CTFR 18/251,414 CTFR 100571 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Applicants’ arguments, filed 04/27/2026, have been fully considered. Rejections and/or objections not reiterated from previous office action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Claim Rejections - 35 USC § 103--Previous 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA 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. 07-20-02-aia AIA 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. 1) Claims 4-6 and 17-18 remain rejected under 35 U.S.C. 103 as being unpatentable over Colonna et al. (FR 3016291 A1, publication date 07/17/2015; citing machine English translation) in view of Martin et al. (WO 2008/138839 A2, publication date 11/20/2008). Colonna discloses a “composition comprising: (i) one or more monosaccharides, and (ii) one or more extracts of one or more non-photosynthetic filamentous non-fruiting bacteria” [p. 20, claim 1]. Wherein “said non-photosynthetic non-photosynthetic filamentous bacterial extract is an extract of Vitreoscilla filiformis ” [p. 20, claim 5]. Colonna also discloses that “[t]he composition of the invention may also advantageously contain a thermal and / or mineral water , in particular chosen from Vittel water, the waters of the Vichy basin and Roche Posay water” ( i.e., Vichy thermal water ) [p. 9, lines 1-3]. With respect to the V. filiformis extract, Colonna discloses that “[i]t is also possible to use in another embodiment the culture described in the patent application WO 2008/138839 . By non-photosynthetic and non-fruiting filamentous bacteria extract, it is intended both the culture supernatant, the biomass obtained after culturing the said bacteria , the envelopes or fractions of envelopes, or the extracts of the biomass obtained by treatment of this biomass” [p. 7, para. 1, lines 16-20]. Finally, Colonna discloses “solvents that can be used in the invention, mention may be made of lower alcohols, in particular ethanol and isopropanol, and propylene glycol ” ( i.e., physiological acceptable medium ) [p. 8, last 3 lines]. The extract disclosed by Colonna at p. 7, para. 1, lines 16-20 (see above) reads on the definition of an extract given by the instant specification, i.e., comprising the supernatant and biomass ( see instant specification at paragraph 76). Colonna does not disclose an extract of Vitreoscilla filiformis cultured on a medium comprising at least Vichy thermal water. Martin ( i.e., WO patent referenced by Colonna) “relates to a process for the preparation of a cosmetic or dermatological active principle” [abstract]. The process comprises “culturing of at least one nonphotosynthetic and nonfruiting filamentous bacterium on a medium comprising at least one nonsulphurous mineral and/or thermal water” [p. 23, claim 1]. Wherein the bacterium is Vitreoscilla filiformis [p. 23, claim 3] and the thermal water is “chosen from water from Vittel, waters from the Vichy basin , … ” [p. 24, claim 9]. First, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the culture method of Martin with the composition taught by Colonna, because Colonna desires extracts according to the methods disclosed by Martin. One would have had an expectation of success because, according to Colonna, the methods of Martin are suitable for the compositions discloses by Colonna. See MPEP 2143, Exemplary Rationale A. Second, it is generally a prima facie obvious to select a known material based on its suitability for its intended use. See MPEP 2144.07 In the present case it would have been obvious to one of ordinary skill in the art, at the time of filling, to have selected Vichy thermal water for the thermal water desired by Colonna and for the culture medium of Martin because Colonna and Martin (respectively) disclose Vichy thermal water is suitable for those purposes. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated a composition comprising Vichy thermal water and V. filiformis cultured on a medium comprising at least Vichy thermal water in a physiologically acceptable medium (ethanol and isopropanol, and propylene glycol). Regarding instant claim 5, 6, and 17 Colonna also discloses the composition “comprises from 10 to 90% by weight of water , preferably from 30 to 80% by weight of water, particularly from 40 to 60% by weight” such as thermal waters [p. 20, claims 7-8]. Colonna also discloses the extract ( i.e., V. filiformis) may be present in an amount from 0.001 to 10% by weight expressed as the dry weight [p. 20, claim 6]. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). In the present case, the instantly claimed ranges for thermal water (0.1-95% w/w and 10-90% w/w; instant claims 5, and 17 ) and extract (0.001%-20% and 0.01-10% weight of dry matter; instant claims 6, and 18 ) overlap with the ranges of the prior art (10-90% w/w and 0.001-10% by weight of dry matter). Accordingly, a prima facie case of obviousness exists for both ranges. