DETAILED ACTION
Receipt is acknowledged of applicant’s Amendment/Remarks filed 2/12/2026.
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 the Claims
Claims 1, 2, 5, 7, 9-13 and 18-21 have been amended. Claims 6, 14 and 17 are cancelled. Claims 22 and 23 are newly added. Accordingly, claims 1-5, 7-13, 15, 16 and 18-23 remain pending in the application and are currently under examination.
Withdrawn Rejections
Applicant’s amendment renders the rejection of claims 6, 7, 9 and 21 under 35 USC 112(a) moot. Specifically, the claims have either been cancelled or amended to remedy the written description issues. Thus, said rejection has been withdrawn.
Maintained Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 13 stands rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 13 recites “wherein the interpenetrating continuous pathways of the guest polymer in swollen condition has a cross dimension of up to 2 µm”. It is noted that there is a presumption that an adequate written description of the claimed invention is present when the application is filed, however issues of adequate written description may arise even for original claims, for example, when an aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the inventor had possession of the claimed invention at the time of filing (MPEP 2163(I)(A)). The dimension claimed does not appear to have support in the disclosure as filed. There is no explicit written support for said dimension. Looking to the drawings, the instant specification provides a description of Figure 9a which states,
In Fig. 9a the silicone host/guest polymer IPN of Figs 8a and 8b which has been swollen with water. The strand filaments 71a are almost fully covered with the beads 73a which have swollen and thereby increased in size. In the SEM image the intrastrand pathways 72a can only slightly be seen. In the corresponding illustration in FIG. 9b it can be seen that the guest polymer beads 73b has been swollen. For illustrative purpose the swollen guest polymer beads are illustrated in less swollen state than in the real life cry-SEM image of FIG. 9a. However, it can be seen that the swollen guest polymer beads takes up more of the intrastrand pathways 72b between the strand shaped filaments 71b.
The quality of the image in Fig. 9a is poor and, as such, it is unclear what physical features are being pointed to. For example, intrastrand pathways are labeled as 72a and an arrow is pointing to a structural feature; however, the quality of the image makes it difficult to visually see the structural feature being pointed to. Accordingly, it is further difficult to determine the size of said structural feature. A determinization of the size of the continuous pathways in a swollen condition from the image in Fig. 9a cannot be made. Even assuming the dimension of up to 2 microns is supported, the specification describes Fig. 9a as a particular embodiment where the host polymer is silicone and the guest polymer is a hydrogel. The claim is not limited to said specific materials. Thus, the claim is lacking written description of the subject matter, “wherein the interpenetrating continuous pathways of the guest polymer in swollen condition has a cross dimension of up to 2 µm”.
Applicant is invited to identify the portion of the specification that teaches said limitation, as the examiner has not been able to locate the applicable disclosure. For these reasons, the claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention.
Response to Arguments
Applicant's arguments, filed 2/12/2026, regarding 112(a) rejection of claims 13 has been fully considered but they are not persuasive.
Applicant alleges that Fig. 9a shows an SEM image of the delivery membrane in a swollen condition, i.e., where the guest polymer is saturated with liquid. Applicant asserts that the annotated double arrows correspond to a length of 2 microns and indicate that the largest cross-dimension of the continuous pathways of the guest polymer of interpenetrating guest polymer is 2 microns. Applicant further asserts that there are many sections of the swollen interpenetrating continuous pathways of the guest polymer have small cross-dimensions such as 10-fold smaller or 100-fold smaller. Remarks, pages 9-10.
In response, it is respectfully submitted that, as discussed in the rejection above, there is no explicit written support for said dimension. Looking to the drawings, the instant specification provides a description of Figure 9a which states,
In Fig. 9a the silicone host/guest polymer IPN of Figs 8a and 8b which has been swollen with water. The strand filaments 71a are almost fully covered with the beads 73a which have swollen and thereby increased in size. In the SEM image the intrastrand pathways 72a can only slightly be seen. In the corresponding illustration in FIG. 9b it can be seen that the guest polymer beads 73b has been swollen. For illustrative purpose the swollen guest polymer beads are illustrated in less swollen state than in the real life cry-SEM image of FIG. 9a. However, it can be seen that the swollen guest polymer beads takes up more of the intrastrand pathways 72b between the strand shaped filaments 71b.
