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.
Claim 1 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.
The claim recites that “there is an inclination angle theta between the inclined surface and a plane of a nostril end of the patient”. However, section 33(a) of the America Invents Act reads as follows: “Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.” See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). As such, it is unclear if applicant intends to positively claim a human organism – thus running afoul of 35 USC 101 and section 33(a) – or rather claim the human organism under an intended use. For the purposes of claim interpretation and compact prosecution, examiner hereby considers the claim as directed to its intended use. Accordingly, the limitation is hereby interpreted as “there is configured to be an inclination angle theta between the inclined surface and a plane of a nostril end of the patient”.
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, 4 – 14, and 16 - 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klenner (US 20200114109) in view of Schwaiger (US 20210338960).
1. Klenner discloses an oxygen inhalation nasal prong device (see Fig. 2a), comprising: a catheter assembly, configured as a hollow tubular structure (gas supply tube 150); a nasal prong assembly (114), arranged at one end of the catheter assembly (unlabeled end inserted into 116, see [0469]), the other end of the catheter assembly being configured to communicate with an oxygen supply device (152, see [0469]), and the nasal prong assembly being connected with the catheter assembly in a through connection way (see [0469], the nasal prong assembly is inserted through the catheter); a lanyard assembly, arranged on the nasal prong assembly, and the lanyard assembly being configured to be sleeved on a head of a patient (140, see [0468]), so that the nasal prong assembly is fixed at a nostril of the patient (see [0467] and Fig. 1a); a neck strap assembly (146), configured to fix the other end of the catheter assembly to neck of the patient (see 146, [0466], [0470]).
Klenner discloses wherein the nasal prong assembly comprises a nasal prong body (e.g. at least partially formed by 112, 126, and 130) and a pair of nostril protruding pillars connected to a side of the nasal prong body (120a/b), the nasal prong body is internally provided with an airflow cavity, and the pair of nostril protruding pillars are each internally provided with an air outlet through-communicated with the airflow cavity (see illustration found in Fig. 15a, giving a general teaching of the airflow cavity communicating with pillar outlets for appropriate delivery of air). However, while Klenner additionally discloses that various components and features of the nasal cannula assembly can be selected and modified based on the benefit, see [0466], and discloses a number of different cannula embodiments throughout the specification, e.g. Fig. 2 versus Figs. 5, 14, 15, etc., Klenner does not disclose that the nasal prong body is internally provided with a contracted airflow cavity; wherein an inner wall of one side of the airflow cavity has an inclined surface, there is an inclination angle theta between the inclined surface and a plane of a nostril end of the patient, and an inner wall of the other side of the airflow cavity has an arc surface; wherein the inclined surface expands away from the arc surface when it approaches an air inlet end of the airflow cavity; and the inclined surface gradually approaches the arc surface when it moves away from the air inlet end of the airflow cavity until it intersects with the arc surface, wherein the airflow cavity has a maximum diameter at the inlet end. Nonetheless, Schwaiger discloses the nasal prong assembly comprises a nasal prong body (12 and 14) and a pair of nostril protruding pillars connected to a side of the nasal prong body (26a/28a), the nasal prong body is internally provided with a contracted airflow cavity (see Fig. 2, wherein the cavity is contracted via arced surface 44), and the pair of nostril protruding pillars are each internally provided with an air outlet through-communicated with the airflow cavity (see Fig. 2), wherein an inner wall of one side of the airflow cavity (see attachment 1 below, “IW”) has an inclined surface, there is configured to be an inclination angle theta between the inclined surface and a plane of a nostril end of the patient (examiner considers the nasal prong body fully capable of being worn at a slight angle on the face of the patient; upon wearing the nasal body at the slight angle, the inner wall would have an inclined surface relative to the nostril end of the patient), and an inner wall of the other side of the airflow cavity has an arc surface (44); wherein the inclined surface expands away from the arc surface when it approaches an air inlet end of the airflow cavity (see attachment 1, “AIE”, where the inclined surface “IW” expands in a left to right direction away from arc surface 44 as it approaches air inlet “AIE”); and the inclined surface gradually approaches the arc surface when it moves away from the air inlet end of the airflow cavity until it intersects with the arc surface (see attachment 1, “IW” and 44 gradually approach each other when moving away from “AIE”; intersection is best understood from the exploded view of Fig. 1, as the intersection occurs on a plane offset from the protruding pillars of Fig. 2, similar to applicant’s Fig. 7 in the instant application), wherein the airflow cavity has a maximum diameter at the inlet end (see attachment 2, air inlet end “AIE” is the maximum diameter of nasal prong body 12 and 14; examiner notes that element 16 is considered part of the catheter connector rather than the nasal prong body 12, 14; air is initially received at AIE during use, see Fig. 2, [0069]). 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 cannula assembly of Klenner according to the arced plug and bevel of Schweiger for the benefit of best directing flow into the naris of the patient, see [0005].
