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 .
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.
This office action is a response to applicant’s communication submitted May 25, 2023, wherein claims 8, 10-11, and 13-14 were preliminarily amended, claims 1-7 were canceled, and claims 20-23 were added.
Claims 8-23 are pending in this application.
Priority
This application is a Continuation Application of U.S. Patent Application Serial No. 16/847,716, filed April 14, 2020, which is a Continuation Application of U.S. Patent Application Serial No. 15/126,293, filed September 15, 2016, which claims priority is a 371 National Filing of Application No. PCT/FR2015/050706, filed March 20, 2015, which claims priority from French Patent Application No. 14 52354, filed on March 21, 2014. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 15/126,293, filed September 15, 2016.
Drawings
The drawings are objected to because:
Figures 1-5 use the term “matrice”.
Figures 1-5 use commas instead of periods for numerical values (i.e. 0,5).
Figures 7-11 use the terms “Résponse”, “du total”, “Traitements”, “non traité”, “à”, “résin”, “circuit fermé pendant”.
Figures 7-11 use commas instead of periods for numerical values (i.e. pH 4,5).
Figures 7-11 recite the tradename Mannaway® as the enzyme used in the experiments.
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.
Specification
The use of the terms “Norit C Extra USP” and “ENO-PC”, which is a trademark and trade name, respectively, have been noted in this application (page 2 and 9, respectively). The terms should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 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 8-23 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 pre-AIA the applicant regards as the invention.
Regarding claims 8-23: Claim 8 is drawn to a method that recites “a pharmaceutical-grade activated carbon with high absorption capacity and microporous porosity”. Claims 20-23 recite the phrase “high adsorption capacity and microporous porosity”.
The terms “high,” “microporous” as recited in the indicated claims are relative terms which render the claims indefinite. The term "high" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding the term “microporous”, the term are defined by claims 10 and 14 as well as the specification (pg. 6, lines 21-23). However, this definition is based on a trademark names or tradenames (“Norit”) “Norit” is a trademarked name for an activated carbon.
The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name.
Additionally, claims 8, 11, 14, and 20-23 attempt to define the phrase “high adsorption capacity and microporous porosity” by describing what it does, rather than what it is. For example. Claim 8 recites inter alia, “high adsorption capacity and microporous porosity to decrease TLR2 response”, and claims 20-23 recite changes in TLR2 response that occur as a result of using the activated carbon (i.e. “decreases TLR2 response from XX% to XX%). For example claim 8 recites inter alia, “activated carbon with mesoporous porosity to eliminate molecules with a molecular weight of <100 kDA”. Claims 10 and 14 recite that the microporous porosity further “eliminates LPS and degradation products of PGNs”. Including descriptions of what occurs as a result (i.e. eliminating PGNS or decreases TLR2 response) does not provide for sufficient structure for one to ascertain the metes and bounds of the invention (i.e. particularly what constitutes having “high adsorption capacity”, given that the definition itself is based upon a tradename product. Without reciting the particular structure, materials or steps that accomplish the function or achieve the result, all means or methods of resolving the problem may be encompassed by the claim (See MPEP 2173.05 (g)). Given that the definitions are linked to trade names, it remains unclear at what porosity for both terms is encompassed.
Thus, although the terms microporous and mesoporous are defined in the claims and the specification, their metes and bounds cannot be determined because the porosity for both terms is defined by referring to trademark or tradename products. The porosity of such products in not clear because they are a source of goods supra, not the product per se, so one reading the claim or the specification cannot immediately understand what pore size is being claimed.
Claims 9-23 are rejected because they do not overcome the deficiencies of the claims from which they depend.
Regarding claims 14: Claim 14 recite inter alia, “mesoporous porosity eliminates PGNs and degradation products of PGNs”. However, according to the instant specification, the elimination of such contaminants is attributed towards activated carbon with microporous porosity (pg. 9, lines 23-27), while “mesoporous porosity” is associated with the elimination of LPS and degradation products of PGNs (i.e. not PGNs, pg. 9, lines 33-36, pg. 10, lines 1-2). Thus, based on the description of the specification, it is unclear what is to be encompassed by claim 14, as the specification does not describe this activated carbon as being capable of removing PGNS, but rather LPS and degradation products of PGNs.
