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 Objections
Claims 1, 3, 4-6, 9, 11, 12, and 14 are objected to because of the following informalities:
The phrase “an access port” should be changed to –the access port—for consistency (Claim 1, Lines 4-5).
The phrase “an PPV mask” should be changed to –the PPV mask—for consistency (Claim 1, Line 5).
The phrase “the oral end of a patient” should be changed to –an oral end of a patient—since this is the first time this is mentioned (Claim 1, Line 6).
The phrase “the mask” should be changed to –the PPV mask—for consistency (Claim 1, Line 7 [two instances]).
The phrase “gasses” should be changed to –gases—to correct the typographical error (Claim 1, Line 10).
The phrase “elongate support housing” should be changed to –support housing—for consistency (Claim 1, Line 12).
The phrase “the external” should be changed to –an external—since this is the first time this is mentioned (Claim 1, Line 13).
The phrase “a sampled gas” should be changed to –the sampled oral gases—for consistency (Claim 1, Line 15).
The phrase “the pressure of the ventilator” should be changed to –a pressure of a ventilator—since this is the first time this is mentioned (Claim 3, Line 5).
The phrase “exposed to a pressure” should be changed to –configured to be exposed to a pressure—to make it clear that the pressure external is not positively claimed (Claim 3, Line 6).
The phrase “the adapter” should be changed to –the PPV adapter—for consistency (Claim 3, Line 6).
The phrase “the adapter” should be changed to –the PPV adapter—for consistency (Claim 4, Line 2).
The phrase “elongate housing” should be changed to –support housing—for consistency (Claim 4, Lines 2-3).
The phrase “the adapter” should be changed to –the PPV adapter—for consistency (Claim 5, Line 2).
The phrase “the adapter” should be changed to –the PPV adapter—for consistency (Claim 5, Line 4).
The phrase “an outside portion of the adapter” should be changed to –the outside portion of the adapter—for consistency (Claim 6, Line 3).
The phrase “the depth” should be changed to –a depth—since this is the first time this is mentioned (Claim 6, Line 5).
The phrase “attached the” should be changed to –attached to the—to correct the grammatical error (Claim 9, Line 2).
The phrase “the tubing wall” should be changed to –a wall of the tubing—for consistency (Claim 11, Line 2).
The phrase “the mouth” should be changed to –a mouth—since this is the first time this is mentioned (Claim 12, Line 3).
The phrase “the module” should be changed to –the capnometry module—for consistency (Claim 14, Line 4).
A comma should be added after “access port” to correct the grammatical error (Claim 14, Line 2 and Line 4 [two instances]).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 states “the support housing sized and configured to be placed through an access port of an PPV mask and form a first PPV seal therewith” (Line 5). This statement fails to comply with the written description requirement since there is nothing in the disclosure that indicates the support housing is forming a PPV seal with the PPV mask. It appears the applicant was trying to say the adapter is the component forming the PPV seal with the PPV mask. However, the support housing 228 is shown to be smaller in diameter than the adapter 224 (Fig 15A) and the adapter 224 is described to attach to the access port of the PPV mask (Specification: paragraph 136). Additionally, the appliance adapters are described to have sealing surfaces that seal the adapter to the access port of the PPV mask (Specification: paragraph 097). There is nothing in the disclosure that describes the support housing 228 is directly forming the PPV seal with the PPV mask. For examination purposes, the claim limitation will be interpreted as the adapter is positively recited in Claim 1.
Claims 2-14 are rejected for being dependent on rejected Claim 1.
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 1-14 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 1 states “the support housing sized and configured to be placed through an access port of an PPV mask and form a first PPV seal therewith” (Line 5). This statement is indefinite because it is unclear how the support housing is forming the first PPV seal with the PPV mask. It appears the applicant was trying to say there is an adapter that is forming the first PPV seal with the PPV mask that goes along with the support housing. However, as described earlier in the 35 USC 112(a) rejection above, there is nothing in the disclosure that indicates the support housing itself is forming the first PPV seal with the PPV mask. Rather, the adapter is the component that is actually forming the first PPV seal with the PPV mask. The claim, though, does not positively recite the adapter. Therefore, how the support housing is capable of forming the first PPV seal with the PPV mask cannot be determined. For examination purposes, the claim limitation will be interpreted as the adapter is positively recited in Claim 1.
Claim 1 states “the sampling line passing through an aperture in the support housing to the outside portion of the adapter” (Lines 11-13). This statement is indefinite because it is unclear if the adapter is positively claimed. It appears the applicant was trying to say that the sampling line is configured to pass through the aperture to the outside portion of an adapter and the adapter is not positively claimed. However, the adapter is not mentioned earlier and it is unclear if the adapter is required to be positively recited so that the sampling line goes to the outside portion of the adapter. Therefore, whether or not the adapter is positively claimed cannot be determined. For examination purposes, the claim limitation will be interpreted as the adapter is positively claimed in Claim 1. Similar rejections are applied to Claim 6 (Line 3).
