DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9 July 2025 has been entered.
Notice of 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 .
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 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.
Response to Arguments
In the response filed 9 July 2025, Applicant argues Rossignol’062, KR-010, KR-667 and Silverstein’172 fail to each a removable reservoir configured for replacement within the handle, as required by claims 36 and 57. Specifically, Applicant argues Silverstein’172, relied on the last rejection to teach the removable reservoir, is not removed it has broken, separated or ruptured to release the fluid. This argument is not persuasive.
Silverstein’172’s reservoir 58 is considered to be removable because it is a separate element. The claim does not require a step of removing the reservoir, but rather, a capability of being removed. Silverstein’172’s element 58 is considered to meet this limitation because it is a separate element which can be removed from the handle. The fact that it is broken or ruptured does not preclude element 58 from being removed from the handle. For example, if the chamber 58 is broken, it can be removed from the handle using a tweezers or forceps and replaced with a new chamber for subsequent use.
Additionally, the 4/9/2025 Office Action contained a second rejection to independent claim 36 under 35 USC 103 under Rossignol’062, KR-010, KR-667 and Watters’103. Watters’103 was relied on to teach a removable reservoir configured for replacement within the handle. There were no specific arguments regarding this combination of references, so this rejection is maintained. This combination of references was newly applied to independent claim 57 and all dependent claims, as well – see below.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 36, 37, 39-42, 46, 50, 51, 53, 57, 58, 63 are rejected under 35 U.S.C. 103 as being unpatentable over Rossignol (US Patent 3,923,061) in view of KR-10-2014-0005010 (“KR-010”) in view of KR-10-2009-011667 (“KR-667”) in view of Silverstein (US Patent Publication 2011/0066172).
Note: KR-10-2014-0005010 and KR-10-2009-011667 are listed on the IDS submitted 8/29/2023, therefore no copies of these references are being provided. The references and translations are available in the file wrapper of the parent application 17/472478 (mail date 4/19/2023).
Claim 36, 46: Rossignol’061 teaches a method for delivering a formulation a body cavity (column 2, lines 41-51) using a rubber tipped device having a handle (1) defining a longitudinal axis. The method includes inserting the device into the cavity (column 1, lines 40-41) and rotating the cleansing tip in a first direction (F) and a second opposite direction (column 2, lines 6-15).
Rossignol’061 does not teach the tip has leaflets which, upon rotation, each leaflet of the plurality of leaflets flip to expose only delivery surface to the body cavity surface at a time. Rossiginol’061’s method is disclosed for cleaning the nose and ears (column 1, lines 8-9)
Like Rossignol’061, KR-010 teaches a cleansing tip for cleaning the internal surface of a nipple (40) for a bottle (Figure 6). The internal surface of the nipple (40) is a small internal cavity and therefore KR-010 is pertinent to the problem of cleaning internal cavity surfaces. The size of the nipple (40) cavity is substantially equal to the size of the ear and nasal cavities disclosed by Rossignol’061. KR-010’s device is used to sterilize the cavity and is harmless to the human body.
KR-010’s cleansing device includes:
a handle (10) defining a longitudinal axis (Figure 1) and having a distal end (towards 20) and a proximal end (opposite end);
a molded elastomer tip (30; paragraph 4 under “DESCRIPTION-OF-EMBODIMENTS” states: “…while harmless to the human body preferably molded to be produced, and it would be ideal for washing the sphere 30 is known as a material harmless to the human body with excellent heat resistance, yet has a flexible resilient silicone.”) comprising a plurality of leaflets (31) disposed about the longitudinal axis,
each leaflet of the plurality of leaflets (31) comprises a first delivery surface and a second delivery surface on the opposite side of the first cleansing surface (see annotated copy of Figure 7 below)
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Figure 7 shows that upon rotation of the tip, each leaflet of the plurality of leaflets flips to expose only one delivery surface to the body cavity at a time, such that the first delivery surface is exposed to the body cavity upon rotation of the cleansing tip in a first direction and the second delivery surface is exposed to the body cavity surface upon rotation in a second direction.
If it is not convincing that elements 31 are leaflets, the Office maintains it would be obvious to make the protrusions flat, thus forming leaflets: KR-‘067 teaches a similar device having a handle (10) and an elastomeric delivery tip (20). KR-667 teaches providing the cleansing tips with elongate leaflets (20a; Figure 1) or smaller leaflets (20b; Figure 1c) – both of which are flat- that all perform the same function of cleaning a bottle.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device of KR-010 with delivery leaflets as taught by KR-667 because KR-667 teaches this arrangement allows “quick and easy cleaning of the bottle”. Furthermore, one of ordinary skill in the art would have expected either the cleansing tip of KR-010 or the cleansing tip in KR-667 to perform equally well since they are made of the same material and have the same disclosed function of cleaning bottles.
