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 .
In view of the notice of appeal filed on May 14, 2026, PROSECUTION IS HEREBY REOPENED. New grounds of rejection are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792
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.
Claims 1, 4, 6, and 10-12 are 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 pre-AIA the applicant regards as the invention.
Claim 1 recites the limitation “culturing the lactic acid bacterium in the medium” in line 5. A step of culturing in the context of a fermented milk cannot occur without a medium. There is insufficient antecedent basis for culturing without the medium. It is unclear if the lactic acid bacterium is required to already be disposed within the medium and then the medium is cultured.
Clarification is required.
Claims 4, 6, and 10-12 are rejected as being dependent on a rejected base claim.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Kuma et al. US 5,466,472 as further evidenced by Pietrangelo “Why You Should Use the Probiotic Lactobacillus Casei” <https://www.healthline.com/health/digestive-health/lactobacillus-casei> (published March 21, 2017) (herein referred to as “Pietrangelo”) in view of Han US 2009/02585936 and Sako et al. US 2012/0329059.
Regarding Claim 1, Kuma et al. discloses a method for producing fermented milk containing a galactooligosaccharide and a lactic acid bacterium (‘472, Column 3, lines 22-40). The method comprises providing a medium comprising the galactooligosaccharide and adding the lactic acid bacterium to the medium and culturing the lactic acid bacterium in the medium (‘472, Column 2, lines 25-32) wherein the lactic acid bacterium is Lactobacillus casei (‘472, Column 2, lines 3-7 and 45-51) wherein the culture comprises a dairy product (‘472, Column 2, lines 45-51). Pietrangelo provides evidence that it was known in the art that Lactobacillus casei or L. casei is a type of living bacteria organism (Pietrangelo, Page 1).
Further regarding Claim 1, Kuma et al. discloses a particular example wherein a culture medium is cooled and starters of Lactobacillus casei was inoculated and cultured and 400 g of commercial oligosaccharide product containing 35% galactooligosaccahrides, 15% galactosyldisaccharides, 12% lactose, and 38% monosaccharides was dissolved in water to make a syrup having a volume of 540 mL and the syrup is mixed and homogenized with 460 ml of the culture broth obtained by the culture to form about 1000 ml of a cultured milk beverage having a viable count of Lactobacillus casei (‘472, Column 5, lines 30-46) (‘472, Column 6, lines 1-6). This equates to a concentration of galactooligosaccharides in the medium of (0.35 galactooligosacharide x400g oligosaccharide product)/1000mL medium of cultured milk beverage = 14 wt% galactooligosaccharide, which falls within the claimed amount of galactooligosaccharide in the medium of 5.0 mass% to 20 mass%. Where the claimed concentration of galactooligosaccharide in the medium encompasses concentrations of galactooligosaccharide in the medium disclosed by the prior art, a prima facie case of obviousness exists in view of 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) (MPEP § 2144.05.I.).
Further regarding Claim 1, Kuma et al. discloses the process comprising providing at least one type of lactic acid bacterium, culturing the lactic acid bacteria, and then adding to the resultant culture a mixture containing galactooligosaccharide (‘472, Column 2, lines 25-32). However, Kuma et al. is silent regarding the claimed order of providing a medium comprising the galactooligosaccharide and then adding the lactic acid bacterium to the medium and then culturing the lactic acid bacterium in the medium.
Han discloses a method for producing a fermented milk containing an oligosaccharide and a lactic acid bacteria (‘936, Paragraph [0008]) comprising providing a medium (milk) comprising the oligosaccharide and then adding the lactic acid bacterium to the medium (inoculating the milk with lactic acid bacteria for fermenting the milk) and then culturing the lactic acid bacterium in the medium (milk) (‘936, Paragraph [0009]).
Both Kuma et al. and Han are directed towards the same field of endeavor of methods of making fermented milk containing an oligosaccharide and a lactic acid bacteria. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of Kuma et al. that provides the medium containing the oligosaccharide and then add lactic acid bacterium that has already been cultured to the medium and perform the processing steps such that the medium comprising the oligosaccharide is initially provided, then lactic acid bacterium is added to the medium, and then the lactic acid bacterium in the medium is cultured as taught by the order of process steps disclosed by Han since the selection of any order of mixing ingredients is prima facie obvious in view of In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (MPEP § 2144.04.IV.C.). Han teaches that it was known in the fermented milk production art to conduct the steps in the claimed order.
Further regarding Claim 1, Kuma et al. discloses using an oligosaccharide mixture commercially marketed under the trade name oligomate 50 by Yakult Yakuhin Kogyo Co. Lt. (‘472, Column 3, lines 16-21), which is similar to the oligomate 55N also manufactured by Yakult (Specification, Paragraph [0014]). However, Kuma et al. modified with Han is silent regarding the osmotic pressure of the medium during the culture being 800 to 1200 mOsm.