Attachment 1
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4. The modified Klenner discloses the oxygen inhalation nasal prong device according to claim 1, wherein the inclination angle θ remains unchanged along an inclined direction of the inclined surface relative to the plane (See Schwaiger, “IW” and thus the inclined surface maintains a constant angle).
5. The modified Klenner discloses the oxygen inhalation nasal prong device according to claim 1, the inclined surface is provided at one side of the airflow cavity close to the air outlet through-communicated with the airflow cavity, and the arc surface is provided at the other side of the airflow cavity far away from the air outlet through-communicated with the airflow cavity (see Fig. 2 from attachment 1 above).
6. The modified Klenner discloses the oxygen inhalation nasal prong device according to claim 1, wherein the arc surface expands away from the inclined surface when it approaches an air inlet end of the airflow cavity; and the arc surface gradually approaches the inclined surface when it moves away from the air inlet end of the airflow cavity until it intersects with the inclined surface (see Fig. 2 from attachment 1 above, as well as explanation to the similar limitation found in claim 1).
7. The modified Klenner discloses the oxygen inhalation nasal prong device according to claim 1, wherein the inclination angle theta of the inclined surface is 5 – 15 degrees (examiner considers the nasal prong body fully capable of being worn at a slight angle on the face of the patient; upon wearing the nasal body at the slight angle, the inner wall would have an inclined surface relative to the nostril end of the patient, and is fully capable of having an angle between 5 – 15 degrees).
8. The modified Klenner discloses the oxygen inhalation nasal prong device according to claim 7, wherein the inclination angle θ of the inclined surface is 5° (examiner considers the nasal prong body fully capable of being worn at a slight angle on the face of the patient; upon wearing the nasal body at the slight angle, the inner wall would have an inclined surface relative to the nostril end of the patient, and is fully capable of having an angle of 5 degrees).
9. Klenner discloses the oxygen inhalation nasal prong device according to claim 1, wherein the lanyard assembly comprises a first lanyard connecting member and a second lanyard connecting member respectively arranged at both sides of the nasal prong body (Klenner, side straps 122), and the first lanyard connecting member and the second lanyard connecting member are integrally formed with the nasal prong body (see [0467]; integral components of the nasal prong body include 126 and 130); the lanyard assembly further comprises a lanyard connected between the first lanyard connecting member and the second lanyard connecting member (140).
10. Klenner discloses the oxygen inhalation nasal prong device according to claim 1, wherein the lanyard assembly comprises a first lanyard connecting member and a second lanyard connecting member respectively arranged at both sides of the nasal prong body (side straps 122), and the first lanyard connecting member and the second lanyard connecting member are integrally formed with the nasal prong body (see [0467]; integral components of the nasal prong body include 126 and 130); the lanyard assembly further comprises a lanyard connected between the first lanyard connecting member and the second lanyard connecting member (140).
11. Klenner discloses the oxygen inhalation nasal prong device according to claim 4, wherein the lanyard assembly comprises a first lanyard connecting member and a second lanyard connecting member respectively arranged at both sides of the nasal prong body, and the first lanyard connecting member and the second lanyard connecting member are integrally formed with the nasal prong body; the lanyard assembly further comprises a lanyard connected between the first lanyard connecting member and the second lanyard connecting member (see claim 10 above).