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated a composition comprising Vichy thermal water and V. filiformis cultured on a medium comprising at least Vichy thermal water in a physiologically acceptable medium (ethanol and isopropanol, and propylene glycol). Wherein the amount of Vichy thermal water and V. filiformis extract are present within the ranges of instant claims 5, 6, 17 and 18. 2) Claims 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Colonna et al. (FR 3016291 A1, publication date 07/17/2015; citing machine English translation) in view of Martin et al. (WO 2008/138839 A2, publication date 11/20/2008) as applied to claims 4-6 and 17-18 above, and further in view of Breton et al. (FR 2746642 A1, date of patent 10/03/1997; citing machine English translation). Colonna and Martin, which are taught above, differ from the instant claims insofar as the instantly claimed ranges are outside the preferred ranges of the prior art. Colonna also discloses the composition “comprises from 10 to 90% by weight of water, preferably from 30 to 80% by weight of water, particularly from 40 to 60% by weight” such as thermal waters [p. 20, claims 7-8]. Colonna also discloses the extract (i.e., V. filiformis) may be present in an amount from 0.001 to 10% by weight expressed as the dry weight [p. 20, claim 6]. Colonna desires anti-inflammatory action [p. 8, para. 2]. Breton “a cosmetic or pharmaceutical composition comprising an extract of at least one non-photosynthetic filamentous bacterium and a compound which reduces the synthesis, the release and / or the activity of at least one inflammation mediator” [abstract]. According to Breton compound which decreases the synthesis, release and / or activity of at least one inflammation mediator is a substance P agonist [p. 7, para. 4] such as thermal waters [p. 7, para. 7]. To that end, Breton discloses a composition comprises 10% Vichy thermal water and 0.5% V. filiformis extracts ( see Composition 2 on page 20 and Example 1 at the 5 th paragraph of page 19). It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the amounts of Vichy thermal water of Breton with the composition taught by Colonna and Martin for the anti-inflammatory affect disclosed by Breton and desired by Colonna . One would have had an expectation of success because Breton discloses these are suitable ranges for a cosmetic and pharmaceutical composition. One would have also had an expectation of success because even though the amount of thermal water resides outside the preferred range of Colonna , 10% Vichy thermal water nevertheless remains inside the broadest range recited by Colonna , i.e., 10-90% w/w. See MPEP 2143, Exemplary Rationale A. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). In the present case, the instantly claimed ranges for thermal water (0.1-30 % w/w and 1-25% w/w; instant claims 20 and 21 ) and extract (0.01-0.1% and 0.1-0.5% by weight of dry matter; instant claims 22 and 23 ) overlap with the ranges of the prior art (10 w/w and 0.001-10% by weight of dry matter). Accordingly, a prima facie case of obviousness exists for both ranges. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated a composition comprising Vichy thermal water and V. filiformis cultured on a medium comprising at least Vichy thermal water in a physiologically acceptable medium (ethanol and isopropanol, and propylene glycol). Wherein the amount of Vichy thermal water and V. filiformis extract are present within the ranges of instant claims 20-23. Double Patenting 08-33 AIA The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. 1) Claims 4-6, 17-18 and 20-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 9,770,474 B2 in view of Colonna et al. (FR 3016291 A1, publication date 07/17/2015; citing machine English translation). The claims of ‘474 disclose “a method comprising administering an effective amount of an extract of Vitreoscilla filiformis … wherein the Vitreoscilla filiformis is cultured in a medium which comprises at least on non-sulfurous mineral or thermal water” [col. 18, claim 1]. The claims also disclose the thermal water may be from the Vichy basin [col. 18, claim 5] and the extract may be present in compositions in amounts from 0.001 to 20% w/w [col. 18, claim 7]. The claims of ‘474 does not disclose Vichy thermal water other than the Vichy thermal water used in the culture medium. Colonna discloses a “composition comprising: (i) one or more monosaccharides, and (ii) one or more extracts of one or more non-photosynthetic filamentous non-fruiting bacteria” [p. 20, claim 1]. Wherein “said non-photosynthetic non-photosynthetic filamentous bacterial extract is an extract of Vitreoscilla filiformis ” [p. 20, claim 5]. Colonna also discloses that “[t]he composition of the invention may