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 .
Amendment
This office action is responsive to the amendment filed on 3/12/26. As directed by the amendment: claims 1, 6, 8, 15 and 19 have been amended, no claims have been canceled, and no new claims have been added. Thus, claims 1-20 are presently pending in the application.
Election/Restrictions
Claims 4-5 and 7 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/19/25.
Priority Note
Only the claims of the continuation-in-part application that are disclosed in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph in the prior-filed application are entitled to the benefit of the filing date of the prior-filed application. Therefore, claims 1-20 are entitled the filing date of 3/31/22 since none of the prior-filed applications disclose at least “an air filter operatively disposed on an inside of the vacuum tube”.
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:
“vacuum unit” in claims 1, 15 and 19 (corresponding structure is a negative pressure vacuum, [0040].
“reinforcement structure” in claim 11, (corresponding structure is an elongated structure forming a proximal portion of the body, [0047], fig. 1D)
“overlapping portion” in claim 12 (corresponding structure is an overlay [0047])
“audiovisual component” in claim 16 (corresponding structure is a camera [0042].
“expandable component” in claim 18, (corresponding structure is a corrugation or groove [0047])
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.
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.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference characters not mentioned in the description: 65 (Fig. 17), 69 (fig. 17-18) and 43 (Fig. 18). Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
Claim Objections
Claims 6 and 9 are objected to because of the following informalities:
Claim 6 recites “a negative pressure,” which is suggested to be changed to --the negative pressure-- since a negative pressure is already recited in claim 1. Appropriate correction is required.
Claim 9 recites “an enclosure area,” which is suggested to be changed to --the enclosure areas-- since an enclosure area is already recited in claim 1. 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.
Claim 18 is 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 18 recites “said sleeve retainer” in line 1, which lacks proper antecedent basis.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 10-14 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 10 recites “The intubation assembly as recited in claim 9” and Claims 11-14 recite “the shield assembly recited in claim 9”. The language is suggested to be changed to --The systems as recited in claim 9-- in order to include all the limitations of the claim upon which it depends. Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements.
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.
Claims 1-3, 6 and 8-13 are rejected under 35 U.S.C. 103 as being unpatentable over Giulianotti et al. (2016/0107006) in view of Breegi et al. (2016/0074268) and Vizulis et al. (2021/0307872).
Regarding claim 1, in fig. 1-3 Giulianotti discloses a system configured to remove exhaled air from a patient [0014], the system comprising: a vacuum tube 818, a shield assembly 800 structured for insertion of an intubation apparatus ([0026]), said shield assembly comprising: a shield body (804, 802 and 806) comprising an opening (aperture closed by flexible membrane 820 [0026]) structured and dimensioned for insertion of the intubation apparatus [0026], and at least one vacuum opening (opening that couples to tube 818 [0014]) disposed on said shield body and structured for attachment to said vacuum tube [0014], but is silent regarding a vacuum unit, said vacuum unit disposed in fluid communication with an inside of said vacuum tube and an inside of said shield body, a filter operatively disposed on said inside of said vacuum tube between said shield body and said vacuum unit. However, in fig. 4 Breegi teaches a vacuum unit ([0042] there must be a vacuum unit that suctions the air out), said vacuum unit disposed in fluid communication with an inside of said vacuum tube [0042] and an inside of said shield body 73, a filter (70 [0042]) operatively disposed on said inside of said vacuum tube between said shield body 73 and said vacuum unit (Fig. 4). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Giulianotti’s system with the addition of a vacuum unit and filter, as taught by Breegi, for the purpose of providing protection to user’s outside of the system. The modified Giulianotti discloses that said vacuum tube, said shield body and said vacuum unit collectively disposable into and out of an operative orientation and an inoperative orientation (Fig. 2 shows the inoperative orientation, while fig 1 and 3 show an operative orientation, Giulianotti) wherein, in said operative orientation (Fig. 3 Giulianotti), said shield body is disposed adjacent to a face of the patient with an interior of said shield body facing the patient (Fig. 3 Giulianotti) and defining an enclosure area between the shield body and the face of the patient (Fig. 3 Giulianotti), but is silent regarding that said vacuum unit is activated in said operative orientation to exert a negative pressure through said vacuum tube on said enclosure area such that air is removed from the enclosure area through said vacuum tube. However, Vizulis teaches a vacuum unit that is activated in said operative orientation to exert a negative pressure through a vacuum tube 28 on said enclosure area such that air is removed from the enclosure area through said vacuum tube ([0048] there must be a vacuum unit in connected to the vacuum tube). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Giulianotti’s operative orientation with exerting negative pressure during intubation, as taught by Vizulis, for the purpose of providing protection to user’s outside of the system ([0048] Vizulis).
