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 .
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No.15/595,990 and 17/215,589, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Specifically, the parent applications fail to provide support for two exhalation manifolds, each of the two exhalation manifolds having a plurality of holes for expelling gases.
As stated above, claims 1-14 and 17-20 include certain subject matter that is not supported by the parent applications. The examiner notes that individual claims have their own priority dates, and priority does not belong to individual limitations within a claim. (see. e.g., Santarus, Inc. v. Par Pharmaceutical, Inc., 694 F.3d 1344 (Fed. Cir. 2012)). Therefore, each of the claims of the current application (including each of the limitations of each of the claims) has a priority date of 12/31/22 which is the filing date of the current application.
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.
Claim Objections
Claim 15 is objected to because of the following informalities:
Add –for—before “sealing”. Appropriate correction is required.
Response to Arguments
Applicant's arguments filed 2/26/26 have been fully considered but they are not persuasive.
Regarding claim 15, Applicant argues against the combination of Rummery with Beber. Applicant argues that Beber does not teach a planar wall. The examiner notes that the claim language reads “flattened side” and the examiner considers that the side of Beber shows a flattened formation. Applicant argues that Beber it not be obvious to combine Beber with Rummery since Beber is directed to a nasal filter insert and Rummery is a nasal interface pillow. The examiner respectfully disagrees since Beber is concerned with a fit to the nostril and therefore would reasonably be considered to solve the same issues as Rummery.
Regarding claim 17, the arguments are moot as a new reference has been applied to teach the precisely sized holes.
Regarding claim 1, Applicant argues that the flow of gas is not substantially linear in Rummery. However, the examiner respectfully disagrees as even in the annotated figure shown on page 8 of the remarks, the flow is substantially linear. Applicant does not claim that the flow is direct from the base without any angular feature to the flow.
Applicant further argues that the Beber reference is not flattened on one side and that Beber is not from the same field of endeavor. However, as argued above for claim 15, the claim language reads “flattened side” and the examiner considers that the side of Beber shows a flattened formation. Applicant argues that Beber it not be obvious to combine Beber with Rummery since Beber is directed to a nasal filter insert and Rummery is a nasal interface pillow. The examiner respectfully disagrees since Beber is concerned with a fit to the nostril and therefore would reasonably be considered to solve the same issues as Rummery.
Regarding claim 9, Applicant argues that the body is made from a soft pliable material and the exhaust manifolds are made from a stiffer material and that the exhaust manifolds are affixed to openings in the body and that these features are not taught by the prior art. However, the examiner notes that Barlow teaches exhaust manifold located in a body which is made of a soft, flexible material (paragraph 32). It appears that the exhaust manifolds are located in the body which would appear to need openings to hold the exhaust manifolds. However, the examiner has added the reference Henry to teach the exhaust manifolds affixed in openings. Further, Henry also teaches that the exhaust manifolds may be located in a cushion which is made of a soft, pliable material. The examiner also notes the primary reference, Rummery, teaches that when exhaust manifolds are used in flexible material and more rigid exhaust insert should be used. (paragraph 165) Therefore, the examiner has considered that the combination of references teaches an exhaust manifold made of a stiffer material than the body portion.
Applicant further argues that since Rummery ‘918 teaches using the vent in a body portion which is also rigid that this teaches away from making the body and the nasal interface out of a soft material and making vents out of a stiffer material. The examiner disagrees as Rummery ‘918 was merely cited to teach using a polycarbonate material for the vent.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over Rummery et al (US 2010/0229868), hereinafter Rummery, in view of Barlow (US 2012/0138060), hereinafter Barlow, and further in view of Beber (US Pat. No. 3,145,711), hereinafter Beber.
Regarding claim 1, Rummery teaches a nasal airway interface apparatus (Fig. 4) comprising:
a body section (Fig. 4: 6, paragraph 152) having a gas delivery connector for receiving a gas from a source of gas (Figs. 17f: aperture 324, paragraph 152), two nasal interfaces (Fig. 4: 8, paragraph 151), and strap connectors for attaching a head strap (Fig. 4: 12. Paragraph 152);
each nasal interface of the two nasal interfaces extends from the body section (Fig. 4), has an insertion tip that has an opening that is distal from the body section (Fig. 4, paragraph 151, each nasal pillow is configured to be inserted into the patient’s nasal passageway);
and
whereas gas flows in a substantially linear path from the gas delivery connector, through the body section, through the two nasal interfaces and out the openings. (Fig. 4, the gas would flow in through the opening at the bottom and out through the openings in the nasal interfaces)
wherein the body section, including the two nasal interfaces, comprises a soft, pliable material. (Paragraph 154, flexible base, paragraph 155)
Rummery does not teach two exhalation manifolds, each of the two exhalation manifolds having a plurality of holes for expelling exhalation gases.
