DETAILED ACTION
This is the initial Office action for application 18/928,851 filed October 28, 2024, which is a continuation of application 17/303,668 (now US Patent 12,128,259) filed June 4, 2021, which is a continuation of application 14/285,202 (now US Patent 11,052,268) filed May 22, 2014, which is continuation-in-part of application 13/757,373 (now US Patent 9,950,202) filed February 1, 2013. Claims 18-35, as presented in the preliminary amendments filed February 11, 2025, are currently pending.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions. 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.
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 18-35 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.
Claim 18 recites the limitation “a mask body” in line 8; however, it is unclear if the “mask body” is the same previously recited “a mask body” from line 1 or another mask body. For examination purposes, the limitation “a mask body” recited in line 8 of claim 1 has been interpreted as “the mask body” in order to clearly refer to the same mask body throughout the claim.
Claims 19-35 are included in the rejection under 35 U.S.C. 112(b) based on their dependence from rejected claim 18.
Claim Rejections - 35 USC § 102 / 103
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 18, 19, 22, and 24-28 are rejected under pre-AIA 35 U.S.C. 102(a) as anticipated by Morelli et al. (US 8,443,806) or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over Morelli et al. (US 8,443,806) in view of Ramsey et al. (US 2014/0103044).
Regarding claim 18, Morelli discloses a respiratory mask (Fig. 1) comprising a mask body (face mask 2 + exhalation valve assembly 4), a shut-off valve (positive pressure test apparatus 10), and an actuator (frame 20 + cap 30 + link 40) for the shut-off valve (10) (Figs. 1-10; column 4, line 66 – column 5, line 8), the actuator (20+30+40) comprising:
an outer surface (wall 31 + top 39) and a seal surface (sealing surface 32), wherein, absent an applied force to the outer surface (31+39), the actuator (20+30+40) is in an open position (Fig. 5) and, in response to an applied force, the actuator (20+30+40) exhibits a force response (biasing force of flexible link 40) as the actuator (20+30+40) is displaced along a linear path from the open position (Fig. 5) to a closed position (Fig. 6) (column 5, line 61 – column 6, lines 3 & 19-29);
wherein, when the actuator (20+30+40) is in the closed position (Fig. 6), the seal surface (32) is sealed against an interior wall (flap valve 5) of the mask body (2+4), wherein the force response provides tactile feedback to an operator (based on the bending of the flexible link 40 with link elements 42) so as to indicate that a seal check is being implemented (column 5, lines 9-29 & 61 – column 6, line 3).
The limitation “tactile feedback” has been interpreted as any physical sensation that is capable of confirming the seal, wherein the movement of the cap (30) and the bending of the flexible link (40) provide a physical sensation to a user providing the applied force to the actuator (20+30+40) taught by Morelli. Further, the limitation “so as to indicate that a seal check is being implemented” has been interpreted as the intended use of the tactile feedback provided by the actuator, wherein a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Since the structure of the actuator (20+30+40) taught by Morelli is capable of providing tactile feedback which in turn in capable indicating that a seal check is being implemented, the structure of Morelli anticipates the invention as claimed.
Alternatively, Applicant discloses in the specification that the “tactile feedback” may be provided by the actuator when it buckles or distorts and produces a “pop” or “click” [00102]. Although claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). However, if given a narrower interpretation of the limitation “tactile feedback” to require a “pop” or “click”, claim 18 is alternatively rejection under 35 U.S.C. 103 over Morelli in view of Ramsey.
Ramsey discloses an analogous actuator (lid 1) comprising an outer surface (top surface 2) and seal surface (skirt 3), wherein in response to an applied force (to pop-up button 4 of top surface 2), the actuator (1) exhibits a force response (pop-up) as the actuator (1) is displaced along a linear path, and wherein, when the seal surface (3) is sealed against an interior wall of a container, the force response provides tactile feedback (a “click” or “pop”) to an operator (Figs. 4-5; ¶ 0034-0035).
Therefore, it would have been obvious to one having ordinary skill in the art, at the time the invention was made, to modify the tactile feedback of the actuator taught by Morelli to provide a “click” or “pop” as taught by Ramsey for the purpose of providing an obvious indication confirming the seal.
Regarding claim 19, Morelli further discloses that the force response depends on the position of actuator (20+30+40) along the linear path (the biasing force of the link 40 depends on the position of the cap 30 along the linear path as the cap is pressed towards the flap valve 5).
