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 .
Election/Restrictions
Applicant's election with traverse of claims 1-7 and 10-42 in the reply filed on 06/22/2026 is acknowledged. The traversal is on the ground(s) that both Species A and B are nasal dilation systems comprising nasal inserts with varied configurations and circumferential profiles. This found persuasive by the examiner. Therefore, the restriction requirement filed 04/22/2026 is withdrawn and claims 1-42 will be examined.
Claim Objections
Claims 1, 9, 14, and 38-40 are objected to because of the following informalities:
Claim 1 (line 3): “each insert” should recite “each nasal insert”.
Claim 1 (line 7): “the insert” should recite “the nasal insert”.
Claim 9 (line 1): “the mesh” should recite “the mesh structure”.
Claim 14 (line 2): “the opening” should recite “the one or more of the top opening and the base opening”.
Claims 38-40 (line 2): “the inserts” should recite “the two nasal inserts”. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a common carrier mechanism” in claim 41. The limitation describing the common carrier mechanism in claim 41 fails to include sufficient structure to perform the recited function of "carrying”. In the specification, the common carrier mechanism is described as “star-lock washers, pin clutches, and locking ratchets such as those used on zip ties, retail security labels, and the like”. Therefore, the common carrier mechanism is interpreted as star-lock washers, pin clutches, locking ratchets or any structural equivalents thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-42 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, line 5, recites “a group of potential users”. It is unclear to the examiner if “a group of potential users” is meant to further define the group of potential users introduced in line 3. For examination purposes “a group of potential users” is interpreted as “the group of potential users”.
Claim 1 recites the limitation "anatomical information" in line 11. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “anatomical information” is interpreted as “the anatomical information”.
Claim 13 recites the limitation "the insert profile" in line 1. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “the insert profile” is interpreted as “an insert profile”.
Claims 14 and 28-34 recite the limitation “bottom opening”. It is unclear to the examiner if the “bottom opening” is meant to further define the base opening recited in claim 6. For examination purposes, “bottom opening” is interpreted as “the base opening”.
Claim 16 recites the limitation “wherein the base opening is sized, dimensioned, and configured for insertion within the nasal insert in within the nasal passages”. It is unclear to the examiner how the base opening can be “sized, dimensioned, and configured for insertion within the nasal insert” if the base opening is a part of the nasal insert. For examination purposes, claim 16 is interpreted as “wherein the base opening is sized, dimensioned, and configured for insertion within the nasal passages”.
Claims 38-40 recites the limitation “the connecting bridge”. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “the connecting bridge” is interpreted as “the connector bridge”.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-42 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1, lines 4-5 recite the limitation “one or more varied configurations that fit nasal passage anatomical configurations common to a group of potential users”. As written, the language describing the structural component of the nasal insert (i.e. the one or more varied configurations) require and therefore positively claim the “nasal passage anatomical configurations common to a group of potential users” to meet the limitation. For examination purposes, the limitation is interpreted and should be written as “one or more varied configurations configured to fit nasal passage anatomical configurations common to the group of potential users”.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 5-8, 10, 12-17, and 36-37are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wood (US 20040147954).
Regarding claim 1, Wood discloses a nasal dilation system 10 (Fig. 2, para. 0035), comprising:
one or more nasal inserts 20 structurally adapted to align with a nasal passage surface anatomy common to a group of potential users (Fig. 2, para. 0035: “Nasal dilator 10 includes at least one, and preferably two, tubular mesh nostril insert structures, each of which is generally referenced as 20, sized and shaped for removable insertion within the human nostril(s)”), each insert comprising:
one or more varied configurations that fit nasal passage anatomical configurations common to a group of potential users (Figs. 6-7, para. 0036: “Each nostril insert 20 is preferably fabricated from a soft and resilient material configured in tubular mesh form sized and shaped for removable insertion within the nostril. Nostril inserts 20 are preferably defined by tubular structures formed by interwoven mesh of resilient elongate members. The tubular mesh configuration provides superior internal support to the nasal wall structure due to the superior support structure inherent in an interwoven configuration”);
wherein the one or more nasal inserts are shaped, sized, and configured based upon anatomical information of nasal passage surface features derived through an analysis of anatomical information from the group of potential users (see para. 0012 and para. 0035-0036: “Nasal dilator 10 includes at least one, and preferably two, tubular mesh nostril insert structures, each of which is generally referenced as 20, sized and shaped for removable insertion within the human nostril(s)…Nostril inserts 20 are preferably defined by tubular structures formed by interwoven mesh of resilient elongate members. The tubular mesh configuration provides superior internal support to the nasal wall structure due to the superior support structure inherent in an interwoven configuration. Another advantage realized by the mesh structure of the present invention relates to retaining the filtration functionality of the nasal hair structures of the human nose”).
