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 10 is objected to because of the following informalities: “leukaemia” should be “leukemia” and “oesophageal” should be “esophageal”. Appropriate correction is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 2, 4, 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Connelly-Smith et al. (NPL: Therapeutic Apheresis For Patients With Cancer) in view of Naito et al. (US 20240408553 A1).
Regarding claim 1, Connelly-Smith discloses a method for the treatment of a patient diagnosed with cancer (page 1 column 1 lines 1-5), comprising the step of depleting a specific molecule, antibody, or cellular element of extracted blood from the patient by plasma exchange (page 1 column 2 lines 9-13) prior to being re-administered to said patient (page 2 column 1 lines 6-10).
However, Connelly-Smith fails to disclose depleting the extracellular vesicle content.
Naito teaches a similar plasma exchange therapy method of removing extracellular vesicles (abstract, para. [0002, 0013, 0166]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Connelly-Smith and incorporate the removal of extracellular vesicle content as taught by Naito because Connelly-Smith already supports the removal of specific molecules, antibodies, or cellular elements from the bloodstream for treating the underlying pathological process of cancer complications, and Naito similarly removes extracellular vesicles produced by cancer cells.
Regarding claim 2, the combination of Connelly-Smith and Naito discloses the method of claim 1. Connelly-Smith further discloses wherein from about 0.25 to about 2 blood volumes of the patient diagnosed with the cancer is subjected to plasma exchange (page 4 column 1 lines 26-29). Per the Applicant’s specification, plasma exchanges are also reported in terms of plasma volumes; therefore, 0.25 to about 2 total blood volumes subject to exchange is equivalent to 0.25 to about 2 total plasma volumes subject to exchange.
Regarding claim 4, the combination of Connelly-Smith and Naito discloses the method of claim 1. Connelly-Smith further discloses wherein from about 1 to about 1.5 blood volumes of the patient diagnosed with the cancer is subjected to plasma exchange (page 4 column 1 lines 26-29). Per the Applicant’s specification, plasma exchanges are also reported in terms of plasma volumes; therefore, 0.25 to about 2 total blood volumes subject to exchange is equivalent to 0.25 to about 2 total plasma volumes subject to exchange.
Regarding claim 8, the combination of Connelly-Smith and Naito discloses the method of claim 1. Connelly-Smith further discloses wherein the patient is subjected to multiple iterances of plasma exchange, each iterance of plasma exchange happening within 1 to 45 days of the previous iterance of plasma exchange (page 8 column 1 lines 39-55).
Regarding claim 9, the combination of Connelly-Smith and Naito discloses the method of claim 8. Connelly-Smith further discloses wherein each iterance of plasma exchange occurs within 1 to 7 days of the previous iterance of plasma exchange (page 8 column 1 lines 39-55).
Regarding claim 10, the combination of Connelly-Smith and Naito discloses the method of claim 1. Connelly-Smith further discloses wherein the cancer is selected from the group consisting of soft tissue sarcomas, kidney cancer, liver cancer, intestinal cancer, rectal cancer, leukaemia, lymphomas, brain cancer, oesophageal cancer, uterine cancer, cervical cancer, bone cancer, lung cancer, bladder cancer, breast cancer, laryngeal cancer, colorectal cancer, stomach cancer, ovarian cancer, pancreatic cancer, adrenal gland cancer, prostate cancer, and combinations thereof (Table 1, pages 4-9).
Claim(s) 5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Connelly-Smith et al. (NPL: Therapeutic Apheresis For Patients With Cancer) in view of Naito et al. (US 20240408553 A1), and in view of Iriguchi (US 4424132 A).
Regarding claims 5 and 6, the combination of Connelly-Smith and Naito discloses the method of claim 1. However, the combination fails to disclose:
(Claim 5) wherein the patient diagnosed with the cancer has from about 10 % to about 95 % of their plasma removed from their blood as part of the plasma exchange procedure;
(Claim 6) wherein the patient diagnosed with the cancer has from about 10 % to about 40 % of their plasma removed from their blood as part of the plasma exchange procedure.
Iriguchi teaches a method for separating blood components wherein the patient diagnosed with the cancer has from about 10% to about 95% and 10 % to about 40 % of their plasma removed from their blood as part of the plasma exchange procedure (Table 1, column 10 lines 46-50).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Connelly-Smith and incorporate the plasma removal percentages of Iriguchi 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. In re Aller, 105 USPQ 233.
Claim(s) 5 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Connelly-Smith et al. (NPL: Therapeutic Apheresis For Patients With Cancer) in view of Naito et al. (US 20240408553 A1), and in view of Fischel (US 5034135 A).
Regarding claims 5 and 7, the combination of Connelly-Smith and Naito discloses the method of claim 1. However, the combination fails to disclose:
(Claim 5) wherein the patient diagnosed with the cancer has from about 10 % to about 95 % of their plasma removed from their blood as part of the plasma exchange procedure;
(Claim 7) wherein the patient diagnosed with the cancer has from about 60% to about 95% of their plasma removed from their blood as part of the plasma exchange procedure.
Fischel teaches a method for separating blood components wherein the patient diagnosed with the cancer has from about 10% to about 95% and 60% to about 95% of their plasma removed from their blood as part of the plasma exchange procedure (column 6 lines 58-67).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Connelly-Smith and incorporate the plasma removal percentages of Fischel 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. In re Aller, 105 USPQ 233.
Claim(s) 11-13, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Connelly-Smith et al. (NPL: Therapeutic Apheresis For Patients With Cancer) in view of Naito et al. (US 20240408553 A1), and in view of Halbert et al. (US 20130287772 A1).
Regarding claims 11-13 and 27, the combination of Connelly-Smith and Naito discloses the method of claim 1. However, the combination fails to disclose:
(Claim 11) wherein the cancer is a KRAS mutant cancer;
(Claim 12) wherein the KRAS mutant cancer is a cancer that is refractory to chemotherapy treatment;
(Claim 13) wherein the KRAS mutant cancer is a metastatic cancer;
(Claim 27) wherein the KRAS mutant cancer is a metastatic cancer.
Halbert teaches biomarkers for a variety of conditions and diseases including KRAS (para. [0021, 0031]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Connelly-Smith and target a KRAS marker as shown in Halbert. Para. [0356] states an increasing amount of a vesicle can be associated with a metastatic cancer; therefore, a spreading KRAS cancer is no longer localized and it would have been an obvious application of plasma exchange therapy as an alternative to chemotherapy if that is not appropriate (para. [0114, 0965]).
Allowable Subject Matter
Claim 3 is objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Connelly-Smith supports a therapeutic plasma exchange requiring a large volume of plasma of at least 1 plasma volume. Claim 3 requires a volume of blood that is less than a full total volume, and Connelly teaches away from a low-volume of blood/plasma plasma exchange. Further, Connelly states that this type of apheresis would not be tolerated by the elderly or individuals with small blood volumes; therefore, it would not have been obvious to modify Connelly-Smith and reduce the amount of plasma/blood subject to the treatment without the necessary support or teaching.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN A KIM whose telephone number is (703)756-4738. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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/ERIN A KIM/Examiner, Art Unit 3781
/SUSAN S SU/Primary Examiner, Art Unit 3781 24 September 2026