Regarding claim 2, the modified Giulianotti discloses that said shield body is disposable into and out of an operative position (Figures 1 and 3, Giulianotti) and an inoperative position (Fig. 2 Giulianotti).
Regarding claim 3, the modified Giulianotti discloses that said operative position comprises the intubation apparatus (826 laryngeal mask, Giulianotti) disposed on said shield opening and into the mouth of the patient (Fig. 3 [0026] Giulianotti), and said interior of said shield body facing the patient (Fig. 3, Giulianotti).
Regarding claim 6, the modified Giulianotti discloses that said operative orientation comprises: said shield body disposed into an operative position comprising the intubation apparatus disposed on said shield opening and in the mouth of the patient (Fig. 3, [0026] Giulianotti) and said interior of said shield body facing the patient (Fig. 3, Giulianotti), that said vacuum unit is activated and exerting a negative pressure on an inside of said shield body at least partially removing exhaled air from the patient ([0048] Vizulis), wherein said vacuum unit exerts said negative pressure while the intubation apparatus is inserted through said shield opening and into the mouth of the patient ([0048] Vizulis, fig. 3 Giulianotti).
Regarding claim 8, the modified Giulianotti discloses that said filter comprises an air filter operatively disposed on the inside of said vacuum tube (70 [0042] Breegi) adjacent to said vacuum unit (near to the vacuum unit, Breegi); said vacuum tube operatively connected to said vacuum unit and said shield body (Fig. 4 Breegi, Fig. 1 Giulianotti).
Regarding claim 9, the modified Giulianotti discloses that said shield body of said shield assembly comprises: a top surface (outer surfaces of helmet body, Giulianotti) and a bottom surface (inner surfaces of helmet body, Giulianotti), a top portion (811 or 812 near top of user’s head in use, Giulianotti) disposed on a distal end (top end of the shield body closer to the top of the user’s head in use, Giulianotti) of said shield body, a first side segment (portion of 812 to the left of 806, Giulianotti) and a second side segment (portion of 812 to the right of 806, Giulianotti), each one of said first side segment and said second side segment disposed on a proximal end (portion of the shield body closer to the user’s neck in use, Giulianotti) of said shield body, and said top portion and said bottom surface of said shield body collectively define an enclosure area (within the shield body as shown in fig. 1-3 Giulianotti).
Regarding claim 10, the modified Giulianotti discloses that each of said first side segment and said second side segment are disposed in a spaced apart relation to one another (Fig. 2, the segments are separated by 806, Giulianotti); said first side segment and said second side segment collectively defining an aperture (the first and second segments define part of opening to portion 802 when in the inoperative position in Fig. 2, Giulianotti) configured and dimensioned to allow access to a hand and arm of a user to said enclosure area (when in the inoperative position in fig. 2, Giulianotti).
Regarding claim 11, the modified Giulianotti discloses that a reinforcement (806, Giulianotti) structure disposed around said proximal end of said shield body; said reinforcement structure configured to at least partially reduce bending of said shield body (the added material will in part help reduce bending of the shield body, Giulianotti).
Regarding claim 12, the modified Giulianotti discloses that an overlapping portion (where 811 and shield body meet, Giulianotti) formed around said distal end of said shield body; said overlapping portion configured to at least partially reduce bending of said shield body (the added material will in part help reduce bending of the shield body, Giulianotti).
Regarding claim 13, the modified Giulianotti discloses that said operative orientation comprises said vacuum unit ([0042] Breegi) activated and exerting a negative pressure around the enclosure area at least partially removing exhaled air from the patient between said shield body and the patient ([0014] Giulianotti, [0042] Breegi).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Giulianotti, Breegi and Vizulis, as applied to claim 9 above, in further view of Luk (2022/0015860).
