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 .
Priority
This application is a 371 of PCT/ES2020/070297 (05/11/2020).
Status
Claim rejections not reiterated in this action are withdrawn.
Claims 1-7, 9-10 are pending.
Claim Interpretation
Claim 1 refers to formula 2R-TG which is being interpreted as corresponding to the chemical structure from the specification page 3 as follows:
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Claim 1 thus corresponds to a compound which is also known OPL triglyceride(O is oleate (C18:1,9z); P is palmitate (C16:0); L is lineolate (C18:2,9z,12z)).
New 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.
Claims 1-7 and 9-10 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 was amended to include the language “where in the subject in need thereof is suspected to have a cancer disease or a disease regulated by the actin cytoskeleton.” This language is ambiguous with respect to “suspected” and “disease regulated by the actin skeleton”. Regarding “suspected” to have disease, the claim does not clearly define the scope and the term does not appear anywhere in the specification, thus it is left to one of skill in the art to determine what scope of subjects and disease are within claim. One of skill in the art would not know whether a specific diagnosis is required or alternatively is a mere suspicion of disease all that is required – i.e., could mean any kind symptom or alternatively no symptom required at all. Regarding “disease regulated by the actin skeleton”, the specification provides the following:
[0012] This compound acts as a biological response modifier (BRM) since it specifically alters the actin cytoskeleton. Therefore, it has direct applications in all those phenomena regulated by this component of the cytoskeleton, including in a non-exclusive way: i) changes in cell morphology, ii) cell motility (including metastasis), iii) muscle contraction, iv) modification of cell-cell junctions, v) regulation of endocytosis and phagocytosis, vi) embryogenesis, vii) control of gene expression, viii) regulation of the immune system, ix) defense against pathogens (bacteria, fungi, viruses, parasites, etc.) and x) regulation of apoptosis, among others.
[0013] Due to its properties, in a second aspect of the invention, the TG10 triglyceride of the invention is provided for use as a medicine.
[0014] The TG10 triglyceride positively influences all those diseases related to the actin cytoskeleton. Thus, another aspect of the invention provides the use of triglyceride in the treatment of actin cytoskeleton regulated diseases such as, but not limited to, amyloidosis, retinitis pigmentosa, infectious diseases, kidney diseases and congenital deafness syndrome.
One of ordinary skill in the art attempting to determine the metes and bounds of the claim would find the scope unclear because the specification suggests through examples in [0012] that the scope includes all cellular functions – i.e., all disease. Alternatively, in paragraph [0014] is recited examples of specific disease. Thus, one of skill in the art would not know whether the scope of disease is actually limiting or not. Therefore, the claims and those that depend therefrom are indefinite.
Claims 5 and 6 use the language “for its use in” which is unclear how the language limits the method claim. For example, the claim is unclear with respect to how the language limits the steps of the method (whether intended use or specific step required) and the claim is unclear as to what “its” is referring to.
Claim 6 has unclear and indefinite language in the following:
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Claim 9 has the language “wherein the triglyceride comprises a Macrocybe titans extract” but is ambiguous as to how the specific triglyceride 2R-TG chemical compound can comprise an extract. One of skill in the art would find such language confusing and ambiguous.
Claim 10 was amended to include the language “HP20-SS polymeric resin” which appears to be a trade name. See MPEP 2173.05(u): “If the trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of the 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982).”
Claim 10 uses the following language when referring to the mobile phase:
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which is confusing as to what is being referred to. One of skill in the art would not know what mobile phase is referred to with such language. In particular, “IP” is unclear as to whether is meant isopropanol, and similarly “CH2L2” does not have a clear and accepted meaning in the art. Furthermore, the “8:2” is unclear as to whether this is indicating the ratio of the components.
New 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 1-7, 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cacho et al. (Front. Immunol. 8:584 (2017), 10 pages) as evidenced by Qi et al. (J. Agric. Food Chem. 2018, 66, 3118−3126).
Cacho teaches administration of breast milk to infants to prevent infection and cancer (p. 1). Breast milk inherently contains the triglyceride of formula 2R-TG (aka OPL) as evidenced by Qi (p. 3118: “The major TAG species in mature human milk are oleic−palmitic−oleic (OPO; ∼21%) and oleic−palmitic−linoleic (OPL; ∼17%).”). Thus, the claims are anticipated.
Regarding claim 7 specifying a “tracer”, the claim does not clearly delineate what a tracer is referring to. Thus, giving the term its BRI means any additional detectable component. Therefore, as evidenced by Qi breast milk contains such an element (p. 2: “Many components in milk are multifunctional, serving as enzymes, antimicrobial proteins/peptides (AMPs), growth factors, chemokines, antioxidants, anti-inflammatory elements, prebiotics, probiotics, and nutrients”).
Regarding claim 9 giving the claim its BRI of the triglyceride, as evidenced by Qi, the same elements are present in Cacho.
Regarding claim 10 which specifies a method of administering a product-by-process, as per MPEP 2113, determination of patentability is based on the product itself and not the process. In this case, the product administered is 2R-TG and thus the claim is anticipated.
Response to Applicant Remarks
Applicant’s arguments relating to withdrawn rejections are rendered moot. In addition, the remarks are not germane to the new grounds of rejection.
Conclusion
No claims 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.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626