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 .
Election/Restrictions
Applicant’s election of Group IA, Clm. 1-7, 9, 11-13, 15-20, 31, and 77 in the reply filed on 25 May 2026 is acknowledged.
Claim Objections
Claim(s) 1-6 and 15-20 is/are objected to under 37 CFR 1.75 as being a substantial duplicate of each other. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Regarding Claims 1 and 15, Examiner notes that the body of Claim 15 is identical to that of Claim 1 whereby the two claims only differ based on the preamble with Claim 1 reciting “a gastrostomy tube device for implantation within an abdomen of a patient…” and claim 15 reciting “a kit for implanting a gastrostomy tube within an abdomen of a patient”. However, to the extent that the preamble in this instance is not found to be limiting these two claims are found to be substantially duplicate to one another.
Claim 16 corresponds to Claim 2.
Claim 17 corresponds to Claim 3.
Claim 18 corresponds to Claim 4.
Claim 19 corresponds to Claim 5.
Claim 20 corresponds to Claim 6.
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.
Claim(s) 15-20 is/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.
Regarding Claim 15, alternatively, should Applicant argue that the “kit” of Claim 15 is intended to be limiting to differentiate it from Claim 1, these claims are alternatively rejected under 35 USC 112(b) as being indefinite inasmuch as the “kit” does not particularly collect any additional components or articles beyond the gastrostomy tube device recited in the body of the claims. As such, it would not be clear to the ordinary artisan what additional articles, if any, would need to be collected together with the gastrostomy tube device for infringement to occur. Specifically, it is unclear if the “kit” when paired with the function of implanting the gastrostomy tube would require this “kit” to be a complete kit with each and every component necessary to reduce this claimed concept to actual practice, e.g. a guidewire, needle, endoscope, topical disinfectant, scalpel, syringe with inflation media, packaging…etc.
In other words, either Claim 15 is identical in scope to Claim 1 (and should be canceled) or is of an indefinite and indeterminate scope and therefore should be properly rejected under 35 USC 112(b).
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(s) 1-6, 9, 13, 15-20, 31, and 77 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2003/0139703 (“Burkett”) in view of U.S. Publication No. 2003/0216712 (“Kessler”).
Regarding Claims 1 and 15, Burkett disclose a gastrostomy tube device/kit (Fig. 9) for implantation within an abdomen of a patient, comprising:
an elongate tubular member (10) comprising a first end (19) sized for introduction into the patient's mouth, a second end (39) including an expandable member (44), and a feeding lumen (14) extending between the first and second ends;
a bolster (46, 48) connectable around the first end after the first end has been directed from within the patient's stomach through intervening tissue and extends from the patient's skin (see Fig. 9); and
an adapter (12) connectable to the assembly, the adapter comprising a connector (22) for removably connecting to a feeding tube.
Burkett discloses the invention substantially as claimed except that the adapter is configured to be connected to the “bolster after the first end and excess material of the tubular member beyond the bolster has been separated”. Burkett does suggest that the elongate tubular member, in some embodiments, may be trimmed/cut (Par. 27, 50) to remove a desired excess and to allow for receipt of the adapter, but there is no suggestion that the adapter should be connectable to the bolster, per se, and Burkett only explicitly suggests maintaining the two elements remote from one another separated by a length of tubing (see Fig. 9). However, Kessler discloses a similar PEG tube (2) which is configured with a bolster and adapter arrangement that is designed to provide a “small overall height” (Abstract) and reduce the profile of the device above the abdominal wall while providing a “very reliable connection” (Par. 12, 18, and 23). To permit such an arrangement Kessler discloses that the tubular member can be provided with a bolster (8) connectable around the first end of the tubing and an adapter (1) which can be connected to the bolster after the first end and excess material of the tubular member beyond the bolster have been separated (see Fig. 1 or 4). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the adapter (12) of Burkett to be connectable to the bolster (48, 46) after the excess material of the tubing (10) has been removed, as disclosed by Kessler, in order to reduce the height/profile of the device and provide a reliable connection.
Regarding Claims 2 and 16, Burkett discloses the tubular member has a length between the first and second ends such that the first end extends from the patient's skin when the first end is directed from within the patient's stomach through intervening tissue and the expandable member is positioned against an anterior wall of the stomach (see Fig. 9).
Regarding Claims 3 and 17, Burkett discloses the expandable member comprises an annular balloon on the second end (Par. 37).
Regarding Claims 4 and 18, Burkett discloses the tubular member further comprises an inflation lumen (18) extending from the first end and communicating with an interior of the balloon (Par. 34).
Regarding Claims 5 and 19, Burkett discloses a valve (32) communicating with the inflation lumen to prevent inflation media from escaping from the interior of the balloon after the balloon is inflated. (Par. 34, 47, 48).
Regarding Claims 6 and 20, Burkett discloses the valve allows inflation when positive pressure is applied (Par. 47) and deflation when vacuum pressure is applied above a predetermined threshold (Par. 48).
Regarding Claim 9, Burkett, as modified by Kessler, discloses the bolster and the adapter comprise cooperating connectors for securing the adapter to the bolster (see Kessler, generally at 11 and 10 and Burkett at 20, 17) whereby the ordinary artisan would have found it obvious to utilize suitable cooperative connectors between the adapter and bolster to be affixed together.
