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
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
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 Nos. 62/052980, 62/064106, and 62/121144, fail 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 prior filed provisional applications fail to provide support for a cross-section of the fluid passageway varying in shape along a portion of the length of the body portion to provide a bending region between the bridge portion and an inlet of the passageway, as illustrated in Figs. 39 – 41 of the instant specification. The features are supported in Figs. 16 – 18 and claim 1 of provisional Application No. 62/183099, and the effective filing date of claims 2 – 21 is thus 06/22/2015.
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 § 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) 2, 5, 7, 13 – 16, and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JP-3107788 (hereinafter “’788”).
2. ‘788 discloses a patient interface (see provided translation, “Abstract”) comprising: a body portion (21) comprising a left side arm, a right side arm (left portion 23 and right portion 23, respectively, see Figs. 1 – 2), and a bridge portion between the left side arm and the right side arm (portion 25, see Figs. 1 and 2); a pair of nasal prongs extending from the bridge portion, each of the pair of nasal prongs having a nasal prong passageway and configured to be inserted into a corresponding nare of a user's nose in an operational position (24, see Fig. 4, second paragraph after section “best-mode”, wherein the prong passageway corresponds the cannula lumen at 24 as illustrated in Fig. 1 and described in the third paragraph after “advantageous-effect”); wherein the body portion has a fluid passageway connected to at least one of the pair of nasal prongs (cannula lumen at 23 as illustrated in Fig. 1, feeding oxygen to nasal prongs as described in the second and third paragraph after “advantageous-effect”); wherein a cross-section of the fluid passageway varies in shape along a portion of the length of the body portion (see dashed lines in Fig. 2, third paragraph after “best-mode”) to provide a bending region (portion 26, see p. 4, paras 3 - 6; see Fig. 3 bent compared to Fig. 2) between the bridge portion and an inlet to the passageway at which a breathing tube is attached to the body portion (see Fig. 4, third paragraph after “best-mode”); and wherein the body portion has a U-shaped region in the bending region (see curved U-shaped surface formed by 26 in Fig. 3, p. 4, paras 3 – 6).
5. ‘788 discloses the patient interface of claim 2, wherein the bending region bends in a valley of the U-shaped region (see Fig. 3).
7. ‘788 discloses the patient interface of claim 2, wherein the bridge portion is more rigid than the bending region such that, in response to movement of the left side arm or right side arm, the bending region flexes to at least partially isolate the bridge portion from the movement of the left side arm or the right side arm (see p. 4, paras. 2 – 6, Figs. 1 and 3, the same shaped bridge portion 25 is thicker in material, and thereby more rigid such that the bend occurs in the thinner bending region 26 as described).
13. ‘788 discloses the patient interface of claim 2, wherein the bridge portion transitions into the left side arm and right side arm by curving outwardly away from a face-contacting side of the bridge portion (the bridge portion 25 contacts the patient’s face and curves outwardly laterally away to the left and right side arms by virtue of the bending region 26; furthermore, the bulge formed by bending region 26 is curved away from the face rather than into the face).
14. ‘788 discloses the patient interface of claim 2, wherein a transition between the bridge portion and each of the left side arm and right side arm is an arcuate transition (see curved surface in Fig. 3, p. 4, paras 3 – 6).
15. ‘788 discloses the patient interface of claim 2, wherein the bending region has greater flexibility than the left side arm and the right side arm (see p. 3, last para – p. 4, para 1, Figs. 1 and 3, the bending region 26 is made of the same material as the left/right portions 23, but is thinner in material along its short side; this gives the bending region its relative flexibility as described in p. 4, paras 2 – 6).
16. ‘788 discloses the patient interface of claim 2, wherein the left side arm and right side arm have greater flexibility than the bridge portion (the same material left and right sides 23 are shorter in thickness along the long side as compared to bridge region 25, as illustrated in Fig. 2 and described in third paragraph after “best-mode”; thus the sides 23 have greater flexibility along an inferior/superior axis of the patient).
