DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. Applicant’s election, without traverse, of Group I, in the reply filed on 11/18/25, is acknowledged.
Claim Status
3. The amendment, filed 11/18/25, has been entered. Claims 1-6 and 8-10 are pending and under examination. Claims 7 and 11-20 are cancelled.
Claim Objections
4. Claim 6 is objected to because of the following informalities: missing word. Claim 6 is missing the word “and” between the final two options in the list of alternatives; see MPEP 2173.05(h) for proper Markush-type language. Appropriate correction is required.
Claim Rejections - 35 USC § 101
5. 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.
6. Claims 1-6 and 8-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e. law of nature; nature-based product) without significantly more.
The claims recite “A … composition … comprising… a Bacillus velezensis fermentate and/or metabolite thereof …” ; which appears to be the natural products (i.e. fermentates and metabolites) of a naturally occurring bacterial species (see instant Example 1; and Ye et al. 2018 (Characteristics and Application of a Novel Species of Bacillus: Bacillus velezensis; ACS Chem Biol 13: 500-515). Therefore, the product claims are directed to a statutory category and Step 1 of the Subject Matter Eligibility analysis is Yes. However, this judicial exception is not integrated into a practical application because the naturally occurring bacterium, and thus the natural products thereof, does not appear to be markedly different from its naturally occurring counterpart, in its natural state, since it was not modified in any way (e.g. “…use in the treatment of a scalp disorder” is interpreted as the intended use of the product per se). Therefore, although the product claims are directed to a statutory category, they are also directed to a judicial exception (e.g. nature-based products; Step 2A prong 1 is Yes) that is not integrated into a practical application (i.e. Step 2A, prong 2 is No).
Further, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements in claims 1, 2, 4, 5, and 10. For claims 6, 8 and 9, the additional element encompasses water (i.e. a skin care acceptable excipient). For the anti-dandruff active agent(s) in claim 3, this additional element is not sufficient to amount to significantly more than the judicial exception because there is no indication that this additional element changes any structural or functional features of the judicial exception per se. Therefore, all the components in the composition function as they would individually, and a mere mixture or aggregation of products, natural or not, does not structurally and/or functionally change the nature-based product from what exists in the environment and that in order to be eligible, every embodiment within the broadest reasonable interpretation of the claim must be eligible.
Thus, taken alone, the additional elements do not amount to significantly more than the above identified judicial exceptions (i.e. naturally occurring bacteria and the naturally occurring fermentates and metabolites thereof). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually because the additional element(s) are recited at a high level of generality and are well-understood, routine, conventional activities engaged in by the scientific community as evidenced by, for example, Ye et al. 2018 (Characteristics and Application of a Novel Species of Bacillus: Bacillus velezensis; ACS Chem Biol 13: 500-515). Consequently, the additional element(s) are not sufficient to make the judicial exception eligible for patent protection (Step 2B is no).
Therefore, based upon consideration of all of the relevant factors with respect to the claim as a whole, the claims are held to claim a law of nature and natural products, and are consequently rejected as ineligible subject matter under 35 U.S.C. 101.
Claim Rejections - 35 USC § 112
7. 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.
8. Claims 1-6 and 8-10 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
With regards to claim 1, the term “reduces” (i.e. see line 3) is a relative term which renders the claim indefinite. The term 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. In other words, how much of a reduction (i.e. to what degree) is included vs. excluded in the scope of the claim? Thus, clarification is required to remove scope ambiguity.
Claim 2 is indefinite because of the use of parentheses. Although parenthesis may be appropriate when defining an abbreviation or acronym, the inclusion of parentheses for phrases (e.g. see line 2), raises uncertainty as to whether the feature in the parentheses is optional or always present. Thus, clarification is required to ascertain the metes and bounds of these claims. The Office suggests the use of commas or semicolons. In addition, the terms “unbalanced”; “discomfort”; and “irritated” in claim 2 are each a relative term which renders the claim indefinite. The terms are 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. In other words, what constitutes unbalanced (i.e. compared to what and to what degree?) and/or how much discomfort and/or irritation (i.e. to what degree) is included vs. excluded in the scope of the claim? Thus, clarification is required to remove scope ambiguity.
With regards to claim 9, 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 9 recites the broad recitation “at least about 1%” (i.e. at least 1% encompasses about 1% up to 100%), and the claim also recites “up to 5%” which is the narrower statement of the range/limitation (i.e. limits the upper boundary to only 5%). 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. In the interest of compact prosecution, the broader interpretation (i.e. 1 to 100%) will be employed. Nevertheless, clarification is required.
Other dependent claims do not clarify the issues identified above. Therefore, clarification is required to delineate what is included and what is excluded and thereby ascertain the metes and bounds of these claims.