Regarding claim 2, Wood discloses wherein the one or more nasal inserts 20 are formed of a pliant material (para. 0036: “Each nostril insert 20 is preferably fabricated from a soft and resilient material”; claim 3: “wherein said tapered body is formed from a rubber-like material”; See para. 0035 of the instant application which states that rubber is a pliant material.).
Regarding claim 5, Wood discloses further comprising a longitudinal profile configured and arranged to provide an opening force on an external nasal valve of a user’s nose upon placement therein, which exerts a force on an inner nasal valve of the user’s nose (Figs. 2, 6-7, para. 0034: “Devices similar to the internal nasal dilator depicted in FIG. 1 are sized for comfortable insertion within the human nose such that the left and right nostril modules function to maintain clear nasal passages by propping open the internal nasal walls. As a result, breathing is facilitated by preventing the collapse of the nasal walls during inhalation”; para. 0035).
Regarding claim 6, Wood discloses wherein each nasal insert 20 comprises:
a top opening (see annotated Figs. 2 and 3 of Wood below);
a base opening (see annotated Figs. 2 and 3 of Wood below); and
at least one support (interpreted as at least one of the struts forming the mesh) extending between the top opening and the base opening forming a passage extending between the top opening and the base opening (see annotated Figs. 2 and 3 of Wood below).
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Annotated Figs. 2 and 3 of Wood
Regarding claim 7, Wood discloses wherein the at least one support comprises a wall (see Fig. 2 of Wood).
Regarding claim 8, Wood discloses wherein the wall comprises a mesh structure (see Fig. 2 of Wood, para. 0035: “Nasal dilator 10 includes at least one, and preferably two, tubular mesh nostril insert structures, each of which is generally referenced as 20”).
Regarding claim 10, Wood discloses further comprising an insert profile (interpreted as the tapered profile of the nasal inserts 20) in a coronal plane comprising a tapering angle that is greater in a caudal part toward the base opening than a superior part toward the top opening (see Fig. 2, claim 1: “a generally cylindrical nasal passage dilator having a tapered body defining open top and bottom ends and an interior volume”).
Regarding claim 12, Wood discloses wherein the insert profile comprises one or more of: lines interconnected by one or more vertices (see Fig. 2 of Wood which illustrates the insert profile comprising lines interconnected by one or more vertices by way of the mesh).
Regarding claim 13, Wood discloses wherein the insert profile in a sagittal plane comprises a taper profile designed to conform to a curve of nasal ridge of a nose of a user (Figs. 2, 6-7, para. 0036: “Each nostril insert 20 is preferably fabricated from a soft and resilient material configured in tubular mesh form sized and shaped for removable insertion within the nostril”).
Regarding claim 14, Wood discloses wherein one or more of the top opening and bottom opening comprise a ring defining the opening (see annotated Figs. 2 and 3 of Wood above).
Regarding claim 15, Wood discloses wherein the top opening is sized, dimensioned, and configured for insertion within the nasal passages (see Figs. 6-7 of Wood, see quote from para. 0036 above).
Regarding claim 16, Wood discloses wherein the base opening is sized, dimensioned, and configured for insertion within the nasal insert in within the nasal passages (see Figs. 6-7 of Wood, see quote from para. 0036 above).
Regarding claim 17, Wood discloses wherein the base opening is sized, dimensioned, and configured to engage a vestibular rim of a nose of a user (see Figs. 6-7 of Wood).
