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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission has been entered.
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 12 is 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 the end portion “alternatively or additionally” comprises one or more fixing elements. The language “alternatively” is confusing, and appears to imply the earlier dependent claims are absent fixing elements. However, earlier dependent claims are of such scope that they may or may not comprise fixing elements, rather than of a scope in which they explicitly disavow fixing elements. Deletion of the term “alternatively” would overcome the rejection under 35 USC 112(b).
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- 2, 4 – 12, 14, and 18 – 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biener (US 20170049984) in view of Campbell (US 6505624).
1. Biener discloses a connecting element (3310, 3350, 3340, see Figs. 3a, 3j) for a patient interface (3100), wherein the connecting element comprises two curved straps (see [0196, 0202]) which are configured for connection to the patient interface (see Fig. 3a, [0204]) the two curved straps each comprising a beginning and an end (strap edges at 3100 and 3350, respectively) and at least three points between the beginning and the end at which a radius of curvature of the curved strap changes (see annotated attachment of Fig. 3d, illustrating the three points similar to applicant’s Fig. 5; the three points correspond to the solid lines in the annotated figure, and a fourth point has been illustrated using dashed lines; the beginning and end have been illustrated with “B” and “E” respectively).
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While Biener discloses that there may be many suitable forms of headgear, see [0242], including headgear in which multiple headgear portions may each hook around a base of the ear, see [0244], Biener does not explicitly disclose two behind-the-ear elements. Nonetheless, Campbell discloses a respiratory interface or other breathing apparatus comprising two curved straps (see Fig. 5, c. 5: 18 – 34), furthermore comprising two behind-the-ear elements, (see 108, c. 5: 18 – 26). Therefore, according to the teachings of Campbell, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the headgear portions hooked around the base of the ear in Biener with two separate behind-the-ear clips for the predictable result of hooking around the base of the ear, thus providing the benefit of engaging the patient’s head and preventing slippage therefrom. Examiner notes that one of ordinary skill in the art would understand the ear clips of Campbell may be attached to the device of Biener in any number of known methods for attaching ear clips to respiratory systems as typical in the art, including sliding, latching, permanent, clipping, adjusting, etc.. See conclusion below.
2. Biener in view of Campbell discloses the connecting element of claim 1. Campbell does not explicitly disclose reversible coupling in Fig. 5. Nonetheless, Campbell discloses wherein the two behind- the-ear elements can be coupled reversibly to the two straps in Figs. 1 and 3, see c. 2: 55 – c. 3: 10, c. 4: 45 – 65. Therefore, according to the teachings of Campbell, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the device of Biener with reversible coupling for the benefit of reversibly adjusting the connecting element according to the facial dimensions of the user. One of ordinary skill in the art would realize other benefits to reversible coupling, such as swapping out behind-the-ear elements. Further known methods for reversibly coupling ear clips as typical in the art are discussed in the conclusion below.
4. Biener as modified by Campbell discloses the connecting element of claim 1, wherein a coupling system for coupling a strap to the patient interface is disposed and configured adjacent to the beginning of the strap (3320) and an end portion of the strap to which the behind-the-ear element can be coupled is arranged adjacent to the end of the strap (see end portion in Fig. 3j of Biener, as well as end portion in Fig. 5 of Campbell; the behind-the-ear elements and/or end portion may be attached according to known methods for securing the ear clips, as discussed above.)
5. Biener discloses the connecting element of claim 1, wherein the two straps are produced at least from a stiffening and at the same time flexible material and/or composite material selected from plastics materials, metals, silicones and foams ([0197, 0241]).
6. Biener discloses the connecting element of claim 1, but does not explicitly disclose the two straps have a length L and a width B, a ratio of the length L to the width B being at least 10:1. Biener appears to illustrate wherein the two straps have a length L and a width B, a ratio of the length L to the width B being at least 10:1 in Fig. 3d, where the width is measured at the beginning end. Nonetheless, the description of the article pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art (MPEP 2125). 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 relative length of the strap of Biener for the benefit of fitting various anatomies of the wearers.
7. Biener as modified by Campbell discloses the connecting element of claim 1, wherein the two behind- the-ear elements are manufactured from an elastic material selected from silicones, thermoplastic elastomers, neoprenes and textiles (see Campbell, c. 3: 21 – 22).
8. Biener as modified by Campbell discloses the connecting element of claim 1, wherein the two behind- the-ear elements each comprise at least one retaining element which can be coupled to an end portion of a strap (see Fig. 5 of Campbell, as well as close-up Fig. 2b, 62; the retaining element may be coupled via methods such as overmoulding disclosed in Biener, see [0243]; alternatively, according to the teachings found in Figs. 1 and 3 of Campbell, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the device of Biener with a reversible coupling retaining element, as discussed in claim 2 above).
