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 .
This Office Action is responsive to the Amendment filed 29 January 2026. Claims 1-23 are currently under consideration. The Office acknowledges the amendments to claims 1, 5, 10-13, 20, 21, and 23.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 6, 7, 11-14, 17-19, 21, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (U.S. Pub. No. 2021/0315757 A1; hereinafter known as “Nguyen”), in view of Levine et al. (U.S. Pub. No. 2021/0401532 A1; hereinafter known as “Levine”).
Regarding claim 1, Nguyen discloses a hygienic barrier 100A for suspending over a patient to limit a spread of fluids (Abstract; Fig. 1), the hygienic barrier comprising: a flat sheet material ([0044]; [0048]) having a reinforced region 400 and an enclosure portion 108, the enclosure portion being unreinforced, where the enclosure portion encircles the reinforced region such that when suspended above the patient, in a deployed configuration, the enclosure portion hangs down from the reinforced region through a force of gravity to form an enclosure space, where at least the enclosure portion allows for direct visualization of the patient therethrough ([0046]; [0048]); the enclosure portion having a patient-side on an interior of the enclosure space and a caregiver-side exterior to the enclosure space ([0048]); a plurality of arm openings 118 located in the enclosure portion, the plurality of arm openings includes an arm sleeve 115, the arm sleeve having a near end, a far end, and a sleeve wall extending therebetween, the near end being joined to the enclosure portion about a respective arm opening, where the sleeve wall extends within the enclosure space such that the far end can be moveably positioned in the enclosure space when a caregiver extends a hand into one of the plurality of arm openings from the caregiver-side, where the arm sleeve and the enclosure portion maintain a fluid barrier between the patient and the caregiver (Figs. 1, 2C; [0049]-[0050]); and a plurality of tool openings in the enclosure portion that allows an instrument to be passed from the caregiver-side through the enclosure portion to the patient-side and into the enclosure space (the additional arm openings can also comprise tool openings). Nguyen fails to disclose that, in the deployed configuration, the plurality of arm openings surrounds the enclosure space. Nguyen teaches that, for example, there may be two openings on each of three sides, as well as that other configurations are possible. Levine discloses a similar apparatus (Abstract) wherein a plurality of arm openings 122 surround an enclosure space in order to provide easy access to multiple portions of the patient and allow multiple health care workers to simultaneously have access to the patient (Fig. 6; [0042]-[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 invention of Nguyen so that the plurality of arm openings surrounds the enclosure space, as taught by Levine, in order to provide easy access to multiple portions of the patient and allow multiple health care workers to simultaneously have access to the patient.
Regarding claim 2, the combination of Nguyen and Levine discloses the invention as claimed, see rejection supra, and Nguyen further discloses that the reinforced region and enclosure portion comprises a continuous sheet of material, and wherein the reinforced region includes a reinforcement support structure 107 ([0046]; [0048]; [0054]).
Regarding claim 3, the combination of Nguyen and Levine discloses the invention as claimed, see rejection supra, and Nguyen further discloses that the reinforced region comprises a material having a pre-determined shape 107, wherein the enclosure portion is joined to the reinforced region ([0046]; [0050]; [0054]).
Regarding claim 4, the combination of Nguyen and Levine discloses the invention as claimed, see rejection supra, and Nguyen further discloses that the reinforced region comprises a shape selected from a group consisting of a planar shape, a concave shape, and a polygonal shape (Fig. 1; [0046]).
Regarding claim 6, the combination of Nguyen and Levine discloses the invention as claimed, see rejection supra, and Nguyen further discloses that the reinforced region comprises a frame structure 107 adjacent to the reinforced region ([0046]).
Regarding claim 7, the combination of Nguyen and Levine discloses the invention as claimed, see rejection supra, and Nguyen further discloses that the reinforced region bends to a lesser degree than the enclosure portion to create an increased area of the enclosure space adjacent to the reinforced region ([0046]; capable of such, as the reinforced region includes wood/metal/coat hanger/PVC pipes, which bend less than the plastic sheet material of the enclosure portion).
Regarding claim 11, the combination of Nguyen and Levine discloses the invention as claimed, see rejection supra, and Nguyen further discloses a temporary barrier in at least one tool opening ([0068]).
Regarding claim 12, the combination of Nguyen and Levine discloses the invention as claimed, see rejection supra, and Levine further discloses at least two overlapping flaps 136 in at least one tool opening in order to facilitate access while still protecting the caregiver ([0042]-[0046]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Nguyen and Levine with the flaps taught by Levine in order to facilitate access while still protecting the caregiver.
