DETAILED ACTION
Primary Examiner acknowledges Claims 25-32, and 43-54* are pending in this application, with Claims 25-32, 43-46, and 48-52 having been currently amended, Claims 53 and 54* having been newly added, and Claims 1-24 and 33-42 having been cancelled.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Misnumbered claim 53 (2nd instance) been renumbered 54.
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 25-32, and 43-54* 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.
Specifically, Claim 25, Line 10 and Claim 26, Line 3 recite “the gas receiving aperture”; however, this limitation appears to lack antecedent basis in the claims. It appears the limitation should read “the at least one gas receiving aperture” to be consistent with the former recitation of “at least one gas receiving aperture” in Claim 25, Line 9 and Claim 26, Line 2. Dependent claims, Claims 26-32 and 54*, incorporate the indefinite subject matter form which they depend. Appropriate correction and clarification is required.
Specifically, Claim 25, Line 11 recites “the tip”; however, this limitation appears to lack antecedent basis in the claims. It appears the limitation should read “the gas sampling tip” to be consistent with the former recitation of “a gas sampling tip” in Claim 25, Line 8. Dependent claims, Claims 26-32 and 54*, incorporate the indefinite subject matter form which they depend. Appropriate correction and clarification is required.
Specifically, Claims 26 and 44 recites the concept of “the gas receiving aperture extends from the distal end surface and along the outer side surface”; however, the breadth and scope of this limitation is unclear. It is noted, the claims require “at least one gas receiving surface” whereby there is a hole “formed both in the distal end surface and outer side surface”. Primary Examiner is unsure if Applicant requires a singular hole which is “formed both in the distal end surface and outer side surface … [and] extends from the distal end surface and along the outer side surface” or if there can be multiple holes whereby one hole is formed in the “distal end surface” and another hole is formed in the “outer side surface” whereby each of the multiple holes “extends from the distal end surface and along the outer side surface”. Still further, do the multiple holes have to be connected on the surfaces? Appropriate correction and clarification is required.
Specifically, Claim 28, Line 3 recites “distal end”; however, the breadth and scope of this limitation is unclear. Primary Examiner is unsure if Applicant is intending to reference the “distal end portion” as introduced in Claim 25, Line 12, or the “distal end surface” as introduced in Claim25, Line 12. Consequently, it appears this limitation of “distal end” lacks antecedent basis in the claims. Appropriate correction and clarification is required.
Specifically, Claims 31 and 32 recites “a breathing apparatus”; however, the breadth and scope of this limitation is unclear. Primary Examiner is unsure what is the relationship if any between the “breathing apparatus” of Claim 31/32 and the “high flow gas delivery system” of Claim 25. Still further, it is unclear if the gas provided by the “high flow gas delivery system” of Claim 25 is “breathing gas” as claimed in Claim 31/32. Appropriate correction and clarification is required.
Specifically, Claim 43, Line 2 recites “the gas receiving aperture”; however, this limitation appears to lack antecedent basis in the claims. It appears the limitation should read “the three gas receiving apertures” to be consistent with the former recitation of “three gas receiving apertures” in Claim 28, Line 2. Appropriate correction and clarification is required.
Specifically, Claim 43, Line 11; Claim 44, Line 3; and Claim 50, Line 2 recite “the gas receiving aperture”; however, this limitation appears to lack antecedent basis in the claims. It appears the limitation should read “the at least one gas receiving aperture” to be consistent with the former recitation of “at least one gas receiving aperture” in Claim 43, Line 9 and Claim 44, Line 1-2. Dependent claims, Claims 33-42 and 53, incorporate the indefinite subject matter form which they depend. Appropriate correction and clarification is required.
Specifically, Claim 43, Line 10 recites “the hollow interior region”; however, this limitation appears to lack antecedent basis in the claims. It appears the limitation should read “the substantially hollow interior region” to be consistent with the former recitation of “substantially hollow interior region” in Claim 43, Line 4. Dependent claims, Claims 33-42 and 53, incorporate the indefinite subject matter form which they depend. Appropriate correction and clarification is required.
Specifically, Claim 46, Line 2; Claim 49, Line 3 recite “distal end”; however, the breadth and scope of this limitation is unclear. Primary Examiner is unsure if Applicant is intending to reference the “distal end portion” as introduced in Claim 43, Line 7, or the “distal end surface” as introduced in Claim 43, Line 7. Consequently, it appears this limitation of “distal end” lacks antecedent basis in the claims. Appropriate correction and clarification is required.
Specifically, Claim 49, Line 3 recites “the sampling tip”; however, this limitation appears to lack antecedent basis in the claims. It appears the limitation should read “the gas sampling tip” to be consistent with the former recitation of “a gas sampling tip” in Claim 43, Line 1. Appropriate correction and clarification is required.
Specifically, Claim 50, Line 2 recites “the gas receiving apertures” in plurality; however, this limitation appears to lack antecedent basis in the claims. However, the former recitation only recites “at least one gas sampling aperture” as shown in Claim 43, Line 9. It is unclear how the flute structure can be formed “between the gas receiving apertures”. Should Claim 50 depend from Claim 49, as was done with the parentage of Claims 28 and 29 – where Claim 28 recited “three gas apertures” and Claim 29 depends from Claim 28? Appropriate correction and clarification is required.
Specifically, Claims 51 and 52 recites “a breathing apparatus”; however, the breadth and scope of this limitation is unclear. Primary Examiner is unsure what is the relationship if any between the “breathing apparatus” of Claim 51/52 and the “gas sampling tip” of Claim 43. Still further, it is unclear if the gas provided by the “gas sampling tip” of Claim 43 is the “breathing gas” as claimed in Claim 51/52. Appropriate correction and clarification is required.
Specifically, Claim 53, Line 3 recites “the tip”; however, this limitation appears to lack antecedent basis in the claims. It appears the limitation should read “the gas sampling tip” to be consistent with the former recitation of “a gas sampling tip” in Claim 43, Line 1. Appropriate correction and clarification is required.
Specifically, Claim 53, Line 3 recites “a second, distal end” of a conduit; however, the breadth and scope of this limitation is unclear. Primary Examiner is unsure if this “second, distal end” of Claim 53, Line 3, is the same as the “distal end” of Claim 43, Line 1, or if it’s a separate and distinct feature. Appropriate correction and clarification is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 25, 27, 30, 43, 44, 46-48, 50, 53, and 54* are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (2016/0345894) in view of Payton (4,660,555).