18. ‘788 discloses the patient interface of claim 2, wherein the left side arm comprises the bending region, and wherein the right side arm comprises a second bending region (see Fig. 3).
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) 3 – 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over ‘788 in view of Hobson (US 20100192957).
3. ‘788 discloses the patient interface of claim 2, but does not disclose wherein a cross-section of the nasal prong passageway of each nasal prong is an asymmetric or D-shape at a base of each nasal prong, wherein one side of the cross-section is flatter than an opposite side of the cross-section. Nonetheless, Hobson discloses that a cross-section of the nasal prong passageway of each nasal prong is an asymmetric or D-shape at a base of each nasal prong, wherein one side of the cross-section is flatter than an opposite side of the cross-section (see Fig. 9, [0107]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify ‘788 with the flattened prong inlet of Hobson for the benefit of improved comfort such as a flattened shape against the skin of the patient, as well as other benefits such as improved airflow, see [0157 – 160], and/or reinforcement, see [0155].
4. ‘788 as modified discloses the patient interface of claim 3, wherein the cross-section of the nasal prong passageway of each nasal prong transitions from the asymmetric or D-shape at the base of the nasal prong to circular at a tip of the nasal prong (‘788 discloses a circular tip, and Hobson furthermore discloses transition to a circular tip, see [0147], Fig. 4).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over ‘788.
6. ‘788 discloses the patient interface of claim 2, but does not disclose wherein an internal angle of the U-shaped region is less than 130 degrees. Nonetheless, ‘788 discloses that the patient interface is made from soft resin material and constructed to bend to lessen the internal angle of the interface. ‘788 discloses that the configuration results in improved conformity to the anatomical face region of a user. See p. 4, paras. 2 – 6, Figs. 1 and 3. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to optimize ‘788 within Applicant's claimed range of 130 degrees for the benefit of conforming to the anatomy of a user such as differing facial anatomies to thereby improve ergonomics and comfort of the patient interface. It has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. Additionally, a change in size in the angle or bend is generally recognized as being within the level of ordinary skill in the art.
Claim(s) 8 and 19 – 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over ‘788 in view of Curti (US 20100113956).
8. ‘788 discloses the patient interface of claim 2, and that the bridge portion is more rigid than the bending region (see p. 4, paras. 2 – 6, Figs. 1 and 3, the same shaped bridge portion 25 is thicker in material, and thereby more rigid such that the bend occurs in the thinner bending region 26 as described). However, ‘788 does not disclose wherein the bridge portion comprises a solid section between the pair of nasal prongs. Nonetheless, Curti discloses wherein the bridge portion comprises a solid section between the pair of nasal prongs, see Fig. 2, septum section 15, [0014]. 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 passageway of ‘788 with the septum of Curti for the benefit of dividing the separate passageways thus allowing for differing functions and/or sensing between the two, e.g. one passageway devoted to gas delivery and another to gas sensing, see [0048]. Examiner notes that placement of the solid section septum at the central passageway 25 of ‘788 would further reinforce relative rigidity of the region.
19. ‘788 discloses the patient interface of claim 2, but does not disclose wherein the pair of nasal prongs comprises a left nasal prong and a right nasal prong, and wherein the left nasal prong is connected to the fluid passageway and the right nasal prong is connected to a second fluid passageway separated from the fluid passageway. Nonetheless, Curti discloses wherein the pair of nasal prongs comprises a left nasal prong and a right nasal prong, and wherein the left nasal prong is connected to the fluid passageway and the right nasal prong is connected to a second fluid passageway separated from the fluid passageway, see Fig. 2, septum section 15, [0014]. 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 passageway of ‘788 with the septum of Curti for the benefit of dividing the separate passageways thus allowing for differing functions and/or sensing between the two, e.g. one passageway devoted to gas delivery and another to gas sensing, see [0048].
