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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/21/2026 has been entered.
DETAILED ACTION
Claims 1-34, 36-37, and 46-81 are canceled. Claims 35, 38-45, and 82-87 are pending. Claims 40-45 are withdrawn from consideration as being drawn to a nonelected invention. Claims 35, 38-39, and 82-87 are examined.
Priority
The instant claims are entitled to the effective filing date of 11/30/2016.
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.
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.
Regarding claims 35 and 87, Wiggins teaches containers that separate a nutritive substance from a food or drink, and the user can dispense the nutritive substance into the food or drink prior to consumption. See [0003]. 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]).
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.
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.
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.
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 04/21/2026 have been fully considered but they are not persuasive.
Rejection of claims 35, 38-39, 83 and 87 under 35 U.S.C. 103 as being unpatentable over Wiggins in view of Garbolino:
Applicant argues that the teachings in paragraph [0056] of Wiggins falls within the more general restriction taught by Wiggins, “[T]he nutritive substance may be present on present on an insert or may be coated onto the interior of the container such that it does not contact the contents of the container until the container is altered by the consumer just before consumption” [0030]. Applicant, in the remarks, states “Applicant has removed the later limitation in the text of claim 35” (see the remarks p. 6 last passage). Applicant asserts that the consumer is free to mix the contents of the container with the nutritive substance, then proceed to pasteurize. Wiggins intends for the pasteurization to be done first, before disruption by the consumer of a seal that separates the container food or drink contents from the nutritive substance. See the remarks the paragraph spanning p. 6-7. Applicant argues that the system of Wiggins prevents inactivation of the nutritive substance by physically separating it from heat. In contrast Applicant’s system of claim 35 prevents inactivation by selecting a nutritive substance that will survive the heat of a pasteurization. See the remarks p. 7 the first paragraph.
This argument is not persuasive 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). The rejection of claim 35 is based on the combination of Wiggins and Garbolino, not Wiggins alone. Applicant indicates that “the later limitation in the text of claim 35” was removed in the amendment (see the remarks p. 6 last passage). However, it is unclear which limitation is being referenced by Applicant because no limitations were removed from claim 35; in the amendment, the recitation “product comprising a composition comprising” (line 2, claim 35 filed 08/20/2025) was amended to “product combined with a composition comprising” (line 2, claim 35 filed 04/21/2026), but this amendment does not alter the scope of claim 35 in anyway. Furthermore, Applicant asserts that Wiggins prevents inactivation [of the probiotic] by physically separating it from heat, whereas the instantly claimed system prevents inactivation [of the probiotic] by selecting a nutritive substance [sic. amphipathic substance] that will survive heat pasteurization. This argument is unpersuasive because instant claims 35, 38-39, and 82-87 are product claims that do not require any active pasteurization step. The most relevant limitation to pasteurization in claim 35 recites “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” in lines 3-6. This claimed enhanced viability function is inherent to the claimed product structure. Since Applicant has not pointed to a structural limitation not taught by the combination of Wiggins and Garbolino, the argument is unpersuasive.
Applicant argues that Garbolino does not mention or test conditions of pasteurization, instead focusing on refrigeration and physiological temperatures. The proposed modification changes the principle of operation from physical separation of the nutritive substance from heat to physiological tolerance of heat by the nutritive substance. The goal is to pasteurize the food or drink without deactivating the nutritive substance. See the remarks p. 7 last passage.
This argument is not persuasive because mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). The instant claims do not require pasteurization, nor do the instant claims require an active step of applying heat. Wiggins and Garbolino meet every claimed structural limitation. The fact that applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant argues that functional claim language can be considered to have structural implications that need to be taken into account. Here, the claimed container is suitable for containing a food product combined with…a probiotic in an admixture with… an amphipathic substance that enhances viability of the probiotic…when the composition is subjected to a dry heat…or a liquid heat. Thus, claim 35 requires that the claimed container must include in its inner surface coating a probiotic that is viable in admixture with an amphipathic substance under the claimed heating conditions. See the remarks p. 8 the first passage.
This argument is not persuasive because MPEP 2111.04(II) states that “[t]he broadest reasonable interpretation of a system (or apparatus or product) claim having structure that performs a function, which only needs to occur if a condition precedent is met, requires structure for performing the function should the condition occur”. Instant claim 35 requires an effective amount of an amphipathic substance (i.e. a structure) that performs an enhanced viability function when a heat condition precedent is met, because claim 35 recites “an effective amount of an amphipathic substance that enhances viability of the probiotic in the composition when the composition is subjected” (lines 3-5) to dry or liquid heat. Wiggins and Garbolino meet every claimed structural limitation.
Applicant argues that the invention has a central feature/advantage that the seal of the Wiggins container is not needed, where said seal separates the contents of the container (food or drink) from the nutritive substance until after any pasteurization step. Applicant’s claimed invention features a simpler design and obviates any need or use for the step in which the consumer disrupts the seal to allow mixing of the container contents with the nutritive substance. See the remarks p. 8 first passage.
This argument is not persuasive because claim 35 recites the open-ended transition term “comprising”. Therefore, claim 35 does not exclude additional unrecited elements, such a seal.
