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 § 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.
Claim(s) 1-6, 8-10, 13-17 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pre-Grant Publication 2017/0065491 to Waitzman et al. (Waitzman hereinafter).
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 light emitting tip (54), the light guide having a diameter and a length constructed and arranged for insertion into a lumen of the NGT; and a stop (34, 52, 71) that prevents the distal end of the light guide from exiting a distal end of the NGT.
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 3, Waitzman teaches a radial emitter (e.g. at 32).
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 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 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).
Regarding claim 14, Waitzman teaches placing the distal end into a stomach (paragraph 14) of an infant (paragraph 45).
Regarding claim 15, 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 16, Waitzman teaches a radial emitter (e.g. at 32).
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).
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) 7, 11, 12, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Waitzman.
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 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.
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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US Pre-Grant Publication 2018/0000320 teaches another optically guided feeding tube with a different tip assembly (see e.g. Figs. 2A, 2B).
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 8 January 2026