DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims 27-32 have been examined on the merits.
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 27-32 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.
The claims amended recite “wherein the equol and ornithine are present in a fermented substance obtained by fermenting a material containing at least one daidzein compound selected from the group consisting of daidzein glycosides, daidzein and dihydrodaidzein,the fermenting is by Lactococcus garvieae, and the material is at least one selected from the group consisting of soybean hypocotyl and soybean hypocotyl extract.”
An extract of soybean hypocotyl extract can be a daidzein compound itself. Thus, the scope is unclear since the material may be daidzein itself, i.e. an extract of soybean hypocotyl.” Therefore the recitation “a material containing at least one daidzein compound selected from the group consisting of daidzein glycosides, daidzein and dihydrodaidzein” is unclear.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claim(s) 27-32 are rejected under pre-AIA 35 U.S.C. 102 (a) as being anticipated by JP2006296434A as evidenced provided by Takuya et al. (JP2010098962A).
JP teaches a composition containing lactic acid bacterium, specifically Lactococcus 20-92, which is capable of producing equol. See abstract. JP teaches fermenting a substrate that contains daidzein or daidzein containing substances which the bacterium can assimilate daidzeins in the soymilk to produce equol. This substrate used include “soybean flour, boiled soybean, tofu fried, soy milk, soybean hypocotyl extract and the like, and fermented preparations thereof such as natto, soy sauce, miso, tempeh, fermented soy beverage, and the like.” The composition may be in the form of beverages including juice (apple or orange), milk, dairy including yogurt”.
The cited evidentiary reference of Takuya ‘962 teaches that lactic acid bacteria have the property of converting arginine to claimed ornithine. ‘962 states that “It is known that soybean, rice… used as raw materials for miso contain relatively large amount of arginine, which is a precursor of ornithine (for example, fermenting the soybean product in lactic acid bacteria to convert the arginine contained within the soybean into the claimed composition active ingredient of ornithine) (see ‘962 entire reference, e.g. under Best Mode).
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 27-32 are rejected under pre-AIA 35 U.S.C. 102 (a) and (e) as being anticipated by US PGPUB 20060148045 as evidenced provided by Takuya et al. (JP2010098962A).
US ‘045 teaches a a lactic acid bacterial strain belonging to the genus Lactococcus having an ability to utilize at least one daidzein compound selected from the group consisting of daidzein glycosides, daidzein, and dihydrodaidzein to produce equol. See abstract. Specifically Lactococcus 20-92 is taught. [0012]. The composition is in the form of a beverage or milk product. [0014]. which is capable of producing equol. US ‘045 teaches fermenting a substrate that contains daidzein or daidzein containing substances which the bacterium can assimilate daidzeins in the soymilk to produce equol. This substrate used includes “soybean and soybean process product including soybean hypocotyl extract”. [0070]. Also note soybean include the hypocotyl. The species taught are limited such that the use of soybean hypocotyl extract is immediately envisaged. The composition may be in the form of beverages including juice (apple or orange), milk, dairy including yogurt. [0093] and [0095]
The cited evidentiary reference of Takuya ‘962 teaches that lactic acid bacteria have the property of converting arginine to claimed ornithine. ‘962 states that “It is known that soybean, rice… used as raw materials for miso contain relatively large amount of arginine, which is a precursor of ornithine (for example, fermenting the soybean product in lactic acid bacteria to convert the arginine contained within the soybean into the claimed composition active ingredient of ornithine) (see ‘962 entire reference, e.g. under Best Mode).
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 27-32 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by WO2005000042 as evidenced provided by Takuya et al. (JP2010098962A).
WO 2005000042 teaches a composition comprising equol producing Lactococcus garvieae 20-92.. The bacterium is taught to have the ability to metabolize daidzein compound using soy as a substrate to produce equol. See abstract. ]. Note since WO teaches daidzein, this reads on soybean hypocotyl extract; however the reference also teaches the use of soybean hypocotyl extract. The composition may be in the form of beverages including juice (apple or orange), milk, dairy including yogurt.
The cited evidentiary reference of Takuya ‘962 teaches that lactic acid bacteria have the property of converting arginine to claimed ornithine. ‘962 states that “It is known that soybean, rice… used as raw materials for miso contain relatively large amount of arginine, which is a precursor of ornithine (for example, fermenting the soybean product in lactic acid bacteria to convert the arginine contained within the soybean into the claimed composition active ingredient of ornithine) (see ‘962 entire reference, e.g. under Best Mode).
