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
Claims 1-26 are pending in the instant application. Applicant's election with traverse of Group I, Claims 1-19 in the reply filed on 18 May 2026 is acknowledged. The traversal is on the ground that search and examination can be made without serious search burden. This is not found persuasive because the inventions are classified separately (A23L 5/23 and A23L 33/12) and require separate fields of search for methods of extracting lipids from Serenoa repens and dietary supplements comprising lipids obtained from Serenoa repens, respectively, as set forth in the restriction requirement mailed on 1 May 2026.
The requirement is still deemed proper and is therefore made FINAL.
Claims 20-26 are therefore withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-19 are being examined on the merits.
Claim Objections
Claims 1-19 are objected to because in Claims 1 and 16, the phrase “Centigrade dried,” should instead read --Centigrade, dried--.
All other claims depend directly or indirectly from rejected claims and are, therefore, also objected to for the reasons set forth above.
Appropriate correction is required.
Claim Interpretation
Regarding ratios of Claims 2-7 and 16, the enrichment of four specific free fatty acids to total fatty acids is being interpreted as lauric, myristic, oleic, and linoleic free fatty acids equaling the given percentage (e.g., 70.0% of Claim 2) or more relative to the total amount of free fatty acids. The ratio of free fatty acids to total fatty acids is being interpreted as the given percentage (e.g., 83.0-90.0% or more of Claim 6) or more of the amount of total fatty acids are free fatty acids. The balance of total fatty acids to free fatty acids is being interpreted as wherein the extract as a whole is made up of 90% fatty acids and 72.0-75.0% free fatty acids (e.g., Claim 4).
Claim Rejections - 35 USC § 112(b)
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, 3, and 16-19 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 Claims 2 and 3, the enrichment of lauric, myristic, oleic, and linoleic acids to total fatty acids is greater than 70.0% and 65.0%, respectively, however Claim 1 requires the enrichment of the same four free fatty acids to be greater than about 81.0%. It is therefore unclear how these lower proportions of lauric, myristic, oleic, and linoleic acids without additionally requiring a dilution step.
Regarding Claims 16-19, 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 16 recites an enrichment of lauric, myristic, oleic, and linoleic acids as free fatty acids to total fatty acids of about 81.0-84.0%; greater than about 70.0%; and greater than about 65.0%. The claims 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.
All other claims depend directly or indirectly from rejected claims and are, therefore, also rejected under 35 U.S.C. §112(b) for the reasons set forth above.
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.
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.
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Minatelli et al. (US 9,592,264 B2) in view of Gregg Jr., et al. (US 6,669,968 B2), Liu et al. (J Food Sci Technol, 2018, 2130-2142), and Prabakaran et al. (Molecules, 2018, 11 pages).
The instant claims are as of record, drawn to methods of producing enhanced lipidosterolic extracts of Serenoa repens comprising cryogenic milling, aging the resulting saw palmetto powder, supercritical CO2 extraction, and fractionation.
Minatelli et al. teach a method of extracting saw palmetto berries by supercritical fluid extraction using CO2 under high pressure, incorporating by reference the method of Gregg, Jr et al. for further details of the method (Minatelli, et al., col. 8, ln. 33-35). The method comprises drying the berries, which comprise 66% moisture at harvest (greater than about 10%), and then grinding the dried berries to a fineness from about -40 to about 60 mesh, resulting in a powder (e.g., any powder that passes through a given mesh within the range is 100% less than that given mesh; Gregg Jr., et al., col. 4, ln. 57-65; as required for instant Claims 1, 11, and 16). The powder is then contacted with CO2 at an extraction pressure of at least about 500 bar (first extraction pressure) and at a temperature lower than about 80°C (first extraction temperature; Gregg Jr., et al., col. 4-5, ln. 66-67, 1-5; as required for instant Claims 1, 8, and 16). Next, the extracted saw palmetto compounds are separated into fractions, wherein the first separation pressure is 180-260 bar and the first separation temperature is 62-75°C; the second separation pressure is about 30-120 bar and the second separation temperature is 15-48°C; and the third separation pressure is about 30 bar and the third separation temperature is 15°C (Gregg Jr., et al., col. 5, ln. 18-47; Tables 1-4; as required for instant Claims 1, 9, 10, and 16). The various extraction fractions can be blended in predetermined amounts to prepare a saw palmetto composition comprising desired proportions of various saw palmetto compounds including phytosterols, triglycerides (fatty acids), and fatty alcohols (enhanced LSESr; Gregg Jr., et al., col. 6, lines 1-8; as required for instant Claim 16).
