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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/30/25 has been entered.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 21-28, 30, 32, and 41 are rejected under 35 U.S.C. 101 because Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 21-28, 30, 32, and 41 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 21 directly claims “the membrane sheet completely covers the breast and extends outward from an outer perimeter of the breast”, and directly recites structural features of the device in relation to the patient’s breast.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-28, 30, and 32-42 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In claims 21 and 33, the limitation “the membrane sheet completely covers the breast and extends outward from an outer perimeter of the breast” is not mentioned in the specification and is considered new matter.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 21-28, 30, and 32-42 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claims 21 and 33, the limitation “the membrane sheet completely covers the breast and extends outward from an outer perimeter of the breast” renders the claim indefinite. The examiner notes that different patients may have different sizes and shapes of breasts, and the scope and bounds of the limitation “completely covers” is unclear. Furthermore, the size of the membrane sheet should be not defined in relation to the patient’s body. The limitation is also not mentioned in the specification.
Claim Rejections - 35 USC § 103
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.
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) 21-26, 32-35, and 38-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wayne Eberhard et al. (US 2007/0092059; hereinafter Wayne) in view of Lee et al. (US 2004/0073106; hereinafter Lee).
Wayne shows an imaging system and method for a breast (abstract), the imaging system comprising: a tube head (while not explicitly stated, the x-ray source is considered to include a tube head or other structural components for arranging the x-ray source in position; [0020]); an x-ray source disposed in the tube head ([0020]); an x-ray detector ([0020]); and a breast support device disposed between the x-ray source and the x-ray detector (breast holder, [0023]), wherein the breast support device comprises a breast tray configured to support the breast (breast holder body, [0023]) and a membrane sheet configured to cover at least a portion of the breast tray and the breast ([0023]), the membrane sheet being flexible ([0023]-[0024]), wherein the breast support device further includes a vacuum system configured to couple the membrane to the breast tray via a suction force and immobilize the breast ([0023]-[0024]).
Wayne also shows wherein the breast tray comprises a stabilization surface in fluid communication with the vacuum system (outer body 38, rim 44; Figs. 8-9); wherein a vacuum chamber is defined at least partially within the breast tray and adjacent the stabilization surface ([0023]-[0024]); wherein the vacuum chamber is configured to induce a vacuum between the membrane and the breast tray during operation of the vacuum system ([0023]-[0024]); wherein a vacuum chamber is defined at least partially within the breast tray ([0023]-[0024]); wherein the vacuum chamber is in fluid communication with the vacuum system ([0023]-[0024]); wherein the membrane is coupled to the breast tray and the suction force is applied directly to the membrane ([0023]-[0024]); wherein the imaging system is a mammography or tomosynthesis imaging system ([0020]); shaping at least a portion of the breast with the suction force ([0023]-[0024]); pulling breast tissue away from a chest wall with the suction force ([0023]-[0024]).
Wayne fails to show a planar stabilization surface. Wayne also fails to show a planar stabilization surface has a plurality of holes in fluid communication with the vacuum system. Wayne also fails to show and wherein the membrane sheet completely covers the breast and extends outward from an outer perimeter of the breast covering at least a portion of the stabilization surface such that the membrane sheet couples directly to the stabilization surface of the breast tray via the suction force of the vacuum system.
Lee discloses breast stabilizers for imaging. Lee teaches a planar stabilization surface ([0049]-[0050], [0062], [0064]). Lee also teaches the planar stabilization surface has a plurality of holes in fluid communication with the vacuum system ([0051]-[0052]; Fig. 9).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Wayne to utilize a stabilization surface having other shapes such as a planar surface or a D-shape as taught by Lee, in order to aid in securing the breast in a desired shape for the imaging procedure. A flat surface may be used in a mammography procedures to aid in allowing the breast to be supported while distributing the tissue to allow for the imaging system to accurately image through dense breast tissues. It is noted that Wayne also considers other shapes, including a more flattened shape as illustrated in Figures 8 and 9. Furthermore, a change in shape/size is generally recognized as being within the level of one of ordinary skill in the art (In re Dailey, 357 F.2d 669, 149 USPQ 47; CCPA 1966); (In re Rose, 220 F.2d 459, 105 USPQ 237; CCPA 1955).
Furthermore, in the combined invention of Wayne and Lee, the breast would be positioned between the planar surface and an upper portion of the membrane of Wayne (Fig. 8), and it would be an obvious design choice to one of ordinary skill in the art, without undue experimentation, to arrange the patient’s breast in relation to the device in a manner that allows for the breast to be completely covered depending on the size and shape of the patients breast, including “wherein the membrane sheet completely covers the breast and extends outward from an outer perimeter of the breast covering at least a portion of the stabilization surface such that the membrane sheet couples directly to the stabilization surface of the breast tray via the suction force of the vacuum system”.
Furthermore, regarding the limitation “wherein the x-ray detector has an imaging area configured to receive x-ray emissions from the x-ray source, and wherein a plurality of holes is defined within the stabilization surface and outside of the imaging area, the vacuum system configured to apply the suction force through the plurality of holes” and “wherein the plurality of holes is outside of an imaging area of the x-ray detector such that the x-ray energy emissions is free from image artifacts containing the plurality of holes”, in the combined invention of Wayne and Lee, the plurality of holes shown in the stabilization surface of Lee (Fig. 9) may be considered to be outside of the imaging area depending on the particular angle or plane being imaged. The examiner notes that the holes in the stabilization surface are a separate structure from the detector having an imaging area. In addition, it is known in the field of x-ray imaging to position the source/detector in relation to the imaging field and the patient to avoid artifacts when acquiring an x-ray image, and it would be an obvious design choice for the operator to position the holes outside of the imaging view, in order to achieved the desired reduction in artifacts while sufficiently imaging the patient’s breast.
Claim(s) 27-28, 30, and 36-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wayne Eberhard et al. (US 2007/0092059; hereinafter Wayne) and Lee et al. (US 2004/0073106; hereinafter Lee) as applied to claims 21 and 34 above, and further in view of Cormican et al. (US 2016/0183898; hereinafter Cormican).
Wayne shows the invention substantially as described in the 102 rejection above.
Wayne fails to show a cover configured to be disposed between the breast and the breast tray; wherein the cover covers one or more holes defined on the breast tray; wherein the membrane is disposable.
Cormican discloses a mammographic device. Cormican teaches a cover configured to be disposed between the breast and the breast tray ([0033], [0149], [0204]); wherein the cover covers one or more holes defined on the breast tray ([0033], [0149], [0204]); wherein the membrane is disposable (cover or surface material for compression paddle or breast support member is disposable; [0033], [0149], [0204]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Wayne and Lee to utilize a cover and disposable components as taught by Cormican, in order to protect and ensure that only sanitized medical components come in contact with the patient thereby preventing infection/disease.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The examiner appreciates the distinction between applicant’s drawings (Fig 5A-5B) and the drawings illustrated in the combined prior art documents. However, the examiner notes that the claims raise new 112 and 101 rejections, and further, the claims have not been sufficiently amended to narrow the claim limitations to applicant’s drawings (Fig. 5A-5B). The claims have been interpreted in light of the broadest reasonable interpretation of the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN CWERN whose telephone number is (571)270-1560. The examiner can normally be reached Monday - Friday, 8:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN CWERN/Primary Examiner, Art Unit 3797