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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/08/26 has been entered.
Response to Amendment
The amendment filed 06/08/26 has been entered. Claims 34 and 49 have been amended. Claims 35-38, 40, 47-48, and 54-55 are in the original/previously form. Claims 50-53 are withdrawn. Claim 56 is newly presented. Claims 1-33, 39, 41-46 remain cancelled. Thus, claims 34-38, 40, 47-49, and 54-56 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every objection previously set forth in the Final Office Action mailed 12/31/25.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the curvature extending through 270 degrees such as in at least claim 34 must be shown or the feature(s) canceled from the claim(s). See the 112a rejection below for further information. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The amendment filed 06/08/26 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
Claim 34 lines 7-8: “wherein the clip has an open circular ring shape of a constant radius and a continuous circular curvature extending through greater than 270 degrees”.
Claim 56 lines 1-2: “wherein the silicone material is at least partially transparent”
See 112a new matter rejections below for further information.
Applicant is required to cancel the new matter in the reply to this Office Action.
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 34-38, 40, 47-49, and 54-56 are 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.
Regarding claim 34, lines 7-8 read “wherein the clip has an open circular ring shape of a constant radius and a continuous circular curvature extending through greater than 270 degrees”. However, a continuous circular curvature “extending through greater than 270 degrees” is neither described in the specification nor shown in the figures. There is no description related to the curvature degree. Thus, the examiner consulted the drawings to search for sufficient support of the newly amended limitation for the curvature “extending through greater than 270 degrees”. Fig. 1a appears to show a degree of separation between the centers of the two spherical knobs (shown as 57° in ‘Modified FIG. 1a’ below).
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However, this depicted degree value does not correspond to the structure of the continuous circular curvature of the ring shape of constant radius (filled in gray in ‘Modified FIG. 1a’ above). Further, because the figures are not cited as being to scale and because several diameter values of the knobs are provided (see at least [0020] of the current Application’s disclosure describing a range between 3 and 20mm diameter for each knob), this 57° angle cannot be used to determine the radius or degree of curvature for the continuous circular ring segment portion. Fig. 1a appears to support a curvature of at least 180degrees by the center axis “+” (see ‘Modified FIG. 1a’ above). However, it is unclear by the figure alone whether or not the other segments result in a total curvature “greater than 270degrees” as currently introduced by the newly amended limitation.
Therefore, because there does not appear to be a figure or paragraph from the original disclosure to support this amended claim limitation, new matter has been introduced that affects the scope of the claims (see MPEP § 608.04(a): new matter rejections should be made when the scope of the claim is modified by the amendment) and is rejected under 112a.
Due to claim dependency from claim 34, claims 35-38, 40, 47-49, and 54-56 are subsequently rejected under 112a for new matter issues.
Regarding claim 56, lines 1-2 read “wherein the silicone material is at least partially transparent”. However, the silicone material “is at least partially transparent” is neither described in the specification nor shown in the figures. None of the paragraphs describe the silicone material “is at least partially transparent”. The figures show a white cross-section of the nose clip (i.e.: see Fig. 1) that could be either transparent/ white/ or any number of colors and thus is insufficient to support this limitation by figure alone. Therefore, because there does not appear to be a figure or paragraph from the original disclosure to support this amended claim limitation, new matter has been introduced that affects the scope of the claims (see MPEP § 608.04(a): new matter rejections should be made when the scope of the claim is modified by the amendment) and is rejected under 112a.
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.
Claims 34-38, 40, and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Davi (U.S. PGPUB No. 2016/0367773) in view of Chang (U.S. PGPUB No. 2009/0020125), Santin et al. (U.S. PGPUB No. 2006/0085027), hereinafter Santin, and Marsh et al. (U.S. PGPUB No. U.S. PGPUB No. 2018/0015247), hereinafter Marsh.
