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 .
Response to Amendment
On 6/12/2026, Applicant submitted an amendment to the application in response to the Restriction Requirement dated 4/14/2026. The amendment contains an amended claim set and remarks/arguments including an election. The amendment has been entered and considered for this Office action.
Election/Restrictions
Applicant's election with traverse of Invention I (claims 1-13 and 16-20) in the reply filed on 3/12/2026 is acknowledged. The restriction requirement is withdrawn in view of the following:
Regarding claim 14: Claim 1 is directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(B), claim 14 as currently amended, now directed to the process of making or using an allowable product (i.e., the product of claim 1), is hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Regarding claim 15: It is noted that Invention I (e.g., claim 1) and Invention III (claim 15) were found to be distinct as combination and subcombination under the principle of MPEP 806.05(d) which recites in part: “Where claims to two or more subcombinations are presented along with a claim to a combination that includes the particulars of at least two subcombinations, the presence of the claim to the second subcombination is evidence that the details of the first subcombination are not required for patentability (and vice versa). For example, if an application claims ABC/B/C wherein ABC is a combination claim and B and C are each subcombinations that are properly restrictable from each other, the presence of a claim to C provides evidence that the details of B are not required for the patentability of combination ABC.”
It is noted however, that invention II (claim 14) has been amended in such a way that it is no longer considered a subcombination. Therefore, the claims no longer recite two or more subcombinations along with a combination. Therefore, claim 15 is hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 4/14/2026 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 15 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 15 recites: “A hand-held biopsy device for the biopsy equipment of claim 1, comprising the biopsy needle and the position sensor configured to measure the position information indicating the orientation of the biopsy needle.”
Claim 15 is a dependent claim: The recitation of “for the biopsy equipment of claim 1” is being construed as a recitation of intended use or purpose of the claimed invention and therefore not given patentable weight beyond the capability of the hand-held biopsy device to be used with/for the biopsy equipment of claim 1. In other words, a hand-held biopsy device that is incapable of being used with/for biopsy equipment of claim 1 does not read on claim 15. A determination of such capability/incapability depends at least in-part on the nature of the biopsy equipment of claim 1. For example, if the biopsy equipment of claim 1 hypothetically included an MRI scanner, the intended use recitation of claim 15 would therefore require that the hand-held biopsy device be MRI compatible (e.g., made of non-magnetic materials due to the high strength magnetic field of the MRI environment) in such hypothetical. However, since claim 1 does not actually recite an MRI scanner, the device of claim 15 need not necessarily be MRI compatible. In this sense, claim 15 appears to be a dependent claim because the scope of claim 15 depends on subject matter claimed in claim 1.
Claim 15 makes a reference to claim 1: The preamble of claim 15 recites “A hand-held biopsy device for the biopsy equipment of claim 1, comprising”.
Claim 15 does not include all the limitations of claim 1: Since the reference to claim 1 is being construed as a recitation of intended use or purpose of the hand-held biopsy device, the biopsy equipment of claim 1 is not within the scope of claim 15. In other words, claim 15 is only directed to the hand-held biopsy device; i.e., claim 15 does not require the imaging equipment, marking equipment, outputting equipment or control equipment. Therefore, claim 15 is an improper dependent claim.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim 15 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yilmaz et al., US 2019/0321065 A1 (hereinafter “Yilmaz”).
Yilmaz discloses a hand-held biopsy comprising a biopsy need and a position sensor configured to measure position information indicating an orientation of the biopsy needle (¶ [0077]: “Further comprising the system of FIG. 7 is a sensor 708 that senses position information of a moveable device 710. The sensor 708 can be an active or a passive sensor. For example, the sensor 708 can be a three-dimensional sensor. For example, a Kinect™(Microsoft Corporation) or Kinect™-type depth sensor can be used to obtain the position information of the moveable device 710. In other instances, the sensor 708 can be one or more cameras (infrared or visible), accelerometers, gyroscopes, and the like that can be used to obtain location information of the moveable device 710. In various embodiments, sensor 708 can be located on at least one of the moveable device 710, eyeglasses of a person in view of the moveable device, or anywhere the sensor 708 can sense the moveable device 710. The moveable device 710 can be, for example, a biopsy needle, a scalpel, a pathology wand, a locator wand, a bone segment, and the like.” ¶ [0066]-[0067]: “Tool localization 508 comprises positioning and orientation estimation of a tool used by a professional such as a wand, scalpel, needle, probe, and the like or can even be used to estimate the location of a bone segment. This can be accomplished in at least two ways one way comprises tracking and triangulation of visual markers on the tool or bone segment and the other way comprises special tools designed with inertial sensors such as accelerometers, gyroscopes, magnetometer, and the like.”).
The ordinarily skilled artisan would have recognized that the hand-held biopsy device of Yilmaz could be used with/for the biopsy equipment of claim 1 because the hand-held biopsy device of Yilmaz would be understood as being usable for biopsy of soft tissue (e.g., breast) and the position/orientation sensors (e.g., accelerometer and gyroscope) could be used to provide the position/orientation of the biopsy needle to the outputting equipment of claim 1.
Allowable Subject Matter
Claims 1-14 and 16-20 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
Palma et al., US 2016/0310215 A1 (hereinafter “Palma”) and Yilmaz are considered prior art closest to the claimed invention.
