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 Interpretation
Claim 5 recites that the first and second adsorbents are the same. As best understood by the examiner, claim 5 is interpreted as the first and second extracorporeal devices utilizing adsorbents of the same composition and not that the first adsorbent is also the second adsorbent (i.e., they have identical compositions but are not referring to the same structure).
Moreover, claim 15 recites a range of ratios that have more than one variable (in this instance, a ratio of activated carbon/non-ionic aliphatic ester resin/non-ionic polystyrene divinyl benzene resin being 10:1:1 to 1:1:1). However, as only the amount of activated carbon as being changed, it is assumed that the activated carbon is the only variable, wherein the claim is essentially treated as reciting a 10:1 ratio of the activated carbon and non-ionic aliphatic ester resin, and a 10:1 ratio of activated carbon and non-ionic polystyrene divinyl benzene resin.
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 24 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 24 recites that the adsorbents are positioned outside in the extraluminal space. There is no antecedent basis for this extraluminal space. For the purpose of examination, the limitation will be interpreted as -an extraluminal space-.
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.
Claims 1, 4-17, 22-25, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Roberts (US 20210030942, published 02/04/2021 versus provisional priority of 09/28/2022) in view of Hetts (US 20150305850).
Regarding claim 1, Roberts discloses a method for improving the safety and efficacy of a chemotherapy drug in a subject in need thereof (abstract and paragraph 0074), comprising:
a) introducing blood or plasma from a subject into a first extracorporeal device (10) comprising an adsorbent (fig. 3, cartridge 10 to introduce blood into, further described in fig. 2 with adsorption component 5), wherein the blood or plasma comprises an amount of a pre- chemotherapy target molecule or compound, and wherein said pre-chemotherapy target molecule or compound is induced by a tumor (paragraph 0053 describes a cytokine as a tumor necrosis factor);
b) contacting the blood or plasma with the adsorbent in the first extracorporeal device to allow the pre-chemotherapy target molecule or compound to bind to the adsorbent (paragraph 0063 describes the adsorption component 5 that binds inflammatory agents);
c) reintroducing the blood or plasma into the subject (paragraph 0062 describes blood/plasma exiting the device for reintroduction into the circulatory system), wherein the blood or plasma obtained after (b) has a reduced amount of the pre-chemotherapy target molecule or compound as compared to the blood or plasma of the subject prior to (b) (paragraph 0062, “By contrast, agents and blood components having diameters greater than about 0.60 microns are blocked by the fiber walls and cannot enter the extra-lumen space”, also see paragraph 0064 wherein the adsorption component binds/captures the inflammatory agents);
Roberts discloses a separate method comprising:
d) administering a chemotherapy drug to the subject (paragraph 0074 describes reducing the presence of unwanted drug agents including chemotherapeutic agents, thus implying a step of administering a chemotherapy drug beforehand);
e) introducing blood or plasma from the subject into a second extracorporeal device comprising a second adsorbent, wherein the blood or plasma comprises an amount of a post-chemotherapy target molecule or compound (paragraph 0074 describes the post-chemotherapy target molecule as the chemotherapeutic agent, and removing this involves binding the target to the hollow fibers.)
f) contacting the blood or plasma with the second adsorbent in the second extracorporeal device to allow the post-chemotherapy target molecule or compound present in blood or plasma to bind to the adsorbent (paragraph 0074); and
g) reintroducing the blood or plasma into the subject, wherein the blood or plasma obtained after (f) is measured to have a reduced amount of the post- chemotherapy target molecule or compound as compared to the blood or plasma of the subject prior to (f) (paragraph 0074, also noting that due to the same device being used, it is reasonable to assume the blood is also being returned to the patient. The reduction of presence of unwanted drug agents described would imply the blood being measured to have reduced amount of target. Paragraph 0075 also describes quantification of inflammatory particles from blood or plasma, taken before and after administration of the therapy).
but does not explicitly teach utilizing both the described methods one after the other, utilizing a second extracorporeal device.
However, Hetts teaches a method wherein a chemotherapeutic drug is provided, and is later filtered out to minimize systemic toxicity levels of the chemotherapeutic agent (paragraph 0014).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Roberts such that both methods were used one after the other, as suggested by Hetts, for the purpose of providing a suitable method both reduces pro-inflammatory cytokines (see Roberts, abstract) and treats a cancer target while also minimizing systemic toxicity levels of the agent after passing through the tumor (see Hetts, paragraphs 0013-0014).
