DETAILED ACTION
Status of Application
The Examiner acknowledges receipt of the amendments filed on 6/4/2026 wherein claim 1 has been amended.
Claims 1-9 and 15-17 are presented for examination on the merits. The following rejections are made.
Response to Applicants’ Arguments
Applicant’s arguments filed 6/4/2026 regarding the rejection of claims 1-9 and 15-17 made by the Examiner under 35 USC 103 over Inarejos et al (US 2019/0099464), evidenced by Applicants specification and Koulakiotis et al. (Planta Med, 2015, 81, 606-612) have been fully considered but they are not found persuasive and is MAINTAINED for the reasons of record in the office action mailed on 2/4/2026.
In regards to the 103 rejection, Applicant asserts the following:
A) Example 4 demonstrates that a composition comprising at least 20% crocin has significantly improved squalene peroxidation inhibition activity as compared to compositions containing less crocin content.
In response to A, the Examiner is not persuaded as the Inarejos provides a composition which comprises a minimum of 3.48wt% crocins which are recognized by the prior art for their antioxidant activity. The present limitation to a composition comprising ‘at least 20%’ of crocins is obvious because any ordinary person would identify other concentrations in excess of that the ‘at least’ taught by the prior art with a reasonable expectation for success in providing a crocin containing composition having antioxidant activity.
As to the property of providing efficacy against squalene peroxidation, this appears to be a feature of a composition including the crocin compounds. Table 4 of the present specification compares Example 2 and Example 3 composition for their ability to reduce squalene oxidation. Example 2 contains 22.7wt% crocins whereas Example 3 contains 12.2wt% crocins. However, according to Table 4, both formulations are capable of providing efficacy against squalene peroxidation. The finding that the increased concentration of crocin results in more effective activity against peroxidation is not reflected by the claim, although it’s not clear that such would be considered unexpected as concentration is generally related to chemical activity.
In any regard, the present limitation to ‘at least 20%’ crocin is within the range set forth by the prior art and one of ordinary skill would be capable of working within that prior art range to identify concentrations which yielded desired outcomes. If such a finding were that at least 20% crocins improved the compositions’ antioxidant properties, then such would have been the product of ordinary skill and common sense rather than innovation.
Applicant’s arguments filed 6/4/2026 regarding the rejection of claims 1-9 made by the Examiner under 35 USC 101 have been fully considered but they are not found persuasive and is MAINTAINED for the reasons of record in the office action mailed on 2/4/2026.
In regards to the 101 rejection, Applicant asserts the following:
B) Claim 1 is directed to patentable subject matter as it encompasses a “composition of matter”
In response to B, the Examiner acknowledges that the present invention is to a “composition of matter”. However, this is not the issue. Rather, the issue is that the claims are to a concentrated form of components that naturally exist in saffron. Example 11 (‘purified amazonic acid’) of Section 101 Examples is similar the present case. Example 11 states that compositions which comprise structurally and functionally identical compounds to that which naturally occur, absent a showing of markedly different characteristics, are no different from what is in nature and should be considered a “product of nature” exception.
The finding that compositions having increased concentrations of the naturally occurring compounds perform better than compositions with lower concentrations is not persuasive as outcomes, such as antioxidant activity, are tied to the concentration of the compounds in the composition. The greater the concentration, the greater the antioxidant activity. The more molecules present to perform a biochemical function, the more of that function can occur. Conversely, The lower the concentration, the lower the activity. As Applicant has not identified a markedly different chemical or biological property for the concentrated compounds, the claims are found to be directed to products of nature and therefore not qualify as eligible subject matter.
Maintained Rejections, of Record
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.
Claim 1-9 and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Inarejos et al (US 2019/0099464), evidenced by Applicants specification and Koulakiotis et al. (Planta Med, 2015, 81, 606-612).
Inarejos describes a dry saffron (Crocus sativus) extract where the resulting extract is characterized by comprising 0.03-1% by dry weight of safranal and at least 3.48% by dry weight of crocins (see abstract and claim 1). Regarding safranal, 0.03% dry weight is less than the 0.08% by dry weight of instant claim 1 and the 0.07% by dry weight of instant claim 3.
The extract may be formulated into a solution (see [0070]) or combined with a food supplement such as fatty acids and/or fiber (‘a physiologically acceptable medium’) (see [0074]) (see instant claim 8). The extract is to be administered in a daily dosage of between 20-40 mg/day (see claim 14) and any solution or supplement intended for administration would necessarily contain some mass percentage of the extract in order to achieve this dosage. If the end result was a composition that comprised between 0.0001-20% of the extract, then this would have been a product of ordinary skill and common sense as the general framework for such a composition is spelled out by the reference (see instant claim 9). Moreover, the claimed range spans 5 orders of magnitude and, as it is quite broad, the range lacks criticality.
