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 .
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 17-20 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.
Regarding claim 17, the limitation “an adhesive strip comprising… the adhesive strip comprising one or more layers of the adhesive strip… wherein the adhesive strips comprises…” renders the claim indefinite. It is unclear how an adhesive strip, which is recited as a singular strip, may comprise multiple layers of itself. From the claim construction and language it is unclear if applicant is attempting to claim one or more sublayers which make up the adhesive strip, but has mistakenly called the sublayer the adhesive strip as well. Alternatively, it is unclear if applicant intends to simply claim the adhesive strip as having one or more layers. For claim examination purposes, the limitation will be interpreted as the adhesive strip comprising one or more layers, which would include a layer of gel cushion and associated adhesive attached thereon, and the adhesive strip further comprising additional layers of an adhesive seal.
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 1-7, 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 12,214,133 B2 in view of Hara (U.S 2022/0218931 A1).
Regarding claim 1, Patent 12,214,133 B2 discloses a positive pressure ventilation apparatus (Claim 1, Col. 9 lines 57), comprising:
a multi-use positive pressure mask (Claim 1, Col. 9 line 58; Additionally, the positive pressure mask is not explicitly single-use and thus can simply be used multiple times, making it multi-use);
a positive-pressure source coupled to the positive pressure mask (Claim 1, Col. 9 lines 59-60); and
an exhalation filter and positive pressure mask (Claim 1, Col. 9 lines 60-61), the positive pressure mask comprising a main body (Claim 1, Col. 9 line 62);
wherein the main body comprises:
a main body configured to cover user's mouth and nostrils (Claim 1, Col. 9 lines 62-63),the main body further having a gas inlet (Claim 1, Col. 10 line 6);
a user-contact perimeter, a flexible concertinaed portion of uniform flexion continuously around the mask body, the flexible concertinaed portion comprising a plurality of ridges at or adjacent to the user-contact perimeter to accommodate movement of a user's face during use (Claim 1, Col. 9 line 63 – Col. 10 line 5), and
two or more layers of adhesive seal positioned at the second ridged body portion to secure the mask body to the user's face and prevent leakage of the concertinaed portion, the adhesive seal further comprising one or more removable layers (Claim 1, Col. 10 lines 8-14).
Patent 12,214,133 B2 is silent specifically regarding a first main body portion and a second ridged body portion, the main body projecting beyond the user's mouth and nostrils, the main body being comprised of light-transmissible material, such that the main body may be fully see-through.
Hara teaches a respiratory mask with a first main body portion and second ridged body portion, the main body projecting beyond the user's mouth and nostrils, the main body being comprised of light-transmissible material, such that the main body may be fully see-through (see Paragraph 0035, 0042; The mask has a ridged bellows portion 103 and a main body portion 104, which extends beyond the mouth and nose; The portion of 104 is transparent to allow visualization of the mouth during use).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Patent 12,214,133 B2 to have included a first main body portion and second ridged body portion, the main body projecting beyond the mouth/nostrils and being transparent, such as that taught by Hara, in order provide a body offset from the mouth which allows visualization of the mouth during use (Paragraph 0035, 0042).
Regarding claim 2, Patent 12,214,133 B2 discloses the device of claim 1.
Patent 12,214,133 B2 further discloses wherein the user- contact perimeter comprises a cushioned portion (Claim 2).
Regarding claim 3, Patent 12,214,133 B2 discloses the device of claim 2.
Patent 12,214,133 B2 further discloses wherein the cushioned portion comprises a gel cushion (Claim 3).
Regarding claim 4, Patent 12,214,133 B2 discloses the device of claim 1.
Patent 12,214,133 B2 further discloses wherein the adhesive seal is modular and interchangeable (Claim 5).
Regarding claim 5, Patent 12,214,133 B2 discloses the device of claim 1.
Patent 12,214,133 B2 further discloses a strap for engaging with a user's head to hold the positive pressure mask in position (Claim 6).
Regarding claim 6, Patent 12,214,133 B2 discloses the device of claim 5.