As to Claim 25, Johnson discloses a gas sampling interface (200D, as best seen in Figure 7 – in situ, and Figure 2D – ex situ, “In FIGS. 2A-2D, various alternative embodiments of the sampling apparatus 200A-200D are shown.” Para 0055; “Generally, each apparatus (200A-200D) may include: a first tubular member (202A-202D), a joint member (204A-204D), a cap (206A-206D), a manipulable member (208A-208D), a second tubular member (210A-210D), a connector (212A-212D), a sampling return line (214A-214D), length measurement indicator marks (shown on FIGS. 2D, 3A, and 3B-4E).” Paras 0056-0064; “In the embodiment depicted in FIG. 2D, the connector 212D may appear similar to caps 206A-206D, however, connector 212D may function as the connection point between the apparatus 200D and a nasal mask like the one shown in FIG. 7, and therefore, is considered a connector.” Para 0076; “Another example of a nasal mask to which the sampling apparatus of the instant application may be coupled is the Safe Sedate® 700 (“nasal mask”) depicted in FIG. 7. In embodiments, the nasal mask 700 may include a nose port 702, which has one or more exhaust holes 704. As illustrated, the nasal mask 700 may be strapped to a patient's face so that the mouth is clearly accessible. FIG. 7 further depicts an example of a sampling apparatus 200D (FIG. 2D) being connected to the nasal mask 700. In particular, the sampling apparatus 200D may include a first tubular member 202D and a second tubular member 210D, and the sampling apparatus 200D may draw exhaled breath to a systemic biomarker sampling device (such as device 750).” Para 0099; “Thus, the embodiment of sampling apparatus 200D in FIG. 2D is well-suited for connection to the Safe Sedate® nasal mask 700.” Para 0100) for use with a high flow respiratory gas delivery system (via 700, “Another example of a nasal mask to which the sampling apparatus of the instant application may be coupled is the Safe Sedate® 700 (“nasal mask”) depicted in FIG. 7. In embodiments, the nasal mask 700 may include a nose port 702, which has one or more exhaust holes 704. As illustrated, the nasal mask 700 may be strapped to a patient's face so that the mouth is clearly accessible. FIG. 7 further depicts an example of a sampling apparatus 200D (FIG. 2D) being connected to the nasal mask 700. In particular, the sampling apparatus 200D may include a first tubular member 202D and a second tubular member 210D, and the sampling apparatus 200D may draw exhaled breath to a systemic biomarker sampling device (such as device 750).” Para 0099; “Thus, the embodiment of sampling apparatus 200D in FIG. 2D is well-suited for connection to the Safe Sedate® nasal mask 700.” Para 0100), the gas sampling interface (200D) comprising: a conduit (one of 202D/210D, “a first tubular member (202A-202D), … a second tubular member (210A-210D)” Paras 0056-0064), comprising: a first end (one of 202D/210D as connected to 214D, “a sampling return line (214A-214D)” Paras 0056-0064) fluidly connectable with a respiratory gas monitor (750, “a systemic biomarker sampling device (such as device 750).” Para 0099); and a second end (one of 202D/210D as connected to 206D/212D, respectively, “a cap (206A-206D), … a connector (212A-212D)” Paras 0056-0064) comprising at least one inlet (defined by the lumen of 202D/210D) for receiving exhaled or expired breathing gas from the patient (along 202D/212D to 214D and 750, “FIGS. 2A-2D also depict a sampling return line 214A-214D. The sampling return line 214A-214D may extend from the respective joint member 204A-204D to a systemic biomarker monitor device (not shown). Moreover, the suction that draws exhaled breath from the first tubular member 202A-202D to the monitor device may also draw exhaled breath from the second tubular member 210A-210D by way of the joint member 204A-204D, which joins the first and second tubular members to the respective sampling return line 214A-214D. Thusly, exhaled breath may be sampled directly from a patient's mouth and nose in order to provide a more accurate assessment of the vital statistics of a patient under anesthesia.” Para 0077; a gas sampling tip (one of 206D/212D, “a cap (206A-206D), … a connector (212A-212D)” Paras 0056-0064) located at the second end (one of 202D/210D as connected to 206D/212D, respectively) of the conduit (202D/210D).
Additionally, It is noted the gas sampling tip (212D) is removably connected to the conduit (210D) through the application of interfacing structure that includes constructions which “may be threaded, possibly like a Luer-Lok® connection, or may be structured to form a compression fit, an interference fit, a friction fit, or any other connection that permits a gas flow.” (Para 0075).
Yet, does not expressly disclose the gas sampling tip “comprising a substantially hollow body comprising at least one gas receiving aperture to receive gases exhaled or expired by a patient, wherein the gas receiving aperture is in fluid communication with the at least one inlet of the conduit, and wherein the body of the tip further comprises a distal end portion comprising a distal end surface and an outer side surface.”
Payton teaches a gas tip (10, best seen Figures 1-7, “Referring to FIGS. 2-5, the nosepiece 10 is formed by molding a body 12 of relatively soft elastomeric material, such as silicone rubber, or FDA grade vinyl.” Column 4, Lines 1-25) connected to a second end of a conduit (36, “The outer curved tube-like portion 22 is proportioned to slip over the outside surface of an oxygen delivery tube 36, as shown in FIGS. 1 and 7. The curvature of the portion 22 permits the tube 36 to be carried off from the side of the face in a pleasing and attractive manner.” Column 4, Lines 60-70) for the conveyance of gas along the conduit (36), wherein the gas tip (10) and the second end of the conduit (36) are removably connected by an interference fitment (“The outer curved tube-like portion 22 is proportioned to slip over the outside surface of an oxygen delivery tube 36, as shown in FIGS. 1 and 7. The curvature of the portion 22 permits the tube 36 to be carried off from the side of the face in a pleasing and attractive manner.” Column 4, Lines 60-70).
Regarding the remaining limitations of the claims, Payton teaches the gas tip (10) comprises a substantially hollow body (best seen Figures 3 and 4), comprising at least one gas receiving aperture (25/30-32, “The truncated end 15 is formed with an inwardly tapering or reverse conical surface 24, leading to a central oxygen outlet 25 at the terminal end of the passageway 20. The improved nosepiece of the embodient of FIGS. 2-5 also includes one or more supplemental, laterally directed passages 30. As shown in FIG. 3, a pair of the passages 30 extend laterally from the axial or main passageway 20 and terminate at outlets 32 on the surface 17 of the conical section 14 adjacent the truncated end 15. The purpose of the supplemental passage is to ensure a free and adequate supply of oxygen in the event one of the other oxygen passageways becomes plugged or stopped. Thus, if the primary central oxygen outlet 25 should become temporarily stopped with mucous or the like, oxygen can still be delivered through the opposed pair of lateral passages 30 and the outlets 32.” Column 4, Lines 20-60) to receive gases, wherein the at least one gas receiving aperture (25/30-32) is in fluid communication with the at least one inlet (lumen of 36) of the conduit (36), and wherein the body (12, “The body 12 defines a primary generally axially-extending oxygen passageway 20 therethrough, leading from a curved inlet tube-like portion 22 extending from the body 12 and through the conical section 14, and opening centrally at the truncated end 15.” Column 4, Lines 20-60) of the gas tip (10) further comprises a distal end portion (14, “conical section 14” Column 4, Lines 20-60), comprising a distal end surface (24 of 15, “The truncated end 15 is formed with an inwardly tapering or reverse conical surface 24, leading to a central oxygen outlet 25 at the terminal end of the passageway 20.” Column 4, Lines 20-60) and an outer side surface (17 of 14, “The skirt 16 forms at its outer surface a continuation of the outside conical surface 17 of the section 14 and extends rearwardly in partially overlying relation to the cyindrical section 13.” Column 4, Lines 1-25; “As shown in FIG. 3, a pair of the passages 30 extend laterally from the axial or main passageway 20 and terminate at outlets 32 on the surface 17 of the conical section 14 adjacent the truncated end 15.” Column 4, Lines 20-60).
