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 .
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.
Claims 1-17 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 recites grafted polymers and chelating agents that complexes metals. This recital results in unlimited number of possibilities from unlimited number of polymers and unlimited number of chelating agents, resulting in no defined metes and bounds for the claim. Applicant’s disclosure in [0108]-[0111] are not specific to the polymers or the chelating agents, but unlimited, and citing exemplary and/or preferable polymers and chelating agents, resulting in indefinite metes and bounds for the claim. See MPEP 2173.02.
Claim 1 also recites “an efficient amount,” which is not defined in the disclosure is indefinite.
Claims 8, 12, 13, : “the polymers” lacks antecedent basis.
Claim 11: usage of the term “… preferably” is indefinite.
Claims 14 and 15: “based on chitosan polymer” is indefinite. It is unclear what applicant means by, or included in, “based on chitosan polymer.”
Claims 9 and 10: chelating agent containing alkaline earth cation, Ca or Mg, is indefinite because it can be interpreted as the agent being precomplexed, or the agent complexing the ions during the process. For examination, the latter is assumed.
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.
(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.
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.
Claim(s) 1-8 and 12-17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lux et al (US 2021/0205213)
The applied reference has a common applicant with the instant application, but a different inventive entity. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Lux teaches a dialysis/microdialysis process in which a microdialysis device has a membrane and a reservoir or tank containing the perfusion fluid. The perfusion fluid is made of a polymer (chitosan, etc.,) grafted with the recited chelating agents. See [0038]-[0044]. Chelating agents – see [0077]-0081]. The metal ions are as recited in the claims: see [0082], [0091], [0162]. The polymers are in [0086]. Specifically, chitosan and DFO – see [0086], [0087], [0090] and example 4. Patients with metal hemostasis (title) and Wilson’s disease [0107]. Claims 4 and 5: Log(KC1) is inherent property of the agent. These elements are also mostly claimed by the reference.
Claim(s) 1 and 6-10 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Strahilevitz (US 2001/0039392)
Strahilevitz teaches the apparatus as claimed - see figure 1 copied herein with
Annotations – and the related process of removing metal cations like mercury and copper [0040]. The apparatus has dialysis membrane module 1 with membrane 4 (pleated or hollow fiber (Fig. 2 shows hollow fiber), catheters 8a and 9a for insertion into a patient's vein, and compartment 3 of the membrane module has metal chelating agent and affinity chelation agent for removal of metal and other toxic target molecules. [0039] has details of fig. 1 and [0054-0055] for fig. 2. Strahilevitz teaches various chelating agents like CHELEX, EDTA and deferoxamine (DFO) bound to silica (an inorganic polymer,) hydroxamic acid, etc. [0042]. Strahilevitz teaches 0.001 micron membrane and molecular weight cut off between 1000-10,000 Daltons, and the particles in Strahilevitz solution is retained by the membrane.
PNG
media_image1.png
552
609
media_image1.png
Greyscale
Regarding "solution" as recited in the claims, applicant defines solution as a
mixture of liquid and solid particles in [87], page 21. Strahilevitz teaches the dialysis as
being conducted with such a "solution" by circulating it through the membrane and the
regeneration unit - see the figures.
Claims 6-10: see [0040] for iron and copper binding. EDTA is well-known for Ca and Mg ion binding. DFO is well-known for aluminum binding and binding of other metal ions. The chelating agents in Strahilevitz are CHELEX, EDTA and DFO [0042].
Claim(s) 1-10 and 14-15 are rejected under 35 U.S.C. 103 as unpatentable over Strahilevitz (US 2001/0039392) in view of Hansen et al (US 2009/0252731)
Teaching of Strahilevitz is described in rejection 2 above.
Claims 2 and 3: since these diseases are caused by metal ions like Cu, it would have been obvious to one of ordinary skill in the art to use the teaching of Strahilevitz to treat these diseases.
Claims 4 and 5: the complexation constant also would be inherent property of the polymers – same composition as in claim 1.
Other dependent claims: while Strahilevitz does not teach all the grafted polymers claimed, usage of them as recited is taught by Hansen. Hansen teaches peptide or carbohydrate or metal complex of chelates like DTPA, NOTA, DOTA, TETA, etc., as claimed - see DTPA [0070]. The solution is used in dialysis with detailed explanation of dialysis and hemodialysis system - see [0214]- [0223]. Chitosan as the polymer for grafting is taught in [0415]. PEG: [0281]. Usage of various treatment solutions as taught by Hansen in the invention of Strahilevitz would have been prima-facie obvious: Strahilevitz is capable of using such solutions. Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results - MPEP 2143-1. Applicant in [88] also discloses that these are commercially available solutions.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISHNAN S MENON whose telephone number is (571)272-1143. The examiner can normally be reached Flexible, but generally Monday-Friday: 8:00AM-4:30PM.
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, Prem Singh can be reached at 5712720579. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KRISHNAN S MENON/ Primary Examiner, Art Unit 1771
Prosecution Insights