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 Statement (IDS) filed on 07/15/2026 has been considered by the Examiner inasmuch as foreign documents have been submitted into the file wrapper in English.
Claim Status
The claim set and Applicant’s remarks filed June 26, 2026 have been entered.
Claims 1-15 and 30 are canceled.
Claim 36 is new.
Thus, claims 16-29 and 31-36 as amended are examined on the merits herein.
Withdrawn Objections and Rejections
With respect to the objections and/or rejections mailed in the non-final office action on March 26, 2026:
(I) The objection to the specification is withdrawn in view of Applicant filing a substituted specification on June 26, 2026.
(II) The objection to claims 29 and 31 is withdrawn in view of Applicant’s amendment to each of these claims.
(III) The rejection of claim 30 under 35 U.S.C. 103 is withdrawn in view of Applicant canceling this claim as discussed above.
Response to Arguments
The rejection of claims 16-29 and 31-35 under 35 U.S.C. 103 is maintained.
Applicant argues:
(A) The cited references do not provide sufficient reasons, supported by rational underpinnings, for modifying the gel-forming system of Grunwald-1, as packed in the kit of Gunwald-2, to include the specific NaCl/phosphate-buffer system recited in component (A), see Applicant’s remarks, pg. 8, paragraph 3.
With respect to Applicant’s argument (A), the Examiner notes Grunwald-1 teaches within composition (C) said composition comprises a physiological buffer (e.g. phosphate buffer); and this solution is added to composition (A) which comprises the cationically crosslinkable polymer, exemplified as sodium alginate.
The Examiner notes Bender teaches the alginate-based composition contains other components such as and including sodium chloride and a phosphate buffer.
Additionally, the Examiner notes Grunwald-1, Grunwald-2 and Bender are all drawn to the same field of endeavor of crosslinked alginate aqueous compositions for medical use.
(B) Grunwald-1 does not describe a sterilized multi-component kit in which a sodium alginate-containing component (A) includes both NaCl in the recited amount and one or more phosphate buffers, see Applicant’s remarks, pg. 8, last paragraph.
(C) Grunwald-2 does not teach or suggest the claimed component (A) with sodium alginate, water, 0.3 to 1.2 wt.% NaCl, and one or more phosphate buffers, see Applicant’s remarks, pg. 9, paragraph 1.
With respect to Applicant’s arguments (B)-(C), the Examiner reiterates as discussed above and further notes Grunwald-2 is relied on for the kit; Grunwald-1 teaches separate composition (A) and composition (B) and when combined form a gel; and Bender is relied on for a process for sterilizing alginate-based aqueous compositions.
Furthermore, with particular attention to Applicant’s argument the NaCl at the recited amount as claimed is not taught by the cited references, specifically the limitation 0.3 to 1.2 wt% NaCl, as discussed above; the Examiner reiterates from the 103 rejection for convenience the remaining 0-4 wt.% of the composition may comprise the C8-C12 fatty acid salts, sodium chloride, and the cross-linking divalent Ca2+ cations as taught by the combination of Grunwald-1, Grunwald-2 and Bender.
Accordingly, the Examiner reasonably interpreted that it would have been within the scope of the artisan to use the teachings of Bender as a starting point to optimize through routine experimentation and optimization the wt.% of NaCl within the alginate-based aqueous composition taught by Grunwald-1 as discussed in greater detail in the modified 103 rejection below.
(D) The rejection therefore relies on hindsight reconstruction to select isolated disclosures from Bender and insert them into the Grunwald’s-2 kit, without sufficient reasons why a person of ordinary skill in the art would have expected the specific NaCl/phosphate-buffer system to provide a sterilized component (A) capable of forming a gel when later mixed with component (B), see Applicant’s remarks, pg. 9, paragraph 2.
With respect to Applicant’s argument (D), the Examiner reiterates above and further notes Grunwald-1 and Grunwald-2 are both drawn to multi-component systems comprising separate compositions (A) and (B), where (A) contains sodium alginate and (B) contains a crosslinking agent to crosslink said alginate into a gels for the same purpose of removing urinary calculi and fragments thereof.
