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 .
Reopening of Prosecution After Appeal Brief
In view of the appeal brief filed on 01/09/2026, PROSECUTION IS HEREBY REOPENED. New grounds of rejection are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:[AltContent: rect]
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 21 and dependents therein are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant lacks support to limitation “wherein the upper posts and the lower posts are oriented such that, in use, the longitudinal axes of each of the upper posts and the lower posts are parallel” in claim 21. The specification discloses that the positioning and stabilizing structure may generate an even distribution of sealing force on the seal-forming structure with sealing force vectors F1 and F2 substantially parallel to horizontal, see [0223 – 0225]. Applicant offers no explicit disclosure of the posts as parallel in use, and said posts may not necessarily orient parallel to each other in order to achieve sealing force vectors substantially parallel to horizontal. See for example, MPEP 2163(II)(3)(b) "To establish inherency, the extrinsic evidence ‘must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill. Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.’" Claim 52 has been rejected along similar grounds.
The disclosure would support claim language reciting that “the longitudinal axes of each of the upper posts and the lower posts are substantially parallel” (emphasis added). For compact prosecution, the claims are hereby examined under the supported language substantially parallel.
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) 21-40, 42-52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ng (US 20100319700) in view of Eves (WO 2011060479).
21. Ng discloses a patient interface (Figures 10 and 27, 1110 and 10 respectively; Fig. 1 is additionally referenced below for its general teachings) to treat a respiratory disorder of a patient (as per Paragraph 0002), the patient interface comprising: a positioning and stabilising structure (headgear 1090 as per Paragraph 125; see headgear 90 in Fig. 27) comprising a back portion (1098 and 98, respectively) configured to engage the back of the patient's head in use, a pair of upper straps extending from the back portion (1092 and 92, respectively), a pair of lower straps extending from the back portion (1094 and 94, respectively), and a pair of clips (clip corresponding to 1031, see Fig. 1b; clip 33 in Fig. 27), each of the clips comprising a lower post having a longitudinal axis (see attachment 1, “P”, as well as general teaching in Fig. 27, 37) and each of the lower straps forming a loop around a corresponding lower post to releasably attach each of the lower straps to the corresponding lower post (see Fig. 1b, general teaching [0133]); a plenum chamber constructed from a first material (1140 and 40 respectively); a seal-forming structure configured to contact and seal against the patient's face in use (1060 and 60 respectively), the seal-forming structure being constructed from a second material that is more flexible than the first material (see [0143]; see [0096]), and the seal-forming structure being connected to the plenum chamber (see Fig. 1c, and Fig. 28, respectively); a frame releasably connected to the plenum chamber (1120 as per Paragraph 193, and 20 respectively; it is noted that the frame of 1120 is vertically truncated compared to other frames such as 1020, and is considered to end near label 1145(2) in Fig. 10), the frame comprising a pair of lower attachment points (1031 as per Paragraph 106, and 31 respectively), each of the clips being attached to a corresponding one of the lower attachment points (see Fig. 1b and Fig. 27, respectively); and a pair of rigidiser arms, each of the rigidiser arms being connected to and extending from the frame (1126 (non-labelled) corresponding to 1026, which are appreciably rigid as per paragraph 103; element 26 in Fig. 27), each of the rigidiser arms having an upper attachment point opposite the frame (upper slot in Figs. 10 and 27 corresponding to 1027), each of the upper attachment points comprising an upper post having a longitudinal axis (see attachment 1 below, “P2”, as well as the unlabelled post after the slot in Fig. 10), and each of the upper straps forming a loop around a corresponding upper post to releasably attach each of the upper straps to the corresponding upper post (see Fig. 1b, general teaching [0133]), each of the slots being positioned superior to the frame in use (see Fig. 14, where frame 1120 is vertically truncated, with the rigidizer arm beginning near label 1145(2); Fig. 29 illustrates the rigidizer slot above its frame 20).
