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 the Claims
Claims 1-10 and 12-16 are pending.
Claims 1-6 are withdrawn from consideration as directed to a non-elected invention.
Claims 7-10 and 12-16 are presented for examination and rejected as set forth below.
Claim Interpretation
Applicants claims are directed to methods of making microcapsules wherein a composition containing a combination of denatured whey protein and an active agent is extruded into a curing bath to form microparticles of an active agent in a denatured whey protein matrix, removing the microcapsules from the curing bath and drying the microparticles under vacuum twice. Claim 8 specifies that the active agent is to be a probiotic. Claims 9, 10, and 15 require that the microcapsules are dried to a particular water activity, which applicants specification indicates is a function of the partial vapor pressure of water in a substance divided by the standard state partial vapor pressure of water. Art describing drying microparticles to obtain a dry powder will be considered by the examiner as having all water removable from such a composition removed, and therefore having no water present, thereby addressing the water activity limitations of the claims. Claims 12-14 specify parameters under which the vacuum drying is to be performed. Claim 16 indicates the microparticles are to be treated by pasteurization or exposure to ultra high temperatures.
Response to Amendment
The Declaration of inventor Bleiel under 37 CFR 1.132 filed 17 February 2026 is insufficient to overcome the rejection of amended claims 7-10 and 12-16 based upon the teachings of Bleiel, Yulia, and Fang, either alone or in further combination with McLaughlin as set forth in the last Office action because while applicants data demonstrates some improvement in properties obtained by the repetition of the drying processes, the improvement shown amounts to what a skilled artisan would expect to see from duplicating drying steps of encapsulated probiotics.
Applicants are reminded that once a prima facie case of obviousness is established, the burden shifts to the applicant to come forward with arguments and/or evidence to rebut the prima facie case. In re Dillon, 919 F.2d 688, 692, 16 USPQ2d 1897, 1901 (Fed. Cir. 1990). Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Here, applicants attempt to assert that the repetition of a drying step taught by the art leads to an unexpected improvement in the consistency of particles, reduction in moisture and water content, and viability of the probiotics so encapsulated. The data demonstrates an improvement in each of these properties. In re Soni, 54 F.3d 746, 751 (Fed. Cir. 1995) (establishing that when an applicant demonstrates substantially improved results ... and states that the results were unexpected, this should suffice to establish unexpected results in the absence of evidence to the contrary). However, it must be understood that repeating a drying step suggested by the art would be expected to reduce both the moisture and water content of the encapsulates, as this is the purpose of exposing an encapsulated pharmaceutical to a drying step. See In re Skoll, 523 F.2d 1392, 187 USPQ 481, 484 (CCPA 1975)(indicating that i)f an applicant merely submits evidence to establish the obtention of a result which would have been expected based upon the knowledge of the worker in the art, the evidence merely buttresses the Examiner’s case for obviousness). Furthermore, it is well understood that decreasing the moister level or water content of probiotic formulations preserves both the activity and survival of dried probiotics. See Chalat Santivarangkna, Storage Stability of Probiotic Powder in Advances in Probiotic Technology, Petra Ger & Chalat Santivarangkna, eds., pg.291-92, CRC Press (2015)(indicating that stability increases with decreasing moisture content of probiotic powders and that probiotics with water activity levels of about 0.1 should be practically low enough for long-term storage). As such, the Examiner cannot agree that the results provided by Declarant/Inventor represent unexpected results, and the arguments predicated on this showing are unpersuasive.
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 7-10 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Bleiel (U.S. PGPub. 2019/0022180), in view of Yulia (WO2008/017962), and Fang (WO2012/142153).
Bleiel describes microencapsulates of dairy proteins. (Abs.). Denatured whey protein is identified by Bleiel as a suitable protein for such use. [0023; 0100-01]. Bleiel indicates that these microcapsules are to be used for any of a variety of reasons, including but not limited to inducing satiety, promoting weight loss, treating obesity, glycaemic management, promoting insulin secretion, reducing blood sugar, stimulating the ileal brake and regulating insulin in subjects to which they are administered, but also serving to protect any active agents contained within the core of the particles from digestion while transiting through the stomach environment. [0021; 0040-45; 0075]. Bleiel creates these microcapsules by extruding a solution to form microdroplets which are then cured in a gelling bath before being washed and filtered to remove un-reacted components. [0046-48; 0137-41]. Bleiel indicates that the strength of the microencapsulates significantly increases as a function of drying, but does not specify that the drying is under vacuum, nor are particular dryness parameters described. [0168].
Yulia also describes the formation of microencapsulates possessing gelled protein shells providing a stable coating on the microcapsule surface. (Pg.33). Yulia indicates that drying these capsules employing any number of dehydration methods known in the art provides advantages in the form of the resulting composition being a free-flowing powder. (Pg.30, 32).
Fang indicates that the vacuum drying of the instant claims is a means of obtaining powdered extruded microcapsules of denatured whey protein containing probiotics. [071-73; 0110]. Fang indicates that the presence of moisture has deleterious effects on the shelf-life of probiotics, and that encapsulation, as well as combining probiotics with whey proteins serves to provide enhanced digestive stability to the probiotic bacteria so formulated. [007-09; 048]. Fang also indicates that these steps to stabilization lead to improved performance during subsequent processing steps including pasteurization of Claim 16. [010].