Grunwald-1 already teaches the compositions (A) and (B) are contacted to form a gel.
Moreover, Bender teaches the combination of buffer compositions, NaCl, and sodium alginate to form a gel, see Bender, pg. 10, lines 4-9; Bender exemplifies both phosphate buffers and teaches octanoic acid, e.g. a C8 fatty acid, as a physiologically acceptable buffer, see pg. 9, example 1, lines 20-25; and where the alginate-based aqueous compositions of Bender containing 0.01-0.5 M of one or more dissolved C8-C12 fatty acid salts do not suffer from instability when heat sterilized as discussed in the modified 103 rejection below.
Finally, in response to Applicant's argument that the Examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the Applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
(E) Bender identifies phosphate buffers as unsuitable systems in the context of heat-sterilized alginate-based aqueous compositions; and Bender discourages the use of phosphate buffers to maintain viscosity and pH stability in heat-sterilized alginate-based aqueous compositions, see Applicant’s remarks, pg. 9, last paragraph.
(F) The teachings of Bender discourage the use of phosphate buffer to maintain post-sterilization viscosity and pH stability in alginate compositions, see Applicant’s remarks, pg. 11, paragraph 1.
With respect to Applicant’s arguments (E)-(F), the Examiner reiterates above and particularly reiterates instant claim 16, line 3, recites “sterilized component (A), separate from component (B), comprising:”; which the Examiner notes does not exclude additional unrecited elements, see MPEP 2111.03(I), and could include the C8-C12 fatty acids for the reason Bender teaches as discussed above, which the Examiner respectfully notes was a teaching of Bender the Examiner had written in the 103 rejection in the non-final rejection mailed March 26, 2026.
Additionally, the Examiner notes the teachings of Bender were included specifically to correspond to the physiological buffer of composition (C) of Grunwald-1 which was combined with composition (A) which comprised the sodium alginate as taught by Grunwald-1 as discussed above.
Furthermore, Bender explicitly teaches their results show that the pH decrease in combination with the viscosity decrease observed after sterilization can be minimized by inclusion of a buffering agent containing a fatty acid salt, see pg. 10, lines 24-26.
(G) A formulation containing NaCl but no phosphate buffer did not form a gel after sterilization. A formulation containing phosphate buffer/PBS but no added NaCl also did not form a gel after sterilization. Only the formulation containing both NaCl and phosphate buffer formed a gel after sterilization, Applicant’s remarks, pg. 10, paragraph 1.
(H) The issue is whether the cited art would have led a person of ordinary skill to include both NaCl and phosphate buffer in the sodium-alginate component of a sterilized gel-forming multi-component kit with reasonable expectation that the sterilized component would remain capable of forming a gel when later combined with the crosslinking component.
With respect to Applicant’s argument (G)-(H), the Examiner reiterates above and further notes these arguments point out the presence of both NaCl and a phosphate buffer are critical to form an alginate gel, which the Examiner notes the combination of Grunwald-1 and Bender already teach as discussed above.
Additionally, the Examiner notes Example 3 of the specification (see pg. 23) compares composition 3, the claimed invention, which comprises both NaCl and a phosphate buffer, while compositions 1 and 2 are missing either the NaCl or the phosphate buffer.
Accordingly, the Examiner reiterates the prior art combination of Grunwald-1, Grunwald-2 and Bender already teach NaCl and a phosphate buffer as components within the alginate gel.
Furthermore, the Examiner notes composition 3 of Example 3 within the specification discloses a specific weight of sodium alginate, water, and phosphate buffer within the composition; discloses the specific phosphate buffer as phosphate-buffered saline (PBS); and discloses a specific pH of each composition; all of which as the Examiner notes is either narrower than the corresponding limitations within instant claim 16, or not claimed at all with respect to pH.
Thus, Applicant’s arguments (A)-(H) have been fully considered but are not found persuasive.
New Claim Rejections
The following is a modified rejection necessitated by Applicant's amendment, filed on June 26, 2026, where the limitations in pending claims 1-29 and 31-35 as amended now have been changed and claim 36 has been newly added.
