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 .
Election/Restrictions
Applicant’s election of group I claims 1-10 in the reply filed on March 12, 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 § 818.01(a)).
Applicant’s response just makes an allegation of no search burden with no specific arguments.
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 2, 6, and 7 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.
Regarding claim 2, the limitation “1% to 20%” is indefinite as it is unclear if this is in relation to the total composition weight or volume or in relation to just the active or neuroprotective ingredient.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 6 recites the broad recitation polyphenols, and the claim also recites preferably curcumin or quercetin which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The term “useful” in claim 7 is a relative term which renders the claim indefinite. The term “useful” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
It is unclear as to what constitutes a useful drug. What level of effectiveness is needed?
Claim Rejections - 35 USC § 102
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 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 and 3-10 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Van Der Giessen (WO 2004/039385 A2).
Regarding claim 1 and 3-10, Van der Geissen teaches:
A pharmaceutical composition for neuroprotection of neurological diseases such as Parkinson’s disease. (See abstract, page 1 line 19-23, page 5 lines 21-23, Page 22 line 20 to page 23 line 17, and claims 1-20).
The compositions comprising:
An active ingredient (L-DOPA),
See page 5 lines 21-23 disclosing that Mucuna Pruriens extract provide L-DOPA ad other phytochemicals for neurological treatment like Parkinson’s disease.
A neuroprotective ingredient, and
See claim 1
See claim 13 (polysaccharides).
See page 4 line 31 to page 5 line 12, and page 5 lines 21-23 (Phytochemicals)
A Pharmaceutically acceptable excipient (diluent).
See claim 1
Wherein the composition is used in the form of an injection/infusion (blend), capsule, tablet.
See claim 4
Additional active ingredients such as antioxidants, vitamin C (Ascorbic acid).
See page 28 line 37.
See page 9 line 14 and page 21 and page 25 line 24.
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.
The factual inquiries 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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Van Der Giessen (WO 2004/039385 A2) in view of Rouru et al. (WO 2011/107653 A2).
Regarding claim 2, Van der Giessen does not expressly teach a specific embodiment that uses 10-500mg of active ingredient (L-DOPA), 50-300mg of the neuroprotective ingredient (extract from Mucuna Pruriens) and 1-20% of an excipient.
Examiner note: Applicant is not claiming these ranges with respect to any specific formulation or end product (capsule, tablet, liquid). The ranges seem to be general workable conditions for the broad claims that encompass likely millions of potential combinations of ingredients. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
Van der Giessen, does teach that the amount of extract can be reduced or increased. (See page 18 lines 17-20 and 26).
It is further taught that the formulation and doe would take into account the needs of the patient, the schedule of the administration, amongst many other factors. (See page 27 lines 21-27). This is evidence that the art recognizes the extract which has the active ingredient and the neuroprotective ingredient as optimizable ingredients depending on the situation.
It is taught that the extract amount depends on age, weight, condition and would be at least 5-60 grams. (See page 32 lines 16-24).
Van der Giessen does not expressly teach wherein the amount of the excipient is between 1-20%.
However, in the same field of Parkinson drugs using levodopa with excipients/diluents, Rouru teaches that diluents/excipients can be between 1-60 wt%. (See paragraph 0119).
It would have bene obvious to those having the ordinary skill in the art to apply known amounts of excipients depending on the formulation need of the end product and the desired characteristics of the end formulation.
As the art has recognized that the amount of the active, neuroprotective, and excipients/diluents are optimizable and a result of routine optimization.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMJAD A ABRAHAM whose telephone number is (571)270-7058. The examiner can normally be reached Mon-Friday 830 AM to 500 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A Abraham can be reached at 571-270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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AMJAD A. ABRAHAM
SPE AU 1663
Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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