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 .
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later- filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. V. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994). The disclosure of the prior-filed application, Application No. 17/191823, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The '823 application does not provide support for at least the limitation "an air filter operatively disposed in fluid communication with said vacuum tube and positioned between said shield body and said vacuum unit". Accordingly, the claims have an effective filing date of 04/08/2022.
Claim Objections
Claim 8 is objected to because of the following informalities: “a connecting portion” should recite “the connecting portion”. Appropriate correction is required.
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) 1 – 3 and 17 - 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lindkvist (US 4794921) in view of Howell (US 5871011).
Claim 1. Lindkvist discloses a system configured to remove exhaled air from a patient wearing a medical mask (see Fig. 5, c. 4: 63 – 68), the system comprising: a vacuum tube (20), a vacuum shield assembly disposable onto the patient wearing the medical mask (50, 52), the vacuum shield assembly comprising a shield body (50), said shield body comprising a connecting portion disposed in fluid communication with said vacuum tube (62, c. 9: 22 – 29), a retaining assembly (52) structured to retain said vacuum tube and a component of the medical mask (component 18, c. 5: 35 - 40; see also c. 9: 24 – 25, c. 8: 9) said retaining assembly comprising: a retaining component configured and dimensioned to retain said connecting portion of said shield body (see Figs. 4 and 5, proximal portion of 104 downstream 150 that connects to 62; the proximal portion may be additionally interpreted to include proximal section 106, see c. 8: 1- 7), a lower section of said retaining component configured and dimensioned for attachment of said vacuum tube (150, see c. 9: 24 – 25), and a retaining frame connected to said retaining component and configured to retain the component of the medical mask (distally protruding section 106 upstream 150, see c. 8: 9), a vacuum unit (26), said vacuum unit disposed in fluid communication with said vacuum tube and an inside of said shield body (c. 4: 63 – 68), and said vacuum unit, said vacuum tube and said shield body collectively disposable into and out of an operative orientation and an inoperative orientation (see operative position in Figs. 1, 2, and 4 upon connection, versus inoperative position in Fig. 5 upon disconnection; the vacuum port allows for the vacuum tube to be installed).
However, Lindkvist does not disclose an air filter operatively disposed in fluid communication with said vacuum tube and positioned between said shield body and said vacuum unit. However, Howell discloses a system configured to remove exhaled air from a patient wearing a medical mask, the system comprising a vacuum unit (see Fig. 3, "pump", C. 4: 28 - 29), and an air filter operatively disposed in fluid communication with said vacuum tube and positioned between said mask and said vacuum unit (see Fig. 3, 130, C. 4: 66 - 67 "filter media"). Said vacuum unit would be collectively disposable into and out of an operative orientation and an inoperative orientation upon disconnecting the vacuum tube from the shield body as described in Lindkvist above, since the vacuum unit operates via fluid communication with said the vacuum tube (c. 4: 28 - 37, Fig. 1, Fig. 3). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the vacuum tube of Lindkvist with an air filter as taught in Howell for the benefit of reliably and safely disposing of the harmful exhalations (c. 4: 33 – 35).
Claim 2. Lindkvist discloses the system recited in claim 1 wherein said operative orientation comprises: said vacuum unit configured to be activated and exerting a negative pressure on an inside of said shield body at least partially removing exhaled air from the patient (c. 4: 63 – 68).
Claim 3. The modified Lindkvist discloses the system as recited in claim 1 wherein said air filter is positioned between said vacuum tube and said vacuum unit (see Fig. 3 of Howell, 130, line “waste gas”, and “pump”, respectively).