Regarding claim 34, Davi discloses device comprising:
a clip (200, see FIG. 3 and [0044]: nasal clip 200) to removably attach to a nose (see FIG. 10) of a human user (see [0048]: nose clip "opened" to place and thus can be "opened" to remove, see Fig. 8a), wherein:
the clip (200) comprises a partial ring segment (36) with two ends (48, 49), wherein each of the two ends (48, 49) comprises a respective spherical knob (see ‘Modified FIG. 3’ below, curvature of knobs 48, 49 is substantially spherical, and in [0044]: shape described as "bulbous". Further, in [0045]: 48,49 described as three-dimensional and partially cylindrical),
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each of the spherical knobs (knobs on ends 48/49) defines a solid geometry (see [0045]: ends 48,49, including spherical knobs, described as three-dimensional and partially cylindrical. Thus, the spherical knobs have a 3-dimensional geometry and are therefore “solid” by definition), and each of the spherical knobs (knobs on ends 48/49) is to be at least partially inserted into a respective nostril (see [0054]: 48,49 engage opposite sides of cartilaginous septum, i.e., in separate nostrils, see FIG. 9) of the nose of the user (see FIG. 9) to secure the clip to the nose of the user (see [0057]: 48,49 retain clip in nose), wherein the clip has an open circular shape (see open, generally annular shape of clip 200 in FIG. 8a) and a continuous circular curvature extending through greater than 270 degrees (see ‘Modified FIG. 3’ above showing the ring segment 36 extending through a circular curvature “extending through greater than 270degrees” in as much as is shown by Applicant—see 112a rejection above. Davi has the ring segment extending through 180degrees, plus extra segments above), the open circular shape (see open, generally annular shape of clip 200 in FIG. 8a) comprises an opening (see FIG. 8a and [0048-0049]: gap formed to open ring to insert into nose) formed by a distance (71, see FIG. 8A) between the two spherical knobs (knobs of 48,49), and the clip (200) is unitarily formed of a solid (the clip has a 3-dimensional geometry and is therefore “solid” by definition) unitary (see [0043]: clip is a one piece==unitary construction) silicone material (see [0052]: “The nasal clip 200 is characterized in being made of a heat sensitive plastic having a volatile material infused therein, such as at least one of a volatile medicant and a volatile therapeutic aromatic material.” and [0053]: the heat sensitive plastic may be silicone) configured to both (i) encourage absorption of oil into the two spherical knobs and the partial ring segment (see [0070]: material permeates entire device clip and see FIG. 9, [0059]: aromatic oils 60 released by entire clip including ring 36 and knobs—therefore, absorption of oil must occur within both knobs and ring segment in order for ring and knobs to release oils. Further, [0052-0053] notes the entirety of the material has volatile material infused therein. Therefore, Davi discloses its silicone material “encouraging” absorption of oil into the device in alignment with the disclosure by Applicant in [0019]) and (ii) springload the partial ring segment (see [0043-0047]: material of clip 200 is pre-spring loaded to generate specific inward pressure of knobs 48,49 and see [0048]: “the inherent resiliency of the clip 200 causes the limbs 38, 39 to be spring-biased towards each other to close the gap.”) to cause the two spherical knobs (knobs of 48/49) to grip the septum of the nose of the user when in use (see [0057]: 48,49 retain clip in septum of user), and
wherein the silicone material of the two spherical knobs and the partial ring segment is infused with an oil through absorption of the oil into the silicone material based on the silicone material (see [0062]: resin bead used to form device is coated with aromatic material 81 by, see [0067], being mixed in mechanical tumbler and thus, see [0070], aromatic material is infused/ permeated into entire device clip 200 formed of the silicone material. Therefore the SILICONE MATERIAL is infused, through absorption, with an oil. See also [0065]: aromatic material may be essential oils and [0052-0053]: entire nasal clip infused with volatile medicament and silicone being an appropriate material to allow for absorption),
