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 .
Status of Claims
Amendment filed on 05/25/2026 is acknowledged.
Claims 4, 7-9, 13-14, 16, 20, 22, 25-28, 36, 39, 41-44, 47, and 49 remain cancelled. Claims 2 and 24 are now cancelled.
Claims 37-38, 40, 45-46, 48 and 50 are withdrawn due to being drawn to nonelected group.
Claims 3, 5, 10, 15, 17, 19, 21, 23-24 and 29-34 are amended.
Claims 51-52 are new.
Claims 1, 3, 5-6, 10-12, 15, 17-19, 21, 23, 29-35 and 51-52 are pending and being examined on the merits herein.
Priority
The instant application 18564127, filed on 11/27/2023, is a PCT/IL2022050568, filed on 05/27/2022, which claims benefit of 63/193703, filed on 05/27/2021.
Withdrawn Objections/Rejections
All previous claim Objection(s) / Rejection(s) as set forth in the previous Office action (mailed 02/24/2026) that are not repeated and/or maintained in the instant Office action are withdrawn, in light of applicant’s amendment and remark filed on 05/25/2026.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 5-6, 10-12, 15, 17, 21, 23, 29-32, 34-35 and 51-52 are rejected under 35 U.S.C. 103 as being unpatentable over Guriev (US2020/0108105, Published on 04/09/2020; Filed on 12/28/2018 or earlier, IDS of 01/08/2024), as evidenced by ChemSrc (Ethyl cellulose, 07/17/2026, PTO-892).
Guriev throughout the reference teaches microcapsule for improving skin and mucus membranes condition includes a matrix material in a solid state, in which a live probiotic microorganism is encapsulated (e.g., Abstract; Claim 1).
Regarding instant claims 1, 21 and 23, Guriev teaches many live probiotic microorganisms that can be used in the microcapsule including Saccharomyces cerevisiae (e.g., [0063]) (corresponding to living microorganism in instant claims 1 and 23), and exemplifies microorganisms encapsulated in microcapsules containing a core and a shell in multiple examples (corresponding to inner core and outer shell in instant claim 1). For instance, Guriev exemplifies using cellulose ethyl ether in microcapsules with ethyl cellulose shell (as wall-forming polymeric material) in example 9 [0138], comprising Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus plantarum [example 5, 0112] in the core, using hydroxypropyl methyl cellulose as microcapsule shell (wall-forming material) for comprising Escherichia coli (example 5, [0119]) in example 10 [0145] (shell polymers corresponding to wall-forming polymeric material in instant claim 1). Guriev teaches that the microcapsule is capable to disintegrate when applied to the skin by rubbing (e.g., [0162], Table 1), indicating that the microcapsule is rupturable by a mechanical action of rubbing with a human hand corresponding to instant claim 1.
As evidenced by ChemSrc, ethyl cellulose constitutes a LogP value 6.62 (Pg. 2/8, bottom), falling within the range from 2 to 20 in instant claim 1, or from 2 to 10 in instant claim 21.
Guriev teaches in Example 9 microcapsules with an ethyl cellulose shell dissolving 2 g of cellulose ethyl ether of the Ethocel trademark (DOW) into 20 ml of 96% ethanol with stirring [0139], resulting in the wall-forming polymer concentration of 100 grams per liter in the organic solvent, which reads into at least 100 grams per liter concentration as recited in instant claim 1; as evidenced by instant specification, cellulose ethers are among the suitable wall-forming polymers (Pg. 5, Line 27) and alcohols such as ethanol, same as ethyl acetate and ethyl formate are such solvents (Pg. 22, Line 30). Because the resulted shells are used for microorganism encapsulation in Guriev, the organic solvents are anticipated to be compatible with said microorganisms (e.g., Claim 25) in prior art. Moreover, MPEP 2112.01.II states "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable, as indicated in MPEP 2112.01.II. Therefore, a cellulose ether as ethyl cellulose having the claimed LogP value, constituting the property of solubility in partial water-miscible organic solvent would necessarily present in prior art.