Although Johnson is intended for gas sampling through its gas tip, while Payton is intended for oxygen delivery through its gas tip, there is no structure that would preclude, prevent, or hinder, the ability of the gas tips of Johnson and Payton to be interchanged as both are removably connected to the conduit. Consequently, as expected gas pressures through sampling would be commensurate with the expected gas pressures through delivery, the gas tips would be sufficiently constructed to handle the same pressures regardless of directionality of the gas flow being conveyed. Furthermore, it should be noted both the gas tip of Johnson and Payton are capable of being utilized in the breathing passageways (nose or mouth) of the patient; thus, it appears the construction of the gas tips of Johnson and Payton are functionally equivalent alternative structures suitable for the conveyance of gas. Additionally, it should be noted the gas tip of Payton has additional functionality that would be beneficial to Johnson, as Johnson only discloses a singular gas receiving aperture; whilst, Payton discloses a plurality of gas receiving apertures (25/30-32) which operate provide a primary gas passageway of the gas receiving aperture (25) but additionally secondary gas passageways of the gas receiving apertures (30-32) should the primary gas passageway “become temporarily stopped with mucous or the like” Column 4, Lines 20-60).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the gas sampling tip of Johnson to have the claimed features as taught by Payton to provide a functionally equivalent alternative structure suitable for conveying gas.
As to Claim 27, the modified Johnson, specifically Payton teaches the construction of the distal end portion (14) of the gas sampling tip (10) is substantially bulbous (by the widened base at from the conical shape as best seen in Figures 1-7).
Should Applicant respectfully disagree with Primary Examiner’s assertion of “substantially bulbous”, Primary Examiner presents extrinsic evidence in the form of Semple (290,486) and McGeary (377,571) patented in 1883 and 1888, respectively, which teaches the construction of a gas tip for insertion in the nose of the patient in a bulb shape was known (Semple: Page 1, Column 2, Lines 60-70; McGeary: Page 2, Column 1, Lines 5-15).
As to Claim 30, the modified Johnson, specifically Johnson discloses the gas sampling conduit (210D) is connectable to a gas sampling tube (214D, “a sampling return line (214A-214D)” Paras 0056-0064) of the respiratory gas monitor (750) via a luer (“may be threaded, possibly like a Luer-Lok® connection, or may be structured to form a compression fit, an interference fit, a friction fit, or any other connection that permits a gas flow.” Para 0075).
As to Claim 43, Johnson discloses a gas sampling tip (one of 206D/212D, “a cap (206A-206D), … a connector (212A-212D)” Paras 0056-0064) to removably connect (explicitly 212D via “may be threaded, possibly like a Luer-Lok® connection, or may be structured to form a compression fit, an interference fit, a friction fit, or any other connection that permits a gas flow.” Para 0075) to a distal end (one of 202D/210D as connected to 206D/212D, respectively, “a cap (206A-206D), … a connector (212A-212D)” Paras 0056-0064) of a gas sampling conduit (one of 202D/210D, “a first tubular member (202A-202D), … a second tubular member (210A-210D)” Paras 0056-0064), the gas sampling tip (212D) comprising: a body (perimeter of 212D).
In operation, Johnson discloses the gas sampling tip (212D) receives exhaled or expired breathing gas from the patient (along 212D to 214D and 750, “FIGS. 2A-2D also depict a sampling return line 214A-214D. The sampling return line 214A-214D may extend from the respective joint member 204A-204D to a systemic biomarker monitor device (not shown). Moreover, the suction that draws exhaled breath from the first tubular member 202A-202D to the monitor device may also draw exhaled breath from the second tubular member 210A-210D by way of the joint member 204A-204D, which joins the first and second tubular members to the respective sampling return line 214A-214D. Thusly, exhaled breath may be sampled directly from a patient's mouth and nose in order to provide a more accurate assessment of the vital statistics of a patient under anesthesia.” Para 0077; a gas sampling tip (one of 206D/212D, “a cap (206A-206D), … a connector (212A-212D)” Paras 0056-0064) as connected to the gas sampling conduit (one of 202D/210D).
Yet, does not expressly disclose the body of the gas sampling tip “comprising a substantially hollow interior region configured to be in fluid communication with an inlet of the gas sampling conduit when connected to the gas sampling conduit, a distal end portion comprising a distal end surface and an outer side surface, and at least one gas receiving aperture connected to the hollow interior region to receive gases exhaled or expired by a patient, and wherein the gas receiving aperture is in fluid communication with the substantially hollow interior region of the body.”
Payton teaches a gas tip (10, best seen Figures 1-7, “Referring to FIGS. 2-5, the nosepiece 10 is formed by molding a body 12 of relatively soft elastomeric material, such as silicone rubber, or FDA grade vinyl.” Column 4, Lines 1-25) connected to a distal end of a gas sampling conduit (36, “The outer curved tube-like portion 22 is proportioned to slip over the outside surface of an oxygen delivery tube 36, as shown in FIGS. 1 and 7. The curvature of the portion 22 permits the tube 36 to be carried off from the side of the face in a pleasing and attractive manner.” Column 4, Lines 60-70) for the conveyance of gas along the conduit (36), wherein the gas tip (10) and the second end of the conduit (36) are removably connected by an interference fitment (“The outer curved tube-like portion 22 is proportioned to slip over the outside surface of an oxygen delivery tube 36, as shown in FIGS. 1 and 7. The curvature of the portion 22 permits the tube 36 to be carried off from the side of the face in a pleasing and attractive manner.” Column 4, Lines 60-70).
