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 .
Status of the Claims
Claims 1-20 were originally filed December 18, 2023.
The amendment received August 14, 2026 changed the status identifiers only.
Claims 1-20 are currently pending.
Claims 1-4 and 9 are currently under consideration.
Election/Restrictions
Applicant’s election of Group I (claims 1-9) in the reply filed on August 14, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected “system” and a nonelected method of treating, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 14, 2026.
Please note: a “system” does not fall within one of the four categories of patent eligible subject matter (i.e. process, machine, manufacture, or composition of matter). The “system” is presently being interpreted as an apparatus.
Applicant’s election of morin, LPS, claim 9, MCL-NHS as the species in the reply filed on August 14, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Please note: morin and MCL-NHS are not part of the present claims and, therefore, are not required for any art rejection of record.
Claims 5-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 14, 2026.
Priority
The present application claims the benefit of 63/476,493 filed December 21, 2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 18, 2023 is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 1 is objected to because of the following informalities: “with amyloid peptide” should read “with an amyloid peptide”. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: “complex with Ab42” should read “complex with the Ab42”. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: “and the analyte is selected as the drug candidate” should read “and (c) selecting the analyte as the drug candidate” (i.e. all method steps recited as active, positive steps). Appropriate correction is required.
Claim 4 is objected to because of the following informalities: the spacing should be corrected. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: a conjunction is missing between (b2) and (b3). Appropriate correction is required.
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 1-4 and 9 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.
The present claims are drawn to a method for selecting a drug candidate comprising contacting an analyte with an amyloid peptide 1-42 (Ab42) and an amphiphilic liposaccharide or part thereof is “capable” of forming a complex with Ab42, determining if the analyte extends an “oscillatory event” of the complex, and selecting the analyte as the drug candidate. The claims do not clarify what “part thereof” is “capable” of forming a complex with the Ab42. The claims put no limit on the “analyte” or the “oscillatory event”. Therefore, the claims encompass any “part thereof” of an amphiphilic liposaccharide; any analyte, and any oscillatory event. The analyte can be a small molecule, a polypeptide, a polynucleotide, etc. The oscillatory event can be anything. The originally filed specification at paragraph 53 states that the “oscillatory event of the complex” may refer to an oscillating pattern of association and dissociation between two molecules of the complex (emphasis added; i.e. not a definition).
With regard to the written description requirement, the attention of the Applicant is directed to The Court of Appeals for the Federal Circuit which held that a “written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1405 (1997), quoting Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) (bracketed material in original) [The claims at issue in University of California v. Eli Lilly defined the invention by function of the claimed DNA (encoding insulin)] (the case is referred to herein as “Lilly”).
Additionally, it is noted that written description is legally distinct from enablement: “Although the two concepts are entwined, they are distinct and each is evaluated under separate legal criteria. The written description requirement, a question of fact, ensures that the inventor conveys to others that he or she had possession of the claimed invention; whereas, the enablement requirement, a question of law, ensures that the inventor conveys to others how to make and use the claimed invention.” See 1242 OG 169 (January 30, 2001) citing University of California v. Eli Lilly & Co.
Although directed to DNA compounds, this Eli Lilly holding would be deemed to be applicable to any compound or a generic of compounds; which requires a representative sample of compounds and/or a showing of sufficient identifying characteristics; to demonstrate possession of the compound or generic(s). In this regard, applicant is further referred to University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997); “Guidelines for Examination of Patent Applications Under the 35 USC 112, first paragraph, ‘Written Description’ Requirement” published in 1242 OG 168-178 (January 30, 2001); and Univ. Of Rochester v G. D. Searle and Co. 249 F. Supp. 2d 216 (W.D.N.Y. 2003) affirmed by the CAFC on February 13, 2004 (03-1304) publication pending.
Additionally, Lilly sets forth a two part test for written description:
A description of a genus of cDNA’s may be achieved by means of a recitation of:
a representative number of cDNA’s, defined by nucleotide sequence, falling within the scope of the genus OR of a recitation of structural features common to the members of the genus.
See Regents of the University of California v. Eli Lilly & Co. 119 F.3d 1559 (Fed. Cir. 1997) at 1569.
Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that:
...To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.
Additionally, Cf. University of Rochester v G.D. Searle & Co., Inc., Monsanto Company, Pharmacia Corporation, and Pfizer Inc., No. 03-1304, 2004 WL 260813 (Fed. Cir., Feb. 13, 2004) held that:
Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to that subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods.
The originally filed specification only refers to morin as an analyte (paragraph 103). The originally filed specification only refers to binding as an oscillatory event (paragraph 103). In the present instance, the specification discloses only limited examples that are not representative of the claimed genus of an analyte or an oscillatory event; nor do the claims recite sufficient structural features which are common to members of the genus sufficient to demonstrate possession of the genus. The instant claims define the analyte by the functional limitation of “extends an oscillatory event”. The instant claims define the part thereof by the functional limitation of “capable of forming a complex with Ab42”. The claimed analyte and part thereof are only defined by functional properties. The CAFC held that a functional definition is insufficient to adequately describe a product, therefore, an adequate written description not based on a functional definition is necessary.
The Examiner further notes the present claims stated by Applicant are broader in scope that those that were held to be impermissible in Lilly because, unlike Lilly, Applicants’ claims encompass a vast number of “parts thereof”, analytes, and oscillatory events. The scope of these claims include a vast number of analytes and parts thereof because the specification and claims do not place any limit on the number of components, the type of components, or how the components are combined. Furthermore, the specification and claims do not place any limit on the number of components, the types of components, or the manner in which the components might be connected to achieve the capability of forming a complex with Ab42 or extending an oscillatory event. Therefore, Applicants are using an inadequately described part thereof and analyte to inadequately describe the claimed reagents in the method. In addition, the oscillatory event further exacerbates this problem because the conditions under which the analyte, part thereof, or Ab42 interact are not specified. Consequently, there is no teaching that would allow a person of skill in the art to determine a priori that the Applicant was in possession of the full scope of the claimed invention at the time of filing because there is no common structural attributes that can link together all of the claimed parts thereof or analytes.
While the general knowledge and level of skill in the art for screening methods is high, this knowledge and level of skill does not supplement the omitted description because specific, not general, guidance is needed for the part thereof, analyte, and oscillatory event. Since the disclosure fails to describe the common attributes or characteristics that identify all of the members of the genus or even a substantial portion thereof, and because the genus is vast and highly variant, the limited examples in the specification (please refer to paragraphs 103) are insufficient to teach the entire genus.
The specification discloses only limited examples that are not representative of the claimed genus of a part thereof, analyte, or oscillatory event; nor do the claims recite sufficient structural features which are common to members of the genus sufficient to demonstrate possession of the genus. Therefore, the teachings in the specification are general teachings relating without guidance as to the individual components of the product. In addition, there are numerous parts thereof, analytes, or oscillatory events that could be employed in the invention with little direction or guidance for one of skill in the art to practice the claimed invention. The expedient statements in the specification do not relate to an adequate disclosure or how to make and use the claimed invention. Consequently, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to adequately describe the vast genus. Thus, Applicant does not appear to be in possession of the claimed genus.
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 1-4 and 9 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. One of skill in the art would not be able to determine the scope of the present method. For example, it is unclear under what conditions the amphiphilic liposaccharide or part thereof is “capable of” forming a complex with Ab42. The interaction should be clarified (e.g. is the formation of the complex necessary for the method, etc.).
Claims 1-4 and 9 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. One of skill in the art would not be able to determine the scope of the present method. For example, it is unclear what “determining” and “selecting” require. Are these steps simply mental steps?
Claim 2 is 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. One of skill in the art would not be able to determine the scope of the present method. For example, it is unclear how “is for clearance of Ab42” requires (e.g. simply disassociation from the complex or something else).
Claim 9 is 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. One of skill in the art would not be able to determine the scope of the present method. For example, it is unclear what “obtaining” and “comparing” require. Are these steps simply mental steps?
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 9 is rejected under 35 U.S.C. 101 because the claim limitations are drawn to an abstract idea. See MPEP § 2106.04(a)(2).
