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
Acknowledgment is made of applicant’s claim for priority under 35 U.S.C. § 119(e) with reference to Application Number: 63/019043 filed on 05/01/2020.
Information Disclosure Statement
The Information Disclosure Statement(s) have been reviewed by the examiner and are found to comply with the provisions of 37 CFR 1.97, 1.98, and MPEP § 609.
Drawings
The drawing(s) have been reviewed by the examiner and are found to comply with the provisions of 37 CFR 1.81 to 1.85.
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 13, 18, 21, and dependents therein 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 13, applicant claims “a second flow pathway that allows fluid flow between the second port and the third port when the piston is in a second position” then subsequently claims “the piston prevents fluid flow between the airflow module and the procedure module when in the second position”. The limitations are contradictory. As established earlier in the claim, the airflow module comprises the second port, and the procedure module comprises the third port. Thus, the piston cannot prevent fluid flow between the airflow module (comprising the second port) and the procedure module (comprising third port), because the second pathway allows for that precise flow! Additionally, such language is contradictory to the specification. Applicant is encouraged to amend the last limitation similar to that found in claim 1 (e.g., by describing the ports). The claim limitation will be interpreted along similar lines to the specification and claim 1, e.g. prevention of flow between the appropriate ports.
Regarding claim 18, the recited “first conduit” corresponds to applicant’s first conduit 136, see Fig. 8. At the outset, said first conduit does not “include” the first port, but rather connects to the first port. Regardless, it is unclear how the first conduit can include the first connection member, when the first connection member is already connected to the second connection member, as recited in claim 13. The claim additionally recites “the housing” with no antecedent basis. The claim limitation will be interpreted along similar lines to the specification and claim 6, e.g. where the conduit first connection member is separate structure from the first connection member recited in claim 13.
Claim 21 is rejected and will be examined in a similar fashion to claim 18 as explained above.
Claim Objections
Claims 3 and 15 are objected to because of the following informalities: the claim should recite “the second position” (emphasis added). Appropriate correction is required.
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 - 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weikert (WO 2018106808).
Regarding claim 1, Weikert discloses a respiratory valve apparatus (Figs. 1 – 8, [023 – 0 37]), comprising: a first port configured to releasably couple to a ventilator (140, Fig. 1- 2, [025]); a second port configured to releasably couple to a resuscitation bag or a transport ventilator (112, Fig. 1 – 2, [023]); a third port configured to releasably couple to an endotracheal tube (150, Fig. 1 – 2, [026]) ; and a piston (160, Fig. 2 – 3, [030]) slidably disposed within a housing of the respiratory valve apparatus (102, Fig. 1 -3, [023]; Figs. 2 – 3 who piston 160 sliding within housing 102), the piston being biased in a first position within the housing (Fig. 2, [035], Fig. 2 shows piston 160 biased in a first position by spring 162), the piston comprising: a first flow pathway that allows fluid flow between the first port and the third port when the piston is in the first position (Fig. 2, [031]; first pathway P1 allows fluid flow between 140 and 150); and a second flow pathway that allows fluid flow between the second port and the third port when the piston is in a second position (Fig. 3, para. [031]; see P2 in Fig. 2 with communication between 112 and 150); and wherein the piston prevents fluid flow between the second port and the third port when in the first position and prevents fluid flow between the first port and the third port when in the second position (Figs. 2 – 3, [035]).
2. The respiratory valve apparatus of claim 1, further comprising a spring that biases the piston in the first position (162, Fig. 2 – 3, [035]).
3. The respiratory valve apparatus of claim 2, wherein the spring is compressible to thereby allow the piston to move into a second position (Fig. 2 – 3, [035]).
4. The respiratory valve apparatus of claim 3, wherein the piston is positioned adjacent the second port when in the first position for allowing the resuscitation bag or transport ventilator to move the piston into the second position as a result of coupling the resuscitation bag or transport ventilator to the second port (Fig. 2 – 3, [035]).
