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
Acknowledgment is made of applicant’s claim for priority to Application No. (AU2021900718) filed on the March 12, 2021.
Election/Restrictions
Applicant’s election of Species A in the reply filed on August 13, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 8, 13, and 20-21 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species B, there being no allowable generic or linking claim. Therefore claims 1-7, 12, 19, 24-30 are the only claims being examined on merit.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the limitations of the air passage wall, the oropharyngeal wall, or oropharyngeal space as described in the specification must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Pg. 15 para. 2, “or” after outer should be removed.
Pg. 15 last line, “orophargeal” should read as “oropharyngeal”.
Appropriate correction is required.
Claim Objections
Claims 1-7, 12, 19, 24-30 are objected to because of the following informalities:
Regarding Claim 1, line 9, "said outer oropharyngeal surface" should be "said outer oropharyngeal surface of the mask”.
Regarding Claim 1 and 24 recites “positioned adjacent to the glottis of a patient” in line 9. It is suggested that the language be amended to read --… configured to be positioned adjacent to a glottis of a patient — to clear the record.
Regarding Claim 1 and 24 recites “an oropharyngeal wall” in line 9 and line 3 respectively. It is suggested that the language be amended to read --…an oropharyngeal wall of the mask— to clear the record.
Regarding Claim 1, recites “the oropharyngeal wall” in line 11, 14, 15, 16. It is suggested that the language be amended to read --…the oropharyngeal wall of the mask— to clear the record.
Regarding Claim 1, recites an oropharyngeal space” in line 11 and “the oropharyngeal space” in line 13. It is suggested that the language be amended to read –an oropharyngeal space of the mask—and –the oropharyngeal space of the mask—respectively to clear the record.
Regarding Claim 1, line 12, 22, "through the suction openings" should read as "through the plurality of suction openings”.
Regarding Claim 1, line 21, "said oropharyngeal surface" should be "said outer oropharyngeal surface of the mask”.
Regarding Claim 1, line 22 and 23, "into the oropharyngeal suction conduit” should be "into the separate oropharyngeal suction conduit”.
Regarding Claim 2-7, 12, and 19, line 1, “A laryngeal mask airway device according ..” should read as “The laryngeal mask airway device according…”
Regarding Claim 2, line 2, “the oropharyngeal surface" should be "the outer oropharyngeal surface of the mask” for consistency.
Regarding Claim 2, line 3-4, “the oropharyngeal surface" should be "the outer oropharyngeal surface of the mask” for consistency.
Regarding Claim 4, line 3, "the collector includes a further plurality" should read as "the collector further includes a plurality”.
Regarding Claim 5, line 3, "towards the suction openings" should read as "towards the plurality of suction openings”.
Regarding Claim 6, line 2 and 5, "the oropharyngeal suction conduit” should be "the separate oropharyngeal suction conduit”.
Regarding Claim 12, line 1, a comma should come after “claim 1”
Regarding Claim 19, line 3 and 4, "the oropharyngeal suction conduit” should be "the separate oropharyngeal suction conduit”.
Regarding Claim 24 and 28 recites “oropharyngeal space”. It is suggested that the language be amended to read –oropharyngeal space of the mask— to clear the record.
Regarding Claim 24 recites “the oropharyngeal wall” in line 5 and 8. It is suggested that the language be amended to read --…the oropharyngeal wall of the mask— to clear the record.
Regarding Claim 24, line 7, " the suction openings" should read as " the plurality of suction openings”. Regarding Claim 25-30, line 1, “A mask in accordance ..” should read as “The mask in accordance…”
Regarding Claim 25-30, line 1, a comma should come after “claim 24”
Regarding Claim 25, 26, 27, 29, 30 recites “the oropharyngeal wall”. It is suggested that the language be amended to read --…the oropharyngeal wall of the mask—to clear the record.
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 19, 25, and 27 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.
Regarding Claim 19, the claim recites the limitation "the male pipe" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding Claim 25, the claim recites “wherein the air passage wall, the oropharyngeal wall, and the at least one internal support” without a finishing the clause. Examiner is assuming there is an error in amendment and Applicant was intending to amend for the claim to read “wherein the air passage wall, the oropharyngeal wall, and the at least one internal support are integrally formed.” For the purpose of this Office Action, Examiner is interpreting the claim as such.
Regarding Claim 27, the claim recites the limitation "each of these walls”. There is insufficient antecedent basis for this limitation in the claim.
Regarding Claim 29, the claim recites the limitation "the walls”. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3, and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vadivelu (WO 2019140135 A1).
