DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Receipt of Remarks/Amendments filed on 04/10/2026 is acknowledged. Claim 1 is amended. Claim 17 is cancelled. Claims 1-16 and 18-19 are currently pending and are examined on the merits herein.
Priority
The instant application filed 04/05/2023, is a 371 filing of PCT/US2021/053741, filed 10/06/2021, which claims benefit of Provisional Application No. 63/088,272, filed 10/06/2020.
The following grounds of rejection are maintained, with any new reasoning being necessitated by amendment:
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 1-4 and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Mazeaud, I., et al. (WO 2011/018509 A1, 02/17/2011, on record), hereinafter Mazeaud in view of DePablo, J., et al. (US 6919172 B2, 07/19/2005, on record).
Mazeaud teaches coated dehydrated microorganisms comprising a dehydrated microorganism surrounded by at least one coating. The invention also relates to liquid coating compositions, methods for coating and protecting a dehydrated microorganism. The methods are used for the preparation of food products, feed products, consumer healthcare products or agri-products (abstract).
Example 1 teaches the preparation of a liquid route-type composition (p. 43-47). A primary particle was prepared first by spray-coating an inert carrier particle (i.e., an inert core) with a liquid composition containing L. acidophilus NCFM (i.e., culture mixture). The liquid culture mixture also comprises sucrose (p. 44, top table). A fluid bed was then charged with sucrose cores and spray-dried with the culture mixture. Thus, Mazeaud teaches a layered granule comprising a core surrounded by a coating layer comprising at least one bioactive agent as instantly claimed.
Next a liquid coating composition was prepared comprising: sucrose, KH2PO4, K2HPO4, talc, and distilled water. The fluid bed was then charged with the primary particles (i.e., sucrose core + culture mixture) and spray-coated with the above liquid coating composition.
Regarding claims 2-4, the core of Mazeaud is sucrose which is the same as that of the instant invention as recited in claim 4. As such, the sucrose core of Mazeaud will inherently possesses the properties recited in claims 2-3. "Products of identical chemical composition cannot have mutually exclusive properties." See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
The teachings of Mazeaud differ from the instant invention in that Mazeaud does not explicitly teach wherein the bioactive agent is distributed within a protectant matrix, as defined in claim 1, which comprises the polyhydroxy and phosphate compounds of claims 6 and 7.
However, Mazeaud further teaches that it is known in the art, that cells which are freeze-dried in the presence of protective agents are better suited to maintain their viability and stability than cells which are freeze-dried without the addition of said protective agents. For example, US 6,919,172 relates to the use of a protective mixture (i.e. sucrose and potassium phosphates) mixed with biological material in order to form a preservation medium, prior to the biological medium undergoing at least one preservation process (eg. freezing, freeze-drying, vacuum-drying or spray-drying) (p. 1, lines 13-21).
DePablo (US 6,919,172 above) teaches a protectant mixture for use in preserving biological materials comprising (1) at least one polyhydroxy compound and (2) phosphate ions. A preservation medium comprising the biological material and the protectant mixture is also taught (abstract). Example 1 teaches preparing a protectant mixture comprising the polyhydroxy compound and phosphate ions and adding the mixture to a L. acidophilus cell solution, which is then subjected to drying (Ex. 1, col. 8-9). The drying step can be performed by one or more techniques known in the art, including freezing, freeze-drying, vacuum-drying, ambient, air-drying, and/or spray-drying (col. 8, lines 45-48).
The polyhydroxy compound of DePablo may be sucrose or trehalose, with trehalose being most preferred (col. 5, lines 25-29; claim 5), thereby reading on the polyhydroxy compounds of claim 6. The phosphate ions are preferably provided by a mixture of monobasic and dibasic potassium phosphate (i.e., KH2PO4, K2HPO4) (col. 6, lines 34-37), thereby reading on the phosphate compounds of claim 7.
It is believed that the phosphate ions form a complex with the polyhydroxy compound, which may contain several molecules of the polyhydroxy compound in a three-dimensional supermolecular structure cross-linked by the phosphate ions. The aqueous preservation medium has a much higher viscosity than a system containing the polyhydroxy compound alone in the same amount, and the preserved biological material composition has a higher glass transition temperature (Tg) than a composition containing only the polyhydroxy compound (col. 6, lines 15-28).