also advantageously contain a thermal and / or mineral water , in particular chosen from Vittel water, the waters of the Vichy basin and Roche Posay water” [p. 9, lines 1-3]. According to Colonna and appropriate amount of thermal water in composition is from 10 to 90% by weight [p. 20, claims 7-8]. It would have been obvious to one of ordinary skill in the art, at the time of filling, to have combined the teachings of 10-90% Vichy thermal water with the composition taught by the claims of ‘474. One would have been motivated to make this combination because Colonna discloses it is advantageous to have thermal water in these amounts in a compositions comprising Vitreoscilla filiformis extracts. One would have had an expectation of success because the compositions are so similar and used in the same context ( i.e., topical cosmetics). Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). In the present case, the instantly claimed ranges for thermal water (0.1-95% w/w, 10-90% w/w, 0.1-30 % w/w and 1-25% w/w; instant claims 5, 17, 20 and 21 ) and extract (0.001%-20%, 0.01-10%, 0.01-0.1% and 0.1-0.5% by weight of dry matter; instant claims 6, 18, 22 and 23 ) overlap with the ranges of the prior art (10-90% and 0.001-20% by weight). Accordingly, a prima facie case of obviousness exists for both ranges. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated a composition comprising an associated of Vichy thermal water and V. filiformis cultured on a medium comprising at least Vichy thermal water in a physiologically acceptable medium (water). Wherein the weight ratio of extract to Vichy thermal water is within the instantly claimed range. 2) Claims 4-6, 17-18 and 20-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,046,014 B2 in view of Hilaire et al. (US 10,046,014 B2, date of patent 08/14/2018) and Martin et al. (WO 2008/138839 A2, publication date 11/20/2008). The claims of ‘014 teach a composition comprising “one lysate of a bacterium, said lysate consisting of a lysate of a bacterium belonging to the genus of Vitreoscilla , and being administered with all or parts, in terms of amount, of a complete fermentation medium” ( i.e., an extract with the supernatant) [col. 23, claim 23], “wherein the genus of Vitreoscilla is Vitreoscilla filiformis ” [col. 24, claim 6]. The claims of ‘014 do not disclose an amount of extract and Vichy thermal water. Hilaire “relates to the cosmetic use of a lysate of a bacterium or bacteria belonging to the Vitreoscilla sp. genus (in particular the species: Vitreoscilla filiformis) in a complete fermentation medium” [abstract]. Hilaire discloses a “composition according to the invention advantageously comprises an amount of lysate of a bacterium or bacteria belonging to the Vitreoscilla sp. genus in a complete fermentation medium ranging from 0.001% to 10% by weight, relative to the total weight of dry extract of said composition ” [col. 12, lines 35-40]. Hilaire also discloses that “[t]that composition of the invention may also advantageously contain a spring and/or mineral water, chosen in particular from Vittel water, waters from the Vichy Basin, and la Roche Posay water” [col. 14, lines 9-12]. Hilaire does not disclose culturing the bacterium in a medium comprising Vichy thermal water. Martin “relates to a process for the preparation of a cosmetic or dermatological active principle” [abstract]. The process comprises “culturing of at least one nonphotosynthetic and nonfruiting filamentous bacterium on a medium comprising at least one nonsulphurous mineral and/or thermal water” [p. 23, claim 1]. Wherein the bacterium is Vitreoscilla filiformis [p. 23, claim 3] and the thermal water is “chosen from water from Vittel, waters from the Vichy basin , … ” [p. 24, claim 9]. Marin also discloses that “[u]nexpectedly, it has been found, in the context of the invention, that the incorporation of thermal and/or mineral water in the culture medium in a relatively small proportion can confer, on the microorganism, advantageous properties distinct from those of a microorganism cultured on a medium in which the water incorporated is exclusively distilled and/or osmotically treated water” [p. 7, lines 29-36]. It would have been obvious to one of ordinary skill in the art, at the time of filling, to have used the methods of Marin to improve the composition taught by the claims of ‘014. One would have been motivated to do so because Martin discloses the method of including thermal water in the culture medium results in advantageous properties which are distinct from a culture medium of distilled water. One would have had an expectation of success because Martin discloses method for preparing a dermatological active principle, as desired by the claims of ‘014. See MPEP 2143, Exemplary Rationale C. Additionally, "where 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" (see MPEP 2144.05 IIA quoting In re Aller, 220 F.2d 454, 456 (105 USPQ 233)). In the present case it would have been obvious to optimize the amount of Vichy thermal water during routine experimentation. 