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 .
Receipt is acknowledged of IDS filed on 02/13/2024 and 022/06/2024
Claims 1-15 are pending.
Claim Rejections - 35 USC § 112a
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 13 and 14 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling treating, does not reasonably provide enablement for preventing. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Enablement is considered in view of the Wands factors (MPEP 2164.01 (a)). These include: (1) breadth of the claims; (2) nature of the invention; (3) state of the prior art; (4) amount of direction provided by the inventor; (5) the level of predictability in the art; (6) the existence of working examples; (7) quantity of experimentation needed to make or use the invention based on the content of the disclosure; and (8) relative skill in the art. All of the factors have been considered with regard to these claims, with the most relevant factors discussed below:
1) The breadth of claims: The instant claims are directed to a method of preventing a neuroinflammatory disease. This is a very broad claim, one that is not supported by the instant specification.
2) The nature of the invention: The nature of the invention is prevention of a neuroinflammatory disease. Currently, there are no known agents that prevent a neuroinflammatory disease from occurring.
3) The state of the prior art: The state of the art is very high in terms of compositions comprising a drug for the treating a neuroinflammatory disease. However, there is no evidence in the prior art that the instant composition would prevent a neuroinflammatory disease from occurring.
4) The amount of direction provided by the inventor: There is nothing in the specification that would indicate that the current invention prevents a neuroinflammatory disease from occurring or reoccurring. The prevention of a neuroinflammatory disease is a very broad claim. However, there is a substantial gap between treatment and prevention. Consequently, a burdensome amount of research would be required by one of ordinary skill in the art to bridge this gap.
5) Predictability of the art: The preventing of a neuroinflammatory disease is highly unpredictable due to the numerous sources that could trigger a neuroinflammatory disease. For example, a patient could genetically be born with a neuroinflammatory disease. The fact that genetics cannot be adjusted to avoid a neuroinflammatory disease that there is nothing in the prior art that could possibly prevent a neuroinflammatory disease.
6) The presence or absence of working examples: Applicant has some examples of making the composition in the instant specification, none of which teaches how to prevent a neuroinflammatory disease from occurring due to genetics. Overall, applicant fails to provide examples showing that the instant method could cause a neuroinflammatory disease. Therefore, the practitioner would turn to trial and error experimentations to make/use the instant compositions for preventing a neuroinflammatory disease from the specification or the prior art.
7) The quantity of experimentation: In the instant case, there is a substantial gap between treatment and prevention. Consequently, a burdensome amount of research would be required by one of ordinary skill in the art to bridge this gap. In order to utilize the composition as claimed, the skilled artisan would be presented with an unpredictable amount of experimentation. An undetermined number of experimental factors utilizing a system for preventing a neuroinflammatory disease would have to be resolved by the practitioner and/or the patient. The disclosure is not sufficiently discussed in the specification to provide guidance to utilize the invention as claimed.
8) The relative skill of those in the art: the skill of one of ordinary skill in the art is high, e.g. Ph.D. and M.D. level skill.
In summation, Applicant does not reasonably provide enablement for preventing a neuroinflammatory disease.
The dependent claim falls therewith.
Claim Rejections - 35 USC § 112b
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 7 and 15 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.
In regard to claim 7, it is unclear why the term “oligomeric Aβ” is in parenthesis. Thus, it is unclear if this is a limitation in the claim or just a preferred embodiment.
Claim 15 is rejected under 112b due to the combined use of “selected from the group consisting of” and the use of “or” combining the recited Markush group. See MPEP 2173.05(h) which states Markush format as "a material selected from the group consisting of A, B, and C". This rejection can be obviated by changing “or” to “and” to connect the Markush elements recited.
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 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over LEONE (Accelerating water exchange in GdIII–DO3Aderivatives by favoring the dissociative mechanism through hydrogen bonding. Chem Commun. 2019.) in view of MIN (WO2019182395A1).
LEONE teaches the following compound for a MRI contrast agent that utilized DO3A and gadolinium (Gd) (abstract):
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(scheme 1), where R1 is H and R2 is OH.
LEONE does not teach the linker (L) used in instant claim 1.
MIN teaches the following structure for a MRI contrast agent (abstract):
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(page 2, formula 3), which has the linker taught in instant claim 1 and utilizes DO3A and Gd.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate the linker from MIN. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because the linker from LEONE and the linker from MIN are functional equivalents of linkers commonly used in the pharmaceutical industry for MRI contrast agents that utilize DO3A and Gd. Additionally MIN teaches that various linkers can be used for these types of compounds (page 4, paragraph 3).
Regarding claim 2, MIN teaches within the linker A2 is -NH- (page 2, formula 3).
Regarding claim 3, MIN teaches within the linker A1 is -CONH- (page 2, formula 3).
Regarding claim 4, MIN teaches within the linker x is 1, y is 2 and z is 0 (page 2, formula 3).
Regarding claim 5, the structure of LEONE with the linker taught in MIN would result in the chemical formula of instant claim 5.
Regarding claim 6, LEONE teaches the compound coordinated with a water molecule (page 1, paragraph 1). MIN also teaches the compound coordinates with a w2ater molecule (page 10, paragraph 5).
Regarding claims 7-9, Note, the prior art’s composition would have the same chemical/physical properties of “specifically binds to amyloid beta polymer (oligomeric Aβ) of a mammal”, “the compound has a relaxivity of 3.5 to 4.2s-1” and “when the compound is injected intravenously, the compound flows through a blood-brain-barrier (BBB)” as claimed by Applicant, because the prior art has the same ingredients as claimed by Applicant, unless proven otherwise.
Regarding claim 10, LEONE teaches the compound is a MRI contrast agent (abstract).
Regarding claims 11-15, Claims 11-15 are a product claim with intended use. As the prior art teaches the product, it would be capable of the use. Also, MIN teaches the compound is used for brain diseases (abstract).
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA L. MEJIAS whose telephone number is (703)756-5666. The examiner can normally be reached M-F.
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/S.L.M./Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618
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