The quality of the image in Fig. 9a is poor and, as such, it is unclear what physical features are being pointed to. For example, intrastrand pathways are labeled as 72a and an arrow is pointing to a structural feature; however, the quality of the image makes it difficult to visually see the structural feature being pointed to. Accordingly, it is further difficult to determine the size of said structural feature. A determinization of the size of the continuous pathways in a swollen condition from the image in Fig. 9a cannot be made. Even assuming the dimension of up to 2 microns is supported, the specification describes Fig. 9a as a particular embodiment where the host polymer is silicone and the guest polymer is a hydrogel. The claim is not limited to said specific materials. Thus, the claim is lacking written description of the subject matter, “wherein the interpenetrating continuous pathways of the guest polymer in swollen condition has a cross dimension of up to 2 µm”.
For these reasons, Applicant’s arguments are found unpersuasive. Said rejection is maintained.
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.
Claims 1, 5, 7-12, 15, 16, 19 and 21 stand rejected and newly added claims 22 and 23 are newly rejected under 35 U.S.C. 103 as being unpatentable over Alm et al. (WO 2013/075724 A1, May 30, 2013, hereafter as “Alm”) in view of Otto (WO 2014/131742 A1, Sep. 4, 2014, machine translated, hereafter as “Otto”).
The instant claims are drawn to a balloon catheter comprising at least one expandable balloon, wherein the at least one balloon comprises a balloon wall forming a balloon cavity, wherein the balloon cavity is a closed cavity configured for holding an amount of water within the closed cavity without leaking, wherein the closed cavity is configured for being filled with at least one chemical substance in the form of fluid(s) and/or particle(s), wherein at least a section of the wall of the balloon is a delivery membrane, wherein the delivery membrane is of an interpenetrating polymer network (IPN) substrate comprising a cross-linked host polymer and a cross-linked guest polymer, where the delivery membrane comprises a continuous matrix of the host polymer and wherein the guest polymer is interpenetrating the continuous matrix of the host polymer and forms continuous pathways within said host polymer, wherein the continuous pathways of the guest polymer extend through a thickness of the delivery membrane from an inner surface of the delivery membrane to an outer surface of the delivery membrane and wherein the delivery membrane is configured for migration of chemical compound(s) of the chemical substance from the closed cavity and through the continuous pathways of the guest polymer to be release/delivered at the outer surface of the delivery membrane; a combination; and a method of using thereof.
Regarding instant claims 1, 8, 10, 22 and 23, Alm teaches a delivery device for delivering a chemical compound, the delivery device comprises an interpenetrating polymer substrate (IP substrate) comprising a first continuous polymer comprising rubber and a second polymer comprising hydrogel or a hydrogelable precursor, where the second polymer is interpenetrating in the first polymer creating a plurality of interpenetrating paths of the second polymer (abstract; page 12, lines 17-18). Alm teaches that both the first polymer and second polymer can be crosslinked (page 6, last para. – page 7, 2nd para.; page 10, lines 14-20). Alm also teaches that the plurality of interpenetrating paths of the second polymer is in the form of paths that form a network (i.e., continuous) (page 13, 1-3). Alm also teaches the particular delivery device, a catheter for any body fluid such as urine (page 28, line 20). Alm further teaches that in a particular embodiment, “the IP substrate is an IPN in its whole structure (i.e., extend through a thickness of the membrane from an inner surface to an outer surface of the membrane)” (page 15, lines 9-10). Alm teaches the particular chemical compounds, antimicrobials, biocides, bactericides, etc. (anti-infection drugs) (page 22, line 22 - page 23, line 4).
Alm is silent to the device having a “closed cavity” and the particular catheter, a balloon catheter (instant claims 1 and 15). It is noted that “closed cavity” is defined as “the delivery device is configured for holding an amount of liquid such as water within the cavity without leaking the liquid. The delivery device may comprise a closable opening or may be adapted for penetration for filling the chemical substance into the cavity” (page 4, lines 22-25 of the instant specification). A balloon catheter necessarily meets the requirements of a “closed cavity”.
Alm is silent to the limitations, “wherein the delivery membrane is configured for migration of chemical compound(s) of the chemical substance from the closed cavity and through the continuous pathways of the guest polymer to be released/delivered at the outer surface of the delivery membrane” and “at least one chemical substance is in the form of fluid(s) and/or particles” (instant claim 1). Alm also does not explicitly teach the method of using (instant claims 22 and 23).