Moreover, in addition to ethyl cellulose Guriev exemplifies in microcapsules with ethylcellulose shell in example 9 [0138] comprising Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus plantarum [example 5, 0112] in the core, Guriev indicates that the shell material can be selected from many suitable compounds including cellulose ethers and its derivatives, such as cellulose acetate phthalate (e.g., [0050]; Claim 20), hydroxypropyl methyl cellulose as microcapsule shell for comprising Escherichia coli (example 5, [0119]) in example 10 [0145], demonstrating they are biocompatible; further, as evidenced by instant specification (e.g., Pg. 23, Lines 17-20; Pg. 24, Lines 28-29; Pg. 5, Line 27), they are suitable wall-forming polymers for current invention. MPEP 2112.01.II states "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable, as indicated in MPEP 2112.01.II. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. For this instance, the features of positive LogP value and being dissolvable at a concentration at least 100 grams per liter in a partially water-miscible organic solvent are inherent properties of the polymeric materials, which would necessarily present in prior art.
Guriev specifies that the amount of the shell material does not exceed 50% of the total weight of the microcapsule (e.g., Claim 15), or does not exceed 20% of the total weight of the microcapsule (e.g., Claims 17 and 21), overlapping with the range from 20 to 80% by weight of the total weight of the microcapsule in instant claim 1.
Regarding instant claims 3 and 5-6, Guriev teaches the microorganisms are encapsulated in microcapsules consisting of a matrix [0027], which corresponds to a shell surrounding the microorganism forming a microcapsule, and the matrix material can be selected from animal and vegetal oils and fats, plant waxes, mineral waxes, etc. (e.g., [0030]; Claim 3), corresponding to naturally occurring and/or biocompatible fatty substance, and natural wax in instant claims 3 and 5-6.
Regarding instant claim 10, Guriev specifies that microcapsules consist of a matrix, in which the encapsulated microorganisms in the microcapsules are in the range of 0.001 to 80 wt.% of the total weight of the microcapsules (e.g., [0027]), overlapping with the ranges from about 1 to 30%, or from about 5 to about 25%, or from about 10 to 20 % by weight of the total weight of the microcapsule as recited in instant claim 10.
Regarding instant claims 11-12, Guriev teaches using paraffin (as evidenced by instant specification paraffin is a plasticizer, Pg. 5, Line 16) cosmetic of the Depiflax trademark in microcapsules preparation examples 6 comprising microorganism E. coli [0119] and example 11 comprising Bifidobacterium bifidum and Bifidobacterium longum [0151], demonstrating paraffin being biocompatible with microorganisms.
Regarding instant claims 15 and 17, Guriev teaches shell material (corresponding to wall-forming polymer) selected from cellulose ethers: hydroxymethylpropylcellulose (HPMC) and its derivatives, hydroxypropylcellulose, methylcellulose, ethylcellulose, carboxymethylcellulose
(CMC), cellulose acetate phthalate (as a cellulose ester, corresponding to instant claim 17), polysaccharides and their derivatives: starch, modified starch, guar gum, pectin, amidated pectin, carrageenan, locust bean gum; protein: wheat protein, soy protein, and many others [0050], corresponding to instant claim 15 of naturally occurring biocompatible polymers.
Regarding instant claim 29, Guriev shows in Tables 2 and 3 that non-encapsulated microorganisms formulated as water-containing gel and cosmetic cream quickly lose their viability (e.g., [0169]), while microorganisms in microcapsules remain high numbers of viable microorganisms even close to a year (6.3 x 10 9 at 364 days vs. 9.5 x 109 at 0 day, viability at 6.3/9.5= about 66%) (Table 3; [0168]). Based on the data on 5 days, the viability of microorganism is 8.6/9.5=90.5%, therefore the specific viability values within 66% to 90.5% range falling within at least 60, 70, 80, or 90% of the instantly claimed ranges. MPEP 2131.03.I states that "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023). Therefore, the viability microorganism in the microcapsule is anticipated.
Regarding instant claim 30, Guriev teaches uncoated microcapsules in examples 2, 3, 4 and 6 (e.g., [0097]; [0103]; [0107]; [0119]) and other examples, corresponding to a single-layer microcapsule without further coating.
