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
The present Office action is responsive to the Remarks and Amendments filed in the Request for Continued Examination on 12-05-2024. As directed, claim 1 has been amended. Thus, claims 1-10 are currently pending examination.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12-05-2024 has been entered.
Response to Amendment
Applicant has amended claim 1 to overcome minor informalities. The previously held claim objection is hereby withdrawn.
Response to Arguments
Applicant argues that the proposed combination of Fortuna and Avitsian fails to disclose all of the claimed elements of claim 1. Applicant argues that the Office has failed to take into account Fortuna laryngeal airway mask, and has instead only focused on the esophageal drain tube. Applicant additionally argues that Fortuna cannot teach a flexible and collapsible duct because Fortuna discloses that the drain tube 18 is sufficiently rigid so as to not collapse under normal operating pressures, and further seems to argue that the claimed duct should be comparable to esophageal drain tube 18, defined as sufficiently rigid, but even if conduit 20 were used to read on the flexible and collapsible service duct, Fortuna also discloses that the conduit is sufficiently rigid to withstand collapse.
Examiner respectfully disagrees with Applicant’s contentions. First, the entirety of the Fortuna reference has been taken into account. While it is true the device includes a supraglottic airway and an esophageal drain tube, Fortuna also contemplates a tracheal limb (24) and a tracheal lumen (34) (see paragraphs 62-63). Further, Fortuna expressly discloses that the overall device is flexible enough to allow for proper handling (see paragraph 60), and as was stated in the previous Office action, additionally uses a reinforcing ring (30) to ensure against collapse of the tube by the patient’s teeth (paragraph 62, lines 1-4). Thus, it is understood that the duct is flexible and collapsible by virtue of its flexible nature. In addition, whole paragraph 67 does indicate that conduit 20 is rigid enough to withstand collapse when cuff 14 is inflated, this does not preclude the conduit itself from being collapsible from outside mechanical forces, as evidenced by the notion that bite force can collapse the tube, and being sufficiently rigid does not preclude a conduit from being flexible or having flexibility.
Therefore, these arguments are not found to be persuasive, and Fortuna will be maintained below.
Applicant further argues that replacing the supraglottic cuff of Fortuna with the airway of Avitsian, as allegedly indicated in the previously Office action, would render Fortuna incapable of achieving its purpose. Applicant alleges that Avitsian does not disclose an esophageal component, that the modification as proposed in the Office action would somehow require three lumens, and filling the Fortuna device with Avitsian’s device may cause patient asphyxiation. Thus, Applicant argues the combination of references is impermissible.
Examiner respectfully disagrees, and notes that Applicant’s suppositions have entirely mischaracterized the 103-combination made of record. Fortuna expressly indicates a tracheal lumen (34) (paragraph 63, lines 1-3; Fig. 6), and throughout the disclosure also makes reference to patient intubation (paragraph 38, lines 1-10), a procedure well known in the art to require the placement of a tube in the trachea for breathing. Further, the supraglottic cuff is described as being placed within the pharynx, which is positioned above the trachea and esophagus within the airway (see paragraph 20 for pharynx placement), and thus, given that the esophageal lumen is named for the ultimate destination of the tube (18), it is understood that the trachea lumen (34) also refers to a lumen for intubating the patient’s trachea. Further, even if this were not the case, claim 1 is a device claim, and as such the device need only be configured for/adapted for performing the claimed functions/positions of the claims. Thus, given that Fortuna indicates a lumen in communication with the trachea, the device of Fortuna is understood to reasonably be adapted for the positioning of tubes recited in the claims.
In addition, the proposed modification has only served to add Avitsian’s tube (26) to be placed and guided through Fortuna’s tracheal lumen (34). There exists no language in the rejection of record which attempts to deliver Avistian’s entire device through Fortuna’s conduit (20). Rather, the rejection points out that both Avitsian and Fortuna utilize supraglottic cuffs each with a double lumen design, making them analogous art, but Avitsian is relied on for its explicit teaching of passage of a tracheal tube through the supraglottic cuff, which Fortuna’s supraglottic cuff is understood to be adapted for, given the presence of the tracheal lumen (34). Fortuna makes clear that the esophageal drain tube (18) is deployed to ensure the stomach contents are not regurgitated while attempting to provide the patient with respiratory air (see paragraph 7).
