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
This office action is responsive to a preliminary amendment filed on 11/15/2024. As directed by the amendment, claims 3-4, 6, 8-16, and 19-20 were amended, no claims were cancelled nor added. Thus, claims 1-20 are presently pending in this application.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it contains legal phraseology, (i.e., the term “comprises” in line 6 of the abstract). Correction is required. See MPEP § 608.01(b).
Claim Objections
Claims 8 and 20 are objected to because of the following informalities:
In claim 8, line 3, the term “TPE” is suggested to be changed to --thermo-plastic elastomer (TPE)-- in order to clarify the claim.
In claim 20, line 1, the term “A CPAP” is suggested to be changed to --A Continuous Positive Airway Pressure (CPAP)--.
In claim 20, line 3, the term “an RPT device” is suggested to be changed to --a Respiratory Pressure Therapy (RPT) device-- in order to clarify the claim.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Presently, no limitation(s) is/are being interpreted under 112(f).
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 15 and 20 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 pre-AIA the applicant regards as the invention.
Regarding claim 15, the limitation “The patient interface according to claim 1, further comprising a cushion assembly configured to removably and repeatably connect to the frame assembly, wherein the cushion assembly comprises a nasal cradle cushion adapted to from a seal against at least an underside of the patient’s nose, and wherein a selected one of the cushion assembly and the nasal pillows assembly is attachable interchangeably to the frame assembly” (lines 1-6) is unclear if the applicant is trying to claim an apparatus claim or a system claim, the limitation “The patient interface” appears to be an apparatus claim, however, having a cushion assembly and nasal pillows assembly to be interchangeable with the frame assembly appears to be claiming a system claim.
Regarding claim 20, the limitation “a patient interface” (line 4) is unclear if the patient interface is the same as or different from “A patient interface” being claimed in claim 1, line 1. If they are the same, suggest to amend to --the patient interface--.
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 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 6-14, and 16-20 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Hartono (2022/0134039) or, in the alternative, under 35 U.S.C. 103 as obvious over Hartono (2022/0134039) in view of Henry (2016/0296720).
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Regarding claim 1, Hartono discloses a patient interface (3000, figs. 4-43, paragraphs 0103-0105 and 0233-0239) to deliver a flow of air at a positive pressure with respect to ambient air pressure to an entrance to the patient’s airways including at least the entrance of a patient’s nares while the patient is sleeping, to ameliorate sleep disordered breathing (see abstract and paragraph 0083), the patient interface comprising: a frame assembly (3500, figs. 4-18, paragraphs 0233-0235); and a nasal pillows assembly (3075 with the nasal pillows embodiment, figs. 4-43 and paragraphs 0233-0235, see paragraphs 0035, 0103, and 0258-0259 regarding nasal pillows, Hartono discloses that seal-forming structure can be the cradle as shown in figs. 25-37 or can be nasal pillows comprising a frusto-cone end, therefore, for structural reference of the nasal pillows assembly and the seal-forming structure, the cushion assembly 3075 will be used as a reference structure of the nasal pillows assembly and the seal-forming structure 3100 will be used as the seal-forming structure of the nasal pillows) configured to removably and repeatably connect to the frame assembly (see paragraph 0271), wherein the frame assembly and the nasal pillows assembly form at least part of a plenum chamber (3200, fig. 9, paragraphs 0235, 0246, 0282, and 0285) pressurizable to a therapeutic pressure, wherein the nasal pillows assembly comprises a one-piece construction (see paragraphs 0081, 0083, and 0274) including a seal-forming structure (3100, fig. 9, paragraph 0274) constructed and arranged to form a seal with a region of a patient’s face surrounding the entrance to the patient’s airways and a frame connection structure (3150, fig. 9, paragraph 0274) constructed and arranged to removably and repeatably connect the nasal pillows assembly to the frame assembly (see paragraph 0271), wherein the seal-forming structure comprises a pair of nasal pillows (see the annotated-Hartono fig. 28 above, Hartono discloses that the seal-forming structure 3100 can include nasal pillows) configured to form a seal with a respective nares of the patient’s nose (portion of 3100 comprising 3102 forms the pair of nasal pillows for the nasal pillows seal-forming structure, see paragraphs 0264, see paragraphs 0035, 0103, and 0258-0259 regarding the term “nasal pillows”), wherein the seal-forming structure comprises a first elastomeric material and the frame connection structure comprise a second elastomeric material, wherein the first elastomeric material comprises a lower durometer or hardness than the second elastomeric material (see paragraphs 0081-0084 and 0276-0281), wherein the frame connection structure comprises an undercut (3175, figs. 29-30, paragraphs 0281-0283) that acts as an interface or catch adapted to connect to the frame assembly (paragraphs 0281-0283), wherein the frame connection structure (3150) is arranged along an interior surface or interior periphery of the seal-forming structure such that the frame connection structure and the undercut thereof is arranged or oriented towards an interior of the nasal pillows assembly that forms at least a portion of the plenum chamber (figs. 29-30, paragraphs 0281-0283), and wherein at least a portion of the nasal pillows assembly is configured to directly contact the superior or upper lip of the patient in use (see fig. 4 and paragraphs 0253-0254 and 0261).
