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 .
Specification
The abstract of the disclosure is objected to because:
Applicant is reminded of the proper content of an abstract of the disclosure. Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length. Currently, the abstract is greater than 150 words in length.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means,” “comprising,” and “said,” should be avoided.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1-44 are objected to because of the following informalities:
The phrase “the filling medium” should be changed to –a filling medium—since this is the first time this is mentioned (Claim 1, Line 22).
The phrase “mechanic” should be changed to –mechanical—to correct the grammatical error (Claim 5, Line 2).
The phrase “mechanic” should be changed to –mechanical—to correct the grammatical error (Claim 6, Line 2).
The phrase “mechanic” should be changed to –mechanical—to correct the grammatical error (Claim 7, Line 2).
The phrase “cuff-like” should be removed for consistency (Claim 11, Line 3).
The phrase “dirrection” should be changed to –direction—to correct the typographical error (Claim 19, Line 6).
The phrase “everey” should be changed to –every—to correct the typographical error (Claim 19, Line 10).
The phrase “supplying” should be removed for consistency (Claim 20, Line 2).
The phrase “a designed as an” should be changed to –designed as a—to correct the grammatical error (Claim 33, Line 2).
The phrase “an derivative” should be changed to –a derivative—to correct the grammatical error (Claim 34, Line 3).
The phrase “for the secondary lumen(s)” should be changed to –for the at least one or more secondary lumens— for consistency (Claim 36, Line 5).
The phrase “the filling medium” should be changed to –a filling medium—since this is the first time this is mentioned (Claim 44, Line 23).
Claim 44 states “according to one of the preceding claims”. Claim 44 is objected for containing structural claim limitations that have already been stated in Claim 1 since at a minimum, Claim 44 must be dependent on Claim 1. It is suggested that Applicant amend Claim 44 to avoid redundancy and antecedent basis issues.
Claims 2-4, 8-18, 21-32, 35, and 37-43 are objected for being dependent on objected Claim 1.
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:
The control device in Claim 1. The corresponding structures are one or more of the control devices (2, 8, 21, 22, 24, 23, 24’, 23’, 27, 28, 38, 37, 36, 34, 31, 32, 33, 35, 24’’, 24’’’) depicted in the drawings (Figs 1, 6, 9, and 10).
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 1-44 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 intracorporeal sealing tube” (Lines 23, 24, 28, and 29). There is insufficient antecedent basis for this limitation in the claim. It appears the applicant was trying to say “the intracorporeal sealing balloon”. 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 “the intracorporeal sealing balloon”. Similar rejections are applied to Claim 44 (Lines 24, 25, 29, and 30).
Claim 3 states “preferably” (Line 7). This statement is indefinite because it is unclear if the Shore hardness values are positively claimed. It appears the applicant was trying to say these are mere suggestions. However, the use of “preferably” causes confusion regarding whether or not these values are positively claimed. Therefore, whether or not the claim limitations are positively claimed cannot be determined. For examination purposes, the claim limitation will be interpreted as they’re mere preferences.
Claim 6 states “the balloon or bellows” (Line 3). There is insufficient antecedent basis for this limitation in the claim. It appears the applicant was trying to say the balloon or bellows of Claim 3. However, since this is the first time this is mentioned, it is unclear what it is referring back to. Additionally, Claim 6 is not dependent on Claim 3. Therefore, the identity of the term cannot be determined. For examination purposes, the claim limitation will be interpreted as “a balloon or bellows”.
Claim 17 states “a filling tube” (Line 3). This statement is indefinite because it is unclear what the filling tube is. It appears the applicant was trying to say the filling tube is the same as the extracorporeal filling tube in Claim 16. However, it is possible there are multiple filling tubes involved. Therefore, the number of filling tubes involved cannot be determined. For examination purposes, the claim limitation will be interpreted as a different filling tube from extracorporeal filling tube in Claim 16.
Claim 20 states “the system”, “the extracorporeal reservoir”, and “the balloon system” (Lines 4-7). There is insufficient antecedent basis for this limitation in the claim. It appears the applicant was trying to say the device with an extracorporeal reservoir and the balloon being the intracorporeal sealing balloon. However, the use of the system implies the device is part of a larger system that has not been previously mentioned. Additionally, this is the first time the reservoir is mentioned which has not been mentioned in previous claims. Therefore, the identity of the phrases cannot be determined. For examination purposes, the claim limitation will be interpreted as the device with an extracorporeal reservoir and that the pressure differences are in relation to the pressure in the intracorporeal sealing balloon and the extracorporeal reservoir.
Claim 20 states “after a compensation time of max. 20 ms, or after a compensation time of max. 10 ms.” (Lines 10-11). This statement is indefinite because is unclear if the compensation times listed are positively claimed in conjunction with the previously listed residual pressure differences. It appears the applicant was trying to say the compensation times are positively claimed alongside each of the listed residual pressure differences. However, it is possible that the compensation times do not have to be positively claimed in conjunction with the previously listed residual pressure differences. Therefore, whether or not each of the residual pressure differences have to have the compensation times paired up with them cannot be determined. For examination purposes, the claim limitation will be interpreted as the compensation times do not have to apply to every one of the previously listed residual pressure differences.
Claim 24 states “preferably e.g.” (Lines 3, 5, and 7). This statement is indefinite because it is unclear if the ranges are positively claimed. It appears the applicant was trying to say they’re mere examples. However, the use of “preferably e.g.” creates confusion regarding whether or not these ranges are being positively claimed. Therefore, the ranges involved cannot be determined. For examination purposes, the claim limitation will be interpreted as these ranges are mere examples.
Claim 27 states “in one of the lumens connected to it” (Line 3). This statement is indefinite because it is unclear what lumen is this referring to. It appears the applicant was trying to say the secondary lumens. However, it is possible it is a completely different lumen or other lumen/tube components connected to the device. Therefore, the identity of the lumens cannot be determined. For examination purposes, the claim limitation will be interpreted as the secondary lumens.
Claim 41 states “the minimal overall cross-section of all channels molded into the tube material” and “maximum cross-section of the annular secondary lumen” (Lines 1-2 and 4-5). This statement is indefinite because it is unclear what governs the minimal or maximum cross-sections. It appears the applicant was trying to say the minimal or maximum cross sections that make the device still operable. However, the claim limitations never specify what the minimal or maximum cross sections that are possible. The claim limitations also don’t detail what governs or limits a minimal or maximum cross section. Therefore, the minimal or maximum cross section limits cannot be determined. For examination purposes, the claim limitation will be interpreted as minimal or maximum cross sections are based on design choice and are based on the users preferences or opinions on what they consider a minimal or maximum cross section.
Claim 41 states “the annular secondary lumen” (Line 5). There is insufficient antecedent basis for this limitation in the claim. It appears the applicant was trying to say “an annular secondary lumen” that is separate from the one or more secondary lumens mentioned earlier. However, since this is the first time this is mentioned, it is unclear what it is referring back to. Additionally, it is unclear if this annular secondary lumen would be considered one of the one or more secondary lumens mentioned earlier. Therefore, the identity of the term cannot be determined. For examination purposes, the claim limitation will be interpreted as the annular secondary lumen is a separate lumen.
