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. Information Disclosure Statement The Information Disclosure Statements (IDS) filed on 11/30/2023 and 09/25/2024 have been considered by the Examiner inasmuch as foreign documents have been submitted into the file wrapper in English. Claim Status The preliminary amendment filed November 30, 2023 has been entered. Claims 1-15 are canceled. Claims 16-35 are new. Thus, claims 16-35 as amended are examined on the merits herein. Specification The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The Examiner respectfully notes claim 16, line 1, recites "A sterilized gel-forming multi-component kit " . The Examiner has r eviewed the entire disclosure for the recitation of “ A sterilized gel-forming multi-component kit ” which the Examiner respectfully notes the entire disclosure does not make mention of or reference to said kit as discussed above. However , the Examiner respectfully notes the specification does make reference to “ a sterilized, gel-forming, multi-component composition ” , see specification, pg. 1, line 1; and define s “gel-forming composition” on pg. 8, lines 5-7 of the specification ; but the Examiner respectfully notes said definition does not define said composition as a kit. Consequently, in reviewing the entire specification as a whole the Examiner respectfully notes the specification refers only to “a sterilized gel-forming multi-component composition ” throughout the disclosure, example references are provided by the Examiner below but are not exhaustive , for example: specification, pg. 5, lines 5 – pg. 6, line 5 corresponds to the recited limitations of instant claims 16 and 19-20; specification, pg. 17, lines 25-30 correspond to said composition for use in a method for removing undesirable particles from a patient corresponding to the recited limitations of instant claim 27; and specification, pg. 19, lines 15-25 correspond to the prepared composition by the method corresponding to instant claim 29. Therefore, in view of the example references above and in order to provide proper antecedent basis for "A sterilized gel-forming multi-component kit " as recited above, the specification should be corrected to replace each and every reference referring to “a sterilized gel-forming multi-component composition ” within the specification with the phrase "A sterilized gel-forming multi-component kit " as discussed above. Claim Objections Claim FILLIN "Enter claim indentification information" \* MERGEFORMAT s 29 and 31 are objected to because of the following informalities: Claim 29, line 1 , recites “a sterilised gel-forming composition of claim 16”; and Claim 31, line 1 recites “A sterili s ed gel-forming composition ” where each claim recite s the word “composition” , although the Examiner respectfully notes both claims either depend from or rely on the kit recited within claim 16; therefore, the Examiner respectfully notes the recited “composition” discussed above is inconsistent with the recitation of “a sterilized gel-forming kit ” as recited within claim 16, line 1. Thus, to promote clarity the Examiner respectfully suggests replacing each recitation of “composition” with the word “kit” as discussed above. In the interest of compact prosecution, the Examiner reasonably interprets the recitations of “a sterilised gel-forming composition” as recited above are in fact “ a sterilised gel-forming kit ”. Appropriate correction is required. 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. 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. Claims FILLIN "Insert the claim numbers which are under rejection." \d "[ 1 ]" 16-35 are rejected under 35 U.S.C. 103 as being unpatentable over FILLIN "Insert the prior art relied upon." \d "[ 2 ]" Grunwald et al. (hereafter referred to as "Grundwald-1", Published 10 March 2016, US-20160067373-A1, PTO-892) in view of Grunwald et al. (hereafter referred to as "Grundwald-2", Published 17 March 2016, US-20160074561-A1, PTO-892) and Bender et al. (Published 21 March 2013, WO-2013039380-A1, PTO-892) . Regarding claim 1 6-35 , Grunwald-1 teaches gel-forming systems for removing urinary calculi and fragments thereof, see title. Grunwald-1 teaches gel forming systems comprising: a composition (A), comprising one or several cationically crosslinkable polymer(s); and a composition (B), comprising one or several crosslinking agent(s) for crosslinking the cationically crosslinkable polymer(s), see abstract. Grunwald-1 teaches the gel-forming system is an adhesive-forming system comprising compositions (A) and ( B) as well as in addition comprising magnetizable particles for part ly or full y surrounding urinary calculi and/or fragments thereof, see paragraph [0003]. Grunwald-1 teaches the addition of the magnetizable particles provides a method to remove the set “adhesive composite” (e.g. gel-calculus fragment- conglomerate) from the body by utilizing the magnetic properties, see paragraph [0061]. Grunwald-1 teaches the cationically crosslinkable polymer(s) of composition (A) is/are selected from the group consisting of and include polysaccharides, wherein the particularly p referred polysaccharides are from the group of alginates (e.g. sodium alginate, required in claim 16, line 4 ), see paragraph [0050]. Grunwald-1 teaches