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
Summary
The response and amendments filed on 12/22/2025 is acknowledged. Claims 1-2 and 4-32 are pending, claims 6-8, 13-15, 22 and 25-26 remain withdrawn and while claims 1-2, 4-5, 9-12, 16-21, 23-24 and 27-32 are examined herein and rejected.
Modified REJECTIONS
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2, 4-5, 9-12, 16-19, 21, 23-24 and 27-32 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claim(s) recite(s) ‘a method of reducing blood pressure in a human comprising orally administering to the human a single composition comprising NO2- and an acid; wherein the acid is one or more of citric acid, ascorbic acid, and acetic acid’ which reads on eating a beet salad or eating cabbage or sauerkraut. This judicial exception is not integrated into a practical application because the act of
ingesting a single composition (i.e. a salad or fruit smoothie) which necessarily results in
lowered blood pressure does not add a meaningful limitation to the method. The
claim(s) do not include additional elements that are sufficient to amount to significantly
more than the judicial exception because nitrites and acids are found naturally in food
products and the results of a diet rich in fruits and vegetables is necessarily lower blood
pressure. The instant claims do not contain anything significantly more than what is
found in natural food products which are ingested by humans via a normal healthy diet
which results in lower cardiovascular risk and lowered blood pressure. For example, Smiechowska teaches that beets, carrots, cabbage, sour cabbage, black currants, etc. all contain various amounts of NaNO2 and also vitamin C (i.e. ascorbic acid) (Tables 2-5). According to Appel et al the diet rich in vegetables and fruit is known to treat and lower blood pressure both systolic and diastolic (abstract, diets pg 1118, Table 1, 1121-1122).
Therefore the instant claims read on nothing more than eating a beet salad or
sauerkraut or drinking black currant juice the end result of lower blood pressure is a
natural phenomenon of eating a DASH type diet or a combination diet with > amounts of
fruit and vegetables. Further Houston et al teaches that juice powder concentrates are
known to decrease systemic blood pressure (abstract).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 3-4, 9-12, 16-21, 23-24 and 27-32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Houston et al as evidenced by Smiechowska and Toldam-Anderson.
Houston et al teaches the oral intake of a capsule to effectively treat high blood
pressure and lower cardiovascular risk (abstract, method). Capsules contained a
phytonutrient mix of fruits, vegetables, and berries “including: acerola cherry, apple,
beet, bilberry, blackberry, black currant, blueberry, broccoli, cabbage, carrot, cranberry,
Concord grape, elderberry, kale, orange, papaya, parsley, peach, pineapple, raspberry,
red currant, spinach and tomato.” As evidenced by Smiechowska many of these beets,
carrots, cabbage, sour cabbage, black currants, etc. all contain various amounts of
NaNO2 and also vitamin C (i.e. ascorbic acid) (Tables 2-5), whereas Toldam-Anderson shows that black currants additionally contain malic acid and citric acid. Houston shows that both systolic and diastolic blood pressure were lowered in Tables 1 and 3. Further it is noted that many of the above fruits and vegetables in the capsules are known to contain polyphenols since they are the same ones instant claimed.
Claims 1-2, 3-4, 9-12, 16-21, 23-24 and 27-32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Appel et al as evidenced by Smiechowska.
Appel et al teach that blood pressure both systolic and diastolic is lowered by the
eating of more than 3 servings of vegetables and more than 5 servings of fruits for a
total of 8-10 servings combined a day (abstract, table 1 and 5, pg. 1122). According to
Appel et al the blood pressure was reduced in those eating a strict DASH diet and even
more so in those eating a combination diet that just included more than the 2.5 avg
vegetable servings that a typical American diet has (pg. 1121-1122, Table 4 and Fig. 1).
Appel teaches by increasing the intake of vegetables and fruit that blood pressure is
lowered such that drug monotherapies are not needed (pg. 1123). According to Smiechowska numerous fruit and vegetables have both nitrite (NaNO2) and also acid in
them not limited to but including apples, black currants, carrots, beets, cabbage,
tomatos, greens, sour cabbage, etc all contain various amounts of
NaNO2 and also vitamin C (i.e. ascorbic acid) (Tables 1-5). As such eating a diet rich in
vegetables and fruit would necessarily include nitrite and acid with polyphenols and the
method is anticipated by the eating of a salad or smoothie.
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 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.
Claims 1-2, 4-5, 9-12, 16-21, 23-24 and 27-32 are rejected under 35 U.S.C. 103 as being unpatentable over by Houston et al as evidenced by Smiechowska and Toldam-Anderson et al and further in view of Gladwin et al.
In the instance that the claims are not anticipated they are then obvious over the
above cited references as the combination of various vegetables and fruits in a single
meal would necessarily result in the intake of nitrite and acid which is known to
decrease both systolic and diastolic blood pressure.
