DETAILED ACTION
*Note in the following document:
1. Texts in italic bold format are limitations quoted either directly or conceptually from claims/descriptions disclosed in the instant application.
2. Texts in regular italic format are quoted directly from cited reference or Applicant’s arguments.
3. Texts with underlining are added by the Examiner for emphasis.
4. Texts with
5. Acronym “PHOSITA” stands for “Person Having Ordinary Skill In The Art”.
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 .
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claim(s) 1-3, 5-10, 12-17 and 19-20 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,-2, 4, 7, 12 and 14 of U.S. Patent No.11,551,380 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim of the instant application is either anticipated by, or the obvious variation of, the claim of copending application/U.S. Patent No. 11,551,380 B2, as shown in the table below.
Instant Application
US 11,551,380 B2
1. A medical interventional system for performing an interventional procedure, The system comprising:
an interactive medical device including a plurality of components;
an augmented reality display device worn by a user and configured to show an image that includes one or more components of the plurality of components of the interactive medical device in an environment during the interventional procedure using the interactive medical device; and
a processor connected to memory and configured to generate a contextual overlay over the image shown on the augmented reality display device, wherein the processor is configured to generate the contextual overlay to indicate one or more steps to perform the interventional procedure.
A medical interventional system, comprising:
an interactive medical device including a plurality of components;
an augmented reality display device worn by a user and configured to show an image of at least one component of the plurality of components of the interactive medical device viewed by the user during an interventional procedure in an environment using the interactive medical device; and
a processor connected to memory and configured to generate a contextual overlay over the image of the at least one component shown on the augmented reality display device, wherein the processor is configured to generate the contextual overlay to include identification of control of the at least one component to assist the user in performing the interventional procedure using the interactive medical device.
4. The system as recited in claim 1, wherein the processor is further configured to generate the contextual overlay to include an identification of a step of the interventional procedure to be performed by the user.
2. The system as recited in claim 1, wherein the processor is configured to generate the contextual overlay to further identify the one or more components.
1, 4
3. The system as recited in claim 1, wherein, to indicate each of the one or more steps, the processor is further configured to identify a component of the one or more components and indicate an instruction to control the identified component for performance of the interventional procedure.
1, 4
5. The system as recited in claim 3, wherein the processor is configured to generate the contextual overlay to further identify a specific region in the environment to position a component of the interactive medical device.
7. The system as recited in claim 1, wherein the processor is further configured to generate the contextual overlay to include identification of a specific region in the environment.
6. The system as recited in claim 1, wherein the processor is further configured to:
obtain information including at least one of: feedback from the user, feedback from a subject, feedback from the interactive medical device during the interventional procedure, a history of signals from the one or more components, or a history of signals from a database;
determine the one or more steps to perform the interventional procedure based on the information; and
provide signals to generate the contextual overlay to identify the one or more steps.
2. The system as recited in claim 1, wherein the processor is further configured to: receive feedback from at least one of the user, a subject, and the interactive medical device during the interventional procedure; and receive the feedback and provide the contextual overlay based on the feedback.
7. The system as recited in claim 1, wherein the one or more steps of the contextual overlay are indicated to be performed by the user.
4. The system as recited in claim 1, wherein the processor is further configured to generate the contextual overlay to include an identification of a step of the interventional procedure to be performed by the user.
8
1, 4 and 12, 14
9
1, 4 and 12, 14
10
1, 4 and 12, 14
12
7
13
2
14
4
15
1, 4 and 12, 14
16
1, 4 and 12, 14
17
1, 4 and 12, 14
19
7
20
2
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 8-20 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.
Independent Claim 8/15 recites the limitation "the user". There is insufficient antecedent basis for this limitation in the claim. Other dependent claims are rejected due to their dependence on their respective independent claims. For examination purpose, the Examiner assumes it is a typo and the cited the user is intended to be “a user”.
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 of this title, 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.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 6-9, 13-16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Belei (US 2015/0230768 A1) in view of Boettger et al. (US 2017/0186157 A1).
Regarding Claim 1, Belei teaches or suggests a medical interventional system (Fig.2a-c: notice the X-ray imaging system) for performing an interventional procedure ([0002]: In movable X-ray imaging systems, for example mobile C-arm systems, the positioning is of importance for optimal image quality and also for the ease of use. As an example, during an operation or intervention, the X-ray imaging system can be moved at least partially for different purposes. [0002]: In movable X-ray imaging systems, for example mobile C-arm systems, the positioning is of importance for optimal image quality and also for the ease of use. As an example, during an operation or intervention, the X-ray imaging system can be moved at least partially for different purposes), the system comprising:
an interactive medical device including a plurality of components (Fig.2a);
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an augmented reality display device (Fig.2a-c: display 22) configured to show an image that includes one or more components (The image 70 in Fig.5 is interpreted as the displayed image that includes one or more components clamps 60. Also see [0077]: FIG. 5 shows a further schematic setup for the alignment movement. An image 58 indicates clamps 60 holding open an operational field 62. As a manually applied outline, a manually applied marking 64 is provided, together with the angular arrangement of the clamps 60, represented by centre lines 66. These manually applied outlines can then be used further, for example as reference points in a further image setup 68, which is a combination of the result of the image 58, in combination with an actual image 70, provided for the combination of image setup 68, as indicated with first arrow 72 and second arrow 74, the latter indicating the provision of the manually applied outline structures) of the plurality of components of the interactive medical device in an environment (see Fig.8 and [0049]: FIG. 8 shows a further example of movable X-ray imaging system in relation with other equipment in an interventional room) during the interventional procedure using the interactive medical device ([0053]: For an acquisition of at least one further X-ray image in a projection coincident with the first projection parameters of the first X-ray image, the display 22 is configured to display at least a graphical representation of the at least one reference point in the first image at least partly overlaid with an actual image provided by the at least one camera 18 to guide an alignment movement of the X-ray source and/or the X-ray detector and the object in relation to each other after an intermediate displacement); and
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a processor connected to memory ([0093]: In another exemplary embodiment of the present invention, a computer program or a computer program element is provided that is characterized by being adapted to execute the method steps of the method according to one of the preceding embodiments, on an appropriate system) and configured to generate a contextual overlay over the image shown on the augmented reality display device, wherein the processor is configured to generate the contextual overlay to indicate one or more steps to perform the interventional procedure ([0082]: Further, also on the display, second movement direction indicators 81 are provided in relation to the displayed image data of the object to indicate the possible movement directions of the image acquisition arrangement in relation to the object).
