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 § 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.
Claim(s) 2-7 and 14-19 is/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 2 recites the limitation “the mouth closure structure comprises a mouth closure member” in Ln. 1-2 which deems the claim indefinite. Claim 1 has already recited the mouth closure structure as comprising a strip or strap. The present limitation adds a mouth closure member to the mouth closure structure without making mention of the strip or strap. The claim thus appears to be defining a mouth closure member as in addition to the strip or strap of claim 1. However, the disclosure of the instant application appears to indicate the mouth closure member and the strip or strap are in fact the same structure (e.g. ¶214 – the mouth closure members 3912 comprise elongate strips). The claim is thus indefinite as it is unclear whether the “mouth closure member” and the “strip or strap” should be understood as distinct from each other (as claimed) or as the same structure (as the disclosure appears to indicate). One suggested amending of the limitation would be “the mouth closure structure comprises a mouth closure member comprising the strip or strap.” Note how the same issue continues through the claims depending from claim 2 which broadly recite the mouth closure member as being located in certain areas and performing functions which appear to specifically relate to the strip or strap of claim 1.
Claim 14 recites the limitation “the mouth closure structure comprises a mouth closure member” in Ln. 1-2 which deems the claim indefinite. Claim 10 has already recited the mouth closure structure as comprising a strip or strap. The present limitation adds a mouth closure member to the mouth closure structure without making mention of the strip or strap. The claim thus appears to be defining a mouth closure member as in addition to the strip or strap of claim 10. However, the disclosure of the instant application appears to indicate the mouth closure member and the strip or strap are in fact the same structure (e.g. ¶214 – the mouth closure members 3912 comprise elongate strips). The claim is thus indefinite as it is unclear whether the “mouth closure member” and the “strip or strap” should be understood as distinct from each other (as claimed) or as the same structure (as the disclosure appears to indicate). One suggested amending of the limitation would be “the mouth closure structure comprises a mouth closure member comprising the strip or strap.” Note how the same issue continues through the claims depending from claim 14 which broadly recite the mouth closure member as being located in certain areas and performing functions which appear to specifically relate to the strip or strap of claim 10.
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 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) 1-2, 4, 7-14, 16 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Belfer et al. (U.S. Patent 5918598).
Regarding claim 1, Belfer discloses a patient interface (Figs. 1-7) for use in delivering breathable gas to a patient (Col. 6, Ln. 3-22), the patient interface comprising: a plenum chamber (Fig. 2 interior of #20) pressurisable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure (Col. 6, Ln. 18-22; Col. 8, Ln. 57-61 – can receive pressurized gas from a pump), said plenum chamber including a plenum chamber inlet port (Figs. 1-3 #34; Col. 8, Ln. 57-61) capable of receiving a flow of breathable gas at the therapeutic pressure for breathing by the patient; a seal-forming structure (Figs. 2-3 #70; Col. 7, Ln. 1-32) provided to the plenum chamber, wherein the seal-forming structure is configured to form a seal with a region of the patient’s face surrounding an entrance to the patient’s nares but not around the patient’s mouth (Fig. 7 – only covers nose; Col. 9, Ln. 24-31 – nasal only mask), said seal-forming structure having an opening (Fig. 3 central opening in #70) therein such that the flow of breathable gas is delivered to the entrance to the patient’s nares, the seal-forming structure being configured to maintain said therapeutic pressure in the plenum chamber throughout the patient’s respiratory cycle in use, wherein the seal-forming structure comprises at least one adhesive surface (Col. 7, Ln. 1-32 – double-sided pressure sensitive adhesive tape) configured in use to adhere to a region of the patient’s face to form the seal; a vent structure (Figs. 1-3 #40, 42; Col. 6, Ln. 39-41) to allow a continuous flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent structure being configured to maintain the therapeutic pressure in the plenum chamber in use (vent openings are small enough to maintain interior pressure of the mask); and a mouth closure structure (Figs. 2-3 & 7 #102; Col. 7, Ln. 66 – Col. 8, Ln. 30 – affixing to upper and lower lips) configured to promote closure of the patient’s mouth, wherein the mouth closure structure is connected to the seal-forming structure and/or the plenum chamber (Figs. 2 & 7), and wherein the mouth closure structure comprises a strip or strap (Figs. 2-3 & 7 #102 – lip section 102 is readable as a strip or strap) configured to engage the patient’s mouth (Col. 7, Ln. 66 – Col. 8, Ln. 30 – affixing to upper and lower lips)
Regarding claim 2, Belfer discloses the mouth closure structure comprises a mouth closure member comprising an adhesive surface (Col. 7, Ln. 66 – Col. 8, Ln. 30 – double-sided adhesive tape) configured in use to adhere to the patient’s lips and/or a region of the patient’s face proximate the patient’s lips.
