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 .
Status of Claims
Claims 1-20 are pending and under examination.
Priority
The instant application filed on 7/17/2024, which is a continuation of 17/184,713 filed on 2/25/2021, which claims priority from US provisional application 62/982,860 filed on 2/28/2020.
Information Disclosure Statements
The information disclosure statements filed on 07/17/2024, 02/24/2025, 03/26/2025 and 07/07/2025 have been considered by the examiner.
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 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, 3-6, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abele EP2851102A1 (in applicant’s IDS).
Abele teaches in figure 1 and figure 2, a tube (having a lumen) with a porous body on the distal end (also see claims of Abele). The porous body will have a number of openings called pores. Abele provides that the tube has openings (figure 1, item 127, also figure 2). These openings are under the porous body (see figures 1 and 2), and thus, are in fluid communication with the tube lumen (see abstract). Abele teaches flock material (a material of the fluid collecting body) that can either be antimicrobials, antibiotic, growth factors or other agents (English translation). Abele teaches these active agents are released from the material during use (English translation). These would be agents that can elute/come off of the porous body to be released. Abele teaches flock material with polymer or copolymer, synthetic or natural and that it can be water swellable with an additive with pharmaceutical or medicinal ingredients (English translation -polymers include cellulose compounds, polylactide, polyglycolic acid, polysaccharides – these are hygroscopic polymers able to attract water). Abele teaches “It is understood that the flock material may also comprise or consist of a mixture of the materials described in the preceding embodiments.” Abele teaches the fluid communication body (the tube, item 120 of figure 2). Abele teaches open-porous sponge or foam body (English translation). Abele teaches that the fluid collection body can be compressed by securing means at the distal end (English translation). Abele teaches collecting by applying a negative pressure or vacuum to deliver to a fluid communication body (English translation). Abele teaches a securing device for the fluid communication body and the fluid collecting body (English translation and item 130 on figure 1). The securing device can be adhesive bonding (English translation). Abele teaches “For example, the securing device 130 may be designed to be attachable to the distal end 121 of the fluid communication body 120”. Abele teaches “it may be provided according to the invention that the kit further comprises a fixing element 117, for example in the form of a thread loop”. Abele teaches “The fluid collection body 110 may further be formed in the shape of a circular cylinder, as shown”. Thus, Abele allows for combining additives with polymer for flock material and forming porous bodies which can then be secured to the tube via adhesive bonding or threads (construed as suture). Abele teaches “the fluid collecting body 110 can be slightly compressed at the distal end 111, for example, constricted and in particular stabilized, without thereby appreciably impairing the mutual displaceability / displacement of fluid collecting body 110 and fluid communication body 120.” (see figure descriptions, also claims of Abele regarding “compressed state”). Abele teaches “it is provided in a further embodiment that the fluid communication body has openings, in particular holes, pores, perforations or the like, and / or notches” to help ensure the connection (English translation). Abele teaches “In a further embodiment, the fluid collecting body has an elongate cavity (elongated lumen){construed as recess into this porous body}, in particular a channel, which preferably extends continuously in the longitudinal direction of the fluid collecting body” (English translation). Thus, Abele allows for combining additives including antibiotics with polymer for flock material and forming porous bodies which can then be secured to the tube via adhesive bonding or threads (construed as suture). Abele teaches “the fluid communication body can be designed with multiple lumens or multiple channels. For this purpose, an original cavity (lumen), in particular an original channel, of the fluid communication body can be subdivided into two or more cavities, in particular channels, by means of one or possibly several partitions” (English translation). Abele teaches pore diameters of 200 microns to 1000 microns in the fluid collection body.
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 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 8, 10, 11 and 12 in addition to claims 1, 3-6, and 9 is rejected under 35 U.S.C. 103 as being unpatentable over Abele EP2851102A1.
Abele teaches the claims as discussed above.
Although Abele recognizes compressing its porous body, Abele does not provide compressing it with the tube attached. Abele does not explicitly teach the cutting in half prior to forming the channels and the reassembling of claim 11.