Claim Rejections - 35 USC § 102/103
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 the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless -
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e),(f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 27-30 are rejected under under pre-AIA 35 U.S.C. 103(a) as obvious over Ishikawa et al. (JP11012172, translation provided herein) as evidenced by Kimura (US 20090311353) and/or Takuya et al. (JP2010098962A) in further view WO 2005000042
Ishikawa ‘172 teaches a processed soybean product containing daidzein (See e.g. para 0008-0009), wherein the soybean product can be fermented soybean obtained by inoculating lactic acid bacteria and bifidobacteria into soybean milk and fermenting soybean and that fermented soymilk is preferable (See e.g. para 0009). Ishikawa further teaches that the product is a Helicobacter pylori inhibitor and can contain vitamin C (ascorbic acid, See ‘172 e.g. para 009; and which is instantly claimed in claim 29). ‘172 teaches using any soy product as long as it contains isoflavones and saponins. [0009]. Note since ‘172 teaches daidzein, this reads on soybean hypocotyl extract. Moreover, ‘172 teaches any part of the soybean may be used, thus absent evidence to the contrary, the use of the hypocotyl is obvious in light of the prior art.
Ishikawa further teaches that the formulation can be a liquid food such as liquid foods such yogurt and the active can be in the formulation in an amount of about 0.01 to 100 mg per day for an adult. It is preferably about 0.1 mg to 5 g per day for an adult, orally or parenterally once or several times a day (See e.g. para 0009). Consequently, the instantly claimed composition (as a yogurt beverage) comprising a fermented soybean product of the clamed active ingredients appears to be anticipated by the reference composition (as a yogurt beverage) comprising a fermented soybean product of the claimed active ingredients.
The cited evidentiary reference of Kimura ‘353 teaches that the claimed soybean product inherently contains the claimed soybean isoflavones such as daidzein and equol (see paragraph 0003) for example, the claimed soybean inherently contains the claimed composition’s active ingredient of equol and the fermented soybean inherently contains the claimed composition’s active ingredient of daidzein. The instant specification also provides evidence of such.
Furthermore, the cited evidentiary reference of Takuya ‘962 teaches that lactic acid bacteria have the property of converting arginine to claimed ornithine. ‘962 states that “It is known that soybean, rice… used as raw materials for miso contain relatively large amount of arginine, which is a precursor of ornithine (for example, fermenting the soybean product in lactic acid bacteria to convert the arginine contained within the soybean into the claimed composition active ingredient of ornithine) (see ‘962 entire reference, e.g. under Best Mode).
Although Ishikawa does not expressly teach that the fermented soybean beverage yogurt product contains ornithine and equol, the claimed functional ornithine and equal are inherent to the fermented soy yogurt because soybeans inherently contain daidzein and Ishikawa teaches that daidzein is found in the soybean ferment, equol is naturally found in soybeans and ornithine is a fermentation product of soy fermented with a lactic acid bacteria and/or bifidobacteria the ingredients are one and the same as disclosed in the instantly claimed invention of Applicant and as evidenced by Kimura (US 20090311353) and/or Takuya et al. (JP2010098962A) discussed above. Thus, equol and ornithine are inherent to the yogurt soybean fermented product taught by Ishikawa. If applicant contends that the two components, ornithine and equol are not inherent, Applicant must provide evidence of such in light of the evidence provided that these two components are inherent and in light of the prior art teaching the same process, i.e using a lactic acid bacterium with a soybean substrate containing daidzein compounds.
Although Ishikawa does not specify the lactic acid strain, the use of any lactic acid strain to produce the composition comprising equol and ornithine is considered obvious since the composition produced is one that contains fermented substance comprising equol and ornithine and the bacteria is metabolizes the daidzein compound. However, in the interest of compact prosecution, WO 2005000042 is cited to show Lactococcus garvieae was known in the art to metabolize daidzein compound using soy as a substrate. See abstract. Thus, it would have been obvious for one of ordinary skill in the art to utilize any bacterium to facilitate the fermentation process.
Response to Arguments
Applicants' arguments presented within the 09 September 2024 reply concerning the previous art rejection of record are deemed moot in view of the new grounds of rejection set forth above.
Conclusion
No claim is allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHARMILA G. LANDAU whose telephone number is (571)272-0614. The examiner can normally be reached Monday-Friday 7-3:30.
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/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653