DETAILED ACTION
Acknowledgment and entry of the Amendment submitted on 1/28/26 is made.
Claims 1, 3-6, 11, 13 and new claim 18 are currently under examination.
Claims 2, 7-10, 12 and 14-17 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention.
Claims 1, 3-6 and 13 have been amended. New grounds of rejection are included with maintained rejections below pursuant to the amendments.
Priority
The present application claims status as a 371 (National Stage) of PCT/JP2020/038832 filed on October 20, 2021 and claims priority under 119(a)-(d) to Japanese Application No. 2020-176165 filed on October 20, 2020.
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d) for Japanese Application No. 2020-176165, which papers have been placed of record in the file. Please note that the application is in Japanese, and thus, cannot be verified.
Please note that Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Claim Rejections - 35 USC § 112-2nd paragraph
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, 3-6, 11, 13 and 18 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 remains rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of the different ingredients, e.g., honey or celery or perilla or all three or more and any variety of fruits or beans or root vegetables is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: there are vastly different ingredients listed which may be in any number of different combinations and, therefore, would be expected to produce different fermented products.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Response to Applicants’ arguments:
Applicants have argued that the amendments have now clearly delineated subparagraphs and that there are functional alternatives in each group. That has been fully and carefully considered but is not deemed persuasive. The Markush grouping of the different ingredients, e.g., honey or celery or perilla or all three or more and any variety of fruits or beans or root vegetables is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: there are vastly different ingredients listed which may be in any number of different combinations and, therefore, would be expected to produce different fermented products. Unpredictability with regard to natural extracts and probiotics due to their highly complex nature has been well documented. Revilla et al. (J. Agric. Food Chem. (1998), vol. 46, pp. 4592-4597) showed that the slightest variations in polarity of solvent and reaction time upon grape extraction provided respective products with unique characteristic properties (See tables 1, 2, 4, 5, 6 and 7 in Revilla). In turn, each product would possess varying pharmacological properties based upon their respective methods of extraction. Thus, the functional property of an extract of beeswax bloom as an anti-inflammatory is not considered to be predictable because the type of extraction used to produce the extract would have a significant impact on the chemical characteristics of the extract. Raskin et al (Current Pharma. Design. 10, 3419-3429, 2004) teaches that multi-component botanical therapeutics also present unique challenges in identifying their active ingredients and in validating their clinical effects. Activity-guided fractionation and reconstitution experiments currently used to characterize compound interferences within a mixture are cumbersome and time consuming…..While chromatographic analysis is often employed to produce biochemical fingerprints used for product comparison…..in the absence of information about the identity of active ingredients, such analysis is hardly reliable, since chromatography provides an incomplete picture of the qualitative and quantitative comparison of a complex extract (p. 3426, col. 2 – p. 3427, col. 1) emphasis added.
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.
Claim(s) 1, 3-6, 11, 13 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matsuura et al (WO 98/001042 A1, January 1998; provided by Applicants, which corresponds to US Patent No. 6,395,315; filed 3/10/98); note the paragraph numbering below is from the US Patent, in view of Sun et al (US 20130302454 A1).
Matsuura recites in the abstract:
Fermented and aged fruits such as apples, persimmons, bananas, pineapples, akebia, silvervine, figs, wild strawberries, wild vines, Myrica, and Ume (Japanese apricot), citrus fruits such as Navel oranges, Hassaku oranges, Mandarin oranges, Sour oranges, Iyokan oranges, kumquats, citrons, Kabosu oranges, shaddocks, Ponkan oranges, and lemons, edible roots such as Burdock, carrots, garlic, lotus root, and lily bulbs, grains such as brown rice, glutinous rice, polished rice, millet, corn, wheat, barley, and Foxtail millet, beans and sesames such as soybeans, black soybeans, black sesame, white sesame, and walnuts, seaweed [kelp] such as Konbu, Wakame, Hijiki, and Laver, saccharides such as brown sugar as lump, fructose, and glucose, as well as honey, starch, cucumbers, Perilla, and celery are used as food quality improvers.