Abele teaches “the fluid collecting body 110 can be slightly compressed at the distal end 111, for example, constricted and in particular stabilized, without thereby appreciably impairing the mutual displaceability / displacement of fluid collecting body 110 and fluid communication body 120.” (see figure descriptions, also claims of Abele regarding “compressed state”). Abele provides the porous body being in half in figure 1. Abele also teaches “the fluid collecting body may have an incision, preferably a cross cut, preferably extending in the longitudinal direction of the fluid collection body. This also makes it possible to slide the fluid collecting body onto the fluid communication body.” (English translation of Abele). Abele teaches “Furthermore, it can be provided that the fluid collecting body is subdivided into individual segments, in particular into spongy or foam-like individual segments.” Thus, Abele allows for cutting its porous body (the fluid collecting body) into segments/parts and then reconnect/reassemble them when connecting to the fluid communication body (tube). In regards to opening the pores this occurs when the fluid collecting body goes from compressed to expanded state (e.g. expanded when soaked in liquid/fluid). The teachings of Abele allow for both states (compressed and expanded), which allows one of ordinary skill in the art to choose an option during its process. Abele teaches “The fluid communication body is preferably tubular, in particular in the form of at least one tube, preferably at least one drainage tube”. Abele provides for openings such as notches or holes in the communication body. Abele teaches “In the case of a tubular or in particular flocked fluid collection body, it may also be expedient if these openings, in particular holes, pores, perforations or the like, and / or incisions has at its distal end. In this way, a fluid line between the fluid collection body and the fluid communication body is possible.” Thus, the teachings of Abele recognize the importance of the tubes having multiple fluid lines between the fluid collection body and fluid communication body, which would lead one of ordinary skill in the art to provide tubes with multiple opening lines whether holes, notches or branches each ending in an opening.
One of ordinary skill in the art before the time of filing would have compressed the porous body (fluid collecting body 110) of Abele’s product as it is seen as compressible without impairment. Therefore, there was a reasonable expectation of success of compressing it while also attached to the fluid communication body as depicted in figure 2. There was also a reasonable expectation of producing the method of applicant’s claims as Abele provides for combining polymers/copolymers and additives, then forming a porous body with it, and forming channels in the fluid communication body based on a design, while also attaching a tube/fluid communication body by known means in the prior art.
Claims 7, 15, 16, 17, 19 and 20 in addition to claims 1, 3-6, 8-11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Abele EP2851102A1 and Odermatt US20110270205A1.
Abele teaches the claims as discussed above.
Abele does not teach a coating with antimicrobial material, coating of silver nanoparticles, and dehydrating the porous body while attached to the tube, the immersing into a water bath and removal thereof, the forming of openings due to the immersing, and the dehydrating to obtain the compressed state.
Odermatt teaches and absorbent (hygroscopic) medical body for removing wound fluids from human and/or animal body cavities includes a material which holds the absorbent body together in a compressed form and can be removed upon contact with a biocompatible liquid (abstract and figures 1-3). It is the nature of absorbent materials like sponges (sponges in claim 14 of Odermatt) to expand after absorbing fluid. This absorbent material is attached to a tube at an end which can be considered the distal end opposed to a proximal end (distal and proximal are just the opposite sides of the length of the tube – thus, as long as the prior art has the porous body to one end of the tube that would be considered the distal end) (see claim 19 and figures of Odermatt and paragraphs 35-36). A tube is a hollow (with lumen), long structure where fluids can flow through. Odermatt teaches the absorbent material having pores (claims 5 and 6 of Odermatt). Odermatt teaches various polymer materials for the absorbent body including polysaccharides, polymers, proteins (polypeptides), cellulose compounds, hyaluronic acid, polyethylene glycol and others (claims 9 and 15-17 of Odermatt). Odermatt teaches materials for the porous absorbent body that include polysaccharides like hyaluronic acid, alginic acid and others (paragraph 23). Odermatt teaches polyurethane sponges with pore size of 600 microns integrally connected to a drainage tube (paragraph 58). Odermatt teaches a pore diameter of 100 to 1500 microns (claim 18 of Odermatt). Odermatt teaches drying the absorbent body by lyophilization (claim 27 of Odermatt). Odermatt teaches wherein, during or after the wetting or soaking of the absorbent body, a negative pressure or vacuum is generated so that the solution or suspension penetrates fully through the absorbent body (claim 26 of Odermatt and paragraph 36 