DETAILED ACTION
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 .
Response to Amendment
Examiner acknowledges the reply filed on 2/09/2026 in which claims 13-17, 26 and 27 have been amended. Claims 4 and 18-23 have been cancelled. Currently claims 1-3, 5-17 and 24-27 are pending for examination in this application.
Claims 6 and 10 previously were dependent on claim 14. Both are listed improperly as “previously presented”, since they both have been amended to depend from claim 1.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3, 5-17 and 24-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lang et al. (US 2016/0271350 A1), hereinafter Lang, in view of Thornton et al. (US 2014/0290668 A1), hereinafter Thornton.
Regarding claim 1, Lang disloses discloses:
A patient interface (3000) comprising:
a frame (3250); and,
a seal (3100), the seal coupled to the frame (see figure 4a-4b) configured to be positioned on a user's face (see figure 1c), the seal manufactured from an irradiated thermoplastic polymer (polycaprolactone as per [0050]-[0051]) configured to soften and be mouldable to a shape of a portion of the user's face when the seal is heated to a temperature of 50-70°C [0052]; and
wherein, when the patient interface is positioned on the user's face, the seal is located substantially between the frame and the user's face (as shown in figures 4a-4b the user’s face would be on the left with the seal 3100 between user and frame 3250); and
wherein the seal, prior to use, has a first shape not customised to the user's face, and once heated to 50-700C, the seal is configured to soften and mould to the shape of the user's face [0052]-[0053].
Lang does not explicitly state that the polycaprolactone is cross-linked.
However, Thornton teaches it is known to use a cross-linked polycaprolactone [0115]-[0116] (describe polycaprolactone as the thermoplastic and the thermoplastic material cross-linked by radiation) during a moulding process to conform to a particular user [0115]-[0116]. The examiner notes temperatures are discussed in [0114], with a particular softening temperature of 60 degrees C. Therefore, it would have been obvious to have modified Lang such that the polycaprolactone is an irradiated, cross-linked polycaprolactone as taught by Thornton for the ability to return to its original shape after reheating [0116]. Further, the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). See also In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960).
Regarding claim 2, Lang as modified discloses the claimed invention substantially as claimed in claim 1 above. Lang as modified further discloses wherein the seal is configured to soften and mould when heated to a temperature of 50-700C to conform to the contours proximate a nose of the user's face (Lang: [0052]; Thornton: [0114]).
Regarding claim 3, Lang as modified discloses the claimed invention substantially as claimed in claim 1 above. Lang as modified further discloses wherein the seal has a shape memory, the shape memory of the seal allowing the seal to substantially return to the first shape after being reheated above its melt temperature (Thornton: [0116]).
Regarding claim 5, Lang as modified discloses the claimed invention substantially as claimed in claim 1 above. Lang as modified further discloses wherein the irradiated, cross-linked thermoplastic polymer comprises polycaprolactone (Lang: [0050]-[0051]; Thornton: [0115]).
Regarding claim 6, Lang as modified discloses the claimed invention substantially as claimed in claim 1 above. Lang as modified further discloses wherein at least a portion of the frame (Lang: 3250 including 3254) is permanently attached to the seal (Lang: via adhesive [0130]).
Regarding claim 7, Lang as modified discloses the claimed invention substantially as claimed in claim 1 above. Lang as modified further discloses wherein, in use, the frame defines a breathing chamber (Lang: [0130]), the breathing chamber being in contact with pressurised gas (Lang: via 3600 [0130]), and wherein the seal substantially contacts the user's face in a region located outside of the a perimeter of an outlet (Lang: where frame 3250 meets seal 3100) of the breathing chamber (Lang: see figure 3a and 5a-5c), the perimeter as calculated in a coronal plane (Lang: see figure 3a and 5a-5c).
