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 .
Response to Amendment
Applicant’s amendments filed on 08/20/2025 have been fully considered. Claims 1-24 and 32-37 are pending in this application. Claims 22-24 and 36 are withdrawn from consideration. Claims 1, 3, and 17 are amended. Claim 37 is newly added. Claims 25-31 are cancelled.
Response to Arguments
Applicant’s amendment of claim 3 overcomes the claim objection of record. The objection of claim 3 is now withdrawn.
Applicant’s arguments with respect to amended independent claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Though some of the same prior art references are used herein, at least applicant’s amended claims 1, 3, and 17 and newly added claim 37 required a change in the grounds of rejection as detailed below in the prior art rejection.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 9-13, 17-20, 32, 34-35, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Loske (Publication No. US 2016/0367747 A1) in view of Tout et al. (Publication No. US 2019/0053954 A1) and Liska (Publication No. US 2004/0044314 A1).
Regarding claim 1, Loske teaches a catheter for transcutaneous and transluminal vacuum closure of perianal or entero-cutaneous fistulas and abscesses (catheter; Figure 5a-5b; Abstract; Paragraph 0013), the catheter comprising: a flexible and resilient body structure (fluid-carrying element 2; Figure 5a-5b) comprising an outer layer forming an inner enclosed catheter chamber (open-pore balloon wall made of an elastic plastic material and forming an inner enclosed catheter chamber; Figure 5a-5b: Paragraph 0030 and 0133-0134), the outer layer comprising a series of openings fluidly connected to the catheter chamber (pores in balloon wall; Figures 5a-5b; Paragraph 0030 and 0133-0134); and a tube configured to be connected to a vacuum generating system and to the body (tube 7b connects body 2 of catheter 20 to vacuum source 30; Figure 6a; Paragraph 0135). Loske does not teach the outer layer made of impervious material.
However, Tout teaches teach the outer layer can be made of PTFE member, a GORE material; perforated polyurethane film; a sintered polymer with apertures; hydrophilic micro-porous or micro-perforated silicone elastomer, micro-porous or micro-perforated polyester or acrylic membranes coated or plasma treated to confer hydrophilic characteristics (Paragraph 0031).
Loske and Tout are analogous to the claimed invention because they are in the same field of negative pressure drainage systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have substituted one known element (elastic plastic material with pores of Loske) for another (perforated polyurethane film of Tout) since the substitution of the material of the outer layer would have yielded predictable results, namely, an outer layer of the housing with multiple openings to allow for fluid to enter through the device through suctioning. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143(I)B). The combination of Loske in view of Tout further teaches the outer layer made of impervious material (outer layer of device of Loske in view of Tout is made of perforated polyurethane film, an impervious material to water; see combination above).
The combination of Loske in view of Tout does not teach a flange surrounding the body to define a maximum insertion length of the body into the fistula or abscess, the flange comprising a surface adapted to adhere to the skin to form a seal over an opening of the fistula or abscess.
However, Liska teaches a flange surrounding the body to define a maximum insertion length of the body into the fistula or abscess (collar 11 surrounding the tubing 12 to fix the body in place – fully capable of defining the maximum insertion length of the tubing into the skin; Paragraph 0021; Figures 1-2), the flange comprising a surface adapted to adhere to the skin to form a seal over an opening of the fistula or abscess (collar 11 has an adhesive on the lower surface 11b for sealing over the opening on the skin; Paragraph 0021; Figure 1 and 2).
Loske in view of Tout and Liska are both considered to be analogous to the claimed invention because they are in the same field of drainage catheters. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Loske in view of Tout to incorporate the teachings of Liska and have the collar of Liska on the body structure of Loske in view of Tout, between the connection of the tubing and the body structure. This prevents the access of bacteria and moisture into the opening where the device is inserted through the skin of the patient (Liska; Paragraph 0021).
Regarding claim 2, Loske in view of Tout and Liska teaches the catheter of claim 1. Loske further teaches the body further comprising an inner resilient structure within the catheter chamber (elastically compressible filler material 1e made of open-pore polyurethane foam inside the balloon wall 2c; Figure 5a-5b; Paragraph 0133-0134).
Regarding claim 3, Loske in view of Tout and Liska teaches the catheter of claim 2. Loske further teaches where the inner resilient structure is a spatial lattice structure configured to maintain the structural integrity of the catheter and promoting drainage (open-pore polyurethane foam 1e is a 3-dimensional structure that forms the balloon structure of the catheter body 2 and promotes drainage of fluid; Paragraph 0133-0134; Figure 5a-5b). A spatial lattice is interpreted to be a three-dimensional structure or mesh system.
