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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. DE10 2024 100 938.1, filed on 2024.01.12.
CLAIM INTERPRETATION
The following is a quotation of 35 U.S.C. 112(f): (FP 7.30.03)
(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. (FP 7.30.05)
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:
“patient monitoring unit configured to” in Claim 1, 2,
“procedure step detection unit configured to” in Claim 1, 2, 7, 15
“patient condition detection unit configured to” in Claim 11,
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. (FP 7.30.06).
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, 11, 12), 3, 4, 5, 6, 13, 14, 15, 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 7, 8, 9, 2, 10, 11, 12 respectively of copending Application No. 19/016,539. Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1, 11, 12 is/are determined to be obvious in light of Claim 1 of copending Application No. 19/016,539 based on reasons below for having similar limitations.
Instant application 19/016,188 claims
1, 11, 12
19/016,539 claim 1
1. A medical system, comprising: a patient monitoring unit configured to record a vital sign of a patient; a portable display which can be worn on the head of a user and which, when worn, provides a user with an at least substantially unobstructed view of an environment within a field of view of the user, wherein the portable display is configured, when worn, to display a piece of vital information in the field of view of the user which relates to the one vital sign; and a procedure step detection unit configured to determine at least one procedure step parameter describing which step of a plurality of steps of a procedure to be performed by the user on the patient the user is currently performing; wherein the portable display is configured to display and/or not display the vital information on the basis of the procedure step parameter.
1. A medical system, comprising: a patient monitoring unit configured to record a vital sign of a patient; a portable display which can be worn on the head of a user and which, when worn, provides a user with an at least substantially unobstructed view of an environment within a field of view of the user, wherein the portable display is configured, when worn, to display a piece of vital information in the field of view of the user which relates to the one vital sign;
11. The medical system as set forth in claim 1, further including: a patient condition detection unit configured to determine at least one patient condition parameter relating to a current vital condition of the patient.
and a patient condition detection unit configured to determine at least one patient condition parameter relating to a current vital condition of the patient;
12. The medical system as set forth in claim 11, wherein the portable display is configured to either display or not display the vital information on the basis of the procedure step parameter and the patient condition parameter
wherein the portable display is configured to either display or not display the vital information on the basis of the patient condition parameter.
Although the claims at issue are not identical, they are not patentably distinct from each other. For example, Claim 1 of 19/016,539 discloses “A medical system, comprising: a patient monitoring unit configured to record a vital sign of a patient;” “a patient condition detection unit configured to determine at least one patient condition parameter relating to a current vital condition of the patient” “wherein the portable display is configured to either display or not display the vital information on the basis of the patient condition parameter”. While Claim 1 of 19/016,188 discloses "select a movement classification of the respective at least one object according to the lidar points” it is not identical as Claim 1 of 19/016,539, however, in Claim 11 of 19/016,188 then discloses “a patient condition detection unit configured to determine at least one patient condition parameter relating to a current vital condition of the patient.” and Claim 12 of 19/016,188 additionally discloses “wherein the portable display is configured to either display or not display the vital information on the basis of the procedure step parameter and the patient condition parameter”. Therefore, claim 1 of 19/016,539 discloses all limitations of 19/016,188 claim 1, 17 & 18 combined.
Claim 3 is determined to be obvious in light of Claim 6 of copending Application No. 19/016,539 based on reasons below for having similar limitations.
Instant application 19/016,188 claim
19/016,539 claim 6
3. The medical system as set forth in claim 1, wherein the portable display is configured to visually enhance the vital information displayed on the basis of the procedure step parameter.
6. The medical system as set forth in claim 1, wherein the portable display is configured to visually enhance the vital information displayed on the basis of the patient condition parameter.
Claim 3 of the instant application recites visually enhancing the displayed vital information based on the procedure step parameter. Claim 6 of the reference recites the identical visual-enhancement function, differing only in that the enhancement is triggered by the patient condition parameter rather than the procedure step parameter. Selecting between these two parameters as the trigger is an obvious variation and not patentably distinct.
Claim 4 is determined to be obvious in light of Claim 7 of copending Application No. 19/016,539 based on reasons below for having similar limitations.