5. The respiratory valve apparatus of claim 4, wherein the movement of the piston into the second position prevents fluid flow through the first port and allows fluid flow through and between the second port and the third port (Fig. 2 – 3, [035]).
6. The respiratory valve apparatus of claim 5, further comprising a first conduit including the first port at a first end and a first connection member at a second end (136, Fig. 1 – 2, [025], with the first and second ends corresponding to 142 and 140), the first connection member being coupled to the housing and allowing rotational movement of the first conduit relative to the housing [025].
7. The respiratory valve apparatus of claim 6, further comprising a second conduit (144) including the third port and a fourth port configured to releasably couple an accessory device (148, [026]).
8. The respiratory valve apparatus of claim 7, wherein the accessory device includes one or more of a suction catheter, a bronchoscope, and a drug delivery catheter ([026]).
9. The respiratory valve apparatus of claim 7, wherein the second conduit further includes a second connection member configured to couple to the housing and allow rotational movement of the second conduit relative to the housing (152, [026 – 027]).
10. The respiratory valve apparatus of claim 7, wherein the fourth port includes a sealing member that prevents fluid flow therethrough when the accessory device is uncoupled from the fourth port ([026]).
11. A respiratory valve apparatus (Fig. 1 – 3, [023 – 27], [043 – 47]), comprising: a first port configured to releasably couple to a ventilator (140); a second port configured to releasably couple to a resuscitation bag or a transport ventilator (112); a third port configured to releasably couple to an endotracheal tube (150); and a lever member (402, Fig. 10 – 11, [043]’ the leaver member 402 and housing 406 are used to replace the piston 160 and housing 102, shown in Figs. 1 – 3, while maintaining the rest of the respiratory valve apparatus 100) pivotably disposed within a flow pathway extending along a housing of the respiratory valve apparatus (406, Fig. 10 – 11; [043 – 44]), the lever member being biased in a first position to allow fluid flow between the first port and the third port (Fig. 10, para [043]; Fig. 10 shows the lever in a first position to allow for fluid flow between a first passageway P1; [045] further teaches 402 biased in the first position), the lever member being positioned adjacent the second port (Fig. 10, [043]), the lever member pivoting into a second position as a result of coupling the resuscitation bag or the transport ventilator to the second port thereby allowing fluid flow between the second port and the third port (Fig. 11, [045 – 46]).
12. The respiratory valve apparatus of claim 11, wherein the lever member prevents fluid flow between the second port and the third port when the lever member is in the first position, the lever member prevents fluid flow between the first port and the third port when the lever member is in the second position ([045 – 46]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 13 – 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weikert in view of Henry (US 20200398011).
Regarding claim 13, Weikert discloses a modular respiratory valve apparatus (Fig. 1 – 8, [023 – 037]), comprising: an airflow module (102, 136, collectively) comprising: a first port configured to releasably couple to a ventilator (140, Fig. 1 – 2, [0025]); a second port configured to releasably couple to a resuscitation bag or a transport ventilator (112, Fig, 1 – 2, [023]); and a first housing connection port (126, Fig. 1 – 2, [025]); and a procedure module (144; see [026 – 30]) comprising: a third port configured to releasably couple to an endotracheal tube (144, see [026 – 027]); and a second housing connection port configured to couple to the first housing connection port (152, [027]); and a piston slidably disposed within the airflow module (160, [030]), the piston being biased in a first position within the airflow module ([035], Fig. 2), the piston comprising: a first flow pathway that allows fluid flow between the first port and the third port when the piston is in the first position (P1, [031]); and a second flow pathway that allows fluid flow between the second port and the third port when the piston is in a second position (P2, [031]); and wherein the piston prevents fluid flow between the airflow module and the procedure module when in the second position (prevents fluid flow between the procedure module and port 140 on the airflow module, see also 112(b) above) and allows fluid flow between the first port and the third port when in the first position (see Fig. 2).