Sako et al. discloses a method of making a fermented milk product comprising a galactooligosaccharide (‘059, Paragraph [0079]) wherein the lactic acid bacteria used for the culture broth and the fermented milk food or drink includes Lactobacillus casei (‘059, Paragraph [0043]) wherein the osmotic pressure of a culture is adjusted to take into consideration one or more culture conditions and environmental factors such as osmotic pressure are taken into consideration depending on the bacterial species used wherein the osmotic pressure of the medium during culturing is 150 to 1000 mOsm (‘059, Paragraphs [0030]-[0031]), which overlaps the claimed osmotic pressure of the medium during culturing of 800 to 1200 mOsm. Sako et al. also discloses the osmotic pressure conditions during culture varying within the range of 150 to 1000 mOsm or can be set outside this range (‘059, Paragraph [0031]). Sako et al. also discloses a syrup blended into a bacterial suspension to prepare a milk product having an osmotic pressure of 950 mOsm (059, paragraph [0068]), which falls within the claimed osmotic pressure of the medium during culture being 800-1200 mOsm.
Both modified Kuma et al. and Sako et al. are directed towards the same field of endeavor of methods of making fermented milk products comprising lactic acid bacteria strains of Lactobacillus casei. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of modified Kuma et al. and use an osmotic pressure during culture that falls within the claimed osmotic pressure range as taught by Sako et al. since where the claimed osmotic pressure ranges encompasses osmotic pressure ranges disclosed by the prior art, a prima facie case of obviousness exists in view of 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) (MPEP § 2144.05.I.). Sako et al. teaches that there was known utility in the fermented milk art to use the claimed osmotic pressures during culture for making fermented milk. Furthermore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the osmotic pressure of the medium during culture of modified Kuma et al. since the osmotic pressure of the medium during culture will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such osmotic pressure of the medium during culture is critical. 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 view of In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP § 2144.05.II.A.). Sako et al. establishes the culture conditions can be varied to within an osmotic pressure of 150 to 1000 mOsm or set outside this range and that the environmental factors and condition of a culture broth or food or drink to which bacteria are applied are appropriately selected and used (‘059, Paragraph [0031]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Kuma et al. US 5,466,472 as further evidenced by Pietrangelo “Why You Should Use the Probiotic Lactobacillus Casei” <https://www.healthline.com/health/digestive-health/lactobacillus-casei> (published March 21, 2017) (herein referred to as “Pietrangelo”) in view of Han US 2009/02585936 and Sako et al. US 2012/0329059 as applied to claim 1 as further evidenced by Takahashi et al. US 2021/0068414.
Regarding Claim 4, Kuma et al. discloses the method using Lactobacillus casei (‘472, Column 2, lines 3-7). Applicant discloses examples of lactic acid bacteria which do not substantially assimilate oligosaccharides include Lactobacillus casei (Specification, Paragraph [0027]). Since Kuma et al. teaches the microorganism used to be Lactobacillus casei, which applicant discloses is a type of lactic acid bacterium which does not substantially assimilate oliogosaccharides, the combination of modified Kuma et al. necessarily entails using lactic acid bacterium that does not substantially assimilate tri or higher oligosaccharides. Where the claimed and prior art products are identical or substantially identical in structure or compositions, a prima facie case of obviousness has been established in view of In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977) (MPEP § 2112.01.I.). Products of identical chemical composition can not have mutually exclusive properties in view of In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (MPEP § 2112.01.II.). Since the combination of modified Kuma et al. teaches using the claimed Lactobacillus casei, which applicant discloses is a type of lactic acid bacteria that does not substantially assimilate oligosaccharides, the prior art combination reasonably reads on the claimed properties of the lactic acid bacterium not substantially assimilating tri or higher oligosaccharides. Furthermore, Takahashi et al. provides evidence that it was known in the food and beverage art that Lactobacillus casei is a type of bacteria having low ability or no assimilability of human milk oligosaccharides (‘414, Paragraphs [0045]-[0050]). Therefore, the Lactobacillus casei used in the combination of modified Kuma et al. necessarily reads on the claimed properties of lactic acid bacterium not substantially assimilating oligosaccharides as further evidenced by Takahashi et al.
Claims 6 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Kuma et al. US 5,466,472 as further evidenced by Pietrangelo “Why You Should Use the Probiotic Lactobacillus Casei” <https://www.healthline.com/health/digestive-health/lactobacillus-casei> (published March 21, 2017) (herein referred to as “Pietrangelo”) in view of Han US 2009/02585936, and Sako et al. US 2012/0329059 as applied to claim 1 in further view of Amen et al. US 4,851,239, Oh et al. US 2020/0093148, and Bundus et al. US 4,307,123.
Regarding Claims 6 and 10, Kuma et al. modified with Han and Sako et al. is silent regarding a further oligosaccharide and/or galactooligosaccharide being added after culturing the lactic acid bacterium in the medium containing the galactooligosaccharide.
