DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-2,7,10,12-14,17,21,23 and 28-32 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.
The examiner notes that while the drugs may still be interpreted as within the pores, as they are located and travel through the pores. The examiner notes that while Beyar does disclose a thickness of the balloon and one or more apertures, the limitation of specifically that the drugs are within a thickness of the wall is not clear from the disclosure of Beyar.
The examiner relies on the new reference Magana et al. US 20100249702, hereafter Magana 0124466 to further detail the rejection.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2,10,12-14,23,29,32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beyar et al. WO 2012/156914 previously provided and attached by the examiner (on 12/29/25), hereafter Beyar and further in view of Magana et al. US 2010/0249702, hereafter Magana.
Regarding claim 1, Beyar and Magana teach a tube device (figure 1A) comprising: an elongate tube body (shaft 106) having an exterior surface (external wall of shaft 106), an interior surface (internal wall of shaft 106), and at least one lumen extending between a proximal end and a distal end (document page 17, line 25-30, defining that the shaft is a tubular member where said shaft comprises a lumen). The examiner notes that as the balloon (104) is attached to the shaft and communicates with the inner lumen of the shaft (page 17, lines 25-30), the balloon is interpreted as part of the tube body. Beyar further discloses at least one drug loaded on the tube body (document page 17, line 29-30, where drug is delivered through the shaft, see also document page 13, lines 27-30). The examiner notes that per the page 13 citation, the drug may be loaded into the balloon, and thus is loaded through the lumen (as the balloon is connected through the lumen of the shaft). The examiner notes that as the drug is delivered through the pores, it is interpreted that said loading of the drug within the balloon and shaft is interpreted to be loading the drug on the tube body in the pores. Therefore, as Beyar teaches that in embodiments it is suitable to preload the drug on the tube body as a method of using the device, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to load the drug on the body (interpreted above as in the pores) with the embodiment of figure 1A of Beyar.
The examiner notes that as detailed under the response to arguments Magana is brought in to teach the amended limitations of the drug being located within the thickness of the wall. Beyar does disclose a thickness in the balloon is it not clear that the drug is specifically within the thickness. Magana teaches a drug delivery device where the tubing is formed from a balloon containing pores, where said pores can be loaded with therapeutic agents and ejected into the vascular wall. The pores are formed by impurities (59 per para. 0043), where said impurities can be seen within the thickness of the wall seen in figures 11 and 12. Therefore, the pores of Magana are being used both as a conduit for drug delivery and a location at which the drug is loaded. As the pore of Beyar are used to deliver the drug (as stated in the previous rejection and per applicant’s admission in the remarks page 9), and Magana teaches that pores for delivering the fluid may also be loaded with the drugs, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to specifically load the drugs of Beyar in the pores of the wall of the balloon. Doing so would merely require combining prior art elements according to known methods to yield predictable results, that being the delivery of drugs through a catheter and thus a prima facie case of obviousness exists.
The prior art as previously applied also does not specifically state that the device comprises apertures connecting the lumen to the exterior of the tube body. The examiner notes that while this language is broad and merely an open end of the tube could be interpreted as an aperture through which the lumen connects outside the tube, in an effort to achieve compact prosecution the examiner again relies on Magana. Magana figure 15 depicts the tube body in which the impurities (59) used to form the pores in which a drug is loaded are provided alongside “injection ports” (24) (see para. 0030) that extend through the wall of the tube and thus extend between an inner lumen and the exterior. Said ports allow fluid to be dispensed and have significant influence on the effectiveness of the therapeutic agents by enhancing the delivery of the agents into endothelial gaps. Therefore, as Magana teaches that injection ports alongside pores create a significant influence on the effectiveness of therapeutic agents, it would have further been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to include injection ports (interpreted as apertures) along side the pores in the wall of Beyar, to further aid in effectively delivery agents. Doing so would merely require Combining prior art elements according to known methods to yield predictable results, that being the delivery of therapeutic agents, and thus a prima facie case of obviousness exists.
Regarding claim 2, Beyar and Magana teach, the device of claim 1, wherein the tube body is porous, such that the at least one drug is loaded within pores of the porous tube body (document page 17, line 27-30). The examiner notes that per said citation, the shaft includes openings within the balloon (104) to allow for inflation and drug delivery through the lumen of the shaft. The balloon itself also comprises pores (120). The examiner notes that per the claim 1 rejection, per 13, lines 27-30, the drug may be loaded into the balloon, and thus is loaded through the lumen (as the balloon is connected through the lumen of the shaft). The examiner notes that as the drug is delivered through the pores, it is interpreted that said loading of the drug within the balloon and shaft is interpreted to be loading the drug on the tube body in the pores. Thus, Beyar reads to the claimed limitation. The examiner notes that with regard to the amendments filed 06/16/2026, required that the thickness is porous and the drug is positioned within the pores, the updated rejection of claim 1 in view of Magana reads to this limitation.
