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 Application
Receipt of the Response and Amendment after Non-Final Office Action filed June 18, 2026 and June 26, 2026 is acknowledged.
The status of the claims upon entry of the present amendments stands as follows:
Pending claims:
1, 3-7, 10, 12-13, 16
Withdrawn claims:
6-7
Previously canceled claims:
None
Newly canceled claims:
2, 8-9, 11, 14-15
Amended claims:
1
New claims:
None
Claims currently under consideration:
1, 3-5, 10, 12-13, 16
Currently rejected claims:
1, 3-5, 10, 12-13, 16
Allowed claims:
None
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3-5, 10, 12-13, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Komeda (US 2008/0096266)(IDS Reference filed 12/01/2023) in view of Amano (JP 2017079683 A)(IDS Reference filed 06/18/2025).
Claims 1 and 3 are product-by-process claims. MPEP §2113 states “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). “The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product.”
Regarding claim 1, the structure imparted by the process of claim 1 is a tea beverage including JCM5805.
Regarding claim 1, Komeda teaches a drink having lactic acid bacterium resistant to high-temperature heat treatment and polyphenols, where the drink is a tea drink that is packed in a sealed container (i.e., packaged; [0020]). Komeda also teaches that the polyphenols are mixed with extract solutions of tea selected from green tea to make a drink ([0042]). Komeda also teaches that the concentrations of polyphenols in the present invention are in a range of 50 to 130 mg/100 mL ([0031]), which falls within the claimed range of “10 mg or more/ 100 mL”. Komeda also teaches subjecting drinks to high-temperature heat treatments ([0011]) and that high-temperature heat treatments include sterilization at 50°C or higher ([0029]), which overlaps with the claimed range of “heating to 100°C or higher”).
Komeda also teaches that lactic acid bacterium is added to the drink at an amount of 109 to 1011 bacteria per 100 g of drink ([0020]). Because tea is primarily water, one of ordinary skill would reasonably presume that the density of a tea beverage is approximately that of water, which is 1 g/mL. Thus, the lactic acid bacteria would be added to Komeda in an amount of 109 to 1011 (1 billion to 100 billion) bacteria per 100 mL of drink, which encompasses the claimed range of “6 billion to 60 billion bacteria/100 mL”).
With respect to the overlapping ranges, MPEP §2144.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Komeda does not teach the tea beverage comprising JCM5805.
However, in the same field of endeavor, Amano teaches a packaged beverage ([0001]) comprising JCM5805 as the lactic acid bacteria in the drink ([0025]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the drink of Komeda with the use of JCM5805 as the lactic acid bacteria as taught by Amano. One of ordinary skill would have been motivated to make this modification because Amano teaches that the JCM5805 stain killed bacteria in the beverage composition ([0025]).
Regarding claim 3, the structure imparted by the process of claim 3 is a tea beverage.
Regarding claim 3, Komeda teaches subjecting the drink to high-temperature heat treatment ([0011]) and that high-temperature heat treatments include sterilization at 50°C or higher ([0029]), which overlaps with the claimed range of “heating to 111°C to 150°C”). Although Komeda does not teach that the high-temperature heat treatment has an F0 value of 1 to 40, the product of Komeda is patentably indistinct from that of the claimed invention. The required F0 value does not result in a structurally different product.
Regarding claims 4 and 10, Komeda also teaches that the concentrations of polyphenols in the present invention are in a range of 50 to 130 mg/100 mL ([0031]), which falls within the claimed range of “10 mg/100 mL to 200 mg/100 mL”.
Regarding claims 5, 12, 13, and 16, Komeda teaches that the polyphenols are mixed with extract solutions of tea selected from green tea to make a drink ([0042]).
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
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 1, 3-5, 10, 12-13, 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-5, 10-16 of copending Application No. 18/281,985 (reference application), hereinafter ‘985. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 1, 4, and 10, ‘985, claim 1 recites a heat-treated packaged tea beverage with a polyphenol concentration of 10 to 200 mg/100 mL and lactic acid bacteria. Although ‘985 claim 1 does not specify the type of lactic acid bacteria, it would have been obvious to include JCM5805. ‘985 claim 2 further recites the amount of lactic acid bacteria included in the composition, which falls within the range of instant claim 1. ‘985, claims 3 and 4 further recite the lactic acid bacteria strain, which matches that of the instantly claimed invention. Although the instant claims do not recite the pH of the tea composition, it would have been obvious to adjust the pH of the instant tea composition to be that of ‘985.
Regarding claim 3, this is a product-by-process limitation. The composition of ‘985 would be patentably indistinct from that of instant claim 3.
Regarding claims 5, 12, 13, and 16, ‘985, claims 5 and 12-16 also recite wherein the packaged tea beverage is a packaged green tea beverage or a packaged black tea beverage.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Claim Rejections – 35 U.S.C. §103 of claims 1-5 and 8-16 over Komeda and Amano: Applicant’s arguments filed June 18, 2026 and June 26, 2026 have been fully considered but they are not persuasive.
Applicant argued that Komeda does not teach the JCM5805 strain and thus does not teach the content of JCM5805, and that the lactic acid of Komeda in the examples of Komeda is outside the range of the claimed invention (Remarks filed 6/18/26, p. 6, ¶ 7- p. 2; Remarks filed 06/26/26, p. 2, ¶ 2-7).
