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 . Claims 1-17 are pending and examined below.
Claim Objections
Claim 11, 15, and 16 are objected to because of the following informalities: "when the patent attempts to speak" should read when the patient attempts to speak . Appropriate correction is required.
Claim 3 is objected to because of the following informalities “from a throat of the patient” should read as “from the throat of the patient.” 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.
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 11 and 13-15 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.
Claims 11 and 15 are indefinite due to phrase "improving speech quality", because the meaning of the term "improving" depends solely on a subjective opinion. The Courts have determined that applicants “are required to make clear and precise the terms that are used to define the invention whereby the metes and bounds of the claimed invention can be ascertained”, see MPEP 2173.05(a).
Claim 13 has indefinite scope in regards to the valve apparatus as it “comprising part of a tracheostomy apparatus.” The term “comprising” means that the valve includes part of the tracheostomy apparatus, however according to the specification, this does not appear to be true.
Claims 14 and 15 recites the limitation "tracheostomy apparatus". There is insufficient antecedent basis for this limitation in the claim. Claims should cite to claim 13 where the apparatus is introduced.
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.
(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.
Claim 12 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2009/0032028 A1 ("Bare et al.").
In regards to claim 12, Bare et al. discloses a valve apparatus (Fig. 2, valve, 30, para 0035),
comprising a hollow cylindrical body (see below, Annotated Fig. 4., H1, para 0037)
configured to fit over a curved cannula (tracheostomy tube, para 0009),
the valve comprising at least three circumferentially spaced-apart longitudinal ribs (Fig. 2, rib, 56, para 0041)
formed on an inner surface (Fig. 2, inner body, 42, para 0035) of the hollow cylindrical body;
the retaining means (Fig. 2, rib, 56, para 0041) comprising a series of ribs perpendicular to and positioned through the hollow cylindrical body;
and a disc (Fig. 2, diaphragm, 38, para 0035) disposed within the hollow cylindrical body between a proximal opening (Fig. 2, distal end, 34, para 0034) and the retaining means (Fig. 2, rib, 56, para 0041).
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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.
Claim(s) 1-11 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over US 6,722,367 B1 ("Blom et al.") in view of US 2009/0032028 A1 (“Bare et al.”)
In regards to claim 1, Blom et al. discloses a tracheostomy apparatus (Fig. 1, tracheotomy tube system, 10, col. 4 lines 17-20) comprising,
a curved cannula (Fig. 1, inner cannula, 40, col. 5 line 18-25),
having an open first end (Fig. 1, first port, 21, col. 4 line 47-49)
and an opposite second end (Fig. 1, second port, 23, col. 4 line 47-49)
configured for surgical insertion into a trachea of a patient (Fig. 1, open end, 33, col. 4 line 57-60);
a neck plate to the curved cannula (Fig. 1, mounted attachment, 30, col. 4 lines 64-67)
and configured for disposal on an outside of a throat of the patient (Fig. 1, outer cannula, 12, col. 4 lines 64-67)
Blom et al. does not explicitly disclose a hollow cylindrical valve, however, Bare et al. discloses a tracheostomy valve unit (Fig. 2, valve, 30, para 0035) comprising
a hollow cylindrical body (see below, Annotated Fig. 4, H1, para 0037) configured to fit over the curved cannula,
the valve comprising at least three circumferentially spaced-apart longitudinal ribs (Fig. 2, rib, 56, para 0041)
formed on an inner surface (Fig. 2, inner body, 42, para 0035) of the hollow cylindrical body. Before the effective filing date of the claimed invention it would have been obvious to one of ordinary skill in the art to modify the tracheostomy apparatus disclosed by Blom et al. to include the hollow cylindrical body valve unit disclosed by Bare et al. in order to allow uninterrupted, low resistance airflow during inhalation (Bare et al. Abs).