Claim Rejections - 35 USC § 112
9. Claims 1-6 and 8-10 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor had possession of the claimed invention.
Instant claims are drawn to a skin care composition for use in the treatment of a scalp disorder, comprising an effective amount of a Bacillus velezensis fermentate, and/or metabolite thereof, wherein said composition reduces and/or treats said scalp disorder. However, it is the Office’s position that the fermentates and metabolites (and by extension, the use thereof) have not been described with sufficient particularity, such that one skilled in the art would recognize that Applicant had possession of the claimed invention, at the time of filing, because of (A) a lack of a correlation, known or disclosed, between the claimed functional requirements and the structures that meet those requirements; and/or (B) a lack of a representative number and variety of species; for either to constitute possession of the full scope of the claimed genus.
For example, the specification does not provide adequate written description to identify the broad genus of the claims because, inter alia, the specification does not disclose a correlation between the necessary structure of the fermentate or metabolite (e.g. chemical structures), and the claimed function to be maintained (i.e. treatment of a scalp disorder; reduces or treats the scalp disorder).
The specification describes testing fermentates obtained under very specific growth conditions (see Example 2) from three newly isolated strains of Bacillus velezensis, namely Bacillus velezensis E04 deposited at Westerdijk Fungal Biodiversity Institute (WFDB) under number CBS147469, Bacillus velezensis H02 deposited at Westerdijk Fungal Biodiversity Institute (WFDB) under number CBS 147473, and Bacillus velezensis F03 deposited at Westerdijk Fungal Biodiversity Institute (WFDB) under number CBS147471 (see Table 1) each of which were identified to have efficacy based on inhibition assays. However, none of the fermentates, obtained from what appear to be very closely related strains, were adequately characterized by chemical composition (i.e. structure) and each of the fermentates demonstrated variability in their functional properties including the percent growth inhibition for targets Staphylococcus aureus and S. epidermidis (see Table 2, range 74.9 to 77.7%); and removal of Malassezia biofilms (see Table 3, range 77.9 to 80.2%); and removal of S. aureus biofilms (see Table 4, range 70.8 to 76.9%); and percent growth inhibition of Malassezia fungal targets (see Table 5, range 97.9 to 100%). Consequently, the specification does not provide adequate written description support for all Bacillus velezensis fermentates, grown under all growth conditions, because of the variability demonstrated among closely related strains grown under the same conditions. Further, the fermentates are not adequately described because they are not characterized such that one of ordinary skill in the art could recognize any sort of structure-function correlation to predictably practice the invention as claimed. In other words, even a skilled artisan cannot envision the structures required in the fermentate by only knowing what and how much the fermentate inhibits growth and/or biofilm removal. Thus, the specification does not adequately describe what chemical structures in the fermentate are necessary.
With regards to “metabolites thereof”, it is noted that no metabolites appear to be described. Example 6 is directed to “Fractionation of fermentate of Bacillus velezensis” but only physically separates the otherwise poorly described fermentate using cut-off filters. The actual structures (i.e. chemical composition) are not described and there is variation among the fractions but no correlation to what structures correlate to the claimed functions (i.e. see Table 6, range 86.8 to 100%).
Accordingly, the specification fails to adequately describe the particular structural features (i.e. what is necessary in the fermentate and/or which metabolites?) that are required to meet the claimed functional attributes (i.e. treat scalp disorders). Therefore, the specification does not define any structural features commonly possessed by members of the claimed genus because, while the description of the ability of a fermentate and/or metabolite to treat a scalp disorder, might generically describe that fermentate’s or metabolite’s function, it does not describe the fermentate or metabolite itself and a definition by function does not suffice to define the genus because it is only an indication of what the fermentate or metabolite does, rather than what it is. Accordingly, even one of skill in the art cannot visualize or recognize the necessary structures by only knowing what it is expected to reduce or treat. This, the specification does not provide substantive evidence for possession of this large and variable genus, encompassing the use of a potentially massive number of fermentates or metabolites generated under an almost unlimited number and variety of culture conditions, but claimed only by functional characteristics. Consequently, it is the Office’s position that even one of skill in the art would not conclude that Applicant was in possession of the entire genus claimed.
In addition, the specification does not provide adequate written description to identify the broad genus of the claims because, inter alia, it does not describe a sufficient number and/or a sufficient variety of representative species to reflect the breadth and variation within the claimed genus. It is noted that the genus of fermentates and/or metabolites having the claimed ability to treat scalp disorders is potentially large and variable. However, the specification only identifies fermentates from three newly isolated bacteria, each generated under the same culture conditions, but does not adequately describe the chemical structures from the fermentates per se and does not adequately describe any metabolites thereof. Further, the specification describes size-fractioned samples of the fermentate, but again does not adequately describe the chemical structures such that a skilled artisan would recognize Applicant was in possession of the entire genus encompassed by all fermentates and all metabolites generated under all culturing conditions of newly isolated bacterial strains.