If a claim recites a limitation that can practically be performed in the human mind, with or without the use of a physical aid such as pen and paper, the limitation falls within the mental processes grouping, and the claim recites an abstract idea. See, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674 (noting that the claimed "conversion of [binary-coded decimal] numerals to pure binary numerals can be done mentally," i.e., "as a person would do it by head and hand."); Synopsys, 839 F.3d at 1139, 120 USPQ2d at 1474 (holding that claims to the mental process of "translating a functional description of a logic circuit into a hardware component description of the logic circuit" are directed to an abstract idea, because the claims "read on an individual performing the claimed steps mentally or with pencil and paper").
The use of a physical aid (e.g., pencil and paper or a slide rule) to help perform a mental step (e.g., a mathematical calculation) does not negate the mental nature of the limitation, but simply accounts for variations in memory capacity from one person to another. For instance, in CyberSource, the court determined that the step of "constructing a map of credit card numbers" was a limitation that was able to be performed "by writing down a list of credit card transactions made from a particular IP address." In making this determination, the court looked to the specification, which explained that the claimed map was nothing more than a listing of several (e.g., four) credit card transactions. The court concluded that this step was able to be performed mentally with a pen and paper, and therefore, it qualified as a mental process. 654 F.3d at 1372-73, 99 USPQ2d at 1695. See also Flook, 437 U.S. at 586, 198 USPQ at 196 (claimed "computations can be made by pencil and paper calculations"); University of Florida Research Foundation, Inc. v. General Electric Co., 916 F.3d 1363, 1367, 129 USPQ2d 1409, 1411-12 (Fed. Cir. 2019) (relying on specification’s description of the claimed analysis and manipulation of data as being performed mentally "‘using pen and paper methodologies, such as flowsheets and patient charts’"); Symantec, 838 F.3d at 1318, 120 USPQ2d at 1360 (although claimed as computer-implemented, steps of screening messages can be "performed by a human, mentally or with pen and paper").
Claim Rejections - 35 USC § 102
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 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wu et al., February 19, 2021, Supramolecular Bait to Trigger Non-Equilibrium Co-Assembly and Clearance of Ab42, Angew Chem Int, 60: 4014-4017.
For present claims 1-4 and 9, Wu et al. teach methods of contacting an analyte with Ab42 and LPS which forms an oscillating complex (please refer to the entire reference particularly pages 4014-4017; Figures 1-4).
Therefore, the teachings of Wu et al. anticipate the presently claimed method and various mental steps.
Claims 1-4 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dempsey et al., 2017, Inhibiting the NLRP3 inflammasome with MCC950 promotes non-phlogistic clearance of amyloid-b and cognitive function in APP/PS1 mice, Brain, Behavior, and Immunity, 61: 306-316.
For present claims 1-4 and 9, Dempsey et al. teach methods of contacting an analyte with Ab1-42 and LPS and determining phagocytosis (please refer to the entire specification particularly the abstract; sections 2.5, 2.7, 2.10, 3, 4; Figures 1-8).
Therefore, the teachings of Dempsey et al. anticipate the presently claimed method and various mental steps.
Claims 1-4 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Finucane et al., 2019, The NLRP3 inflammasome modultes glycolysis by increasing PFKFB3 in an IL-1beta-dependent manner in macrophages, Scientific Reports, 9: 4034 (10 pages).
For present claims 1-4 and 9, Finucane et al. teach methods of contacting an analyte with Ab1-42 and LPS (please refer to the entire reference particularly the abstract; Figures 1-5; Results).
Therefore, the teachings of Finucane et al. anticipate the presently claimed method and various mental steps.
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.
Claims 1-4 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Tanzi, WO 2019/013838 published January 17, 2019 and Philippens et al., 2017, Acceleration of Amyloidosis by Inflammation in the Amyloid-Beta Marmoset Monkey Model of Alzheimer’s Disease, Journal of Alzheimer’s Disease, 55: 101-113.
For present claims 1-4 and 9, Tanzi teaches methods of screening analytes in cells treated with either LPS or amyloid-b/Ab42 (please refer to the entire specification particularly the abstract; paragraphs 7, 9, 17, 58, 60, 63, 66, 73, 74).