Regarding claim 4, Belfer discloses when the mouth closure member is adhered to the patient’s face, the mouth closure member leaves at least a portion of the patient’s mouth uncovered (Col. 7, Ln. 66 – Col. 8, Ln. 30 – can be affixed to only the upper lip or otherwise trimmed such that some portion of the mouth will still be uncovered).
Regarding claim 7, Belfer discloses the mouth closure member is configured to span across the patient’s mouth (Col. 7, Ln. 66 – Col. 8, Ln. 30 – affixed to upper and lower lips).
Regarding claim 8, Belfer discloses the mouth closure structure is integrally connected to the seal-forming structure and/or the plenum chamber (Col. 8, Ln. 1-4 – glued or bonded into place forms an integral connection).
Regarding claim 9, Belfer discloses the mouth closure structure is configured to be disconnectable from the seal-forming structure and/or the plenum chamber (e.g. Fig. 3 – adhesive connection is disconnectable).
Regarding claim 10, Belfer discloses a patient interface (Figs. 1-7) for use in delivering breathable gas to a patient (Col. 6, Ln. 3-22), the patient interface comprising: a plenum chamber (Fig. 2 interior of #20) pressurisable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure (Col. 6, Ln. 18-22; Col. 8, Ln. 57-61 – can receive pressurized gas from a pump), said plenum chamber including a plenum chamber inlet port (Figs. 1-3 #34; Col. 8, Ln. 57-61) capable of receiving a flow of breathable gas at the therapeutic pressure for breathing by the patient; a seal-forming structure (Figs. 2-3 #70; Col. 7, Ln. 1-32) provided to the plenum chamber, wherein the seal-forming structure is configured to form a seal with a region of the patient’s face surrounding an entrance to the patient’s nares but not around the patient’s mouth (Fig. 7 – only covers nose; Col. 9, Ln. 24-31 – nasal only mask), said seal-forming structure having an opening (Fig. 3 central opening in #70) therein such that the flow of breathable gas is delivered to the entrance to the patient’s nares, the seal-forming structure being configured to maintain said therapeutic pressure in the plenum chamber throughout the patient’s respiratory cycle in use; a vent structure (Figs. 1-3 #40, 42; Col. 6, Ln. 39-41) to allow a continuous flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent structure being configured to maintain the therapeutic pressure in the plenum chamber in use (vent openings are small enough to maintain interior pressure of the mask); and a mouth closure structure (Figs. 2-3 & 7 #102; Col. 7, Ln. 66 – Col. 8, Ln. 30 – affixing to upper and lower lips) configured to promote closure of the patient’s mouth, wherein the mouth closure structure is connected to the seal-forming structure and/or the plenum chamber (Figs. 2 & 7), and wherein the mouth closure structure comprises a strip or strap (Figs. 2-3 & 7 #102 – lip section 102 is readable as a strip or strap) configured to engage the patient’s mouth (Col. 7, Ln. 66 – Col. 8, Ln. 30 – affixing to upper and lower lips) and/or chin regions. It is noted that the claim does not positively recite delivery of the therapeutic pressure as a generator of that therapeutic pressure is not positively recited.
Regarding claim 11, Belfer discloses the seal-forming structure comprises at least one adhesive surface (Col. 7, Ln. 1-32 – double-sided pressure sensitive adhesive tape) configured in use to adhere to a region of the patient’s face to form the seal.
Regarding claim 12, Belfer discloses the patient interface further comprises headgear (Figs. 1-3 #82, 92; Col. 7, Ln. 32-65) configured to hold the seal-forming structure in sealing position on the patient’s face in use. The claim does not specify a particular form of headgear.
