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 .
Election/Restrictions
Applicant's election of Group I, Claims 1-3, 5-6, 10-12, 15, 17-19, 21, 23-24 and 29-35, in the reply filed on 01/05/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 37-38, 40, 45-46, 48 and 50 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/05/2026.
Status of Claims
Preliminary amendment filed on 11/27/2023 is acknowledged.
Claims 4, 7-9, 13-14, 16, 20, 22, 25-28, 36, 39, 41-44, 47, and 49 are 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Claims 37-38, 40, 45-46, 48 and 50 are withdrawn due to being drawn to nonelected group.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 1-3, 5-6, 10-12, 15, 17-19, 21, 23-24 and 29-35 are pending and being examined herein on the merits.
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.
Information Disclosure Statement
The information disclosure statement (IDS), filed on 01/01/2025, 01/08/2024, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the Examiner.
Claim Interpretation
Claims 1, 2, 21, 24 and 29 are interpreted as following.
Claim 1 is interpreted as a microcapsule comprising a living microorganism, an inner core, and an outer shell comprising wall-forming polymeric material.
The phrases of “the microcapsule being characterized by: a) said wall-forming polymeric material having a positive LogP value; and/or b) the microcapsule is rupturable by a mechanical action of rubbing or pressing with human hand; and/or c) said wall-forming polymeric material being dissolvable at a concentration of at least 100 grams per liter in a partially water-miscible organic solvent that is compatible with said microorganism” are interpreted as microcapsule characters or features that the microcapsule has either one of the features, or a combination thereof. Among the features, a) and c) are interpreted as wall-forming polymeric material’s properties.
Claim 2 is interpreted as the microcapsule property or “intended use” of the microcapsule, because the characters described in claim 1 a)-c) do not contribute to the structural limitations of microcapsule composition.
Claim 21 is interpreted as the property of wall-forming polymeric material in the microcapsule of claim 1. The said wall-forming polymeric material has a logP value in a range of from 2 to 20, or from 2 to 10; and/or is dissolvable in ethyl acetate at a concentration of from 100 grams to 1,000 grams per liter, or from 100 grams to 800 grams per liter. In other words, the wall-forming polymeric material can be limited either by a logP value, or by the solubility in ethyl acetate, or by both logP value and solubility in ethyl acetate.
Claim 24 is interpreted as “intended use” of the probiotic microorganism in microcapsule of claim 23.
Claim 29 is interpreted as the viability and/or activity of living microorganism in the microcapsule is at least 50, or at least 60, or at least 70, or at least 80, or at least 90, %, relative to viability of the original living microorganism prior to be encapsulated, or to viability of encapsulated microorganism at day 0.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 24 is rejected under 35 U.S.C. 101 because the claimed invention is not supported by either a specific and substantial asserted utility or a well-established utility.
Claim 24 recites “said probiotic microorganism is beneficial for use in a pharmaceutical product, …”. It is a “use” claim that directs the claimed invention to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter of useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 21, 24 and 29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 21 recites “or from 2 to 10 and/or …”. It is unclear whether the feature led by “and/or” is only defining the polymeric material having a log P value from 2 to 10, or it is supposed to be defining for polymeric material in either log P value range. If it is the latter, there is a missing “;” in front of “and/or”. The current language is unclear of the claim scope.
Claim 24 recites ““said probiotic microorganism is beneficial for use in a pharmaceutical product, …”. It is a “use” claim that to the extent drawn to a method, the claim is unclear because it does not recite any active or positive steps. Attempts to claim a method or process for “beneficial for use” without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b). Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).
Claim 29 recites “a viability and/or activity …, relative to a free, non-encapsulated form of said living microorganism when tested under the same experimental conditions”. The term “free” and “the same … conditions” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear at what degree or under what condition of the microorganism is meant to be “free” (e.g., in wild natural environment, or laboratory culture), and under what conditions are considered “same experimental conditions”, especially when the encapsulated vs. non-encapsulated microorganisms already are under different experimental conditions.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 24 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 24 recites “the microcapsule of claim 23, wherein said probiotic microorganism is beneficial for use in …”. Because the claim scope does not contribute further structural limitation of claim 23 or claim 1, upon which claim 24 directly or indirectly depending, claim 24 fails to further limit the subject matter.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 5-6, 11-12, 15, 17, 23-24, 29-30 and 34-35 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Guriev (US2020/0108105, Published on 04/09/2020; Filed on 12/28/2018 or earlier, IDS of 01/08/2024).
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 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 ethylcellulose 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 feature (b) of microcapsule in instant claim 1.
Regarding instant claims 2 and 21, 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, as discussed above, corresponding to instant claim 2 (b). Guriev indicates that the shell material is selected from many suitable compounds including cellulose ethers and its derivatives, such as cellulose acetate phthalate (e.g., [0050]; Claim 20), and Guriev exemplifies using cellulose ethyl ether in microcapsules with ethylcellulose shell in example 9 [0138] comprising Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus plantarum [example 5, 0112] in the core, using hydroxypropyl methyl cellulose as microcapsule shell for comprising Escherichia coli (example 5, [0119]) in example 10 [0145], demonstrating they are biocompatible. 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 compounds of cellulose acetate phthalate, cellulose ether, and hydroxypropyl methyl cellulose, 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, therefore, 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 as inherent properties of the polymeric materials as in recited in instant claim 2(a) and (c) are taught by prior art, or log P value and solubility properties of the wall-forming materials as recited in instant claim 21.
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 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 24, Guriev indicates that use of microcapsules containing probiotic microorganisms makes possible to obtain stable product for external use with satisfactory organoleptic properties, which allows to use microorganisms as an active component in the composition of external pharmaceutical and cosmetic products (e.g., [0169]), thus it is beneficial for use in pharmaceutical product and cosmetic products.
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 34-35, 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, and it 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).
MPEP 2144.01 points out "[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom." In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968).
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, 17-19, 21, 23-24 and 29-35 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 applied to Claims 1, 3, 5-6, 11-12, 15, 17, 23-24 and 29-30 above, in view of Goldstein et al. (US20170071865, 03/16/2017, IDS of 01/08/2024), and evidenced by PubChem (tricaprylin, 02/12/2026, Weblink: https://pubchem.ncbi.nlm.nih.gov/compound/Tricaprylin , PTO-892).
Guriev teaches microcapsule comprising a living microorganism, an inner core, and an outer shell comprising wall-forming polymeric material, e.g., cellulose acetate phthalate (e.g., [0050]; Claim 20), cellulose ethyl ether [0138], hydroxypropyl methyl cellulose [0145], and the microcapsule is rupturable by a mechanical action of rubbing, as applied to claims 1, 3, 5-6, 11-12, 15, 17, 23-24, 29-30 and 34-35 above discussed in great detail, and incorporated herein.
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 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. Guriev teaches that the shell material desirable amount does not exceed 50% of the microcapsules (e.g., [0051]; Claim 15), or does not exceed 20% of the total weight of the microcapsule (e.g., [0052]; Claim 17 or 21), which is overlapping with the claimed range from about 10 to about 95% of wall-forming polymeric material.
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), or does not exceed 20% of the total weight of the microcapsule (e.g., [0052]; Claim 17 or 21), which is overlapping with the claimed range from about 15 to about 80% wall-forming polymeric material in instant claim 32.
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 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 claims 19 and 33, or 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 claims 19 and 33, with overlapping with free hydroxy group percentage from 1 to 10% in instant claim 18. 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 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).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DONGXIU ZHANG SPIERING whose telephone number is (703)756-4796. The examiner can normally be reached 7:30am-5:00pm (Except for Fridays).
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/DX.Z./ Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616