Palma discloses Biopsy equipment for performing a biopsy on a female breast, comprising:
imaging equipment for tomosynthesis of the breast (¶ [0032]: “Referring to FIG. 1 and FIG. 2, an image of an exemplary tomosynthesis apparatus is shown. The tomosynthesis apparatus 10 of FIG. 1 is a digital breast tomosynthesis (“DBT”) apparatus, and is supplied for exemplary purposes.” ¶ [0034]: “In an exemplary embodiment, a DBT apparatus includes a digital detector 12 and an x-ray source 14 used to project through an object 16 being scanned, such as a portion of a patient. The detector receives x-rays that pass through the object being scanned and produces digital signals relating to the intensity of the x-rays.”), the imaging equipment including compression equipment configured to fix the breast (¶ [0035]: “Throughout the procedure the breast or object should remain substantially stationary. This may be accomplished by using compression devices such as a compression paddle 100, a compression grid, a tool holder 200, or similar means to hold the breast in a substantially stationary position at least for the time when the breast is initially scanned to a time when the biopsy is performed. The compression paddle 100 may hold the breast still while providing apertures that allow for insertion of a biopsy tool, needle, core needle, or vacuum assisted core needle and the tool holder 200 or grid may be used to hold the biopsy tool or needle in place. The compression paddle 100 or the tool holder 200 may also serve to compress the object or breast to minimize the thickness traversed by x-rays.”);
a hand-held biopsy device (biopsy tool 300) including a biopsy needle (¶ [0069]: “biopsy tool 300 may be configured as a biopsy needle mounted to a handpiece.”);
marking equipment (projection means 700) registered with the imaging equipment (registered via marker 126, ¶ [0039], [0056], [0059], [0063], [0067]), the marking equipment configured to mark an entry point for the biopsy needle on the breast fixed in the compression equipment according to planning information for a biopsy to be performed based on image data from the imaging equipment (¶ [0067]: “Referring to FIG. 17, a projector 700 is shown displaying a projection 710 of a tomosynthesis slice on the object 16 to be biopsied. The projection 710 may be displayed in any form or in any manner that allows a user to identify a lesion and/or target. For example, the projection may be displayed on any surface, screen, monitor, object, and/or directly onto the skin of a patient. In at least one embodiment, a user may locate the lesion 720 on a display screen as previously described. The displayed slice 418 or slices 414 may be transformed using the at least one marker 126, and displayed on a surface, such the patient's skin, close to or coinciding with the proposed entrance point 734 using optical or projection means 700 such as “picoprojector” or any means which can produce a projection. The image of the selected DBT slice can be projected with a satisfactory light level (a few hundred lumens) with modern technology devices. This would allow any device to position the tool on the transformed image without any consideration of coordinates. The projection 700 would typically be displayed between the compression paddle 100 and detector 12. In another embodiment, the projector 700 may display the projection 710 onto the object 16, where the projection 710 also provides an image of a tool holder. Tool holder 200 may then be aligned, based upon the projection 710 and a biopsy tool fixed accordingly to align with an entry point.”);
outputting equipment configured to output guidance information indicating a relative orientation of the biopsy needle according to the position information to a target orientation according to the planning information for a person performing the biopsy; and
control equipment configured to control the biopsy equipment according to the planning information (controller, ¶ [0060]-[0061]; further see above).
Palma does not disclose that the hand-held biopsy device includes a position sensor configured to measure position information indicating an orientation of the biopsy needle, let alone outputting equipment configured to output guidance information indicating a relative orientation of the biopsy needle according to the position information to a target orientation according to the planning information for a person performing the biopsy.
Although the position sensor and the outputting equipment is known from Yilmaz, it is unclear why the ordinarily skilled artisan, short of improper hindsight, would have combined Palma with Yilmaz in such a way to arrive at the claimed invention. Palma uses a grid which has a thickness or depth extent as shown in Figs. 6, 7, and 16. Further, a holding device is inserted into one of the grid squares as shown in Figs. 7 and 16. The hand-held biopsy device is then inserted into one of the apertures of the holding device. Due to the thickness/depth of the gride and the holding device as well as the apparent size of the aperture relative to the needle of the biopsy device, the insertion angle of the needle appears to be limited/restricted to the predetermined orientation relationship of the grid, holding device, and aperture. In other words, insertion angle does not appear to be a degree-of-freedom that is controllable by the user in a free-hand manner. This is similar in nature of frame-based stereotactic surgical technique. This appears to be consistent with the fact that the disclosure of Palma appears to take the insertion angle/orientation of the needle for granted as merely “known” (e.g., “the geometry is based upon a known needle angle and the determined x-coordinate and y-coordinate of lesion 420”). Palma does not appear to disclose any technique for measuring the angle of the needle because the angle of the needle should already be known due to the degree-of-freedom restrictions by the grid/holding device/aperture as discussed above. In this sense, there is no reason or need to measure the orientation of the needle such as via Yilmaz’s frameless stereotactic technique. Otherwise, such a modification would be considered a change the principle of operation (i.e., frame-based to frameless).
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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COLIN T. SAKAMOTO
Primary Examiner
Art Unit 3798
/COLIN T. SAKAMOTO/Primary Examiner, Art Unit 3798
5 September 2026
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