Thus, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to combined the teachings of DePablo with those of Mazeaud by incorporating the protectant mixture of DePablo into the culture mixture of Mazeaud prior to spray-coating the mixture onto the cores. One of ordinary skill in the art would have been motivated to (1) simply add a phosphate ion source into the culture mixture of Mazeaud which already comprises sucrose or (2) to incorporate trehalose and phosphate ions together into the culture mixture of Mazeaud, both in order to generated a polyhydroxy-phosphate complex that better preserves and stabilizes the biological material as taught by DePablo. Both scenarios would result in a culture mixture comprising a bioactive agent (i.e., L. acidophilus), a polyhydroxy compound, and a phosphate compound, which reads on the protectant matrix as instantly recited in claim 1.
The polyhydroxy compound in the combined product is sucrose or trehalose, both of which read on claim 6.
Regarding claim 7, it would have been prima facie obvious to use a mixture of monobasic and dibasic potassium phosphate as the source of phosphate ions in the protectant medium comprising the bioactive, since these are known and routine in the art as taught by both Mazeaud and DePablo. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07.
Regarding claim 8, Mazeaud teaches the final granule of example 1 (i.e., sample 11) to comprise 59% inert core (i.e., sucrose core) (p. 46, lines 4-5).
Regarding the water-solubility and fast-dissolving properties of the granule as recited in claim 1, the combined granule of Mazeaud and DePablo teaches the same chemical components as the instant invention. For example, the core is sucrose, which is the same as the instantly claimed core of claim 4. Similarly, sucrose or trehalose are defined as the polyhydroxy compound in claim 6. The phosphate compound(s) are potassium salts of phosphoric acid which are the same as the phosphate compounds of claim 7. As such, each of these components will inherently possess the water-soluble and fast-dissolving properties of claim 1. "Products of identical chemical composition cannot have mutually exclusive properties." See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Furthermore, the granule structure as defined in claim 1, is made obvious in its entirety by Mazeaud and DePablo. Because the composition made obvious by the prior art is identical to the composition claimed, the composition must necessarily have the characteristics claimed as an inherent property. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.
One of ordinary skill in the art would have had a reasonable expectation of success in making the above modifications since both Mazeaud and DePablo teach methods of preserving biological materials, specifically L. acidophilus, using protectant mixtures of polyhydroxy compounds and phosphate ions.
Claims 1-12 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Mazeaud and DePablo as applied to claims 1-4 and 6-8 above, and further in view of Becker, N., et al. (US 2010/0124586 A1, 05/20/2010, on record), hereinafter Becker.
The combined teachings of Mazeaud and DePablo are discussed above.
DePablo further teaches wherein the preserved biological material may comprises enzymes (col. 4, lines 50-59), which reads on the bioactive agent of claim 14.
The combined teachings of Mazeaud and DePablo differ from that of the instantly claimed invention in neither explicitly teach wherein the at least one polyhydroxy compound is maltodextrin as recited in claim 5, nor that the granule comprises an additional “fast-dissolving” coating or coatings as recited in claim 9, wherein “fast-dissolving” is specifically defined by the specification. Additionally, neither explicitly teach an embodiment wherein the bioactive agent is an enzyme as defined in claims 14-15.
Becker teaches a stable, durable granule for feed compositions comprising: a core, an active agent; and at least one coating (abstract; claim 1). The at least one coating comprises a moisture hydrating material (claim 2) selected from inorganic salts, sucrose, maltodextrin, and others (claim 6). Becker teaches that moisture hydrating materials, such as sodium sulfate, sucrose, and maltodextrin, act to absorb or bind aqueous liquids and retard or reduce the rate or extent of migration of such liquids to the active agent. They also act to thermally insulate the active agent by retarding heat transfer to the active agent within the granule and by maintaining the active agent at a lower temperature than the temperature at the exterior surface of the granule ([0046]). Maltodextrin and sodium sulfate are both used in the coatings of various formulation examples of Table 2. Maltodextrin reads on the polyhydroxy compound of claim 5, while sodium sulfate reads on reads on the fast-dissolving coating of claim 9.
Becker further teaches that the active agent in the granule is one or more enzymes (claim 7), which reads on the bioactive agent of claim 14. Any enzyme may be used, including phytases, proteases, amylases, cellulases, lipases, oxidases, transferases, reductases, hemicellulases, mannanases, peroxidases, and mixtures thereof ([0031]), which read on the enzymes of claims 15.
