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 .
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 425 & 431 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable by Anderson et al. (WO 2016077876 A1).
Regarding claim 425, A headgear for securing a patient interface to a patient, the headgear comprising:
a base layer 18 forming a body of the headgear (Figure 8), the base layer 18 comprising a lower portion 12 (Page 4, last paragraph – Page 5, Paragraph 1); and
a headband region 21 comprising:
an outer engagement layer (Note: the examiner considers this to be the part of the reference number 12 that overlaps with the reference number 11) that at least partly overlaps the lower portion 12 (Figure 6), the outer engagement layer (Note: the examiner considers this to be the part of the reference number 12 that overlaps with the reference number 11) being fused to an underlying portion of the base layer 18 (Page 4, Last Paragraph – Page 5, Paragraph 1); and
areas of fused material (Note: the examiner considers this to be the areas that are sewn) and areas of unfused material 19 (Figure 9), the areas of unfused material 19 at least in part defining connection zones for releasably securing connectors to the headgear (Figure 8).
Regarding claim 431, Anderson discloses the headgear as claimed in claim 425.
Anderson discloses wherein the headband region 21 comprises over-ear regions shaped to at least partly cover ears of the patient (Figure 8 – 9 discloses the headband covers the ears of the patient).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 432 is rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (WO 2016077876 A1).
Regarding claim 432, Anderson discloses the headgear as claimed in claim 431.
Anderson does not expressly disclose wherein the over-ear regions are configured to provide the connection zones to facilitate attachment of one or more connectors to the headband region to hold the patient interface in place.
However it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Anderson to include wherein the over-ear regions are configured to provide the connection zones to facilitate attachment of one or more connectors to the headband region to hold the patient interface in place as there is no specific connection region that is solely for holding the patient interface meaning it would be obvious to consider any of the presented connection areas to be able to hold the patient interface. (Page 5, Paragraph 3) Anderson also teaches the chin strap to connect with the headband can be reasonably seen over the ear region. (Figure 9 – 16 & 19 - 21
Claim(s) 425, 427 – 431 & 433 – 439 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 20180093060 A1).
Regarding claim 425, A headgear for securing a patient interface to a patient, the headgear comprising:
a base layer 110 forming a body of the headgear 100 (Figure 1), the base layer 110 comprising a lower portion 120 (Paragraph 0022) and
a headband region 150 comprising:
an outer engagement layer (Note: the examiner considers this to be the fabric of the headband) that at least partly overlaps the lower portion 120 (Paragraph 0025 discloses the band is adjacent to the edge of the first opening 120); and
areas of fused material (Note: the examiner considers this to be where the two parts are stitched together) and areas of unfused material (Note: the examiner considers to be where the materials are not connected), the areas of unfused material at least in part defining connection zones for releasably securing connectors (The examiner considers this to be what secures the patient interface to the headgear) to the headgear 100 (Figure 1).
Lee does not expressly disclose the outer engagement layer being fused to an underlying portion of the base layer.
However, it would be obvious to one of ordinary skill in the art prior to the effective filing date to further modify Lee to include the outer engagement layer being fused to an underlying portion of the base layer as it is a known practice of stitching to create a secure and long-lasting attachment.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either designs, these modifications are a matter of design choice. Absent a teaching as to criticality of the portion the outer engagement layer that is fused with the underlying portion, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). MPEP 2144.05. It has been clearly stated in the specification that the portion that is fused has many different options and it has not been stated any specific reasoning to any of the options. This change would not affect the functionality of the device and can be clearly seen as a design choice.
Regarding claim 427, Modified Lee discloses the headgear as claimed in claim 425.
Modified Lee does not expressly disclose wherein the outer engagement layer is fused to the underlying portion across a majority of the outer engagement layer.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either designs, these modifications are a matter of design choice. Absent a teaching as to criticality of the portion the outer engagement layer that is fused with the underlying portion, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). MPEP 2144.05. It has been clearly stated in the specification that the portion that is fused has many different options and it has not been stated any specific reasoning to any of the options. This change would not affect the functionality of the device and can be clearly seen as a design choice.
Regarding claim 428, Modified Lee discloses the headgear as claimed in claim 425.
Modified Lee discloses wherein the base layer 110 comprises a single panel of material. (Paragraph 0022)
Regarding claim 429, Modified Lee discloses the headgear as claimed in claim 425.
Modified Lee discloses wherein the outer engagement layer (Note: the examiner considers this to be the fabric of the headband) comprises a single panel of material. (Paragraph 0024)
Regarding claim 430, Modified Lee discloses the headgear as claimed in claim 425.
Modified Lee discloses wherein the patient interface 10 comprises a respiratory interface comprising a nasal cannula 30. (Paragraph 0020)
Regarding claim 431, Modified Lee discloses the headgear as claimed in claim 425.
Modified Lee does not disclose wherein the headband region comprises over-ear regions shaped to at least partly cover ears of the patient.
However, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Lee to include wherein the headband region comprises over-ear regions shaped to at least partly cover ears of the patient as Lee discloses the connection portion of the elastic band to be adjacent to an edge of the first opening 120 meaning it can be close to the over-ear portion of the cap 110. This means it would be obvious for the headband region to cover partly the ears of the patient based on the location it can be found. (Paragraph 0025)
Based on the modification, shape of the over-ear region, the courts have held that a change in shape alone, without demonstration of the criticality of a specific limitation, may be considered obvious to a person of ordinary skill in the art. “In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), [t]he court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.” MPEP § 2144.04-IV-B.
Regarding claim 433, Modified Lee discloses the headgear as claimed in claim 431,
Modified Lee discloses wherein the over-ear regions comprise a first over-ear region and a second over-ear region (as claimed in claim 31), wherein the headband region 150 further comprises an extension portion extending from at least one of the first over-ear region or the second over-ear region. (Figure 2)
Regarding claim 434, Modified Lee discloses the headgear as claimed in claim 431.
Modified Lee does not expressly disclose wherein the headband region further comprises a region of increased stretch between the over-ear regions.
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Lee to include wherein the headband region further comprises a region of increased stretch between the over-ear regions as it is clear that the headband is an elastic band that is able to connect between the over-ears region meaning it would provide an increased stretch in order to be able to hold the patient interface in place and stay connected in the connection area of 140 and 160 (Figure 2 & Paragraph 0022)
Regarding claim 435, Modified Lee discloses the headgear as claimed in claim 425.
Modified Lee does not expressly disclose wherein the headband region is configured to wrap around a head of the patient such that opposing end portions of the headband region overlap and secure to each other.
However, it would be prima facie obvious to one of ordinary skill in the art prior to the effective filing date to further modify Lee to include wherein the headband region is configured to wrap around a head of the patient such that opposing end portions of the headband region overlap and secure to each other as Lee discloses the first connection portion can be selectively disposed on other places of the cap body meaning it could be disposed in a place that allows for the band to wrap around the head. Based on the fact that it can be altered, means the modification is known by the reference to not affect the functionality of the device. (Paragraph 0025 – 0026)
Regarding claim 436, Modified Lee discloses the headgear as claimed in claim 425.
Modified Lee discloses further comprising an end fixture 180 securing a top edge 130 of the base layer 110 together at a securement point (Figure 3).
Regarding claim 437, Modified Lee discloses the headgear as claimed in claim 425.
Modified Lee discloses wherein the headgear 100 is a bonnet (Paragraph 0011). Regarding claim 438, Modified Lee discloses the headgear as claimed in claim 425.
Modified Lee does not expressly disclose wherein the areas of fused material exhibit different stretch to the areas of unfused material.
However, it would be obvious to one of ordinary skill in the art prior to the effective filing date to further modify Lee to include wherein the areas of fused material exhibit different stretch to the areas of unfused material as the unfused material are the areas of the elastic band that are not connected to the base. Based on this, it would be obvious for the parts that are connected to the base to have a different stretch than the parts of the elastic band that are not connected as they are able to stretch based on the users needs while the connected areas stay in place. (Paragraph 0022)
Regarding claim 439, Modified Lee discloses the headgear as claimed in claim 438.
Modified Lee does not expressly disclose wherein at least one of a shape, an orientation, or a position of the areas of fused material is selected to reduce a stretch of a respective portion of the headband region in one or more directions.
However, it would be obvious to one of ordinary skill in the art prior to the effective filing date to further modify Lee to include wherein at least one of a shape, an orientation, or a position of the areas of fused material is selected to reduce a stretch of a respective portion of the headband region in one or more directions as the sewing position of the connection will reduce the stretch in that area for the elastic band as it will not allow it to move in one or more directions. (Paragraph 0022 – 0027)
Claim 426 is rejected under 35 U.S.C. 103 as being unpatentable over
Lee et al. (US 20180093060 A1) as claimed in claim 425, in view of Bearne et al. (WO 2014175753 A1).
Regarding claim 426, Modified Lee discloses the headgear as claimed in claim 425.
Modified Lee discloses wherein the areas of unfused material form a raised engagement surface of the headband region 160, (Paragraph 0026) and
the use of stitches to be the preferable use to connect the headband and headgear together. (Paragraph 0025)
Modified Lee does not disclose wherein the areas of fused material form depressions in the headband region.
Bearne discloses the use of welding to assemble two parts together. (Paragraph 0333)
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to modify the assembly process between headgear and headband of Lee to use welding to assemble as they are considered known attachment processes in the art that could be used. This would not change the functionality of the device as both processes maintain the both parts of the device connected. By changing the process of the attachment the fused material would form in the headband region as it is commonly known that the welding process squeezes the two layers of material together to form depressions at the welded locations. Meaning the depressions are considered to be a known result of the welding process.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACIELA NATALIA LEBRON DE JESUS whose telephone number is (571)270-3892. The examiner can normally be reached Mon - Fri 8:00-5:00 CST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at 571-272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GRACIELA NATALIA LEBRON DE JESUS/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
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