12. Klenner discloses the oxygen inhalation nasal prong device according to claim 9, wherein the lanyard is provided with an adjusting buckle (144, see [0468]).
13. Klenner discloses the oxygen inhalation nasal prong device according to claim 12, wherein the lanyard repeatedly passes through the adjusting buckle to adjust a length of the lanyard (see the lanyard passing through the two apertures of the buckle in Fig. 2a).
14. Klenner discloses the oxygen inhalation nasal prong device according to claim 1, wherein the catheter assembly comprises an air conducting tube (150), a lower joint (152), the the lower joint respectively connected with the air conducting tube (see Fig. 2b). However, Klenner does not disclose an upper joint connected with the air conducting tube and, the nasal prong body is connected with the upper joint in a through connection way. Nonetheless, Schwaiger discloses an upper joint connected with the air conducting tube (16) and, the nasal prong body is connected with the upper joint in a through connection way (see Fig. 2). 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 air conducting tube of Klenner according to the upper joint of Schwaiger for the benefit of forming a surmountable positive latching engagement when the nasal cannula is in the operationally ready state, see [0066, 0067].
16. The modified Klenner discloses the oxygen inhalation nasal prong device according to claim 4, wherein the catheter assembly comprises an air conducting tube, an upper joint and a lower joint, the upper joint and the lower joint are respectively connected at both ends of the air conducting tube, and the nasal prong body is connected with the upper joint in a through connection way (see claim 14 above).
17. Klenner discloses the oxygen inhalation nasal prong device according to claim 14, wherein the air conducting tube is provided with a lanyard clamp (see clamp provided to lanyard and tubing on the reader’s left side of the nasal cannula in Fig. 1a of Klenner).
18. Klenner discloses the oxygen inhalation nasal prong device according to claim 14, wherein the air conducting tube is a threaded tube (see Klenner, Fig. 2a, threading around the air conducting tube 150; Schwaiger additionally discloses threading, see Fig. 1, 18).
19. Klenner discloses the oxygen inhalation nasal prong device according to claim 14, further comprising a joint assembly (See Klenner, examiner hereby considers the joint assembly at 152, and the lower joint as 154), wherein the joint assembly is through-connected to the other end of the catheter assembly (grip 156 allows for release of the joint assembly 152, which would therefore require through-connection, as discussed in [0469 – 0470]), the joint assembly comprises a machine joint (end connected to main delivery conduit, see [0469]) and a joint connecting member connected to one end of the machine joint, and the joint connecting member is connected to the lower joint (end releasably through-connected to lower joint 154 and its connecting tube 150, as described in [0469 – 0470]; it is noted that the machine joint need only comprise one end as claimed).
Claim(s) 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klenner (US 20200114109) in view of Schwaiger (US 20210338960) in view of Benke (US 20180043125).
19. Klenner discloses the oxygen inhalation nasal prong device according to claim 14.
Without admitting otherwise, in the event Klenner does not disclose further comprising a joint assembly, wherein the joint assembly is through-connected to the other end of the catheter assembly, the joint assembly comprises a machine joint and a joint connecting member connected to one end of the machine joint, and the joint connecting member is connected to the lower joint, Benke discloses such features. Benke discloses a lower joint (see attachment 2 below, “LJ”) comprising a joint assembly comprising a machine joint (see attachment 2, “MJ”, and also note machine joint 9002 in Figs. 6a – 6c) and a joint connecting member connected to one end of the machine joint (see attachment 2, “JCM”), and the joint connecting member is connected to the lower joint (see Fig. 6e). 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 catheter of Klenner according to the joint assembly of Benke for the benefit of easily and securely connecting the airway catheter to other components such as a ventilator, see [0100].
Attachment 2
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20. The modified Klenner discloses the oxygen inhalation nasal prong device according to claim 19, wherein a groove is arranged on a periphery of the lower joint (see Benke, attachment 2, “groove” is arranged on or atop the periphery of lower joint “LJ”, similar to applicant’s arrangement), a claw is arranged in the joint connecting member, and the claw is configured to be stuck in the groove (see attachment 2, claw of the JCM).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and dependents therein have been considered but are moot because the new ground of rejection does not rely on the interpretation applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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