It would have been prima facie obvious to modify the combined teachings of Mazeaud and DePablo with those of Becker before the effective filing date of the claimed invention by incorporating the maltodextrin of Becker into the protectant matrix comprising the bioactive to yield the instant invention as defined by claim 5. One of ordinary skill in the art would have been motivated to add maltodextrin into the protective matrix comprising the bioactive of Mazeaud and DePablo since maltodextrin reduces the exposure of the active agent to aqueous liquids and helps to thermally insulate the active agent. One of ordinary skill in the art would have had a reasonable expectation of success in incorporating the maltodextrin of Becker into the protectant matrix comprising the bioactive of Mazeaud and DePablo since Becker teaches that maltodextrin is specifically used as a coating for stable granules that comprise a core and an active agent.
It would have been further obvious to modify the combined teachings of Mazeaud and DePablo with those of Becker to provide an additional coating of sodium sulfate on the granules to yield the instant invention as defined by claim 9. One of ordinary skill in the art would have been motivated to incorporate an additional coating of sodium sulfate to the granule since sodium sulfate reduces the exposure of the active agent to aqueous liquids and helps to thermally insulate the active agent as taught by Becker. One of ordinary skill in the art would have had a reasonable expectation of success in incorporating an additional coating of sodium sulfate since Mazeaud welcomes an additional outercoating and Becker teaches that sodium sulfate is specifically used as a coating for stable granules that comprise a core and an active agent. Sodium sulfate is an example of a “fast-dissolving” coating as evidenced by the instant specification. A Na2SO4 coating is “fast-dissolving” as demonstrated by the dissolution testing of example 2 of the instant specification. (p. 21-22). Thus, the sodium sulfate (i.e., Na2SO4) taught by Becker would also be fast-dissolving. "Products of identical chemical composition cannot have mutually exclusive properties." See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding claim 10, Mazeaud teaches preparing the particles via a fluid-bed and spray-coating process, as discussed above (Ex. 1). As such, it would have been prima facie obvious to generate the combined composition in the same manner to give a fluidized bed spray-coated particle.
Regarding claims 11-12, Mazeaud teaches that the bioactive agent is a dehydrated living microorganism. Specifically, the microorganism of example 1 is L. acidophilus NCFM (i.e., Lactobacillus acidophilus NCFM). It would have been prima facie obvious to maintain this microorganism as the bioactive agent in the combined granule.
Regarding claims 14-15, it would have been prima facie obvious to one of ordinary skill in the art to incorporate an enzyme as taught by DePablo or Becker into the combined granule above since enzymes are known and routine in the art as bioactive agents in granules. One of ordinary skill in the art could have substituted one bioactive agent for another in order to predictably generate the instantly claimed granule. It would have been further obvious to use a protease, amylase, cellulase, lipase, mannanase, phytase, oxidase, peroxidase, reductase, or transferase enzyme as recited in instant claim 15, since these are all known and effective enzymes for layered granule products as taught by Becker. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. One of ordinary skill in the art would have had a reasonable expectation of success since DePablo teaches that enzymes can be stabilized by a polyhydroxy/phosphate protectant mixture and Becker teaches enzymes as common actives for layer/coated granules used in feed applications.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Mazeaud, DePablo, and Becker as applied to claims 1-12 and 14-15 above, and further in view of Salas, L. et al. (2017). Antifungal Microbial Agents for Food Biopreservation—A Review. Microorganisms, 5(3), 37, (on record), hereinafter Salas.
The combined teachings of Mazeaud, DePablo, and Becker are discussed above.
Mazeaud further teaches that the dehydrated microorganism of the invention is typically selected from yeasts, molds, fungi, bacteria or any mixture thereof (p. 24, lines 17-18).
The combined teachings of Mazeaud, DePablo, and Becker differ from that of the instant invention in that none explicitly teach wherein the microorganism is Gluconobacter cerinus or Hanseniaspora uvarum as recited in claim 13.
