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 .
Response to Arguments
The previous objection to the drawings is withdrawn in light of the amended drawings (filed 03/09/2026).
The previous rejections to the claims under 35 U.S.C. § 112 are withdrawn in light of the amended claims (filed 03/09/2026).
The previous rejection to claims 1-7, 9-13, and 15-19 under 35 U.S.C. § 102 are withdrawn in light of the amended claims (filed 03/09/2026). However, the claims now stand rejected under 35 U.S.C. 103 in view of the previously cited art “Fuller” modified by US 2014/0154656 (“Segall”), as necessitated by amendments.
With regards to independent claims 1 and 11, Applicant first argues that Fuller does not teach or suggest “a medical training adjunct that is configured to combine its own features with features of the training platform it attaches to in order to collectively form a training cavity to be used in association with the adjunct” (Remarks, filed 03/09/2026, p. 18). Examiner respectfully disagrees. Fuller teaches a training platform/base with an orifice, in which a training adjunct with a set of passages are at least partially inserted into and attached to the training platform—the combination of the adjunct passages and at least part of the platform orifice forming the training cavity (Fuller, figs. 1-5, 12-16).
Applicant continues to argue that Fuller discloses does not teach or suggest “utilizing its ‘platform’ as anything other than a base to secure its ‘adjunct’ in which the… training actually takes place” (Remarks, filed 03/09/2026, p. 19). To this, Examiner reiterates that Fuller teaches a training cavity, which is formed by the attachment of the adjunct having passages to the platform having an orifice. Furthermore, since the structure of Fuller positively recites such a training cavity, it is viewed as being “configured to receive the insertion of at least a portion of… one of a nasopharyngeal airway device and an intubation device through said first and second passages and into said inner chamber,” as recited by amended claim 1. When the cited prior art teaches all of the positively recited structure of the claimed apparatus, it will be held that the prior art apparatus is capable of performing all of the claimed functional limitations of the claimed apparatus. The courts have held that: (1) "apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990), and (2) a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP § 2114.
See rejections of the claims under 35 U.S.C. § 103, as presented in detail below.
Claim Objections
Claims 1, 2, 9, 11, and 13 are objected to because of the following informalities:
In claims 1, 2, and 11, the phrase “a portion of a one of a…” should instead read “a portion of one of a…”
In claim 1, the phrase “proximate said orifice” should instead read “proximate to said orifice”
In claim 1, “in said base.” should instead read “in said base;”
In claim 9, “said medical training platform body that is… tubular” should instead read “said medical training platform body is… tubular,” or similar
In claim 11, the phrase “said orifice,” should be removed from “a first orifice, said orifice, said inner chamber having a second orifice separate from said first orifice”
In claim 11, “there through” should instead read “therethrough”
In claim 13, “comprises one of” should be removed from “said fastener comprises one of comprises one of a grip,…”
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 9-10 and 15-16 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.
The term “generally tubular” in claims 9 and 15 is a relative term which renders the claim indefinite. The term “generally tubular” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For example, it is unclear how “similar” a platform would have to be in shape to a tube to be considered “generally tubular.”
Claims 10 and 16 are rejected for depending upon claims 9 and 15.
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 1-7, 10-13, and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Fuller in view of US 2014/0154656 (hereinafter “Segall”).