Claim 3 states “a PPV adapter” (Line 2). This statement is indefinite because it is unclear if this is the same adapter mentioned in Claim 1. It appears the applicant was trying to say they’re the same. However, it is possible there are multiple adapters involved. Therefore, the number of adapters cannot be determined. For examination purposes, the claim limitation will be interpreted as they’re the same.
Claim 3 states “a PPV adapter having a first seal surface configured to form the first PPV seal with the access port of the PPV mask” (Lines 2-3). This statement is indefinite because it is unclear which component is actually forming the first PPV seal. It appears the applicant was trying to say the adapter is forming the first PPV seal. However, Claim 1 describes the support housing being the component that forms the first PPV seal which creates confusion. Therefore, the component actually involved in forming the first PPV seal cannot be determined. For examination purposes, the claim limitation will be interpreted as the first PPV seal is formed by the support housing, not the PPV adapter.
Claim 3 states “the inside portion is exposed to the pressure of the ventilator” (Line 5). This statement is indefinite because it is unclear if the pressure and the ventilator are positively claimed. It appears the applicant was trying to say the inside portion is capable of being exposed to the pressure of the ventilator and that the pressure and ventilator are not positively recited. However, the wording the claim creates confusion regarding whether or not the inside portion needs to be exposed to the pressure of the ventilator. Therefore, whether or not the pressure of the ventilator is positively claimed cannot be determined. For examination purposes, the claim limitation will be interpreted as the inside portion is capable of being exposed to the pressure of the ventilator and that the pressure and ventilator are not positively recited.
Claim 4 states “the second seal” (Line 4). This statement is indefinite because it is unclear if this is the same second PPV seal mentioned in Claim 1. It appears the applicant was trying to say they’re the same. However, it is possible this is completely distinct seal. Therefore, the number of seals involved cannot be determined. For examination purposes, the claim limitation will be interpreted as they’re the same.
Claim 6 states “the adapter body” (Lines 5-6). There is insufficient antecedent basis for this limitation in the claim. It appears the applicant was trying to say “a body of the adapter”. However, since this is the first time this is mentioned, it is unclear what it is referring back to. Therefore, the identity of the term cannot be determined. For examination purposes, the claim limitation will be interpreted as “a body of the adapter”. Similar rejections are applied to Claim 8 (Line 2).
Claim 7 states “sampling exhalation gases in the oral cavity” (Lines 4-5). This statement is indefinite because it is unclear if this is the same sampled oral gases mentioned in Claim 1. It appears the applicant was trying to say they’re the same. However, it is possible “exhalation gases” might be a more specific kind of gas and is distinct from the ones mentioned in Claim 1. Therefore, the number of gases involved cannot be determined. For examination purposes, the claim limitation will be interpreted as they’re the same. Similar rejections are applied to Claim 12 (Line 3).
Claim 8 states “the covered position to the extended position” (Line 4). There is insufficient antecedent basis for this limitation in the claim. It appears the applicant was trying to refer back to the covered position and extended position mentioned in Claim 7. However, since this is the first time this is mentioned, it is unclear what it is referring back to. Additionally, Claim 8 is dependent on Claim 1. Therefore, the identity of the phrase cannot be determined. For examination purposes, the claim limitation will be interpreted as “a covered position to an extended position”.
Claim 11 states “the casing” (Line 2). There is insufficient antecedent basis for this limitation in the claim. It appears the applicant was trying to say “a casing”. However, since this is the first time this is mentioned, it is unclear what it is referring back to. Therefore, the identity of the term cannot be determined. For examination purposes, the claim limitation will be interpreted as “a casing”.
Claim 12 states “the housing tubing”, “the tubing wall”, “the housing tube”, and “the tubing” (Lines 1-4). There is insufficient antecedent basis for this limitation in the claim. It appears the applicant was trying to say the support housing comprises tubing and a wall of the tubing and that all of these limitations are further describing the support housing. However, it is unclear where the tubing and tubing wall come from since they’re not mentioned earlier in Claim 1. Therefore, the identity of these components cannot be determined. For examination purposes, the claim limitation will be interpreted as the support housing comprises tubing and a wall of the tubing and that all of these limitations are further describing the support housing.
