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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/29/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 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 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schulze-Ganzlin (US 5,539,799; hereinafter “SG”).
Regarding claim 1, SG discloses a quality assurance phantom configured for connection to an x-ray device 11 (Figs.7-11), including:
a) a housing member 35 having an opening 38, 39 configured to receive a digital sensor or phosphorus plate (Fig.11);
b) an attachment member 36 configured to detachably secure the housing member 35 to the x-ray device 11 (Fig.9); and
c) a frame member 35 disposed within the housing member 35, the frame member configured to receive a phantom device 29; where the phantom device 29 includes:
d) a contrast layer configured to assess a contrast resolution (fields A and D), where the contrast layer is configured to provide two or more different contrast levels (col.5, lines 48-50); and
e) a spatial resolution test layer 30, 31, where the spatial resolution test layer 30, 31 includes at least one trace disposed on a first surface of a substrate (col.5, lines 50-54).
Claims 16, 18 and 20-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang (US 2008/0093544 A1).
Regarding claim 16, Wang discloses a method of creating a quality assurance phantom for an x-ray device (Figs.1-5), including:
a) obtaining a spatial resolution test layer 16, the spatial resolution test layer including one or more traces 32 disposed on a first surface of a substrate 34 (Figs.1-3);
b) obtaining a contrast layer 42 to assess a contrast resolution, the contrast layer 42 configured to provide two or more different contrast levels (Figs.2 and 4); and
c) coupling the contrast layer 42 to the first surface of the substrate 34 of the spatial resolution test layer 16 to form the quality assurance phantom (Fig.5).
With respect to claim 18, Wang further discloses that the one or more traces are spaced apart at different widths (aperture spacings, Figs.1-3).
With respect to claims 20 and 21, Wang further discloses that the traces are formed with a copper material (par.0046).
With respect to claim 22, Wang further discloses that the contrast layer 42 is formed from a single material 42 having one or more sections, each section having different thicknesses (section 24 having a thickness, and remaining area having no thickness, Fig.4).
With respect to claim 23, Wang further discloses that the material 42 may include aluminum (par.0046).
With respect to claim 24, Wang further discloses that the contrast layer 42 is formed from one or more different materials, the contrast layer having a uniform thickness (metal layer 42 in region 24 and air or adhesive elsewhere; once the sandwich is formed, Fig.5, the thickness is uniform).
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 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.
Claims 1-3, 11 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Nosil (US 9,936,935 B1) in view of Wang (US 2008/0093544 A1).
Regarding claim 1, Nosil discloses a quality assurance phantom 720 configured for connecting to an x-ray device 750 (Figs.30-34 and cols.16-19), including:
a) a housing member 730 having an opening 762 configured to receive a digital sensor 752 or phosphorous plate (Figs.33A and 33B; also see col.19, lines 16-22);
b) an attachment member 732 configured to detachably secure the housing member 730 to the x-ray device 750 (Figs.33C and 33D); and
c) a frame member 732 disposed within the housing member 730, the frame member 732 configured to receive a phantom device, the phantom device including:
d) a contrast layer 722 configured to assess a contrast resolution, where the contrast layer 722 is configured to provide two or more different contrast levels (Fig.30B); and
e) a spatial resolution test layer 728.
Further regarding claim 1, Nosil does not specifically disclose that the spatial resolution layer includes at least one trace disposed on a first surface of a substrate. Nosil teaches the common practice of providing a mesh insert placed in a recess of the PMMA body, where the mesh is understood to be made of fine copper wires (see at least col.15, lines 56-43).
Wang teaches the practice of providing a contrast and spatial resolution radiographic imaging phantom having a spatial resolution pattern 32 on a substrate 34 (Figs.2 and 5). In this manner, any desired pattern may be readily printed or etched using known PCB-based fabrication methods for well-defined edges (par.0044).
It would have been obvious to one of ordinary skill in the art at the time of the invention for Nosil to have the spatial resolution test layer formed with at least one trace disposed on the surface of a substrate in order to provide a precise spatial pattern that is easy to manufacture, as taught by Wang.