Claim 43 states “the connector” (Lines 1-2). There is insufficient antecedent basis for this limitation in the claim. It appears the applicant was trying to say “a connector”. 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 connector”.
Claims 2, 4, 5, 7-16, 18, 19, 21-23, 25, 26, 28-40, 42, and 44 are rejected for being dependent on rejected Claim 1.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 2, 5, 8, 10-12, 20-27, 31-33, 35-37, 39, 40, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Gobel (US 2003/0066532 A1) in view of Teves (US 5,029,591 A) and Pothmann et al. (US 5,361,753 A).
Regarding Claim 1, Gobel discloses a device for the dynamically sealing intubation of a hollow organ (Abstract; ensure the sealing of the tracheal cannula, the unfolded state of the tampon balloon is upheld via a communicating, extracorporeally mounted reservoir at a gentle filling pressure of preferably 10 to 15 mbar, paragraph 0090; such reservoirs may be equipped with a self-regulating valve mechanism, paragraph 0041), comprising a tube (1, Fig 6) in the form of a shaft (1 is a shaft, Fig 6) that can be inserted into the hollow organ (1 shown inside trachea 2, Fig 1), with a primary lumen (3, Fig 6) to provide access through or to the hollow organ in question, and comprising an intracorporeal sealing balloon (5, 23, and/or 24, Fig 6), which surrounds a distal region of the shaft of said tube in the manner of a cuff (5 surrounds 3 at distal end of 3, Fig 6) for the purpose of sealing it against the hollow organ (5 is shape of balloon and surrounds 3, paragraph 0062; cuff 5 comes to rest in region of middle of trachea, paragraph 0061; cuffed balloon blocks trachea, Abstract), wherein one or more secondary lumens (part of 28 and/or 32 inside of 3, Fig 6) for filling said intracorporeal sealing balloon are integrated into the wall of at least a proximal region of said shaft (28 and/or 32 shown to be part of proximal end of 3, Fig 6; 32 integrated into tube shaft, paragraph 0084). Gobel also discloses an extracorporeal filling tube (part of 28 and/or 32 outside of 3, Fig 6), an extracorporeally mounted reservoir equipped with a self-regulating valve mechanism (paragraph 0041), and a filling balloon equipped with a self-regulating valve mechanism (paragraph 0084).
Gobel fails to disclose wherein, within each cross- sectional plane that is intersected perpendicularly by the local longitudinal direction of the device, the following applies for the overall interior cross-section Q1 of the primary lumen and the sum Q2 of the interior cross-sections of all secondary lumens: Q2/(Q1+Q2)≥0.06, wherein at an extracorporeal filling tube, which communicates with all secondary lumens, a control device is provided in order to keep the pressure within the intracorporeal sealing balloon nearly constant in such a way that a) when the volume of the hollow organ increases, a corresponding amount of the filling medium is forced to flow into the intracorporeal sealing tube in order to increase the volume of the intracorporeal sealing tube accordingly, and b) when the volume of the hollow organ decreases, a corresponding amount of the filling medium is allowed to flow out of the intracorporeal sealing tube in order to decrease the volume of the intracorporeal sealing tube accordingly. It is noted that the claim limitation “within each cross- sectional plane that is intersected perpendicularly by the local longitudinal direction of the device” is being interpreted as the cross-sectional planes that include both the secondary and primary lumens and not the entire device from tip to tip.
However, Teves, of the same field of endeavor, teaches a flexible endotracheal tube (Abstract) including within each cross- sectional plane that is intersected perpendicularly by the local longitudinal direction of the device, the following applies for the overall interior cross-section Q1 of the primary lumen and the sum Q2 of the interior cross-sections of all secondary lumens: Q2/(Q1+Q2)≥0.06 (conduit 121 has a diameter of 7.4 mm and conduit 122 has a diameter of 2.16 mm, the area of a circular cross-section Q1 with a diameter of 7.4 mm is 43.01 mm2 and the area of a circular cross-section Q2 with a diameter of 7.4 mm is 3.66 mm2, therefore, (3.66/(43.01+3.66)) = 0.078 which is greater on 0.06) since these are known dimensions for a functional endotracheal tube.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize these dimensions for an endotracheal tube, as taught by Teves, since these are known dimensions for a functional endotracheal tube. Teves shows that these dimensions are well-known in the art and would be expected in tracheal tubes. Additionally, one of ordinary skill in the art would be capable of finding this claimed range through routine optimization and experimentation since these cross-sections and dimensions would be obviously expected in this field of art.
Gobel-Teves combination fails to teach wherein at an extracorporeal filling tube, which communicates with all secondary lumens, a control device is provided in order to keep the pressure within the intracorporeal sealing balloon nearly constant in such a way that a) when the volume of the hollow organ increases, a corresponding amount of the filling medium is forced to flow into the intracorporeal sealing tube in order to increase the volume of the intracorporeal sealing tube accordingly, and b) when the volume of the hollow organ decreases, a corresponding amount of the filling medium is allowed to flow out of the intracorporeal sealing tube in order to decrease the volume of the intracorporeal sealing tube accordingly.
However, Pothmann, of the same field of endeavor, teaches a processor based method of measuring and regulating pressure in the inflatable sealing cuff of a tracheal tube (Abstract) including wherein at an extracorporeal filling tube (8, Figs 2 and 2a-2c), which communicates with all secondary lumens (8 communicates with lumen inside of 5 and feeds 4, Figs 2 and 2a-2c), a control device (1, 9, 18, 20, 6, and 7, Fig 2) is provided in order to keep the pressure within the intracorporeal sealing balloon nearly constant in such a way that a) when the volume of the hollow organ increases, a corresponding amount of the filling medium is forced to flow into the intracorporeal sealing tube in order to increase the volume of the intracorporeal sealing tube accordingly (404, 406, and 408, Fig 4; cuff 4 is continuously sensed by 6 by 9, widening of trachea results in drop in pressure of sealing cuff 4, 9 increases pressure in 5 by causing 18 to add air, 9 regulates pressure of cuff at slow speed toward nominal pressure, Column 3, Lines 53-68), and b) when the volume of the hollow organ decreases, a corresponding amount of the filling medium is allowed to flow out of the intracorporeal sealing tube in order to decrease the volume of the intracorporeal sealing tube accordingly (if pressure increases beyond upper threshold of rest zone, 9 intervenes at slow speed in compensating manner, Column 4, Lines 1-12; regulating pressure in tracheal sealing cuff gradually toward nominal pressure with air discharge valve, Claim 12; menus would automatically provide nominal adult and child pressure values and thresholds, Column 4, Lines 23-32) to prevent the aspiration of fluids from the patient’s oral cavity especially during coughing (Column 2, Lines 4-7) and to allow for the device to adapt to a variety of patients including adults and children (Column 4, Lines 23-32).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the control device including the pressure generator, valves, control computer, and pressure sensor and replace the balloons with this system to adapt the cuff pressure, as taught by Pothmann, to prevent the aspiration of fluids from the patient’s oral cavity especially during coughing (Pothmann: Column 2, Lines 4-7) and to allow for the device to adapt to a variety of patients including adults and children (Pothmann: Column 4, Lines 23-32). The use of the control device of Pothmann allows the device to automatically adapt the cuff pressure to be a nominal pressure even when the dimensions of the trachea changes over time. This ensures an optimal cuff seal is provided to the trachea during use and automates the cuff inflation/deflation process.