Regarding claims 20-23: Claims 20-23 recite changes in TLR2 response that occur as a result of using the activated carbon (i.e. “decreases TLR2 response from XX% to XX%). However, it is unclear whether the claim is attempting to describe a property of the activated carbon (a certain activated carbon gives a certain result), or is a description of a result that occurs based upon the sample it interacts with. According to the instant specification the TLR2 response is directly correlated to the amount of peptidoglycan (PGNs) with a given sample, wherein a purification/decontamination of said sample that removes PGNs would decrease said TLR2 response (pg. 14, lines 35-37, pg. 15, lines 1-3). The instant specification demonstrates that depending on the purification procedure utilized on a given sample, the TLR response can be modified (drawings figures 7-11). The instant specification demonstrates that samples have varying levels of starting PGN levels, (E1565, E3063, E1242, E5248, E209J) which accounts for variation in starting TLR2 response (pg. 12, top of page, table, drawings, figure 6). Based on the specification, the change in response is not necessarily related to the activated carbon, but rather the starting/ending concentrations of PGNs in the sample. Thus, due to multiple interpretations, claims 20-23 are rendered indefinite.
Claim Rejections - 35 USC § 112 (d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 10-11, 13-14, and 20-23 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claims 10-11 and 13-14: Claims 10-11 and 13-14 attempt to limit claims drawn to a method by reciting a result of practicing the method, “eliminates LPS and degradation products of PGNs” and “eliminates LPS and degradation products of PGNs”. However, given the claims merely describe a property that results from practicing the method, they fail to further the method claims of which they depend.
Regarding claims 20-23: Claims 20-23 recite changes in TLR2 response that occur as a result of using the activated carbon (i.e. “decreases TLR2 response from XX% to XX%). However, given the claims merely describe a property that results from practicing the method, they fail to further the method claims of which they depend.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Duflot et al. (WO 2012059685; English translation provided) in view of Lanos et al. (WO 2012/143647; English translation provided), Hirai et al. (US 6,951,644) and Yang (US 20060182740), as evidenced by Boven et al. (US 20110033843), McLellan et al. (US 20150284356) and Keshavarzian et al. (US 20170184569).
Regarding claims 8 and 11: Duflot teaches a method for decontaminating a starch hydrolysate to prepare glucose polymers for the use in peritoneal dialysis (page 2, first paragraph).
The process comprises, in the following order:
preparing a starch hydrolysate, filtering to remove contaminants that are yeast-size; treating the starch hydrolysate with a polysaccharide-cell wall-degrading enzyme that is laminarinase or lysozyme; ultrafiltering the enzyme-treated starch hydrolysate; treating the hydrolysate on activated carbon with a high absorption capacity and collecting the decontaminated starch hydrolysate (pg.11, first preferred embodiment).
On pages 27-28 (English translation, Duflot teaches the method of embodiment 1 in Example 3 wherein commercial maltodextrins were hydrolyzed and treated with laminarinase or lysozyme to degrade the endotoxins, beta-glucans and peptidoglycans in order to degrade them significantly. Boven (pg. 7, para. 0043), McLellan (pg. 36, para. 0321) and Keshavarzian (pg. 1, para. 0003) teach that peptidoglycan, beta-glucan and endotoxins, respectively, are pro-inflammatory molecules.
Duflot teaches ultrafiltration with 30 kDa threshold removes PGNs, particularly large PGNs from the sample, which are TLR2 agonists (English translation, pg. 15, fifth para. from bottom, pg. 17, last para.). Table V shows the results of the purification after each step, including treatment with a NORIT SX activated carbon (English translation, pgs. 28-29, table V, Original document, pg. 36, table 5). It can be seen that even after these treatments that endotoxins, beta-glucans and peptidoglycans are still present in the supernatant preparation.