Therefore, the rejection from the previous Office Action, dated March 26, 2026, has been modified and is listed below.
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 16-29 and 31-36 are rejected under 35 U.S.C. 103 as being unpatentable over Grunwald et al. (hereafter referred to as "Grundwald-1", Published 10 March 2016, US-20160067373-A1, PTO-892 mailed 03/26/2026) in view of Grunwald et al. (hereafter referred to as "Grunwald-2", Published 17 March 2016, US-20160074561-A1, PTO-892 mailed 03/26/2026) and Bender et al. (Published 21 March 2013, WO-2013039380-A1, PTO-892 mailed 03/23/2026).
Regarding claims 16-29 and 31-36, 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 partly or fully 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 preferred polysaccharides are from the group of alginates (e.g. sodium alginate, required in claim 16, line 4 and claim 36, line 5), 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 CaCl2, 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 and claim 36, line 7), 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, claim 17 and claim 36, line 10-11); 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; the 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 dextran 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) coming into contact with each other enables 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 endangers 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, claims 25-26, claim 27, line 2, claims 29-31 and claim 36, line 1; (b) NaCl, required in claim 16, lines 6-7 and claim 36, line 8-9; (c) the weight percentage range of either or both of sodium alginate or the crosslinking agent, required in claims 18, 32-33 and claim 36, lines 5 and 13; 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 used 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, claim 29-31 and claim 36, line 1), 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) comprise 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 25, line 4), see paragraph [0062].
Grunwald-2 teaches composition (A) and composition (B) comprised within 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 these limitations are physical limitations of adding “one or more crosslinking agents” within component (B) as required in claim 16, lines 10-11. Since both Grunwald-1 and Grunwald-2 teach multiple crosslinking agents to crosslink alginates, the physical limitations 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, lines 1 and 3, claims 25-26, claim 27, line 2, claim 29-31, and claim 36, line 1), 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. sterilized, required in claim 16, lines 1 and 4, claim 27, line 3, claims 29, line 1, and 31, line 1; and steam sterilization, required in claim 36, line 3); 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 containing 10-500 mM of one or more dissolved C8-C12 fatty acid salts, see abstract.
Bender teaches the alginate-based aqueous compositions containing 0.01-0.5 M of one or more dissolved C8-C12 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 pg. 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 including Ca2+, see pg. 6, lines 3-5. Bender teaches calcium chloride was combined with the gel (e.g. CaCl2, required in claim 36, line 13), see pg. 10, lines 7-8.
Bender teaches a phosphate buffer was used in their alginate-based aqueous compositions, see pg. 11, comparative example 1, lines 15-20.
Accordingly, 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 C8-C12 fatty acid salts, sodium chloride, and the cross-linking divalent Ca2+ cations, exemplified as calcium chloride as discussed above.
Moreover, since the combination of Grunwald-1 and Bender teach alginate-based aqueous compositions for a medical use, particularly for removing urinary calculi and/or fragments thereof as taught by Grunwald-1 wherein the composition (A) may comprise alginate, water, NaCl, and dye(s); and composition (B) may comprise cross-linking divalent Ca2+ 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 the wt.% of NaCl, the cross-linking divalent Ca2+ 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, claims 18, 23 and 32-34, and claim 36, lines 5, 8, and 13 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, 18, 23, 32-34 and 36 as discussed above.
Additionally, Bender explicitly teaches after considering the wt.% 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 Ca2+ 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, claims 18, 23 and 32-34 and claim 36, lines 5, 8 and 13 through routine experimentation and optimization to arrive at the claimed component (A) and component (B) as recited within claims 16, 18, 23, 32-34 and 36 as discussed above in order to create a kit for removing urinary calculi and/or fragments thereof as taught by Grunwald-1.
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 said combined teachings 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, claims 18, 23, 32-34 and claim 36, lines 5, 8 and 13 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, using the teachings of Bender, 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, particularly 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 as physical characteristics 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 into the compositions as taught by Grunwald-1 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 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 into 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.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARET J CREWS whose telephone number is (571)270-0962. The examiner can normally be reached Monday-Friday: 9:00am-5:30pm EST.
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/JARET J CREWS/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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