DETAILED ACTION
Status of Application
The Examiner acknowledges receipt of the amendments filed on 12/15/2025 wherein claim 1 has been amended, claims 3, 15 and 20 have been cancelled and claims 21 and 22 have been added.
Claims 1, 2, 4-12, 18, 19, 21 and 22 are presented for examination on the merits. The following rejections are made.
Response to Applicants’ Arguments
Applicant’s amendment cancelling claims 3 and 20, filed 12/15/2025, renders moot the rejection made by the Examiner under 35 USC 102(a)(1) over Tawashi et al. (US 2013/0011349).
Applicant’s amendment cancelling claims 3 and 20, filed 12/15/2025, renders moot the rejection made by the Examiner under 35 USC 101.
Applicant’s arguments filed 12/15/2025 regarding the rejection of claims 1, 2, 4-12, 18 and 19 made by the Examiner under 35 USC 102(a)(1) over Tawashi et al. (US 2013/0011349) have been fully considered but they are not found persuasive and is MAINTAINED for the reasons of record in the office action mailed on 9/16/2025.
In regards to the 102(a)(1) rejection, Applicant asserts the following:
A) the present invention requires be irradiated to as to remove unwanted microbes from the pollen.
In response to A, instant claim 1 requires the pollen be “subjected to radiation”. Radiation is inclusive to all forms of light such as microwave, radio, infrared, visible, ultraviolet, etc. which are ubiquitous in the environment where pollen would exist. For example, pollen isolated from the Phoenix genus would be isolated from a plant that requires light to grow, that light, at a minimum, being comprised of visible light radiation which would contact the pollen thereby rendering that pollen subjected to radiation prior to inclusion in the end product such as that claimed.
Applicant’s arguments filed 12/15/2025 regarding the rejection of claims 1, 4-11, 18 and 19 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 9/16/2025.
A) the present invention requires pollen be present in an amount of between 2-20% and be irradiated to as to remove unwanted microbes from the pollen.
In response to A, the concentration of pollen in the end composition is not sufficient to overcome the 101 as the composition is still a product comprising components found in a naturally occurring source. Regarding the limitation that pollen be “subjected to radiation”, the claims does not specify the type of radiation. Radiation is inclusive to all forms of light, such as microwave, radio, infrared, visible, ultraviolet, etc., several of which are ubiquitous in the environment where pollen would exist. For example, pollen isolated from the Phoenix genus would be isolated from a plant that requires light to grow, that light, at a minimum, being comprised of visible light (radiation) which would contact the pollen thereby rendering that pollen subjected to radiation prior to inclusion in the end product such as that claimed. Thus, so long as any form of light radiation encounters the pollen, said pollen would possess the property of having been “subjected to radiation” as required by instant claim 1.
Maintained Rejections, of Record
Claim Rejections - 35 USC § 102
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.
Claims 1, 2, 4-12, 18-19 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tawashi et al. (US 2013/0011349; of record).
Tawashi is directed to topical formulations containing palm pollen.
The formulation may be an anhydrous base (see Table 2 and claim 3) (see instant claims 2 and 9), an emulsion (see [0007] and claim 3) or a powder (see claim 3) (see instant claims 9, 11, 18 and 20). Tawashi’s formulation is to contain pollen in an amount of between 10-30% (see Table 2) (10% disclosed by Tawashi lies within 2-20% range disclosed; see instant claims 1 and 3) (wherein the pollen may be sourced from Phoenix datylifera L. (see [0007]) (see instant claims 1 and 4). The formulation is to comprise oleaginous compounds such as stearic acid (a lipid) (see [0078]) (see instant claim 8) in addition to components that facilitate topical application (see [0008]) (see instant claim 10). It is noted that the instant claim pollen is ‘subjected to radiation’, however, radiation is broadly encompassing of infrared, visible, ultraviolet, radio, etc. which are ubiquitous in the everyday environment which the pollen of Tawashi, simply by existing, would necessarily be subject to.
Regarding the properties identified by instant claims 1, 5, 6, 18, 19 and 22, e.g. ‘said pollen or extract thereof acts as a stabilizer and/or preservative in said composition’, ‘said composition is resistant to microbial growth and/or oxidative damage or color change over a period of time of at least about 1 year (or at least 3 years) at about 20oC’, ‘wherein said composition is a drug or cosmetic composition that limits microbial growth to a maximum of 100 CFU per g or mL’, etc., these are properties inherently associated with the composition as claimed. As the claimed product and the product of the art are identical in that they both are directed to formulations comprising pollen/extract of a palm species, the formulation of the art must have the same properties despite being unrecognized as so. Where the claimed and prior art products are identical or substantially identical in composition, said compositions must have the same properties, unless shown otherwise. See MPEP 2112.01.
