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
Applicant's election with traverse of claim 8 in the reply filed on February 5th, 2026 is acknowledged. The traversal is on the grounds that, according the applicant, there exists no undue administrative burden for the Examiner to search and consider all claims in their entirety. This is not found persuasive because group II, drawn to a method of preparing a bee pollen exosome is patentably distinct from groups I and III-V. Examining group II with any groups from I or III-V would add significant search burden for reasons already recited in the restriction, especially non-overlapping subject matter and/or CPC classifications. The Examiner specifically points out that examining group V in addition to group II would add search burden with the additional CPC classification A61Q 19/00 under A61Q, specific use of cosmetics or similar toiletry preparations, inapplicable to group II.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-5 and 9-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on February 5th, 2026.
Claim 8 was examined on the merits.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application, filed on January 5, 2024. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The effective filing date is November 29th, 2022.
Information Disclosure Statement
The information disclosure statement filed February 4th, 2026 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because of illegible text in Figure 1 of document 1 under Non Patent Literature Documents. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
The examiner notes that illegibility can result from inadequate scanning resolution.
The examiner has supplied digital copies of documents 1 and 3 under Non Patent Literature Documents on the IDS submitted on February 4th, 2026. These copies are supplied because of illegibility in Figure 1 on document 1, and color-dependent visualizations in document 3 (Figures 2A and 3A). These copies are cited on the PTO-892 form.
Drawings
The drawings were received on November 28th, 2023. These drawings are acceptable.
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.
The term “low” in claim 8 is a relative term which renders the claim indefinite. The term “low” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The temperature of the bee pollen extraction, recited in claim 8, is indefinite. Although the instant specification provides examples of low temperatures, it also recites that the low temperature is not limited to these examples (page 15 of 30, fifth paragraph). Therefore, the term "low" in "low temperature" in claim 8 is indefinite.
In claim 8, in the third line it is unclear what “the extract” is composed of? Clarification is requested as to the origin of the extract composition.
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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Schuh et al. (Journal of Experimental Biology 2019, 222, jeb208702) .
Claim 8 recites a method of preparing a bee pollen exosome comprising the steps of extracting bee pollen and isolating the exosome from the extract.
Schuh et al. recites the following procedure for the isolation of exosomes from bee products: “Honey and royal jelly (Apicola del Alba, Chile) were diluted 1:20 in particle-free phosphate-buffered saline (pf-PBS). Bee pollen was dissolved 1:40 (w/v) in pf-PBS. All samples were centrifuged at 500 g, 1500 g and 2500 g for 15 min each and subsequently filtered (0.2 µm). Supernatant was ultra centrifuged twice at 100,000 g for 70 min (Thermo Scientific Sorvall). The resulting pellet containing exosomes was resuspended in pf-PBS and stored at −80°C until experimentation (scheme depicted in Fig. S1)” (Schuh et al., Materials and Methods, Isolation of exosomes from bee products; instant claim 8). The method recited by Schuh et al. is explicitly recited as isolating exosomes from bee products in the first subheading under Materials and Methods, and provides a pellet containing exosomes (instant claim 8).
Although the extraction of bee pollen is not explicitly recited by Schuh et al., dissolving the bee pollen in an aqueous solvent such as particle-free phosphate-buffered saline (pf-PBS) before centrifugation would have provided a solvent in which water-soluble components of the bee pollen could concentrate. Exosomes are predictably water soluble because of their double phospholipid membrane (instant specification page 2, paragraph 3), where the polar head of each phospholipid in the outer layer of the membrane interfaces with polar solvent molecules such as water. Therefore, it would be obvious to one of skill in the art to apply an extraction technique as disclosed by Schuh et al. to bee pollen in a bee pollen exosome preparation method (instant claim 8).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert F Spaine whose telephone number is (571)272-9099. The examiner can normally be reached 8:00 AM - 4:00 PM United States Eastern Time, Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at (571) 272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655