wherein the oil comprises a volatile oil (see [0008]: device infused with volatile therapeutic aromatic material, where aromatic materials include, see [0065]: essential oils) and evaporates at a temperature less than 95 degrees Fahrenheit (see [0059-0061]: aromatic materials 60 continuously released under warm inhalation—less than body temperature-- and ‘controllably’ released at body temp. The combination results in the overall release of aromatic substance to user as shown in FIG. 10. The volatile oil is likely capable of evaporating at less than 95 degrees Fahrenheit in order to be released under ‘warm inhalation’ as discussed in [0059]. Also see [0065]: essential oils are used in Davi’s device, which are a ‘volatile oil’ as disclosed by Applicant in [0034-0051]. Because applicant does not specifically disclose the volatile oil of the current application evaporating at a temperature less than 95 degrees Fahrenheit, volatile oils listed by Applicant in [0034-0051] must be capable of such evaporation as claimed in the original disclosure ‘at a temperature of less than 95 degrees Fahrenheit’. Essential oils are listed as a volatile oil by applicant in [0034-0051]. Therefore, the essential oils disclosed in Davi [0065] align with Applicant’s disclosure and would also be capable of evaporating at a temperature of less than 95 degrees Fahrenheit.), and the clip is to apply vapors of the volatile oil through the nose of the user when the clip is attached to the nose of the user (see FIG. 10, [0059-0061], and [0054]: vapors delivered through nose to olfactory sensors), and the spherical knobs (knobs of 48, 49) and the partial ring segment (36) of the clip (200) are configured to absorb oil from an external source when the clip is placed in the external source to repeatedly recharge the clip with oil (see [0052-0053]: the silicone material forming both the knobs and ring segment are infused, via absorption, with the aromatic oil. Therefore, the silicone material forming the device, including the knobs and ring segment, is permeable to oil and thus absorbs oil from an external source. Also see the following paragraph).
According to applicant’s disclosure, the device “infused with an oil through absorption of the oil into the silicone material based on the durometer of the silicone material” and the device “configured to absorb oil…” as in claim 34, is achieved because the silicone material durometer allows oil to be absorbed into the device (see [0028]: the oil is reinfused by slow absorption and see [0029]: absorption of oil is attributed to the durometer of silicone between 0 and 120A. See further in [0018-0020]: silicone of less than 120a is particularly adapted for the absorption of volatile oils). Therefore, the claimed limitation of the device “infused with an oil through absorption of the oil into the silicone material based on the durometer of the silicone material” and the device “configured to absorb oil…” is an inherent property to the apparatus material (silicone of a durometer between 0 and 120A). Thus, applicant appears to claim an apparatus in terms of a property characteristic (durometer is a material property), which has been held to be unpatentable over the prior art—see MPEP § 2112.01 (I). Thus, Davi both explicitly and inherently discloses the claimed limitation of the device “infused with an oil through absorption of the oil into the silicone material based on the durometer of the silicone material” and the device “configured to absorb oil…”.
Davi is silent to each of the spherical knobs defines the solid geometry of “a sphere of constant radius” and “an open circular ring shape of a constant radius”, the open “ring” shape comprises an opening formed by a distance between the two spherical knobs “when the clip is at rest”, the silicone material being specifically “with a durometer greater than 50a and equal to or less than 90a” such that the oil being absorbed into the silicone material based on the “durometer” of the silicone material.
However, Chang teaches a device comprising a clip (see Fig. 3b) to removably attach to the nose of a human user (see [0024]: device inserted into nasal cavity and device may be infused with volatile substances), wherein the clip (see Fig. 3b) comprises two ends (100, see [0027]), wherein each of the two ends (100) comprises a respective spherical knob, each of the spherical knobs defines a sphere of constant radius (see [0027]: body 100 may be a sphere shape. The definition of a sphere is a round solid figure with every point of its surface equidistant from its center, which inherently has a constant radius).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the spherical knobs forming the clip ends as disclosed in Davi to be formed as spheres with a constant radius as taught by Chang for the purpose of forming the device with a shape that is similar to the nasal cavity (see [0013]), which prevents the device from unintentionally coming off the nostril (see [0024]), thus achieving each of the spherical knobs defines the solid geometry of “a sphere of constant radius”.
Davi in view of Chang remain silent to “an open circular ring shape of a constant radius”, the open “ring” shape comprises an opening formed by a distance between the two spherical knobs “when the clip is at rest”, the silicone material being specifically “with a durometer greater than 50a and equal to or less than 90a” such that the oil being absorbed into the silicone material based on the “durometer” of the silicone material.
