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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, recites “the airway lumen”. It is unclear if this is the same lumen recited earlier in the claim (“a lumen”) or if it is another lumen.
Claims 2 and 3 recite “the inner lumen”. It is unclear if this is the same lumen recited earlier in the claim 1 (“a lumen”) or if it is another lumen (“the airway lumen” from claim 1).
Regarding claim 2, it is unclear if “foldable fins”, “fenestrations” and “a fluid path” are the same or in addition to those recited in claim 1.
Regarding claim 3, it is unclear if “lattice structure”, “fenestrations” and “a fluid path” are the same or in addition to those recited in claim 1.
Claim 9 recites “the self-expanding structure”. There is no antecedent basis for this claimed limitation.
Claim 11 recites “an expandable proximal end”. This is unclear as the device has an expandable distal end (see claim 1). For purposes of examination this has been interpreted as an expandable distal end. Further claim 11 recites additional features that were previously recited in claim 1 including “a distal end” “fins” “lattice structure” “alternate paths”. It is unclear if applicant is referring back to those limitations recited in claim 1 or if applicant is claiming new limitations.
All dependent claims inherit the rejections from the claims from which they depend.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 8, 9, 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by De Silva et al. (US 2008/0053458 A1)
Regarding Claim 1, De Silva discloses an airway device (400, figures 4a-4b) comprising an elongated body forming a lumen (410, 420 forms a lumen therewithin), the elongated body having a proximal end (a proximal end at 440) to be positioned outside of a patient during use [0012] and a distal end (a distal end at 422 to be inserted into a patient airway during use [0038], the elongated body having a distal expandable portion (420; see figures 4a-4b) configured to be positioned in the pharyngeal segment of a patient airway [0002]-[0003] which when the distal expandable portion expands in the pharynx a structure is deployed stenting open of soft tissues increasing the luminal diameter of the airway and providing an alternate path for airflow [0003], the alternate path for airflow comprising the airway lumen and/or fluid paths provided by fin structures, lattice structures, or fenestrations (420b) [0024].
Regarding Claim 2, De Silva further discloses wherein the expandable portion comprises foldable fins (420b) and traverse openings or fenestrations (as shown in figure 4b between 420b) forming a fluid path between the inner lumen and exterior of the airway device (see figure 4b).
Regarding Claim 8, De Silva further discloses a central introducer (420a).
Regarding Claim 9, De Silva further discloses wherein the central introducer (420a) is axially rigid and is configured to retain the self-expanding structure in a collapsed state until deployed [0034].
Regarding Claim 11, De Silva further discloses: A method for inserting the airway device of claim 1 (see claim 1 above) comprising of advancing a distal end of an airway device through a nostril opening or an oral cavity into a patient airway and caudally into the pharynx [0038] [0003], the airway device having an expandable proximal end (interpreted as distal end, see figures 4a-4b) in a collapsed configuration during insertion [0034], wherein the collapsed configuration is reversibly retained by an introducer, mesh, filament (420a), cord, or string, expanding the expandable proximal end in the pharynx [0003] [0034] or releasing the retention of the collapsed state thereby deploying stenting fins or a lattice structure increasing the luminal diameter of the airway device and providing alternate paths for airflow (see figure 4b; [0024]).
Claim(s) 1, 6 and 12-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barodka (US 2012/0118286 A1)
Regarding Claim 1, Barodka discloses an airway device (a nasal airway management device 10, Para [0027], Fig.1) comprising an elongated body forming a lumen (a hollow flexible tube 12 defining a lumen, Para [0027], Fig.1, the tube 12 has an elongated body), the elongated body having a proximal end (a proximal end 18, Para [0027], Fig.1) to be positioned outside of a patient during use (Fig.3, show the proximal end 18 positioned outside the patient during use) and a distal end (a distal end 20, Para [0027], Fig.1) to be inserted into a patient airway during use (Fig.3, show the distal end inserted into the patient airway), the elongated body having a distal expandable portion (An inflatable supraglottic laryngeal cuff 16 may be attached at or near the distal end 20 of the tube 12, Para [0027], Fig.2) configured to be positioned in the pharyngeal segment of a patient airway (Fig.3 show the cuff 16 positioned in the laryngopharynx or LP) which when the distal expandable portion expands in the pharynx a structure is deployed stenting open of soft tissues increasing the luminal diameter of the airway and providing an alternate path for airflow (The inflatable cuff 16 defines an opening 26 fluidly coupled with the lumen of the tube 12 to allow passage of air or other gaseous substance, Para [0030], Fig.2, Fig.4 Show the inflatable cuff 16 expanded in the pharynx region making an opening through the tissues by increasing the diameter of the airway), the alternate path for airflow comprising the airway lumen and/or fluid paths provided by fin structures, lattice structures, or fenestrations (The inflatable cuff 16 defines an opening 26 fluidly coupled with the lumen of the tube 12 to allow passage of air or other gaseous substance, Para [0030], Fig.2 show the airflow supplied by the opening 26 or fenestration).