However, Barlow teaches a nasal interface having two exhalation manifolds (Figs. 1-3:40), each of the two exhalation manifolds having a plurality of holes for expelling exhalation gases. (paragraph 33, a plurality of holes 45)
It would have been obvious to a person of ordinary skill in the art to have included the two vents in the nasal interface as taught by Barlow to allow for CO2 gas washout. The location near the nasal inserts would allow for easier gas washout.)
Rummery is silent as to wherein each of the two exhalation manifolds is made from a material that is harder than the soft, pliable material.
However, Rummery teaches that when a valve insert is used in a flexible material a solid insert should be used. (Paragraph 165)
Since Barlow teaches that the exhalation manifolds may be located in the soft body (Paragraph 32, nasal seal is a soft flexible body) and Rummery teaches that when using exhalation vents in a soft body a solid insert should be used (paragraph 165), the combination of Rummer and Barlow teaches wherein each of the two exhalation manifolds is made from a material that is harder than the soft pliable material.
Therefore, it would have been obvious to a person of ordinary skill in the art to have the exhalation manifold made of a material that is harder than the soft pliable material in order to avoid collapsing or closing of the vent holes.
Rummery does not teach the nasal inserts comprising a flattened side for sealing against a septum of a nose.
However, Beber teaches nasal inserts (Figs. 1-3) wherein the insertion area is flattened on side for sealing against a septum of a nose. (Fig. 2, Col. 1: lines 45-50 and lines 55-60)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have provided Rummery with the flattened side as taught by Beber so that the nasal inserts conform to the cross-sectional configuration of the nasal passage. (Col. 1: lines 47-50)
Regarding claim 2, Rummery in view of Barlow and Beber teaches the nasal airway interface apparatus of claim 1, and Rummery further teaches wherein each of the two nasal interfaces have insertion bulges that bulge outward for sealing against a respective nostril of the nose. (Fig. 4: 8a, paragraph 151, the conical portion 8 includes a sealing surface or zone 8a, that is configured to engage the nare of the patient and form a seal)
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Rummery in view of Barlow and Beber, and further in view of Kotler (US 2009/0248058), hereinafter Kotler.
Regarding claim 4, Rummery in view of Barlow and Beber teaches the nasal airway interface apparatus of claim 1, and Rummery further teaches wherein the soft, pliable material is silicone. (paragraphs 154, 155) but does not teach it is a medical grade silicone.
However, Kotler teaches a nasal Insert device (Fig. 1, Abstract) which is made from medical grade silicone. (paragraph 41)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have provided Rummery with the medical grade silicone as taught by Kotler since the courts have held that the selection of a known material based on its suitability for its intended used supported a prima facie obviousness determination. See In re Leshin, MPEP 2144.07)
Regarding claim 5, Rummery in view of Barlow and Beber teaches the nasal airway interface apparatus of claim 1, and Rummery further teaches wherein the soft pliable material is silicone. (paragraph 154) but does not teach wherein the soft, pliable material is type IV silicon.
However, Kotler teaches a nasal Insert device (Fig. 1, Abstract) which is made from medical grade silicone. (paragraph 41, the examiner notes that type IV silicone is a type of medical grade silicone as per Applicant’s specification paragraph 75)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have provided Rummery with the type 1V silicone or medical grade silicone as taught by Kotler since the courts have held that the selection of a known material based on its suitability for its intended used supported a prima facie obviousness determination. See In re Leshin, MPEP 2144.07)
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Rummery in view of Barlow and Beber and further in view of Rummery et al (US 2013/0152918), hereinafter Rummery ‘918.
Regarding claim 7, Rummery in view of Barlow and Beber teaches the nasal airway interface apparatus of claim 1, but is silent as to the material of the vent.
However, Rummery ‘918 teaches a mask system wherein the material of the vent is polycarbonate. (Paragraph 102, the vent may be constructed of a rigid or semi-rigid material such as polypropylene or polycarbonate.
