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 is objected to because of the following informalities:
Claim 11 reads “20-1000 nanometer or the particles are of 1-1000 micrometer” but should be corrected to “20-1000 nanometers or the particles are of 1-1000 micrometers”
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 7, 15 and all claims dependent thereon is 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.
Claim 7 line 4 recites the limitation “preparing at least one administration hydraulic element” rendering this claim unclear. It is unclear what is meant by “preparing” a hydraulic element. Please describe how exactly the hydraulic element is prepared.
Claim 7 line 4-5 recites the limitation “preparing at least one administration hydraulic element of a system for administration of the mixture containing particles, wherein the system comprises:” As the limitation is about prepping the administration hydraulic element, and not about the system for administration of the mixture containing particles, it is not clear if the system for administration of the mixture containing particles is positively recited in the claim or not. It is suggested the claim be amended to more clearly positively recite the system for administration of the mixture containing particles.
Claim 7 recites the limitation “wherein the actuation system is, hydraulically, decoupled administration subsystem” rendering this claim unclear. The examiner interprets this limitation as the actuation system is separate from the administration system but the specification notes that the actuation and administration system are operably connected through element 33 in figure 1. Please specify what is meant by the systems being “hydraulically decoupled”. For examination purposes, this is being interpreted as the systems being separate syringes.
Claim 15 contains the trademark/trade names QuiremSpheres, SIR-Speres, and TheraSphere. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe different types of microparticles and, accordingly, the identification/description is indefinite.
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.
Claim(s) 7-8, 10, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hodgson (US 2021/0369947) in view of Agris (US 2016/0296692) further in view of Uber (US 2007/0106208).
Regarding claim 7, Hodgson teaches a method of treating an individual with cancer
with a mixture containing particles, the method comprising:
preparing at least one administration hydraulic element of a system for
administration of the mixture containing particles wherein the system comprises:
an administration subsystem comprising the at least one administration hydraulic element configured to contain the mixture containing the particles (fig. 9, element 904. Paragraph [0078] “The transport medium (904) and the displacement medium (906) enter the T-junction from the two branches and exit the T-junction through the trunk and flow to the fluid outlet (908)”) wherein said at least one administration hydraulic element is arranged for administering of the mixture to a further system (paragraph [0011] “intravenously administering to the patient the resulting mixture of the microparticles”) and
an actuation subsystem comprising at least one actuation hydraulic element; wherein the at least one actuation hydraulic element is operably connected, providing an operable connection, to the at least one administration hydraulic element and is configured to actuate said administration hydraulic element to administer mixture to the further system (paragraph [0079] “The displacement medium (906) travels into the elongate housing (910), and pushes microparticles from the elongate housing (910) into the fluid mixer (902).”)
wherein the at least one actuation hydraulic element is further fluidly connected, providing a fluid connection with an operating element to operate the at least one actuation hydraulic element (paragraph [0082] “using an aspirating syringe (944) which applies a reduced pressure at the loading fluid outlet (946).” The examiner notes the syringe 944 as the operating element that initiates the process.) wherein the actuation subsystem is, hydraulically, decoupled from the administration subsystem (The examiner notes that the actuation subsystem and administration subsystem are two different syringes, thus making the system hydraulically decoupled.)
flushing the mixture through the further system with flushing fluid (paragraph [0081] “a source of flushing medium (950), which is fluidly connectable via fluid control valves (952) to fluid outlet (908)”);
However, Hodgson fails to teach wherein the at least one administration hydraulic element is movably mounted in a movable arrangement configured to, when moving, homogenize the mixture, and moving the said administration hydraulic element until the mixture is homogeneous:
Agris teaches a fluid administration system wherein the at least one administration hydraulic element is movably mounted in a movable arrangement configured to, when moving (paragraph [0060] “the syringe 10 and/or fluid path set may include means for automatically agitating or mixing the at least one tracer compound and fluid to be injected by, for example, vibration, rotation, or similar mechanical manipulation of the syringe and/or fluid path set.”), homogenize the mixture (paragraph [0060] “Ensuring that the at least one tracer compound is homogenously mixed throughout the fluid” The examiner notes here that this system would move the administration hydraulic element until it is homogenous.)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by Hodgson in view of Argis. One of ordinary skill in the art would have been able to recognize that the manipulation means are useful for ensuring that the dissolved, broken, or mixed capsule or tablet containing the tracer compound is homogenously mixed throughout the fluid to be injected. Ensuring that the at least one tracer compound is homogenously mixed throughout the fluid ensures that the at least one tracer compound may be readily identified by the at least one sensor. See paragraph [0060] of Hodgson.
However, both Hodgson and Argis are silent on operating the actuation subsystem to actuate the administration hydraulic element such that a predefined volume of mixture is administered to the individual.