This blending results in a standardized saw palmetto extract comprising at least 90% free fatty acids, including about 40% oleic acid, about 20% lauric acid, about 12% myristic acid, and less than about 8% of linoleic acid, which is a range of about 72% - 80% of oleic, lauric, myristic, and linoleic acids which therefore comprise about 80% - 88.9% of the total free fatty acids (enrichment; 81.0%; 70.0%; 65.0% or greater; 81.0% to 84.0%; Minatelli, et al., col. 9, ln 43-50; as required for instant Claims 1-3, 5, and 16). The extract has a peroxide value of less than 5.0 meq/kg and a minimum shelf life of 24 months (shelf stable; less than about 4 meq/kg; at least about 4 years; without added antioxidants and stabilizers; Minatelli, et al., col. 6, ln. 24 and 38; as required for instant Claims 13 and 18). The total fatty acids range from 59.3 - 93.4% (Minatelli, et al., Tables 1-4), and thus when the total fatty acids are 93.4% and the total free fatty acids are 90%, the ratio of free fatty acids to total fatty acids is 96.4% (greater than 83.0%; greater than 90.0%; as required for instant Claims 6, 7, 16, and 17). The balance of total fatty acids to free fatty acids is therefore 59.3 - 93.4% total fatty acids to 90% free fatty acids.
Neither Gregg Jr., et al. nor Minatelli et al. teach cryogenic milling or aging the saw palmetto powder.
Liu et al. teach cryogenic milling of peppercorns dried to 9.0-14.0% moisture (Liu et al., Materials, page 2131; as required for instant Claim 16). The peppercorns are frozen at -210 to -196°C (no greater than -20°C) and ground with a cryogenic grinder (milled), with re-freezing steps to maintain cryogenic temperature during the process (Liu et al., Materials, 2131; as required for instant Claims 1, 11, 12, and 16).
Prabakaran et al. teach that total fatty acid content of roasted soy beans increases between 0 and 4 weeks (28 days) and again around 8 weeks (56 days) when stored at room temperature (20°C or 68°F; Prabakaran et al., Figure 1B, page 4; as required for instant Claims 1, 14-16, and 19).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to use the cryogenic milling of Liu et al. as the grinding method and also to age the powder as disclosed in Prabakaran et al. in the method of Gregg Jr., et al. and Minatelli et al. because the peppercorn extracts of Liu et al. had increased amounts of fatty acids, including lauric, myristic, oleic, and linoleic acids when cryogenically milled compared to hammer milling (Liu et al., Table 4, page 2138). Additionally, a skilled artisan would be motivated to age the powder because as indicated by Prabakaran et al., aging also increases the amounts of fatty acids in roasted soybeans. A skilled artisan could therefore reasonably expect to produce an extract of saw palmetto with higher amounts of fatty acids by using cryogenic milling and aging prior to extraction in the method of Gregg Jr., et al. and Minatelli et al.
Gregg Jr., et al. and Minatelli et al., Liu et al., and Prabakaran et al. are relied upon for the reasons discussed above. If not expressly taught by the prior art, based upon the overall beneficial teaching provided by this reference with respect to cryogenic milling for increasing fatty acid content in extraction processes, the adjustments of particular conventional working conditions (e.g., determining one or more suitable cryogenic milling temperature (instant Claims 12 and 16)), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product (as made by the method disclosed therein) and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685,
688 (CCPA 1972).
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-15 of copending U.S. Patent Application No. 19/169,218 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other, and consequently practicing at least one of the instant or conflicting reference patent as claimed would have at least rendered obvious the other, because:
Instant Claim 1 and reference Claim 1 recite an identical method with the resulting enhanced LSESr having overlapping ranges of the enrichment of lauric, myristic, oleic, and linoleic acids and ratio of free to total fatty acids.
Instant Claims 2-5 share overlapping ranges with reference Claims 2 and 3.
Instant Claim 4 shares overlapping (e.g., about 83.0% overlaps about 82.0%) ranges with reference Claim 4.
Instant Claims 8-15 are identical to reference Claims 5-12.
Instant Claim 16 is disclosed as a whole by reference Claims 1, 3, 5-7, 9, 11, and 12, when taken together, referencing each step of the method with overlapping ranges.
Instant Claims 16 and 17 and reference Claim 13 recite an identical method with the resulting enhanced LSESr having overlapping ranges of the enrichment of lauric, myristic, oleic, and linoleic acids and ratio of free to total fatty acids (e.g., about 83.0% overlaps about 82.0%).
Instant Claims 18 and 19 are identical to reference Claims 14 and 15.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER L CAIN whose telephone number is (703)756-1318. The examiner can normally be reached M-Th 11:00am to 5:00pm EST.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655
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