In light of these teachings, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the method taught by Rossignol’061 by using the device taught KR-010, as modified, because both references are disclosed for use in cleaning a small internal cavity. The unique tapering of the ear and nasal cavities is similar to the size and shape of the inside of the nipple (40) taught by KR-010. Both devices are used to clean the cavity while remaining harmless to the human body. One of ordinary skill in the art would have looked to KR-010 due to the unusual tapering shape of the ear and nasal cavities which is similar to the internal surface of nipple for a bottle.
Rossignol’061 does not teach the handle includes a removable reservoir configured for replacement within the handle.
Like Rossignol’061, Silverstein’172 is directed towards a cleansing tip (22) for a body cavity (paragraph [0002]). The cleansing tip (22) includes a handle (12).
Silverstein’`171 teaches providing a removable reservoir (58) within the handle (12) for carrying a formulation for delivery to the cleansing tip (Figure 8). The removable reservoir (58) can be removed from the handle for replacement because it is a separate element. Silverstein’172 teaches a step of dispensing a formulation from the removable reservoir to the tip (22) (paragraph [0068] and Figures 4-6, 8, 13, 14).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Rossignol’061 such that the handle comprises a reservoir, as taught by Silverstein’172, in order to aid in quickly delivering a fluid to the cleansing tip to aid in cleansing the body cavity (paragraph [0022]).
Claim 37: Rossignol’061 discloses using the device in the nose (column 1, lines 5-6).
Claim 39: Rossignol’061’s method will include axial movement of the molded elastomer tip during insertion into the nasal cavity.
Claim 40: The molded elastomer tip of KR-010, as modified, is configured to remove mucus, pollen, dust, dead skin cells, bacteria, etc. because it has the claimed structure. See MPEP 2112.01.
Claim 41, 42: Rossignol’061 teaches applying a liquid formulation to the molded elastomer tip and distributing the formulation to the body cavity when moving the tip in the first direction (column 2, lines 40-46).
Silverstein’172 further teaches distributing the liquid formation on the tip (22) (Figures 13, 14).
Claim 50: Rossignol’061 teaches delivering an active agent to the body cavity with the cleansing tip (column 2, lines 40-46).
Claim 57: Rossignol’061 teaches A system for delivering a formulation to a surface of a body cavity (column 2, lines 41-51) comprising:
a device (Figure 1) comprising a handle (1), the handle defining a longitudinal axis and comprising a proximal end (opposite of end of element 2) and a distal end (towards 2), and
a molded rubber tip (2; column 2, lines 31-32), wherein the molded rubber tip comprises a plurality of flexible leaflets (6) disposed about the longitudinal axis.
Rossignol’061 does not teach the tip has leaflets which, upon rotation, each leaflet of the plurality of leaflets flip to expose only delivery surface to the body cavity surface at a time. Rossiginol’061’s method is disclosed for cleaning the nose and ears (column 1, lines 8-9).
Like Rossignol’061, KR-010 teaches a cleansing tip for cleaning the internal surface of a nipple (40) for a bottle (Figure 6). The internal surface of the nipple (40) is a small internal cavity and therefore KR-010 is pertinent to the problem of cleaning internal cavity surfaces. The size of the nipple (40) cavity is substantially equal to the size of the ear and nasal cavities disclosed by Rossignol’061. KR-010’s device is used to sterilize the cavity and is harmless to the human body.
KR-010’s cleansing device includes:
a handle (10) defining a longitudinal axis (Figure 1) and having a distal end (towards 20) and a proximal end (opposite end);
a molded elastomer tip (30; paragraph 4 under “DESCRIPTION-OF-EMBODIMENTS” states: “…while harmless to the human body preferably molded to be produced, and it would be ideal for washing the sphere 30 is known as a material harmless to the human body with excellent heat resistance, yet has a flexible resilient silicone.”) comprising a plurality of leaflets (31) disposed about the longitudinal axis,
each leaflet of the plurality of leaflets (31) comprises a first delivery surface and a second delivery surface on the opposite side of the first delivery surface (see annotated copy of Figure 7 below)
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Figure 7 shows that upon rotation of the tip, each leaflet of the plurality of leaflets flips to expose only one delivery surface to the body cavity at a time, such that the first delivery surface is exposed to the body cavity upon rotation of the cleansing tip in a first direction and the second delivery surface is exposed to the body cavity surface upon rotation in a second direction.