In addition, Kreck (US 2013/0030411) shows in Fig. 1B, that tubes employing inflatable cuffs can be deployed into the trachea and the esophagus at the same time. Thus, one of ordinary skill in the art would recognize that the two tubes could be deployed to avoid patient asphyxiation.
Thus, the combination will be maintained hereinbelow. It is, however, noted that the closest prior art of record to Applicant’s device, is Applicant’s own prior work (WO 2013/118059). As such, Examiner encourages amendments of the claims to specifically and structurally detail the connection of the instantly disclosed conduit 16 on an external portion of the conduit 2, such that it is made clear that the conduits are in a side-by-side configuration when the device is in an undeployed state, while maintaining the limitations which refer explicitly to service duct 20.
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.
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:
-First and second sealing elements in claims 1, 2, and 7, which are interpreted relative to claims 5 and 6 to be inflatable cuff elements.
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 § 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 non-obviousness.
Claims 1-7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Fortuna (US 2010/0242957) in view of Avitsian (US 2018/0104427).
Regarding claim 1, Fortuna discloses a tracheal device (LMA 10, which is adapted to engage the trachea via tracheal limb 24) adapted for assisted respiration of a patient (paragraph 59, lines 1-5; paragraph 61, lines 1-3, where the device has a tracheal lumen; Fig. 1), comprising:
a second tube (18) having a distal end adapted to cover a second orifice (paragraph 59, lines 1-5, see “cuff 16 near distal end”, where the distal end extends past the cuff 16 as shown in Fig. 1 and 18 is adapted for placement to cover the esophagus regarded as the second orifice; Figs. 1 and 11);
a second sealing element (16) coupled to an outer surface of said second tube (18) (paragraph 59, lines 1-5; Fig. 1); and
a flexible and collapsible service duct (conduit 20, extending to limbs 22, 24, and 26) having a first end open to an outer environment and a second end in fluid communication with said second tube (18) (paragraph 60, lines 1-7, see lines 6-7 which describe the flexible nature of the device, the duct is also interpreted to be collapsible given that the material used to make it is flexible, and thus the duct could flex inwardly under outside force/pressure (see also paragraph 77, lines 1-7 which describe reinforcing ring 30 as preventing the collapse of the tube under bite force, insinuating that the conduit 20 itself would be collapsible under bite force); paragraph 61, lines 1-3, see “proximal end of conduit” as it relates to limbs 22, 24, and 26; see Fig. 11 where the ends of the limbs are in communication with an outer environment outside of the patient’s mouth; paragraph 65, lines 1-7 and Fig. 2, where conduit 20 includes section 52 from which tube 18 extends from, this end of the conduit 20 is regarded as the second end in communication with the second tube 18, and where section 52 is described as including lumen 34 which is an esophageal lumen), said service duct (20) being stably coupled to said second tube (18) to allow said distal end of said second tube (18) to be inserted into an esophagus (70) of the patient (paragraph 75, lines 1-8; Fig. 11),
whereby said service duct (20) enables a fluid discharge from said second tube (18) to said outer environment when said service duct (20) is a non-collapsed configuration (paragraph 86, lines 1-5, where esophageal limb 22 is a portion of the proximal part of conduit 20 which leads to the outer environment).
While Fortuna does introduce a tracheal lumen (32) within the device (10) (paragraph 63, lines 1-3; Fig. 6), Fortuna fails to disclose a first tube having a proximal end adapted to be arranged protruding from a mouth of the patient and connectable to an assisted respiration device, and a distal end adapted to cover a first orifice;
a first sealing element coupled to an outer surface of said first tube;
and given that the first tube is not contemplated within Fortuna, Fortuna currently fails to disclose said service duct being stably coupled to said first tube to allow said service duct and said first and said second tubes to be arranged in a first configuration, in which said distal end of said first tube is inserted into a supraglottic region of the patient when said distal end of said second tube is adapted to be inserted into an esophagus of the patient, and in a second configuration, in which said distal end of said first tube is adapted to be inserted into a trachea of the patient when said distal end of said second tube is adapted to be inserted into the esophagus of the patient.