However, Santin teaches a device comprising a clip (see FIG. 2) to removably attach to the nose of a human user (see [0049]: device inserted into nose), the clip (see FIG. 2) comprises a partial ring segment (16) with two ends (10), wherein the clip (see FIG. 2) has an open circular ring shape (see “U” shape formed by curve of 16) of a constant radius (see [0089]: 16 is curved strut and therefore by definition comprises an arc/bend. The definition of an arc is part of a circumference of a circle and therefore by definition, the curved strut 16 comprises a circular shape with a constant radius), the open ring shape (see “U” shape formed by curve of 16) comprises an opening (see U-shaped opening between ends 10) formed by a distance between the two knobs when the clip is at rest (see [0089]: 16 maintains the ends spaced apart, by a nominal distance D, see [0091].).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ring segment disclosed in Davi to be formed as an open circular ring shape of a constant radius and comprising an opening formed by a distance between the two end knobs when the clip is at rest as taught by Santin for the purpose of forming the ring shape with a spacing and degree of flexion between the two ends that is sufficient to span the distance between the user’s nostrils (see [0091]), thus achieving “an open circular ring shape of a constant radius”, the open “ring” shape comprises an opening formed by a distance between the two spherical knobs “when the clip is at rest””.
Davi in view of Chang and Santin remain silent to the silicone material being specifically “with a durometer greater than 50a and equal to or less than 90a” such that the oil being absorbed into the silicone material based on the “durometer” of the silicone material.
However, Marsh teaches a device (see FIG. 1) with spherical knobs (14a, 14b) for insertion into a nose of a human user (see [0020-0021]: 14a,b inserted into user nostrils) wherein the spherical knobs (14a, 14b) for insertion into the nose are formed from a silicone material with a durometer greater than 50a and equal to or less than 90a (see [0032]: a natural/ synthetic rubber material of Shore A scale 10-70 and one such suitable material is silicone).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to select the silicone material of the nose clip device including spherical knobs disclosed in Davi to be formed of a silicone material with a durometer of greater than 50a and equal to or less than 90a as taught by Marsh for the purpose of forming the device from a rubbery material that makes a tight fit in the user’s nose (see [0020]) and that is hypo-allergenic and soft yet compliant (see [0032]), thus achieving the silicone material being specifically “with a durometer greater than 50a and equal to or less than 90a” such that the oil being absorbed into the silicone material based on the “durometer” of the silicone material.
Regarding claim 35, the modified system of Davi teaches the device of claim 34, and Davi further discloses wherein the oil (see [0065]: essential oils released by device) evaporates at a temperature less than 75 degrees Fahrenheit (Because applicant does not specifically disclose the volatile oil of the current application evaporating at a temperature less than 75 degrees Fahrenheit, volatile oils listed by Applicant in [0034-0051] must be capable of such evaporation as claimed in the original disclosure ‘at a temperature of less than 75 degrees Fahrenheit’. Essential oils are listed as a volatile oil by applicant in [0034-0051]. Therefore, the essential oils disclosed in Davi [0065] align with Applicant’s disclosure and would also be capable of evaporating at a temperature of less than 75 degrees Fahrenheit).
Regarding claim 36, the modified system of Davi teaches the device of claim 34, and Davi further discloses wherein the oil comprises an essential oil (see [0065]).
Regarding claim 37, the modified system of Davi teaches the device of claim 34, and Davi further discloses wherein the clip (200, see FIG. 3) is to provide aromatherapy to the user (see [0059-0061]: aromatic materials 60 delivered to user via nasal cavity as shown in FIG. 10; therefore, the device delivers aromatherapy. See [0065] aromatic materials may be essential oils).
Regarding claim 38, the modified system of Davi teaches the device of claim 34, and Davi further discloses wherein the spherical knobs (see [0055]: bulbous portions 48,49 assist in delivery of vaporized medicament) are to deliver the vapors to olfactory receptors (see [0054]: vapors delivered by clip and bulbous portions through nose to olfactory sensors) in the nose of the user (see FIG. 9-10).