Regarding instant claim 7, the means by which the composition is used/stored and for how long is an intended use limitation. See MPEP 2111.02(II) which states that where a claim merely states the intended use of the invention rather than any distinct definition to further limit the claimed invention, such is not considered a limitation and is of no significance to claim construction. In the present case, how the claimed composition is stored and the type of container for doing so is an intended use just as hypothetical limitation to applying the composition on to the skin with a napkin would be. The limitation for how the composition is stored does not limit the composition itself, the pollen extract, but instead provides an avenue for how the composition may be used (‘stored’) and is thus not seen as further limiting the composition as claimed but instead providing a means for which the composition may be used.
Regarding instant claim 12, the limitation that the composition be a ‘food composition in the form of ‘an oil, a dehydrated food or a powdered food or baking mix’ is described by Tawashi. As discussed above, Tawashi discloses that their pollen/extract composition be in the form of an anhydrous oil composition or a powder, both of which would read on the “oil” and the “powdered food”. Other than the functional descriptor of ‘food’ the claimed composition is no different in composition from that of the prior art. Therefore, the requirement that the composition and powder be a ‘food’ is a functional description of which the powder of Tawashi could broadly be construed as.
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, 4-11, 18-19 and 21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Claim 1 is directed to a composition comprising pollen from a palm species of the genus Phoenix or an extract thereof wherein the pollen is present in an amount of between 2-20% w/w and the pollen is subject to radiation prior to incorporation in the end product. The concentration of pollen and the step of being subject to radiation are not differentiating the claimed composition from its closest natural counterpart, pollen from the Phoenix genus. Regarding the radiated pollen, radiation can include ultraviolet, visible and/or radio waves which are ubiquitous in the environment and would necessarily interact with a pollen. Claim 1 also provides various functional properties of the composition, e.g. acts as a stabilizer and/ or preservative in the composition, etc., but these properties are understood to be tied to the Phoenix pollen/extract. Similar analysis is applicable to claim 18. Dependent claims (from claims 1 and 18) are to ranges of the Phoenix pollen/extract in the composition, to the exact species of Phoenix, to additional properties of the composition (e.g. composition does not degrade over time, limitation to bacterial growth, etc), the composition containing a lipid and being in the form of a suspension/powder. These dependent claims are not seen as different from their closest natural counterpart, the pollen/extract of the palm species Phoenix, because there is no limitation that the composition has a material difference from said closest natural counterpart.
This judicial exception is not integrated into a practical application because the claims are to a composition comprising pollen/extract of a palm species Phoenix and the claims do not provide any meaningful limitation thereon which would sufficiently differentiate the claims from the closest natural counterpart. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because a claim that recites only a pollen/extract is patent ineligible as it reads on a naturally occurring material. Therefore, as the claims do no differ from their closest natural counterpart they are considered ineligible.
New Rejections, Necessitated by Amendment
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.
Claims 1, 2, 4-12, 18-19, 21 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tawashi et al. (US 2013/0011349; of record) in view of Postmes et al. (Experiments 51, 1995, 986-989).
Tawashi is relied upon for disclosure described in the rejection of claims 1, 2, 4-12, 18, 19, 21 and 22 under 35 U.S.C. 102(a)(1).
Tawashi teaches that their composition be sterilized via e-beam sterilization techniques (see [0084]), but fails to teach the pollen as being subject to radiation, e.g. gamma radiation, prior to incorporation into the composition wherein the gamma radiation is provided at 25 kGy.
Postmes is directed to the irradiation of honey and pollen using gamma irradiation so as to produce sterile samples free of unwanted microorganisms. It is demonstrated that administration of gamma radiation of 22 kGy and 25 kGy results in the inactivation of unwanted microorganisms such as fungal spores (see Figure 1 and page 988). Thus, it would have been obvious and desirable to irradiate the pollen of Tawashi with gamma irradiation prior to inclusion in the final composition as doing so would ensure that the pollen contribution was ensured to be free of unwanted microorganisms. See MPEP 2143(I)(D) which states that the application of a known technique to a known product ready for improvement to yield predictable results is indicative of obviousness.
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.
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 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 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