DETAILED ACTION
This application has been transferred to Primary Examiner Annette Dixon, AU 3785.
This Office Action is in response to the amendment, filed on June 8, 2026. Primary Examiner acknowledges Claims 10-22 are pending in this application, with Claims 10, 11, and 16 having been currently amended, Claims 19-22 having been newly added, and Claims 1-9 having been cancelled.
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 10 and 16 are objected to because of the following informalities:
The preamble of Claim 10 recites “An HME device”; however, this is grammatically incorrect and should recite “A HME device”. Appropriate correction is required.
The preamble of Claim 16 recites “An HME element … an HME device”; however, this is grammatically incorrect and should recite “A HME element … a HME device”. Appropriate correction is required.
The preamble of Claim 17 recites “an HME device”; however, this is grammatically incorrect and should recite “a HME device”. Appropriate correction is required.
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 10-22 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.
Specifically, Claim 10, Line 2 recites “the housing”; however, this limitation appears to lack antecedent basis in the claims. Primary Examiner is unsure of the breadth and scope of this limitation. Should the claims read “the outer housing” to have consistency with the former recitation of “an outer housing” in Claim 10, Line 1, OR ALTERNATIVELY, is Applicant attempting to claim a separate and distinct limitation? Dependent claims, Claims 11-15, 19, and 20 incorporate the indefinite subject matter from which they depend. Explicitly, Claim 14, Line 4 also recites “the housing”. Appropriate correction and clarification is required.
Specifically, Claim 12, Line 2 recites “the inner surface of the outer housing”; however, this limitation appears to lack antecedent basis in the claims. Primary Examiner is unsure of the breadth and scope of this limitation. Is Applicant attempting to refer back to the “tapered inner surface” of Claim 11? If so, the parentage of Claim 12 does not include Claim 11 and still the recitation would need to be changed to the “tapered inner surface of the outer housing” to have consistency. Is Applicant attempting to recite a new limitation and furthermore is this new limitation separate and distinct from the “tapered inner surface” of Claim 11? Appropriate correction and clarification is required.
Specifically, Claim 12, Line 4 recites “the device”; however, this limitation appears to lack antecedent basis in the claims. Primary Examiner is unsure of the breadth and scope of this limitation. Should the claims read “the HME device”, “the breathing device” or some other limitation? Appropriate correction and clarification is required.
Specifically, Claim 12, Lines 3 and 4 recite “the patient end” and “the machine end”; however, the breadth and scope of this limitation is unclear. By convention, when an object is placed within the body, the portion deepest within the body is called the “distal end”; whilst, the portion closes to the surface/orifice of the patient is called the “proximal end”. Yet, when an object is located outside of the body, the portion closest to the surface/orifice of the patient is called the “proximal end”; whilst the portion most removed from the patient is called the “distal end”. Applicant is attempting to utilize the terms “the patient end” and “the machine end”; yet, the claims do not introduce these terms nor their proximity to the patient, nor a requirement of a machine being connected to the claimed “machine end”. Appropriate correction and clarification is required.
Specifically, Claim 13, Line 3 recites “the machine end”; however, this limitation appears to lack antecedent basis in the claims. Primary Examiner is unsure of the breadth and scope of this limitation. Is Applicant attempting to refer back to the “machine end” of Claim 12? If so, the parentage of Claim 13 does not include Claim 12. Is Applicant attempting to recite a new limitation and furthermore is this new limitation separate and distinct? Appropriate correction and clarification is required.
Specifically, Claim 13, Line 3 recites “on a connector”; however, this limitation appears to lack antecedent basis in the claims. Primary Examiner is unsure of the breadth and scope of this limitation. Should the claims read “the coopering connector” or Applicant attempting to recite a separate and distinct limitation? Appropriate correction and clarification is required.
Specifically, Claim 14, Line 4 recites “the element”; however, this limitation appears to lack antecedent basis in the claims. Primary Examiner is unsure of the breadth and scope of this limitation. Should the claims read “the HME element” or is Applicant attempting to recite a separate and distinct limitation? Appropriate correction and clarification is required.
Specifically, Claim 15, Line 2 recites “the machine end”; however, this limitation appears to lack antecedent basis in the claims. Primary Examiner is unsure of the breadth and scope of this limitation. Is Applicant attempting to refer back to the “machine end” of Claims 12 and/or 13? If so, the parentage of Claim 15 does not include Claims 12 nor 13. Is Applicant attempting to recite a new limitation and furthermore is this new limitation separate and distinct? Appropriate correction and clarification is required.
