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 .
Status of Claims
This present office action is responsive to the Application filed on August 14, 2024. As directed, claims 1-10 are presently pending in this application.
Drawings
The drawings are objected to because of the following informalities:
Figure 2 recites, “FfG.2” which Examiner suggest amending to read --FIG.2-- and further graph seems to be overlapped with other markings including y-axis representation. Refer to the drawing filed 09/25/2020 from 17/032565.
Figures 4A and 4B are crowded and contain overlapping/indistinguishable lines and/or reference numerals. Refer to the drawing filed 09/25/2020 from 17/032565.
In figures 7A and 7B, the reference character “40” is missing a leader to the component. Refer to the drawing filed 09/25/2020 from 17/032565.
In figure 8, the reference characters, “r,J”, “,J”, “L”, and “7” fail to identify associated components. These reference characters are deemed to be either dimensional indication or overall with other drawing lines. Refer to the drawing filed 09/25/2020 from 17/032565.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because the abstract does not accurately reflect the current technical disclosure of the application. In particular, the abstract appears to describe subject matter from an earlier version of the application and does not correspond to the subject matter presently set forth in the claims (a patient interface assembly comprising a mask component and a headgear assembly). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Claim Objections
Claims 1-10 are objected to because of the following informalities:
Claim 1 recites, “a user’s head” in ln 14 which Examiner suggest amending to read --the user’s head-- as the “user” is introduced in ln 3.
Claim 1 recites, “portion the fabric material” in ln 17 which Examiner suggest amending to read --portion of the fabric material--
Claims 2-10 are objected by virtue of dependency to claim 1.
Claim 8 recites, “a user’s head” in ln 3-4 which Examiner suggest amending to read --the user’s head--
Claim 9 recites, “includes a first” in ln 2 which Examiner suggest amending to read --includes (i) a first--
Claim 9 recites, “a user’s head” in ln 6 which Examiner suggest amending to read --the user’s head--
Claim 9 recites, “portion the second” in ln 9 which Examiner suggest amending to read --portion of the second--
Claim 10 recites, “portion the fabric material” in ln 2 and “the stiffened portion the second fabric” which Examiner suggest amending to read --portion of the fabric material-- and --the stiffened portion of the second fabric--
Appropriate correction is required.
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.
Claims 8-10 are 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.
Claim 8 recites, “wherein the first headgear strap and the second headgear strap are coupled together” which renders claim indefinite. It is unclear whether said straps are separate and distinct components which are capable of being separated, as the term “strap” would commonly be understood. However, in light of specification, the headgear arrangement of Fig 4A includes a top strap portion and a rear strap portion forming a unitary piece which cannot be separated. The claim thus appears to define what would be better understood as first and second headgear strap portions rather than separate first and second headgear straps.
For the examination purposes, it is understood as --the first strap portion and the strap portion forming a unitary piece-- as described in ¶0031.
Claims 9-10 are rejected by virtue of dependency to claim 8.
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.
Claims 1-3, 5, and 8 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Dunn et al. (US 20200171262 A1; same family as US Pat 10569044 which is cited in IDS filed 08/14/2024).
Regarding claim 1, Dunn et al. discloses, a patient interface assembly (an assembly of Fig 25-1) comprising:
(a) a mask component (a patient interface 2530, Fig 25-1) comprising:
(1) a first portion (a portion of 2530 facing the patient’s nose as shown in Fig 1 as it is being donned by a user via a headgear as described in ¶0162) that contacts a portion of a face of a user responsive to the patient interface assembly being donned by such user, and
(2) a second portion (a portion of 2530 facing towards an airway as shown in Fig 25-1) that is adapted to be coupled a supply of gas such that a flow of gas is delivered to an airway of a patient responsive to the patient interface assembly being donned by such user and gas being delivered to the mask component (¶0007, “headgear for use in supporting a respiratory mask in position on a patient's face for positive pressure treatment of the patient”; ¶0127 implies the patient interface is attached to a supply tube for delivering breathable gas to the patient’s airways via the patient interface as shown in Fig 11; claim 11, “….a mask adapted to seal against a patient's face thereby forming a breathing cavity to deliver pressurized air to the patient's airways… for positive pressure treatment of the patient”); and
(b) a headgear assembly (a headgear 2500, Figs 25-1 and 25-2), comprising:
a first headgear strap (a strap towards vertical direction of 2500 on the cheek region as shown in Fig 25-1; ¶0007, “wherein the headgear comprises at least one component (e.g., strap, crown portion, other head/face contacting portions) formed of a single unitary, seamless structure”; ¶0009, “a first strap may extend in a substantially horizontal direction and a second strap may extend in a substantially vertical direction”) having
(i) a first end (a first end of the strap is coupled to one side of the patient interface as shown in Fig 25-1) coupled to a first side of the mask component,
(ii) a second end (Fig 25-1 in view of Fig 23, implies that an opposite end of the strap is coupled to an opposite side of the mask) coupled to a second side of the mask component generally opposite the first side of the mask component, and
(iii) a lateral portion (Examiner interprets the “lateral portion” as any part of the first headgear strap between two ends as BRI; the horizontal strap of 2500 as shown in Fig 25-1) extending between the first end and the second end, wherein the lateral portion extends around at least a portion (the rigidizer is surrounding the cheek portion of the user’s head while donning the assembly as shown in Fig 25-1) of the user’s head responsive to the patient interface assembly being donned by such user, and
wherein the lateral portion comprises: a strip of fabric material (¶0045, “a base headgear material to form a headgear component adapted to at least partially support the mask”), wherein a stiffened portion the fabric material (¶0045, “the yarn or thread having a higher stiffness than the base material”; ¶0162-0163, “yarn having a higher stiffness than the surrounding yarn of the headgear 2500 may be knitted in specific regions… the yarn forming the rigidizer 2510 may be melted or fused to further stiffen the yarn into a welded rigidizer… the rigidizer yarn includes polypropylene and the surrounding yarn includes nylon or other non-plastic material”) is physically altered to have an extension versus load characteristic that differs from a remaining portion of the fabric material, and
wherein the stiffened portion of the fabric material is disposed in a lengthwise direction along the lateral portion (the rigidizer is arranged in a lengthwise direction along the lateral portion as shown in Figs 25-1 and 25-2).