This argument has been considered. However, the Examiner maintains that one of ordinary skill would have found it obvious at the time of the filing of the instant application to use JCM5805 as taught by Amano as the lactic acid in an amount taught by Komeda. One of ordinary skill would have been motivated to make this modification because Amano teaches that the JCM5805 stain killed bacteria in the beverage composition ([0025]). The Examiner maintains that one of ordinary skill would have had a reasonable expectation of success in adding JCM5805 as the lactic acid used in the composition of Komeda absent evidence to the contrary. Additionally, it is noted that the examples discussed by the Applicant are not relied upon in the prior art rejection. The Examiner maintains that tea is primarily water, one of ordinary skill would reasonably presume that the density of a tea beverage is approximately that of water, which is 1 g/mL. Thus, the lactic acid bacteria would be added to Komeda in an amount of 109 to 1011 (1 billion to 100 billion) bacteria per 100 mL of drink.
Applicant further argued that a skilled person would not combine Komeda with Amano because Komeda relates to an invention of stabilizing an anti-allergenic activity of lactic acid bacteria whereas Amano relates to an invention of suppressing flavor deterioration (Remarks 6/18/26, p. 8, ¶ 3).
This argument has been considered. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, JCM5805 is a lactic acid bacteria useful in drinks ([0025]). Thus, one of ordinary skill would have found it obvious to include it in the beverage of Komeda.
Applicant also argued nothing in Komeda or Amano discloses or suggests the paper odor caused by a tea component can be suppressed by including JCM5805 and that it would not have been possible to predict the such a subject matter would provide the effect (Remarks 6/18/26, p. 8, ¶ 4).
This argument has been considered. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., paper odor) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Additionally, MPEP §2112.01 states where the claimed and prior art 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 declaration under 37 CFR §1.132 filed June 26, 2026 (hereinafter “Declaration”) is insufficient to overcome the rejection of the claims based upon Komeda and Amano as set forth in the office action.
MPEP §716.01(c)(III) states “In assessing the probative value of an expert opinion, the examiner must consider:
The nature of the matter sought to be established,
The strength of any opposing evidence,
The interest of the expert in the outcome of the case, and
The presence or absence of factual support for the expert’s opinion.”
Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 227 USPQ 657 (Fed. Cir. 1985), cert. denied, 475 U.S. 1017 (1986)
The Declaration seeks to establish that Komeda does not disclose the claimed concentration of bacteria (Declaration, p. 2).
Regarding the strength of the opposing evidence, Applicant provided data to demonstrate that Examples 1-3 of Komeda result in a bacteria concentration of 62 billion cells /100 mL (Disclosure, p. 2-3). However, the 35 USC 103 rejection of the claims does not rely upon Examples 1-3 of Komeda. Komeda teaches that lactic acid bacterium is added to the drink at an amount of 109 to 1011 bacteria per 100 g of drink ([0020]). Because tea is primarily water, one of ordinary skill would reasonably presume that the density of a tea beverage is approximately that of water, which is 1 g/mL. Thus, the lactic acid bacteria would be added to Komeda in an amount of 109 to 1011 (1 billion to 100 billion) bacteria per 100 mL of drink, which overlaps with the claimed range of “6 billion or more bacteria/100 mL).
Although the data provided by the Applicant does demonstrate that specifically Examples 1-3 contain more than the claimed concentration of bacteria, MPEP §2123(I) states “A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments.” Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989) and “The court held that the prior art anticipated the claims even though it taught away from the claimed invention. ‘The fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed.’” Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998).
Thus, the strength of the opposing evidence is not sufficient to overcome the rejection of the claims over Komeda and Amano.
Regarding the interest of the expert in the outcome of the case, the Declaration is submitted by Kiichi Yokoyama. Although Yokoyama is not listed as Inventor, Yokomaya does work for the Applicant, and is thus an interested party. An affidavit of an applicant as to the advantages of their claimed invention, while less persuasive than that of a disinterested person, cannot be disregarded for this reason alone. Ex parte Keyes, 214 USPQ 579 (Bd. App. 1982); In re McKenna, 203 F.2d 717, 97 USPQ 348 (CCPA 1953).
Regarding the presence or absence of factual support for the expert’s opinion, it has been found that the statement is unsupported by the provided evidence. Although the data provided by the Applicant does demonstrate that specifically Examples 1-3 contain more than the claimed concentration of bacteria, the 35 USC 103 rejection of the claims does not rely upon Examples 1-3 of Komeda.
Double Patenting Rejections – Claims 1-5, 8-16 on the ground of nonstatutory double patenting over claims 1-5, 10-16 of copending Application No. 18/281,985 (reference application).
Applicant argued that claim 1 of ‘985 is directed to suppressing liquid color degradation during heat sterilization whereas the instant claim 1 is directed to suppressing paper odor caused by a tea component and a JCM5805 (Remarks 6/18/26, p. 9, ¶ 2-4).
This argument has been considered. In response to applicant's argument that the reference application does not have certain features of the invention, it is noted that the features upon which applicant relies (i.e., paper odor) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Thus, the double patenting rejection of the claims in maintained.
The rejections of claims 1, 3-5, 10, 12-13, 16 have been maintained herein.
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 Amanda S Hawkins whose telephone number is (703)756-1530. The examiner can normally be reached M-Th 8:00a-4:00p, F 8:00a-1:00p ET.
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/A.S.H./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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