However, Avitsian teaches a reversible airway device (10) including a supraglottic airway (12) with a multi-lumen guide (14) (paragraph 39, lines 1-5; Fig. 1), including:
a first tube (26) having a proximal end adapted to be arranged protruding from a mouth of the patient and connectable to an assisted respiration device (see “ventilator”) (paragraph 48, lines 1-10; Fig. 6), and a distal end adapted to cover a first orifice when the first tube (26) is inserted through the multi-lumen guide (14) (paragraph 48, lines 1-6, where the first orifice is the trachea which is covered under inflation of cuff 40; Fig. 5); and
a first sealing element (40) coupled to an outer surface of said first tube (26) (paragraph 48, lines 1-6). Avitsian teaches that the use of the first tube (26) advantageously delivers respiratory assistance further into the patient’s trachea while still permitting retraction of the first tube (26), while the first sealing element blocks liquids and solids from passing along the outside of the first tube (26) (paragraph 41, lines 11-18; paragraph 48, lines 10-13).
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 modified the use of Fortuna’s trachea device to include the passage of a first tube through the tracheal lumen (Fortuna: 34), where the first tube is configured as an endotracheal tube with a first sealing element, as taught by Avitsian, in order to provide ventilation to a deeper portion of the patient’s trachea, and block solids and liquids from coming between the first tube and the patient’s lungs.
Now modified Fortuna further discloses said service duct (Fortuna: 20) being stably coupled to said first tube (Avitsian: 26, configured to be directed through Fortuna’s conduit 20 at tracheal limb 24 extending to tracheal lumen 34) to allow said service duct (Fortuna: 20) and said first and said second tubes (see Avitsian’s 26 and Fortuna’s 18 respectively) to be arranged in a first configuration, in which said distal end of said first tube (Avitsian: 26, configured to be directed through Fortuna’s conduit 20 at tracheal limb 24 through and out tracheal lumen 34) is inserted into a supraglottic region of the patient when said distal end of said second tube (Fortuna: 18) is adapted to be inserted into an esophagus of the patient (Avitsian: paragraph 48, lines 1-12 which describes placement of endotracheal tube within the trachea, but to get to this position, the tube would have to first pass through the supraglottic region of the patient above the trachea; Fortuna: paragraph 75, lines 1-8; Fig. 11), and in a second configuration, in which said distal end of said first tube (Avitsian: 26, configured to be directed through Fortuna’s conduit 20 at tracheal limb 24 through and out tracheal lumen 34) is adapted to be inserted into a trachea of the patient when said distal end of said second tube (Fortuna: 18) is adapted to be inserted into the esophagus of the patient (Avitsian: paragraph 48, lines 1-12 which describes placement of endotracheal tube within the trachea; Fortuna: paragraph 75, lines 1-8; Fig. 11).
Regarding claim 2, Fortuna in view of Avitsian disclose the tracheal device according to claim 1, as discussed above.
Modified Fortuna further discloses wherein said service duct (Fortuna: 20) is stably coupled to a portion of said first tube (Avitsian: 26, configured to be directed through Fortuna’s conduit 20 at tracheal limb 24) located between said first sealing element (Avitsian: 40) and said proximal end of said first tube (Avitsian: 26, configured to be directed through Fortuna’s conduit 20) (Avitsian: see Fig. 1, where tube 26 exits its lumen above cuff 40 at its distal end, and where its proximal end extends out of the lumen, when placed within Fortuna’s service duct 20, the same configuration is expected, and the stable coupling is interpreted to be along the length of first tube 26 within the service duct 20, which occurs between the sealing element 40 and the proximal end in use).
Regarding claim 3, Fortuna in view of Avitsian disclose the tracheal device according to claim 1, as discussed above.
Modified Avitsian discloses the device further comprising one or more medical accessories adapted to cover said service duct (20) (Fortuna: paragraph 65, lines 1-7 and Fig. 2, where conduit 20 includes section 52 from which tube 18 extends from, and covers this portion of the conduit 20, as well as the length of conduit 20 at limb 22; Avitsian: paragraph 48, lines 1-12 which describes placement of endotracheal tube within the trachea through the device, and as the modification of claim 1, the first tube 26 is interpreted to be placed within service duct 20 at limb 24 of Fortuna, and thus cover it; see also Fortuna’s paragraph 86, “oro-gastric tube”).
Regarding claim 4, Fortuna in view of Avitsian disclose the tracheal device according to claim 3, as discussed above.
Modified Fortuna further discloses wherein said one or more medical accessories is a gastric probe (paragraph 86, lines 1-5).
Regarding claim 5, Fortuna in view of Avitsian disclose the tracheal device according to claim 1, as discussed above.
Modifeid Fortuna further discloses wherein said first sealing element (Fortuna: 16) is a first inflatable cuff connected to a first duct (29) for passage of inflation fluid (paragraph 63, lines 4-6).