With regards to the state of the art, the use of fermentates and metabolites from Bacillus velezensis was still under development and therefore necessarily unpredictable as evidenced by, for example, Ye et al. 2018 (Characteristics and Application of a Novel Species of Bacillus: Bacillus velezensis; ACS Chem Biol 13: 500-515) which teaches Bacillus velezensis is a relatively novel species (circa 2015-2018) with an increasing interest in research on its properties and applications (see abstract and introduction). Ye teaches B. velezensis may be isolated from plant roots, soil, seawater and/or feces but that the taxonomic identification is still not settled (e.g. see introduction). Thus, the art does not support which Bacillus velezensis strains grown under which conditions would predictably produce which fermentates and/or metabolites to reliably maintain any particular functional properties because research on this species is still in its infancy.
Therefore, neither the specification nor the state of the art provides sufficient written description to support the genus encompassed by the claims. Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.).
Consequently, it is the Office’s position that Applicant has not satisfied the requirements as set forth under 35 U.S.C. 112(a).
Claim Rejections - 35 USC § 112
10. Claims 1-6 and 8-10 are rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. This is a biological deposit rejection.
The invention appears to employ novel biological materials, specifically the fermentates and metabolites of newly isolated strains of Bacillus velezensis identified in the specification as Bacillus velezensis E04 deposited at Westerdijk Fungal Biodiversity Institute (WFDB) under number CBS147469, Bacillus velezensis H02 deposited at Westerdijk Fungal Biodiversity Institute (WFDB) under number CBS 147473, and Bacillus velezensis F03 deposited at Westerdijk Fungal Biodiversity Institute (WFDB) under number CBS147471 (see Specification at page 57; Example 2). Since these biological materials appear to be essential to the claimed invention, they must be obtainable by a repeatable method set forth in the specification or otherwise readily available to the public. If the biological materials are not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the biological materials.
If the deposit is made under the Budapest Treaty, then an affidavit or declaration by Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that “…the specific biological materials have been deposited under the Budapest Treaty and that the biological materials will be irrevocably and without restriction or condition released to the public upon the issuance of a patent”, would satisfy the deposit requirement made herein. If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 C.F.R. §§ 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
(a) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer;
(d) a test of the viability of the biological material at the time of deposit will be made (see 37 C.F.R. § 1.807); and
(e) the deposit will be replaced if it should ever become inviable.
Applicant's attention is directed to M.P.E.P. §2400 in general, and specifically to §2411.05, as well as to 37 C.F.R. § 1.809(d), wherein it is set forth that "the specification shall contain the accession number for the deposit, the date of the deposit, the name and address of the depository, and a description of the deposited material sufficient to specifically identify it and to permit examination." The specification should be amended to include this information; however, Applicant is cautioned to avoid the entry of new matter into the specification by adding any other information.
Although Applicants have noted on page 57 of their specification that the biological material was deposited and provided the corresponding deposit numbers, a specific statement regarding deposition under Treaty of Budapest and a statement that the biological materials will be irrevocably and without restriction or condition released to the public upon the issuance of a patent; or a statement including (a)-(e) above, is required to satisfy the conditions set forth in 35 U.S.C. 112(a).
Claim Rejections - 35 USC § 102
11. 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.
12. 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.
13. Claims 1-6 and 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ye et al. 2018 (Characteristics and Application of a Novel Species of Bacillus: Bacillus velezensis; ACS Chem Biol 2018 (13): 500-515).
Ye teaches compositions comprising Bacillus velezensis grown for optimal culture conditions (i.e. the bacterium and its fermentate in growth media having at least water and acceptable excipients; e.g. see Table 2; meeting limitations found in instant claims 1, 6, and 8-9). Ye teaches the compositions comprise salt (i.e. an anti-dandruff component; an excipient; formulated for topical; see Table 2 and Pertinent Art section below; meeting limitations found in instant claims 3, 6, 8 and 10).
With regards to “…or use in the treatment of a scalp disorder … wherein said composition reduces and/or treats said scalp disorder” in claim 1; and “…wherein the scalp disorder is selected from the group consisting of a dandruff condition of the scalp (seborrheic dermatitis), unbalanced ecoflora of the scalp, discomfort of the scalp, tinea versicolor, dry skin, irritated skin, or any one combination thereof” in claim 2; and “…wherein the composition reduces the growth of Staphylococcus species and/or Malassezia species” in claim 4; and “…wherein the composition removes
biofilm of Malassezia species and/or Staphylococcus species” in claim 5; and “…is formulated for topical administration” in claim 10; it is noted that none of these limitations add a structural component to the composition and thus have each been interpreted as an intended use (see MPEP 2144/07) and/or a functional property (see MPEP 2112.01) of the product per se.
Therefore, Ye anticipates the invention as claimed.
Pertinent Art
14. The following prior art, made of record and not relied upon, is considered pertinent to applicant’s disclosure.
It is the Office’s position that one of ordinary skill in the art would recognized salt as an anti-dandruff agent (i.e. see art rejection above). For example:
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Conclusion
15. No claims are allowed.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY MAILLE LYONS whose telephone number is (571)272-2966. The examiner can normally be reached on Monday-Friday 8 am to 5 pm EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http: //www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached on (571)-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
17. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARY MAILLE LYONS/Examiner, Art Unit 1645
January 5, 2026