Rejection of claim 82 under 35 U.S.C. 103 as being unpatentable over Wiggins in view of Garbolino, and further in view of Lin:
Applicant argues that Lin does not cure the defects in combination of Wiggins with Garbolino, namely that the proposed combination changes the principle of operation for achieving the central goal of the claimed apparatus, to provide a container for both adding a nutritive substance to a food or drink product and pasteurizing that product without inactivating the nutritive substance. See the remarks p. 9 first full paragraph.
This argument is not persuasive because it is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006). Applicant has not pointed to a claimed structural element not taught by Wiggins, Garbolino and Lin.
Rejection of claim 84-85 under 35 U.S.C. 103 as being unpatentable over Wiggins in view of Garbolino, and further in view of Gorrepati
Applicant argues that Gorrepati likewise does not cure the defects in the combination of Wiggins with Garbolino. See the remarks p. 9 paragraph 2.
This argument is not persuasive for reasons discussed above.
Rejection of claim 86 under 35 U.S.C. 103 as being unpatentable over Wiggins in view of Garbolino, and further in view of Shelly
Applicant argues that Shelly is not cited for insight into containers and does not cure the defect in the combination of Wiggins with Garbolino. See the remarks p. 9 second to last paragraph.
This argument is not persuasive because Shelly is relied upon for teaching cookie butter, not a 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.
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.
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].
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 to Lin ‘237 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).
Claim 1 of Lin ‘237 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 ‘237 recites the composition of claim 1, wherein the Pediococcus acidilactici probiotic is formulated as a tablet.
Claim 3 of Lin ‘237 recites the composition of claim 1, wherein the Pediococcus acidilactici probiotic is formulated as a capsule.
Claim 5 of Lin ‘237 recites A food product comprising the composition of claim 1.
Claim 6 of Lin ‘237 recites the food product of claim 5, wherein the food comprises peanut butter.
Claim 8 of Lin ‘237 recites the food product of claim 5, wherein the food comprises an oil.
Claim 9 of Lin ‘237 recites the food product of claim 5, wherein the food comprises a beverage.
Claim 14 of Lin ‘237 recites the food product of claim 5, wherein the food comprises milk.
The Lin ‘237 patent claims 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 ‘237 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 ‘237 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's arguments filed 04/21/2026 have been fully considered but they are not persuasive.
Double Patenting Rejections
Applicant argues that Lin ’50 (U.S. Patent No. 10946050) fails to mention or describe a container at all, and the Examiner admits that they lack a manufactured container of the kind depicted in instant claim 35. Then, substituting the composition provided by the claims of Lin ‘050 for the composition provided by Garbolino, the above arguments apply in a similar way to these double patenting rejections. The Examiner’s suggested combination cannot provide Applicant’s claimed invention because the various references have no means of modifying the container structure of Wiggins. See the remarks p. 10 paragraph 2.
This argument is not persuasive because Garbolino is not relied upon in the rejection of instant claims 35, 38-39, and 82-87 as being unpatentable over the patent claims of Lin ‘050 (.S. Patent No. 10946050) in view of Wiggins. Therefore, the rationale for the rejection does not rely on substituting the composition provided by Lin ‘050 for the composition of Garbolino, as asserted by Applicant. Furthermore, Lin ‘050 is not relied upon for teaching the claimed container element. Rather, Wiggins is relied upon for teaching that claim element. Applicant argues that the container of Wiggins needs to be modified to arrive at the instantly claimed container. However, Applicant has not pointed to a claimed structural element that differentiates the container of Wiggins from the claimed container, so the argument is unpersuasive.
Applicant argues that the structures of Wiggins physically separate the claimed composition (probiotic plus amphipathic substance) from a food product that might be added to the container, so the containers of Wiggins are not suitable for containing the food product combined with the composition. Examiner might argue that the combined food product and composition would be contained after the consumer intervenes to remove the barrier separating the food product from the composition, but this would be a modified form of the manufactured container, not the container as manufactured. See the remarks p. 10 third paragraph.
This argument is not persuasive because arguments of counsel cannot take the place of factually supported objective evidence (MPEP 2145 or 716.01(c)). Applicant has not provided evidence that the containers of Wiggins are not suitable for containing a food product combined with the composition. Instant claim 35 requires a manufactured container suitable for containing a food product combined with a composition comprising an effective amount of a Pediococcus acidilactici probiotic in an admixture with an effective amount of an amphipathic substance…the composition is coated onto an inner surface of the container. As such, the instant claims do not require a food product combined with a composition, as indicated by Applicant. Rather, the claims require a container suitable for containing a food product combined with a composition. Regardless, Wiggins suggests that a probiotic nutritive substance coated onto an inner surface of the container can be combined with a food product. See, e.g. [0062] for support that the nutritive substance includes a probiotic, see [0056] for coating the nutritive substance on an inner surface of a container, and see [0003] for dispensing the nutritive substance into food. Therefore, Wiggins suggests that the container is manufactured to have a probiotic coating that can be physically separated or combined with a food product.
Applicant does not directly address the rejection of claims 35, 38-39 and 82-87 on the ground of nonstatutory double patenting as being unpatentable over the patent claims of US 10195237 (Lin ‘327) in view of Wiggins, Garbolino, Gorrepati and Shelly, with evidence from Schaefer. Therefore, this double patenting rejection of record is maintained as no response to the rejection has been filed by Applicant at this time.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/K.C.B./Examiner, Art Unit 1657
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