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 Objections
Claim 11 objected to because of the following informalities: the phrase “wherein the data are taken into” should be “ wherein the data is taken into”. Appropriate correction is required.
Claim 12 objected to because of the following informalities: the phrase "tumor that is to be removed are received" should be "tumor that is to be removed is received". Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 11 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.
Regarding claim 11, the word “captured” in line 4 is indefinite as it is unclear what is being captured (i.e. captured photo, captured tissue, captured data).
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.
Claim(s) 1-2, 3-8, 11-12, & 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0038691 hereinafter Fishman in view of US 2009/0326359 hereinafter Hendricks.
In regards to Claim 1: Fishman teaches A method for operating a medical radiation therapy arrangement, the method comprising:
three-dimensionally measuring, in a reference coordinate system (Fishman, Paragraph 119), a wound cavity in a patient from which a tumor has been surgically removed (Fishman, Paragraph 112), and a probe-based registration device of the medical therapy arrangement (Fishman, Figure 1 Items 118); and,
at least one of selecting and arranging an x-ray applicator (Fishman, Paragraph 37; Figure 1 Items 116) of an intraoperative radiation therapy device of the medical radiation therapy arrangement (Fishman, Paragraph 9) in the wound cavity on a basis of three-dimensional measurement data generated during said three-dimensional measuring with the x-ray applicator being navigable in the reference coordinate system (Fishman, Paragraph 119).
Fiashman does not teach wherein said three-dimensional measuring is performed via at least one of a surgical microscope of the medical radiation therapy arrangement.
Hendricks teaches wherein said three-dimensional measuring is performed via at least one of a surgical microscope of the medical radiation therapy arrangement (Hendricks, Paragraph 119).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the microscope taught by Hendricks to the treatment validation system taught by Fishman, the motivation being to provide a tool for viewing the surgical area.
In regards to Claim 3: A modified Fishman teaches, the method of claim 1, wherein, for said arranging, a feed trajectory for the x-ray applicator to and/or into the wound cavity is at least one of determined, output, and implemented by moving the x-ray applicator, on the basis of the generated three-dimensional measurement data (Fishman, Paragraph 45).
In regards to Claim 4: A modified Fishman teaches the method of claim 1, wherein said arranging of the x-ray applicator is performed via a robotic stand on which the x-ray applicator is arranged (Fishman, Paragraph 45).
In regards to Claim 5: A modified Fishman teaches the method of claim 1, wherein, as part of selecting the x-ray applicator, at least one external part of the x-ray applicator is made taking into account the three-dimensional measurement data (Fishman, Paragraph 46; Figure 2 Item 234).
In regards to Claim 11: A modified Fishman teaches the method of claim 1, wherein marked regions adjoin at least one of the tumor and the wound cavity (Fishman, Paragraph 99; Figure 3 Item 322);
wherein at least one of:
the marked regions are captured (Fishman, Paragraph 99; Figure 3 Item 322),
the marked regions are identified (Fishman, Paragraph 128),
measurement data describing the marked regions are received (Fishman, Paragraph 117), and
simulation data describing the marked regions are received; and,
wherein the data are taken into account during the selection and/or during a making of the x-ray applicator (Fishman, Paragraph 113 &114; “The treatment head has a plurality of apertures from which a radiation beam can be emitted. A schematic illustration of the treatment head and its apertures is provided in a second portion 1708 of the GUI 1700. As shown in portion 1708, the treatment head comprises a plurality of apertures represented by multiple areas, with a unique mark for each area.”).
In regards to Claim 12: A modified Fishman teaches the method of claim 1, wherein three-dimensional external measurement data describing the tumor that is to be removed are received (Fishman, Paragraph 138); at least one of a start position and a start orientation for at least one of the surgical microscope and the intraoperative radiation therapy device are determined in the reference coordinate system on a basis of the received three-dimensional external measurement data (Fishman, Paragraph 37); and, at least one of the surgical microscope and the intraoperative radiation therapy device is brought into at least one of a corresponding one of the determined start position and the determined start orientation in the reference coordinate system (Fishman, Paragraph 133).