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have provided Rummery with the vent made of polycarbonate as taught by Rummery ‘918 since the courts have held that the selection of a known material based on its suitability for its intended used supported a prima facie obviousness determination. See In re Leshin, MPEP 2144.07)
Regarding claim 8, Rummery in view of Barlow and Beber teaches the nasal airway interface apparatus of claim 1, but does not teach wherein the material is polypropylene.
However, Rummery ‘918 teaches a mask system wherein the material of the vent is polypropylene. (Paragraph 102, the vent may be constructed of a rigid or semi-rigid material such as polypropylene or polycarbonate.
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have provided Rummery with the vent made of polypropylene as taught by Rummery ‘918 since the courts have held that the selection of a known material based on its suitability for its intended used supported a prima facie obviousness determination. See In re Leshin, MPEP 2144.07)
Claim 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Rummery et al (US 2010/0229868), hereinafter Rummery, in view of Barlow (US 2012/0138060), hereinafter Barlow, and further in view of Beber (US Pat. No. 3,145,711), hereinafter Beber, and further in view of Henry et al (US 2016/0296720), hereinafter Henry.
Regarding claim 9, Rummery teaches a nasal airway interface apparatus (Fig. 4) comprising:
a body section (Fig. 4: 6, paragraph 152) made of a soft, pliable material. (Paragraph 154, flexible base, paragraph 155)
and a gas delivery connector for receiving a gas from a source of gas (Figs. 17f: aperture 324, paragraph 152), two nasal interfaces (Fig. 4: 8, paragraph 151), and means for holding the body section; (Fig. 4: 12. Paragraph 152);
each nasal interface of the two nasal interfaces extends from the body section (Fig. 4, conical section 8 extends from body 6), has an insertion tip that has an opening at and end that is distal from the body section (Fig. 4, paragraph 151, each nasal pillow is configured to be inserted into the patient’s nasal passageway);
whereas gas flows in a substantially linear path from the gas delivery connector, through the body section, through the two nasal interfaces and out the openings. (Fig. 4, the gas would flow in through the opening at the bottom and out through the openings in the nasal interfaces)
Rummery does not teach two exhalation manifolds made of a stiff plastic material, each of the two exhalation manifolds having a plurality of holes for expelling exhalation gases.
However, Barlow teaches a nasal interface having two exhalation manifolds (Figs. 1-3:40), each of the two exhalation manifolds having a plurality of holes for expelling exhalation gases. (paragraph 33, a plurality of holes 45)
Barlow appears to show the two exhalation manifolds affixed to openings in the body. (Fig. 1-3: vent 40 is affixed in body 10)
It would have been obvious to a person of ordinary skill in the art to have included the two exhalation manifolds in the nasal interface as taught by Barlow to allow for CO2 gas washout. The location near the nasal inserts would allow for easier gas washout.)
Rummery in view of Barlow is silent as to the material of the vent.
However, Rummery ‘918 teaches a mask system wherein the material of the vent is polycarbonate or polycarbonate. (Paragraph 102, the vent may be constructed of a rigid or semi-rigid material such as polypropylene or polycarbonate.
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have provided Rummery with the vent made of rigid or semi-rigid material as taught by Rummery ‘918 since the courts have held that the selection of a known material based on its suitability for its intended used supported a prima facie obviousness determination. See In re Leshin, MPEP 2144.07)
Rummery does not teach the nasal inserts comprising a flattened side for sealing against a septum of a nose.
However, Beber teaches nasal inserts (Figs. 1-3) wherein the insertion area is flattened on side for sealing against a septum of a nose. (Fig. 2, Col. 1: lines 45-50 and lines 55-60)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have provided Rummery with the flattened side as taught by Beber so that the nasal inserts conform to the cross-sectional configuration of the nasal passage. (Col. 1: lines 47-50)
If Applicant does not agree that Barlow shows the exhalation manifolds affixed to openings in the body, then Henry teaches a patient interface device (Abstract) with vents may be installed into a vent orifice located on a cushion member/plenum chamber. (paragraph 867)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have modified the nasal interface of Rummer in view of Barlow to include openings for the vents to allow installation of the vents into the nasal interface.
