DETAILED ACTION
Formal Matters
Claims 2 and 14 are cancelled. Claims 1, 3-13 and 15-21 are pending. Claims 15 and 17-20 are withdrawn. Claims 1, 3-13, 16 and 21 are under examination.
Priority
The instant application is a continuation of 16/638,834 filed on 2/13/2020, which is an international stage entry of PCT/US2018/048678 filed on 8/30/2018, which claims priority from US provisional application 62/552,424 filed on 8/31/2017.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/12/2025 has been entered.
Rejections Withdrawn
The objection over claims 1 and 5 is withdrawn per applicant’s corrections to the claims.
The rejections under USC 112(b) over claim 5 are withdrawn per applicant’s amendments and arguments.
The rejection under USC 103 over Inoue, Chan and Kandarakis is withdrawn per applicant’s amendment to the claim and arguments provided.
As these objections and rejections are withdrawn, applicant’s arguments toward these objections and rejections are now moot.
Examiner Comments to Elected Species
As applicant’s amendments have overcome the previous rejections under USC 103 that provided for macular degeneration (elected species) associated with advanced glycation end products and the examiner could not motivate another obviousness rejection to teach the species of macular degeneration associated with advanced glycation end products being treated, the examiner moved to a next species of degenerative disease that the prior art was capable of teaching and motivating (Alzheimer’s disease) for the method. Note Chan also provides for kidney failure.
Claim Objections
Claims 8-11 are objected to for the language of “is one or more of……and….” Which is more appropriately “is one or more of…..or….” for these groups of options. Appropriate correction is required.
Rejection under USC 112(a) -Written Description
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, 3-9, 11-13, 16 and 21 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. In claim 1, Applicant provides for a sorbent that has the characteristics of being uncharged, having a plurality of pores in the size and volume range of the claim, and sorbent size range of the claim, however, the claim does not provide what material the sorbent is. The disclosed invention of applicant is provided to sorb advanced glycation end products and note the method treats degenerative disease associated with advanced glycation end products. Applicant provides for the sorbent having crosslinking agent and at least one monomer (paragraph 20). Applicant describes macroporous polymers prepared from styrene, divinylbenzene, ethylvinylbenzene and acrylate and methacrylate monomers with listing various examples (see paragraph 28 of the specification, also list of monomers for polymers in paragraph 21). There are no descriptions of sorbents made of other materials outside of these such as silicones, clays, metals, celluloses, starches and many others. Therefore, it is not described whether sorbents of various other materials would also be capable of sorbing advanced glycation end products and would be able to have the described function for the method of the claim. Applicant might consider amending the claim to incorporate the limitation of claim 10, which also needs to have the limitation of claim 7 through dependency, to overcome this rejection.
Rejection under 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, 3-13, 16 and 21 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 is indefinite as the claim states “A method of treating a degenerative disease associated with advanced glycation end products” and then “comprising contacting a bodily fluid with an uncharged sorbent”, since it is unclear whether a bodily fluid is coming from the same subject that has the degenerative disease in the preamble. Thus, it could be that one can treat such a disease by contacting any bodily fluid from another subject, then possibly providing (e.g. a transfusion possibly) that bodily fluid to the diseased subject or one has to be contacting a bodily fluid from the same subject that has the degenerative disease. For the purpose of compact prosecution, as long as the prior art provides for treatment of a degenerative disease and has some step where a bodily fluid is contacted with a sorbent as in the claim, it will read on the claim. Applicant might consider the language “…treating a degenerative disease associated with advanced glycation end products in a subject, the method comprising contacting a bodily fluid of the subject with an uncharged sorbent…..” if this is the intent.
Claims 3-13, 16 and 21 are rejected as being dependent on an indefinite claim.
Claim 8 recites the limitation "the dispersing agent" in dependence to claim 7, which provides for “at least one dispersing agent” making it unclear which of the at least one dispersing agents is the dispersing agent. There is insufficient antecedent basis for this limitation in the claim. Applicant may amend claim 8 to say “the at least one dispersing agent”.
Claim 9 recites the limitation "the crosslinking agent" in dependence to claim 7, which provides for “at least one crosslinking agent” making it unclear which of the at least one crosslinking agents is the crosslinking agent. There is insufficient antecedent basis for this limitation in the claim. Applicant may amend claim 9 to say “the at least one crosslinking agent”.
Claim 10 recites the limitation "the monomer" in dependence to claim 7, which provides for “at least one monomer” making it unclear which of the at least one monomers is the monomer. There is insufficient antecedent basis for this limitation in the claim. Applicant may amend claim 10 to say “the at least one monomer”.
