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 .
Election/Restrictions
Applicant’s election without traverse of claims 2-16 in the reply filed on October 10, 2025 is acknowledged.
Note that Applicant responded with “Claims 17-22 are now withdrawn without prejudice …” The Examiner view this as a typo. The correct withdrawn claims are claims 17-23.
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)(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(s) 2-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Michael Berman (US 2013/0267850, hereinafter Berman ‘850).
In re claim 2, Berman ‘850 teaches a method of imaging tissue, the method comprising: scanning, using a transducer enclosed in a scanning assembly coupled to a wearable housing that is configured to secure to a user's body (0124, fig. 2, 30), a first portion of tissue at a first position relative to the user (fig. 10a-d), wherein the transducer is configured to direct a beam at the user's skin (fig. 10a-d, 0077, 0085, 0139, 0235); and moving the transducer within the scanning assembly to a second position along a scan path relative to the user while scanning the tissue (fig. 10a-d, 50 can be moved; 0127, many path shown by arrows 85, 86, 87).
In re claim 3, Berman ‘850 teaches wherein the second position is in a different plane relative to the first position (fig. 10, not that any new 86 position with a rotated 85 will be in a different plant than the first position).
In re claim 4, Berman ‘850 teaches wherein the second position is based on identifying anatomical data or user-specific tissue characteristics (0123, note that this claim does not exclude that the first position is also based on user-specific tissue characteristic; hence, it is up to the user to decide what parameter to input for the patient’s tissue of interest from the start to finish).
In re claim 5, Berman ‘850 teaches wherein the tissue is imaged by combining the scan of the first portion of tissue at the first position relative to the user and the scan of the second portion of tissue at the second position relative to the user (fig. 7, fig. 10, 0125, 0127, 0128, 0132-0134).
In re claim 6, Berman ‘850 teaches further comprising adjusting one or more acquisition parameters of the scanning (0123).
In re claim 7, Berman ‘850 teaches wherein the one or more acquisition parameters include at least one of a focal length, frequency, or beam steering angle in relation to the tissue (0123).
In re claim 8, Berman ‘850 teaches wherein the adjustment of the one or more acquisition parameters is based on anatomical data, user-specific tissue characteristics or image quality (0123).
In re claim 9, Berman ‘850 teaches wherein the transducer is configured to direct the beam at the user's skin at two or more angles through electrical or mechanical beam steering (fig. 10a-d, 0125, 0127).
In re claim 10, Berman ‘850 teaches wherein the transducer is configured to scan the tissue along the scan path by rotating or translating the transducer along more than one axis (fig. 10a-d, 0125, 0127).
In re claim 11, Berman ‘850 teaches further comprising recording a position of the transducer (0125-0128, note that the step motor is monitoring the position of the transducer).
In re claim 12, Berman ‘850 teaches further comprising coordinating acquisition of scans based on the position of the transducer (0125-0128).
In re claim 13, Berman ‘850 teaches wherein the wearable housing includes a set of markings relative to the user's skin configured to guide the moving the transducer to a predefined second position in relation to the tissue (0134, needle holes).
In re claim 14, Berman ‘850 teaches wherein the wearable housing comprises a flexible material configured to conform to the user's anatomical curvature (0130).
In re claim 15, Berman ‘850 teaches further comprising adjusting the wearable housing to enclose a variable depth of tissue (0130, the dome encloses a variable depth, fig. 3).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berman ‘850 alone, or in view of Hong, Hyundae (US 6,478,739, hereinafter Hong ‘739).
In re claim 16, it would have been obvious when using the device of Berman ‘850 that adjusting a pressure applied to the tissue by adjusting the wearable housing relative to the user is necessary and obvious to allow comfortable fitting to different patient with different size of tissue that’s being covered by the device of Berman ‘850.
Furthermore, Hong ‘739 teaches adjusting a pressure applied to the tissue by adjusting the wearable housing relative to the user (col. 5, line 29-col. 6, line 24).
Hence, it would also have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Berman ‘850 to include the features of Hong ‘739 in order to provide breast comfortableness and provide better quality of acoustic coupling.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BO JOSEPH PENG whose telephone number is (571)270-1792. The examiner can normally be reached Monday thru Friday: 8:00 AM-5:00 PM EST.
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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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/BO JOSEPH PENG/Primary Examiner, Art Unit 3798