Regarding Claim 2, Gobel-Teves-Pothmann combination teaches an extracorporeal reservoir is connected to the extracorporeal filling tube that communicates with all secondary lumens (Pothmann: cuff 4 is continuously sensed by 6 by 9, widening of trachea results in drop in pressure of sealing cuff 4, 9 increases pressure in 5 by causing 18 to add air, 9 regulates pressure of cuff at slow speed toward nominal pressure, Column 3, Lines 53-68; 9 must inherently have a reservoir inside to generate and push out air).
Regarding Claim 5, Gobel-Teves-Pothmann combination teaches the control device is designed as a mechanic or electronic control device (Pothmann: control computer 9 is electronic, Fig 2; valves 18 and 20 are mechanical and control flow of air, Fig 2).
Regarding Claim 8, Gobel-Teves-Pothmann combination teaches the electronic control device comprises a compressor as an actuator for a controlled filling or refilling of the extracorporeal reservoir (Pothmann: compressed air pressure generator for providing compressed air, Claim 7; reservoir inside of 9 would fill and refill due to 9 being a compressed air pressure generator).
Regarding Claim 10, Gobel-Teves-Pothmann combination teaches the pressure in the extracorporeal reservoir is actively controlled or regulated (Pothmann: compressed air pressure generator for providing compressed air, Claim 7; 18 and 20, Fig 2; cuff 4 is continuously sensed by 6 by 9, widening of trachea results in drop in pressure of sealing cuff 4, 9 increases pressure in 5 by causing 18 to add air, 9 regulates pressure of cuff at slow speed toward nominal pressure, Column 3, Lines 53-68; pressure of 9 is regulated or controlled depending on when 9 is activated; pressure of gas leaving 9 would be regulated by valves 18 and 20).
Regarding Claim 11, Gobel-Teves-Pothmann combination teaches the pressure in the extracorporeal reservoir is actively regulated such that the pressure in the intracorporeal cuff-like sealing balloon is kept constant (Pothmann: 18 and 20, Fig 2; 18 and 20 of Pothmann with the pressure sensor 6 of Pothmann would actively control and regulate the pressure in the cuff to be constant).
Regarding Claim 12, Gobel-Teves-Pothmann combination teaches the pressure in the intracorporeal sealing balloon is measured and serves as an actual value for a control loop, which exerts an influence on the pressure in the extracorporeal reservoir (Pothmann: cuff 4 is continuously sensed by 6 by 9, widening of trachea results in drop in pressure of sealing cuff 4, 9 increases pressure in 5 by causing 18 to add air, 9 regulates pressure of cuff at slow speed toward nominal pressure, Column 3, Lines 53-68; since cuff of Gobel would be fluidly connected to 9 of Pothmann, the pressure of cuff would exert some influence on the pressure of the reservoir in 9 due to their connection).
Regarding Claim 20, Gobel-Teves-Pothmann combination teaches the supplying secondary lumens to the intracorporeal sealing balloon are dimensioned such that, at a pressure level within the system comprising the intracorporeal sealing balloon and the extracorporeal reservoir of 20 to 35 mbar above atmospheric pressure (Gobel: filling pressure about 20 to 30 mbar, paragraph 0064), initial pressure differences within the balloon system have reduced to a residual pressure difference of 5 mbar or less, or to a residual pressure difference of 2 mbar or less, or to a residual pressure difference of 1 mbar or less (Gobel: the maintenance of the filling pressure in all of the above-described cuff and tampon balloons is ensured by an extracorporeally mounted reservoir, paragraph 0041; filling pressure differences between cuff and reservoir of 9 in Pothmann would obviously be the same or minimally different).
Regarding Claim 21, Gobel-Teves-Pothmann combination teaches in that a pressure source is connected to the extracorporeal filling tube that communicates with all secondary lumens (Pothmann: pressure generator 1, Fig 2; pressure generator to tracheal sealing cuff, Claim 7).
Regarding Claim 22, Gobel-Teves-Pothmann combination teaches the pressure source is in the form of a source for compressed air (Pothmann: compressed air pressure generator for providing compressed air, Claim 7).
Regarding Claim 23, Gobel-Teves-Pothmann combination teaches the pressure of the compressed air is actively controlled (Pothmann: pressure of compressed air would be actively controlled by valves 18 and 20 and control computer 9, Fig 2).
Regarding Claim 24, Gobel-Teves-Pothmann combination teaches the pressure of the compressed air is held constant at a pressure level within a range from 5 mbar to 60 mbar (Pothmann: nominal value shown to be 25 mbar, Fig 3; cuff 4 is continuously sensed by 6 by 9, widening of trachea results in drop in pressure of sealing cuff 4, 9 increases pressure in 5 by causing 18 to add air, 9 regulates pressure of cuff at slow speed toward nominal pressure, Column 3, Lines 53-68).
Regarding Claim 25, Gobel-Teves-Pothmann combination teaches a proportional valve is arranged between the pressure source and the extracorporeal filling tube (Pothmann: 18 and 20, Fig 2; electrically actuatable air intake valve, an electrically actuatable air discharge valve, Column 2, Lines 30-35; increasing pressure by adding air with air intake valve, regulating pressure gradually toward nominal pressure with air discharge valve, Claim 12). It is noted that although “proportional valve” is not explicitly stated, the valves of Pothmann obviously behave and act like a proportional valve.
Regarding Claim 26, Gobel-Teves-Pothmann combination teaches the proportional valve is controlled by the control device such that the pressure in the intracorporeal sealing balloon is kept constant (Pothmann: cuff 4 is continuously sensed by 6 by 9, widening of trachea results in drop in pressure of sealing cuff 4, 9 increases pressure in 5 by causing 18 to add air, 9 regulates pressure of cuff at slow speed toward nominal pressure, Column 3, Lines 53-68; if pressure increases beyond upper threshold of rest zone, 9 intervenes at slow speed in compensating manner, Column 4, Lines 1-12; regulating pressure in tracheal sealing cuff gradually toward nominal pressure with air discharge valve, Claim 12).
Regarding Claim 27, Gobel-Teves-Pothmann combination teaches a pressure sensor is provided in the intracorporeal sealing balloon or in one of the lumens connected to it in order to provide an actual value of the pressure inside of the intracorporeal sealing balloon for the control device (Pothmann: 6, Figs 2 and 2a-2c; cuff 4 is continuously sensed by 6 by 9, widening of trachea results in drop in pressure of sealing cuff 4, 9 increases pressure in 5 by causing 18 to add air, 24 regulates pressure of cuff at slow speed toward nominal pressure, Column 3, Lines 53-68).