If it is not convincing that elements 31 are leaflets, the Office maintains it would be obvious to make the protrusions flat, thus forming leaflets: KR-‘067 teaches a similar device having a handle (10) and an elastomeric delivery tip (20). KR-667 teaches providing the cleansing tips with elongate leaflets (20a; Figure 1) or smaller leaflets (20b; Figure 1c) – both of which are flat- that all perform the same function of cleaning a bottle.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device of KR-010 with delivery leaflets as taught by KR-667 because KR-667 teaches this arrangement allows “quick and easy cleaning of the bottle”. Furthermore, one of ordinary skill in the art would have expected either the cleansing tip of KR-010 or the cleansing tip in KR-667 to perform equally well since they are made of the same material and have the same disclosed function of cleaning bottles.
In light of these teachings, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the method taught by Rossignol’061 by using the device taught KR-010, as modified, because both references are disclosed for use in cleaning a small internal cavity. The unique tapering of the ear and nasal cavities is similar to the size and shape of the inside of the nipple (40) taught by KR-010. Both devices are used to clean the cavity while remaining harmless to the human body. One of ordinary skill in the art would have looked to KR-010 due to the unusual tapering shape of the ear and nasal cavities which is similar to the internal surface of nipple for a bottle.
Rossignol’061 does not teach the handle includes a removable reservoir configured for replacement within the handle.
Like Rossignol’061, Silverstein’172 is directed towards a cleansing tip (22) for a body cavity (paragraph [0002]). The cleansing tip (22) includes a handle (12).
Silverstein’171 teaches providing a removable reservoir (58) within the handle (12) for carrying a formulation for delivery to the cleansing tip (Figure 8). The removable reservoir (58) can be removed from the handle for replacement because it is a separate element. Silverstein’172 teaches a step of dispensing a formulation from the removable reservoir to the tip (22) (paragraph [0068] and Figures 4-6, 8, 13, 14).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Rossignol’061 such that the handle comprises a reservoir, as taught by Silverstein’172, in order to aid in quickly delivering a fluid to the cleansing tip to aid in cleansing the body cavity (paragraph [0022]).
Claim 58, 63: Rossignol’061 teaches applying a liquid formulation to the molded elastomer tip and distributing the formulation to the body cavity when moving the tip in the first direction (column 2, lines 40-46).
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Rossignol’061 in view of KR-010 in view of KR-667 in view of Silverstein’172, as applied to claim 36, further in view of Przepasniak et al. (US Patent Publication 2006/0004318).
Rossignol’061, as modified, teaches the limitations of claim 38 including a step of cleaning body cavities (column 1, lines 5-10), but does not specifically teach cleansing a vaginal cavity.
It is old and well known to use a swab to clean the vaginal cavity. For example, Przepasniak’318 teaches a swab that is inserted into the vaginal cavity and rotated to aid in cleaning or applying a material to the vagina (Figure 24, paragraph [0094]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the method taught by Rossignol by using the cleansing tip in the vagina, as taught by Przepasniak’318, in order to aid in cleaning a the vagina when needed (paragraph [0003]) and to apply a material to the vagina with minimal mess (paragraph [0008]).
Claims 43, 44, 52, 56, 59, 60, 65 are rejected as being unpatentable over Rossignol’061 in view of KR-010 in view of KR-667 in view of Silverstein’172, as applied to claims 42, 48, 50 and 58 respectively, further in view of Perez et al. (US Patent 7,951,106).
Claim 43, 44, 59, 62: Rossignol’061, as modified, teaches applying a “pasty or liquid substance” to the delivery surface and distributing the substance to the body cavity when rotating the tip (column 2, lines 40-50). Rossignol’061 fails to specifically disclose the substance is a gel formulation or a cream.
Perez’106 teaches providing a device having a handle (12) and a cleansing tip (18) having a plurality of leaflets (solid openings between openings 40a-40f) in order to clean the nostril (column 1, lines 5-15).
Perez’106 teaches a step of applying a gel formulation or a cream to the cleansing tip (column 5, lines 24-28, 34-39; column 2, lines 58-61; column 3, lines 65 to column 4, lines 2) in order to dispense a medication into the body.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the method taught by Rossignol’061 to include a gel formulation or cream, as taught by Perez’106, in order to allow the user to apply a medication into the body during the cleaning step.
