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 .
Letter of Express Abandonment
A letter of Express Abandonment and Nonpublication request were both filed along with the application itself (08/29/2023). This letter was found to be improper in a communication to Applicant dated 09/05/2023. Thus, the pending claims 1-11 will be examined under normal procedure.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 1 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 1 recites, “A reservoir portion in the vaginal canal”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-11 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mugadza (US 20240207085 A1).
Regarding Claim 1, Mugadza discloses a menstrual reservoir with valvular outlet (Figs 1-7 ¶[0109][0114] menstrual cup 100 with selectively openable drainage slot 118) comprising:
a) A reservoir portion in the vaginal canal allowing for the collection of blood during menstruation (Figs 1-3 ¶[0109] interior of receptacle 102); the reservoir portion comprising a rim (Figs 1-3, top rim 104), and outer wall (Fig 1, outer wall of 102) and a cavity allowing for the collection of blood in the vaginal canal (Fig 1-3 ¶[0109] interior of 102 and interior of stem 108 may collect blood);
b) the reservoir portion comprises at least one outlet allowing for fluid to be drained from the reservoir, referred to as the reservoir outlet portion (Fig 3 ¶[0113] hole 103);
c) the reservoir outlet portion will be connected to a valvular portion (Figs 1-7 ¶[0109][0114] hole 103 is connected to stem 108);
d) the valvular portion comprises at least one inlet (Fig 1-7, portion of stem 108 disposed at hole 103), at least one valve mechanism (Fig 1-7 ¶[0114] tab 116 may selectively open and close drainage slot 118) and at least one outlet (Fig 1-7 ¶[0114] drainage slot 118);
e) the valvular mechanism allows for the selective retention of fluid in the reservoir and controlled drainage of fluid from the reservoir through the reservoir outlet portion (Fig 1-7 ¶[0114] tab 116 may selectively open and close drainage slot 118, which fluidly communicates with hole 103).
Regarding Claim 2, Mugadza discloses that the reservoir portion comprises a flexible and elastic rim, outer wall and cavity that will create a suction force in the vaginal canal fixing it in place (Fig 1-7 ¶[0109][0113-0114] collapsible and foldable receptacle 102 and collapsible hollow telescoping stem 108 with suction bulb 110. Suction bulb 110 may apply negative pressure to the interior of the menstrual cup).
Regarding Claim 3, Mugadza discloses a method of using the menstrual reservoir with valvular outlet of claim 2 (see above for claim 2), wherein the valvular portion in conjunction with the reservoir outlet portion will allow for the selective drainage of menstrual fluid from the reservoir portion and vaginal canal without needing to remove the device from the vaginal canal (Fig 1-7 ¶[0114] tab 116 may selectively open and close drainage slot 118); the method comprises:
a) closing the valvular portion of the device (¶[0134-0136] drainage means are not actuated before insertion into the vagina);
b) fixing the device in place, creating suction force in the vaginal canal (¶[0134-0136] negative pressure may be applied after the receptacle is in place);
c) allowing menstruation to occur, filling the reservoir (¶[0135]);
d) setting the valvular portion to an open configuration;
e) partially draining the reservoir, preserving suction force (¶[0134-0137] user will be able to actuate drainage means without the receptacle being removed from the vagina, thus preserving suction force);
f) setting the valvular portion to a closed configuration (¶[0103-0104][0114] tab 116 may be selectively closed. The valve may also comprise a duckbill valve which automatically returns to a closed configuration after actuation be the user);
g) repeating the process of menstruation and partial draining of the reservoir until menstruation has ceased (¶[0137] users are encouraged to drain the device before removal).
Regarding Claim 4, Mugadza discloses that the reservoir outlet portion in conjunction with the valvular portion extend to or out of the vaginal opening (¶[0097] stem 108, which comprises the valve may be extended until it is outside of the vagina).
Regarding Claim 5, Mugadza discloses A method of extracting the menstrual reservoir with valvular outlet of claim 4 (see above for claim 4) from the vaginal canal without needing to insert hands into the vaginal canal (¶[0102][0136] stem 108 acts as a built in applicator for insertion and a handle for removal); the method comprises:
a) setting the valvular portion to an open configuration and draining any remaining fluid (¶[0137] users are encouraged to drain the device before removal);
b) pulling on the valvular portion and/or reservoir outlet portion (¶[0136] stem is pulled out along with the receptacle portion);
c) air will rush in through the valvular portion, breaking the suction force of the reservoir in the vaginal canal allowing the device to be extracted (¶[0114] opening tab 116 breaks suction force after drainage has occurred). The valvular portion or reservoir outlet portion can be pulled out without any resistance of suction, and the insertion of the hands into the vaginal canal to grab or pinch the reservoir or any attachments to the reservoir will not be necessary (¶[0136] stem is pulled out along with the receptacle portion).
Regarding Claim 6, Mugadza discloses that the reservoir portion comprises a flexible and elastic rim (Fig 1-7 ¶[0109-0110] collapsible and foldable receptacle 102 includes top rim 104), outer wall (Fig 1, outer wall of 102) and cavity (Fig 1-3 ¶[0109] interior of 102 and interior of stem 108) that will fit against the vaginal fornix between the pubic bone and posterior fornix fixing it into place (¶[0097][0136]).
Regarding Claim 7, Mugadza discloses that the valvular portion in conjunction with the reservoir outlet portion will allow for the selective drainage of menstrual fluid from the reservoir portion and vaginal canal without needing to remove the device from the vaginal canal (¶[0136-0137] drainage means of the stem allow for the receptacle to be drained without it having to be removed from the vagina).
Regarding Claim 8, Mugadza discloses that the reservoir outlet portion in conjunction with the valvular portion extend to or out of the vaginal opening (¶[0097] stem 108, which comprises the valve may be extended until it is outside of the vagina).
Regarding Claim 9, Mugadza discloses a method of extracting the menstrual reservoir with valvular outlet of claim 8 (see above for claim 8) from the vaginal canal without needing to insert hands into the vaginal canal (¶[0102][0136] stem 108 acts as a built in applicator for insertion and a handle for removal); the method comprises:
a) setting the valvular portion to an open configuration and draining any remaining fluid (¶[0137] users are encouraged to drain the device before removal);
b) pulling on the valvular portion and/or reservoir outlet portion (¶[0136] stem is pulled out along with the receptacle portion);
c) the reservoir will flex and dislodge from the vaginal fornix and allow for extraction without the insertion of hands into the vaginal canal through pulling on the valvular portion and/or reservoir outlet portion (¶[0136] stem is pulled out along with the receptacle portion).
Regarding Claim 10, Mugadza discloses that the device or any portion of the device is composed of any suitable elastomer, plastic, natural, or metal material or any combination of suitable materials (¶[0132] The menstrual cup can be made out of silicone (including medical grade silicone) or latex rubber).
Regarding Claim 11, Mugadza discloses that the device or any portion of the device is composed of any suitable elastomer, plastic, natural, or metal material or any combination of suitable materials (¶[0132] The menstrual cup can be made out of silicone (including medical grade silicone) or latex rubber).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Nicklas (US 20230301820 A1) and Cull (US 20220175575 A1), which are both drawn to menstrual cups with drainage means.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY LEE FLYNN whose telephone number is (571)272-8255. The examiner can normally be reached Monday-Friday 7:30-5 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TIMOTHY LEE. FLYNN
Examiner
Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781