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 .
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.
Claim(s) 1,8-9 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Mahruki US 4592740, hereafter Mahruki.
Regarding claim 1, Mahruki discloses
A menstrual disc applicator comprising (Fig. 1): a housing (outer barrel (12), including an applicator body, where the applicator body is interpreted as the space for holding a sponge in a loaded position, seen in figure 1. Mahruki further discloses the housing having a lumen extending from a proximal end (formed by the piston head (24)) of the applicator body to an open distal end (13A), where the lumen is interpreted as the hollow portion of the outer barrel in which the sponge (40) is inserted in. The examiner further notes that sponge (40) is further depicted in figures 3-6, where the sponge is seen to be and further disclosed to be disc shaped per column 2, lines 49-64. Per the same citation, it is disclosed that the disc shaped sponge is to be folded in order to be placed into the applicator, and per the abstract, the sponge is to be directly applied to the cervix, as also seen in figure 2 (50). Therefore the sponge is interpreted as a menstrual disc, where the opposing ends are the respectful proximal and distal portions, and as such the applicator is interpreted as a menstrual disc applicator.
Mahruki further discloses the open distal end is beveled from an extending bottom portion to a recessed upper portion (Where open distal end is beveled between edges 15 and 16, where 16 is interpreted as the extending bottom portion and 15 is interpreted as the recessed upper portion).
Mahruki further discloses that the applicator body has a length that is less than a length of the folded menstrual disc. The examiner notes that as detailed above, figure 1 of Mahruki details a view of the applicator in a loaded position. Per this configuration, the plunger head (24) forms a small open space between itself and open end (13A) within which the sponge (40) is placed in. Based on this configuration, it is interpreted that the applicator body therefore extends from open end (13A) to plunger head (24), as this is the only open space (and therefore the applicator body) located between said open end and plunger head. Further as seen in figure 1, the sponge (40) extends outside this defined body and is thus interpreted to be longer in length than said body. The examiner further notes that per column 2 lines 57-64, various shapes for the sponge may be used.
Further, the examiner notes that the folded sponge can be seen in figure 1 and figures 3-6. In the loaded position (figure 1) it can be seen that the disc extends distally from the distal end of the body and forms a convex arc with the extending bottom portion.
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Regarding claim 8, Mahruki discloses the menstrual disc applicator system of claim 1, wherein a midpoint of the folded menstrual disc engages with an upper surface of the lumen (figure 1, where the recessed upper portion of the body was defined as 15 under the rejection of claim 1). As seen in figure 1, the folded sponge (40) engages with the upper surface (formed by 15) at a middle portion of the sponge.
Regarding claim 9, Mahruki discloses the menstrual disc applicator system of claim 8, wherein a distal end of the folded menstrual disc engages with a lower surface of the lumen (figure 1, where the extending lower portion of the body was defined as 16 under the rejection of claim 1). As seen in figure 1, the folded sponge (40) engages with the lower surface (formed by 16) at a distal end of the sponge
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(s) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mahruki in view of Callaghan et al. US 2018/0243125, hereafter Callaghan.
Regarding Claim 2, Mahruki discloses the menstrual disc applicator system of claim 1, however, fails to disclose wherein the housing includes a narrowed portion in which a diameter of the lumen is insufficient to receive the folded menstrual disc, the narrowed portion being adjacent to the proximal end of the applicator body.
Callaghan teaches a device for applying a vaginal insert and is thus considered analogous to the claimed invention. Callaghan teaches that the barrel of such a device may have a flared end at the plunger end of the barrel (see figure 4), where said flared end has a narrow portion (34 see figure 4). The examiner notes that said narrow portion includes the narrowing of the lumen as seen best in figure 4. Per paragraph 0038, Callaghan teaches that the narrow end provides a stopping point for the plunger so that the plunger and barrel cannot be easily separated. Therefore it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide the flared end of Mahruki with a narrowed portion to aid in preventing the barrel and plunger from being easily separated. Doing so would merely involve the use of a known technique (narrowing the body and lumen on an applicator) to improve similar devices (applicator) in the same way, and would achieve the predicable result of providing a stopping point for the plunger in addition to aiding in preventing the lumen and plunger from being separated easily, and thus a prima facie case of obviousness exists. The examiner notes that as the narrowed end of Callaghan is at the proximal end of the device, said combination would see the narrowed end at the proximal end of Mahruki. The examiner notes that this narrowed portion would narrow the lumen of the Mahruki device making said lumen insufficient to receive the disc. However, should the applicant disagree with this interpretation, MPEP 2144.04 (IV.A) states in re Rose 220 F.2d 459, 105 USPQ 237 (CCPA 1955) "limitations relating to the size of the package were not sufficient to patentably distinguish over the prior art." The examiner notes that as it was found to be obvious to modify the device of Mahruki to include a narrowed portion, it would further have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the size of the narrowed portion based on the size of the plunger to prevent it from being separated from the device. The examiner notes that the menstrual disc is not positively claimed in the claimed limitations and therefore is directed to functional language.
Regarding claim 3, Mahruki and Callaghan teach the he menstrual disc applicator system of claim 2, further comprising: a plunger (24, as defined under the rejection of claim 1, seen in Mahruki figure 1) configured to engage with the lumen and to extrude the folded menstrual disc from the open distal end of the housing (figure 1-2 of Mahruki, see also column 3, lines 20-46, where the action of pushing the piston (24) cause the sponge to be ejected from the applicator and positioned within the user).