Regarding claim 22, Morelli further discloses that the actuator (20+30+40) is formed of a flexible body (link 40 is flexible) and wherein the outer surface (31+39) forms a dome-like structure (cap 30 can have a generally hemispherical shape) that at least partially extends above an outer surface of the mask body (2+4) for interface with the operator’s finger (Figs. 6, 8, & 10; column 6, lines 11-15; column 7, lines 47-49).
Regarding claim 24, Morelli further discloses that the actuator (20+30+40) comprises a flange (outer frame 20) and a span (cap 30 + link 40) extending inwardly from the flange (20) such that, while the actuator (20+30+40) is depressed, the span (30+40) moved toward the interior wall (5) while the flange (20) remains substantially fixed (Figs. 5-6).
Regarding claim 25, Morelli further discloses that the actuator (20+30+40) comprises a projection (lower end of wall 31 adjacent sealing surface 32) that extends from the span (30+40) and cooperates with an opening (space between sealing surface 32 and border area 5A of flap valve 5) of a seal (formed when sealing surface 32 mates with a secured to border area 5A) to secure the actuator (20+30+40) to the seal (32+5A), wherein the seal (32+5A) comprises the seal surface (32) (Figs. 5-6; column 5, lines 61-64; column 6, line 58 – column 7, line 8).
Regarding claim 26, Morelli further discloses that the span (30+40) and seal (32+5A) translate in concert with one another in response to the applied force to the outer surface (31+39) of the actuator (20+30+40) (Figs. 5+6).
Regarding claim 27, Morelli further discloses a retainer (wall 21) defining a rim (distal edge 29) that terminates at a surface that faces an outer periphery of the span (30+40), wherein the surface defines a plane such that, during operation of the actuator (20+30+40), at least a portion of the span (30+40) passes through the plane (Figs. 2 & 6; column 5, lines 36-37).
Regarding claim 28, Morelli further discloses that a portion of the outer surface (31+39) passes through the plane upon the actuator (20+30+40) reaching the closed position (Fig. 6).
Claim 23 is rejected under pre-AIA 35 U.S.C. 103(a) as obvious over Morelli, or alternatively Morelli in view of Ramsey, as applied to claim 18 above.
Morelli further discloses that the actuator (20+30+40) is formed of a flexible body (link 40 is flexible) and wherein the outer surface (39) forms a dome-like structure (cap 30 can have a generally hemispherical shape) for interface with the operator’s finger (Figs. 6, 8, & 10; column 6, lines 11-15; column 7, lines 47-49).
Although Morelli, or alternatively the combination of Morelli and Ramsey, fails to teach that the outer surface of the actuator is entirely below an outer surface of the mask body, it would have been obvious to one having ordinary skill in the art to modify the arrangement of the actuator and mask body of the respiratory mask taught by Morelli, or alternatively the combination of Morelli and Ramsey, such that the outer surface of the actuator is entirely below an outer surface of the mask body since it has been held that rearranging parts of an invention that would not have modified the operation of the device involves only routine skill in the art. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Allowable Subject Matter
Claim 20 would be allowable if rewritten to overcome the rejection under 35 U.S.C. 112 (pre-AIA ), 2nd paragraph set forth in this Office action and to include all of the limitations of base claim 18 and intervening claim 19. Claims 21 and 29-35 would also be allowable based on their dependence from allowable claim 20.
The claims in this application are indicated allowable because the closest prior art of Morelli and Ramsey fails to disclose the recited loading curve of the force response detailed in claim 20 in combination with the limitations of claims 18 and 19.
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.
Claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 8, and 25 of US Patent 9,950,202 (reference patent ‘202), in view of Morelli et al. (US 8,443,806), or alternatively in view of Morelli and Ramsey et al. (US 2014/0103044).
The limitations therein are substantially recited in claims 1, 8, and 25 of reference patent ‘202, including a respiratory mask comprising a mask body (column 16, lines 45-46), a shut-off valve (column 16, line 50), and an actuator for the shut-off valve (column 16, line 51), the actuator comprising:
an outer surface (the actuator will implicitly have an outer surface for being engageable by the wearer; column 16, lines 51-52) and a seal surface (to provide an adequate seal; column 16, line 60), wherein absent an applied force to the outer surface, the actuator is in an open position (claim 25) and, in response to an applied force, the actuator is displaced along a linear path from the open position to a closed position (claim 8);
wherein, when the actuator is in the closed position, the seal surface is sealed against an interior wall (inlet ports) of a mask body (column 16, lines 46-48 & 54-56).
However, the claims of reference patent ‘202 fail to recite “the actuator exhibits a force response” and “wherein the force response provides tactile feedback to an operator so as to indicate that a seal check is being implemented.”