Otto teaches a catheter, in particular an indwelling catheter, via insertion is used for the treatment of functional disorders or diseases of the prostate and the bladder, in particular for medicinal and/or physical treatment of the prostate and the bladder, preferably in connection with or after a transurethral resection or vaporization of the prostate, in connection with a benign prostatic hyperplasia or in connection with or after a radiation therapy of a prostate carcinoma (urinary catheter) (abstract; [0004], [0028]-[0029], [0044], [0053]; Fig. 1). Said catheter comprises a catheter body with a proximal end and a distal end and an inflation lumen in fluid communication with the closed cavity of a balloon and extending from the proximal end towards the distal end of the catheter body to the balloon cavity (Figures). Otto also teaches local application of medication through a targeted release of medication via the permeable wall of the prostate balloon over a defined period of time ([0039]). Otto teaches that by delivering the drugs directly to the therapy site, small amounts of active ingredient can be used, thus saving drug costs and avoiding undesirable systemic side effects ([0039]). Otto further teaches the balloon of the catheter fulfills several functions: a) the filling of the balloon causes compression of the prostate and expansion of the urethra and b) the drug delivery through the permeable wall of the balloon delivers the drug to the local tissue ([0038]). Otto also teaches that the expandable balloon is filled with a drug, which can be in liquid form (inflation liquid), to be administered and thus provides a depot or a reservoir which releases a defined amount of a drug directly at the therapy site in a controlled manner over a longer, defined period of time, preferably via physical processes, in particular via diffusion processes ([0038], [0062] and [0069]).
Alm and Otto are both drawn to catheters for local drug delivery, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the particular catheter, a balloon catheter, having a closed cavity that is filled with a chemical substance (e.g., drug in liquid form) that can be delivered from the cavity and through the wall of the device in Alm as suggested by Otto with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Otto teaches that filling of the balloon of the balloon catheter compresses the prostate and expands the urethra and also provides a depot/reservoir that releases a drug directly at the therapy site in a controlled manner over a longer period of time. One of skill in the art would have reasonably expected a balloon catheter having a cavity filled with a drug that can move through the walls of the device to locally deliver a therapeutic substance. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a method delivering a drug such as an anti-infection drug to a patient by inserting a catheter body of the balloon catheter in a deflated state into a bladder of the patient and inflating the balloon by injecting an inflation liquid comprising the chemical substance and allowing the chemical compound to migrate through the delivery membrane in Alm as suggested by Otto with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Otto teaches said method is suitable and effective in delivering the therapeutic substance to the targeted tissue.
Regarding instant claim 5, the references are silent to the explicit recitation of “strand shaped filaments comprising a plurality of intrastrand hollow pathways” and “the continuous pathways of the guest polymer within said host polymer comprises a plurality of beads of the guest polymer arranged in said intrastrand pathways along the strand filaments”. However, page 9, lines 17-23 of the instant specification states,
Such host polymer structure of a network of strand shaped filaments comprising a plurality of intrastrand pathways may for example be obtained by preparing the host polymer with a surplus of residuals prior to crosslinking and after crosslinking removing at least a part of such residuals e.g. by supercritical fluid extraction or near supercritical fluid extraction e.g. using CO2, as extraction fluid. In an embodiment the extraction of residuals from the host polymer is performed using dense CO2, gas extraction.
and at page 14, lines 1-5, the specification also states,
It has been found to be very beneficial to provide the guest polymer to have a structure comprising a plurality of beads forming the substantially continuous pathways within the host polymer. By loading the guest monomer into the host polymer using a solvent in its supercritical, near supercritical or dense gas state the resulting guest polymer will form beads like units within the host polymer structure when it precipitates.
Alm teaches crosslinking the first polymer, exposing the first polymer to the one or more monomers for the second polymer and the solvent (e.g., CO2) in liquid, supercritical or subcritical condition, precipitation, crosslinking and extracting residuals using CO2 (page 7, lines 7-12; pages 13-15). MPEP 2112.01(I) states,
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of ether anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Alm teaches a substantially identical process of making and, as such, a skilled artisan would reasonably expect a substantially identical method of making would produce a substantially identical product having the same characteristics including strand shaped filaments, intrastrand pathways and a plurality of beads.
Regarding instant claim 7, Alm teaches the particular chemical compounds, anticonvulsants, analgesics, antiparkinsons, antiinflammatories, calcium antagonists, anesthetics, antimicrobials, antimalarials, antiparasitics, antihypertensives, antihistamines, antipyretics, alpha-adrenergic agonists, alpha-blockers, biocides, bactericides, bronchial dilators, beta-adrenergic blocking drugs, contraceptives, cardiovascular drugs, calcium channel inhibitors, depressants, diagnostics, diuretics, electrolytes, enzymes, hypnotics, hormones, hypoglycemics, hyperglycemics, muscle contractants, muscle relaxants, neoplastics, glycoproteins, nucleoproteins, lipoproteins, ophthalmics, psychic energizers, sedatives, steroids sympathomimetics, parasympathomimetics, tranquilizers, urinary tract drugs, vaccines, vaginal drugs, vitamins, collagen, hyaluronic acid, nonsteroidal anti-inflammatory drugs, angiotensin converting enzymes, polynucleotides, polypeptides, polysaccharides, nicotine, adrenal hormones and mixtures thereof (page 22, line 19 – page 23, line 4).
