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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/8/2026 has been entered.
Claims 1, 19, 22, 23, 25-30, 32-37, 39-42 are pending.
Claims 28, 29, 34, 35 are withdrawn.
Claims 1, 19, 22, 23, 25-27, 30, 32, 33, 36, 37, 39-42 have been considered on the merits herein.
It should be noted that the application is now under examination by a new Examiner.
New rejections of record necessitated by amendment and consideration by new Examiner
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 42 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 42 depends from claim 1, which requires 35-95% of the particles to have a size not larger than 200 µm; however, claim 42 states that at least 85% of the particles have a size with falls within the range of 32-500 µm. Thus, it is not clear how, if at the very least, 35% of the particles are not larger than 200 µm, 85% of the particles could be 500 µm according to claim 42, and thus greater than 200 µm required by claim 1.
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.
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.
Claim(s) 1, 23, 25-27, 37, 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2013133903 to Kamler et al.
WO’903 teaches an ingestible nutritional powder formulation designed for delivery to a user’s mouth having good delivery, flavoring and sensory experience (abstract). The formulation is designed to have at least 50% of the particles having a size of about 20-220 microns (p. 2, lines 3-29), with greater than 50-95% having a size between 20-100 microns (p. 6, whole page).
Regarding claims 1, the formulation comprises a sweetener, a flavor compound including a natural flavoring agent (p. 4, lines 21, 22, p. 14, lines 15-27), an antioxidant (p. 14, lines 12-13, p. 20, lines 18-21), an acidulant, i.e. acidity regulator (p. 2, lines 24-29), and a plant oil extracts including eucalyptus (p. 3, lines 32-33, p. 21, lines 24).
Regarding claims 1 and 25, the sweetening agents include sorbitol, erythritol, mannitol, and xylitol, for example (p. 15, lines 10-13).
Regarding claim 1, 26 and 27, the dry powder formulation includes at least one probiotic bacterium including Lactobacillus acidophilus, L. paracasei, L. plantarum, L. reuteri (ATCC 55730, DSM17938), L. rhamnosus, L. johnsonii (NCC533) (p. 20, lines 30-p. 21, lines 1-7).
The formulation comprises citric acid (p. 4, line 13, p. 15, lines 25-32).
The flavoring agents may include those which is preferred by the user, which increases flavors or perception of flavor and may include fruit flavors, or sweet or mint flavors (p. 15, lines 16-24, p. 27, lines 1-8) and may be present in amounts ranging from 0.04-4%, for example (see Table 4-6, 8, Ex. 15C). (Applicants specification includes flavors compounds as aroma compounds (0032)).
Regarding claims 1, 23, the formulation may comprise magnesium oxide (p. 16, lines 22) in amounts up to 17% w/w (Table 14).
Regarding claim 37, the formulation comprises the plant oil extract eucalyptus (p. 3, lines 32-33, p. 21, lines 24)
While the reference does not specifically teach 4-8% of magnesium oxide, they do teach up to 17% which is optimizable and dependent upon the amounts of other composition components present in the composition.
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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also 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 2144.05
Claim(s) 19, 22, 30, 32, 39-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2013133903 to Kamler et al. as applied to claims 1, 23, 25-27, 37, 42 above, and further in view of WO2008/039531 to Hodal et al. (IDS) and Ritter et al. (US20150087616 A1).
The teachings of WO’903 are found above.
WO903 differs from the claimed invention in that it does not teach the limitations of claims 19, 22, 30, 32, 39-41.
Regarding claim 19 and 22, WO’531 teaches a powder composition (0029) comprising probiotic bacterium combined with a carrier comprises of at least two sugar alcohols selected from xylitol, erythritol, lactitol, maltitol, mannitol and sorbitol, wherein the combination provides for maximum stability and viability under storage conditions (0022-0024, 0030). The composition may further include silicon dioxide (0025).