the one or several or all of the crosslinking agent(s) of composition (B) is/are selected from the group consisting of and including divalent cations, preferably calcium ions (e.g. the crosslinking agent of component (B)(a) is CaCl 2 , required in claim 19 ), see paragraph [0052]. Grunwald-1 teaches compositions (A) and (B) contain water (e.g. the water, required in claim 16, line 5 and line 12 ), see paragraphs [0102]-[0103]. Grunwald-1 teaches said gel-forming system comprises a composition (C), see paragraph [0058]- [ 0059]. Grunwald-1 teaches within composition (C) comprises water or physiological buffer and is prepared (e.g. one phosphate buffer, required in claim 16, line 8 and claim 17 ) ; and this solution is added to composition (A) or (B) , see paragraph [0104]. Grunwald-1 teaches preferably composition(s) (A) and/or (B) additionally contain(s) one or several dye(s) that facilitate to visualize the set gel (e.g. the dye, required in claims 20-23 and 34 ) , see paragraph [0049]. With respect to the limitation of “wherein at least one dye in component (A) is different from at least one dye in component (B) ” , required in claim 21, lines 2-3 ; t he Examiner reasonably interprets this limitation as a physical limitation of the at least one dye comprised within components (A) and (B) as required in claim 20 . Since Grunwald -1 teaches one or several dyes may be present within components (A) and/or (B) to facilitate visualizing the set gel, the Examiner reasonably interprets the physical limitation discussed above is met by the teachings of Grunwald-1 as discussed above. Additionally, the Examiner reasonably interprets both dextr a n blue and riboflavin as recited within claims 22-23 and 34 are dyes as evidenced by their dependency to claim 20 which recites component (A) and component (B) include at least one dye. Grunwald-1 teaches removing at least one of urinary calculi and fragments of urinary calculi (e.g. removing particles, required in claim 27, line 1 ) from a region of a urinary tract comprising introducing composition (A) into the region of the urinary tract that contains at least one of urinary calculi and fragments of urinary calculi , introducing composition (B) into the region of the urinary tract, wherein in response to the composition (A) and the composition (B) com ing into contact with each other enabl es crosslinking of the cationically crosslinkable polymers , where a crosslinked gel is formed (e.g. the gel, required in claim 26 ) that partly or fully surrounds at least one of the urinary calculi and fragments of urinary calculi, and removing the crosslinked gel with at least one of the urinary calculi and fragments of the urinary calculi (e.g. the introducing, contacting and removing required within claim 27, lines 3-9 ) , see pg. 8, claim #1, left-right column . Grunwald-1 teaches urinary calculi left untreated can lead to serious health problems and vitally endanger s the patient (e.g. the human patient, required in claim 27, line 1 ), see paragraph [0006]. Grunwald-1 teaches prior to introducing the composition (A) and the composition (B), the method further includes fragmenting of one or more urinary calculus/calculi in the urinary tract so that a plurality of urinary calculus fragments are formed (e.g. the fragmenting, required in claim 28 ), see pg. 8, right column, claim #7. Although, Grunwald-1 does not teach (a) a sterilized kit, required in claim 16, line 1 , claim s 25 -26 , claim 27, line 2 and claim s 29 -31 ; (b) NaCl, required in claim 16, lines 6-7; (c) the weight percentage range of either or both of sodium alginate or the crosslinking agent, required in claims 18 and 32-33; and (d) the weight percentage range of either or both dextran blue or riboflavin, required in claims 23 and 34. However, in the same field of endeavor of crosslinked alginate aqueous compositions for medical use , with respect to limitations (a)-(d), Grunwald-2 teaches a kit use d to reliably extract urinary calculus fragments from the body (e.g. a kit, required in claim 16, line 1, claims 25-26, claim 27, line 2 and claim 29-31), see paragraph [0026]; wherein said kit produces a crosslinked gel, which is particularly adhesive, for partly or fully surrounding urinary calculus fragments, see paragraph [0028]; comprising a composition (A) comprising one or several cationically crosslinkable polymer(s), see paragraph [0029]; a composition (B) comprising one or several crosslinking agent(s) for crosslinking the cationically crosslinkable polymer(s), see paragraph [0031]; and wherein composition (A) and/or composition (B) additionally comprise(s) magnetizable particles, see paragraphs [0032]-[0033]. Grunwald-2 teaches the cationically crosslinkable polymer(s) particularly preferred are polysaccharides from the group of alginates, see paragraph [0047]. Grunwald-2 teaches within the kit , composition (A) and composition (B) compris e one or several substances for improving the crosslinking of the cationically crosslinkable polymer(s), more particularly crosslinkers (e.g. improving cross-linking of the sodium alginate, required in claim 2 5, line 4 ), see paragraph [0062]. Grunwald-2 teaches composition (A) and composition (B) comprised with in the kit comprise one or several further substances from the following list