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 .
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 16-20 and 22-30 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by O’Driscoll et al., US 2023/0204473.
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);
wherein the system further comprises 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).
Regarding claim 17, the specimen receptacle system according to claim 16, O’Driscoll further discloses wherein the additional bottom plate is made of foam (para 0093).
Regarding claim 18, the specimen receptacle system according to claim 16, O’Driscoll further discloses 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 further discloses 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 further discloses wherein the specimen receptacle is at least partly transparent (para 0094 and 0096).
Regarding claim 22, the specimen receptacle system according to claim 16, O’Driscoll further discloses 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 further discloses 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 further discloses 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 further discloses 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 further discloses 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, O’Driscoll discloses a computer-implemented method for assigning an orientation to an ex-vivo tissue specimen laying in a specimen receptacle (figs. 45-46, 48, and 51-52; para 0137-0150) 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 a user input an assignation of a first orientation marker of the at least two orientation markers to a first of six anatomical directions (figs. 45-46, 48, and 51-52; para 0137-0150);
optionally, displaying on a 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 a 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 (figs. 45-46, 48, and 51-52; para 0137-0150);
deriving from said first and second transverse anatomical directions the orientation of the ex-vivo tissue specimen (para 0144-0148);
optionally, displaying on a screen the assigned orientation of the ex-vivo tissue specimen (this limitation is not addressed because of the claimed “optionally”).
Regarding claim 29, this claim recites substantially the same limitations that are performed by claim 28 above, and it is rejected for the same reasons.
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.
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) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Driscoll et al., US 2023/0204473 in view of Fan et al., US 2019/0062681.
Regarding claim 21, the specimen receptacle system according to claim 16, O’Driscoll does not explicitly disclose wherein the specimen receptacle is substantially cylindrical as claimed.
However, Fan discloses a cylindrical sample container (figs. 2-3; para 0061).
Therefore, taking the combined disclosures of O’Driscoll and Fan 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 a cylindrical sample container as taught by Fan into the invention of O’Driscoll for the benefit of positioning and securing an excised biological tissue specimen for imaging and analysis (Fan: para 0002).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Purdy et al., US 2025/0134477 discloses a method of generating images of a specimen that includes triggering a source of electromagnetic radiation to emit a beam of electromagnetic radiation along an axis through a tissue specimen and towards an imaging detector.
Pogue et al., US 2021/0113146 discloses a system for specimen imaging with combined x-ray and optical measurement includes a micro-X-ray computed tomography (CT) unit adapted to provide voxel-based CT images of the specimen.
Wismuellet et al., US 2015/0083893 discloses a method and device for preserving and imaging an object, such as a breast biopsy specimen, and more particularly to such a method and device in which the spatial orientation of the object is not distorted.
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.
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, Stephen R Koziol can be reached at (408) 918-7630. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/VAN D HUYNH/Primary Examiner, Art Unit 2665