Regarding claim 7, The device of claim 2, wherein the at least one drug is loaded in a drug-release polymer within the pores following removal of at least one solvent (page 45, lines 7-12). The examiner notes that per said citation, one example used Rapamycin encapsulated in a polymer. The examiner notes that per the rejection of claim 2, the drug is loaded into the pores. Thus, the drug release polymer containing the drug is loaded into the pores.
Regarding claim 10, Beyar and Magana teach the device of claim 1, wherein the tube body comprises at least one flexible region positioned between the proximal end and the distal end. The examiner notes that per the abstract and page 9 lines 4-5, the catheter may be made from a compliant material and thus is interpreted to have at least one flexible region as a compliant material is flexible.
Regarding claim 12, Beyar and Magana teach the device of claim 1, wherein the tube body has an outer diameter between about 1 mm (3 Fr) to about 11.3 mm (34 Fr). Per page 19, lines 15-20, the shaft diameter may be less than 10mm to less than 3mm. Based on said range it is interpreted that the diameter may be within a range of 0-10mm. As such that prior art range overlaps with the claimed range and therefore Beyar reads to the claimed limitation.
Regarding claim 13, Beyar and Magana teach the device of claim 1, wherein the tube body has a diameter of 0-10mm (Per page 19, lines 15-20, the shaft diameter may be less than 10mm to less than 3mm) but fails to specifically disclose an inner diameter between about 0.5 mm to about 10 mm. The examiner notes however, that the inner diameter would be less than the outer diameter of the catheter. As, for example, 9mm is a suitable outer diameter, the inner diameter would have to be at least between 0 and 9mm(for example 8mm). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to select an inner diameter within the claimed range as the inner diameter must be less than the outer diameter, and the outer diameter is within the claimed range. It has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Therefore, as an outer diameter between 0 and 10mm is a suitable dimension (for example 9mm) and the inner diameter must be smaller than the outer diameter, and the claimed range lies inside the prior art range, a prima facie case of obviousness exists.
Regarding claim 14, Beyar and Magana teach the device of claim 1, wherein the tube body comprises one or more apertures fluidly connected to the at least one lumen (document page 17, line 29-30, where the shaft includes openings to allow flow through the lumen into the balloon).
Regarding claim 23, Beyar and Magana teach the device of claim 10, wherein the at least one flexible region comprises a section of the tube body constructed from a flexible and stretchable membrane. The examiner notes that per the rejection of claim 10, Beyar per page 9 lines 4-5 discloses that the catheter may be made from a compliant material and thus is interpreted to have at least one flexible region as a compliant material is flexible. Thus the at least one flexible region include the tube body being constructed from a flexible membrane.
Regarding claim 29, Beyar and Magana teach the device of claim 1, wherein the elongate tube body comprises a flexible and stretchable membrane. The examiner notes that per the abstract and page 9 lines 4-5, the catheter may be made from a compliant material and thus is interpreted to be made from a flexible and stretchable membrane.
Regarding claim 32, Beyar and Magana teach the device of claim 1, where said device is inserted into the body and delivers a drug (page 9 lines 1-7) where treatment may include locations such as the trachea. Therefore, it is interpreted that the device may include treatment of wherein the tube device forms part of a medical device selected from the group consisting of: endotracheal tubes. However, should applicant disagree, the examiner notes that per MPEP Section 2114 II, "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Therefore, as Beyar and Magana teach the required structural limitations of the claim, that being a tube device with a tube body and lumen and at least one drug loaded on the body, where use in various medical apparatuses is interpreted to be an intended use of the device, Beyar is understood to read to the claimed limitation.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beyar and Magana in view of Palasis et al. US 2004/0204672, hereafter Palasis.