Regarding Claim 1, Vadivelu discloses a laryngeal mask airway device, comprising:
a ventilation conduit (Fig. 28-30; 2010) having an operatively upper end (closer to 2001 through joint 2006) and an operatively lower end (closer 2025; pg 3 In 13-15);
a mask (Fig. 28-30; 2001) at the operatively lower end of the ventilation conduit (Fig. 28-30; the mask is on the lower end), the mask having an inner surface (2002, 2005A) forming a receptacle that is in fluid communication with the ventilation conduit (Figs 25-28; pg 3 In 3-6, 18-23) and an outer oropharyngeal surface (2004) opposed to said inner surface and facing away from the receptacle (Fig. 28-30); wherein the mask comprises an air passage wall having the inner surface that is positioned adjacent to the glottis of a patient in use (pg. 28 lines 8-23; pg. 29 lines 1-pg. 33 line 4);
an oropharyngeal wall (of the mask; see above; where 2018 sits on that is configured to be against the oropharyngeal of a patient) providing said outer oropharyngeal surface (2004) extending across the air passage wall spaced away from the air passage wall and defining an oropharyngeal space therebetween (pg. 28 lines 8-20; Examiner notes: the outer oropharyngeal surface of the mask is on one side of the mask that lays against the patients oropharyngeal and opposite is the air passage wall on the inner surface), the oropharyngeal wall defining a plurality of suction openings (2009) and forming a collector (2019) for drawing secretions through the suction openings into the oropharyngeal space (pg. 2 lines 3-23);
at least one internal support (2007, 2005A) for supporting the oropharyngeal wall in fixed spaced relation relative to the air passage wall (pg. 28 lines 8-20);
a conforming cuff or seal (2005) extending around a perimeter of the air passage wall and the oropharyngeal wall (Fig. 28-30);
wherein the air passage wall, the oropharyngeal wall, the at least one internal support, and the conforming cuff or seal are integrally formed (Fig. 28-30; 2000); and
a separate oropharyngeal suction conduit (2018) having an operatively upper end (2018B), and an operatively lower end (2018A) forming the collector defining the plurality of suction openings that extend across the oropharyngeal surface of the mask (pg. 3 lines 21 to pg. 4 line 4) wherein in use secretions are drawn through the suction openings into the oropharyngeal suction conduit for removal from the patient through the oropharyngeal suction conduit (Fig 28 - Fig 30; pg 3 In 2-23 to pg 5 In 1-2; pg. 28 lines 8-23; pg. 29 lines 1-pg. 33 line 4).
Regarding Claim 2, Vadivelu discloses the laryngeal mask airway device according to claim 1, wherein the collector (Fig. 28-30, 35; tube 2018 and 2019) extends across substantially all of the oropharyngeal surface of the mask (2004; pg. 3 lines 16-19; the collector extends more than 50% of the surface in one direction before the cuff section), and the plurality of suction openings (2009) are spaced apart from each other across the oropharyngeal surface (Fig. 28-30; the holes are spaced apart on the tube that is “across” the oropharyngeal surface).
Regarding Claim 3, Vadivelu discloses the laryngeal mask airway device according to claim 1, wherein the collector (Fig. 35; in tube 2018, 2019) has a perimeter region extending along at least part of the collector (around the tube 2018), and a raised inner region inward of the perimeter region (best shown in Fig. 33).
Regarding Claim 12, Vadivelu discloses the laryngeal mask airway device according to claim 1 wherein the conforming cuff or seal (2005) is an inflatable cuff that is inflated for sealing the mask to the body of a patient (Fig. 28-30), the cuff further including an inflation line (2012) extending away from the cuff for inflating the cuff (pg. 33 lines 9-22).
Claim(s) 1, 24-30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baska (US 20110265800 A1).
Regarding Claim 1, Baska discloses a laryngeal mask airway device (LMA), comprising:
a ventilation conduit (Fig. 7; 14) having an operatively upper end (outside the patient mouth in Fig. 7) and an operatively lower end (Fig. 7; attached to the mask 12); a mask (12) at the operatively lower end of the ventilation conduit (Fig. 7; the mask is connected to the conduit 14 at a “lower end”), the mask having an inner surface (Fig. 8; 16) forming a receptacle that is in fluid communication with the ventilation conduit and an outer oropharyngeal surface (Fig. 8-9; 26) opposed to said inner surface and facing away from the receptacle (26 faces away from 16);
wherein the mask (12) comprises an air passage wall (facing L in Fig. 7) having the inner surface (16) that is positioned adjacent to the glottis of a patient in use (Fig. 7);
an oropharyngeal wall (18) providing said outer oropharyngeal surface extending across the air passage wall spaced away from the air passage wall (Fig. 7; is on the other side of 16) and defining an oropharyngeal space therebetween (Fig. 8-9), the oropharyngeal wall defining a plurality of suction openings (50, 52, 54, 46, 68, 56) and forming a collector (into the tubes 46, 48) for drawing secretions through the suction openings into the oropharyngeal space (para. 0089);
at least one internal support (Fig. 8; 74 and 76) for supporting the oropharyngeal wall in fixed spaced relation relative to the air passage wall (shown in Fig. 8);
a seal (20, 22) extending around a perimeter of the air passage wall and the oropharyngeal wall (Fig. 7; para. 129);
wherein the air passage wall, the oropharyngeal wall, the at least one internal support, and the seal are integrally formed (Fig. 8);
and a separate oropharyngeal suction conduit (46 or 48) having an operatively upper end (Fig. 7; outside the mouth), and an operatively lower end (collected to the mask 12) forming the collector defining the plurality of suction openings that extend across the oropharyngeal surface of the mask (Fig. 3 and 7; 50, 52, 54, 46, 68, 56; para. 0089, 0092) wherein in use secretions are drawn through the suction openings into the oropharyngeal suction conduit for removal from the patient through the oropharyngeal suction conduit (para. 0091-0097; specifically 0089, 0092).
