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. Status of Claims This Office Action is in responsive to the preliminary amendments filed on 10/27/2023. As directed by the Preliminary amendment, claims 1-9 were cancelled, and claims 10-18 have been added. Thus, claims 10-18 are currently pending in this application . Drawings The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the inner cannula of claim 15 must be shown or the feature canceled from the claim(s). The specification states the inner cannula is adapted to extend along the bore of the tracheostomy tube (see page 7, second paragraph), but no inner cannula is present in the drawings. No new matter should be entered. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Specification The disclosure is objected to because of the following informalities: Page 4, paragraph 4 recites “HME element 20”. However, the same paragraph later identifies “HME element 23”. The drawings do not show a reference character “20”. For examination purposes, examiner interprets that HME element is solely referred to as reference character 23. Examiner suggests rephrasing “HME element 20” to “HME element 23”. Appropriate correction 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. Claim s 1 0 , 12-14, and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dantanarayana (US 20190351173 A1). Regarding claim 1 0 , D antanarayana teaches a n HME device (Figs. 15 A- 15 F where HME housing 9 180 and its interior components is an HME device ; paragraph 0423 “ The HME material (not shown) may be a coiled or cylindrical structure that is inserted into the HME housing 9180 and retained therein by the HME clip 9170 ”) including an outer housing (HME housing 9 180 ) and at least one HME element mounted in the housing (paragraph 0423 “ The HME material (not shown) may be a coiled or cylindrical structure that is inserted into the HME housing 9180 and retained therein by the HME clip 9170 ” ) , the HME device being arranged to fit with a cooperating connector (vent adaptor 9100 ; Fig. 15F; paragraph 0426 “ In this example, the HME housing 9180 is not completely contained inside of the vent adaptor 9100. Rather, it is exposed partially such that it forms part of the structure that connects the vent housing 9120 to the vent adaptor connector 9200 ”) on a breathing device (paragraph 0454 “ The vent housing 9120 may be connected to a conduit connector 9110 that in turn may connect the vent adaptor 9100 to an air circuit ” where an air circuit is part of a breathing device) , characterised in that the HME device is configured such that a major part of the length of the HME element is arranged to extend inside the cooperating connector on the breathing device (paragraph 0426 “ In this example, the HME housing 9180 is not completely contained inside of the vent adaptor 9100. Rather, it is exposed partially such that it forms part of the structure that connects the vent housing 9120 to the vent adaptor connector 9200 ”; Fig. 15F shows HME element 9145 and HME housing 9180 being majorly contained inside connector 91 0 0) . Regarding claim 12, D antanarayana teaches the device of claim 10. D antanarayana further teaches wherein the device is characterised in that the outside of the HME element is spaced from the inner surface of the outer housing (Fig. 15F where element 9145 is spaced from the right side of the inner surface of outer housing 9180) at least along its patient end (Fig. 15F where the right side of element 9145 is the patient end as tube 9210 connects to a patient interface; paragraph 0429 “ One end of the short tube 9210 may be joined to the patient interface 3000A, 3000B and the other end may be joined to the vent adaptor connector 9200 described above ”) such as to define an annular recess at the patient end of the device in which at least the machine end of the cooperating connector can be received (paragraph 0436 “ The HME housing 9400 may also include an annular recess 9405 around the outer periphery of the atmosphere-side HME housing portion 9404 that removably receives the retaining protrusions 9328. The annular recess 9405 may be continuous about the outer periphery of the atmosphere-side HME housing portion 9404, which allows the HME housing 9400 to be attached to the vent housing 9320 without regard to the relative orientation of the components ”; paragraph 0438 “I t is also envisioned that the removable connection interface between the HME housing 9400 and the vent adaptor 9100 may occur between the patient-side HME housing portion 9402 and the vent housing connector 9160, instead of between the atmosphere-side HME housing portion 9404 and the vent housing 9320 ”; paragraph 0438 suggests that the annular recess to receive the connector can also be on the patient-side of the HME) such that at least the patient end of the HME element is located within the cooperating connector (paragraph 0423 “ an HME housing 9180 to retain HME material within the vent adaptor 9100 in a position that is between the internal vent holes 9126 and the patient, as described above ”; HME material is secured in the HME housing which is located with connector 9100). Regarding claim 13, D antanarayana teaches the device of claim 10. Dantanarayana further teaches wherein the device is characterised in that the HME element is removable from the outer housing of the HME device (paragraph 0423 “ The HME material (not shown) may be a coiled or cylindrical structure that is inserted into the HME housing 9180 and retained therein by the HME clip 9170 ”; One skilled in the art would reasonably expect that the use of a clip 9170 would allow the HME element to be