Specifically, Claim 16, Line 2 recites “the housing”; however, this limitation appears to lack antecedent basis in the claims. Primary Examiner is unsure of the breadth and scope of this limitation. Should the claims read “the outer housing” to have consistency with the former recitation of “an outer housing” in Claim 16, Line 2, OR ALTERNATIVELY, is Applicant attempting to claim a separate and distinct limitation? Dependent claims, Claims 21 and 22, incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 17, Line 3 recites “the housing”; however, this limitation appears to lack antecedent basis in the claims. Primary Examiner is unsure of the breadth and scope of this limitation. Should the claims read “the outer housing” to have consistency with the former recitation of “an outer housing” in Claim 17, Line 2, OR ALTERNATIVELY, is Applicant attempting to claim a separate and distinct limitation? Dependent claim, Claim 18, incorporates the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 17, Lines 4 and 6 recite “the breathing device”; however, this limitation appears to lack antecedent basis in the claims. Primary Examiner is unsure of the breadth and scope of this limitation. Should the claims read “patient breathing device” to have consistency with the former recitation of “a patient breathing device” of Claim 17, Line 1, OR ALTERNATIVELY, is Applicant attempting to claim a separate and distinct limitation? Dependent claim, Claim 18, incorporates the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 19, Line 2 recites “the patient end”; however, this limitation appears to lack antecedent basis in the claims. Primary Examiner is unsure of the breadth and scope of this limitation. Is Applicant attempting to refer back to the “patient end” of Claim 12? If so, the parentage of Claim 19 does not include Claim 12. Is Applicant attempting to recite a new limitation and furthermore is this new limitation separate and distinct? Appropriate correction and clarification is required.
Specifically, Claim 20, Line 2 recites “the machine end”; however, this limitation appears to lack antecedent basis in the claims. Primary Examiner is unsure of the breadth and scope of this limitation. Is Applicant attempting to refer back to the “machine end” of Claim 12? If so, the parentage of Claim 20 does not include Claim 12. Is Applicant attempting to recite a new limitation and furthermore is this new limitation separate and distinct? Appropriate correction and clarification is required.
Specifically, Claim 21, Line 3 recites “the device”; however, this limitation appears to lack antecedent basis in the claims. Primary Examiner is unsure of the breadth and scope of this limitation. Should the claims read “the HME device”, “the breathing device” or some other limitation? Appropriate correction and clarification is required.
Specifically, Claim 21, Lines 2 and 3 recite “the patient end” and “the machine end”; however, the breadth and scope of this limitation is unclear. By convention, when an object is placed within the body, the portion deepest within the body is called the “distal end”; whilst, the portion closes to the surface/orifice of the patient is called the “proximal end”. Yet, when an object is located outside of the body, the portion closest to the surface/orifice of the patient is called the “proximal end”; whilst the portion most removed from the patient is called the “distal end”. Applicant is attempting to utilize the terms “the patient end” and “the machine end”; yet, the claims do not introduce these terms nor their proximity to the patient, nor a requirement of a machine being connected to the claimed “machine end”. Appropriate correction and clarification is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 10-22 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Chmielinski (4,763,645).
As to Claim 10, Chmielinski discloses a HME device (16, “The exchanger device 10 has a collar 14 bearing a heat and moisture exchanger (HME) cartridge 16.” Column 2, Lines 40-50; “A tubular sleeve 40 extends outwardly from a flat portion 41 of the forward wall to define an opening 42 for mounting the HME cartridge 16. The opening, 42 is positioned opposite the tracheostomy. In the preferred embodiment, the sleeve extends outwardly approximately 1/4 of an inch. The sleeve is integrally formed with the body and is deformable to permit insertion of the cartridge 16. The HME cartridge 16 is formed of a heat and moisture exchanger (HME) material sandwiched in, a chamber formed between a front casing 44 and a rear casing 46.” Column 3, Lines 20-50; “As shown in FIG. 4, the cartridge is formed by press-fitting the outer flange 62 of a rear casing over the inner flange 52 of the front casing with the paper roll 48 positioned inside the chamber formed within the casings. In this way, the cartridge 16 is formed having a thin cross-section. The cartridge 16 is inserted in the opening of the collar 14. The cylindrical sleeve 40 of the collar, being formed of flexible material, may be manipulated over the inner surface of the cartridge so that the sleeve 40 is positioned between the inner and outer annular surfaces of the cartridge, with the sleeve 40 contacting the outer flange 62 of the rear casing.” Column 4, Lines 5-25) including