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 .
DETAILED ACTION
Claims 1-34, 36-37, and 46-81 are canceled. Claim 87 is new. Claims 35, 38-45, and 82-87 are pending. Claims 40-45 are withdrawn from consideration as being drawn to a nonelected invention.
Accordingly, claims 35, 38-39, and 82-87 are under consideration in this action.
Response to Amendment and Arguments
The amendment filed 08/20/2025 is entered.
The objection to claims 38-39 and 82-86 is obviated in light of the amendment.
The § 112(a) new matter rejection of claims 35, 38-39 and 82-86 is withdrawn in light of the amendment. Specifically, the claims now require dry heat from about 50˚C to about 100˚C or liquid heat of from about 65˚C to about 95˚C. See pages 10-11 of the instant specification for support for these amended limitations. Furthermore, Applicant's arguments, see the last full paragraph on page 5 of the remarks, filed 08/20/2025, with respect to the “manufactured” limitation discussed in the § 112(a) new matter rejection of claims 35, 38-39 and 82-86 have been fully considered and are persuasive. The § 112(a) new matter rejection of claims 35, 38-39 and 82-86 is withdrawn.
Applicant's arguments, see the last paragraph on page 7 of the remarks, filed 08/20/2025, with respect to § 112(a) written description rejection of claims 35, 38-39 and 82-86 have been fully considered and are persuasive. The § 112(a) written description rejection of claims 35, 38-39 and 82-86 is withdrawn.
Applicant's arguments, see paragraphs 3-4 on page 8 of the remarks, filed 08/20/2025, with respect to the § 112(b) rejection of claims 35, 38-39 and 82-86 have been fully considered and are persuasive. The § 112(b) rejection of claims 35, 38-39 and 82-86 is withdrawn.
The § 101 rejection of claims 35, 38-39 and 82-86 has been withdrawn upon further consideration. Under the broadest reasonable interpretation, the claims require a manufactured container that contains a food product composition comprising Pediococcus acidilactici in an admixture with an amphipathic substance that enhances viability of the probiotic in the composition, and wherein the composition is coated onto an inner surface of the container, wherein the container is made from a substance comprising glass, plastic, paper, carton or aluminum. As described in the specification, the P. acidilactici exhibits enhanced viability in the presence of heat when combined with an amphipathic substance, as compared when the P. acidilactici alone is subjected to heat. See, for example, table 13 on page 59 of the instant specification. This functional difference rises to the level of a marked difference, and accordingly the claimed product is not a “product of nature” exception.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Priority
The instant claims are entitled to the effective filing date of 11/30/2016.
Specification
The disclosure is objected to because of the following informalities:
The specification recites “of 100˚C” on page 10 in line 7, which should be replaced with “or 100˚C”
Appropriate correction is required.
Claim Objections
(New objection) Claim 35 is objected to because of the following informalities:
Claim 35 recites “of from” in line 6, which should be replaced with either “of” or “from” because the use of both prepositions is unnecessary.
Appropriate correction is required.
Claim Interpretation
Claim 35 is a container product with a composition coated onto an inner surface of the container. The container is made from glass, plastic, paper, carton or aluminum. The composition coated onto the inner surface comprises any amount of Pediococcus acidilactici in an admixture with an amphipathic substance selected from lecithin, almond butter, soy butter, and cookie butter. The ability of the amphipathic substance to enhance the viability of the probiotic in the composition when subjected to the claimed dry or liquid heat ranges is considered to be inherent to any amount of lecithin, almond butter, soy butter, or cookie butter structure; and the claims do not require the active method step of subjecting the composition to dry or liquid heat. The ratio of the amphipathic substance to the probiotic is required to range from about 1:1 to about 25:1 w/w. According to the instant specification the term “about” means at most plus or minus 10% of the numerical value. See lines 8-9 on page 6. Therefore, the claims encompass a ratio from about 0.99-1.01:0.99-1.01, to about 25.25-24.75:0.99-1.01. Claim 35 recites a “manufactured container”; however the term “manufactured” does not structurally define the container.
