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 7/8/25. As directed by the amendment: claims 1 and 15 have been amended, claims 21-22 have been canceled, and no new claims have been added. Thus, claims 1-20 are presently pending in the application.
Claim Objections
Claim 2 is objected to because of the following informalities:
Claim 2 recites “the interior space” in line 4, suggested to be changed to --the interior space of the housing-- for consistency. 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 1-20 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.
Claims 1 and 20 recites “the material is a fabric consisting of cotton, nylon, and a combination thereof” however it is unclear if the material is only cotton, only nylon or both cotton and nylon. The language is suggested to be changed to --the material is a fabric selected from the group consisting of cotton, nylon, and a combination thereof-- for clarity.
Any remaining claims are rejected as being dependent on a rejected base claim.
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.
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.
Claims 1, 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (2004/0216736) in view of Walker et al. (8,936,022) and Salter (2017/0348498).
Regarding claim 1, in fig. 1-3 Lee discloses a protective surgical helmet (structure in fig 1) comprising: a hood 1 formed from a material (“side wall 2 can flex and bend” [0081], also see [0029] in which the outer wall is a “stable” material, which is defined by applicant is [0024] as elastic since “if locally deformed, the duct can return to its original formed shape and does not retain the deformed shape when the deforming force is removed”), wherein an interior space of the hood is adapted to enclose the head (Fig. 1), the hood comprising an inside surface (inside surfaces shown in Fig. 2); a duct 12 bonded (207 is bonded with 209 [0097]) with the inside surface and having an air inlet 13 and an air outlet 17, wherein the air outlet is positioned to direct a flow of filtered air [0069] into the interior space [0075]; wherein the duct is formed by the material (Lee [0029] the outer wall and inner wall is made from a pliant polymer, see [0024] in which a “stable” material is defined by applicant as elastic “if locally deformed, the duct can return to its original formed shape and does not retain the deformed shape when the deforming force is removed”), a connector (5 and 15), wherein a proximal end of the connector is connected with the air inlet (Fig. 2); and a filter unit [0069] connected with a distal end of the connector and defining a fluid path for delivering the flow of filtered air from an ambient environment to the air inlet via the connector [0075], wherein the filter unit comprises: one or more filter elements [0075], the one or more filter elements disposed along the fluid path [0075]; and an air pump connected with the one or more filter elements and disposed along the fluid path [0075], wherein the pump moves air from the ambient environment through the one or more filter elements to generate the flow of filtered air [0075], but is silent regarding a helmet frame adapted to fit on a head of a human. However, in fig. 1 Walker teaches a helmet frame (14, which supports conduits 20) adapted to fit on a head of a human. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lee’s duct with the addition of a frame, as taught by Walker, for the purpose of keeping the duct in place during use. The modified Lee is silent regarding that the material is fabric consisting of cotton, nylon, and a combination thereof. However, Salter teaches a gas conduit made of a resilient flexible nylon [0129]. 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 Lee’s resilient material with resilient nylon, as taught by Salter, for the purpose of providing an alternate resilient gas conduit material having the predictable results of directing gas.
Regarding claim 3, the modified Lee discloses that the filter unit is adapted to be worn adjacent to a back of the human ([0068] Lee), wherein the air outlet (17 Lee) is adapted to be positioned adjacent a crown of the head of the human (Fig. 2 Lee).
Regarding claim 5, the modified Lee discloses that the helmet frame further comprises a scaffold 22 extending outward from the frame inside the hood, wherein the scaffold is adapted to hold a portion of the hood away from a face of the human (22 holds the anterior portion of the hood slightly away from the user’s face).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Lee, Walker and Salter, as applied to claim 1 above, in further view of Ehler et al. (2016/0236014).
Regarding claim 2, the modified Lee is silent regarding that the filter unit comprises a housing, wherein an input side of the one or more filter elements is exposed to the ambient environment, wherein an output side of the one or more filter elements is connected with an interior space of the housing, wherein an input side of the air pump is connected with the interior space, and wherein an output side of the pump is connected with the distal end of the connector. However, in fig. 1-2 Ehler teaches a filter unit 50 comprises a housing 52, wherein an input side (near 54) of the one or more filter elements 30 is exposed to the ambient environment (Fig. 1-2), wherein an output side (near 60) of the one or more filter elements 30 is connected with an interior space of the housing (see fig. 2), wherein an input side (near 30) of the air pump 60 is connected with the interior space (see fig. 2), and wherein an output side (near 56) of the pump is connected with the distal end of the connector (20, see fig. 2). 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 Lee’s filter unit with a housing connected to a distal end of the connector, as taught by Ehler, for the purpose of providing protection for the filter unit.
Claims 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Lee, Walker and Salter, as applied to claim 1 above, in further view of Pavalarajan et al. (2015/0090254).