With respect to claim 2, Nosil further discloses a flexible holder 742 coupled to the frame member 732 and configured to align a central axis of the digital sensor 752 or phosphorus plate with a central axis of the frame member 732 (Figs.30B, 31 and 33A-33B).
With respect to claim 3, Nosil further discloses a plurality of flexible members 764 and 766 configured to secure and align the digital sensor 752 or phosphorous plate with respect to the frame member 732 (Figs.30B and 33A-33B).
With respect to claim 11, Wang further teaches that the substrate 34 includes a PCB material (par.0045) for a mechanically robust and efficiently-produced phantom (par.0044).
It would have been obvious to one of ordinary skill in the art at the time of the invention for Nosil to have the substrate be formed of PCB materials in order to leverage the efficient and cost-effective materials of PCB manufacture, as taught by Wang.
With respect to claim 15, Nosil further discloses that the substrate is made of a nonconductive material (PMMA).
Allowable Subject Matter
Claims 4-10, 12-14, 17 and 19 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.
The following is a statement of reasons for the indication of allowable subject matter:
With respect to claim 4, the prior art neither teaches nor reasonably suggests the additional limitation of having a release mechanism movable from a first position to a second position and configured to eject the digital sensor or phosphorous plate from the opening of the housing member, as required by the combination as claimed. Although the prior art teaches various movable release mechanisms for releasing an intraoral detector from an aligned position (US patent documents to Dove et al, to Kilcher et al., and to Quarry et al.), none may reasonably be considered to “eject” the x-ray detector as required by the claim.
With respect to claim 5, the prior art neither teaches nor reasonably suggests the additional limitation of having the attachment member include an adjustable clamp member configured to align the x-ray transmission axis of the x-ray device with the phantom device, as required by the combination as claimed. The prior art teaches either a frictional fit (Nosil) or traditional non-adjustable clamps (exemplified by US patent documents to Ji et al. and to Razzano et al.).
Claims 6-10 are objected to by virtue of their dependence upon claim 5, thus incorporating the allowable subject matter.
With respect to claims 12 and 17, the prior art neither teaches nor reasonably suggests the additional limitation that the traces are formed with different thicknesses, as required by the respective combination of features as claimed in each claim. The prior art provides spatial resolution testing areas having lines at different widths and at different spacings (see at least US patent documents to Dove et al., to SG et al., to Arnold, to Farrokhnia et al., etc.). Having structures of different thicknesses are separately provided (such as region 80 of Dove et al., region 160 of Farrokhnia et al., and region 26A of US patent documents to Sandrik et al., for example).
Claims 13, 14, and 19 are objected to by virtue of their respective dependencies, thus incorporating the combination of allowable features.
Claim 25 is allowed.
The following is an examiner’s statement of reasons for allowance: the prior art teaches most aspects of the claimed invention, including Dove (US 2011/0096911 A1) and Nosil (cited above). However, the prior art neither teaches nor reasonably suggests an x-ray imaging quality assurance phantom having both (a) a contrast layer having different contrast levels and configured to assess contrast resolution in the x-ray image, and (b) a spatial resolution test pattern layer including tracings of variable pattern and thickness and configured to assess spatial resolution in the x-ray image, as required by the combination of features as claimed.
As noted with respect to claims 12 and 17 above, the prior art neither teaches nor reasonably suggests a spatial resolution pattern that is formed having different thicknesses when there are already areas of the phantom that test contrast. There appears to be no reason for doing so absent the benefit of Applicant’s disclosure.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: the remaining prior art (see attached PTO-892) further establishes the state of the art in radiographic imaging phantoms.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS R ARTMAN whose telephone number is (571)272-2485. The examiner can normally be reached Monday-Thursday 10am-6:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Makiya can be reached on 571.272.2273. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
THOMAS R. ARTMAN
Primary Examiner
Art Unit 2884
/THOMAS R ARTMAN/ Primary Examiner, Art Unit 2884