Regarding the crocin component being at least 20% by dry weight of the extract (or between 20-40% by dry weight per instant claim 2), such is considered obvious as it is encompassed by the range of Inarejos. See MPEP 2144.05(I) which states that claimed ranges that overlap or lie inside ranges disclosed by the prior art are considered obvious. As to an endpoint for concentrating the crocin component (e.g. 20-40% by dry weight), this would be obvious as the upper bound of Inarejos is without limit and the net result would be the mere carrying forward of a patented conception involving only the change of proportion. Where the general conditions of a claim are described by the prior art, it is not inventive to discover optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
Identified crocins’ include trans-crocin-4, trans-crocin-3, trans-crocin-2, cis-crocin-4, trans-crocin-2, trans-crocin-1, cis-crocin-3, etc. (see abstract, see [0009, 0026]). Koulakiotis is cited as evidence to demonstrate that the crocin species of Inarejos are the same as those claimed (see pages 606 and 607). The alignment of the crocin species of Inarejos and those of the instant claims are provided in the following table:
bis-gentiobiosyl-E-crocetin
trans-crocin-4
gentiobiosyl-glucosyl-E-crocetin
trans-crocin-3
big-glucosyl-E-crocetin
trans-crocin-2
Bis-gentiobiosyl-13-Z-crocetin
cis-crocin-3
With respect to instant claims 5 and 6, the concentration of the various crocin species in the extract would be dependent on the degree to which one concentrated the extract. The more concentrated to the extract, the greater the concentration of the extracted crocin species. As Inarejos teaches that the concentration of the crocin species can be modulated (e.g. at least 3.48% by dry weight), one of ordinary skill in the art would be capable of concentrating the extract to a desired concentration and if such a manipulation resulted in concentrations such as those claimed, then this would have been the product of ordinary skill and common sense.
Regarding instant claim 7, where the plant originates from is ultimately immaterial to the final extract so long as the material extracted belongs to the Crocus sativus species. This limitation is in essence a product-by-process limitation as it seeks to define where the plant used for producing the extract is grown. However, so long as the material being extracted is a plant of the Crocus sativus species, which Inarejos teaches, the limitation is met. See MPEP 2113 regarding product-by-process limitations.
Inarejos teaches a method for preparing their extract by a process that comprises mixing Crocus sativus stigmas and hydroalcohol mixtures (e.g. ethanol and water) (see [0032]) and then drying to remove solvents and produce a powder of the extract (see [0033]) (see instant claim 17). The method may also involve separation of the compounds from the mixture via HPLC. Separating and isolating desired components from the mixture is broadly understood to overlap with ‘filtration’ (see instant claim 16(i)). It is noted that Applicant’s specification identifies ethanol as a “water-miscible organic solvent” (as required by instant claim 15).
The only difference between Inarejos and the instant claims is that Inarejos does not provide the crocin component of the extract in an amount within the range claimed as required by MPEP 2131.03. However, the crocin concentration of Inarejos overlaps the claimed range and is therefore considered obvious per MPEP 2144.05(I). See section 9 above.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Claim 1 claims an “[E]xtract of at least one plant of the Crocus sativus species comprising (i) at least 20% by dry weight of one of more crocin(s) relative to the total weight of the components of a dry extract and (ii) less than 0.08% by dry weight of safranal relative to the total weight of the components of the dry extract.” Dependent claims are drawn to concentrations of extracted components and that the extract composition contain a physiologically acceptable medium. The extract of the claims are not considered different from their closest natural counterpart, a plant of Crocus sativus, because there is no limitation that the extract exhibit a material difference from said closest natural counterpart.
This judicial exception is not integrated into a practical application because the claims are to a Crocus sativus extract. The extract does not set forth any meaningful limitation to differentiate the claimed extract from the plant of Crocus sativus. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because a claim that simply recites a Crocus sativus extract is patent ineligible as it reads on a naturally occurring substance. Therefore, the claims do not differ from their closest natural counterpart and are considered ineligible.
Potentially relevant prior art:
Bai et al. (CN 102657747; translation provided)
Conclusion
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 extension fee 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 KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE A PURDY/Primary Examiner, Art Unit 1611
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