Duflot teaches testing activated carbons that are mesoporous and microporous (ECO-PC and NORIT-SX) for the removal of peptidoglycan (English translation, pg. 41, paras. 1-3). Duflot also teaches that a two-stage carbon-activated treatment is more effective than a one-step treatment where the hydrolysate is treated with ENO-PC NORIT mesopore type and then treated with NORIT SX of a microporous type (English translation, pg. 41, paras. 1-3). According to the instant specification, an ENO-PC activated carbon eliminates molecules with a molecular weight of <100 kDa (pgs. 9-10, bridging para.).
Therefore, Duflot teaches treating a maltodextrin by:
Pretreatment of a hydrolysate with an enzymatic preparation;
30 kDa Ultrafiltration;
Treatment with microporous NORIT SX.
Duflot does not specifically teach in the first embodiment performing mesoporous activated carbon treatment followed by a microporous activated carbon treatment after the enzymatic treatment e.g., (double treatment with activated carbons) where the resultant mixture is passed over a macroporous polymer resin having a pore size of greater than 100 angstroms followed by a last step of continuous ultrafiltration using a membrane with a 5 kDa cutoff (claim 8).
Hirai teaches the removal of peptidoglycans from a biological sample by contacting the sample with a porous material comprising styrene/divinylbenzene resin copolymer having a quaternary base and a pore size of at least 25,000 Angstroms and a molecular weight limit for a globular protein of at least 50,000. After contacting with this material, a supernatant was obtained having 0.09 ng/ml of peptidoglycan (Example 1, col. 7 and Table 1, col. 8).
Lanos teaches a method for detecting contaminants in glucose polymer hydrolysates solutions for peritoneal dialysis (English translation, abstract, pg. 4, para. 3-5). In order to remove microbial peptide contaminants 5 kDa ultrafiltration is performed on a column (English translation, pg. 17, para. 7). This is reasonably interpreted as continuous as a column is continuous.
Yang teaches that ultrafiltration to remove small polypeptides during the preparation of antibodies is a final step in such a purification method (pg. 6, para. 0058).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to subject the sugar hydrolysate of Duflot to a purification treatment for peritoneal dialysis by the following steps:
Treatment with laminarinase or lysozyme;
30 kDa ultrafiltration;
Treatment with mesoporous activated carbon (ENO-PC);
Treatment with Norit SX a microporous activated carbon;
Subjecting the resultant product of the Norit SX treatment to the ion exchange resin with a pore size of 25,000 Angstrom as in the method of Hirai;
followed by a last step of continuous 5 kDa filtration.
The ordinary artisan would have been motivated to do a purification in this order because each step successively clears contaminants such as endotoxins, beta-glucans and peptidoglycan or their fragments and the cited secondary references teach these methods as ridding a biological composition of these very contaminants. That is, the enzyme treatment of the hydrolysate would be first in order to cleave the endotoxins, beta-glucans and peptidoglycan as disclosed by Duflot. Further, Duflot teaches that the double activated carbon treatment is more effective than a single treatment. While Duflot teaches treatment with the mesoporous resin first followed by the microporous resin, the MPEP at 2144.04 states the following regarding a sequence of steps in a claims:
C. Changes in Sequence of Adding Ingredients
Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959) (Prior art reference disclosing a process of making a laminated sheet wherein a base sheet is first coated with a metallic film and thereafter impregnated with a thermosetting material was held to render prima facie obvious claims directed to a process of making a laminated sheet by reversing the order of the prior art process steps.). See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.).
It is noted supra that the treatment method still results in contaminants such as peptidoglycans in the preparation. The ordinary artisan would be motivated to add the cation exchange resin having the pores of 25,000 Angstrom because it is shown to be very effective to remove contaminating peptidoglycans as shown by Hirai.
The ordinary artisan would have been motivated to do the continuous ultrafiltration with the 5 kDa membrane as a final step because Yang teaches that in a purification process ultrafiltration to remove small polypeptide fragments is carried out as a final step. The ordinary would have had a reasonable expectation that these further method steps would further purify the starch hydrolysate of Duflot because the supporting references all teach that these methods purify starch hydrolysates or biological preparations of the contaminants that Duflot is desirous of removing from a starch hydrolysate.
