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 .
Claim Objections
Claim 114 is objected to because of the following informalities: Line 9 recites “an injection lumen” but line 3 already introduces “at least one injection lumen”; since it is clear that the “injection lumen” of line 9 is intended to be the same as the “at least one injection lumen” of line 3, line 9 should be amended to recite “[[an]] the at least one injection lumen”. Appropriate correction is required.
Claim 129 is objected to because of the following informalities: The phrase “the injection lumen” on line 2 should be amended to recite “the at least one injection lumen” to match the language of claim 114. Appropriate correction is required.
Claim 132 is objected to because of the following informalities: The term “couple” on line 2 should be amended to recite “coupled” in order to be grammatically correct. Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 114, 116, 121, 124, 125 and 129 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 9, 10, 11 and 16 of U.S. Patent No. 11,654,267.
Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of pending claims 114, 116, 121, 124, 125 and 129 is fully disclosed in patented claims 1, 6, 9, 10, 11 and 16. Specifically, the subject matter of pending claim 114 (a medical instrument comprising a catheter shaft with three lumen, an inflatable body, a tissue penetrating member and at least one radio-opaque protective element) is fully disclosed in patented claim 1 (with patented claim 1 being more narrow than pending claim 114 by also requiring a hub and a flexible drug line tubing), the subject matter of pending claim 116 (wherein the at least one protective element is on a lateral side of the tissue penetrating member) is fully disclosed in patented claim 6, the subject matter of pending claim 121 (wherein the at least one protective element is integrated with the inflatable body) is fully disclosed in patented claim 11, the subject matter of pending claim 124 (wherein the at least one protective element is provided in a specific pattern or shape) is fully disclosed in patented claim 9, the subject matter of pending claim 125 (wherein the specific pattern or shape is asymmetric) is fully disclosed in patented claim 10, and the subject matter of pending claim 129 (wherein the tissue penetrating member is in fluid communication with the at least one injection lumen) is fully disclosed in patented claim 16.
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.
Claims 114-124 and 127-133 are rejected under 35 U.S.C. 103 as being unpatentable over Seward et al. (PG PUB 2008/0228136) in view of Kelley et al. (US Pat 7,413,558) and O’Brien et al. (PG PUB 2005/0245864).
Re claim 114, Seward discloses a medical instrument 10 (Fig 1A; it is noted that all reference characters cited below refer to Fig 1A-2B unless otherwise noted) for localized drug delivery to tissue (Para 54), comprising: a catheter shaft assembly 20 having a proximal end (to the left in Fig 1A), a distal end (to the right in Fig 1A), a longitudinal axis 12b between the proximal and distal ends (as seen in Fig 1A), at least one injection lumen 14d (Para 55) and at least one inflation lumen 26 (Para 50); an inflatable body 12 at the distal end of the catheter shaft assembly (as seen in Fig 1A), the inflatable body being inflatable from an involuted contracted configuration (seen in Fig 1B); a tissue penetrating member 14 coupled to the inflatable body in an orientation transverse to the longitudinal axis of the catheter shaft assembly with a tip end 14a of the tissue penetrating member pointing outwardly of the inflatable body (as seen in Fig 1B) and coupled to the at least one injection lumen of the catheter shaft assembly (Para 55), wherein the tissue penetrating member is enclosed within walls of the inflatable body when in the involuted contracted configuration (as seen in Fig 1B). Seward discloses that the catheter shaft assembly can be inserted over a guidewire (Para 57) but does not explicitly disclose that the shaft assembly includes a guidewire lumen (in addition to the injection lumen 14d and the inflation lumen 26); Seward also does not disclose that the medical instrument also comprises at least one protective element coupled to the inflatable body in proximity to the tissue penetrating member, wherein the at least one protective element is radio-opaque and borders the tip end of the tissue penetrating member when the inflatable body is in the involuted contracted configuration.
Kelley, however, teaches a medical instrument 20 (Fig 1; it is noted that all reference characters cited below refer to Fig 2-4 unless otherwise noted) comprising a catheter shaft assembly 28, an inflatable body 30 being inflatable from an involuted contracted configuration (as seen in Fig 4), a tissue penetrating member 44 coupled to the inflatable body in an orientation transverse to a longitudinal axis of the catheter shaft assembly with a tip end 48 of the tissue penetrating member pointing outwardly of the inflatable body (as seen in Fig 4), and a protective element 46 coupled to the inflatable body in proximity to the tissue penetrating member (as seen in Fig 3,4; Col 6, Lines 19-23), wherein the protective element borders the tip end of the tissue penetrating member when the inflatable body is in the involuted contracted configuration (as seen in Fig 4; Col 6, Lines 46-52); Kelley teaches that providing a protective element covers and protects the tip end of the penetrating member when the inflatable body is in the involuted contracted configuration (Col 6, Lines 46-52). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Seward to include a protective element, as taught by Kelley, for the purpose of covering and protecting the tip end of the penetrating member when the inflatable body is in the involuted contracted configuration (Col 6, Lines 46-52). Kelley does not explicitly disclose that the at least one protective element is radio-opaque or that the shaft assembly includes a guidewire lumen.