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In regards to claim 2, Blom et al. further discloses the tracheostomy apparatus (Fig. 1, tracheotomy tube system, 10, col. 4 line 17-20) of claim 1, wherein the curved cannula (see below, Annotated Fig. 6, C1) is bent at or about 90 degrees.
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In regards to claim 3, Blom et al. discloses the tracheostomy apparatus (Fig. 1, tracheotomy tube system, 10, col. 4 line 17-20) of claim 1,
wherein when used by the patient, the open first end extends outwardly (see above, Annotated Fig. 6, O1, see also col. 4 line 47-50) from a throat of the patient,
and the opposite second end extends downwardly (see above, Annotated Fig. 6, O2, see also col. 4 line 53-55) toward lungs of the patient.
In regards to claim 4, Blom et al. discloses the tracheostomy apparatus (Fig. 1, tracheotomy tube system, 10, col. 4 line 17-20) of claim 1. However, Blom et al does not explicitly disclose a hollow cylindrical valve with retaining means. Bare et al. further discloses a tracheostomy valve unit,
wherein the valve (Fig. 2, valve, 30, para 0034)
further comprises retaining means (Fig. 2, rib, 56, para 0041) disposed within the
hollow cylindrical body (see below, Annotated Fig. 4, H1, para 0037). Before the effective filing date of the claimed invention it would have been obvious to one of ordinary skill in the art to modify the tracheostomy apparatus disclosed by Blom et al. to include the retaining means and hollow cylindrical body disclosed by Bare et al. in order allow air to flow smoothly into the valve (Bare et. al, Abs).
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Regarding claim 5, Blom et al. discloses the tracheostomy apparatus (Fig 1, tracheotomy tube system, 10, col. 4 line 17-20) of claim 4. Blom et al does not explicitly disclose a hollow cylindrical valve. However, Bare et al. further discloses a tracheostomy valve unit including,
wherein the retaining means comprises a series of ribs (Fig 2, rib, 56, para 0041) perpendicular to
and positioned through the hollow cylindrical body (see above, Annotated Fig. 4, H1 and R1, para 0037). Therefore, before the effective filing date of the claimed invention it would have been obvious to one of ordinary skill in the art to modify the tracheostomy apparatus of Blom et al. to include the valve and disc disclosed by Bare et al. in order to allow air to flow smoothly into the valve (Bare et. al, Abs).
Regarding claim 6, Blom et al. discloses the tracheostomy apparatus (Fig 1, tracheotomy tube system, 10, col. 4 line 17-20) of claim 4. Blom et al does not explicitly disclose a hollow cylindrical valve. However, Bare et al. further discloses a tracheostomy valve unit including,
comprising a disc (Fig. 2, diaphragm, 38, para 0035) disposed
within the hollow cylindrical body (see above, Annotated Fig 4., H1, para 0037, see also Fig 5 and para 0055)
between a proximal opening (Fig. 2, distal end, 34, para 0034) and
the retaining means (Fig. 2, rib, 56, para 0041). Before the effective filing date of the claimed invention it would have been obvious to one of ordinary skill in the art to modify the tracheostomy apparatus disclosed by Blom et al. to include the disc, hollow cylindrical body, proximal opening, and retaining means as disclosed by Bare et al. as doing so merely involves combing prior art elements according to known methods to yield predictable results (see MPEP 2143).
Regarding claim 7, Blom et al. discloses the tracheostomy apparatus (Fig. 1, tracheotomy tube system, 10, col. 4 line 17-20) of claim 6. Blom et al does not explicitly disclose a hollow cylindrical valve. Bare et al. further discloses a tracheostomy valve unit with a hollow cylindrical valve including,:
wherein an annular flat surface (Fig. 4, inner surface, 52, para 0037) is formed
within the hollow cylindrical body (see above, Annotated Fig. 4, H1, para 0037, see also Fig 5 para 0055) so that the disc (Fig. 2, diaphragm, 38, para 0035) is seated when the patient exhales. Therefore, before the effective filing date of the claimed invention it would have been obvious to one of ordinary skill in the art to modify the tracheostomy apparatus disclosed by Blom et al. to include the annular surface, hollow cylindrical body and diaphragm disclosed by Bare et al. in order to improve user speech and health considerations such as decreased nasal secretions and decreasing likelihood of chronic infections (Bare et al, para 0057).
