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
Pursuant to the amendment dated 07/01/2026, claim 11 has been cancelled. Claims 1-6, 9, 10, 12-21, and 23 are pending. Claims 16-21 stand withdrawn with traverse.
Claims 1-6, 9, 10, 12-15, and 23 are under current examination.
All rejections and objections not reiterated have been withdrawn.
In the most recent amendment to the claims, claims 16-21 are marked as “Currently Amended” or “Original”; however these claims are withdrawn and should be marked accordingly. In all future communications the status of the claims must be properly identified. Please refer to MPEP 714(II)(C).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 14 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 14 recites the limitation "particles" in lines 3 and 5. There is insufficient antecedent basis for this limitation in the claim.
Response to Arguments
Applicant’s comment on page 9 of the remarks filed 07/01/2026 that the amendments to the claims have overcome all indefiniteness rejections is noted. In the case of claim 14, the examiner has maintained the rejection for lack of antecedent basis because the particulate structure of the composition has not been expressly introduced in either claim 1 or earlier in claim 14. One way to overcome the rejection would be to introduce that the composition is in particulate form in claim 14, e.g. as follows:
14. (Currently Amended) The spray-dried composition according to claim 1, wherein the composition is in particulate form and, wherein at least one of the following conditions are fulfilled: …
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 1-5, 9-12, 14, 15, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 20180119088; publication date: 03/03/2018) in view of Mortazavian (Iranian Journal of Biotechnology, 5:1-17 (2007); cited in the IDS filed 07/16/2026), and further in view of Knutsen et al. (US 20110104239; publication date: 05/05/2011).
With regard to claim 1, Wang discloses a microparticle formed by spray drying and containing a probiotic bacteria (abstract). The probiotic bacteria comprises one or more Lactobacillus species (0007). The particle may further comprise a prebiotic such as sugars, oligosaccharides, and polysaccharides including maltodextrin, inulin, and trehalose (0045). The particle also contains an encapsulating substance such as alginate (0040). Although Wang’s example microparticles do not contain a prebiotic and are coated with ether caseinate or a caseinate-gum Arabic mixture, the broader teachings of Wang embrace a spray-dried composition comprising Lactobacillus probiotic; oligosaccharide, polysaccharide or protein; and alginic acid (i.e. alginate).
With regard to claim 1, Wang discloses mixtures (i.e. at least two different) of the materials for encapsulation (0040), but does not disclose that the mixtures are formed from the polymers recited in instant claim 1.
Mortazavian, in the analogous art of improving probiotic viability (abstract), teaches that alginate has been widely used to encapsulate bacteria and has many benefits including easily forming gel matrices, low expense, non-toxic, simple and easy to handle (page 3, left col). Mortazavian teaches further that alginate itself has some disadvantages in terms of durability; however, it was known in the art to address these problems by blending with other polymers (page 3, right col).
Knutsen, in the analogous art of probiotic-containing edible products (title: probiotic chewing gum) teaches that shellac is a moisture resistant barrier (0059).
It would have been prima facie obvious select the alginate encapsulation material taught by Wang and blend this with shellac to encapsulation the probiotic bacteria in Wang. The artisan of ordinary skill would have been motivated to use alginate to take advantage of the benefits taught by Mortazavian and to include shellac in a blend with alginate in order to mitigate the drawbacks of alginate and as a means to adjust moisture in the particle. As discussed above, Wang discloses optimizing water activity for probiotic viability in the particle. Including a moisture resistant barrier in the encapsulation material would aid in preventing undesirable moisture loss or absorption. The skilled artisan would have had reasonable expectation of success because shellac was known as of the instant effective filing date to be a useful coating to protect prebiotics.
With regard to the limitations on percentages of probiotic, prebiotic, and coating material recited in instant claims 1 and 2, Wang does not describe the amount of the ingredients in the microparticle in terms of their percent by weight relative to the total weight of the microparticle composition but rather provides ratios of encapsulating material to other ingredients in the microparticle (particularly, a low melting point fat; 0042) and describes the quantity of probiotic in terms of CFU per mL added when combining ingredients to the solution that will be spray dried in examples (0059). This would have given the artisan of ordinary skill a starting point to optimize the handful of ingredients used to form the microparticle, and for this reason the examiner does not consider the percentages of probiotic, prebiotic, and coating material required by the instant claims to patentably define over the cited prior art. Please refer to MPEP 2144.05(II)(A): Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
With regard to claims 3 and 4, as noted above, Wang teaches including the prebiotics maltodextrin, inulin, and trehalose. The examiner notes that the encapsulating material also includes the prebiotic whey protein, thus it also would have been prima facie obvious to include this material in the microparticle.