Roberts, as modified by Hetts, discloses wherein the described extracorporeal device may be used for either of the two separate methods, but is silent to wherein the method utilizes a first and second extracorporeal device.
However, one of ordinary skill in the art would appreciate that after a first procedure is finished with one extracorporeal device, a separate extracorporeal device would be beneficial to prevent potential contamination.
Regarding claim 4, Roberts discloses wherein the post-chemotherapy target molecule or compound that binds to the second adsorbent is selected as a chemotherapy drug (paragraph 0074).
Regarding claim 5, Roberts discloses wherein the first adsorbent and second adsorbent are the same (paragraph 0074 discloses a method of reducing the presence of unwanted drug agents from the bloodstream utilizing the device that was used in the method of removing inflammatory agents).
Regarding claim 6, Roberts discloses wherein the first adsorbent comprises activated carbon (paragraph 0009).
Regarding claim 7, Roberts discloses wherein the activated carbon is coated coconut shell granule (paragraph 0012).
Regarding claim 8, Roberts discloses wherein the activated carbon has a pore size distribution of a micropore region of less than 100 Angstroms, a mesopore region of between 100 and 1000 Angstroms, and a macropore region of greater than 1000 Angstroms (paragraph 0014).
Regarding claim 9, Roberts discloses wherein the first adsorbent comprises at least one non- ionic exchange resin (paragraph 0064)
Regarding claim 10, Roberts discloses wherein the non-ionic exchange resin comprises a non- ionic aliphatic ester resin, a non-ionic polystyrene divinyl benzene resin, or combinations thereof (paragraph 0064).
Regarding claim 11, Roberts discloses wherein the non-ionic aliphatic ester resin has an average surface area of approximately 500 m2/g, an average pore size of approximately 300-600 Angstroms, and a mean particle diameter of 560 microns (paragraph 0064).
Regarding claim 12, Roberts discloses wherein the non-ionic polystyrene divinyl benzene resin has an average surface area of approximately 700 m2/g, an average pore size of 300 Angstroms, and a mean particle diameter from approximately 35 microns to approximately 120 microns (paragraph 0013)
Regarding claim 13, Roberts discloses wherein the non-ionic polystyrene divinyl benzene resin has an average surface area of approximately 600 m2/g, an average pore size of 100- 400 Angstroms, and a mean particle diameter from approximately 300 microns to 500 microns (paragraph 0013).
Regarding claim 14, Roberts discloses wherein the second adsorbent is selected from the group consisting of activated carbon, a non-ionic aliphatic ester resin, and a non-ionic polystyrene divinyl benzene resin (paragraph 0009 describes the adsorption component being an activated carbon, with paragraph 0074 describing the method used for this adsorbent is the same device).
Regarding claim 15, Roberts discloses wherein the adsorbent is activated carbon, non-ionic exchange resins, ion exchange resins, or combinations thereof (paragraph 0064), but is silent to wherein the ratio of activated carbon to non-ionic aliphatic ester resin to non-ionic polystyrene divinyl benzene resin is from about 10:1:1 to about 1:1:1 on weight basis.
However, there is no evidence of record that establishes that changing the ratio of these components would result in a difference in function of the method/device of Roberts. Further, a person having ordinary skill in the art, being faced with modifying the ratio of the components in the adsorbent would have a reasonable expectation of success in making such a modification and it appears the device would function given as intended given the claimed ratio. Lastly, applicant has not disclosed that the claimed range solves any state problem, indicating that the ratio is merely preferred (paragraph 0121).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Roberts such that the ratio of activated carbon to non-ionic aliphatic ester resin to non-ionic polystyrene divinyl benzene resin is from about 10:1:1 to about 1:1:1 on weight basis, as there does not appear to be criticality on the claimed range such that it produces an unexpected result.
Regarding claim 16, Roberts discloses wherein the second adsorbent comprises at least one ion exchange resin (paragraph 0009).
Regarding claim 17, Roberts is silent to wherein the at least one ion exchange resin comprises an anion exchange resin.
However, Hetts teaches wherein anion exchange resins are known in the art (paragraph 0023).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Roberts such that the at least one ion exchange resin comprises an anion exchange resin, as taught by Hetts, for the purpose of providing a suitable means of targeting specifically negatively charged drugs (see Hetts, paragraph 0023).
