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 .
Drawings
The drawings were received on 01/19/2026 and 01/08/2026. These drawings are acceptable and approved.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 3-4,6-8, 11, 12, 16, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schon et al (US 20030153898 A1) as evidenced by Jones (US 4, 248, 224) and Chiang (US 5899890 A).
Regarding claim 1, Schon discloses a gastrointestinal catheter [0047; figs 1-2e] for insertion into a treatment site in a patient, the site in need of medical treatment, the treatment site comprising at least one of a first treatment site and a second treatment site, the catheter comprising:
a treatment member 12, the treatment member comprising at least one of a first treatment member 14 and a second treatment member 16 and comprising a lumen, a proximal portion at 36, a distal portion 32,34, and a distal end region 49,50 within the distal portion;
wherein the first treatment member is sized and configured for insertion of its distal end into the first treatment site in an upper portion of a gastrointestinal tract, and wherein the second treatment member is sized and configured for placement of its distal end into the second treatment site within a bowel or a stomach of the patient (see [0049] and fig 6);
wherein the distal end region of the first treatment member comprises an anchoring configuration (when the treatment members are separated once junction point 46 dissolves or break), the treatment member being capable of assuming a linear constrained configuration (by using a sheath/sleeve upon insertion of the catheter as well known in the art and as evidence by Jones), wherein the anchoring configuration is adapted to anchor the distal end region within the first treatment site (see also figs 5 and 8 where ends 14,16 are in a V-configuration in Schon);
wherein the distal end region of the first treatment member comprises one or more fluid ports at 49,50 in communication with the lumen, wherein the fluid ports are configured to allow through flow of a fluid;
wherein the proximal portions of the first and second treatment members are detachably er slidably conjoinable side by side (via junction point 46), and wherein the distal portions of the first and second treatment members are separated from each other;
wherein the distal end region of the first treatment member comprises a sufficiently high elasticity that upon insertion into the first treatment site and release from the linear constrained configuration, the distal end region assumes the anchoring configuration ([0063, 0069-0072], figs 5, 8). Schon discloses in [0107-0110] the distal region can be made of an elastomer having a durometer from about 75A to about 85A. As evidenced by Chiang, (col 5, line 65 – col 6, line 26), shows that catheters are made of resins that have a distal body segment with a hardness in a range of 20A-100A with a flexural modulus from 50 psi to 15,000 psi showing that Schon’s materials have high elasticity as applicants. The hardness overlaps between Schon and Chiang, and the Flexural modulus is between Applicant’s ranges on page 8 of application. Therefore, this sufficient high elasticity which allows anchoring configuration as seen by Schon in the separated configuration.
Regarding claim 3, Schon discloses the proximal portion of the first treatment member comprises an elastic modulus that provides a level of compliance that mitigates a possibility of injury to the patient in a facial area proximate a nasal site of entry of the first treatment member [0002,0009].
Regarding claim 4, Schon discloses the elasticity of the distal end region of the first treatment member is not less than that of the proximal portion by virtue of a difference in a sidewall structure of the first treatment member [0049].
Regarding claim 6, Schon discloses the first treatment site comprises an anatomical cavity, and the anatomical cavity is in need of medical treatment because of infection and/or necrosis [0047, capable to treat this area].
Regarding claim 7, Schon discloses wherein the anatomical cavity is an encapsulated pancreatic necrotic site, and wherein the distal end region of the first treatment member is sized and configured for insertion into the encapsulated pancreatic necrotic site [0047, capable to treat this area].
Regarding claim 8, Schon discloses further comprising a guidewire hosted within the lumen of the at least one of the first treatment member and the second treatment member; wherein the guidewire is sufficiently stiff to maintain the distal end of the first treatment member in the linear constrained configuration (in [0003-0006, 0011-0012] disclose prior art using catheterization where guidewires are used). Therefore, this is old and well known in the art.
Regarding claim 11, Schon discloses the distal end region of the first treatment member comprises an atraumatic tip or a distal end fluid port in communication with the lumen [0099].
Regarding claim 12, Schon discloses the fluid ports are positioned within the distal end region of the first treatment member at 49,50 such that when the distal end is anchored within the first treatment site, the fluid ports are disposed within the first treatment site.
Regarding claim 16, Schon discloses the length of the at least one of the first treatment member and the second treatment member is/are sufficient to reach the treatment site by way of a route that originates in the nostril or at a percutaneous gastrostomy site of the patient [0049].
Regarding claim 17, Schon discloses the proximal portions of the first and second treatment members are conjoinable by way of both members being enclosed within a surrounding sheath (fig 2d, when a sleeve is used on the catheter upon removal).
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.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Schon et al.
Regarding claim 15, Schon discloses in [0049] that the catheter assemblies can be configured and adapted, by increasing or decreasing a size (diameter or length) and/or number of distal end tubes and/or lumens in the respective catheter assembly, so that the catheter assembly can be beneficially used for other medical applications in which fluids are introduced into and/or removed from the body. However, it fails to specifically disclose the outer diameter of the first treatment member ranges from 3 French to 13 French.
Therefore, this parameter is deemed matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results.
Allowable Subject Matter
Claims 9, 18-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 01/082026 have been fully considered but they are not persuasive.
Applicant’s arguments are narrower than claim1. In response to arguments on page 14 about the preamble including “A gastrointestinal catheter”, the examiner disagrees. “Gastrointestinal” is intended use and does not impart any structure to the preamble.
With respect to arguments (pages 14-15) about “wherein the anchoring configuration is adapted to anchor the distal end region within the first treatment site” and “upon insertion into the first treatment site and release from the linear constrained configuration, the distal end region assumes the anchoring configuration”, it is noted that the claim is not specific at to what anchoring configuration. The examiner is taking a broader interpretation. Once the distal tubes 14,16 are released or split they form a V-shape as shown in figures 4 and 8 within a vessel and they would float freely separate from each other. The tubes are separated and are anchored within the vessel which is the first treatment site due to separation. It is also shown in Jones as evidence that the separation and anchoring can be at free floating (Schon) or a more significant split (Jones). The “first treatment site” could be an upper portion in the vessel from the lower portion of the other distal tube, due to different distal tube lengths, see for example figure 4 in Schon.
The examiner recommends to further define the first treatment site and the anchoring configuration.
Also, Schon discloses in [0107-0110] the distal region can be made of an elastomer having a durometer from about 75A to about 85A. As evidenced by Chiang, (col 5, line 65 – col 6, line 26), shows that catheters are made of resins that have a distal body segment with a hardness in a range of 20A-100A with a flexural modulus from 50 psi to 15,000 psi showing that Schon’s materials have high elasticity as applicants. The hardness overlaps between Schon and Chiang, and the flexural modulus is between Applicant’s ranges on page 8 of application. This allows the catheter to anchor within the vessel as shown by Schon, and as evidenced by Jones.
Again, the examiner recommends to further define the first treatment site and the anchoring configuration.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form.
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 Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Monday-Thursday 8am- 2pm..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783