Claim 52, 56, 60, 65: Rossignol’061 teaches applying a “pasty or liquid substance” to the delivery surface and distributing the substance to the body cavity when rotating the tip (column 2, lines 40-50). Rossignol’061 fails to specifically disclose the substance is an antiseptic agent (Claim 52, 60) or an antibacterial/anti-inflammatory agent (claim 56, 65).
Like Rossignol’061, Perez’106 teaches providing a device having a handle (12) and a cleansing tip (18) having a plurality of leaflets (solid openings between openings 40a-40f) in order to clean the nostril (column 1, lines 5-15).
Perez’106 teaches a step of applying an active agent to the cleansing tip (column 5, lines 24-28, 34-39) in order to dispense a medication into the body. The medication can include an antiseptic or antibacterial/anti-inflammatory agent (column 3, lines 65 to column 4, line 2).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the method taught by Rossignol’061 to include a particular drug, as taught by Perez’106, in order to provide the user with the benefit of the medication while performing the cleaning step.
Claims 47 and 64 are rejected as being unpatentable over Rossignol’061 in view of KR-010 in view of KR-667 in view of Silverstein’172, as applied to claim 36 and 57, further in view of Bivins (US Patent Application 2008/0300527).
Claim 47, 64: Rossignol’061 teaches applying a “pasty or liquid substance” to the delivery surface and distributing the substance to the body cavity when rotating the tip (column 2, lines 40-50). Rossignol’061 fails to specifically disclose the substance is an essential oil.
Like Rossignol’061, Bivins’527 teaches providing a device having a handle (220) and a cleansing tip (216) for cleaning the nostril (paragraph [0017]). Bivins’527 further teaches applying an essential oil to the cleansing tip to “provide a refreshing and invigorating cleansing experience” (paragraph [0029]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to provide the cleansing tip of modified Rossignol’061 with an essential oil, as taught by Bivins’527, in order to “provide a refreshing and invigorating cleansing experience” (paragraph [0029]).
Claim 55 is rejected under 35 U.S.C. 103 as being unpatentable over Rossignol’061 in view of KR-010 in view of KR-667 in view of Silverstein’172, as applied to claim 50, further in view of Malibran-Santibanez et al. (US Patent Publication 2019/0021831).
Rossignol’061, as modified, teaches the limitations of claim 55 except for using the swab to deliver a vaccine. Rossignol’061 teaches using the swab in the nose (column 1, lines 8-10)
Malibran-Santibanez’831 teaches a swab (27, 28) for placement in the nose of an animal in order to deliver a vaccine (paragraph [0004]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the method taught by Rossignol’061 by providing the device with a vaccine, as taught by Malibran-Santibanez’831, in order to use the device to deliver a vaccine to an animal because the delivery of vaccine via the nose to animals is well known.
Claim 61: Rossignol’061, as modified by Perez’106, teaches the limitations of claim 61 except that the substance being delivered is benzalkonium chloride.
Like Rossignol’061 and Perez’106, Makower’147teaches a device for placement of substances in the sinuses. Makower’147 teaches the device can be used to deliver anti-microbial agents including benzalkonium chloride (paragraphs [0167], [1068]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Rossignol’061 to specifically deliver benzalkonium chloride, as taught by Makower’147, because benzalkonium chloride is well known to serve as an antimicrobial substance in the sinuses and it is well known to enhance cleaning with therapeutic substances.
Claim 67 is rejected under 35 U.S.C. 103 as being unpatentable over Rossignol’061 in view of KR-010 in view of KR-667 in view of Silverstein’171, as applied to claim 57, further in view of Fournier et al. (US Patent 3,818,911).
Rossignol’061, as modified, teaches the limitations of claim 67 except for a cover for placement over the cleansing tip.
Fournier’911 teaches a device having a tip (17). The device further includes a cover (16) in order to protect the tip for packaging and/or storage.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Rossignol’061 with a cover, as taught by Fournier’911, in order to protect the tip when it’s not being used.
Claims 36, 37, 39-42, 46, 50, 70, 71 are rejected under 35 U.S.C. 103 as being unpatentable over Rossignol’061 in view of KR-010 in view of KR-667 in view of Watters (US Patent 9,339,103).
Claim 36, 46: Rossignol’061 teaches a method for delivering a formulation a body cavity (column 2, lines 41-51) using a rubber tipped device having a handle (1) defining a longitudinal axis. The method includes inserting the device into the cavity (column 1, lines 40-41) and rotating the cleansing tip in a first direction (F) and a second opposite direction (column 2, lines 6-15).
