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 .
Claims 1-17 are pending in the instant application. Preliminary amendment filed 24 January 2024.
Priority
This application is a 371 of PCT/FR2022/051518 filed 07/28/2022. This application claims foreign priority to FRANCE 2108374 filed 07/28/2022, under 35 U.S.C. 119(a)-(d). The certified copy of the priority document has been filed in the instant application.
Drawings
The drawings are objected to because Figures 1-2, and 8 are fuzzy. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Also, the brackets enclosing the figure numbers should be deleted.
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 17 is rejected under 35 U.S.C. § 101 as being drawn to a use claim, which are non-statutory process claims, as defined in 35 U.S.C. § 101. The claims do not fall within at least one of the four categories of patent eligible subject matter because Claim 17 is neither a composition claim nor a proper process claim. "Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 "). In Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967), the Board held the following claim to be an improper definition of a process: "The use of a high carbon austenitic iron alloy having a proportion of free carbon as a vehicle brake part subject to stress by sliding friction." In Clinical Products Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966), the district court held the following claim was definite, but that it was not a proper process claim under 35 U.S.C. 101: "The use of a sustained release therapeutic agent in the body of ephedrine absorbed upon polystyrene sulfonic acid." Additionally, although a claim should be interpreted in light of the specification disclosure, it is generally considered improper to read limitations contained in the specification into the claims. See In re Prater, 415 F.2d 1393, 162 USPQ 541 (CCPA 1969) and In re Winkhaus, 527 F.2d 637, 188 USPQ 129 (CCPA 1975), which discuss the premise that one cannot rely on the specification to impart limitations to the claim that are not recited in the claim. See MPEP 2173.05.
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 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.
Regarding claim 1, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). The said phrase is also seen in claims 2, and 10. This also applies to the recitation ‘for example’ in claim 6.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 3, 5, 7-9, and 17 recite the broad recitations preferably, preferentially, in particular, for example and the claims also recite chelating agents, ranges for x, y, x+y, specific acids, electrolytes, amounts of polymer, and types of dialysis, which are the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 8 is drawn to the presence of electrolytes, which indicates cations and anions. The claim recites chlorine. Does applicant intend chloride ion? The claim is examined as drawn to the recited metal ions and chloride ion.
Claim 17 provides for the use of polymer, but, since the claim does not set forth any steps involved in the method/process of use, it is unclear what method/process of use applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. The claim recitation as a whole is also unclear as to what is intended. For the purpose of prosecution claim 17 is being examined as drawn to a method of preparing a dialysis fluid.
Claims 4, and 11-16, which depend from a rejected base claim that is unclear/indefinite are also rendered unclear/indefinite and are rejected for the same reasons. All claims which depend from an indefinite claim are also indefinite. Ex parte Cordova, 10 U.S.P.Q. 2d 1949, 1952 (P.T.O. Bd. App. 1989).
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 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Francois et al (WO 2019122790 A1; machine English Translation, pages 1-19) in view of Bae et al (ACS Nano, ACS Nano, 2012, 6(6), 5266-5273), and further in view of Hwang (US 2014/0242870 A1).
Francois et al teaches a composition comprising chitosan having molecular weight of 200kDa and DTPA and chitosan and DFO (pages 14-15, Examples 3-4; the fluid as in claims 1 and 17 comprising a polymer and chelating agent, and molecular weight; limitation of claims 3, 17). The chelating agent complex metals like lead and cadmium, and several other metals (page 5; see para starting at line 2; limitation of claims 2, 17). Several other chelating agents DOTAGA, DOTAM, NOTAM, DOTP, NOTP, TETA, TETAM can be used (page 8, third para from the bottom; limitation of claims 3-4, 17, and part of the limitation of claim 5). The chitosan used by Francois is a biocompatible polymer as in claim 6.
Francois et al does not teach a fluid wherein the concentration of the polymer in the fluid is between 0.01mg/L and 10mg/L as in claim 1, some of the chelating agents in claim 3, the structural requirements regarding Rc, Z, x, y and x+y as in claim 5, and the polymer being PEG type as in claim 6.