O’Brien, however, teaches a medical instrument 20 (Fig 1; it is noted that all reference characters cited below refer to Fig 1-3 unless otherwise noted) comprising a catheter shaft assembly 32 having an inflation lumen (within tube 44, Para 25) and a guidewire lumen 45b (within tube 32, Para 26) having an axis that is offset from an axis of the inflation lumen (as seen in Fig 3; Para 8), an inflatable body 24, a tissue penetrating member 48, and at least one protective element 50 (comparable to protective element 46 of Kelley) that is coupled to the inflatable body in proximity to the tissue penetrating member (as seen in Fig 3) and is radio-opaque (Para 32; “the blade pad 50 can be made of a polymeric material […] doped with a radio-opaque material”); O’Brien teaches that providing a guidewire lumen separate to and axially offset from the inflation lumen ensures that the tissue penetrating member is driven in a pre-selected direction during inflation of the inflatable body (Para 9) and also teaches that providing the protective element as radio-opaque allows for fluoroscopy to be used to obtain an image of the instrument and guide proper orientation of the penetrating member (Para 32,35).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Seward to include a guidewire lumen, as taught by O’Brien, for the purpose of ensuring that the tissue penetrating member is driven in a pre-selected direction during inflation of the inflatable body (Para 9) and it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Kelley to include the protective element as radio-opaque, as also taught by O’Brien, for the purpose of allowing for fluoroscopy to be used to obtain an image of the instrument and guide proper orientation of the penetrating member (Para 32,35).
Re claim 115, Seward (as modified by Kelley and O’Brien in the rejection of claim 114) discloses that the inflatable body comprises a U-shaped cross-section in the involuted contracted configuration (as seen in Fig 1B; Para 82).
Re claim 116, Seward (as modified by Kelley and O’Brien in the rejection of claim 114) discloses all the claimed features with Kelley teaching that the at least one protective element comprises a protective element on a lateral side of the tissue penetrating member when the inflatable body in the involuted contracted configuration (as seen in Fig 4, the protective element 46 extends to both lateral sides of the tissue penetrating member 44). The motivation set forth in the rejection of claim 114 also applies to this claim.
Re claim 117, Seward (as modified by Kelley and O’Brien in the rejection of claim 114) discloses all the claimed features with Kelley teaching that the at least one protective element is configured to protect the inflatable body from damage by the tip end of the tissue penetrating member during a use of the medical instrument (Col 6, Lines 46-52). The motivation set forth in the rejection of claim 114 also applies to this claim.
Re claim 118, Seward (as modified by Kelley and O’Brien in the rejection of claim 114) discloses that the use of the medical instrument comprises an inflation of the inflatable body (Para 49).
Re claims 119 and 120, Seward (as modified by Kelley and O’Brien in the rejection of claim 114) discloses all the claimed features with O’Brien teaching that the at least protective element comprises the metal tungsten (Para 29). Since the inclusion of the metal is what causes the radiopacity, the motivation cited in the rejection of claim 114 above also applies to these claims.
Re claim 121, Seward (as modified by Kelley and O’Brien in the rejection of claim 114) discloses all the claimed features with Kelley teaching that the at least one protective element is integrated with the inflatable body (as seen in Fig 3; Col 6, Lines 43-45). The motivation set forth in the rejection of claim 114 also applies to this claim.
Re claims 122 and 123, Seward (as modified by Kelley and O’Brien in the rejection of claim 114) discloses that the penetrating member 14 is formed of parylene (Para 56); since the modification of Seward with the protective element of Kelley would place the penetrating member directly on top of the protective element (as seen in the arrangement of Fig 3 of Kelley), the material of the penetrating member would cover a center portion of the protective element (as seen in Fig 3 of Kelley). Therefore, one of ordinary skill in the art would interpret the parylene material of the penetrating member as a “covering material” of the protective element.
Re claim 124, Seward (as modified by Kelley and O’Brien in the rejection of claim 114) discloses all the claimed features with Kelley teaching that the at least one protective element is provided in a specific pattern or shape (as seen in Fig 2, the specific shape is a rectangle). The motivation set forth in the rejection of claim 114 also applies to this claim.