Regarding claim 36, Wood discloses comprising two nasal inserts 20 (see Figs. 2-3 of Wood).
Regarding claim 37, Wood discloses further comprising a connector bridge 30 connecting the two nasal inserts 20 (Fig. 2, para. 0035: “In a preferred embodiment, nasal dilator 10 includes a pair of similarly shaped nostril insert structures that are connectably attached by a cross member 30”).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3, 4, 9, 11, and 29-32 are rejected under 35 U.S.C. 103 as being unpatentable over Wood (US 20040147954) as applied to claim 1 above, and further in view of Hellman et al. (US 20200206547) [hereinafter Hellman].
Regarding claims 3 and 4, Wood discloses all of the limitations set forth above in claim 1. However, Wood fails to disclose wherein the one or more nasal inserts are formed of one or more of metal, plastic, polymer, and rubber (claim 3)/comprised of a biocompatible material (claim 4).
Hellman in the same field of endeavor of nasal devices 1 teaches that it is known in the art for one or more nasal inserts 3 (Fig. 1a, para. 0034: “At both ends of the support member 2, two rounded holder members 3 are provided, wherein the closed ends 4 of each of the rounded holder members are adapted to be inserted distally into a respective nostril”) to be formed from biocompatible polymer material (para. 0042: “The material of at least the holder members is preferably a biocompatible, flexible polymer.”).
In light of this teaching, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the one or more nasal inserts of Wood to be formed from biocompatible polymer material, as taught by Hellman, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). (See MPEP 2144.07).
Regarding claim 9, Wood discloses all of the limitations set forth above in claim 8. Wood further discloses that the mesh comprises a uniform shape and configuration (see Fig. 2 of Wood). However, Wood fails to disclose wherein the mesh comprises a varying shape and configuration.
Hellman further teaches that it is known in the art for one or more nasal inserts 33 to include a mesh 36 comprising a varying shape and configuration as a known alternative mesh structure (Figs. 2e-f, para. 0048: “The set of through holes 6, 36, 46, 56 may be formed by a mesh structure, or multiple holes arranged in different patterns, such as, for example, but not limited to, honeycomb-shaped holes, flower petal-shaped holes, round holes, square or rectangular holes, elliptical holes, triangular holes”).
The substitution of one known mesh structure (mesh comprising the varying shape and configuration as shown in Hellman) for another (mesh comprising the uniform shape and configuration as shown in Wood) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of mesh structure shown in Hellman would have yielded predictable results, namely, an alternative mesh structure that still allows for air pass through when the nasal device is inserted into the nostrils of a patient (para. 0048 of Hellman: “These through holes allow air to pass through the distal portion, and thereby from the inside to the outside of the nasal device, or vice versa”); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 11, Wood discloses all of the limitations set forth above in claim 10. However, Wood fails to disclose wherein the insert profile comprises a freeform profile.
Herman further teaches that it is known in art to provide one or more nasal inserts 63 (Fig. 1, para. 0068: “The nasal device 61 comprises…two rounded holder members 63”) with a freeform insert profile (see annotated Fig. 11c of Herman below which illustrates the nasal inserts 63 having an irregular or asymmetrical shape which is defined as “freeform”; see attached Merriam-Webster dictionary definition of “freeform”; para. 0047: “Thus, the combination of the bell-shaped profile and the protruding outer rim provides a comfortable and secure fit at the nostril opening, with minimal risk of irritation inside the nostril”).
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Annotated Fig. 11c of Herman
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the shape of the insert profile of Wood to have a freeform shape as taught by Herman, since it has been held that the variations in shape were a matter of choice and only involves routine skill in the art. See In re Dailey, 357 F.2d 669, 149 USPQ (CCPA 1966). (See MPEP 2144.04).
Regarding claims 29-31, Wood discloses all of the limitations set forth above in claim 6. Wood further discloses that one or more of the top opening and bottom opening of the nasal inserts comprises a uniform, circular shape (see Figs. 2-3 of Wood). However, Wood fails to disclose wherein the one or more of the top opening and bottom opening comprises an ellipse shape (claim 29), an oblong shape (claim 30), an ovoid shape (claim 31).