Regarding claim 8, Lang as modified discloses the claimed invention substantially as claimed in claim 1 above. Lang as modified further discloses wherein, in use, the frame defines a breathing chamber (Lang: [0130]), the breathing chamber being in contact with pressurised gas (Lang: via 3600 [0130]), and wherein the seal substantially contacts the user's face in a region located outside of the a perimeter of an outlet (Lang: where frame 3250 meets seal 3100) of the breathing chamber (Lang: see figure 3a and 5a-5c), the perimeter as calculated in a coronal plane (Lang: see figure 3a and 5a-5c).
However, Lang does not explicitly disclose the seal extends beyond a perimeter of the outlet of the breathing chamber vertically by at least 20mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Lang such that the seal extends beyond a perimeter of the outlet of the breathing chamber vertically by at least 20mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the seal of Lang would not operate differently with the claimed dimensions and the seal of the device would function appropriately having the claimed dimension. Further, applicant places no criticality on the range claimed.
Regarding claim 9, Lang as modified discloses the claimed invention substantially as claimed in claim 7 above. Lang as modified further discloses, wherein the frame (Lang: 3250) is configured, in use, to be located at least partially superior relative to a tip of a nose of the user's face (Lang: figures 4a-4b) to hold the seal away from at least a portion of an alar of the user's face when the seal is softened and moulded to the user's face (Lang: [0139]). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here it is the examiner’s position that Lang discloses all the structural limitations of the claim.
Regarding claim 10, Lang as modified discloses the claimed invention substantially as claimed in claim 1 above. Lang as modified further discloses wherein the frame (Lang: 3250) comprises a material that is substantially rigid at temperatures at or below 100°C (Lang: polycarbonate [0130]).
Regarding claim 11, Lang as modified discloses the claimed invention substantially as claimed in claim 1 above. Lang as modified further discloses wherein the frame comprises polycarbonate (Lang: polycarbonate [0130]).
Regarding claim 12, Lang discloses: A face shield (3100) configured for use with a patient interface (3250), the face shield comprising:
an inner surface (left side of 3100 in figure 4a-b) and an opposinq outer surfaces (right side of 3100 in figure 4a-4b), an outer edge (outer periphery in figures 4a-4b), an inner edge (inner periphery of figures 4a-4b) and an opening with a perimeter in the face shield (see figures 4a-4b), the perimeter of which is defined by an inner edge of the face shield (see figures 4a-4b);
wherein:,
the inner surface is configured to communicate with a patient's face or part thereof when the face shield is fitted to the patient's face or a part thereof [0130];
the outer surface is configured to communicate with a patient interface (see figures 4a-4b); and
the face shield is manufactured from an irradiated thermoplastic polymer (polycaprolactone as per [0050]-[0051]) configured to soften to be mouldable to a shape of a portion of the patient's face when the face shield is heated to a temperature of 50-700C [0052];
the shape of the face shield on manufacture, having a common first shape and, the shape of the face shield after heating to 50-700C softening, moulding to the patient's face and cooling, being a second shape customised to the patient's face [0052].
Lang does not explicitly state that the polycaprolactone is cross-linked.
However, Thornton teaches it is known to use a cross-linked polycaprolactone [0115]-[0116] (describe polycaprolactone as the thermoplastic and the thermoplastic material cross-linked by radiation) during a moulding process to conform to a particular user [0115]-[0116]. The examiner notes temperatures are discussed in [0114], with a particular softening temperature of 60 degrees C. Therefore, it would have been obvious to have modified Lang such that the polycaprolactone is an irradiated, cross-linked polycaprolactone as taught by Thornton for the ability to return to its original shape after reheating [0116]. Further, the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). See also In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960).
Regarding claim 13, Lang as modified discloses the claimed invention substantially as claimed in claim 12 above. Lang as modified further discloses wherein the common first shape is generally flat and, wherein the second shape customised to the patient's face is contoured to follow facial contours of the patient's face (Lang: See figure 5a).
Regarding claim 14, Lang as modified discloses the claimed invention substantially as claimed in claim 12 above. Lang as modified further discloses wherein the face shield at 10-300C (sets at 60C as per Thornton [0115]), has a hardness equal to or greater than 15 Shore D (the examiner notes that both applicant (see page 21 of applicant’s disclosure) and the prior art disclose the same irradiated cross-linked polycaprolactone and thus it is the examiner’s position that the prior art also has a hardness equal to or greater than 15 Shore D).
