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 .
Priority
Receipt is acknowledged of a certified copy of foreign application AU 2020903544. However, applicant is notified that the copy of the ‘544 AU application received by the USPTO appears to be missing important portions of the drawings in Figs. 3A-7K (e.g. see screenshot of Fig. 3A below).
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Applicant is notified in case they wish to refile a copy of the ‘544 AU application with complete drawings, only assuming the presently viewed drawings of the ‘544 AU application are incomplete in their transmission.
Claim Objections
Claim(s) 216-248 is/are objected to because of the following informalities:
Claim 216, Ln. 4 recites “the proportion of a flow of respiratory gas” which should read “a proportion of the flow of respiratory gas”
Claim 217, Ln. 3 recites “a relatively less portion” which should read “a relatively lesser portion”
Claim 223, Ln. 2 recites “a flow of respiratory gas” which should read “the flow of respiratory gas” following after claim 216
Claim 242, Ln. 3 recites “a patient interface” which should read “the patient interface” following after claim 238
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.
Claim(s) 216-248 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 pre-AIA the applicant regards as the invention.
Claim 216 recites the phrasing “the flow regulator is configured to in use receive a flow of respiratory gas and to adjust [a] proportion of [the] flow of respiratory gas which flows from the flow regulator into the first headgear tube and the second headgear tube” in Ln. 3-5 which deems the claim indefinite. A plain reading of the limitation appears to indicate that the proportion which is able to be adjusted is a relative comparison between the flow the flow regulator receives and the flow which the flow regulator outputs to the combination of the first headgear tube and the second headgear tube. However, the disclosed invention does not appear to use the flow regulator to alter a balance between received flow and outputted flow. The flow received by the disclosed flow regulator appears to exactly match the flow outputted from the flow regulator. What appears intended, but not accurately captured in the present claim language, is that the flow regulator is being used to adjust a proportioning of the flow between the first headgear tube and the second headgear tube. Thus, the proportion of the claim is understood to be intended as a relative splitting of the flow received at the flow regulator between the first headgear tube and the second headgear tube. As opposed to how the claim is currently written and read, the adjusting of proportion is not properly understood as a change in cumulative output from the flow regulator in relation to a constant input at the flow regulator. Rather, the adjusting of proportion selectively diverts flow to one of the headgear tubes instead of the other of the headgear tubes while maintaining an ongoing cumulative output of flow from the flow regulator. This interpretation will be applied to the below examination and should be made clear when amending the claim.
Claim 218 recites the phrasing “all, or a substantial portion of, the flow” which deems the claim indefinite. The term “substantial” is a relative term which is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how much less than all of the flow is readable on the “substantial portion” of the flow recited by the claim. For the purposes of examination the claim will be interpreted as defining the relatively greater portion of the flow as at least a majority of the flow.
Claim 219 recites the phrasing “all, or a substantial portion of, the flow” which deems the claim indefinite. The term “substantial” is a relative term which is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how much less than all of the flow is readable on the “substantial portion” of the flow recited by the claim. For the purposes of examination the claim will be interpreted as defining the relatively greater portion of the flow as at least a majority of the flow. The same limitation in dependent claim 220 is found indefinite in the same manner.
Claim 219 recites the phrasing “the flow regulator is configured to, in use, direct all, or a substantial portion of, the flow of respiratory gas to the first headgear tube when the patient's head is tilted substantially to a first side” which deems the claim indefinite. The flow regulator as claimed includes no positively recited structure to link it to a patient’s head. The claim is thus overly broad as it recites a function without reciting sufficient structure to perform the function, since the flow regulator alone is not secured to the patient’s head to alone allow perform of the claimed function (see MPEP 2173.05(g)). The claim should be amended to positively recite the structure which interfaces the flow regulator to the patient’s head to allow the claimed function to be performed. The similar limitation in dependent claim 220 is found indefinite in the same manner.
Claim 226 recites the limitation “a / the duct” in Ln. 2 which deems the claim indefinite. The instant claim depends from claim 224 which has already recited a duct. It is thus unclear whether the present limitation includes a typographical error and should only read “the duct” or is instead attempting to alternatively refer back to either the prior duct or to a new duct. For the purposes of examination the limitation will be interpreted as reading “the duct”.
Claim 230 recites the phrasing “completely or substantially blocks the second outlet” which deems the claim indefinite. The term “substantially” is a relative term which is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how much less than a complete blocking of the flow is readable on the “substantially” blocking recited by the claim. It is unclear how to interpret the claim beyond a requirement of complete blocking of the second outlet.
Claim 231 recites the phrasing “substantially or completely prevents the flow of respiratory gas” which deems the claim indefinite. The term “substantially” is a relative term which is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how much less than a complete preventing of the flow is readable on the “substantially” blocking recited by the claim. It is unclear how to interpret the claim beyond a requirement of complete preventing of the flow.
