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 .
Claims 1, 2, 4 and 6-9 are presented for examination.
Claims 10-20 and 22 are withdrawn from consideration.
The amendments and remarks filed on 06/05/2026 have been received and entered.
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.
Claim 1 is 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 1 is indefinite as to the phrase “a cyclodextrin other than unmodified-beta-cyclodextrin”. Such phrase fails to set forth the modified beta-cyclodextrin used. Modified cyclodextrin can encompass numerous compounds, which are not set forth in the claims. The claims fails to set forth metes and bounds of the claimed invention.
The claims dependent on claim 1 are also rejected, since they have all the limitations of claim 1.
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, 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.
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.
1, 2, 4 and 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Loftsson (US 20030109492) in view of Behmer (Submitted by the applicant).
Loftsson teaches a method for enhancing the aqueous solubility of an active ingredient which is insoluble or sparingly soluble in water, said active ingredient being a drug, cosmetic additive, food additive or agrochemical, said method comprising combining said active ingredient with beta. - cyclodextrin in an aqueous complexation medium, said medium comprising from about 0.1% to about 80% (weight/volume) of eta.-cyclodextrin and from about 0. 1% to about 5% (weight/volume) of a negatively- or positively-charged compound which forms an inclusion or non-inclusion complex with beta.-cyclodextrin and its inclusion complexes, said charged compound being acceptable for use in a pharmaceutical, cosmetic, food or agricultural composition. See Para [0023] and claims. The use of methylated cyclodextrin is taught in Para [0036], which reads on modified cyclodextrin claimed herein. Loftsson teaches that With regard to agrochemicals, those contemplated for use in this invention include pesticides (including, for example, insecticides and nematicides), fungicides, herbicides and plant growth regulators. See Para [0059] and claim 21. The use of a sterol, such as cholesterol, is taught in claim 28. The determination of optimum proportions or amounts are considered to be within the skill of artisan in the absence of evidence to the contrary. Loftsson makes clear that cyclodextrins have been previously used for stabilizing compounds, such as sterols.
It would have been obvious to a person skilled in the art to solubilize sterols with cyclodextrins, motivated by the teachings of Loftsson, which teaches the use of stabilized sterols by cyclodextrins in agricultural field. Loftsson does not teach wherein the sterol is sequestered by the plant and being transported to the root, stalks and fruit of the plant via the phloem and where the sterol is solubilized by cyclodextrin.
Behmer teaches sterols are sequestered by the plant and are transported via the phloem. See page 489, column 1, para 1. It would have been obvious to combine Loftsson and Behmer, considering that Loftsson teaches the use of sterols and cyclodextrin in agriculture as old and well known and Behmer teaches sequestering sterols by the plant and transported by the phloem. The transportation to any parts of the plant, such as roots, stalks and fruits, by phloem is the expected property Behmer's teachings.
The relied upon references in combination make clear that sterols which have been encapsulated or solubilized by modified cyclodextrin have been previously used in agriculture. Behmer teaches sterols are sequestered by the plant and are transported via the phloem to the roots and different parts of the plant. Therefore, it would have been obvious to a person skilled in the art to use stabilized and encapsulated sterols in the method of Behmer in the absence of evidence to the contrary.
Response to Arguments
Applicant’s arguments have been noted. Applicant in his remarks argues that “Loftsson does not teach or suggest the use of cyclodextrins other than unmodified beta-cyclodextrin for solubilizing sterols in the context of modifying seedling growth. Loftsson does not include methyl-beta-cyclodextrin or other modified cyclodextrins in its claims. Independent claim 1, as amended, now explicitly excludes unmodified beta-cyclodextrin as the solubilization agent. This amendment places the claims outside the scope of Loftsson's teachings, because Loftsson relies specifically on beta-cyclodextrin as its solubilization platform.”. It is the examiner’s position that Loftsson teaches the use of methylated cyclodextrin for stabilizing sterols, such as cholesterol. Loftsson also teaches the sterol cyclodextrin complex for agrochemical use. Loftsson teaches that With regard to agrochemicals, those contemplated for use in this invention include pesticides (including, for example, insecticides and nematicides), fungicides, herbicides and plant growth regulators. Therefore, Loftsson teaches the use of the claimed complex as a plant regulator in general. To select seeds or seedlings in a plant is considered to be within the scope of Loftsson’s teachings. Sequestering the sterol by the plant is a mechanism, which is expected to happen by contacting sterol, cyclodextrin complex with the plant. The mechanism by which the sterol is transported to the roots does not create a patentably distinct use.
THIS ACTION IS MADE FINAL. 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.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, sue Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617