However, if there is any doubt that Hartono discloses that the seal-forming structure as shown and disclosed would comprise nasal pillows.
Henry teaches a seal-forming structure (3100, figs. 7-9, paragraphs 0456-0462) is a nasal pillows comprising nasal pillows including frusto-cones (3140, figs. 7-9, paragraph 0463) and stalk (3150, figs. 7-9, paragraphs 00462-0465).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the seal-forming structure of Hartono to have the nasal pillows having the frusto-cones as taught by Henry for the purposes of providing an alternative nasal interface that would provide comfort to the user while maintaining effective seal between the user’s nostrils and the seal forming structure (see paragraphs 0462-0465 of Henry).
Regarding claim 2, Hartono or the modified Hartono discloses that the plenum chamber comprises a posterior wall including a posterior surface configured and arranged to directly contact the superior or upper lip of the patient (see fig. 4 and paragraph 0261 of Hartono).
Regarding claim 3, Hartono or the modified Hartono discloses each of the pair of nasal pillows includes a frusto-cone configured to form a seal against a peripheral region of the nares of the patient (see paragraphs 0258-0259 of Hartono, Hartono discloses that the non-invasive patient interface 3000 can include nasal pillows, and furthermore, the nasal pillows can include frusto-cone, alternatively, see the modification with Henry and paragraphs 0462-0465 of Henry).
Regarding claim 6, Hartono or the modified Hartono discloses that the seal-forming structure (3100 of Hartono) and the frame connection structure (3150 of Hartono) comprise an overmolded construction to form a one-piece integrated component (see paragraph 0273 of Hartono).
Regarding claim 7, Hartono or the modified Hartono discloses that the frame connection structure (3150 of Hartono) comprises a base mold and the seal-forming structure (3100 of Hartono) comprises an overmold provided to the base mold (see paragraph 0275 of Hartono).
Regarding claim 8, Hartono or the modified Hartono discloses that each of the first elastomeric material and the second elastomeric material comprises a TPE or silicone material (0276 of Hartono).
Regarding claim 9, Hartono or the modified Hartono discloses that the frame connection structure (3150 of Hartono) comprises one or more interfacing surfaces (see interfacing surfaces in paragraph 0278 of Hartono, see “3165” in fig. 30 of Hartono) structured to bond with the seal-forming structure (3100 of Hartono).
Regarding claim 10, Hartono or the modified Hartono discloses that the first elastomeric material comprises a durometer in the range of 30-50 Shore A and the second elastomeric material comprises a durometer in the range of 60-90 Shore A (see paragraphs 0084 and 0279, claim 7, it is noted that the seal forming structure 3100 of Hartono comprises the first elastomeric material and the frame connection structure (3150 of Hartono) comprises the second elastomeric material).
Regarding claim 11, Hartono or the modified Hartono discloses a sealing lip (3850, fig. 30, paragraphs 0285-0286) provided to the seal-forming structure (3100 of Hartono) of the first elastomeric material, the sealing lip constructed and arranged to form a seal with the frame assembly (fig. 30, paragraphs 0285-0286).
Regarding claim 12, Hartono or the modified Hartono discloses that the frame assembly (3500 of Hartono) is relatively harder than the frame connection structure (3150 of Hartono, see paragraph 0304 of Hartono).
Regarding claim 13, Hartono or the modified Hartono discloses that the frame connection structure (3150 of Hartono) and the undercut thereof extend around the entire perimeter or interior periphery of the seal-forming structure (3100 of Hartono, see paragraph 0283 of Hartono).
Regarding claim 14, Hartono or the modified Hartono discloses positioning and stabilizing structure (3300, figs. 4-18, paragraphs 0233-0234) to provide a force to hold the seal-forming structure (3100 of Hartono) in a therapeutically effective position on a patient’s head (paragraphs 0080, 0085-0086, 0233-0234, 0341 of Hartono).
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Regarding claim 16, Hartono or the modified Hartono discloses one or more portions of the plenum chamber formed by the nasal pillows assembly includes stiffening configured to increase the stiffness or rigidity of the plenum chamber (see paragraph 0263 of Hartono, Hartono discloses that the seal-forming structure 3100 may include at least two regions of different thickness, therefore, the thicker section relatively would be a stiffening and would increase stiffness or rigidity of the plenum chamber relative to the area that is more thin, alternatively, see the annotated-Hartono figs. 29-30 above for the alternative stiffening).
Regarding claim 17, Hartono or the modified Hartono discloses that the stiffening includes a thickened wall region along one or more portions of a posterior wall and/or an anterior wall of the plenum chamber formed by the nasal pillows assembly (see paragraph 0263 of Hartono, Hartono discloses that the seal-forming structure 3100 may include at least two regions of different thickness, therefore, the thicker section relatively would be a stiffening and would increase stiffness or rigidity of the plenum chamber relative to the area that is more thin, the thickened wall as shown is a thickened wall region that would be along a posterior wall or an anterior wall of the planum (the wall portion that the thickened wall is on can be interpreted as either the posterior or anterior wall), alternatively, see the annotated-Hartono figs. 29-30 for the alternative stiffening).