Claim 232 recites the phrasing “substantially or completely open” which deems the claim indefinite. The term “substantially” is a relative term which is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how much less than completely open is readable on the “substantially” open recited by the claim. It is unclear how to interpret the claim beyond a requirement of being completely open.
Claim 230 recites the phrasing “completely or substantially blocks the second outlet” which deems the claim indefinite. The term “substantially” is a relative term which is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how much less than a complete blocking of the flow is readable on the “substantially” blocking recited by the claim. It is unclear how to interpret the claim beyond a requirement of complete blocking of the second outlet.
Claim 233 recites the phrasing “completely or substantially blocks the first outlet” which deems the claim indefinite. The term “substantially” is a relative term which is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how much less than a complete blocking of the flow is readable on the “substantially” blocking recited by the claim. It is unclear how to interpret the claim beyond a requirement of complete blocking of the first outlet.
Claim 234 recites the phrasing “substantially or completely prevents the flow of respiratory gas” which deems the claim indefinite. The term “substantially” is a relative term which is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how much less than a complete preventing of the flow is readable on the “substantially” blocking recited by the claim. It is unclear how to interpret the claim beyond a requirement of complete preventing of the flow.
Claim 235 recites the phrasing “substantially or completely open” which deems the claim indefinite. The term “substantially” is a relative term which is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how much less than completely open is readable on the “substantially” open recited by the claim. It is unclear how to interpret the claim beyond a requirement of being completely open.
Claim Interpretation - 35 USC § 112(f)
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “decoupling component” in claim 226 and “sealing component” in claim 244.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The corresponding structure for the “decoupling component” is best understood from the specification as at least: a ball and socket-type joint, one of a swivel ring or swivel cuff, a gusset, a fold, a concertina section, an area of relatively lower stiffness, and an area of reduced thickness (¶0701).
The corresponding structure for the “sealing component” is best understood from the specification as at least: a cushion in the form of either a full-face cushion or one or more nasal pillow or nasal prong (¶¶0103-0105).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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) 216-224 and 227-237 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goff et al. (U.S. Pub. 2015/0367092).
Regarding claim 216, Goff discloses a flow regulator (Figs. 8A-8C; ¶¶0102-0106) for a respiratory therapy treatment system (e.g. Fig. 1), wherein the respiratory therapy treatment system includes system is not positively recited by the claim and thus the details recited of it are not read as positively recited (e.g. a first headgear tube and a second headgear tube). Note additionally the discussion in ¶0103 of Goff that the first channel 176 may be connected to an air tube of the system instead of to a mask. It is additionally noted that first and second side channels 178a, 178b may be read as tubes or they may instead read as capable of being connected to respective downstream tubes.
Regarding claim 217, Goff discloses the flow regulator is configured to direct a relatively greater portion of the flow of respiratory gas into one of the first tube or the second tube and a relatively lesser portion of the flow of respiratory gas into the other of the first tube and the second tube (Fig. 8B vs. Fig. 8C changes whether #174b or #174a is the available outlet).
Regarding claim 218, Goff discloses the relatively greater portion of the flow of respiratory is all, or a substantial portion of, the flow (e.g. Fig. 8B flow through #174b and not #174a; ¶0104).
Regarding claim 219, Goff discloses the flow regulator is configured to, in use, direct all, or a substantial portion of, the flow of respiratory gas to the first tube when the patient's head is tilted substantially to a first side (¶¶0104-0105; e.g. Figs. 8B-8C).
Regarding claim 220, Goff discloses the flow regulator is configured to, in use, direct all, or a substantial portion of, the flow of respiratory gas to the second tube when the patient's head is tilted to a second side (¶¶0104-0105; e.g. Figs. 8B-8C).
Regarding claim 221, Goff discloses the ratio of the portion of the flow directed to first headgear tube and the second headgear tube is dependent on the orientation of the patient's head (¶¶0104-0105; Figs. 8A-8C).
Regarding claim 222, Goff discloses the flow regulator comprises a body (Figs. 8A-8C outer body) which defines a chamber (Figs. 8A-8C internal space).
Regarding claim 223, Goff discloses the chamber includes an inlet (Figs. 8A-8C into #176; ¶0103) configured to facilitate the flow of respiratory gas flowing into the chamber.
Regarding claim 224, Goff discloses the flow regulator includes an inlet connector (Figs. 8A-8C #176 when connected to an air tube as discussed in ¶0103 while use a connector to connect to the air tube) that is configured to capable of in use connecting a duct to the inlet (e.g. ¶0103 – air tube). It is noted that the duct is not positively recited by the claim.
Regarding claim 227, Goff discloses the chamber includes a first outlet (Figs. 8A-8C one of #178a, 178b) capable of being in flow communication with the first headgear tube and a second outlet (Figs. 8A-8C other of #178a, 178b) capable of being in flow communication with the second headgear tube. It is noted again that the first headgear tube and the second headgear tube are not read as positively recited.