9. Biener as modified by Campbell discloses the connecting element of claim 8, wherein the retaining element is in the form of a hollow body with a lumen into which the end portion of the strap is placed for coupling at at least one position (see Fig. 5 of Campbell, as well as close-up Fig. 2b; the retaining element may be coupled via methods such as overmoulding disclosed in Biener, see [0243]; alternatively, according to the teachings found in Figs. 1 and 3 of Campbell, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the device of Biener with a reversible coupling retaining element, as discussed in claim 2 above).
10. Biener as modified by Campbell discloses the connecting element of claim 8, wherein the retaining element is displaceably coupled at any desired positions of the end portion and a length adjustment of the connecting element is thus provided (as discussed it claims 2 and 8 above, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the device of Biener with a displaceable coupling retaining element for the benefit of adjusting the connecting element according to the facial dimensions of the user. One of ordinary skill in the art would realize other benefits to reversible coupling, such as swapping out different types of behind-the-ear elements. Additionally methods for displaceably coupling ear clips are discussed in the conclusion below).
11. Biener as modified by Campbell disclose the connecting element of claim 8, wherein the end portion comprises at least one anchor element for anchoring the coupling of the retaining element to the straps (as discussed in [0243], the retaining element may be coupled to the end portion via methods such as stitching, wherein the stitching is considered as an anchor element; alternatively, Campbell discloses that the end portion comprises an anchor element for anchoring the coupling of the retaining element to the straps in c. 2: 67 – c. 3: 3, and it would have been obvious to modify strap of Biener to include such anchor element for the benefit of easily removing/attaching the ear clip).
12. Biener as modified by Campbell discloses the connecting element of claim 8, wherein the end portion alternatively or additionally comprises one or more fixing elements for fixing a coupling of the behind-the-ear element to the straps (as discussed in [0243], the retaining element may be coupled to the end portion via methods such as stitching, wherein the stitching is considered as a fixing element; alternatively, Campbell discloses that the end portion comprises an anchor fixing element for fixing the coupling of the retaining element to the straps in c. 2: 67 – c. 3: 3, and it would have been obvious to modify strap of Biener to include such anchor element for the benefit of easily removing/attaching the ear clip).
14. Biener as modified by Campbell discloses the connecting element of claim 1, wherein a ratio of a length L to a width B of a behind-the-ear element is at least 1:1 (examiner considers the length as the longitudinal length of the ear clip of Campbell, whereas the width is the dimension of the clip itself running along the longitudinal length; the width may accordingly change, and any width is appropriately considered “a” width; such interpretation is consistent with Fig. 4 in applicant’s disclosure; as such, Campbell discloses a length to width ratio of at least 1:1, where the width is measured across the furthest extent of the ear clip, closest to the neck of the patient, as such feature is clearly illustrated; in an alternative interpretation, examiner additionally notes that embodiments such as Fig. 2d and Fig. 5 appear to illustrate the claimed ratio when taking the length and width across the entire extent of the device; the description of the article pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art (MPEP 2125); therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the within applicant’s claimed ratio for the benefit of appropriately fitting the ear).
18. Biener as modified by Campbell discloses the connecting element of claim 1, wherein the behind-the- ear elements run behind an ear of a user or patient in a use state (see Fig. 5 of Campbell).
19. Biener as modified by Campbell discloses the connecting element of claim 18, wherein a ratio of a length L to a width B of the behind-the-ear elements in each case is less than 20:1 (in an interpretation taking the length and width across the entire extent of the device, the BEE of Campbell is clearly illustrated to be less than 20:1; additionally, the description of the article pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art (MPEP 2125); therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the within applicant’s claimed ratio for the benefit of appropriately fitting the ear).
20. Biener discloses a system for ventilation and/or respiratory support, wherein the system comprises at least a patient interface, the connecting element of claim 1, a ventilator, and at least one line, the patient interface being coupled to the connecting element and being connected by the connecting element to a head of a patient, and the patient interface and the ventilator being connected in a gas-conducting manner by the at least one line (see Fig. 1a, Fig. 3b, [0103]).
Claim(s) 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biener (US 20170049984) in view of Campbell (US 6505624) in view of McGilvray (US 4878491).
12 and 13. Biener as modified discloses the connecting element of claim 8, but does not disclose wherein the end portion alternatively or additionally comprises one or more fixing elements for fixing a coupling of the behind-the-ear element to the straps, wherein the fixing of the behind-the- ear element to the straps permits a stepwise length adjustment of the connecting element. McGilvray discloses wherein the end portion alternatively or additionally comprises one or more fixing elements for fixing a coupling of the behind-the-ear element to the straps, wherein the fixing of the behind-the- ear element to the straps permits a stepwise length adjustment of the connecting element (male/female configuration in McGilvray performs stepwise adjustment by pins 69 to allow for length adjustment of the ear element, see c. 6: 3 – 36; the male/female configuration corresponds to the retaining element and fixing element). 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 retaining element of Biener in view of Campbell with stepwise length adjustment as taught in McGilvray for the benefit of adjusting the ear element relative to the individual wearer's ears in the known manner.