Bae discloses a polymer with a weight-average molecular weight of between 3-5 kDa of formula I wherein, Rc represents a group comprising a chelating agent, catechol, Z is a hydrocarbon-based chain comprising 3 carbon atoms and comprises one O heteroatom, x is 0.048 (deacetylation degree = 95.2%), y is 0.31 (degree of substitution = 30.9%), y/x ratio is ~6.5, which is greater than or equal to 0.05, and the sum of x + y is ~0.36, which is greater than 0.30.
Bae further discloses that -NH-Z-Rc together form DOPA. (Bae, Supporting Information, page 1, paragraphs 1-2 and page 5, Figure S1). This reads on part of the limitations of claims 1 and 17, and limitations of claims 4-5. In view of Francois, the polymer of Bae which has the chelating agent DOPA attached to it can be used in a dialysis fluid composition.
Hwang discloses a composite comprising chitosan having a weight-average molecular weight of between 5 kDa and 500 kDa and DOPA or catechol, wherein the catechol or DOPA is crosslinked to the amine groups of chitosan (paras 0016, 0018).
It would be obvious to one of ordinary skill in the art to modify the polysaccharide disclosed by Bae so that the polysaccharide has a weight-average molecular weight of between 20kDa and 1000 kDa and have a reasonable expectation of success. Bae discloses a polysaccharide, chitosan, conjugated to a chelator, DOPA via the amine group of chitosan. Hwang discloses a polysaccharide, chitosan having a weight-average molecular weight of between 5 kDa and 500 kDa, crosslinked to DOPA via the amine group of chitosan. Thus, the combined teachings of Bae and Hwang suggest the chitosan-DOPA conjugate having a weight-average molecular weight of between 20 kDa and 1000 kDa. Therefore, it is reasonable to expect the polysaccharide disclosed by Bae may be modified so that the polysaccharide has a weight-average molecular weight of between 5kDa and 500 kDa as in claims 1, 10 and 17 and also make and use the polymer (polysaccharide) as in claim 5.
However, in view of the teachings of Francois, Bae and Hwang one of ordinary skill in the art make the fluid having the concentration of the polymer as in claim 1 using all the other chelating agents as in claim 3 and the polymers as in claims 5-6 as alternative compositions since Francois teaches that the compositions are used for extracting metals from the body (see claim 1 of Francois at page 17).
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, a fluid comprising a polymer having an average molecular mass of between 20kDa and 100kDa having at least one chelating agent for chelating metals is known in the art. Thus, it is obvious to combine prior art elements and arrive at the claimed fluid.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art. One of ordinary skill in the art will arrive at the claimed invention as an alternative composition for chelating metals since the artisan would have a reasonable expectation that the claimed compositions would chelate and remove toxic metals present even at low concentrations of both the metals and the polymer containing the chelating agent.
Claim(s) 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Francois et al (WO 2019122790 A1; machine English Translation, pages 1-19) in view of Sharma et al (Expert Reviews on Medical Devices, 2016, 13(10), 933-943).
The teachings of Francois et al are set forth above. Francois does not teach the limitations of claims 7-9.
Sharma et al teaches that acetate, citrate, potassium, calcium, sodium, magnesium and chloride are present in dialysates (page 935, Table 2). This renders obvious to add a sufficient amount of acetic acid and citric acid as additives or water to a concentrated solution of the dialysis solution for preparing the dialysis fluid as in claim 7, and also add the components recited in claim 8 in view of Sharma and Francois. It would be obvious to one of ordinary skill in the art to provide the dialysis fluid as a concentrated solution in a bag as in claim 9.
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, a fluid comprising a polymer having an average molecular mass of between 20kDa and 100kDa having at least one chelating agent for chelating metals is known in the art, and dialysis fluids are known to contain electrolytes, citrates and acetates Thus, it is obvious to combine prior art elements and arrive at the claimed method of preparing a dialysis fluid.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art. One of ordinary skill in the art will arrive at the claimed invention in order to provide compositions that can be diluted if needed according to individual needs (Sharma-part 1.1).
Claim(s) 10-16 are rejected under 35 U.S.C. 103 as being unpatentable over Francois et al (WO 2019122790 A1; machine English Translation, pages 1-19).
