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 Objections
Claims 1, 6, 8, 10, 12, and 13 are objected to because of the following informalities:
“a mask frame” in claim 1, line 5 should be amended to recite --the mask frame--
“at least one port” in claim 6, line 1 should be amended to recite --the at least one port--
“the mounts” in claim 8, line 2 should be amended to recite --the at least two mounts--
“the dimensions” in claim 10, line 1 should be amended to recite --dimensions--
“gastric tube positioned” in claim 12, line 3 should be amended to recite --gastric tube configured to be positioned-- to most clearly avoid claiming a human organism
“straps anchored to the mounts” in claim 13, lines 16-17 should be amended to recite --the at least two straps anchored to the at least two mounts--
Appropriate correction is required.
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 11 and 12 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 11, the claim recites the limitation “the first and second frame portions” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 12, the claim recites the limitation “the hinge and latch system” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: airway management device in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof (see [0007] of the instant specification).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 4, and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kumar et al. US 2003/0047189 A1.
Regarding claim 1, Kumar discloses an aerosol containment mask 100 configured to contain aerosols released from a subject during insertion or removal of an airway management device or gastric tube (fig. 3 and [0033], face mask 100, which is capable of containing aerosols during insertion or removal of an instrument such as an airway management/gastric tube, as iris 110 can vary its diameter and can thus easily and quickly allow removal of the instrument prior to capping off by the snap fit lid), the mask 100 comprising:
a mask frame 108 sized to fit over a face of the subject (fig. 3 and [0033], central dome 108 forms the body/frame of the mask),
a central valve 110 formed within a mask frame 108, the central valve 110 configured to reversibly receive a portion of the airway management device or gastric tube (fig. 3 and [0033], instrument port 104 includes iris 110 for varying the inside diameter of the aperture 112 in the port 104; since the iris 110 is adjustable to vary the diameter of the aperture, the instrument would be capable of being released by increasing the diameter beyond the size of the instrument; [0002], the mask may be used to introduce endotracheal tubes, which may be considered airway management devices); and
a cushion 106 affixed to a contact surface of the mask frame 108, the cushion 106 configured to seal against the face of the subject when the aerosol containment mask 100 is secured to the face of the subject (fig. 3 and [0033], central dome 108 has a peripheral soft seal 106, which is shown in the figure as being disposed on the face and would be capable of sealing depending on how tight the mask is worn; please note The Brittanica Dictionary defines cushion as “a soft object or part that is used to make something (such as a seat) more comfortable or to protect a surface from damage: a soft pillow, pad, etc.”; in this case, a soft seal is a soft part that makes the mask 100 more comfortable on the face).
Regarding claim 2, Kumar discloses the airway management device being selected from an endotracheal tube ([0002], the mask may be used to introduce endotracheal tubes, which may be considered airway management devices), a laryngeal mask, an oropharyngeal airway, and a nasopharyngeal airway.
Regarding claim 4, Kumar discloses the central valve 110 being a rotary seal configured to seal around the airway management device or the gastric tube (fig. 3 and [0033], instrument port 104 includes iris 110 for varying the inside diameter of the aperture 112 in the port 104, which would be capable of sealing against the instrument/tube with the proper diameter; the iris 110 is stated to be formed and controlled in the same way as a camera aperture iris, which functions via blades that rotate outwards to overlap each other in order to increase diameter size, as evidenced by Photokonnexion (see copy of NPL attached to the Office Action)).
Regarding claim 5, Kumar discloses the mask 100 further comprising at least one port 102 to supply oxygen to the subject or vent exhaled air from the subject ([0033], mask 100 comprises breathing circuit port 102, which is capable of being used to supply oxygen or vent air).
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.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kumar et al. US 2003/0047189 A1 in view of Saad US 2003/0213493 A1.
Regarding claim 3, Kumar discloses the claimed invention as discussed above.
Kumar is silent on the gastric tube being selected from a nasogastric tube or an orogastric tube.
However, Saad teaches an analogous mask 100 (fig. 2 and [0025], mask 100) for a gastric tube 107, the gastric tube 107 being selected from a nasogastric tube or an orogastric tube ([0025], connectors 101/103 are used to connect a nasogastric tube 107).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the gastric tube of Kumar to be selected from a nasogastric tube or an orogastric tube, as taught by Saad, to allow the mask to hold the nasogastric tube in place during use).
Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kumar et al. US 2003/0047189 A1 in view of Allum et al. US 2010/0071693 A1.
Regarding claims 6 and 7, Kumar discloses the claimed invention as discussed above.
Kumar is silent on at least one port comprising a sensor to monitor gas levels, wherein the sensor monitors gas levels comprising oxygen, carbon dioxide levels, and any combination thereof.