Hellman in the same field of endeavor of nasal devices teaches that top and bottom openings of one or more nasal inserts 63 can be formed in an ellipse, oblong, ovoid shape as a known shape in the art (Figs. 11a-11b, para. 0068).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the shape of the top and bottom openings of the one or more nasal inserts of Wood to have the ellipse, oblong, ovoid shape as taught by Hellman, since it has been held that the variations in shape were a matter of choice and only involves routine skill in the art. See In re Dailey, 357 F.2d 669, 149 USPQ (CCPA 1966). (See MPEP 2144.04).
Regarding claim 32, Wood discloses all of the limitations set forth above in claim 6. Wood further discloses that one or more of the top opening and bottom opening of the nasal inserts comprises a uniform, circular shape (see Figs. 2-3 of Wood). However, Wood fails to disclose wherein the one or more of the top opening and bottom opening comprises an n-ellipse shape, wherein n is greater than 2.
Hellman in the same field of endeavor of nasal devices teaches that top and bottom openings of one or more nasal inserts 63 can be formed in an ellipse shape as a known shape in the art (Figs. 11a-11b, para. 0068).
Since Hellman teaches that an ellipse shape is known in the art for the top and bottom openings of the nasal inserts, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the shape of the top and bottom openings of the one or more nasal inserts of Wood to have the n-ellipse shape, wherein n is greater than 2, since it has been held that the variations in shape were a matter of choice and only involves routine skill in the art. See In re Dailey, 357 F.2d 669, 149 USPQ (CCPA 1966). (See MPEP 2144.04).
Claim(s) 18-20, 23, 26, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Wood (US 20040147954) as applied to claim 1 above, and further in view of Abullon (US 20060272640).
Regarding claims 18-20, 23, 26, and 27, Wood discloses all of the limitations set forth above in claim 17 above. Wood further discloses wherein the base opening is configured to have an angle in a coronal plane that is 90 degrees from the sagittal plane (see annotated Fig. 5 of Wood below and Figs. 6-7 of Wood which illustrates the base opening oriented at a 90 degree angle relative to the sagittal plane when positioned inside the nose of a patient).
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Annotated Fig. 5 of Wood
However, Wood fails to disclose wherein the base opening is configured to have the angle in the coronal plane that is other than 90 degrees from the sagittal plane (claim 18), less than 85 degrees from the sagittal plane (claim 19), less than 80 degrees from the sagittal plane (claim 20); wherein the base opening is configured to have an angle in the sagittal plane that is other than 90 degrees from the coronal plane (claim 23), less than 85 degrees from the coronal plane (claim 26), less than 80 degrees from the coronal plane (claim 27).
Abullon in the same field of endeavor of nasal devices 1 teaches that it is known in the art for a base opening 3 of at least one nasal insert 1.1 (see Fig. 4 which illustrates the opening 3 located at the bottom of the nasal insert, para. 0064: “FIG. 4 is the view from a perspective of the inhaler drawn in an ideal position for introduction into the nasal cavities.”; The examiner notes that Fig. 4 mislabels the internal opening 4 and external opening 3 such that the external opening 3 is located at the bottom of the nasal insert.) to be configured to have an angle in a coronal plane that is other than 90 degrees, less than 85 degrees (claim 19), and less than 80 degrees from a sagittal plane (claim 20); and an angle in the sagittal plane that is other than 90 degrees from the coronal plane (claim 23), less than 85 degrees from the coronal plane (claim 26), and less than 80 degrees from the coronal plane (claim 27) (see annotated Fig. 1E below, para. 0070: “The planes of the external opening (3) form a 130.degree. angle (9)”. Since the total angle created by each base opening of the nasal inserts 1.1. equates to 130 degrees, bisecting said angle would result in each base opening having a 65 degree angle.).
Since Abullon expressly teaches that angling the base openings such that they are less than 80 degrees from the sagittal plane is a known configuration in the art of nasal devices, one skilled in the art would have readily recognized that providing Wood with the angled base openings of Abullon, would provide an ideal configuration for introduction into the nasal cavities of a patient.
