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
Election/Restrictions
Claims 1-54 are pending.
Applicant’s election without traverse of Group I, claims 1-9, 11, 13, 28-30, 33, 34, 36-44, 46, 48, 50, and 51 in the reply filed on 11/24/25 is acknowledged.
Claims 10, 12, 14-27, 31, 32, 35, 45, 47, 49, and 52-54 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/24/25 2008.
Claims 1-9, 11, 13, 28-30, 33, 34, 36-44, 46, 48, 50, and 51 are examined on the merits.
Claim Objections
Claims 1-9, 11, 13, 28-30, 33, 34, 36-44, 46, 48, 50, and 51 are objected to because of the following informalities: Claim 1 recites an enriched, full-spectrum, polyphenolic extract derived from plant material, comprising:
1. phenolic monomers, dimers and trimers;
2. phenolic oligomers; and
3. phenolic polymers; etc.
The recitation is incorrect, as there are two “1” in the claim 1. Applicant is suggested to recites 1). phenolic monomers, dimers and trimers;
2). phenolic oligomers; and
3). phenolic polymers; etc. so as to distinguish with the claim number.
All other cited claims depend directly or indirectly from objected claims and are, therefore, also, objected for the reasons set forth above.
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 1-9, 11, 13, 28-30, 33, 34, 36-44, 46, and 48 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
First, the claimed invention must be to one of the four statutory categories. 35 U.S.C. 101 defines the four categories of invention that Congress deemed to be the appropriate subject matter of a patent: processes, machines, manufactures and compositions of matter. The latter three categories define "things" or "products" while the first category defines "actions" (i.e., inventions that consist of a series of steps or acts to be performed). See 35 U.S.C. 100(b) ("The term ‘process’ means process, art, or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material."). See MPEP § 2106.03 for detailed information on the four categories.
Second, the claimed invention also must qualify as patent-eligible subject matter, i.e., the claim must not be directed to a judicial exception unless the claim as a whole includes additional limitations amounting to significantly more than the exception. The judicial exceptions (also called "judicially recognized exceptions" or simply "exceptions") are subject matter that the courts have found to be outside of, or exceptions to, the four statutory categories of invention, and are limited to abstract ideas, laws of nature and natural phenomena (including products of nature). Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 216, 110 USPQ2d 1976, 1980 (2014) (citing Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589, 106 USPQ2d 1972, 1979 (2013). See MPEP § 2106.04 for detailed information on the judicial exceptions.
Claim(s) 1-9, 11, 13, 28-30, 33, 34, 36-44, 46, and 48 is/are directed to an enriched, full-spectrum, polyphenolic extract derived from plant material, comprising:
1. phenolic monomers, dimers and trimers;
2. phenolic oligomers; and
3. phenolic polymers; wherein the polyphenolic extract contains > 35% by weight total phenols; wherein a phenolic compound in the polyphenolic extract is selected from the group consisting of catechins, epicatechins, proanthocyanidins, gallocatechins, galloepicatechins, anthocyanins, glycosides, acylglycosides, polyacylglycosides, anthocyanidins, phenolic acids of C6-C1 class, benzoic and hydroxybenzoic acids, C6-C3 class of acids, and cinnamic, chlorogenic, and related acids; and wherein at least 10% by weight of the polyphenolic extract are phenolic polymers.
Analysis of the flowchart:
Step 1, is the claim directed to a process, machine, manufacture or composition of matter?
Yes. The claim is directed to a composition of matter.
Step 2A. Prong one: Is the claim directed to a law of nature, a natural phenomenon (product of nature), or an abstract idea?
Yes, the claims are directed to nature based components, polyphenolic extract derived from plant material because there is no indication that extraction has caused the components of an extract of polyphenolic compounds that comprise the claimed compositions to have any characteristics that are different from the naturally occurring polyphenolic compounds in plant material such as blueberry.
Step 2A. Prong two: Does the claims recite additional elements that amount to significantly more than the judicial exception?
No. The claim(s) of 1-9, 11, 13, 28-30, 33, 34, 36-44, 46, and 48 does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception, This is a product claim and since there are no claimed method steps, there are no additional elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception themselves. Therefore, the claims do not recite something significantly more than a judicial exception and are thus deemed patent ineligible subject matter.
Claims 1-9, 11, 13, 28-30, 33, 34, 36-44, 46, and 48 require certain amounts of components being present in the composition. However, there is no indication that the amounts claimed in the compositions result in a markedly different characteristic for the composition as compared to the components that occur in the nature.
Step 2B. If additional elements of the claim provide an inventive concept (Step 2B) (also called "significantly more" than the recited judicial exception).
No, no non-nature based components were recited in the claims.
For the reasons described above, the claimed compositions are not markedly different from their closest naturally occurring counterparts and thus are product of nature judicial exceptions.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not recite any additional elements beyond the claimed compositions themselves. Also, this is a product claim and since there are no claimed method steps, there are no additional elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception themselves. Therefore, the claims do not recite something significantly more than a judicial exception and are thus deemed patent ineligible subject matter.
Claim Rejections –35 USC § 112, 2nd
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.
Claim 34 are rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 34 recites “The enriched, full-spectrum, polyphenolic extract derived from thplant material of claim 28, wherein the molar ratio of trisodium citrate to phenols in the polyphenolic extract is from 1:10 to 1:20”. However, there is insufficient antecedent basis for the recitation of “the molar ratio of trisodium citrate to phenols” in the claims.