Rossignol’061 does not teach the tip has leaflets which, upon rotation, each leaflet of the plurality of leaflets flip to expose only delivery surface to the body cavity surface at a time. Rossiginol’061’s method is disclosed for cleaning the nose and ears (column 1, lines 8-9)
Like Rossignol’061, KR-010 teaches a cleansing tip for cleaning the internal surface of a nipple (40) for a bottle (Figure 6). The internal surface of the nipple (40) is a small internal cavity and therefore KR-010 is pertinent to the problem of cleaning internal cavity surfaces. The size of the nipple (40) cavity is substantially equal to the size of the ear and nasal cavities disclosed by Rossignol’061. KR-010’s device is used to sterilize the cavity and is harmless to the human body.
KR-010’s cleansing device includes:
a handle (10) defining a longitudinal axis (Figure 1) and having a distal end (towards 20) and a proximal end (opposite end);
a molded elastomer tip (30; paragraph 4 under “DESCRIPTION-OF-EMBODIMENTS” states: “…while harmless to the human body preferably molded to be produced, and it would be ideal for washing the sphere 30 is known as a material harmless to the human body with excellent heat resistance, yet has a flexible resilient silicone.”) comprising a plurality of leaflets (31) disposed about the longitudinal axis,
each leaflet of the plurality of leaflets (31) comprises a first delivery surface and a second delivery surface on the opposite side of the first cleansing surface (see annotated copy of Figure 7 below)
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Figure 7 shows that upon rotation of the tip, each leaflet of the plurality of leaflets flips to expose only one delivery surface to the body cavity at a time, such that the first delivery surface is exposed to the body cavity upon rotation of the cleansing tip in a first direction and the second delivery surface is exposed to the body cavity surface upon rotation in a second direction.
If it is not convincing that elements 31 are leaflets, the Office maintains it would be obvious to make the protrusions flat, thus forming leaflets: KR-‘067 teaches a similar device having a handle (10) and an elastomeric delivery tip (20). KR-667 teaches providing the cleansing tips with elongate leaflets (20a; Figure 1) or smaller leaflets (20b; Figure 1c) – both of which are flat- that all perform the same function of cleaning a bottle.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device of KR-010 with delivery leaflets as taught by KR-667 because KR-667 teaches this arrangement allows “quick and easy cleaning of the bottle”. Furthermore, one of ordinary skill in the art would have expected either the cleansing tip of KR-010 or the cleansing tip in KR-667 to perform equally well since they are made of the same material and have the same disclosed function of cleaning bottles.
In light of these teachings, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the method taught by Rossignol’061 by using the device taught KR-010, as modified, because both references are disclosed for use in cleaning a small internal cavity. The unique tapering of the ear and nasal cavities is similar to the size and shape of the inside of the nipple (40) taught by KR-010. Both devices are used to clean the cavity while remaining harmless to the human body. One of ordinary skill in the art would have looked to KR-010 due to the unusual tapering shape of the ear and nasal cavities which is similar to the internal surface of nipple for a bottle.
Rossignol’061 does not teach the handle includes a removable reservoir configured for replacement within the handle.
Like Rossignol’061, Watters’103 is directed towards a cleansing tip (22) for a body cavity (column 1, lines 10-17). The cleansing tip (70; Figure 1) includes a handle (20).
Watters’103 teaches providing a removable reservoir (11) within the handle (20) for carrying a formulation for delivery to the cleansing tip (Figures 1, 2; column 6, lines 61-67). Watters’103 teaches a step of dispensing a formulation from the removable reservoir to the tip (column 6, lines 36-54).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Rossignol’061 such that the handle comprises a reservoir, as taught by Watters’103, in order to aid in quickly delivering a fluid to the cleansing tip without having to store and transport two separate items and to allow for controlled dispensing of a substance on the cleansing tip (column 1, lines 33-40).
Claim 37: Rossignol’061 discloses using the device in the nose (column 1, lines 5-6).
Claim 39: Rossignol’061’s method will include axial movement of the molded elastomer tip during insertion into the nasal cavity.
Claim 40: The molded elastomer tip of KR-010, as modified, is configured to remove mucus, pollen, dust, dead skin cells, bacteria, etc. because it has the claimed structure. See MPEP 2112.01.
Claim 41, 42: Rossignol’061 teaches applying a liquid formulation to the molded elastomer tip and distributing the formulation to the body cavity when moving the tip in the first direction (column 2, lines 40-46).