Regarding the remaining limitations of the claims, Payton teaches a body (perimeter of 10) of the gas tip (10) comprises a substantially hollow interior region (best seen Figures 3 and 4) configured to be in fluid communication with an inlet (lumen of 36) of the gas sampling conduit (36) when connected to the gas sampling conduit (36), a distal end portion (14, “conical section 14” Column 4, Lines 20-60), comprising a distal end surface (24 of 15, “The truncated end 15 is formed with an inwardly tapering or reverse conical surface 24, leading to a central oxygen outlet 25 at the terminal end of the passageway 20.” Column 4, Lines 20-60) and an outer side surface (17 of 14, “The skirt 16 forms at its outer surface a continuation of the outside conical surface 17 of the section 14 and extends rearwardly in partially overlying relation to the cyindrical section 13.” Column 4, Lines 1-25; “As shown in FIG. 3, a pair of the passages 30 extend laterally from the axial or main passageway 20 and terminate at outlets 32 on the surface 17 of the conical section 14 adjacent the truncated end 15.” Column 4, Lines 20-60); and at least one gas receiving aperture (25/30-32, “The truncated end 15 is formed with an inwardly tapering or reverse conical surface 24, leading to a central oxygen outlet 25 at the terminal end of the passageway 20. The improved nosepiece of the embodient of FIGS. 2-5 also includes one or more supplemental, laterally directed passages 30. As shown in FIG. 3, a pair of the passages 30 extend laterally from the axial or main passageway 20 and terminate at outlets 32 on the surface 17 of the conical section 14 adjacent the truncated end 15. The purpose of the supplemental passage is to ensure a free and adequate supply of oxygen in the event one of the other oxygen passageways becomes plugged or stopped. Thus, if the primary central oxygen outlet 25 should become temporarily stopped with mucous or the like, oxygen can still be delivered through the opposed pair of lateral passages 30 and the outlets 32.” Column 4, Lines 20-60) to receive gases, wherein the at least one gas receiving aperture (25/30-32) connected to the substantially hollow interior region (best seen Figures 3 and 4), and wherein at least one gas receiving aperture (25/30-32) is in fluid communication with the substantially hollow interior region (best seen Figures 3 and 4) of the body (perimeter of 10).
Although Johnson is intended for gas sampling through its gas tip, while Payton is intended for oxygen delivery through its gas tip, there is no structure that would preclude, prevent, or hinder, the ability of the gas tips of Johnson and Payton to be interchanged as both are removably connected to the conduit. Consequently, as expected gas pressures through sampling would be commensurate with the expected gas pressures through delivery, the gas tips would be sufficiently constructed to handle the same pressures regardless of directionality of the gas flow being conveyed. Furthermore, it should be noted both the gas tip of Johnson and Payton are capable of being utilized in the breathing passageways (nose or mouth) of the patient; thus, it appears the construction of the gas tips of Johnson and Payton are functionally equivalent alternative structures suitable for the conveyance of gas. Additionally, it should be noted the gas tip of Payton has additional functionality that would be beneficial to Johnson, as Johnson only discloses a singular gas receiving aperture; whilst, Payton discloses a plurality of gas receiving apertures (25/30-32) which operate provide a primary gas passageway of the gas receiving aperture (25) but additionally secondary gas passageways of the gas receiving apertures (30-32) should the primary gas passageway “become temporarily stopped with mucous or the like” Column 4, Lines 20-60).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the gas sampling tip of Johnson to have the claimed features as taught by Payton to provide a functionally equivalent alternative structure suitable for conveying gas.
As to Claim 44, the modified Johnson, specifically Payton teaches the at least one gas receiving aperture (25/30-32) is formed in both the distal end surface (25 via 24 of 15) and the outer side surface (30-32 via 17 of 14) such that the at least one gas receiving aperture (25/30-32) extends from the distal end surface (24 of 15) and along the outer side surface (17 of 14).
As to Claim 46, the modified Johnson, specifically Payton teaches a distal end portion (14) of the gas sampling tip (10) Is outwardly curved. As noted in Figures 1-7 of Payton, the distal end portion (14) of the gas sampling tip (10) is wider in an outwardly shaped curvature than that of the distal end surface (24 of 15) and the proximal end surface (at 13 and 22).
As to Claim 47, the modified Johnson, specifically Payton teaches the construction of the distal end portion (14) of the gas sampling tip (10) is substantially bulbous (by the widened base at from the conical shape as best seen in Figures 1-7).
Should Applicant respectfully disagree with Primary Examiner’s assertion of “substantially bulbous”, Primary Examiner presents extrinsic evidence in the form of Semple (290,486) and McGeary (377,571) patented in 1883 and 1888, respectively, which teaches the construction of a gas tip for insertion in the nose of the patient in a bulb shape was known (Semple: Page 1, Column 2, Lines 60-70; McGeary: Page 2, Column 1, Lines 5-15).
As to Claim 48, the modified Johnson, specifically Payton teaches the at least one gas sampling tip (10) has a substantially cylindrical shape (13, “The body 12 has an outwardly or rearwardly extending cylindrical section 13 and a forward section 14 formed generally in the shape of a cone.” Column 4, Lines 1-25).
As to Claim 50, the modified Johnson, specifically Payton teaches at least one gas receiving aperture (25) and a subsequent gas aperture (via 22 of 20) that is connected to the substantially hollow interior region (best seen Figures 3 and 4) and in fluid communication with the substantially hollow interior region (best seen Figures 3 and 4) on the body (perimeter of 10) of the gas sampling tip (10).
Yet, does not expressly disclose “each portion of the body located between the gas receiving apertures forms a flute, wherein the flutes are substantially evenly spaced around a circumference of the distal end portion of the gas sampling tip”.
Payton teaches an additional gas sampling tip (Figures 10-12) having a gas receiving aperture (via 24a) and a subsequent gas receiving aperture (via 41 of 20a) that is connected to the substantially hollow interior region (best seen Figure 12) and in fluid communication with the substantially hollow interior region (best seen Figure 12) on the body (perimeter of 10b) of the gas sampling tip (10b).
Regarding the remaining limitations of the claims, each portion of the body (perimeter of 10b) located between the gas receiving aperture (via 24a) and the subsequent gas receiving aperture (via 41 of 20a) forms a flute (45, “Means for providing auxiliary air, to alleviate feelings of claustrophobia, take the form of a plurality of external semi-cylindrically shaped grooves or passageways 45 formed in the outer surface of the conical end 42. The passageways 45 lead from the wide or large end of the conical surface 46 to the small end and permit the ingress of outside air. They perform the same purpose as the passageways 35 of the preceding embodiment. While four such semi-cylindrical grooves 45 are shown in the improved nosepiece 10b, more or less may be employed as determined desirable for the comfort and well being of the patient.” Column 5, Lines 20-40; “In addition, the auxiliary and optional air inlets 35 or 45, permit ingress of outside air, where desired, permitting the patient to breath "through" the nosepiece.” Column 6, Lines 35-55), wherein the flutes (“four such semi-cylindrical grooves 45”) are substantially evenly spaced around a circumference (46, “conical surface 46” Column 5, Lines 20-40) of the distal end portion (40, “In the modifications of the preferred embodiment of FIGS. 10-12, the nosepiece 10b is formed with a molded body 40 having, at its outer end, a right angle elbow lead-in section 41 defining the central passageway 20a therethrough.” Column 5, Lines 5-20) of the gas sampling tip (Figures 10-12). The resultant effect of the configuration of the flutes is the ability to for “the patient to breath "through" the nosepiece.” (Column 6, Lines 35-55) and “providing auxiliary air” (Column 5, Lines 20-40).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the construction of the body of the gas sampling tip of the modified Payton to include flutes as taught by the further modification of Payton to enable “the patient to breath "through" the nosepiece.”