Francois’ teachings are set forth above. Francois method covers part of the limitations of claims 10, 12, and 13, and the limitation of claim 11. Francois does not teach a method for capturing at least one toxic metal present in a dialysis fluid using its composition as in claim 10. Francois deals with extracting metals from body of a patient. Francois also does not teach the concentration of the metals as in claims 12-13, and the limitations of claims 14-16.
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, a fluid comprising a polymer having an average molecular mass of between 20kDa and 100kDa having at least one chelating agent for chelating metals, including toxic metals is known in the art to be useful for removing such metals from body fluids.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention that the fluid taught by Francois can also be used to scavenge toxic metals present in a dialysis fluid since Francois teaches that its composition is for scavenging metals, including toxic metals, even at lower concentrations (claims 2 and 4 of Francois). The artisan would be motivated to use the composition taught by Francois in the claimed method of capturing at least one toxic metal present in a dialysis fluid since it can capture such metals even at concentration of part per billion (as in claims 12-13). It would be obvious to the artisan to use the volume of dialysis fluid as in claim 14 in order to ensure complete removal of toxic metals, and introduce the dialysis fluid in a tank of the dialysis device that is connected to a blood circulation device comprising a membrane as in claims 15-16. These can be done by the artisan for purpose of optimization of the method.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The USPTO Internet website contains Terminal Disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-5, and 10-17 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6 of copending Application No. 18/007,254 (‘254) in view of Francois et al (WO 2019122790 A1; machine English Translation, pages 1-19) in view of Bae et al (ACS Nano, 2012, 6(6), 5266-5273), and further in view of Hwang (US 2014/0242870 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1 is drawn to a fluid comprising a polymer having average molecular mass between 20kDa and 100kDa and bearing at least one agent for chelating a metal. Dependent claims 2-6 recite limitations drawn to specific metals, chelating groups, and the type of polymer. Independent claim 10 is drawn to a method of capturing at least one toxic metal in a dialysis fluid using the polymer having average molecular mass between 20kDa and 100kDa and bearing at least one agent. Dependent claims 11-16 recite limitations drawn to specific toxic metals and their concentrations, the volume of dialysis fluid used, adding the fluid containing the polymer to tank of a dialysis device, and cutoff threshold for the dialysis membrane. Claim 17 is drawn to the use of a polymer having average molecular mass between 20kDa and 100kDa and bearing at least one agent for chelating a metal for preparing a dialysis composition as in claim 1.
The copending claims 1 and 3 of ‘254 are drawn to compounds of formula (I) and (II) with a weight average molecular weight of between 100kDa and 1000kDa. This overlaps with claims 1, 4-5 and 17 of the instant application. Copending claims 2, and 4 recite specific chelating groups which overlap with instant claim3 of the instant application. Copending claims 5-7 and 9 are drawn to x and y in the formula in claim 1, the composition being in the form of a hydrogel, and wherein polysaccharide chelates at least one metal.
The copending claims of ‘254 differ from the instant claims in that the instant claims are drawn to a dialysis fluid comprising the polymer with a broader molecular mass range, and is used in a method of capturing at least one toxic metal in a dialysis fluid by chelation, whereas the claims of ‘254 are drawn to the polysaccharide having a narrower molecular mass, and having a chelating agent attached to it. However, it can also be used for chelating a metal (claim 9 of ‘254).
Although the claims of '254 teach polymers having a narrower molecular weight range, the teachings of Francois, Bae and Hwang as set forth above, renders obvious the use of the claimed polymer containing a chelating group for complexing and removing toxic metals from a dialysis fluid.
Therefore, one of ordinary skill in the art would find it obvious to make and use the dialysis fluid comprising the claimed polymer before the effective filing date of the instant invention, which is also taught by the ‘254 application, in view of Francois, Bae and Hwang with a reasonable expectation of success. The artisan would be motivated to do so since Francois teaches that its composition is for scavenging metals, including toxic metals, even at lower concentrations (claims 2 and 4 of Francois). The artisan would be motivated to use the composition taught by Francois in view of Bae and Hwang in the claimed method of capturing at least one toxic metal present in a dialysis fluid since it can capture such metals even at concentration of part per billion. The other limitations in claims 14-16 are process parameters which can be adjusted by the artisan for the purpose of optimization.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
Pending claims 1-17 are rejected
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/GANAPATHY KRISHNAN/Primary Examiner, Art Unit 1693
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