Instant application 19/016,188 claim
19/016,539 claim 7
4. The medical system as set forth in claim 1, wherein the portable display is configured to enlarge the vital information displayed on the basis of the procedure step parameter.
7. The medical system as set forth in claim 1, wherein the portable display is configured to enlarge the vital information displayed on the basis of the patient condition parameter.
Claim 4 of the instant application recites enlarging the displayed vital information based on the procedure step parameter. Claim 7 of the reference recites the identical enlarging function on the basis of the patient condition parameter. The substitution of one gating parameter for the other is an obvious variation; Claim 4 is therefore not patentably distinct.
Claim 5 is determined to be obvious in light of Claim 8 of copending Application No. 19/016,539 based on reasons below for having similar limitations.
Instant application 19/016,188 claim
19/016,539 claim 8
5. The medical system as set forth in claim 1, wherein the portable display is configured to display the vital information so as to flash, at least in part, on the basis of the procedure step parameter.
8. The medical system as set forth in claim 1, wherein the portable display is configured to display the vital information displayed in a manner in which it flashes, at least in part, on the basis of the patient condition parameter.
Claim 5 of the instant application recites flashing the displayed vital information based on the procedure step parameter. Claim 8 of the reference recites the identical flashing function on the basis of the patient condition parameter. The two claims differ only in the gating parameter, and Claim 5 is therefore not patentably distinct.
Claim 6 is determined to be obvious in light of Claim 9 of copending Application No. 19/016,539 based on reasons below for having similar limitations.
Instant application 19/016,188 claim
19/016,539 claim 9
6. The medical system as set forth in claim 1, wherein the portable display is configured to display the vital information independently of a viewing direction of the user.
9. The medical system as set forth in claim 1, wherein the portable display is configured to display the vital information independently of a viewing direction of the user.
Claim 13 is determined to be obvious in light of Claim 2 of copending Application No. 19/016,539 based on reasons below for having similar limitations.
Instant application 19/016,188 claim
19/016,539 claim 2
13. The medical system as set forth in claim 12, the portable display is configured to, when the patient condition parameter indicates a critical vital condition of the patient, either display or not display the vital information independently of the procedure step parameter.
2. The medical system as set forth in claim 1, wherein the portable display is configured to display the vital information if the at least one patient condition parameter is within a critical range, and wherein the portable display is configured not to display the vital information if the at least one patient condition parameter is not within the critical range.
Claim 13 of the instant application recites that, when the patient condition parameter indicates a critical vital condition, the display is controlled independently of the procedure step parameter — i.e., display is driven solely by the patient condition parameter under critical conditions. Application 19/016,539 Claim 2 recites the same critical-condition-driven display behavior (display when within the critical range, do not display when outside it), based solely on the patient condition parameter. The two claims describe substantively the same critical-condition-controlled display behavior and are not patentably distinct.
Claim 14 is determined to be obvious in light of Claim 10 of copending Application No. 19/016,539 based on reasons below for having similar limitations.
Instant application 19/016,188 claim
19/016,539 claim 10
14. The medical system as set forth in claim 1, wherein the portable display can be integrated into optical corrective glasses.
10. The medical system as set forth in claim 1, wherein the portable display can be integrated into optical corrective glasses.
Claim 15 is determined to be obvious in light of Claim 11 of copending Application No. 19/016,539 based on reasons below for having similar limitations.
Instant application 19/016,188 claim
19/016,539 claim 11
15. The portable display, in particular for the medical system, as set forth in claim 1, which can be worn on the head of a user and which, when worn, provides a user with an at least substantially unobstructed view of an environment within a field of view of the user, wherein the portable display is configured, when worn, to display vital information within the field of view of the user which relates to the one vital sign; and includes a procedure step detection unit configured to determine at least one procedure step parameter describing which step of a plurality of steps of a procedure to be performed by the user on the patient the user is currently performing; wherein the portable display is configured to display and/or not display the vital information on the basis of the procedure step parameter.