Regarding claim 14, the modified Giulianotti is silent regarding at least one slot structured to allow an insertion of an endotracheal tube into said enclosure area. However, in fig. 3 Lux teaches a shield body having an opening for insertion of an intubation apparatus as well as at least one slot structured to allow an insertion of an endotracheal tube into said enclosure area [0023]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Giulianotti’s shield assembly with the addition of a slot, as taught by Luk, for the purpose of providing a further opening for alternate intubation devices or instruments ([0023] Luk).
Claims 15 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Giulianotti et al. (2016/0107006) in view of Brain (WO 95/33506), Breegi et al. (2016/0074268) and Vizulis et al. (2021/0307872).
Regarding claim 15, Giulianotti discloses a system configured to remove exhaled air from a patient [0014], the system comprising: a vacuum tube 818, an intubation apparatus assembly comprising a sleeve (826 laryngeal mask), said sleeve further configured and dimensioned for insertion into the mouth of the patient [0026], a shield assembly 800 structured for insertion of said sleeve (Fig. 3), said shield assembly comprising: a shield body (804, 802 and 806) comprising a top surface (outer surfaces of helmet body, Giulianotti) and a bottom surface (inner surfaces of helmet body, Giulianotti), said shield body further comprising a flexible material (flexible membrane/valve 820 [0026]), a top portion comprising a flexible material and disposed on a distal end of said shield body ([0017] 812 near top of user’s head is a rubber O-ring seal or airtight gasket, which is flexible), a first side segment (portion of 812 to the left of 806) and a second side segment (portion of 812 to the right of 806), each one of said first side segment and said second side segment disposed on a proximal end (portion of the shield body closer to the user’s neck in use) of said shield body, said top portion and said bottom surface of said shield body collectively defining an enclosure area (within the shield body as shown in fig. 1-3), said shield body comprising an opening (aperture closed by flexible membrane 820 [0026]) structured and dimensioned for insertion of the said sleeve [0026], at least one vacuum opening(outlet opening for coupling to outlet tube 818 [0014]) disposed on said shield body and structured for attachment to a vacuum tube 818, and said shield body and said sleeve collectively disposable into and out of an operative position (Fig. 3) and an inoperative position (Fig. 2), but is silent regarding that said sleeve configured and dimensioned to receive an intubation apparatus on an inside thereof. However, Brain teaches sleeve (laryngeal mask Page 6, ll. 26-Page 7, ll. 6) configured and dimensioned to receive an intubation apparatus (endotracheal tube Page 6, ll. 26-Page 7, ll. 6) on an inside thereof (Page 6, ll. 26-Page 7, ll. 6). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Giulianotti’s laryngeal mask with a laryngeal mask that has a slot big enough for insertion of an endotracheal tube, as taught by Brain, for the purpose of providing an alternate airway having the predictable results of providing gas to a user. The modified Giulianotti is silent regarding a vacuum unit, an air filter operatively disposed on an inside of said vacuum tube. However, in fig. 4 Breegi teaches a vacuum unit ([0042] there must be a vacuum unit that suctions the air out), an air filter (70 [0042]) operatively disposed on an inside of said vacuum tube (Fig. 4). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Giulianotti’s system with the addition of a vacuum unit and filter, as taught by Breegi, for the purpose of providing protection to user’s outside of the system. The modified Giulianotti discloses that said vacuum tube, said shield body and said vacuum unit are collectively disposable into and out of an operative orientation and an inoperative orientation (Fig. 2 shows the inoperative orientation, while fig 1 and 3 show an operative orientation, Giulianotti). The modified Giulianotti is silent regarding wherein said operative orientation comprises said vacuum unit exerting a negative pressure within said enclosure area between said shield body and the patient to remove exhaled air from the patient. However, Vizulis teaches an operative orientation that comprises a vacuum unit ([0048] there must be a vacuum unit in connected to the vacuum tube 28) exerting a negative pressure within said enclosure area between said shield body and the patient to remove exhaled air from the patient ([0048] negative pressure is exerted during intubation, which removes exhaled air). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Giulianotti’s operative orientation with exerting negative pressure during intubation, as taught by Vizulis, for the purpose of providing protection to user’s outside of the system ([0048] Vizulis).