of dyes and stabilizers, see paragraph [0066]. With respect to the limitation of “for improving the stability of the sodium alginate of (A)( i ), required in claim 25, line 4 ; and “for increasing density of the sodium alginate of (A)( i )”, required in claim 25, line 7 ; the Examiner reasonably interprets th ese limitation s a re physical limitation s of adding “one or more crosslinking agents” within component (B) as required in claim 16, line s 10-11. Since both Grunwald-1 and Grunwald-2 teach multiple crosslinking agents to crosslink alginates, the physical limitation s as discussed above are met by the teachings of both Grunwald-1 and Grunwald-2. Although, Grunwald-2 does not teach a sterilized kit. However, in the same field of endeavor of crosslinked alginate aqueous compositions for medical use , Bender teaches a sterile alginate-based aqueous composition for medical use and process for the preparation thereof (e .g. the sterilized kit, required in claim 16, line 1, claims 25-26, claim 27, line 2 and claim 29-31) , see title. Bender teaches ready-to-use sterile, alginate-based, aqueous compositions for medical use; where the aqueous composition for medical use has been sterilized (e.g. sterilizing the component (A), required in claim 29, pg. 6, line 1 ) by heat sterilization (e.g. steam sterilization, required in claim 30 ); wherein said composition has a pH in the range of 6.5 - 7.5, containing 0.5-10 wt % of an alginate salt (e.g. the weight percent of sodium alginate, required in claims 18 and 32-33 ); and further contain ing 10-500 mM of one or more dissolved C 8 -C 12 fatty acid salts, see abstract. Bender teaches the alginate-based aqueous compositions containing 0.01-0.5 M of one or more dissolved C 8 -C 12 fatty acid salts do not suffer from instability when heat sterilized, see pg. 2, summary of the invention, last paragraph of the page. Bender exemplifies the alginate salt as sodium alginate, see pg. 9, Example 1, lines 15-20. Bender teaches the alginate-based aqueous composition contains 95-99 wt . % of water; and besides the alginate salt, the one or more fatty acid salts and the water within the composition , the alginate-based composition may suitably contain other components such as and including sodium chloride (e.g. the NaCl, required in claim 16, lines 6-7 ), see p g. 7 , lines 25-31. Bender teaches most preferably the alginate salt content of the composition is in the range of 1- 5 wt. %, see pg. 5, lines 15-20. Bender teaches the alginate salts contained within the alginate-based composition is cross-linked by divalent cations selected from and includ ing Ca 2+ , see pg. 6, lines 3-5. Bender teaches a phosphate buffer was used in their alginate-based aqueous compositions, see pg. 11, comparative example 1, lines 15-20. Therefore, in view of the teachings of Bender within the preceding paragraphs as discussed above , the Examiner respectfully notes within the alginate-based aqueous composition of Bender, 96- 100 wt . % of the composition comprises the alginate salt and water. Thus, the remaining 0-4 wt . % of the composition may comprise the C 8 -C 12 fatty acid salts, sodium chloride, and the cross-linking divalent Ca 2+ cations. Moreover, since the combination of Grunwald-1 and Bender teach alginate-based aqueous compositions for a medical use, particular ly for removing urinary calculi and/or fragments thereof, wherein the compositions (A) may compris e alginate , water , NaCl, and dye(s); and composition (B) may comprise cross-linking divalent Ca 2+ cations , water and dye(s) , it would have been within the scope of the artisan to use to teachings of Bender as a starting point in order to optimize through routine experimentation and optimization th e wt . % of NaCl, the cross-linking divalent Ca 2+ cations and dye(s) within the aqueous compositions (A) and (B) as taught by the combination of Grunwald-1 and Bender as discussed above in order to create the aqueous composition (A) comprising sodium alginate, water, sodium chloride (e.g. NaCl), phosphate buffers and dye(s) and composition (B) comprising crosslinking agent(s) of the alginate and water at the recited weight percentages within instant claim 16, lines 6-7 and claims 18, 23 and 32-34 as within the scope of the artisan as the Examiner respectfully notes the combined teachings of Grunwald-1 , Grunwald-2 and Bender as discussed above teach a sterilized gel-forming multicomponent kit for medical use comprising each recited component within claims 16, 1 8 , 23 and 32-34 as discussed above . Additionally, Bender explicitly teaches after considering the w t. % of alginate and water within their sterile alginate-based aqueous compositions, the remaining weight of 0 - 4 wt. % of the alginate-based aqueous composition corresponding to component (A) of claim 16 or of an aqueous composition comprising water corresponding to component (B) of claim 16 may comprise additional components taught by the combination of Grunwald-1 and Bender, for example the crosslinking diavalent Ca 2+ ions and dyes of Gunwald-1; and the phosphate buffer and sodium chloride taught by Bender as discussed above. Therefore, the combination of Grunwald-1 and Bender provide a starting point for one of ordinary skill in the art to arrive at the claimed invention of claim 16, lines 