With regard to claim 5, as discussed supra the genus is Lactobacillus.
With regard to claims 9 and 10, these claims limit the identity of the polymer of acrylic acid and/or acrylates if present; however, as these claims are currently worded they do not require the presence of the recited polymers in the event that the spray-dried composition contains any of the other coating materials. As Wang’s microparticles contain alginate and adding shellac was obvious in view of Mortazavian and Knutsen, these claims read on Wang’s spray-dried microparticles exactly as described for claim 1.
With regard to claim 12, as detailed above, the prebiotics disclosed by Wang are different from the encapsulating materials.
With regard to claim 14, the particles have a smooth, dimpled appearance (Fig 2C, drawing sheet 1; 0069).
With regard to claim 15, Wang discloses an example composition having 0.18 or 0.19 and 0.20 water activity (0092) and provides the teaching that a water activity between 0.11 and 0.23 can prevent cell death during storage, while water activity above this range is related to accelerated mortality of probiotics (0093). Thus, it would have been obvious to formulate the microparticles such that their water activity was between 0.11 and 0.23, which falls within the scope of instant claim 15.
With regard to claim 23, Wang discloses adding probiotics to food (0002), and thus it would have been prima facie obvious to do so.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 20180119088; publication date: 03/03/2018), Mortazavian (Iranian Journal of Biotechnology, 5:1-17 (2007); cited in the IDS filed 07/16/2026), and Knutsen et al. (US 20110104239; publication date: 05/05/2011), as applied to claims 1-5, 9-12, 14, 15, and 23 above, and further in view of Espadaler Mazo et al. (US 20160193260; publication date: 07/07/2016).
The relevant disclosure of Wang is set forth above. Wang does not disclose Lacticaseibacillus rhamnosus GG.
Espadaler Mazo discloses that L. rhamnosus GG was a well-known probiotic (Fig 3) as of the instant effective filing date.
It would have been prima facie obvious to use L. rhamnosus GG as a probiotic in Wang’s spray dried microparticles because it was known for the same purpose as the probiotics disclosed by Wang. See MPEP 2144.06.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 20180119088; publication date: 03/03/2018), Mortazavian (Iranian Journal of Biotechnology, 5:1-17 (2007); cited in the IDS filed 07/16/2026), Knutsen et al. (US 20110104239; publication date: 05/05/2011), and Espadaler Mazo et al. (US 20160193260; publication date: 07/07/2016) as applied to claims 1-6 9-12, 14, 15, and 23 above, and further in view of Li et al. (US 20200236977; publication date: 07/30/2020).
The relevant disclosures of Wang, Mortazavian, Knutsen, and Espadaler Mazo are set forth above and render obvious a spray dried microparticle containing the probiotic Lacticaseibacillus rhamnosus GG, alginic acid as a coating material, and a prebiotic in percentages that would have been optimizable as a matter of routine for one of ordinary skill at the time the instant invention was filed. Wang and Espadaler Mazo do not disclose soluble soybean polysaccharides as a prebiotic.
Li teaches that soluble soybean polysaccharide is a known prebiotic (0025).
It would have been prima facie obvious to use soluble soy polysaccharide as the prebiotic in Wang’s spray dried particles because this substance was known to serve the same purpose as of the instant effective filing date. See MPEP 2144.06.
