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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/23/25 has been entered.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 4, 10-11, 16-18, 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spearman et al. (US 2018/0071118 A1).
With regard to claim 1, Spearman discloses A catheter (Fig. 1 and Fig. 2a), comprising: an elongated body (generally where 4 is pointing) defining one or more lumen (at 6); the elongated body comprising a biodegradable crosslinked polymer ([0028], first aqueous-swellable biocompatible and biodegradable polymer or mixture of polymers; also a list of possible materials are found in [0034]); wherein: the biodegradable crosslinked polymer has a differentiated crosslinked density through a cross-sectional portion of the elongated body (stent body/catheter can be made of a first and second aqueous-swellable polymer that has different densities to alter the swellable [0029] the second layer may be less swellable due to relative increase in density); the differentiated crosslinked density leads to differentiated swelling of the elongated body due to water uptake ([0029], different density material is used such that the second layer may be less swellable).
With regard to claim 4, Spearman discloses further comprising: a delivery system comprising at least one moiety (22 barrier layer) embedded within the elongated body, the moiety configured to controllably release an agent encapsulated within the moiety ([0046], control transport solvents and solutes along the lumen wall).
With regard to claim 10, Spearman discloses further comprising: an anchoring mechanism configured to anchor the catheter to tissue (anchoring is due to the surface friction of the outside of the catheter once it has swelled as shown in Fig. 1c, [0045] and as shown in Fig. 2a, [0006]).
With regard to claim 11, Spearman discloses wherein: the anchoring mechanism includes any one or combination of: surface roughness of the catheter ([0006], [0045], the outer surface after swelling forms an anchor by pushing against the lumen of the body); nano- or micro- structures formed on a surface of the catheter; porous structures formed on a surface of the catheter; or adhesion moieties formed on a surface of the catheter.
With regard to claim 16, Spearman discloses A method of administering peripheral nerve block, the method comprising: inserting a catheter (claim 12) in tissue of a patient, the catheter comprising a biodegradable crosslinked polymer ([0028], first aqueous-swellable biocompatible and biodegradable polymer or mixture of polymers; also a list of possible materials are found in [0034]); wherein: the biodegradable crosslinked polymer has a differentiated crosslinked density through a cross-sectional portion of the elongated body (stent body/catheter can be made of a first and second aqueous-swellable polymer that has different densities to alter the swellable [0029] the second layer may be less swellable due to relative increase in density); the differentiated crosslinked density leads to differentiated swelling of the elongated body due to water uptake ([0029], different density material is used such that the second layer may be less swellable); allowing the catheter to swell so as to cause catheter anchorage to the tissue ([0006]); delivering agent via the catheter ([0046], 22 delivers solvents and solutes through the lumen); and allowing the catheter to biodegrade ([0041]).
With regard to claim 17, Spearman discloses wherein: swelling is the only form of tissue anchorage for the catheter (Fig. 1 and 2 show no other tissue anchorage).
With regard to claim 18, Spearman discloses wherein: the catheter includes an elongated body (see Fig. 1a and Fig. 2a) defining one or more lumen (6 or 24); swelling at or near the one or more lumen is less than swelling at an outer periphery of the elongated body ([0029]).
With regard to claim 20, Spearman discloses further comprising: delivering agent via at least one moiety embedded within the catheter (barrier layer 22 delivers solvents and solutes along the lumen, [0046]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spearman et al. (US 2018/0071118 A1) in view of Bruggeman et al. (WO 2008/144514 A2).
With regard to claim 2, Spearman discloses the claimed invention except for a citrate/xylitol-based elastomer (CXBE).
Bruggeman teaches a catheter that can be made of citrate/xylitol-based elastomers ([0205], [0056]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Spearman with the material of Bruggeman because the substitution of one known material for another for use in medical catheters would not alter the overall function of the device ([0056]).
Claim(s) 3, 5, 6, 7, 8, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spearman et al. (US 2018/0071118 A1) in view of Ramos et al. (US 2015/0366462 A1).
With regard to claim 3, Spearman discloses the claimed invention except for a sensor.
Ramos teaches catheter (Fig. 1 and 3) further comprising: a monitoring system comprising at least one moiety embedded within the elongated body, the moiety configured as a sensor [[0028], temperature sensor 20 is embedded in the catheter 10).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Spearman with the embedded sensor as taught by Ramos for the purpose of transmitting information wirelessly to an external display to monitor the conditions within the body ([0028]).
With regard to claim 5 and 21, Spearman discloses the claimed invention except for an embedded moiety for modulating flow.
Ramos teaches an embedded sensor (20) that is used to modulate flow of an agent through the lumen or portion of the elongated body ([0028], temperature data is used to manage treatment (abstract) and is therefore considered to “modulate” flow. Further definition of the term modulate may help to overcome the current rejection).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Spearman with the embedded sensor as taught by Ramos for the purpose of transmitting information wirelessly to an external display to monitor the conditions within the body ([0028]).
With regard to claim 6, Spearman discloses a delivery system comprising an encapsulation material (22) that releases an agent upon degradation of the encapsulation or a shape memory material that releases an agent upon being activated ([0046]); and a modulation system (the system of the expandable catheter in combination with the barrier layer) that controls the degradation of the encapsulation material or controls the activation of the shape memory material (.
However, Chappa/Courage does not disclose an embedded sensor.