Regarding claim 2, Dunn et al. discloses, the assembly of claim 1 as discussed above.
Dunn et al. further discloses, wherein the fabric material comprises at least one of nylon or polyester fibers (¶0162; ¶0169, “the yarn may be synthetic, and may be twisted or textured, and could be made from, but not limited to nylon, polyester, acrylic, rayon, or polypropylene. The yarn could be a conventional staple yarn, a microfiber yarn, or combination of both”).
Regarding claim 3, Dunn et al. discloses the assembly of claim 1 as discussed above.
Dunn et al. further discloses, wherein physically altering the fabric material includes selectively melting a number of portions of the fabric material in a predetermined pattern (¶0163, implies melting the yarn forming rigidizer which is melted or fused to the strap; Examiner interprets the “predetermined pattern” as to any shape or size or arrangement as BRI; ¶0164).
Regarding claim 5, Dunn et al. discloses the assembly of claim 1 as discussed above.
Dunn et al. further discloses, wherein the stiffened portion of the fabric material comprises a number of arcuate portions (the arrangement of the ridgidizer comprises curved portions/arc-like portions as shown in Fig 25-1).
Regarding claim 8, Dunn et al. discloses the assembly of claim 1 as discussed above.
Dunn et al. further discloses a second headgear strap (a horizontal strap of 2500 near the occiput region/behind the head as shown in Fig 25-1; ¶0007, “wherein the headgear comprises at least one component (e.g., strap, crown portion, other head/face contacting portions) formed of a single unitary, seamless structure”; ¶0009, “a first strap may extend in a substantially horizontal direction and a second strap may extend in a substantially vertical direction”), wherein the first headgear strap and the second headgear strap are coupled together (the horizontal and vertical straps are integrated together as shown in Fig 25-1; ¶0007) such that the first headgear strap extends generally over a top of the user’s head (the first strap is arranged over the top of the user’s head as shown in Fig 25-1) and the second headgear strap extends generally behind the user’s head (the second strap is arranged over the behind the user’s head as shown in Fig 25-1) responsive to the patient interface assembly being donned by such user.
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.
Claims 4 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Dunn et al. (US 20200171262 A1; same family as US Pat 10569044 which is cited in IDS filed 08/14/2024).
Regarding claim 4, Dunn et al. discloses the assembly of claim 1 as discussed above.
While Dunn et al. discloses, one or more features of any one example may be combinable with one or more features of the other example (¶0098,0180), the embodiment of Figure 25-1 does not specifically discloses, wherein the stiffened portion of the fabric material comprises a number of linear portions.
However, the embodiment of Figure 26 teaches wherein the stiffened portion of the fabric material comprises a number of linear portions (in the forms of the knit loops in x marks and forming the rigidizer which can be welded, fused, or knitted in different areas while only specific portions are heated modified as described in ¶0163-0165) in order to provide higher stiffness in specific areas using different known methods.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the assembly of Dunn et al. to include wherein the stiffened portion of the fabric material comprises a number of linear portions as taught by the embodiment of Figure 26 in order to provide higher stiffness in specific areas using different known methods.
Regarding claim 9, Dunn et al. as modified discloses the assembly of claim 8 as discussed above.
While Dunn et al. as further discloses wherein the second headgear strap includes a first end coupled to a first portion of the first headgear strap (the second strap is connected to the first strap above a ear of the user as shown in Fig 25-1), (ii) a second end couped to a second portion of the first headgear strap (Fig 25-1 in view of Fig 23, implies that an opposite end of the second strap is connected to the first strap on the other side), and (iii) a second lateral portion (Examiner interprets the “lateral portion” as any part of the second headgear strap between two ends as BRI; any portion of the second strap of Fig 25-1) extending between the first end of the second headgear strap and the second end of the second headgear strap, but Dunn et al. does not specifically disclose, wherein the lateral portion comprises: a second strip of second fabric material, wherein a stiffened portion the second fabric material is physically altered to have an extension versus load characteristic that differs from a remaining portion of the second fabric material, and wherein the stiffened portion of the second fabric material is disposed in a lengthwise direction along the lateral portion.
