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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/03/2025 has been entered.
Status of the Claims
Claims 1-5, 10-14 and 16-21 are pending in the application. Claims 16-20 remain withdrawn. Claims 1-5, 10-14 and 21 are under consideration and currently rejected.
Response to Arguments
Applicant's arguments filed 02/03/2025 have been fully considered but they are not persuasive.
With regard applicant’s argument, pages 3-4, under that “claimed feminine sanitary fold device is not a pad, sanitary napkin, or tampon”, and therefore the cited references do not properly anticipate or render the claimed invention obvious. The argument is not persuasive. First off, the limitation renders the claim indefinite because it conflicts with the claimed structural limitations and lacks clear boundaries. For example claim 1 recites a feminine sanitary fold device comprising a body with additional structural features including "an exterior layer comprising an absorbent material, the exterior comprising a one-way membrane layer and semi-permeable material, a middle layer comprising an absorbent layer, an interior layer comprising a sealed non-permeable membrane layer," and the negative limitation “wherein the feminine sanitary fold device is not a pad, sanitary napkin, or tampon conflicts with the structural limitation above, rendering the boundaries of the claimed invention unclear.
Because the negative limitation is indefinite and does not clearly distinguish the claimed invention from the prior art in a patentable manner, it does not overcome the § 103 rejection. Although MPEP 2143.03 states "All words in a claim must be considered in judging the patentability of that claim against the prior art," when a limitation is indefinite, the Examiner may reasonably interpret it based on the disclosed structure, as has been done here.
In response to applicant’s argument “distinct structural design and functional features” The applicant has not identified specific structural features in the claims that are not taught or suggested by the prior art. As the rejection under 35 USC 103 relies on Mizutani (US 20050215969 A1) in view of Heyman (US 20150209194 A1), which teaches all the structural limitation recited in claim 1 (see final rejection mailed 08/01/2024), and therefore the argument is not persuasive.
In response to applicant’s argument “Non-analogous art- cited prior art is not relevant’ is not persuasive, because cited prior art above teaches all the structural limitation of the claim and relate to feminine hygiene, particularly to absorb fluid related to feminine discharge. Furthermore applicant’s assertion that cited prior art is not relevant because they are not “conforming directly to the vaginal opening”, ”concave, form-fitting structure” and “sanitary fold device is non-invasive”. However, the feature above do not explicitly required by the claim language, and therefore the argument is not persuasive.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5, 10-14 and 21 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
For instance, Claims 1 and 21 recite “wherein the feminine sanitary fold device is not a pad, sanitary napkin, or tampon.", and the amendment introduces a negative limitation that excludes the device from being a pad, sanitary napkin, or tampon, yet the specification fails to provide sufficient detail, such as specific structural or functional boundaries, to demonstrate that the inventor had possession of a device explicitly defined by this exclusion at the time of filing. For instance, specification [0075]: "the disclosure overcomes the shortcomings of conventional cups, pads, tampons, and conventional sanitary devices.". This statement indicates that the invention is intended to differ from conventional sanitary devices in some manner, but it does not explicitly describe the invention as excluding all characteristics or structural features of a pad, sanitary napkin, or tampon.
Claims 2-5 and 10-14 are rejected for at least being dependent of claim 1.
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 1-5, 10-14 and 21are 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.
Claims 1 and 21 recite “wherein the feminine sanitary fold device is not a pad, sanitary napkin, or tampon” which renders the claim indefinite. For instance Claim 1 recites structural features “a body having a curved portion”, “an exterior layer comprises an absorbent material, semi-permeable material, one-way membrane layer”, “middle layer comprises an absorbent layer” and “an interior layer comprises a non-permeable membrane layer” are characters of devices commonly understood in the art to be pads or sanitary napkins. The negative limitation “is not a pad, sanitary napkin, or tampon” introduces ambiguity because it does not specify how the claimed device structurally or functionally differs from these excluded categories. MPEP 2173.05 states that negative limitations are permissible “as long as the boundaries of the patent protection sought are clear” Here, the specification does not define "pad," "sanitary napkin," or "tampon" or explain how the claimed device avoids these classifications beyond the general statement in [0075] that it overcomes their shortcomings. Absent such clarification, the scope of the claim is indefinite, as it is unclear what structural or functional features are excluded by the negative limitation. In an effort to compact prosecution, the examiner interprets the claim based on its structural limitations.