Claim 11 recites the limitation "the porogen" in dependence to claim 7, which provides for “the at least one porogen” making it unclear which of the at least one porogens is the porogen. There is insufficient antecedent basis for this limitation in the claim. Applicant may amend claim 11 to say “the at least one porogen”.
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.
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, 3-13, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Chan US 2015/0335576 and Sasaki et al (The American Journal of Pathology, 1998, volume 153, pages 1149-1155).
Chan teaches a method of reducing contamination by one or more toxins in a biological substance comprising “contacting the biological substance with an effective amount of a sorbent capable of sorbing the toxin, wherein the sorbent comprises a plurality of pores ranging from 50 {acute over (Å)} to 40,000 {acute over (Å)} with a pore volume of 0.5 cc/g to 5.0 cc/g and a size of 0.05 mm to 2 cm.” (abstract and claim 1 of Chan). Chan teaches the sorbent is biocompatible (claim 3 of Chan). Chan teaches a macroporous polymeric sorbent (claim 6 of Chan). Chan teaches in vivo and ex vivo sorbing (claims 7 and 8 of Chan). Chan teaches the biological substance comprising saliva, blood, plasma, serum, gastrointestinal fluid, cerebrospinal fluid, vaginal fluid, peritoneal fluid, pleural fluid, urine, synovial fluid, lymph, alveolar mucus or vitreous humor (claim 53 of Chan). Chan teaches blood (claim 78 of Chan). Chan teaches “the sorbent has a pore structure such that the total pore volume of pore size in the range of 50 Å to 40,000 Å is greater than 0.5 cc/g to 5.0 cc/g dry sorbent; wherein the ratio of pore volume between 50 {acute over (Å)} to 40,000 {acute over (Å)} (pore diameter) to pore volume between 100 {acute over (Å)} to 1,000 {acute over (Å)} (pore diameter) of the sorbent is smaller than 3:1” (claim 54 of Chan) or “the sorbent has a pore structure such that the total pore volume of pore size in the range of 50 Å to 40,000 Å is greater than 0.5 cc/g to 5.0 cc/g dry sorbent; wherein the ratio of pore volume between 50 {acute over (Å)} to 40,000 {acute over (Å)} (pore diameter) to pore volume between 1,000 {acute over (Å)} to 10,000 {acute over (Å)} (pore diameter) of the sorbent is smaller than 2:1” (claim 56 of Chan). Chan teaches “the sorbent comprises a plurality of pores comprising at least one crosslinking agent, at least one monomer, at least one dispersing agent and at least one porogen” (claim 60 of Chan). Chan teaches “Suitable crosslinking agents include divinylbenzene, trivinylbenzene, divinylnaphthalene, trivinylcyclohexane, divinylsulfone, trimethylolpropane trimethacrylate, trimethylolpropane dimethacrylate, trimethylolpropane triacrylate, trimethylolpropane diacrylate, pentaerythrital dimethacrylates, pentaerythrital trimethacrylates, pentaerythrital, tetramethacrylates, pentaerythritol diacrylates, pentaerythritol triiacrylates, pentaerythritol tetraacrylates, dipentaerythritol dimethacrylates, dipentaerythritol trimethacrylates, dipentaerythritol tetramethacrylates, dipentaerythritol diacrylates, dipentaerythritol triacrylates, dipentaerythritol tetraacrylates, divinylformamide and mixtures thereof” (paragraph 53). Chan teaches “Suitable dispersing agents include hydroxyethyl cellulose, hydroxypopyl cellulose, poly(hydroxyethyl methacrylate), poly(hydroxyethyl acrylate), poly(hydroxypropyl methacrylate), poly(hydroxypropyl acrylate), poly(dimethylaminoethyl methacrylate), poly(dimethylaminoethyl acrylate), poly(diethylamimoethyl methacrylate), poly(diethylaminoethyl acrylate), poly(vinyl alcohol), poly(N-vinylpyrrolidinone), salts of poly(methacrylic acid), and salts of poly(acrylic acid) and mixtures thereof” (paragraph 52). Chan teaches “one or more monomers selected from divinylbenzene and ethylvinylbezene, styrene, ethylstyrene, acrylonitrile, butyl methacrylate, octyl methacrylate, butyl acrylate, octyl acrylate, cetyl methacrylate, cetyl acrylate, ethyl methacrylate, ethyl acrylate, vinyltoluene, vinylnaphthalene, vinylbenzyl alcohol, vinylformamide, methyl methacrylate, methyl acrylate, trivinylbenzene, divinylnaphthalene, trivinylcyclohexane, divinylsulfone, trimethylolpropane