With regard to the percentages of each component of the claimed spray-dried composition, as explained above, Wang does not describe the amount of the ingredients in the microparticle in terms of their percent by weight relative to the total weight of the microparticle composition but rather provides ratios of encapsulating material to other ingredients in the microparticle (particularly, a low melting point fat; 0042) and describes the quantity of probiotic in terms of CFU per mL added when combining ingredients to the solution that will be spray dried in examples (0059). This would have given the artisan of ordinary skill a starting point to optimize the handful of ingredients used to form the microparticle, and for this reason the examiner does not consider the percentages of probiotic, prebiotic, and coating material required by the instant claims to patentably define over the cited prior art. Please refer to MPEP 2144.05(II)(A): Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Response to Arguments
Applicant's arguments filed 07/01/2026 have been fully considered but they are not persuasive.
On page 10, Applicant argues that Wang broadly lists encapsulating materials and that the list, while including alginate, also includes other materials. Applicant argues further that Want does not disclose a polymer of acrylic acid and/or acrylates and does not disclose shellac. On page 11, Applicant argues further that Wang’s general reference to mixtures of polymers refers to mixtures of the polymers listed by Wang and not the presently claimed combination. On page 11, Applicant cites Wang’s working examples and points out that the examples also do not contain a polymer of acrylic acid and/or acrylates or shellac.
These arguments have been addressed by the new grounds of rejection, above, necessitated by Applicant’s amendment to the claims.
On page 11, Applicant argues that Wang is directed to protecting heat-sensitive biomaterials and that the way in which Wang’s encapsulated probiotic bacteria are protected is materially different from simply selecting an enteric or moisture barrier polymer such as a polymer of acrylic acid and/or acrylates or shellac. Applicant argues that Wang’s stated solution is based on heat absorption by low-melting point fat not the claimed two-polymer coating system. On page 12, Applicant argues further that Wang teaches bacterial cells observed in the sodium-caseinate matrix not in the oil phase and that Wang’s examples are built around a sodium caseinate matrix and nothing in Wang suggests replacing or supplementing that matrix with a coating material comprising at least two different polymers selected from acrylic acid, and/or acrylates, shellac, and alginic acid. Applicant argues that Wang does not describe the amounts of probiotic, prebiotic, and coating materials as weight percentages of the final spray-dried composition but rather provides ratios of low-melting point fat. Applicant asserts that the claimed ranges are not merely an optimization of a known Wang composition, but define a different composition framework in combination with a coating material that Wang does not teach or suggest.
Applicant’s arguments traversing the rejection of claim 1 over Wang based on Wang’s teaching alone are moot as they have been addressed in the new grounds above; however, insomuch as these arguments are relevant to the new grounds of rejection they are addressed as follows: Regarding the purpose of Wang’s invention, the examiner points out that the purpose of the invention, as a whole, is to protect the bacteria, and the prior art teaches that the encapsulating material contributes to this effect (see Mortazavian, abstract: microencapsulation accomplishes improvement of probiotic viability). With regard to Applicant’s discussion of the fat phase in Wang’s particles, the current claims employ open language and do not exclude Wang’s low melting point fat material. With regard to Wang’s silence on a combination of two or more of the specifically claimed polymers, as noted in the rejection above, Wang teaches alginic acid as one of the encapsulating polymers according to their invention (see MPEP 2123: Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).) Additional prior art is now cited to establish that the benefits of blending alginic acid with other polymers had been recognized in the field as of the instant effective filing date. Regarding the amounts of each substance in the claimed invention, "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also In re Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."). See MPEP 2141.03 and 2144.05(II)(A). In the instant case, the benefits of the polymers had been recognized, and arriving at optimal proportions of each polymer to achieve their recognized benefits would not have been inventive within the meaning of 35 USC 103.
On pages 12-13, Applicant argues that Knutsen does not disclose or suggest a coating material comprising at least two different polymers mixed together. On page 13, Applicant argues that Wang mentions alginate and Knutsen mentions shellac but neither teaches mixing them to form the presently claimed coating material.
This argument has been addressed in the new grounds of rejection above.
On pages 13 and 14, Applicant argues that Mazo and Li do not describe the claimed mixture of coating material.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant’s comments regarding withdrawn claim 16 on page 14 of the remarks are noted. As claim 16 is not currently under examination, the remarks are not addressed further at this time.
Conclusion
No claims are 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE PEEBLES whose telephone number is (571)272-6247. The examiner can normally be reached Monday through Friday: 9 am to 3 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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/KATHERINE PEEBLES/ Primary Examiner, Art Unit 1617
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