11. A portable display configured to communicate with a patient monitoring unit, the patient monitoring unit configured to record a vital sign of a patient, the portable device configured to worn on the head of a user and, when worn, provides a user with an at least substantially unobstructed view of an environment within a field of vision of the user, wherein the portable display is configured to display a vital information which relates to the vital sign, within the field of vision of the user when worn, the portable display comprising: a patient condition detection unit configured to determine at least one patient condition parameter relating to a current vital condition of the patient; wherein the portable display is configured to either display or not display the vital information on the basis of the patient condition parameter.
Claim 15 of the instant application is a portable-display claim that recites essentially the same elements as instant Claim 1 (head-worn display, substantially unobstructed view, display of vital information, procedure step detection unit, and display control based on the procedure step parameter), differing only in claim category. Application 19/016,539 Claim 11 is the parallel portable-display claim of the reference application, reciting the same head-worn display architecture with a patient condition detection unit and display control based on the patient condition parameter. For the same reasons given with respect to Claim 1, substituting the procedure step parameter for the patient condition parameter (or vice versa) as the gating parameter is an obvious variation, and the two portable-display claims are not patentably distinct.
Claim 16 is determined to be obvious in light of Claim 12 of copending Application No. 19/016,539 based on reasons below for having similar limitations.
Instant application 19/016,188 claim
19/016,539 claim 12
16. A method, in particular carried out by means of the medical system set forth in claim 1, comprising the steps of:
recording a vital sign of a patient; displaying vital information, which relates to the vital sign, within the field of view of the user by means of the portable display when the display is being worn;
determining a procedure step parameter that describes which step of a plurality of steps of a procedure to be performed by the user on the patient the user is currently performing; and displaying or not displaying the vital information on the basis of the procedure step parameter.
12. A method carried out by means of the medical system set forth in claim 1, comprising the steps of:
recording a vital sign of a patient;
displaying vital information, which relates to the vital sign, within the field of view of the user by means of the portable display when the display is being worn;
determining a patient condition parameter relating to a current vital condition of the patient;
and displaying or not displaying the vital information on the basis of the patient condition parameter.
Claim 16 of the instant application is a method claim reciting recording a vital sign, displaying vital information on a head-worn display, determining a procedure step parameter, and displaying or not displaying based on the procedure step parameter. Application 19/016,539 Claim 12 is the parallel method claim of the reference application, reciting the same steps using a patient condition parameter as the gating parameter. For the same reasons given with respect to Claim 1, the two method claims differ only in the choice of gating parameter and are not patentably distinct.
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.
Claim(s) 1-4, 7-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rodgiguez et al. (US 20190197055 A1, hereinafter Rodgiguez) in view of Jogan et al. (US 20220334787 A1, hereinafter Jogan).
Regarding Claim 1, Rodgiguez teaches a medical system, comprising: (Rodgiguez , Paragraph [0011], "Broadly, an embodiment of the present invention provides a head mounted display, typically in the form of glasses or eyewear, which can be used to electronically document patient information and chart patient care."), a patient monitoring unit configured to record a vital sign of a patient; (Rodgiguez , Paragraph [0024], "The device 10 may communicate with other devices, such as patient vital sign monitoring devices <read on patient monitoring unit configured to record a vital sign of a patient>. In this embodiment, a vital sign monitoring device may send information to the device 10 to be displayed thereupon."), a portable display which can be worn on the head of a user and which, when worn, provides a user with an at least substantially unobstructed view of an environment within a field of view of the user, wherein the portable display is configured, when worn, to display a piece of vital information in the field of view of the user which relates to the one vital sign; and (Rodgiguez, Paragraph [0006], "disposing glasses on the medical personnel, the glasses including lenses for displaying information"; [0028], "The lenses 14 of the device 10 can take various forms. For example, they may be clear lenses that can be used as a display from an inner surface thereof."; [0024], "The vital sign monitoring device may be a machine in a patient's room, such as a pulse oximeter, for example, or may be a device in a surgical suite, allowing a surgeon to “see” the vital signs without having to turn one's head to look at a machine."; it is noted since glasses with clear, see-through lenses that overlay data on the inner surface, so the wearer retains a view of the OR/patient while the data appears which is what "at least substantially unobstructed view), [[ a procedure step detection unit configured to determine at least one procedure step parameter describing which step of a plurality of steps of a procedure to be performed by the user on the patient the user is currently performing; ]], [[ wherein the portable display is configured to display and/or not display the vital information on the basis of the procedure step parameter. ]]
But Rodgiguez does not explicitly disclose a procedure step detection unit configured to determine at least one procedure step parameter describing which step of a plurality of steps of a procedure to be performed by the user on the patient the user is currently performing.