Regarding claim 13, the combination of Nguyen and Levine discloses the invention as claimed, see rejection supra, and Levine further discloses the far end of an arm sleeve that comprises a hand opening surrounded by an elastic portion 155, such that when a caregiver extends the hand into the hand opening and through the hand opening, the elastic portion causes the sleeve wall to close about the hand or an arm of the caregiver in order to securely protect the caregiver ([0060]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Nguyen and Levine with such an elastic portion as taught by Levine in order to securely protect the caregiver.
Regarding claim 14, the combination of Nguyen and Levine discloses the invention as claimed, see rejection supra, and Levine further discloses an enclosure portion with an outer perimeter that is weighted relative to an inner perimeter in order to secure the enclosure portion to a patient table ([0040]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Nguyen and Levine with the weights taught by Levine in order to secure the enclosure portion to a patient table.
Regarding claim 17, the combination of Nguyen and Levine discloses the invention as claimed, see rejection supra, and Nguyen further discloses that the enclosure portion is frameless (Fig. 1; [0048]).
Regarding claim 18, the combination of Nguyen and Levine discloses the invention as claimed, see rejection supra, and Nguyen further discloses an attachment arm 110 coupled to the reinforced region, where the attachment arm can be detachably coupled to an external structure to suspend the hygienic barrier ([0046]-[0047]).
Regarding claim 19, the combination of Nguyen and Levine discloses the invention as claimed, see rejection supra, and Nguyen further discloses a pre-deployment configuration wherein the enclosure portion is folded in a flat shape ([0069]).
Regarding claim 21, Nguyen discloses a method for a caregiver to interact with a patient through a hygienic barrier (Abstract; Fig. 1), the method comprising: suspending a reinforced section 400 of a sheet of material having a flat configuration such that gravity causes an enclosure portion 108 of the sheet of material to hang down from the reinforced section to form an enclosure space having a plurality of arm openings 118 positioned around the enclosure space, such that a patient-side of the sheet of material is located on an interior of the enclosure space and a caregiver side of the sheet of material is exterior to the enclosure space; positioning the patient within the enclosure space such that the reinforced section is spaced from the patient (Figs. 2D, 12C; [0046]; [0048]; [0054]); inserting an arm of the caregiver through an arm opening 118 of the plurality of arm openings in the enclosure portion where the arm opening includes an arm sleeve 115 having a near end, a far end, and a sleeve wall extending therebetween, the near end being joined to the sheet of material about the arm opening, where the arm sleeve wall extends within the enclosure space ([0049]; [0068]); inserting an instrument through a tool opening in the enclosure portion such that an end of the instrument passes from the caregiver-side through the sheet of material to the patient-side and into the enclosure space ([0053]); and handling the patient or manipulating the instrument through the arm sleeve such that the caregiver can directly visualize the patient through the hygienic barrier ([0048]-[0049]; [0068]). Nguyen fails to disclose that the plurality of arm openings is positioned to surround the enclosure space. Nguyen teaches that, for example, there may be two openings on each of three sides, as well as that other configurations are possible. Levine discloses a similar method (Abstract) wherein a plurality of arm openings 122 surround an enclosure space in order to provide easy access to multiple portions of the patient and allow multiple health care workers to simultaneously have access to the patient (Fig. 6; [0042]-[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 invention of Nguyen so that the plurality of arm openings is positioned to surround the enclosure space, as taught by Levine, in order to provide easy access to multiple portions of the patient and allow multiple health care workers to simultaneously have access to the patient.
Regarding claim 22, the combination of Nguyen and Levine discloses the invention as claimed, see rejection supra, and Nguyen further discloses that the instrument comprises a device selected from the group consisting of an illumination device, a positive pressure device, a ventilation device, a suction device, and a UVC illumination device ([0053]; [0062]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Nguyen and Levine as applied to claim 1 above, and further in view of Cuschieri et al. (U.S. No. 5,480,410; hereinafter known as “Cuschieri”). The combination of Nguyen and Levine discloses the invention as claimed, see rejection supra, and Nguyen further discloses that the at least one tool opening is located adjacent to the at least one arm opening (Fig. 1; e.g., two openings are next to each other). The combination of Nguyen and Levine fails to expressly discloses that a size of at least one tool opening is less than a size of the plurality of arm openings. Cuschieri discloses a similar apparatus (Abstract; Fig. 1) that includes at least one tool opening 5 and a plurality of arm openings 5, wherein a size of at least one tool opening is less than a size of the plurality of arm openings in order to allow access of instruments through the smaller openings while allowing hand/arm access through the larger openings, so as to maintain a substantially gastight seal (Abstract; col. 3, lines 25-33; col. 4, lines 34-37). 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 combination of Nguyen and Levine so that a size of at least one tool opening is less than a size of the plurality of arm openings, as taught by Cuschieri, in order to allow access of instruments through the smaller openings while allowing hand/arm access through the larger openings, so as to maintain a substantially gastight seal.