with vacuum source). Odermatt teaches active agents in the absorbent body including antimicrobial agents (antibiotics are antimicrobial agents), antiseptic agents, growth promoting agents, silver, triclosan and anti-inflammatory agents (paragraph 33). Odermatt teaches the absorbent body can include a gel, paste or lubricant cream and teaches the gel can be washed away when in contact with a biocompatible liquid (paragraph 34). Odermatt teaches the gel or cream can prevent uncontrolled deployment of the absorbent body (paragraph 34). Odermatt allows for the absorbent body to be stitched, adhesively bonded or welded to the drainage tube (paragraph 37), and thus, fixed to the tube. Since Odermatt teaches polymers and active ingredients, it has the first and second materials. The gel or cream could also be the second material and it is taught to be flushed away/eluted upon contact with biological fluid. Odermatt teaches nano or microparticles of the active agent with silver as one active (paragraph 33). This small particle form included in the absorbent body would be releasable/elutable as the biological liquid passed through the sponge material. This would be desirable for the patient to benefit from the effects of these active agents for decreasing risk of infection or better wound/surgical healing. Odermatt teaches “The absorbent body is preferably connected integrally to a drainage tube. In the case of the drainage tube, distinction can generally be made between a proximal (near the body) and a distal (away from the body) tube end.” (paragraph 36). Odermatt teaches “That part of the drainage tube which is encapsulated by the absorbent body conventionally has openings. A uniform negative pressure can therefore particularly advantageously be generated on the entire absorbent body. The openings also permit more rapid and more efficient discharge of the wound fluids absorbed by the absorbent body” (paragraph 37). The drainage tube has openings (paragraphs 55-56). Thus, the drainage tube does connect openings of the absorbent material with the lumen of the tube for effective drainage. Again, distal and proximal refer to two ends of the tube and whether one end is considered distal or one end is proximal is defined by the user and may be considered differently by another user. If the prior art teaches the porous body at one end of the tube, it will be considered the distal end for the purpose of examination. Odermatt has teachings to “provide a method for producing the absorbent medical body including compressing an absorbent body into a compressed form, wetting or soaking the absorbent body provided in the compressed form with a solution or suspension including a material which is removable upon contact with a biocompatible liquid and a solvent or solvent mixture, and drying the compressed and wetted or soaked absorbent body by removing the solvent or solvent mixture.” (paragraph 7). Odermatt teaches “The drying removes the solvent or solvent mixture and dries the material which is intended to hold the absorbent body together in the compressed form. By the dried material, the absorbent body is held in a compressed form or in a compressed state.” (paragraph 49). Dried is dehydrated. Thus, the hydrated form would be more expanded if drying compresses it. Odermatt teaches coating or partial coating on and/or inside the absorbent body (paragraphs 21-22). Odermatt teaches various active agents for the absorbent body and/or material (of which coating is a material) including antimicrobials including silver and nano- and/or microparticle forms (paragraph 33).
The nature of a sponge or foam is that when pores/openings fill with liquid, it causes them to open more (connect more) and allow more liquid to be absorbed throughout more opened passages of the sponge until the sponge has absorbed its limit.
One of ordinary skill in the art at the time of instant filing would have produced a system of the instant claims having a tube with lumen and a porous body with a plurality of openings (pores) that are in fluid connection with the lumen of the tube with also having a first polymeric material and second material of agent including particle active agents (like growth agents and antimicrobials) with the absorbent/porous/sponge body being connected to an end of the luminal tube by a stitch/suture or adhesive by the teachings of Abele and Odermatt, which teaches each of these limitations for its product pictured in its figures and discussed in its disclosure. There would have been a reasonable expectation of success in using the teachings of Abele and Odermatt to arrive at the claimed system as the teachings of Abele and Odermatt provide reasonings to use components and structure of the claimed invention and to form such a product with porous structure attached to a tube that can contain active agents/drugs. Abele and Odermatt provide for polymers that would be insoluble in water (polyurethane, polyethylene) as well as agents that have solubility in water (polyethylene glycol, hyaluronic acid).
Claims 1, 3-12, 15-17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Abele EP2851102A1, Odermatt US20110270205A1 and Nelson US 6596296.
Abele and Odermatt teach the claims as discussed above.
Abele and Odermatt do not teach thermoresponsive polymers, which is the other option of polymer for the claims.