Regarding Claim 31, Gobel-Teves-Pothmann combination teaches the control device is designed as a closed-loop controller (Pothmann: cuff 4 is continuously sensed by 6 by 9, widening of trachea results in drop in pressure of sealing cuff 4, 9 increases pressure in 5 by causing 18 to add air, 24 regulates pressure of cuff at slow speed toward nominal pressure, Column 3, Lines 53-68; 9 is a closed-loop controller since it uses 6 for feedback).
Regarding Claim 32, Gobel-Teves-Pothmann combination teaches the control device is a designed as an on-off control device (Pothmann: control processor increases pressure in sealing cuff by adding air for a limited and defined period of time, Column 2, Lines 13-19; since air is added for a limited and defined period of time, the control processor would turn off the air source after the period of time has passed).
Regarding Claim 33, Gobel-Teves-Pothmann combination teaches the control device is a designed as an continuous control device (Pothmann: cuff 4 is continuously sensed by 6 by 9, widening of trachea results in drop in pressure of sealing cuff 4, 9 increases pressure in 5 by causing 18 to add air, 24 regulates pressure of cuff at slow speed toward nominal pressure, Column 3, Lines 53-68; cuff 4 is continuously sensed by pressure sensor 6).
Regarding Claim 35, Gobel-Teves-Pothmann combination does not explicitly teach within each cross-sectional plane that is intersected perpendicularly by the local longitudinal direction of the device, the following applies for the overall interior cross-section Q1 of the primary lumen and the sum Q2 of the interior cross-sections of all secondary lumens: Q2/(Q1+Q2)≥0.08, or Q2/(Q1+Q2)≥0.10, or Q2/(Q1+Q2)≥0.12.
However, Teves teaches the Q2/(Q1+Q2)≥0.078 which is near 0.08 (conduit 121 has a diameter of 7.4 mm and conduit 122 has a diameter of 2.16 mm, the area of a circular cross-section Q1 with a diameter of 7.4 mm is 43.01 mm2 and the area of a circular cross-section Q2 with a diameter of 7.4 mm is 3.66 mm2, therefore, (3.66/(43.01+3.66)) = 0.078).
Therefore, one of ordinary skill in the art would be capable of finding these claimed ranges and modifying the Q2/(Q1+Q2)≥ 0.08 through routine optimization and experimentation since these cross-sections and dimensions would be obviously expected in this field of art. Additionally, modifications to these dimensions would obviously be made depending on the user of the device, like adults or children, to further optimize the endotracheal tube’s effectiveness.
Regarding Claim 36, Gobel-Teves-Pothmann combination teaches the intracorporeal sealing balloon has a radially widened distal region (Gobel: distal region, distal region is radially wider than proximal region, see annotated Fig 6 below) for making a seal and a proximal region (Gobel: proximal region, see annotated Fig 6 below), which adjoins the distal region and tapers radially relative to it (Gobel: distal region shown to taper radially relative to proximal region, see annotated Fig 6 below), as an envelope for the secondary lumen(s) for filling the distal sealing region (Gobel: proximal region shown to envelope the lumens 28 and 32 inside 3, see annotated Fig 6 below).
Regarding Claim 37, Gobel-Teves-Pothmann combination teaches the intracorporeal sealing balloon is preformed with different outer diameters in its distal and proximal regions (Gobel: distal and proximal regions shown to have different outer diameters, see annotated Fig 6 below).
Regarding Claim 39, Gobel-Teves-Pothmann combination teaches a proximal region of the intracorporeal sealing balloon does not extend all the way to the proximal end of the tube but ends before that (Gobel: proximal region does not extend all the way to proximal end of 3, see annotated Fig 6 below).
Regarding Claim 40, Gobel-Teves-Pothmann combination teaches the proximal region of said shaft comprises a tubular shaft element (Gobel: section of 3 in proximal region, see annotated Fig 6 below), wherein the intracorporeal sealing balloon or a proximal region of the intracorporeal sealing balloon ends at an end face of said tubular shaft element consisting of a tube material (Gobel: section of 3 in proximal region ends the proximal portion of 5, see annotated Fig 6 below), in which the primary lumen continues as an interior opening radially within said tubular shaft element (Gobel: lumen of 3 goes through section of 3 in proximal region, see annotated Fig 6 below), while the one or more secondary lumens continue in the form of one or more channels molded into the tube material of said tubular shaft element (Gobel: 32 and 28 go through section of 3 in proximal region, see annotated Fig 6 below).
Regarding Claim 44, Gobel-Teves-Pothmann combination teaches a method for the dynamically sealing intubation of a hollow organ by inserting a device according to one of the preceding claims into the hollow organ (Abstract; ensure the sealing of the tracheal cannula, the unfolded state of the tampon balloon is upheld via a communicating, extracorporeally mounted reservoir at a gentle filling pressure of preferably 10 to 15 mbar, paragraph 0090; such reservoirs may be equipped with a self-regulating valve mechanism, paragraph 0041; See Rejection of Claim 1 above), the device comprising a tube in the form of a shaft that can be inserted into the hollow organ, with a primary lumen to provide access through or to the hollow organ in question, and comprising an intracorporeal sealing balloon, which surrounds a distal region of the shaft of said tube in the manner of a cuff for the purpose of sealing it against the hollow organ, wherein one or more secondary lumens for filling said intracorporeal sealing balloon are integrated into the wall of at least a proximal region of said shaft, wherein, within each cross-sectional plane that is intersected perpendicularly by the local longitudinal direction of the device, the following applies for the overall interior cross-section Q1 of the primary lumen and the sum Q2 of the interior cross-sections of all secondary lumens: Q2/(Q1+Q2)≥0.06, wherein at an extracorporeal filling tube, which communicates with all secondary lumens, a control device is provided in order to keep the pressure within the intracorporeal sealing balloon nearly constant in such a way that a) when the volume of the hollow organ increases, a corresponding amount of the filling medium is forced to flow into the intracorporeal sealing tube in order to increase the volume of the intracorporeal sealing tube accordingly, and b) when the volume of the hollow organ decreases, a corresponding amount of the filling medium is allowed to flow out of the intracorporeal sealing tube in order to decrease the volume of the intracorporeal sealing tube accordingly (See Rejection of Claim 1 above). It is noted that the claim limitation “within each cross- sectional plane that is intersected perpendicularly by the local longitudinal direction of the device” is being interpreted as the cross-sectional planes that include both the secondary and primary lumens and not the entire device from tip to tip. It is also noted that the structural limitations of Claim 44 are the same as the structural limitations of Claim 1 and are interpreted as the same.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Gobel (US 2003/0066532 A1), Teves (US 5,029,591 A), and Pothmann et al. (US 5,361,753 A) as applied to Claim 5, and in further view of Peters et al. (US 5,024,668 A).
Regarding Claim 9, Gobel-Teves-Pothmann combination teaches the claimed invention of Claim 5. Gobel-Teves-Pothmann combination also teaches the electronic control device comprises a valve as an actuator for a controlled deflating of the extracorporeal reservoir (Pothmann: 18 and 20, Fig 2; electrically actuatable air intake valve, an electrically actuatable air discharge valve, Column 2, Lines 30-35; increasing pressure by adding air with air intake valve, regulating pressure gradually toward nominal pressure with air discharge valve, Claim 12; since the extracorporeal reservoir of Gobel is connected to the cuff of Gobel, the valves of Pothmann would allow for controlled deflating of the extracorporeal reservoir of Gobel).