Claim(s) 1, 4 – 9, 11 – 12, 17, 18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biener (US 20170049984) in view of Johnson (US 5438979).
1. Biener discloses a connecting element (3310, 3350, 3340, see Figs. 3a, 3j) for a patient interface (3100), wherein the connecting element comprises two curved straps (see [0196, 0202]) which are configured for connection to the patient interface (see Fig. 3a, [0204]) the two curved straps each comprising a beginning and an end (strap edges at 3100 and 3350, respectively) and at least three points between the beginning and the end at which a radius of curvature of the curved strap changes (see annotated attachment of Fig. 3d, illustrating the three points similar to applicant’s annotated Fig. 5; the three points correspond to the solid lines in the annotated figure, and a fourth point has been illustrated using dashed lines; the beginning and end have been illustrated with “B” and “E” respectively).
Biener discloses that rear behind-the-ear element 3350 can be engaged to the curved straps using stitching, see [0243], and may include more than one strap, see [0244], but does not disclose 3350 as two behind-the-ear elements. Nonetheless, Johnson discloses a patient interface having two straps, and two behind-the-ear elements (see Fig. 6, c. 4: 16 – 20). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify behind-the-ear element 3350 of Biener as two behind-the-ear elements as taught by Johnson for the benefit of easily adjusting the strap length for different patients.
4. Biener as modified by Johnson discloses the connecting element of claim 1, wherein a coupling system for coupling a strap to the patient interface is disposed and configured adjacent to the beginning of the strap (3320) and an end portion of the strap to which the behind-the-ear element can be coupled is arranged adjacent to the end of the strap (see end portion in Fig. 3j of Biener, as well as end portion in Fig. 6 of Johnson).
5. Biener discloses the connecting element of claim 1, wherein the two straps are produced at least from a stiffening and at the same time flexible material and/or composite material selected from plastics materials, metals, silicones and foams ([0197, 0241]).
6. Biener discloses the connecting element of claim 1, but does not explicitly disclose the two straps have a length L and a width B, a ratio of the length L to the width B being at least 10:1. Biener appears to illustrate wherein the two straps have a length L and a width B, a ratio of the length L to the width B being at least 10:1 in Fig. 3d, where the width is measured at the beginning end. Nonetheless, the description of the article pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art (MPEP 2125). 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 relative length of the strap of Biener for the benefit of fitting various anatomies of the wearers.
7. Biener as modified by Johnson discloses the connecting element of claim 1, wherein the two behind- the-ear elements are manufactured from an elastic material selected from silicones, thermoplastic elastomers, neoprenes and textiles (Johnson, c. 3: 67).
8. Biener as modified by Johnson discloses the connecting element of claim 1, wherein the two behind- the-ear elements each comprise at least one retaining element which can be coupled to an end portion of a strap (see Fig. 6, 35 of Johnson).
9. Biener as modified by Johnson discloses the connecting element of claim 8, wherein the retaining element is in the form of a hollow body with a lumen into which the end portion of the strap is placed for coupling at at least one position (see Fig. 6, 35 of Johnson).
11. Biener as modified by Johnson discloses the connecting element of claim 8, wherein the end portion comprises at least one anchor element for anchoring the coupling of the retaining element to the straps (see Fig. 6, 36 of Johnson).
12. Biener as modified by Johnson discloses the connecting element of claim 8, wherein the end portion alternatively or additionally comprises one or more fixing elements for fixing a coupling of the behind-the-ear element to the straps see Fig. 6, 36 of Johnson).
14. Biener as modified by Johnson discloses the connecting element of claim 1, wherein a ratio of a length L to a width B of a behind-the-ear element is at least 1:1 (Fig. 6 of Johnson clearly illustrates the claim ratio).
18. Beiner as modified by Johnson discloses the connecting element of claim 1, wherein the behind-the- ear elements run behind an ear of a user or patient in a use state (see Fig. 4 of Johnson).
20. Biener discloses a system for ventilation and/or respiratory support, wherein the system comprises at least a patient interface, the connecting element of claim 1, a ventilator, and at least one line, the patient interface being coupled to the connecting element and being connected by the connecting element to a head of a patient, and the patient interface and the ventilator being connected in a gas-conducting manner by the at least one line (see Fig. 1a, Fig. 3b, [0103]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Campbell (US 6505624) – sliding ear clip, Fig. 1
Campbell (US 6505624) – latching ear clip, Fig. 3
Campbell (US 20030150459) – permanent ear clip
Holyoake (US 20190175861, Fig. 14c) – clipping ear clip
McGilvray (US 4878491) – adjusting ear clip
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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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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