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 .
Claims 2 -21 are presented for examination.
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.
Claim 2-8 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.
Claim 2 recites “an immobilization region”. However, there is no support for the limitation I the specification.
Claims 3 – 8 are rejected on the same basis as claim 2 for dependency reasons.
Claim 9-15 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.
Claim 9 recites “an immobilization surface”. However, there is no support for the limitation I the specification.
Claims 4 – 15 are rejected on the same basis as claim 2 for dependency reasons.
Claim 9-15 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.
Claim 9 recites “an immobilization region”. However, there is no support for the limitation I the specification.
Claims 4 – 15 are rejected on the same basis as claim 2 for dependency reasons.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 2 – 8 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hermann et al. (UU 2006/0126794 A1; pub. Jun. 15, 2006).
Regarding claim 2, Hermann et al. disclose: A paddle for a breast imaging system (para. [0017], [0019]) comprising: a connection portion configured to couple to the breast imaging system;
an immobilization region (top of fig.11 item 414) extending from the connection portion (fig.11 item 419) and configured to transfer force applied by the breast imaging system towards a patient's breast; and
a foam element slidable relative to the immobilization region between at least a first position disposed below the immobilization region and a different second position (para. [0075] teach that pad is made of foam material, para. [0082] teaches a slidable pad).
Regarding claim 3, Hermann et al. disclose: the immobilization region includes a rigid substrate (the claim is rejected on the same basis claim 2, item 414 is made of rigid material in order to support a human breast).
Regarding claim 4, Hermann et al. disclose: the foam element is secured to a coupling element (fig.11 item 417) configured to couple the foam element to the immobilization region.
Regarding claim 5, Hermann et al. disclose: the coupling element is rigid, semi-rigid, or flexible (the claim is rejected on the same basis as claim 4, the coupling element 417 is inherently rigid otherwise the foam 420 will slide off or break).
Regarding claim 6, Hermann et al. disclose: the immobilization region defines a mid-plane between lateral edges thereof, and wherein the sliding movement of the foam element between the first position and the second position is substantially parallel to the mid-plane (the claim does not recites any additional structure that further limits claim 6, therefore the claim is rejected on the same basis as claim 2).
Regarding claim 7, Hermann et al. disclose: the foam element includes an immobilization surface configured to at least partially contact the patient's breast, at least one outer perimeter
edge of the immobilization surface projecting horizontally outward from a corresponding outer perimeter edge of the immobilization region (the claim is rejected on the same basis as claim 2 because a human breast rests horizontally on the foam surface).
Regarding claim 8, Hermann et al. disclose: a disposable cover for at least a portion of the foam element (para. [0035]).
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.
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.
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.
Claims 9-11, 13, 16-17, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hermann et al. (UU 2006/0126794 A1; pub. Jun. 15, 2006).
Regarding claim 9, Hermann et al. disclose in a first embodiment: An imaging system comprising: an x-ray source (fig.1 item 16); a support platform housing an x-ray receptor (fig.1 item 20), the support platform having an immobilization surface for supporting a patient's breast (fig.1 item 20); and an immobilization paddle (fig.1 item 18) disposed between the x-ray source and the support platform.
In the first embodiment, Hermann et al. are silent about: the immobilization paddle comprising: a connection portion for coupling to the imaging system; an immobilization region extending from the connection portion; and a foam element slidable in a horizontal direction, parallel to the immobilization surface of the support platform, between at least a first position whereby the foam element is configured to contact the patient's breast and the immobilization region transfers force applied by the imaging system towards the patient's breast, and a different second position.
In a further embodiment, Hermann et al. disclose: the immobilization paddle comprising: a connection portion (fig.11 item 419) for coupling to the imaging system; an immobilization region (fig.11 item 410) extending from the connection portion; and a foam element slidable in a horizontal direction (para. [0081], [0082]), parallel to the immobilization surface of the support platform, between at least a first position whereby the foam element is configured to contact the patient's breast and the immobilization region transfers force applied by the imaging system towards the patient's breast, and a different second position (para. [0081], [0082]) motivated by the benefits for improved patient comfort.
In light of the benefits for improved patient comfort, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the two embodiments of Hermann et al.
Regarding claim 10, Hermann et al. disclose: the immobilization surface has a patient contact edge, and wherein the sliding movement of the foam element between the first position and the second position is substantially parallel to the patient contact edge (para. [0081], [0082]).
Regarding claim 11, Hermann et al. disclose: the immobilization region moves with the foam element relative to the connection portion between the first and second positions (para. [0081], [0082]).