Regarding claim 40, the modified system of Davi teaches the device of claim 38, and Davi further discloses wherein each of the spherical knobs (48, 49, see FIG. 3) are to grip the nose through contact with the septum of the nose to secure the clip in the nose of the user (see [0057]: 48,49 engage/ grip opposite sides of septum to retain clip in nose).
Regarding claim 54, the modified system of Davi teaches the device of claim 34, but Davi is silent to “wherein the silicone material has a durometer of 70a.”
However, Marsh teaches a device (see FIG. 1) with spherical knobs (14a, 14b) for insertion into a nose of a human user (see [0020-0021]: 14a,b inserted into user nostrils) wherein the spherical knobs (14a, 14b) for insertion into the nose are formed from a silicone material (see [0032]), wherein the silicone material has a durometer of 70a (see [0032]: a natural/ synthetic rubber material of Shore A scale 10-70 and one such suitable material is silicone).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to choose the silicone material of the nose clip device including spherical knobs for insertion to a nose of a user disclosed in Davi to be formed of a silicone material with a durometer of 70a as taught by Marsh for the purpose of forming the device from a rubbery material that makes a tight fit in the user’s nose (see [0020]) and that is hypo-allergenic and soft yet compliant (see [0032]), thus achieving “wherein the silicone material has a durometer of 70a.”
Claim 47 is rejected under 35 U.S.C. 103 as being unpatentable over Davi in view of Change, Santin, and Marsh as applied to claim 34 above, and further in view of Mirowski (U.S. PGPUB No. 2013/0230431).
Regarding claim 47, the modified system of Davi teaches the device of Claim 34, and, to reiterate, Davi discloses absorption of the oil into the silicone material of the clip (see [0062]: resin bead used to form device is coated with aromatic material 81 by, see [0067], being mixed in mechanical tumbler and thus, see [0070], aromatic material is infused/ permeated into entire device clip 200. See [0065]: aromatic material may be essential oils), but Davi is silent to “further comprising a sealable, airtight container to store the clip after” absorption of the oil in the silicone material of the clip.
However, Mirowski teaches a material (see [0009], and [0018-0019]: a desiccant) with infused active volatile components (see [0016]: material has volatile components), i.e., an essential oil (see [0028]: volatile components may comprise essential oils), comprising mixing and further comprising a sealable, airtight container to store the material after absorption of oil (see [0069-0070]: the material is coated/ shaken in a sealed vessel and allowed time for further absorption of the oil).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to provide the clip disclosed in Davi with the sealable, airtight container for storing the device as taught by Mirowski for the purpose of ensuring the fragrance or oil is completely absorbed into the device (see Mirowski [0070]), thus achieving “further comprising a sealable, airtight container to store the clip after absorption of the oil in the silicone material of the clip”.
Claims 48-49 are rejected under 35 U.S.C. 103 as being unpatentable over Davi in view of Chang, Santin, Marsh, and Mirowski as applied to claim 47 above, and further in view of Giniger et al. (U.S. PGPUB No. 2007/0122362), hereinafter Giniger.
Regarding claim 48, the modified system of Davi teaches the device of Claim 47, but is silent to “wherein the container comprises a resealable mylar pouch”.
However, Giniger teaches a method for preparing a solution for aromatherapy (a hydrogel known in the art to be used in aroma release and delivery, see [0005], including releasing essential oils, see [0028]), where the solution is stored in a container, wherein the container comprises a resealable mylar pouch (see [0043]: a crimped or heat sealed--thus resealable-- mylar plastic airtight pouch).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the sealable, airtight container for storing the clip after oil absorption as taught by Modified Davi with the resealable mylar pouch as taught by Giniger for the purpose of preventing moisture loss during storage (see Giniger [0043]), and allowing for reuse via the resealing function of the container, thus achieving “wherein the container comprises a resealable mylar pouch”.
