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 .
DETAILED ACTION
The amendment filed 02/19/2026 has been entered. Claims 8-10 have been cancelled. Claims 20-23 have been newly added. Claims 1-7 and 11-23 are pending and under examination.
Response to Arguments
With respect to the rejection of claim 11 under 35 USC 112(b), Applicant's arguments filed 02/19/2026 have been fully considered and are persuasive. Applicant argues that p. 7 of the instant specification details that the pH decreases as a result of the formation of acid, therefore, one of ordinary skill would understand that a decrease in pH is an inherent result of the method of claim 1. Therefore, the rejection has been withdrawn.
With respect to the rejection of claims 12 and 13 under 35 USC 112(d), Applicant’s arguments filed 02/192026 have been fully considered but they are not persuasive. Applicant argues that the claims further limit the method because claim 1 may be conducted in any number of ways such that the limitations recited in instant claims 12 and 13 do not occur. However, the claims do not recite any additional method steps, therefore it is interpreted that the method of claim 1 inherently results in the limitations recited in instant claims 12 and 13. Unless claims 12 and 13 recite additional method steps they do not further limit the method of claim 1.
With respect to the rejection of claims 1-7 and 11-19 under 35 USC 103, Applicant’s arguments filed 02/19/2025 have been fully considered but they are not persuasive. Applicant argues that the combination of Assarudin and Cevallos fails to teach the limitations of amended claim 1. However, claim 1 has been amended to include the limitations of previously presented claims, which were also rejected under Assarudin in view of Cevallos. Claim 1 has been amended to include a fermentation time and a fermentation temperature, and a cell surface hydrophobicity. Although Asaruddin teaches a fermentation time of 24-48h, MPEP§ 2144.05 II states: “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.")”. The selection of a specific fermentation time would have been a routine matter of optimization on the part of the artisan of ordinary skill, said artisan recognizing that fermentation time would affect fermentation product concentration.
Cell surface hydrophobicity is considered an inherent property of the product produced by the method of claim 1. MPEP§ 2112.01(I) states: Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). The combination of Asaruddin and Cevallos teaches both the composition of instant claim 1 and the method of producing said composition, therefore, cell surface hydrophobicity is considered inherent properties that result from the process taught by modified Asaruddin.
Claim Objections
Claim 13 is objected to because of the following informalities: the claim is missing the word ”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 12 and 13 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 12 and 13 recite inherent features of the composition produced by the method of claim 1 but do not recite any additional method steps. Therefore, the claims fail to further limit the subject matter of the claim from which they depend, i.e., the claims fail to further limit the method of claim 1.
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements.
Claim Rejections - 35 USC § 103
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 1-7 and 11-23 are rejected under 35 U.S.C. 103 as being unpatentable over Asaruddin et al., (US 2017/0304452 A1, previously cited), in view of Cevallos et al., (WO 2015/084531 A1, previously cited)..
Regarding claim 1, Asaruddin teaches a method of preparing an emulsion composition comprising a) a mixing step of mixing coconut oil, lecithin, a co-emulsifier, and deionized water, and b) a fermentation step of permitting fermentation of the mixture obtained in the mixing step (para. [0063]). Asaruddin teaches that the co-emulsifier may be glucose, galactose, mannose, lactose, fructose, maltose, sucrose, xylose, or trehalose (Abstract), which include fermentable carbohydrates. Asaruddin teaches that the microorganism that may be used in the fermentation step include lactic acid bacteria, such as Lactobacillus plantarum (para. [0064]; para. [0065]), which are asporogenous bacteria. Asaruddin teaches that the fermentation time period is 24-48h (para. [0066]) and the fermentation temperature is 10-40˚C (para. [0067]). Asaruddin teaches that the production method may include a step of freeze-drying, i.e., lyophilizing, the aqueous solution obtained in the fermentation step (para. [0063]).
Although Asaruddin teaches a fermentation time of 24-48h, MPEP§ 2144.05 II states: “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.")”. The selection of a specific fermentation time would have been a routine matter of optimization on the part of the artisan of ordinary skill, said artisan recognizing that fermentation time would affect fermentation product concentration.
Asaruddin does not teach that the bacteria are in the form of a cell concentrate.
However, Cevallos teaches a method of producing a stabilized probiotic composition (para. [0001]), and teaches that the probiotic bacteria are grown, washed, and centrifuged to obtain a pellet (para. [0091]), i.e., a cell concentrate, and said pellet is then mixed with a stabilization mixture (para. [0091]).
Cell surface hydrophobicity is considered an inherent property of the product produced by the method of claim 1. MPEP§ 2112.01(I) states: Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). The combination of Asaruddin and Cevallos teaches both the composition of instant claim 1 and the method of producing said composition, therefore, cell surface hydrophobicity is considered inherent properties that result from the process taught by modified Asaruddin.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have concentrated the bacteria, as taught by Cellavos, prior to fermentation with carbohydrate and freeze-drying, as taught by Asaruddin. One of ordinary skill in the art would have been motivated to do so to increase the bacterial concentration and therefore increase fermentation output. One of ordinary skill in the art would have had a reasonable expectation of success because Asaruddin and Cellavos are in the same field of endeavor of probiotic nutritional supplement development.