Regarding instant claim 9, said claim recites similar limitations to that of instant claim 1. Discussion of claim 1 can be found above and is also applicable to instant claim 9. Regarding the limitation, a drug against bacterial infection, Alma teaches the particular drug, a bactericide (page 22, line 25).
Regarding instant claims 11 and 16, Alm further teaches that the first polymer is preferably vulcanized (i.e., cross-linked) such as rubber or a silicone rubber (elastomer) (page 7, lines 7-12; claim 3).
Regarding instant claim 12, Alm and Otto teach the elements discussed above. It is noted that the combination of Alm and Otto meet the limitation, wherein the entire wall of the balloon is the membrane as Alm teaches that the interpenetrating network forms the wall of a device such as a catheter (see above).
Regarding instant claim 19, Alm further teaches the plurality of interpenetrating paths of the second polymer coincides with a surface of the substrate, whereby the chemical compound can be released via this surface (page 12, lines 22-26).
Regarding instant claim 21, said claim recites the limitation, “wherein the closed cavity is configured to include an inflation liquid a similar limitation” which is similar to that of the limitation “wherein the closed cavity is configured for being filled with at least one chemical substance in the form of fluid(s) and/or particle(s)” as recited in instant claim 1. Discussion of claim 1 can be found above and is also applicable to instant claim 21 including “an inflation liquid”. In addition, claim 21 recites that the inflation liquid comprises particles comprising cells. Alm further teaches that the chemical compound can be in the form of fluids and/or particles (page 21, line 9). Alm also teaches that the chemical compound is or comprises cells, catalysts, nanoparticles or combinations thereof (page 24, line 15). While Alm does not specifically disclose the combination of particles comprising cells, Alm suggests the combination. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include particles comprising cells with a reasonable expectation of success because Alm teaches that the chemical compound can be in the form of fluids and/or particles and also that the chemical compound is or comprises cells, catalysts, nanoparticles or combinations thereof. A skilled artisan would have been motivated to do so because Alm teaches a finite number of potential combinations and choosing from a finite number of identified, predictable solutions provides a reasonable expectation of success.
Thus, the combined teachings of Alm and Otto render the instant claim prima facie obvious.
Response to Arguments
Applicant's arguments, filed 2/12/2026, regarding the 103 rejection over Alm and Otto have been fully considered but they are not persuasive. Applicant’s arguments are largely the same as previously presented. For the same reasons as previously stated, Applicant’s arguments are not persuasive.
Applicant alleges that Alm does not teach a balloon catheter, an IPN in membrane form, or a closed cavity with an IPN membrane. Applicant alleges that the chemical substance (drug) in Alm does not pass from one side of the IPN to another side of the IPN but rather the chemical compound is loaded into the IPN to form the reservoir within the IPN and then in use the chemical compound is released from the IPN. Applicant further asserts that Alm teaches that to ensure release of the chemical substances, the chemical substances are loaded into the IPN material by using a loading solvent (e.g., N2 and/or CO2 in liquid, subcritical phase or supercritical phase) and at a condition where the work adhesion between the second polymer and the chemical compound during at least a part of the loading is at least about 0 j/m2. Remarks, pages 11-15.
In response, it is respectfully submitted that the rejection is based on the combination of teachings of Alm and Otto and one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the rejection above, it is explicitly states that Alm is silent to “a balloon catheter”. Otto is relied upon to teach said feature. Regarding the IPN in membrane form limitation, Alm does not explicitly teach the term “membrane”, however Alm teaches that a substrate such as a catheter can be composed of an IPN. Alm also teaches that the IPN provides a diffusion path for drug release (page 45, lines 15-23). Further, the instant specification states that the IPN enables diffusion (Example 1). Thus, while “membrane” is not explicitly recited in Alm, Alm describes an IPN substrate that allows diffusion and release of the drug which implies that the IPN substrate functions as a membrane. Regarding the loading of the substrate, the instant specification at page 16, lines 2-3 states, “The chemical compound may advantageously be loaded into the delivery membrane by the method described in WO 2013/075724”. WO 2013/075724 is the Alm reference cited in the rejection. Accordingly, Applicant appears to be arguing against the method of loading the chemical compound disclosed in the instant specification. Regarding the limitation, “a closed cavity”, said limitation is defined in the instant specification as “the delivery device is configured for holding an amount of liquid such as water within the cavity without leaking the liquid. The delivery device may comprise a closable opening or may be adapted for penetration for filling the chemical substance into the cavity” (page 4, lines 22-25 of the instant specification). A balloon catheter necessarily meets the requirements of a “closed cavity” and, as stated above, Otto is relied upon to teach a balloon catheter. For these reasons, Applicant’s arguments are not persuasive.