Regarding claim 13, Hermann et al. disclose: when the foam element is in the second position, the foam element is disposed below at least a portion of the connection portion (para. [0081], [0082]).
Regarding claim 16, Hermann et al. disclose: A method of positioning a patient's breast for x-ray imaging, the method comprising:
coupling a connection portion of an immobilization paddle to an imaging system between an x-ray source and a support platform housing an x-ray receptor;
positioning the patient's breast on an immobilization surface of a support platform; moving the connection portion of the immobilization paddle towards the patient's breast; and
prior to contacting the patient's breast with the immobilization paddle, sliding a foam element of the immobilization paddle in a horizontal direction, parallel to the immobilization surface of the platform to a position whereby the foam element is configured to contact the patient's breast and an immobilization region of the immobilization paddle can transfer force applied by the imaging system to the patient's breast for immobilization via the foam element (the claim is rejected on the same basis as claim 9).
Regarding claim 17, Hermann et al. disclose: the sliding movement of the foam element is parallel to a lateral direction of the patient's breast (para. [0075] teach that pad is made of foam material, para. [0082]).
Regarding claim 20, Hermann et al. disclose: attaching a disposable cover to at least a portion of the foam element of the immobilization paddle (para. [0035]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Hermann et al. (UU 2006/0126794 A1; pub. Jun. 15, 2006) in view of Souchay et al. (US 2008/0056441 A1; pub. Mar. 6, 2008).
Regarding claim 14, Hermann et al. disclose: a foam attached to a slidable pad (para. [0075] teach that pad is made of foam material, para. [0082] teaches a slidable pad). However, Hermann et al. are silent about: a motorized drive system for driving movement of the foam element between the first and second positions.
In a similar field of endeavor Souchay et al. disclose: a motorized drive system for driving movement of a pad between the first and second positions (para. [0078]) motivated by the benefits for an accurate pad positioning.
In light of the benefits for an accurate pad positioning, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the motor of Souchay et al. to move the foam element of Hermann et al.
Claims 15, 19, 21 are rejected under 35 U.S.C. 103 as being unpatentable over Hermann et al. (UU 2006/0126794 A1; pub. Jun. 15, 2006) in view of Defreitas et al. (US 2007/0280412 A1; pub. Dec. 6, 2007).
Regarding claim 15, Hermann et al. are silent about: a secondary foam element coupled to at least a portion of the support platform.
In a similar field of endeavor Defreitas et al. disclose: a secondary foam element coupled to at least a portion of the support platform (para. [0007]) motivated by the benefits for improved patient comfort (Defreitas et al. para. [0007]).
In light of the benefits for improved patient comfort as taught by Defreitas et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the foam of Defreitas et al. on the support platform of Hermann et al.
Regarding claim 19, Hermann et al. and Defreitas et al. disclose: attaching the foam element to the immobilization region of the immobilization paddle (the claim is rejected on the same basis as claim 15).
Regarding claim 21, Hermann et al. and Defreitas et al. disclose: attaching a secondary foam element to at least a portion of the support platform (the claim is rejected on the same basis as claim 15).
Claims 12, 18 are rejected under 35 U.S.C. 103 as being unpatentable over Hermann et al. (UU 2006/0126794 A1; pub. Jun. 15, 2006) in view of Subrahmanyam et al. (US 2017/0172530 A1; pub. Jun. 22, 2017).
Regarding claim 12, Hermann et al. are silent about: the immobilization surface has a patient contact edge (top of fig.11 item 414), a foam attached to a slidable pad (para. [0075] teach that pad is made of foam material, para. [0082] teaches a slidable pad). However, Hermann et al. are silent about: the sliding movement of the foam element between the first position and the second position is substantially orthogonal to the patient contact edge.
In a similar field of endeavor Subrahmanyam et al. disclose: the sliding movement of the pad between the first position and the second position is substantially orthogonal to the patient contact edge (para. [0019]) motivated by the benefits for accommodating the patient’s breast (Subrahmanyam et al. para. [0019]).
In light of the benefits for improved patient comfort as taught by Subrahmanyam et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the movement of Subrahmanyam et al. to control the foam element of Hermann et al.
Regarding claim 18, Hermann et al. and Subrahmanyam et al. disclose: the sliding movement of the foam element is orthogonal to a lateral direction of the patient's breast (the claim is rejected on the same basis as claim 12).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAMADOU FAYE whose telephone number is (571)270-0371. The examiner can normally be reached Mon – Fri 9AM-6PM.
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/MAMADOU FAYE/Examiner, Art Unit 2884
/UZMA ALAM/Supervisory Patent Examiner, Art Unit 2884
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