Regarding claim 8, Blom discloses the tracheostomy apparatus (Fig. 1, tracheotomy tube system, 10, col. 4 line 17-20) of claim 7. Blom et al does not explicitly disclose a hollow cylindrical valve with a disc. However, Bare et al. further discloses a tracheostomy valve unit with a hollow cylindrical valve, including:
wherein when the disc (Fig. 2, diaphragm, 38, para 0035) is seated,
a seal (Fig. 2, diaphragm 38, in combination with the cap, 40, para 0048) is created, preventing exhaled air from passing through the tracheostomy tube. Therefore, before the effective filing date of the claimed invention it would have been obvious to one of ordinary skill in the art to modify the tracheostomy apparatus disclosed by Blom et al. to include the disc and seal disclosed by Bare et al. in order to improve user speech and health considerations such as decreased nasal secretions and decreasing likelihood of chronic infections (Bare et al, para 0057).
Regarding claim 9, Blom et al. discloses the tracheostomy apparatus (Fig. 1, tracheotomy tube system, 10, col. 4 line 17-20) of claim 6, and the curved cannula (see below, Annotated Fig. 6, C1, col. 2 line 31-34). Blom et al. does not disclose the passing of air around a disc. However, Bare et al. further teaches wherein when used by the patient, inhaled air passes through the valve (Fig. 2, valve, 30, para 0035),
around the disc (Fig. 2, diaphragm, 38, para 0035) and into the curved cannula (para 0038). Therefore, before the effective filing date of the claimed invention it would have been obvious to one of ordinary skill in the art to modify the tracheostomy apparatus and curved cannula disclosed by Blom et al. to include the valve and disc disclosed by Bare et al. as doing so merely involves combing prior art elements according to known methods to yield predictable results (see MPEP 2143).
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Regarding claim 10, Blom et al. discloses the tracheostomy apparatus (Fig. 1, tracheotomy tube system, 10, col. 4 line 17-20) of claim 4, wherein when used by the patient, exhaled air passed through the curved cannula to the disc (see below, Annotated Fig. 7, A2, see also col. 7 line 16-22), causing the disc to be seated (see Fig. 6, flap 166 in combination with seal 172, see also col. 7 lines 11-15), creating a seal.
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Regarding claim 11, Blom et al. discloses the tracheostomy apparatus (Fig. 1, tracheotomy tube system, 10, col. 4 line 17-20) of claim 10 whereby the exhaled air is forced to enter a larynx of the patient (see above, Annotated Fig. 7, see also col. 7 line 16-22), improving speech quality of the patient when the patent attempts to speak.
Regarding claim 16, Blom et al. discloses a method of improving speech quality,
comprising the steps of: positioning the opposite second end (Fig. 1, second port, 23, col. 4 line 47-49)
of the curved cannula (Fig. 1, inner cannula, 40, col. 5 lines 18-25) of the tracheostomy apparatus (Fig. 1, tracheotomy tube system, 10, col. 4 lines 17-20) of claim 1 into the trachea of the patient and positioning the neck plate (Fig. 1, attachment plate, 30, col. 4 lines 64-65) on a relative outside of a neck of the patient (Fig. 1, outer cannula, 12, col. 4 lines 64-67);
wherein inhaled air can pass through the valve (Fig. 7, opening, 164, col. 7 lines 5-11) into lungs of the patient (see below, Annotated Fig. 6, A1, see also col. 7 lines 5-11);
and wherein exhaled air causes the valve to close (see below, Annotated Fig. 7, A2 in combination with flap 166), diverting the exhaled air into a larynx of the patient, improving speech quality of the patient when the patent attempts to speak.