Regarding instant claims 31, Guriev exemplifies in example 10 microcapsule using 95g mixture from example 6 composition comprising 80g mixture of paraffin (as plasticizer) and sorbitan stearate at 19 : 1 ratio, and 20g living microorganism E. coli ([0119], example 6), equivalent of paraffin 95g * 76%, sorbitan stearate 95g* 4%, and 95g *20% E. coli, combined with 5 g of hydroxy propyl methyl cellulose (HPMC) as shell wall-forming natural polymer to make the microcapsules in HPMC shell ([0145-0146], example 10), resulting in living microorganism at 19%, falling within from about 1 to about 30% of microorganism amount in instant claim. Guriev exemplifies using 20% of mixture of triglycerides (as fatty substance, known in field of art, and evidenced by instant specification Pg.25, line 32) in microcapsule example 3 [0103], amount falling upon the range of about 1 to about 20% fatty substance in instant claim.
Regarding instant claim 32, Guriev teaches suitable shell materials including wall-forming polymers same as matrix materials such as cellulose ethers and derivatives including cellulose ester cellulose acetate phthalate (e.g., [0050]), many types of waxes (e.g., Claim 3), plasticizers such as paraffin (e.g., example 6 or 10, [0119], [0145]). As discussed above, in example 10, living microorganism is 19%, falling within the range from about 5 to about 25% as in instant claim 32. In example 8, synthetic wax present at 9% (as fatty substance, evidenced by instant specification, Pg. 25, Line 31) is used in the microcapsule [0132], amount falling within the range from about 5 to about 15% in instant claim 32. Guriev teaches that the shell material (as wall-forming material) desirable amount does not exceed 50% of the microcapsules (e.g., [0051]; Claim 15).
Regarding instant claims 34-35 and 51-52, Guriev teaches a composition contains the probiotic microorganism encapsulated microcapsule in a dosage of 0.01 to 80 wt.% of the total weight of the composition (e.g., Claim 28), corresponding to the composition comprising a plurality of microcapsules as instantly claimed. Guriev teaches that the probiotic organisms can be selected from a broad range of organisms (e.g., Claim 25), and the microcapsule can be an external pharmaceutical, cosmetic, cosmeceutical product for treatment of skin or mucous membrane of the subject in need thereof (e.g., Claim 26). Guriev teaches that at the time of use, when applied to the skin, the microcapsule melt under the action of body temperature, releasing live microorganisms, where the latter have a probiotic effect (e.g., [0172]), therefore, the releasing of the microorganisms result in the viability and/or bioactivity of said living organisms for the intended effect, e.g., cosmetic effect, pharmaceutical, or cosmeceutical effect.
Guriev anticipates the instantly claimed limitations with most of the amount ranges. However, Guriev does not explicitly teach the wall-forming polymeric material is dissolvable at a concentration of at least 100 grams per liter in partially water-miscible organic solvent, and does not anticipate the amount range of the wall-forming polymeric material ranging from 20 to 80% as recited in instant claim 1; or about 1 to about 30, or from about 5 to about 25, or from about 10 to about 20, % of encapsulated microorganisms in the microcapsules in instant claim 10.
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. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP §2144.05(I) states that “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). For this instance, the amount ranges overlap with those taught by prior art. Furthermore, “[i]t would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
MPEP 2145 II. states that “prima facie obviousness is not rebutted by merely recognizing additional advantages or latent properties present but not recognized in the prior art”, see In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991) (Appellant argued that the presence of DEHP as the plasticizer in a blood collection bag unexpectedly suppressed hemolysis and therefore rebutted any prima facie showing of obviousness. However, the closest prior art utilizing a DEHP plasticized blood collection bag inherently achieved same result, although this fact was unknown in the prior art.). For this instance, because prior art teaches the cellulose ethers and cellulose esters, e.g., ethyl cellulose, hydroxypropyl methyl cellulose, cellulose acetate phthalate, their LogP values and the solubility levels in partially water-miscible organic solvent as properties of the cellulose ether or ester would necessarily present in prior art even if they are not recognized in prior art, as demonstrated by ethyl cellulose having LogP value 6.62.