Regarding claim 17, the modified Giulianotti discloses that said shield body comprises a sleeve retainer (annular wall 822 and 820 [0026] Giulianotti) disposed on said bottom surface (Fig. 3 Giulianotti); said sleeve retainer configured and dimensioned to orient said sleeve into the mouth of the patient ([0026] Giulianotti).
Regarding claim 18, the modified Giulianotti discloses that said sleeve retainer (annular wall 822 and 820 [0026] Giulianotti) comprises at least one expandable component (820 expands as the sleeve is placed into it [0026] Giulianotti); said at least one expandable component defined along the length of said sleeve retainer (Fig. 3 Giulianotti) and structured to at least partially allow for movement of said sleeve within said shield body (due to the flexible material of 820 [0026] Giulianotti).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Giulianotti, Brain, Breegi and Vizulis, as applied to claim 15 above, in further view of Nearman (2011/0144436).
Regarding claim 16, the modified Giulianotti discloses that said sleeve comprises a sleeve body (body of laryngeal mask, Giulianotti) configured and dimensioned to correspond to a sleeve body of the intubation apparatus (endotracheal tube Page 6, ll. 26-Page 7, ll. 6, Brain), but is silent regarding that said intubation apparatus assembly comprises an audiovisual component. However, Nearman teaches a laryngeal device that comprises an audiovisual component [0043]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Giulianotti’s laryngeal mask with the addition of an audiovisual component, as taught by Nearman, for the purpose of providing audio and visuals to a user for ease of intubation.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Giulianotti et al. (2016/0107006) in view of Breegi et al. (2016/0074268), Brain (WO 95/33506) and Vizulis et al. (2021/0307872).
Regarding claim 19, in fig. 1-3 Giulianotti discloses a method for removing exhaled air from a patient [0014], the method comprising: (i) providing a system configured to remove exhaled air from the patient [0014], the system comprising: a vacuum tube 818, a shield assembly 800 structured for insertion of an intubation apparatus [0026], the shield assembly comprising: a shield body (804, 802 and 806) comprising at least an opening (aperture closed by flexible membrane 820 [0026]) structured and dimensioned for insertion of the intubation apparatus [0026], and at least one vacuum opening (opening that couples to tube 818 [0014]) disposed on the shield body and structured for attachment to the vacuum tube [0014], (ii) attaching the vacuum tube to the at least one vacuum opening (Fig. 1), (iv) inserting the intubation apparatus into the mouth of the patient (Fig. 3 [0026]), and (vi) removing the vacuum shield from the patient [0022], but is silent regarding a vacuum unit, and an air filter operatively disposed on an inside of the vacuum tube. However, in fig. 4 Breegi teaches a vacuum unit ([0042] there must be a vacuum unit that suctions the air out) and an air filter (70 [0042]) operatively disposed on said inside of said vacuum tube (Fig. 4). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Giulianotti’s method with the addition of a vacuum unit and filter, as taught by Breegi, for the purpose of providing protection to user’s outside of the system. The modified Giulianotti discloses (iii) using the vacuum unit to exert a negative pressure on an inside of the shield body ([0042] Breegi, [0014] Giulianotti), but is silent regarding (v) inserting an endotracheal tube through the shield body and positioning the endotracheal tube on the trachea of the patient. However, Brain teaches inserting an endotracheal tube through an intubation apparatus (laryngeal mask Page 6, ll. 26-Page 7, ll. 6) and positioning the endotracheal tube on the trachea of the patient (Page 6, ll. 26-Page 7, ll. 6). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Giulianotti’s laryngeal mask with a laryngeal mask that has a slot big enough for insertion of an endotracheal tube, as taught by Brain, for the purpose of providing an alternate airway having the predictable results of providing gas to a user. The modified Giulianotti does not explicitly recite using the vacuum unit to exert a negative pressure on an inside of the shield body within an enclosure area defined between the shield body and the face of the patient. However, Vizulis teaches using a vacuum unit ([0048] there must be a vacuum unit in connected to the vacuum tube 28) to exert a negative pressure on an inside of the shield body within an enclosure area defined between the shield body and the face of the patient ([0048] negative pressure is exerted during intubation). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Giulianotti’s negative pressure step with exerting negative pressure during intubation, as taught by Vizulis, for the purpose of providing protection to user’s outside of the system ([0048] Vizulis).
