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 .
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
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on the same grounds of rejection applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding the arguments over the embodiment of Figure 1 of Cohen (US 20110313359), that it does not disclose the new limitation “the one or more spokes are rotatable into the expanded position when the inner tube is inserted through the distal opening of the outer tube, and applies a downward force to the actuatable portion”, the examiner respectfully disagrees as spokes 20, rotate to the expanded position shown in figure 1b, when the inner tube 11, is pressed downward, as it applies a downward force to the actuatable portion, since it is part of the inner tube.
Applicant’s arguments, see Remarks filed 6/30/26, with respect to the rejection(s) of claim(s) 1, 4-5 under 35 USC 102a1 anticipated by the embodiment of Figure 3 of Cohen (US 20110313359), 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 Therefore, the rejection has been withdrawn.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 over Prechtel et al. (US 2011/0009828).
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) 1-8, 10-12 and 15-19 is/are rejected under 35 U.S.C. 102 (A)(1) as being anticipated by Cohen (US 20110313359).
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Regarding claim 1, Cohen teaches a gastrostomy tube (Fig. 1a-b) for insertion through an abdomen and into a stomach, comprising:
a cylindrical outer tube (13/24) including a first proximal opening and a first distal opening;
a flange (71/17) surrounding the first proximal opening of the outer tube;
a detachable cylindrical inner tube (11) including a second proximal opening and a second distal opening;
and one or more spokes (20) attached to a distal end of the gastrostomy tube, wherein the one or more spokes include an actuatable portion (joint portion of spokes 62, refer to paragraph 50 “Once the proximal ends 62 of the retention members 20 are moved from contact with the second end 39 of the concentric outer sleeve 13, their inherent outward bias causes them to move outwardly”) configured to rotate the one or more spokes between a retracted position and an expanded position (Figs. 1A-1B),
wherein the inner tube is insertable into the first proximal opening of the outer tube, wherein the one or more spokes are rotatable (when the inner tube is manipulated to be pushed down and locked) into the expanded position when the inner tube is inserted through the first distal opening of the outer tube and applies a downward force to the actuatable portion (when the inner tube 11, is pressed downward, it applies a downward force to the actuatable portion, since it is part of the inner tube),
and
wherein the one or more spokes are substantially perpendicular to the outer tube in the expanded position (refer to paragraph 46 and see figures 1a-1b)
Regarding claim 2, Cohen teaches the flange of the outer tube includes a locking mechanism (25/31) configured to secure the inner tube inside the outer tube.
Regarding claim 3, Cohen teaches the outer tube includes a locking mechanism (25/31) along a body of the outer tube configured to secure the inner tube inside the outer tube.
Regarding claim 4, Cohen teaches the one or more spokes are attached to the first distal opening of the outer tube (by means of the locking mechanism see Figure 1B).
Regarding claim 6, Cohen teaches the actuatable portion includes a flexible joint (joint portion of spokes 62, that bias outward bias”.
Regarding claim 7, Cohen teaches the flexible joint is configured for a continuous range of motion (from Fig 1a to 1b).
Regarding claim 8, Cohen teaches a position of the one or more spokes corresponds to a curvature of the flexible joint (see Fig. 1a-1b).
Regarding claim 10, Cohen teaches the one or more spokes are attached to the second distal opening of the inner tube (See Figure 1A).
Regarding claim 11, Cohen teaches the actuatable portion is a flexible region of the one or more spokes (biasing portion of 60, see paragraph 50).
Regarding claim 12, Cohen teaches a position of the one or more spokes corresponds to a curvature of the flexible region (Fig. 1a-1b)
Regarding claim 15, Cohen teaches a method for inserting a gastrostomy tube through an abdomen and into a stomach, the method comprising:
arranging one or more spokes (20) attached to a distal opening of the gastrostomy tube in a retracted position;
inserting an outer tube of the gastrostomy tube through the abdomen and into the stomach (Refer to paragraph 47-48); inserting an inner tube into the outer tube (Figs 1a-1b); engaging, through an application of downward force by the inner tube (when the inner tube 11, is pressed downward, it applies a downward force to the actuatable portion, since it is part of the inner tube), an actuatable portion of the one or more spokes to rotate the one or more spokes into an expanded position (See figs 1a-1b and paragraphs 46-48), the one or more spokes being substantially perpendicular to the outer tube in the expanded position; and locking the inner tube inside the outer tube (see paragraph 46).
Regarding claim 16, Cohen teaches the one or more spokes is attached to a distal opening of the outer tube (see Fig. 1b, by means of locking mechanism).
Regarding claim 17, Cohen teaches the one or more spokes is attached to a distal opening of the inner tube (see Fig. 1a).