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Guriev (US2020/0108105, Published on 04/09/2020; Filed on 12/28/2018 or earlier; IDS of 01/08/2024), evidenced by ChemSrc (Ethyl cellulose, 07/17/2026, PTO-892), as applied to Claims 1, 3, 5-6, 10-12, 15, 17, 21, 23, 29-32, 34-35 and 51-52 above, in view of Goldstein et al. (US20170071865, 03/16/2017, IDS of 01/08/2024).
Guriev teaches microcapsule comprising a living microorganism, an inner core, and an outer shell comprising wall-forming polymeric material, e.g., cellulose acetate phthalate, ethyl cellulose (which has a LogP value at 6.62), or cellulose ethyl ether, hydroxypropyl methyl cellulose, and the microcapsule is rupturable by a mechanical action of rubbing, the wall-forming polymeric material is dissolvable at a concentration of 100 grams per liter in a partially-miscible organic solvent, and wherein the wall-forming material does not exceed 50% or 20% of the total weight of the microcapsule, as applied to claims 1, 3, 5-6, 10-12, 15, 17, 21, 23, 29-32, 34-35 and 51-52 above discussed in great detail, and incorporated herein.
Guriev does not teach the cellulose ester comprising from 1 to 10% free hydroxy groups as recited instant claim 18, or wall-forming polymer is cellulose acetate butyrate as recited in instant claim 19.
Goldstein throughout the refence teaches multi-layer microcapsules comprising a core comprising one or more active agents and two or more shells comprised of a wall-forming polymeric material (e.g., Abstract).
Goldstein teaches suitable wall-forming polymeric material of at least one of the outer shells can be cellulose ether or ester such as HPMC, ethyl cellulose, cellulose acetate butyrate, cellulose acetate phthalate, etc., preferably containing about 4-20% free hydroxyl groups (e.g., [0109]), corresponding to cellulose acetate butyrate in instant claim 19, with overlapping with free hydroxy group percentage from 1 to 10% in instant claim 18.
It would have been prima facie obvious for a person with ordinary skills in the art prior to filing date to incorporate the teaching of Goldstein and implement the specific materials into the microcapsule taught by Guriev to arrive at current invention. Because both Goldstein and Guriev teach microcapsule compositions using shell or wall-forming polymer for enveloping active ingredients, and Goldstein provides the preferable wall-forming materials with specific features, including sufficient amount of functional groups capable of forming hydrogen bonds (e.g., [0103]) of the wall-forming polymeric materials, and plasticizer in the shell to control physical properties and level of elasticity of the microcapsule’s outer shell (e.g., [0146]), that can make the microcapsule rupturable when applied (e.g., rubbed or pressed) on the skin (e.g., [0102]), as the same intended use with Guriev, selecting these specific materials would have provided reasonable expectation of success. It is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (MPEP §2144.07). See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
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. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP §2144.05(I) states that “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). For this instance, all the ingredient amounts and hydroxy group percentage overlap with those taught by prior art. Furthermore, “[i]t would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
Claims 33 is rejected under 35 U.S.C. 103 as being unpatentable over Guriev (US2020/0108105, Published on 04/09/2020; Filed on 12/28/2018 or earlier; IDS of 01/08/2024), evidenced by ChemSrc (Ethyl cellulose, 07/17/2026, PTO-892), as applied to Claims 1, 3, 5-6, 10-12, 15, 17, 21, 23, 29-32, 34-35 and 51-52 above, in view of Goldstein et al. (US20170071865, 03/16/2017, IDS of 01/08/2024), further evidenced by PubChem (tricaprylin, 02/12/2026, in record of 02/24/2026).
Guriev teaches microcapsule comprising a living microorganism, an inner core, and an outer shell comprising wall-forming polymeric material, e.g., cellulose acetate phthalate, ethyl cellulose (which has a LogP value at 6.62), or cellulose ethyl ether, hydroxypropyl methyl cellulose, and the microcapsule is rupturable by a mechanical action of rubbing, the wall-forming polymeric material is dissolvable at a concentration of 100 grams per liter in a partially-miscible organic solvent, and wherein the wall-forming material does not exceed 50% or 20% of the total weight of the microcapsule, as applied to claims 1, 3, 5-6, 10-12, 15, 17, 21, 23, 29-30, 34-35 and 51-52 above discussed in great detail, and incorporated herein.
