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 .
Election/Restrictions
Applicant’s election without traverse of claims 18-28 in the reply filed on 06/18/2026 is acknowledged.
Claims 1-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected set of apparatus and method claims, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/18/2026.
Claim Objections
Claim 20 is objected to because of the following informalities:
Regarding claim 20, in line 3, “micropsheres” should be rewritten as “microspheres”.
Appropriate correction is required.
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 33 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.
Regarding claims 33, there is no description of detecting radioactivity with the detector that is configured for positioning within a 2.5 inch x 3.0 inch holder or less opening within the administration housing in the specification. The Examiner will broadly interpret the limitation as detecting radioactivity with the detector within the administration housing.
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.
Claims 18-24, 26-30, and 32-34 are rejected under 35 U.S.C. 103 as being obvious over Line (US 20040258614 A1) in view of Holmes (US 20130079599 A1).
Regarding claim 18, Line teaches a method for performing real-time measuring of radioactivity during radiation microsphere delivery to a patient (“a method of radiation therapy of a patient by administering to the patient the microparticles”, abstract), comprising:
Measuring an initial reading of radioactivity in a microsphere vial (“an accurate dosage of radioactivity can be delivered by administering the entire contents of one vial according to the radioactivity in selected vial as determined by the initial measurement of radioactivity”, paragraph [0064]) prior to beginning radiation microsphere delivery to a patient during selective internal radiation therapy (SIRT) (“microspheres are administered into the blood supply…known as Selective Internal Radiation Therapy (SIRT)”, paragraph [0011]) and
Measuring an ending reading of radioactivity in the microsphere vial after a SIRT period (“if the microspheres or small particles do not contain sufficient ionizing radiation, then an excessive number will be required to deliver the required radiation dose”, paragraph [0043]; the radioactivity would be measured after a SIRT period).
Line does not teach a radiation detector enclosed within an administration housing, where the radiation detector is connected to an electronic display.
However, Holmes teaches a method for performing real-time measuring of radioactivity (“methods are provided for sample processing”, abstract), comprising:
A radiation detector (“detection unit may include one or more…radioactivity sensor”, paragraph [1206]) enclosed within an administration housing (“one or more detection unit may be provided within a device housing”, paragraph [1201]), the radiation detector being connected to an electronic display that displays an output in units of radioactivity (“system may be provided…detection station; and a controller operatively coupled to said at least one module and an electronic display”, paragraph [0210]), the administration housing also including a delivery apparatus configured to deliver radiation microspheres through tubing from the microsphere vial to the patient (“fluid handling system…contained within a module housing…may permit…delivery, processing and/or transport of a fluid…fluid with particles”, paragraph [0566], “fluid handling system may use a pipette or similar device”, paragraph [0567]);
Displaying the initial reading (“display of data may include longitudinal data presented over time”, paragraph [1463]; display can display any information).
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 method of Line with the method of Holmes and implemented a radiation detector within an administration housing that is coupled to an electronic display, in order to gather and display the results of the radiation of the microsphere vials before and after SIRT treatment in order to help the operator ensure that the correct dosage is being delivered to the patient.
Regarding claim 19, Line in view of Holmes teaches all the limitations of claim 18.
Furthermore, Holmes teaches displaying an administered radioactivity reading at the end of SIRT based on the initial and ending readings (“user interface may display information relating to the operation of the device and/or data collected from the device”, paragraph [1279]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Line in view of Holmes and display the administered radioactivity reading at the end of the SIRT treatment, in order for the operator to easily know how much the administered radioactivity is for the patient based off the initial and ending readings.
Regarding claim 20, Line in view of Holmes teaches all the limitations of claim 18.
Furthermore, Holmes teaches measuring an interim reading of radioactivity in the microsphere vial (“detector…at selected time intervals or when triggered by an event”, paragraph [1210]) after each separate administration of radiation microspheres to the patient during SIRT; and
Displaying a current administered radioactivity reading following each measured interim reading, the current administered radioactivity reading based on the initial reading and one or more interim readings (“user interface may display information relating to the operation of the device and/or data collected from the device”, paragraph [1279]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Line in view of Holmes and measure an interim reading of radioactivity as well as displaying a current administered radioactivity in order to measure levels of radioactivity throughout the treatment and ensure that the operator can easily know much the current administered radioactivity levels are for the patient specifically.
Regarding claim 21, Line in view of Holmes teaches performing the measuring of the initial, interim and ending readings of radioactivity during a SIRT procedure that is performed using the same microsphere vial (“microsphere vial and the delivery catheters…values measured before and after”, paragraph [0030]) to deliver radiation microspheres to two or more separate locations within the patient (“administered into the arterial supply of target organs to be treated”, paragraph [0078]).
Regarding claim 22, Line in view of Holmes teaches the radiation emitting microspheres are resin microspheres (“modifications of the .sup.90Y carrier which include resin-based”, paragraph [0017]).
Regarding claim 23, Line in view of Holmes teaches the radiation emitting microspheres being glass microspheres (“microsphere comprising a biologically compatible glass material”, paragraph [0013]).
Regarding claim 24, Line in view of Holmes teaches the radiation emitting microspheres being biodegradable (“suitable polymer compositions preferably have intrinsic and controllable biodegradability”, paragraph [0113]).