It would have been prima facie obvious to have combined denatured whey protein and probiotics, extruded such a mixture into microdroplets to enter a gelling bath, then filtered the resulting microcapsules and vacuum dried and pasteurized the resulting microcapsules to obtain a dehydrated, free-flowing powder per the method steps of the present claims. This is because the art at the time the present application was filed recognized that denatured whey proteins not only serve as an active agent encapsulating carrier, but that probiotic bacteria encapsulated by such gelling proteins are thereby protected from degradation in the gastric environment. Extruding denatured whey protein compositions to form microencapsulates of active agents by their being cured in a gelation bath is also a well-known means of providing such encapsulates. Filtration and drying, such as by vacuum drying, are also well-known methods of obtaining dehydrated active agents microencapsulated and in the form of free-flowing powders. While the art does not specify the particular water activity of Claims 9, 10, and 15, by indicating the benefits associated with dehydration to provide a free flowing powder of strong encapsulates as well as improvement in storage stability of such probiotics, the art establishes that the degree of desiccation of these probiotic microcapsules is a result-effective variable, rendering the parameters of the present claims little more than the result of optimization through routine experimentation within the parameters established by the art. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that 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 addition, while the art does not specify the repetition of drying steps, applicants are reminded that simply duplicating elements has no patentable significance unless a new and unexpected result is produced. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). Where, as here, the art establishes the benefits associated with drying microcapsules under vacuum to provide stable dehydrated free-flowing powders, repeating such a drying step imparts no patentable distinction and in fact would be expected to further remove stability-impacting moisture levels.
Claims 7-10 and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Bleiel, Yulia, and Fang as applied to claims 7-10 and 15-16 above, and further in view of McLoughlin (C.M. McLoughlin, et al, Microwave-Vacuum Drying of Pharmaceutical Powders, 21 Cry. Tech. 1719 (2003)).
Bleiel, Yulia, and Fang, discussed in greater detail above, suggest the presently claimed method of extruding microdroplets into a curing bath, isolating the cured microcapsules and vacuum drying the resulting microencapsulates. None of Bleiel, Yulia, and Fang, however, specify agitation of such microcapsules during the drying step, nor is a particular vacuum pressure identified as suitable for obtaining such dehydrated microcapsules.
However, McLoughlin indicates that pressures from 1-26 kilopascals, corresponding to 10-260 mBar, are employed in the drying of pharmaceutical powders, a range overlapping and therefore rendering obvious those of the present claims. (Pg.1721), see also In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”).
It would have been prima facie obvious to have performed the vacuum drying suggested by the combined teachings of Bleiel, Yulia, and Fang at a pressure overlapping the ranges of the instant claims owing to the fact that the art as evidenced by McLaughlin teaches that vacuum drying of pharmaceutical agents has been performed at a range overlapping that of the instant claims.
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 7, 9, and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 and 23-25 of copending Application No. 18/019,954 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘954 application anticipate those of the present application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 7 and 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 14 of copending Application No. 18/832,837 in view of Fang as discussed in greater detail above. While the copending ‘837 application employs a plant protein rather than whey protein, Fang establishes that the use of denatured whey protein is known to protect probiotics when used to encapsulate them in the manner recited by the ‘837 claims, making the substitution of a denatured whey protein for the plant protein of the copending application prima facie obvious. See In re Sernaker, 702 F.2d 989, 994-95 (Fed. Cir. 1983) (“The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination.”).
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 17 February 2026 have been fully considered but they are not persuasive.
Applicants initial arguments address, piecemeal, the teachings of each of the relied-upon references without properly considering the knowledge each of these individual references contribute to the skilled artisan’s understanding of the probiotic encapsulation and desiccation art, considered as a whole. Applicants are reminded that it is not possible to establish the non-obviousness of an invention rendered obvious by the combined teachings of multiple prior art references by arguing that each of the references relied upon fails to teach the entirety of the invention which has been claimed; the absence of a single anticipatory reference is implied by both the reliance on the combined teachings of multiple references as well as the fact that the rejection being made is one of obviousness under 35 U.S.C. 103 rather than any of the subsections of 35 U.S.C. 102. MPEP § 2145(IV), see In re Keller, 642 F.2d 413, 426 (C.C.P.A. 1981) (citing Application of Young, 403 F.2d 754, 757 (C.C.P.A. 1968) (indicating that "[O]ne cannot show non-obviousness by attacking references individually where ... the rejections are based on combinations of references"). As such, applicants discussion of what each of the Bleiel, Yulia, Fang, and McLoughlin references teach, considered in a vacuum in the manner applicants set forth, are unpersuasive.
Applicants assert that the Fang reference, relied on by the examiner to establish that vacuum drying was a drying process known at the time of the instant application’s filing, in fact teaches that vacuum drying was a purification process to be employed with probiotic formulations. The entirety of the relevant section of Fang, paragraph [0110], is reproduced below.
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Contrary to applicants assertion, the teachings of Fang establish that certain specified techniques for processing, not solely purifying, these probiotic formulations include “drying (e.g., spray, freeze drying, vacuum, etc.)” as processing steps available to the skilled artisan.
The probative value of the Bleiel declaration has been discussed above and will not be duplicated here.
Applicants arguments concerning the double patenting rejections effectively fail to put forth an argument concerning their propriety, or assert the same unpersuasive arguments concerning the obviousness of these claims as set forth above, and as a result these rejections are maintained.
For at least these reasons, applicants arguments are unpersuasive.
Conclusion
No Claims are allowable.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
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, Ali Soroush can be reached at (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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