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 .
Response to Amendment
Claims 16, 28, and 30 is amended. Claim 29 is canceled. Claim 31 is added. Claims 16-28 and 30-31 are pending in this application.
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) 16-28 and 30-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Driscoll et al., US 2023/0204473 in view of Purdy et al., US 2022/0015729.
Regarding claim 16, O’Driscoll discloses a specimen receptacle system for an imaging apparatus for imaging ex-vivo tissue specimens (para 0006; systems (i.e., utilities) for maintaining an excised tissue specimen in a fixed or stable orientation during imaging), the specimen receptacle system comprising a specimen receptacle having a bottom and an upstanding wall (fig. 12, element 104; para 0093; an apparatus having a bottom and an upstanding wall);
an additional bottom plate which is attachable to the bottom of the specimen receptacle (fig. 12, element 182; para 0093; a grid member attached to the first position member),
wherein the additional bottom plate is configured to receive the ex-vivo tissue specimen (fig. 12, element 300; para 0093; the specimen is placed on the grid member), and
wherein the additional bottom plate includes at least two distinctive orientation markers configured to allow assignation of at least two substantially transverse anatomical directions to said at least two distinctive orientation markers (figs. 45-46 and 48, elements 1000 and 1004; para 0138-0150; first and second orientation markers with directions).
O’Driscoll discloses claim 16 as enumerated above, but O’Driscoll does not explicitly disclose the orientation of the ex-vivo tissue specimen on the additional bottom plate chosen by the user and a controller comprising at least one processor and at least one memory including computer program code, wherein the controller is configured to assign an anatomical meaning to the orientation markers based on the orientation of the ex- vivo tissue specimen on the bottom plate chosen by the user as claimed.
However, Purdy discloses an operator (e.g., surgeon) of the system may be instructed to position the specimen over the receiving surface of the platform in its home position such that a particular portion of the specimen (e.g., a first portion of the specimen facing a first anatomical region of the patient (e.g., the caudal region) before excision) faces towards a first particular fixed portion of the system (para 0010-0011, 0055, and 0063). Further, Purdy discloses the controller including processor(s) and a memory may automatically convey graphical orientation indications in the resulting image(s) in any appropriate manner. As one example, the controller may utilize numbers, letters, and/or words to connote the various portions of the specimen. For instance, the controller may automatically superimpose an “A” above the specimen to connote that such portion of the specimen faces the anterior portion of the patient, an “L” to the right of the specimen to connote that such portion of the specimen faces the lateral portion of the patient, and so on. Other examples include the use of different background colors in the image to connote various portions of the specimen, an avatar whose body position/orientation changes depending upon the particular orientation of the specimen in the image, and/or the like (para 0018, 0044-0045, and 0068).
Therefore, taking the combined disclosures of O’Driscoll and Purdy as a whole, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate an operator (e.g., surgeon) of the system may be instructed to position the specimen over the receiving surface of the platform in its home position such that a particular portion of the specimen (e.g., a first portion of the specimen facing a first anatomical region of the patient (e.g., the caudal region) before excision) faces towards a first particular fixed portion of the system. Further, the controller including processor(s) and a memory may automatically convey graphical orientation indications in the resulting image(s) in any appropriate manner. As one example, the controller may utilize numbers, letters, and/or words to connote the various portions of the specimen. For instance, the controller may automatically superimpose an “A” above the specimen to connote that such portion of the specimen faces the anterior portion of the patient, an “L” to the right of the specimen to connote that such portion of the specimen faces the lateral portion of the patient, and so on. Other examples include the use of different background colors in the image to connote various portions of the specimen, an avatar whose body position/orientation changes depending upon the particular orientation of the specimen in the image, and/or the like as taught by Purdy into the invention of O’Driscoll for the benefit of understanding how the specimen is oriented relative to the patient's body. (Purdy: para 0006).
Regarding claim 17, the specimen receptacle system according to claim 16, O’Driscoll in the combination further disclose wherein the additional bottom plate is made of foam (para 0093).
Regarding claim 18, the specimen receptacle system according to claim 16, O’Driscoll in the combination further disclose wherein the specimen receptacle includes an inwardly protruding edge (fig. 8, element 117; para 0089), and wherein the additional bottom plate includes a corresponding recess configured to receive said protruding edge of the specimen receptacle (fig. 12, element 182; para 0093).
Regarding claim 19, the specimen receptacle system according to claim 16, O’Driscoll in the combination further disclose wherein the additional bottom plate includes at least four distinctive orientation markers configured to indicate at least four anatomical directions of which at least two anatomical directions are substantially transverse to each other (para 0150), wherein in particular every two adjacent orientation markers are configured to indicate substantially transverse anatomical directions (figs. 45-46 and 48, elements 1000 and 1004; para 0138-0150).