3) Claims 4-6, 17-18 and 20-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 9,393,266 B2 in view of Martin et al. (WO 2008/138839 A2, publication date 11/20/2008) and Colonna et al. (FR 3016291 A1, publication date 07/17/2015; citing machine English translation). The claims of ‘266 teach a composition comprising 0.001% to 20% by weight go an extract, wherein the extract comprising culture medium and Vitreoscilla filiformis and wherein the culture medium comprises a water with carbonates, silicon oxide, calcium ions and sulfate [col. 20, line 54 to col. 21, lines 10; claim 1]. The claims of ‘266 do not explicitly disclose Vichy thermal water and they do not disclose a composition further comprising Vichy thermal water. Martin discloses Vichy thermal water is an appropriate water with these desired compounds ( see pages 3-4). Colonna discloses a “composition comprising: (i) one or more monosaccharides, and (ii) one or more extracts of one or more non-photosynthetic filamentous non-fruiting bacteria” [p. 20, claim 1]. Wherein “said non-photosynthetic non-photosynthetic filamentous bacterial extract is an extract of Vitreoscilla filiformis ” [p. 20, claim 5]. Colonna also discloses that “[t]he composition of the invention may also advantageously contain a thermal and / or mineral water , in particular chosen from Vittel water, the waters of the Vichy basin and Roche Posay water” [p. 9, lines 1-3]. According to Colonna and appropriate amount of thermal water in composition is from 10 to 90% by weight [p. 20, claims 7-8]. Generally, it is prima facie obvious to select a known material based on its suitability for its intended use. See MPEP 2144.07. In the present case it would have been obvious to one of ordinary skill in the art, at the time of filling, to have selected Vichy thermal water for the composition of ‘266 because Martin discloses it is a suitable water for the purpose intended by the claims. It would have been obvious to one of ordinary skill in the art, at the time of filling, to have combined the teachings of 10-90% Vichy thermal water with the composition taught by the claims of ‘266. One would have been motivated to make this combination because Colonna discloses it is advantageous to have thermal water in these amounts in a compositions comprising Vitreoscilla filiformis extracts. One would have had an expectation of success because the compositions are so similar and used in the same context ( i.e., topical cosmetics). Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A. In the present case, the instantly claimed ranges for thermal water (0.1-95% w/w, 10-90% w/w, 0.1-30 % w/w and 1-25% w/w; instant claims 5, 17, 20 and 21 ) and extract (0.001%-20%, 0.01-10%, 0.01-0.1% and 0.1-0.5% by weight of dry matter; instant claims 6, 18, 22 and 23 ) overlap with the ranges of the prior art (10-90% and 0.001-20% by weight). Accordingly, a prima facie case of obviousness exists for both ranges. 4) Claims 4-6 and 16-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 9,125,934 B2 in view of Martin et al. (WO 2008/138839 A2, publication date 11/20/2008) and Colonna et al. (FR 3016291 A1, publication date 07/17/2015; citing machine English translation). The claims of ‘934 teach a composition comprising 0.001% to 20% by weight go an extract, wherein the extract comprising culture medium and Vitreoscilla filiformis and wherein the culture medium comprises a water with carbonates, silicon oxide, calcium ions and sulfate [col. 14, line 54 to col. 15, lines 14; claim 1]. The claims of ‘934 do not explicitly disclose Vichy thermal water and they do not disclose a composition further comprising Vichy thermal water. Martin discloses Vichy thermal water is an appropriate water with these desired compounds ( see pages 3-4). Colonna discloses a “composition comprising: (i) one or more monosaccharides, and (ii) one or more extracts of one or more non-photosynthetic filamentous non-fruiting bacteria” [p. 20, claim 1]. Wherein “said non-photosynthetic non-photosynthetic filamentous bacterial extract is an extract of Vitreoscilla filiformis ” [p. 20, claim 5]. Colonna also discloses that “[t]he composition of the invention may also advantageously contain a thermal and / or mineral water , in particular chosen from Vittel water, the waters of the Vichy basin and Roche Posay water” [p. 9, lines 1-3]. According to Colonna and appropriate amount of thermal water in composition is from 10 to 90% by weight [p. 20, claims 7-8]. Generally, it is prima facie obvious to select a known material based on its suitability for its intended use. See MPEP 2144.07. In the present case it would have been obvious to one of ordinary