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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the support structure extending internally as in claim 12 and the support structure is a tubular extension as in claim 13 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 20 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.
The term “a few millimeters” in claim 20 is a relative term which renders the claim indefinite. The term “a few millimeters” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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) 1-4 and 6-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bush et al. (US Pub 2021/0345699).
With respect to claim 1, Bush discloses a PPE shield (see figures 2 and 4B and C below) for use by a healthcare provider when performing an oral or nasal procedure on a patient (paragraph 82), said shield comprising: a sheet of plastic material (fig 2 and paragraph 104) ; an opening (see fig 4C, 21) in the plastic material; and a support structure (fig 4C, 20) surrounding the opening and extending from a surface of the sheet of plastic (fig 4c) wherein: when a tongue depressor or an oral/nasal swab is inserted through the opening, the PPE shield becomes mounted on the tongue depressor or oral/nasal swab (paragraph 10, the ports are self-sealing with the instrument in the port), and the support structure provides more stability to the PPE shield when it is mounted on the tongue depressor or oral/nasal swab (paragraph 82 the thicker portions of the port improve sealability and positioning of the instruments);and when the PPE shield which is mounted on the tongue depressor or oral/nasal swab is placed by the healthcare provider in front of but not mounted to the patient's face, the PPE shield establishes a barrier between the patient and the healthcare provider (can be used without the straps as the straps or shown as removable from the shield and paragraph 53 placed on “or” strapped to form a barrier). With respect to claim 2, Bush discloses wherein: the sheet of material is concave, to conform to the generally convex shape of the patient's face (see fig 2 and 4C . With respect to claim 3, Bush discloses wherein: the sheet of material is in the shape of a truncated cone (frustrum) (see fig 2 below) or hemispherical. With respect to claim 4, Bush discloses wherein: the plastic material is transparent (paragraph 108). With respect to claim 6, Bush discloses wherein: the shield is sufficiently rigid to not deform when slight forces are applied thereto, such as when inserting a tongue depressor or nasal swab through the opening, and subsequently manipulating the depressor or swab (paragraph 106, stiffer and durable). With respect to claim 7, Bush discloses wherein: the shield is sized and shaped to fit over (in front of) the mouth of a patient, including the patient's jaw (fig 12). With respect to claim 8, Bush discloses wherein: the shield is sized and shaped to fit over (in front of) the lower facial area of a patient, including patient's mouth and optionally the patient's nose (fig 12). With respect to claim 9, Bush discloses wherein: in use, when the shield placed onto (in front of) the patient's face, the shield establishes a barrier between the patient and a healthcare provider to substantially block aerosols and the like which may be exhaled or expelled by the patient, thereby protecting the healthcare provider from exposure to these aerosols and the like (fig 12 and paragraph 102). With respect to claim 10, Bush discloses, wherein: the opening is in the form of a slot or slit (fig 4B, 21) which is sized to receive a tongue depressor or nasal swab with a slight interference fit (title, self-sealing) which allows the tongue depressor or nasal swab to be inserted through the shield, resulting in the shield being supported on the tongue depressor or nasal swab during performing the oral or nasal procedure, respectively. With respect to claim 11, Bush discloses further comprising: a support structure disposed at or around the opening to provide stability to a tongue depressor or nasal swab inserted through the opening (paragraph 106). With respect to claim 12, Bush discloses wherein: the support structure is formed integrally with the shield, and extends either internally (in use, towards the patient) or externally (in use, towards the healthcare provider) from a respective inner or outer surface of the shield (fig 4C shows the support 20 extending both internally and externally). With respect to claim 13, Bush discloses wherein: the support structure is in the form of a tubular extension of the opening (fig 4B and C shows 20 as a tubular extension through the surface). With respect to claim 14, Bush discloses wherein: a portion of the shield is flat (see fig 2 below), providing a view port allowing the healthcare provider to have an unobstructed and undistorted view of the patient's oral cavity or nasal passage while performing the procedure. With respect to claim 15, Bush discloses wherein: the opening is disposed on the view port (fig 4C shows the opening on the port). With respect to claim 16, Bush discloses wherein: the opening is disposed offset from a center of the view port (fig 2 shows the opening off-center from the port center). With respect to claim 17, Bush discloses wherein: the opening is disposed offset from a center of the overall shield (fig 2). With respect to claim 18, Bush discloses a method of performing an oral or nasal procedure on a patient, comprising: providing a shield as described in claim 1 (fig 12); inserting a tongue depressor or swab through the opening of the shield (paragraph 82); and performing the procedure (paragraph 82).