Regarding claim 32, 40, WO531 teaches a powder composition (0029) comprising probiotic bacterium combined with a carrier comprises of at least two sugar alcohols selected from xylitol, erythritol, lactitol, maltitol, mannitol and sorbitol, wherein the combination provides for maximum stability and viability under storage conditions (0022-0024, 0030).
Regarding claim 32, 39, 41, the carrier is present in the composition in amounts ranging from 30-98% w/w (0055, Table 1, 3, 6, for example).
The probiotic bacterium includes L. acidophilus, L. casei, L. paracasei, L. plantarum, and L. rhamnosus in amounts of 106-10 colonies (0026, 0065).
The composition comprises a flavoring agent (Table 3, 0076, for example).
Ritter teaches a powder (0018) probiotic composition comprising L. rhamnosus GG ATCC53013 and B. lactis BL-04 (0199) wherein the probiotic bacteria is present in amounts of 0.5-20% w/w of the composition (0203), sweeteners including xylitol, sorbitol, mannitol, maltitol, and like sugar alcohols (0296), magnesium oxide (0018-0021), silicon dioxide to inhibit clumping (0018-0021, 0216), about 1% w/w citric acid (0018-0021, 0278, 0299) and flavors including fruit juice powders in amounts of about 2% (0226, 0300).
Thus, before the effective filing date of the claimed invention, probiotic compositions comprising the claimed amounts of probiotic bacteria per dose together with silicon dioxide and sweeteners including xylitol and erythritol were known. It would have been obvious to a phosita to add silicon dioxide and a mixture of erythritol and xylitol in the claimed amounts in a powder probiotic nutritional composition of WO903 in light of the teachings of WO531 and Ritter because at least two sugar alcohols are taught by WO531 to provide stability and viability to the probiotic composition under storage conditions and silicon dioxide is added to prevent clumping in the composition. Thus, one of ordinary skill in the art would have motivated by the teachings of the prior art to combine the components each taught to have beneficial properties and effect within a probiotic composition
Further, and specifically regarding the limitations of claim 32, WO903 teaches a powder probiotic composition comprising a live probiotic bacteria selected from Lactobacillus and Bifidobacterium, sweeteners including erythritol and xylitol, magnesium oxide up to 17%, thus overlapping within applicants claimed range of 4-7% of claim 32, citric acid, and at least an aroma/flavor compound in amounts ranging from 0.04-4% falling within applicants claimed range of 1-5% aroma compound of claim 32, wherein the particles have a particle size of less than 200 micrometers.
WO903 does not teach the claimed amount of sweetener.
WO531 teaches a powder composition (0029) comprising probiotic bacterium combined with a carrier comprises of at least two sugar alcohols selected from xylitol, erythritol, lactitol, maltitol, mannitol and sorbitol, wherein the combination provides for maximum stability and viability under storage conditions (0022-0024, 0030).
Regarding claim 32, the carrier is present in the composition in amounts ranging from 30-98% w/w (0055, Table 1, 3, 6, for example).
The probiotic bacterium includes L. acidophilus, L. casei, L. paracasei, L. plantarum, and L. rhamnosus in amounts of 106-10 colonies (0026, 0065).
The composition comprises a flavoring agent (Table 3, 0076, for example).
Thus, WO531 provides motivation of using both xylitol and erythritol together in a probiotic composition in the claimed amounts as addressed above.
The above references do not teach the claimed amount of citric acid of claim 32, nor the specific probiotic bacteria of claim 32.
Ritter teaches a powder (0018) probiotic composition comprising L. rhamnosus GG ATCC53013 and B. lactis BL-04 (0199) wherein the probiotic bacteria is present in amounts of 0.5-20% w/w of the composition (0203), sweeteners including xylitol, sorbitol, mannitol, maltitol, and like sugar alcohols (0296), magnesium oxide (0018-0021), silicon dioxide to inhibit clumping (0018-0021, 0216), about 1% w/w citric acid (0018-0021, 0278, 0299) and flavors including fruit juice powders in amounts of about 2% (0226, 0300).