Claims 2-5 and 10-14 are rejected for at least being dependent of claim 1.
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.
Claims 1-5, 10-12 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Mizutani (US 20050215969 A1) in view of Heyman (US 20150209194 A1)
Examiner’s note: limitation “semi-permeable” is being interpreted as any material including a porous membrane, where the pores permit liquid, such as bodily fluids, to pass through the membrane as per applicant’s spec [0053].
Regarding claim 1, Mizutani teaches feminine sanitary fold device, comprising:
A body (figure 6, body of pad 40) having a curved portion (figure 6, convex area 84), wherein the curved portion forms an inverted cup like apparatus (see figure 6, convex area 84 forms an inverted cup like structure) is configured to be contoured to the female genitalia ([0070] “the interlabial pad with a shape capable of being placed between a woman's interlabia comfortably”);
Two lateral side portions (annotated figure 6, lateral side portions) that extend downward from the curved portion forming a fold (see figure 5, the side portions extend from the top portion 44a that forms a fold), wherein the fold is configured to be contoured to insert between the labia folds of the female genitalia ([0070] and figures 9-11, the fold is configured to be inserted between labia fold);
An exterior layer component (figure 6, surface side sheet 46a) comprising a top surface of the body (figure 6, upper surface of the sheet 46a) comprising an absorbent material to absorb bodily fluid secreted from the female genitalia ([0130], [0133] and [0145], sheet 46a is configured to face the bodyside and at least comprising a water permeable material that absorbs bodily fluid from the female genitalia)
A middle layer component (figure 5, following layer 44) wherein the middle layer component comprises an absorbent layer (the following layer comprising an absorbent layer [0095] “The menstrual blood once absorbed in the top part 44a and the side parts 44b of the labial following layer”);
an interior layer component (figure 6, back face side sheet 46b) wherein the interior layer component comprises a sealed non-permeable membrane layer ([0130] "impermeable back face side sheet" and [0080] and figure 6, the back face side sheet 46b sealed to surface side sheet at joining 49);
a bottom surface (figure 6, surface of 46b facing storage layer 42b) of the body configured to collect the bodily fluid secreted from the female genitalia ([0022] and [0095], covering material 46 have water impermeability comprising surface 46b with storage layer 42b that capable of storing bodily fluid);
comprising a first ridge (figure 6, extending area 82 of back face side sheet 46b) along an edge of the fold the interior layer component (annotated figure 6, edge) configured to be inserted between the labial folds of the female genitalia (as shown figure 14, pad including the extending area is configured to be placed between labia 56), wherein the labial folds are labia majora and labia minora (figure 14 and [0002] and [0031], labia majora and labia minora between labia)
comprising a middle ridge (figure 6, extending area 82 of following layer 44) along an edge of the fold the interior layer component (annotated figure 6, edge) configured to be inserted between the labial folds of the female genitalia (as shown figure 14, pad including the extending area of the pad is configured to be placed between labia 56); and
comprising a third ridge (figure 6, extending area 82 of surface side sheet 46a) along an edge of the fold the interior layer component (annotated figure 6, edge) configured to be inserted between the labial folds of the female genitalia (as shown figure 14, pad including the extending area is configured to be placed between labia 56),
wherein the feminine sanitary fold device is not a pad, sanitary napkin, or tampon (see 112(b) rejection above, the claim is being interpreted based on its structural limitations above)
PNG
media_image1.png
451
638
media_image1.png
Greyscale
Mizutani does not teach wherein the exterior layer component comprises a one-way membrane layer further comprising a semi-permeable material that permeates the bodily fluid through the one-way membrane layer;