Regarding claim 22, Roberts discloses wherein the first and second extracorporeal devices comprise hollow fiber plasma filters (paragraph 0015).
Regarding claim 23, Roberts does not teach wherein the hollow fiber plasma filters comprise hollow fibers with pore sizes less than 500 nm.
However, Roberts teaches wherein the hollow fiber plasma filters comprise hollow fibers between 200-6000 Angstrom [or 20-600 nm] (paragraph 0015, “a hollow fiber plasma filter having a number of pores sized between 200-6000 Angstrom).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Roberts such that wherein the hollow fiber plasma filters comprise hollow fibers with pore sizes less than 500 nm, as applicant appears to have placed no criticality on the claimed range (paragraph 0108 describes hollow fiber having pore sizes of 500 nm or larger, paragraph 0125 describes binding targets less than 500 nm or less than 1,000 nm in diameter) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 24, Roberts discloses wherein the first and second adsorbents are positioned outside the hollow fibers in the extraluminal space (paragraph 0008, “The system further includes an adsorption component positioned inside the housing and outside the hollow fiber in an extra-lumen space”)
Regarding claim 25, Roberts discloses wherein the first and second extracorporeal devices are connected with blood processing systems selected from the group consisting of: hemodialysis, apheresis, continuous renal replacement therapy, and therapeutic plasma exchange (TPE) (paragraph 0046, “Recent advances in extracorporeal blood purification have led to the design of single “blood-in-blood-out” cartridges that can be deployed within the established infrastructure of hemodialysis”).
Regarding claim 27, Roberts discloses a method for improving the safety and efficacy of a chemotherapy drug in a subject in need thereof prior to administration of a chemotherapeutic agent, comprising:
a) providing a pre-chemotherapy extracorporeal device comprising an adsorbent (fig. 3, device 10 to serve in extracorporeal device, fig. 2 shows this device with adsorbent 5);
b) introducing blood or plasma from a subject into said extracorporeal device, wherein the blood or plasma comprises an amount of a target molecule or compound, and wherein said target molecule or compound is induced by a tumor (paragraph 0053 describes a cytokine as a tumor necrosis factor, paragraph 0063 describes the adsorption component 5 that binds inflammatory agents);
c) contacting the blood or plasma with the adsorbent in the extracorporeal device to allow the target molecule or compound to bind to the adsorbent (paragraph 0063 describes the adsorption component 5 that binds inflammatory agents);
d) reintroducing the blood or plasma into the subject (paragraph 0062 describes blood/plasma exiting the device for reintroduction into the circulatory system), wherein
the blood or plasma obtained after (c) has a reduced amount of the target molecule or compound as compared to the blood or plasma of the subject prior to (c) (paragraph 0062, “By contrast, agents and blood components having diameters greater than about 0.60 microns are blocked by the fiber walls and cannot enter the extra-lumen space”, also see paragraph 0064 wherein the adsorption component binds/captures the inflammatory agents)
Roberts describes a separate method that is utilized for removing unwanted chemotherapy drug, implying a step of administering a chemotherapy drug to the subject (paragraph 0074), but does not teach
e) administering a chemotherapy drug to the subject after the above steps.
However, Hetts teaches a method wherein a chemotherapeutic drug is provided, and is later filtered out to minimize systemic toxicity levels of the chemotherapeutic agent (paragraph 0014).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Roberts such that both methods were used one after the other, as suggested by Hetts, for the purpose of providing a suitable method both reduces pro-inflammatory cytokines (see Roberts, abstract) and treats a cancer target while also minimizing systemic toxicity levels of the agent after passing through the tumor (see Hetts, paragraphs 0013-0014).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Roberts in view of Hetts, and further in view of Ichim (US 20090304677).
Regarding claim 2, Roberts is silent to wherein the pre-chemotherapy target or compound to be bound in the first adsorbent is an exosome
However, Ichim teaches a means of removal of micro vesicular particles (abstract) that binds exosomes (abstract).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Roberts such that the pre-chemotherapy target to be bound in the first adsorbent is an exosome, as taught by Ichim, for the purpose of providing a suitable method that targets a specific structure.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Roberts in view of Hetts and Ichim, and further in view of Winqvist (US 20140175018).
Regarding claim 3, Roberts discloses wherein the amount of said exosome in blood or plasma is measured by identifying expression of a cytokine (paragraph 0065), but is silent to wherein the expression is of one or more molecules comprising: CD9, CD63, CD81, HSP70 Lamp2b, Tsg101, flotillin, and/or annexin.