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Regarding claim 17, Blom et al. discloses the method of claim 16, wherein the valve (Fig. 7, opening, 164, col. 7 lines 5-11) is configured to close (see above, Annotated Fig. 7, A2 in combination with flap 166, see also col. 7 lines 15-21) due to a disc (Fig. 7, flap, 166, col. 7 lines 15-21) positioned within the valve being able to seal an opening of the valve (see Fig. 6, flap 166 in combination with seal 172, see also col. 7 lines 11-15).
Claim(s) 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0032028 A1 (“Bare et al.”) in view of US 6,722,367 B1 ("Blom et al.").
In regards to claim 13, Bare et al. discloses a valve apparatus (Fig. 2, valve, 30, para 0035) of claim 12. However, it does not disclose the specific configuration of the tracheostomy apparatus. Blom et al. further discloses a tracheostomy apparatus (Fig. 1, tracheotomy tube system, 10, col. 4 line 17-20), the tracheostomy apparatus further comprising:
a curved cannula (Fig. 1, outer cannula, 12 and 20, col. 4 line 42-45) having an open first (Fig. 1, first port, 21, col. 4 line 47-49) end and an opposite second end (Fig. 1, second port, 23, col. 4 line 47-49) configured for surgical insertion into a trachea of a patient (Fig. 1, open end, 33, col. 4 line 57-60);
and a neck plate (Fig. 1, attachment plate, 30, col. 4 lines 64-65) connected to the curved cannula and configured for disposal on an outside of throat of the patient.
Therefore, before the effective filing date of the claimed invention it would have been obvious to one of ordinary skill in the art to modify the valve disclosed by Bare et al. to include the tracheostomy apparatus disclosed by Blom et al. as doing so merely involves combing prior art elements according to known methods to yield predictable results (see MPEP 2143).
In regards to claim 14, Bare et al. discloses a valve apparatus (Fig. 2, valve, 30, para 0035) of claim 12, inhaled air can pass through the proximal opening (Fig. 2, distal end, 34, para 0034) of the valve apparatus, around the disc (Fig. 2, diaphragm, 38, para 0035). However Bare et al., does not disclose the tracheostomy apparatus. Blom et al. further discloses wherein when the tracheostomy apparatus (Fig. 1, tracheotomy tube system, 10, col. 4 line 17-20) is used by the patient, inhaled air can pass into the curved cannula (Fig. 1, outer cannula, 12 and 20, col. 4 line 42-45), and into lungs of the patient. Before the effective filing date of the claimed invention it would have been obvious to one of ordinary skill in the art to modify the valve disclosed by Bare et al. to include the tracheostomy apparatus disclosed by Blom et al. in order to allow access outside the neck of the wearer and to allow for inhalation and exhalation of the user (Blom et al., col. 2 lines 28-35).
In regards to claim 15, Bare et al. discloses a valve apparatus (Fig. 2, valve, 30, para 0035) of claim 12. However Bare et al., does not disclose the tracheostomy apparatus. Blom et al. further discloses wherein when the tracheostomy apparatus (Fig. 1, tracheotomy tube system, 10, col. 4 line 17-20) is used by the patient, exhaled air causes the disc (Fig. 2, diaphragm, 38, para 0035) to form a seal within the valve apparatus (Fig. 2, diaphragm, 38, in combination with the cap, 40, para 0048), effectively diverting the exhaled air through a larynx of the patient, improving speech quality of the patient when the patent attempts to speak. Before the effective filing date of the claimed invention it would have been obvious to one of ordinary skill in the art to modify the valve disclosed by Bare et al. to include the tracheostomy apparatus disclosed by Blom et al. in order to improve user speech and health considerations such as decreased nasal secretions and likelihood of chronic infections (Bare et al, para 0057).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JICHELE MONIQUE SANDERS whose telephone number is (571)272-2240. The examiner can normally be reached M-Thu 6:30-5:15.
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/J.M.S./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774