Gobel-Teves-Pothmann combination fails to teach an electromagnetic valve.
However, Peters, of the same field of endeavor, teaches a catheter with a balloon (Abstract) including an electromagnetic valve (air pressure supplied by the compressor 300 and accumulator 325 arrangement is supplied via tubing 326 through the solenoid valve 327B to tubing 236 and 234 to the air actuated piston 216, valve 327B receives an operate signal to cause balloon inflation from the control means 280 via conductor 340B to cause it to shift to the pressurize position, Column 16, Lines 25-36) since electromagnetic valves or solenoid valves are known valves in the art that can control flow of air.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize solenoid valves for the air intake valve and air discharge valve, as taught by Peters, since electromagnetic valves or solenoid valves are known valves in the art that can control flow of air.
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Gobel (US 2003/0066532 A1), Teves (US 5,029,591 A), and Pothmann et al. (US 5,361,753 A) as applied to Claim 2, and in further view of Young et al. (US 2010/0252048 A1).
Regarding Claim 13, Gobel-Teves-Pothmann combination teaches the claimed invention of Claim 2. Gobel-Teves-Pothmann combination fails to teach the extracorporeal reservoir is in the form of a piston within a cylinder, wherein the displacement of the piston within the cylinder defines the storage volume of the reservoir.
However, Young, of the same field of endeavor, teaches an airway device (Abstract) including the extracorporeal reservoir is in the form of a piston within a cylinder (36 and 34, Fig 2), wherein the displacement of the piston within the cylinder defines the storage volume of the reservoir (displacement of 36 defines storage volume of the reservoir of 34, Fig 2; control the stepper motor 44 to drive the piston 36 at speed N backwards in the cylindrical bore 34 to increase the volume of, and thus reduce the pressure in, the closed volume pressure system, and thus reduce pressure in the inflatable cuff 26, control the stepper motor 44 to drive the piston at speed N forwards in the cylindrical bore 34 to reduce the volume of, and thus increase the pressure in, the closed volume pressure system, and thus increase pressure in the inflatable cuff 26, paragraph 0074) since this is a known alternative way to control the seal of the inflatable cuff (Abstract).
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 extracorporeal reservoir to be in the form of a piston with a cylinder, as taught by Young, since this is a known alternative way to control the seal of the inflatable cuff (Abstract).
Regarding Claim 14, Gobel-Teves-Pothmann-Young combination teaches in that the pressure within the extracorporeal reservoir a) is increased, if the piston is displaced within the cylinder in a direction which decreases the storage volume of the reservoir (Young: control the stepper motor 44 to drive the piston at speed N forwards in the cylindrical bore 34 to reduce the volume of, and thus increase the pressure in, the closed volume pressure system, and thus increase pressure in the inflatable cuff 26, paragraph 0074), and b) is decreased, if the piston is displaced within the cylinder in a direction which increases the storage volume of the reservoir (Young: control the stepper motor 44 to drive the piston 36 at speed N backwards in the cylindrical bore 34 to increase the volume of, and thus reduce the pressure in, the closed volume pressure system, and thus reduce pressure in the inflatable cuff 26, paragraph 0074).
Regarding Claim 15, Gobel-Teves-Pothmann-Young combination teaches the piston of the extracorporeal reservoir is coupled to an actuator which is driven by the control device in order to increase or decrease the storage volume of the reservoir (Young: 36 is controlled by 44, Fig 2; piston 36 driven by step motor 44, under control of motor controller and driver means 48, 48 operates in response to commands from processor 50 to change pressure in cuff 26, paragraph 0055).
Claims 28 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Gobel (US 2003/0066532 A1), Teves (US 5,029,591 A), and Pothmann et al. (US 5,361,753 A) as applied to Claim 27, and in further view of Wood et al. (US 2010/0319702 A1).
Regarding Claim 28, Gobel-Teves-Pothmann combination teaches the claimed invention of Claim 27. Gobel-Teves-Pothmann combination fails to teach the pressure sensor is combined with a temperature sensor.
However, Wood, of the same field of endeavor, teaches a tracheal tube (Abstract) including the pressure sensor is combined with a temperature sensor (one or more of the signal sources may include wireless sensors that are capable of providing information about the immediate environment, such as pressure transducers, temperature sensors, paragraph 0019) since it is one of many known signals that can be monitored in a tracheal tube system.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add a temperature sensor, as taught by Wood, since it is one of many known signals that can be monitored in a tracheal tube system. Adding a temperature sensor would help to gather more information about the trachea’s environment, allowing an operator to make a better assessment of the patient and the device’s operation.
Regarding Claim 30, Gobel-Teves-Pothmann-Wood combination teaches the temperature sensor can be used to measure the body core temperature (Wood: one or more of the signal sources may include wireless sensors that are capable of providing information about the immediate environment, such as pressure transducers, temperature sensors, paragraph 0019; signal sources 18, Fig 1; the temperature sensor would be capable of measuring the body core temperature due to its presence in the immediate environment).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Gobel (US 2003/0066532 A1), Teves (US 5,029,591 A), Pothmann et al. (US 5,361,753 A), and Wood et al. (US 2010/0319702 A1) as applied to Claim 28, and in further view of Shipman (US 2011/0109458 A1).
Regarding Claim 29, Gobel-Teves-Pothmann-Wood combination teaches the claimed invention of Claim 28. Gobel-Teves-Pothmann-Wood combination fails to teach the pressure sensor is designed as a self-calibrating sensor in order to compensate temperature effects of the pressure sensor.
However, Shipman, of the same field of endeavor, teaches the use of a medical breathing tube (Abstract) including the pressure sensor is designed as a self-calibrating sensor (the sensor also has internal temperature compensation, paragraph 0053) since calibration of a pressure sensor for temperature compensation is known in the art (paragraph 0053).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the pressure sensor self-calibrate or self-compensate for temperature using the temperature sensor, as taught by Shipman, since calibration of a pressure sensor for temperature compensation is known in the art (Shipman: paragraph 0053).
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Gobel (US 2003/0066532 A1), Teves (US 5,029,591 A), and Pothmann et al. (US 5,361,753 A) as applied to Claim 33, and in further view of Daly (US 2007/0255160 A1).
Regarding Claim 34, Gobel-Teves-Pothmann combination teaches the claimed invention of Claim 33. Gobel-Teves-Pothmann combination fails to teach the control device comprises a proportional term, and/or an integral term, and/or an derivative term.
However, Daly, reasonably pertinent to the problem of feedback loops in a control system, teaches a system for controlling breathing of a patient (Abstract) including the control device comprises a proportional term, and/or an integral term, and/or an derivative term (magnitude and direction of the error are determined using a conventional control algorithm such as a proportional integral derivative ("PID") control loop, paragraph 0148) since PID control loop is a conventional feedback loop used in various control systems (paragraph 0148).