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Annotated Fig. 1E of Abullon
Claim(s) 21-22, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Wood (US 20040147954).
Regarding claims 21 and 22, Wood discloses all of the limitations set forth above in claim 17 above. Wood further discloses wherein the base opening is configured to have an angle in a coronal plane that is 90 degrees from the sagittal plane (see annotated Fig. 5 of Wood below and Figs. 6-7 of Wood which illustrates the base opening oriented at a 90 degree angle relative to the sagittal plane when positioned inside the nose of a patient). The nasal device of Wood is intended for “insertion within the human nose such that the left and right nostril modules function to maintain clear nasal passages by propping open the internal nasal walls. As a result, breathing is facilitated by preventing the collapse of the nasal walls during inhalation” (para. 0034). The reference further illustrates the base opening positioned at a vestibular rim of the nose such that “air drawn [is] in through the nasal passages enters the open end 40a of air filters 40 and passes through the filter wall prior to entering the user's lungs” (para. 0038).
However, Wood fails to disclose wherein the base opening is configured to have the angle in the coronal plane that is more than 95 degrees from the sagittal plane (claim 21), more than 100 degrees from the sagittal plane (claim 22).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the angle of the base opening of the one or more nasal inserts of Wood to be more than 95 degrees/100 degrees from the sagittal plane since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984).
In the instant case, the base opening of the one or more nasal inserts of Wood would not operate differently with the claimed angle range and since the base opening of the one or more nasal inserts are intended to be positioned within the vestibular rim of the nose (see Figs. 6 and 7 of Wood) and expand against the vestibular rim to open up an airway of the nose (para. 0034 of Wood). Therefore, having the angle of the base opening of the one or more nasal inserts of Wood to be more than 95 degrees/100 degrees from the sagittal plane would function appropriately having the claimed angle.
Further, it appears that applicant places no criticality on the angle claimed, indicating simply that “The angles of the base ring 216A of the base opening 206A of the insert 202A to the medial septum edge of the insert 202A in both the coronal and sagittal planes are such as to engage the base ring 216A of the base opening 206A uniformly within the vestibular rim 702…The angles of the base ring 216A of the base opening 206A may differ for different user groups, i.e., dilator shape selections. In one embodiment, the angle in the coronal plane 700 is an angle other than 90 degrees (+/- 5 degrees) from the sagittal plane 800. In other embodiments, the angle in the coronal plane 700 is less than 85 degrees from the sagittal plane 800. In still further embodiments, the angle in the coronal plane 700 is less than 80 degrees from the sagittal plane 800. In alternate embodiments, the angle in the coronal plane 700 is more than 95 degrees from the sagittal plane 800. In further still alternates, the angle in the coronal plane 700 is more than 100 degrees from the sagittal plane 800.” (para. 0043 of the instant application).
Regarding claims 24 and 25, Wood discloses all of the limitations set forth above in claim 17 above. Wood further discloses wherein the base opening is configured to have an angle in a sagittal plane that is 90 degrees from the coronal plane (see annotated Fig. 5 of Wood below and Figs. 6-7 of Wood which illustrates the base opening oriented at a 90 degree angle relative to the coronal plane when positioned inside the nose of a patient). The nasal device of Wood is intended for “insertion within the human nose such that the left and right nostril modules function to maintain clear nasal passages by propping open the internal nasal walls. As a result, breathing is facilitated by preventing the collapse of the nasal walls during inhalation” (para. 0034). The reference further illustrates the base opening positioned at a vestibular rim of the nose such that “air drawn [is] in through the nasal passages enters the open end 40a of air filters 40 and passes through the filter wall prior to entering the user's lungs” (para. 0038).
However, Wood fails to disclose wherein the base opening is configured to have an angle in a sagittal plane more than 95 degrees from the coronal plane (claim 24) and more than 100 degrees from the coronal plane (claim 25)).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the angle of the base opening of the one or more nasal inserts of Wood to be more than 95 degrees and more than 100 degrees from the coronal plane since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984).