Regarding Claim 1, Fuller discloses a medical training platform, said medical platform having a body with an inner chamber, said inner chamber having a first orifice (figs. 1A-1B: medical training platform 1 with inner chamber 2 and outward-facing orifice leading to inner chamber 2; col. 6, lines 20-23: “midface cavity 2 of the modified skull 1”),
a nasopharyngeal airway insertion training adjunct (figs. 15A-16A: training adjunct comprising base 5 and simulated human nasal anterior attached to front of base 5) comprising:
a base, said base releasably attaching to said medical training platform proximate said first orifice (figs. 3-5: base 5; col. 6, lns. 12-23: “The holes 11 of the midface boney structure 5 are configured to receive fasteners (for example, fasteners 36 shown in FIG. 12) which are useable to securably attach the midface boney structure 5 to the modified skull 1;” Examiner further notes the fasteners disclosed are screws, which would allow a user to releasably attach the base 5 to the medical training device 1), said base having a first passage therethrough, said first passage communicating at least in part with said first orifice when said base is attached to said platform medical training device (figs. 1-4: orifice 2 of platform connected to and in communication with interior end of nasal orifice 15 when base 5 is attached to platform 1); and
a simulated human nasal anterior aspect having a front face corresponding to one of a right nostril and a left nostril (figs. 15A, 17: simulated nasal anterior aspect attached to base 5; figs. 15A-15B: first nasal orifice corresponding to right nostril under cartilage 38), said simulated human nasal anterior aspect being attached to said base and having a second passage, said second passage extending from said front face through said simulated nasal anterior aspect, said second passage communicating at least in part with said first passage in said base (figs. 3B, 12-16A: second passage extends from exterior end of nasal orifice—under cartilage 38 and 40—through the simulated nose to interior end of nasal orifice 15 and is in communication with first passage which begins where the second passage ends);
wherein said first and second passages and said platform inner chamber collectively form a first training cavity (figs. 1-4: internal space/cavity formed by attaching the adjunct 5 comprising first and second passages with the platform 1 comprising inner chamber 2), said first training cavity being configured to receive the insertion of at least a portion of a one of a nasopharyngeal airway device and an intubation device through said first and second passages and into said inner chamber (figs. 15A-15B, 16-16B: first nasal orifice extends through nasal anterior aspect and the access orifice of base 5; figs. 1A-1B, 3A, 15A-15B, 16A-16B: the orifices of the medical training device 1 and base 5 are at least as large or larger than the first nasal orifice, which can fit such a tube; therefore, Examiner notes the tube must necessarily also fit through the aligned orifices when the adjunct is attached to the device; Examiner further notes such an NPA or intubation device would enter through the exterior end of the nostril of the adjunct, travel through the simulated nose, and then exit through toward the formed cavity)
Fuller does not explicitly disclose said inner chamber having a second orifice. However, Segall discloses said inner chamber having a second orifice separate from said first orifice (figs. 5-6, 9, 11-12; par. 0059: “The nasal airway 178 is inserted through the nostril into the nasal cavity 114, proceeding into the nasal pharynx, and into the trachea module 152, as it would in reality, providing a realistic simulation of airway management;” Examiner notes the nasal cavity 114 is the inner chamber, with a first orifice connecting it to the nostril and a second orifice leading into the nasal pharynx).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the second orifice of Segall with the training system of Fuller in order to provide a more realistic simulation of airway management (Segall, par. 0059).
Regarding Claim 11, Fuller discloses a medical training platform, said platform having a body with an inner chamber, said inner chamber having a first orifice (figs. 1A-1B: medical training platform 1 with inner chamber 2 and outward-facing orifice leading to inner chamber 2; col. 6, lines 20-23: “midface cavity 2 of the modified skull 1”);
a simulated human nasal adjunct (figs. 15A-16A: training adjunct comprising base 5 and simulated human nasal anterior attached to front of base 5), said adjunct having a base with a simulated nasal anterior aspect attached thereto, said base releasably attaching to said medical training platform proximate to said first orifice (figs. 3-5: base 5; col. 6, lns. 12-23: “The holes 11 of the midface boney structure 5 are configured to receive fasteners (for example, fasteners 36 shown in FIG. 12) which are useable to securably attach the midface boney structure 5 to the modified skull 1;” Examiner further notes the fasteners disclosed are screws, which would allow a user to releasably attach the base 5 to the medical training device 1), said base having a first passage therethrough, said first passage communicating at least in part with said first orifice when said base