Salas teaches antifungal microbial agents for food biopreservation (title). In past years, many strains from various microbial species that harbor antifungal properties have been identified (section 3, para. 1). A specific study demonstrated that among 55 yeast isolates (Aureobasidium pullulans, Cryptococcus magnus, Hanseniaspora uvarum, Candida zeylanoides, Candida sake, Rhodotorula mucilaginosa, and Pseudozyma aphidis) from the surface of grape varieties, 58% were able to inhibit A. tubingensis growth in vitro (section 3, para. 2). Another study indicated that Hanseniaspora uvarum isolated from grape surfaces acts as a natural preservative acting against the disintegration of gray post-harvest grapes caused by B. cinerea. The same species was active against the green mold P. digitatum that spoils citrus fruits (section 3.2.4, para. 2).
It would have been prima facie obvious to modify the combined composition of Mazeaud, DePablo, and Becker according to the teachings of Salas by using Hanseniaspora uvarum as the microorganism to yield the invention as defined in instant claim 13. One of ordinary skill in the art would have been motivated to incorporate Hanseniaspora uvarum as the microorganism in the combined granule since Hanseniaspora uvarum possesses antifungal properties that make it useful for food biopreservation as taught by Salas. One of ordinary skill in the art would have a reasonable expectation of success in using Hanseniaspora uvarum as the microorganism since Mazeaud teaches that the microorganism may be selected from yeasts. Furthermore, both Mazeaud and Becker teach compositions that are useful as feed products which would reasonably benefit from the inclusion of a biopreserving agent.
Claims 1-16 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Mazeaud, DePablo, Beckers, and Salas as applied to claims 1-15 above, and further in view of 36Ready.com, (2019, February 6). Mylar bags: Step-by-step instructions for Packing Food and emergency supplies. READINESS UNIVERSITY, (on record), hereinafter 36Ready.com.
The combined teachings of Mazeaud, DePablo, Beckers, and Salas are discussed above.
Mazeaud further teaches that viable microorganisms are often inactivated by heat and/or moisture and/or other processing conditions or storage conditions, thereby decreasing their viability in the final product over time, during storage and/or during consumption, in such a way that the desired effect of the final product containing the microorganisms is eventually lost (p. 1, lines 28-32).
The combined teachings of Mazeaud, DePablo, Beckers, and Salas differ from that of the instantly claimed invention in that none explicitly teach wherein the granule is packaged inside a packaging material with a low water vapor transmission rate along with a desiccant, such as a molecular sieve as defined by claims 16 and 18-19.
36Ready.com reaches step-by-step instructions for packing food and emergency supplies in mylar bags (title). Mylar bag food storage is a convenient, easy, and low-cost do-it-yourself way to extend the shelf-life of dry foods (p. 1, para. 1). Today, Mylar bags are the simplest and most cost-efficient do-it-yourself (D-I-Y) method for obtaining long shelf-life (p. 1, para. 3). Mylar bags may also be used for gear storage in order to protect items from moisture or liquid (p. 1, para. 4), indicating that mylar possesses a low water vapor transmission rate. Just before sealing the Mylar bag, 36Ready.com teaches to add a ‘Desiccant’ to gear and moisture-sensitive foods (p. 4, step #3). Desiccants include molecular sieves (p. 4, Desiccant).
It would have been prima facie obvious to modify the combined teachings of Mazeaud, DePablo, Beckers, and Salas with those of 36Ready.com by packaging the combined granule of in mylar bags with a molecular sieve desiccant as taught by 36Ready.com to yield the instant invention of claims 16 and 18-19. One of ordinary skill in the art would have been motivated to package the combined granules in the moisture resistant packaging of 36Ready.com since viable microorganisms present in the granule are often inactivated by moisture during storage and the packaging method of 36Ready.com protects the bag contents from moisture to extend shelf-life. One of ordinary skill in the art would have had a reasonable expectation of success in packaging the combined granule of Mazeaud, DePablo, Beckers, and Salas in a mylar bag with a molecular sieve desiccant since 36Ready.com teaches a step-by-step guide of packaging food or gear in this manner.
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.
1. Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 33 of U.S. Patent No. 6,790,643 B2 in view of DePablo.
The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of DePablo.
Claim 1 of ‘643 recites a granule comprising: an admixture layered over an inert particle, the admixture consisting essentially of; (I) an enzyme, (ii) a corn starch, and (iii) a sugar; and a barrier layer surrounding the admixture. The sugar is further defined as sucrose (claim 33). The granule of ‘643 reads on the layered granule of the instant invention comprising a coating layer comprising a bioactive agent (i.e., an enzyme), distributed within a protectant matrix that comprises a polyhydroxy compound (i.e., a sugar).