Regarding claim 10, Rummery in view of Barlow, Beber, Rummery ‘918 and Henry teaches the nasal airway interface apparatus of claim 9, and Rummery further teaches wherein each of the two nasal interfaces have insertion bulges that bulge outward for sealing against a respective nostril of the nose. (Fig. 4: 8a, paragraph 151, the conical portion 8 includes a sealing surface or zone 8a, that is configured to engage the nare of the patient and form a seal)
Claims 11and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Rummery et al (US 2010/0229868), hereinafter Rummery, in view of Barlow (US 2012/0138060), hereinafter Barlow, and further in view of Beber (US Pat. No. 3,145,711), hereinafter Beber, and further in view of Henry et al (US 2016/0296720), hereinafter Henry, and further in view of Kotler.
Regarding claim 11, Rummery in view of Barlow, Beber, and Henry teaches the nasal airway interface apparatus of claim 9, and Rummery further teaches wherein the body section, including the two nasal interfaces, comprises a soft, pliable material. (Paragraph 154, flexible base, paragraph 155)
Rummery does not state if the silicone is medical grade silicone.
However, Kotler teaches a nasal Insert device (Fig. 1, Abstract) which is made from medical grade silicone. (paragraph 41)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have provided Rummery with the medical grade silicone as taught by Kotler since the courts have held that the selection of a known material based on its suitability for its intended used supported a prima facie obviousness determination. See In re Leshin, MPEP 2144.07)
Regarding claim 12, Rummery in view of Barlow and Beber teaches the nasal airway interface apparatus of claim 9, and Rummery further teaches wherein the soft pliable material is silicone. (paragraph 154) but does not teach wherein the soft, pliable material is type IV silicon.
However, Kotler teaches a nasal Insert device (Fig. 1, Abstract) which is made from medical grade silicone. (paragraph 41, the examiner notes that type IV silicone is a type of medical grade silicone as per Applicant’s specification paragraph 75)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have provided Rummery with the type 1V silicone or medical grade silicone as taught by Kotler since the courts have held that the selection of a known material based on its suitability for its intended used supported a prima facie obviousness determination. See In re Leshin, MPEP 2144.07)
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Rummery in view of Barlow, further in view of Beber, further in view of Henry, and further in view of Rummery ‘918.
Regarding claim 13, Rummery in view of Barlow and Beber teaches the nasal airway interface apparatus of claim 9, but is silent as to the material of the vent.
However, Rummery ‘918 teaches a mask system wherein the material of the vent is polycarbonate. (Paragraph 102, the vent may be constructed of a rigid or semi-rigid material such as polypropylene or polycarbonate.
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have provided Rummery with the vent made of polycarbonate as taught by Rummery ‘918 since the courts have held that the selection of a known material based on its suitability for its intended used supported a prima facie obviousness determination. See In re Leshin, MPEP 2144.07)
Regarding claim 14, Rummery in view of Barlow and Beber teaches the nasal airway interface apparatus of claim 9, but does not teach wherein the material is polypropylene.
However, Rummery ‘918 teaches a mask system wherein the material of the vent is polypropylene. (Paragraph 102, the vent may be constructed of a rigid or semi-rigid material such as polypropylene or polycarbonate.
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have provided Rummery with the vent made of polypropylene as taught by Rummery ‘918 since the courts have held that the selection of a known material based on its suitability for its intended used supported a prima facie obviousness determination. See In re Leshin, MPEP 2144.07)
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Rummery et al (US 2010/0229868), hereinafter Rummery, in view of Barlow (US 2012/0138060), hereinafter Barlow, and further in view of Beber (US Pat. No. 3,145,711), hereinafter Beber.
Regarding claim 15, Rummery teaches a method of delivering positive airway pressure to a user (Fig. 4, paragraph 152), the method comprising:
inserting an insertion tip (Fig. 4: top of conical sections 8) of each of two nasal interfaces into a respective nostril of the user(Fig. 4: 8, paragraph 151, each nasal pillow is configured to be inserted into the patient’s nasal passageway) until an insertion bulge of each of the two nasal interfaces abut an outer edge of respective nostrils of the user, (Fig. 4: 8a, paragraph 151, the conical portion 8 includes a sealing surface or zone 8a, that is configured to engage the nare of the patient and form a seal)
each of the two nasal interfaces extending into the respective nostril of the user (paragraph 151, each nasal pillow is configured to be inserted into the patient’s nasal passageway) and each of the two nasal interfaces connected to a body section (Fig. 4: nasal interfaces 8 connected to body 6);
the insertion bulge of each insertion tip sealing against an edge of the respective nostrils of the user; (Fig. 4: 8a, paragraph 151, the conical portion 8 includes a sealing surface or zone 8a, that is configured to engage the nare of the patient and form a seal)
and
during inhalation, gas from a gas delivery connector flowing through the body section and through the two nasal interfaces and into the respective nostrils of the user, thereby providing positive airway pressure to the user. (paragraph 152, a supply of air is delivered through aperture 324, paragraph 164, paragraph 153, breathable gas inside body 6, Fig. 4 the gas flows through the opening at the bottom and through conical portions 8 to the user)
but does not teach wherein a flattened side of each of the two nasal interfaces sealing against a septum of a nose of the respective nostrils.
