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 in response to preliminary amendment filed on 06/19/2023. As directed by the amendment, no claims were canceled, no claims were amended, and no claims were newly added. Thus, claims 1-5 are presently pending in this application.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: “exhaled air entrance 11” of paragraph [0023]. 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. 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 disclosure is objected to because of the following informalities: on specification page 8, at the end of paragraph [0027], there is an unfinished sentence that reads “A paddle style”. This should either be amended to a full sentence or amended to remove from the specification.
Appropriate correction is required.
Claim Objections
Claims 1-5 are objected to because of the following informalities:
Regarding claim 1 line 10, the term “said distal end” should read --said distal end,-- to provide punctuation between the structures in the claim.
Regarding claims 2-5 line 2, the term “claim 1 wherein” of claim 2 and the equivalent phrases in claims 3-5 should read --claim 1, wherein-- including the comma to distinguish the preamble from the claim body.
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.
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:
“an airway clearance device” of claim 1 line 3-4
“a variable suction control means” of claim 1 line 11
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.
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 § 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 1-5 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.
Regarding claim 1 line 4, the term “said body” is indefinite because it lacks proper antecedent basis. In line 7, the term “said body polymer” is indefinite because it lacks proper antecedent basis. All terms relating to “a sterilizable polymer body” of line 3 should read --said sterilizable polymer body-- for consistency. In line 11-12, the term “said suction control means” is indefinite because it lacks proper antecedent basis.
Regarding claim 3 line 3, the term “the set of group” is indefinite because it lacks proper antecedent basis. In line 6, the terms “said body” is indefinite because it lacks proper antecedent basis.
Regarding claim 4 line 2, the term “said sections of tubing” is indefinite because it lacks proper antecedent basis.
Regarding claim 5 line 2, the term “said suction control means” is indefinite because it lacks proper antecedent basis. In line 3, the term “said body” is indefinite because it lacks proper antecedent basis.
Any remaining claims are rejected as being dependent upon a rejected base claim.
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.
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Von Hollen et al. (US 2013/0184619; hereinafter “Von Hollen”) in view of Sheridan (US 3,375,828) and Hadley et al. (US 2016/0256139; hereinafter “Hadley”).
Regarding claim 1, Von Hollen discloses a patient operated airway clearance and phlegm elimination device (see Von Hollen vibratory positive expiratory pressure (PEP) device 2; [0003] device provides vibration to the patient lungs to shake mucus loose), comprising:
a sterilizeable polymer body with an internal cavity that houses an airway clearance device (see Von Hollen device 2 housing contains duckbill valve 26 and other therapy structures working together to provide PEP therapy), said body having a front end with an exhaled air exit (see Von Hollen second end 8 with Fig. 3 arrows showing flow of exhaled air through therapy apparatus out chamber 46), and a back end with a patient mouthpiece having a exhaled air entrance (see Von Hollen mouthpiece portion 4 on first end 6);
Van Hollen is silent as to a catheter removably attached to said polymer body, said catheter having a proximal end and a distal end, an orifice formed through a side wall of said catheter between said proximal end and said distal end a variable suction control means positioned adjacent said orifice, said suction control means moveable between a position that occludes or does not occlude said orifice; and a vacuum system connected to said distal end of said catheter.
However, Sheridan teaches a catheter (see Sheridan airway suction catheter 10), said catheter having a proximal end and a distal end (see Sheridan proximal, distal ends 12, 14), an orifice formed through a side wall of said catheter between said proximal end and said distal end (see Sheridan control aperture 21), a variable suction control means positioned adjacent said orifice (see Sheridan latex sleeve 20 rolling into ring 22), said suction control means moveable between a position that occludes or does not occlude said orifice (see Sheridan Fig. 2 manual rolling of ring 22 to either occlude or not occlude the aperture 21); and a vacuum system connected to said distal end of said catheter (see Sheridan Col. 2 lines 25-27 tube 15 connects to any conventional suction device such as a suction pump).
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 phlegm elimination device of Von Hollen with the addition of a suction catheter as taught by Sheridan so as to provide a structure to physically remove the phlegm produced from use of the elimination device.
Modified Von Hollen is silent as to a catheter removably attached to said polymer body. However, Hadley teaches a catheter removably attached to a polymer body (see Hadley suction hose clip 110 on jar collar 148, a rounded surface). 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 outer housing of the device of modified Von Hollen with the addition of catheter clips as taught by Hadley to hold the catheter of modified Von Hollen on the airway clearance device so as to provide ease of use of all components of the device to the user.
Regarding claim 2, modified Von Hollen discloses said proximal end of said catheter adjustably extends beyond said patient mouthpiece (see Von Hollen modified with Sheridan to include the suction catheter 10, mounted onto the PEP device 2 with clips 110 of Hadley. The positioning of the catheter in the clips can extend beyond mouthpiece 4 by placement or sliding).
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Von Hollen in view of Sheridan and Hadley as applied to claim 2 above, and further in view of Brimhall (US 5,935,110).
Regarding claim 3, modified Von Hollen discloses a catheter securement means selected from the set of group consisting of openable tubing clips (see modified Von Hollen of claim 1, where clip 110 of Hadley are modified onto the housing of PEP device 2); wherein said catheter securement means is affixed to an exterior face of said body and restrains said catheter thereon said body (see modified Von Hollen of claim 1, where suction catheter 10 of Sheridan is modified to sit within clips 110).
Modified Von Hollen is silent as to a catheter securement means selected from the set of group consisting of a section of tubing. However, Brimhall teaches a catheter securement means selected from the set of group consisting of a section of tubing (see Brimhall Fig. 1 tubular member 26 holding tube 50). 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 suction catheter securement means of modified Von Hollen with the section of tubing securement means as taught by Brimhall as this would have been an obvious substitution for one known type of securement means for a catheter for another and would yield predictable results, i.e. secure the catheter to the device.
Regarding claim 4, modified Von Hollen discloses said sections of tubing are clear (see Brimhall Col. 3 lines 48-50 tubular member 26 is made of a clear material such as polycarbonate).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Von Hollen in view of Sheridan, Hadley, and Brimall as applied to claim 4 above, and further in view of Vazales et al. (US 10,850,062; hereinafter “Vazales”).
Regarding claim 5, modified Von Hollen is silent as to said suction control means is a swivel arm mounted to said body with a pivot pin. However, Vazales teaches said suction control means is a swivel arm mounted to said body with a pivot pin (see Vazales valve 3060 with handle 3062 turned between positions open/close; and Col. 20 lines 48-29 can be used to control a suction catheter). 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 variable suction control means “ring 22” of modified Von Hollen with the swivel arm and pivot pin control means as taught by Vazales as this would have been an obvious substitution for one known type of manually operated variable suction control means for another and would yield predictable results, i.e. control the amount of suction according to the user’s manual operation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to the applicant’s disclosure.
Stenzler et al. (US 2009/0229615), Tokunga (US 2018/0110949), Avitsian et al. (US 2014/0144432), Zhou et al. (US 2023/0149646), Davenport et al. (US 2016/0121062), and Brain (US 2003/0051734) is cited to show an airway clearance device connected to a suction tube.
Moulton et al. (US 2023/0114722), Martin (US 2022/0143369), and Fassouliotis (US 6,638,240) cited to show a securement means for a suction catheter.
Schmidt et al. (US 2002/0029779) and Rozario et al. (US 2012/0097164) are cited to show PEP devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GWYNNETH L HOWELL whose telephone number is (703)756-4742. The examiner can normally be reached 8:30-4:30 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Justine Yu can be reached at (571) 272-4835. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GWYNNETH L HOWELL/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785