an outer housing (50, “The front casing 44 has a flat disc portion 50 and a cylindrical inner flange portion 52 extending outwardly from the disc portion. The inner flange portion 52 is positioned inwardly from the circumferential edge of the disc 50 to form an outer annular surface 54 for a purpose set forth below.” Column 3, Lines 50-65) and at least one HME element (48, “In the preferred embodiment, the HME material is a hygroscopically treated paper roll 48, such as used in the Humid-Vent artificial nose marketed by Portex. The paper roll 48 is corrugated to provide axially aligned passages for the gas. As gas is expired from the patient, heat and humidity is trapped in the exchanger material so that gas which is subsequently inspired is instantaneously heated and humidified as it passes through the paper roll. The paper roll 48 is dimensioned to fill the chamber of the cartridge.” Column 3, Lines 25-50; “The plurality of openings may be of any suitable size and shape to permit the passage of the gas while retaining the roll 48 in position.” Column 3, Lines 50-65; “As shown in FIG. 4, the cartridge is formed by press-fitting the outer flange 62 of a rear casing over the inner flange 52 of the front casing with the paper roll 48 positioned inside the chamber formed within the casings. In this way, the cartridge 16 is formed having a thin cross-section.” Column 4, Lines 5-15) mounted in the outer housing (50), the HME device (16) being arranged to fit with a cooperating connector (40, “A tubular sleeve 40 extends outwardly from a flat portion 41 of the forward wall to define an opening 42 for mounting the HME cartridge 16. The opening, 42 is positioned opposite the tracheostomy. In the preferred embodiment, the sleeve extends outwardly approximately 1/4 of an inch. The sleeve is integrally formed with the body and is deformable to permit insertion of the cartridge 16.” Column 3, Lines 20-30; “The inner and outer flange portions of the front casing and rear casing have equal axial length which are generally equivalent to the axial length of the sleeve 40.” Column 3, Line 60 thru Column 4, Line 10; “The cartridge 16 is inserted in the opening of the collar 14. The cylindrical sleeve 40 of the collar, being formed of flexible material, may be manipulated over the inner surface of the cartridge so that the sleeve 40 is positioned between the inner and outer annular surfaces of the cartridge, with the sleeve 40 contacting the outer flange 62 of the rear casing. The cartridge may be easily removed by snapping the cartridge out of the collar and be replaced by another cartridge when necessary because of deterioration of the filter medium or clogging of the exchanger material.” Column 4, Lines 10-25; “The cylindrical portion 74 of the cover 70 has an inner diameter adapted to snuggly receive the cartridge 70 and cylindrical sleeve 40.” Column 4, Lines 25-35) on a breathing device (14, “The exchanger device 10 has a collar 14 bearing a heat and moisture exchanger (HME) cartridge 16. … As best shown in FIG. 3, the collar 14 has a body 22 formed of a suitable soft flexible elastomeric material which is held in position by a strap 24.” Column 2, Lines 40-65; “The cartridge 16 is inserted in the opening of the collar 14.” Column 4, Lines 5-25), characterized in that the HME device (16) is configured such that a major part of the length of the HME element (48) is arranged to extend inside (best seen Figure 4) the cooperating connector (40) on the breathing device (14) and the outer housing (50) fit onto the outside (via 54 of 50, “The inner flange portion 52 is positioned inwardly from the circumferential edge of the disc 50 to form an outer annular surface 54 for a purpose set forth below.” Column 3, Lines 50-65) of the cooperating connector (40), the HME element (48) being longer than (defined by the thickness of 48 as compared thicknesses of 50 and 54 of 50, as seen in Figure 4) the outer housing (50).
As to Claim 11, Chmielinski discloses the outer housing (50) of the HME device (16) has a tapered inner surface (54, best seen Figures 3 and 4) adapted to slip fit (“The cartridge may be easily removed by snapping the cartridge out of the collar and be replaced by another cartridge when necessary because of deterioration of the filter medium or clogging of the exchanger material.” Column 4, Lines 10-25; whereby “The inner diameter of the outer flange portion of the rear casing is slightly smaller than the outer diameter of the inner flange portion 52 of the front casing. The inner and outer flange portions of the front casing and rear casing have equal axial length which are generally equivalent to the axial length of the sleeve 40. As shown in FIG. 4, the cartridge is formed by press-fitting the outer flange 62 of a rear casing over the inner flange 52 of the front casing with the paper roll 48 positioned inside the chamber formed within the casings. … The cartridge 16 is inserted in the opening of the collar 14.” Column 3, Line 60 thru Column 4, Line 25) on the outside of the cooperating connector (40). As best shown in Figures 3 and 4, the tapered inner surface (54) of the outer housing (50) abuts onto the outside of the coopering connector (40) when the apex of 54 is aligned with exterior perimeter of 40.