Regarding claim 49, the modified system of Davi teaches the device of Claim 48, and Davi further discloses at least a portion of oil is absorbed into the silicone material (see [0052-0053]: the silicone material forming the device is infused with aromatic oil and is therefore permeable to oil and absorbing additional oil into the clip), but Davi is silent to “wherein the container contains additional oil” and at least a portion of the “additional” oil is absorbed into the silicone material “while the clip is in the container.”
However, Mirowski teaches infusing a material with active volatile components by pouring an oil mixture into a container, wherein the container contains additional oil (see [0070]: pouring the oil mixture/ fragrance component into a sealed vessel/ container for infusion/ absorption of the oil).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the resealable mylar pouch for storing the device clip taught by Modified Davi to include additional oil as taught by Mirowski for the purpose of allowing the material more time to absorb more oil into the infused material (see Mirowski [0070]), thus achieving “wherein the container contains additional oil” and at least a portion of the “additional” oil is absorbed into the silicone material “while the clip is in the container.”
Further, according to applicant’s disclosure, the device having a silicone material, wherein “at least a portion of the additional oil is absorbed into the silicone material” as in claim 49 above, is achieved because the silicone material itself encourages absorption of oil into the clip (see [0028]: the oil is reinfused by slow absorption and see [0029]: absorption of oil is attributed to the durometer of silicone between 0 and 120A. See further in [0019-0020]: silicone of less than 120a is particularly adapted for the absorption of volatile oils). Therefore, the claimed limitation of the device having a silicone material, wherein “at least a portion of the additional oil is absorbed into the silicone material” is an inherent property to the apparatus material (silicone of a durometer between 0 and 120A). Thus, applicant appears to claim an apparatus in terms of a property characteristic (the silicone material encourages absorption of oil into the device and thus absorbs “additional” oil from an external source. Thus, the absorption is due to a material property), which has been held to be unpatentable over the prior art—see MPEP § 2112.01 (I). Therefore, Davi appears to already inherently disclose this property as claimed.
Claims 55-56 are rejected under 35 U.S.C. 103 as being unpatentable over Davi in view of Chang, Santin, and Marsh as applied to claim 34 above, and further in view of Rummery et al. (U.S. PGPUB No. 2012/0132209), hereinafter Rummery.
Regarding claim 55, the modified system of Davi teaches the device of claim 34, but Davi is silent to “wherein the silicone material has a durometer greater than 70a.”
However, Rummery teaches a nasal clip device (32, see FIG. 4) formed of silicone (see [0185]: device is formed by one piece of molded silicone), wherein the silicone material has a durometer greater than 70a (see [0200]: silicone durometer up to 80A).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the unitary silicone material of the nose clip device including spherical knobs for insertion to a nose of a user disclosed in Davi to be formed of a silicone material with a durometer of greater than 70a as taught by Rummery for the purpose of stiffening the device to control how the device collapses, such as moving laterally and axially to fit into nostrils (see [0199-0200]), thus achieving “wherein the silicone material has a durometer greater than 70a.”
Regarding claim 56, the modified system of Davi teaches the device of claim 34, but Davi is silent to “wherein the silicone material is at least partially transparent.”
However, Rummery teaches a nasal clip device (32, see FIG. 4) formed of silicone (see [0185]: device is formed by one piece of molded silicone). Rummery further teaches that silicone may be formed such that the silicone material is at least partially transparent (see [0179]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the silicone material disclosed in Davi to be transparent as taught by Rummery for the purpose of presenting a less obtrusive and visually more appealing appearance (see [0179]), such as to people the user passes by while using Davi’s device, thus achieving “wherein the silicone material is at least partially transparent.”
Response to Arguments
Applicant's arguments filed 06/08/26 have been fully considered but they are not persuasive.
On page 3 of Applicant remarks, Applicant submits that none of the references teach the geometry of the claimed device and therefore the 35 U.S.C. § 103 claim rejection of claim 34 should be withdrawn. The examiner disagrees with this piecemeal analysis and has maintained the 35 U.S.C. § 103 rejection.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Therefore the examiner was not persuaded by the arguments on page 3 and has maintained the 35 U.S.C. § 103 rejection.