Applicant argues that Otto does not remedy the above deficiencies. Applicant asserts that Otto teaches a catheter having a balloon which has a wall that is permeable by means of pores and delivery of a medication can take place through said wall. Applicant asserts that it would not be obvious to combine the teachings of Alm and Otto because a) while Alm describes a catheter, Alm does not disclose or suggest a balloon catheter having a closed cavity, b) Otto discloses a balloon catheter, but this balloon catheter does not have a closed cavity because a medication can be delivered from the (not closed) cavity and through the wall of the balloon. Remarks, pages 16-18.
In response, it is respectfully submitted that the rejection is based on the combination of teachings of Alm and Otto and one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). A discussion of Alm above explains that Alm does not teach a balloon catheter, however Otto is relied upon for this feature. Otto teaches a balloon catheter that provides diffusion-controlled release of a medication via pores on the micron scale such that rapid release is prevented ([0030]-[0031]). The instant specification also discusses that the chemical substance diffuses through the membrane (page 21, lines 16-17). Further, as discussed above, Alm teaches that the IPN substrate allows diffusion and release of the drug. Thus, both the instant invention and the prior art references release the active agent via diffusion through a substrate/membrane of a catheter. It is important to note that the instant claims do not exclude “pores” and the mere recitation of “pores” does not disqualify the reference from reading on the limitation, “closed cavity”. Given that the same release mechanism is relied upon in the instant invention and the prior art and Otto also explicitly teaches that rapid release of the medication is prevented due to the small size of the pores, it is reasonable to conclude that Otto reads on the limitation of “the delivery device is configured for holding an amount of liquid such as water within the cavity without leaking the liquid”. MPEP 2112.01(I) states,
Where the claimed and prior art products are identical or substantially identical
in structure or composition, or are produced by identical or substantially identical
processes, a prima facie case of either anticipation or obviousness has been established.
In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO
shows a sound basis for believing that the products of the applicant and the prior art are
the same, the applicant has the burden of showing that they are not.” In re Spada, 911
F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
The prior art suggests a substantially identical product to the claimed product and, as such, a prima facie case of ether anticipation or obviousness has been established. Applicant has not met their burden in showing that the product of the prior art is not the same as the claimed product. Furthermore, regarding the limitation, “a closed cavity”, said limitation is defined in the instant specification as “the delivery device is configured for holding an amount of liquid such as water within the cavity without leaking the liquid. The delivery device may comprise a closable opening or may be adapted for penetration for filling the chemical substance into the cavity” (page 4, lines 22-25 of the instant specification). A balloon catheter necessarily meets the requirements of a “closed cavity”. For these reasons, applicant’s argument is not persuasive.
Applicant argues that Otto does not have a closed cavity because Otto teaches “pores” are made by laser perforations ([0032]). Applicant asserts that the prostate balloon would not be capable of holding an amount of water within the cavity without leaking. Remarks, pages 17-21.
In response, it is respectfully submitted that the rejection is based on the combination of teachings of Alm and Otto and one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Further, the instant specification discusses the chemical substance diffuses through the membrane (page 21, lines 16-17). Otto also teaches diffusion-controlled release of the medication via pores on the micron scale such that rapid release is prevented ((0030]-[0031]). Thus, both the instant invention and the prior art release the active agent via diffusion through the membrane of a balloon catheter. It is important to note that the instant claims do not exclude “pores” and the mere recitation of “pores” does not disqualify the reference from reading on the limitation, “closed cavity”. Given that the same release mechanism is relied upon in the instant invention and the prior art and Otto also explicitly teaches that rapid release of the medication is prevented due to the small size of the pores, it is reasonable to conclude that Otto reads on the limitation of “the delivery device is configured for holding an amount of liquid such as water within the cavity without leaking the liquid”. Moreover, Alm teaches an interpenetrating network substrate. The combination of Alm and Otto suggest a balloon catheter having said interpenetrating network substrate that would further provide a membrane having the characteristics of a closed cavity such that it is capable of holding an amount of water within the cavity without leaking. MPEP 2112.01(I) states,
Where the claimed and prior art products are identical or substantially identical
in structure or composition, or are produced by identical or substantially identical
processes, a prima facie case of either anticipation or obviousness has been established.
