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 § 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) 1-6, 9-14, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Connor (US 2010/0104505) in view of Volokh et al (US 2011/0268339).
Regarding claims 1 and 10, O’Connor discloses and teaches a breast imaging system (0011, 0014) including first and second detector heads (12L/U) where the heads are coupled to an MBI system and include a gamma ray detector (0029) for detection at a particular resolution (0029, 0078, solid state Gamma camera), a processor in communication with the detector heads (0030, Fig 1) which is capable of determining distance between the detector heads (0039-0043, 0031) where the compression and thickness are known (determined by system when adjusted via input), and when a breast is placed between the heads, the depth of a lesion in the breast is determined based on the distance between the detector heads (which are adjustable in space relative to one another (0031).
O’Connor fails to disclose or teach the determination of system resolution of the detector(s) (first and second) as a result or function of the depth from a facing surface of the respective gamma ray detectors and determine the depth of a lesion in the breast based on the first/second system resolution (in combination with the distance between the detector heads). While the depth is determined based on measured tumor size (0048) and photon count (0041-0045) as well as the distance between heads (taking into account the sensitivity of the detectors (Fig 4, 0044)). One of ordinary skill in the art at the time of the invention would understand a relationship exists between the sensitivity of the detectors and resolution (which is in turn, impacted by depth), but attention is hereby directed to the teaching reference to Volokh et al which expressly teaches the relationship between depth and resolution (distance from detector, Volokh et al, 0037-0042, 0063, 0080). It would have been obvious to one of ordinary skill in the art given the disclosure of Volokh et al to have utilized the disclosed relationship between depth and resolution to determine the system resolution at a given depth from a collimator or detector pair/unit.
Regarding claims 2-3 and 11-12, O’Connor discloses and teaches the reception of different images from each detector set and displays them (Fig 2) with sizes changing based on distance to/from the detector(s) (0035) and the lesion size is determined by a FWHM (0156, which calculates 50%, 35%, 25% of the counts).
Regarding claims 5, 9, 17, multiple collimators are utilized (including first and second collimators, coupled with first and second detectors, Fig 15 0142).
Regrading claims 4, 6 and 13-14, as mentioned above, O’Connor does not disclose or teach the relationship between the depth and resolution from the detector, but attention is again directed to the teaching reference to Volokh et al which discloses depth as a function of a linear model which are dependent on the collimator (See Volokh et al, 0037-0042, above). It would have been obvious to one of ordinary skill in the art given the disclosure of Volokh et al to have utilized the disclosed relationship between depth and resolution to determine the system resolution at a given depth from a collimator or detector pair/unit.
Claim(s) 7, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Connor (US 2010/0104505) in view of Volokh et al (US 2011/0268339) in view of Welch et al (Gamma-Guided stereotactic Breast Biopsy System, Cited by Applicant). O’Connor in view of Volokh et al disclose and teach what is listed above, and additionally disclose the extraction of lesion data from the relationship between depth and resolution measurements (0144-0146, Fig 4-5, 0094), but fail to expressly disclose that a slope intercept model is utilized for the linear regression model. Attention is briefly directed to the teachings of Welch et al which expressly teaches the slope/intercept model (Formula 10) in the relationship between distance from detector/collimator and resolution (pp2693-2694, Collimator Spatial Resolution).
It would have been obvious to one of ordinary skill in the art given the disclosure of Welch et al for the relationship to have utilized the teachings of Volokh et al in view of O’Connor to resolve the model with a slope intercept equation.
Allowable Subject Matter
Claims 8 and 16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. None of the combinations of prior art references disclose the content of claims 8 or 16. While O’Connor in view of Volokh et al utilizes FWHM determinations, as well as changes in size from previously measured tumor size
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL M. LAMPRECHT whose telephone number is (571)272-3250. The examiner can normally be reached Mon - Fri 9:00-5:30.
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/JOEL LAMPRECHT/Primary Examiner, Art Unit 3798