In regards to Claim 13: A modified Fishman teaches a medical radiation therapy arrangement comprising:
at least one of a surgical microscope (Fishman, Paragraph 83) and a probe-based registration device (Fishman, Figure 1 Item 118);
said at least one of said surgical microscope and said probe-based registration device being configured to three-dimensionally measure in a reference coordinate system a wound cavity in a patient from which a tumor was surgically removed (Fishman, Paragraphs 5 & 119); an
intraoperative radiation therapy device having an x-ray applicator (Fishman, Paragraphs 34 & 36; Figure 1 Items 100 & 116);
said x-ray applicator being navigable in the reference coordinate system (Fishman, Paragraph 120); and,
said intraoperative radiation therapy device being configured to at least one of select the x-ray applicator and arrange the x-ray applicator in the wound cavity on a basis of three-dimensional measurement data generated during the measurement (Fishman, Paragraph 36; “position the head unit”).
In regards to Claim 2: A modified Fishman teaches all of Claim 1 and transmitting the three-dimensional measurement data via interconnected interfaces (Fishman, Paragraph 46), which are configured for said transmitting, of at least one of the surgical microscopes (Fishman, Paragraph 83), the probe-based registration device (Fishman, Paragraph 34; Figure 1 Item 106), and a further apparatus for tissue differentiation and the intraoperative radiation therapy device (Fishman, Paragraph 34; Figure 1 Item 100).
Hendricks teaches of a confocal endomicroscope (Hendricks, Paragraph 120).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the confocal endomicroscope taught in Hendricks to the treatment validation system taught by Fishman, the motivation being to provide a device for identifying in vivo cancerous cells in a human.
In regards to Claim 6: A modified Fishman teaches all of claim 1 and a further apparatus for tissue differentiation (Fishman, Paragraph 34; Figure 1 Item 100), selecting of the x-ray applicator takes place taking into account a density of a corresponding one of the tumor cells determined in the spatially resolved manner and the other tissue characteristic that is relevant for the therapy (Fishman, Paragraph 113 &114; “The treatment head has a plurality of apertures from which a radiation beam can be emitted. A schematic illustration of the treatment head and its apertures is provided in a second portion 1708 of the GUI 1700. As shown in portion 1708, the treatment head comprises a plurality of apertures represented by multiple areas, with a unique mark for each area.”).
Hendrick teaches the wound cavity is measured additionally via at least one of a confocal endomicroscope of the medical radiation therapy arrangement and wherein a density of tumor cells left behind in the wound cavity after the surgical removal of at least one of the tumors and another tissue characteristic that is relevant for the therapy is determined in the reference coordinate system in a spatially resolved manner (Hendricks, Paragraph 120).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the confocal endomicroscope and identification of cancerous cells in vivo taught by Hendricks to the treatment validation system taught in Fishman, the motivation being to provide a tool to more accurately differentiate between cancerous cells and healthy cells in vivo.
In regards to Claim 7: A modified Fishman teaches all of claim 1 and a further apparatus for tissue differentiation (Fishman, Paragraph 34; Figure 1 Item 100), wherein a density of tumor cells left behind in the wound cavity after the surgical removal of at least one of the tumor and another tissue characteristic that is relevant for the therapy is determined in the reference coordinate system in a spatially resolved manner; and, at least an outer part of the x-ray applicator is made taking into account the density of a corresponding one of the tumor cells determined in a spatially resolved manner and the other tissue characteristic that is relevant for the therapy (Fishman, Paragraph 113 &114; “The treatment head has a plurality of apertures from which a radiation beam can be emitted. A schematic illustration of the treatment head and its apertures is provided in a second portion 1708 of the GUI 1700. As shown in portion 1708, the treatment head comprises a plurality of apertures represented by multiple areas, with a unique mark for each area.”).
Hendricks teaches the wound cavity is measured additionally via at least one of a confocal endomicroscope of the medical radiation therapy arrangement (Hendricks, Paragraph 120).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the confocal endomicroscope taught in Hendricks to the therapy validation system taught in Fishman, the motivation being to provide a tool for identifying in vivo cancerous cells in a human.