In the instant case, the base opening of the one or more nasal inserts of Wood would not operate differently with the claimed angle range and since the base opening of the one or more nasal inserts are intended to be positioned within the vestibular rim of the nose (see Figs. 6 and 7 of Wood) and expand against the vestibular rim to open up an airway of the nose (para. 0034 of Wood). Therefore, having the angle of the base opening of the one or more nasal inserts of Wood to be other than 90 degrees, more than 95 degrees, more than 100 degrees, less than 85 degrees, less than 80 degrees from the coronal plane would function appropriately having the claimed angle.
Further, it appears that applicant places no criticality on the angle claimed, indicating simply that “The angles of the base ring 216A of the base opening 206A of the insert 202A to the medial septum edge of the insert 202A in both the coronal and sagittal planes are such as to engage the base ring 216A of the base opening 206A uniformly within the vestibular rim 702…The angles of the base ring 216A of the base opening 206A may differ for different user groups, i.e., dilator shape selections. In one embodiment, the angle in the coronal plane 700 is an angle other than 90 degrees (+/- 5 degrees) from the sagittal plane 800. In other embodiments, the angle in the coronal plane 700 is less than 85 degrees from the sagittal plane 800. In still further embodiments, the angle in the coronal plane 700 is less than 80 degrees from the sagittal plane 800. In alternate embodiments, the angle in the coronal plane 700 is more than 95 degrees from the sagittal plane 800. In further still alternates, the angle in the coronal plane 700 is more than 100 degrees from the sagittal plane 800.” (para. 0043 of the instant application).
Claim(s) 28 and 33-35 are rejected under 35 U.S.C. 103 as being unpatentable over Wood (US 20040147954) as applied to claim 1 above, and further in view of Bende et al. (US 20160120689) [hereinafter Bende].
Regarding claims 28 and 33-35, Wood discloses all of the limitations set forth above in claim 6. Wood further discloses that one or more of the top opening and bottom opening of the nasal inserts comprises a uniform, circular shape (see Figs. 2-3 of Wood). However, Wood fails to disclose wherein the one or more of the top opening and bottom opening comprises a non-uniform, not approximately circular, or irregular shape to better conform to a shape of a user’s nose (claim 28), a nephroid, fabiform, or bean curve (claim 33), a totally irregular, broadly convex, shape (claim 34), further comprising one or more concavities (claim 35).
Bende in the same field of endeavor of nasal devices teaches that top and bottom openings of one or more nasal inserts 11, 12 can be formed in an irregular, fabiform shape (see Fig. 4 of Bende) with one or more concavities 16, 17 (Fig. 4, para. 0045) as a known alternative to a circular shape (see Fig. 3) in order to accommodate other nose shapes such as for a western model nose, or for a divided or over sensitive nostril (para. 0045).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the shape of the top and bottom openings of the one or more nasal inserts of Wood to have the irregular, fabiform shape as taught by Bende, since it has been held that the variations in shape were a matter of choice and only involves routine skill in the art. See In re Dailey, 357 F.2d 669, 149 USPQ (CCPA 1966). (See MPEP 2144.04).
Claim(s) 38-40 are rejected under 35 U.S.C. 103 as being unpatentable over Wood (US 20040147954) as applied to claim 1 above, and further in view of Lee (US 20220168133).
Regarding claims 38-40, Wood discloses all of the limitations set forth above in claim 37. Wood further discloses the connecting bridge 30 comprises a length that is less than a length of the two nasal inserts 20 (see Fig. 2 of Wood). However, Wood fails to disclose wherein the connecting bridge comprises a length that is equal to the length of the inserts (as required in claims 38-40).
Lee in the same field of endeavor of nasal devices 200 (Fig. 1, para. 0067) teaches that it is known in in the art for a connecting bridge 50 to have a length that is substantially equal to a length of two nasal inserts (see annotated Fig. 2 of Lee below, para. 0052: “a connecting ring 50 for connecting each of the anti-snoring devices to each other is in contact with one lower side of each anti-snoring device”).
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Annotated Fig. 2 of Lee
In light of this teaching, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the length of the connecting bridge of Wood to be equal to the length of the inserts since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984).