removable based on the understanding of how a clip functions) from the machine end of the outer housing when the HME device is fitted on a connector (Fig. 15C shows clip 9170 secures HME element 9145 to housing 9180 via the machine side of the device on the right half as 9210 is the patient side that connects to a patient interface which is taught in paragraph 0429; One skilled in the art would reasonably expect that removing the clip 9170 would remove element 9145 from the machine end of housing 9180) . Regarding claim 14, D antanarayana teaches the device of claim 13. Dantanarayana further teaches wherein the device is characterised in that the HME element is retained with the outer housing by a clip fitting (clip 9170, see paragraph 0423) , and that the clip fitting is releasable from the outer housing by pulling away from the outer housing without the need to twist the element relative to the housing (paragraph 0423 teaches the clip 9170 in Figs. 12A-12D have arms 9171 that secure into housing 9180 via slots 9181 shown in Fig. 13A which prevents any rotation of the clip 9170 relative to HME housing 9180; One skilled in the art would reasonably expect that this structure of arms and slots would allow the clip to be releasable by pulling away without any twisting of the element). Regarding claim 16, D antanarayana teaches a n HME element (HME material 9145) for an HME device (Figs. 15A-15F where HME housing 9180 and its interior components is an HME device; paragraph 0423 “ The HME material (not shown) may be a coiled or cylindrical structure that is inserted into the HME housing 9180 and retained therein by the HME clip 9170 ”), the HME device including an outer housing (HME housing 9180) and at least the HME element mounted in the housing (paragraph 0423 “ The HME material (not shown) may be a coiled or cylindrical structure that is inserted into the HME housing 9180 and retained therein by the HME clip 9170 ”) , the HME device being arranged to fit with a cooperating connector (vent adaptor 9100; Fig. 15F; paragraph 0426 “ In this example, the HME housing 9180 is not completely contained inside of the vent adaptor 9100. Rather, it is exposed partially such that it forms part of the structure that connects the vent housing 9120 to the vent adaptor connector 9200 ”) on a breathing device (paragraph 0454 “ The vent housing 9120 may be connected to a conduit connector 9110 that in turn may connect the vent adaptor 9100 to an air circuit ” where an air circuit is part of a breathing device) , and is configured such that a major part of the length of the HME element is arranged to extend inside the cooperating connector on the breathing device (paragraph 0426 “ In this example, the HME housing 9180 is not completely contained inside of the vent adaptor 9100. Rather, it is exposed partially such that it forms part of the structure that connects the vent housing 9120 to the vent adaptor connector 9200 ”; Fig. 15F shows HME element 9145 and HME housing 9180 being majorly contained inside connector 91 0 0) . Regarding claim 1 7 , D antanarayana teaches a n assembly of a patient breathing device (paragraph 0429 “ the vent adaptor 9100 may be joined to either patient interface via a short tube 9210 ”; Fig. 23 where 9100 has an HME assembly to connect to the different patient breathing devices ) and an HME device ( Figs. 15A-15F where HME housing 9180 and its interior components is an HME device; paragraph 0423 “The HME material (not shown) may be a coiled or cylindrical structure that is inserted into the HME housing 9180 and retained therein by the HME clip 9170” ) , wherein the HME device includes an outer housing ( HME housing 918 0) and at least one HME element mounted in the housing ( paragraph 0423 “The HME material (not shown) may be a coiled or cylindrical structure that is inserted into the HME housing 9180 and retained therein by the HME clip 9170” ) , the HME device being arranged to fit with a cooperating connector ( vent adaptor 9100; Fig. 15F; paragraph 0426 “In this example, the HME housing 9180 is not completely contained inside of the vent adaptor 9100. Rather, it is exposed partially such that it forms part of the structure that connects the vent housing 9120 to the vent adaptor connector 9200”) on a breathing device (paragraph 0454 “The vent housing 9120 may be connected to a conduit connector 9110 that in turn may connect the vent adaptor 9100 to an air circuit” where an air circuit is part of the breathing device ) , the HME device being configured such that a major part of the length of the HME element is arranged to extend inside the cooperating connector on the breathing device ( paragraph 0426 “In this example, the HME housing 9180 is not completely contained inside of the vent adaptor 9100. Rather, it is exposed partially such that it forms part of the structure that connects the vent housing 9120 to the vent adaptor connector 9200”; Fig. 15F shows HME element 9145 and HME housing 9180 being majorly contained inside connector 91 0 0 ) , wherein the patient breathing device has a male connector at its machine end (Fig. 15F, connector 9166; paragraph 0433 “ The vent adaptor 9100 may include a vent housing connector 9160 to join the short tube assembly 9210 with the vent housing 9320 ”; paragraph 0433 “ The vent housing connector 9160 may also include a bayonet connector 9166 to facilitate a releasable bayonet-style connection with the vent housing 9320 or a heat and moisture exchanger (HME) housing 9400 such as those shown in FIGS. 38A to 39C. Thus the HME associated with the HME housing 9400 may be optional and, as such, is not shown in FIGS. 33A to 33F. The bayonet connectors 9166 may be male or female ”) , and wherein the outer housing of the HME device is fitted on the outside of the male connector (Figs. 15D and 15F show how the housing 9180 is fitted with connector 9166 ; One reasonably skilled in the art would expect that if bayonet connector is male and facilitates a connection with HME housing, then the HME device would fit on the outside of the male connector for a proper male-female connection ) with a part at least of the HME element extending within the male connector (Fig. 15F where HME element 9145 is within the area encompassed by the connector 9166) . Claim Rejections - 35 USC § 103 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 . Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Dantanarayana (US 20190351173 A1) in view of Chandler (US 20190275282 A1) . Regarding claim 11, D antanarayana teaches the device of claim 10 . D antanarayana is silent wherein the device is characterised in that the outer housing of the HME device has a tapered inner surface adapted to fit on the outside of the cooperating connector . However, Chandler teaches wherein teaches the outer housing of the an HME device has a tapered inner surface adapted to fit on the outside of the cooperating connector (paragraph 0013 “ an HME device 1 having an outer housing 10 of circular section with a patient end coupling or inlet 11 having a luer tapered inner surface 11′ adapted to fit onto a mating male connector at the end of a breathing device (not shown) such as an endotracheal or tracheostomy tube ”). Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of D antanarayana to include tapered inner surface to more tightly fit to a connector and conform to different shaped connectors such as a breathing tube as suggested by Chandler (paragraph 0015 “t he inner surface 11 ′ of which is tapered and is adapted provide a female coupling for fitting on the outside of a conventional 15 mm male coupling (not shown) attached to a breathing tube or the like ”). Claims 15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Dantanarayana (US 20190351173 A1) in view of Pagan (US 20050133028 A1). Regarding claim 15, D antanarayana teaches the device of claim 10. D antanarayana is silent wherein the device is characterised in that the HME device is joined to the machine end of an inner cannula so that the HME device and inner cannula can be removed and replaced as a single unit . However, Pagan teaches an HME device (Fig. 1, HME 3) characterised in that the HME device is joined to the machine end of an inner cannula (paragraph 0016 “ a removable inner cannula or liner 2 and an HME gas-treatment device 3 connected to the machine end of the cannula ”) so that the HME device and inner cannula can be removed and replaced as a single unit (paragraph 0024 “ The inner cannula with the HME is removed and replaced periodically when secretions start to collect ”). Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the HME product of D antanarayana to join to a machine end of an inner cannula to secure the airflow passage between the HME and cannula ( paragraph 0022 “ When the patient inhales, air flows in through the wall 30, through the element 38 and the foam 35 taking up the major part of the heat and moisture absorbed in these parts. The warmed and moistened air then flows through the coupling 24 along the tracheostomy tube 1, via the inner cannula 2, to the patient ” ) and easily remove and replace a cannula and HME simultaneously (paragraph 0024 “ The inner cannula with the HME is removed and replaced periodically when secretions start to collect ”) . Regarding claim 18, D antanarayana teaches the device of claim 17. Dantanarayana is silent wherein the patient breathing device is a tracheostomy tube. However, Chandler teaches an HME device (Fig. 1, HME 3) with a housing ( paragraph 0019 “ The HME 3 has an outer wall or housing 30 of a bonded- fibre fabric or other gas-permeable flexible material, such as a perforated material ” ) fitted on the outside of a male connector (paragraph 0018 “ The coupling 24 has a tapered female bore adapted to receive a 15 mm male coupling and it also has a number of side ports 25 equally spaced around its circumference ”) to connect with a tracheostomy tube (paragraph 0022 “ The warmed and moistened air then flows through the coupling 24 along the tracheostomy tube 1, via the inner cannula 2, to the patient ”; paragraph 0024 “ t will be appreciated, however, that the HME could be attached directly to the flange of the tracheostomy tube where an inner cannula is not used, the HME being removed and replaced as necessary ”). Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the HME product of D antanarayana to connect with a tracheostomy tube to directly warm and moisten gas supplied to a patient when a patient has a trachea tube and reduce patient discomfort when using a tracheostomy tube (paragraph 0003 “ The gas is, therefore, preferably warmed and moistened to prevent discomfort and damage to the lining of the trachea. This is often achieved by a heat and moisture exchange device or HME connected to the tracheal tube to receive both exhaled and inhaled gases ”). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT AKHIL A JAYAN whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-6099 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Friday 8am-5pm . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Kendra Carter can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 5712729034 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /AKHIL A JAYAN/ Examiner, Art Unit 3785 /KENDRA D CARTER/ Supervisory Patent Examiner, Art Unit 3785