The references are silent regarding the that the method results in purification of the starch hydrolysate from pro-inflammatory molecules and that the laminarinase or lysozyme have detergent and clarification properties but meets the claimed limitations because the steps of the instant invention are carried out and laminarinase or lysozyme degrades polysaccharide cells walls of yeasts which indicates that the claimed characteristics should be present in the prior art invention as also as those instantly claimed. In this case, burden is shifted to the Applicant to distinguish the instant invention over the prior art.
It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe naturally includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
Additionally, wherein the method results in removing PGNSs using the microporous material, a known TLR2 agonist, from the composition, the method necessarily decreases TLR2 response.
Claims 9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Duflot et al. (WO 2012059685; English translation provided) in view of Lanos et al. (WO 2012/143647, English translation provided), Hirai et al. (US 6,951,644) and Yang (US 20060182740), as evidenced by Boven et al. (US 20110033843), McLellan et al. (US 20150284356) and Keshavarzian et al. (US 20170184569), as applied to claims 8 and 11 in further view of Shi (CN 103060307 A; English translation provided).
Regarding claims 9 and 14: The disclosure by Duflot in view of the supporting references is discussed supra.
Modified Duflot does not teach that the enzyme to cleave the polysaccharide cell walls is a mannanase (claim 9) and claim 14 (drawn to the use of ENO-PC) which is disclosed by modified Duflot supra.
Shi teaches that mannanase decomposes the cell walls of yeast (English translation, abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to employ mannanase in the method of modified Duflot to purify starch hydrolysates. The ordinary artisan would have been motivated to do so because mannanase like laminarinase has yeast cell-wall degrading activity. The ordinary artisan would have had a reasonable expectation that one could use mannanase to degrade cell walls of yeast because Hatanaka teaches this.
The references are silent regarding the that the method results in purification of the composition from pro-inflammatory molecules and that the mannanase has detergent and clarification properties but meets the claimed limitations because the steps of the instant invention are carried out and mannanase degrades polysaccharide cells walls of yeasts which indicates that the claimed characteristics should be present in the prior art invention as also as those instantly claimed. In this case, burden is shifted to the Applicant to distinguish the instant invention over the prior art.
It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe naturally includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
Claims 12 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Duflot et al. (WO 2012059685, English translation provided) in view of Lanos et al. (WO 2012/143647, English translation provided) Hirai et al. (US 6,951,644) and Yang (US 20060182740), as evidenced by Boven et al. (US 20110033843), McLellan et al. (US 20150284356) and Keshavarzian et al. (US 20170184569), as applied to claims 8 and 11 in further view of Johnson et al. (US 20090236284).
Regarding claims 12 and 16: The disclosure by Duflot in view of the supporting references is discussed supra.
Modified Duflot does not teach that a glucose polymer or just glucose (e.g., fully hydrolyzed glucose polymer) is decontaminated by the method of modified Duflot where the glucose polymer is icodextrin or maltodextrin which can be branched or unbranched (claims 12 and 16).