Claim 17. Lindkvist in view of Howell discloses a method for removing exhaled air from a patient wearing a medical mask, the method comprising: (i) providing a system configured to remove exhaled air from the patient wearing the medical mask, the system comprising: a vacuum tube, a vacuum shield assembly disposable onto the patient wearing the medical mask, the vacuum shield assembly comprising a shield body, said shield body comprising a connecting portion disposed in fluid communication with said vacuum tube, a retaining assembly structured to retain the vacuum tube and a component of the medical mask, said retaining assembly comprising: a retaining component configured and dimensioned to retain said connecting portion of said shield body, a lower section of said retaining component configured and dimensioned for attachment of said vacuum tube, and a retaining frame connected to said retaining component and configured to retain the component of the medical mask, a vacuum unit, an air filter operatively disposed in fluid communication with said vacuum tube and positioned between said shield body and said vacuum unit, the vacuum tube disposed in fluid communication with an inside of the shield body and the vacuum unit, and the vacuum tube, the shield body and the vacuum unit collectively disposable into and out of an operative orientation and an inoperative orientation (see claims 1 – 3 above), (ii) disposing the shield body onto the retaining assembly (see Fig. 4 of Lindkvist), (iii) disposing the component of the medical mask on to the retaining assembly (see Fig. 4 of Lindkvist), (iv) disposing the vacuum tube in fluid communication with an inside of the shield body (c. 4: 63 – 68), (v) at least partially disposing the medical mask on the head of the patient (see Fig. 1 of Lindkvist), and (vi) at least partially disposing the shield body around the medical mask (see Fig. 4 of Lindkvist).
Claim 18. Lindkvist discloses the method as recited in claim 17 wherein (v) at least partially disposing the shield body around the medical mask comprises at least partially disposing the shield body around the medical mask and in proximity to the face of the patient creating an enclosure zone (see Fig. 1 and c. 4: 63 – 68).
Claim 19. Lindkvist discloses the method as recited in claim 17 further comprising: (vii) disposing the vacuum tube in fluid communication with an inside of the vacuum unit, and (viii) activating the vacuum unit to exert a negative pressure on the enclosure zone and remove exhaled air from the patient (see Fig. 4 and c. 4: 63 – 68).
Claim 20. Lindkvist discloses the method as recited in claim 19 wherein (viii) activating the vacuum unit to exert a negative pressure on the enclosure zone and remove exhaled air from the patient comprises activating the vacuum unit to exert a negative pressure on the inside of the vacuum tube and on the inside of the shield body to remove exhaled air from the patient between the inside of the shield body and the face of the patient (see Fig. 4 and c. 4: 63 – 68).
Claim(s) 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lindkvist (US 4794921) in view of Howell (US 5871011) in view of Martone (US 5806819).
Claims 10 and 11. Lindkvist discloses the vacuum shield assembly as recited in claim 1, but does not disclose wherein said retaining frame comprises a semi-cylindrical configuration, and does not disclose wherein said retaining assembly comprises a first closing mechanism comprising a plurality of serrations; said retaining assembly further comprising a second closing mechanism comprising a snap mechanism operatively configured and dimensioned with said plurality of serrations to adjust the size of said retaining frame. Nonetheless, Martone discloses wherein said retaining frame comprises a semi-cylindrical configuration (16, see Fig. 2), and said retaining assembly comprises a first closing mechanism comprising a plurality of serrations (Fig. 1, 24); said retaining assembly further comprising a second closing mechanism comprising a snap mechanism operatively configured and dimensioned with said plurality of serrations to adjust the size of said retaining frame (Fig. 1, 38). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the distal retaining frame 106 of Lindkvist to include the configuration with closing mechanism(s) of Martone for the benefit of adjustably securing conduits having different diameters (c. 1: 60 - 65).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1- 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 14 of U.S. Patent No. US 12083273 (hereinafter ‘273) in view of in view of Howell (US 5871011).
A table has been provided comparing the instant claims to USPN ‘273. Differences between the claims are highlighted below by bolding limitations that are not anticipated, italicizing limitations that are anticipated, and underlining limitations that will be addressed below.
Patent claim ‘273
Application claim 1
1. A vacuum shield assembly disposable onto a patient wearing a medical mask and configured to remove exhaled air from the patient, said vacuum shield assembly comprising: a shield body comprising a concave configuration, a lower segment disposed around a lower perimeter of said shield body, said lower segment comprising an opening, said concave configuration of said shield body configured and dimensioned to at least partially surround the medical mask, said shield body disposed in proximity, but in a spaced apart relation to the medical mask and the patient, a retaining assembly structured to retain a vacuum tube and an oxygen supply tube or a nebulizer unit of the medical mask, said retaining assembly adjacently disposed to said lower segment, said retaining assembly comprising: a retaining component configured and dimensioned to retain a connecting portion of said shield body, a lower section of said retaining component configured and dimensioned for attachment of the vacuum tube, and a retaining frame connected to said retaining component and configured to retain the oxygen supply tube or the nebulizer unit of the medical mask, at least one retaining segment disposed on said retaining frame; said at least one retaining segment configured to at least partially retain the nebulizer unit, said at least one retaining segment comprising a latch disposed on an upper end thereof; said latch structured to at least partially reduce movement of the nebulizer unit in a vertical direction, said lower segment configured for attachment to the vacuum tube below said lower perimeter of said shield body and configured to exert a negative pressure on an inside of said shield body, and said shield body and said retaining assembly collectively disposable into and out of an operative position and an inoperative position.