However, Jogan teaches a procedure step detection unit configured to determine at least one procedure step parameter (Jogan, Paragraph [0121], "The surgical hub 5104 can determine or infer when each step of a given surgical procedure is taking place according to data received from the various data sources 5126 that are communicably coupled to the surgical hub 5104."), describing which step of a plurality of steps of a procedure to be performed by the user on the patient the user is currently performing; (Jogan, Paragraph [0160], "The interactive surgical system may determine a task of a member of the surgical team based on one or more of the situational awareness of the intelligent surgical instrument status, the team member's functional role, and the step in the procedure."); wherein the portable display is configured to display and/or not display the vital information on the basis of the procedure step parameter. (Jogan, Paragraph [0160], "The situational awareness may be used to adapt the augmented reality virtual object display information based on the task at hand."; [0004], "The augmented reality display on the display device includes virtual objects based on the imaging data, the device-dependent data, the functional role of the member of the surgical team, and a surgical activity by the member of the surgical team.")
Jogan and Rodgiguez are analogous because both concern wearable displays that present patient-related data to clinicians during care. Rodgiguez provided a way of taking vital-sign data from bedside monitors and showing it on clear glasses so the surgeon sees the numbers without turning away from the patient. Jogan provided a way of having a surgical hub determine which step of a procedure is occurring and adapting an AR display based on that step and on device-dependent data. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the step-determination and display-adaptation logic of Jogan into the head-mounted vital-sign glasses of Rodgiguez, such that the glasses show or hide the vital information depending on the current procedural step. The motivation is to reduce cognitive load and avoid distracting information during critical steps, as Rodgiguez notes the surgeon can "see the vital signs without having to turn one's head" in Paragraph [0024] and Jogan explains adapting display "based on the task at hand" in Paragraph [0160].
Regarding Claim 2, the combination of Rodgiguez and Jogan teaches the invention in Claim 1.
The combination further teaches wherein the patient monitoring unit is configured to record different vital signs (Rodgiguez, Paragraph [0011], "The eyewear display can also be able to interface with other medical equipment to pull in vital information from heart monitors, respiratory devices, IV devices, and other numerical valuations <read on patient monitoring unit configured to record different vital signs>”). wherein the portable display is configured to display a plurality of different pieces of vital information, which relate to different vital signs, within the field of view of the user when worn (Rodgiguez, (, Paragraph [0024], "The device 10 may communicate with other devices, such as patient vital sign monitoring devices <read on plurality of different pieces of vital information>. In this embodiment, a vital sign monitoring device may send information to the device 10 to be displayed thereupon" ); and wherein the portable display is configured to display at least one of the plurality of different items of vital information on the basis of the particular step of the procedure to be performed that is detected by the procedure step detection unit (Jogan, Paragraph, [0160], "The situational awareness may be used to adapt the augmented reality virtual object display information based on the task at hand <read on display at least one item on the basis of the particular step>")
Jogan and Rodgiguez are analogous since both are dealing with head-worn systems that present patient data during care. Rodgiguez provided a way of pulling multiple vital signs (heart, respiratory, IV) into glasses. Jogan provided a way of adapting what is shown based on the current procedural step. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the step-based adaptation taught by into the multi-vital-sign glasses of such that at least one vital-sign item is displayed per step. The motivation is to reduce information overload discussed by Jogan in Paragraph [0024].
Regarding Claim 3, the combination of Rodgiguez and Jogan teaches the invention in Claim 1.
The combination further teaches wherein the portable display is configured to visually enhance the vital information displayed on the basis of the procedure step parameter ( Jogan, Paragraph [0160], "The situational awareness may be used to adapt the augmented reality virtual object display information based on the task at hand <read on visually enhance>").