As to Claim 53, the modified Johnson, specifically Johnson discloses the gas sampling tip (212D) is attachable to a gas sampling interface (200D, as best seen in Figure 7 – in situ, and Figure 2D – ex situ, “In FIGS. 2A-2D, various alternative embodiments of the sampling apparatus 200A-200D are shown.” Para 0055; “Generally, each apparatus (200A-200D) may include: a first tubular member (202A-202D), a joint member (204A-204D), a cap (206A-206D), a manipulable member (208A-208D), a second tubular member (210A-210D), a connector (212A-212D), a sampling return line (214A-214D), length measurement indicator marks (shown on FIGS. 2D, 3A, and 3B-4E).” Paras 0056-0064; “In the embodiment depicted in FIG. 2D, the connector 212D may appear similar to caps 206A-206D, however, connector 212D may function as the connection point between the apparatus 200D and a nasal mask like the one shown in FIG. 7, and therefore, is considered a connector.” Para 0076; “Another example of a nasal mask to which the sampling apparatus of the instant application may be coupled is the Safe Sedate® 700 (“nasal mask”) depicted in FIG. 7. In embodiments, the nasal mask 700 may include a nose port 702, which has one or more exhaust holes 704. As illustrated, the nasal mask 700 may be strapped to a patient's face so that the mouth is clearly accessible. FIG. 7 further depicts an example of a sampling apparatus 200D (FIG. 2D) being connected to the nasal mask 700. In particular, the sampling apparatus 200D may include a first tubular member 202D and a second tubular member 210D, and the sampling apparatus 200D may draw exhaled breath to a systemic biomarker sampling device (such as device 750).” Para 0099; “Thus, the embodiment of sampling apparatus 200D in FIG. 2D is well-suited for connection to the Safe Sedate® nasal mask 700.” Para 0100) comprising a conduit (one of 202D/210D, “a first tubular member (202A-202D), … a second tubular member (210A-210D)” Paras 0056-0064), comprising: a first end (one of 202D/210D as connected to 214D, “a sampling return line (214A-214D)” Paras 0056-0064) fluidly connectable with a respiratory gas monitor (750, “a systemic biomarker sampling device (such as device 750).” Para 0099); and a second, distal end (one of 202D/210D as connected to 206D/212D, respectively, “a cap (206A-206D), … a connector (212A-212D)” Paras 0056-0064) that attaches to the gas sampling tip (212D) and that comprises at least one inlet (defined by the lumen of 202D/210D) for receiving exhaled or expired breathing gas from the patient (along 202D/212D to 214D and 750, “FIGS. 2A-2D also depict a sampling return line 214A-214D. The sampling return line 214A-214D may extend from the respective joint member 204A-204D to a systemic biomarker monitor device (not shown). Moreover, the suction that draws exhaled breath from the first tubular member 202A-202D to the monitor device may also draw exhaled breath from the second tubular member 210A-210D by way of the joint member 204A-204D, which joins the first and second tubular members to the respective sampling return line 214A-214D. Thusly, exhaled breath may be sampled directly from a patient's mouth and nose in order to provide a more accurate assessment of the vital statistics of a patient under anesthesia.” Para 0077; a gas sampling tip (one of 206D/212D, “a cap (206A-206D), … a connector (212A-212D)” Paras 0056-0064).
Regarding the limitation to “flexible”, the modified Johnson, specifically Johnson discloses at least a portion of the conduit (one of 202D/210D) is flexible (“Depending on the embodiment used for the apparatus, shortening the length of the tubular member(s) may be accomplished by many ways, including cutting, bending, breaking, snapping, sliding, etc.” Para 0079) to allow the inlet (defined by the lumen of 202D/210D) to be selectively positioned at the patient’s mouth or nose (Figure 7). Still further, the modified Johson, specifically Payton teaches at least a portion of the conduit (36) is flexible (as a function of the relationship of 36 with 11, as best seen in Figure 1, “The curved tube holder 11 has particular advantage of simplicity and low cost. It may be readily adjusted by sliding the same along the patch 62, to position the electrode 63 within the slot 80, as is desired, so as to locate the section of the oxygen tube 36 leading to the nosepiece, and accommodate variations in facial contours and the like.” Column 6, Lines 50-70).
As to Claim 54*, the modified Johnson, specifically Johnson discloses at least a portion of the conduit (one of 202D/210D) is flexible (“Depending on the embodiment used for the apparatus, shortening the length of the tubular member(s) may be accomplished by many ways, including cutting, bending, breaking, snapping, sliding, etc.” Para 0079) to allow the inlet (defined by the lumen of 202D/210D) to be selectively positioned at the patient’s mouth or nose (Figure 7). Still further, the modified Johson, specifically Payton teaches at least a portion of the conduit (36) is flexible (as a function of the relationship of 36 with 11, as best seen in Figure 1, “The curved tube holder 11 has particular advantage of simplicity and low cost. It may be readily adjusted by sliding the same along the patch 62, to position the electrode 63 within the slot 80, as is desired, so as to locate the section of the oxygen tube 36 leading to the nosepiece, and accommodate variations in facial contours and the like.” Column 6, Lines 50-70).
Claims 26, 28, 29, 45, and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (2016/0345894) in view of Payton (4,660,555), as applied to Claims 25 and 43, and further in view of Tsutsui (2014/0060535).
As to Claim 26, the modified Johnson, specifically Payton teaches the at least one gas receiving aperture (25/30-32) is formed in both the distal end surface (25 via 24 of 15) and the outer side surface (30-32 via 17 of 14) such that the at least one gas receiving aperture (25/30-32) extends from the distal end surface (24 of 15) and along the outer side surface (17 of 14).
Yet, does not expressly disclose the construction of the at least one gas receiving aperture “to form an elongate opening in the distal end portion of the gas sampling tip.”
Tsutsui teaches a gas tip (114, “The throat (108) can comprise an external thread (112) for attachment of a nozzle (114).” Para 0036) which is removably connected (via 112, “an external thread (112)” Para 0036) to a source (102, “The intranasal delivery device (100) can comprise air source, which can be a flexible vial (102).” Para 0036) for the conveyance of gas between the nose of the patient (via insertion of 114, “a nozzle (114) that can comprise a nozzle pipe (130) which can be inserted or partially inserted into the nasal cavity or a nostril of a subject” Para 0039) and the source (102). Tsutsui teaches a gas tip (114) includes a gas receiving aperture (132, “An intranasal device (100) can further comprise a nozzle (114) that can comprise a nozzle pipe (130) which can be inserted or partially inserted into the nasal cavity or a nostril of a subject. The nozzle (114) can further comprise a nozzle hole (132), a removable or breakable cover (134), and a reservoir for a powdered therapeutic formulation (138).” Para 0039).
Regarding the remaining limitations of the claims, Tsutsui teaches the shape of the gas receiving aperture (132) “can be any of a number of shapes including but not limited to a circle, oval, triangle, rectangle, or combination thereof” (Para 0115). It is noted the shape of an oval would form the claimed “elongated opening”. The resultant effect of the shape of the gas receiving aperture is to provide conveyance points between the nose of the patient (via insertion of 114) and the source (102).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the shape of the gas receiving aperture of the modified Johnson, to be in the form of an oval – an elongate opening, as taught by Tsutsui to provide conveyance points between the nose of the patient (via insertion of 114) and the source (102).