1. A system configured to remove exhaled air from a patient wearing a medical mask, the system comprising: a vacuum tube, a vacuum shield assembly disposable onto the patient wearing the medical mask, the vacuum shield assembly comprising a shield body, a retaining assembly structured to retain said vacuum tube and a component of the medical mask, said shield body comprising a connecting portion disposed in fluid communication with said vacuum tube, said retaining assembly comprising: a retaining component configured and dimensioned to retain said connecting portion of said shield body, a lower section of said retaining component configured and dimensioned for attachment of said vacuum tube, and a retaining frame connected to said retaining component and configured to retain the component of the medical mask, a vacuum unit, an air filter operatively disposed on an inside of said vacuum tube, said vacuum unit disposed in fluid communication with said vacuum tube and an inside of said shield body and said vacuum unit, and said vacuum unit, said vacuum tube and said shield body collectively disposable into and out of an operative orientation and an inoperative orientation.
As clear from the comparison, patent claims ‘273 do not disclose a system comprising: a vacuum tube, a vacuum unit, an air filter operatively disposed on an inside of said vacuum tube, said vacuum unit disposed in fluid communication with said vacuum tube and an inside of said shield body and said vacuum unit. Nonetheless, Howell renders obvious said limitations for the benefit of reliably and safely disposing of the harmful exhalations as discussed in the action above. Since patent claim ‘273 recite said shield body collectively disposable into and out of an operative position and an inoperative position, incorporation of Howell into ‘273 renders obvious said vacuum unit, said vacuum tube and said shield body collectively disposable into and out of an operative orientation and an inoperative orientation. As discussed in the action above, placing the shield body in an inoperative position with respect to the connecting retaining assembly, as claimed, would additionally dispose the vacuum unit and vacuum tube into an inoperative position.
Patent claim ‘273
Application claim 12
1. A vacuum shield assembly disposable onto a patient wearing a medical mask and configured to remove exhaled air from the patient, said vacuum shield assembly comprising: a shield body comprising a concave configuration, a lower segment disposed around a lower perimeter of said shield body, said lower segment comprising an opening, said concave configuration of said shield body configured and dimensioned to at least partially surround the medical mask, said shield body disposed in proximity, but in a spaced apart relation to the medical mask and the patient, a retaining assembly structured to retain a vacuum tube and an oxygen supply tube or a nebulizer unit of the medical mask, said retaining assembly adjacently disposed to said lower segment, said retaining assembly comprising: a retaining component configured and dimensioned to retain a connecting portion of said shield body, a lower section of said retaining component configured and dimensioned for attachment of the vacuum tube, and a retaining frame connected to said retaining component and configured to retain the oxygen supply tube or the nebulizer unit of the medical mask, at least one retaining segment disposed on said retaining frame; said at least one retaining segment configured to at least partially retain the nebulizer unit, said at least one retaining segment comprising a latch disposed on an upper end thereof; said latch structured to at least partially reduce movement of the nebulizer unit in a vertical direction, said lower segment configured for attachment to the vacuum tube below said lower perimeter of said shield body and configured to exert a negative pressure on an inside of said shield body, and said shield body and said retaining assembly collectively disposable into and out of an operative position and an inoperative position.