Ng discloses longitudinal axes of each of the upper posts parallel to each other (see [0102], Fig. 1, disclosing identical arms on the right and left sides; identical posts are parallel, as perhaps best generally illustrated in Fig. 36), and each of the lower posts parallel to each other (see Fig. 1b, [0106]). Ng additionally discloses that each of the upper straps and lower straps are substantially parallel to each other (see paragraphs [0102] and [0129], where the upper and lower straps are considered as “substantially parallel”, and directed/aligned by the mask system within 10 degrees of each other; the general teaching applies to the embodiments of Figs. 10 and 27; it is noted that the discussed headgear vectors are formed by the headgear strap, see [0094] “headgear with associated headgear vectors”). However, Ng does not explicitly disclose wherein the upper posts and the lower posts are oriented such that, in use, the longitudinal axes of each of the upper posts and the lower posts are substantially parallel. However, Eves discloses a patient interface wherein an attachment point or slot includes a post with a strap forming a loop or weaved around the post, such that the strap is aligned with the slot and thus aligned in angle with the longitudinal axis of the post (see [0408], Figs. 3 – 70 to 3 – 76, the slots and thus post(s) are parallel and aligned with the orientation of the strap to be received; see for example post 5139(1) (though most of the slots/posts are generally unlabeled throughout Figs. 3 – 70 to 3- 76)). Therefore, according to the teachings of Eves, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to align the orientation of the upper and lower posts of Ng according to the angle of respective straps for the benefit of easy looping/weaving of the straps around their respective post/slot, e.g. to avoid bunching or snagging the straps.
Upon modifying Ng with Eves as disclosed, the upper posts and the lower posts are oriented such that, in use, the longitudinal axes of each of the upper posts and the lower posts are substantially parallel (the upper and lower straps are substantially parallel to each other as disclosed in Ng, and modified by Eves such that the upper and lower straps are respectively aligned in angle with the longitudinal axis of their corresponding post).
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22. Ng discloses the patient interface of claim 21, wherein the upper posts and the lower posts are oriented such that, in use, the upper straps lie in a first plane and the lower straps lie in a second plane that is parallel to the first plane (see attachment 1 above, illustrating the parallel planes intersecting longitudinal axes of the posts; it is noted that the claim merely requires the straps to lie in parallel planes, rather than actually extend parallelly along the parallel planes; examiner interprets the term “lie” to broadly include the definition “to occupy a certain relative place or position”, see attached NPL; in an alternative interpretation, examiner notes that the upper strap is fully capable of extending parallel to the lower strap in use, e.g. upon lowering top strap 96 and placing the strap 92 over the ear).
23. Ng discloses the patient interface of claim 21, wherein each of the upper posts is positioned on a corresponding one of the rigidiser arms such that in use the upper straps lie in a plane parallel to the patient's Frankfort horizontal plane (the patient’s Frankfort horizontal plane runs from the orbital margin to the tragion of the ear; the upper plane in attachment 1 is parallel to such plane, and the upper straps lie in such parallel plane; similar to claim 22 above, it is noted that the claim merely requires the straps to lie in the parallel plane, rather than actually extend parallelly along the plane; examiner interprets the term “lie” to broadly include the definition “to occupy a certain relative place or position”, see attached NPL; in an alternative interpretation, examiner notes that the upper strap is fully capable of extending parallel to the Frankfort horizontal in use, e.g. upon lowering top strap 96 and placing the strap 92 over the ear).
24. Ng discloses the patient interface of claim 21, wherein each of the rigidiser arms is constructed separately from the frame and permanently connected to the frame separately from one another (see general teaching end of [0102], the arms are integrally molded to the shroud by molding the arms onto the shroud).
25. Ng discloses the patient interface of claim 21, wherein the lower attachment points are connected to the frame separately from the rigidiser arms (see Fig. 10, Fig. 27).
26. Ng discloses the patient interface of claim 21, wherein the patient interface does not include a forehead support (see Fig. 10, Fig. 27).
27. Ng discloses the patient interface of claim 21, wherein the seal-forming structure is configured to contact and seal against the patient's face around the nose and the mouth in use (see Fig. 10, Fig. 27).