As to Claim 45, the modified Johnson, specifically Payton teaches the at least one gas receiving aperture (25/30-32); yet, does not expressly disclose the construction of the at least one gas receiving aperture “to form an elongate opening in the distal end portion of the gas sampling tip.”
Tsutsui teaches a gas tip (114, “The throat (108) can comprise an external thread (112) for attachment of a nozzle (114).” Para 0036) which is removably connected (via 112, “an external thread (112)” Para 0036) to a source (102, “The intranasal delivery device (100) can comprise air source, which can be a flexible vial (102).” Para 0036) for the conveyance of gas between the nose of the patient (via insertion of 114, “a nozzle (114) that can comprise a nozzle pipe (130) which can be inserted or partially inserted into the nasal cavity or a nostril of a subject” Para 0039) and the source (102). Tsutsui teaches a gas tip (114) includes a gas receiving aperture (132, “An intranasal device (100) can further comprise a nozzle (114) that can comprise a nozzle pipe (130) which can be inserted or partially inserted into the nasal cavity or a nostril of a subject. The nozzle (114) can further comprise a nozzle hole (132), a removable or breakable cover (134), and a reservoir for a powdered therapeutic formulation (138).” Para 0039).
Regarding the remaining limitations of the claims, Tsutsui teaches the shape of the gas receiving aperture (132) “can be any of a number of shapes including but not limited to a circle, oval, triangle, rectangle, or combination thereof” (Para 0115). It is noted the shape of an oval would form the claimed “elongated opening”. The resultant effect of the shape of the gas receiving aperture is to provide conveyance points between the nose of the patient (via insertion of 114) and the source (102).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the shape of the gas receiving aperture of the modified Johnson, to be in the form of an oval – an elongate opening, as taught by Tsutsui to provide conveyance points between the nose of the patient (via insertion of 114) and the source (102).
As to Claims 28 and 49, the modified Johnson, specifically Payton teaches the at least one gas receiving aperture (25/30-32) and further a subsequent gas aperture (via 22 of 20) that is connected to the substantially hollow body/interior region (best seen Figures 3 and 4) and in fluid communication with the substantially hollow body/ interior region (best seen Figures 3 and 4) on the body (perimeter of 10) of the gas sampling tip (10).
The modified Johnson, specifically Payton teaches the configuration of a plurality of gas receiving apertures (30-32) oriented on the outer side surface (30-32 via 17 of 14) of the distal end portion (14) of the gas sampling tip (10), whereby there are two gas receiving apertures “pair of lateral passages 30 and the outlets 32” (Column 4, Lines 20-45) laterally spaced about the outer side surface (30-32 via 17 of 14) of the distal end portion (14) of the gas sampling tip (10).
Yet, does not expressly disclose the construction of “three gas receiving apertures evenly spaced about the distal end portion of the gas sampling tip”.
Tsutsui teaches a gas tip (114, “The throat (108) can comprise an external thread (112) for attachment of a nozzle (114).” Para 0036) which is removably connected (via 112, “an external thread (112)” Para 0036) to a source (102, “The intranasal delivery device (100) can comprise air source, which can be a flexible vial (102).” Para 0036) for the conveyance of gas between the nose of the patient (via insertion of 114, “a nozzle (114) that can comprise a nozzle pipe (130) which can be inserted or partially inserted into the nasal cavity or a nostril of a subject” Para 0039) and the source (102). Tsutsui teaches a gas tip (114) includes a gas receiving aperture (132, “An intranasal device (100) can further comprise a nozzle (114) that can comprise a nozzle pipe (130) which can be inserted or partially inserted into the nasal cavity or a nostril of a subject. The nozzle (114) can further comprise a nozzle hole (132), a removable or breakable cover (134), and a reservoir for a powdered therapeutic formulation (138).” Para 0039).
Regarding the remaining limitations of the claims, Tsutsui teaches number of the gas receiving aperture (132) can include “multiple holes that can emit a powdered therapeutic formulation as multiple streams that remain separate or that can combine into a single stream.” (Para 0115). The resultant effect of the number of gas receiving apertures does not affect the ability to convey gases to/from the nose of the patient (via insertion of 114).
In light of the relationship of the number of holes and the ability to convey gases to/from the nose of the patient (via insertion of 114), it would have been obvious to one having ordinary skill in the art to select the number of “three” gas receiving ports, since it has been held that discovering the optimum or workable ranges involves only routine skill in the art. Moreover, Applicant has not asserted the specific number of “three” provides a particular advantage, solves a stated problem, or serves a particular purpose, different from that of providing a conveyance point to/from the nose of the patient (via insertion of 114); thus, the use of the specific numerical value of “three” lacks criticality in its design. As the modified Johnson, specifically Payton considers “two” gas receiving aperture, and Tsutsui teaches “multiple holes”, the configuration of “three” is obvious to try choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success, whereby success would be defined by the ability to provide a conveyance point to/from the nose of the patient. Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the modified Johnson, as the construction of “three” would yield the predictable results of providing a conveyance point to/from the nose of the patient. Therefore, it would have been obvious to one having ordinary skill in the art to modify the number of gas receiving apertures of the modified Johnson to be “three” a known result effective variable suitable for providing a conveyance point to/from the nose of the patient.
As to Claim 29, the modified Johnson, specifically Tsutsui teaches the possibility of “three” gas receiving apertures were a known result effective variable.
Yet, does not expressly disclose the configuration of “each portion of the body located between the gas receiving apertures forms a flute, wherein the flutes are substantially evenly spaced around a circumference of the distal end portion of the gas sampling tip.”
Payton teaches an additional gas sampling tip (Figures 10-12) having a gas receiving aperture (via 24a) and a subsequent gas receiving aperture (via 41 of 20a) that is connected to the substantially hollow interior region (best seen Figure 12) and in fluid communication with the substantially hollow interior region (best seen Figure 12) on the body (perimeter of 10b) of the gas sampling tip (10b).