Regarding claim 15, Lang as modified discloses the claimed invention substantially as claimed in claim 12 above. Lang as modified further discloses wherein at least part of the inner surface of the face shield (Lang: 3100) is configured to contact the patient's face about: a chin region, over a nasal bridge region, a cheek, an upper lip region, and combinations thereof (Lang: see figure 5a for example).
Regarding claim 16, Lang as modified discloses the claimed invention substantially as claimed in claim 12 above. Lang as modified further discloses wherein the face shield (Lang: 3100), in use, is located between a patient interface (Lang: 3250) and a patient's face (Lang: see figures 4a-4b and 1c).
Regarding claim 17, Lang as modified discloses the claimed invention substantially as claimed in claim 12 above. Lang as modified further discloses wherein the face shield is configured to direct contact between a patient interface and a patient's face (Lang: see figure 4a).
Regarding claim 24, Lang as modified discloses the claimed invention substantially as claimed in claim 1 above. Lang as modified further discloses wherein the seal becomes translucent when the seal is heated to 50-700C and, wherein the seal becomes opaque when the seal cools to a temperature below 500C (The examiner notes the material in the prior art as taught by Lang as modified is the same material as that disclosed by applicant: cross-linked polycaprolactone. If an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima case of anticipation or obviousness, the examiner should explain that the prior art structure inherently possesses the functionally defined limitations of the claimed apparatus. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432. See also Bettcher Industries, Inc. v. Bunzl USA, Inc., 661 F.3d 629, 639-40, 100 USPQ2d 1433, 1440 (Fed. Cir. 2011). The burden then shifts to applicant to establish that the prior art does not possess the characteristic relied on. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432; In re Swinehart, 439 F.2d 210, 213, 169 USPQ 226, 228 (CCPA 1971). In this case, it is the examiner’s position that Lang as modified discloses the structural features of the claim and the translucent vs opaqueness is an inherent characteristic of the material disclosed in the prior art (Thornton: [0115]-[0116]).
Regarding claim 25, Lang as modified discloses the claimed invention substantially as claimed in claim 1 above. Lang as modified further discloses wherein the patient interface is configured to be used in a CPAP (Lang: [0023]-[0025]), APAP or BiPAP system.
Regarding claim 26, Lang as modified discloses the claimed invention substantially as claimed in claim 12 above. Lang as modified further discloses wherein the seal becomes translucent when the seal is heated to 50-700C and, wherein the seal becomes opaque when the seal cools to a temperature below 500C (The examiner notes the material in the prior art as taught by Lang as modified is the same material as that disclosed by applicant: cross-linked polycaprolactone. If an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima case of anticipation or obviousness, the examiner should explain that the prior art structure inherently possesses the functionally defined limitations of the claimed apparatus. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432. See also Bettcher Industries, Inc. v. Bunzl USA, Inc., 661 F.3d 629, 639-40, 100 USPQ2d 1433, 1440 (Fed. Cir. 2011). The burden then shifts to applicant to establish that the prior art does not possess the characteristic relied on. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432; In re Swinehart, 439 F.2d 210, 213, 169 USPQ 226, 228 (CCPA 1971). In this case, it is the examiner’s position that Lang as modified discloses the structural features of the claim and the translucent vs opaqueness is an inherent characteristic of the material disclosed in the prior art (Thornton: [0115]-[0116]).
Regarding claim 27, Lang as modified discloses the claimed invention substantially as claimed in claim 12 above. Lang as modified further discloses wherein the patient interface is configured to be used in a CPAP (Lang: [0023]-[0025]), APAP or BiPAP system.
Response to Arguments
Applicant's arguments filed 2/09/2026 have been fully considered but they are not persuasive.
