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 .
Applicant’s election without traverse in the reply filed on 4 August 2026 is acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
Applicant elects:
(A) an amount effective to decrease serum levels of at least one pro- inflammatory cytokine or increase serum levels of at least one anti-inflammatory cytokine in the animal relative to a control animal not administered the complexed composition (i.e., claim 20)
(B) Plant Compound: flavonoid (i.e., claim 28)
(C) Metal: zinc (i.e., claim 30)
(D) Active Ingredient: polyphenol (i.e., claim 36).
Claims 18-19, 21-22, 27, 29 and 35 are withdrawn as being directed to a nonelected invention.
Claims 16, 17, 20, 23-26, 28, 30-34 and 36-39 are presented for examination 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 16, 17, 20, 23-26, 28, 30-34 and 36-39 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 16 is rendered vague and indefinite by the phrase "metal complexed plant compound" as used in the present claims is vague and unclear and leaves the reader in doubt as to the meaning of the technical feature to which it refers, thereby rendering the definition of the subject-matter of said claim unclear. This is especially true in view of claim 25, referring to plant pomace, plant juice etc. It cannot be envisaged how a compound complexed to a metal can comprise a plant juice.
The term "semi-purified" is vague and unclear and leaves the reader in doubt as to the meaning of the technical feature to which it refers.
Appropriate clarification is required.
Note: For purposes of examination the claims are given their broadest reasonable interpretation (BRI). It would appear that the composition employed in the claims is simply a composition comprising a plant compound and a metal. Thus, the BRI of the claims under examination are any method of applying a composition containing any plant compound and any metal to any animal. This is the scope of the claims that is being examined.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 16, 17, 20, 23-26, 28, 30-34 and 36-39 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed" (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed" (See Vas-Cath at page 1116).
The MPEP states that the purpose of the written description requirement is to ensure that the invention had possession, as of the filing date of the application, of the specific subject matter later claimed by him or her. The courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention.’ Lockwood v. American Airlines, Inc., 107 F. 3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F. 2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the invention, with all its claimed limitations, no that which makes it obvious,” and by using “such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention.” Lockwood, 107 F. 3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
In Ariad Pharm. Inc. v. Eli Lily & Co. 598 F ad 1336 (Fed. Cir. 2010) en banc}, the Federal Circuit noted the importance of an application's disclosure, stating, “the hallmark of written description is disclosure.” A disclosure adequately describes an invention when it “reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Id. at 1354. “A ‘mere wish or plan’ for obtaining the claimed invention is not adequate written description.” Centocor Ortho Biotech, Inc. v. Abbot Labs, 636 F.3d 1341, 1948 (Fed. Cir. 2011)
Satisfying the written description requirement “varies with the nature and scape of the invention at issue, and with the scientific and technologic knowledge already in existence.” Capon v. Eshhar, 418 F. 3d 1349, 1357 (Fed. Cir. 2005). The Federal Circuit explained what is required to meet the written description requirement in Ariad Pharm., Inc. v. Eli Lilly & Co:
This inquiry, as we have long held, is a question of fact. Ralston Purina, 772 F.2d at 575. Thus, we have recognized that determining whether a patent complies with the written description requirement will necessarily vary depending on the context. Capon v Eshhar, 418 F.3d 1349, 1357-58 (Fed. Cir. 2005). Specifically, the level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology. Id. For generic claims, we have set forth a number of factors for evaluating the adequacy of the disclosure, including “the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, [and] the predictability of the aspect at issue." Id. at 1359.
A written description of a genus in biotechnological arts “requires a precise definition, such as by structure, formula, [or] chemical name” of the claimed subject matter sufficient to distinguish it from other materials. Regents of the Univ. of Cal. v. Eli Lilly & Co., 199 F.3d 1559, 1568 (Fed. Cir. 1997). The Federal Circuit reflected on Eli Lilly in Ariad while explaining how to sufficiently describe a genus in biotechnological applications:
We held that a sufficient description of a genus instead requires the disclosure of either a representative number of species fitting within the scope of the genus of structural features common to the members of the genus so that one of skill in the art can “visualize or recognize” the members of the genus. Id. at 1568-69. We explained that an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials. Id. at 1568 (quoting Fiers v. Revel 984 F.2d 1164, 1171 (Fed. Cir. 1993). We have also held that functional claim language can meet the written description requirement when the art has established a correlation between structure and function. See Enzo, 323 F.3d at 964 (quoting 66 Fed. Reg. 1099 (Jan. 5, 2001). But merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.
