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 .
Priority
This application claims the benefit of provisional application No. 63/391,792, filed 07/24/2022.
Information Disclosure Statement
No IDS has been filed by applicant for consideration at the time of examination.
Status of the Application
Claims 41-56 are pending. Claims 1-40 have been cancelled by applicant. Claims 41-56 are currently under examination.
Claim Interpretation
The limitations of independent claim 41 are being interpreted to mean that a patient population being treated for Parkinson’s disease is a patient population which has Parkinson’s disease.
The claim limitation term of “about” is defined in the specification to mean up to 20% plus or minus of referenced numerical quantity, value or amount.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. Hyperlinks to websites found in paragraph [0138] in the specification.
The use of the term GraphPad Prism 9.0 in paragraph [0140], which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 51-52 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The patient population of “a subject at risk of developing Parkinson’s disease” as recited in claim 51 includes subjects who do not have Parkinson’s disease and is dependent on independent claim 41 wherein the patient population is being treated for and understood to have Parkinson’s disease. As such, claim 51 fails to include all limitations of claim 41. Similarly, claim 52 recites “wherein the subject has Parkinson’s disease” which is already implied by claim 41 because a subject must have Parkinson’s disease in order to treat the Parkinson’s disease. As such, claim 52 fails to further limit claim 41, from which it depends. Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 41-56 are rejected under 35 U.S.C. 103 as being unpatentable over Agrawal (Neurodegenerative Shielding by Curcumin and Its Derivatives on Brain Lesions Induced by 6-OHDA Model of Parkinson's Disease in Albino Wistar Rats) in view of Anthony (U.S. Pat. 9,492,402 B2).
The instant claims are directed to a method of treating Parkinson's disease, comprising orally administering a composition comprising a mixture of curcuminoids extracted from turmeric rhizome, wherein said mixture contains an amount of demethoxycurcumin (DMC), bisdemethoxycurcumin (BDMC) and an amount of curcumin, wherein said amount of BDMC is greater than said amount of curcumin.
Agrawal et al. teaches a study was undertaken to evaluate the neurodegenerative defending potential of curcumin (CUR), demethoxycurcumin (DMC), and bisdemethoxycurcumin (BDMC) on 6-hydroxydopamine-(6-OHDA) induced Parkinsonism model in rats. Curcuminoids were administered (60 mg/kg, body weight, per oral) for three weeks (Abstract). Agrawal teaches that 6-OHDA induces Parkinson's-like symptoms confirmed by behavioral, histopathological, and D2 receptor binding studies and that curcuminoids of curcumin, demethoxycurcumin and bisdemethoxycurcumin were found to shield the neurodegeneration caused by 6-OHDA. All these curcuminoids are known to elicit the protective effect due to their antioxidant properties, and CUR is found to be significantly more potent than DMC and BDMC (conclusion, page 8). Agrawal also teaches CUR, DMC, and BDMC have shown a prognostic beneficial effect in preventing the neurodegeneration (Page 8, 3rd para.). Agrawal also discloses administering a BDMC (60mg/kg/per oral suspended in 0.5% carboxymethyl cellulose (CMC)) dose to Wistar rats wherein the selected dose levels were based on a pilot study (3-100 mg/kg/per oral) on CUR, DMC and BDMC (para. 2.2, page 2). Agrawal also discloses “Since CUR is showing maximum, DMC intermediate and BDMC least activity, this suggest that phenyl methoxy group in chemical structure plays a key role in ameliorating PD. Contrary to these findings, their antimetastatic activity of CUR, DMC, and BDMC was found to be in the order of BDMC > DMC > CUR, [22] increased penetration of these compounds into brain in order of CUR > DMC > BDMC, explains higher potency of CUR in shielding brain against 6-OHDA-induced PD” (page 4, 3.5, last para.).
However, Agrawal et al. fail to disclose BDMC in a composition wherein the amount of BDMC is greater than CUR.