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 control device or computer to use a PID control loop, as taught by Daly, since PID control loop is a conventional feedback loop used in various control systems (Daly: paragraph 0148).
Allowable Subject Matter
Claims 3, 4, 6, 7, 16-19, 38, and 41-43 contain allowable subject matter.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 3 discusses the use of the extracorporeal reservoir balloon or extracorporeal reservoir bellows. Claim 6 shares similar limitations to Claim 3. Claim 7 uses a weight or spring that urges outside of the extracorporeal reservoir, which implies the use of a balloon or bellows. Claim 16 discusses the use of an extracorporeal reservoir balloon along with a one-way valve. Claim 19 shares similar limitations to Claim 16. Claim 38 requires only one concentrically surrounding secondary lumen at the proximal region of the intracorporeal sealing balloon. Claim 41 shares similar limitations to Claim 38 as it discusses an “annular secondary lumen”. Claim 42 discusses an annular structure that acts as a collecting channel for all secondary lumens to communicate at the proximal end of the tube.
Claims 4, 17, 18, and 43 contain allowable subject matter due to their dependencies on Claims 3, 16, and 42.
Gobel (US 2003/0066532 A1) discusses a tracheal ventilating device. Regarding Claim 3, although Gobel does discuss about extracorporeal balloons 31 and 33, the combination with Pothmann et al. (US 5,361,753 A) replaces these balloons with a pressure system that includes a pressure generator. There is nothing in Gobel that teaches the balloons can be connected to a pressure generator or that the balloons can be connected to a more automated system. Because of this, it would be non-obvious to connect the pressure generator to the balloons. Similar arguments are applied to Claim 6. Regarding Claim 7, though a balloon is not explicitly mentioned, the use of weights and springs on the outside of the extracorporeal reservoir implies the reservoir being a balloon or bellows. Thus, similar arguments of Claims 3 and 6 are applied to Claim 7. Claim 16 and Claim 19 also share similar arguments to Claims 3, 6, and 7 due to the mention of an extracorporeal reservoir balloon along with a one-way valve. Regarding Claim 38, the claim requires only one concentrically surrounding secondary lumen at the proximal region of the intracorporeal sealing balloon, which Gobel does not have. The lumen’s description implies that the lumen is an annular structure. At most, Gobel has two secondary lumens that are not concentrically surrounding and are not annular. Gobel intended for the secondary lumens 28 and 32 to be separate, distinct lumens. Thus, it is unreasonable to modify these lumens to be a single, annular lumen. Similar arguments are applied to Claim 41. Regarding Claim 42, similar to the arguments of Claim 38, there is no reason or motivation to provide an annular structure for all of the secondary lumens to communicate at the proximal end of the tube. Secondary lumens 28 and 32 were made to be separate, distinct lumens taking gas from two different sources. Therefore, they cannot share an annular structure that acts as a collecting channel.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 5-8, 10-12, 16-23, 25-27, 31-33, and 35-44 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 and 15 of U.S. Patent No. 11,207,482, hereafter ‘482, in view of Pothmann et al. (US 5,361,753 A). Although the claims are not identical, the instant claims would be anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 1, ‘482 discloses most of the claimed invention (Claim 1) except for: wherein at an extracorporeal filling tube, which communicates with all secondary lumens, a control device is provided in order to keep the pressure within the intracorporeal sealing balloon nearly constant in such a way that a) when the volume of the hollow organ increases, a corresponding amount of the filling medium is forced to flow into the intracorporeal sealing tube in order to increase the volume of the intracorporeal sealing tube accordingly, and b) when the volume of the hollow organ decreases, a corresponding amount of the filling medium is allowed to flow out of the intracorporeal sealing tube in order to decrease the volume of the intracorporeal sealing tube accordingly.
However, Pothmann, of the same field of endeavor, teaches a processor based method of measuring and regulating pressure in the inflatable sealing cuff of a tracheal tube (Abstract) including wherein at an extracorporeal filling tube (8, Figs 2 and 2a-2c), which communicates with all secondary lumens (8 communicates with lumen inside of 5 and feeds 4, Figs 2 and 2a-2c), a control device (1, 9, 18, 20, 6, and 7, Fig 2) is provided in order to keep the pressure within the intracorporeal sealing balloon nearly constant in such a way that a) when the volume of the hollow organ increases, a corresponding amount of the filling medium is forced to flow into the intracorporeal sealing tube in order to increase the volume of the intracorporeal sealing tube accordingly (404, 406, and 408, Fig 4; cuff 4 is continuously sensed by 6 by 9, widening of trachea results in drop in pressure of sealing cuff 4, 9 increases pressure in 5 by causing 18 to add air, 9 regulates pressure of cuff at slow speed toward nominal pressure, Column 3, Lines 53-68), and b) when the volume of the hollow organ decreases, a corresponding amount of the filling medium is allowed to flow out of the intracorporeal sealing tube in order to decrease the volume of the intracorporeal sealing tube accordingly (if pressure increases beyond upper threshold of rest zone, 9 intervenes at slow speed in compensating manner, Column 4, Lines 1-12; regulating pressure in tracheal sealing cuff gradually toward nominal pressure with air discharge valve, Claim 12; menus would automatically provide nominal adult and child pressure values and thresholds, Column 4, Lines 23-32) to prevent the aspiration of fluids from the patient’s oral cavity especially during coughing (Column 2, Lines 4-7) and to allow for the device to adapt to a variety of patients including adults and children (Column 4, Lines 23-32).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the control device including the pressure generator, valves, control computer, and pressure sensor and add them to the extracorporeal filling tube to adapt the cuff pressure, as taught by Pothmann, to prevent the aspiration of fluids from the patient’s oral cavity especially during coughing (Pothmann: Column 2, Lines 4-7) and to allow for the device to adapt to a variety of patients including adults and children (Pothmann: Column 4, Lines 23-32). The use of the control device of Pothmann allows the device to automatically adapt the cuff pressure to be a nominal pressure even when the dimensions of the trachea changes over time. This ensures an optimal cuff seal is provided to the trachea during use and automates the cuff inflation/deflation process.
Regarding Claim 2, ‘482-Pothmann combination teaches all of the claimed invention (‘482: Claim 1).
Regarding Claim 5, ‘482-Pothmann combination teaches all of the claimed invention (Pothmann: control computer 9 is electronic, Fig 2; valves 18 and 20 are mechanical and control flow of air, Fig 2).
Regarding Claim 6, ‘482-Pothmann combination teaches all of the claimed invention (‘482: Claim 7; walls of balloon would help keep filling pressure constant).
Regarding Claim 7, ‘482-Pothmann combination teaches all of the claimed invention (‘482: Claim 15).
Regarding Claim 8, ‘482-Pothmann combination teaches all of the claimed invention (Pothmann: compressed air pressure generator for providing compressed air, Claim 7; 1 in conjunction with 18 and 9 of Pothmann would be providing controlled air to the reservoir of ‘482).
Regarding Claim 10, ‘482-Pothmann combination teaches all of the claimed invention (‘482: Claim 6).