wherein the one-way membrane layer comprises a semi-permeable material that permeates the bodily fluid through the one-way membrane layer;
However, in the same field of endeavor, namely a hygienic articles, Heyman teaches a hygienic article (figure 9, 10) comprising an inner most layer (figure 9, 42) that adjacent its wearer is a one way member layer ([0077] “the first layer 42 is a water permeable surface that provides wicking action to draw liquid from the body towards the second layer”) further comprising a semi-permeable material that permeates the bodily fluid through the one-way membrane layer ([0077] “ the first layer 42 is a water permeable surface that provides wicking action to draw liquid from the body towards the second layer”);
Heyman provides the one way member inner most layer comprising a semi-permeable material in order to provide wicking action to draw liquid away from the inner most layer which helps reduces excess moisture on skin ([0008] and [0077]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mizutani to incorporate the teachings of Heyman and provides the exterior layer component comprises a one-way membrane layer further comprising a semi-permeable material that permeates the bodily fluid through the one-way membrane layer, and one of skill in the art motivated to do so, for the purpose of effectively draw excess moisture away from skin.
Regarding Claim 2, Mizutani, as modified by Heyman, teaches the feminine sanitary fold device of claim 1.
Mizutani further teaches wherein the body comprises dimensions configured to be form-fitting to the shape of the female genitalia (Mizutani; the shape of pad 40a comprises dimensions configured to be fit with shape of the female genitalia [0131] “The shape of the interlabial absorbent layer is not especially limited as long as it is a shape capable of being placed between a woman's interlabia comfortably. The shape is not limited, as long as it is a form, which fits a woman's labia area such as oval, gourd and droplet shapes.”).
Regarding Claim 3, Mizutani, as modified by Heyman, teaches the feminine sanitary fold device of claim 2.
Mizutani further teaches wherein the dimensions comprise a length configured to be parallel aligned to a length of the female genitalia (Mizutani; the dimension comprises a length configured to be fit with a length of the female genitalia [0131] “The shape of the interlabial absorbent layer is not especially limited as long as it is a shape capable of being placed between a woman's interlabia comfortably. The shape is not limited, as long as it is a form, which fits a woman's labia area such as oval, gourd and droplet shapes.”.)
Regarding Claim 4, Mizutani, as modified by Heyman, teaches the feminine sanitary fold device of claim 2.
Mizutani further teaches wherein the dimensions comprise a width configured to be aligned to a width of the female genitalia (Mizutani; the dimension comprises a width configured to be fit with shape of a width of female genitalia [0131] “The shape of the interlabial absorbent layer is not especially limited as long as it is a shape capable of being placed between a woman's interlabia comfortably. The shape is not limited, as long as it is a form, which fits a woman's labia area such as oval, gourd and droplet shapes.”.)
Regarding Claim 5, Mizutani, as modified by Heyman, teaches the feminine sanitary fold device of claim 1.
Mizutani further teaches further teaches wherein the absorbent material comprises at least one of: organic material, organic bamboo, and absorbent cotton (Mizutani; [0132]-[0134] surface side sheet 46a comprises a water permeable fibrous sheet made of rayon, acetate, cotton, pump or synthetic resin).
Regarding Claim 10, Mizutani, as modified by Heyman, teaches the feminine sanitary fold device of claim 1.
Mizutani further teaches further teaches wherein the bottom surface comprises a sealed non-permeable membrane layer (Mizutani; figure 6, back face side sheet 46b sealed to surface side sheet 46a at 90, [0089] "back face side sheet 46b can be water impermeable” and [0088] “Right and left side end parts 49 of this back face side sheet 46b are joined at the side end parts”) that block the bodily fluid from penetrating through the sealed non-permeable membrane layer (Mizutani; water impermeable back face side sheet 46b blocks bodily from penetrating through).
