NON-FINAL REJECTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/11/2026 has been entered.
The RCE dated 8/11/2026 references the after-final amendment dated 7/10/2026. Therefore, the after-final amendment has been entered and considered for this Office Action.
Response to Arguments
Applicant's arguments filed 7/10/2026 have been fully considered but they are not persuasive entirely.
The previous Office Actions1 rejected the claims under §112(b) and further stated the following in reference to MPEP 2173.06 and In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962): “There is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of the claims as discussed above and therefore it would not be proper to reject the claims on the basis of prior art. Any attempt to reject the claims in their current form on the basis of prior art would necessarily be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as the scope of the claim (e.g., whether limitation B should be interpreted as a structural limitation of the collimator itself, a limitation of electronic circuitry, or a recitation of intended use).”
The previous Office Actions then further stated: “Note: Although the claims are not currently rejected on the basis of prior art, the claims may not necessarily be allowable upon overcoming the §112(b).”
The amendment filed on 7/10/2026 is sufficient to overcome the §112(b) issues discussed in the previous Office Actions by deleting the offending limitation. However, now that there is no confusion or uncertainty as to the proper interpretation of the limitation of the claims, one or more rejections over prior art may now be proper because such rejection(s) would not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as the scope of the claim. In other words, the examiner must now consider whether the claims as currently amended are rejectable over prior art.
In view of the amendment, claim rejections under §102 based on Hugg, US 2016/0296186 A1 (which has already been made of record2) are presented below.
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 3-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hugg, US 2016/0296186 A1 (hereinafter “Hugg”).
Regarding claim 1: Hugg discloses a molecular imaging system for guidance of a biopsy or a surgical procedure (e.g., see Abstract), comprising:
a solid-state gamma camera (e.g., lower gamma camera 30, Figs. 3-6; Hugg teaches CZT detectors, ¶ [0026]; CZT detectors are considered solid-state “direct conversion” detectors ¶ [0003]);
a variable-angle slant hole (VASH) collimator (¶ [0035]-[0037]; Figs. 7 and 8); and
electronic circuitry (computer 42, Fig. 4; with motors/actuators, ¶ [0036]) in communicative connection with the solid-state gamma camera and with the VASH collimator (¶ [0023]-[0024]), wherein the electronic circuitry is configured to:
control slant angles of the VASH collimator (“The slant may be controlled manually or automatically by use of motors or actuators. The collimator slant angle (62) may be adjusted specifically for each patient to accommodate anatomical and body habitus variations. In particular, the technologist will want to avoid exposing the gamma cameras (30) to direct view of internal organs, such as the heart and liver, which may take up significant concentrations of the radiopharmaceutical.” ¶ [0037]; “Before the examination begins, the slant angles of the variable-angle collimator can be set (111).” ¶ [0040])
control the solid-state gamma camera to acquire a stereotactic molecular image at each of two different slant angles (“The next step (112) is to acquire a stereotactic molecular image of the suspect lesion.” ¶ [0040]; “One advantage of the variable-angle slant-hole collimator design (FIGS. 7 and 8) is that either parallel-hole or slant-hole imaging may be performed without swapping collimators. Also, during biopsy or surgery guidance, when one of the cameras (30, and its collimator) is tilted (or rotated or translated) away from the breast (10), the remaining camera (30) can still stereotactically verify the lesion and biopsy needle position by acquiring two images with the slant-hole collimator set at plus and then minus 15 degrees, for example.” ¶ [0046]),
calculate a 3D position of area indicative of a lesion from the stereotactic molecular image at each of the two different slant angles (“After simple triangulation, the three-dimensional location of the lesion (13) will be known, typically within several millimeters.” ¶ [0040]; “One advantage of the variable-angle slant-hole collimator design (FIGS. 7 and 8) is that either parallel-hole or slant-hole imaging may be performed without swapping collimators. Also, during biopsy or surgery guidance, when one of the cameras (30, and its collimator) is tilted (or rotated or translated) away from the breast (10), the remaining camera (30) can still stereotactically verify the lesion and biopsy needle position by acquiring two images with the slant-hole collimator set at plus and then minus 15 degrees, for example.” ¶ [0046]).
Regarding claim 3: Huff further discloses that the two different slant angles have a spread of 10 to 60 degrees (“plus then minus 15 degrees” as discussed above is a spread of 30 degrees which falls within the claimed spread range of 10 to 60 degrees).