28. Ng discloses the patient interface of claim 21, wherein the seal-forming structure is configured to contact and seal against the patient's face around the nose in use (see Fig. 10, Fig. 27, by sealing against nose and mouth, seals around the nose).
29. Ng discloses the patient interface of claim 21, wherein each of the rigidiser arms is configured to extend between the patient's corresponding eye and ear in use (as per Paragraph 102 and as shown in figure 1B, extending below the eye thus laterally between the region of the eye closest to the sagittal plane and the respective ear, and also by way of being fully capable of extending between the eye and ear depending on particular patient anatomy; general teaching applicable to Fig. 10; see also Fig. 27).
30. Ng discloses the patient interface of claim 21, wherein each of the rigidiser arms is configured such that, when the patient interface is donned by the patient, the corresponding upper attachment point is positioned rearward of patient's eyes (being rearward of the eye as shown in Figure 1b of Ng, [0102], applicable to Fig. 10; see also Fig. 27).
31. Ng discloses the patient interface of claim 21. The discussed embodiments of Ng do not disclose wherein the plenum chamber and the seal-forming structure are permanently connected, integrally molded, and/or joined by comolding to form a one-piece component. Nonetheless, Ng discloses an alternative embodiment in which the plenum chamber and the seal-forming structure are permanently connected, integrally molded, and/or joined by comolding to form a one-piece component [0215]. Therefore, according to the teachings of the alternative embodiment, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the pleneum chamber and seal-forming structure to be comolded for the benefit of no cracks, a gas tight seal, and clean interface [0217].
32. Ng discloses the patient interface of claim 21, wherein the positioning and stabilising structure is shaped and dimensioned such that the entire back portion is positioned rearward of the patient's ears in use, and wherein the upper strap and the lower strap on each lateral side of the positioning and stabilising structure are only connected to each other by the back portion of the positioning and stabilising structure (see Fig. 1, Fig. 9).
33. Ng discloses the patient interface of claim 21, wherein the first material is polycarbonate [0096] and the second material is silicone [0143].
34. Ng discloses the patient interface of claim 33, wherein the silicone is molded onto the polycarbonate (see [0215] and discussion in claim 31 above).
35. Ng discloses the patient interface of claim 33, wherein the frame is constructed from polycarbonate [0099].
36. Ng discloses the patient interface of claim 21, but does not disclose wherein the rigidiser arms are constructed from nylon. However, Ng discloses that the shroud and rigidizer arms are integrally formed, and the shroud may be constructed from nylon [0099]. Therefore, it would have been obvious to construct the rigidizer arms of Ng from nylon for the benefit of using the same material as the shroud for manufacturing simplicity.
37. Ng discloses the patient interface of claim 21, wherein the plenum chamber further comprises a plurality of vent holes configured to wash out exhaled carbon dioxide from within the plenum chamber (see Ng, 1077, [0097]).
38. Ng discloses the patient interface of claim 21, wherein the seal-forming structure comprises a sealing flange configured to contact and seal against the patient's face and a support flange configured to support the sealing flange against the patient's face (see Fig. 1c).
39. Ng discloses the patient interface of claim 21, wherein the rigidiser arms and the frame are formed separately and the rigidiser arms are connected to the frame with a permanent, mechanical connection (see [0102], as well as discussion in claim 24 above).
40. Ng discloses the patient interface of claim 21, wherein the rigidiser arms are overmolded to the frame (see [0102], discussion in claim 24 above).
42. Ng discloses the patient interface of claim 21, wherein the seal-forming structure is removably attached to the plenum chamber [0213].
43. Ng discloses the patient interface of claim 21, wherein each of the upper straps and each of the lower straps comprises a layer of loop material and a portion of hook material, each portion of hook material being configured to releasably connect to the corresponding layer of loop material to form the corresponding loop (Fig. 1b, [0125]).
44. Ng discloses the patient interface of claim 21, further comprising an elbow configured to be connected to an air circuit (see Fig. 1).