Uber teaches a fluid dispensing system that stops operating after a predetermined volume. (paragraph [0157] “If the button is held down, injector 100 stops at a predetermined volume.”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by Hodgson and Argis in view of Uber. One of ordinary skill in the art would have been able to recognize that every patient would require a specific amount of therapy for treatment of their conditioned and it would be not safe to have them over or under dosed.
Regarding claim 8, Hodgson, Argis, and Uber teach the method according to claim 7, and Hodgson further teaches wherein the mixture is administered through an administration selected from the group consisting of intravenous administration, intratumoral administration and intra-arterial administration. (abstract “A delivery device for intravenous delivery of microparticles to a patient.”)
Regarding claim 10, Hodgson, Argis, and Uber teach the method according to claim 7, and Hodgson further teaches (paragraph [0005] “In SIRT, yttrium-90 (.sup.90Y) radiolabeled microparticles are injected into a hepatic artery of a patient, preferentially localizing in the hepatic tumours due to their increased vascularization.”)
Regarding claim 14, A method for outputting a predetermined volume of particles from a hydraulic element containing a mixture with the particles, the method comprising:
providing a system for administration of the mixture containing particles, wherein the system comprises:
an administration subsystem comprising the at least one administration hydraulic element configured to contain the mixture containing the particles (fig. 9, element 904. Paragraph [0078] “The transport medium (904) and the displacement medium (906) enter the T-junction from the two branches and exit the T-junction through the trunk and flow to the fluid outlet (908)”) wherein said at least one administration hydraulic element is arranged for administering of the mixture to a further system (paragraph [0011] “intravenously administering to the patient the resulting mixture of the microparticles”) and
an actuation subsystem comprising at least one actuation hydraulic element; wherein the at least one actuation hydraulic element is operably connected, providing an operable connection, to the at least one administration hydraulic element and is configured to actuate said administration hydraulic element to administer mixture to the further system (paragraph [0079] “The displacement medium (906) travels into the elongate housing (910), and pushes microparticles from the elongate housing (910) into the fluid mixer (902).”)
wherein the at least one actuation hydraulic element is further fluidly connected, providing a fluid connection with an operating element to operate the at least one actuation hydraulic element (paragraph [0082] “using an aspirating syringe (944) which applies a reduced pressure at the loading fluid outlet (946).” The examiner notes the syringe 944 as the operating element that initiates the process.) wherein the actuation subsystem is, hydraulically, decoupled from the administration subsystem (The examiner notes that the actuation subsystem and administration subsystem are two different syringes, thus making the system hydraulically decoupled.)
preparing the at least one administration hydraulic element with the mixture containing the particles; (paragraph [0042] “The loading fluid and microparticles may be drawn from the chamber by applying a reduced pressure at the loading fluid outlet, such as using an aspirating syringe.”)
However, Hodgson fails to teach wherein the at least one administration hydraulic element is movably mounted in a movable arrangement configured to, when moving, homogenize the mixture, and moving the said administration hydraulic element until the mixture is homogeneous:
Agris teaches a fluid administration system wherein the at least one administration hydraulic element is movably mounted in a movable arrangement configured to, when moving (paragraph [0060] “the syringe 10 and/or fluid path set may include means for automatically agitating or mixing the at least one tracer compound and fluid to be injected by, for example, vibration, rotation, or similar mechanical manipulation of the syringe and/or fluid path set.”), homogenize the mixture (paragraph [0060] “Ensuring that the at least one tracer compound is homogenously mixed throughout the fluid” The examiner notes here that this system would move the administration hydraulic element until it is homogenous.)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by Hodgson in view of Argis. One of ordinary skill in the art would have been able to recognize that the manipulation means are useful for ensuring that the dissolved, broken, or mixed capsule or tablet containing the tracer compound is homogenously mixed throughout the fluid to be injected. Ensuring that the at least one tracer compound is homogenously mixed throughout the fluid ensures that the at least one tracer compound may be readily identified by the at least one sensor. See paragraph [0060] of Hodgson.
However, both Hodgson and Argis are silent on operating the actuation subsystem to actuate the administration hydraulic element such that a predefined volume of mixture is administered to the individual.
Uber teaches a fluid dispensing system that stops operating after a predetermined volume. (paragraph [0157] “If the button is held down, injector 100 stops at a predetermined volume.”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by Hodgson and Argis in view of Uber. One of ordinary skill in the art would have been able to recognize that every patient would require a specific amount of therapy for treatment of their conditioned and it would be not safe to have them over or under dosed.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hodgson in view of Argis further in view of Uber further in view of Taniguchi (US 2011/0142813).