Amen et al. discloses yogurt products which meet the FDA Standards of Identity are produced by culturing cream, milk or mixture of these optional dairy ingredients using a bacterial culture containing lactic acid producing bacteria (‘239, Column 1, lines 38-46) wherein sugar is used in the initial blend (‘239, Column 5, lines 3-18) and that other optional dairy ingredients and other constituents of the final product can be added such as sugar if the particular formulation calls for the addition of such ingredients both before and after pasteurization (‘239, Column 5, lines 59-67). Oh et al. discloses a method of making fermented milk comprising the steps of culturing a medium containing a lactic acid bacterium and then adding sugar syrup to the cultured medium (solution) (‘931, Paragraphs [0023]-[0024]). Bundus et al. discloses a dairy derived protein system wherein additives such as corn syrup solids, sugars, and agents for promoting culture growth are added before, during, or after culturing as is appropriate (‘123, Column 2, lines 40-48) wherein the sweetener is any edible dry natural or synthetic sweetener including sugars wherein the amount of sweetener utilized is sufficient to adjust the sweetness to the level desired (‘123, Column 3, lines 48-63). Although Amen et al., Oh et al., and Bundus et al. do not explicitly teach the further sugar that is added after culturing to be a further oligosaccharide and/or a further galactooligosaccharide, the primary reference of Sakaibara et al. already teaches the sugar being oligosaccharides such as galactooligosaccharides (‘545, Paragraph [0037]). Bundus et al. also discloses the sweetener used to be any edible natural or synthetic sweetener (‘123, Column 3, lines 48-63).
Modified Kuma et al., Amen et al., Oh et al., and Bundus et al. are all directed towards the same field of endeavor of methods of making fermented dairy product comprising sugars. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of modified Kuma et al. and incorporate a further sugar after the culturing step as taught by Amen et al., Oh et al., and Bundus et al. in order to adjust the sweetness of the final product to the level desired as suggested by Bundus et al. (‘123, Column 3, lines 48-63).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Kuma et al. US 5,466,472 as further evidenced by Pietrangelo “Why You Should Use the Probiotic Lactobacillus Casei” <https://www.healthline.com/health/digestive-health/lactobacillus-casei> (published March 21, 2017) (herein referred to as “Pietrangelo”) in view of Han US 2009/02585936, and Sako et al. US 2012/0329059 as applied to claim 1 above in further view of Kato-Kataoka et al. “Fermented Milk Containing Lactobacillus casei Strain Shirota Preserves the Diversity of the Gut Microbiota and Relieves Abdominal Dysfunction in Healthy Medical Students Exposed to Academic Stress” (Applied and Environmental Microbiology, Volume 82, Number 12) (published June 2016) (herein referred to as “Kato-Kataoka et al.”).
Regarding Claim 11, Kuma et al. discloses the lactic acid bacterium being Lactobacillus casei (‘472, Column 2, lines 3-7). However, modified Kuma et al. is silent regarding the lactic acid bacterium being Lactobacillus casei YIT9029.
Kato-Kataoka et al. discloses a milk beverage fermented with L. casei strain Shirota YIT 9029 wherein the lactobacillus casei strain Shirota is a well known probiotic strain that provides health benefits by balancing the gut microbiota, improving gastrointestinal dysfunction, preventing infection and cancer, and modulating inflammatory and immune responses (Kato-Kataoka et al., Page 3650).
Both modified Kuma et al. and Kato-Kataoka et al. are directed towards the same field of endeavor of methods of making fermented milk beverages with L. casei strains. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of modified Kuma et al. and use a strain of Lactobacillus casei YIT9029 as taught by Kato-Kataoka et al. since the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination in view of Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (MPEP § 2144.07). Kato-Kataoka et al. teaches that there was known utility in the milk fermentation art to utilize the claimed strain of L. casei for making fermented beverages. Additionally, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of modified Kuma et al. and use the specifically claimed L. casei strain of Lactobacillus casei YIT 9029 since Kato-Kataoka et al. teaches that the lactobacillus casei Shirota YIT 9029 strain is a well known probiotic strain that provides health benefits by balancing the gut microbiota, improving gastrointestinal dysfunction, preventing infection and cancer, and modulates inflammatory and immune responses (Kato-Kataoka et al., Page 3650).
Response to Arguments
Applicant’s arguments with respect to the previous obviousness rejections of Claim 1 under 35 USC 103(a) have been considered but are moot because the new ground of rejection does not rely on the combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The current rejection does not rely upon the secondary reference of Hsu et al. to teach the limitations regarding the concentration of galactooligosaccharide in the medium. Instead, Example 2 of the primary reference of Kuma et al. is being relied upon to teach the limitations regarding the concentration of galactooligosaccharide in the medium.
A Non Final Office Action has been issued herein in view of the updated rejection.
It is noted that a new indefiniteness rejection under 35 USC 112(b) has been made as well.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICSON M LACHICA whose telephone number is (571)270-0278. The examiner can normally be reached M-F, 8:30am-5pm, EST.
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/ERICSON M LACHICA/Examiner, Art Unit 1792
Prosecution Insights