The ‘643 claims differ from those of the instant invention in that they do not recite wherein the admixture comprises at least one phosphate compound nor do the ‘643 claims explicitly recite that the components are water soluble or fast-dissolving.
DePablo teaches a protectant mixture for use in preserving biological materials comprising (1) at least one polyhydroxy compound and (2) phosphate ions. A preservation medium comprising the biological material and the protectant mixture is also taught (abstract). The preserved biological material may comprise enzymes (col. 4, lines 50-59). The polyhydroxy compound of DePablo may be sucrose or trehalose (col. 5, lines 25-29; claim 5). The phosphate ions are preferably provided by a mixture of monobasic and dibasic potassium phosphate (i.e., KH2PO4, K2HPO4) (col. 6, lines 34-37).
It is believed that the phosphate ions form a complex with the polyhydroxy compound, which may contain several molecules of the polyhydroxy compound in a three-dimensional supermolecular structure cross-linked by the phosphate ions. The aqueous preservation medium has a much higher viscosity than a system containing the polyhydroxy compound alone in the same amount, and the preserved biological material composition has a higher glass transition temperature (Tg) than a composition containing only the polyhydroxy compound (col. 6, lines 15-28).
Thus, it would have been prima facie obvious to one of ordinary skill in the art to combined the teachings of DePablo with the granule of the ‘643 claims by incorporating the protectant mixture of DePablo into the admixture comprising the enzyme of ‘643. One of ordinary skill in the art would have been motivated to add a phosphate ion source into the admixture of ‘643 which already comprises sucrose in order to generated a polyhydroxy-phosphate complex that better preserves and stabilizes the biological material as taught by DePablo. Regarding the water soluble and fast dissolving properties of the instantly claimed granule, because the composition made obvious by the prior art is identical to the composition claimed, the composition must necessarily have the characteristics claimed as an inherent property. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.
Response to Arguments
Applicant's arguments filed 04/10/2026 have been fully considered but they are not persuasive:
(1) Applicant argues that the claimed functional result now expressly recited in amended claim 1 is not taught or suggested by Mazeaud or DePablo, and that one of ordinary skill in the art would not have a reasonable expectation of achieving that result (p. 1 of Remarks). Applicant asserts that the present specification demonstrates that particles produced using DePablo-type protectant chemistry, when formed as homogenous matrix particles rather than layered granules, dissolve slowly. Importantly, the structural modification introduced by Applicant -- namely, providing a layered granule in which a fast-dissolving core is surrounded by a coating layer comprising the bioactive agent distributed within a thin protectant matrix -- produces a functional result that is neither taught nor suggested by the cited art (p. 2 of Remarks).
In response to the above arguments, it is noted that the prior art is not required to teach the instantly claimed functional result. As discussed in the rejections above, when the composition made obvious by the prior art is identical to the composition claimed, the composition must necessarily have the characteristics claimed as an inherent property. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Applicants reference to the specification is not evidence of non-inherency since particles produced by DePablo-type protectant chemistry are not considered the closest prior art. Applicant argues against DePablo stating that homogenous matrix particles rather than layered granules, dissolve slowly. However, as set forth in the prior art rejections above, Mazeaud is the closest prior art which does in fact teach layered granules. The combined particles of Mazeaud and DePablo are made obvious in a way that retains the layered structure as claimed. Thus, the granule made obvious by the prior art is identical to the granule as instantly defined in claim 1 in both chemical composition and structure, meaning the instantly recited functional result is inherent. Moreover, one cannot show nonobviousness by attacking references individually, such as DePablo alone, 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).
If Applicant means to demonstrate unexpected results regarding the dissolution profile of the instantly claimed granules, an affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. See In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979). In this case, applicant has not provided a comparison to the closest prior art (i.e., the granules of Mazeaud) to sufficiently show unexpected results.
