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 .
This is a Final Office Action.
Election/Restrictions
Applicant's election without traverse of claim 1 or 21 based on the amended restriction requirement above, in the reply filed on April 24, 2025 is acknowledged.
Claims 20, 21, 23-25, 27 and 30-38 are pending and claims 20, 23-25, 27, 30, 31 and 38 are under examination. Claims 21 and 32-37 are withdrawn based on the species election.
Claim Objections
Claim 27 is objected to because of the following informalities: the term “and” should be inserted between the last two solvents. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The rejection of claim 1 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the phrase "such as" is withdrawn based on the amendments.
The rejection of claim 22 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the phrase, “the at least one polar aprotic solvent” is withdrawn based on the amendments.
The rejection of claim 22 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the term, “heptane” as an “at least one polar aprotic solvent” is withdrawn based on the amendments.
The rejection of claim 29 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the broad recitation “via a process,” and the claim also recites “transesterifications and distillations,” is withdrawn based on the amendments.
The rejection of claims 20, 22-31 and 38 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement, is withdrawn based on the amendments.
The rejection of claims 20, 22-31 and 38 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a process for purification of a phytosterol obtained by a rapeseed methyl ester distillation residue, does not reasonably provide enablement of a process for purification of phytosterols, generally, is withdrawn based on the amendments.
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 20 and 38 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.
Regarding claim 38, the phrase, “the ratio of polar aprotic solvent to polar protic solvent” lacks antecedent basis.
The above rejection was not addressed, and therefore, is maintained.
To overcome the rejection, the claim may be reworded to remove the term “the” prior to ratio.
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 20 recites the broad recitation “mechanical means”, and the claim also recites “including filtration and/or centrifugation.” 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.
To overcome the rejection, the narrower or broader recitation may be removed from the claim.
With regards to claim 20, the term, "heptane" as an "at least one polar aprotic solvent" is vague. Heptane is not a polar solvent. Therefore, said claims is indefinite.
To overcome the rejection, the term may be removed from the claim.
With regards to claim 20, the phrase, "the at least one polar aprotic solvent" is vague. The phrase is defined more than once in the claim and the second definition cites solvents that are not polar aprotic solvents.
To overcome the rejection, the solvents should be properly categorized in the claim.
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 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.
Claim Rejections - 35 USC § 102/103
The rejection of claims 20, 22-31 and 38 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Cross et al. (WO 0064921), is withdrawn based on the amendments.
The rejection of claims 20, 22-29 and 38 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Hamunen, A. (US 4420427), is withdrawn based on the amendments.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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(a) 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 under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 20, 22-31 and 38 are rejected under AIA 35 U.S.C. 103(a) as being unpatentable over Wollman et al. (20020058827) in view of Hamunen, A. (US 4420427).
The present application claims the following a process for purification of phytosterols, said process comprising at least the steps of:
a. providing a liquid mixture comprising a phytosterol obtained from vegetable oil and a lower alcohol, wherein the lower alcohol is present in an amount of from 25 to 800% by weight, based on the amount of phytosterol;
b. cooling the liquid mixture of step a. to form phytosterol crystals, wherein the phytosterol crystals are formed at a temperature of from 10° C to 75° C;
c. separating the phytosterol crystals of step b. from the remainder of the liquid mixture by mechanical means including filtration and/or centrifugation;
d. subjecting the phytosterol crystals of step c. to washing with a solvent system (comprising at least one polar protic solvent) comprising at least one polar aprotic solvent to obtain purified phytosterol crystals;
e. optionally repeating step (d) once, twice or three times;
f. optionally subjecting the phytosterol crystals obtained in step d or - if employed - step e to a washing using at least one lower alcohol, and optionally repeat this step f once or twice or three time;
g. drying the purified phytosterol crystals;
h. optionally melting and drying in molted state to remove traces of remaining solvent;
i. optionally subjecting to a particle-forming process to obtain solid sterol particles.
The ‘827 publication teaches the purification of phytosterols from a soybean oil distillate (130 g) with about 8% of sterols (10.4 g) in about 40 g of methanol (400 % by weight), see Example 6, paragraph [0057-0058] on page 6. The product was crystallized at 15 ºC and the filter cake washed with 65g of methyl ester (FME or fatty acid methyl ester), 65g of methanol, and 65g of water, followed by drying by filtration, see paragraph [0059].
The ’827 publication does not teach if the washings were done as a mixture of solvents or consecutive washings with each solvent.
The ‘427 patent teaches a process for purifying phytosterols, see column 1, lines 54-68 and column 2, lines 1-2, and Table 1. A sample of these is mixed with 100% by weight of methanol. This mixture is then cooled to room temperature, followed by filtration and washing with a solvent system (comprising at least one polar protic solvent) of acetone and methanol or methyl ethyl ketone and water.
Claims 23 and 38 are drawn to 30 to 50% by weight of the lower alcohol in step a); and 90:10 to 70:30 volume by volume ratio of polar aprotic to polar protic solvents in the solvent system, respectfully. The amounts of solvent used to crystallize and/or wash a compound is considered routine and conventional in an organic chemistry lab since crystallizations and filtrations are commonly employed for purification of organic compounds.
The adjustment of particular conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited references, especially within the broad ranges instantly claimed), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results. "Where 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, 105 USPQ 233, 235 (CCPA 1955).
Thus, said claims are rendered obvious.
This is a new rejection necessitated by amendment.
Unexpected results may overcome the rejection. However, the claims must be commensurate in scope with the unexpected results.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 20, 22-31 and 38 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11781088. Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims in the ‘088 patent are drawn to a process for producing and purifying sterols, which is embraced by the present claim 1.
Applicant states, “Applicants respectfully request that this rejection be held in abeyance until such time that all other outstanding rejections of any of the pending claims are withdrawn. At that time, Applicants will consider whether to address this rejection on the merits or file a terminal disclaimer.”
Thus, the rejection is maintained.
Conclusion
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 SUSANNA MOORE whose telephone number is (571)272-9046. The examiner can normally be reached Monday - Friday, 10:00 am to 7:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUSANNA MOORE/Primary Examiner, Art Unit 1624