DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Examiner of Record has Changed
The Examiner of Record has changed from Randall O. Winston to Shubo (Joe) Zhou.
Claim Status
Claims 1-6, 8-9, and 18 are pending.
Claims 5-6 are withdrawn as being drawn to a nonelected invention.
Claims 1 and 4-6 are currently amended.
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 1-4, 7-9 and 18 remain 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. Claim(s) 1-4, 7-9 and 18 is/are directed to a natural phenomenon (i.e., a law of nature and a product of nature-e.g. step 1 (MPEP 2106.03)). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial (i.e. do not recite additional elements/steps that integrate the exception into a practical application and/or do not recite additional elements that amount to significant more than the exception of the claimed naturally-occurring ingredients-e.g. step 2A2 (MPEP 2106.04(d) and 2B (MPEP 2106.5)) – i.e., as drafted, the cited claims read upon a product of nature for the following reasons:
Claims 1-4, 7-9 and 18 are drawn to a composition (as a pharmaceutical and/or nutritional supplement of a solid or liquid) comprising a compound (an active ingredient) [i.e. the claimed compound that upregulates IRS2 function is a natural compounds as disclosed within Applicant’s specification in paragraph 0045 and [0084] whereas page 2 last paragraph discloses Zhang et al. conducted a high-throughput screen of more than 50,000 synthetic compounds and natural compound that activated the Insulin Receptor (IR). The compound, however, turned out to not be derived from an edible plant source at all. Rather, the compound was derived from a natural fungal extract (Pseudomassaria) that had been recovered from leaves of an undetermined plant collected near Kinshasa, Democratic Republic of Congo. This work showed, however, that it was at least possible to identify a small molecule capable of having partial activity toward the Insulin Receptor (IR.)] and a natural botanical extract (an active ingredient), wherein the extract is an aqueous extract of Cichorium Endivia var. Latifolium (i.e. all the claimed active ingredients are naturally-occurring ingredients). [Please note that where the claim is to a nature-based product in combination with non-nature based elements (e.g. a claim to “a yogurt starter kit comprising Lactobacillus in a container with instructions for culturing Lactobacillus with milk to produce yogurt”), the markedly different characteristics analysis should be applied only to the nature-based product limitation (MPEP 2106.04(c)(I)(A))]. Moreover, the clamed composition (as a pharmaceutical and/or nutritional supplement) comprising the botanical extract, wherein the extract is an aqueous extract of Cichorium Endivia var. Latifolium is not markedly different from its naturally-occurring counterpart because there is no adequate indication and/or sufficient evidence/support within Applicant’s specification that the claimed natural botanical extract has any characteristics or properties that are different from the naturally-occurring counterpart (including the natural compounds found therein).- i.e., there is no adequate indication and/or sufficient evidence/support within Applicant’s specification that the instantly claimed preparatory steps (i.e. the claimed natural botanical extract obtained by the instantly claimed preparatory step of an aqueous extract of Cichorium Endivia var. Latifolium as disclosed within Applicant’s specification’s in paragraphs [0044]-[0045] has caused the resulting extract/product to have any characteristics that are different from the naturally-occurring counterpart. [Also, Please note that there is no adequate evidence/support within Applicant’s specification that its claimed composition/extract is markedly different in terms of having a change in structure of having an unexpected functional difference (i.e. a difference in properties and/or characteristics) as compared to its/their naturally-occurring counterpart(s) and/or there is no adequate evidence/support within Applicant’s specification that its claimed composition comprising the claimed natural compound (as an active ingredient) and the claimed natural botanical extract (as an active ingredient) is markedly different in terms of having a change in structure (by demonstrating “synergism”) that produced an unexpected/synergistic functional effect as compared to its/their naturally-occurring counterpart(s)] and that the composition has any characteristics or properties that are different from the naturally-occurring counterpart(s) (including the natural compounds found therein- e.g. step 2A1(MPEP 2106.04 (a-c)). Moreover, the cited 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 (i.e. do not recite additional elements/steps that integrate the exception into a practical application and do not recite additional elements that amount to significant more than the exception of the claimed naturally-occurring ingredients).