is attached to said platform (figs. 1-4: orifice 2 of platform connected to and in communication with interior end of nasal orifice 15 when base 5 is attached to platform 1), said anterior aspect having a front face corresponding to one of a right nostril and a left nostril (figs. 15A, 17: simulated nasal anterior aspect attached to base 5; figs. 15A-15B: first nasal orifice corresponding to right nostril under cartilage 38), said nasal anterior aspect having a second passage therethrough, said second passage extending from said front face through said nasal anterior aspect and communicating at least in part with said first passage (figs. 3B, 12-16A: second passage extends from exterior end of nasal orifice—under cartilage 38 and 40—through the simulated nose to interior end of nasal orifice 15 and is in communication with first passage which begins where the second passage ends), said nasal orifice shaped and sized to enable the insertion of a Nasopharyngeal Airway tube therethrough (col. 9, lines 3-29: “The nose model simulator 100 is an anatomically correct replication of important nasal structures that allow surgical trainees to better understand the nasal anatomy and on which to learn to perform key surgical procedures. The nose model simulator 100 shown in FIG. 17 is provided for use in training a person to perform a medical procedure on the nose or within the nasal cavity. The nose model simulator 100 is adapted to simulate a human nose, thereby enabling a trainee (e.g., a medical doctor, resident, medical student, or other medical practitioner or personnel) to be provided with a realistic exposure;” Examiner notes that because the nasal orifice and surrounding nasal anterior aspect is an anatomically correct replication of a human nose that is to be used in a variety of surgical training applications, any Nasopharyngeal Airway tube which could fit into a typical human’s nasal orifice must necessarily fit into an anatomically correct replication of one); and
a fastener, said fastener releasably attaching said adjunct to said platform (fig. 15B: fastener 36; col. 6, lines 12-34: “The holes 11 of the midface boney structure 5 are configured to receive fasteners (for example, fasteners 36 shown in FIG. 12) which are useable to securably attach the midface boney structure 5 to the modified skull 1;” Examiner further notes the disclosed fasteners are screws, which would allow a user to releasably attach the base 5 to the medical training device 1);
wherein said first and second passages and said platform inner chamber collectively form a first training cavity (figs. 1-4: internal space/cavity formed by attaching the adjunct 5 comprising first and second passages with the platform 1 comprising inner chamber 2), said first training cavity being configured to receive the insertion of at least a portion of a one of a nasopharyngeal airway device and an intubation device through said first and second passages and into said inner chamber (figs. 15A-15B, 16-16B: first nasal orifice extends through nasal anterior aspect and the access orifice of base 5; figs. 1A-1B, 3A, 15A-15B, 16A-16B: the orifices of the medical training device 1 and base 5 are at least as large or larger than the first nasal orifice, which can fit such a tube; therefore, Examiner notes the tube must necessarily also fit through the aligned orifices when the adjunct is attached to the device; Examiner further notes such an NPA or intubation device would enter through the exterior end of the nostril of the adjunct, travel through the simulated nose, and then exit through toward the formed cavity).
Fuller does not explicitly disclose said inner chamber having a second orifice. However, Segall discloses said inner chamber having a second orifice separate from said first orifice (figs. 5-6, 9, 11-12; par. 0059: “The nasal airway 178 is inserted through the nostril into the nasal cavity 114, proceeding into the nasal pharynx, and into the trachea module 152, as it would in reality, providing a realistic simulation of airway management;” Examiner notes the nasal cavity 114 is the inner chamber, with a first orifice connecting it to the nostril and a second orifice leading into the nasal pharynx).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the second orifice of Segall with the training system of Fuller in order to provide a more realistic simulation of airway management (Segall, par. 0059).
Regarding Claims 2 and 19, Fuller modified by Segall further discloses said first and second passages and said platform inner chamber and second orifice collectively form a second training cavity, said second training cavity being configured to receive the insertion of at least a portion of a one of a nasopharyngeal airway device and an intubation device through said first and second passages, into said body inner chamber and through said second orifice (figs. 5-6, 9, 11-12; par. 0059: “The nasal airway 178 is inserted through the nostril into the nasal cavity 114, proceeding into the nasal pharynx, and into the trachea module 152, as it would in reality, providing a realistic simulation of airway management;” Examiner notes the nasal pharynx and trachea module 152 is the second chamber, and the NPA device 178 is able to arrive there by traversing through the first and second passages and the inner chamber).