Lastly, there is no requirement for a reasonable expectation of success in providing a specific property, only that there is a reasonable expectation of success in combining or modifying prior art disclosures. See MPEP 2143.02. The modification of structural limitations is then what results in the inherency of a given property, and the motivation to make such a structural modification is not required to be the same as Applicants (i.e., to provide said property). 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 provided no specific arguments or evidence as to why one of ordinary skill in the art would not have a reasonable expectation of success in combining the granules of Mazeaud and DePablo, especially given that both referenced teach methods of preserving biological materials, specifically L. acidophilus, using protectant mixtures of polyhydroxy compounds and phosphate ions.
(2) Applicant argues that Becker does not cure the deficiencies of the Mazeaud-DePablo combination and does not provide any suggestion or motivation that would lead a person of ordinary skill in the art to the claimed invention, particularly in view of the of the dissolution performance now recited in claim 1 (p. 3 of Remarks). Applicant also argues that claims 14-15 do not hinge on the mere selection of enzymes, but on their incorporation into the specific layered granule architecture defined in claim 1 (p. 4 of Remarks).
As discussed above, it is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant (i.e., to provide the instant dissolution profile). See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006). If the instantly claimed structure is made obvious for an given reason and such a structure is identical to the claimed structure, then the structure inherently possesses the claimed property and the claim limitations are met. Furthermore, the limitations taught by Becker (i.e., those defined in claims 5, 9, and 14-15) are not required in instant claim 1 which defines the granule as having a specific dissolution profile. As such, only the structural limitations defined in instant claim 1 are essential for the argument of inherency. Regarding the incorporation of the enzymes into a layered granule, Mazeaud teaches a layered granule comprising bioactive agents. Thus, the substitution of one bioactive for another, made obvious above, would result in the incorporation of enzymes in the layered granule architecture as claimed.
(3) Applicant argues against Salas, stating that Salas is directed to an entirely different context and does not remedy the deficiencies of the Mazeaud-DePablo-Becker combination (p. 5 of Remarks). Applicant states that Salas at most discloses an additional potential microorganism for use as a bioactive agent, but does not supply any missing claim limitation, does not motivated the claimed layered, fast-dissolving granule architecture, and does not render the amended claims obvious (p. 6 of Remarks).
First, Examiner respectfully disagrees that Salas is directed to an entirely different context given that both Mazeaud and Becker teach compositions that are useful as feed products which would reasonably benefit from the inclusion of a biopreserving agent, such as that taught by Salas. Applicant admits that Salas discloses an additional potential microorganism for use as a bioactive agent, which is the very detail for which Salas is relied on for. Salas teaches a known and routine microorganism used in the art. One of ordinary skill in the art would have been motivated to incorporate Hanseniaspora uvarum as the microorganism in the combined granule since Hanseniaspora uvarum possesses antifungal properties that make it useful for food biopreservation as taught by Salas. Furthermore, the simple substitution of one known element for another (i.e., a bioactive microorganism) to obtain predictable results is considered prima facie obvious. See MPEPE 2143. Salas is not required to teach the layered, fast-dissolving granule architecture as claimed since these limitations are made obvious and inherent to the Mazeaud-DePablo-Becker combination.
(4) Applicant argues against 36Ready.com, stating that it is not a technical disclosure concerning bioactive granules, layered particle architectures, dissolution performance, or the interaction between formulation and packaging (p. 6 of Remarks). Applicant asserts that the specification demonstrates that packaging is not a mere afterthought, but interacts with the claimed formulation to preserve both viability and fast dissolution over time – an outcome not disclosed or suggested by the cited art (p. 7 of Remarks).
It is noted that 36Ready.com is not relied on for teaching the bioactive granules, layered particle architectures, or dissolution performance as instantly claimed since such limitations are made obvious and inherent to the Mazeaud-DePablo-Becker-Salas combination. Furthermore, it is not required that 36Ready.com explicitly teach the interaction between formulation and packaging since packaging is not a required component of claim 1 wherein the inherency of the dissolution profile is established. Even so, the ability of packaging to preserve viability and fast dissolution of the instantly claimed formulation is not a surprising or unexpected discovery. Packaging and desiccants are widely known in the art for preserving the properties and functionality of the product within. Given the lengthy discussion of maintaining bioactive agent viability throughout Mazeaud, DePablo, and Becker, it is reasonable that one of ordinary skill in the art would seek out some sort of low moisture packaging system for the combined granules which comprise a bioactive agent.
(5) Applicant argues similarly against the double patenting rejection. Examiners response to such arguments is the same as those above.
Conclusion
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
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