Therefore, the metes and bounds of claims are rendered vague and indefinite. The lack of clarity renders the claims very confusing and ambiguous since the resulting claims do not clearly set forth the metes and bounds of the patent protection desired.
All other cited claims depend directly or indirectly from rejected claims and are, therefore, also, rejected under U.S.C. 112, second paragraph for the reasons set forth above.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 8, 9, 28, 50, and 51 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Lila et al (US 20170333386 A1).
Lila et al teach procyanidins (thus 100% proanthocyanidins, thus >35% by weight total phenols) in blueberry (thus claims 8, 9, and 28, thus vaccinium species are met) pomace extract) comprising DP1 0.02; DP2 0.08; DP3 0.09; DP4 0.09, DP>4 0.36; polymers 0.60 (thus at least 10% by weight of the polyphenolic extract are phenolic polymers; total 1.24, wherein DP1, monomers expressed as epicatechin; DP2, dimers expressed as PAC A2; DP3, trimers expressed as PAC C1 (thus claim 1-1)) is met); DP4, tetramers expressed as PAC D; DP > 4, oligomers expressed as PAC D (thus claim 1-2 is met) polymers, expressed as PAC D )thus claim 1-3 is met)(page 15, Table 2-continued).
Lila et al teach a method of attenuating an allergic response in a subject in need thereof, comprising administering to the subject the protein-polyphenol aggregate matrix of claim 2, wherein the protein polyphenol aggregate matrix comprises about 5% to about 40% polyphenols (w/w) (see claim 36). Lila et al teach for food applications, the high concentration polyphenol product can be provided as a powdered (pill or capsule form or other) dietary supplement (thus orally, or it may be an ingredient incorporated into a food product. Thus, the concentrations and ratios of the aqueous solvent to the low sugar or sugar free plant tissue can vary according to the plant polyphenol [0066] (thus claims 50 and 51 are met, as everyone needs to prevent urogenital infection, the claims read on everyone who is being administered with the claimed extract)
Therefore, the reference is deemed to anticipate the instant claim above.
Claim Rejections –35 USC § 103
The following is a quotation of 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 through the invention is not identically disclosed or described as set forth in section 102 of this title, 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.
Claims 1, 2, 7-9, 28-30, 50, and 51 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Lila et al (US 20170333386 A1).
Claims 1, 7-9, 28-30, 50, and 51 are rejected under 35 U.S.C. 103(a) as being unpatentable over Lila et al as applied to claims 1, 8, 9, 28, 50, and 51 above, and further in view of Sweeney et al (Sweeney et al, Heart health functionality of cranberries and blueberries. Pharmaceutical Biology, (May 2010) Vol. 48, Supp. SUPPL. 1, pp. 21-22).
The teachings of Lila et al are set forth above and applied as before.
The teachings of Lila et al do not specifically teach at least 1% of anthocyanins in claim 2, Vaccinium macrocarpon in claim 29, or Vaccinium angustifolium in claim 30.
Sweeney et al teach the American cranberry (Vaccinium macrocarpon) and lowbush blueberry (V. angustifolium) have attracted interest as functional foods due to their high content of polyphenols (e.g. anthocyanins). Cranberry is best known for benefitting urinary tract health, while blueberries benefit the brain, reversing age-related declines. Our laboratory has evaluated effects of these berries on major risk factors for cardiovascular diseases (CVD), such as the clusters of disorders that make up metabolic syndrome. These disorders include hypertension, abdominal obesity, atherosclerosis and insulin resistance, and their pathologies involve oxidative stress and inflammation to some degree. Thus, a central hypothesis of our research is that polyphenolic compounds from blueberries and cranberries mitigate the effects of oxidative stress and inflammation in animals and humans at risk of CVD. Using animal models of CVD, we have shown that feeding freeze-dried cranberries over 6-8 weeks lowers LDL-cholesterol and various pro-inflammatory cytokines in atherosclerotic mice and obese rats. Mice fed cranberries also gained less weight compared to control diets. The main effects seen after feeding freeze-dried blueberries for 2-8 weeks were a dramatic blood-pressure lowering effect in spontaneously hypertensive stroke-prone rats, possibly due to renal protection from oxidative injury and inhibition of ACE activity. Interestingly, dietary cranberry had only mild anti-hypertensive effects but prolonged survival times in stroke-prone animals. In a pilot human study, we found mild anti-diabetic effects in men at moderate risk of CVD fed blueberry juice for 3 weeks. There is good evidence that diets containing blueberries and cranberries are part of a heart-healthy diet (see Abstract).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to obtain polyphenolic extract from Vaccinium macrocarpon or Vaccinium angustifolium since Sweeney et al teach the American cranberry (Vaccinium macrocarpon) and lowbush blueberry (V. angustifolium) have attracted interest as functional foods due to their high content of polyphenols.
It would also have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have at least 1% of polyphenolic extract are anthocyanins since Sweeney et al teach the American cranberry (Vaccinium macrocarpon) and lowbush blueberry (V. angustifolium) have attracted interest as functional foods due to their high content of polyphenols (e.g. anthocyanins).
Regarding the claimed amount of anthocyanins in claim 2, determining an appropriate amount of the components within the composition is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of the references, it is apparent that one of the ordinary skills in the art would have had a reasonable expectation of success in producing the claimed invention.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Conclusion
No claim is allowed (Claims 3-6, 11, 13, 33, 34, 36-44, 46, and 48 are free of art).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QIUWEN MI whose telephone number is (571)272-5984. The examiner can normally be reached on Monday-Friday 9:00 am to 5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached on 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Qiuwen Mi/
Primary Examiner, Art Unit 1655
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