Regarding claim 17, Beyar and Magana teach the device of claim 1, but fails to teach wherein the at least one drug comprises one or more anesthetic selected from the group consisting of: articaine, benzocaine, benzonatate, bupivacaine, chloroprocaine, cinchocaine, diclofenac-diethylamine,dimethocaine, eucaine, etidocaine, exparel, hexylcaine, levobupivacaine, lidocaine, mepivacaine, meprylcaine, oxybuprocaine, phenacaine, piperocaine, pramocaine, prilocaine, procaine, proparacaine, quinisocaine, ropivacaine, tetracaine, and trimecaine.
Palasis teaches a drug delivery catheter and is thus considered analogous to the claimed invention. Palasis teaches that therapeutic agents that may be delivered include rapamycin (also disclosed in Beyar), lidocaine, bupivacaine, and ropivacaine, among more. Therefore, as Palasis teaches that drug delivery catheters may use various agents, such as rapamycin, lidocaine, and more, it would have been obvious to use lidocaine as the agent of Beyar instead of rapamycin, as Palasis teaches that lidocaine and rapamycin are both suitable to be delivered by catheters. Doing so would merely involve simple substitution of one known element (rapamycin) for another (lidocaine) to obtain predictable results (delivery through a catheter), and thus a prima facie case of obviousness exists.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beyar and Magana in view of Benjamin US 2001/0016702, hereafter Benjamin.
Regarding claim 21, Beyar and Magana teach the device of claim 1, but fails to teach the device further comprising a protective sheath encasing at least a portion of the tube body.
Benjamin teaches a catheter and is thus considered analogous to the claimed invention. Benjamin teaches that suitable construction of a catheter shaft includes an outer sheath (110) and inner sheath (105) and a braid (115) (para. 0032). Therefore, it would have been obvious to one having ordinary skill in the art to provide the shaft of Beyar with a sheath construction as taught in Benjamin, as Benjamin teaches that said sheath construction is known in the art to be suitable for catheters. Doing so would merely involve applying a known technique (sheath formation of the shaft) to a known device (method, or product) ready for improvement to yield predictable results (that being construction of a catheter shaft), and thus a prima facie case of obviousness exists.
. Claim(s) 28,30-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beyar and Magana in view of Makower et al. US 2005/0245906, hereafter Makower.
Regarding claim 28, Beyar and Magana teach the device of claim 1, where the body may be a compliant material per the abstract and page 9 lines 4-5, but fails to teach wherein the elongate tube body comprises ultra-high-molecular-weight polyethylene.
Makower teaches an implantable drug delivery device and is thus considered analogous to the claimed invention. Makower teaches that device includes a tube, where said tube may be made from any suitable material including ultra-high molecular weight polyethylene (para. 0085). Therefore, as Makower teaches that implanted drug delivery tubes may be suitably made from ultra-high molecular weight polyethylene, it would have been obvious to one having ordinary skill in the art to make the catheter (drug delivery tube) of Beyar out of ultra-high molecular weight polyethylene, as said material is known to be suitable for the intended purpose of being inserted into the body and delivering a drug through it and thus a prima facie case of obviousness exists.
Regarding claim 30, Beyar and Magana teach the device of claim 29, where the body may be a compliant material per the abstract and page 9 lines 4-5, but fails to teach wherein the flexible and stretchable membrane comprises a silicone.
Makower teaches an implantable drug delivery device and is thus considered analogous to the claimed invention. Makower teaches that device includes a tube, where said tube may be made from any suitable material including silicone rubber (para. 0085). Therefore, as Makower teaches that implanted drug delivery tubes may be suitably made from silicone rubber, it would have been obvious to one having ordinary skill in the art to make the catheter (drug delivery tube) of Beyar out of silicone rubber, as said material is known to be suitable for the intended purpose of being inserted into the body and delivering a drug through it and thus a prima facie case of obviousness exists.
Regarding claim 31, Beyar and Magana teach the device of claim 1, where the body may be a compliant material per the abstract and page 9 lines 4-5, but fails to teach wherein the elongate tube body comprises a silicone tube.
Makower teaches an implantable drug delivery device and is thus considered analogous to the claimed invention. Makower teaches that device includes a tube, where said tube may be made from any suitable material including silicone rubber (para. 0085). Therefore, as Makower teaches that implanted drug delivery tubes may be suitably made from silicone rubber, it would have been obvious to one having ordinary skill in the art to make the catheter (drug delivery tube) of Beyar out of silicone rubber, as said material is known to be suitable for the intended purpose of being inserted into the body and delivering a drug through it and thus a prima facie case of obviousness exists.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Matthew Wrubleski whose telephone number is (571)272-1150. The examiner can normally be reached M-F 8:00-4:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781 /ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
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