Regarding claim 34, Loske in view of Tout and Liska teaches the catheter of claim 1. Loske in view of Tout and Liska further teaches the body having an enlarged distal portion forming the catheter chamber (Loske; balloon wall 1d creates an enlarged distal portion that forms the catheter chamber; Paragraph 0134; Figure 5b).
Regarding claim 4, Loske in view of Tout and Liska teaches the catheter of claim 34. The combination of Loske in view of Tout and Liska does not teach wherein the enlarged portion and the resilient structure are unitary.
Since the specification of the instant application is silent to unexpected results, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the enlarged portion of the balloon made of a polyurethane perforated film of Loske in view of Tout and Liska with the polyurethane foam resilient structure of Loske be made integral, with the same functionality of allowing fluid to drain through the catheter device. Making elements integral is generally recognized as being within the level of ordinary skill in the art. In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) (MPEP 2143(I)(B)).
The modified combination of Loske in view of Tout and Liska further teaches wherein the enlarged portion and the resilient structure are unitary (see combination above).
Regarding claim 9, Loske in view of Tout and Liska teaches the catheter of claim 1. The combination of Loske in view of Tout and Liska further teaches wherein an outer surface of the catheter is low friction and non-tissue adherent (Tout; perforated polyurethane film with hydrophilic, slippery properties; Paragraph 0031).
Regarding claim 10, Loske in view of Tout and Liska teaches the catheter of claim 34. The combination of Loske in view of Tout and Liska wherein the enlarged portion is made of biocompatible flexible and resilient material selected from silicone, PVC, and other medical grade polymers and elastomers (enlarged portion of Loske in view of Tout and Liska is made of perforated polyurethane film; see Tout, Paragraph 0031).
Regarding claim 11, Loske in view of Tout and Liska teaches the catheter of claim 1. The combination of Loske in view of Tout and Liska further teaches wherein the catheter is made of material which is visible during medical imaging (Loske; radiological marking is on catheter for identifying insertion depth; Paragraph 0069).
Regarding claim 12, Loske in view of Tout and Liska teaches the catheter of claim 11. The combination of Loske in view of Tout and Liska further teaches wherein the material of the catheter comprising a radio-opaque formulation or coating (Loske; radiological marking is on catheter for identifying insertion depth; Paragraph 0069).
Regarding claim 13, Loske in view of Tout and Liska teaches the catheter of claim 11. The combination of Loske in view of Tout and Liska does not teach wherein the catheter comprises a closed internal channel for advancement of the catheter adapted to receive a rigid guidewire.
However, the embodiment of Figures 3a-3b of Loske further teaches wherein the catheter comprises a closed internal channel for advancement of the catheter adapted to receive a rigid guidewire (closed tube 6a that is in the catheter 20 to receive a guidewire; Figures 3a-3b; Paragraph 0119).
Loske is analogous to the claimed invention, therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Loske in view of Tout and Liska to incorporate the teachings of the embodiment of Figures 3a-3b of Loske and have the internal tube 6a of Figures 3a-3b of Loske in the catheter tube of Loske in view of Tout and Liska. This allows for the catheter to be controlled for advancing the catheter (Loske; Paragraph 0025, and 0119-0120).
Regarding claim 17, Loske in view of Tout and Liska teaches the catheter of claim 1.
The Examiner recognizes claim 17 as a "product-by-process" claim. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (see MPEP 2113).
As a product claim, Examiner has determined claim 17 to require the catheter to comprise the following structural elements in addition to those in the claims from which they depend:
• A body having an enlarged portion with a series of openings fluidly connected to a catheter chamber;
• A tube;
• A flange.
In the prior art rejection in this Office action, Examiner considers claim 17 to be met when the limitations of claim 1 are met, which is discussed above.
Regarding claim 18, Loske in view of Tout and Liska teaches the catheter of claim 17.
The Examiner recognizes claim 18 as a "product-by-process" claim. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (see MPEP 2113).
As a product claim, Examiner has determined claim 18 to require the catheter to comprise the following structural elements in addition to those in the claims from which they depend:
• A body having an enlarged portion with a series of openings fluidly connected to a catheter chamber;
• A tube;
• A flange.
In the prior art rejection in this Office action, Examiner considers claim 18 to be met when the limitations of claim 1 are met, which is discussed above.