Regarding the remaining limitations of the claims, each portion of the body (perimeter of 10b) located between the gas receiving aperture (via 24a) and the subsequent gas receiving aperture (via 41 of 20a) forms a flute (45, “Means for providing auxiliary air, to alleviate feelings of claustrophobia, take the form of a plurality of external semi-cylindrically shaped grooves or passageways 45 formed in the outer surface of the conical end 42. The passageways 45 lead from the wide or large end of the conical surface 46 to the small end and permit the ingress of outside air. They perform the same purpose as the passageways 35 of the preceding embodiment. While four such semi-cylindrical grooves 45 are shown in the improved nosepiece 10b, more or less may be employed as determined desirable for the comfort and well being of the patient.” Column 5, Lines 20-40; “In addition, the auxiliary and optional air inlets 35 or 45, permit ingress of outside air, where desired, permitting the patient to breath "through" the nosepiece.” Column 6, Lines 35-55), wherein the flutes (“four such semi-cylindrical grooves 45”) are substantially evenly spaced around a circumference (46, “conical surface 46” Column 5, Lines 20-40) of the distal end portion (40, “In the modifications of the preferred embodiment of FIGS. 10-12, the nosepiece 10b is formed with a molded body 40 having, at its outer end, a right angle elbow lead-in section 41 defining the central passageway 20a therethrough.” Column 5, Lines 5-20) of the gas sampling tip (Figures 10-12). The resultant effect of the configuration of the flutes is the ability to for “the patient to breath "through" the nosepiece.” (Column 6, Lines 35-55) and “providing auxiliary air” (Column 5, Lines 20-40).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the construction of the body of the gas sampling tip of the modified Payton to include flutes as taught by the further modification of Payton to enable “the patient to breath "through" the nosepiece.”
Claims 31 and 51 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (2016/0345894) in view of Payton (4,660,555), as applied to Claims 25 and 43, and further in view of McComb (5,349,946).
As to Claims 31 and 51, the modified Johnson, specifically Johnson discloses a high flow respiratory gas delivery system (via 700, “Another example of a nasal mask to which the sampling apparatus of the instant application may be coupled is the Safe Sedate® 700 (“nasal mask”) depicted in FIG. 7. In embodiments, the nasal mask 700 may include a nose port 702, which has one or more exhaust holes 704. As illustrated, the nasal mask 700 may be strapped to a patient's face so that the mouth is clearly accessible. FIG. 7 further depicts an example of a sampling apparatus 200D (FIG. 2D) being connected to the nasal mask 700. In particular, the sampling apparatus 200D may include a first tubular member 202D and a second tubular member 210D, and the sampling apparatus 200D may draw exhaled breath to a systemic biomarker sampling device (such as device 750).” Para 0099; “Thus, the embodiment of sampling apparatus 200D in FIG. 2D is well-suited for connection to the Safe Sedate® nasal mask 700.” Para 0100) for conveying gas to the patient (via 702), whereby the high flow respiratory gas delivery system (via 700) is oriented on the patient with the gas sampling interface (200D), so that the gas sampling interface (200D) is configured to receive exhaled or expired gas from the patient (along 212D to 214D and 750, “FIGS. 2A-2D also depict a sampling return line 214A-214D. The sampling return line 214A-214D may extend from the respective joint member 204A-204D to a systemic biomarker monitor device (not shown). Moreover, the suction that draws exhaled breath from the first tubular member 202A-202D to the monitor device may also draw exhaled breath from the second tubular member 210A-210D by way of the joint member 204A-204D, which joins the first and second tubular members to the respective sampling return line 214A-214D. Thusly, exhaled breath may be sampled directly from a patient's mouth and nose in order to provide a more accurate assessment of the vital statistics of a patient under anesthesia.” Para 0077; a gas sampling tip (one of 206D/212D, “a cap (206A-206D), … a connector (212A-212D)” Paras 0056-0064) as connected to the gas sampling conduit (one of 202D/210D).
Yet, does not expressly disclose the operating flow rate of the high flow gas delivery system to provide “breathing gas, from a breathing apparatus, at a flow rate of between about 15 to about 150 L/min.”
McComb teaches conventional ventilation of gases to a patient are between “2 and 150 LPM” (Column 5, Lines 45-65), with a specific illustrated operational flow rate of “125 LPM” to provide sufficient ventilation to the patient (Column 5, Lines 45-65). As “125 LPM” is within the claimed value, the operational flow rate of “125 LPM” meets the limitation of the claims.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the operational flow rate of the high flow gas delivery system of the modified Johnson to operate between the claimed values, as taught by McComb to be a known operational pressure suitable for providing ventilation to a patient.
Claims 32 and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (2016/0345894) in view of Payton (4,660,555), as applied to Claims 25 and 43, and further in view of Cortez et al. (2008/0223375)
As to Claims 32 and 52, the modified Johnson, specifically Johnson discloses a high flow respiratory gas delivery system (via 700, “Another example of a nasal mask to which the sampling apparatus of the instant application may be coupled is the Safe Sedate® 700 (“nasal mask”) depicted in FIG. 7. In embodiments, the nasal mask 700 may include a nose port 702, which has one or more exhaust holes 704. As illustrated, the nasal mask 700 may be strapped to a patient's face so that the mouth is clearly accessible. FIG. 7 further depicts an example of a sampling apparatus 200D (FIG. 2D) being connected to the nasal mask 700. In particular, the sampling apparatus 200D may include a first tubular member 202D and a second tubular member 210D, and the sampling apparatus 200D may draw exhaled breath to a systemic biomarker sampling device (such as device 750).” Para 0099; “Thus, the embodiment of sampling apparatus 200D in FIG. 2D is well-suited for connection to the Safe Sedate® nasal mask 700.” Para 0100) for conveying gas to the patient (via 702), whereby the high flow respiratory gas delivery system (via 700) is oriented on the patient with the gas sampling interface (200D), so that the gas sampling interface (200D) is configured to receive exhaled or expired gas from the patient (along 212D to 214D and 750, “FIGS. 2A-2D also depict a sampling return line 214A-214D. The sampling return line 214A-214D may extend from the respective joint member 204A-204D to a systemic biomarker monitor device (not shown). Moreover, the suction that draws exhaled breath from the first tubular member 202A-202D to the monitor device may also draw exhaled breath from the second tubular member 210A-210D by way of the joint member 204A-204D, which joins the first and second tubular members to the respective sampling return line 214A-214D. Thusly, exhaled breath may be sampled directly from a patient's mouth and nose in order to provide a more accurate assessment of the vital statistics of a patient under anesthesia.” Para 0077; a gas sampling tip (one of 206D/212D, “a cap (206A-206D), … a connector (212A-212D)” Paras 0056-0064) as connected to the gas sampling conduit (one of 202D/210D).
Yet, does not expressly disclose the operating flow rate of the high flow gas delivery system to provide breathing gas for a “neonatal infant patient” having “a flow rate of about 2 L/min/kg”.
Cortez teaches “Starting flow rate of breathing gas with the inventive nasal cannula for a 2-4 Kg patient is between about 8 and about 10 liters per minute.” (Para 0053). As the claims require the units of “L/min/kg”, for a 2kg patient the flow rate would be 4-5 L/min/kg; whilst for a 4 kg patient the flow rate would be 2 to 2.5 L/min/kg. It should be noted a 4 kg patient is approximately 8.8 pounds and the average full term baby is between 2.5 kg and 4.5 kg. Thus, it appears Cortez teaches the specific flow rate for “a neonatal infant patient” as claimed.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the operational flow rate of the high flow gas delivery system of the modified Johnson to operate between the claimed values, as taught by Cortez to be a known operational pressure suitable for providing ventilation of a neonatal infant patient,
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 25, 28, 29, 43, 44, 49, and 50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-15 of U.S. Patent No. 11,964,104.