Regarding claim 9, Hodgson, Argis, and Uber teach the method of claim 7 but fail to teach wherein the cancer is gastro-intestinal cancer, a head tumor, and/or a neck tumor.
Taniguchi describes a method of administering a chemotherapeutic agent to a head or neck tumor. (paragraph [0001] “a method of treating head and neck cancer, comprising administrating an anti-cancer cell composition into the tumor nutrient artery” paragraph [0092] “The NKT cell stimulating agent according to the present invention is generally provided in dosage forms such as injections and drip infusions.”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by Hodgson, Argis, and Uber in view of Taniguchi. One of ordinary skill in the art would have been able to recognize that injecting cancer treatments would yield the predictable results of treating head and neck tumors.
Claim(s) 11 – 12, 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hodgson in view of Argis further in view of Uber further in view of Barnett (US 2011/0104052).
Regarding claim 11, Hodgson, Argis, and Uber teach the method of claim 7 but fail to teach wherein the particles are nanoparticles of 20-1000 nanometer or the particles are of 1-1000 micrometers.
Barnett teaches making a composition of chemotherapy spheres on the nanometer and micrometer range. (Paragraph [0319] “small unilamellar vesicles having a diameter of from 30 to 150 nanometers“; Paragraph [0649] “catheter chemospheres ranging from 50 to 200 micrometers are injected”)
It would be prima facie obvious to modify the system taught by Hodgson, Argis, and Uber in view of Barnett. One of ordinary skill would have been able to recognize that every condition and system would require customized treatments based on the type of therapeutic administered. Further, even though where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. Please see MPEP 2144, section II, A; in re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); and in re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997).
Regarding claim 12, Hodgson, Argis and Uber teach the method of claim 7 but fails to teach further comprising administering to the individual a chemotherapeutic agent.
Barnett teaches administering a chemotherapeutic agent to an individual. (paragraph [0351] “the methods of treating a tumor, e.g. a cancerous tumor, comprise administering to a subject composition and administering a second agent to a subject. The second agent can be a second chemotherapeutic agent,”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by Hodgson, Argis, and Uber in view of Barnett. One of ordinary skill in the art would have been able to recognize that using chemotherapeutics are a well known method of treating tumors as noted in paragraph [0351] of Barnett.
Regarding claim 17, Hodgson, Argis, Uber and Barnett teach the method of claim 12, and Barnett further teaches wherein the chemotherapeutic agent is coupled to the particles. (paragraph [0011] “compositions comprising a hydrogel and an agent, for example a therapeutic agent or an imaging agent, for locoregional delivery. In certain preferred embodiments of the invention, the hydrogel compositions are detectable by Magnetic Resonance and CT Scan and are used for locoregional delivery of therapeutic agents, for example chemotherapeutic agents 3-Bromopyruvate and Doxorubicin.”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught in claim 12 in view of Barnett. One of ordinary skill in the art would have been able to recognize that therapeutic agent-eluting microspheres and stents show promise in the burgeoning field of interventional radiology, many therapeutics in the current clinical armaterium are unstable at the high temperatures required for traditional microsphere synthesis, and so current commercially available drug eluting beads are loaded after synthesis. See paragraph [0007] of Barnett.
Regarding claim 18, Hodgson, Argis, Uber, and Barnett teach the method of claim 12 and Hodgson further teaches flushing the mixture through the further system with flushing fluid (paragraph [0081] “a source of flushing medium (950), which is fluidly connectable via fluid control valves (952) to fluid outlet (908)”)
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hodgson in view of Argis further in view of Tribble (US 2010/0217431).
Regarding claim 13, Hodgson teaches a method for filling multiple vials, the method comprising:
Providing a system for administration of the mixture containing particles wherein the system comprises:
an administration subsystem comprising the at least one administration hydraulic element configured to contain the mixture containing the particles (fig. 9, element 904. Paragraph [0078] “The transport medium (904) and the displacement medium (906) enter the T-junction from the two branches and exit the T-junction through the trunk and flow to the fluid outlet (908)”) wherein said at least one administration hydraulic element is arranged for administering of the mixture to a further system (paragraph [0011] “intravenously administering to the patient the resulting mixture of the microparticles”) and
an actuation subsystem comprising at least one actuation hydraulic element; wherein the at least one actuation hydraulic element is operably connected, providing an operable connection, to the at least one administration hydraulic element and is configured to actuate said administration hydraulic element to administer mixture to the further system (paragraph [0079] “The displacement medium (906) travels into the elongate housing (910), and pushes microparticles from the elongate housing (910) into the fluid mixer (902).”)
wherein the at least one actuation hydraulic element is further fluidly connected, providing a fluid connection with an operating element to operate the at least one actuation hydraulic element (paragraph [0082] “using an aspirating syringe (944) which applies a reduced pressure at the loading fluid outlet (946).” The examiner notes the syringe 944 as the operating element that initiates the process.) wherein the actuation subsystem is, hydraulically, decoupled from the administration subsystem (The examiner notes that the actuation subsystem and administration subsystem are two different syringes, thus making the system hydraulically decoupled.)
preparing the at least one administration hydraulic element with the mixture containing the particles; (paragraph [0042] “The loading fluid and microparticles may be drawn from the chamber by applying a reduced pressure at the loading fluid outlet, such as using an aspirating syringe.”)