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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) 5 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bush et al. (US Pub 2021/0345699) in view of Salce et al. (US Patent 4,950,445).
With respect to claim 5, Bush discloses the claimed invention with the material being any suitable material but does not specifically disclose the material is PET (polyethylene terephthalate).
Salce discloses a mask being made of PET (polyethylene terephthalate) (col. 5, ll. 6) to be transparent, inexpensive and lightweight (col. 4, ll. 66 and col. 3, ll. and col. 3, ll. 43)
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the shield out of PET (polyethylene terephthalate) in view of Salce in order to be transparent, inexpensive and lightweight.
With respect to claim 19, Bush discloses the claimed invention except for is silent on the method of forming the shield including comprising: vacuum forming the shield of claim 1, including a protruding portion of the shield which forms a support structure; and then cutting or slitting the protruding portion of the shield which forms the support structure.
Salce disclose a method of forming a shield comprising: vacuum forming the shield, including a protruding portion of the shield which forms a support structure (col. 6, ll. 18); and then cutting or slitting the protruding portion of the shield which forms the support structure (col. 5, ll. 45-50 die cutting the openings) to make the shield in a lightweight and inexpensive method to allow for disposing of the shield (col. 1, ll. 43-50).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the Shield of Bush by comprising: vacuum forming the shield of claim 1, including a protruding portion of the shield which forms a support structure; and then cutting or slitting the protruding portion of the shield which forms the support structure in view of Salce in order to make the shield in a lightweight and inexpensive method to allow for disposing of the shield.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bush et al. (US Pub 2021/0345699).
With respect to claim 20, Bush discloses the support structure extending from the internal and external surface of the shield (fig 4C) but does not specifically disclose it extends a few millimeters. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention have the support extend a few millimeters since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Response to Arguments
Applicant’s arguments, see remarks, filed 7/21/2025, with respect to the objection of the IDS have been fully considered and are persuasive. The objection of the IDS has been withdrawn.
Applicant’s arguments, see remarks, filed 7/21/2025, with respect to the objection of the Specification have been fully considered and are persuasive. The objection of the Specification has been withdrawn.
Applicant’s arguments, with respect to the U.S.C. 112 rejection of claims 4 and 11-16 have been fully considered and are persuasive. The U.S.C. 112 rejection of claims 4 and 11-16 has been withdrawn.
Applicant's arguments filed 7/21/2025 have been fully considered but they are not persuasive. With respect to the objection of the drawing the applicant argues that the drawings are provided in an appendix to the specification these drawings are not part of the drawings such that the claimed features are not shown in the drawings.
Applicant's arguments filed 7/21/2025 have been fully considered but they are not persuasive. The applicant argues that the current application mounts the instrument to the mask while Bush discloses that the mask is mounted to the face of the patient. The examiner respectfully disagrees. Bush does disclose that the mask mounts to the instrument. Paragraph 10 discloses that the port seals to the instrument positioned therethrough such that they are mounted together. Bush also discloses that the shield can be used without the straps as paragraph 53 states the shield can be placed on “or” strapped to form a barrier such that bush also discloses not fixing the shield to the face.
The applicant does not individually argue the 103 rejection.
The rejections are deemed proper.
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 STEVEN J COTRONEO whose telephone number is (571)270-7388. The examiner can normally be reached Monday-Friday 9am-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.J.C/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773