20. ‘788 as modified discloses the patient interface of claim 19, wherein the fluid passageway is separated from the second fluid passageway by a solid section between the pair of nasal prongs (see Fig. 2, septum section 15, [0014]).
Claim(s) 9 – 12 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over ‘788 in view of O’Connor (WO 2012053910).
9. ‘788 discloses the patient interface of claim 2, but does not disclose further comprising a retention system comprising a pad configured to retain the patient interface to the user's cheek in use. Nonetheless, O’Connor discloses a similar shaped patient interface further comprising a retention system comprising a pad configured to retain the patient interface to the user's cheek in use (see Figs. 15 – 17, 551, p. 54: 5 – p. 55: 14). 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 patient interface of ‘788 to include the retaining pad of O’Connor for the benefit of improved or simplified ease of application, for example easing the exchange of patient interfaces. Examiner notes that the pad may furthermore improve securing of the patient interface device to the face of the patient and/or allow for alternative configurations in which tubing need not uncomfortably rest atop the patient’s ear. Examiner further notes that the modification may additionally include the teaching in O’Connor to incorporate lateral outriggers to distal portions of left and right arms 23 in ‘788, though need not necessarily include the adjunct modification.
10. ‘788 discloses the patient interface of claim 2, but fails to disclose comprising a pad for retaining the patient interface in position when worn in-use by a user, the pad attached to at least one of the left side arm or right side arm. Nonetheless, O’Connor discloses a similar shaped patient interface comprising a pad for retaining the patient interface in position when worn in-use by a user, the pad attached to at least one of the left side arm or right side arm (see Figs. 15 – 17, 551, p. 54: 5 – p. 55: 14). 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 patient interface of ‘788 to include the retaining pad of O’Connor for the benefit of improved or simplified ease of application, for example upon the exchange of patient interfaces. Examiner notes that the pad may furthermore improve securing of the patient interface device to the face of the patient and/or allow for alternative configurations in which tubing need not uncomfortably rest atop the patient’s ear. Examiner further notes that the modification may additionally include the teaching in O’Connor to incorporate lateral outriggers to distal portions of left and right arms 23 in ‘788, though need not necessarily include the adjunct modification.
11. ‘788 discloses the patient interface of claim 2, but does not disclose further comprising a retention system comprising a two-part releasable attachment arrangement for retaining the patient interface in position when worn in use by a user. Nonetheless, O’Connor discloses a similar shaped patient interface further comprising a retention system comprising a two-part releasable attachment arrangement for retaining the patient interface in position when worn in use by a user (see Figs. 15 – 17, 551, p. 54: 5 – p. 55: 14). 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 patient interface of ‘788 to include the retaining pad of O’Connor for the benefit of improved or simplified ease of application, for example upon the exchange of patient interfaces. Examiner notes that the pad may furthermore improve securing of the patient interface device to the face of the patient and/or allow for alternative configurations in which tubing need not uncomfortably rest atop the patient’s ear. Examiner further notes that the modification may additionally include the teaching in O’Connor to incorporate lateral outriggers to distal portions of left and right arms 23 in ‘788, though need not necessarily include the adjunct modification.
12. ‘788 as modified discloses the patient interface of claim 11, wherein the two-part releasable attachment arrangement comprises a dermal patch and a user interface patch, wherein the dermal patch comprises a patient side configured to be attached to the user's skin and a user interface patch side configured to engage with the user interface patch, wherein the user interface patch comprises a dermal patch side configured to engage with the user interface patch side of the dermal patch and an interface side configured to attach to the patient interface (see Figs. 15 – 17, 551, p. 54: 5 – p. 55: 14).