Regarding claim 20, the modified Giulianotti discloses inserting the intubation apparatus into the mouth of the patient comprises: inserting the intubation apparatus into the mouth of the patient when the shield body is adjacently disposed to the face of the patient (Fig. 3, Giulianotti), and using the vacuum unit to exert a negative pressure between the shield body and the face of the patient ([0048] Vizulis).
Response to Arguments
Applicant's arguments filed 3/12/26 have been fully considered but they are not persuasive.
Applicant’s arguments, see pages 17-21, filed 3/12/26, with respect to the rejection of claim 1 under Giulianotti and Breegi have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Giulianotti, Breegi and Vizulis.
Applicant’s arguments, see pages 24-26, filed 3/12/26, with respect to the rejection of claim 14 under Giulianotti, Breegi and Brain have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Giulianotti, Breegi, Vizulis and Luk.
Applicant’s arguments, see pages 26-28, filed 3/12/26, with respect to the rejection of claim 15 under Giulianotti, Brain and Breegi have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Giulianotti, Brain, Breegi and Vizulis.
Applicant’s arguments, see pages 20-31, filed 3/12/26, with respect to the rejection of claim 19 under Giulianotti, Breegi and Brain have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Giulianotti, Breegi, Brain and Vizulis.
Applicant argues on page 19 that Giulianotti does not disclose a shield body positioned adjacent to the face of the patient and defining an enclosure area between the shield body and the patient's face.
Examiner disagrees. Giulianotti’s shield body is defined at portions 804, 806 and 802 and figure 3 shows an enclosure area between at least portion 802 and the patient’s face.
Applicant argues on page 23 that while Vizulis describes maintaining negative pressure within the chamber during a procedure, Vizulis does not disclose a shield body having an opening through which an intubation apparatus is inserted while a vacuum unit is connected to the shield body is activated.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Applicant’s argument is not taken well since Giulianotti was applied to teach the shield body having an opening through which an intubation apparatus is inserted while a vacuum unit is connected to the shield body and Vizulis, while also teaching a shield body having an opening through which an intubation apparatus is inserted while a vacuum unit is connected to the shield body, is only applied to teach that the negative pressure is applied during activation and intubation. Since Vizulis teaches a shield body that protects a user outside of the shield body from contaminants in the same way as applicant’s shield body, one of ordinary skill in the art would look to Vizulis to teach negative pressure applied during intubation.
Applicant argues on pages 28-29 that Nearman does not teach or suggest the claimed system in which the intubation apparatus assembly is used in combination with a shield body forming an enclosure area and a vacuum system configured to remove exhaled air from the patient.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The other references applied in the rejection of claim 16 teach an intubation apparatus assembly is used in combination with a shield body forming an enclosure area and a vacuum system configured to remove exhaled air from the patient.
Applicant argues on page 32 that Vizulis does not disclose a shield body defining a localized enclosure adjacent to the face of the patient, does not disclose insertion of an intubation apparatus through such a shield body, and does not disclose exerting negative pressure between a shield body and the face of the patient during insertion of the intubation apparatus.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Applicant’s argument is not taken well since Giulianotti was applied to teach a shield body defining a localized enclosure adjacent to the face of the patient, and insertion of an intubation apparatus through such a shield body and Vizulis, while also teaching a shield body defining a localized enclosure adjacent to the face of the patient, and insertion of an intubation apparatus through such a shield body, is only applied to teach exerting negative pressure between a shield body and the face of the patient during insertion of the intubation apparatus. Since Vizulis teaches a shield body that protects a user outside of the shield body from contaminants in the same way as applicant’s shield body, one of ordinary skill in the art would look to Vizulis to teach negative pressure applied during intubation.
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.
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/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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