Claims 38-39 requires the container to further have a food product. In other words, the container must have an additional food component besides the amphipathic substance, the additional food product is not required to be coated on the container. In accordance with instant claim 39, the food product may be oil, vinegar , any dairy product (e.g. yogurt), any beverage (e.g. juice), or any food that could be consumed as a snack or dessert (e.g. yogurt, applesauce, candy cookies, cake, gelatin, fruit bars, fruit custard, tiramisu).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
(Maintained/Modified to address the amendment for claims 35, 38-39 and 83; New rejection necessitated by amendment for new claim 87)
Claims 35, 38-39, 83 and 87 are rejected under 35 U.S.C. 103 as being unpatentable over Wiggins 2010/0094243 in view of Garbolino US 2009/0017163. The underlined text below is relevant to the amendment
Regarding claims 35 and 87, Wiggins teaches coating a nutritive substance directly on an inside surface (e.g. an inner surface) of an annular end wall extension. See paragraph [0056]. The nutritive substance is a probiotic. The probiotic may be any probiotic known in the art. See [0063]. The probiotic may be applied as a powder that is suspended in an oil or wax suspension. Any oil or wax known in the art may be utilized, provided it does not adversely affect the properties of the container or the contents of the container. See [0064]. The container itself may be constructed from a polymer, such as polystyrene (e.g. plastic), the container may also be constructed from paper, cardboard, or another fibrous material, optionally coated with a plastic material or foil laminate [0069]. Wiggins implies that the container is manufactured because Wiggins teaches a method of making a delivery apparatus comprising providing a container body. See claim 18. Thus, Wiggin teaches a container suitable for a food product comprising plastic or paper, wherein a composition of probiotics is coated onto a surface or portion of the container.
Wiggins does not teach a composition comprising an effective amount of a Pediococcus acidilactici probiotic in an admixture with an effective amount of an amphipathic substance that enhances viability of the probiotic in the composition when the composition is subjected to a dry heat from about 50˚C to about 100˚C or a liquid heat from about 65˚C to about 95˚C (relevant to instant claim 35).
Wiggins does not teach an amphipathic substance is selected from lecithin, almond butter, soy butter, and cookie butter (relevant to instant claim 35).
Wiggins does not teach a ratio of an amphipathic substance to a probiotic that ranges from about 1:1 to about 25:1 (relevant to instant claim 35).
Wiggins does not teach a ratio of an amphipathic substance to a probiotic that ranges from about 1:1 to about 10:1 (relevant to claim 87).
Garbolino teaches compositions comprising live food grade bacterium and lecithin(e.g. an amphipathic substance), wherein the amount of bacterium is “104 to 1011” cfu per gram of product (e.g. an effective amount). See claims 1 and 5, and paragraph [0025]. The 104 to 1011 range recited in claim 5 is understood to be a typo for 104 to 1011. The food grade bacterium is a probiotic. See claim 2. Garbolino discloses that suitable types of probiotic bacteria include Pediococcus acidilactici. See [0022]. The lecithin is present in an amount from 0.01 to 10 wt% (e.g. an effective amount). See claim 4. Garbolino discloses that the amount of bacterium depends on the type of bacterium used and the serving size of the composition. See paragraph [0026]. Thus, Garbolino a composition comprising an effective amount of a Pediococcus acidilactici probiotic in an admixture with an effective amount of lecithin, an amphipathic substance.
Wiggins and Garbolino do not teach a ratio of an amphipathic substance to a probiotic that ranges from about 1:1 to about 25:1 (relevant to instant claim 35).
Wiggins and Garbolino do not teach a ratio of an amphipathic substance to a probiotic that ranges from about 1:1 to about 10:1 (relevant to instant claim 87).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to replace the nutritive substance of Wiggins with the probiotic and lecithin composition of Garbolino, to further select Pediococcus acidilactici as the probiotic, and to adjust the amount of the probiotic, such that the ratio between the probiotic and lecithin adjusts as well. One would be motivated to use a probiotic and lecithin composition of Garbolino because Wiggins suggest that probiotics are often sensitive [0003][0066]; and Garbolino suggests that lecithin can help improve the viability of probiotics (e.g. see the abstract or [0042]). There would be a reasonable expectation of success because Wiggins suggests that the nutritive substance comprising a probiotic can be directly coated onto the container, and Garbolino demonstrates storing live probiotics with lecithin (e.g. see example 3 [0042]). One would be further motivated to select Pediococcus acidilactici from the list of Garbolino, because a person of ordinary skill in the art has good reason to pursue the known options within his or her technical grasp. There would be a reasonable expectation of success because Garbolino lists a finite number of probiotics to choose from. One would be motivated to optimize the amount of the P. acidilactici probiotic, because Garbolino suggests that the amount of bacterium depends on the type of bacterium used and the serving size of the composition (paragraph [0026]). There would be a reasonable expectation of success because by adjusting the amount of the bacterium in the composition one would reasonably expect the ratio between the probiotic bacterium and the lecithin to adjust as well. MPEP 2144.05(II) indicates that differences in concentration generally amount to “routine optimization” and will not support patentability unless there is evidence indicating the claimed feature is critical. “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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claims 38-39, Wiggins suggests that the probiotic may be mixed with any oil known in the art [0064].