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen and Levine as applied to claim 1 above, and further in view of Breegi (U.S. Pub. No. 2019/0380901 A1; hereinafter known as “Breegi”).
Regarding claims 8 and 9, the combination of Nguyen and Levine discloses the invention as claimed, see rejection supra, but fails to expressly disclose that the far end of the arm sleeve comprises a glove shape with at least two opposable portions, wherein the glove shape comprises four finger portions and a thumb portion. Breegi discloses a similar apparatus (Abstract) comprising an arm sleeve with a glove shape with at least two opposable portions, wherein the glove shape comprises four finger portions and a thumb portion, in order to allow for manipulation within the enclosure space without direct contact with the caregiver’s hands ([0063]; Fig. 5). 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 combination of Nguyen and Levine with the glove shaped arm sleeve taught by Breegi in order to allow for manipulation within the enclosure space without direct contact with the caregiver’s hands.
Regarding claim 10, the combination of Nguyen and Levine discloses the invention as claimed, see rejection supra, but fails to expressly disclose a valve structure located in the at least one tool opening. Breegi discloses a similar apparatus (Abstract) comprising a valve structure 54 located in at least one tool opening in order to provide a controlled flow mechanism ([0066]; [0078]). 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 combination of Nguyen and Levine with the valve structure taught by Breegi in order to provide a controlled flow mechanism.
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen and Levine as applied to claim 1 above, and further in view of Sharitz (U.S. Pub. No. 2016/0038363 A1). The combination of Nguyen and Levine discloses the invention as claimed, see rejection supra, but fails to expressly disclose one or more pockets on the caregiver-side or on the patient-side of the enclosure portion. Sharitz discloses a similar apparatus (Abstract; Figs. 3, 5, 6) comprising pockets on both exterior and interior surfaces in order to hold various equipment as needed ([0011]; [0050]). 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 combination of Nguyen and Levine with the pockets taught by Sharitz in order to hold various equipment as needed.
Claims 20 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen, in view of Cuschieri.
Regarding claim 20, Nguyen discloses a method for establishing a hygienic barrier between a caregiver and a patient (Abstract; Fig. 1), the method comprising: suspending a reinforced section 400 of a sheet of material having a flat configuration above the patient such that gravity causes an enclosure portion 108 of the sheet of material to hang down from the reinforced section to form an enclosure space about the patient, where a patient-side of the sheet of material is located on an interior of the enclosure space and a caregiver-side of the sheet of material is exterior to the enclosure space (Figs. 2D, 12C; [0046]; [0048]; [0054]); wherein the enclosure portion includes a plurality of arm openings 118, and at least one of the plurality of arm openings includes an arm sleeve 115 having a near end, a far end, and a sleeve wall extending therebetween, the near end being joined to the sheet of material about a respective arm opening, where the sleeve wall extends within the enclosure space (Figs. 1, 2C; [0049]-[0050]); wherein the enclosure portion includes at least one tool opening adjacent to at least one arm opening, where the at least one tool opening allows an instrument to be passed from the caregiver-side through the sheet of material to the patient-side and into the enclosure space (the additional arm openings can also comprise tool openings); and wherein the caregiver can insert a hand into the sleeve wall through the one or more arm openings and to the far end allowing for the caregiver to manipulate the instrument while the sleeve wall and the sheet of material maintains the hygienic barrier between the caregiver and the patient allowing the caregiver to attend to and directly visualize the patient through the hygienic barrier ([0048]-[0049]; [0068]). Nguyen fails to expressly disclose that a size of the at least one tool opening is less than a size of the at least one arm opening. Cuschieri discloses a similar method (Abstract; Fig. 1) that includes at least one tool opening 5 and at least one arm opening 5, wherein a size of at least one tool opening is less than a size of the at least one arm opening in order to allow access of instruments through the smaller openings while allowing hand/arm access through the larger openings, so as to maintain a substantially gastight seal (Abstract; col. 3, lines 25-33; col. 4, lines 34-37). 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 invention of Nguyen so that a size of at least one tool opening is less than a size of the at least one arm opening, as taught by Cuschieri, in order to allow access of instruments through the smaller openings while allowing hand/arm access through the larger openings, so as to maintain a substantially gastight seal.