Regarding claim 19, Loske in view of Tout and Liska teaches the catheter of claim 1. Loske further teaches wherein the tube comprises an angled portion (tube 7b is angled between the container 40 and the catheter body 2; Figure 6a; Paragraph 0135).
Regarding claim 20, Loske in view of Tout and Liska teaches the catheter of claim 34. The combination of Loske in view of Tout and Liska further teaches the enlarged portion being shaped as a dome (balloon shaped enlarged portion of Loske is dome shaped; Figures 5a-5b; Paragraph 0133-0134).
Regarding claim 32, Loske in view of Tout and Liska teaches the catheter of claim 1. The combination of Loske in view of Tout and Liska further teaches the flange having an annular shape (Liska; collar 11 is annular; Figure 1; Paragraph 0021).
Regarding claim 35, Loske in view of Tout and Liska teaches the catheter of claim 1. The combination of Loske in view of Tout and Liska does not teach the body structure being unitary.
Since the specification of the instant application is silent to unexpected results, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the enlarged portion of the balloon made of a polyurethane perforated film of Loske in view of Tout and Liska with the polyurethane foam resilient structure of Loske be made integral, with the same functionality of allowing fluid to drain through the catheter device. Making elements integral is generally recognized as being within the level of ordinary skill in the art. In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) (MPEP 2143(I)(B)).
The modified combination of Loske in view of Tout and Liska further teaches the body structure being unitary (see combination above).
Regarding claim 37, Loske in view of Tout and Liska teaches the catheter of claim 1. The combination of Loske in view of Tout and Liska further teaches wherein the surface of the flange is adapted to receive an adhesive (Liska; collar 11 has an adhesive on the lower surface 11b for sealing over the opening on the skin; Paragraph 0021; Figure 1 and 2).
Claim(s) 5-8 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Loske (Publication No. US 2016/0367747 A1) in view of Tout et al. (Publication No. US 2019/0053954 A1) and Liska (Publication No. US 2004/0044314 A1), as applied to claims 1 and 12 above, and further in view of Lad et al. (Publication No. US 2019/0201662 A1).
Regarding claim 5, Loske in view of Tout and Liska teaches the catheter of claim 1. The combination of Loske in view of Tout and Liska does not teach wherein the body further comprises ridges arranged longitudinally along the catheter.
However, Lad teaches wherein the body further comprises ridges arranged longitudinally along the catheter (protrusions 124/ridges is helical at tip 120, where the tip is made of polyurethane and extends longitudinally along the catheter; Paragraph 0025 and 0040; Figure 1).
Loske in view of Tout and Liska and Lad are both considered to be analogous to the claimed invention because they are in the same field of catheters. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Loske in view of Tout and Liska to incorporate the teachings of Lad and have the body of the catheter/surface of Loske in view of Tout and Liska to comprise helical ridges made of the same polyurethane material, as taught by Lad. This prevents the occurrence of catheter occlusion and to protect the openings/ports of the device from being exposed to tissue (Lad; Paragraphs 0025 and 0032).
Regarding claim 6, Loske in view of Tout, Liska, and Lad teaches the catheter of claim 5. The combination of Loske in view of Tout, Liska, and Lad further teaches the ridges being helicoidal (Lad; protrusions 124/ridges is helical at tip 120, where the tip is made of polyurethane; Paragraph 0025 and 0040; Figure 1).
Regarding claim 7, Loske in view of Tout, Liska, and Lad teaches the catheter of claim 5. The combination of Loske in view of Tout, Liska, and Lad further teaches wherein the ridges channel fluids, pus and tissue debris into the openings (Lad; protrusions 124 do not contain ports 122, ports 122 are located in the recesses 134 so drainage can occur – fluid travels from protrusions 124 down to recesses 134 where ports 122 are located; Paragraphs 0025-0032; Figure 3).
Regarding claim 8, Loske in view of Tout, Liska, and Lad teaches the catheter of claim 5. The combination of Loske in view of Tout, Liska, and Lad further teaches wherein the openings are disposed between the ridges (Lad; protrusions 124 do not contain ports 122, ports 122 are located in the recesses 134, between the protrusions 124, so drainage can occur – fluid travels from protrusions 124 down to recesses 134 where ports 122 are located; Paragraphs 0025-0032; Figure 3).
Regarding claim 33, Loske in view of Tout, and Liska teaches the catheter of claim 12. The combination of Loske in view of Tout and Liska does not teach the material of the catheter comprising barium sulfate.