Regarding claim 20, the specimen receptacle system according to claim 16, O’Driscoll in the combination further disclose wherein the specimen receptacle is at least partly transparent (para 0094 and 0096).
Regarding claim 21, the specimen receptacle system according to claim 16, Purdy in the combination further disclose wherein the specimen receptacle is substantially cylindrical (para 0079).
Regarding claim 22, the specimen receptacle system according to claim 16, O’Driscoll in the combination further disclose wherein an upper side of the specimen receptacle is open (fig. 12, element 104; para 0093-0094).
Regarding claim 23, the specimen receptacle system according to claim 16, O’Driscoll in the combination further disclose wherein an upper edge of the upstanding wall includes a visual indicator such as a notch (fig. 12, elements 132 and 136; para 0072 and 0094).
Regarding claim 24, the specimen receptacle system according to claim 16, O’Driscoll in the combination further disclose comprising a platform on which the bottom of the specimen receptacle is releasably fixable (fig. 12, elements 132 and 136; para 0072 and 0094).
Regarding claim 25, the specimen receptacle system according to claim 24, O’Driscoll in the combination further disclose wherein the specimen receptacle and/or the platform are configured to allow a releasable fixating of the specimen receptacle on the platform in a single orientation only (fig. 12, elements 132 and 136; para 0072 and 0094).
Regarding claim 26, O’Driscoll discloses an imaging apparatus system for imaging ex-vivo tissue specimens including a specimen receptacle system according to claim 16 (figs. 5 and 7, element 404; para 0070 and 0077; X-ray source).
Regarding claim 27, the imaging apparatus system according to claim 26, O’Driscoll in the combination further disclose comprising a positron emission tomography (PET) imaging module and/or a computed tomography (CT) imaging module (figs. 5 and 7, element 404; para 0070 and 0077).
Regarding claim 28, the specimen receptacle system according to claim 16, O’Driscoll and Purdy in the combination further disclose wherein assigning the anatomical meaning to the orientation markers comprises (Purdy: para 0018, 0044-0045, and 0068) according to claim 16, comprising the steps of:
optionally, displaying on a screen the at least two orientation markers and six anatomical directions (this limitation is not addressed because of the claimed “optionally”);
receiving from the user input an assignation of a first orientation marker of the at least two orientation markers to a first of six anatomical directions (O’Driscoll: figs. 45-46, 48, and 51-52; para 0137-0150 and Purdy: figs. 8-9; para 0016-0018 and 0067-0068);
optionally, displaying on the screen four of the six anatomical directions eliminating the anatomical direction to which the first orientation marker has been assigned and its opposite anatomical direction (this limitation is not addressed because of the claimed “optionally”);
receiving from the user input an assignation of a second orientation marker, which is next to the first orientation marker, to a second anatomical direction which is transverse to the first anatomical direction, and which is one of the four anatomical directions displayed on the screen (O’Driscoll: figs. 45-46, 48, and 51-52; para 0137-0150 and Purdy: figs. 8-9; para 0016-0018 and 0067-0068);
deriving from said first and second transverse anatomical directions the orientation of the ex-vivo tissue specimen (O’Driscoll: para 0144-0148 and Purdy: figs. 8-9; para 0016-0018 and 0067-0068); and
optionally, displaying on the screen the assigned orientation of the ex-vivo tissue specimen (this limitation is not addressed because of the claimed “optionally”).
Regarding claim 30, this claim recites substantially the same limitations that are performed by claim 28 above, and it is rejected for the same reasons.
Regarding claim 31, the specimen receptacle system according to claim 28, Purdy in the combination further disclose wherein assigning the anatomical meaning to the orientation markers (para 0018, 0044-0045, and 0068) includes:
the displaying on the screen the at least two orientation markers and six anatomical directions (figs. 8-9; para 0016-0018 and 0067-0068);
the displaying on the screen four of the six anatomical directions eliminating the anatomical direction to which the first orientation marker has been assigned and its opposite anatomical direction (figs. 8-9; para 0016-0018 and 0067-0068); and
the displaying on the screen the assigned orientation of the ex-vivo tissue specimen (figs. 8-9; para 0016-0018 and 0067-0068).
Response to Arguments
Applicant's arguments with respect to claims 16-28 and 30-31 have been considered but are moot in view of the new ground(s) of rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VAN D HUYNH whose telephone number is (571)270-1937. The examiner can normally be reached 8AM-6PM.
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/VAN D HUYNH/Primary Examiner, Art Unit 2665
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