Claim 14 states “a capnometry adapter” (Line 4). This statement is indefinite because it is unclear if this is the same adapter mentioned in Claim 1. It appears the applicant was trying to say they’re the same. However, it is possible a completely different adapter is involved. Therefore, the number of adapters involve cannot be determined. For examination purposes, the claim limitation will be interpreted as they’re the same.
Claims 2, 5, 9, 10, and 13 are rejected for being dependent on rejected Claim 1.
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.
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.
Claims 1, 6, and 9-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Evans (US 5,474,060 A).
Regarding Claim 1, Evans discloses a positive pressure ventilation (PPV) capnometry module (28, Figs 1-2), comprising: an elongate support housing (32, Fig 2) sized and configured to be placed through (32 is sized and configured to be placed through 30, Fig 2) an access port (30, Fig 2) of a PPV mask (mask 10, Fig 1), the support housing extending from an oral end (end of 38, Fig 2) to an external end (end of 34, Fig 2) opposite the oral end, the support housing sized and configured to be placed through an access port of an PPV mask (32 is sized and configured to be placed through 30, Fig 2) and form a first PPV seal therewith (32 would form a seal around the port 30, Fig 2; 46 both seals and supports orientation of 32 within 30, Column 5, Lines 24-31), wherein with the support housing inserted and sealed, the oral end is positioned in the oral end of a patient wearing the mask and the external end is external to the mask (32 extends within and through 30 so that 34 extends beyond interior surface 36 of body 12 of mask 10 and into interior 20 of such mask, 38 extends beyond exterior surface 40 of body 12 of mask 10, Column 5, Lines 15-25; oral end of 32 is positioned in or at the oral end or near the mouth of the patient); a capnometry sampling line (26, Fig 2) positioned within the support housing (26 goes inside of 32, Fig 2) and having a sampling inlet (end of 26 closest to 38, Fig 2) positioned near the oral end of the support housing (when assembled, end of 26 closest to 38 would be positioned near 34, Fig 2; 38 presents at end 42 a substantially cylindrical outer surface to which 26 can be releasably secured, Column 6, Lines 25-31), the sampling inlet in fluid communication with an exterior of the support housing for sampling oral gasses (end of 26 closest to 38 would be in fluid communication with the exterior of 32 or exterior of 34 within interior of mask, Fig 2; 26 for directing to the monitoring apparatus the repeated samplings of exhaled air from patient, Column 6, Lines 25-31), the sampling line passing through an aperture (aperture of 32, Fig 2) in the support housing to the outside portion of the adapter (outside portion of 44, Fig 2) and forming a second PPV seal with the elongate support housing or an adapter attached thereto (to releasably secure tube 26 to end 42 of second part 38 of tubular portion or element 32 of connector 28 so that same cannot be dislodged, it is, in the preferred embodiment, found that a threaded screw mechanism in the form of a luer lock provides efficient, quick, and safe releasable engagement, as well as provides for a releasable connection which prevents outside air from entering tube 26 at the point of connection to connector 28, Column 6, Lines 32-40; preferably presenting internal thread 56 of adaptor 44 in alignment with complementary external thread 52 presented by end 42 of second part 38 of tubular portion of element 32 of connector 28, rotating wings 58 of adaptor 44 internal thread 56 and external thread 52 releasably engage one another in a well known manner and tube 26 is thus releasably secured to the end presented by second part 38 of tubular portion or element 32, Column 7, Lines 45-60), the sampling line having a line connector distal to the external end and configured to attach the sampling line to a capnometry system suitable for measuring end tidal CO2 of a sampled gas (desirable to monitor the exhaled air stream from a patient and deliver a portion of such exhaled air stream to proper monitoring apparatus such as a mass spectrometer or capnograph, accomplished through connecting a tube 26 from the monitoring apparatus to face mask 10 and preferably to a location on body 12 of face mask 10 to optimize the repeated samplings taken of the exhaled air stream by the patient or wearer of the face mask so that an accurate measurement of the oxygen and carbon dioxide levels therein is accomplished, Column 4, Lines 58-64; 26 would inherently be connected to the capnograph by a connector).
Regarding Claim 6, Evans discloses the support housing has a second end (38, Fig 2) opposite the oral end, the support housing extending through an outside portion of the adapter (38 goes through the outside portion of 44 via the interaction of 56 and 52, Fig 2) to the second end and having a proximal connector (52, Fig 2) that forms the second seal with the sampling line (26 forms seal with 32 via connection of 56 and 52, Fig 2), the outside connector providing a grip surface suitable for a user to slidably adjust the depth of the support housing relative to the adapter body (surface of 52 with its interaction with 56 of 44 would allow a user to slidably rotate and adjust the depth of 32 relative to 44, Fig 2; user would use 52 and 38 to hold or grip mask in place while 44 is screwed onto 38 via the interaction of 52 and 56, Fig 2).