Therefore, the claimed composition/extract is not deemed to be markedly different from what exists in nature in terms of structural and/or functional differences. In other words, the claims do not set forth a marked difference in terms of structural and/or or functional differences (properties and/or characteristics) as compared to the naturally-occurring counterpart(s) (see, e.g., Diamond v. Chakrabarty, 447 U.S. 303(1980)). Please note that combining natural products does not remove the claims from reading upon a judicial selection (Funk Brothers Seed Col. V. Kalo Inoclulant Col. – 333 U.S. 127 (1948)) because again there is no sufficient evidence/support of a marked difference brought about by combining the instantly claimed natural products. Please also note that modifying the concentration of the product/composition is not sufficient to remove the claimed composition from a judicial exception (see, e.g., Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107, 106 USPQ2d 1972 (2013)).
Thus, when the relevant factors are analyzed, they weigh against a significant difference between the claimed invention and a judicial exception. Therefore, the claimed invention is not considered to be patent eligible subject matter.
Response to Arguments - Claim Rejections - 35 USC § 101
Applicant's arguments filed 21 May 2025 have been fully considered but they are not persuasive.
Applicant urges that the claimed botanical extract is derived from a naturally occurring plant and that a transformation occurs during the extraction such that at least one compound becomes activated to become insulin-like.
This argument is not persuasive, because Applicant has failed to provide any evidence as to whether the endive itself does not have insulin-like activity. Moreover, the art suggest that the plant itself may in fact have insulin-like activity. Bok et al (US 2005/003026 A1) teach that endive has anti-obesity effects in many preparations including things such as soups and salads (see examples).
Claim Rejections - 35 USC § 112
Indefiniteness
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.
Claims 1-4, 8-9, 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 pre-AIA the applicant regards as the invention.
The claims are drawn to compositions comprising a botanical extract and a compound that upregulates IRS2 function wherein the composition provides a certain amount of “Insulin Equivalent units.”
A screen capture is below of the page in the specification which provides more information about the meaning of the phrase “Insulin Equivalent units.”
The specification states that one “Insulin Equivalent unit” is the minimum amount of material necessary to increase growth of IRS2 overproducing test cells by 1% compared to control. This definition does not limit the cell type, the culture conditions, or the form of insulin used for the assay. It is well-understood in the art that insulin signaling pathways are high-regulated pathway that are influenced by several factors. Different cell types respond to insulin differently (see Patel et 2008 2:4, p.188-205 for example). Culture conditions can dramatically affect how a cell respond to insulin, such as concentration of glucose in the growth medium or whether the cells were serum-starved prior to initiating the experiment. For example, De Nigris 2015 (Cardiovascular Diabetology 14: 114) report that high glucose in the growth medium impaired insulin signaling endothelial cells. Additionally, there are many different forms of insulin that are manufactured today that have different characteristics including different half-lives and potencies (see Donnor T, Sarkar S. Insulin- Pharmacology, Therapeutic Regimens and Principles of Intensive Insulin Therapy. [Updated 2023 Feb 15]. In: Feingold KR, Ahmed SF, Anawalt B, et al., editors. Endotext [Internet]. South Dartmouth (MA): MDText.com, Inc.; 2000-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK278938/).
Given these potential points of variability which can influence the meaning of one “Insulin Equivalent unit,” the metes and bounds of the claims cannot be determined.
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Lack of Written Description
The following is a quotation 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.
Claims 1-4, 8-9, and 18 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.
The claims are broadly drawn to compositions comprising any aqueous botanical extract and any compound that upregulates IRS2 function, wherein the composition comprises at least a 1x104 Insulin Equivalent units in 1ml. Even in the case of claim 4, which specifies that the extract is from Cichorium endivia var. latifolium, written description is lacking, because the there is no requirement that the botanical extract is what is actually upregulating IRS2 function (see rejection under 35 U.S.C. 102(b) over Ahrén et al below).