However, Dunn et al. teaches the rigidizing of the headgear may be positioned at boney regions of the patient's head, for example the cheeks, occiput or crown and materials used for rigidizing the headgear may include plastics such as nylon, polypropylene, polycarbonate, or higher stiffness textiles such as braided ropes (¶0128). Thus, the arrangements of the rigidizer around the regions of the head is a results effective variable so one of ordinary skills in the art would have try different combinations of the arrangement placing of the rigidizer for stability.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the assembly of Dunn et al. to include a second strip of second fabric material, wherein a stiffened portion the second fabric material is physically altered to have an extension versus load characteristic that differs from a remaining portion of the second fabric material, and wherein the stiffened portion of the second fabric material is disposed in a lengthwise direction along the lateral portion as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II).
Regarding claim 10, Dunn et al. as modified discloses the assembly of claim 9 as discussed above.
While Dunn et al. as modified above discloses, wherein the stiffened portion of the fabric material (the stiffened portion of the first strap is covering the cheek as shown in Fig 25-1) and the stiffened portion of the second fabric material (the stiffened portion of the second strap covering the occiput region as modified in claim 9), Dunn et al. as modified is silent on integral with one another.
However, Dunn et al. teaches that the yarn forming the rigidizer may be melted or fused to further stiffen the yarn into a welded rigidizer (¶0163) and a thermoplastic yarn that is fused in different regions of the knitted component to impart different properties by fusing to each other in those areas to lock the knit loops together, thereby increasing stiffness or wear-resistance or stability of the mask on the patient's face (¶0164; Fig 26). Thus, one of ordinary skills would have recognize that the rigidizer of the first strap and the second strap is formed by fusing/heating the thermoplastic yarn that is looped around the cheek and the occiput regions as arranged by the straps in purpose of improving the manufacturing process (¶0008-0009,0132-0133,0137).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the assembly of Dunn et al. to include wherein the stiffened portion of the fabric material and the stiffened portion of the second fabric material as taught by the method of forming rigidizer to the headgear in purpose of improving the manufacturing process (¶0008-0009,0132-0133,0137).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over (US 20200171262 A1; same family as US Pat 10569044 which is cited in IDS filed 08/14/2024) as applied to claim 1 above, and further in view of Blaszczykiewicz et al. (US 20100000544 A1).
Regarding claim 6, Dunn et al. discloses the assembly of claim 1 as discussed above.
Dunn et al. does not specifically discloses, wherein the fabric material is a one of a plurality of layers of a laminate material.
However, Blaszczykiewicz et al. which is analogous art to the claimed invention for a medical headgear and a rigid material providing a degree of stiffness to the assembly to provide proper and appropriate placement of the device on a person's face and crown (¶0046), teaches a strap of known headgear made of a breathable, elastic foam material laminated on both sides with a soft, moisture-wicking fabric (¶0014) and the multi-layer product like the medical headgears comprising two-layer laminate subassemblies (¶0064) for increased comfort (¶0064).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the assembly of Dunn et al. to include wherein the fabric material is a one of a plurality of layers of a laminate material as taught by Blaszczykiewicz et al. for increased comfort (¶0064).
Regarding claim 7, Dunn et al. discloses the assembly of claim 1 as discussed above.
Dunn et al. is silent on layers of the strap and does not specifically discloses, wherein the lateral portion of the first headgear strap includes a second layer of another material laminated to the fabric material.
However, Blaszczykiewicz et al. which is analogous art to the claimed invention for a medical headgear and a rigid material providing a degree of stiffness to the assembly to provide proper and appropriate placement of the device on a person's face and crown (¶0046), teaches a strap of known headgear made of a breathable, elastic foam material laminated on both sides with a soft, moisture-wicking fabric (¶0014) and the multi-layer product like the medical headgears comprising two-layer laminate subassemblies (¶0064) for increased comfort (¶0064).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the assembly of Dunn et al. to include wherein the lateral portion of the first headgear strap includes a second layer of another material laminated to the fabric material as taught by Blaszczykiewicz et al. for increased comfort (¶0064).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wondka (US 20090183739 A1) is cited for a stiffening member adjoining two straps in purpose of creating different angle setting (¶0079; Fig 4)
Formica et al. (US 20150128953 A1; which is same family as US Pat 9878118) is cited for the rigidizer that is extended to enhance support along the bottom strap while the first strap portion can be the combination of crown strap and the top strap and the second strap portion can be the lower strap covering the back of the user’s head (¶0146; Figs 38-39)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAEICK JANG whose telephone number is (703)756-4569. The examiner can normally be reached M-F 8:30 - 4:30.
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, Kendra D 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.J./Examiner, Art Unit 3785
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