As to Claim 12, Chmielinski discloses the outside of the HME element (48) is spaced from (via 52 of 50, “The front casing 44 has a flat disc portion 50 and a cylindrical inner flange portion 52 extending outwardly from the disc portion. The inner flange portion 52 is positioned inwardly from the circumferential edge of the disc 50 to form an outer annular surface 54 for a purpose set forth below. … The inner diameter of the outer flange portion of the rear casing is slightly smaller than the outer diameter of the inner flange portion 52 of the front casing. The inner and outer flange portions of the front casing and rear casing have equal axial length which are generally equivalent to the axial length of the sleeve 40. As shown in FIG. 4, the cartridge is formed by press-fitting the outer flange 62 of a rear casing over the inner flange 52 of the front casing with the paper roll 48 positioned inside the chamber formed within the casings. … The cartridge 16 is inserted in the opening of the collar 14.” Column 3, Line 50 thru Column 4, Line 25) the tapered inner surface (54) of the outer housing (50) along at least its patient end (the portion of 48 most proximate 50 as exposed to the ambient) such as to define an annular recess (via grates of 50 as seen in Figure 3) at the patient end (the portion of 48 most proximate 50 as exposed to the ambient) of the HME device (16) in which at least the machine end (the portion of 52 abutted by 64 and encased by 40) of the cooperating connector (40) can be received such that at least the patient end (the portion of 48 most proximate 50 as exposed to the ambient) of the HME element (48) is located within (best seen Figure 4) the cooperating connector (40).
As to Claim 13, Chmielinski discloses the HME element (48) is removable from the outer housing (50) of the HME device (16) from the machine end (the portion of 52 abutted by 64 and encased by 40) of the outer housing (50) when the HME device (16) is fitted on the cooperating connector (40).
As to Claim 14, Chmielinski discloses the HME element (48) is retained with the outer housing (50) by a clip fitting (encasement of 52 of 50 with 62 of 60 – “As shown in FIG. 4, the cartridge is formed by press-fitting the outer flange 62 of a rear casing over the inner flange 52 of the front casing with the paper roll 48 positioned inside the chamber formed within the casings.” Column 4, Lines 5-25), and that the clip fitting (encasement of 52 of 50 with 62 of 60) is releasable from the outer housing (50) by pulling away from the outer housing (50) without need to twist the HME element (48) relative to the outer housing (50).
As to Claim 15, Chmielinski discloses the HME device (16) is joined to the machine end (the portion of 52 abutted by 64 and encased by 40) of an inner cannula (via 62/64 of 60, “The rear casing has a disc portion 60 with an outer flange portion 62 extending from the disc portion. The disc portion extends outwardly beyond the outer flange portion to form an annular inner surface 64.” Column 3, Line 60 thru Column 4, Line 10) so that the HME device (16) and the inner cannula (60) can be removed and replaced as a single unit (“The cylindrical sleeve 40 of the collar, being formed of flexible material, may be manipulated over the inner surface of the cartridge so that the sleeve 40 is positioned between the inner and outer annular surfaces of the cartridge, with the sleeve 40 contacting the outer flange 62 of the rear casing. The cartridge may be easily removed by snapping the cartridge out of the collar and be replaced by another cartridge when necessary because of deterioration of the filter medium or clogging of the exchanger material.” Column 4, Lines 10-25).
As to Claim 19, Chmielinski discloses the HME element (48) is longer than (defined by the thickness of 48 as compared thicknesses of 50 and 54 of 50, as seen in Figure 4) the outer housing (50) such that a patient end (the portion of 48 most proximate the neck of the user) of the HME element (48) projects beyond (best seen Figure 4) a distal end (54) of the outer housing (50) in the cooperating connector (40).
As to Claim 20, Chmielinski discloses the HME element (48) has its machine end (the portion of 52 abutted by 64 and encased by 40 and proximate to the ambient) securely bonded to an end cap (70, “The cover 70 is adapted to snap tightly over the cartridge when the device is not being used. The cover has a flat portion 72 and a cylindrical portion 74 extending from the flat portion 72. A tab 76 extends from the flat portion 72 for removal of the cover. The cylindrical portion 74 of the cover 70 has an inner diameter adapted to snuggly receive the cartridge 70 and cylindrical sleeve 40. Thus, the cover may be positioned over the cartridge when the device has been removed from the patient.” Column 4, Lines 25-35) such that the HME element (48) is removable from the HME device (16) by pulling the end cap (70) away from the outer housing (50). In operation, as seen in Figures 3 and 4, the HME element (48) is encased by the outer housing (50) and the end cap (70) on the ambient side, and by the inner cannula (60) on the patient side to form the HME device (16) as inserted within the cooperating connector (40) of the breathing device (14). To remove the HME element (48) from the cooperating connector (40) of the breathing device (14) and/or the HME device (16), it would require the displacement of the end cap (70), if applied, and the separation of the outer housing (50) and the inner cannula (60) to expose the HME element (48) for replacement.