Regarding claim 13, Belfer discloses the headgear comprises one or more straps (Figs. 1-3 #82, 92 – strips 82, 92 are readable as short straps) configured to hold the seal-forming structure in sealing position on the patient’s face in use. The claim does not require the straps to be located in any particular position relative to the patient.
Regarding claim 14, Belfer discloses the mouth closure structure comprises a mouth closure member comprising an adhesive surface (Col. 7, Ln. 66 – Col. 8, Ln. 30 – double-sided adhesive tape) configured in use to adhere to the patient’s lips and/or a region of the patient’s face proximate the patient’s lips.
Regarding claim 16, Belfer discloses when the mouth closure member is adhered to the patient’s face, the mouth closure member leaves at least a portion of the patient’s mouth uncovered (Col. 7, Ln. 66 – Col. 8, Ln. 30 – can be affixed to only the upper lip or otherwise trimmed such that some portion of the mouth will still be uncovered).
Regarding claim 20, Belfer discloses the mouth closure structure is configured to be disconnectable from the seal-forming structure and/or the plenum chamber (e.g. Fig. 3 – adhesive connection is disconnectable).
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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) 3, 6, 15 and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Belfer et al. (U.S. Patent 5918598).
Regarding claim 3, Belfer fails to explicitly disclose the mouth closure member is configured to adhere to a region of the patient’s face inferior to the mouth and to a region of the patient’s face superior to the mouth.
However, Belfer teaches lip section 102 as configured with double-sided adhesive tape 130 to be able to cover both the upper and lower lips (Col. 8, Ln. 4-9). One of ordinary skill in the art recognizing that different persons have different sized lips would have considered it prima facie obvious that for at least persons with smaller lips the double-sided adhesive tape 130 would be expected to be sized in such a way as to extend as least minimally both superior and inferior to the person’s lips.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Belfer the mouth closure member is configured to adhere to a region of the patient’s face inferior to the mouth and to a region of the patient’s face superior to the mouth at least considering that when using the double-sided adhesive tape 130 of Belfer, which is designed to be able to cover both the upper and lower lips of a patient, that for at least persons with smaller lips the double-sided adhesive tape 130 would be expected to be sized in such a way as to extend as least minimally both superior and inferior to the person’s lips.
Regarding claim 6, Belfer fails to explicitly disclose the mouth closure member is configured to adhere to one or more side-of-mouth regions on one or both lateral sides of the patient’s mouth and to a lower lip/chin region between the patient’s mouth and chin.
However, Belfer teaches lip section 102 as configured with double-sided adhesive tape 130 to be able to cover both the upper and lower lips (Col. 8, Ln. 4-9). One of ordinary skill in the art recognizing that different persons have different sized lips would have considered it prima facie obvious that for at least persons with smaller lips the double-sided adhesive tape 130 would be expected to be sized in such a way as to extend as least minimally both laterally beyond the person’s lips as well as inferior to the person’s lips.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Belfer the mouth closure member is configured to adhere to a side-of-mouth region on one or both lateral sides of the patient’s mouth and to a lower lip/chin region between the patient’s mouth and chin at least considering that when using the double-sided adhesive tape 130 of Belfer, which is designed to be able to cover both the upper and lower lips of a patient, that for at least persons with smaller lips the double-sided adhesive tape 130 would be expected to be sized in such a way as to extend as least minimally both laterally beyond the person’s lips as well as inferior to the person’s lips.
Regarding claim 15, Belfer fails to explicitly disclose the mouth closure member is configured to adhere to a region of the patient’s face inferior to the mouth and to a region of the patient’s face superior to the mouth.
However, Belfer teaches lip section 102 as configured with double-sided adhesive tape 130 to be able to cover both the upper and lower lips (Col. 8, Ln. 4-9). One of ordinary skill in the art recognizing that different persons have different sized lips would have considered it prima facie obvious that for at least persons with smaller lips the double-sided adhesive tape 130 would be expected to be sized in such a way as to extend as least minimally both superior and inferior to the person’s lips.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Belfer the mouth closure member is configured to adhere to a region of the patient’s face inferior to the mouth and to a region of the patient’s face superior to the mouth at least considering that when using the double-sided adhesive tape 130 of Belfer, which is designed to be able to cover both the upper and lower lips of a patient, that for at least persons with smaller lips the double-sided adhesive tape 130 would be expected to be sized in such a way as to extend as least minimally both superior and inferior to the person’s lips.