Jogan and Rodgiguez are analogous since both are dealing with head-worn systems that present patient data during care. Rodgiguez provided a way of showing vital signs on clear lenses. Jogan provided a way of adapting AR display information per task. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate visually enhance per step taught by Jogan into modified invention of Jogan such that the portable display visually enhances the vital information on the basis of the procedure step parameter.
Regarding Claim 4, the combination of Rodgiguez and Jogan teaches the invention in Claim 1.
The combination further teaches wherein the portable display is configured to enlarge the vital information displayed on the basis of the procedure step parameter.
(Jogan], Paragraph [0160], "adapt the augmented reality virtual object display information based on the task at hand <read on enlarge>").
As explained in rejection of claim 1, the obviousness for combining of enlargement as a form of visual enhancement of Jogan into Rodgiguez is provided above.
Regarding Claim 7, the combination of Rodgiguez and Jogan teaches the invention in Claim 1.
The combination further teaches wherein the procedure step detection unit comprises a camera configured to generate image data, and (, Rodgiguez, Paragraph [0007], "reading, by a camera disposed on the glasses, a patient identifier <read on camera configured to generate image data>").
Rodgiguez does not explicitly disclose but Jogan teaches wherein the procedure step detection unit is configured to determine the at least one procedure step parameter using the image data (Jogan, Paragraph [0126], "use the imaging data regarding the surgical device obtained from the visualization device, to determine if the surgical device is the proper device for the current step in the surgical procedure").
Jogan and Rodgiguez are analogous since both are using imaging during procedures. Rodgiguez equipping the head-worn glasses with a camera that reads a patient identifier. Jogan provided a way of using imaging data obtained from a visualization device to determine whether the current surgical step is being performed correctly. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate step determination taught by Jogan into modified invention of Rodgiguez such that the procedure step detection unit comprises a camera configured to generate image data and determines the at least one procedure step parameter using that image data. The motivation is automated situational awareness discussed by Jogan in Paragraph [0126].
Regarding Claim 8, the combination of Rodgiguez and Jogan teaches the invention in Claim 7.
The combination further teaches wherein the camera is arranged on the portable display (Rodgiguez, Paragraph [0007], "reading, by a camera disposed on the glasses <read on camera is arranged on the portable display>”).
Regarding Claim 9, the combination of Rodgiguez and Jogan teaches the invention in Claim 7.
The combination further teaches wherein the camera is arranged separately from the portable display (Jogan, Paragraph [0125], "Alternatively, the movement data may be obtained from a visualization device that can optically track the motion of the surgical instrument."; [0126], "In some aspects, the interactive surgical system may use the imaging data regarding the surgical device <read on portable display> obtained from the visualization device <read on camera>, to determine if the surgical device is the proper device for the current step in the surgical procedure. The augmented reality device may provide a virtual object as a warning, such as an icon or a text box, overlaying an image of the surgical device in the augmented reality display to provide a warning to the surgical device user that the device is not correct for that procedure”).
Jogan and Rodgiguez and are analogous since both of them are dealing with systems that acquire intra-operative images and separately present augmented-reality information. Rodgiguez provided a way of integrating a camera directly on the glasses. Jogan provided a way of obtaining imaging data from a visualization device that optically tracks instruments, while a distinct augmented-reality device provides the visual overlay. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the separate-visualization-device architecture taught by Jogan into the modified invention of Rodgiguez such that the camera is arranged separately from the portable display. The motivation is to allow flexible sensor placement and maintain an unobstructed view.
Regarding Claim 10, the combination of Rodgiguez and Jogan teaches the invention in Claim 1.
The combination further teaches Rodgiguez teaches the procedure is [[the intubation of the patient]]: (Rodgiguez, Paragraph , "The eyewear display can also be able to interface with other medical equipment to pull in vital information from heart monitors, respiratory devices <read on intubation of the patient>, IV devices, and other numerical valuations involved with patient care").
But Rodgiguez does not explicitly disclose that the procedure is specifically the intubation of the patient.