Regarding Claim 13, Burkett and Kessler both disclose the bolster to comprise a base plate (see 5, Kessler; 46, Burkett) configured for placement against the patient’s skin and a nipple (see 7, Kessler; 47, Burkett) extending from the base plate, the further comprising a clamp (9, Kessler; 48, Burkett) configured for positioning around the nipple to compress the nipple inwardly around the tubular member.
Regarding Claim 31, Burkett disclose a gastrostomy tube device/kit/system (Fig. 9) for implantation within an abdomen of a patient, comprising:
an elongate tubular member (10) comprising a first end (19) sized for introduction into the patient's mouth, a second end (39) including an expandable member (44), and a feeding lumen (14) extending between the first and second ends, and an inflation lumen (18) extending from the first end and communicating with an interior of the expandable member and a source of inflation media (58) connectable to the inflation lumen for introducing inflation media into the interior to expand the expandable member;
a bolster (46, 48) connectable around the first end after the first end has been directed from within the patient's stomach through intervening tissue and extends from the patient's skin (see Fig. 9); and
an adapter (12) connectable to the assembly, the adapter comprising a connector (22) for removably connecting to a feeding tube.
Burkett discloses the invention substantially as claimed except that the adapter is configured to be connected to the “bolster after the first end and excess material of the tubular member beyond the bolster has been separated”. Burkett does suggest that the elongate tubular member, in some embodiments, may be trimmed/cut (Par. 27, 50) to remove a desired excess and to allow for receipt of the adapter, but there is no suggestion that the adapter should be connectable to the bolster, per se, and Burkett only explicitly suggests maintaining the two elements remote from one another separated by a length of tubing (see Fig. 9). However, Kessler discloses a similar PEG tube (2) which is configured with a bolster and adapter arrangement that is designed to provide a “small overall height” (Abstract) and reduce the profile of the device above the abdominal wall while providing a “very reliable connection” (Par. 12, 18, and 23). To permit such an arrangement Kessler discloses that the tubular member can be provided with a bolster (8) connectable around the first end of the tubing and an adapter (1) which can be connected to the bolster after the first end and excess material of the tubular member beyond the bolster have been separated (see Fig. 1 or 4). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the adapter (12) of Burkett to be connectable to the bolster (48, 46) after the excess material of the tubing (10) has been removed, as disclosed by Kessler, in order to reduce the height/profile of the device and provide a reliable connection.
Regarding Claim 77, Burkett discloses a valve (32) communicating with the inflation lumen to prevent inflation media from escaping from the interior of the balloon after the balloon is inflated. (Par. 34, 47, 48).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2003/0139703 (“Burkett”) in view of U.S. Publication No. 2003/0216712 (“Kessler”) as applied above, and further in view of U.S. Patent No. 8,177,742 (“Bagwell”).
Regarding Claim 7, Burkett, as modified, discloses the invention substantially as claimed except that that the balloon further comprises “a weakened region in one of the balloon and the inflation lumen configured to fail or open permanently when positive or vacuum pressure above a predetermined threshold is applied to allow the balloon to be collapsed for removing the device from the subject's abdomen.” However, Bagwell discloses a related enteral feeding tube device which is provided with a weakened region in the balloon which is configured to fail when positive pressure above a predetermined threshold is applied to allow the balloon to be rapidly collapsed for removing the device from the subject’s abdomen (Col. 12; Col. 21-22). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the balloon of the invention of modified Burkett to have a weakened area/region which permits bursting/rupturing of the balloon upon the application of a sufficient force or inflation level, as disclosed by Bagwell, in order to allow the balloon to predictably fail for removal either intentionally (due to overinflation) or when accidentally pulled with sufficient force in order to prevent damage to the abdominal wall.
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2003/0139703 (“Burkett”) in view of U.S. Publication No. 2003/0216712 (“Kessler”) as applied above, and further in view of U.S. Publication No. 2012/0029483 (“Griffith”).
Regarding Claims 11-12, Burkett and Kessler both disclose the bolster to comprise a base plate (see 5, Kessler; 46, Burkett) configured for placement against the patient’s skin and a nipple (see 7, Kessler; 47, Burkett) extending from the base plate. Burkett and Kessler discloses the invention substantially as claimed except that the cooperating connectors comprise one or more of snap connectors provided as a plurality of arms extending from a housing of the adapter and one or more elements on the nipple. However, Griffith discloses a related enteral feeding tube comprising a bolster having a nipple (24) extending upwardly from a base (22) with an adapter (10) being provided with a housing having a plurality of snap connectors (inter alia 14, 38) extending therefrom comprising a plurality of arms (38) having elements (60) configured to form a snap-fit connection with the nipple and affix the adapter to the bolster (see Fig. 4B). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the connection of modified Burkett to comprise a snap connector arrangement comprising a plurality of arms having a fitting member configured to cooperate with a rim about the circumference of the nipple, as disclosed by Griffith, in order to provide a strong, secure connection by which the adapter of modified Burkett can be releasably locked in place with respect to a cooperatively shaped retaining bolster to allow for a strong, stable low profile connection to be made.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 07/21/2026
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