Regarding claim 4: Hugg further discloses that the VASH collimator comprises a stack of thin leaves, each of the leaves comprising an array of square holes, and a mechanism for positioning the stack to align the square holes at the two different slant angles (“FIGS. 7 and 8 show how a variable angle slant-hole collimator can be constructed by stacking planar layers of grids (such as etched tungsten) and linearly varying the offset between layers. FIG. 7 shows a top view of the collimator core comprising a plurality of plates, each with metal septa (60) and an array of square holes (61). Only a small portion of a clinically sized collimator core is illustrated here. FIG. 8 shows side views of a small portion of the variable-slant angle stacked plate collimator in two potential positions. In FIG. 8 (a), the stack of collimator plates is shown with zero slant angle as shown by the vertical dashed line overlaid on the leftmost column of aligned square holes, thus forming a typical parallel-hole collimator that admits gamma photons travelling essentially perpendicular to the detector entrance surface, that is, with normal incidence. In FIG. 8 (b), an angle theta (θ, 62) describes the slant of the collimator holes with respect to normal incidence. A lubricant (e.g., graphite or oil) may be needed to allow smooth gliding of the metal plate layers. Alignment pins connecting all layers may be slanted like a joystick to change the slant angle. The slant may be controlled manually or automatically by use of motors or actuators. The collimator slant angle (62) may be adjusted specifically for each patient to accommodate anatomical and body habitus variations. In particular, the technologist will want to avoid exposing the gamma cameras (30) to direct view of internal organs, such as the heart and liver, which may take up significant concentrations of the radiopharmaceutical.” ¶ [0037]).
Regarding claim 5: Huff further discloses a compression paddle (20) comprising an aperture (46, Figs. 5 and 6) and a second solid-state gamma camera (top gamma camera 30, Fig. 6), the second solid-state gamma camera being movable in and out of connection with the compression paddle, such that when the second solid-state gamma camera is moved out of connection with the compression paddle, access is provided to the aperture (“By way of illustration, the top gamma camera (30) is tilted away from the breast (10), exposing the top compression paddle (20), which may have an aperture (46) (typically 10 cm×10 cm). The compression paddle (20) may optionally have a grid of smaller apertures (46) (not shown, but typically on a 1-cm pitch) through which a core biopsy needle (50) can be introduced to sample an imaged lesion (13).” ¶ [0030]; “FIG. 6 shows the top gamma camera (30) tilted away with a pivot point hidden inside the gantry (40). This is a preferred embodiment, but other motions are also contemplated. One optional movement would be to slide the gamma camera (30) toward the gantry (40) using the support arms (31) as rails. One or more apertures (46) in the compression paddle (20) could thus be exposed for access by a biopsy core needle (50). Another possible motion is to rotate the gamma camera (30) about the vertical axis of the gantry (40) to expose the compression paddle (20). Those skilled in the art can understand that similar motions that expose the breast (10) for biopsy or surgery access are anticipated by this invention.” ¶ [0031]).
Regarding claim 6: Hugg further disclose that the molecular imaging system comprises a molecular breast imaging (MBI) system, a single photon emission (SPE) planar imaging system, a single photon emission computed tomography (SPECT) system, or positron emission tomography (PET) system (e.g., “molecular breast imaging”/“MBI” is mentioned in the Title, the Abstract, and all throughout the Specification).
Regarding claim 7: Hugg further discloses at least one other gamma camera (top gamma camera 30, Figs. 5-6; ¶ [0030]), the at least one other gamma camera comprising one of a parallel-hole collimator, a slant-hole collimator, a focusing collimator, a VASH collimator, and a multiple pinhole collimator (“As those skilled in the art will understand, the gamma cameras (30) comprise a collimator and a detector assembly. In a preferred embodiment, the collimator may have a pixel-registered square parallel-hole core and the detector assembly may be an array of pixelated CZT detectors. The collimator can comprise parallel-hole, slant-hole, focusing (convergent or divergent), multiple-pinhole collimators, or Compton camera (a form of “electronic collimation”). For pixelated detectors, pixel-registered square-hole collimators are preferred, but traditional hexagonal-hole collimators can also be used (although they are not as efficient).” ¶ [0026]; alternatively/additionally, Hugg discloses a VASH collimator as discussed above, Abstract, ¶ [0037], [0042], [0046], claim 7).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLIN T. SAKAMOTO whose telephone number is (571)272-4958. The examiner can normally be reached Monday - Friday, ~9AM-5PM Pacific.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEITH M. RAYMOND can be reached at (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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COLIN T. SAKAMOTO
Primary Examiner
Art Unit 3798
/COLIN T. SAKAMOTO/Primary Examiner, Art Unit 3798
20 August 2026
1 Non-Final Rejection dated 10/22/2025 and Final Rejection dated 3/11/2026
2 see Advisory Action dated 7/16/2026, PTO-892 form attached to the Non-Final Rejection dated 10/22/2025, and application 18/751,223 (US Patent 12,383,216) in same patent family