For present claims 1-4 and 9, Philippens et al. teach an animal model of Alzheimer’s disease wherein both LPS and Ab42 are administered (please refer to the entire reference particularly the abstract; pages 103).
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (i.e. method of screening analytes in an animal model of Alzheimer’s disease) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. cell culture screening method) for another (i.e. animal model screening method) would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. moving from cell culture screening methods to animal model screening methods) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Dempsey et al., 2017, Inhibiting the NLRP3 inflammasome with MCC950 promotes non-phlogistic clearance of amyloid-beta and cognitive function in APP/PS1 mice, Brain, Behavior, and Immunity, 61: 306-316.
Erickson et al., 2012, Lipopolysaccharide impairs amyloid beta efflux from brain: altered vascular sequestration, cerebrospinal fluid reabsorption, peripheral clearance and transporter function at the blood-brain barrier, Journal of Neuroinflammation, 9: 150 (15 pages).
Liu et al., 2011, The protective effects of coumestrol against amyloid-beta peptide- and lipopolysaccharide-induced toxicity on mice astrocytes, Neurological Research, 33(5): 663-672.
Liu et al., 2020, Beta-amyloid activates NLRP3 inflammasome via TLR4 in mouse microglia, Neuroscience Letters, 736: 135279 (7 pages).
Mohammadi et al., 2021, Morin attenuates memory deficits in a rat model of Alzheimer’s disease by ameliorating oxidative stress and neuroinflammation, European Journal of Pharmacology, 910: 174506 (8 pages).
El-ezz et al., 2018, Trans-cinnamaldehyde Modulates Hippocampal Nrf2 Factor and Inhibits Amyloid Beta Aggregation in LPS-Induced Neuroinflammation Mouse Model, Neurochemical Research, 43: 2333-2342.
Liu et al., 2005, LPS receptor (CD14): a receptor for phagocytosis of Alzheimer’s amyloid peptide, Brain, 128: 1778-1789.
Lemkul et al., 2010, Destabilizing Alzheimer’s Ab42 protofibrils with Morin: Mechanistic Insights from Molecular Dynamics Simulations, Biochemistry, 49: 3935-3946.
Ono et al., 2003, Potent anti-amyloidogenic and fibril-destabilizing effects of polyphenols in vitro: implications for the prevention and therapeutics of Alzheimer’s disease, Journal of Neurochemistry, 87: 172-181.
Gargari et al., 2020, Simulations on the dual effects of flavonoids as suppressors of Ab42 fibrillogenesis and destabilizers of mature fibrils, Scientific Reports, 10: 16636 (15 pages).
Hanaki et al., 2016, Structural insights into mechanisms for inhibiting amyloid b42 aggregation by non-catechol-type flavonoids, Bioorganic & Medicinal Chemistry, 24: 304-313.
Jiang et al., 2010, An enzyme-linked immunosorbent assay to compare the affinity of chemical compounds for b-amyloid peptide as a monomer, Anal Bioanal Chem, 396: 1745-1754.
Alberdi et al., 2018, Mangiferin and Morin Attenuate Oxidative Stress, Mitochondrial Dysfunction, and Neurocytotoxicity, Induced by Amyloid Beta Oligomers, Oxidative Medicine and Cellular Longevity, 13 pages.
Noor et al., 2012, Morin hydrate inhibits amyloid formation by islet amyloid polypeptide and disaggregates amyloid fibers, Protein Science, 21: 373-382.
Patel et al., 2018, Inhibition of insulin amyloid fibrillation by Morin hydrate, International Journal of Biological Macromolecules, 108: 225-239.
Lemkul et al., 2012, Morin inhibits the Early Stages of Amyloid beta-peptide Aggregation by Altering Tertiary and Quaternary Interactions to Produce “Off-Pathway” Structures, Biochemistry, 51: 5990-6009.
Future Communications
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMBER D STEELE whose telephone number is (571)272-5538. The examiner can normally be reached M-F 8-5.
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/AMBER D STEELE/Primary Examiner, Art Unit 1658
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