However, Jogan teaches the procedure is the intubation of the patient (Jogan, Paragraph [0069], " In various aspects, the imaging device 24 is configured for use in a minimally invasive surgical procedure. Examples of imaging devices suitable for use with this disclosure include, but not limited to, an arthroscope, angioscope, bronchoscope, choledochoscope, colonoscope, cytoscope, duodenoscope, enteroscope, esophagogastro-duodenoscope (gastroscope ), endoscope, laryngoscope <read on intubation of the patient>, nasopharyngo-neproscope, sigmoidoscope, thoracoscope, and ureteroscope; it is noted by identifying the laryngoscope — the primary instrument used by a clinician to visualize the patient's airway during endotracheal intubation — as a compatible imaging device within the interactive surgical system).
Jogan and Rodgiguez are analogous since both are directed to medical display systems used by a medical professional in a clinical/surgical setting that display patient-related information to a clinician during a procedure performed on a patient. Rodgiguez provides a head-mounted display that interfaces with patient vital sign monitoring devices and respiratory equipment during medical procedures, keeping the clinician informed during patient care. Jogan provides the specific procedure type — laryngoscope-based airway visualization, which directly corresponds to intubation — filling the gap left by Rodgiguez regarding the specific identity of the procedure. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the laryngoscope-based procedure context taught by Jogan into the head-mounted medical display system of Rodgiguez, such that the procedure is the intubation of the patient. The motivation is to extend the clinically useful HMD system to intubation which is a critical airway procedure where hands-free access to patient vital signs is especially important.
Regarding Claim 11, the combination of Rodgiguez and Jogan teaches the invention in Claim 1.
The combination further teaches including: a patient condition detection unit configured to determine at least one patient condition parameter relating to a current vital condition of the patient. (Rodgiguez, Paragraph [0025], " a doctor wearing the device 10 can be alerted of a patient's vital signs when away from the patient, thereby alerting a doctor (or other such professional) before a patent “crashes” <read on determine at least one patient condition parameter relating to a current vital condition>").
Regarding Claim 12, the combination of Rodgiguez and Jogan teaches the invention in Claim 11.
The combination further teaches wherein the portable display is configured to either display or not display the vital information [[ on the basis of the procedure step parameter ]] and the patient condition parameter (Rodgiguez, Paragraph [0025], "alerted of a patient's vital signs... before a patent 'crashes’”).
Rodgiguez does not explicitly disclose but Jogan teaches the vital information on the basis of the procedure step parameter (Jogan, Paragraph [0160], "adapt the augmented reality virtual object display information based on the task at hand”).
As explained in rejection of claim 1, the obviousness for combining of enlargement as a form of visual enhancement of Jogan into Rodgiguez is provided above.
Regarding Claim 13, the combination of Rodgiguez and Jogan teaches the invention in Claim 12.
The combination further teaches the portable display is configured to, when the patient condition parameter indicates a critical vital condition of the patient, either display or not display the vital information independently [[ of the procedure step parameter ]] (Rodgiguez, Paragraph [0025], “alerted of a patient's vital signs... before a patent 'crashes' <read on display independently of the procedure step parameter when critical>").
Rodgiguez does not explicitly disclose but Jogan teaches the vital information of the procedure step parameter (Jogan, Paragraph [0160], "adapt the augmented reality virtual object display information based on the task at hand”).
As explained in rejection of claim 1, the obviousness for combining of enlargement as a form of visual enhancement of Jogan into Rodgiguez is provided above.
Regarding Claim 14, the combination of Rodgiguez and Jogan teaches the invention in Claim 1.
The combination further teaches wherein the portable display can be integrated into optical corrective glasses (Rodgiguez, Paragraph [0028], "The lenses 14 of the device 10 can take various forms. For example, they may be clear lenses that can be used as a display from an inner surface thereof <read on integrated into optical corrective glasses>").
Regarding Claim 15, it recites limitations similar in scope to the limitations of claim 1, but in a portable display. As shown in the rejection, the combination of Rodgiguez and Jogan disclose the limitations of claims 1. Additionally, Rodgiguez discloses an portable display that maps to Fig. 8 and Paragraph [0011] (Rodgiguez, Paragraph [0011], an embodiment of the present invention provides a head mounted display, typically in the form of glasses or eyewear) Thus, Claim 11 is met by Rodgiguez according to the mapping presented in the rejection of claims 1, given the system corresponds to the portable display.