12. A system configured to remove exhaled air from a patient wearing a medical mask, the system comprising: a vacuum tube, a retaining assembly structured to retain said vacuum tube and an oxygen supply tube or a nebulizer unit of the medical mask, a vacuum shield assembly disposable onto the patient wearing the medical mask, the vacuum shield assembly comprising: a shield body comprising a concave configuration, a lower segment comprising an opening and disposed around a lower perimeter of said shield body, said lower segment configured for attachment to the vacuum tube and configured to exert a negative pressure on an inside of said shield body, said shield body, said vacuum tube and said retaining assembly collectively disposable into and out of an operative position and an inoperative position, said shield body comprising a connecting portion disposed in fluid communication with said vacuum tube, said retaining assembly comprising: a retaining component configured and dimensioned to retain said connecting portion of said shield body, a lower section of said retaining component configured and dimensioned for attachment of said vacuum tube, and a retaining frame connected to said retaining component and configured to retain the component of the medical mask, a vacuum unit, an air filter operatively disposed on an inside of said vacuum tube adjacent to said vacuum unit, said vacuum tube disposed in fluid communication with an inside of said vacuum unit and an inside of said shield body around its opening, and said vacuum unit, said vacuum tube and said vacuum shield collectively disposable into and out of an operative orientation and an inoperative orientation.
As clear from the comparison, patent claims ‘273 do not disclose a system comprising: a vacuum tube, a vacuum unit, an air filter operatively disposed on an inside of said vacuum tube, said vacuum unit disposed in fluid communication with said vacuum tube and an inside of said shield body and said vacuum unit. Nonetheless, Howell renders obvious said limitations for the benefit of reliably and safely disposing of the harmful exhalations as discussed in the action above. Since patent claim ‘273 recite said shield body collectively disposable into and out of an operative position and an inoperative position, incorporation of Howell into ‘273 renders obvious said vacuum unit, said vacuum tube and said shield body collectively disposable into and out of an operative orientation and an inoperative orientation, and said shield body, said vacuum tube and said retaining assembly collectively disposable into and out of an operative position and an inoperative position. As discussed in the action above, placing the shield body in an inoperative position, as claimed, would additionally dispose the vacuum unit and vacuum tube into an inoperative position.
With regard to claim 17, examiner has already addressed the step of providing the system, as disclosed in claims 1 and 12 above. The additional method steps are anticipated as follows: (ii) disposing the shield body onto the retaining assembly (“said retaining assembly adjacently disposed to said lower segment, said retaining assembly comprising: a retaining component configured and dimensioned to retain a connecting portion of said shield body”) (iii) disposing the component of the medical mask onto the retaining assembly (“retaining frame connected to said retaining component and configured to retain the oxygen supply tube or the nebulizer unit of the medical mask”), (v) at least partially disposing the medical mask on the head of the patient (“a patient wearing a medical mask and configured to remove exhaled air from the patient”), and (vi) at least partially disposing the shield body around the medical mask (“said concave configuration of said shield body configured and dimensioned to at least partially surround the medical mask”). As explained in the paragraph above, the step of (iv) disposing the vacuum tube in fluid communication with an inside of the shield body would be rendered obvious upon incorporation of Howell.
Dependent claims from the instant application are furthermore rendered obvious by the double patenting rejection of ‘273 in view of Howell. Accordingly, claims 1 – 20 in the instant application are rejected over ‘273 in view of Howell.
Allowable Subject Matter
Claim 12 would be allowable upon submission of a terminal disclaimer. Similarly, claim 4 would be allowable if rewritten to include all of the limitations of the base claim and intervening claims, and upon submission of a terminal disclaimer.
The following is an examiner’s statement of reasons for allowance:
Lindkvist fails to disclose that the shield assembly further comprises a lower segment comprising an opening and disposed around a lower perimeter of said shield body, wherein said lower segment is configured for attachment to the vacuum tube. Under a broad interpretation of the claim the lower half of the shield of Lindkvist may be considered as the lower segment comprising the vacuum opening, as best illustrated in Fig. 6 of Lindkvist, in which the lower segment encompasses opening 56. However, the lower segment is not reasonably disposed around a lower perimeter of the shield body, since the lower segment itself forms the lower perimeter of the shield body, and is thus disposed around a central portion or upper segment of the shield body.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 12, 17, and dependents therein have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant states a terminal disclaimer has been filed obviating the double patenting rejection to ‘273. However, it appears no terminal disclaimer is present on record.
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 BRADLEY H PHILIPS whose telephone number is (571)270-5180. The examiner can normally be reached 8:00 - 5:00 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799