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 .
Claims Status
The remarks filed 07/13/2026 are acknowledged.
Claims 1-12 are pending.
Claims 7, 10, and 12 are amended.
Claims 13-24 are cancelled.
Applicant’s election without traverse of the following species in the reply filed on 07/13/2026 is acknowledged: an IL3 peptide and intrathecal administration.
Claims 3-9 and 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/13/2026.
Therefore, claims 1, 2, 10, and 12 are under examination.
Priority
The instant application is a 371 of PCT/US2022/015238 and claims priority to provisional application 63/146,015. Priority is given with the earliest effective filing date of 02/05/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/12/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Notably, the disclosure statement filed lists a Search Report. The listing of the references cited in a Search Report itself is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, "the list ... must be submitted on a separate paper." Therefore, the references cited in the Search Report have not been considered. Applicant is advised that the date of submission of any item of information or any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the IDS, including all "statement" requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Note: If copies of the individual references cited on the Search Report are also cited separately on the IDS (and these references have not been lined-through) they have been considered.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
The drawings are objected to because:
1) Figures 1A-1F, 2A-2E, 2G-2M, 3A-3H, 4A-4O, 5A-5N, 7A-7D, 8A-8B, and 9 have pixelated backgrounds. 37 CFR 1.84(a)(1) which requires that “india ink, or its equivalent that secures solid black lines, must be used for drawings”.
2) Figures 1C, 2L, 2M, 4F, 4G, 4H, 4L, 4N, 4O, 5A, 5B, 5C, 5D, 5F, 5G, 5H, 5I, 5L, 5M, 7A, 7C, 7D, and 8B comprise multiple panels. 37 CFR 1.84(u) states that the different views must be numbered in consecutive Arabic numerals and that "partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter". Each panel should be separately numbered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because it contains embedded hyperlinks and/or other forms of browser-executable code (see page 31, line 3 of the specification). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http://, www., or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 112(b)
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 1-2, 10, and 12 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 recites the limitation “a method of treating a subject with Alzheimer's disease, the method comprising administering a therapeutically effective amount of an Interleukin 3 Receptor (IL3R) agonist.” It is unclear how the IL3 agonist can treat the subject without being administered to the subject. Therefore, the scope of this claim is indefinite.
Claims 2, 10, and 12, which depend from claim 1, are therefore indefinite for the same reasons set forth above.
This rejection can be overcome by amending claim 1 to recite “a method of treating a subject with Alzheimer's disease, the method comprising administering to the subject a therapeutically effective amount of an Interleukin 3 Receptor (IL3R) agonist.”
Claim 12 recites the limitation “wherein the IL3R agonist is administered into the CNS via infusion or injection into the cerebrospinal fluid (CSF), intrathecally, or by direct injection or infusion using stereotactic methods”. Intrathecal administration is the administration of a drug to the CSF surrounding the spinal cord [see page 2, fourth paragraph of Soderquist et al., 2010 (instant PTO-892)]. Thus, it is unclear if applicant intends for “infusion or injection into the cerebrospinal fluid (CSF)” to be something different from intrathecal administration or if applicant is simply defining this as “intrathecally” which would be redundant. Therefore, the scope of this claim is indefinite.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 and 10 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Schaebitz (US20080241097; 04/12/2024 IDS).
Regarding claims 1 and 2, Schaebitz teaches a method of treating a neurological or a psychiatric condition in a mammal by administering to the mammal a hematopoietic factor such as IL-3 to treat the condition [0040]. Schaebitz further teaches that the neurological conditions that can be treated include neurodegenerative diseases [0167] which includes Alzheimer’s disease [0169]. Schaebitz also teaches that IL-3 has a neuroprotective effect in rat and human cell cultures [0123-0124].
While the art teaches alternatives of neurodegenerative diseases, alternatives do not negate that the species of Alzheimer’s disease is explicitly named. A generic disclosure will anticipate a claimed species covered by that disclosure when the species can be “at once envisaged” from the disclosure. See MPEP 2131.02(III).
Regarding claim 10, Schaebitz teaches that the IL-3 may be administered in microvesicles [0260].
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.
Claims 1-2 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over
Schaebitz (US20080241097; 04/12/2024 IDS).
The teachings of Schaebitz are above. It is the Examiner’s position that the claims are anticipated by Schaebitz.
Nonetheless, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have picked among the various
embodiments of Schaebitz to arrive at the claimed method with a reasonable expectation of success.
Claims 1-2, 10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Schaebitz (US20080241097; 04/12/2024 IDS), as applied to claims 1-2 and 10 above, and further in view of Soderquist et al., 2010 (instant PTO-892).
The teachings of Schaebitz are above.
However, Schaebitz does not specifically teach that the IL3 agonist (i.e. IL-3) is administered into the CNS intrathecally.
Regarding claim 12, Soderquist teaches that the administration of a drug to the CSF surrounding the spinal cord is known as intrathecal administration [page 2, fourth paragraph], and that intrathecal delivery offers several advantages, beyond the obvious advantage of bypassing the blood-brain barrier, for the administration of biological macromolecules (i.e. proteins; IL-3) to the spinal cord, such as increased potency and safety when injected into the intrathecal space, and due to the increased proximity to the target tissue smaller dosages can be used which potentially minimizes systemic toxicity [page 3, first paragraph].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have specifically administered the IL-3 of Schaebitz into the CNS intrathecally as taught by Soderquist. One would have been motivated to have administered the IL-3 of Schaebitz into the CNS intrathecally as taught by Soderquist with a reasonable expectation of success because Soderquist teaches that intrathecal delivery offers several advantages for the administration of biological macromolecules (i.e. proteins; IL-3) to the spinal cord, such as bypassing the blood-brain barrier, increased potency and safety when injected into the intrathecal space, and due to the increased proximity to the target tissue smaller dosages can be used which potentially minimizes systemic toxicity.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brittney E Donoghue whose telephone number is (571)272-9883. The examiner can normally be reached Mon - Fri 7:30 - 3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571) 272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B.E.D./Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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