Regarding Claim 16, it recites limitations similar in scope to the limitations of Claim 1 but as a method and the combination of Rodgiguez and Jogan teaches all the limitations as of Claim 1. Therefore is rejected under the same rationale.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rodgiguez et al. (US 20190197055 A1, hereinafter Rodgiguez) in view of Jogan et al. (US 20220334787 A1, hereinafter Jogan) as applied to Claim 1 above and further in view of Murata (US 20200100688 A1).
Regarding Claim 5, the combination of Rodgiguez and Jogan teaches the invention in Claim 1.
The combination further teaches to display the vital information so as to [[ flash ]] , at least in part, on the basis of the procedure step parameter (Jogan, Paragraph [0160], "The situational awareness may be used to adapt the augmented reality virtual object display information based on the task at hand").
But the combination does not explicitly disclose as to flash, [[ at least in part, on the basis of the procedure step parameter ]].
However, Murata teaches to flash, at least in part, on the basis of the procedure step parameter (Murata, Paragraph [0027], "The tab portions 134, 144, and 154 are lighted or blinked <read on flash> after the measurement of the vital information is completed"; [0040], "The characters indicating the types of the vital information are lighted or blinked before the measurement of the vital information is completed").
Murata and Rodgiguez combined with Jogan are analogous since both dealing with displaying patient vital information during care. Rodgiguez provides the head-worn display of vitals. Jogan provides adapting that display based on the procedural step. Murata provides the specific visual technique of flashing/blinking to indicate status. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the lighting-or-blinking taught by Murata into the step-adaptive display of Rodgiguez/Jogan, resulting in a portable display configured to display the vital information so as to flash, at least in part, on the basis of the procedure step parameter. The motivation is improved visibility of critical status changes, as Murata states the blinking notifies completion "with high visibility."
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rodgiguez et al. (US 20190197055 A1, hereinafter Rodgiguez) in view of Jogan et al. (US 20220334787 A1, hereinafter Jogan) as applied to Claim 1 above and further in view of Iwasaki (US 20170296035 A1).
Regarding Claim 6, the combination of Rodgiguez and Jogan teaches the invention in Claim 1.
The combination further teaches the portable display is configured to display the vital information [[independently of a viewing direction of the user]]: (Rodgiguez, Paragraph [0024], "a vital sign monitoring device may send information to the device 10 to be displayed thereupon. The vital sign monitoring device may be a machine in a patient's room, such as a pulse oximeter, for example, or may be a device in a surgical suite, allowing a surgeon to 'see' the vital signs without having to turn one's head to look at a machine").
But Rodgiguez does not explicitly disclose that [[ the portable display is configured to display the vital information ]] independently of a viewing direction of the user.
However, Iwasaki teaches the portable display is configured to display the vital information independently of a viewing direction of the user: (Iwasaki, Paragraph [0039], "the OSD circuit 42 b may be controlled to display the warning information image at all times <read on display the vital information independently of a viewing direction of the user> when the endoscopic image is displayed. That is, the OSD circuit 42 b may not be able to hide the warning information image by the user operation or the like").
Iwasaki and Rodgiguez are analogous since both are directed to medical display systems used in a clinical/operating room setting that display patient-critical information to a medical professional during a patient care procedure. Rodgiguez provides a head-mounted display worn by a clinician that delivers vital sign information persistently to the user's field of view during medical procedures, with the benefit of keeping that information accessible without redirecting one's gaze to a separate monitor. Iwasaki provides the specific display control configuration that ensures patient-critical information is displayed at all times, independent of operator action — directly reading on displaying vital information independently of a viewing direction. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the always-on display configuration taught by Iwasaki into the head-mounted medical display system of Rodgiguez, such that the portable display is configured to display the vital information independently of a viewing direction of the user. The motivation is to ensure that vital patient information is reliably and persistently visible to the clinician at all times during a procedure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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/YuJang Tswei/Primary Examiner, Art Unit 2614
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