Regarding claim 4, Mahruki and Callaghan teach
The menstrual disc applicator of claim 1, wherein the extending bottom portion is rounded. The examiner notes that the device of Mahruki is defined as a barrel (see abstract, claims). It is therefore interpreted that the body as a whole is rounded (due to it being a barrel) and thus the extending bottom portion is rounded.
Claim(s) 5-6,10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mahruki in view of Callaghan and further in view of Lloveras et al. US 2020/0022835, hereafter Lloveras.
Regarding claim 5, Mahruki and Callaghan teach the menstrual disc applicator system of claim 3. The examiner notes that while the folded configuration, as seen in figure 3 of Mahruki appears to have an extending structure, a notch is not specifically disclosed. As such Mahruki and Callaghan fail to teach wherein a rim of the folded menstrual disc has an inner surface having a first notch at a proximal end of the proximal portion and having a second notch at a distal end of the distal portion.
Lloveras teaches a menstrual collection device and is thus considered analogous to the claimed invention. Lloveras teaches that said device, specifically the upper rim, may have between one and four notches that produce a reduction in thickness of the inner part of the cup allowing for an ease of folding and insertion (para. 0018, see one example notch (14) in figure 3). Further, per para. 0047, the notches (when four notches are used) are diametrically opposed and equidistant from one another and thus it is interpreted that there would be at least a notch corresponding with the distal and proximal end (as said ends are diametrically opposed from one another). Therefore, as a means to ease fold and insertion, it would have been obvious to one having ordinary skill in the art to provide the foldable menstrual sponge device of Mahruki with four notches (including distal and proximal end notches). Doing so would merely require combining prior art elements according to known methods to yield predictable results (that being folding and insertion of a menstrual device), and thus a prima facie case of obviousness exists.
Regarding claim 6, Mahruki, Callaghan, and Lloveras teach the menstrual disc applicator system of claim 5, wherein a rim of the folded menstrual disc is beveled to aid insertion into a vaginal canal. The examiner notes that as seen in figure 4 of Mahruki, the opening of the folded sponge has a curved portion (thus not a straight opening) and is thus interpreted as beveled.
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Regarding claim 10, Mahruki discloses the menstrual disc applicator system of claim 1, wherein a rim of the folded menstrual disc includes at least one ridge. The examiner notes that as seen in figure 4 of Mahruki, the folded sponge, at the rim, can be seen to extend inward, and the extend backward, forming what is interpreted as a ridge.
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Should applicant disagree with this interpretation of a ridge, the examiner provides a further rejection in view of Lloveras.
Lloveras teaches a menstrual collection device and is thus considered analogous to the claimed invention. Lloveras teaches that as a means to improve sealing of the device against drop leakage, a double ring (15 see figure 4) is provided on the insertable device. Therefore as a means to prevent drop leakage, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the sponge of Mahruki with a double ring, as taught by Lloveras. Doing so would combining prior art elements according to known methods to yield predictable results (prevent leakage) and thus a prima facie case of obviousness exists. The examiner notes that extending portions of the rings (seen in figure 4 of Lloveras) are interpreted as ridges.
Regarding claim 11, Mahruki discloses the menstrual disc applicator system of claim 1, but fails to specifically teach wherein a rim of the folded menstrual disc includes at least one groove.
Lloveras teaches a menstrual collection device and is thus considered analogous to the claimed invention. Lloveras teaches that as a means to improve sealing of the device against drop leakage, a double ring (15 see figure 4) is provided on the insertable device. Therefore as a means to prevent drop leakage, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the sponge of Mahruki with a double ring, as taught by Lloveras. Doing so would combining prior art elements according to known methods to yield predictable results (prevent leakage) and thus a prima facie case of obviousness exists. The examiner notes that space between the rings (16 as seen in figure 4 of Lloveras) are interpreted as grooves.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mahruki in view of Callaghan and Lloveras and further in view of Price et al. US 2019/0336260, hereafter Price.
Regarding claim 7, Mahruki, Callaghan, and Lloveras teach the menstrual disc applicator system of claim 6, but fails to teach wherein a distal end of the plunger includes a hook configured to engage with a rim of the folded menstrual disc. The examiner notes that while Mahruki discloses a means for pushing the device out of the applicator (ejector level 30), where said lever may be interpreted as a hook in part due to its shape, and is connected to the defined plunger (column 2 lines 64-65), said lever does not hook to the rim of the disc.
Price teaches an insertable vaginal device and is thus considered analogous to the claimed invention. Price teaches that the device comprises an applicator (figure 8A-B, (840)) and a plunger (848) for pushing the plunger inserts the device into a user (para. 0074-0075). Per paragraph 0077 the applicator (840) may comprise a removal device in the form of a hook, that catches on the open space between legs of the device (as it is an open space in to the device, where the hook hooks on, it is interpreted that the portion that catches the hook is a rim). As the portion (854) is configured to hold the device (para. 0073) and thus insert the device said portion is interpreted to be the insertion end and thus the hook is understood to be on said insertion end, since the plunger fills the other end of the device. Therefore, as Mahruki teaches a lever component for interfacing with the sponge at the distal (insertion) end of the plunger, and Price teaches that applicators may comprise a hook for removal of an insertable vaginal device, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the distal end of the plunger (or lever connected to the plunger) with a hook to remove the inserted device when desired. Doing so would merely involve combining prior art elements according to known methods to yield predictable results (that being a means to remove the inserted device), and thus a prima facie case of obviousness exists.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Matthew Wrubleski whose telephone number is (571)272-1150. The examiner can normally be reached M-F 8:00-4:00 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, Rebecca Eisenberg can be reached on 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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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
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