Regarding claim 26, Line in view of Holmes teaches the radiation emitting microspheres including radioisotope yttrium-90 (“yttrium-90 is the preferred radionuclide”, paragraph [0046]) or Holmium-166.
Regarding claim 27, Line in view of Holmes teaches all the limitations of claim 18.
Furthermore, Holmes teaches controlling an operation of the radiation detector (“controller 250 which may provide instructions to one or more components of the device”, paragraph [0558]) with a programmable controller (“controller that includes programmable commands”, paragraph [0085]) connected to a radiation detector and a memory (“controller of a system 700 by way of a communications bus…bus may bring various components…in communication with a…memory”, paragraph [0430]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Line in view of Holmes and implement a programmable controller to be connected to the radiation detector and a memory to provide instructions for the operation of the system.
Regarding claim 28, Line in view of Holmes teaches all the limitations of claim 18.
Furthermore, Holmes teaches communicating a data record of delivered radioactivity to a network interface (“the user interface may display information relating to the operation of the dvice and/or data collected from the device”, paragraph [1279]) to record a SIRT procedure in an electronic medical record of a patient (“the user interface may display information relating to a subject and/or health care access for the subject”, paragraph [1279]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Line in view of Holmes and implement a network interface to provide data record and medical record of a patient in order for the operator and patient to view on a display.
Regarding claim 29, Line in view of Holmes teaches all the limitations of claim 18.
Furthermore, Holmes teaches administering a SIRT procedure with the administration housing that is at least partially transparent for viewing of the delivery apparatus (“the device housing may be…a transparent material”, paragraph [1253]) that includes one or more tubes for transport of fluid including the microspheres (“beads may be stored and/or used in any…conduits, tubes, pipes…beads may be provided in a fluid”, paragraph [1013]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Line in view of Holmes and make the administration housing to be partially transparent in order to allow the operator to view inside the device, as well as providing one or more tubes for transport of fluid in order to provide the SIRT procedure to the patient.
Regarding claim 30, Line in view of Holmes teaches all the limitations of claim 18. Line teaches actuating a fluid flow through the delivery apparatus and into a delivery catheter (“administration device routes the microspheres from the vial into the patient’s catheter”, paragraph [0035]).
Furthermore, Holmes teaches actuating a fluid flow through the delivery apparatus for insertion into a patient using a syringe or a pump (“fluid handling system may comprise pumps”, paragraph [0305]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Line in view of Holmes and utilize a pump in order to deliver fluid with the microspheres to the patient for SIRT treatment.
Regarding claims 32 and 33, Line in view of Holmes teaches all the limitations of claim 18.
Furthermore, Holmes teaches detecting radioactivity with the detector that is configured for positioning within a 2.5 inch x 2.5 inch holder or less/3.0 inch opening within the administration housing (“housing…comprising at least one…detection station”, paragraph [0028]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Line in view of Holmes and detect radioactivity with the detector within the administration housing. It also would have been obvious to one of ordinary skill in the art to have recognized that the range of 2.5 inch x 2.5 inch holder or less/3.0 inch opening within the administration housing would be subject for optimization within the claimed range by routine experimentation with a reasonable expectation of success, in order to obtain accurate detection of radioactivity. Moreover, it would have been obvious to one of ordinary skill in the art at the time of the invention to choose the instantly claimed ranges through process optimization, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05 II and in re Boesch, 205 USPQ 215 (1980).
Regarding claim 34, Line in view of Holmes teaches all the limitations of claim 18.
Furthermore, Holmes teaches generating a data record with a controller connected to the detector (“system may be capable of accessing one or more medical history”, paragraph [1455]) for a selected time interval during a delivery procedure, the data record including patient data, a time stamp and radioactivity data measured during the time interval (“the system may be able to access electronic health records and/or pull up patient records and history”, paragraph [1455]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Line in view of Holmes and configure the controller to provide data record including patient data in order to provide the operator the ability to view patient data with the controller connected to the detector of the device.
Claim 25 is rejected under 35 U.S.C. 103 as being obvious over Line in view of Holmes and further in view of Parsons (US 20030175846 A1).
Regarding claim 25, Line in view of Holmes teaches all the limitations of claim 18, but does not teach a radiation probe of a Geiger Mueller counter.
However, Parsons teaches a method of using a radiation detector that comprises of a radiation probe of a Geiger Mueller counter (“using a Geiger counter where the probe is”, paragraph [0061]).
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 method of Line in view of Holmes with the method of Parsons and utilize a radiation probe of a Geiger Mueller counter in order to provide real-time monitoring of the delivered radioactivity.
Claim 31 is rejected under 35 U.S.C. 103 as being obvious over Line in view of Holmes and further in view of Akerele-Ale (US 20210369946 A1).
Regarding claim 31, Line in view of Holmes teaches all the limitations of claim 18, but does not teach inhibiting transmission of radioactivity from the administration housing with a lead element.
However, Akerele-Ale teaches a method of inhibiting transmission of radioactivity from the administration housing with a lead element (“lead…configured to inhibit radioactive emissions”, paragraph [0060]).
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 method of Line in view of Holmes with the method of Akerele-Ale and utilize a lead element to inhibit transmission of radioactivity in order to limit backscatter interference when detecting radioactivity.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARA LINH TRAN whose telephone number is (571)272-3598. The examiner can normally be reached 7:30am-5:00pm M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at 5712724233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.L.T./Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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