Next, on pages 4-5 of Applicant remarks, Applicant submits that Modified Davi fails to teach a nose clip formed of a “solid unitary silicone adapted to absorb oil” and therefore the 35 U.S.C. § 103 claim rejection of claim 34 should be withdrawn. The examiner disagrees and has maintained the 35 U.S.C. § 103 rejection.
First on page 4, Applicant submits that because the injection molded silicone material of Davi includes other materials (i.e.: “a less volatile plasticizer”), the device has two different materials and thus is not a “solid unitary silicone”. The examiner disagrees with this argument because it does not align with the breadth of the claim language. This argument seems to imply that Applicant considers the definition of “unitary” to be that the device has only a single material. However, there is no such specific definition for “unitary” provided by Applicant in Applicant’s disclosure. Therefore, the examiner gives the definition of “unitary” the broadest reasonable interpretation. According to the Oxford dictionary (see 2a), the definition of “unitary” is “of the nature of a unit, indivisible”. Davi discloses the device is a one-piece construction (see [0043]), the entire device clip is formed of a heat sensitive plastic (see [0052] and see [0053]: heat sensitive plastics include silicone), and the device is formed by an injection molding process (see [0070-0073]). Therefore, Davi’s device is characterized as being a one-piece construction, the entirety of such construction formed of a silicone and being indivisible due to being formed by injection molding. Therefore, by definition, Davi discloses the nose clip device formed of a “unitary”, or indivisible, silicone material. Thus, the examiner has maintained Davi as the reference for teaching the limitation of a “unitary” silicone material.
Further, the examiner notes the word “comprising” in the preamble of the claim language. “Comprising” indicates that the composition must include the recited components, but also can include unrecited components (see MPEP § 2111.03 (I)). Therefore, because Davi discloses a solid unitary silicone material achieving the claimed limitations, Davi discloses AT LEAST the silicone material as claimed, regardless of additional materials that may be present. Therefore the examiner was not persuaded by this first argument on page 4 and has maintained the 35 U.S.C. § 103 rejection.
Next on page 4, Applicant argues that Davi’s silicone material is incapable of absorbing the oil alone (i.e.: without the “loss volatile plasticizer”) and therefore does not meet the claimed limitation. Again, the examiner disagrees. Applicant argues that Davi’s silicone material is unable to trap/ absorb the oil because the manufacturing process includes molding and cooling to form a matrix. However, the breadth of the claim is not as argued by Applicant. Claim 34 requires “wherein the silicone material of the two spherical knobs and the partial ring segment is infused with an oil through absorption of the oil into the silicone material based on the durometer of the material”. Therefore, regardless of the process that is used to infuse the silicone material with oil and/or whether the process includes additional materials, Davi’s silicone material is still infused with the oil. Thus, Davi meets the claim language of claim 34. Applicant attempts to argue that the less volatile plasticizers (plasticizers 84 in Davi) are required to allow for absorption of the oil into the silicone material. However, the examiner disagrees with this characterization in view of Davi’s disclosure. Specifically, Davi [0072] discloses that the oil is infused into the silicone material itself (see [0072]: “bonded volatile medicant solutions 83 will constantly release from the original less volatile plasticizers 84 and from the heat sensitive plastic material 85”. The heat sensitive material is disclosed in Davi [0053] as silicone). Thus, in view of Davi [0072], the oil is constantly released from the silicone material, and therefore the silicone material MUST be infused with such an oil. It does not matter whether the plasticizer is also infused with oil or not (see the examiner’s argument regarding “comprising” in the preceding paragraphs) because the silicone material itself already achieves this claimed limitation. Further in a counter-argument presented by the examiner in the final rejection mailed 12/31/25 on page 18, it appears that the plasticizer is merely a conventional additive used in an injection molding process and is therefore not critical to the function of the device as a whole. Therefore the examiner was not persuaded by this argument on page 4 that the silicone material cannot absorb oil and has maintained the 35 U.S.C. § 103 rejection.