Claim 50: Rossignol’061 teaches delivering an active agent to the body cavity with the cleansing tip (column 2, lines 40-46).
Claims 70: Watters’10-3 teaches the step of dispensing is performed by compressing the removable reservoir (11) via a button (120) on the handle (20) (column 6, lines 48-50).
Claim 71: Watters’103 teaches replacing the removable reservoir (11) with another removable reservoir (column 6, line 61-67).
Claim 57: Rossignol’061 teaches a system for delivering a formulation to a surface of a body cavity (column 2, lines 41-51) comprising:
a device (Figure 1) comprising a handle (1), the handle defining a longitudinal axis and comprising a proximal end (opposite of end of element 2) and a distal end (towards 2), and
a molded rubber tip (2; column 2, lines 31-32), wherein the molded rubber tip comprises a plurality of flexible leaflets (6) disposed about the longitudinal axis.
Rossignol’061 does not teach the tip has leaflets which, upon rotation, each leaflet of the plurality of leaflets flip to expose only delivery surface to the body cavity surface at a time. Rossiginol’061’s method is disclosed for cleaning the nose and ears (column 1, lines 8-9).
Like Rossignol’061, KR-010 teaches a cleansing tip for cleaning the internal surface of a nipple (40) for a bottle (Figure 6). The internal surface of the nipple (40) is a small internal cavity and therefore KR-010 is pertinent to the problem of cleaning internal cavity surfaces. The size of the nipple (40) cavity is substantially equal to the size of the ear and nasal cavities disclosed by Rossignol’061. KR-010’s device is used to sterilize the cavity and is harmless to the human body.
KR-010’s cleansing device includes:
a handle (10) defining a longitudinal axis (Figure 1) and having a distal end (towards 20) and a proximal end (opposite end);
a molded elastomer tip (30; paragraph 4 under “DESCRIPTION-OF-EMBODIMENTS” states: “…while harmless to the human body preferably molded to be produced, and it would be ideal for washing the sphere 30 is known as a material harmless to the human body with excellent heat resistance, yet has a flexible resilient silicone.”) comprising a plurality of leaflets (31) disposed about the longitudinal axis,
each leaflet of the plurality of leaflets (31) comprises a first delivery surface and a second delivery surface on the opposite side of the first delivery surface (see annotated copy of Figure 7 below)
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Figure 7 shows that upon rotation of the tip, each leaflet of the plurality of leaflets flips to expose only one delivery surface to the body cavity at a time, such that the first delivery surface is exposed to the body cavity upon rotation of the cleansing tip in a first direction and the second delivery surface is exposed to the body cavity surface upon rotation in a second direction.
If it is not convincing that elements 31 are leaflets, the Office maintains it would be obvious to make the protrusions flat, thus forming leaflets: KR-‘067 teaches a similar device having a handle (10) and an elastomeric delivery tip (20). KR-667 teaches providing the cleansing tips with elongate leaflets (20a; Figure 1) or smaller leaflets (20b; Figure 1c) – both of which are flat- that all perform the same function of cleaning a bottle.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device of KR-010 with delivery leaflets as taught by KR-667 because KR-667 teaches this arrangement allows “quick and easy cleaning of the bottle”. Furthermore, one of ordinary skill in the art would have expected either the cleansing tip of KR-010 or the cleansing tip in KR-667 to perform equally well since they are made of the same material and have the same disclosed function of cleaning bottles.
In light of these teachings, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the method taught by Rossignol’061 by using the device taught KR-010, as modified, because both references are disclosed for use in cleaning a small internal cavity. The unique tapering of the ear and nasal cavities is similar to the size and shape of the inside of the nipple (40) taught by KR-010. Both devices are used to clean the cavity while remaining harmless to the human body. One of ordinary skill in the art would have looked to KR-010 due to the unusual tapering shape of the ear and nasal cavities which is similar to the internal surface of nipple for a bottle.
Rossignol’061 does not teach the handle includes a removable reservoir configured for replacement within the handle.
Like Rossignol’061, Watters’103 is directed towards a cleansing tip (22) for a body cavity (column 1, lines 10-17). The cleansing tip (70; Figure 1) includes a handle (20).
Watters’103 teaches providing a removable reservoir (11) within the handle (20) for carrying a formulation for delivery to the cleansing tip (Figures 1, 2; column 6, lines 61-67). Watters’103 teaches a step of dispensing a formulation from the removable reservoir to the tip (column 6, lines 36-54).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Rossignol’061 such that the handle comprises a reservoir, as taught by Watters’103, in order to aid in quickly delivering a fluid to the cleansing tip without having to store and transport two separate items and to allow for controlled dispensing of a substance on the cleansing tip (column 1, lines 33-40).