Applicant’s representative states that there is no teaching or motivation to modify Lang with Thornton and therefore the rejection relies on impermissible hindsight. The examiner respectfully disagrees. The examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the disclosure of Thornton is drawn to a breathing device (see abstract), and therefore is analogous art. As set forth in the Non-final rejection mailed 10/10/2025, Thornton teaches it is known to use cross-linked polycaprolactone during a moulding process to conform to a particular user [0115]-[0116] and this material carries the benefit of having the ability to return to its original shape after reheating [0116]. Therefore, the examiner maintains that the rejection is proper and the rejection is maintained.
Applicant’s representative states that Lang does not disclose a cross-linked material. The examiner notes that Lang is not relied upon to disclose the cross-linked material. Further applicant’s representative states that Lang teaches away from modifying the thermoplastic material itself. The examiner has not found any disclosure in Lang which teaches away from the combination the examiner has set forth above and in the previous Office action. Lang’s mere disclosure of a different material does not constitute a teaching away from the claimed cross-linked polycaprolactone material because the disclosure of Lang does not criticize, discredit, or otherwise discourage the cross-linked polycaprolactone material taught by Thornton (see MPEP 2145).
Applicant’s representative asserts that Thornton does not teach or suggest using cross-linked thermoplastic material for facial sealing. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Thornton is relied upon to modify the polycaprolactone of Lang (which is part of seal 3100) to be cross-linked.
Applicant’s representative asserts that the proposed modification is not routine substitution and this is not a predictable substitution. The examiner respectfully disagrees. Obviousness does not require absolute predictability, however, at least some degree of predictability is required. Evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness. In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). Applicant has not provided such evidence. Further, applicant appears to be alleging unexpected results without providing the evidence necessary to prove these alleged unexpected results. Arguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) and In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984). To be or probative value, any objective evidence should be supported by actual proof. Objective evidence which must be factually supported by an appropriate affidavit or declaration to be of probative value includes evidence of unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor. See, for example, In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984)
Regarding claims 7 and 8, Applicant’s representative asserts that Lang nor Thornton disclose the claimed invention. Applicant's arguments in regard to claim 7 fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. Applicant’s representative simply states that Lang does not disclose a frame configured superior to the nasal tip to keep the molded seal off the alar during fitting. These limitations do not appear to be in claims 7 nor 8. The examiner notes that claim 7 requires the seal to substantially contact the user’s face in a region located outside of a perimeter of an outlet of the breathing chamber. The examiner maintains that Lang reads on the claimed limitations. Regarding claim 8, the examiner maintains it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Lang such that the seal extends beyond a perimeter of the outlet of the breathing chamber vertically by at least 20mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the seal of Lang would not operate differently with the claimed dimensions and the seal of the device would function appropriately having the claimed dimension. Further, applicant places no criticality on the range claimed.
Regarding claim 9, the examiner reiterates: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here it is the examiner’s position that Lang discloses all the structural limitations of the claim.
Regarding claims 24 and 26 the examiner notes the material in the prior art as taught by Lang as modified is the same material as that disclosed by applicant: cross-linked polycaprolactone. If an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima case of anticipation or obviousness, the examiner should explain that the prior art structure inherently possesses the functionally defined limitations of the claimed apparatus. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432. See also Bettcher Industries, Inc. v. Bunzl USA, Inc., 661 F.3d 629, 639-40, 100 USPQ2d 1433, 1440 (Fed. Cir. 2011). The burden then shifts to applicant to establish that the prior art does not possess the characteristic relied on. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432; In re Swinehart, 439 F.2d 210, 213, 169 USPQ 226, 228 (CCPA 1971). In this case, it is the examiner’s position that Lang as modified discloses the structural features of the claim and the translucent vs opaqueness is an inherent characteristic of the material disclosed in the prior art (Thornton: [0115]-[0116]). The examiner notes that applicant has not met the burden to establish that the prior art does not possess the characteristic relied upon. Arguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) and In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984). To be or probative value, any objective evidence should be supported by actual proof.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. VANDENBROUCQUE (WO 9628207 A1).
THIS ACTION IS MADE FINAL. 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 VICTORIA MURPHY whose telephone number is (571)270-7362. The examiner can normally be reached M-F 8:00am-4:00pm.
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/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785