Patent 12,214,133 B2 is silent regarding specifically wherein the strap comprises of an upper strap and a lower strap.
However, Hara teaches a facemask with a concertina portion with straps comprising an upper and lower strap (Fig. 5, 10, 12, 16 and Paragraph 0038, 0046, 0047; Mask 100 can include upper/lower belt 141 and 541 to secure the mask to the face).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Patent 12,214,133 B2 to have included upper and lower straps, such as that taught by Hara, in order to enhance securement of the mask to the user’s face (Paragraph 0038, 0046-0047).
Regarding claim 7, Patent 12,214,133 B2 discloses the device of claim 1.
Patent 12,214,133 B2 further discloses wherein the gas inlet comprises an elbow swivel assembly, configured to be connected to the positive-pressure source (Claim 7; also see claim 1, where the gas inlet is connected is connected to the positive-pressure source, and thus the elbow swivel will also be connected).
Regarding claim 9, Patent 12,214,133 B2 discloses the device of claim 1.
Patent 12,214,133 B2 further discloses wherein there is a uniform distance between the flexible concertinaed portion and the user-contact perimeter around at least a majority of the mask body (Claim 8).
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. 12,214,133 B2, as applied to claims 1 and 7, in view of Belfer (U.S 6,196,223 B1).
Regarding claim 8, Patent 12,214,133 B2 discloses the device of claim 7.
Patent 12,214,133 B2 is silent regarding specifically wherein the elbow swivel assembly may be removable or releasably engageable from the first main body portion.
However, Belfer teaches a facemask wherein the elbow swivel assembly may be removable or releasably engageable from the first main body portion (Fig. 5A and Col. 8 lines 52-60; The L-shaped swivel connector has a snap-in connection 84 and thus can be removable/releasably engaged).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Patent 12,214,133 B2 to have included a removable/releasably engageable connection to the swivel assembly, such as that taught by Belfer, in order to provide a known adjustable configuration to deliver gases to the user (Col. 8 lines 52-60) while preventing unintended disconnection.
Claims 10-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-16, 18-19 of U.S. Patent No. 12,214,133 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because they are co-extensive in scope and cover essentially the same subject matter.
Regarding claim 10, Patent 12,214,133 B2 discloses a multi-use positive pressure mask (Claim 9, Col. 10 line 39; Additionally, the positive pressure mask is not explicitly single-use and thus can simply be used multiple times, making it multi-use), comprising:
a mask body configured to cover a user's mouth and nostrils, the mask body having a user-contact perimeter, the mask body comprising a uniform flexion around the mask body, a flexible concertinaed portion comprising a plurality of ridges, at or adjacent to the user-contact perimeter to accommodate movement of a user's face during use (Claim 9, Col. 10 lines 40-47);
a gas inlet to the mask body configured to be to be connected to a positive-pressure source (Claim 9, Col. 10 lines 51-52); and
two or more layers of adhesive seal positioned at the user-contact perimeter to secure the mask body to the user's face, the adhesive seal further comprising one or more layers, each layer comprising (Claim 9, Col. 10 lines 53-58):
one or more cover members, the cover members each comprising (Claim 9, Col. 10 lines 59-60):
at least one removable tab (Claim 9, Col. 10 line 61); and
at least one perforation (Claim 9, Col. 10 line 62) and
a dual-sided form carrier with adhesive material on one or both sides (Claim 9, Col. 10 lines 63-64).
Regarding claim 11, Patent 12,214,133 B2 discloses the device of claim 10.
Patent 12,214,133 B2 further discloses wherein the user-contact perimeter comprises a cushioned portion (Claim 10).
Regarding claim 12, Patent 12,214,133 B2 discloses the device of claim 10.
Patent 12,214,133 B2 further discloses further including a cushioned portion comprising a gel cushion (Claim 11).
Regarding claim 13, Patent 12,214,133 B2 discloses the device of claim 10.
Patent 12,214,133 B2 further discloses wherein the adhesive seal is modular and interchangeable (Claim 12).
Regarding claim 14, Patent 12,214,133 B2 discloses the device of claim 10.
