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 .
Clams 1, 6, 8-12, 14, 18, 19, 21, 23-25, 27-30, 32 and 164 are presented for examination.
Applicants’ drawings and information disclosure statement filed November 15, 2023 have been received and entered.
Applicants’ preliminary amendments filed November 15, 2023 and August 26, 2024 have been received and entered.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Claim Objections
Claim 164 is objected to as being dependent upon a rejected base claim.
Claim Rejections - 35 USC § 112
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, 6, 8, 9, 12, 14, 19, 21, 22, 24, 25, 27-30 and 32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains 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 or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a Written Description rejection.
A lack of adequate written description issue arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a "laundry list" disclosure of every possible moiety does not constitute a written description of every species in a genus because it would not "reasonably lead" those skilled in the art to any particular species); In re Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA 1967).
An applicant may also show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.
In particular, the specification as original filed fails to provide sufficient written bases of any of the agents demonstrating wherein possession of use of the broad terms: a neurological condition, a neurodegenerative disease, neuropathy, neurotrauma, one or more symptoms of the neurological condition, and an additional therapeutic agent. The mere fact that Applicant may have discovered one type of neurological condition is treated with a combination of a HIFI-α pathway inhibitor and an PFKFB3 inhibitor is not sufficient to claim the entire genus.
The mere fact that Applicant may have discovered one type of neurodegenerative disease is treated with a combination of a HIFI-α pathway inhibitor and an PFKFB3 inhibitor is not sufficient to claim the entire genus.
The mere fact that Applicant may have discovered one type of neuropathy is treated with a combination of a HIFI-α pathway inhibitor and an PFKFB3 inhibitor is not sufficient to claim the entire genus.
The mere fact that Applicant may have discovered one type of neurotrauma is treated with a combination of a HIFI-α pathway inhibitor and an PFKFB3 inhibitor is not sufficient to claim the entire genus.
The mere fact that Applicant may have discovered one type of symptom of the neurological condition with treated with a combination of a HIFI-α pathway inhibitor and an PFKFB3 inhibitor is not sufficient to claim the entire genus.
The mere fact that Applicant may have discovered one type of additional therapeutic agent in combination with a HIFI-α pathway inhibitor and an PFKFB3 inhibitor for the treatment of a neurological condition is not sufficient to claim the entire genus.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]."
Claims 1, 6, 8, 9, 12, 14, 19, 21, 22, 24, 25, 27-30 and 32 are not allowed.
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 14, 18, 19, 21, 28 and 30 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 14 is rendered indefinite and vague because the claim is written that all the HIFI-α pathway inhibitors set forth in the claim must all be used in the combination. Should this claim be a Markush grouping?
Claim 18 is rendered indefinite and vague because the claim is written that all the HIFI-α inhibitors set forth in the claim must all be used in the combination. Should this claim be a Markush grouping?
Claim 19 is rendered indefinite and vague because the claim is written that all the HIFI-α pathway inhibitor and/or PFKFB3 inhibitor set forth in the claim must all be used in the combination. Should this claim be a Markush grouping?
Regarding claims 19 and 28, the phrases “e.g.” , interpreted as "for example" and “such as” renders the claims indefinite because it is unclear whether the limitation(s) following the phrases are part of the claimed invention. See MPEP § 2173.05(d).
Claim 21 is rendered indefinite and vague by the phrases “has the structure of formula 1-53 or 54”, “Compound 26”, “depicted in FIG. 1A-1C or 1D, or a salt thereof”, and “has the structure of formula AZ44-AZ70 or AZ71, depicted in FIG. 1E, or a salt thereof”. What are the structures of formula 1-53 or 54? What is the structure of compound 26? What the structures of formulae AZ44-AZ70 or AZ71? What are the figures for FIG. 1A-1E? The figures must be set forth in the claims.
Claim 30 is rendered indefinite because the claim lacks antecedent basis. Are these symptoms associated with a neurological condition?
Claims 14, 18, 19, 21, 28 and 30 are not allowed.
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, 6, 8, 9, 14, 19, 21and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Duan et al., “Silibinin inhibits acetylcholinesterase activity and amyloid β peptide aggregation: a dual-target drug for the treatment of Alzheimer’s disease”, Neurobiology of Aging, Vol. 13, No. 10, pages 1792-1807 (2015) in view of WO 2017/208174 A2, hereby known as Tudzarova-Trajkovska et al. of PTO-1449.
Duan et al. teach silibinin, a HIB1-α pathway inhibitor, for the treatment of Alzheimer’s disease, a neurological disease (see the abstract).
The instant invention differs from the cited reference in that the cited reference does not teach the addition of a PFKFB inhibitor. However, the secondary reference, Tudzarova-Trajkovska et al., teaches PFKFB3 inhibitors are effective in the treatment of neurological diseases such as Alzheimer and Parkinson (see page 61, claim 9). Also note the PFKFB3 inhibitor is an antibody (see page 61, claim 14) and antisense molecule (see page 62, claim 19). Also see page 62, claim 21 teaches the active agent can be administered intravenously, intramuscularly, intraperitoneally, subcutaneously, intra-articularly, intrasynovially, intrathecally, orally, topically, and through inhalation.
Clearly, one skilled in the art would have assumed the combination of two individual agents, each known to treat a neurological disease, into a single composition would give an additive effect in the absence of evidence to the contrary.
The instant invention differs from the cited references in that the cited references do not teach the administering an effective amount of a HIF1-α pathway inhibitor to the subject has previously been administered a PFKFB3 inhibitor or administering an effective amount of a PFKFB3 inhibitor to the subject has previously been administered a HIF1-α pathway inhibitor.
Clearly, it would have been obvious to one skilled in the art to utilize the method disclosed and administer disclosed active agents to the subject in need of treatment according to various schedules of treatment, such as subsequent administration of one active agent following another.
Claims 1, 6, 8, 9, 14, 19, 21 and 22 are not allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN E WEDDINGTON whose telephone number is (571)272-0587. The examiner can normally be reached M-F 1:30-10:00.
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, Jeff Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KEVIN E. WEDDINGTON
Primary Examiner
Art Unit 1629
/KEVIN E WEDDINGTON/ Primary Examiner, Art Unit 1629
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