Regarding claim 4, the modified Lee is silent regarding that the air outlet comprises a louver adapted to be positioned adjacent a forehead of the human at a proximal end of the duct. However, Pavalarajan teaches an air outlet comprises a louver adjacent a forehead of the human at a proximal end of the duct ([0060] “airflow deflectors may be included at other outlets” such at 64 in the brow bar 22). 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 Lee’s air outlet with the addition of louvers, as taught by Pavalarajan, for the purpose of directing airflow as desired.
Regarding claim 14, the modified Lee discloses that the hood further comprises a transparent face plate ([0042] Lee), wherein the louver is positioned and configured to direct filtered air along an interior surface of the faceplate (the louver taught by Pavalarajan located within the outlet 17 of Lee directs air along an interior surface of the faceplate).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Lee, Walker and Salter, as applied to claim 1 above, in further view of Clupper et al. (7,192,151).
Regarding claim 6, the modified Lee is silent regarding a removable accessory attachable to the frame, wherein the accessory comprises one or more of a light source, a camera, a microphone, and a headphone. However, Clupper teaches a removable light source attachable to a frame (snap fit Col. 4, ll. 48-54). 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 Lee’s frame with the addition of a removable light source, as taught by Clupper, for the purpose of providing additional light.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Lee, Walker and Salter, as applied to claim 1 above, in further view of Plut et al. (2006/0277668).
Regarding claim 7, the modified Lee is silent regarding that the hood is adapted to engage with a surgical gown, wherein the interior space of the hood is in fluid communication with an interior space of the gown, and wherein filtered air flowing into the hood flows through the gown and out of the gown below a hem of the gown. However, in fig. 3A Plut teaches a hood that is adapted to engage with a surgical gown [0083], wherein the interior space of the hood is in fluid communication with an interior space of the gown (Fig. 3C), and wherein filtered air flowing into the hood flows through the gown and out of the gown below a hem of the gown [0083]. 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 Lee’s hood and skirt with the addition of a gown, as taught by Plut, for the purpose of providing further protection to the user and others in the vicinity.
Regarding claim 8, the modified Lee is silent regarding that the one or more filter elements are selected from one or more of a high efficiency particulate air filter, an activated carbon filter, an electrostatic filter, and an ultraviolet air purifier. However, Plut teaches HEPA filters [0059]. 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 Lee’s filter with a HEPA filter, as taught by Plut, for the purpose of providing further protection to the user.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Lee, Walker and Salter, as applied to claim 1 above, in further view of Conrad et al. (2006/0277668).
Regarding claim 9, the modified Lee is silent regarding an antimicrobial coating along an inside surface of the housing, pump, connector, or duct. However, Conrad teaches an antimicrobial coating along an inside surface of the housing, pump, connector ([0513] “any or all portions of the air flow path may be coated with, e.g., Indian tin oxide copper”), or duct. 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 Lee’s connector with the addition of copper, as taught by Conrad, for the purpose of providing further protection to the user.
Regarding claim 10, the modified Lee discloses that the antimicrobial coating comprises one or more of copper ([0513] Conrad) or an alloy of copper.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Lee, Walker, Salter and Ehler, as applied to claim 2 above, in further view of Allsworth et al. (2017/0303823).
Regarding claim 11, the modified Lee is silent regarding an input pressure sensor in fluid communication with the interior of the housing at the input of the pump and a controller connected with the pressure sensor and with the pump, wherein the pressure sensor detects an input air pressure. However, Allsworth teaches an input pressure sensor in fluid communication with the interior of the housing at the input of the pump and a controller (computer controlled [0145]) connected with the pressure sensor and with the pump, wherein the pressure sensor detects an input air pressure [0147]. 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 Lee’s housing with the addition of pressure sensors, as taught by Allsworth, for the purpose of determining is a leak is present.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Lee, Walker, Ehler, Salter and Allsworth, as applied to claim 11 above, in further view of Mielcarz et al. (2015/0283442).
Regarding claim 12, the modified Lee discloses an output pressure sensor in fluid communication with the output of the pump to detect an output pressure and connected with the controller ([0147] Allsworth), wherein the controller monitors the input air pressure and the output air pressure to detect an error condition (leak or blockage [0147] Allsworth), but is silent regarding that the controller further comprises an alert signal, and wherein, when the error condition is detected, the controller activates the alert signal. However, Mielcarz teaches a controller that comprises an alert signal, and wherein, when the error condition is detected, the controller activates the alert signal (see claim 2 of Mielcarz). 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 Lee’s controller with a controller that activates an alert signal due to leakage, as taught by Mielcarz, for the purpose of alerting a user if a leak is present.
Regarding claim 13, the modified Lee discloses the error condition comprises one or more of a filter blocked condition, a filter input leak condition, a low airflow condition, an air flow leak condition ([0147] Allsworth and claim 2 of Mielcarz), and an air flow blocked condition.