Regarding claim 18, Belfer fails to explicitly disclose the mouth closure member is configured to adhere to one or more side-of-mouth regions on one or both lateral sides of the patient’s mouth and to a lower lip/chin region between the patient’s mouth and chin.
However, Belfer teaches lip section 102 as configured with double-sided adhesive tape 130 to be able to cover both the upper and lower lips (Col. 8, Ln. 4-9). One of ordinary skill in the art recognizing that different persons have different sized lips would have considered it prima facie obvious that for at least persons with smaller lips the double-sided adhesive tape 130 would be expected to be sized in such a way as to extend as least minimally both laterally beyond the person’s lips as well as inferior to the person’s lips.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Belfer the mouth closure member is configured to adhere to a side-of-mouth region on one or both lateral sides of the patient’s mouth and to a lower lip/chin region between the patient’s mouth and chin at least considering that when using the double-sided adhesive tape 130 of Belfer, which is designed to be able to cover both the upper and lower lips of a patient, that for at least persons with smaller lips the double-sided adhesive tape 130 would be expected to be sized in such a way as to extend as least minimally both laterally beyond the person’s lips as well as inferior to the person’s lips.
Regarding claim 19, Belfer further teaches the mouth closure member is configured to span across the patient’s mouth (Col. 7, Ln. 66 – Col. 8, Ln. 30 – affixed to upper and lower lips).
Allowable Subject Matter
Claim(s) 5 and 17 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 5, Belfer fails to teach or suggest when the mouth closure member is adhered to the patient’s face, the mouth closure member leaves the patient’s mouth fully uncovered. Lip section 102 is the only possible mouth closure member in Belfer. Lip section 102 in use will never be expected to leave the patient’s mouth fully uncovered.
It is noted that Belfer is considered the only prior art readable on claim 1. As an initial matter, claim 1 recites the seal-forming structure, which only covers the patient’s nares and not the patient’s mouth, as including an adhesive surface which enables it to be adhered to the patient’s face. Additionally, claim 1 recites the mouth closure member as connected to the seal-forming structure and/or plenum chamber which means there cannot be intermediary parts between the mouth closure member and the seal-forming structure and/or plenum chamber. And finally, the mouth closure member is recited as being a strip or strap configured to engage the patient’s mouth and/or chin regions, with the terms strip and strap given a plain language definition as being a general flat, elongated piece of material. No other prior art beyond Belfer is found which can accurately read on all of the structural and functional limitations of claim 1.
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Regarding claim 17, Belfer fails to teach or suggest when the mouth closure member is adhered to the patient’s face, the mouth closure member leaves the patient’s mouth fully uncovered. Lip section 102 is the only possible mouth closure member in Belfer. Lip section 102 in use will never be expected to leave the patient’s mouth fully uncovered.
Several notes are made regarding claim 10. As an initial matter, claim 10 recites the seal-forming structure as only covering the patient’s nares and not the patient’s mouth. Additionally, claim 10 recites the mouth closure member as connected to the seal-forming structure and/or plenum chamber which means there cannot be intermediary parts between the mouth closure member and the seal-forming structure and/or plenum chamber. And finally, the mouth closure member is recited as being a strip or strap configured to engage the patient’s mouth and/or chin regions, with the terms strip and strap given a plain language definition as being a general flat, elongated piece of material. Further, claim 17 is dependent from claim 14 which requires the mouth closure member to include an adhesive surface for adhering to the patient.
Other prior art potentially readable on claim 10 include Goldstein (U.S. Pub. 2011/0114099; Fig. 5), Kushida et al. (U.S. Pub. 2014/0360502; Fig. 2) and Michalak et al. (U.S. Pub. 2020/0306482). However, none of these alternate references teach or suggest when the mouth closure member is adhered to the patient’s face, the mouth closure member leaves the patient’s mouth fully uncovered. Instead the mouth closure member in each of these alternate references will always be expected when adhered to cover the patient’s mouth.
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see PTO-892 for additional attached references.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH D BOECKER whose telephone number is (571)270-0376. The examiner can normally be reached M-F 9:00 AM - 4:00 PM.
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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
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