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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application, filed on October 27, 2023. The foreign priority date is April 30, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 27, 2023 is being considered by the examiner. The signed IDS form is attached with the instant office action.
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.
Claims 1 and 4-17 are 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 1 and the depending claims do not require any actual steps of administration or active treatment steps to a patient. The claim, although directed to conventional therapeutic plasma exchange and low-volume plasma exchange does not require the patient in need thereof to be administered any composition or treatment. Rather the claims merely direct one to different treatment types. The claims are indefinite.
Claim 1 refers to an human albumin solution, but the composition is unclear. What makes up the contents of the solution?
Claim 4 recites wherein before the treatment regime of LVPE previous rounds of TPE are carried out and it is unclear how many rounds are required or what steps are considered a round of treatment.
Claims 5 recites wherein said TPE regime can be conducted and it is unclear as to what conducting is limiting. The same is unclear for the independent and depending claims which recite the term.
Claims 6 recites wherein said TPE regime is conducted at least during 6 weeks and it is unclear to what conducting is limiting and/or how many times treatment must happen in a 6-week period. Is it once over a 6-week period, once a week for 6 weeks?
Regarding claim 7, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 10 is indefinite because it recites “at least during 12 months” and it is unclear if the intent is for once during the 12 months or every month for 12 months.
Claims dependent on a rejected claim are rejected for failing to cure the indefiniteness.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4-7, and 9-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mercè Boada et. al. (From 10/27/2023 IDS, NPL doc#6, Plasma exchange for Alzheimer’s disease Management by Albumin Replacement (AMBAR) trial: Study design and progress, Alzheimer’s & Dementia: Translational Research & Clinical Interventions 5 (2019) 61-69).
Regarding claim 1, 4-7, 10, 13-14 and 16-17, Boada describes an active treatment protocol for Alzheimer’s disease wherein “the intervention regime lasts 14 months, which includes a first 6-week stage of intensive treatment with one session of conventional therapeutic plasma exchange (TPE) per week, when all the patients assigned to any of the study groups (active treatment and control) follow the same treatment regime, followed by a second 12-month stage of maintenance treatment with one session of low-volume plasma exchange (LVPE) per month, as summarized in Fig. 2”. Boada describes that for the TPE and LPVE treatments that “TPE, 2500 to 3000 mL of the patient’s plasma is being replaced with the same volume of Albutein 5%, whereas during LVPE, only 650 mL to 880 mL of the patient’s plasma is replaced with Albutein 20%, 100 mL or 200 mL depending on the treatment arm randomization” (see page 64, first para.). Boada also describes wherein patients that have received treatment have an MMSE score of less than or equal to 21 (see page 66, right column, 2nd para.).
Regarding claim 9, Boada describes a monthly LVPE treatment (see page 67, right column, third para.).
Regarding claims 11-12, Boada teaches wherein there is 20 or 40 grams of Albutein® replacement (see page 64, para.). Albutein® is a brand name for albumin (human).
Regarding claim 15, Boada describes the treatment is intended for mild to moderate AD (see discission, first para., page 67).
Boada describes “the intervention regime lasts 14 months, which includes a first 6-week stage of intensive treatment with one session of conventional therapeutic plasma exchange (TPE) per week” (see first line of page 64).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1 and 4-17 are rejected under 35 U.S.C. 103 as being unpatentable over Mercè Boada et. al. (From 10/27/2023 IDS, NPL doc#6, Plasma exchange for Alzheimer’s disease Management by Albumin Replacement (AMBAR) trial: Study design and progress, Alzheimer’s & Dementia: Translational Research & Clinical Interventions 5 (2019) 61-69).
Regarding claim 1, 4-7, 10, 13-14 and 16-17, Boada describes an active treatment protocol for Alzheimer’s disease wherein “the intervention regime lasts 14 months, which includes a first 6-week stage of intensive treatment with one session of conventional therapeutic plasma exchange (TPE) per week, when all the patients assigned to any of the study groups (active treatment and control) follow the same treatment regime, followed by a second 12-month stage of maintenance treatment with one session of low-volume plasma exchange (LVPE) per month, as summarized in Fig. 2”. Boada describes that for the TPE and LPVE treatments that “TPE, 2500 to 3000 mL of the patient’s plasma is being replaced with the same volume of Albutein 5%, whereas during LVPE, only 650 mL to 880 mL of the patient’s plasma is replaced with Albutein 20%, 100 mL or 200 mL depending on the treatment arm randomization” (see page 64, first para.). Boada also describes wherein patients that have received treatment have an MMSE score of less than or equal to 21 (see page 66, right column, 2nd para.).
Regarding claim 9, Boada describes a monthly LVPE treatment (see page 67, right column, third para.).
Regarding claims 11-12, Boada teaches wherein there is 20 or 40 grams of Albutein® replacement (see page 64, para.). Albutein® is a brand name for albumin (human).
Regarding claim 15, Boada describes the treatment is intended for mild to moderate AD (see discission, first para., page 67).
Boada describes “the intervention regime lasts 14 months, which includes a first 6-week stage of intensive treatment with one session of conventional therapeutic plasma exchange (TPE) per week” (see first line of page 64).
Boada does not specifically teach that each subsequent round of LVPE is conducted 10-45 days after the previous round, however Boada teaches a range of LVPE rounds which are within the instantly claimed range because Boada describes the window for LVPE (weeks 9 to 53) and TPE (weeks 1 to 6). Therefore it would have been obvious to persons having ordinary skill in the art to optimize to within the instantly claimed range because Boada already teaches effective ranges within that time frame.
Conclusion
Currently no claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655