Regarding Claim 6, Barodka discloses the airway device of claim 1, wherein the airway device is made of a polymer material (The tube 12 may be formed from a variety of suitable materials such as, for example but not limited to, polyvinylchloride or PVC, although other materials are possible so long as they are body tolerated and constructed to provide enough rigidity to prevent collapse, twisting, kinking and/or buckling of the tube in the nasal cavity and in the pharynx, Para [0028], The outer sleeve 14 and inflatable cuff 16 may include thin, flexible and compliant material such as, for example, PVC or polyurethane, although other materials are possible, Para [0030]).
Regarding Claim 12, Barodka discloses an airway device (a nasal airway management device 10, Para [0027], Fig.1) comprising an elongated body forming a lumen (a hollow flexible tube 12 defining a lumen, Para [0027], Fig.1, the tube 12 has an elongated body), the elongated body having a proximal end (a proximal end 18, Para [0027], Fig.1) to be positioned outside of a patient during use (Fig.3, show the proximal end 18 positioned outside the patient during use) and a distal end (a distal end 20, Para [0027], Fig.1) to be inserted into a patient airway during use (Fig.3, show the distal end inserted into the patient airway), the elongated body having a distal expandable portion (An inflatable supraglottic laryngeal cuff 16 may be attached at or near the distal end 20 of the tube 12, Para [0027], Fig.2) configured to be positioned in the pharyngeal segment of the patient airway (Fig.3 show the cuff 16 positioned in the laryngopharynx or LP) which when the distal expandable portion is expanded in the pharynx a structure is deployed stenting open of soft tissues increasing the luminal diameter of the airway (Fig.4, Show the inflatable cuff 16 expanded in the pharynx region making an opening through the tissues by increasing the diameter of the airway) and providing an alternate path for airflow (The inflatable cuff 16 defines an opening 26 fluidly coupled with the lumen of the tube 12 to allow passage of air or other gaseous substance, Para [0030], Fig.2), the alternate path for airflow comprising the airway device lumen and/or fluid paths provided by fin structures, lattice structures, or fenestrations( (The inflatable cuff 16 defines an opening 26 fluidly coupled with the lumen of the tube 12 to allow passage of air or other gaseous substance, Para [0030], Fig.2, the airflow supplied by the opening or fenestration).
Regarding Claim 13, Barodka discloses the airway device of claim 12, wherein the airway device is configured as a nasopharyngeal airway (NPA)(The tube is configured to be expanded radially after insertion through a patient's nasopharyngeal passageway, Abstract).
Regarding Claim 14, Barodka discloses the airway device of claim 12, wherein the airway device is configured as an oral airway (OA) (the device of Barodka is structurally capable of being used as an oral airway, see Fig.3).
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.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barodka (US 2012/0118286).
Regarding Claim 7, Barodka discloses the airway device of claim 1, wherein the distal most portion is a beveled tip (The deflated cuff 16 may define, for example, a round, smooth elongated tip with a gradually increasing diameter to facilitate atraumatic insertion of the device 10, Para [0030], the tip is at distal end, Fig.1).
Barodka does not explicitly disclose wherein the distal most 0.2 cm to 5 cm is a beveled tip. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the beveled tip to be 0.2 cm to 5 cm in length, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Barodka would not operate differently with the claimed dimensions and the device would function appropriately. Further, applicant places no criticality on the range claimed, indicating simply that the beveled tip “can” be within the claimed ranges [0054].
Claim(s) 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barodka (US 2012/0118286) in view of Renner et al. (US 11,116,950 B2).
Regarding Claim 3, Barodka discloses the airway device of claim 1, wherein the expandable portion comprises a collapsible and expanding structure (Both outer sleeve 14 and cuff 16 are shown in a deflated state in Fig.1, In Fig.2, both the outer sleeve 14 and cuff 16 are shown in an inflated state, Para [0027], so the cuff and sleeve 14 are collapsible and expanding structure) with fenestrations forming a fluid path between the inner lumen and exterior of the airway device (The inflatable cuff 16 defines an opening 26 fluidly coupled with the lumen of the tube 12 to allow passage of air or other gaseous substance, Para [0030], Fig.2 show the airflow supplied by the transverse opening 26 or fenestration).
Barodka fails to explicitly disclose a self-expanding lattice structure.
Renner teaches a device with a self-expanding lattice structure (Fig.3A show braided lattice structure, the stent self-expands and positions itself in the nasal passage, Col.9, Lns 2-3).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Barodka with the teaching of Renner for the purpose of allowing passage of air (Barodka, Para [0030]) and as an alternate means of expanding the device of Barodka.