In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO
shows a sound basis for believing that the products of the applicant and the prior art are
the same, the applicant has the burden of showing that they are not.” In re Spada, 911
F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
The prior art teaches a substantially identical product to the claimed product and, as such, a prima facie case of ether anticipation or obviousness has been established. Applicant has not met their burden in showing that the product of the prior art is not the same as the claimed product. For these reasons, Applicant’s argument is not persuasive.
Applicant asserts that claim 1 now specifies that the delivery membrane is configured for migration of chemical compound(s) of the chemical substance from the closed cavity and through the continuous pathways of the guest polymer to be released/delivered at the outer surface of the delivery membrane. Remarks, pages 20-21.
In response, it is respectfully submitted that Alm teaches delivery devices comprising an IPN substrate and the particular delivery device, a catheter. The term “substrate” of Alm implies the device itself and in the case of a catheter, would include the walls of the catheter. Alm also teaches that in a particular embodiment, “the IP substrate is an IPN in its whole structure (i.e., extend through a thickness of the membrane from an inner surface to an outer surface of the membrane)”. Alm further teaches the plurality of interpenetrating paths of the second polymer coincides with a surface of the substrate, whereby the chemical compound can be released via this surface (page 12, lines 22-26). Otto teaches the particular catheter, a balloon catheter having a membrane that allows an active agent to pass through the membrane and deliver the active agent to the surrounding tissue. Both of the references are drawn to catheters for local drug delivery via a substrate/membrane that allows active agents to pass through and be delivered to the surrounding tissues. Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the particular catheter, a balloon catheter, into the invention of Alm as suggested by Otto because both of the references are drawn to catheters having a substrate/membrane that allows delivery of active agents through said substrate/membrane to the surrounding tissues. Accordingly, the combined teachings of the references meet the limitations.
Thus, for the above reasons, said rejection is maintained.
Claim 2 stands rejected under 35 U.S.C. 103 as being unpatentable over Alm et al. (WO 2013/075724 A1, May 30, 2013, hereafter as “Alm”) in view of Otto (WO 2014/131742 A1, Sep. 4, 2014, machine translated, hereafter as “Otto”), as applied to claim 1 above, and further in view of Gerrans et al. (US 2012/0259216 A1, Oct. 11, 2012; hereafter as “Gerrans”).
The instant invention is discussed above.
Alm and Otto teach the elements discussed above. Otto additionally teaches that the catheter channel can include a valve mechanism ([0084]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a valve in the catheter of Alm/Otto with a reasonable expectation of success because Otto teaches that a valve mechanism allows for one to control opening and closing the channel as desired.
Alm and Otto are silent to “wherein the balloon catheter comprises a diagnostic probe incorporated or mounted in the distal end of the balloon catheter, wherein the diagnostic probe comprises a marker configured for changing upon a change of at least one biomarker, wherein the change is detectable”.
Gerrans teaches a balloon catheter with drug delivery probe (abstract). Gerrans teaches said probe delivers a diagnostic (e.g., biomarker) and/or therapeutic agent to lumen tissue (abstract; [0029]). Gerrans also teaches that the biomarker/therapeutic agent can be temperature sensitive and can be observed and monitored via various imagining techniques ([0067]-[-0068] and [0092]-[0099]). Gerrans additionally teaches that the probe can located distally of the balloon ([0066]).
The references are drawn to drug delivery devices, including balloon catheters, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a diagnostic probe, wherein the diagnostic probe detects a temperature-sensitive biomarker, and a catheter comprising an optical or electrochemical reader as suggested by Gerrans into the invention of Alm/Otto with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to do so because Gerrans teaches that said balloon catheter yields effective local delivery of temperature-sensitive therapeutic and/or diagnostic agents to a specific target site ([0015]).
It is noted that the instant claims are product claims and any intended use recitation such as “for reading the probe and transmitting the read signal to a displaying element for visually or audibly displaying the change in at least one biomarker” in claim 60 does not alone show patentable distinction. A recitation of intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. In other words, if the prior art structure is capable of performing the intended use, then it meets the claim.