However, Johnson teaches that specific microbial contaminants such as peptidoglycans, which are pro-inflammatory, can be found in dialysis solutions (pg. 2, para. 0020). Johnson teaches that peritoneal dialysis solutions contain osmotic agents such as glucose polymers or their derivatives such as icodextrin, maltodextrin and hydroxyethyl starch. These compounds can be used in place of glucose (pgs. 3-4, para. 0041). The disclosure of maltodextrin reasonably includes branched and unbranched because the genus of maltodextrins includes these two species. That is, maltodextrins are branched or unbranched polymers.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use an icodextrin, maltodextrin or straight glucose as the osmotic agent for peritoneal dialysis and to purify any of these agents from the composition by the method of modified Duflot. The ordinary artisan would have been motivated to do so because Johnson teaches that icodextrins, maltodextrins or glucose can be used as the osmotic agent but that such preparations can contain peptidoglycan contaminants. Thus, as the ordinary artisan recognizes that the method of modified Duflot removes such impurities, the ordinary artisan would be motivated to remove them. The ordinary artisan would have had a reasonable expectation that one could use icodextrin, maltodextrin, branched or unbranched, or glucose for peritoneal dialysis because Johnson teaches this. The ordinary artisan would have had a reasonable expectation that one could remove peptidoglycans by the method of modified Duflot from icodextrin or maltodextrin preparations but the method of modified Duflot effectively does so.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Duflot et al. (WO 2012059685, English translation provided) in view of Lanos et al. (WO 2012/143647, English translation provided), Hirai et al. (US 6,951,644), Yang (US 20060182740) and Johnson et al. (US 20090236284), as evidenced by Boven et al. (US 20110033843), McLellan et al. (US 20150284356) and Keshavarzian et al. (US 20170184569), as applied to claims 8, 11, 12, 16 in further view of Nentwick (US 20110245665).
Regarding claim 17: The disclosure of Duflot modified by the supporting references is discussed supra.
Modified Duflot does not teach that the glucose used is glucose monohydrate (dextrose; claim 17).
Nentwick teaches that a dialysate solution for peritoneal dialysis contains dextrose which is glucose monohydrate (pg. 1, paras. 0001-0002, pg. 11, table 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use dextrose as the glucose use in peritoneal dialysis and purified by the method of modified Duflot. The ordinary artisan would have been motivated to do so because Johnson teaches that glucose is suitable for peritoneal dialysis and Nentwick teaches that glucose in the form of dextrose is used. The ordinary artisan would have had a reasonable expectation that one could use a preparation of glucose monohydrate for peritoneal dialysis because modified Duflot teaches that hydrolysates can be used, Johnson teaches the use of glucose as an alternative to maltodextrin or icodextrin and Nentwick teaches using glucose monohydrate for a dialysate.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Duflot et al. (WO 2012059685, English translation provided) in view of Lanos et al. (WO 2012/143647,English translation provided), Hirai et al. (US 6,951,644), Yang (US 200060182740) and Shi (CN 103060307 A; machine translation provided), as evidenced by Boven et al. (US 20110033843), McLellan et al. (US 20150284356) and Keshavarzian et al. (US 20170184569), as applied to 8, 9, 11, 14 in further view of Youn (US 20050245481).
Regarding claim 13: The disclosure by Duflot in view of the supporting references is discussed supra.
Modified Duflot does not teach that the microporous activated carbon eliminates PGNS and degradation products of PGNs. According to the instant specification, this can be accomplished with Norit C extra USP activated carbon ( pg. 9, lines 25-27). The specification also stats that porosity equivalent to Norit C Extra USP activated carbons are suitable substitutions (pg. 6, lines 21-23).
Youn teaches that impurities can be removed via activated carbons including Norit C extra USP and various Norit SX activated carbons (pgs. 4-5, para. 0046). From this disclosure the ordinary artisan would reasonably conclude that Norit C Extra USP and the Norit SX used by Duflot as a microporous resin are comparable in their porosity. It is prima facie obvious to substitute equivalents for the same purpose (pg. 2144.06 (II)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to employ Norit C Extra USP as the microporous activated carbon in the method of modified Duflot. The ordinary artisan would have been motivated to do so because Youn teaches that the Norit SX activated carbons, as use by Duflot for microporous adsorption, are comparable to Norit C Extra USP. The ordinary artisan would have had a reasonable expectation that one could use Norit C Extra USP as the microporous activated carbon in the method of modified Duflot because Youn identifies them as being comparable activated carbon adsorbents.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Duflot et al. (WO 2012059685, English translation provided) in view of Lanos et al. (WO 2012/143647, English translation provided), Hirai et al. (US 6,951,644) and Yang (US 200060182740), as evidenced by Boven et al. (US 20110033843), McLellan et al. (US 20150284356) and Keshavarzian et al. (US 20170184569), as applied to 8 and 11 in further view of Youn (US 20050245481).