Garbolino teaches a composition comprising a probiotic, lecithin, and palm oil (e.g. a food product). See paragraph [0042] and table 1. Garbolino also suggests that the composition may be a food product such as a spread, yogurt, a dairy spread, or cream. See paragraph [0028] and claims 1-9 of Garbolino. Thus, Garbolino teaches composition comprising a probiotic and lecithin and further comprising an oil.
Regarding claim 83, Garbolino teaches lecithin (e.g. see [0042]).
(Maintained) Claim 82 is rejected under 35 U.S.C. 103 as being unpatentable over Wiggins 2010/0094243 and Garbolino 2009/0017163, as applied above to claims 35, 38-39 and 83, and further in view of Lin 2015/0246082. Lin was previously relied upon in the non-final action mailed 10/25/2023.
The teachings of Wiggins and Garbolino with respect to instant claim 35 are discussed above.
Regarding claim 82, Wiggins suggests that probiotics are often heat, light, oxygen or moisture sensitive [0003][0063][0066].
Garbolino suggests that viability of probiotics can be enhanced by lecithin. See, for example, the abstract. Garbolino teaches a Pediococcus acidilactici probiotic. See paragraphs [0022].
Wiggins and Garbolino do not teach Pediococcus acidilactici NRRL B-50517.
However, Lin teaches Pediococcus acidilactici NRRL B-50517 (e.g. see claim 1). Lin suggests that P. acidilactici NRRL B-50517 is an optimized strain of P. acidilactici that is viable above 65ºC and can, in many cases be subjected to temperatures of 85 ºC without being destroyed [0010]. In examples 1-5, Lin teaches heating P. acidilactici NRRL B-50517 with carriers, such as milk [0041-44].
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to replace the Pediococcus acidilactici of Garbolino with the Pediococcus acidilactici NRRL B-50517 of Lin within the probiotic coated container of Garbolino and Wiggins. Doing so is merely substituting one known element for another. One would be motivated to use Pediococcus acidilactici NRRL B-50517, because Lin suggests that the strain is optimized and can withstand high temperatures, which is often required in food manufacturing processes. There would be a reasonable expectation of success because Wiggin teaches coating a paper or plastic container with probiotics, but suggests that probiotics are often sensitive to heat; and Lin demonstrates the viability of P. acidilactici NRRL B-50517 in the presence of heat.
(Maintained) Claims 84-85 are rejected under 35 U.S.C. 103 as being unpatentable over Wiggins 2010/0094243 and Garbolino 2009/0017163, as applied above to claims 35, 38-39 and 82-83, and further in view of Gorrepati, (2015). Plant based butters. Journal of food science and technology, 52, 3965-3976 with evidence from Schaefer, A. (2015, March 18). Is Soy Lecithin Good or Bad for Me? Healthline.
The teachings of Wiggins and Garbolino regarding instant claim 35 are discussed above.
Wiggins and Garbolino do not teach the amphipathic substance almond butter (relevant to instant claim 84) or soy butter (relevant to instant claim 85).