Appel et al does not specifically link nitrite and acid to the ‘lowered blood
pressure’ but just increased intake of fruits and vegetables which necessarily have
nitrite and acid in them as affirmed by Smiechowska. Other acids other than vitamin C
were not studied by Smiechowska.
Further Gladwin confirms that increasing nitrite intake is known to reduce blood
pressure when administered orally (title, abstract, claims) and claims state that sodium
nitrite is a known salt to administer.
As such it would have been obvious to one of ordinary skill at the time of filing
that increasing the intake of fruits and vegetables rich in nitrite and acids and
polyphenols are known to reduce blood pressure. The combination of a known method
of reducing blood pressure with various naturally occurring fruits and vegetables
concentrates in a capsule with the known method of reducing blood pressure with nitrite
would necessarily yield lowered blood pressure since the fruits and vegetables of the
concentrate capsules of Houston contain the same components of nitrite, acid such as ascorbic acid (i.e. Vitamin C) and polyphenol naturally. The combination of 2 known methods for the same purpose for a 3rd formulation or enriched composition which would necessarily treat blood pressure would be obvious to the skilled artisan at the time of filing.
Response to Arguments
Applicant's arguments with respect to claims 1-2, 4-5, 9-12, 16-21, 23-25 and 27-32 have been considered but are not persuasive in light of the above modified rejections necessitated by applicants’ amendments.
Applicant argues that ‘administration of a single nutritional supplement composition comprising…a nitrite …an acid’ wherein the acid is now one of ascorbic acid, acetic acid or citric acid withdraws from possibility of reading on natural food items. Applicant argues that as supported by the spec the acidifying agents can include those that “reduce pH and include artificial compounds as well as natural juices…”. The examiner is not persuaded that the applicants amendments to the claims are directed to ‘synthetic’ or ‘artificial’ acids as argued especially since citrus fruits and vegetables contain things like citric acid and as well as the shown vitamin C which the ‘other’ common name for vitamin C is ascorbic acid (see Wikipedia cite for support). Applicants argument with respect to the phrase ‘nutritional supplement’ excluding natural fruits and vegetables is also not persuasive since clearly as shown in the prior art the natural products of fruits and vegetables contain the same instant claimed components and can also be ‘powdered’ or concentrated in juices. The definition provided by applicant for nutritional supplement does not support their argument with regards to natural products and as such the rejection is maintained.
Further with respect to the prior art rejections (modified herein due to the amendment to the claims) a similar reason as above they are maintained since the prior art clearly envisages people eating vegetables and fruits as well as a capsule concentrate which contains a mixture of fruits, vegetables include beets, blackberry, black currants, etc. which contain as supported by Smiechowska various amounts of nitrite and acids including vitamin C (i.e. ascorbic acid) and Toldam Anderson shows that black currants also contain citric acid as well…wherein these compositions are known to treat and lower blood pressure. Applicant argues that the ‘capsule’ of Houston is not a single nutritional supplement as instant claimed. The examiner disagrees and argues that while applicant can be its own lexicographer applicant has not distinguished how the ‘nutritional supplement’ as claimed is novel over the capsule of Houston which contains the same components in powdered form the evidentiary nutritional references supplied are merely to show that these claimed acids and nitrite are found in the components that are in the capsule of Houston necessarily and a product is not separable from its physical characteristics (i.e. Vitamin C containing fruits and vegetables necessarily contain at least ascorbic acid while citrus fruits and others in Houston also contain citric acid). Eating the same fruits and vegetables produces the same results of lowering blood pressure as provided by the art and nothing in applicants claims seeks to modify the ‘structure’ of the composition to overcome the fact that this reads on eating a natural product especially since the majority of the claims contain no % or amounts of the nitrite and acid and further the nutritional tables provided by the examiner shows that these are the same and/or overlapping amounts found within the fruits and vegetables themselves and as such would be anticipated or obvious. Applicant bears the burden of distinguishing their invention over that of these natural products which are already known to treat and lower blood pressure when eaten either in their natural form or in the capsule of Houston.
Cited As Interest
From Wayback Machine 12/05/2005 Wikipedia page –“Vitamin C” wherein the structure is shown is the same as ascorbic acid and further ‘other names’ lists ascorbic acid which is further taught to be in citrus, sauerkraut, and other fruits such as berries and vegetables (pages 1-2). Further pages 3-4 tables and text support the known natural sources which includes beets, various fruits berries and citrus, and black currant etc..
Conclusions
Applicant's amendment necessitated the modified 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 extension fee 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 date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the
examiner should be directed to BETHANY BARHAM whose telephone number is
(571)272-6175. The examiner can normally be reached on M-F 9:30AM-6pm.
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/BETHANY P BARHAM/
Supervisory Patent Examiner, Art Unit 1611
Prosecution Insights