However, Allum teaches an analogous port 163 for delivering gas (fig. 28 and [0089], gas delivery circuit 21) comprising a sensor to monitor gas levels, wherein the sensor 163 monitors gas levels comprising oxygen, carbon dioxide levels, and any combination thereof ([0089], oxygen and/or carbon dioxide sensing port 163).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the at least one port of Kumar to comprise a sensor to monitor gas levels, wherein the sensor monitors gas levels comprising oxygen, carbon dioxide levels, and any combination thereof, as taught by Allum, to allow the state of the patient to be monitored while using the mask.
Claim(s) 8-10, 13, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kumar et al. US 2003/0047189 A1 in view of Reddy et al. US 2019/0091434 A1.
Regarding claim 8, Kumar discloses the claimed invention as discussed above.
Kumar is silent on at least two mounts affixed around a perimeter of the mask frame, wherein the mounts are configured to provide an attachment point for at least one strap to the mask.
However, Reddy teaches an analogous mask 10 (fig. 1A and [0068], mask 10) with at least two mounts 18/20 affixed around a perimeter of the mask frame 12, wherein the mounts 18/20 are configured to provide an attachment point for at least one strap 14/16 to the mask 10 (fig. 1A and [0069], mask body 12 comprises eyelets 18/20 along its perimeter for attaching straps 14/16).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the mask of Kumar with at least two mounts affixed around a perimeter of the mask frame, wherein the mounts are configured to provide an attachment point for at least one strap to the mask, as taught by Reddy, to allow the mask to be attached to the user’s face securely.
Regarding claim 9, Kumar in view of Reddy discloses the claimed invention as discussed above.
Reddy further teaches the at least one strap 14/16 being configured to secure the mask 10 to the subject’s face (fig. 1A), to allow the mask to be attached to the user’s face and head securely.
Regarding claim 10, Kumar in view of Reddy discloses the claimed invention as discussed above.
Kumar further discloses the dimensions of the mask frame 108 being custom-designed to fit the subject’s face (the mask frame being custom-designed is considered a product-by-process limitation, since the final product (a mask that fits on the face) is the same regardless of the process by which it was designed; please see MPEP 2113).
Regarding claim 13, Kumar discloses a method of inserting an airway management device into a trachea of a subject (fig. 3 and [0014], method includes advancing a shaft member into the mouth or trachea), the method comprising:
placing an aerosol containment mask 100 of any previous claim over the subject’s nose and mouth (interpreted to be the mask 100 of claim 1; [0014], method includes placing the mask on the face of the patient, which can be seen covering the nose and mouth in fig. 3), the mask 100 comprising:
a mask frame 108 sized to fit over the face of the subject (fig. 3 and [0033], central dome 108 forms the body/frame of the mask);
a central valve 110 formed within a mask frame 108, the central valve 110 configured to reversibly receive a portion of the airway management device or gastric tube (fig. 3 and [0033], instrument port 104 includes iris 110 for varying the inside diameter of the aperture 112 in the port 104; since the iris 110 is adjustable to vary the diameter of the aperture, the instrument would be capable of being released by increasing the diameter beyond the size of the instrument; [0002], the mask may be used to introduce endotracheal tubes, which may be considered airway management devices);
a cushion 106 affixed to a contact surface of the mask frame 108, the cushion 106 configured to seal against the face of the subject when the aerosol containment mask 100 is secured to the face of the subject (fig. 3 and [0033], central dome 108 has a peripheral soft seal 106, which is shown in the figure as being disposed on the face and would be capable of sealing against the face depending on how tightly the mask is worn; please note The Brittanica Dictionary defines cushion as “a soft object or part that is used to make something (such as a seat) more comfortable or to protect a surface from damage: a soft pillow, pad, etc.”; in this case, a soft seal is a soft part that makes the mask 100 more comfortable on the face);
inserting the airway management device through the central valve 110 and into the trachea of the subject ([0014], the shaft member is inserted through the aperture and can be advanced into the mouth and nose), wherein the central valve 110 maintains a seal around the airway management device ([0014], the aperture can be closed about the inserted shaft member such that there is an airtight seal between the shaft and aperture walls).
Kumar is silent on at least two mounts attached around a perimeter of the mask; at least two straps anchored to the at least two mounts; securing and sealing the mask to the subject’s face with straps anchored to the mounts.
However, Reddy teaches an analogous mask 10 (fig. 1A and [0068], mask 10) with at least two mounts 18/20 attached around a perimeter of the mask frame 12; at least two straps 14/16 anchored to the at least two mounts 18/20 (fig. 1A and [0069], mask body 12 comprises eyelets 18/20 along its perimeter for attaching straps 14/16); securing and sealing the mask 10 to the subject’s face with straps 14/16 anchored to the mounts 18/20 (fig. 1A and [0069], the straps secure the mask to the head, allowing positive pressure seal to be obtained).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the mask and method of Kumar with at least two mounts attached around a perimeter of the mask; at least two straps anchored to the at least two mounts; securing and sealing the mask to the subject’s face with straps anchored to the mounts, as taught by Reddy, to allow the mask to be attached to the user’s face securely.