Regarding Claim 11, Mizutani, as modified by Heyman, teaches the feminine sanitary fold device of claim 10.
Mizutani further teaches further teaches comprising an absorbent layer (Mizutani; figure 6, body fluid storage layer 42) between the bottom surface disposed between the bottom surface and the top surface (Mizutani; figure 6, body fluid storage layer 42 between surface of surface side sheet 46a and surface of back face side sheet 46b)
Regarding Claim 12, Mizutani, as modified by Heyman, teaches the feminine sanitary fold device of claim 1.
Mizutani further teaches further teaches wherein the absorbent layer comprises an absorbent material (Mizutani; the body fluid storage layer at least comprises absorbent material [0088] “absorbent body including the body fluid storage layer 42”).
Regarding Claim 21, Mizutani teaches an interlabial feminine device, comprising:
A body (figure 6, body of pad 40) having a curved portion (figure 6, convex arear 84), wherein the curved portion wherein the curved portion forms an inverted cup like apparatus (see figure 6, convex area 84 forms an inverted cup like structure) is configured to be contoured to the female genitalia ([0070] “the interlabial pad with a shape capable of being placed between a woman's interlabia comfortably”);
Two lateral side portions (annotated figure 6 above, lateral side portions) that extend downward from the curved portion forming a fold (see figure 5, side portions 44b extend from the top portion 44a that forms a fold), wherein the fold is configured to be contoured to insert between the labia folds of the female genitalia ([0070] and figures 9-11, the folds is being configured to be inserted between labia fold);
An exterior layer component (figure 6, surface side sheet 46a) comprising a top surface of the body (figure 6, upper surface of sheet 46a) comprising an absorbent material to absorb bodily fluid secreted from the female genitalia ([0130], [0133] and [0145], sheet 46a is configured to face the bodyside and at least comprising a water permeable material that absorbs bodily fluid from the female genitalia)
further comprising middle layer component (figure 5, following layer 44) wherein the middle layer component comprises an absorbent layer (the following layer comprising an absorbent layer [0095] “The menstrual blood once absorbed in the top part 44a and the side parts 44b of the labial following layer”);
an interior layer component (figure 6, back face side sheet 46b) wherein the interior layer component comprises a sealed non-permeable membrane layer ([0130] "impermeable back face side sheet " and [0080] and figure 6, the back face side sheet 46b sealed to surface side sheet at joining 49);
a bottom surface (figure 6, surface of 46b facing storage layer 42b) of the body configured to collect the bodily fluid secreted from the female genitalia ([00022] and [0095], covering material 46 have water impermeability comprising surface 46b with storage layer 42b that capable of storing bodily fluid);
comprising a first ridge (figure 6, extending area 82 of back face side sheet 46b) along an edge of the fold the interior layer component (annotated figure 6, edge) configured to be inserted between the labial folds of the female genitalia (as shown figure 14, pad including the extending area is configured to be placed between labia 56), wherein the labial folds are labia majora and labia minora (figure 14 and [0002] and [0031], labia majora and labia minora between labia)
comprising a middle ridge (figure 6, extending area 82 of following layer 44) along an edge of the fold the interior layer component (annotated figure 6, edge) configured to be inserted between the labial folds of the female genitalia (as shown figure 14, pad including the extending area of the pad is configured to be placed between labia 56); and
comprising a third ridge (figure 6, extending area 82 of surface side sheet 46a) along an edge of the fold the interior layer component (annotated figure 6, edge) configured to be inserted between the labial folds of the female genitalia (as shown figure 14, pad including the extending area is configured to be placed between labia 56);
wherein the feminine sanitary fold device is not a pad, sanitary napkin, or tampon (see 112(b) rejection above, the claim is being interpreted based on its structural limitations above)
Mizutani does not teach wherein the exterior layer component comprises a one-way membrane layer further comprising a semi-permeable material that permeates the bodily fluid through the one-way membrane layer;
wherein the one-way membrane layer comprises a semi-permeable material that permeates the bodily fluid through the one-way membrane layer;
However, in the same field of endeavor, namely a hygienic articles, Heyman teaches a hygienic article (figure 9, 10) comprising an inner most layer (figure 9, 42) that adjacent its wearer is a one way member layer ([0077] “the first layer 42 is a water permeable surface that provides wicking action to draw liquid from the body towards the second layer”) further comprising a semi-permeable material that permeates the bodily fluid through the one-way membrane layer ([0077] “ the first layer 42 is a water permeable surface that provides wicking action to draw liquid from the body towards the second layer”);
Heyman provides the one way member inner most layer comprising a semi-permeable material in order to provide wicking action to draw liquid away from the inner most layer which helps reduces excess moisture on skin ([0008] and [0077]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mizutani to incorporate the teachings of Heyman and provides the exterior layer component comprises a one-way membrane layer further comprising a semi-permeable material that permeates the bodily fluid through the one-way membrane layer, and one of skill in the art motivated to do so, for the purpose of effectively draw excess moisture away from skin.