Next on page 4, Applicant appears to argue that the heating and cooling process described in the manufacturing of Davi’s device would somehow render the silicone inoperable for absorbing oil. However, in [0019] of the current Application, Applicant discloses that “the silicone may be dipped, submerged, subject to distillation, or otherwise directly exposed to volatile oils, such as essential oils, to cause the silicone of the device to be infused with the oil.” Thus a heating and cooling process as disclosed by Davi aligns with Applicant disclosure of the process for infusing the material with oil (distillation requires heating and cooling). Therefore, the examiner was not persuaded by this argument on page 4 and has maintained the 35 U.S.C. § 103 rejection.
Lastly on page 4, Applicant argues that because Davi teaches an embodiment of the device comprising an absorbent pad, Davi’s silicone material is “unable to function to absorb and contain a volatile material”. However, in the embodiment (see FIG. 3) used in the rejection, Davi discloses the clip being a one piece construction (see [0043]) formed of a material infused with a volatile substance/oil (see [0052]), the material being silicone (see [0053]). Therefore, in the embodiment used in the rejection, Davi’s silicone material is disclosed as functioning to absorb and contain a volatile material/ oil. Other disclosed embodiments of Davi (such as Davi [0092-0097] as argued by Applicant) do not negate the disclosure in relation to Davi FIG. 3. Further, Applicant also discloses embodiments of the current device that has structures for further enhancing the delivery of the volatile substance (see [0023] of the current application: “various implementations are shown illustrating ring clips with various examples of knobs which may be provided on a ring clip design (e.g., any one of the examples of FIGS. 2A-2F). For instance, knobs may be provided which are configured with features to enhance either or both the device's ability to absorb and carry oil and the device's effectiveness in delivering or exposing the oil to the user. For instance, in FIG. 3A, an example knob (e.g., 305) is shown that is provided with dimples over all or a portion of the outside surface of the knob to enhance the amount of oil that may be absorbed and/or carried on the knobs.”). Thus, as evidenced by Applicant’s disclosure, other embodiments of Davi’s device can include additional structures/elements for enhancing the delivery and/or absorption of the oils while maintaining the device’s inherent ability to absorb oil due to the silicone material. Therefore, the examiner was not persuaded by this argument and maintained Davi as the primary reference.
The bottom of page 4 and top of page 5 appear to include more piecemeal arguments of the references. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
On pages 5-6, Applicant submits that there is no motivation for one of ordinary skill in the art to combine the references and therefore the 35 U.S.C. § 103 claim rejection of claim 34 should be withdrawn. The examiner disagrees and has maintained the 35 U.S.C. § 103 rejection.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, there is motivation provided for each combination as delineated in the rejection above. The examiner uses the phrase “for the purpose of” to indicate the motivation that would have been obvious to one or ordinary skill in the art. A motivation has been provided for each combination. Therefore, the examiner was not persuaded by this argument and has maintained the 35 U.S.C. § 103 rejection.
On page 5, Applicant makes a general statement that the combination “teaches against” a motivation to combine, but Applicant fails to provide an argument related to a specific reference “teaching away” from the combination. Therefore, the examiner was not persuaded by this argument as it appears to be another piecemeal analysis.
On page 5, Applicant argues that Marsh is non-analogous art. The examiner disagrees. The claimed invention is a nose clip device inserted into a nose of a user; the nose clip formed of a silicone material of a specific durometer range. Marsh teaches a device inserted into the nose that is made of silicone of the claimed durometer range. Therefore, Marsh is analogous art to the claimed invention because it is from the same field of endeavor of the claimed invention (i.e.: devices inserted into noses that are formed of silicone), meeting the analogous art test (see MPEP § 2141.01(a).I). Therefore, the examiner was not persuaded by this argument and has maintained the 35 U.S.C. § 103 rejection.
Because no further arguments were presented, the examiner has maintained all subsequent depending claim rejections.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Kenney (U.S. PGPUB No. 2015/0265858) teaches a nasal clip device (see FIG. 2b) with a certain degree of curvature (see [0032-0034]) in order to ensure that the nasal insert is more flexible and easier to adjust inside the nose with a better tightness between the device add the inner walls of the nostrils (see [0032]), which would prevent the device from inadvertently falling out of a user’s nose
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE VOKES whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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