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 .
1. Formal Matters
Claims 1-4 are pending and are the subject of this Office Action.
2. Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors, embedded hyperlinks, or improperly referenced trademarks. Applicants’ cooperation is requested in correcting any errors of which Applicants may become aware.
3. Claim Objections
Claims 1 and 2 are objected to. It is suggested that there be a hyphen between “PVM” and “stimulating”.
4. Claim Rejections - 35 USC § 112(a) – scope of enablement
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 1-4 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for showing that PVM depletion leads to impaired CSF diffusion (Example 1), does not reasonably provide enablement for treating, preventing, or reversing a brain disease or disorder characterized by accumulation of brain debris. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
In In re Wands, 8USPQ2d, 1400 (CAFC 1988) page 1404, the factors to be considered in determining whether a disclosure would require undue experimentation include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
First, it is noted that the claims are rejected below under 35 USC 102, which does not conflict with this rejection. While a rejection under 35 USC 103, it is solely for route of administration. The rejections do not make obvious the instant invention in a manner where it would conflict with this scope of enablement rejection, as the method of Wong does not teach treatment, only increasing resident macrophage activity.
Therefore, the breadth of the claims is excessive with regard to claiming treating, preventing, or reversing a disease or disorder associated with debris accumulation in the brain. The specification does not provide any guidance or working examples of any treatment, prevention, or reversal of a disease or disorder. Given this, it is not predictable that depleting PVM, which inhibits debris transport, can be extrapolated to the idea that stimulating PVM will improve debris clearance and disease progression.
Assuming arguendo the claims are enabled, they would not be enabled for prevention. The Examiner has interpreted “preventing” as a condition will not occur in 100% of the subjects administered the intended compound. Applicants provide no guidance or working examples of achieving this, nor is it predictable to one of ordinary skill in the art how to prevent a disease or disorder associated with debris accumulation in 100% of the subjects.
If the only remaining issue after Applicants’ arguments is “preventing”, Applicants may, without adding new matter, consider using a limitation such as “reducing the likelihood”, or a similar phrase.
These factors lead the Examiner to hold that undue experimentation is necessary to practice the invention as claimed.
5. Claim Rejections - 35 USC § 112(a) – written description
Claims 1, 3 and 4 are rejected under 35 U.S.C. 112, first paragraph, as containing subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention.
These are genus claims. Other than “perivascular macrophage-stimulating compound”, the specification and claims do not indicate what distinguishing attributes are shared by the members of the genus. Thus, the scope of the claims includes numerous structural variants, and the genus is highly variant because a significant number of structural differences between/among genus members is permitted. Although these types of changes are routinely done in the art, the specification and claims do not provide any guidance as to what changes should be made. Structural features that could distinguish compounds in the genus from others in the nucleic acid, protein, or small molecule class are missing from the disclosure. No common structural attributes identify the members of the genus.
The general knowledge and level of skill in the art do not supplement the omitted description because specific, not general, guidance is what is needed. Since the disclosure fails to describe the common attributes or characteristics that identify members of the genus, and because the genus is highly variant, M-CSF, alone, is insufficient to describe the genus. One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus. Thus, Applicant was not in possession of the claimed genus at the time the invention was made.
6. 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 3 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Wong et al. (US 2010/0266528 – cited on the IDS filed 5/7/25).
The claims are drawn to a method of treating, preventing or reversing a brain disease by administering a PVM-stimulating compound, including M-CSF and wherein the disease is AD or PD.
Wong teaches a method of increasing resident macrophage activity (Abstract; claim 13) in AD patients, including reducing Ab plaques in the brain by administering a M-CSF (paragraph [0230]). Wong is silent regarding a compound which stimulated PVM. However, these cells would inherently be stimulated. Case law has established that a compound and all of its properties are inseparable, as are its processes and yields (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963)).
7. Claim Rejections - 35 USC § 103
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Wong et al. Wong does not teach ICM injection. However, it would have been obvious at the time of the invention to have administered the composition via this route since this is a direct route into the CSF.
8. Conclusion
No claim is allowable.
Advisory information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S LANDSMAN whose telephone number is 571-272-0888. The examiner can normally be reached M-F 8 AM – 6 PM (eastern).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama, can be reached at 571-272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/ROBERT S LANDSMAN/Primary Examiner, Art Unit 1647
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