Regarding claims 84, Gorrepati teaches plant-based butter such as almond butter (e.g. see table 2). Gorrepati suggests that almond butter may slightly increase high-density lipoprotein-cholesterol, which is the good cholesterol. See the first passage in the right column on page 3972. Furthermore, Gorrepati suggests that lecithin is an emulsifier used in plant butter to negate stickiness so that it will not stick to the roof of the mouth. See the right column on page 3968.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to combine the P. acidilactici probiotic and lecithin of Garbolino with the almond butter of Gorrepati. Doing so is merely combining known prior art elements. One would be prompted to use an almond butter spread because Gorbolino suggests that the lecithin and probiotic may be part of a fat spread composition (e.g. see table 1 and [0042]). Furthermore, one would be motivated to use almond butter in particular because Gorrepati suggests that almond butter may increase good cholesterol. There would be a reasonable expectation of success because Gorbolino demonstrates a composition comprising a fat spread, lecithin and a probiotic, and Gorrepati discloses the fat content of almond butter (e.g. see table 2), and suggests using lecithin in plant-based butter.
Regarding claim 85, Gorrepati teaches plant-based butter such as soy butter(e.g. see table 2). Gorrepati suggests that consumers’ preferences are increasing for low fat butters (see the conclusion section page 3974). In table 1, Gorrepati suggests that soy butter has less fat than natural peanut butter. Yet, soy butter offers a peanutty taste but is peanut free, which may be safe for school settings (e.g. peanut allergies). See lines 6-10 in the left column on page 3971.
Evidentiary reference Schaefer discloses that lecithin comes from soy. See the last 5 lines on page 1.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to combine the P. acidilactici of Gorbolino with the soy butter of Gorrepati because soy inherently contains lecithin, as evidenced by Schaefer. Doing so is merely combining known prior art elements. One would be prompted to combine soy butter with a probiotic like P. acidilactici because Gorbolino suggests that lecithin, e.g. the lecithin from soy, may contribute to improved probiotic survival (e.g. see the abstract or [0042]). Furthermore, one would be motivated to use soy butter in particular because Gorrepati suggests that consumers prefer lower fat butters and soy butter has a lower fat content, as compared to natural peanut butter. There would be a reasonable expectation of success because Gorbolino demonstrates spread compositions comprising a probiotic and lecithin.
(Maintained) Claim 86 is rejected under 35 U.S.C. 103 as being unpatentable over Wiggins 2010/0094243 and Garbolino 2009/0017163, as applied above to claims 35, 38-39 and 82-85, and further in view of Shelly, R. (2014, October 8). Trader Joe’s Cookies & Creme Cookie Butter. What’s Good at Trader Joe’s.
Relevant to instant claim 35, the teachings of Wiggins and Garbolino are discussed above.
Wiggins and Garbolino do not teach the amphipathic substance cookie butter.
Regarding claim 86, Shelly discloses a cookie butter that is comprised of sunflower lecithin, soy lecithin and palm oil. See the picture of the nutrition facts on page 2.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to combine the P. acidilactici of Gorbolino with the cookie butter comprising lecithin and palm oil of Shelly. Doing so is merely combining known prior art elements. One would be prompted to combine cookie butter of Shelly with the probiotic of Gorbolino, because Gorbolino suggests that lecithin contributes to enhanced viability. There would be a reasonable expectation of success because Gorbolino demonstrates combining probiotics, lecithin and palm oil (table 1 and paragraph [0042]), all of which can be found in the cookie butter of Shelly.
Response to Arguments
Applicant's arguments filed 08/20/2025 have been fully considered but they are not persuasive.
Regarding the 103 rejection over Wiggins and Garbolino:
Applicant asserts that the amendment obviates the rejection. See the paragraph spanning pages 10-11 of the remarks.
This argument is unpersuasive for two reasons. First, claim 35, as amended, requires “an effective amount of an amphipathic substance that enhances viability of the probiotic in the composition when the composition is subjected to a dry heat from about 50˚C to about 100˚C or a liquid heat from about 65˚C to about 95˚C”. However, this limitation does not structurally limit the amphipathic substance, and the ability of the amphipathic substance to enhance viability is considered to be inherent to the structure. Second, claim 35 now specifically requires the composition to be coated onto an inner surface of the container, but Wiggins teaches coating a nutritive substance directly on an inside surface of an annular end wall extension. See paragraph [0056].
Applicant argues that Wiggins teaches away from the present invention because the goal of Wiggins is to separate the nutritive substance from the food product in the container during processes such as heat sterilization because the nutritive substance is sensitive to heat and high sterilization temperatures. In contrast the instant admixture is resistant to heat and high sterilization temperatures. See the first full paragraph on page 11 of the remarks.