Regarding claim 10: The disclosure by Duflot in view of the supporting references is discussed supra.
Modified Duflot does not teach that the microporous activated carbon eliminates PGNS and degradation products of PGNs. According to the instant specification, this can be accomplished with Norit C extra USP activated carbon ( pg. 9, lines 25-27). The specification also stats that porosity equivalent to Norit C Extra USP activated carbons are suitable substitutions (pg. 6, lines 21-23).
Youn teaches that impurities can be removed via activated carbons including Norit C extra USP and various Norit SX activated carbons (pgs. 4-5, para. 0046). From this disclosure the ordinary artisan would reasonably conclude that Norit C Extra USP and the Norit SX used by Duflot as a microporous resin are comparable in their porosity. It is prima facie obvious to substitute equivalents for the same purpose (pg. 2144.06 (II)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to employ Norit C Extra USP as the microporous activated carbon in the method of modified Duflot. The ordinary artisan would have been motivated to do so because Youn teaches that the Norit SX activated carbons, as use by Duflot for microporous adsorption, are comparable to Norit C Extra USP. The ordinary artisan would have had a reasonable expectation that one could use Norit C Extra USP as the microporous activated carbon in the method of modified Duflot because Youn identifies them as being comparable activated carbon adsorbents.
Claims 15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Duflot et al. (WO 2012059685, English translation provided) in view of Lanos et al. (WO 2012/143647, English translation provided), Hirai et al. (US 6,951,644), Yang (US 20060182740) and Shi (CN 103060307 A; English translation provided), as evidenced by Boven et al. (US 20110033843), McLellan et al. (US 20150284356) and Keshavarzian et al. (US 20170184569), as applied to claims 8, 9, 11, 14 in further view of Johnson et al. (US 20090236284).
Regarding claims 15 and 18: The disclosure of Duflot modified by the supporting references is discussed supra.
Modified Duflot does not teach that a glucose polymer or just glucose (e.g., fully hydrolyzed glucose polymer) is decontaminated by the method of modified Duflot where the glucose polymer is icodextrin or maltodextrin which can be branched or unbranched (claims 15 and 18).
However, Johnson teaches that specific microbial contaminants such as peptidoglycans, which are pro-inflammatory, can be found in dialysis solutions (pg. 2, para. 0020). Johnson teaches that peritoneal dialysis solutions contain osmotic agents such as glucose polymers or their derivatives such as icodextrin, maltodextrin and hydroxyethyl starch. These compounds can be used in place of glucose (pgs. 3-4, para. 0041). The disclosure of maltodextrin reasonably includes branched and unbranched because the genus of maltodextrins includes these two species. That is, maltodextrins are branched or unbranched polymers.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use an icodextrin, maltodextrin or straight glucose as the osmotic agent for peritoneal dialysis and to purify any of these agents by the method of modified Duflot. The ordinary artisan would have been motivated to do so because Johnson teaches that icodextrins, maltodextrins or glucose can be used as the osmotic agent but that such preparations can contain peptidoglycan contaminants. Thus, as the ordinary artisan recognizes that the method of modified Duflot removes such impurities, the ordinary artisan would be motivated to remove them. The ordinary artisan would have had a reasonable expectation that one could use icodextrin, maltodextrin, branched or unbranched, or glucose for peritoneal dialysis because Johnson teaches this. The ordinary artisan would have had a reasonable expectation that one could remove peptidoglycans by the method of modified Duflot from icodextrin or maltodextrin preparations but the method of modified Duflot effectively does so.
Claims 19 is rejected under 35 U.S.C. 103 as being unpatentable over Duflot et al. (WO 2012059685, English translation provided) in view of Lanos et al. (WO 2012/143647, English translation provided), Hirai et al. (US 6,951,644), Yang (US 20060182740), Shi (CN 103060307 A; English translation provided) and Johnson et al. (US 20090236284), as evidenced by Boven et al. (US 20110033843), McLellan et al. (US 20150284356) and Keshavarzian et al. (US 20170184569), as applied to claims 8, 9, 11, 14, 15, and 18 in further view of Nentwick (US 20110245665).