Thus, the combined teachings of Alm, Otto and Gerrans render the instant claim prima facie obvious.
Response to Arguments
Applicant's arguments, filed 2/12/2026, regarding 103 rejection over Alm, Otto and Gerrans have been fully considered but they are not persuasive.
Applicant relies on the same arguments as presented for the 103 rejection over Alm and Otto. No further arguments regarding claim 2 are presented.
For the same reasons as discussed above, Applicant’s arguments are not persuasive.
Thus, said rejection is maintained.
Claims 3 and 4 stand rejected under 35 U.S.C. 103 as being unpatentable over Alm et al. (WO 2013/075724 A1, May 30, 2013, hereafter as “Alm”) in view of Otto (WO 2014/131742 A1, Sep. 4, 2014, machine translated, hereafter as “Otto”), as applied to claim 1 above, and further in view of Hooven (WO 2012/075112 A1, Jun. 7, 2012, hereafter as “Hooven”).
The claimed invention is described above.
Alm and Otto teach the elements discussed above.
Alm and Otto do not explicitly teaches the limitations, wherein the expandable ballon is a compliant balloon or non-compliant balloon (instant claims 3 and 4).
Hooven teaches methods and apparatus for remodeling and/or profiling a tissue lumen and, more particularly, the lumen of the urethra through the male prostate gland involving the use of a balloon catheter ([0002] and [0031]; Fig. 3a). Hooven teaches that the balloon may be either relatively compliant, such as silicone or urethane, or non-compliant, such a polyethylene terephthalate or PET, or of intermediate compliance ([00071]). Hooven also teaches that the treatment balloon(s) can be formed with any suitable material with such degree of compliance as may be desirable for treatment of benign prostatic hyperplasia ([000108]).
The references are all drawn to catheters including catheters for the treatment of the urinary tract, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a compliant or non-compliant balloon catheter in the invention of Alm/Otto as suggested by Hooven with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Hooven teaches that the degree of compliance is directly related to the material employed in the catheter and that compliance can be optimized depending on the degree of compliance desired. One of skill in the art would have reasonably expected that either compliant or non-compliant materials are suitable materials in a balloon catheter.
Thus, the combined teachings of Alm, Otto and Hooven render the instant claims prima facie obvious.
Response to Arguments
Applicant's arguments, filed 2/12/2026, regarding 103 rejection over Alm, Otto and Hooven have been fully considered but they are not persuasive.
Applicant relies on the same arguments as presented for the 103 rejection over Alm and Otto. No further arguments regarding claims 3 and 4 are presented.
For the same reasons as discussed above, Applicant’s arguments are not persuasive.
Thus, said rejection is maintained.
Claim 18 stands rejected under 35 U.S.C. 103 as being unpatentable over Alm et al. (WO 2013/075724 A1, May 30, 2013, hereafter as “Alm”) in view of Otto (WO 2014/131742 A1, Sep. 4, 2014, machine translated, hereafter as “Otto”), as applied to claim 1 above, and further in view of Lu et al. (US 2007/0077348 A1, Apr. 5, 2007, hereafter as “Lu”).
The claimed invention is described above.
Alm and Otto teach the elements discussed above. Alm and Otto additionally teach coatings (Alm at page 29, lines 11-14; Otto at [0063]).
Alm and Otto do not explicitly teach an antimicrobial coating.
Lu teaches a process of providing durable antimicrobial surfaces by treating polymer substrates including medical devices such as catheters and balloons with an antimicrobial peptide (abstract; [0066]). Lu teaches that said antimicrobial coatings are useful in reducing the risk of infection ([0002]).
The references are all drawn to medical devices including catheters, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include an antimicrobial coating on the balloon catheter of Alm/Otto as suggested by Lu with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Alm and Otto generally teach the inclusion of coating and Lu specifically teaches antimicrobial coatings which are useful in reducing the risk of infection in a patient. One of skill in the art would have reasonably expected the balloon catheter of Alm/Otto with the additional benefit of an antimicrobial coating.
Thus, the combined teachings of Alm, Otto and Lu render the instant claims prima facie obvious.
Response to Arguments
Applicant's arguments, filed 2/12/2026, regarding 103 rejection over Alm, Otto and Lu have been fully considered but they are not persuasive.
Applicant relies on the same arguments as presented for the 103 rejection over Alm and Otto. No further arguments regarding claim 18 are presented.
For the same reasons as discussed above, Applicant’s arguments are not persuasive.
Thus, said rejection is maintained.