Nelson teaches matrices with polymer fibers capable of controlled delivery of therapeutic agents (abstract and figures). Nelson teaches “A composition comprising at least one biodegradable polymer fiber wherein said fiber is composed of a first phase and a second phase, the first and second phases being immiscible, and wherein the second phase comprises one or more therapeutic agents” (claim 1 of Nelson and claim 11 regarding types of therapeutic agents). Nelson teaches fabrication of environmentally responsive polymer gel fibers that are temperature sensitive and transition at temperatures of 38-39 degrees C (Example 4). Example 4 indicates dramatic volume changes of 100 fold in response to small temperature changes of 2-3 degrees C. Example 4 provides for the ability of the fiber/material to be responsive to the physiological state of the patient.
One of ordinary skill in the art at the time of filing would have created a drug/active containing system of Abele and Odermatt that was temperature responsive to temperatures above 30 or 35 degrees C (38-39 degrees C in Nelson) in order to have control over expansion of the material after insertion into the body by the teachings of Nelson. There would be a reasonable expectation of success in producing the claimed system having temperature responsive porous material by the combined teachings of the prior art.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Abele EP2851102A1, Odermatt US20110270205A1 and Wang et al (International Journal of Nanomedicine, 2017, volume 12, pages 1227-1249).
Abele and Odermatt teach the claims as discussed above.
Abele and Odermatt do not teach silver nanoparticle coating of the porous body although it does provide for including nanoparticles with indication of silver as an active.
Wang teaches antimicrobial nanoparticles and the use in medicinal materials to prevent infection and promote wound healing (abstract and figure 1). Wang teaches an advantage of antimicrobial nanoparticles is to prevent microbial drug resistance in certain cases (Bacterial resistance to NPs and Summary). Wang teaches silver nanoparticles that significantly reduce formation of biofilms (bone cement section and effects of NPs on microbial resistance).
One of ordinary skill in the art at the time of instant filing would include antimicrobial silver nanoparticles in a device of Abele and Odermatt in order to prevent infections on the subjects where the device is used by teachings of Wang. Abele also recognizes using agents like antibiotics in the porous body. Thus, there would be a reasonable expectation of success in replacing the antibiotics with antimicrobial nanoparticles of the prior art and obtaining a device that would prevent infections.
Claims 2 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Abele EP2851102A1 and Roeder US20080206297A1.
Abele teaches the claims as discussed above.
Abele does not teach the ability to make porous materials from 3D printing or electrospinning.
Roeder teaches porous composite biomaterials (abstract). Roeder teaches tailoring porosity with processes such as electrospinning and three-dimensional printing (paragraph 35). Roeder teaches manufacturing of composite material and/or scaffolds can be done by electrospinning and three-dimensional printing (paragraph 45).
One of ordinary skill in the art before the time of filing would have considered technologies such as 3D printing and electrospinning to make the porous materials of Abele as these are seen as acceptable processes to manufacture such materials and to dictate their porosity in teachings of Roeder. Thus, there was a reasonable expectation of success in combining the teachings of Abele with the process teachings of Roeder and obtaining methods of applicant’s claims.
Claim 2, 14 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Abele EP2851102A1, Odermatt US20110270205A1 and Jakus WO2019108531A1 (6-6-2019).
Abele and Odermatt teach the claims as discussed above.
Abele and Odermatt do not teach the water soluble material being crystalline and being substantially the same size as the pores.
Jakus teaches “Compositions for forming porous materials and three-dimensional objects, including fibers, films and coatings made from the materials are provided”. Jakus teaches “The compositions include a solvent, a polymer binder that is soluble in the solvent, and solid particles that are insoluble in the solvent. The solid particles include water-soluble salt particles that can be selectively dissolved from objects made from the compositions to render the resulting structures porous.” (abstract and claims 1-3 of Jakus). Jakus teaches methods for forming 3-D porous materials (paragraph 4) and using 3D printing (paragraphs 8-9 and 21). Jakus teaches scaffolds (paragraph 18). Sizes of the particles are provided in paragraph 28.
One of ordinary skill in the art before the time of filing would have included water soluble particles to the water insoluble polymer mixture in order to form pores as Jakus teaches this as a way to form porous materials and 3D objects. The water soluble particles would dissolve leaving the pores similar to size of the particles before dissolving. Therefore, there was a reasonable expectation of success in combining the teachings of the references to obtain a method of making a porous material that involves the addition of water soluble particles along with water insoluble polymer.
Conclusion
No claim is allowed.
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/MARK V STEVENS/Primary Examiner, Art Unit 1613
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