However, Hodgson fails to teach wherein the at least one administration hydraulic element is movably mounted in a movable arrangement configured to, when moving, homogenize the mixture, and moving the said administration hydraulic element until the mixture is homogeneous:
Agris teaches a fluid administration system wherein the at least one administration hydraulic element is movably mounted in a movable arrangement configured to, when moving (paragraph [0060] “the syringe 10 and/or fluid path set may include means for automatically agitating or mixing the at least one tracer compound and fluid to be injected by, for example, vibration, rotation, or similar mechanical manipulation of the syringe and/or fluid path set.”), homogenize the mixture (paragraph [0060] “Ensuring that the at least one tracer compound is homogenously mixed throughout the fluid” The examiner notes here that this system would move the administration hydraulic element until it is homogenous.)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by Hodgson in view of Argis. One of ordinary skill in the art would have been able to recognize that the manipulation means are useful for ensuring that the dissolved, broken, or mixed capsule or tablet containing the tracer compound is homogenously mixed throughout the fluid to be injected. Ensuring that the at least one tracer compound is homogenously mixed throughout the fluid ensures that the at least one tracer compound may be readily identified by the at least one sensor. See paragraph [0060] of Hodgson.
However, both Hodgson and Argis are silent on operating the actuation subsystem to actuate the administration hydraulic element such that a predefined volume of mixture is administered to the individual and connecting at least one vial to be filled to the system.
Tribble teaches a fluid dispensing system that stops operating after a predetermined volume, providing a vial, and preparing an administration element with microparticles. (paragraph [0014] “advancing the partially filled syringe to another station where a predetermined amount of the reconstituted medication is delivered to the partially filled syringe to produce the dosage of medication”; paragraph [0008] “The drug vial is typically stored in a drug cabinet or the like and is then delivered to other stations where it is processed to receive the diluent.”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by Hodgson and Argis in view of Tribble. One of ordinary skill in the art would have been able to recognize that every patient would require a specific amount of therapy for treatment of their conditioned and it would be not safe to have them over or under dosed. Further, vials are commonly used for storage of medication and treatments, see paragraph [0007] of Tribble.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hodgson in view of Argis further in view of Uber further in view of Gray (AU 2013/315276).
Regarding claim 15, Hodgson, Argis, and Gray teach the method of claim 7 but fail to teach wherein the particles are radio-active particles selected from the group consisting of QuiremSpheres, SIR-Speres, TheraSphere and CT imageable microspheres.
Gray teaches a method of treating cancer naming radioparticles available to treat liver cancer. (Paragraph [0009] “There are currently two commercially-available products readily available for SIRT to treat liver cancer, namely, TheraSphere@ (MDS Nordion, Inc.), and SIR Spheres@ (SIRTeX@ Medical Ltd.).”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by Hodgson, Argis, and Uber in view of Gray. One of ordinary skill in the art would have been able to recognize that these radioparticles are readily and commercially available to use for cancer treatment. See paragraph [0009] of Gray.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hodgson in view of Argis further in view of Uber further in view of Taniguchi further in view of Gray.
Regarding claim 16, Hodgson, Argis, Uber, and Taniguchi teach the method according to claim 9 but fail to teach wherein the gastro-intestinal is a liver cancer or pancreas tumor.
Gray teaches a method of treating cancer naming radioparticles available to treat liver cancer. (Paragraph [0009] “There are currently two commercially-available products readily available for SIRT to treat liver cancer, namely, TheraSphere@ (MDS Nordion, Inc.), and SIR Spheres@ (SIRTeX@ Medical Ltd.).”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by Hodgson, Argis, Uber, and Taniguchi in view of Gray. One of ordinary skill in the art would have been able to recognize that this combination of prior art elements would yield the predictable results of using microparticles to treat liver cancer.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hirschman (US 2011/0178359) teaches a system for administering radiopharmaceutical particles.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARIANA JOY LACAY DECASTRO whose telephone number is (571)272-8316. The examiner can normally be reached Monday - Friday 9:00 AM - 5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at 571-272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.L.D./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
