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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on February 06, 2025 and April 07, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on October 23, 2024 are accepted.
Claim Objections
Claim 2 is objected to because of the following informalities:
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 2 and 21 recite “at least one graphical indication is…without being imaged on the at least one first image and the at least one second image”. The term “without” makes it a negative limitation that requires an explicit disclosure in the specification. The mere absence of a positive recitation is not basis for an exclusion. See MPEP 2173.05(i). “Any negative limitation or exclusionary provision must have basis in the original disclosure. If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims. See In re Johnson, 558 F.2d 1008, 1019, 194 USPQ 187, 196 (CCPA 1977)”.
If Applicant intends to recite that the at least one graphical indication is generated by the controller (as disclosed in [0019]), as opposed to a tangible object such as a radiopaque marker being imaged and shown on the display, the claims should be amended to clearly reflect such.
The dependent claims of the above rejected claims are rejected due to their dependency.
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.
Claim 9 is 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.
Claim 9 depends on claim 2 recites “at least one three-dimensional tissue image” in line 3. It is unclear what the link is between this term and the term “at least one…three-dimensional specimen image” recited in claim 2, line 15. Both the 3D specimen image in claim 2 and the tissue image in claim 9 are displayed. Since claim 9 depends on claim 2, it is unclear if they refer to the same, or what the difference it between a specimen image and a tissue image. In the specification, the term “tissue specimen” is recited. Consistent claim language is required if the above identified two types of images refer to the same.
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.
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.
Claims 2-8 and 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al., US 2017/0336706 A1, in view of Mullaney et al., US 2011/0103676 A1, hereinafter Mullaney.
Claims 2 and 12. Wang teaches in FIGS.2-3, 10 and claim 21 a method of generating images of a specimen (302, 305) and an imaging cabinet comprising:
positioning the specimen on a receiving surface of an imaging system platform disposed within an interior chamber of an imaging cabinet, the imaging system platform being at a home position ([0126]: the container 42 can be used to maintain the excised tissue in a particular orientation; and [0127]: At 16 [of FIG.1], the container 42 is placed in a chamber 40. The container 42 is placed in a chamber 40 of the imaging system 10 for imaging purposes; [0447]: as another example, the container 1000 may include orientation cues (or fiducials) that may permit consistent handling of the contained tissue sample by preserving the orientation of the contained tissue sample);
operating an x-ray source to emit an x-ray beam along a first axis through the specimen when the imaging system platform is in the home position and towards an x-ray imaging detector and generating at least one first image of the specimen along the first axis (FIG.3, step 302: record using an X-ray imager a first X-ray image of the Ex-rays exiting the imaging volume);
rotating the imaging system platform from the home position towards a rotational position (FIG.3, step 303: rotate the imaging stage by a predetermined amount around at least one of the first rotational axis and the second rotational axis);
operating the x-ray source to emit an x-ray beam along a second axis through the specimen when the imaging system platform is in the rotational position and towards the x-ray detector and generating at least one second image of the specimen along the second axis (FIG.3, steps 304 and 305: irradiate the biological sample with X-rays, and record a second X-ray image of the X-rays exiting the imaging volume through the transparent portion of the rotatable imaging stage; and [0045]: As the rotatable imaging stage is moved around one or both of its rotational axes, the locations of any radiodense regions of the biological sample relative to the locations of the X-ray source and X-ray imager will be changed); and
displaying at least one two-dimensional or three-dimensional specimen image based on the at least one first image and the at least one second image ([0007]: the devices and methods are used for X-ray imaging to visualize tissue dentary and radiopaque tissue inserts. The resulting multi-axis 3D rotational images; and [0062]: an X-ray image displayed on the display face 507).
In regard to claim 12, Wang further teaches in FIGS.2 and 5 an imaging cabinet, comprising:
a housing (201) including an interior chamber (203);
an x-ray source (208) and an x-ray imaging detector (209) positioned relative to the interior chamber;
an imaging system platform (200) having a receiving surface (203) disposed within the interior chamber and rotatable (rotational axis 204 and 205) therein;
a display (507); and
a controller ([0014]: a computer processor).
Wang does not teach at least one graphical indication is superimposed on the at least one two- dimensional or three-dimensional specimen image based on the known home position of the imaging system platform and without being imaged on the at least one first image and the at least one second image.
However, in an analogous X-ray based tissue orientation display field of endeavor, Mullaney teaches
at least one graphical indication is superimposed on the at least one two- dimensional or three-dimensional specimen image based on the known home position of the imaging system platform and without being imaged on the at least one first image and the at least one second image (Claim 25: a first two-dimensional digital x-ray image, a second two-dimensional digital x-ray image, superimpose a snapped line in the first two dimensional x-ray image whose endpoints and alignment roughly correspond to the extremes and orientation of a portion of body tissue; superimposing a snapped line in the second two-dimensional x-ray image whose endpoints and alignment roughly correspond to the extremes and orientation of a portion of body tissue).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the method and the controller of Wang employ such features associated with a graphical indicator as taught in Mullaney for the advantage of marking the orientation of the tissue for characterizing the physical configuration of the tissue to assist preceding medical procedures, as suggested in Mullaney, [0012].