In regards to Claim 8: A modified Fishman teaches all of claim 1, and a further apparatus for tissue differentiation (Fishman, Paragraph 34; Figure 1 Item 100), wherein at least one of a density of tumor cells left behind in the wound cavity after the surgical removal of the tumor and another tissue characteristic relevant for the therapy is determined in the reference coordinate system in a spatially resolved manner; said selecting of the x-ray applicator takes place taking into account the density of a corresponding one of the tumor cells determined in the spatially resolved manner and the other tissue characteristic relevant for the therapy; and, at least an outer part of the x-ray applicator is made taking into account the density of a corresponding one of the tumor cells determined in a spatially resolved manner and the other tissue characteristic that is relevant for the therapy (Fishman, Paragraph 113 &114; “The treatment head has a plurality of apertures from which a radiation beam can be emitted. A schematic illustration of the treatment head and its apertures is provided in a second portion 1708 of the GUI 1700. As shown in portion 1708, the treatment head comprises a plurality of apertures represented by multiple areas, with a unique mark for each area.”).
Hendricks teaches he wound cavity is measured additionally via at least one of a confocal endomicroscope of the medical radiation therapy arrangement (Hendricks, Paragraph 120).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the confocal endomicroscope taught in Hendricks to the therapy validation system taught by Fishman, the motivation being to provide a tool for identifying in vivo cancerous cells in a human.
In regards to Claim 14: A modified Fishman teaches all of claim 13 and wherein at least one of said surgical microscope (Fishman, Paragraph 83), said probe-based registration device (Fishman, Paragraph 32), and a further apparatus for tissue differentiation and said intraoperative radiation therapy device have interconnected interfaces configured to transmit the three-dimensional measurement data (Fishman, Paragraph 41).
Hendricks teaches a confocal endomicroscope of the medical radiation therapy arrangement (Hendricks, Paragraph 120).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the confocal endomicroscope taught in Hendricks to the therapy validation system taught in Fishman, the motivation being to provide a tool that allows for identifying in vivo cancerous cells in a human being.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0038691 hereinafter Fishman in view of US 2009/0326359 hereinafter Hendricks 2016/0271379 hereinafter Pouliot.
In regards to Claim 9: A modified Fishman teaches all of claim 1, but does not teach wherein the outer part of the x-ray applicator is made via a 3D printing method.
Pouliot teaches wherein the outer part of the x-ray applicator is made via a 3D printing method (Pouliot, Paragraph 26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the utilization of 3D printing for the applicator taught in Pouliot to the therapy validation device taught by Fishman, the motivation being to provide a method of manufacturing the applicator that allows for quick personalization.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0038691 hereinafter Fishman in view of US 2009/0326359 hereinafter Hendricks in view of 2016/0271379 hereinafter Pouliot.
In regards to Claim 10: A modified Fishman teaches all of claim 1 and 6, but does not teach wherein the outer part of the x-ray applicator is made via a 3D printing method.
Pouliot teaches wherein the outer part of the x-ray applicator is made via a 3D printing method (Pouliot, Paragraph 26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the utilization of 3D printing for the applicator taught in Pouliot to the therapy validation device taught by a modified Fishman, the motivation being to provide a method of manufacturing the applicator that allows for quick personalization.
Claim(s) 15 - 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0038691 hereinafter Fishman in view of US 2009/0326359 hereinafter Hendricks in further view of US 2012/0035462 hereinafter Maurer Jr.
In regards to Claim 15: Fishman teaches all of claim 13 and wherein the selection of said x-ray applicator takes into account at least one of the density of the tumor cells determined in a spatially resolved manner and the other tissue characteristic that is determined (Fishman, Paragraphs 113 &114; “The treatment head has a plurality of apertures from which a radiation beam can be emitted. A schematic illustration of the treatment head and its apertures is provided in a second portion 1708 of the GUI 1700. As shown in portion 1708, the treatment head comprises a plurality of apertures represented by multiple areas, with a unique mark for each area.”). Fishman does not teach at least one of a confocal endomicroscope and a further apparatus for tissue differentiation; said at least one of said confocal endomicroscope and said further apparatus for tissue differentiation being configured to additionally measure the wound cavity, wherein at least one of a density of at least one of tumor cells left behind in the wound cavity after surgical removal of the tumor and another tissue characteristic that is relevant for the therapy is determined in the reference coordinate system in a spatially resolved manner.