Patent 12,214,133 B2 further discloses wherein the gas inlet comprises a swivel assembly (Claim 13).
Regarding claim 15, Patent 12,214,133 B2 discloses the device of claim 10.
Patent 12,214,133 B2 further discloses wherein the mask body is formed from a flexible plastics material (Claim 14).
Regarding claim 16, Patent 12,214,133 B2 discloses the device of claim 10.
Patent 12,214,133 B2 further discloses wherein there is a uniform distance between the flexible concertinaed portion and the user-contact perimeter around at least a majority of the mask (Claim 15).
Regarding claim 17, Patent 12,214,133 B2 discloses a positive pressure ventilation apparatus (Claim 16, Col. 11 line 1), comprising:
a multi-use positive pressure mask (Claim 16, Col. 11 line 16; Additionally, the positive pressure mask is not explicitly single-use and thus can simply be used multiple times, making it multi-use); and
an adhesive strip (Claim 16, Col. 11 line 17), comprising:
a resistant rubber material attached to either side of a gel cushion (Claim 16, Col. 11 lines 19-20);
the adhesive strip comprising one or more layers of the adhesive strip (Claim 16, Col. 11 line 17 – Col. 12 line 2);
wherein the adhesive strips comprises:
two or more layers of a seal positioned at a user-contact perimeter to secure the positive pressure mask to a user's face, the adhesive seal further comprising one or more layers (Claim 16, Col. 12 lines 2-7), each layer comprising:
one or more cover members, the cover members each comprising (Claim 16, Col. 12 lines 8-9):
at least one removable tab (Claim 16, Col. 12 line 10); and
at least one perforation (Claim 16, Col. 12 line 11); and
a multi-sided form carrier with adhesive material on one or both sides (Claim 16, Col. 12 lines 12-13).
Regarding claim 18, Patent 12,214,133 B2 discloses the device of claim 17.
Patent 12,214,133 B2 further discloses wherein the adhesive strips may be attached to a non-invasive ventilation apparatus (Claim 18).
Regarding claim 19, Patent 12,214,133 B2 discloses the device of claim 17.
Patent 12,214,133 B2 further discloses wherein the adhesive strip is prepackaged or provided separately to prolong mask use by the user (Claim 19).
Regarding claim 20, Patent 12,214,133 B2 discloses the device of claim 17.
Patent 12,214,133 B2 further discloses wherein the adhesive strip is multi-sided, and user may remove a first layer to reveal the cover layer of a subsequent layer of the adhesive strip (Claim 16, Col. 11 lines 21-24).
Allowable Subject Matter
Claims 1-20 would be allowable with the filing of a Terminal Disclaimer to overcome the double patenting rejections above.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 17, the closest prior art is Belfer (U.S Patent No. 5,918,598) and Matich (U.S Patent No. 8,381,727) and Bowen (U.S Patent No. 10,849,375) and Belfer (U.S Patent No. 6,196,223) and Chodkowski (U.S Publication No. 2020/0306483) and Kushida (U.S Publication No. 2014/0360502) and Reese (U.S Publication No. 2009/0211582 A1).
None of the prior art discloses or teaches wherein the adhesive strip includes two or more layers of an adhesive seal each with one or more cover members and a dual-sided form carrier with adhesive.
While the prior art such as Belfer, Kushida, Bowen and Reese all disclose adhesive arrangements with multiple adhesive sections, but do not have the adhesives layered in such a way with two adhesive seals each of which has a cover member and a dual-sided form carrier with adhesive. The adhesive strip must include a layer of the rubber material attached to a gel cushion, two or more layers of the seal, the seal layers each including cover with removable tab and a multi-sided form carrier with the adhesive material. This requires a significant number of distinct layers which is not specifically taught by the prior art without impermissible hindsight reasoning.
Similar arguments can be made for claim 1, 10, and because the claims include limitations substantially the same as that in Patents 12,214,133 B2 previously found to be allowable.
Conclusion
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/THOMAS W GREIG/Examiner, Art Unit 3785
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785