A “representative number of species” must typify the entire claimed genus and account for variation between the species of the genus:
[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictably in the results obtained from species other than those specifically enumerated. Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Or. 2004).
In Ariad, the Court also addressed the presence of a genus within a method claim, in Rochester, we held invalid claims directed to a method of selectively inhibiting the COX-2 enzyme by administering a non-steroidal compound that selectively inhibits the COX-2 enzyme. Id. at 918. We reasoned that because the specification did not describe any specific compound capable of performing the claimed method and the skilled artisan would not be able to identify any such compound based on the specification’s function description, the specification did not provide an adequate written description of the claimed invention. Id. at 927-28. Ariad, at 1373.
The claims are directed to any metal “complexed” to any plant compound, indeed the claims are so broad that any plant part such as a leaf or stem, in contact with a metal container, would be encompassed by the scope of the claims. However, but the specification only provides support for a combination of the metal Zn with cranberry pomace. It is noted that the examples relate to a "cranberry pomace" that is complexed in solution with Zinc ions, however, the resulting complexes are specific polyphenols/
flavonoids complexed with metal ions (see the Figures) and not a non-specific "juice" or
"pomace" as a whole.
There is well-known unpredictability regarding natural product extracts and their e.g., pharmaceutical capabilities. The resulting compositions and thus functional properties of an extraction process are highly dependent on the particular steps of the extraction and the extraction solvent employed
Raskin et al. clearly establish the grave unpredictability of elucidating active ingredients from natural sources:
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
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 16, 17, 20, 23-26, 28, 30-34 and 36-39 are rejected under 35 U.S.C. 103 as being unpatentable over any of the following references all of which have been cited by Applicant in IDS filed 5/28/2025.
SELVARAJ ET AL discloses flavonoid metal ion complexes, from plant origin, having an anti-tumor, antimicrobial, free-radical scavenging or anti-inflammatory action. lons are copper, iron or chromium.
White (2010) discloses complexes of polyphenols from plant origin, such as cranberry anthocyans, complexed with zinc or iron. Antimicrobial and anti-inflammatory activities are discussed. (the whole document; See esp. p.9, 2nd paragraph, and p.10, 1st paragraph).
IKEDA NORMA ESTEFANIA ANDRADES ET AL (the whole document) discloses rutin-zinc flavonoid metal complexes, from plant origin, and their antioxidant and antitumor activity.
DuBourdieu (US 2021/353583 A1 (the whole document; See esp. the examples) discloses tetrahydrocurcuminoid- metal complexes and uses of same for maintaining and improving health and/or boosting immunity in animals. The metal can be zinc or other metals. The molecular complex can be combined with additional interferon boosting nutraceuticals, such as Spirulina extracts, lipoic acid, ferulic acid, N-acetyl cysteine, or other nutraceuticals.
HALEVAS ELEFTHERIOS ET AL (Materials and Methods; abstract) discloses zinc complexes of flavonoids from plants, which have an antioxidant activity.
Thus, as compositions containing combinations of metals and plant compounds were known in the prior art at the time of the effective filing date of the instant Application, it would have been obvious to one of ordinary skill in the art to administer them to an animal for their known beneficial effects (e.g., anti-inflammatory effects). Furthermore, it would have been well within the purview of the skill practitioner to prepare such composition by mixing together the plant and metal components.
In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton.").
The adjustment of particular conventional working conditions is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. It is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. V. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) As both dosages, routes of administration, dosage frequency and timing are known to the ordinary artisan, it would have been obvious to optimize the mode of administration as well as dosage amounts and frequency. It also would have been prima facie obvious to optimize the dosage regimen for an additive or synergistic therapeutic result because the general conditions of the dosages are disclosed in the prior art and it is not inventive to discover the optimum or workable ranges by routine experimentation and the art expects that dosages of the invention will vary depending upon such factors as the subject's age, weight, height, sex, general medical conditions and previous medical conditions.
Accordingly, the instant claims, where no unexpected results are observed, would have been obvious to one of ordinary skill having the above cited references before him/her.
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