Prosecution Insights
Last updated: April 19, 2026
Application No. 18/247,965

READILY DISPERSIBLE SHELF-STABLE MICROBIAL GRANULES

Non-Final OA §103§112§DP
Filed
Apr 05, 2023
Examiner
ARMSTRONG, SUSANNAH SIPPLE
Art Unit
1616
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Danisco US Inc.
OA Round
2 (Non-Final)
29%
Grant Probability
At Risk
2-3
OA Rounds
4y 0m
To Grant
66%
With Interview

Examiner Intelligence

Grants only 29% of cases
29%
Career Allow Rate
4 granted / 14 resolved
-31.4% vs TC avg
Strong +38% interview lift
Without
With
+37.5%
Interview Lift
resolved cases with interview
Typical timeline
4y 0m
Avg Prosecution
59 currently pending
Career history
73
Total Applications
across all art units

Statute-Specific Performance

§101
4.6%
-35.4% vs TC avg
§103
38.1%
-1.9% vs TC avg
§102
13.2%
-26.8% vs TC avg
§112
24.2%
-15.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 14 resolved cases

Office Action

§103 §112 §DP
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 10/23/2025 are acknowledged. Claims 6, 13-14, and 18 are 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. Withdrawn Rejections Claim 1 was rejected under 35 USC 112(b) as being indefinite, upon further consideration and an interview with the Applicant the rejection is withdrawn. Claims 6 and 13-14 was rejected under 35 USC 112(b) as being indefinite. Applicant’s amendment to the claim has overcome the rejection and the rejection is withdrawn. Claim 17 was rejected under 35 USC 112(b) and 103. Applicant’s cancellation of claim 17 has rendered the rejection moot and the rejection is withdrawn. Claims 1-12 were rejected under 35 USC 103 in view of Mazeaud and Becker. Upon further consideration this rejection is withdrawn. Claims 1-15 were rejected under 35 USC 103 in view of Mazeaud, Becker, and Salas. Upon further consideration this rejection is withdrawn. Claims 1-19 were rejected under 35 USC 103 in view of Mazeaud, Becker, Salas, and 36Ready.com. Upon further consideration this rejection is withdrawn. Claims 1-19 were rejected on the ground of nonstatutory double patenting over US Patent No. 6,790,643 in view of Mazeaud. Upon further consideration this rejection is withdrawn. The following rejections are new, as such this action is a second non-final: 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, PTO-892). 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). 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, 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 claimed. 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 nature of the granule components, 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 property 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). 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). The combined teachings of Mazeaud and DePablo differ from that of the instantly claimed invention in neither 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. 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. Becker further teaches that the active agent in the granule is one or more enzymes (claim 7). Any enzyme may be used, including phytases, proteases, amylases, cellulases, lipases, oxidases, transferases, reductases, hemicellulases, mannanases, peroxidases, and mixtures thereof ([0031]). It would have been 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. Regarding claim 9, 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 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 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, (PTO-892), 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 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, (PTO-892), 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 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. Response to Arguments Applicant’s arguments, filed 10/23/2025, with respect to the rejection(s) of claim 1 under 112(b) and 103 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, given the new interpretation of the claims, and upon further consideration, new grounds of rejection is made under 103 which incorporates newly cited DePablo. Thus, Applicant’s arguments with respect to claims 1-19 have been considered but are moot because the new ground of rejection makes up for the previous deficiencies with the teachings of DePablo. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNAH S ARMSTRONG whose telephone number is (571)272-0112. The examiner can normally be reached Mon-Fri 7:30-5 (Flex). 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, Sue X Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616 /Mina Haghighatian/Primary Examiner, Art Unit 1616
Read full office action

Prosecution Timeline

Apr 05, 2023
Application Filed
Jun 05, 2025
Non-Final Rejection — §103, §112, §DP
Aug 29, 2025
Interview Requested
Sep 04, 2025
Examiner Interview Summary
Sep 04, 2025
Applicant Interview (Telephonic)
Oct 23, 2025
Response Filed
Jan 12, 2026
Non-Final Rejection — §103, §112, §DP (current)

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Study what changed to get past this examiner. Based on 3 most recent grants.

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Prosecution Projections

2-3
Expected OA Rounds
29%
Grant Probability
66%
With Interview (+37.5%)
4y 0m
Median Time to Grant
Moderate
PTA Risk
Based on 14 resolved cases by this examiner. Grant probability derived from career allow rate.

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