Claims 15-16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (2004/0216736) in view of Salter (2017/0348498).
Regarding claim 15, in fig. 9-10 Lee discloses a protective system comprising: a hood 1 (see fig. 1) formed from a material (“side wall 2 can flex and bend” [0081], also see [0029] in which the outer wall is a “stable” material, which is defined by applicant in [0024] as elastic since “if locally deformed, the duct can return to its original formed shape and does not retain the deformed shape when the deforming force is removed”) and configured to at least partially enclose a head of a human (Fig .9), the hood including a length of a material strip formed from the material (pliant material strip being 207 [0094], the material being pliant since [0029] states that the inner wall is a “stable” material, which is defined by applicant is [0024] as elastic since “if locally deformed, the duct can return to its original formed shape and does not retain the deformed shape when the deforming force is removed”) attached to and extending along an inside surface of the hood such that a lumen is formed between the inside surface of the hood and the pliant material strip (Fig. 10), wherein the lumen forms an air duct 212 having an air inlet 213 and an air outlet 217, wherein the air outlet is positioned to direct a flow of filtered air in a downward direction (Fig. 10 [0100]); an air conduit (15 and 205), wherein a proximal end of the conduit is connected with the air inlet of the air duct (Fig. 9); and a filter unit connected with a distal end of the conduit and defining a fluid path for delivering the flow of filtered air from an ambient environment to the conduit [0075], wherein the filter unit comprises: one or more filter elements [0075], the one or more filter elements disposed along the fluid path [0075]; and an air pump connected with the one or more filter elements and disposed along the fluid path [0075], wherein the pump moves air from the ambient environment through the filter elements to generate the flow of filtered air [0075], but is silent regarding that the material is fabric consisting of cotton, nylon, and a combination thereof. However, Salter teaches a gas conduit made of a resilient flexible nylon [0129]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lee’s resilient material with resilient nylon, as taught by Salter, for the purpose of providing an alternate resilient gas conduit material having the predictable results of directing gas.
Regarding claim 16, the modified Lee discloses that the strip is attached to the inside surface of the hood by seams ([0070] Lee) extending along outer edges of the strip ([0070] Lee) and forming an air-tight bond between the strip and the hood ([0070] Lee).
Regarding claim 18, the modified Lee discloses that the air duct has a proximal end and a distal end (Fig. 10, Lee), wherein the distal end comprises the air outlet formed as one or more openings (217a-e, Lee) or as one or more louvers to direct the flow of filtered air towards a face of the human, and wherein the proximal end is connected to the air conduit in an air-tight manner ([0073] Lee).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Lee and Salter, as applied to claim 15 above, in further view of Vaughan et al. (WO 83/00632).
Regarding claim 17, the modified Lee is silent regarding a coil member disposed within the lumen and dimensioned to hold the lumen in an open configuration. However, Vaughan teaches a coil member 9 disposed within a lumen and dimensioned to hold the lumen in an open configuration (Page 3, ll. 23-27). 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 Lee’s lumen with the addition of a coil member, as taught by Vaughan, for the purpose of providing further resistance to collapse of the lumen.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Lee and Salter, as applied to claim 15 above, in further view of Bare et al. (5,054,480).
Regarding claim 19, the modified Lee discloses that the air duct includes a wide proximal portion and a narrow distal portion [0095], but is silent regarding one or more venting holes disposed between the proximal and distal ends of the air duct to direct the flow of filtered air onto the head or sides of the face of the human. However, in fig. 4 Bare teaches one or more venting holes 452 disposed between the proximal and distal ends of an air duct to direct the flow of filtered air onto the head or sides of the face of the human (Col. 7, ll. 22-26). 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 Lee’s duct with the addition of venting holes, as taught by Bare, for the purpose of providing airflow to the user’s head if desired for cooling.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Lee and Salter, as applied to claim 15 above, in further view of Plut et al. (2006/0277668).
Regarding claim 20, the modified Lee discloses that the filter unit is adapted to be worn adjacent a back of the human [0068], but is silent regarding that the hood is adapted to engage with a surgical gown, and wherein the one or more filter elements are selected from one or more of a high efficiency particulate air filter, an activated carbon filter, an electrostatic filter, and an ultraviolet air purifier. However, in fig. 3A Plut teaches a hood that is adapted to engage with a surgical gown [0083] and HEPA filters [0059]. 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 Lee’s hood and skirt with the addition of a gown and Lee’s filter with a HEPA filter, as taught by Plut, for the purpose of providing further protection to the user and others in the vicinity.
Response to Arguments
Applicant’s arguments, see pages 7-8, filed 7/8/25, with respect to the rejections of claims 1 and 15 under Lee 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 Lee and Salter.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL T SIPPEL whose telephone number is (571)270-1481. The examiner can normally be reached M-F 9:00-5:00 PM.
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/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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