Regarding Claims 3 and 12, Fuller further discloses said nasal anterior aspect further has a second nasal orifice, said second nasal orifice corresponding to the other of said right nostril and left nostril (figs. 15A 15B: second nasal orifice under cartilage 40, corresponding to left nostril).
Regarding Claim 4, Fuller further discloses said base further has an alignment structure, said alignment structure aligning said base with said medical training platform when said adjunct is attached to said platform (figs. 1A-1B, 3A-4: alignment structure 9 fits into center of the orifice 2 of medical training device 1 when the training adjunct is attached to platform 1, thereby aligning the base with the platform).
Regarding Claim 5, Fuller further discloses said alignment structure protrudes at least in part (figs. 3C-4: alignment structure 9 protrudes outwardly toward and into cavity 2 of platform 1).
Regarding Claim 6, Fuller further discloses a fastener, said fastener releasably attaching said base to said medical training platform (fig. 15B: fastener 36; col. 6, lines 12-23: “The holes 11 of the midface boney structure 5 are configured to receive fasteners (for example, fasteners 36 shown in FIG. 12) which are useable to securably attach the midface boney structure 5 to the modified skull 1;” Examiner further notes the disclosed fasteners are screws, which would allow a user to releasably attach the base 5 to the medical training device 1).
Regarding Claims 7 and 13, Fuller further discloses said fastener comprises one of a grip, a clip, a clamp, a ratchet, a belt, a latch, a screw, a bolt, an elastic band, a hook, and a pin (fig. 15B: screws 36; col. 8, lines 59-67: “The midface boney model 5 is configured to be attachable to the modified skull 1 using any means, for example using fasteners (e.g., screws), as shown in FIG. 12”).
Regarding Claims 10 and 16, Fuller further discloses said first orifice comprises a needle insertion training orifice (col. 9, lines 3-29: “The nose model simulator 100 is an anatomically correct replication of important nasal structures that allow surgical trainees to better understand the nasal anatomy and on which to learn to perform key surgical procedures. The nose model simulator 100 shown in FIG. 17 is provided for use in training a person to perform a medical procedure on the nose or within the nasal cavity;” figs. 1A-1B, 4, 15-16: orifice 2 capable of receiving a needle).
Regarding Claim 17, Fuller further discloses said base further has a first alignment structure protruding from said base, said first alignment structure being shaped and sized to extend into said platform orifice when said adjunct is attached to said platform (figs. 1A-1B, 3A-3C, 4: protruding alignment structure 9 fits into center of the orifice of medical training device 1).
Regarding Claim 18, Fuller further discloses said base further has a second alignment structure protruding from said base, said second alignment structure being shaped and sized to extend into said platform orifice, said first and second alignment structures being oriented to secure the proper position and orientation of said base on said platform (figs. 1A-1B, 3B, 4, 12-13, 15A: protruding alignment structure 8 fits along edges of the orifice of medical training device 1, and the base 5 can only be attached to medical training device 1 in the position and orientation shown—protruding structures 9 and 8 further helping to ensure the placement is proper).
Claims 8 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Fuller in view Segall as applied to claims 1 and 11 above, and further in view of Thompson.
Regarding Claim 8, modified Fuller does not disclose a flange. However, Fuller further modified by Thompson discloses said base comprises an elastic flange (Thompson, figs. 2A-2C; par. 0052: “The retention flange 104 also comprises right and left tab portions 106 which extend substantially perpendicular from the central portion 108. The tab portions 106 and the central portion 108 of the retention flange 104 facilitate proper placement of the nasal tube device 100 and prohibit unwanted advancement of the device”), said elastic flange being positioned and oriented to apply pressure to said medical training platform when said base is attached to said medical training platform (Thompson, par. 0057: “the portions of the retention flange 104 adjacent the securing device 110 (e.g., the central portion 108) and/or the portions of the nasal tube 102 adjacent the securing device (e.g., the flange 140) may comprise one or more retaining features, such as, for example, a lip, edge, groove, channel, or the like, configured to attach the securing device to the nasal tube. In one embodiment, the central portion 108 and the flange 140 comprise a circular undercut portion that at least partially surrounds the recessed portion 142 of the nasal tube 102 and forms a lip or flange that retains the securing device 110”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the fastener of Fuller with the fastener (flange) of Thompson because Fuller discloses the need for a fastener to attach the base to the medical training device and merely suggests screws as an example of such a fastener; flanges such as the one disclosed by Thompson are well known methods of attachment in the art and are merely provide an alternative fastening method to screws (Thompson, pars. 0052-0057). Furthermore, attaching and detaching the base via extending flanges which use pressure to secure the attachment is easily understood and known to be quicker for the user rather than manually screwing or unscrewing the base to/from the medical device.