Anthony et al. teach a curcuminoid mixture has curcumin, demethoxycurcumin and bisdemethoxycurcumin in a weight/weight ratio ranging from about 0.8:1:1 to about 1:1.1:1.2 (Abstract). Anthony discloses that turmeric is a tropical spice which has regions of Asia. It has a long history of use in herbal remedies, particularly in China, India, and Indonesia. Turmeric or "yellow root" is a general term for plants and plant materials having a high content of curcuminoids, compounds that have a strong colouring effect and which are used extensively in the colouring of e.g. food products. (Background of the invention, col. 1). Anthony teaches an embodiment in which the ratio of the three curcuminoid mixture obtained from waste obtained after the separation of essential oil and curcuminoids from oleoresin is about 10-90% of curcumin, about 6-70% of demethoxycurcumin and about 2-60% of bisdemethoxycurcumin. (col. 2, lines 48-52). Anthony also teaches The disclosure provides a concentrated solution prepared by solvent treatment of dried turmeric rhizomes. This concentrated solution is also referred to as oleoresin. Curcuminoids are crystallized from the oleoresin, leaving behind a waste liquid which contains essential oil.” And The disclosure provides a method to extract curcuminoids having a weight/weight ratio of curcumin:demethoxycurcumin:bisdemethoxy-curcumin ranging from about 0.8:1:1 to about 1: 1.1: 1.2 from the waste residue.” (col. 4, lines 1-22). Anthony also teaches example 8 where groups 4-7 are administered turmeric extract comprising curcumin, demethoxycurcumin and bisdemethoxycurcumin in the food fed to each group (col. 11-12).
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art, prior to the effective filing date of the instant application, to treat Parkinson’s disease symptoms by orally administering an optimized 100 mg/kg/oral dose of a composition taught by Agrawal comprising CUR, DMC and BDMC. A skilled artisan would have also recognized BDMC’s superior antimetastatic activity to DMC and CUR but also its reduced ability to cross the blood brain barrier and would have sought to improve the bioavailability of BDMC by looking towards Anthony’s disclosure of increasing the bioavailability of CUR, DMC, and BDMC in a curcuminoid composition wherein the ratio of BDMC to CUR is greater. A curcuminoid mixture comprising 75±5 % w/w BDMC and about 1.2±0.8 % w/w curcumin, 62.5 parts BDMC and about 1 part curcumin, 10±5 % w/w DMC, 62.5 parts BDMC, or about 8.3 parts DMC and about 1 part curcumin would have been prima facie obvious over the teachings of Anthony who discloses embodiments wherein the ratio of a three curcuminoid mixture is about 10-90% of curcumin, about 6-70% of demethoxycurcumin and about 2-60% of bisdemethoxycurcumin. Anthony uses systemic oral administration of a curcuminoid composition comprising CUR, DMC and BDMC in the food given to test subjects.
A person of ordinary skill in the art would have been motivated to use oral administration of a curcuminoid composition comprising CUR, DMC, and BDMC to a subject with Parkinson’s disease because turmeric and its products are commonly consumed in food. A person of ordinary skill would have administered the curcuminoids of CUR, DMC and BDMC to treat a subject with Parkinson’s wherein BDMC is in an amount greater than CUR because Agrawal disclosed BDMC was useful in treating the symptoms of Parkinson’s but needed greater bioavailability to be effective. A skilled artisan would have then used Anthony’s disclosure of increasing bioavailability of a curcuminoid greater amount of BDMC to CUR in a curcuminoid formulation to optimize and increase bioavailability of CUR, DMC and BDMC in a subject. Therefore a person of ordinary skill would have had a reasonable expectation of success in treating a subject with Parkinson’s by combining the teachings of treating Parkinson’s with curcuminoids CUR, DMC, and BDMC by Agrawal and the enhanced bioavailability of curcuminoids by Anthony.
Conclusion
All claims are rejected, no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNESTO VALLE JR whose telephone number is (703)756-5356. The examiner can normally be reached 0730-1700 M-F EST, 1st Friday off.
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/E.V./Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623