Hendricks teaches of at least one of a confocal endomicroscope configured to additionally measure the wound cavity, wherein at least one of a density of at least one of tumor cells left behind in the wound cavity after surgical removal of the tumor and another tissue characteristic that is relevant for the therapy is determined in the reference coordinate system in a spatially resolved manner (Hendricks, Paragraph 120).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the confocal endomicroscope taught by Hendricks to the therapy validation device taught by Fishman, the motivation being to provide a tool that can identify in vivo cancerous cells in a human.
Maurer Jr. teaches a further apparatus for tissue differentiation being configured to additionally measure the wound cavity, wherein at least one of a density of at least one of tumor cells left behind in the wound cavity after surgical removal of the tumor and another tissue characteristic that is relevant for the therapy is determined in the reference coordinate system in a spatially resolved manner (Maurer Jr., Paragraph 6 & 44).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the tissue differentiation device taught in Maurer Jr. to the therapy validation system taught in a modified Fishman, the motivation being to provide information to aid a physician in developing a radiation treatment plan.
In regards to Claim 16: A modified Fishman teaches the medical radiation therapy arrangement of claim 15, wherein at least an outer part of the x-ray applicator is produced taking into account at least one of the density of the tumor cells determined in a spatially resolved manner and the other tissue characteristic that is determined (Fishman, Paragraphs 113 &114; “The treatment head has a plurality of apertures from which a radiation beam can be emitted. A schematic illustration of the treatment head and its apertures is provided in a second portion 1708 of the GUI 1700. As shown in portion 1708, the treatment head comprises a plurality of apertures represented by multiple areas, with a unique mark for each area.”).
In regards to Claim 17: Fishman teaches all of claim 13 and wherein the selection of said x-ray applicator takes into account at least one of the density of the tumor cells determined in a spatially resolved manner and the other tissue characteristic that is determined (Fishman, Paragraphs 113 &114; “The treatment head has a plurality of apertures from which a radiation beam can be emitted. A schematic illustration of the treatment head and its apertures is provided in a second portion 1708 of the GUI 1700. As shown in portion 1708, the treatment head comprises a plurality of apertures represented by multiple areas, with a unique mark for each area.”). Fishman does not teach at least one of a confocal endomicroscope and a further apparatus for tissue differentiation; said at least one of said confocal endomicroscope and said further apparatus for tissue differentiation being configured to additionally measure the wound cavity, wherein at least one of a density of at least one of tumor cells left behind in the wound cavity after surgical removal of the tumor and another tissue characteristic that is relevant for the therapy is determined in the reference coordinate system in a spatially resolved manner.
Hendricks teaches of at least one of a confocal endomicroscope configured to additionally measure the wound cavity, wherein at least one of a density of at least one of tumor cells left behind in the wound cavity after surgical removal of the tumor and another tissue characteristic that is relevant for the therapy is determined in the reference coordinate system in a spatially resolved manner (Hendricks, Paragraph 120).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the confocal endomicroscope taught by Hendricks to the therapy validation device taught by Fishman, the motivation being to provide a tool that can identify in vivo cancerous cells in a human.
Maurer Jr. teaches a further apparatus for tissue differentiation being configured to additionally measure the wound cavity, wherein at least one of a density of at least one of tumor cells left behind in the wound cavity after surgical removal of the tumor and another tissue characteristic that is relevant for the therapy is determined in the reference coordinate system in a spatially resolved manner (Maurer Jr., Paragraph 6 & 44).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the tissue differentiation device taught in Maurer Jr. to the therapy validation system taught in a modified Fishman, the motivation being to provide information to aid a physician in developing a radiation treatment plan.
Conclusion
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/N.R.D./Patent Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791