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Mizutani (US 20050215969 A1) in view of Heyman (US 20150209194 A1), as applied to claim 12 and further in view of Hood (US 20190374396 A1).
Regarding Claim 13, Mizutani, as modified by Heyman, teaches the feminine sanitary fold device of claim 12.
Mizutani does not teach the absorbent layer comprises various concentrations of the absorbent material.
However, in the same field of endeavor, namely an absorbent article, Hood teaches an absorber (figure 4a, 4) comprises various concentrations of the absorbent material (the core comprising second area 42 having higher concentration of absorbent material than first area 41 [0062] “The absorbent core 4, which is best shown in FIGS. 4a and 4b, comprises a first area 41 and a second area 42.”,[0013] “By providing the core with a centrally located second area which has a higher grammage than the surrounding first area” and [0014] “The grammage of the absorbent material in the first area can be from 400-600 g/m.sup.2. The grammage of the absorbent material in the second area can be from 600-900 g/m.sup.2.”).
Hood provides the absorber comprises central second area comprises higher grammage than the surrounding first area in order to provide maximum absorbency at central region where most of the liquid to be absorbed is received from body which provide enhanced absorbent capacity and further improve leakage control ([0013]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mizutani, as modified by Heyman, to incorporate the teachings of Hood and provides the absorbent layer comprises various concentration of the absorbent material, and one of skill in the art motivated to do so, for the purpose of providing improved absorbent capacity where most of the liquid to be absorbed is received from body, ie fold region that is being inserted into genitalia, and improving leakage control of the fold device.
Regarding Claim 14, Mizutani, as modified by Heyman and Hood, teaches the feminine sanitary fold device of claim 13.
Mizutani does not teach various concentrations of the absorbent material are tapered from a center of the body to an edge of the fold.
However, In the same field of endeavor, namely an absorbent article, Hood teaches an absorber (figure 4a, 4) comprises various concentration of the absorbent material are tapered from a center of the body (figure 4, second area 42) to an edge of the fold device (figure 4a, first area 41, [0013] “By providing the core with a centrally located second area which has a higher grammage than the surrounding first area”).
Hood provides the absorber comprises central second area comprises higher grammage than the surrounding first area in order to provide maximum absorbency at central region where most of the liquid to be absorbed is received from body which provide enhanced absorbent capacity and further improves leakage control ([0013]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mizutani, as modified by Heyman, to incorporate the teachings of Hood and provides the absorbent layer comprises various concentration of the absorbent material, and one of skill in the art motivated to do so, for the purpose of providing improved absorbent capacity where most of the liquid to be absorbed is received, ie fold region that is being inserted into genitalia, and improving leakage control of the fold device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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, Nicholas J Weiss can be reached on (571)270-1775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/S.H./Examiner, Art Unit 3781
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781