Weikert discloses that the second housing connection port 152 may be configured to rotatably couple (swivel) to the first housing connection connection port 126. However, Weikert does not disclose the second housing connection port configured to releasably couple to the first housing connection port. Nonetheless, Hunter discloses a modular respiratory apparatus (see manifold 70, Figs. 1 – 6, 2 – 2, and 7 – 1, as well as tubular attachments thereto, i.e. 42), wherein the manifold 70 is T-shaped (see Fig. 2-2), the respiratory apparatus having a first port releasably coupled to a ventilator (manifold end 75, see [0190]), the respiratory apparatus having a first housing connection port (e.g. left end 25, similar to applicant’s left connection port), and a second housing connection port (port formed by 42.2, configured to couple with the manifold housing), wherein the second housing connection port 42.2. is configured to rotatably couple (swivel) to the first housing connection port 25 (see section 1.5.2, Fig. 7 – 1, [0158, 0159]), wherein the second housing connection port is configured to releasably couple to the first housing connection port (see detached configured in Fig. 2, before coupling of the first and second connection ports, as described in [0151]; see claim 11; see also [0103, 0104]). 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 first/second connection port of Weikert according to the releasably coupled connection of Hunter for the benefit of selectively adjusting positioning of the respiratory apparatus (see Hunter, [0161]), as well as additional benefits understood in the art, such as improved cleaning and/or storage of the releasable parts. The releasable connection may provide multiple functions, such as described in [0157 – 159].
14. The modular respiratory valve apparatus of claim 13, further comprising a spring that biases the piston in the first position (162, Fig. 2 – 3, [035]).
15. The modular respiratory valve apparatus of claim 14, wherein the spring is compressible to thereby allow the piston to move into a second position (Fig. 2 – 3, [035]).
16. The respiratory valve apparatus of claim 15, wherein the piston is positioned adjacent the second port when in the first position for allowing the resuscitation bag or transport ventilator to move the piston into the second positon as a result of coupling the resuscitation bag or transport ventilator to the second port (Fig. 2 – 3, [035]).
17. The respiratory valve apparatus of claim 16, wherein the movement of the piston into the second position prevents fluid flow through the first port and allows fluid flow through and between the second port and the third port (Fig. 2 – 3, [035]).
18. The respiratory valve apparatus of claim 17, further comprising a first conduit including the first port at a first end and a first connection member at a second end (136, Fig. 1 – 2, [025], with the first and second ends corresponding to 142 and 140; note also rejection under 35 USC 112b above), the first connection member being coupled to the housing and allowing rotational movement of the first conduit relative to the housing ([025]).
19. The respiratory valve apparatus of claim 18, further comprising a second conduit (144) including the third port and a fourth port configured to releasably couple an accessory device (148, [026]).
20. The respiratory valve apparatus of claim 19, wherein the accessory device includes one or more of a suction catheter, a bronchoscope, and a drug delivery catheter ([026]).
21. The respiratory valve apparatus of claim 19, wherein the second conduit further includes a second connection member configured to couple to the housing and allow rotational movement of the second conduit relative to the housing (152, [026 – 027]; note also 112(b) above).
22. The respiratory valve apparatus of claim 19, wherein the fourth port includes a sealing member that prevents fluid flow therethrough when the accessory device is uncoupled from the fourth port ([026]).
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 11 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of U.S. Patent No. 11571540. Although the claims at issue are not identical, they are not patentably distinct from each other. While claim 11 in ‘540 does not disclose the lever member being positioned adjacent the second port, claim 11 discloses the pivotable member being positioned in the inner chamber, and further dependent claim 20 in ‘540 anticipates the inner chamber adjacent the second port (resuscitation bag connection port). Notably, claim 20 recites that passage of the resuscitation bag through the second port (resuscitation bag connection port) also causes actuation of the lever within the inner chamber, therefore the lever member in the inner chamber is implicitly claimed as adjacent the second port.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
See Bayron, US 8656915, p. 8: 3 – 28, removable attachment of connection ports are well known in the art
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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/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799