Regarding instant claim 33, As discussed above regarding instant claims 31-32, Guriev teaches the microcapsules can contain fatty substance 9%, wall-forming polymer not exceeding 50%, and living microorganisms 19%, overlapping with amount ranges recited in instant claim 33.
Regarding soy wax, Guriev teaches suitable matrix material for microcapsule including saturated and unsaturated, partially hydrogenated or fully hydrogenated monoglycerides, diglycerides and triglycerides, plant waxes, lecithins, partially hydrogenated or completely hydrogenated phospholipids and lecithins (e.g., [0030]; Claim 3), and exemplifies soybean lecithin with hydrogenated palm oil in example 4 as the encapsulating matrix material for the microcapsule comprising Streptococcus thermophilus [0107]. “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983), and "A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments." Merck & Co. v.Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), and "Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments." In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). For this instance, for an artisan in the field, soy wax would be a natural component to implement for the probiotic microcapsules based on Guriev’s teaching of hydrogenated lecithins and soybean lecithins, as well as plant waxes.
Guriev does not teach wall-forming polymer comprises cellulose acetate butyrate, and outer shell further comprises caprylic triglyceride in instant claim 33.
Goldstein throughout the refence teaches multi-layer microcapsules comprising a core comprising one or more active agents and two or more shells comprised of a wall-forming polymeric material (e.g., Abstract).
Goldstein teaches suitable wall-forming polymeric material of at least one of the outer shells can be cellulose ether or ester such as HPMC, ethyl cellulose, cellulose acetate butyrate, cellulose acetate phthalate, etc., preferably containing about 4-20% free hydroxyl groups (e.g., [0109]), corresponding to cellulose acetate butyrate in instant claim 33. Goldstein also teaches at least one outer shell further comprising a plasticizer (e.g., [0017]), and suitable plasticizers including triethyl citrate, tricaprylin, trilaurin, tripalmitin, triacetin, paraffin oil, etc. (e.g., [0018]; [0250]). As evidenced by PubChem, tricaprylin is a synonym of caprylic triglyceride, as in instant claim 33.
It would have been prima facie obvious for a person with ordinary skills in the art prior to filing date to incorporate the teaching of Goldstein and implement the specific materials into the microcapsule taught by Guriev to arrive at current invention. Because both Goldstein and Guriev teach microcapsule compositions using shell or wall-forming polymer for enveloping active ingredients, and Goldstein provides the preferable wall-forming materials with specific features, including sufficient amount of functional groups capable of forming hydrogen bonds (e.g., [0103]) of the wall-forming polymeric materials, and plasticizer in the shell to control physical properties and level of elasticity of the microcapsule’s outer shell (e.g., [0146]), that can make the microcapsule rupturable when applied (e.g., rubbed or pressed) on the skin (e.g., [0102]), as the same intended use with Guriev, selecting these specific materials would have provided reasonable expectation of success. It is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (MPEP §2144.07). See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
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. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP §2144.05(I) states that “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). For this instance, all the ingredient amounts overlap with those taught by prior art. Furthermore, “[i]t would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
Response to Arguments
Applicant’s remarks/arguments filed on 05/25/2026 have been fully considered.
The art rejections have been updated in correspondence to claim amendments as presented in this office action above.
Applicant asserts that Guriev is a lipid/wax matrix-based microcapsule, and the optional secondary coatings applied by fluidized bed spray coating onto pre-formed lipid matrix capsules are not the primary wall-forming material encapsulating the microorganism; the primary release mechanism is thermal melting upon skin contact, not mechanical fracture of a rigid polymeric shell.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., it is the wall-forming material as the primary coating that encapsulates the microorganism; or the release mechanism is primarily by mechanical fracture of a rigid polymeric shell) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Moreover, current claims do not exclude the coating and release mechanisms as taught by prior art.