trimethacrylate, trimethylolpropane dimethacrylate, trimethylolpropane triacrylate, trimethylolpropane diacrylate, pentaerythritol dimethacrylate, pentaerythritol trimethacrylate, pentaerythritol tetramethacrylate, pentaerythritol diacrylate, pentaerythritol triiacrylate, pentaerythritol tetraacrylate, dipentaerythritol dimethacrylate, dipentaerythritol trimethacrylate, dipentaerythritol tetramethacrylate, dipentaerythritol diacrylate, dipentaerythritol triacrylate, dipentaerythritol tetraacrylate, divinylformamide and mixtures thereof” (paragraph 55). Chan teaches “Some preferred porogens are Benzyl alcohol, Cyclohexane, Cyclohexanol, Cyclohexanol/toluene mixtures, Cyclohexanone, Decane, Decane/toluene mixtures, Di-2-ethylhexylphosphoric acid, Di-2-ethylhexyl phthalate, 2-Ethyl-1-hexanoic acid, 2-Ethyl-1-hexanol, 2-Ethyl-1-hexanol/n-heptane mixtures, 2-Ethyl-1-hexanol/toluene mixtures, Isoamyl alcohol, n-Heptane, n-Heptane/ethylacetate, n-Heptane/isoamyl acetate, n-Heptane/tetraline mixtures, n-Heptane/toluene mixtures, n-Hexane/toluene mixtures, Pentanol, Poly(styrene-co-methyl methacrylate)/dibutyl phthalate, Polystyrene/2-ethyl-1-hexanol mixtures, Polystyrene/dibutyl phthalate, Polystyrene/n-hexane mixtures, Polystyrene/toluene mixtures, Toluene, Tri-n-butylphosphate, 1,2,3-Trichloropropane/2-ethyl-1-hexanol mixtures, 2,2,4-Trimethyl pentane (isooctane), Trimethyl pentane/toluene mixtures, Poly(propylene glycol)/toluene mixtures Poly(propylene glycol)/cyclohexanol mixtures, and Poly(propylene glycol)/2-Ethyl-1-hexanol mixtures” (paragraph 54). Chan teaches in vitro (examples 22-31). Chan teaches the substance is blood (claim 78 of Chan and paragraphs 50 and 64). Chan teaches “gastrointestinal disorders” (paragraph 22). Chan teaches toxins as etiological agents linked to a negative clinical outcome (paragraph 20). Chan teaches divinylbenzene and cyclohexanol in items (spherical porous polymeric beads) of table 6. There are items with PVA in items of table 6.
Chan teaches various toxins that the sorbent would be useful for removing verotoxin that causes renal failure (kidney disease) and amyloid precursor protein (a precursor to toxic amyloid plaques) that lead to Alzheimer’s disease (paragraph 20). Chan also teaches anthrax disease (paragraph 20). Chan provides that toxins cover a range of items (paragraphs 29 and 30). Chan provides that toxins can be endogenous (paragraph 37). Chan teaches “Toxins are most commonly organic substances such as proteins, peptides, carbohydrates, lipids, nucleic acids, and combinations thereof (e.g. multimeric or multi-subunit proteins, glycoproteins, glycolipids, lipoproteins, etc.).” (paragraph 35).
Chan teaches renal failure and Alzheimer’s disease (both degenerative diseases) treatments while teaching its sorbent binds to numerous molecules including endogenous ones, but does not provide for an association of advanced glycation end products.
Sasaki teaches that Alzheimer’s disease is implicated in Alzheimer’s disease and other neurodegenerative diseases (abstract and Discussion). Figure 1 of Sasaki shows AD brain with colocalization of amyloid beta and AGE (advanced glycogen end products).
Thus, when treating Alzheimer’s disease with sorbents where this is provided in teachings of Chain, AGE would also be present as presented in Sasaki.
One of ordinary skill in the art before the time of filing would have looked to using polymeric sorbents having vinyl components of the prior art in teachings of Chan to include in methods of treating Alzheimer’s disease with AGE buildup as provided in Sasaki with Chan first providing the basis to treat Alzheimer’s disease in its teachings. Therefore, since Chan teaches polymeric sorbents of the claims and use of treating Alzheimer’s disease which applicant and the prior art of Sasaki notes as having AGE associated with the amyloid beta plaques, there was a reasonable expectation of success in treating Alzheimer’s disease associated with AGE with such sorbents (ex vivo or in vivo) as in Chan in order to successfully treat the disease.
Conclusion
No claims are allowed.
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/MARK V STEVENS/Primary Examiner, Art Unit 1613