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 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:
"adjustable PIP valve mechanism" in claim 1, interpreted in accordance with paragraph [0004] and [0033] as being the pressure adjustment portion 18 of the ventilator device including tubular member 56 or an art-recognized equivalent thereof
"gas-pressure responsive displacement member" in claim 1, interpreted in accordance with paragraph [0034] as being a piston or an art-recognized equivalent thereof
"spring support member" in claim 1, interpreted in accordance with paragraph [0035] as being a tubular post or art-recognized equivalent thereof
"spring actuated member" in claim 1, interpreted in accordance with paragraph [0035] as being a spring actuated arm or art-recognized equivalent thereof
"adjustable flow rate valve mechanism" in claim 1, interpreted in accordance with paragraph [0004] as a variable orifice valve or art-recognized equivalent thereof
"gas flow rate adjustment device" in claim 1, interpreted in accordance with paragraph [0004] as a flow control dial or art-recognized equivalent thereof
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 1-24 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 1 recites “the valve body including pressure adjustment open space and gas inlet and gas outlet openings” in lines 5-6. The limitation is confusing because it is not clear if “gas inlet and gas outlet openings” means: (a) one gas inlet and multiple gas outlet openings, (b) multiple gas inlet openings and multiple gas outlet openings, or (c) a gas inlet opening and a gas outlet opening. For examination purposes interpretation (c) is assumed. Examiner suggests the limitation be amended to read --the valve body including pressure adjustment open space a gas inlet opening and a gas outlet opening --.
Claims 2-24 are rejected based on their dependency to claim 1.
Claim 8 recites the limitations "the base floor" in line 2 and “the base portion” in line 2. There is insufficient antecedent basis for these limitations in the claim. Since these features are defined in claim 3, it is assumed, for examination purposes, that Claim 8 is dependent upon claim 3.
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.
Claims 1 and 22 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Koledin (US 2011/0197892).
As to claim 1, Koledin discloses a gas-driven, pressure-regulated ventilator (Fig. 4, col. 1, ln. 20-34), comprising:
a hollow valve body 22, 24 (modulator housing 22 and base 24, Fig. 2, Fig. 3) including an interior 42 and a breathing gas pathway (through inlet chamber 14) in fluid communication with a gas inlet 74 (gas inlet 74 of patient adapter 66, Fig. 4) for supply of gas flow within the interior 42 of the valve body 22, the valve body 22 having first and second ends and defining a longitudinal axis (an axis is defined passing through the center of the pressure dial 18 and the gas inlet 14, see annotated Fig. 3 below), and the valve body 22 including pressure adjustment open space and gas inlet and gas outlet openings (gas inlet opening at gas inlet 14 and gas outlet opening at flow restrictor port 16, see annotated Fig. 3 below), the pressure adjustment open space located nearer to the first end, and the gas inlet and gas outlet openings located nearer to the second end (see annotated Fig. 3 below);
an adjustable peak inspiratory pressure (PIP) valve mechanism (diaphragm assembly 12, see Fig. 2) operatively associated with the valve body 22 and including:
a gas-pressure responsive displacement member (diaphragm plate 26 and ring 27) having a contact surface (plate 26, see Fig. 2, Fig. 3, paragraph [0110]) that, in response to pressure applied by flow of gas along the breathing gas pathway, changes position within the interior 14 of the valve body 22 between open and closed positions along the longitudinal axis (paragraph [0112]), and the gas-pressure responsive displacement member 26, 27 assuming the closed position in absence of gas flow within the interior 14 of the valve body 22 (the diaphragm plate 26 is biased in the closed position, paragraph [0110]);
a spring support member (threaded end of pressure dial 18) operatively connected to the valve body 22 and to a spring-actuated member (spring boss 32) that extends into the pressure adjustment open space (see annotated Fig. 3 below) and applies a force against the contact surface 26 of the gas-pressure responsive displacement member 26, 27, the force applied in a direction opposite to that of force applied to the gas-pressure responsive displacement member by the flow of gas along the breathing gas pathway (the force of the spring 30 on diaphragm 26, 27 is downward while the force of gas entering inlet 14 is upward, see Fig. 3, paragraph [0112]); and
a spring adjustment device (the handle of pressure dial 18) operatively connected to the spring-actuated member 32 (through spring 30) for adjusting the force applied against the contact surface 26 of the gas-pressure responsive displacement member 26, 27 (Fig. 3, paragraph [0110]); and an adjustable gas flow rate valve mechanism (rate dial 20 and flow restricting port 16, see Figs. 1-4) operatively associated with the valve body 22 and including a gas flow rate adjustment device (rate dial having tapered end 55 and slots 54) configured to allow, in cooperation with the gas outlet opening 16, a controllable amount of gas flow out of the valve body 22 when the gas-pressure responsive displacement member 26, 27 is in the open position (paragraph [0111]).