Regarding Claim 4, Barodka discloses the airway device of claim 1. Barodka fails to explicitly disclose the airway device, wherein the airway device is 8 cm to 30 cm in length, with an non-expanded outer diameter ranging from 0.4 cm to 5 cm, and a non-expanded inner diameter of 0.2 cm to 3 cm.
Renner teaches a device, wherein the airway device (stent, Abstract) is 8 cm to 30 cm in length (a length in the range of 25 mm to 120 mm that is between 2.5 cm to 12 cm, Abstract), with an non-expanded outer diameter ranging from 0.4 cm to 5 cm (The support body can be provided with diameters 4 to 20 mm, Col.3, Lns 5-6, that is between 0.4 cm to 2 cm, the stent consists of a braided tubular support body, Abstract), and a non-expanded inner diameter of 0.2 cm to 3 cm (The support body can be provided with diameters 4 to 20 mm, Col.3, Lns 5-6, that is between 0.4 cm to 2 cm, the inner diameter can be adjusted between 0.4 cm to 2 cm, the stent consists of a braided tubular support body, Abstract).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Barodka with the teaching of Renner for the purpose of having an appropriately sized structure to fit into the nasal passage (col. 3, lines 3-11).
Regarding Claim 5, Barodka discloses the airway device of claim 1. Barodka fails to explicitly disclose a device, wherein the distal expandable portion is 2 cm to 10 cm in length and an expanded outer diameter of 1 cm to 6 cm.
Renner teaches a device, wherein the distal expandable portion is 2 cm to 10 cm in length (The fixation section 3 has a length L2 of about 10 to 25 mm, Col.5, Lns 54-55, so that is between 1 cm to 2.5 cm, Fig.3A) and an expanded outer diameter of 1 cm to 6 cm (The ball-shaped widened section should have a diameter of at least 10 mm, preferably 12 mm and particularly 13 mm in order to obtain an efficient widening of the nasal alars, A maximal diameter of 20 mm, Col.8, Lns 21-26, the diameter is between 1 cm to 2 cm).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Barodka with the teaching of Renner for the purpose of having an appropriately sized structure to fit into the nasal passage (col. 3, lines 3-11).
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barodka (US 2012/0118286) in view of view of Mahr et al. (US 10,492,932).
Regarding Claim 8, Barodka discloses the airway device of claim 1. Barodka fails to explicitly disclose a device comprising a central introducer.
Mahr teaches a device comprising a central introducer (To insert the stent into the cavity, organ duct and/or vessel, the stent is inserted into the tube 14 and compressed, Col.6, Lns 53-55, Fig.4, By withdrawing the tube 14, the stent 10 is released, and self-expands to its pre-impressed size. This prevents the collapse of the pharynx and the closing of the air passages, Col.7, Lns 8-11, tube 14 act as the central introducer).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Barodka with the teaching of Mahr for the purpose of preventing the collapse of the pharynx and the closing of the air passage (Mahr: '932, Col.7, Lns 10-11).
Regarding Claim 9, modified Barodka discloses the airway device of claim 8. Barodka as modified by Mahr further discloses the central introducer is axially rigid and is configured to retain the self-expanding structure in a collapsed state until deployed. Mahr: The tube 14 may be made preferably of a plastic polymer, for example a PTFE, PVC, PE, PU, silicon or Teflon tube, or be a catheter, (Col.6, Lns 63-65, Fig.4, PU or polyurethane is a plastic material that can make tube 14 axially rigid) and is configured to retain the self-expanding structure in a collapsed state until deployed (To insert the stent into the cavity, organ duct and/or vessel, the stent is inserted into the tube 14 and compressed, Col.6, Lns 53-55, Fig.4, By withdrawing the tube 14, the stent 10 is released, and self-expands to its pre-impressed size. This prevents the collapse of the pharynx and the closing of the air passages, Col.7, Lns 8-11, the stent is in a compressed state until deployed).
Regarding Claim 10, modified Barodka discloses the airway device of claim 8. Barodka as currently modified fails to explicitly disclose the central introducer is temporarily secured with a locking mechanism on the proximal end of the airway device.
Mahr teaches a device with the central introducer is temporarily secured with a locking mechanism on the proximal end of the airway device (to set the depth of insertion and to prevent the stent from accidentally slipping into the air passage, a fastening 15 may be fixed at the proximal end 21 of the stent 10. A mounting plate 16 may also be provided to prevent the stent from accidentally slipping into the air passage and the pharynx, Col.7, Lns 13-18).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Barodka with the teaching of Mahr for the purpose of preventing the stent from accidentally slipping into the air passage and the pharynx (Mahr '932, Col.7, Lns 17-18).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. White et al. (US 2006/0100475 A1).
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/VICTORIA MURPHY/ Primary Patent Examiner, Art Unit 3785
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