Regarding Claim 24, Baska discloses a mask for a laryngeal mask airway device (LMA; Fig. 7), the mask (12) comprising: an air passage wall (facing L in Fig. 7) that is positioned adjacent to the glottis of a patient in use (Fig. 7); an oropharyngeal wall (18) extending across the air passage wall spaced away from the air passage wall (best shown in Fig. 8) and defining an oropharyngeal space therebetween (Fig. 8), the oropharyngeal wall defining a plurality of suction openings (50, 52, 54, 46, 68, 56) and forming a collector (into the tubes 46, 48) for drawing secretions through the suction openings into the oropharyngeal space (para. 0089, 0092); and at least one internal support (Fig. 8; 74 and 76) for supporting the oropharyngeal wall in fixed spaced relation relative to the air passage wall (Fig. 8; para. 0081-0097).
Regarding Claim 25, Baska discloses the mask in accordance with claim 24 wherein the air passage wall (16, 66), the oropharyngeal wall (18), and the at least one internal support (74, 76) see 112b above see Fig. 8 ”are integrally formed”.
Regarding Claim 26, Baska discloses the mask in accordance with claim 24 wherein the plurality of suction openings (50, 52, 54, 46, 68, 56) may be distributed across the surface of the oropharyngeal wall for collecting secretions from across the full surface thereof (Fig. 3, 7; para. 0089, 0092; Examiner notes: the claim states the openings “may be” distributed, BRI can be read as it may be or may not be).
Regarding Claim 27, Baska discloses the mask in accordance with claim 24 wherein each of the air passage wall (Fig. 7-8; across from L and 66, 16) and the oropharyngeal wall (18) may have a perimeter and the internal supports (74, 76) are spaced inward from the perimeter of each of these walls (Fig. 8).
Regarding Claim 28, Baska discloses the mask in accordance with claim 24 wherein at least one internal support (74, 76) is located substantially centrally within the oropharyngeal space (Fig. 8).
Regarding Claim 29, Baska discloses mask in accordance with claim 24 further comprising a side wall (Fig. 8 on the side of 46, 48) extending between the air passage wall (66 and 16) and the oropharyngeal wall (18) around a perimeter of the walls (shown in Fig. 8).
Regarding Claim 30, Baska discloses the mask in accordance with claim 24 further comprising: a seal (para. 0015, 0016, 0020) extending around a perimeter of the air passage wall (66) and the oropharyngeal wall (18; Examiner notes: that the mask seal with the patient larynx is taught and the seal is from the air passage wall to the oropharyngeal wall on top of the mask).
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 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 4-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vadivelu, as applied claim 1, in view Wang (US 20200054799 A1).
Regarding Claim 4, Vadivelu discloses the laryngeal mask airway device according to claim 3, wherein the plurality of suction openings (2009) arranged in a line and spaced apart from each other along the perimeter region (Fig. 29-30),
Vadivelu does not specifically disclose that the collector includes a further plurality of suction openings on the raised inner region.
However, Wang teaches the collector (Fig. 14; Suction device 1415) includes a further plurality of suction openings (1420) on the raised inner region (examiner notes: Wang teaches may be any size and shape appropriate for laryngeal mask airway system and has many holes; para. 0077-0081).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the LMA of Vadivelu to include the collector includes a further plurality of suction openings on the raised inner region as taught by Wang for the purpose of liquids, such as saliva and other bodily secretions will be evacuated from a patient's airway via use of suction device (para. 0078, 0080) and also having holes that are smaller than the lumen(s) prevents a solid, or semi-solid, from being sucked into a hole that could occlude, or block, a lumen of the respective suction device, extension, and/or suction line to which it may be coupled. This prevents occlusion of the lumens in a suction device and/or medical device system including a suction device and provides for proper functioning of the suction device even if one or more of the holes are blocked (para. 0096).