Thus, before the effective filing date of the claimed invention, all the claimed elements were known in the prior art, i.e. specific probiotic strains, sweeteners, the use of magnesium oxide and citric acid and aroma compounds for use in probiotic compositions, thus a phosita could have combined the elements as claimed by known methods with no change in the respective functions and combination would have yielded nothing more than predictable results. Additionally, the combined art reference teach amounts which meet or overlap with applicants claimed ranges of claim 32, thus adding in amounts according to the teachings of the prior art and the claims would have been obvious to one of ordinary skill in the art. See MPEP2144.05 In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range.")
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2013133903 to Kamler et al as applied to claims 1, 25-27, 37, 42 above, and further in view of WO2013/185941 to Collado et al. (IDS).
The teachings of WO’903 are found above.
The reference differs from the claimed invention in that it does not claim 33.
Collado teaches powder products containing probiotic microorganisms wherein the powder product is a free-flowing powder with particles size between 30µm to 200µm (p. 10 lines 30-31, see claim 10). Collado teaches the probiotic can be selected from Lactobacillus rhamnosus GG (see Ex. 2 on page 11). Collado teaches the composition to comprise at least 107 CFU of the live probiotic bacterium (p. 6, lines 15-18).
Regarding claim 33, Collado teaches the water activity is reduced to between 0.1 and 0.25 Aw and having 5-10% moisture level (see page 10 lines 20-25). Collado teaches its methods are an improved methodology for the production of dried powder products containing probiotics (see page 2 lines 13-15) and that its methods do not subject the probiotic to high temperatures and log reduction of the live microorganisms is typically no more than 1 (see page 2 lines 18-21).
Thus, before the effective filing date of the claimed invention, powder probiotic compositions and methods for making said compositions to have low water activity and moisture levels were known in the art. A phosita would have been capable of applying the known method for making dry powder compositions (having low water levels) of Collado to the composition of WO903 and the results would have been predictable to one of ordinary skill in the art.
Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2013133903 to Kamler et al. in view of WO2008/039531 to Hodal et al. (IDS) and Ritter et al. (US20150087616 A1) as applied to claims 1, 19, 22, 23, 25-27, 30, 32, 37, 39-42 above, and further in view of Ebel (US20090196921).
The teachings of WO2013133903 to Kamler et al. in view of WO2008/039531 to Hodal et al. (IDS) and Ritter et al. (US20150087616 A1) are found above.
While the references teach the compositions to comprise fruit aroma/flavor components, they do not specifically teach honeydew melon aroma of claim 36.
Ebel teaches a powder (0233) probiotic composition comprising 104-14 CFU of live probiotic bacterium including Lactobacillus and Bifidobacterium (0035-0039), sweeteners including sorbitol, xylitol, and erythritol at amounts of 0.001% to 90% (0205, 0206-0208), and extracts of fruit specifically honeydew melon as natural ingredients (0190) at amounts of 0.01% to 10% (0188). Ebel teaches the composition to comprise buffering agents such as citric acid to regulate pH within an environment (0210). Ebel teaches the amount of buffer can vary depending on the agent used and effect desired in the finished product and one of ordinary skill in the art can readily make such determinations (0211).
Therefore, before the effective filing date of the claimed invention, it would have been obvious to chose a desired flavoring/aroma to add to a composition. Fruits including honeydew melon flavorings/aroma were known and used in probiotic composition and thus, it would have been within the purview of one of ordinary skill in the art to pursue known options within his or her technical grasp.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIFFANY MAUREEN GOUGH whose telephone number is (571)272-0697. The examiner can normally be reached M-Thu 8-5.
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, Melenie Gordon can be reached at 571-272-8037. 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.
/TIFFANY M GOUGH/ Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651
Prosecution Insights