In the indefiniteness rejection above, it makes clear that the meaning of Insulin Equivalent units is indefinite as the definition provided in the specification does not set forth all the required parameters to make the determination of “Insulin Equivalent units” present in the composition such that the assay result would not vary significantly as the parameters are changed (See indefiniteness rejection above).
The instant disclosure describes in Table 2 some natural products that have insulin like activity from species including endive, lettuce, and garden bean.
These descriptions are insufficient, because they fail to describe the unlimited genus of any compound that increases IRS2 function.
Given the broad scope of the claimed genus, the lack of working examples and the failure to describe the structures required to confer the claimed function, one of skill in the art would not have recognized that Applicant was in possession of the claimed genus at the time of filing.
Response to Arguments - Claim Rejections - 35 USC § 103
The Examiner has opted to withdrawn the rejection of record as maintaining this rejection may mislead Applicant as to the statutory deficiencies of the instant claims. It is believed that the currently applied and maintained rejections
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 –
(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.
Claims 1-3 and 9 are rejected under 35 U.S.C. 102(b) as being anticipated by Ahrén et al 2010 (Diabetes Care 33: p.730-732) as evidenced by Xu et al 2016 (Journal of Endocrinology 229:2 p.133-144).
Claim 1 is drawn to compositions comprising an aqueous botanical extract and a compound that upregulates IRS2 function wherein the composition comprises at least a 1x104 Insulin Equivalent units in 1ml. Note that as the claim is structured, there is no requirement that the compound be present in the extract. This means that the combination of providing a synthetic drug known to increase IRS2 activity and having a glass of juice is encompassed in the scope of the claims. Further note that the recitation regarding Insulin Equivalent units is indefinite and it unclear how these recitations limit the claims. See indefiniteness rejection above.
Ahrén et al disclose a study in which people consumed both metformin and morning orange juice. The resultant composition in their stomach comprises an aqueous botanical extract (juice, which can be considered a nutritional supplement as it provides both vitamins and macronutrients) and metformin (a compound that improves IRS2 activity, as evidenced by Xu et al). Accordingly, claims 1-3 and 9 are rejected under 35 U.S.C. 102(b) as being anticipated by Ahrén et al as evidenced by Xu et al.
Claims 1-3, 8, 18 are rejected under 35 U.S.C. 102(b) as being anticipated by Park et al 2008 (Genes Nutrition 2: p.347-351).
Park et al disclose providing aqueous extracts (as they were provided in phosphate buffered saline, left column, p. 348) from several different plant species to rate pancreatic islets. Three different species induced IRS2 (Figure 2). As such, claims 1-3, 8, 18 are rejected under 35 U.S.C. 102(b) as being anticipated by Park et al.
Claims 1-4, 8-9, 18 are rejected under 35 U.S.C. 102(e) as being anticipated by Chapal (WO2013072522 A1).
Chapal et al disclose making extracts from Cichorium endivia including using an aqueous solvent system (claims 5,6,9) and using the extracts to treat physiological conditions associated with T2DM and pre-T2DM (claims 15-19). They also disclose that the extract can be provided as a nutraceutical or a pharmaceutical composition (claims 20 and p.7 line 4. Given that the aqueous extract is from the same species as instantly, the anti-diabetic effects of the extract are also mediated through increasing IRS2 activity. Accordingly, claims 1-4, 8-9, 18 are rejected under 35 U.S.C. 102(e) as being anticipated by Chapal.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Shubo (Joe) Zhou, Ph.D., whose telephone number is (571) 272-0724. The examiner can normally be reached Monday through Friday, 9:00 am - 5:00 pm Eastern. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHUBO ZHOU/
/SHUBO (JOE) ZHOU/Supervisory Patent Examiner, Art Units 1661 and 1662