Although the claims at issue are not identical, they are not patentably distinct from each other because instant independent claims, Claims 25 and 43, are merely broader than the patent claim, Claim 12. It is clear all of the elements of the instant claims are found in the patent claims. The difference lies in the fact that the patent claims include many more elements and is thus much more specific. Thus, the invention of the patent claims is in effect a “species” of the “generic” invention of the instant claims. It has been held that the “generic” invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the instant claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Instant Application: 18/608,747
Patent: 11,964,104
25. (Currently Amended) A gas sampling interface for use with a high flow respiratory gas delivery system,
the gas sampling interface comprising:
a conduit comprising:
a first end in fluid communication fluidly connectable with a respiratory gas monitor; and
a second end comprising at least one inlet for receiving exhaled or expired breathing gases from a patient;
a gas sampling tip located at the second end of the conduit and comprising a substantially hollow body comprising at least one gas receiving aperture to receive gases exhaled or expired by a patient, wherein the gas receiving aperture is in fluid communication with the at least one inlet of the conduit, and
wherein the body of the tip further comprises a distal end portion comprising a distal end surface and an outer side surface.
1. A respiratory therapy system for delivery of high flow respiratory therapy to a patient and sampling exhaled or expired gases from the patient, wherein the respiratory therapy system comprises: a breathing apparatus comprising a patient interface and a breathing gas delivery tube connected to a gas source to deliver high flow breathing gas from the gas source via the breathing gas delivery tube to the patient through the patient interface, wherein the patient interface comprises a nasal cannula comprising first and second prongs that are at least partially received within nares of the patient during use to deliver the high flow breathing gas to the patient; and
a gas sampling interface comprising
a conduit comprising
a first end portion in fluid communication with a respiratory gas monitor
and
a second, distal end portion comprising at least one inlet for receiving exhaled or expired breathing gases from the patient, the second, distal end portion of the conduit of the gas sampling interface being configured to be selectively interchangeably positioned at or in each of a mouth and at least one of the nares of the patient while the first and second prongs are at least partially received within the nares of the patient such that the high flow breathing gas can be provided to the nares of the patient through the first and second prongs while the second, distal end portion of the conduit of the gas sampling interface is selectively repositioned.
AND
12. The respiratory therapy system according to claim 1, wherein the gas sampling interface further comprises a tip located at the second, distal end portion of the conduit, wherein the tip comprises a substantially hollow body comprising at least one gas receiving aperture to receive gases exhaled or expired by a patient, wherein the at least one gas receiving aperture is in fluid communication with the at least one inlet of the conduit, and wherein the substantially hollow body of the tip further comprises a distal end portion comprising a distal end surface and an outer side surface.
28. (Currently Amended) The gas sampling interface according to claim 25,
wherein the gas sampling tip comprises three gas receiving apertures evenly spaced around the distal end of the gas sampling tip.
14. The respiratory therapy system according to claim 12,
wherein the tip comprises at least three gas receiving apertures evenly spaced around the distal end portion of the substantially hollow body of the tip.
29. (Currently Amended) The gas sampling interface according to claim 28,
wherein each portion of the body located between the gas receiving apertures forms a flute,
wherein the flutes are substantially evenly spaced around a circumference of the distal end portion of the gas sampling tip.
15. The respiratory therapy system according to claim 14,
wherein each portion of the substantially hollow body located between the at least one gas receiving aperture forms a flute, wherein a plurality of flutes are substantially evenly spaced around a circumference of the distal end portion of the tip.
43. (Currently Amended) A gas sampling tip to removably connect to a distal end of a gas sampling conduit, wherein the gas sampling tip comprising:
a body comprising:
a substantially hollow interior region configured to be in fluid communication with an inlet of the gas sampling conduit when connected to the gas sampling conduit,
a distal end portion comprising a distal end surface and an outer side surface, and
at least one gas receiving aperture connected to the hollow interior region to receive gases exhaled or expired by a patient, and wherein the gas receiving aperture is in fluid communication with the substantially hollow interior region of the body.
1. A respiratory therapy system for delivery of high flow respiratory therapy to a patient and sampling exhaled or expired gases from the patient, wherein the respiratory therapy system comprises: a breathing apparatus comprising a patient interface and a breathing gas delivery tube connected to a gas source to deliver high flow breathing gas from the gas source via the breathing gas delivery tube to the patient through the patient interface, wherein the patient interface comprises a nasal cannula comprising first and second prongs that are at least partially received within nares of the patient during use to deliver the high flow breathing gas to the patient; and a gas sampling interface comprising a conduit comprising a first end portion in fluid communication with a respiratory gas monitor and a second, distal end portion comprising at least one inlet for receiving exhaled or expired breathing gases from the patient, the second, distal end portion of the conduit of the gas sampling interface being configured to be selectively interchangeably positioned at or in each of a mouth and at least one of the nares of the patient while the first and second prongs are at least partially received within the nares of the patient such that the high flow breathing gas can be provided to the nares of the patient through the first and second prongs while the second, distal end portion of the conduit of the gas sampling interface is selectively repositioned.
AND
12. The respiratory therapy system according to claim 1, wherein the gas sampling interface further comprises a tip located at the second, distal end portion of the conduit, wherein the tip comprises a substantially hollow body comprising at least one gas receiving aperture to receive gases exhaled or expired by a patient, wherein the at least one gas receiving aperture is in fluid communication with the at least one inlet of the conduit, and
wherein the substantially hollow body of the tip further comprises a distal end portion comprising a distal end surface and an outer side surface.
44. (Currently Amended) The gas sampling tip according to claim 43,
wherein the at least one gas receiving aperture is formed both in the distal end surface and outer side surface such that the gas receiving aperture extends from the distal end surface and along the outer side surface.
13. The respiratory therapy system of claim 12,
wherein the at least one gas receiving aperture is formed both in the distal end surface and an outer circumferential side surface such that the at least one gas receiving aperture extends from the distal end surface and along the outer side surface.
49. (Currently Amended) The gas sampling tip according to claim 43,
wherein the gas sampling tip comprises three gas receiving apertures evenly spaced around the distal end of the sampling tip.
14. The respiratory therapy system according to claim 12,
wherein the tip comprises at least three gas receiving apertures evenly spaced around the distal end portion of the substantially hollow body of the tip.
50. (Currently Amended) The gas sampling tip according to claim 43,
wherein each portion of the body located between the gas receiving apertures forms a flute, wherein the flutes are substantially evenly spaced around a circumference of the distal end portion of the gas sampling tip.
15. The respiratory therapy system according to claim 14,
wherein each portion of the substantially hollow body located between the at least one gas receiving aperture forms a flute, wherein a plurality of flutes are substantially evenly spaced around a circumference of the distal end portion of the tip.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNETTE F DIXON whose telephone number is (571)272-3392. The examiner can normally be reached M-F 9-5 EST with flexible hours.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785
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