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 .
Response to Arguments
Applicant’s arguments, see Page 11, filed 2 June 2026, with respect to c have been fully considered and are persuasive. The objection of claims 11 & 12 has been withdrawn.
Applicant’s arguments, see Page 11, filed 2 June 2026, with respect to the 35 U.S.C. § 112(b) rejection of claim 11 have been fully considered and are persuasive. The 35 U.S.C. § 112(b) rejection of c has been withdrawn.
Applicant’s arguments, see Pages 13-18, filed 2 June 2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of US 2020/0038691 hereinafter Fishman in view of US 2009/0326359 hereinafter Hendricks in view of US 2009/0299124 hereinafter Francescatti.
Applicant's arguments filed 2 June 2026 with respect to the 35 U.S.C. § 103 rejection of claim 13 have been fully considered but they are not persuasive. The applicator of Fishman can also be used to take three dimensional measurements as taught by paragraph 119 “measurement data from the XRSE can be used to generate estimated information about a three-dimensional radiation pattern produced by the radiation source for portions of the three-dimensional radiation pattern that are not directly sensed by the XRSE”. Therefore the applicator can perform the same functions as the probe of claim 1. The endomicroscope taught by Hendricks can be used to teach the microscope of claim 1, especially in light of specification paragraph 18 “confocal endomicroscopy or other (probe-based) methods can be used to identify tumor tissue left behind, as will be described further below. If the probes of these methods and/or apparatuses are navigated, the site of the tissue in the wound cavity can be contained in the three-dimensional measurement data for the radiation therapy device”. In regards to the movements guidance performed based on the acquired data, examiner points out Fishman paragraph 5 states “the at least one parameter of the applied radiation can be selected from the group consisting of a duration of the applied radiation, an intensity of the applied radiation, and a three-dimensional radiation pattern associated with the applied radiation”.
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.
Claim(s) 1-8 & 11-12, 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 US 2009/0299124 hereinafter Francescatti.
In regards to Claim 1: A method for operating a medical radiation therapy arrangement, wherein the medical radiation therapy arrangement comprises:
(i) a probe-based registration device (Fishman, Paragraph 37; Figure 1 Items 116), and
the method comprising:
(A) 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), thereby generating three-dimensional measurement data, wherein said three- dimensional measuring is performed via the at least one of a surgical microscope and a probe-based registration device (Fishman, Paragraph 118); and then,
(B)at least one of: wherein the x-ray applicator being is navigable in the reference coordinate system (Fishman, Paragraph 119).
Fishman does not teach at least one of a surgical microscope, an intraoperative radiation therapy device comprising a multiplicity of x-ray applicators of different sizes and different shapes, selecting one of the x-ray applicators on a basis of the three- dimensional measurement data, and arranging [[an]] the x-ray applicator in the wound cavity on a basis of the three-dimensional measurement.
Hendricks teaches least one of a surgical microscope (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.
Francescatti teaches an intraoperative radiation therapy device comprising a multiplicity of x-ray applicators of different sizes and different shapes (Francescatti, Paragraph 26; figure 2 Item 38), and selecting one of the x-ray applicators on a basis of the three- dimensional measurement data, and arranging [[an]] the x-ray applicator in the wound cavity on a basis of the three-dimensional measurement (Francescatti, 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 multiple applicators taught in Francescatti to the controller valve device taught by a modified Miller, the motivation being to radiation oncologist may choose to fit the patient's resection cavity.
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 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, and wherein, as part of selecting one of the x-ray applicators, at least one external part of the selected x-ray applicator is made taking into account the three-dimensional measurement data (Fishman, Paragraph 46; Figure 2 Item 234) (Francescatti, Paragraph 26; figure 2 Item 38).
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 11: A modified Fishman teaches the method of claim 1, and 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: image representations of the marked regions are captured (Fishman, Paragraph 99 & 107; Figure 3 Item 322), the marked regions are identified (Fishman, Paragraph 128), measurement data describing the marked regions are received, and simulation data describing the marked regions are received (Fishman, Paragraph 117); and,
wherein the data [[are]] is 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]] is 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).
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 in view of in view of US 2009/0299124 hereinafter Francescatti 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 US 2009/0299124 hereinafter Francescatti 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) 13 & 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 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 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) 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/N.R.D./Patent Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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