Regarding claim 228, Goff discloses the flow regulator includes an outlet connector (Figs. 8A-8C outer circumference of #178a, 178b are capable of functioning as a connector for a tube which is fit over that outer circumference) capable of facilitating connecting the flow regulator to the first headgear tube. It is noted again that the first headgear tube is not read as positively recited.
Regarding claim 229, Goff discloses the flow regulator includes an outlet connector (Figs. 8A-8C outer circumference of #178a, 178b are capable of functioning as a connector for a tube which is fit over that outer circumference) capable of facilitating connecting the flow regulator to the second headgear tube. It is noted again that the second headgear tube is not read as positively recited.
Regarding claim 230, Goff discloses when in the first configuration the barrier arrangement completely or substantially blocks the second outlet (¶¶0104-0105; e.g. Figs. 8B-8C one of #178a, 178b blocked).
Regarding claim 231, Goff discloses the barrier arrangement substantially or completely prevents the flow of respiratory gas flowing into the second headgear tube when the barrier arrangement is in the first configuration (¶¶0104-0105; e.g. Figs. 8B-8C one of #178a, 178b blocked).
Regarding claim 232, Goff discloses when in the first configuration the first outlet is substantially or completely open (¶¶0104-0105; e.g. Figs. 8B-8C one of #178a, 178b open).
Regarding claim 233, Goff discloses when in the second configuration the barrier arrangement completely or substantially blocks the first outlet (¶¶0104-0105; e.g. Figs. 8B-8C one of #178a, 178b blocked).
Regarding claim 234, Goff discloses the barrier arrangement substantially or completely prevents the flow of respiratory gas flowing into the first headgear tube when the barrier arrangement is in the second configuration (¶¶0104-0105; e.g. Figs. 8B-8C one of #178a, 178b blocked).
Regarding claim 235, Goff discloses when in the second configuration the second outlet is substantially or completely open (¶¶0104-0105; e.g. Figs. 8B-8C one of #178a, 178b open).
Regarding claim 236, Goff discloses the barrier arrangement is
Regarding claim 237, Goff discloses the barrier arrangement is provided in the chamber (Figs. 8A-8C).
Allowable Subject Matter
Claims 225-226 and 238-248 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 225, Goff fails to teach or suggest the inlet connector is an elbow. There is no consideration in Goff of connecting between first channel 176 and mask 172 or the air tube of ¶0103 specifically with an elbow. The configuration disclosed in Figs. 8A-8C of Goff is meaningfully different than that of Figs. 4A-9 of the instant invention. While an elbow is essential in the disclosed invention there is no reason one of ordinary skill in the art would have considered incorporating the required elbow into Goff.
Goff is found to be the only prior art readable on claim 216 because of the specific language in that claim which, based upon the 35 U.S.C. 112(b) rejection and interpretation of that claim above, defines the barrier arrangement of the flow regulator as being moveable by gravity to selectively divert more flow to one of the two headgear tubes while simultaneously diverting less flow to the other of the two headgear tubes. No other prior art is found to teach or suggest such a diversion of flow based upon purely a gravitational force.
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 226, Goff fails to teach or suggest the flow regulator further comprises a decoupling component between the inlet and the duct. Goff has no consideration of a decoupling component, in accordance with the 35 U.S.C. 112(f) interpretation of that limitation, at the location of first channel 176. The use of the decoupling component by the instant invention is specific to the placement of the flow regulator where tubing connections are formed such as to avoid drag forces on the patient. Goff has no such consideration.
Goff is found to be the only prior art readable on claim 216 because of the specific language in that claim which, based upon the 35 U.S.C. 112(b) rejection and interpretation of that claim above, defines the barrier arrangement of the flow regulator as being moveable by gravity to selectively divert more flow to one of the two headgear tubes while simultaneously diverting less flow to the other of the two headgear tubes. No other prior art is found to teach or suggest such a diversion of flow based upon purely a gravitational force.
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 238, Goff fails to teach or suggest a positioning and stabilizing structure configured in use to maintain a patient interface in a position relative to a patient's airway(s), comprising: the first headgear tube and the second headgear tube; and the flow regulator of claim 216. Specifically, the vent assembly of Figs. 8A-8C of Goff has no consideration of being connected to a pair of tubes readable as “headgear tubes” in light of the specification. In the disclosed invention “headgear tubes” are tubes which allow for gas transport while also forming a portion of a headgear assembly (e.g. Fig. 4A of the instant application). Goff fails to have any consideration of interfacing the vent assembly of Figs. 8A-8C to the structures required by the instant claim.
Goff is found to be the only prior art readable on claim 216 because of the specific language in that claim which, based upon the 35 U.S.C. 112(b) rejection and interpretation of that claim above, defines the barrier arrangement of the flow regulator as being moveable by gravity to selectively divert more flow to one of the two headgear tubes while simultaneously diverting less flow to the other of the two headgear tubes. No other prior art is found to teach or suggest such a diversion of flow based upon purely a gravitational force.
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