DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Preliminary Amendments and Remarks, filed 18 May 2023, in the matter of Application N° 18/037,637. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
No claims have been added or canceled.
Claims 1, 4, 6-10, and 13-16 have been amended.
No new matter has been added.
Thus, claims 1-16 represent all claims currently under consideration.
Information Disclosure Statement
One Information Disclosure Statement (IDS) filed 18 May 2023 is acknowledged and has been considered.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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. Applicants are 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 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Milanova (WO 2020/026209 A1; IDS/ISR reference) in view of Jäger (WO 2020/035115 A; IDS/ISR reference; machine translation attached and cited), and Geiser et al. (EP 1 455 847 B1).
The limitations of the instantly claimed invention are directed to a tampon comprising an absorbent cotton body and a pharmaceutical composition comprising a cannabidiol and chamomile flowers.
Milanova discloses a tampon for delivering a therapeutic agent comprising an absorbent tampon body made from industrial hemp fiber and cannabidiol in an amount ranging from 2-200 mg (see e.g., claim 1). Paragraph [0047] discloses that the amount of cannabidiol present in the pharmaceutical composition preferably ranges from 1-90 weight% cannabidiol. The absorbent body is further defined as comprising cotton (e.g., organic cotton) stitching and removal cord. See e.g., ¶[0054]. Example 1 additionally discloses that the tampon is covered with CBD (cannabidiol) oil on its surface (see e.g., claim 1; ¶[0052]).
Paragraph [0036] discloses that the composition allows for the diffusion of cannabidiol from the hydrophobic material of the composition to the body of the subject.
The Examiner acknowledges that this does not expressly disclose either the 3-mm or the 5-mm limitations pertaining to the pharmaceutical composition having diffused into the base body as instantly claimed. However, the Examiner submits that Milanova’s disclosure that the pharmaceutical composition diffuses from the absorbent tampon to the body implies two things. First, it directly discloses and defines the tampon as being absorbent and therefore directly implies that at least a portion of the pharmaceutical composition is absorbed below the surface of the absorbent base body (i.e., not all of it remains on the surface of the absorbent body). Secondly, as some the pharmaceutical composition is taught as diffusing out of the tampon into the body, at least a portion of the composition resides at or near the surface of the tampon body (i.e., less than 3-mm or 5-mm from the surface). Thus, the reference is considered to teach and suggest the recited depth limitations.
Furthermore, the Examiner broadly and reasonably considers the reference’s disclosure of surface application to meet a depth limitation reciting “less than 3 mm” or “less than 5 mm,” particularly as a surface application would mean a depth starting a 0 mm.
The foregoing is considered to teach each of the limitations of claims 1-7 and 10-14 with the exception that chamomile flowers, extracts, oils, and tinctures thereof, are not disclosed.
Jäger is considered to remedy this deficiency in its disclosure of a tampon containing at least one active ingredient for the purposes of preventing or alleviating dysmenorrhea (see e.g., claim 1; Abstract). Claims 2 and 3, for instance disclose that the drug may be selected from chamomile flowers, which per ¶[0071], may be applied as or placed within the tampon as a tincture, oil, or liquid extract.
Based on the combined teachings of the references, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success at producing the instantly claimed composition and arriving at the recited method of producing said composition.
MPEP §2144.06(I) states that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.”
The Examiner, in the instant case, has provided Applicants with two showings in the art whereby active agents are applied to or within a tampon delivery device, for the purpose of treating dysmenorrhea. Milanova, for instance discloses administering cannabidiol from a tampon to women experiencing mild to severe dysmenorrhea, while Jäger discloses administering tampons containing tincture, extract, or oil forms of plants such as chamomile for preventing or alleviating dysmenorrhea.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
Lastly, the limitations recited by claims 8, 9, 15, and 16 are directed to the “application aid” of the applied tampon. Therein, the claims are directed to the elongated outer cylinder, dispensing opening, and ejection parts of the tampon which allow the consumer to use the tampon.
The Examiner acknowledges that neither Milanova nor Jäger disclose these structural limitations. However, Jäger does briefly discuss in ¶[0007], the teachings of Geiser (EP 1 455 847 B1) which discloses a tampon which is suitable for delivering a therapeutic agent, such as chamomile. Geiser discloses such an absorbent device as delivering a therapeutic agent as a botanical (see e.g., Abstract; claim 1, 9). Botanicals are further defined as being formulated as extracts and oils. See ¶[0044].
Geiser additionally discloses the recited outer structural elements of the tampon product in Figures 1 and 2, with the latter displaying a detailed profile diagram of a tampon applicator. See also ¶[0024]-¶[0035].
Based on the combined teachings of the references, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success at producing the instantly claimed medicated tampon, complete with outer device layer, and arriving at the product and method of producing it. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615