6-7 and claims 18, 23 and 32-34 through routine experimentation and optimization to arrive at the claimed component (A) and component (B) as recited within claims 16, 18, 23 and 32-34 as discussed above in order to create a kit for removing urinary calculi and/or fragments thereof as discussed above . Moreover, MPEP 2144.04(II)(A) states “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the invention’s effective filing date to have combined the teachings of Grunwald-1 and Bender as discussed above and through routine experimentation and optimization of the aqueous compositions taught by Grunwald-1 above would have guided one of ordinary skill in the art to arrive at the claimed component (A) and component (B) as recited and required within claim 16, lines 6-7 and claims 18, 23 and 32-34 as discussed above as within the scope of the artisan as combining prior art elements according to known compositions and methods to yield predictable results. One of ordinary skill in the art would have been motivated to routinely experiment and optimize the aqueous compositions taught by Grunwald-1 above in order to make the kit comprising component (A) and component (B) for forming a gel used in removing urinary calculi and/or fragments thereof within the urinary tract of the subject of Grunwald-1 and Grundwald-2 as discussed above . One of ordinary skill in the art would have had a reasonable expectation of success to incorporate the teachings of Bender within the compositions of Grunwald-1 and/or Grunwald-2 as discussed above , as Grunwald-1, Gunwald-2 and Bender are all drawn to cross-linked alginate-based aqueous compositions for medical use as discussed above. With respect to the limitation of “ preparing a sterilized gel-forming kit ” required in claim 29, line 1 ; the Examiner respectfully notes Grunwald-1, Grunwald-2 and Bender are silent regarding the preparation of a sterilized gel-forming kit. However, the Examiner respectfully notes the combination of Grunwald-1, Grunwald-2 and Bender teach the kit required within claim 29, particular noting component (A) comprising an alginate-based aqueous composition. Furthermore, Bender teaches sterilizing alginate- based aqueous compositions for medical use via heat sterilization. Therefore, based on the combined teachings of Grunwald-1, Grunwald-2 and Bender as discussed above it would have been prima facie obvious to have included a method of preparing a sterilized gel-forming kit into the teachings of Grunwald-1 above in order to create the kit used for removing urinary calculi and/or fragments thereof within the urinary tract of the subject of the combination taught by Grunwald-1 and Grunwald-2 as discussed above. One of ordinary skill in the art would have had a reasonably expectation of success as Grunwald-2 is drawn to kits comprising component (A) and component (B) for use in removing urinary calculi and/or fragments thereof within the urinary tract; and Bender teaches sterilizing alginate-based aqueous compositions for medical use. With respect to the limitation “component (A), component (B) and/or component (C) has a neutral pH”, required in claim 24 ; and wherein component (A) and component (B) have a pH in the range of 6.5 to 8, required in claim 35 ; the Examiner reasonably interprets each of these limitations a s physical characteristic s of the components comprised within component (A) and component (B) as recited and required within claim 16. Since the combined teachings of Grunwald -1, Grunwald-2 and Bender teach each and every component comprised within component (A) and component (B) as recited within claim 16, the physical limitations as discussed above are met by the combined teachings of Grunwald-1, Grunwald-2 and Bender as discussed above. Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have incorporated the teachings of Grunwald-2 and Bender as discussed above within the compositions as taught by Grunwald-1 above as within the scope of the artisan as combin in g prior art elements according to known compositions and methods to yield predictable results. One of ordinary skill in the art would have been motivated to create a sterilized gel-forming multi-component kit for use in removing urinary calculi and/or fragments thereof within the urinary tract of the subject of Grunwald- 1 as discussed above. One of ordinary skill in the art would have had a reasonable expectation of success to have incorporated the teachings of Grunwald-2 and Bender within the compositions taught by Grunwald-1 above; as Grunwald-1, Grunwald-2 and Bender are all drawn to crosslinked alginate-based aqueous compositions for medical use as discussed above. Thus, the claimed invention as a whole would have been prima facie obvious over the combined teachings of the prior art. Conclusion No claims are allowed in this action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT JARET J CREWS whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-0962 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Friday: 9:00am-5:30pm EST . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. 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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. /JARET J CREWS/ Examiner, Art Unit 1691 /RENEE CLAYTOR/ Supervisory Patent Examiner, Art Unit 1691