Claims 3 and 13. Mullaney further teaches that
the at least one graphical indication includes anatomical indications comprising anterior, posterior, medial, lateral, superior, or inferior lettering or text displayed on the at least one two- dimensional or three-dimensional specimen image (Claim 25: a snapped line; and claim 30: determining an axial rotation, determining an anterior-posterior rotation, determining a lateral rotation).
Claims 4 and 14. In regard to the limitation of the anatomical indicators being adjacent, but spaced, from the specimen on the displayed the at least one two- dimensional or three-dimensional specimen image, since the anatomical indicators are for indicating the orientation of the tissue, the relative location of the indicator and the specimen would not alter or affect such a function.
The above limitation hence is considered among various common practices that normally requires only ordinary skill in the art and hence are considered routine expedients. Such an alternate configuration is considered merely rearrangement of parts, which the court has held normally require only ordinary skill in the art and hence is considered routine expedients. It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to arrive such a configuration through routine experimentation with reasonable expectation of success. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice). MPEP 2144.04.VI.C.
Claims 5 and 15. Mullaney further teaches that the at least one graphical indication includes
a reference axis overlayed on the specimen on the displayed the at least one two-dimensional or three-dimensional specimen image (FIG.14: 1410, 1420, 1430 and 1440).
In regard to whether the reference axis is overlayed on the specimen or on another location of the display, it is considered among various common practices that normally requires only ordinary skill in the art and hence are considered routine expedients. Such an alternate configuration is considered merely rearrangement of parts, which the court has held normally require only ordinary skill in the art and hence is considered routine expedients. It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to arrive such a configuration through routine experimentation with reasonable expectation of success. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice). MPEP 2144.04.VI.C.
Claims 6 and 16. Wang and Mullaney combined teaches all the features of claims 2 and 12, respectively, including “the at least one graphical indication includes anatomical indications” (Mullaney: claim 25).
Mullaney further teaches a corresponding reference axis on the displayed the at least one two-dimensional or three-dimensional specimen image (FIG.14: 1410, 1420, 1430 and 1440).
Claims 7 and 17. Wang and Mullaney combined teaches all the features of claims 2 and 12.
In regard to the feature of “the at least one graphical indication further includes background colors in the displayed the at least one two-dimensional or three-dimensional specimen image”, any display has a suitable background color such that the information to be displayed can be reasonably shown for viewing.
Having a background color for a display, and considering such a background color being part of any element on the display is considered among various common practices that normally requires only ordinary skill in the art and hence are considered routine expedients. Such an alternate configuration is considered merely rearrangement of parts, which the court has held normally require only ordinary skill in the art and hence is considered routine expedients. It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to arrive such a configuration through routine experimentation with reasonable expectation of success. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice). MPEP 2144.04.VI.C. .
Claim 8. Mullaney further teaches that two-dimensional specimen images are displayed and include the at least one graphical indication superimposed on both the at least one first image and the at least one second image (Claim 25: a first two-dimensional digital x-ray image, a second two-dimensional digital x-ray image, superimpose a snapped line in the first two dimensional x-ray image whose endpoints and alignment roughly correspond to the extremes and orientation of a portion of body tissue; superimposing a snapped line in the second two-dimensional x-ray image whose endpoints and alignment roughly correspond to the extremes and orientation of a portion of body tissue).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Mullaney, further in view of Rustici et al., US 2015/0237327 A1, hereinafter Rustici.
Claim 9. Wang and Mullaney combined teaches all the limitations of claim 2.
Wang further teaches
reconstructing a plurality of images that include the at least one first image and the at least one second image into a three-dimensional dataset ([0039]: rotational combinations can allow the entire sample to be imaged. To collect pertinent imaging projections along a sample for subsequent three-dimensional reconstruction, the rotational imaging stage can rotate the object in rolling and tiling degrees of freedom); and
displaying at least one three-dimensional tissue image that includes a three-dimensional image and a slice image ([0007]: the devices and methods are used for X-ray imaging to visualize tissue dentary and radiopaque tissue inserts. The resulting multi-axis 3D rotational images; and [0062]: an X-ray image displayed on the display face 507).
Mullaney further teaches
the three-dimensional image is manipulatable ([0109]: the possible circular images…may be identified by a user, such as by using a pointing device and a graphical user interface. A user could use the pointing device to click on a point inside a circle), and
both the manipulatable three-dimensional image and the slice image include the at least one graphical indication that is superimposed on the manipulatable three-dimensional image and the slice image (Claim 25: a first two-dimensional digital x-ray image, a second two-dimensional digital x-ray image, superimpose a snapped line in the first two dimensional x-ray image whose endpoints and alignment roughly correspond to the extremes and orientation of a portion of body tissue; superimposing a snapped line in the second two-dimensional x-ray image whose endpoints and alignment roughly correspond to the extremes and orientation of a portion of body tissue).
