loss is updated substantially in real-time (paragraph 0054-0055); and
displaying, on the display and in real-time, the estimated blood loss (figure 9; paragraph 0054).
While Examiner believes that a vacuum source is implied as Satish mentions the use of a surgical suction canister, Satish does not explicitly mention directing suction from a vacuum source to suction fluid into the receptacle.
Williams teaches that it is well known in the art that a vacuum source is commonly used with a suction canister collect fluid (paragraph 0155). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method of Satish to include directing suction from a vacuum source to suction fluid into the receptacle to efficiently collect lost fluids.
While Satish mentions triggering the camera in any suitable way, Satish does not explicitly mention triggering based on the receptacle being filled to a first intermediate fluid volume, wherein the images depict the fluids within the receptacle.
Satish’870 teaches triggering the camera to capture the images based on the monitored fluid level (paragraph 0038; trigger image capture once volume threshold is detected). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the method to include triggering the camera to capture the images based on the monitored fluid level in order to preserve/conserve compute resources until actually needed.
Regarding Claim 10, Satish in view of Williams, further in view of Satish’870 teach: The method of claim 9, wherein the system further includes a fluid level sensor, wherein the step of continuously monitoring the fluid level is based fluid level signals from the fluid level sensor (Satish’870 – paragraph 0030).
Regarding Claim 19, Satish in view of Williams teaches: The method of claim 15. While Satish mentions triggering the camera in any suitable way, Satish does not explicitly mention triggering based on the receptacle being filled to a first intermediate fluid volume, wherein the images depict the fluids within the receptacle.
Satish’870 teaches triggering the camera to capture the images based on the monitored fluid level (paragraph 0038; trigger image capture once volume threshold is detected). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the method to include triggering the camera to capture the images based on the monitored fluid level in order to preserve/conserve compute resources until actually needed.
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 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12207924. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims overlap in scope with the patented claims, where the differences in scope are obvious variants over one another.
Allowable Subject Matter
Claims 3-5, 11-14 and 16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: No prior art of record (Satish and Satish’870) teach actuating a valve in response to the fluid level/volume reaching a certain threshold. None of the prior art considered, alone or in combination, teaches that particular feature combined with the other limitations of the claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAY B SHAH whose telephone number is (571)272-0686. The examiner can normally be reached M-F 8-5.
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JAY SHAH
Primary Examiner
Art Unit 3791
/JAY B SHAH/Primary Examiner, Art Unit 3791
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