Ramos teaches catheter (Fig. 1 and 3) further comprising: a monitoring system comprising at least one moiety embedded within the elongated body, the moiety configured as a sensor [[0028], temperature sensor 20 is embedded in the catheter 10).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Chappa/Courage with the embedded sensor as taught by Ramos for the purpose of transmitting information wirelessly to an external display to monitor the conditions within the body ([0028]).
With regard to claim 7, Chappa discloses Chappa discloses a delivery system comprising an encapsulation material (90) that releases an agent upon degradation of the encapsulation or a shape memory material that releases an agent upon being activated ([0055], [0004]); and a modulation system (the system of the expandable catheter in combination with the rails and coating 90 form a system that controls the delivery of the agent via the degradable coating, [0055]) that controls the degradation of the encapsulation material or controls the activation of the shape memory material ([0044]).
However, Spearman does not disclose an embedded sensor.
Ramos teaches catheter (Fig. 1 and 3) further comprising: a monitoring system comprising at least one moiety embedded within the elongated body, the moiety configured as a sensor [[0028], temperature sensor 20 is embedded in the catheter 10). Ramos further teaches a power harvester ([0044]) in electrical connection with the embedded sensor.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Spearman with the power harvester as taught by Ramos for the purpose of provide power to the sensor ([0044]).
With regard to claim 8, Spearman discloses the claimed invention except for a wireless module.
Ramos teaches further comprising: a wireless module in electrical connection with the power harvester and in wireless communication with an operating module ([0046]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Spearman with the wireless module as taught by Ramos for the purpose of reducing the need for additional components such as wires to be connected to the device ([0028]).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spearman et al. (US 2018/0071118 A1) in view of Ramos et al. (US 2015/0366462 A1) and in further view of Pursley (US 6,030, 371).
With regard to claim 9, Spearman/Ramos teach the claimed invention except for electrodes.
Pursley teaches a catheter that can have sensors embedded in the walls (101/101’) that form a pair of electrodes configured to generate electrical stimuli (the use of the phrase “configured to” implies functional language and therefore only the structure must be taught in the prior art and be capable of performing the recited function, Col 8, lines 63-end).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Spearman/Ramos with the electrodes as taught by Pursely because the substation of one known sensor for another is well known in the art and does not alter the overall function of the device.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spearman et al. (US 2018/0071118 A1) in view of Bruggeman et al. (WO 2008/144514 A2) and in further view of Edelman et al. (WO 2006/127907 A2).
With regard to claim 12, Spearman/Bruggeman teach the claimed invention except for epinephrine.
Edelman teaches epinephrine can be embedded within a controlled release polymer ([0068]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Spearman/Bruggeman with the epinephrine as taught by Edelman for the purpose of providing the heart with contractile support and further because the substation of one medication for another is well-known in the art and does not alter the overall function of the device ([0068]).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spearman et al. (US 2018/0071118 A1) in view of Lee et al. (WO 2011/031855 A2).
With regard to claim 13, Spearman discloses the claimed invention except for lidocaine.
Lee teaches a polymer that can be permeable and include lidocaine ([0040]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Spearman with the lidocaine as taught by Lee because the substation of one medication for another is well-known in the art and does not alter the overall function of the device ([0040]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spearman et al. (US 2018/0071118 A1) in view of Patel (US 2006/0052766 A1).
With regard to claim 14, Spearman discloses the claimed invention except for a fluorescent polymer.
Patel teaches a catheter made of a polymer further having fluorescent polymer ([0024]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Spearman with the fluorescent polymer as taught by Patel for the purpose of better visualization ([0024]).
Claim(s) 19, 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spearman et al. (US 2018/0071118 A1) in view of Ramos (US 2015/0366462 A1) and in further view of Imran (US 2012/0296259 A1).
With regard to claim 19, Spearman discloses the claimed invention except for monitoring of the material degradation.
Ramos teaches the use of embedded sensors in a catheter ([0049]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Spearman with the embedded sensor as taught by Ramos for the purpose of transmitting information wirelessly to an external display to monitor the conditions within the body ([0028]).
However, Spearman/Ramos do not teach the sensor is one that monitors functionality and material degradation of the catheter.
Imran teaches a sensor as part of a medical system that can monitor the functionality and material degradation of a biodegradable material ([0015], “sensing the state of disintegration”).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Spearman/Ramos teaches the monitoring of degradation as taught by Imran for the purpose of controlling the delivery of agent to the body ([0015]).
With regard to claim 22, Spearman discloses a delivery system comprising an encapsulation material (22) that releases an agent upon degradation of the encapsulation or a shape memory material that releases an agent upon being activated ([0046]); and a modulation system (the system of the expandable catheter in combination with the barrier layer 22) that controls the degradation of the encapsulation material or controls the activation of the shape memory material ([0044]).
However, Spearman does not teach providing electrical power.
Ramos teaches providing electrical power ([0044, via a battery) to the monitoring moiety (sensor).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Spearman with the electrical power as taught by Ramos for the purpose of provide power to the sensor ([0044]).
However, Spearman/Ramos do not teach the monitoring of material degradation.
Imran teaches a sensor as part of a medical system that can monitor the functionality and material degradation of a biodegradable material ([0015], “sensing the state of disintegration”).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Spearman/Ramos teaches the monitoring of degradation as taught by Imran for the purpose of controlling the delivery of agent to the body ([0015]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-22 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
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, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Lauren P Farrar/Primary Examiner, Art Unit 3783