skill in the art, at the time of filling, to have selected Vichy thermal water for the composition of ‘934 because Martin discloses it is a suitable water for the purpose intended by the claims. It would have been obvious to one of ordinary skill in the art, at the time of filling, to have combined the teachings of 10-90% Vichy thermal water with the composition taught by the claims of ‘934. One would have been motivated to make this combination because Colonna discloses it is advantageous to have thermal water in these amounts in a compositions comprising Vitreoscilla filiformis extracts. One would have had an expectation of success because the compositions are so similar and used in the same context ( i.e., topical cosmetics). Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). In the present case, the instantly claimed ranges for thermal water (0.1-95% w/w, 10-90% w/w, 0.1-30 % w/w and 1-25% w/w; instant claims 5, 17, 20 and 21 ) and extract (0.001%-20%, 0.01-10%, 0.01-0.1% and 0.1-0.5% by weight of dry matter; instant claims 6, 18, 22 and 23 ) overlap with the ranges of the prior art (10-90% and 0.001-20% by weight). Accordingly, a prima facie case of obviousness exists for both ranges. Response to Arguments 1) On pages 5 and 6 of their Remarks , Applicant alleges synergistic results associated with the combination of Vichy thermal water and the bacterial extract as recited in the pending claims. According to applicant “The results in Example 2 show that when smaller amounts of Vichy water and bacterial extract are combined, a pronounced and synergistic effect on polynuclear neutrophil (PMN) stimulation occurs” [p. 5]. Additionally, Applicant asserts the data supports that the alleged “synergism exists at different levels” of Vichy thermal water and extract. This argument is not persuasive. Overcoming a rejection based on unexpected results requires the combination of three different elements: (i) the results must fairly compare with the prior art, (ii) the results must truly be unexpected and (iii) the claims must be commensurate in scope. MPEP §716.02. The burden rests with Applicant to establish results are unexpected and significant. MPEP §716.02(b). Applicant's showing of allegedly unexpected results does not satisfy any of these requirements. (i) In the present case Applicant has not compared the allegedly unexpected result to the closes prior art. In the present case, the closest prior art is Composition 2 of Breton . Composition 2 of Breton comprises 10% Vichy thermal water and 0.5% V. filiformis extracts “cultured according to the process described in Patent Application WO-A-94/02158” ( see Composition 2 on page 20 and Example 1 at the 5 th paragraph of page 19). The reference cited by Breton , Aubert et al. (WO 1994002158 A1, publication date 02/03/1994; citing machine English translation), discloses culturing non-photosynthetic and non-fruiting filamentous bacteria in a medium comprising Heller microelements ( see second half of page 4 and page 5). (ii) Evidence of a greater than expected result may also be shown by demonstrating an effect which is greater than the sum of each of the effects taken separately (i.e., demonstrating " synergism "). Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). However, a greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected . Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. Ex parte The NutraSweet Co., 19 USPQ2d 1586 (Bd. Pat. App. & Inter. 1991) (Evidence showing greater than additive sweetness resulting from the claimed mixture of saccharin and L-aspartyl-L-phenylalanine was not sufficient to outweigh the evidence of obviousness because the teachings of the prior art lead to a general expectation of greater than additive sweetening effects when using mixtures of synthetic sweeteners.) (see MPEP 716.02(a).I.). The results demonstrated in the instant application do not appear to be unobvious over the prior art. For example, Aubert discloses “non-photosynthetic and non-fruiting filamentous bacteria, exhibit particularly interesting immunomodulatory properties. In particular, they stimulate non-specific immune defenses , including cellular immunity” [p. 3, middle of last paragraph]. Wilgus et al. (Adv Wound Care, 2013 Sep;2(7):379-388) discloses “[n]eutrophils are one of the most abundant cells of the immune system and they are extremely active during the repair of cutaneous wounds” [abstract]. Additionally, Martin discloses that incorporating thermal water “in the culture medium in a relatively small proportion can confer, on the microorganism, advantageous properties distinct from those of a microorganism cultured on a medium in which the water incorporated is exclusively distilled and/or osmotically treated water” [p. 7, lines 29-26]. Martin also relates to V. filiformis “extracts or the compositions being of use in improving the