This argument is unpersuasive because one cannot show non-obviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Applicant indicates that the nutritive substance of Wiggins is inferior to the instantly claimed admixture because the nutritive substance of Wiggins is sensitive to heat and high sterilization temperatures. However, Wiggins is not relied upon for teaching the instant admixture. Garbolino is relied upon for teaching that element. Rather, Wiggins is relied upon for teaching a container “made from a substance comprising glass, plastic, paper, carton, or aluminum, wherein [a] composition is coated onto an inner surface of the container”. Applicant indicates that Wiggins teaches away from the instant invention because the container of Wiggins separates the nutritive substance from food. However, this argument is not commensurate in scope with the claims because claims 38-39 do not require the food product to be combined with the admixture of claim 35. In other words, the claim 38-39 require the manufactured container of claim 35 to “further comprise a food product”, which encompasses container embodiments where the admixture and food product are separated or combined within the container.
Double Patenting
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.
(Maintained/Modified to address claims 35, 38-39 and 82-86; new rejection necessitated by amendment for claim 87) Claims 35, 38-39, and 82-87 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10946050 B2 (hereinafter Lin ‘050) in view of Wiggins 2010/0094243. The underlined text is relevant to the amendment.
Claim 1 of Lin ‘050 recites a composition comprising a probiotic in admixture with an effective amount of an amphipathic substance, wherein the composition is made by a process comprising:
i) adding an effective amount of the amphipathic substance to a composition comprising the probiotic; and
ii) subjecting the composition to heat at a temperature of between 50° C. and 100° C., wherein the amphipathic substance enhances viability of the probiotic in the composition when the composition is subjected to a temperature of at least between 50° C. and 100° C., wherein the ratio (w/w) of the amphipathic substance to the probiotic ranges from about 1:1 to about 25:1 (e.g. overlaps with the about 1:1 to about 10:1 ratio of new claim 87),
wherein the probiotic is Pediococcus acidilactici, and
wherein the amphipathic substance comprises lecithin, peanut butter, almond butter, soy butter or cookie butter.
Claim 2 of Lin ‘050 recites the composition of claim 1, further comprising an oil that is mixed with the amphipathic substance and probiotic.
Claim 4 of Lin ‘050 recites the composition of claim 1, wherein the probiotic is Pediococcus acidilactici NRRL B-50517.
Claim 5 of Lin ‘050 recites the composition of claim 1, wherein the composition is subjected to a temperature of between 65°C-100° C.
Claim 7 of Lin ‘050 The composition of claim 1, wherein the ratio (w/w) of the amphipathic substance to the probiotic ranges from about 10:1 to about 25:1.
The patent claims of Lin ‘050 lack a manufactured container made from glass, plastic, paper/carton and aluminum, wherein the composition [i.e. the P. acidilactici and amphipathic substance] is coated onto a surface or portion of the container (relevant to instant claim 35).
However Wiggins teaches a container suitable for a food product comprising plastic or paper [0069], wherein a composition of probiotics [0063]. Wiggins teaches coating a nutritive substance directly on an inside surface (e.g. an inner surface) of an annular end wall extension. See paragraph [0056]. Wiggins implies that the container is manufactured because Wiggins teaches a method for making a delivery apparatus that includes the container. See claim 18 of Wiggins (relevant to instant claim 35).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to modify the probiotic in admixture of Lin ‘050 by coating it onto the inside surface of the annular end wall extension of the container taught by Wiggins. One would be motivated to do so because Wiggins suggests that the container may protect the contents and nutritive substance, e.g. a probiotic, from exposure to the atmosphere [0043][0063]. There would be a reasonable expectation of success because Wiggins suggests that probiotics can be coated onto the inner surface of the container [0056].
(Maintained/Modified to address claims 35, 38-39 and 82-86; new rejection necessitated by amendment for claim 87) Claims 35, 38-39, and 82-87 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. US 10195237 B2 (hereinafter Lin ‘327) in view of Wiggins 2010/0094243, Garbolino 2009/0017163, Gorrepati, (2015). Plant based butters. Journal of food science and technology, 52, 3965-3976, and Shelly (2014, October 8, Trader Joe’s Cookies & Creme Cookie Butter), with evidence from Schaefer, A. (2015, March 18, Healthline). The underlined text is relevant to the amendment.
