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 .
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.
Claim(s) 1-2, 4-8, 10-14 and 17-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pre-Grant Publication 2017/0065491 to Waitzman et al. (Waitzman hereinafter) in view of US Pre-Grant Publication 2015/0231287 to Lin et al. (Lin).
Regarding claim 1, Waitzman teaches a system for verification of nasogastric tube (NGT, element 10 in Waitzman) placement comprising a fiber optic light guide (50) having a proximal end (60) with a light source connection (64) and a distal end (62) having a radial light emitting tip (54), the light guide having a diameter and a length constructed and arranged for insertion into a lumen of the NGT without extending therefrom. Waitzmann does not teach a stop configured to engage a connector at a proximal end of the NGT. Lin teaches another optical device (100) which includes a stop (20) for limiting insertion of the light source (paragraph 95) by engagement with a connector (71). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to include a stopper configured to engage a connector in order to limit insertion of the light guide of Waitzmann.
Regarding claim 2, Waitzman teaches engaging a connector (64) with a stop (34) which is capable, e.g. by friction, of preventing the distal end of the light guide from exiting the distal end of the NGT.
Regarding claim 4, Waitzman teaches an LC connector (paragraph 53).
Regarding claim 5, Waitzman teaches 625-635 or less than 680 nm wavelength light (paragraph 61).
Regarding claim 6, Waitzman teaches wavelengths including 650 nm, as discussed above.
Regarding claim 7, Waitzman is silent to power levels such as 30W of light emission. However, Since Waitzman teaches the use of light through skin, this specifies a minimum power level over which 30W must fall. Accordingly, one of skill, in embodying the system of Waitzman, would have been motivated to use a 30W light source prior to the effective filing date in order to allow the light to be seen through the patient’s skin and thereby verify correct placement.
Regarding claims 8-9, Waitzman teaches that the stop (34, 52, 71) is located such that the distal end of the light guide (50) is positioned at an offset from the distal end of the NGT when the stop engages the connector (for instance, Waitzman teaches a 2mm diameter tube, see paragraph 46, any inner portion of which will be at least 1mm offset from at least some portion of the outer surface of the tube).
Regarding claim 10, Waitzman teaches that the NGT is adapted for infants (paragraph 45).
Regarding claim 11, Waitzman teaches a diameter of French gauge 6, instead of the claimed 6.5. However, it has been held that where the difference between the claimed invention and the prior art is merely a recitation of dimension, as is the case here, a prima facie case of obviousness is present if there is no evidence of the criticality of the dimension (MPEP 2144.04 IV. A). The examiner therefore concludes that claim 11 is obvious over Waitzman in view of Lin.
Regarding claims 12 and 18, Waitzman is silent to any packaging or shipping configuration of the tube. However, there are only two possibilities: the light guide of Waitzman may be packaged either installed in the tube or not installed in the tube. Given these finite choices, one of ordinary skill would have found it obvious to try both configurations. Accordingly, the invention of these claims would have been obvious to try at the time of the effective filing date.
Regarding claim 13, Waitzman teaches a method for verifying placement of a nasogastric tube (NGT) comprising the steps of:
positioning a light guide (50) with a light-emitting distal tip (54) adjacent to a distal end of the NGT (10);
placing a distal end (30) of the NGT at a location within the patient's anatomy via the nose (paragraph 5);
operating a light source (100) to illuminate the light-emitting tip;
visually locating light emitted from the tip through the patient's skin (paragraph 67); and
based upon the locating, verifying proper placement of the distal end of the NGT with respect to the patient's anatomy (paragraph 67).
Waitzmann does not teach a stop configured to engage a connector at a proximal end of the NGT. Lin teaches another optical device (100) which includes a stop (20) for limiting insertion of the light source (paragraph 95) by engagement with a connector (71). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to include a stopper configured to engage a connector in order to limit insertion of the light guide of Waitzmann.
Regarding claim 14, Waitzman teaches placing the distal end into a stomach (paragraph 14) of an infant (paragraph 45).
Regarding claim 11, Waitzman teaches a diameter of French gauge 6, instead of the claimed 6.5. However, it has been held that where the difference between the claimed invention and the prior art is merely a recitation of dimension, as is the case here, a prima facie case of obviousness is present if there is no evidence of the criticality of the dimension (MPEP 2144.04 IV. A). The examiner therefore concludes that claim 11 is obvious over Waitzman in view of Lin.
Regarding claims 12 and 18, Waitzman is silent to any packaging or shipping configuration of the tube. However, there are only two possibilities: the light guide of Waitzman may be packaged either installed in the tube or not installed in the tube. Given these finite choices, one of ordinary skill would have found it obvious to try both configurations. Accordingly, the invention of these claims would have been obvious to try at the time of the effective filing date.
Regarding claim 17, Waitzman teaches wavelengths including 650 nm, as discussed above.
Regarding claim 19, Waitzman teaches proximally removing the light guide and providing a food source to the proximal end (paragraph 68).
Regarding claim 20, Waitzman teaches a system for verification of nasogastric tube (NGT, element 10 in Waitzman) placement comprising a fiber optic light guide (50) having a proximal end (60) with a light source connection (64) and a distal end (62) having a radial light emitting tip (54), the light guide having a diameter and a length constructed and arranged for insertion into a lumen of the NGT. Waitzmann does not teach a stop configured to engage a connector at a proximal end of the NGT. Lin teaches another optical device (100) which includes a stop (20) for limiting insertion of the light source (paragraph 95) by engagement with a connector (71). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to include a stopper configured to engage a connector in order to limit insertion of the light guide of Waitzmann.
Regarding claim 21, Lin teaches the connector (71) to abut the stop (20).
Regarding claim 22, Lin teaches that the stop positions the distal end (12) within the lumen at an offset from the end of the tube (see e.g. Fig. 1).
Regarding claim 23, the previously combined references are silent to the offset length. However, it has been held that where the difference between the claimed invention and the prior art is merely a recitation of dimension, as is the case here, a prima facie case of obviousness is present if there is no evidence of the criticality of the dimension (MPEP 2144.04 IV. A). The examiner therefore concludes that claim 11 is obvious over Waitzman in view of Lin.
Regarding claim 24, Waitzmann teaches a radially emitting tip (at 30).
Response to Arguments
Applicant’s arguments, see page 7, filed 16 April 2026, with respect to the rejection(s) of claim(s) under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Waitzmann in view of Lin as discussed above.
With respect to applicant’s allegation that various features have been critical and non-obvious as a design choice, the examiner is not persuaded. In particular, the examiner has relied on case law as cited above to establish that these features are obvious, rather than holding that such features are obvious design choices. Accordingly, the examiner is not persuaded that these holdings are in error. Further, in the case of preloading, the examiner notes that the MPEP specifically sets forth the obvious to try rationale as exemplary of obviousness. Applicant’s arguments are insufficient to weigh significantly against these holdings.
Conclusion
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 PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 22 June 2026
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