As to Claim 16, Chmielinski discloses a HME element (48, “In the preferred embodiment, the HME material is a hygroscopically treated paper roll 48, such as used in the Humid-Vent artificial nose marketed by Portex. The paper roll 48 is corrugated to provide axially aligned passages for the gas. As gas is expired from the patient, heat and humidity is trapped in the exchanger material so that gas which is subsequently inspired is instantaneously heated and humidified as it passes through the paper roll. The paper roll 48 is dimensioned to fill the chamber of the cartridge.” Column 3, Lines 25-50; “The plurality of openings may be of any suitable size and shape to permit the passage of the gas while retaining the roll 48 in position.” Column 3, Lines 50-65; “As shown in FIG. 4, the cartridge is formed by press-fitting the outer flange 62 of a rear casing over the inner flange 52 of the front casing with the paper roll 48 positioned inside the chamber formed within the casings. In this way, the cartridge 16 is formed having a thin cross-section.” Column 4, Lines 5-15) mounted in the outer housing (50), the HME device (16, “The exchanger device 10 has a collar 14 bearing a heat and moisture exchanger (HME) cartridge 16.” Column 2, Lines 40-50; “A tubular sleeve 40 extends outwardly from a flat portion 41 of the forward wall to define an opening 42 for mounting the HME cartridge 16. The opening, 42 is positioned opposite the tracheostomy. In the preferred embodiment, the sleeve extends outwardly approximately 1/4 of an inch. The sleeve is integrally formed with the body and is deformable to permit insertion of the cartridge 16. The HME cartridge 16 is formed of a heat and moisture exchanger (HME) material sandwiched in, a chamber formed between a front casing 44 and a rear casing 46.” Column 3, Lines 20-50; “As shown in FIG. 4, the cartridge is formed by press-fitting the outer flange 62 of a rear casing over the inner flange 52 of the front casing with the paper roll 48 positioned inside the chamber formed within the casings. In this way, the cartridge 16 is formed having a thin cross-section. The cartridge 16 is inserted in the opening of the collar 14. The cylindrical sleeve 40 of the collar, being formed of flexible material, may be manipulated over the inner surface of the cartridge so that the sleeve 40 is positioned between the inner and outer annular surfaces of the cartridge, with the sleeve 40 contacting the outer flange 62 of the rear casing.” Column 4, Lines 5-25) being arranged to fit with a cooperating connector (40, “A tubular sleeve 40 extends outwardly from a flat portion 41 of the forward wall to define an opening 42 for mounting the HME cartridge 16. The opening, 42 is positioned opposite the tracheostomy. In the preferred embodiment, the sleeve extends outwardly approximately 1/4 of an inch. The sleeve is integrally formed with the body and is deformable to permit insertion of the cartridge 16.” Column 3, Lines 20-30; “The inner and outer flange portions of the front casing and rear casing have equal axial length which are generally equivalent to the axial length of the sleeve 40.” Column 3, Line 60 thru Column 4, Line 10; “The cartridge 16 is inserted in the opening of the collar 14. The cylindrical sleeve 40 of the collar, being formed of flexible material, may be manipulated over the inner surface of the cartridge so that the sleeve 40 is positioned between the inner and outer annular surfaces of the cartridge, with the sleeve 40 contacting the outer flange 62 of the rear casing. The cartridge may be easily removed by snapping the cartridge out of the collar and be replaced by another cartridge when necessary because of deterioration of the filter medium or clogging of the exchanger material.” Column 4, Lines 10-25; “The cylindrical portion 74 of the cover 70 has an inner diameter adapted to snuggly receive the cartridge 70 and cylindrical sleeve 40.” Column 4, Lines 25-35) for a HME device (16), wherein the HME device (16) includes an outer housing (50, “The front casing 44 has a flat disc portion 50 and a cylindrical inner flange portion 52 extending outwardly from the disc portion. The inner flange portion 52 is positioned inwardly from the circumferential edge of the disc 50 to form an outer annular surface 54 for a purpose set forth below.” Column 3, Lines 50-65) and at least one HME element (48) mounted in the outer housing (50), the HME device (16) being arranged to fit with a cooperating connector (40, “A tubular sleeve 40 extends outwardly from a flat portion 41 of the forward wall to define an opening 42 for mounting the HME cartridge 16. The opening, 42 is positioned opposite the tracheostomy. In the preferred embodiment, the sleeve extends outwardly approximately 1/4 of an inch. The sleeve is integrally formed with the body and is deformable to permit insertion of the cartridge 16.” Column 3, Lines 20-30; “The inner and outer flange portions of the front casing and rear casing have equal axial length which are generally equivalent to the axial length of the sleeve 40.” Column 3, Line 60 thru Column 4, Line 10; “The cartridge 16 is inserted in the opening of the collar 14. The cylindrical sleeve 40 of the collar, being formed of flexible material, may be manipulated over the inner surface of the cartridge so that the sleeve 40 is positioned between the inner and outer annular surfaces of the cartridge, with the sleeve 40 contacting the outer flange 62 of the rear casing. The cartridge may be easily removed by snapping the cartridge out of the collar and be replaced by another cartridge when necessary because of deterioration of the filter medium or clogging of the exchanger material.” Column 4, Lines 10-25; “The cylindrical portion 74 of the cover 70 has an inner diameter adapted to snuggly receive the cartridge 70 and cylindrical sleeve 40.” Column 4, Lines 25-35) on a breathing device (14, “The exchanger device 10 has a collar 14 bearing a heat and moisture exchanger (HME) cartridge 16. … As best shown in FIG. 3, the collar 14 has a body 22 formed of a suitable soft flexible elastomeric material which is held in position by a strap 24.” Column 2, Lines 40-65; “The cartridge 16 is inserted in the opening of the collar 14.” Column 4, Lines 5-25) and is configured such that a major part of the length of the HME element (48) is arranged to extend inside (best seen Figure 4) the cooperating connector (40) on the breathing device (14) and the outer housing (50) fit onto the outside (via 54 of 50, “The inner flange portion 52 is positioned inwardly from the circumferential edge of the disc 50 to form an outer annular surface 54 for a purpose set forth below.” Column 3, Lines 50-65) of the cooperating connector (40).
As to Claim 21, Chmielinski discloses the outside of the HME element (48) is spaced from (via 52 of 50, “The front casing 44 has a flat disc portion 50 and a cylindrical inner flange portion 52 extending outwardly from the disc portion. The inner flange portion 52 is positioned inwardly from the circumferential edge of the disc 50 to form an outer annular surface 54 for a purpose set forth below. … The inner diameter of the outer flange portion of the rear casing is slightly smaller than the outer diameter of the inner flange portion 52 of the front casing. The inner and outer flange portions of the front casing and rear casing have equal axial length which are generally equivalent to the axial length of the sleeve 40. As shown in FIG. 4, the cartridge is formed by press-fitting the outer flange 62 of a rear casing over the inner flange 52 of the front casing with the paper roll 48 positioned inside the chamber formed within the casings. … The cartridge 16 is inserted in the opening of the collar 14.” Column 3, Line 50 thru Column 4, Line 25) the tapered inner surface (54) of the outer housing (50) along at least its patient end (the portion of 48 most proximate 50 as exposed to the ambient) such as to define an annular recess (via grates of 50 as seen in Figure 3) at the patient end (the portion of 48 most proximate 50 as exposed to the ambient) of the HME device (16) in which at least the machine end (the portion of 52 abutted by 64 and encased by 40) of the cooperating connector (40) can be received such that at least the patient end (the portion of 48 most proximate 50 as exposed to the ambient) of the HME element (48) is located within (best seen Figure 4) the cooperating connector (40).
As to Claim 22, Chmielinski discloses the HME element (48) is longer than (defined by the thickness of 48 as compared thicknesses of 50 and 54 of 50, as seen in Figure 4) the outer housing (50) such that a patient end (the portion of 48 most proximate the neck of the user) of the HME element (48) projects beyond (best seen Figure 4) a distal end (54) of the outer housing (50) in the cooperating connector (40).