In the instant case, the length of the connecting bridge of Wood would not operate differently with the claimed length range and since the connecting bridge of Wood is intended to “assist the user with comfortable and selective insertion and removal of nasal dilator 10” (para. 0035 of Wood). Therefore, having the length the connecting bridge of Wood to be equal to or greater than the length of the nasal inserts would function appropriately having the claimed length. This is further taught by Lee above.
Further, it appears that applicant places no criticality on the length claimed, indicating simply that “In one embodiment, the bridge length 902 is equal to or greater than the insert length 900. In another embodiment, the bridge length 902 is equal to or greater than 90% of the insert length 900. In still further embodiments, the bridge length 902 is equal to or greater than 75% of the insert length 900. In still further embodiments, the bridge length 902 is equal to or greater than 60% of the insert length 900.” (para. 0044 of the instant application).
Claim(s) 41 is rejected under 35 U.S.C. 103 as being unpatentable over Wood (US 20040147954) as applied to claim 37 above, and further in view of Brown et al. (US 8834512) [hereinafter Brown].
Regarding claim 41, Wood discloses all of the limitations set forth above in claim 37. However, Wood fails to disclose further comprising a common carrier mechanism connecting the two nasal inserts having different profiles and/or configurations.
Brown in the same field of endeavor of nasal devices (Figs. 7A-8; col. 9 lines 14-16: “Member 700 has a curved shape to conform to the shape of the wearer's outer nostril wall and to maximize nostril area for improved air flow (FIG. 8)”; col. 9 lines 21-23: “A vertical member 725, similar to member 700 (FIG. 7A), extends upward from one end of a horizontal rail 730.”) teaches that it is known in the art for a connecting bridge (interpreted as connecting bridge comprising rail 730 of vertical member 725 inserted into rails 706, 707 of vertical member 700; see Figs. 7B-7F, ”) to comprise a common carrier mechanism (interpreted as a ratchet mechanism comprising ratchet teeth 740 of rail 730 which locks with rails 706, 707) (Figs. 7C, 7F, col. 9 lines 24-26: “A series of ratchet teeth 740 protrude from rail 730. Rail 703 is designed to fit in the gap between rails 706 and 707 of the left portion”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the connecting bridge in Wood to include the common carrier mechanism i.e. ratchet mechanism, as taught by Brown, in order to allow the user to customize the amount of dilation to nasal walls of a patient (col. 9 lines 54-60: “Then the user gently squeezes handles 710 and 735 together, forcing members 700 and 725 apart until the desired amount of dilation of walls 610' and 610'' is reached. As rail 730 moves within the gap between rails 706 and 707, ratchet teeth 720 (FIG. 7C) successively engage teeth 740 (FIG. 7F), preventing reverse motion and thereby securing the dilator”).
Claim(s) 42 is rejected under 35 U.S.C. 103 as being unpatentable over Wood (US 20040147954) as applied to claim 1 above, and further in view of Collazo et al. (US 20140083419) [hereinafter Collazo].
Regarding claim 42, Wood discloses all of the limitations set forth above in claim 1. However, Wood fails to disclose wherein the system is configured as part of a CPAP pillow.
Collazo in the same field of endeavor of nasal inserts 202 (Fig. 2A, para. 0021) teaches that the nasal inserts 202 joined by a connector bridge 204 when comprising a valve 210 (Fig. 2B, para. 0023, para. 0023) may alternatively be configured as part of a CPAP pillow (para. 0032: “While the embodiments described herein have been in the form of a nasal insert, it is envisioned that any style of interface could be combined with a valve. This can include, but isn't limited to, full-face masks, nasal masks, nasal prong interfaces, oral masks, and hybrid masks (i.e., combined masks such as an oral mask with nasal prongs or a nasal mask with nasal prongs).; para. 0008: “Nasal prongs can generally be separated into two types: nasal pillows and nasal inserts”).
In light of this teaching, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the nasal inserts system in Roman to comprise a valve such that it may be configured as part of a CPAP pillow, as taught by Collazo in order to treat sleep apnea and snoring (para. 0009 of Collazo), thereby providing an additional utility to the device.
Conclusion
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771
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