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As to claim 22, Koledin discloses the ventilator of claim 1, in which the valve body 22 has a side surface (top side of housing 22) into which the gas outlet opening is formed (see annotated Fig. 3 above).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Koledin (US 2011/0197892), in view of Foote et al. (US 2014/0283831).
As to claim 2, Koledin discloses the ventilator of claim 1, in which the adjustable gas flow rate valve mechanism includes a flow control dial (rate dial 20, Figs. 1-4) that in cooperation with a slot 54 allows an increasing amount of gas flow through the gas outlet opening in response to rotation of the flow control dial 20, paragraph [0111]) but does not disclose a flow control dial that, in cooperation with an arcuate slot, allows an increasing amount of gas flow through the gas outlet opening in response to rotation of the flow control dial to cause more complete alignment of the arcuate slot with the gas outlet opening.
However, Foote teaches an alternative type of flow control dial (disk 970 within conduit 990, see Fig. 9C and Fig. 9A) which, in cooperation with an arcuate slot 595 (on disk 975), see Fig 9C), allows an increasing amount of gas flow through a gas outlet opening (vent opening 590 in conduit 990) in response to rotation of the flow control dial to cause more complete alignment of the arcuate slot 595 with the gas opening 590 (Fig. 9C, paragraph [0124]).
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the ventilator of Koledin so that the flow control dial is of the type with an arcuate slot in adjustable alignment with a gas outlet opening, as taught by Foote, since doing so amounts to simple substitution of one known flow control means for another that accomplishes the same result of creating an adjustable flow through an outlet opening.
Allowable Subject Matter
Claims 3-21, 23, and 24 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:
As to claim 3, Koledin discloses the ventilator of claim 1, in which the valve body comprises a base portion 24 having a base floor (the flat portion of base 24, see Fig. 2) including the gas inlet opening 14 from which a tubular member (the tubular portion of base 24 that extends to interior end 28) extends into the interior of the valve body 22 and terminates in a sealing rim (sealing ring 62) at a free end 28, (see Figs. 2 and 3) and a detachable pressure adjustment portion (housing 22) which interlocks with the base portion 24 via first and second locking features (see Figs. 1-4, paragraphs [0109]-[0112]).
However, the prior art of record does not disclose or render obvious, the ventilator of claim 3, in which the base portion includes, at a first end, the first locking feature, and, at a second end, the base floor (Koledin’s locking feature is on the base floor 24 which is positioned between the top end (at 18) and the bottom end 14 of base 24).
As to claim 20, Koledin discloses the ventilator of claim 1, in which the spring support member is tubular and has a threaded outer surface 34, the tubular spring support member containing a spring 30 having first and second ends (Fig.3, paragraph [0110]).
However, the prior art of record does not disclose or render obvious, the ventilator of claim 20, in which the spring-actuated member has a distal end and a spring connection tab, the distal end of the spring-actuated member applying the contact force against the gas-pressure responsive displacement member, and in which the spring support member is configured for threaded engagement with a spring tension adjustment nut, and the tubular spring support member further comprises two diametrically opposed lengthwise slots, the first end of the spring operatively connected to a spring hanger support bar extending through the two slots in the tubular spring support member and resting against the spring tension adjustment nut, and the second end of the spring operatively connected to the spring connection tab of the spring-actuated member.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bird (US 4,039,139), Takaoka (US 2,996,071), Matsubara et al. (US 2010/0206310), Lugtigheid (US 2011/0168180), and Carden (US 3,561,466) each disclose a ventilator having an adjustable valve.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE L WOODWARD whose telephone number is (571)270-1479. The examiner can normally be reached on Monday - Friday 8:30 am - 4:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KENDRA CARTER can be reached on 571-272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785