Matsuura et al discloses a fermented composition composed of specific components and an amino acid composition and obtained by fermenting and aging the following components: one or more fruits selected from among apples, persimmons, bananas, pineapples, akebia, silver vine, figs, wild strawberries, strawberries, wild vines, grapes, Myrica, peaches, Japanese apricots, blueberries, and raspberries; one or more citrus fruits selected from among navel oranges, Hassaku oranges, mandarin oranges, summer oranges, oranges, iyokan oranges, kumquats, yuzu, kabosu oranges, shaddocks, ponkan oranges, lemons, and limes; one or more edible roots selected from among burdock, carrots, garlic, lotus roots, and lily bulbs; one or more grains selected from among brown rice, glutinous rice, polished rice, millet, corn, wheat, barley, foxtail millet, and sawa millet; one or more beans and sesames selected from among soybeans, black soybeans, black sesame, white sesame, azuki beans, and walnuts; one or more seaweeds selected from among konbu, wakame, hijiki, aonori, and kawanori; one or more saccharides selected from among brown sugar, fructose, and glucose; and one or more selected from among honey, starch, cucumbers, perilla, and celery (in particular, claim 1). Moreover, Matsurra also indicates that: ginger may be added (in particular, p. 16); and when the fermented composition is used to raise cattle, pigs, and the like, abnormal fermentation of intestinal bacteria is restored to normal and the health thereof is maintained, and thus the cattle, pigs, and the like are less likely to get sick (in particular, p. 21). Paragraph 11 of Matsurra recites that the composition (as recited in the abstract and above):
12) Per 100 g primary component:
(13) water: 5.0 g to 50.0 g
(14) protein: 0.5 g to 10.0 g
(15) lipids: 0.05 g to 10.00 g
(16) carbohydrates (non-fibrous carbohydrates): 30.0 g to 75.0 g
(17) carbohydrates (fiber): 0.1 g to 5.0 g
(18) ash: 0.15 g to 5.0 g
(19) .beta.-carotene: 10 .mu.g to 150 .mu.g
(20) Retinol potency: 10 IU to 100 IU
(21) Vitamin B.sub.1 : 0.01 mg to 0.50 mg
(22) Vitamin B.sub.2 : 0.01 mg to 0.50 mg
(23) Vitamin B.sub.6 : 0.01 mg to 0.50 mg
(24) Vitamin E: 10.0 mg or less
(25) niacin: 0.1 mg to 6.0 mg
(26) calcium: 50 mg to 900 mg
(27) phosphorus: 200 mg or less
(28) iron: 1.0 mg to 5.0 mg
(29) sodium: 20 mg to 300 mg
(30) potassium: 300 mg to 1000 mg
(31) magnesium: 40 mg to 200 mg
(32) NaCl deduced from Na content: 0.05 g to 1.00 g
(33) copper: 7.0 ppm or less
(34) Of 100 g amino acid composition:
(35) isoleucine: 30 mg to 200 mg
(36) leucine: 50 mg to 400 mg
(37) lysine: 20 mg to 200 mg
(38) methionine: 10 mg to 150 mg
(39) cystine: 10 mg to 100 mg
(40) phenylalanine: 30 mg to 250 mg
(41) tyrosine: 20 mg to 200 mg
(42) threonine: 40 mg to 200 mg
(43) tryptophan: 1 mg to 100 mg
(44) valine: 30 mg to 300 mg
(45) histidine: 10 mg to 200 mg
(46) arginine: 40 mg to 400 mg
(47) alanine: 50 mg to 300 mg
(48) aspartic acid: 100 mg to 600 mg
(49) glutamic acid: 100 mg to 1200 mg
(50) glycine: 30 mg to 300 mg
(51) proline: 40 mg to 400 mg
(52) serine: 30 mg to 300 mg
Claim 1 of Matsurra include fruits or the like, specific components, and an amino acid composition, and are the same “constituents” set forth in claim 1 of the present application. Matsuurra only differs in that it does not explicitly indicate that the fermented composition is a "prebiotic food" or the use of mulberries. However, paragraph (95) recites: the present invention contains the aforementioned fermented composition as an active component and paragraph (96) Specific examples include food product quality improvers, growth promoters, feed, fertilizer, and foods and drinks. The term “prebiotic food product” is an intended use only. A recitation of the intended use of the claimed invention (product) must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Applicants have amended claim 1 to recite that the fermented composition is also obtained by the fermentation and maturation of mulberries which is included to the laundry list of other possible ingredients. The instant specification at Paragraph [0052] recites: The present invention provides a prebiotic food product that mainly contains a fermented composition obtained by performing fermentation and maturation of the above-mentioned fermented composition by adding one or more among a mulberry, a ginger or a loquat to the ingredients, consists of the above-mentioned constituents and amino-acid composition.
Sun et al teaches a method for preparing fermentation broth of fruits and vegetables. [0021] The fruits and the vegetables refer to a mixture of following 54 kinds of fruits and vegetables, which are [0022] konjak, eggplant, asparagus, spinach, bean sprout, broccoli, cabbage, radish, cucumber, peas, red pepper, celery, scallion, garlic, grapes, grapefruit, watermelon, peach, tangerine, blue berry, sweet orange, banana, litchi, balsam pear, leek, pomegranate, pitaya, carrot, tomato, Chinese cabbage, parsley, bell pepper, lettuce, pear, ginger, taro, kidney bean, pumpkin, lotus root, cherry, kiwi fruit, plum, strawberry, fig, kumquat, mandarin orange, Nanguo pear, cantaloup, Hami melon, papaya, onion, mulberry, sugar beet, and lemon. Claim 1 recites A method for preparing fermentation broth of fruits and vegetables comprising steps of: mixing fruits, vegetables, bacteria liquid of Lactobacillus acidophilus, bacteria liquid of Bifidobactreium longum, bacteria liquid of Lactobacillus delbrueckii subsp. bulgaricus, and bacteria liquid of Streptococcus thermophilus, and processing fermentation to obtain a fermentation product, i.e., the fermentation broth of fruits and vegetables. Claim 4 recites the method, as recited in claim 1, wherein the fruits and the vegetables refer to a mixture of 54 kinds of fruits and vegetables, which are konjak, eggplant, asparagus, spinach, bean sprout, broccoli, cabbage, radish, cucumber, peas, red pepper, celery, scallion, garlic, grapes, grapefruit, watermelon, peach, tangerine, blue berry, sweet orange, banana, litchi, balsam pear, leek, pomegranate, pitaya, carrot, tomato, Chinese cabbage, parsley, bell pepper, lettuce, pear, ginger, taro, kidney bean, pumpkin, lotus root, cherry, kiwi fruit, plum, strawberry, fig, kumquat, mandarin orange, Nanguo pear, cantaloup, Hami melon, papaya, onion, mulberry, sugar beet, and lemon.