Regarding Claim 11, ‘482-Pothmann combination teaches all of the claimed invention (‘482: Claim 7).
Regarding Claim 12, ‘482-Pothmann combination teaches all of the claimed invention (‘482: Claim 8).
Regarding Claim 16, ‘482-Pothmann combination teaches all of the claimed invention (‘482: Claim 1).
Regarding Claim 17, ‘482-Pothmann combination teaches all of the claimed invention (‘482: Claim 1).
Regarding Claim 18, ‘482-Pothmann combination teaches all of the claimed invention (‘482: Claim 1).
Regarding Claim 19, ‘482-Pothmann combination teaches all of the claimed invention (‘482: Claim 1).
Regarding Claim 21, ‘482-Pothmann combination teaches all of the claimed invention (Pothmann: pressure generator 1, Fig 2; pressure generator to tracheal sealing cuff, Claim 7).
Regarding Claim 22, ‘482-Pothmann combination teaches all of the claimed invention (Pothmann: compressed air pressure generator for providing compressed air, Claim 7).
Regarding Claim 23, ‘482-Pothmann combination teaches all of the claimed invention (Pothmann: pressure of compressed air would be actively controlled by valves 18 and 20 and control computer 9, Fig 2).
Regarding Claim 25, ‘482-Pothmann combination teaches all of the claimed invention (Pothmann: 18 and 20, Fig 2; electrically actuatable air intake valve, an electrically actuatable air discharge valve, Column 2, Lines 30-35; increasing pressure by adding air with air intake valve, regulating pressure gradually toward nominal pressure with air discharge valve, Claim 12). It is noted that although “proportional valve” is not explicitly stated, the valves of Pothmann obviously behave and act like a proportional valve.
Regarding Claim 26, ‘482-Pothmann combination teaches all of the claimed invention (Pothmann: cuff 4 is continuously sensed by 6 by 9, widening of trachea results in drop in pressure of sealing cuff 4, 9 increases pressure in 5 by causing 18 to add air, 9 regulates pressure of cuff at slow speed toward nominal pressure, Column 3, Lines 53-68; if pressure increases beyond upper threshold of rest zone, 9 intervenes at slow speed in compensating manner, Column 4, Lines 1-12; regulating pressure in tracheal sealing cuff gradually toward nominal pressure with air discharge valve, Claim 12).
Regarding Claim 27, ‘482-Pothmann combination teaches all of the claimed invention (Pothmann: 6, Figs 2 and 2a-2c; cuff 4 is continuously sensed by 6 by 9, widening of trachea results in drop in pressure of sealing cuff 4, 9 increases pressure in 5 by causing 18 to add air, 24 regulates pressure of cuff at slow speed toward nominal pressure, Column 3, Lines 53-68).
Regarding Claim 31, ‘482-Pothmann combination teaches all of the claimed invention (Pothmann: cuff 4 is continuously sensed by 6 by 9, widening of trachea results in drop in pressure of sealing cuff 4, 9 increases pressure in 5 by causing 18 to add air, 24 regulates pressure of cuff at slow speed toward nominal pressure, Column 3, Lines 53-68; 9 is a closed-loop controller since it uses 6 for feedback).
Regarding Claim 32, ‘482-Pothmann combination teaches all of the claimed invention (Pothmann: control processor increases pressure in sealing cuff by adding air for a limited and defined period of time, Column 2, Lines 13-19; since air is added for a limited and defined period of time, the control processor would turn off the air source after the period of time has passed).
Regarding Claim 33, ‘482-Pothmann combination teaches all of the claimed invention (Pothmann: cuff 4 is continuously sensed by 6 by 9, widening of trachea results in drop in pressure of sealing cuff 4, 9 increases pressure in 5 by causing 18 to add air, 24 regulates pressure of cuff at slow speed toward nominal pressure, Column 3, Lines 53-68; cuff 4 is continuously sensed by pressure sensor 6).
Regarding Claim 35, ‘482-Pothmann combination teaches all of the claimed invention (‘482: Claim 9).
Regarding Claim 36, ‘482-Pothmann combination teaches all of the claimed invention (‘482: Claim 10).
Regarding Claim 37, ‘482-Pothmann combination teaches all of the claimed invention (‘482: Claim 11).
Regarding Claim 38, ‘482-Pothmann combination teaches all of the claimed invention (‘482: Claim 12).
Regarding Claim 39, ‘482-Pothmann combination teaches all of the claimed invention (‘482: Claim 13).
Regarding Claim 40, ‘482-Pothmann combination teaches all of the claimed invention (‘482: Claim 2).
Regarding Claim 41, ‘482-Pothmann combination teaches all of the claimed invention (‘482: Claim 3).
Regarding Claim 42, ‘482-Pothmann combination teaches all of the claimed invention (‘482: Claim 4).
Regarding Claim 43, ‘482-Pothmann combination teaches all of the claimed invention (‘482: Claim 5).
Regarding Claim 44, ‘482-Pothmann combination teaches all of the claimed invention (‘482: Claim 1).
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,207,482, hereafter ‘482, and Pothmann et al. (US 5,361,753 A), as applied to Claim 5, and in further view of Peters et al. (US 5,024,668 A). Although the claims are not identical, the instant claims would be anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 9, ‘482-Pothmann combination teaches the claimed invention of Claim 5. ‘482-Pothmann combination also teaches the electronic control device comprises a valve as an actuator for a controlled deflating of the extracorporeal reservoir (Pothmann: 18 and 20, Fig 2; electrically actuatable air intake valve, an electrically actuatable air discharge valve, Column 2, Lines 30-35; increasing pressure by adding air with air intake valve, regulating pressure gradually toward nominal pressure with air discharge valve, Claim 12).
‘482-Pothmann combination fails to teach an electromagnetic valve.
However, Peters, of the same field of endeavor, teaches a catheter with a balloon (Abstract) including an electromagnetic valve (air pressure supplied by the compressor 300 and accumulator 325 arrangement is supplied via tubing 326 through the solenoid valve 327B to tubing 236 and 234 to the air actuated piston 216, valve 327B receives an operate signal to cause balloon inflation from the control means 280 via conductor 340B to cause it to shift to the pressurize position, Column 16, Lines 25-36) since electromagnetic valves or solenoid valves are known valves in the art that can control flow of air.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize solenoid valves for the air intake valve and air discharge valve, as taught by Peters, since electromagnetic valves or solenoid valves are known valves in the art that can control flow of air.
Claims 13-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,207,482, hereafter ‘482, and Pothmann et al. (US 5,361,753 A), as applied to Claim 2, and in further view of Young et al. (US 2010/0252048 A1). Although the claims are not identical, the instant claims would be anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 13, ‘482-Pothmann combination teaches the claimed invention of Claim 2. ‘482-Pothmann combination fails to teach the extracorporeal reservoir is in the form of a piston within a cylinder, wherein the displacement of the piston within the cylinder defines the storage volume of the reservoir.