45. Ng discloses the patient interface of claim 44, wherein the plenum chamber comprises a connection port, the elbow being connected to the connection port to direct air pressurized from the air circuit into the plenum chamber (see Fig. 1, Fig. 3, Fig. 28).
46. Ng discloses the patient interface of claim 44, wherein the frame forms a hole and the elbow extends through the hole (see Fig. 1, Fig. 3, Fig. 28).
47. Ng discloses the patient interface of claim 21, wherein: the upper posts and the lower posts are oriented such that, in use, the upper straps lie in a first plane and the lower straps lie in a second plane that is parallel to the first plane (see claim 22 above), each of the upper posts is positioned on a corresponding one of the rigidiser arms such that in use the upper straps lie in a plane parallel to the patient's Frankfort horizontal plane (see claim 23 above), each of the rigidiser arms is constructed separately from the frame and permanently connected to the frame separately from one another (see claim 24 above), the lower attachment points are connected to the frame separately from the rigidiser arms (claim 25 above), the patient interface does not include a forehead support (claim 26 above), each of the rigidiser arms is configured to extend between the patient's corresponding eye and ear in use (see claim 29 above), each of the rigidiser arms is configured such that, when the patient interface is donned by the patient, the corresponding upper attachment point is positioned rearward of patient's eyes (see claim 30 above), the plenum chamber and the seal-forming structure are permanently connected, integrally molded, and/or joined by comolding to form a one-piece component (see claim 31 above), the positioning and stabilising structure is shaped and dimensioned such that the entire back portion is positioned rearward of the patient's ears in use (see claim 32 above), the upper strap and the lower strap on each lateral side of the positioning and stabilising structure are only connected to each other by the back portion of the positioning and stabilising structure (claim 32 above), each of the upper straps and each of the lower straps comprises a layer of loop material and a portion of hook material, each portion of hook material being configured to releasably connect to the corresponding layer of loop material to form the corresponding loop (claim 43 above).
48. Ng discloses the patient interface of claim 47, wherein: the first material is polycarbonate and the second material is silicone, the silicone is molded onto the polycarbonate, and the frame is constructed from polycarbonate (claims 33 – 35 above).
49. Ng discloses the patient interface of claim 47, further comprising an elbow configured to be connected to an air circuit, wherein the plenum chamber comprises a connection port, the elbow being connected to the connection port to direct air pressurized from the air circuit into the plenum chamber, and wherein the frame forms a hole and the elbow extends through the hole (claims 44 – 46 above).
50. The patient interface of claim 47, wherein the seal-forming structure is configured to contact and seal against the patient's face around the nose and the mouth in use (see claim 27 above).
51. The patient interface of claim 47, wherein the seal-forming structure is configured to contact and seal against the patient's face around the nose in use (see claim 28 above).
52. The patient interface of claim 21, wherein the upper posts and the lower posts are oriented such that, in use, the longitudinal axes of each of the upper posts define a first plane and the longitudinal axes of each of the lower posts define a second plane that is substantially parallel to the first plane (because each of the longitudinal axes of the lower posts are substantially parallel to each of the longitudinal axes of the upper posts, both planes would be substantially parallel to each other).
Claim(s) 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ng in view of Eves in view of Dravitzki (US 20120138061).
Regarding claim 41, Ng discloses the patient interface of claim 21. Ng discloses molding separate rigidizer arms over the shroud for improved manufacturability, reinforcement, and strengthening. Dravitzki discloses overmolding of numerous rigid arm components, wherein the arms and the frame are formed separately and the arms are connected to the frame by overmolding a third component over each of the arms and the frame (see [0201, 0206], Figs. 66 – 70). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the molded permanent connection of the rigidiser arms to the frame of Ng (see [0102]) according to the permanent joining using a third component described in Dravitzki for the benefit of ensuring mechanical locking between the two components (see Dravitzki, [0201]). Such a component may provide reinforcement and strengthening, and can additionally be selected from materials that improve rigidizer functionality.
Response to Arguments
Applicant’s arguments with respect to claim(s) 21 and dependents therein have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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
/BRANDY S LEE/ Supervisory Patent Examiner, Art Unit 3785