Accordingly, it would have been prima facie obvious to one of ordinary skill in the probiotic art that mulberries could be used as the fermentation product in the compositions as taught by Matsurra, as Sun teaches their use was well known in the prior art at the time the invention was made in very similar product such as instantly claimed. Dependent claims 3-6, 11, 13 and 18 describe functional abilities of the claimed fermented product only. Since the identical fermented compositions in the claims are recited by Matsuurra and Sun, they would inherently possess the same functionality.
Double Patenting
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, 3-6, 11, 13 and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/271,235 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims only differ in that they do not explicitly indicate that the fermented composition is a "prebiotic food", e.g., the fermented compositions are identical and have the same list of “constituents”/ components per 100 g. The term “prebiotic food product” as instantly claimed and the “plant vitality adjuvant” of the co-pending claims are intended uses only. A recitation of the intended use of the claimed invention (product) must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Accordingly, the scope of the claims are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Status of claims:
No claims are presently allowed.
Prior art not presently relied upon:
Document 2: 管理栄養士による「万田酵素 ジンジャー」の効果解説. [online], 13 August 2020, [retrieved on 14 December 2021], , nonofficial translation (Registered Dietitian Comments on Effects of "Manda Koso Ginger".), in particular, p. 5
Commercially available Manda Koso ginger, that "it is a point of attention related to improving bowel movement that dietary fiber is mentioned as a grain-type raw material. Dietary fiber increases the bulk of feces and promotes defecation, and can also serve as food for lactic acid bacteria or bifidobacteria serving as a prebiotic, and thus helps improve the intestinal environment" (in particular, p. 5).
Document 3: 発酵食品を食生活に取り入れたいと思う人が9割以上 腸内環境を整える効果を期待す る声が多数. [online], 19 May 2020, [retrieved on 14 December 2021], , non-official translation (At Least 90% Say They Want to Make Fermented Foods a Part of Their Dietary Life: Many Expect Effect of Regulating Intestinal Environment.), in particular, p. 4, indicates that "an experiment in which nine Japanese people ingested 5 g of a "fermented plant extract" per day was conducted for two weeks, and as a result, it was found that bifidobacteria, which are good bacteria that regulate the intestines, tended to increase" (in particular, p. 4).
Document 4 4: 短鎖脂肪酸に注目! 不足すると腸内環境が悪化. [online], 17 April 2019, [retrieved on 14 December 2021], , nonofficial translation (Pay Attention to Short-Chain Fatty Acids! Deficiencies are Bad for Intestinal Environment.), in particular, p. 1, indicates that "bifidobacteria", which are representative good bacteria in the large intestine, produce "short-chain fatty acids" using dietary fiber or the like as food" (in particular, p. 1).
That is, it can be said that it was known prior to the priority date of the present application that commercially available Manda Koso is a prebiotic; the dietary fiber contained in the Manda Koso serves as food for lactic acid bacteria or bifidobacteria, and thus improves the intestinal environment; bifidobacteria tend to increase; and bifidobacteria produce short-chain fatty acids. Consequently, a person skilled in the art could easily use the fermented plant composition disclosed in document 1 in a method of administration as a prebiotic food, and increase bifidobacteria in the intestine and increase short-chain fatty acids by ingesting the fermented plant composition. Moreover, even considering the specification of the present application, the examples merely indicate that a culture medium containing a fermented plant composition increases bacteria present in human feces and the bacteria produce short-chain fatty acids, and does not indicate that bifidobacteria in the intestine increases and short-chain fatty acids are produced in humans who ingest the fermented plant composition, thus the effect of the present invention would be obvious.
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.
Correspondence regarding this application should be directed to Group Art Unit 1645. Papers related to this application may be submitted to Group 1600 by facsimile transmission. Papers should be faxed to Group 1600 via the PTO Fax Center located in Remsen. The faxing of such papers must conform with the notice published in the Official Gazette, 1096 OG 30 (November 15,1989). The Group 1645 Fax number is 571-273-8300 which is able to receive transmissions 24 hours/day, 7 days/week.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer E. Graser whose telephone number is (571) 272-0858. The examiner can normally be reached on Monday-Friday from 8:00 AM-4 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Thomas Visone, can be reached at (571) 270-0684.
Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-0500.
/JENNIFER E GRASER/ Primary Examiner, Art Unit 1645 4/23/26
Prosecution Insights