Alternative, if Wang and Mullaney combined is considered not providing explicit and sufficient teaching of the image being manipulatable, in an analogous X-ray image presentation field of endeavor, Rustici teaches such a feature in [0038]: the resulting image may be viewed as a three-dimensional image or saved as a JPEG file or the like…Any adjustment or modification of the image required using the original source images, which would be manipulated by a user 112 using the software again.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the 3-D image of Wang and Mullaney combined employ such a feature associated with being manipulatable as taught in Rustici for the advantage of making adjustment or modification as needed, as suggested in Rustici, [0038].
Claims 10-11 and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Mullaney, further in view of Berkeley et al., US 2017/0241897 A1, hereinafter Berkeley.
Claims 10 and 18. Wang and Mullaney combine teaches all the limitations of claims 2 and 12, respectively.
As applied to claims 2 and 12, Wang teaches that
the home position of the imaging system platform is such that a first portion of the specimen faces a first fixed portion of the interior chamber (FIG.3, 301 and 302) and a different second portion of the specimen faces a different second fixed portion of the interior chamber (FIG.3, 303 and 304) – upon rotation, the orientation of the specimen changes.
Neither Wang nor Mullaney teaches that the positioning of the specimen on the receiving surface is aided via at least one indicator associated with the imaging cabinet, wherein the at least one indicator is radiopaque or outside a field of view of the x-ray source.
However, in an analogous species-rotation imaging field of endeavor, Berkeley teaches that
the positioning of the specimen on the receiving surface is aided via at least one indicator associated with the imaging cabinet, wherein the at least one indicator is radiopaque ([0445]: the container 1000 may be used to provide a systematic means of communicating tissue sample orientation information relative to a reference point, such as on a patient’s body for example, by using certain markers such as radio opaque tags and imaging marking beads, for example; [0447]: as another example, the container 1000 may include orientation cues (or fiducials) that may permit consistent handling of the contained tissue sample by preserving the orientation of the contained tissue sample; and [0457]: the interface sleeve 1004 includes orientation markers 1036 distributed about the circumference of the interface sleeve 1004).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the method and the controller of Wang and Mullaney combined employ such features associated with the positioning of the specimen on the receiving surface is aided via at least one indicator associated with the imaging cabinet, wherein the at least one indicator is radiopaque as taught in Berkeley for the advantage of providing proper guidance for orienting the specimen properly for imaging, as suggested in Berkeley, [0445].
Claim 11. Wang and Mullaney combine teaches all the limitations of claim 2.
As applied to claim 2, Wang teaches that
the home position of the imaging system platform is such that a first portion of the specimen faces a first fixed portion of the interior chamber (FIG.3, 301 and 302) and a different second portion of the specimen faces a different second fixed portion of the interior chamber (FIG.3, 303 and 304) – upon rotation, the orientation of the specimen changes.
Neither Wang nor Mullaney teaches that the positioning of the specimen on the receiving surface is aided via instructions displayed on a display screen of the imaging cabinet.
However, in an analogous species-rotation imaging field of endeavor, Berkeley teaches that
the positioning of the specimen on the receiving surface is aided via instructions displayed on a display screen of the imaging cabinet ([0126]: the container 42 can be used to maintain the excised tissue in a particular orientation; and [0127]:…the container 42 is placed in a chamber 40 of the imaging system 10 for imaging purposes; [0447]: as another example, the container 1000 may include orientation cues (or fiducials) that may permit consistent handling of the contained tissue sample by preserving the orientation of the contained tissue sample).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the method of Wang and Mullaney combined employ such features associated with the positioning of the specimen on the receiving surface is aided via instructions displayed on a display screen of the imaging cabinet as taught in Berkeley for the advantage of providing proper guidance for orienting the specimen properly for imaging, as suggested in Berkeley, [0445].
Claim 19. Berkeley further teaches that
the at least one indicator is aligned with the first fixed portion of the interior chamber (FIG.23F and G: the indicators A, B and C are aligned with the side track).
Claim 20. Berkeley further teaches in FIG.23 that
the imaging support platform includes a lower portion (1006, 1014) and an upper portion (1002, 1010, 1004) having the receiving surface (1002, 1004),
at least the receiving surface constructed from radiolucent material ([0456]: the interface sleeve 1004 may be radiographically transparent, which may permit imaging of a contained tissue sample 1008 by radiation-based imaging techniques (e.g., x-ray imaging).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the method of Wang and Mullaney combined employ such features associated with the configuration of the platform as taught in Berkeley for the advantage of providing proper guidance for orienting the specimen properly for imaging, as suggested in Berkeley, [0445].
Claim 21. Berkeley further teaches
a lid removably coupled to the upper portion ([0485]: the container 1100 alternatively or additionally include a top lid similar to the bottom lid 1108 that releasably engages locking pins 1154 extending radially outwardly from the side wall 1124 proximate the upper end 1128).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the method of Wang and Mullaney combined employ such features associated with the configuration of the platform as taught in Berkeley for the advantage of protecting the specimen as needed, as suggested in Berkeley, [0485].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YI-SHAN YANG whose telephone number is (408) 918-7628. The examiner can normally be reached Monday-Friday 8am-4pm PST.
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/YI-SHAN YANG/Primary Examiner, Art Unit 3798