Claim 58, 63: Rossignol’061 teaches applying a liquid formulation to the molded elastomer tip and distributing the formulation to the body cavity when moving the tip in the first direction (column 2, lines 40-46).
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Rossignol’061 in view of KR-010 in view of KR-667 in view of Watters’103, as applied to claim 36, further in view of Przepasniak et al. (US Patent Publication 2006/0004318).
Rossignol’061, as modified, teaches the limitations of claim 38 including a step of cleaning body cavities (column 1, lines 5-10), but does not specifically teach cleansing a vaginal cavity.
It is old and well known to use a swab to clean the vaginal cavity. For example, Przepasniak’318 teaches a swab that is inserted into the vaginal cavity and rotated to aid in cleaning or applying a material to the vagina (Figure 24, paragraph [0094]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the method taught by Rossignol by using the cleansing tip in the vagina, as taught by Przepasniak’318, in order to aid in cleaning a the vagina when needed (paragraph [0003]) and to apply a material to the vagina with minimal mess (paragraph [0008]).
Claims 43, 44, 52, 56, 59, 60, 65 are rejected as being unpatentable over Rossignol’061 in view of KR-010 in view of KR-667 in view of Watters’103, as applied to claims 42, 48, 50 and 58 respectively, further in view of Perez et al. (US Patent 7,951,106).
Claim 43, 44, 59, 62: Rossignol’061, as modified, teaches applying a “pasty or liquid substance” to the delivery surface and distributing the substance to the body cavity when rotating the tip (column 2, lines 40-50). Rossignol’061 fails to specifically disclose the substance is a gel formulation or a cream.
Perez’106 teaches providing a device having a handle (12) and a cleansing tip (18) having a plurality of leaflets (solid openings between openings 40a-40f) in order to clean the nostril (column 1, lines 5-15).
Perez’106 teaches a step of applying a gel formulation or a cream to the cleansing tip (column 5, lines 24-28, 34-39; column 2, lines 58-61; column 3, lines 65 to column 4, lines 2) in order to dispense a medication into the body.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the method taught by Rossignol’061 to include a gel formulation or cream, as taught by Perez’106, in order to allow the user to apply a medication into the body during the cleaning step.
Claim 52, 56, 60, 65: Rossignol’061 teaches applying a “pasty or liquid substance” to the delivery surface and distributing the substance to the body cavity when rotating the tip (column 2, lines 40-50). Rossignol’061 fails to specifically disclose the substance is an antiseptic agent (Claim 52, 60) or an antibacterial/anti-inflammatory agent (claim 56, 65).
Like Rossignol’061, Perez’106 teaches providing a device having a handle (12) and a cleansing tip (18) having a plurality of leaflets (solid openings between openings 40a-40f) in order to clean the nostril (column 1, lines 5-15).
Perez’106 teaches a step of applying an active agent to the cleansing tip (column 5, lines 24-28, 34-39) in order to dispense a medication into the body. The medication can include an antiseptic or antibacterial/anti-inflammatory agent (column 3, lines 65 to column 4, line 2).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the method taught by Rossignol’061 to include a particular drug, as taught by Perez’106, in order to provide the user with the benefit of the medication while performing the cleaning step.
Claims 47 and 64 are rejected as being unpatentable over Rossignol’061 in view of KR-010 in view of KR-667 in view of Watters’103, as applied to claim 36 and 57, further in view of Bivins (US Patent Application 2008/0300527).
Claim 47, 64: Rossignol’061 teaches applying a “pasty or liquid substance” to the delivery surface and distributing the substance to the body cavity when rotating the tip (column 2, lines 40-50). Rossignol’061 fails to specifically disclose the substance is an essential oil.
Like Rossignol’061, Bivins’527 teaches providing a device having a handle (220) and a cleansing tip (216) for cleaning the nostril (paragraph [0017]). Bivins’527 further teaches applying an essential oil to the cleansing tip to “provide a refreshing and invigorating cleansing experience” (paragraph [0029]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to provide the cleansing tip of modified Rossignol’061 with an essential oil, as taught by Bivins’527, in order to “provide a refreshing and invigorating cleansing experience” (paragraph [0029]).
Claim 55 is rejected under 35 U.S.C. 103 as being unpatentable over Rossignol’061 in view of KR-010 in view of KR-667 in view of Watters’103, as applied to claim 50, further in view of Malibran-Santibanez et al. (US Patent Publication 2019/0021831).