As to Claim 17, Chmielinski discloses an assembly (Figures 1 and 3) of a patient breathing device (14, “The exchanger device 10 has a collar 14 bearing a heat and moisture exchanger (HME) cartridge 16. … As best shown in FIG. 3, the collar 14 has a body 22 formed of a suitable soft flexible elastomeric material which is held in position by a strap 24.” Column 2, Lines 40-65; “The cartridge 16 is inserted in the opening of the collar 14.” Column 4, Lines 5-25) and a HME device (16, “The exchanger device 10 has a collar 14 bearing a heat and moisture exchanger (HME) cartridge 16.” Column 2, Lines 40-50; “A tubular sleeve 40 extends outwardly from a flat portion 41 of the forward wall to define an opening 42 for mounting the HME cartridge 16. The opening, 42 is positioned opposite the tracheostomy. In the preferred embodiment, the sleeve extends outwardly approximately 1/4 of an inch. The sleeve is integrally formed with the body and is deformable to permit insertion of the cartridge 16. The HME cartridge 16 is formed of a heat and moisture exchanger (HME) material sandwiched in, a chamber formed between a front casing 44 and a rear casing 46.” Column 3, Lines 20-50; “As shown in FIG. 4, the cartridge is formed by press-fitting the outer flange 62 of a rear casing over the inner flange 52 of the front casing with the paper roll 48 positioned inside the chamber formed within the casings. In this way, the cartridge 16 is formed having a thin cross-section. The cartridge 16 is inserted in the opening of the collar 14. The cylindrical sleeve 40 of the collar, being formed of flexible material, may be manipulated over the inner surface of the cartridge so that the sleeve 40 is positioned between the inner and outer annular surfaces of the cartridge, with the sleeve 40 contacting the outer flange 62 of the rear casing.” Column 4, Lines 5-25), wherein the HME device (16) includes an outer housing (50, “The front casing 44 has a flat disc portion 50 and a cylindrical inner flange portion 52 extending outwardly from the disc portion. The inner flange portion 52 is positioned inwardly from the circumferential edge of the disc 50 to form an outer annular surface 54 for a purpose set forth below.” Column 3, Lines 50-65) and at least one HME element (48,“In the preferred embodiment, the HME material is a hygroscopically treated paper roll 48, such as used in the Humid-Vent artificial nose marketed by Portex. The paper roll 48 is corrugated to provide axially aligned passages for the gas. As gas is expired from the patient, heat and humidity is trapped in the exchanger material so that gas which is subsequently inspired is instantaneously heated and humidified as it passes through the paper roll. The paper roll 48 is dimensioned to fill the chamber of the cartridge.” Column 3, Lines 25-50; “The plurality of openings may be of any suitable size and shape to permit the passage of the gas while retaining the roll 48 in position.” Column 3, Lines 50-65; “As shown in FIG. 4, the cartridge is formed by press-fitting the outer flange 62 of a rear casing over the inner flange 52 of the front casing with the paper roll 48 positioned inside the chamber formed within the casings. In this way, the cartridge 16 is formed having a thin cross-section.” Column 4, Lines 5-15) mounted in the outer housing (50), the HME device (16) being arranged to fit with a cooperating connector (40, “A tubular sleeve 40 extends outwardly from a flat portion 41 of the forward wall to define an opening 42 for mounting the HME cartridge 16. The opening, 42 is positioned opposite the tracheostomy. In the preferred embodiment, the sleeve extends outwardly approximately 1/4 of an inch. The sleeve is integrally formed with the body and is deformable to permit insertion of the cartridge 16.” Column 3, Lines 20-30; “The inner and outer flange portions of the front casing and rear casing have equal axial length which are generally equivalent to the axial length of the sleeve 40.” Column 3, Line 60 thru Column 4, Line 10; “The cartridge 16 is inserted in the opening of the collar 14. The cylindrical sleeve 40 of the collar, being formed of flexible material, may be manipulated over the inner surface of the cartridge so that the sleeve 40 is positioned between the inner and outer annular surfaces of the cartridge, with the sleeve 40 contacting the outer flange 62 of the rear casing. The cartridge may be easily removed by snapping the cartridge out of the collar and be replaced by another cartridge when necessary because of deterioration of the filter medium or clogging of the exchanger material.” Column 4, Lines 10-25; “The cylindrical portion 74 of the cover 70 has an inner diameter adapted to snuggly receive the cartridge 70 and cylindrical sleeve 40.” Column 4, Lines 25-35) on a breathing device (14, “The exchanger device 10 has a collar 14 bearing a heat and moisture exchanger (HME) cartridge 16. … As best shown in FIG. 3, the collar 14 has a body 22 formed of a suitable soft flexible elastomeric material which is held in position by a strap 24.” Column 2, Lines 40-65; “The cartridge 16 is inserted in the opening of the collar 14.” Column 4, Lines 5-25) and is configured such that a major part of the length of the HME element (48) is arranged to extend inside (best seen Figure 4) the cooperating connector (40) on the breathing device (14), wherein the patient breathing device (14) has a male connector (via the protrusion of 40 as inserted into 54 along 52) at its machine end (best seen Figures 3 and 4) and wherein the outer housing (50) of the HME device (16) is fitted on the outside (via 54 of 50, “The inner flange portion 52 is positioned inwardly from the circumferential edge of the disc 50 to form an outer annular surface 54 for a purpose set forth below.” Column 3, Lines 50-65) of the male connector (via the protrusion of 40 as inserted into 54 along 52) with a part at least of the HME element (48) extending within the male connector (via the protrusion of 40 as inserted into 54 along 52).