condition of the skin and/or superficial body growths” [p. 11, lines 15-20]. Finally, Breton discloses a composition comprising Vichy thermal water and V. filiformis extracts ( see Composition 2 on page 20 and Example 1 at the 5 th paragraph of page 19). Accordingly, the prior art expressly discloses the combination of Vichy thermal water and V. filiformis extracts. Additionally, the prior art teaches that culturing V. filiformis in thermal water imparts advantageous properties which are suitable for improving the condition of the skin and that bacteria such as V. filiformis stimulate immune defense. Therefore, a skilled artisan would have expected V. filiformis extracts cultured with thermal water to improve the properties of the prior art composition comprising the combination of Vichy thermal water and V. filiformis extract ( i.e., V. filiformis cultured with Heller microelements). As such, the evidence submitted by applicant should demonstrate that extracts of V. filiformis cultured in at least one thermal water provide synergy beyond what would have been demonstrated by the composition of the prior art, which comprises Vichy thermal water and V. filiformis extracts cultured with Heller microelements. That is to say, the difference lies in the culturing method of the V. filiformis, not the combination of thermal water and V. filiformis. In the present case, Applicant has not demonstrated synergy beyond what would have been expected by the prior art, and so the Examiner cannot determine if the results are truly unexpected. Furthermore, the evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles , 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (MPEP 716.02(b)). In the present case, it does not appear that the evidence supports synergy when the composition comprises 0.3% extracts and 50% Vichy thermal water. Such a combination provides 154 +/- 5 % of the control which is statistically consistent with a simple additive effect of the extract alone and the Vichy thermal water alone. Specifically, 0.3% extract alone for a 24% improvement over the control and 50% Vichy thermal water alone for a 27% improvement over the control would have had an additive effect of 54% improvement over the control ( i.e., 151% control). Therefore, the expected additive effect falls within one standard deviation of the alleged synergistic results. See pages 19-20, Table 1. (iii) The "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support" (see MPEP 716.02(d) quoting In re Clemens , 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)). The claims are not commensurate in scope because the evidence does not support synergy across all amounts of V. filiformis extract and Vichy thermal water. 2) On pages 6-7 of their Remarks, Applicant argues the double patenting rejections should be withdrawn for the reasons above. This argument is not persuasive for the reasons above and of record. Conclusion 07-39 AIA THIS ACTION IS MADE FINAL. 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 COLMAN WELLES whose telephone number is (571)272-3843. The examiner can normally be reached Monday - Friday, 8:30am - 5:00pm ET. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at (571)272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /C.T.W./Examiner, Art Unit 1612 /WALTER E WEBB/Primary Examiner, Art Unit 1612 Application/Control Number: 18/251,414 Page 2 Art Unit: 1612 Application/Control Number: 18/251,414 Page 3 Art Unit: 1612 Application/Control Number: 18/251,414 Page 4 Art Unit: 1612 Application/Control Number: 18/251,414 Page 5 Art Unit: 1612 Application/Control Number: 18/251,414 Page 6 Art Unit: 1612 Application/Control Number: 18/251,414 Page 7 Art Unit: 1612 Application/Control Number: 18/251,414 Page 8 Art Unit: 1612 Application/Control Number: 18/251,414 Page 9 Art Unit: 1612 Application/Control Number: 18/251,414 Page 10 Art Unit: 1612 Application/Control Number: 18/251,414 Page 11 Art Unit: 1612 Application/Control Number: 18/251,414 Page 12 Art Unit: 1612 Application/Control Number: 18/251,414 Page 13 Art Unit: 1612 Application/Control Number: 18/251,414 Page 14 Art Unit: 1612 Application/Control Number: 18/251,414 Page 15 Art Unit: 1612 Application/Control Number: 18/251,414 Page 16 Art Unit: 1612 Application/Control Number: 18/251,414 Page 17 Art Unit: 1612 Application/Control Number: 18/251,414 Page 18 Art Unit: 1612 Application/Control Number: 18/251,414 Page 19 Art Unit: 1612 Application/Control Number: 18/251,414 Page 20 Art Unit: 1612 Application/Control Number: 18/251,414 Page 21 Art Unit: 1612 Application/Control Number: 18/251,414 Page 22 Art Unit: 1612 Application/Control Number: 18/251,414 Page 23 Art Unit: 1612 Application/Control Number: 18/251,414 Page 24 Art Unit: 1612 Application/Control Number: 18/251,414 Page 25 Art Unit: 1612
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