Regarding claim 19: The disclosure of Duflot modified by the supporting references is discussed supra.
Modified Duflot does not teach that the glucose used is glucose monohydrate (dextrose; claim 19).
Nentwick teaches that a dialysate solution for peritoneal dialysis contains dextrose which is glucose monohydrate (pg. 1, paras. 0001-0002, pg. 11, table 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use dextrose as the glucose use in peritoneal dialysis and purified by the method of modified Duflot. The ordinary artisan would have been motivated to do so because Johnson teaches that glucose is suitable for peritoneal dialysis and Nentwick teaches that glucose in the form of dextrose is used. The ordinary artisan would have had a reasonable expectation that one could use a preparation of glucose monohydrate for peritoneal dialysis because modified Duflot teaches that hydrolysates can be used, Johnson teaches the use of glucose as an alternative to maltodextrin or icodextrin and Nentwick teaches using glucose monohydrate for a dialysate.
Claims 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Duflot et al. (WO 2012059685, English translation provided) in view of Lanos et al. (WO 2012/143647, English translation provided), Hirai et al. (US 6,951,644) and Yang (US 20060182740), as evidenced by Boven et al. (US 20110033843), McLellan et al. (US 20150284356) and Keshavarzian et al. (US 20170184569) as applied to claims 8 and 11 above in view of Lanos (FR2978774, English translation provided).
Regarding claims 20-23: As discussed above, the prior art renders obvious the method of claim 8.
The prior art relied upon does not explicitly state wherein the TLR2 response decreases from 80% to 10%, 65% to 10%, 100 to 10%, or 60% to 5% as recited by instant claims 20-23.
However, according to the instant specification the TLR2 response is directly correlated to the amount of peptidoglycan (PGNs) with a given sample, wherein a purification/decontamination of said sample that removes PGNs would decrease said TLR2 response (pg. 14, lines 35-37, pg. 15, lines 1-3). The instant specification demonstrates that depending on the purification procedure utilized on a given sample, the TLR response can be modified (drawings figures 7-11). The instant specification demonstrates that samples have varying levels of starting PGN levels, (E1565, E3063, E1242, E5248, E209J) which accounts for variation in starting TLR2 response (pg. 12, top of page, table, drawings, figure 6). Lanos (FR2978774) teaches a method of detecting proinflammatory contaminants in glucose polymers (English translation, abstract). Lanos (FR2978774) teaches the amount of PGNS can vary widely in glucose samples from <20 PGN ng/g up to 16288 ng/g
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(Original document, pg. 18, table 1). According to the instant specification PGN levels in samples tested range from 21 ng/g up to 16185 ng/g (pg. 12, top of page, table). Lanos (FR2978774) teaches that peptidoglycan concentration in glucose polymers for peritoneal dialysis correlate with TLR2 response (English translation, pg. 7, paras. 3-4).
Given that the prior art renders obvious the method, recognizes the direct relationship between PGN concentration in a glucose polymer sample, and teaches that glucose polymers for intended peritoneal dialysis can have varying concentrations of PGNS ranging from <20 ng/g up to 16288 ng/ng, it would have been prima facie obvious to apply the method to these samples with a reasonable expectation of success in order to remove PGNS from the sample. The corresponding change in TLR2 response would flow naturally as a result from practicing the method, given the method is capable of removing PGNs from the sample. Additionally, It would be within the technical grasp of the skilled artisan to arrive at the claimed concentrations through routine practices in the art.
Conclusion
No claims are allowed in this action.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Biguet (WO 2010125315, English translation provided) teaches a method of purifying glucose polymers for the production of peritoneal dialysis solutions (abstract)
Biguet (US 20120046460) teaches a method of purifying glucose polymers for the production of peritoneal dialysis solutions (abstract).
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/S.L.G./Examiner, Art Unit 1693
/ANDREA OLSON/Primary Examiner, Art Unit 1693