Re claim 127, Seward (as modified by Kelley and O’Brien in the rejection of claim 114) discloses all the claimed features with Kelley teaching that the at least one protective element changes orientation as the inflatable body is inflated or contracted (as seen in comparison of Fig 3 and Fig 4; Col 6, Lines 56-64). The motivation set forth in the rejection of claim 114 also applies to this claim.
Re claim 128, Seward (as modified by Kelley and O’Brien in the rejection of claim 114) discloses all the claimed features with Kelley teaching that the at least one protective element is configured to indicate an inflation status of the inflatable body (due to its changing from concave shape in the non-inflated state to a convex shape in the inflated state; Col 6, Lines 56-64). The motivation set forth in the rejection of claim 114 also applies to this claim.
Re claim 129, Seward (as modified by Kelley and O’Brien in the rejection of claim 114) discloses that the tissue penetrating member is in fluidic communication with the injection lumen (Para 54).
Re claim 130, Seward (as modified by Kelley and O’Brien in the rejection of claim 114) discloses that the inflatable body comprises a first section 400 (Fig 10A) having a first elasticity (defined by the elastomeric material of patch 400, Para 80) and a second section 30 having a second elasticity (defined by the nylon of mesh-like structure 30, Para 53) and wherein the second elasticity is less than the first elasticity (since the nylon of the mesh-like structure 30 is more rigid than the elastomeric material of patch 400).
Re claim 131, Seward (as modified by Kelley and O’Brien in the rejection of claim 114) above discloses that the tissue penetrating member is coupled to the second section of the inflatable body (as seen in Fig 2A, all components of the medical instrument are coupled to each other, whether directly or indirectly).
Re claim 132, Seward (as modified by Kelley and O’Brien in the rejection of claim 114 above) discloses that the at least one protective element is couple to the second section of the inflatable body (as seen in Fig 2A, all components of the medical instrument are coupled to each other, whether directly or indirectly).
Re claim 133, Seward (as modified by Kelley and O’Brien in the rejection of claim 114) discloses that the first section of the inflatable body comprises an elastic membrane (Para 80) and the second section of the inflatable body comprises a rigid polymer (the nylon of mesh-like structure 30, Para 53).
Claims 125 and 126 are rejected under 35 U.S.C. 103 as being unpatentable over Seward et al. (PG PUB 2008/0228136)/Kelley et al. (US Pat 7,413,558)/O’Brien et al. (PG PUB 2005/0245864) in view of Shiber et al. (PG PUB 2002/0151924).
Re claim 125, Seward/Kelley/O’Brien disclose all the claimed features except that the specific pattern or shape of the at least one protective element comprises an asymmetric pattern or shape. Shiber, however, teaches an inflatable body 15 (Fig 18-21), a tissue penetrating member 54 (Fig 18,20), and a protective element 95 (Fig 18,20) coupling the tissue penetrating member to the inflatable body (as seen in Fig 18,20; like Kelley), wherein the protective element is provided in a specific pattern that is asymmetric (the serpentine pattern seen in Fig 19,21) for the purpose of increasing the longitudinal flexibility of the protective element (Para 45). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Seward/Kelley/O’Brien to include the specific pattern of the at least one protective element as an asymmetric pattern, as taught by Shiber, for the purpose of increasing the longitudinal flexibility of the protective element (Para 45).
Re claim 126, Seward/Kelley/O’Brien disclose all the claimed features except that the specific pattern or shape of the at least one protective element comprises a triangle or an arrow. Shiber, however, teaches an inflatable body 15 (Fig 18-21), a tissue penetrating member 54 (Fig 18,20), and a protective element 95 (Fig 18,20) coupling the tissue penetrating member to the inflatable body (as seen in Fig 18,20; like Kelley), wherein the protective element is provided in a specific shape that is a triangle (the arch shape seen in Fig 20 having a thicker mid section 55 and thinner ends 56,56, Para 45) for the purpose of better supporting the penetrating member and lessening the peeling forces that develop when the inflatable body is inflated (Para 45). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Seward/Kelley/O’Brien to include the specific shape of the at least one protective element as a triangle, as taught by Shiber, for the purpose of better supporting the penetrating member and lessening the peeling forces that develop when the inflatable body is inflated (Para 45).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. PG PUB 2005/0149082 to Yee et al., PG PUB 2005/0137616 to Vigil, PG PUB 2005/0119678 to O’Brien et al., and PG PUB 2004/0133223 to Weber each disclose an medical instrument comprising a catheter shaft, an inflatable body, a tissue penetrating member, and at least one protective element to protect the inflatable body from a tip end of the tissue penetrating member.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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.
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783