However, Beber teaches nasal inserts (Figs. 1-3) wherein the insertion area is flattened on side for sealing against a septum of a nose. (Fig. 2, Col. 1: lines 45-50 and lines 55-60)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have provided Rummery with the flattened side as taught by Beber so that the nasal inserts conform to the cross-sectional configuration of the nasal passage. (Col. 1: lines 47-50)
Claims 17and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Rummery in view of Barlow and Beber, and further in view of Henry et al (US 2016/0296720), hereinafter Henry.
Regarding claim 17, Rummery teaches the method of claim 15, wherein the body section (Fig. 4: 6), including the two nasal interfaces, (Fig. 4: 8) comprises a soft, pliable material (paragraph 154, paragraph 155, the interface structure 32 may be formed in one piece)
and wherein during exhalation, exhalation gas from the user flowing through the body section and exiting through exhalation manifolds. (Rummery teaches that the manifold may be modified to include a vent having a plurality of vent holes, paragraph 164. Rummery also teaches that the vent may be located in the flexible elbow, paragraph 165)
Rummery does not teach multiple exhalation manifolds, the exhalation manifolds made of a stiffer plastic material with precisely sized holes.
However, Henry et al teaches a patient interface made of soft flexible material (Paragraph 837, the patient mask includes a nasal mask, full face mask or nasal pillows) exhalation gas from the user flowing through the body section and exiting through exhalation manifolds (Paragraph 832, patient interface 3100 may include a vent constructed and arranged to allow for the washout of exhaled air, paragraph 834, preferably 2 vents), the exhalation manifolds made of a stiffer plastic material (paragraph 842, provides a semi-rigid woven structure, paragraph 868, maybe be made with a fiber reinforced polymer paragraph 865, vents may be located in the seal forming structure 3100, paragraph 460 plenum chamber is made of material such as silicone), with precisely sized holes. (Paragraph 833, may be micro holes defined in a substrate of a semi-permeable material using a laser drill)
It would have been obvious to a person of ordinary skill in the art to have modified Rummery to include multiple exhalation manifolds with precisely sized holes to increase control over the air flow rate and the air diffusion pattern. (paragraph 833)
Claims 19 is rejected under 35 U.S.C. 103 as being unpatentable over Rummery in view of Henry, and further in view of Kotler (US 2009/0248058), hereinafter Kotler.
Regarding claim 19, Rummery teaches the method of claim 17, and further teaches wherein the soft, pliable material is silicone (paragraphs 154, 155) but does not teach it is a medical grade silicone.
However, Kotler teaches a nasal Insert device (Fig. 1, Abstract) which is made from medical grade silicone. (paragraph 41)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have provided Rummery with the medical grade silicone as taught by Kotler since the courts have held that the selection of a known material based on its suitability for its intended used supported a prima facie obviousness determination. See In re Leshin, MPEP 2144.07)
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Rummery in view of Henry et al (US 2016/0296720), hereinafter Henry, and further in view of Ng et al (US 2009/0050156), hereinafter Ng.
Regarding claim 20, Rummery in view of Henry teaches the method of claim 17, but does not teach wherein each of the exhalation manifolds are made from a material selected from a group consisting of polycarbonate and polypropylene.
However, Ng teaches exhalation manifolds provided in the manifold (Fig. 2-3-2) which may be provided in the manifold (paragraph 134) which may be made of polypropylene or polycarbonate. (paragraph 21)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have provided Rummery with the exhalation manifold made from a material selected from polypropylene or polycarbonate since the courts have held that the selection of a known material based on its suitability for its intended used supported a prima facie obviousness determination. See In re Leshin, MPEP 2144.07)
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
/MARGARET M LUARCA/Primary Examiner, Art Unit 3785