Regarding Claim 14, modified Fuller does not disclose a flange. However, Fuller further modified by Thompson discloses said fastener extends from said base and comprises an elastic flange (Thompson, figs. 2A-2C; par. 0052: “The retention flange 104 also comprises right and left tab portions 106 which extend substantially perpendicular from the central portion 108. The tab portions 106 and the central portion 108 of the retention flange 104 facilitate proper placement of the nasal tube device 100 and prohibit unwanted advancement of the device”), said elastic flange being positioned and oriented to apply pressure to said platform when said base is attached to said platform (Thompson, par. 0057: “the portions of the retention flange 104 adjacent the securing device 110 (e.g., the central portion 108) and/or the portions of the nasal tube 102 adjacent the securing device (e.g., the flange 140) may comprise one or more retaining features, such as, for example, a lip, edge, groove, channel, or the like, configured to attach the securing device to the nasal tube. In one embodiment, the central portion 108 and the flange 140 comprise a circular undercut portion that at least partially surrounds the recessed portion 142 of the nasal tube 102 and forms a lip or flange that retains the securing device 110”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the fastener of Fuller with the fastener (flange) of Thompson because Fuller discloses the need for a fastener to attach the base to the medical training device and merely suggests screws as an example of such a fastener; flanges such as the one disclosed by Thompson are well known methods of attachment in the art and are merely provide an alternative fastening method to screws (Thompson, pars. 0052-0057). Furthermore, attaching and detaching the base via extending flanges which use pressure to secure the attachment is easily understood and known to be quicker for the user rather than manually screwing or unscrewing the base to/from the medical device.
Claims 9 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Fuller in view Segall as applied to claims 1 and 11 above, and further in view of US 2017/0213481 (hereinafter “Mourton”).
Regarding Claims 9 and 15, modified Fuller does not disclose a tubular platform body. However, Mourton discloses said medical training platform body is generally tubular and has a sidewall and a first end (fig. 10: tubular training platform body with sidewall and first end 206), said sidewall defining a first opening and a second opening, said first opening being positioned on said sidewall and comprising at least in part a medical training region (fig. 10: first opening 260), said second opening being positioned proximate said first end (fig. 10: second opening at 206, 210), said adjunct further comprising a cap, said cap releasably attaching to said body and covering at least in part said second opening when so attached (fig. 10: cap 212; par. 0053: “the open ends 206 and/or 208 can be configured to removably mate with the closure device 212”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the tubular platform body (with multiple openings/orifices which can receive needles/tubes) with the platform body of Fuller modified by Segall (also comprising multiple openings/orifices which can receive needles/tubes) as a simple design choice and/or in order to confine the platform body to a simpler shape which is easier to scale up/down as needed or to transport (Mourton, pars. 0048-0049, 0058; figs. 10-11).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 3,376,659 (Samson) teaches a medical training/demonstration device which comprises an anterior nasal aspect attached to a base, further comprising first and second passages and first and second training cavities.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE DOSHER whose telephone number is (571) 272-4842. The examiner can normally be reached Monday - Friday, 10 a.m. - 6 p.m. ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dmitry Suhol can be reached at (571) 272-4430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.G.D./Examiner, Art Unit 3715
/DMITRY SUHOL/Supervisory Patent Examiner, Art Unit 3715
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