As to Claim 18, Chmielinski discloses the patient breathing device (14) is a tracheostomy tube (in as much as 18 is utilized to “provide an auxiliary supply of oxygen” to the “neck 12 of a patient having a tracheostomy (not shown).” – “As best shown in FIG. 1, a heat and moisture exchanger device 10 for warming and humidifying air from the atmosphere is positioned on the neck 12 of a patient having a tracheostomy (not shown). The exchanger device 10 has a collar 14 bearing a heat and moisture exchanger (HME) cartridge 16. Also shown is an oxygen hose 18 connected to a nipple 20 to provide an auxiliary supply of oxygen.” Column 2, Lines 40-50).
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot.
Applicant is strongly encouraged to review the following section of “prior art made of record but not relied upon” below in order to efficiently expedite prosecution of this application. Primary Examiner notes at least three (3) of the prior art references appear to have inherency to at least one of independent claims of the current claim listing and an additional three (3) prior art referenced appear to be obvious to at least one of independent claims of the current claim listing. Applicant is strongly encouraged to review, consider, and amend around the current prior art rejections as well as each of the aforementioned references in order to expedite prosecution.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Persson (5,738,095) discloses an assembly (Figure 2) of a patient breathing device (31 – flange for connection to a tracheostoma) and a HME device (10) having an HME element (11) enclosed within the HME device (10) at an outer housing (15), whereby the HME device (10) cooperates with the cooperating connector (30) of the patient breathing device (31 – flange for connection to a tracheostoma), the major part of the length of the HME element (11) extends inside the cooperating connector (30) of the patient breathing device (31 – flange for connection to a tracheostoma), and the outer housing (15) slips onto the outside (at 33 as proximate both 15 and 30) of the cooperating connector (30).
Smith (5,848,590) discloses an assembly (Figure 2) of a patient breathing device (2 – flange for connection to a tracheostoma) and a HME device (the combination of 28/26/8) having a HME element (22) enclosed within the HME device (the combination of 28/26/8) at an outer housing (8), wherein the HME device (the combination of 28/26/8) cooperates with the cooperating connector (12) of the patient breathing device (2 – flange for connection to a tracheostoma), the major part of the length of the HME element (22) extends inside the cooperating connector (12) of the patient breathing device (2 – flange for connection to a tracheostoma), and the outer housing (8) slips onto the outside (at apex of 12 fitted into base of 8) of the cooperating connector (12).
Duveen et al. (11,103,668) discloses an assembly (Figure 5) of a patient breathing device (2 - mask) and a HME device (11) having a HME element (17) enclosed within the HME device (11) at an outer housing (13), wherein the HME device (11) cooperates with the cooperating connector (12) of the patient breathing device (2), the major part of the length of the HME element (17) extends inside the cooperating connector (12) of the patient breathing device (2), and the outer housing (13) slips onto the outside (best seen Figure 5) of the cooperating connector (12).
Kapp (4,763,645) discloses an assembly (Figure 2/3) of a patient breathing device (26 – tracheal tube) and a HME device (22) having a HME element (24) enclosed within the HME device (22) at an outer housing (28), the major part of the length of the HME element (24) extends inside the patient breathing device (26) and the outer housing (28) slips onto the outside (best seen Figures 2/3) of the patient breathing device (26); yet, Kapp does not expressly disclose a cooperating connector of the patient breathing device (26).
Smith (5,606,966) discloses an assembly (Figure 1) of a patient breathing device (2- tracheostomy tube) and a HME device (the combination of 4/24/26/22) having a HME element (20) enclosed within the HME device (the combination of 4/24/26/22) at an outer housing (26/24/22), wherein the HME device (the combination of 4/24/26/22) cooperates with the cooperating connector (12) of the patient breathing device (2), and the outer housing (26/24/22) slips onto the outside of the cooperating connector (12) of the patient breathing device (2); yet, Smith does not expressly disclose the major part of the length of the HME element extending inside the cooperating connector.
Lambert (2003/0029456) discloses an assembly (Figure 7) of a patient breathing device (1 – flange for connector to a tracheostoma) and a HME device (the combination of 10 and 11) having a HME element (6) enclosed within the HME device (the combination of 10 and 11) at an outer housing (11), wherein the HME device (the combination of 10 and 11) cooperates with the cooperating connector (12) of the patient breathing device (1), the outer housing (11) slips onto the cooperating connector (12); yet, Lambert does not expressly disclose the connection of the outer housing to the outside of the cooperating connector nor the major part of the length of the HME element extending inside the cooperating connector.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNETTE F DIXON whose telephone number is (571)272-3392. The examiner can normally be reached M-F 9-5 EST with flexible hours.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785
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