Regarding Claim 9, Evans discloses a casing (48, Fig 2) attached the support housing at or near the oral end (48 is attached near 34, Fig 2), wherein the sampling inlet is formed in the casing (the inlet of 26 would be formed in the area inside of 48, Fig 2).
Regarding Claim 10, Evans discloses the casing is made from a softer material than the support housing (42 typically made of rigid PVC, 48 typically constructed from soft PVC, Column 6, Lines 15-20).
Regarding Claim 11, Evans discloses the support housing comprises tubing (32 is a tubing, Fig 2) and the casing covers the tubing wall at the oral end (48 surrounds 32 near 34, Fig 2).
Regarding Claim 12, Evans discloses the housing tubing includes one aperture in the tubing wall that are positioned to allow exhalation gases to pass into and out of the housing tube when the mouth of the patient is sealed around the tubing (34 has an aperture or hole that allows gas to travel to 26, Fig 2; exhaled gas is capable of passing through 34 when the user has sealed or closed their mouth near 34, Figs 2-3). It is noted that Applicant has not specified that the tubing is inside the mouth of the user.
Regarding Claim 13, Evans discloses a PPV system (apparatus of Fig 1) comprising: a PPV mask (mask 10, Fig 1) with an access port (30, Fig 2); and the capnometry module of Claim 1 (see Rejection of Claim 1 above).
Regarding Claim 14, Evans discloses wherein (iv) the module includes a capnometry adapter (44, Fig 2) that seals with the access port (44 seals with 30 via its interaction with 32, Fig 2; preferably presenting internal thread 56 of adaptor 44 in alignment with complementary external thread 52 presented by end 42 of second part 38 of tubular portion of element 32 of connector 28, rotating wings 58 of adaptor 44 internal thread 56 and external thread 52 releasably engage one another in a well known manner and tube 26 is thus releasably secured to the end presented by second part 38 of tubular portion or element 32, Column 7, Lines 45-60) (iii) the access port is positioned in a shell of the mask (30 is in shell of mask 10, Fig 2; port 30 in body portion 12 of the face mask, Column 5, Lines 5-10); or combinations of these (see earlier citations).
Allowable Subject Matter
Claims 2-5, 7, and 8 contain allowable subject matter.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 2 is dependent on Claim 1 and discusses the access port of the mask having a valve.
Claim 3 is dependent on Claim 1 and discusses the PPV adapter having an inside portion exposed to pressure of the ventilator.
Claim 7 is dependent on Claim 6 and discusses the support housing being able to slidably adjust from a covered position to an extended position.
Claim 8 is dependent on Claim 1 and discusses a sheath connected to the adapter body and support housing and the sheath being compressed when the support housing moves from a covered position to an extended position.
Claims 4-5 contain allowable subject matter due to their dependencies on Claim 3.
Prior art similar to the claimed invention are explained below.
Evans (US 5,474,060 A) discusses a face mask. Regarding Claim 2, Evans does not mention anything about the access port 30 being a valve. Even if the access port 30 was added with a valve, it would not be reasonable in the context of Evans. The component 32 is described to be welded chemically onto port 30 (Evans: Column 5, Lines 61-67). Thus, there is no motivation to make component 32 to be a removable component or a component that is inserted into a valve. Regarding Claim 3, Evans does not mention an adapter that has an inside portion exposed to pressure of the ventilator. At most, Evans has the sampling tube 26 which is the only component that is actually exposed to the pressure within the mask. The adapter 44 is only threaded onto the second part 38 and is outside of 38. Thus, adapter 44’s inside portion is not exposed to any pressure within the mask. Regarding Claim 7, Evans does not have a support housing that is able to adjust between two different positions. Similar to the arguments of Claim 2, the component 32 of Evans does not slide through the access port 30 and does not slidably adjust between two different positions. Regarding Claim 8, Evans does not mention anything about a sheath in between the adapter 44 and component 32 and there would be no reason to add a sheath in between. Additionally, similar to the arguments of Claim 7, the component 32 of Evans does not switch between positions since it is incapable of moving in and out of the access port 30.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for art cited of interest including:
US-20130220326-A1 discusses a breath indicator placed in an elbow of the mask.
US-20140243698-A1 discusses a sensor adapter for coupling a gas sampling tube to the mask.
US-20120271187-A1 discusses a medical device for monitoring carbon dioxide that can be inserted into a mask.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN THAI-BINH KHONG whose telephone number is (571)272-1857. The examiner can normally be reached Monday to Thursday 9:00 am-6:00 pm.
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/BRIAN T KHONG/Examiner, Art Unit 3785
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
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