Regarding claim 14, Kumar in view of Reddy discloses the claimed invention as discussed above.
Kumar further discloses the central valve 110 being a rotary seal configured to seal around the airway management device (fig. 3 and [0033], instrument port 104 includes iris 110 for varying the inside diameter of the aperture 112 in the port 104, which would be capable of sealing against the instrument/tube with the proper diameter; the iris 110 is stated to be formed and controlled in the same way as a camera aperture iris, which functions via blades that rotate outwards to overlap each other in order to increase diameter size, as evidenced by Photokonnexion (see copy of NPL attached to the Office Action)).
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kumar et al. US 2003/0047189 A1 in view of Zhang et al. CN 110170096 A.
Regarding claim 11, Kumar discloses the claimed invention as discussed above.
Kumar is silent on a hinge and latch system comprising a hinge, a first latch component, and a second latch component, wherein:
the mask frame further comprises the first and second frame portions attached at adjoining ends by the hinge;
the first and second frame portions end in the first and second latch components, respectively; and
the first and second latch components are configured to mechanically link and unlink to reversibly separate the first and second frame portions between an opened and closed configuration.
However, Zhang teaches an analogous mask (fig. 1 and p. 2 of translation, medical breathing mask) comprising a hinge and latch system 11/12/21/22 comprising a hinge 12/22, a first latch component 11, and a second latch component 21 (figs. 1 and 2 and p. 6-7 of translation, the mask comprises subsection 1 and subsection 2; subsection 1 comprises connection parts 12 and 11, and subsection 2 comprises connection part 22 and 21; connection parts 12 and 22 are hinged, while connection parts 11 and 21 form a buckle/snap-type connection), wherein:
the mask frame 1/2 further comprises the first and second frame portions 1/2 attached at adjoining ends by the hinge 12/22 (fig. 2 and p. 6-7, connecting parts 12 and 22 are hinged);
the first and second frame portions 1/2 end in the first and second latch components 11/21, respectively (fig. 1, subsection 1 ends in first latch component 11, and subsection 2 ends in second latch component 21); and
the first and second latch components 11/21 are configured to mechanically link and unlink to reversibly separate the first and second frame portions 1/2 between an opened and closed configuration (figs. 1 and 2 and p. 6-7, connection part 11 is provided with a convex portion, and connection part 21 is buckled onto the convex bulging portion 11 to form a snap-type connection, which are reversible).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the mask from of Kumar with a hinge and latch system comprising a hinge, a first latch component, and a second latch component, wherein: a. the mask frame further comprises the first and second frame portions attached at adjoining ends by the hinge; b. the first and second frame portions end in the first and second latch components, respectively; and c. the first and second latch components are configured to mechanically link and unlink to reversibly separate the first and second frame portions between an opened and closed configuration, as taught by Zhang, to provide a way to disassemble the mask while it is still worn to prevent disturbing the patient.
Regarding claim 12, Kumar discloses the claimed invention as discussed above.
Kumar is silent on the hinge and latch system being configured to facilitate opening and reclosing the mask without disturbing the airway management device or gastric tube positioned in the trachea or esophagus of the subject.
However, Zhang teaches an analogous mask (fig. 1 and p. 2 of translation, medical breathing mask) comprising a hinge and latch system 11/12/21/22 (figs. 1 and 2 and p. 6-7 of translation, the mask comprises subsection 1 and subsection 2; subsection 1 comprises connection parts 12 and 11, and subsection 2 comprises connection part 22 and 21; connection parts 12 and 22 are hinged, while connection parts 11 and 21 form a buckle/snap-type connection) configured to facilitate opening and reclosing the mask without disturbing an analogous tube positioned in the trachea or esophagus of the subject (figs. 1 and 2 and p. 7, the first subsection 1 and second subsection 2 form an elastic seal for an air supply tube or cannula via sections 13 and 23; thus, since the mask can be opened and reclosed via the hinge and latch system 11/12/21/22, the tube can stay in place in the patient while the mask is unlatched and relatched).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the mask of Kumar with a hinge and latch system being configured to facilitate opening and reclosing the mask without disturbing the airway management device or gastric tube positioned in the trachea or esophagus of the subject, as taught by Zhang, to provide a way to disassemble the mask while it is still worn to prevent disturbing the patient.
Conclusion
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/MICHELLE J LEE/ Primary Examiner, Art Unit 3786