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 1-18 are pending in the instant application. Applicant’s election without traverse of Group I, Claims 1-17 in the reply filed on 1 December 2025 is acknowledged. Claim 18 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1 December 2025.
Claims 1-17 are being examined on the merits.
Biological Material
It is noted that microorganism(s) useful or required to practice the claimed invention are invoked in the specification (see e.g. para. [0012], [0032-0046], fig 5).
In an application where the invention required access to specific biological material, an applicant could show that the biological material is accessible because it is known and readily available to the public. The concepts of "known and readily available" are considered to reflect a level of public accessibility to a necessary component of an invention disclosure that is consistent with an ability to make and use the invention. To avoid the need for a deposit on this basis, the biological material must be both known and readily available - neither concept alone is sufficient.
If an applicant has adequately established that a biological material is known and readily available, the Office will accept that showing. In those instances, however, the applicant takes the risk that the material may cease to be known and readily available. Such a defect cannot be cured by reissue after the grant of a patent. See MPEP § 2404.01 (see also 37 CFR 1.802).
Relevant Art Made of Record
The following art is considered relevant regarding the state of the art for prevention of HSV infections, and how “prevention” is understood within the art of HSV infection.
Herpes simplex virus (HSV) causes oral and genital herpes and other infections in the body, although many people have no symptoms (Cleveland Clinic, 2024, page 1). The main treatments for HSV infections are antiviral medications, which come in various forms including topical creams or ointments, and can be used for acute clinical outbreaks as well as chronic suppressive therapy (e.g., prevent clinical disease; Cleveland Clinic, pages 11-13). While it is difficult to completely prevent spread between people, risk of infection can be lowered. Whole plant extracts have been shown to prevent viral adsorption, replication, attachment, and penetration into the host cell (Garber et al., 2021, J Evid Based Integ Med, 1-57; Table 1) and yeast glucans have been shown to have potential in counteracting HSV1 infection by preventing epidermal damage upon infection with the virus (Tavares-Valente et al., 2025, Eur J Pharma Biopharma, Figure 5, page 6). Finally, Fabrizi (US 2009/0220440 A1) discusses “prevention” as inclusive of prevention of spread and transmission of the virus as well as relapses of clinical symptoms (Fabrizi, [0001]-[0002]). Taken together these sources indicate that “prevention” in the art of HSV infection encompasses prevention of clinical disease, including relapse of symptoms as well as reducing risk of infection spread.
Claim Objections
Claims 8, 15, and 16 are objected to for the following:
Claim 8 (at line 2) is objected to because the phrase “from 4 6% w/w” should instead read --from 4-6% w/w--.
Claims 15-16 are objected to because the phrase “beewax” (in claim 15 at line 2) should instead read --beeswax--. Claims16 is included in the ground as depending from objected-to claim 15.
Appropriate correction is required.
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 3 and 12-17 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.
Claim 12 recites the limitation “a roll on,” however it is unclear what is meant by this term. This phrase appears to recite a method of application, however, the claim recites it as a dosage form without clarification in the claims or specification regarding this limitation.
Claim 3 is indefinite because the phrase “labial diseases or other areas of the face or of the lips” implies that the labia are a part of the face, however, the labia are generally known as an anatomical term referring to female genitalia, specifically the lips of the vulva. As written, it is unclear whether the composition is formulated for both the female genitals and the face.
Appropriate clarification is required.
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 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Koenig (US 2011/0301118 A1) in view of Fabrizi (US 2009/0220440 A1).
The instant claims are as of record, drawn to a method for treating or preventing a herpes simplex virus infection comprising administering to a subject in need thereof a yeast beta-glucan emulsion comprising 30-80% w/w of an emollient agent and 4-25% w/w of beta-glucan which acts as an antiviral agent.
Koenig teaches methods for treatment of skin wounds of lesions comprising administering to a subject an effective amount of a glucan composition wherein the glucans, including beta-glucan, can be derived from the baker’s yeast Saccharomyces cerevisiae (Koenig, [0002]; as required for instant Claims 1 and 12) and in one example can have a molecular weight ranging from 1200 to 2000 kDa (Koenig, [0049]). The composition comprises 10-99.9% by weight of pharmaceutically acceptable carriers including squalane (emollient agent), paraffin (filler), and beeswax (filler) Koenig, [0058], [0061]; as required for instant Claims 1, 2, and 11-16) as well as preservatives to prevent the action of microorganisms such as sorbic acid (Koenig, [0064]; as required for instant Claims 14 and 15). The composition can be prepared as an emulsion (Koenig, [0092]; as required for instant Claims 1 and 12) and comprises .01-10% by weight of glucan (Koenig, Claim 1, page 8; as required for instant Claims 1 and 6-8). The ratio of glucan:emollient therefore falls within the claimed range because based upon the provided weight percentages, the ratio could be, for example, 1:1 or 1:2 (e.g., 10% glucan and 20% emollient; as required for instant Claim 17).
The composition may be topically administered on skin wounds and lesions (Koenig, [0056]) in the form of face masks and scrubs (e.g., applied topically to the face; Koenig, [0062]; as required for instant Claims 3, 4, and 12). Finally, since the composition of Koenig comprises the same ingredients as the composition of instant Claim 1, absent any evidence to the contrary, the composition of Koenig shares the properties of the claimed composition and therefore is not soluble in water (as required for instant Claim 5). See MPEP § 2112.01.
Koenig does not teach wherein the composition functions specifically as an anti-viral agent for treating or preventing a herpes simplex virus infection or specific beta-glucan molecular weight.
Fabrizi teaches a composition for the topical treatment and prevention of labial herpes lesions comprising beta-glucan extracted from yeast (Fabrizi, [0012], [0023]; as required for instant Claims 1, 3, and 12). Beta-glucan functions to activate the immune system against viral agents at a local level (antiviral agent; Fabrizi, [0012]), and the composition may be presented in form of a labial stick or cream.
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 combine the teachings of Koenig and Fabrizi to arrive at the instantly claimed invention. The composition of Koenig is suitable for direct application to wounds and lesions, and therefore a skilled artisan would be motivated to use that composition for the purpose of treating herpes simplex virus infections as taught by Fabrizi because beta-glucan is known to be an immune-stimulating anti-viral agent at a local level. A skilled artisan could thus use the composition and method of Koenig for treating or preventing a herpes simplex virus infection with a reasonable expectation of success.
Koenig and Fabrizi 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 topically applied beta-glucan compositions applied in the manner disclosed therein, the adjustments of particular conventional working conditions (e.g., determining one or more suitable beta-glucan molecular weight ranges (Claims 9 and 10) and amount of preservative (Claim 16), in which to perform such a method), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
Claims 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Koenig (US 2011/0301118 A1) in view of Fabrizi (US 2009/0220440 A1) as applied to Claims 1-10 above, and further in view of Mann (The Healthy, 2020, 31 pages).
The instant claims and teachings of Koenig and Fabrizi are as of record.
Koenig and Fabrizi do not explicitly teach the dosage forms of lipstick, face stick, lip balm, or a face balm.
Mann teaches various products recommended by dermatologists for getting rid of cold sores occurring on the lip caused by the herpes simplex virus, including creams, lip balms, skin protectants, and ointments (see whole document; as required for instant Claim 12).
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 provide the composition and method as taught by Koenig and Fabrizi in the dosage forms taught by Mann because a skilled artisan would know they are commonly used and well known in the art for treating cold sores on the lip cause by herpes simplex virus, and a recommended by dermatologists. A skilled artisan would therefore be motivated to use well-known dosage forms and could do so with a reasonable expectation of success.
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.
Conclusion
No claims are allowed.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655