Regarding Claim 5, Modified Vadivelu discloses the laryngeal mask airway device according to claim 4,
Vadivelu does not specifically teach wherein the collector further includes a recess extending along a part of the length of the perimeter region for directing secretions towards the suction openings in the perimeter region.
However, Wang further teaches the collector (Fig. 14; 1415) further includes a recess (1410) extending along a part of the length of the perimeter region for directing secretions towards the suction openings in the perimeter region (para. 0079).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the LMA of Vadivelu to include a recess extending along a part of the length of the perimeter region as taught by Wang for the purpose of directing secretions towards the suction openings in the perimeter region (para. 0077-0081).
Regarding Claim 6, Vadivelu discloses the laryngeal mask airway device according to claim 1, wherein the operatively upper end (2018B) of the oropharyngeal suction conduit (2018) includes a pipe coupling formation (2025) for releasable coupling to an external suction conduit (pg. 31 lines 11-21),
Vadivelu does not specifically disclose that the pipe coupling formation (pg. 34 lines 1-8) includes a suction control for enabling a clinician to selectively apply a suction to the oropharyngeal suction conduit (2018).
However, Wang teaches that the pipe coupling formation (Fig. 14; 1455) includes a suction control (adapter) for enabling a clinician to selectively apply a suction to the oropharyngeal suction conduit (Fig. 14; 1440 suction line; para. 0056, 0078-0079).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the LMA of Vadivelu to include a suction control for enabling a clinician to selectively apply a suction to the oropharyngeal suction conduit as taught by Wang for the purpose of coupling to a source of negative pressure, such as a vacuum pump so that negative pressure may be applied to external suction line, suction line, and suction device so that, for example, fluids, solids, and/or gasses may be sucked into a lumen present in suction device (para. 0078).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vadivelu and Wang, as applied to claim 6, in view of Witherow (US 20200232590 A1).
Regarding Claim 7, Modified Vadivelu discloses the laryngeal mask airway device according to claim 6,
Modified Vadivelu does not discloses wherein the pipe coupling formation comprises a male pipe coupling formation for releasable connecting to a female pipe coupling formation on the external suction conduit whereby in use to facilitate detachment of the pipe coupling formation from, and reattachment of the pipe coupling formation to, the external suction conduit.
However, Witherow teaches a pipe coupling formation (Fig. 2) comprises a male pipe coupling (3) formation for releasable connecting to a female pipe coupling (2) formation on the external suction conduit (6) whereby in use to facilitate detachment of the pipe coupling formation from, and reattachment of the pipe coupling formation to, the external suction conduit (para. 0038-0041).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the LMA of Modified Vadivelu to include the wherein the pipe coupling formation comprises a male pipe coupling formation for releasable connecting to a female pipe coupling formation on the external suction conduit whereby in use to facilitate detachment of the pipe coupling formation from, and reattachment of the pipe coupling formation to, the external suction conduit as taught by Witherow for the purpose of quickly removing the tube and easily assembled and disassembled the two parts (para. 0038-0039).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vadivelu and Wang, as applied to claim 6, in view of Tang (WO 2017080347 A1).
Regarding Claim 19, Vadivelu discloses the laryngeal mask airway device according to claim 6,
Modified Vadivelu does not specifically teach wherein the suction control is in the form of a branch pipe on the male pipe coupling formation having an open end that is normally open to the outside air for drawing external air into the oropharyngeal suction conduit, and wherein the open end of the branch pipe is closed to apply a suction to the oropharyngeal suction conduit and draw fluid and secretions into the collector.
However, Tang teaches the suction control is in the form of a branch pipe (Fig. 2; S) on the male pipe coupling formation having an open end (Fig,. 2; S3) that is normally open to the outside air for drawing external air into the oropharyngeal suction conduit, and wherein the open end of the branch pipe is closed to apply a suction to the oropharyngeal suction conduit and draw fluid and secretions into the collector (pg. 3 last paragraph).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the LMA of Modified Vadivelu to include the suction control is in the form of a branch pipe on the male pipe coupling formation having an open end that is normally open to the outside air for drawing external air into the oropharyngeal suction conduit, and wherein the open end of the branch pipe is closed to apply a suction to the oropharyngeal suction conduit and draw fluid and secretions into the collector as taught by Tang for the purpose of control between suction conduit and the ambient (pg. 3 last paragraph).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAAP A ELLABIB whose telephone number is (571)272-5879. The examiner can normally be reached 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KENDRA CARTER can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MAAP A. ELLABIB
Examiner
Art Unit 3785
/M.A.E./Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