Claim 1 of Lin ‘327 recites a composition comprising an effective amount of Pediococcus acidilactici probiotic for use in a method of treating a disease or condition characterized by inflammation in a subject in need thereof, wherein the Pediococcus acidilactici probiotic is strain NRRL B-50517.
Claim 2 of Lin ‘327 recites the composition of claim 1, wherein the Pediococcus acidilactici probiotic is formulated as a tablet.
Claim 3 of Lin ‘327 recites the composition of claim 1, wherein the Pediococcus acidilactici probiotic is formulated as a capsule.
Claim 5 of Lin ‘327 recites A food product comprising the composition of claim 1.
Claim 6 of Lin ‘327 recites the food product of claim 5, wherein the food comprises peanut butter.
Claim 8 of Lin ‘327 recites the food product of claim 5, wherein the food comprises an oil.
Claim 9 of Lin ‘327 recites the food product of claim 5, wherein the food comprises a beverage.
Claim 14 of Lin ‘327 recites the food product of claim 5, wherein the food comprises milk.
The patent claims of Lin ‘327 lack a manufactured container made from glass, plastic, paper/carton and aluminum, wherein a composition [i.e. P. acidilactici and an amphipathic substance] is coated onto an inner surface of the container, and an amphipathic substance that is selected from lecithin, almond butter, soy butter and cookie butter, and wherein the ratio (w/w) of the amphipathic substance to the probiotic ranges from about 1:1 to about 25:1, or about 1:1 to about 10:1 (relevant to instant claims 35 and 87). The patent claims of Lin ‘327 lack and amphipathic substance that is lecithin (relevant to instant claim 83), almond butter (relevant tot instant claim 84), soy butter (relevant to instant claim 85) and cookie butter (relevant to instant claim 86).
However, Wiggin teaches a container suitable for a food product comprising plastic or paper [0069], wherein a composition of probiotics [0063] is coated onto a surface or portion of the container [0056][0066]. Wiggin also suggests that probiotics are often sensitive [0066]. Wiggins implies that the container is manufactured, e.g. see claim 18 of Wiggins. Garbolino teaches compositions comprising lecithin and probiotics such as Pediococcus acidilactici; and suggest lecithin improves survivability of probiotics [0022] [0042] (relevant to instant claim 35 and 83). Gorrepati teaches plant-based butter such as almond butter, e.g. see table 2. Gorrepati suggests that almond butter may increase good cholesterol and that lecithin is used as an emulsifier in plant butters. See the first passage in the right column on page 3972 and the right column on page 3968 of Gorrepati (relevant to instant claim 84). Gorrepati teaches soy butter, e.g. see table 2, and suggests that consumers prefer lower fat butters, e.g. see the conclusion section. Evidentiary reference Schaefer discloses that lecithin comes from soy. See the last 5 lines on page 1 of Schaefer (relevant to instant claim 85). Shelly discloses that cookie butter contains lecithin, and palm oil; see the picture on page 2 (relevant to instant claim 86).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to modify the Pediococcus acidilactici probiotic NRRL B-50517 composition of Lin ‘327 by combining it with the lecithin of Gorbolino, further coating it onto the plastic or paper container of Wiggins, optionally replacing the lecithin of Gorbolino with the following lecithin containing spreads: the almond butter of Gorrepati, the soy butter of Gorrepati or the cookie butter of Shelly; and optimizing the amount of the probiotic, as to affect the ratio of the composition. One would be motivated to do so, because Gorbolino suggests improving the survivability of probiotics with lecithin and Wiggins teaches a container suitable for probiotic coatings. There would be a reasonable expectation of success because Gorrepati demonstrates improving the survivability of probiotics with lecithin in a spread.
Response to Arguments
Applicant requests that the double patenting rejection over Lin ‘050 (US 10946050 B2) and Lin ‘327 (US 10195237 B2) be held in abeyance (remarks page 12). A request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an OBJECTION or REQUIREMENTS AS TO FORM (see 37 CFR 1.111(b) and MPEP §714.02).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIMBERLY C BREEN whose telephone number is (571)272-0980. The examiner can normally be reached M-Th 7:30-4:30, F 8:30-1:30 (EDT/EST).
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, Melenie Gordon can be reached at (571) 272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.C.B./Examiner, Art Unit 1657
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1657