However, these limitations are substantially disclosed by Morelli, or alternatively the combination of Morelli and Ramsey, as discussed above with respect to the rejections under 35 U.S.C. 102/103. Therefore, it would have been obvious to one having ordinary skill in the art, at the time the invention was made, to modify the respiratory mask recited in the claims of reference patent ‘202 such that the actuator exhibits a force response providing tactile feedback to an operator so as to indicate that a seal check is being implemented as taught by Morelli, or alternatively the combination of Morelli and Ramsey, for the purpose of providing an obvious indication confirming the seal.
Claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20 and 21 of US Patent 11,052,268 (reference patent ‘268), in view of Morelli et al. (US 8,443,806), or alternatively in view of Morelli and Ramsey et al. (US 2014/0103044).
The limitations therein are substantially recited in claims 20 and 21 of reference patent ‘268, including a respiratory mask (column 25, line 26) comprising a mask body (column 25, line 27), a shut-off valve (column 25, line 35), and an actuator for the shut-off valve (column 25, line 36), the actuator comprising:
an outer surface (column 25, lines 59-50) and a seal surface (to form a seal with the mask body; column 25, line 43), wherein absent an applied force to the outer surface, the actuator is in an open position (claim 21) and, in response to an applied force, the actuator is displaced along a linear path from the open position to a closed position (column 25, lines 35-36);
wherein, when the actuator is in the closed position, the seal surface is sealed against an interior wall of a mask body (sealing pad blocks an opening defined within the mask body; column 25, lines 33-34 & 38-39).
However, the claims of reference patent ‘268 fail to recite “the actuator exhibits a force response” and “wherein the force response provides tactile feedback to an operator so as to indicate that a seal check is being implemented.”
However, these limitations are substantially disclosed by Morelli, or alternatively the combination of Morelli and Ramsey, as discussed above with respect to the rejections under 35 U.S.C. 102/103. Therefore, it would have been obvious to one having ordinary skill in the art, at the time the invention was made, to modify the respiratory mask recited in the claims of reference patent ‘268 such that the actuator exhibits a force response providing tactile feedback to an operator so as to indicate that a seal check is being implemented as taught by Morelli, or alternatively the combination of Morelli and Ramsey, for the purpose of providing an obvious indication confirming the seal.
Claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 10 of US Patent 12,128,259 (reference patent ‘259), in view of Morelli et al. (US 8,443,806), or alternatively in view of Morelli and Ramsey et al. (US 2014/0103044).
The limitations therein are substantially recited in claims 1 and 10 and of reference patent ‘259, including a respiratory mask (column 23, line 26) comprising a mask body (column 23, line 57), a shut-off valve (column 23, line 65), and an actuator for the shut-off valve (column 24, line 4), the actuator comprising:
an outer surface (the actuator will implicitly have an outer surface to provide tactile feedback; column 24, line 6) and a seal surface (sealing pads; column 23, line 67), wherein absent an applied force to the outer surface, the actuator is in an open position (claim 10) and, in response to an applied force, the actuator is displaced along a linear path from the open position to a closed position (column 24, lines 6-8);
wherein, when the actuator is in the closed position, the seal surface is sealed against an interior wall of a mask body (sealing pads blocks an opening defined within the mask body; column 23, lines 63-64 & 67 – column 24, line 1).
However, the claims of reference patent ‘259 fail to recite “the actuator exhibits a force response” and “wherein the force response provides tactile feedback to an operator so as to indicate that a seal check is being implemented.”
However, these limitations are substantially disclosed by Morelli, or alternatively the combination of Morelli and Ramsey, as discussed above with respect to the rejections under 35 U.S.C. 102/103. Therefore, it would have been obvious to one having ordinary skill in the art, at the time the invention was made, to modify the respiratory mask recited in the claims of reference patent ‘259 such that the actuator exhibits a force response providing tactile feedback to an operator so as to indicate that a seal check is being implemented as taught by Morelli, or alternatively the combination of Morelli and Ramsey, for the purpose of providing an obvious indication confirming the seal.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure: Brooks, Jr. et al. (US 7,584,751), Osendorf et al. (US 5,647,356), and Maryyanek et al. (US 5,299,448).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Keri J. Nelson whose telephone number is 571-270-3821. The examiner can normally be reached Monday - Friday, 9am - 4pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael E. Bredefeld, can be reached at 571-270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KERI J NELSON/Primary Examiner, Art Unit 3786 12/23/2025