However, Winqvist teaches that a marked increase in expression of CD63 is a well-known effect of neutrophils reacting as part of the immune system (paragraph 0770).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Roberts such that the amount of said exosome in blood or plasma is measured by identifying expression of CD63, as taught by Winqvist, for the purpose of providing an alternative means of measuring the response of the immune system to inflammation (see Winqvist, paragraph 0770).
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Roberts in view of Hetts, and further in view of Haemmerich (US 20190336671)
Regarding claims 18-20, Roberts is silent to wherein said chemotherapy drug is delivered within a nanocarrier [claim 18], wherein the nanocarrier is a liposome or an exosome [claim 19], wherein the liposome comprises liposomal doxorubicin [claim 20].
However, Haemmerich teaches wherein drugs utilized in chemotherapy encapsulated in liposomal doxorubicin are well known in the art (paragraph 0019).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Roberts such that the chemotherapy drug is delivered within a nanocarrier, wherein the nanocarrier is a liposome, wherein the liposome comprises liposomal doxorubicin, as taught by Haemmerich, for the purpose of providing a known means of encapsulating chemotherapy drugs for delivery (see Haemmerich, paragraph 0003).
Claims 21 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Roberts in view of Hetts, and further in view of Wang (US 20150283318)
Regarding claim 21, Roberts discloses the method further comprising administering an anticoagulant (paragraph 0066, “Optionally, anticoagulant agents may be administered”), but is silent to wherein the anticoagulant is selected from the group consisting of unfractionated heparin, low molecular weight heparin, citrate, and thrombin inhibitors.
However, Wang teaches heparin as a well-known anticoagulant in the art (paragraph 79)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Roberts such that the anticoagulant is selected from the group consisting of unfractionated heparin, low molecular weight heparin, citrate, and thrombin inhibitors, as taught by Wang, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 26, Roberts is silent to wherein a chemotherapy drug is selected from the group consisting of an antimetabolite, an antimicrotubular agent, an antibiotic, an alkylating agent, an anthracycline an antibody-drug conjugate, and metabolites and combinations thereof.
However, Wang teaches that chemotherapies can include administration of alkylating agents (paragraph 0103).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Roberts such that the chemotherapy drug is selected as an alkylating agent, as taught by ref B, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Roberts.
Regarding claim 28, Roberts discloses a method for improving the safety and efficacy of a chemotherapy drug in a subject in need thereof after a chemotherapeutic has been administered (paragraph 0074 describing filtering out an unwanted drug agent including a chemotherapy drug), comprising:
a) introducing blood or plasma from the subject into an extracorporeal device comprising an adsorbent, wherein the blood or plasma comprises an amount of the target molecule or compound (paragraph 0074 describes the adsorbent targeting and binding drug agents),
b) contacting the blood or plasma with the adsorbent in the extracorporeal device to allow the target molecule or compound present in blood or plasma to bind to the adsorbent (paragraph 0074); and
c) reintroducing the blood or plasma into the subject (fig. 3 shows a complete circuit of the extracorporeal device connects from and back to the patient), wherein
wherein the extracorporeal device is configured to capture circulating target molecules or compounds from blood or plasma after chemotherapy treatment is concluded (paragraph 0074 describes capturing target molecules being chemotherapeutic agents, thus the device is configured to capture these molecules after treatment is concluded).
Roberts implies that the blood or plasma obtained after (b) would have a reduced amount of the target molecule or compound as compared to the blood or plasma of the subject prior to (b) (paragraph 0074 describes the drug being bound to the adsorbent and therefore not in the blood or plasma), but is silent to an active measuring step such that the blood or plasma obtained after (b) is measured to have a reduced amount of the target molecule.
However, Roberts teaches wherein, when filtering out inflammatory particles, measurements are taken in the patient’s blood before and after administration of therapy (paragraph 0075).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Roberts to include a similar step with respect to filtering out chemotherapy drug such that the blood or plasma obtained after (b) is measured to have a reduced amount of the target molecule, for the purpose of providing a similar means of determining the efficacy of the treatment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON W LEVY whose telephone number is (571)272-7582. The examiner can normally be reached M-F 7:30AM- 4:00 PM.
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/Brandon W. Levy/Examiner, Art Unit 3781
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