Regarding claim 23, Nguyen discloses a hygienic barrier 100A for suspending over a patient to limit a spread of fluids (Abstract; Fig. 1), the hygienic barrier comprising: a flat sheet material ([0044]; [0048]) having a reinforced region 400 and an enclosure portion 108, the enclosure portion being unreinforced, where the enclosure portion encircles the reinforced region such that when suspended above the patient, in a deployed configuration, the enclosure portion hangs down from the reinforced region through a force of gravity to form an enclosure space, where at least the enclosure portion allows for direct visualization of the patient therethrough ([0046]; [0048]); the enclosure portion having a patient-side on an interior of the enclosure space and a caregiver-side exterior to the enclosure space ([0048]); a plurality of arm openings 118 located in the enclosure portion, the plurality of arm openings includes an arm sleeve 115, the arm sleeve having a near end, a far end, and a sleeve wall extending therebetween, the near end being joined to the enclosure portion about a respective arm opening, where the sleeve wall extends within the enclosure space such that the far end can be moveably positioned in the enclosure space when a caregiver extends a hand into one of the plurality of arm openings from the caregiver-side, where the arm sleeve and the enclosure portion maintain a fluid barrier between the patient and the caregiver (Figs. 1, 2C; [0049]-[0050]); and a plurality of tool openings 118 in the enclosure portion that allows an instrument to be passed from the caregiver-side through the enclosure portion to the patient-side and into the enclosure space, wherein the plurality of tool openings are positioned adjacent the plurality of arm openings (the additional arm openings can also comprise tool openings; e.g., on each side, there is one arm opening and one tool opening). Nguyen fails to disclose that a size of the plurality of tool openings is less than a size of the plurality of arm openings. Cuschieri discloses a similar method (Abstract; Fig. 1) that includes a plurality of tool openings 5 and a plurality of arm openings 5, wherein a size of the plurality of tool openings is less than a size of the plurality of arm openings in order to allow access of instruments through the smaller openings while allowing hand/arm access through the larger openings, so as to maintain a substantially gastight seal (Abstract; col. 3, lines 25-33; col. 4, lines 34-37). 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 invention of Nguyen so that a size of the plurality of tool openings is less than a size of the plurality of arm openings, as taught by Cuschieri, in order to allow access of instruments through the smaller openings while allowing hand/arm access through the larger openings, so as to maintain a substantially gastight seal.
Response to Arguments
Applicant’s arguments with respect to the objections to claims 1 and 20, as well as the rejections under 35 U.S.C. 112(b), have been fully considered and are persuasive in light of the amendments. The objections and rejections have been withdrawn.
Applicant's arguments with respect to the rejections under 35 U.S.C. 103 have been fully considered but they are not persuasive. Applicant argues that the recited hygienic barrier comprises a structure that is an integrated, single-piece construction and that neither Levine nor Nguyen discloses such a structure. However, this language (“integrated, single-piece construction”) does not appear in the present claims. Instead, the claims merely recite a flat sheet material having a reinforced region and an enclosure portion, which is precisely what Nguyen teaches (e.g., a flat sheet material with a region that is reinforced by a frame and with a hanging enclosure portion that is unreinforced). Applicant also takes issue with Nguyen’s teaching of both a plurality of arm openings and a plurality of tool openings, arguing that the claim requires two different types of openings for two different functions. The examiner disagrees. Nothing in the claim language recites any sort of structural difference between the two types of openings; the only difference is intended-use language. Clearly, the openings taught by Nguyen are able to receive both a hand/arm of a caregiver and a tool/instrument. Where the claims actually recite structural differences between the openings (e.g., claims 5, 20, 23), Nguyen is not relied upon for these claimed features.
Applicant also argues that Cuschieri is non-analogous art that is intended to solve a different problem from Nguyen and therefore is an improper combination. The examiner disagrees. Both references teach enclosures for protection during medical procedures, wherein access is provided from the outside of the enclosure into the interior of the enclosure through a transparent plastic wall. Nguyen also specifically teaches that the openings can be closed to keep the apparatus airtight.
Conclusion
THIS ACTION IS MADE FINAL. 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 THADDEUS B COX whose telephone number is (571)270-5132. The examiner can normally be reached M-F 9am-6pm.
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/THADDEUS B COX/Primary Examiner, Art Unit 3791