Regarding claim 18, Cohen teaches the actuatable portion including a flexible joint (biasing portion of 62).
Regarding claim 19, Cohen teaches flexible joint being configured for a continuous range of motion (see Figures 1a-1b).
Claim(s) 1, 4-5 is/are rejected under 35 U.S.C. 102 (A)(1) as being anticipated by Prechtel et al. (US 2011/0009828) hereinafter Prechtel.
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Regarding claim 1, Prechtel teaches a gastrostomy tube (Fig. 17a-b) for insertion through an abdomen and into a stomach, comprising:
a cylindrical outer tube (312) including a first proximal opening and a first distal opening (opening of 312 closer to spokes 330);
a flange (24) surrounding the first proximal opening of the outer tube;
a detachable cylindrical inner tube (314) including a second proximal opening and a second distal opening;
and one or more spokes (330) attached to a distal end of the gastrostomy tube, wherein the one or more spokes include an actuatable portion (portion where 334 and 336 contact to open the spokes 330, see Figure 17b, Refer to paragraph [0053])
wherein the inner tube is insertable into the first proximal opening of the outer tube (See Figs 17a-17b) and applies a downward force to the actuatable portion see figure 17a-17b, paragraphs [0052-0053]), into the expanded position (refer to paragraph 53)
Regarding claim 4, Prechtel teaches a the one or more spokes are attached to the first distal opening of the outer tube (see Figure 17A-17B).
Regarding claim 5, Prechtel teaches a the first distal opening of the outer tube includes one or more cutouts (338, (See Figure 17A-17B).
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) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cohen in view of Ruffolo et al. (US 20200086107) hereinafter Ruffolo.
Regarding claim 20, Cohen (Figs. 1a-1B) fails to explicitly teach comprising inserting an extension tube into the inner tube. Ruffolo, teaches inserting an extension tube within a gastrotomy device to insert a feeding tube (101) to a proximal end of a grastrotomy device to a patient for gastrotomy intervention. It would have been obvious to one of ordinary skill in the art at the time the invention was made to insert a tube in the proximal end of the outer tube of Cohen, as taught by Ruffolo to provide treatment to a patient in a gastrotomy intervention.
Claim(s) 9 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cohen in view of Joyeux et al. (US 20170340315) hereinafter Joyeux.
Regarding claim 9, Cohen (Figs. 1a-1B) fails to explicitly teach the actuatable portion includes an axle. The actuatable portion of Cohen is a joint.
Joyeux teaches a gastrostomy tube (Fig. 1a-b) for insertion through an abdomen and into a stomach, comprising:
a cylindrical outer tube (1) a flange (1) surrounding the outer tube;
a detachable cylindrical inner tube (13) and one or more rotatable spokes (2.2) attached to a distal end of the gastrostomy tube, wherein the one or more spokes include an actuatable portion (2.11) configured to rotate the one or more spokes between a retracted position and an expanded position (Figs. 4-5a), the actuatable portion includes an axle (2.11).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to include an axle extending from the spokes of Cohen, as taught by Joyeux as an alternative to provide movement between the expanded and retracted positions of the device of Cohen.
Regarding claim 13, Cohen (Figs. 1a-1B) fails to explicitly teach claim 1, further comprising a membrane extending from the one or more spokes.
Joyeux teaches a membrane (5) extending from the one or more spokes (2 see figure 5a).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to include a membrane extending from the spokes of Cohen, as taught by Joyeux, to form a seal about the area where the spokes are deployed.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cohen in view of Prechtel et al. (US 20140243785) hereinafter Prechtel.
Regarding claim 13, Cohen (Figs. 1a-1B) fails to explicitly teach claim 1, further comprising a membrane extending from the one or more spokes.
Prechtel teaches a membrane (90) extending from the one or more spokes (30).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to include a membrane extending from the spokes of Cohen, as taught by Prechtel, to form a seal about the area where the spokes are deployed.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cohen in view of Simovations (WO 2021062106).
Regarding claim 14, Cohen (Figs. 1a-1B) fails to explicitly teach further comprising a biodegradable sheath configured to fit over the one or more spokes in the retracted position. Simovations teaches the use of a biodegradable sheath (187) over an expandable retainer (118). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use a biodegradable sheath over the expandable spokes of Cohen, as taught by Simovations to facilitate insertion of the retainer in the treatment area and reduce the trauma of insertion into and removal from a stomal site.
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 EDELMIRA BOSQUES whose telephone number is (571)270-5614. The examiner can normally be reached 9:00am-5:00pm M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Edelmira Bosques can be reached at 571-270-5614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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EDELMIRA BOSQUES
Supervisory Patent Examiner
Art Unit 3762
/EDELMIRA BOSQUES/Supervisory Patent Examiner, Art Unit 3772
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