However, Lad teaches that bismuth subcarbonate, barium sulfate, tantalum are radio-opaque coatings that can be applied onto a catheter (Paragraph 0044).
Loske in view of Tout and Liska and Lad are analogous to the claimed invention because they are in the same field of catheters. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have substituted one known element (radio-opaque marking of Loske) for another (barium sulfate marking/coating of Lad) since the substitution of the material of the radio-opaque marking would have yielded predictable results, namely, the identification of the position of the catheter under X-ray. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143(I)B).
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Loske (Publication No. US 2016/0367747 A1) in view of Tout et al. (Publication No. US 2019/0053954 A1) and Liska (Publication No. US 2004/0044314 A1), as applied to claim 1 above, and further in view of Hede et al. (Publication No. US 2022/0001136 A1).
Regarding claim 14, Loske in view of Tout and Liska teaches the catheter of claim 1. The combination of Loske in view of Tout and Liska does not teach wherein a concentration of the openings varies along a longitudinal axis of the body.
However, Hede teaches wherein a concentration of the openings varies along a longitudinal axis of the body (Paragraph 0074-0079 and 0220-0221; Figure 10A).
Loske in view of Tout and Liska and Hede are both considered to be analogous to the claimed invention because they are in the same field of catheters. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Loske in view of Tout and Liska to incorporate the teachings of Hede and have the catheter with the openings on the surface of the body of Loske in view of Tout and Liska with varying degrees of perforation, as taught by Hede. This allows for difference in the inflow of different zones of the catheter based on the position of the catheter in the body of the user for better drainage (Hede; Paragraph 0048 and 0078).
Claim(s) 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Loske (Publication No. US 2016/0367747 A1) in view of Tout et al. (Publication No. US 2019/0053954 A1) and Liska (Publication No. US 2004/0044314 A1), as applied to claim 1 above, and further in view of Yee et al. (Publication No. US 2020/0306501 A1).
Regarding claim 15, Loske in view of Tout and Liska teaches the catheter of claim 34. The combination of Loske in view of Tout and Liska does not teach wherein an angle between a normal axis of the openings and a surface of the enlarged portion varies along a longitudinal axis of the enlarged portion.
However, Yee teaches wherein an angle between a normal axis of the openings and a surface of the distal tip varies along a longitudinal axis of the distal tip (flow holes 3634 have varying angles between the normal axis of the openings and a surface of the distal tip; Figure 13Hiii; Paragraph 0168 and 0170).
Loske in view of Tout and Liska and Yee are both considered to be analogous to the claimed invention because they are in the same field of catheters. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Loske in view of Tout and Liska to incorporate the teachings of Yee and have the enlarged portion at the distal end of the catheter of Loske in view of Tout and Liska have the openings that are oriented, as taught by Yee. This allows for fluid flow to vary in force and velocity of the fluid flow (Yee; Paragraph 0170-0171).
Regarding claim 16, Loske in view of Tout, Liska, and Yee teaches the catheter of claim 15. The combination of Loske in view of Tout, Liska, and Yee further teaches wherein the angle is orthogonal at a lower portion of the enlarged portion and decreases near a tip of the enlarged portion (the openings 3634 of Yee is on the enlarged portion of Loske in view of Tout and Liska, where the angle is orthogonal at the lower portion of the enlarged portion and the angle decreases near the tip of the enlarged portion; Figure 13Hiii of Yee; see rejection of claim 1 above).
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Loske (Publication No. US 2016/0367747 A1) in view of Tout et al. (Publication No. US 2019/0053954 A1) and Liska (Publication No. US 2004/0044314 A1), as applied to claim 1 above, and further in view of Lesh et al. (Publication No. US 2002/0165535 A1).
Regarding claim 21, Loske in view of Tout and Liska teaches the catheter of claim 1. The combination of Loske in view of Tout and Liska does not teach a kit comprising a plurality of the catheters, the catheters varying in size for the progressive closure of said fistulas and abscesses.
However, Lesh teaches a kit comprising a plurality of the catheters, the catheters varying in size for the progressive closure of said fistulas and abscesses (Paragraph 0147).
Loske in view of Tout and Liska and Lesh are both considered to be analogous to the claimed invention because they are in the same field of catheters. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Loske in view of Tout and Liska to incorporate the teachings of Lesh and have a plurality of catheters of Loske in view of Tout and Liska with different sizes to be in a kit, as taught by Lesh. This allows for the physician to choose the appropriately sized catheter from the kit that would fit with the anatomy of the patient (Lesh; Paragraph 0147).
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 KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
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, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781
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