Claims 18 and 20 stand rejected under 35 U.S.C. 103 as being unpatentable over Alm et al. (WO 2013/075724 A1, May 30, 2013, hereafter as “Alm”) in view of Otto (WO 2014/131742 A1, Sep. 4, 2014, machine translated, hereafter as “Otto”), as applied to claim 1 above, and further in view of Ahearn et al. (Effects of Hydrogel/Silver Coatings on In Vitro Adhesion to Catheters of Bacteria Associated with Urinary Tract Infections, Current Microbiology, Vol. 41 (2000), pp. 120–125; hereafter as “Ahearn”).
The claimed invention is described above.
Alm and Otto teach the elements discussed above including a hydrogel as a guest polymer. Alm and Otto additionally teach coatings (Alm at page 29, lines 11-14; Otto at [0063]).
Alm and Otto do not explicitly teach an antimicrobial coating (instant claim 18) or a coating on at least part of the inner and/or the outer surface of the membrane, wherein the coating comprises a material identical to the guest polymer (instant claim 20).
Ahearn teaches hydrogel/silver coatings on urinary catheters (abstract). Ahearn teaches that the hydrogel/silver coatings significantly reduced the primary adhesion of representative urinary tract infection (UTI)-associated bacteria and C. albicans to catheter surfaces as compared with an uncoated surface (page 123, right col., last para.). Ahearn further teaches that clinical trials reported the hydrogel/silver coated catheter was effective in reducing the risk of infection of various microbes (para. bridging pages 124-125).
The references are all drawn to medical devices including catheters, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include an antimicrobial silver/hydrogel coating on the balloon catheter of Alm/Otto as suggested by Ahearn with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Alm and Otto generally teach the inclusion of coating and Ahearn specifically teaches a silver/hydrogel coating that is effective in reducing the risk of infection in a patient. One of skill in the art would have reasonably expected the balloon catheter of Alm/Otto with the additional benefit of an antimicrobial/anti-infective coating.
Thus, the combined teachings of Alm, Otto and Ahearn render the instant claims prima facie obvious.
Response to Arguments
Applicant's arguments, filed 2/12/2026, regarding 103 rejection over Alm, Otto and Ahearn have been fully considered but they are not persuasive.
Applicant relies on the same arguments as presented for the 103 rejection over Alm and Otto. No further arguments regarding claims 18 and 20 are presented.
For the same reasons as discussed above, Applicant’s arguments are not persuasive.
Thus, said rejection is maintained.
New Rejections
In light of Applicant’s amendments, the following rejections have been newly added:
Claim Objections
Claim 23 is objected to because of the following informalities: the article “an” should be inserted prior to “anti-infection drug” in the last line of the claim. Appropriate correction is requested.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 23 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
37 CFR §1.118 (a) states that "No amendment shall introduce new matter into the disclosure of an application after the filing date of the application".
There is no explicit or implicit teaching in the specification for an anti-infection drug; the subject matter was not properly described as filed. The instant disclosure recites the particular drug classes, antifungals, antimicrobials, bactericides, biocides, etc. (page 18, lines 1-14); however there is the original disclosure does not provide support for the broader terminology, an “anti-infection drug”. Applicant is invited to identify the portion of the specification that teaches said limitation, as the examiner has not been able to locate the applicable disclosure. The claims within this rejection are examined as written by the applicant; at this time new matter must be considered as part of the claimed subject matter.
MPEP 2163.06 notes: "If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112, first paragraph - written description requirement. In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981)." MPEP 2163.02 teaches that "Whenever the issue arises, the fundamental factual inquiry is whether a claim defines an invention that is clearly conveyed to those skilled in the art at the time the application was filed...If a claim is amended to include subject matter, limitations, or terminology not present in the application as filed, involving a departure from, addition to, or deletion from the disclosure of the application as filed, the examiner should conclude that the claimed subject matter is not described in that application. MPEP 2163.06 further notes "When an amendment is filed in reply to an objection or rejection based on 35 U.S.C. 112, first paragraph, a study of the entire application is often necessary to determine whether or not "new matter" is involved. Applicant should therefore specifically point out the support for any amendments made to the disclosure".
This is a new matter rejection. Correction is respectfully requested.
Conclusion
All claims have been rejected; no claims are allowed.
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY HAGOPIAN whose telephone number is (571)272-6097. The examiner can normally be reached on M-F 9:00 am - 5:00 pm.
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Casey S. Hagopian
Examiner, Art Unit 1617
/CARLOS A AZPURU/Primary Examiner, Art Unit 1617