Regarding claim 2, Asaruddin teaches that the co-emulsifier may be a polyhydric alcohol such as glucose, which is a monosaccharide (Abstract; para. [0032-0033]).
Regarding claims 3 and 22, Asaruddin teaches that the concentration of the co-emulsifier, i.e., the carbohydrate, is 5% to 20% by mass (para. [0036]).
Regarding claim 4, Asaruddin teaches that the co-emulsifier, in addition to the polyhydric alcohol, may contain gum arabic (para. [0035]), i.e., a protective compound.
Regarding claims 5-7 and 23, Asaruddin teaches that the concentration of the co-emulsifier is 5% to 20% by mass (para. [0036]). Although Asaruddin does not specify the concentrations of the individual components of the co-emulsifier, see MPEP§ 2144.05 II. The selection of specific concentrations of the components in the co-emulsifier would have been a routine matter of optimization on the part of the artisan of ordinary skill, said artisan recognizing that the concentrations would have affected emulsion stability.
Regarding claim 11, Asaruddin teaches that the pH of the emulsion composition is between 4.5 and 6.2 (para. [0053]).
Regarding claims 12 and 13, the limitations recited in the claims are considered inherent properties of the product produced by the method of claim 1. See MPEP§ 2112.01(I). The combination of Asaruddin and Cevallos teaches both the composition of instant claim 1 and the method of producing said composition, therefore, isoelectric point, and amount of remaining carbohydrate are all considered inherent properties that result from the process taught by modified Asaruddin.
Regarding claim 14, Asaruddin teaches that the co-emulsifier, in addition to the polyhydric alcohol, may contain gum arabic (para. [0035]), i.e. a protective compound. Asaruddin teaches a) a mixing step of mixing coconut oil, lecithin, a co-emulsifier, and deionized water, and b) a fermentation step of permitting fermentation of the mixture obtained in the mixing step (para. [0063]). Therefore, gum arabic is added to the bacterial culture at the start of fermentation.
Regarding claim 15, Asaruddin teaches that the concentration of the co-emulsifier is 5% to 20% by mass (para. [0036]), which may include a carbohydrate and gum arabic (para. [0035]). Asaruddin does not teach a weight of a cell concentrate. However, Cevallos teaches a protective matrix comprising 11g of probiotic, i.e., a cell concentrate, in a 100g protective matrix comprising a carbohydrate and a protective compound, (page 23, Table 4). Therefore, if 5-20% of the coemulsifier, taught by Asruddin, was mixed with an 11% cell concentrate, as taught by Cevallos, the ratio of carbohydrate + protective compound to cell concentrate would be approximately 0.45:1 to 1.8:1, which falls within the range of the instant claims. It would have been obvious to one of ordinary skill in the art to add the bacteria of Asaruddin in the amount taught by Cevallos, as such is a known suitable amount in the art and therefore the skilled artisan would have reasonable expectation that such amount would successfully form a fermented emulsion for use in a food product, as desired by Asaruddin.
Regarding claims 16 and 17, Asaruddin teaches that the lactic acid bacteria include those belonging to genus Lactobacillus, such as Lactobacillus plantarum (para. [0065], which is the original name for Lactiplantibacillus plantarum.
Regarding claim 18, Asaruddin teaches that the production method may include a step of freeze-drying, i.e., lyophilizing, the aqueous solution obtained in the fermentation step (para. [0063]). Therefore, the lyophilized product of Asaruddin is considered to contain the non-sporulating bacteria. Cevallos also teaches that the stabilization mixture and the Lactobacillus rhamnosus is freeze-dried (para. [0092]).
Regarding claim 19, Cevallos teaches that the concentration of the Lactobacillus in the protective matrix is 1x106 to 1x1014 cfu per gram of the protective matrix (para. [0077]), and teaches that the composition is then freeze-dried (para. [0092]). It would have been obvious to one of ordinary skill in the art to use the bacterial concentration taught by Cevallos in the emulsion-preparation method of Asaruddin. One of ordinary skill in the art would have been motivated to do so because Cevallos teaches that a dried product containing bacteria at the above concentration may be used to form a stabilized probiotic for use in a nutritional product (para. [0093]), while Asaruddin teaches a fermented emulsion that may be used as a food product (para. [0060]).
Regarding claim 20, although Asaruddin teaches a fermentation time of 24-48h. See MPEP§ 2144.05 II. The selection of a specific fermentation time would have been a routine matter of optimization on the part of the artisan of ordinary skill, said artisan recognizing that fermentation time would affect fermentation product concentration.
Regarding claim 21, Asaruddin teaches that the fermentation temperature is 10-40˚C (para. [0067]), which overlaps with the claimed temperature range.
Conclusion
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 RACHEL EMILY MARTIN whose telephone number is (703)756-1416. The examiner can normally be reached M-Th 8:30-16:00, F 8:30-10:00 EST.
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, Louise Humphrey can be reached at (571) 272-5543. 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.
/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/RACHEL EMILY MARTIN/Examiner, Art Unit 1657
Prosecution Insights