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Belei discloses display 22 is an augmented reality display since the display is configured to display at least a graphical representation of the at least one reference point in the first image at least partly overlaid with an actual image provided by the at least one camera to guide an alignment movement of the X-ray source and/or the X-ray detector and the object in relation to each other after an intermediate displacement ([0006]). But Belei fails to disclose the display is a augmented reality display device worn by a user.
However Boettger discloses it had been known to use a wearable augmented reality display device during interventional procedure ([0127]: In accordance with one form of embodiment of the invention the first output module features a first viewing device, in particular in the form of data eyeglasses, a data contact lens and/or a retinal projector. [0143]: One application of medical imaging lies in the field of intervention, in which the images provided by the medical imaging device are used during a medical intervention in order to plan the intervention and to check the progress of the intervention. Also see Fig.6).
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Therefore it would have been obvious to a PHOSITA before the effective filing date to incorporate the teaching of Boettger into that of Belei and to include an augmented reality display device worn by a user so that the user does not need to shift his/her view back and forth between the intervention area and the one or more monitors during the course of the intervention as suggested by Boettger ([0005]).
Regarding Claim 2, Belei further teaches or suggests wherein the processor is configured to generate the contextual overlay to further identify the one or more components (see Fig.5: notice the clamps 60 which is interpreted as the one or more components).
Regarding Claim 6, Belei disclose overlaying a first image captured previously with a current image and providing a movement direction indicators 81 as shown in Fig.7 during an interventional procedure. Belei discloses the display is configured to display at least a graphical representation of the at least one reference point in the first image at least partly overlaid with an actual image provided by the at least one camera to guide an alignment movement of the X-ray source and/or the X-ray detector and the object in relation to each other after an intermediate displacement ([0006]). Therefore it would have been obvious for a PHOSITA before the effective filing date of the claimed invention to incorporate the teaching of Belei and to obtain information including at least one of: feedback from the user, feedback from a subject, feedback from the interactive medical device during the interventional procedure, a history of signals from the one or more components, or a history of signals from a database; determine the one or more steps to perform the interventional procedure based on the information; and provide signals to generate the contextual overlay to identify the one or more steps in order to assist the alignment until the alignment is completed.
Regarding Claim 7, Belei teaches or suggests wherein the one or more steps of the contextual overlay are indicated to be performed by the user ([0082]: Further, also on the display, second movement direction indicators 81 are provided in relation to the displayed image data of the object to indicate the possible movement directions of the image acquisition arrangement in relation to the object. [0085]: The movement direction indicators provide the possibility for an error-free and robust communication between the surgeon and the operating stuff for moving the X-ray imaging system).
Regarding Claims 8-9 and 13-14, Claims 8-9 and 13-14 are similar to Claims 1-2 and 6-7 except in the format of method. Therefore the same reason(s) for rejection is/are applied to Claims 1-2 and 6-7 is/are also applied to Claims 8-9 and 13-14.
Regarding Claims 15-16 and 20, Claims 15-16 and 20 are similar to Claims 1-2 and 6 except in the format of method. Therefore the same reason(s) for rejection is/are applied to Claims 1-2 and 6 is/are also applied to Claims 15-16 and 20.
Allowable Subject Matter
Claims 3-5, 10-13 and 17-19 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 and above double patent rejection and 112 (b) rejection are overcome.
Prior art, either individually or in combination, fails to disclose or render obviousness the limitation of identify a component of the one or more components and indicate an instruction to control the identified component for performance of the interventional procedure as claimed in dependent claim 3 (similar limitation is cited in Claim 10/17). The closest prior art, Belei (US 2015/0230768 A1), discloses identifying a component of the one or more components such as clamps 60. However, prior art fails to disclose indicate an instruction to control the identified component for performance of the interventional procedure. Claims 4-5, 11-12 and 18-19 are objected due to their dependency on Claim 3/10/17.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lang (US 2020/0138518 A1) discloses the use of virtual surgical guides such as a distal femoral cut block displayed by an OHMD and physical surgical guides such as physical distal femoral cut blocks ([1541]) as shown in Fig.19a-d.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YINGCHUN HE whose telephone number is (571)270-7218. The examiner can normally be reached M-F 8:00-5:00 MT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Xiao M Wu can be reached at 571-272-7761. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YINGCHUN HE/Primary Examiner, Art Unit 2613
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