21. ‘788 discloses the patient interface of claim 2, but does not disclose further comprising a pair of pads, each of the pads attached to a rear side of one of the left side arm or the right side arm. Nonetheless, O’Connor discloses a similar shaped patient interface further comprising a pair of pads, each of the pads attached to a rear side of one of the left side arm or the right side arm (see Figs. 15 – 17, 551, p. 54: 5 – p. 55: 14). 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 patient interface of ‘788 to include the retaining pad of O’Connor for the benefit of improved or simplified ease of application, for example upon the exchange of patient interfaces. Examiner notes that the pad may furthermore improve securing of the patient interface device to the face of the patient and/or allow for alternative configurations in which tubing need not uncomfortably rest atop the patient’s ear. Examiner further notes that the modification may additionally include the teaching in O’Connor to incorporate lateral outriggers to distal portions of left and right arms 23 in ‘788, though need not necessarily include the adjunct modification.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over ‘788 in view of Wondka (US 20090183739).
17. ‘788 discloses the patient interface of claim 2, wherein the body portion is a component formed from a single material (see Fig. 2, first paragraph after “best-mode”), but does not disclose wherein the body portion is formed from a material with a Shore A hardness of between 5 to 60. Nonetheless, Wondka discloses wherein the body portion is a component formed from a single material, wherein the body portion is formed from a material with a Shore A hardness of between 5 to 60 (see claim 9, Fig. 6). 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 patient interface of ‘788 according to the Shore A hardness of Wondka for the benefit of a soft synthetic resin that allows for bending and conformability to the face of the user.
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 2 – 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 18 of U.S. Patent No. US 12048814 (hereinafter ‘814). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘814 anticipates all the limitations of the instant claims.
With regard to claim 2, ‘814 discloses a patient interface comprising: a body portion comprising a left side arm, a right side arm, and a bridge portion between the left side arm and the right side arm (c. 91: 38 – 41); a pair of nasal prongs extending from the bridge portion, each of the pair of nasal prongs having a nasal prong passageway and configured to be inserted into a corresponding nare of a user's nose in an operational position (c. 91: 42 – 45, whereby “at least one nasal prong configured to direct a flow” into the patient anticipates a pair of nasal prongs with directing passageways); wherein the body portion has a fluid passageway connected to at least one of the pair of nasal prongs (c. 91: 48 – 50); wherein a cross-section of the fluid passageway varies in shape along a portion of the length of the body portion to provide a bending region between the bridge portion and an inlet to the passageway at which a breathing tube is attached to the body portion (c. 91: 51 – 55); and wherein the body portion has a U-shaped region in the bending region (c. 92: 19-21). Dependent claims 3 – 21 are furthermore rejected on the ground of nonstatutory double patenting.
Claims 2 – 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 32 of U.S. Patent No. US 11058841 (hereinafter ‘841). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘841 anticipates all the limitations of the instant claims.
With regard to claim 2, ‘841 discloses a patient interface comprising: a body portion comprising a left side arm, a right side arm, and a bridge portion between the left side arm and the right side arm (c. 91: 28 – 31); a pair of nasal prongs extending from the bridge portion, each of the pair of nasal prongs having a nasal prong passageway and configured to be inserted into a corresponding nare of a user's nose in an operational position (c. 91: 35-39, whereby “at least one nasal prong configured to direct a flow” into the patient anticipates a pair of nasal prongs with directing passageways); wherein the body portion has a fluid passageway connected to at least one of the pair of nasal prongs (c. 91: 40 – 42); wherein a cross-section of the fluid passageway varies in shape along a portion of the length of the body portion to provide a bending region between the bridge portion and an inlet to the passageway at which a breathing tube is attached to the body portion (c. 91: 47 – 52); and wherein the body portion has a U-shaped region in the bending region (c. 92: 37-40). Dependent claims 3 – 21 are furthermore rejected on the ground of nonstatutory double patenting.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 20090183739 – nasal passageway changes shape
US 20100018534 – passageway changes shape
US 20160235937 – U-shaped region
US 7406966 – passageway changes shape
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
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