Regarding claim 6, Fortuna in view of Avitsian disclose the tracheal device according to claim 1, as discussed above.
Modified Fortuna further discloses wherein said second sealing element (Avitsian: 40) comprises a second inflatable cuff connected to a second duct (see “inflation tube” of paragraph 48) for passage of inflation fluid (paragraph 48, lines 1-6 and 13-17).
Regarding claim 7, Fortuna in view of Avitsian disclose the tracheal device according to claim 1, as discussed above.
Modified Fortuna further discloses wherein said second sealing element (Fortuna: 16) comprises one or more elastically deformable bodies wrapping said second tube (Fortuna: 18) and adapted to be interposed between said second tube (Fortuna: 18) and one or more mucosal walls creating, by deformation, a fluid seal therewith, each of said one or more elastically deformable bodies comprising a casing which hermetically closes an inner portion so as to make said inner portion inaccessible from outside (Fortuna: paragraph 66, lines 1-4; paragraph 78, lines 1-8; Fig. 12).
Regarding claim 10, Fortuna in view of Avitsian disclose the tracheal device according to claim 1, as discussed above.
Modified Fortuna further discloses wherein said second tube (Fortuna: 18) comprises two or more lumens, at least one of said two or more lumens being fluidly coupled to said service duct (20) (Fortuna: paragraph 63, lines 4-6, which describes inflation of cuff 16 on second tube 18, and thus includes a lumen in which inflation gas is directed, and paragraph 65, lines 1-7 and Fig. 2, where conduit 20 includes section 52 from which tube 18 extends from, this end of the conduit 20 is regarded as the second end in communication with the second tube 18).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Fortuna (US 2010/0242957) in view of Avitsian (US 2018/0104427), as applied to claim 7 above, in further view of Kim (US 2013/0047992).
Regarding claim 8, Fortuna in view of Avitsian disclose the tracheal device according to claim 7, as discussed above.
Modified Fortuna fails to disclose wherein said one or more elastically deformable bodies comprise a plurality of discoid elements arranged radially to said second tube material vacancy areas being interposed between said discoid elements, said casing being formed by an outer surface of each of said discoid elements, said inner portion being formed by a thickness of said discoid elements.
However, Kim teaches an elastically deformable body (40) that comprise a plurality of discoid elements (90) arranged radially to said tube (30) (paragraph 30, lines 1-5; Fig. 4), material vacancy areas (80) being interposed between said discoid elements (90) (paragraph 33, lines 1-7; Fig. 4), said casing (casing of cuff 40) being formed by an outer surface of each of said discoid elements (90), said inner portion being formed by a thickness of said discoid elements (90) (paragraph 35, lines 1-8; Fig. 4; the casing of cuff 40 houses an interior portion, and the shape of the casing and the interior portion is defined by the shape of the discoid elements 90). Kim further teaches that the discoid elements (90) allows for smooth contraction and expansion of the deformable body (40) (paragraph 33, lines 1-4).
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 modified the deformable body of modified Fortuna to further include discoid elements and material vacancies, as taught by Kim, in order to allow smoother contraction and expansion of the deformable body.
Regarding claim 8, Fortuna in view of Avitsian disclose the tracheal device according to claim 7, as discussed above.
Modified Fortuna fails to disclose the tracheal device further comprising an inflatable blister interposed between said second tube and said one or more elastically deformable bodies.
However, Kim teaches an elastically deformable body (80 of cuff 40) comprising an inflatable blister (90) interposed between said tube (30) and said one or more elastically deformable bodies (80) arranged radially to said tube (30) (paragraph 30, lines 1-5; Fig. 4; paragraph 33, lines 1-7; paragraph 35, lines 1-8). Kim further teaches that the blister elements (90) allows for smooth contraction and expansion of the deformable body (40) (paragraph 33, lines 1-4).
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 modified the deformable body of modified Fortuna to further include blister elements, as taught by Kim, in order to allow smoother contraction and expansion of the deformable body.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kreck (US 2013/0030411) is cited for its depiction of an esophageal tube and cuff deployed at the same time as an endotracheal tube in Figure 1A.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAIGE K. BUGG whose telephone number is (571)272-8053. The examiner can normally be reached Monday-Friday 9-5.
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/PAIGE KATHLEEN BUGG/Examiner, Art Unit 3785