Rossignol’061, as modified, teaches the limitations of claim 55 except for using the swab to deliver a vaccine. Rossignol’061 teaches using the swab in the nose (column 1, lines 8-10)
Malibran-Santibanez’831 teaches a swab (27, 28) for placement in the nose of an animal in order to deliver a vaccine (paragraph [0004]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the method taught by Rossignol’061 by providing the device with a vaccine, as taught by Malibran-Santibanez’831, in order to use the device to deliver a vaccine to an animal because the delivery of vaccine via the nose to animals is well known.
Claim 61: Rossignol’061, as modified by Perez’106, teaches the limitations of claim 61 except that the substance being delivered is benzalkonium chloride.
Like Rossignol’061 and Perez’106, Makower’147teaches a device for placement of substances in the sinuses. Makower’147 teaches the device can be used to deliver anti-microbial agents including benzalkonium chloride (paragraphs [0167], [1068]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Rossignol’061 to specifically deliver benzalkonium chloride, as taught by Makower’147, because benzalkonium chloride is well known to serve as an antimicrobial substance in the sinuses and it is well known to enhance cleaning with therapeutic substances.
Claim 67 is rejected under 35 U.S.C. 103 as being unpatentable over Rossignol’061 in view of KR-010 in view of KR-667 in view of Watters’103, as applied to claim 57, further in view of Fournier et al. (US Patent 3,818,911).
Rossignol’061, as modified, teaches the limitations of claim 67 except for a cover for placement over the cleansing tip.
Fournier’911 teaches a device having a tip (17). The device further includes a cover (16) in order to protect the tip for packaging and/or storage.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Rossignol’061 with a cover, as taught by Fournier’911, in order to protect the tip when it’s not being used.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
The claims of the patent "anticipate" the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claim. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Claims 36, 41-43, 46, 50, 52, 57-61, 64 and 65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11, 12, 18, 21-23 of U.S. Patent No. 11,684,146 in view of Silverstein’172.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent "anticipate" the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claim. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Specifically, the claims of the claims of the ‘146 patent are obvious under the claims of the present applications as outlined below:
Application claims 18/315,959
Obvious by Patent claims 11,684,146 in view of Silverstein
36
11
41
11
42
11
43
11
46
11
50
11
52
12
56
12
57
18
58
18
59
18
60
21
61
22
64
23
65
21
The ‘146 claims do not recite a removable reservoir containing the formulation.
Silverstein’`171 teaches providing a removable reservoir (58) within the handle (12) for carrying a formulation for delivery to the cleansing tip (Figure 8). The removable reservoir (58) can be removed from the handle for replacement because it is a separate element. Silverstein’172 teaches a step of dispensing a formulation from the removable reservoir to the tip (22) (paragraph [0068] and Figures 4-6, 8, 13, 14).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the ‘146 claims such that the handle comprises a removable reservoir, as taught by Silverstein’172, in order to aid in quickly delivering a fluid to the cleansing tip to aid in cleansing the body cavity (paragraph [0022]).
Claims 36, 41-43, 46, 50, 52, 57-61, 64 and 65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11, 12, 18, 21-23 of U.S. Patent No. 11,684,146 in view of Watters’103.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent "anticipate" the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claim. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Specifically, the claims of the claims of the ‘146 patent are obvious under the claims of the present applications as outlined below:
Application claims 18/315,959
Obvious by Patent claims 11,684,146 in view of Silverstein
36
11
41
11
42
11
43
11
46
11
50
11
52
12
56
12
57
18
58
18
59
18
60
21
61
22
64
23
65
21
The ‘146 claims do not recite a removable reservoir containing the formulation.
Watters’103 is directed towards a cleansing tip (22) for a body cavity (column 1, lines 10-17). The cleansing tip (70; Figure 1) includes a handle (20). Watters’103 teaches providing a removable reservoir (11) within the handle (20) for carrying a formulation for delivery to the cleansing tip (Figures 1, 2; column 6, lines 61-67). Watters’103 teaches a step of dispensing a formulation from the removable reservoir to the tip (column 6, lines 36-54).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by ‘146 claims such that the handle comprises a reservoir, as taught by Watters’103, in order to aid in quickly delivering a fluid to the cleansing tip without having to store and transport two separate items and to allow for controlled dispensing of a substance on the cleansing tip (column 1, lines 33-40).
Conclusion
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Lindsey Bachman
/L.B./Examiner, Art Unit 3771
23 September 2025
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