Guriev explicitly teaches encapsulating the microorganisms in a microcapsule with an inner core enveloped by outer shell formed by wall-forming polymeric material, even if the wall-forming material encapsulating the microorganism is a secondary coating; Guriev also explicitly teaches the microcapsule is rupturable by rubbing, which is mechanical action as instantly claimed, even if the primary release mechanism is thermal melting upon skin contact (the most relevant paragraph copied from office action for reference):
Regarding instant claims 1, 21 and 23, Guriev teaches many live probiotic microorganisms that can be used in the microcapsule including Saccharomyces cerevisiae (e.g., [0063]) (corresponding to living microorganism in instant claims 1 and 23), and exemplifies microorganisms encapsulated in microcapsules containing a core and a shell in multiple examples (corresponding to inner core and outer shell in instant claim 1). For instance, Guriev exemplifies using cellulose ethyl ether in microcapsules with ethyl cellulose shell (as wall-forming polymeric material) in example 9 [0138], comprising Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus plantarum [example 5, 0112] in the core, using hydroxypropyl methyl cellulose as microcapsule shell (wall-forming material) for comprising Escherichia coli (example 5, [0119]) in example 10 [0145] (shell polymers corresponding to wall-forming polymeric material in instant claim 1). Guriev teaches that the microcapsule is capable to disintegrate when applied to the skin by rubbing (e.g., [0162], Table 1), indicating that the microcapsule is rupturable by a mechanical action of rubbing with a human hand corresponding to instant claim 1.
“The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983), and "A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments." Merck & Co. v.Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), and "Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments." In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). Guriev working examples without rubbing does not constitute a teaching away from what Guriev already explicitly teaches as rubbing can be applied for releasing the microorganism from the microcapsules.
Applicant asserts that inherent properties including LogP cannot be relied upon a genus when genus demonstrably do not possess the allegedly inherent properties and the majority of Guriev’s polymers do not have LogP 2-20. Applicant deduces that Guriev’s list of high-melting polymeric materials [0050] would not be thermally compatible with the shell melting point requirement [0044]; due to this restriction, Guriev directs the amount of such material for every LogP 2-20 polymers should not exceed 20% of the total microcapsule weight.
Applicant’s point regarding inherent property of LogP cannot be relied upon a genus is taken into consideration, and the rejection is specifically based upon a species ethyl cellulose as presented in the office action. Regarding Guriev’s list of polymers, arguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). There is no working example or evidence present in Guriev that these polymers would not be thermally compatible, and they have to be used at the amount as applicant concluded. Furthermore, this is moot because office action already addressed the LogP value in the new ground of art rejections.
Applicant asserts that Guriev teaches away from the claimed invention at each of the independently dispositive steps as such: (1) identifies polymeric shells as the problem to be solved, not the solution; (2) teaches that the preferred shell materials are the same lipid/wax materials as the matrix; (3) requires that shell materials melt or soften at certain temperature, which excludes all LogP2-20 polymers, (4) caps no -melting shell materials at 20% by weight.
Arguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). There is no example or evidence present in Guriev that applicant’s deductions are proper and accurate. As presented in the office action, Guriev as evidenced by ChemSrc teaches explicitly a specific polymer LogP and Guriev also explicitly teaches the shell materials amount can be not exceeding 50% of the total weight of the microcapsules in addition to not exceeding 20% as the other amount range, therefore, the argument is moot.
Applicant asserts that Goldstein does not teach and does not relate to the encapsulation of living microorganisms, nor does it provide any motivation to combine its teachings with Guriev’s matrix-based microorganism encapsulation system in the manner claimed.
One cannot show nonobviousness by attacking references individually where the rejections are
based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck
& Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Because "[T]he test for obviousness is what
the combined teachings of the references would have suggested to [a PHOSITA]." In re Mouttet, 686
F.3d 1322, 1333, 103 USPQ2d 1219, 1226 (Fed. Cir. 2012). For this instance, Goldstein is combined with Guriev as obviousness type of rejection, and Goldstein does not have to teach every element of the instant claims. Because Guriev already teaches microcapsules encapsulating microorganisms, Goldstein is combined with Guriev to teach some specific shell materials, as presented in the office action in detail.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In summary, prior art teaches the current invention. Please refer to the entire office action as the complete response to the remarks/arguments.
Conclusion
No claim is allowed.
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.
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/DX.Z./Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
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