Regarding claim 18, Hartono or the modified Hartono discloses that the stiffening includes one or more ribs along a boundary of the thickened wall region (see paragraph 0263 of Hartono, Hartono discloses that the seal-forming structure 3100 may include at least two regions of different thickness, therefore, the thicker section relatively would be a stiffening and would increase stiffness or rigidity of the plenum chamber relative to the area that is more thin, and relative to the thin section, the thickened part would be a rib, alternatively, see the annotated-Hartono figs. 29-30 for the alternative stiffening/rib).
Regarding claim 19, Hartono discloses that the stiffening includes a thickened wall region along a portion of a base of the plenum chamber between the pair of nasal pillows (see the annotated-Hartono fig. 28 above, a wall can be defined as extending from one side of the base to the other (top to bottom), such that the thickened wall is along a portion of a base of the plenum chamber between the pair of nasal pillows, see the annotated-Hartono figs. 29-30 above for reference).
Regarding claim 20, Hartono or the modified Hartono discloses a CPAP system (see claim 11 and paragraph 0095 of Hartono) for providing gas at positive pressure for respiratory therapy to a patient, the CPAP system comprising: an RPT device (see paragraphs 0048-0059, 0103-0105, 0232, 0420-0421 of Hartono) configured to supply a flow of gas at a therapeutic pressure; a patient interface according to claim 1; and an air delivery conduit (see 4170 in paragraphs 0103-0105, 0232 and 0234-0235 of Hartono) configured to pass the flow of gas at the therapeutic pressure from the RPT device to the patient interface (see claim 11 and paragraph 0095 of Hartono).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Hartono (2022/0134039) in view of Henry (2016/0296720).
Regarding claim 4, Hartono fails to disclose that each of the pair of nasal pillows includes a dual-wall construction including an outer wall and an inner wall.
Henry teaches a seal-forming structure (3100, figs. 7-9, paragraphs 0456-0462) is a nasal pillows comprising nasal pillows including frusto-cones (3140, figs. 7-9, paragraph 0463) and stalk (3150, figs. 7-9, paragraphs 00462-0465). Henry teaches that each of the pair of nasal pillows includes a dual-wall construction including an outer wall and an inner wall (see outer wall 3110 and inner wall 3120 of Henry, figs. 8-9 and paragraphs 0462-0465 of Henry).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the seal-forming structure of Hartono to have the nasal pillows having the frusto-cones as taught by Henry for the purposes of providing an alternative nasal interface that would provide comfort to the user while maintaining effective seal between the user’s nostrils and the seal forming structure (see paragraphs 0462-0465 of Henry).
Regarding claim 5, the modified Hartono discloses that the outer wall is relatively thinner than the inner wall (see outer wall 3110 and inner wall 3120 of Henry, figs. 8-9 and paragraphs 0462-0465 of Henry).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Hartono (2022/0134039) alternatively in view of Henry (2016/0296720) as applied to claim 1 above, and further in view of Patel (2018/0177965).
Regarding claim 15, Hartono or the modified Hartono discloses a cushion assembly configured to removably and repeatably connect to the frame assembly, wherein the cushion assembly comprises a nasal cradle cushion adapted to form a seal against at least an underside of the patient’s nose (see paragraph 0235 of Hartono, Hartono discloses that “the frame assembly 3500 and the cushion assembly 3075 are repeatedly and removably engageable with one another, e.g., to allow cleaning and/or replacement of the cushion assembly 3075. The frame assembly 3500 and the cushion assembly 3075 form a plenum chamber 3200 when the frame assembly 3500 and the cushion assembly 3075 are engaged”, therefore, Hartono further discloses a cushion assembly, furthermore, Hartono discloses in paragraph 0035 that there are different forms of the seal-forming structure), Hartono or the modified Hartono discloses that the interface can comprise different types of interfaces having different seal-forming structure (paragraph 0035 of Hartono) including pillows and cradle cushion (see paragraphs 0258-0260 of Hartono), but fails to disclose a selected one of the cushion assembly and the nasal assembly is attachable interchangeably to the frame assembly.
However, Patel teaches that different seal forming structures can be interchange onto a frame (see paragraphs 0025 and 0028-0040).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the different interfaces and seal-forming structures of Hartono or the modified Hartono to be interchangeably attached to the frame assembly of Hartono or the modified Hartono as taught by Patel for the purpose of providing flexibility by accommodating different users’ needs.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Rummery (2020/0061398) is cited to show a patient interface comprising nasal prongs.
Guney (2009/0044808) is cited to show a patient interface comprising a pair of nasal prongs.
Swift (2012/0304999) is cited to show a nasal interface.
Allum (2012/0325206) is cited to show a nasal interface.
Eury (2016/0051784) is cited to show a nasal interface.
Baigent (2017/0326320) is cited to show an interchangeable nasal interface.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TU A VO whose telephone number is (571)270-1045. The examiner can normally be reached Monday-Friday 9:00 AM - 6:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at (571)272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TU A VO/Primary Examiner, Art Unit 3785
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