However, Young, of the same field of endeavor, teaches an airway device (Abstract) including the extracorporeal reservoir is in the form of a piston within a cylinder (36 and 34, Fig 2), wherein the displacement of the piston within the cylinder defines the storage volume of the reservoir (displacement of 36 defines storage volume of the reservoir of 34, Fig 2; control the stepper motor 44 to drive the piston 36 at speed N backwards in the cylindrical bore 34 to increase the volume of, and thus reduce the pressure in, the closed volume pressure system, and thus reduce pressure in the inflatable cuff 26, control the stepper motor 44 to drive the piston at speed N forwards in the cylindrical bore 34 to reduce the volume of, and thus increase the pressure in, the closed volume pressure system, and thus increase pressure in the inflatable cuff 26, paragraph 0074) since this is a known alternative way to control the seal of the inflatable cuff (Abstract).
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 extracorporeal reservoir to be in the form of a piston with a cylinder, as taught by Young, since this is a known alternative way to control the seal of the inflatable cuff (Abstract).
Regarding Claim 14, ‘482-Pothmann-Young combination teaches in that the pressure within the extracorporeal reservoir a) is increased, if the piston is displaced within the cylinder in a direction which decreases the storage volume of the reservoir (Young: control the stepper motor 44 to drive the piston at speed N forwards in the cylindrical bore 34 to reduce the volume of, and thus increase the pressure in, the closed volume pressure system, and thus increase pressure in the inflatable cuff 26, paragraph 0074), and b) is decreased, if the piston is displaced within the cylinder in a direction which increases the storage volume of the reservoir (Young: control the stepper motor 44 to drive the piston 36 at speed N backwards in the cylindrical bore 34 to increase the volume of, and thus reduce the pressure in, the closed volume pressure system, and thus reduce pressure in the inflatable cuff 26, paragraph 0074).
Regarding Claim 15, ‘482-Pothmann-Young combination teaches the piston of the extracorporeal reservoir is coupled to an actuator which is driven by the control device in order to increase or decrease the storage volume of the reservoir (Young: 36 is controlled by 44, Fig 2; piston 36 driven by step motor 44, under control of motor controller and driver means 48, 48 operates in response to commands from processor 50 to change pressure in cuff 26, paragraph 0055).
Claims 28 and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,207,482, hereafter ‘482, and Pothmann et al. (US 5,361,753 A), as applied to Claim 27, and in further view of Wood et al. (US 2010/0319702 A1). Although the claims are not identical, the instant claims would be anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 28, ‘482-Pothmann combination teaches the claimed invention of Claim 27. ‘482-Pothmann combination fails to teach the pressure sensor is combined with a temperature sensor.
However, Wood, of the same field of endeavor, teaches a tracheal tube (Abstract) including the pressure sensor is combined with a temperature sensor (one or more of the signal sources may include wireless sensors that are capable of providing information about the immediate environment, such as pressure transducers, temperature sensors, paragraph 0019) since it is one of many known signals that can be monitored in a tracheal tube system.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add a temperature sensor, as taught by Wood, since it is one of many known signals that can be monitored in a tracheal tube system. Adding a temperature sensor would help to gather more information about the trachea’s environment, allowing an operator to make a better assessment of the patient and the device’s operation.
Regarding Claim 30, ‘482-Pothmann-Wood combination teaches the temperature sensor can be used to measure the body core temperature (Wood: one or more of the signal sources may include wireless sensors that are capable of providing information about the immediate environment, such as pressure transducers, temperature sensors, paragraph 0019; signal sources 18, Fig 1; the temperature sensor would be capable of measuring the body core temperature due to its presence in the immediate environment).
Claim 29 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,207,482, hereafter ‘482, Pothmann et al. (US 5,361,753 A), and Wood et al. (US 2010/0319702 A1) as applied to Claim 28, and in further view of Shipman (US 2011/0109458 A1). Although the claims are not identical, the instant claims would be anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 29, ‘482-Pothmann-Wood combination teaches the claimed invention of Claim 28. ‘482-Pothmann-Wood combination fails to teach the pressure sensor is designed as a self-calibrating sensor in order to compensate temperature effects of the pressure sensor.
However, Shipman, of the same field of endeavor, teaches the use of a medical breathing tube (Abstract) including the pressure sensor is designed as a self-calibrating sensor (the sensor also has internal temperature compensation, paragraph 0053) since calibration of a pressure sensor for temperature compensation is known in the art (paragraph 0053).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the pressure sensor self-calibrate or self-compensate for temperature using the temperature sensor, as taught by Shipman, since calibration of a pressure sensor for temperature compensation is known in the art (Shipman: paragraph 0053).
Claim 34 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,207,482, hereafter ‘482, and Pothmann et al. (US 5,361,753 A), as applied to Claim 33, and in further view of Daly (US 2007/0255160 A1). Although the claims are not identical, the instant claims would be anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 34, ‘482-Pothmann combination teaches the claimed invention of Claim 33. ‘482-Pothmann combination fails to teach the control device comprises a proportional term, and/or an integral term, and/or an derivative term.
However, Daly, reasonably pertinent to the problem of feedback loops in a control system, teaches a system for controlling breathing of a patient (Abstract) including the control device comprises a proportional term, and/or an integral term, and/or an derivative term (magnitude and direction of the error are determined using a conventional control algorithm such as a proportional integral derivative ("PID") control loop, paragraph 0148) since PID control loop is a conventional feedback loop used in various control systems (paragraph 0148).
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 control device or computer to use a PID control loop, as taught by Daly, since PID control loop is a conventional feedback loop used in various control systems (Daly: paragraph 0148).
Claims 1, 2, 16-21, and 44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16 and 17 of U.S. Patent No. 11,207,482, hereafter ‘482. Although the claims are not identical, the instant claims would be anticipated and/or made obvious by the cited patent and prior art.
Regarding Claim 1, ‘482 discloses all of the claimed invention (Claim 16; the claim limitation “the pressure within the intracorporeal sealing balloon is kept nearly constant in such a way that when the volume of the hollow organ changes” implies a control device is involved).
Regarding Claim 2, ‘482 discloses all of the claimed invention (Claim 16).
Regarding Claim 16, ‘482 discloses all of the claimed invention (Claim 16).
Regarding Claim 17, ‘482 discloses all of the claimed invention (Claim 16).
Regarding Claim 18, ‘482 discloses all of the claimed invention (Claim 16).
Regarding Claim 19, ‘482 discloses all of the claimed invention (Claim 16).
Regarding Claim 20, ‘482 discloses all of the claimed invention (Claim 17).
Regarding Claim 21, ‘482 discloses all of the claimed invention (Claim 16; a pressure source of some kind must inherently be connected to the extracorporeal filling tube to inflate the sealing balloon).
Regarding Claim 44, ‘482 discloses all of the claimed invention (Claim 16).
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-4649914-A discusses a cuff with an extracorporeal reservoir balloon
US-4159722-A discusses a cuff with a piston
US-3794043-A discusses a cuff with an extracorporeal reservoir balloon
US-5218970-A discusses a cuff with a pressure monitor
WO-2004004801-A2 discusses a catheter assembly with Shore hardness ranges
US-5188592-A discusses a catheter with specific dimensions and sizes
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/BRIAN T KHONG/Examiner, Art Unit 3785
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785