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
Claims 119 and 120 are objected to because of the following informalities: The phrase “the at least protective element” in each of claims 119 and 120 should be amended to recite “the at least one protective element” to match the language of claim 114. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 126 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 126 recites dependence on now-cancelled claim 124 and, therefore, fails to include all the limitations of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
For the sake of examination, claim 126 is interpreted as reciting dependence on claim 114 instead of now-cancelled claim 124 (because now-cancelled claim 124 previously depended on claim 114) and the term “specific” is interpreted as reciting “asymmetric” to match the language of claim 114. It is suggested to amend claim 126 in this manner.
Double Patenting
The amendments filed 5/22/2026 overcome the double patenting rejection set forth in the last Office Action due to the incorporation of now-cancelled claim 128 into independent claim 114.
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 114-122, 126, 127, and 129-133 are rejected under 35 U.S.C. 103 as being unpatentable over Seward et al. (PG PUB 2008/0228136) in view of Vigil (PG PUB 2005/0137616) 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 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, borders the tip end of the tissue penetrating member when the inflatable body is in the involuted contracted configuration, comprises an asymmetric pattern or shape and is configured to indicate an inflation status of the inflatable body.
Vigil, however, teaches a medical instrument 10 (Fig 1; it is noted that all reference characters cited below refer to Fig 1 and 3a unless otherwise noted) comprising a catheter shaft assembly 12, an inflatable body 14 being inflatable from an involuted contracted configuration (as seen in Fig 3A), a tissue penetrating member 36 coupled to the inflatable body in an orientation transverse to a longitudinal axis of the catheter shaft assembly with a tip end (pointing upward in Fig 3A) of the tissue penetrating member pointing outwardly of the inflatable body (as seen in Fig 3A), and two protective elements 24a,24b coupled to the inflatable body in proximity to the tissue penetrating member (as seen in Fig 3A), wherein each of the protective elements borders the tip end of the tissue penetrating member when the inflatable body is in the involuted contracted configuration (as seen in Fig 3A), and wherein each of the protective elements comprises an asymmetrical pattern or shape (as seen in Fig 3A and 5, the sides 48a,48b of the protective elements that border the slit 28 are shorter than the sides 50a,50b of the protective elements that border the protective channel 30, and both of these sides are straight while the sides that form the outer surfaces 34 are curved) and is configured to indicate an inflation status of the inflatable body (as seen in Fig 3a, the straight sides of the protective elements cannot be seen when in the contracted configuration but can be seen when in the inflated configuration; therefore, the protective elements provide an indication of the inflation status to the naked eye); Vigil teaches that providing a protective element of this nature protects the tissue penetrating member from inadvertently cutting tissue as the medical instrument is maneuvered through the vasculature of the a patient (Para 4) and helps define the fold for the contracted configuration of the inflatable body (Para 22). 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 Vigil, for the purpose of protecting the tissue penetrating member from inadvertently cutting tissue as the medical instrument is maneuvered through the vasculature of the a patient (Para 4) and aiding in defining the fold for the contracted configuration of the inflatable body (Para 22). 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 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 Vigil 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 Vigil 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 Vigil and O’Brien in the rejection of claim 114) discloses all the claimed features with Vigil 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 is in the involuted contracted configuration (as seen in Fig 3A, each of the protective elements 24a,24b are on an opposite lateral side of the tissue penetrating member). The motivation set forth in the rejection of claim 114 also applies to this claim.
Re claim 117, Seward (as modified by Vigil and O’Brien in the rejection of claim 114) discloses all the claimed features with Vigil 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 (Para 4). The motivation set forth in the rejection of claim 114 also applies to this claim.
Re claim 118, Seward (as modified by Vigil 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 Vigil 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 Vigil and O’Brien in the rejection of claim 114) discloses all the claimed features with Vigil teaching that the at least one protective element is integrated with the inflatable body (as seen in Fig 3A; Para 21). The motivation set forth in the rejection of claim 114 also applies to this claim.
Re claim 122, Seward (as modified by Vigil and O’Brien in the rejection of claim 114) discloses all the claimed features with Vigil teaching that the at least one protective element is covered by a covering material (as seen in Fig 3A, the outer surfaces 34 (labeled in Fig 2) are covered by the material that forms the inflatable body 14 – this material is considered the “covering material”). The motivation set forth in the rejection of claim 114 also applies to this claim.
Re claim 123, Seward (as modified by Vigil and O’Brien in the rejection of claim 114) discloses that the covering material comprises parylene, silicone, or a combination thereof (“the central section 24 is made of […] Parylene (types C, D or N), silicone, polyurethane or polyimide” – Para 50).
Re claim 126, Seward (as modified by Vigil and O’Brien in the rejection of claim 114) discloses all the claimed features with Vigil teaching that the asymmetric pattern or shape comprises a triangle or an arrow (as seen in Fig 4, each protective element 24a,24b has a triangular cross-sectional profile). The motivation set forth in the rejection of claim 114 also applies to this claim.
Re claim 127, Seward (as modified by Vigil and O’Brien in the rejection of claim 114) discloses all the claimed features with Vigil teaching that the at least one protective element changes orientation as the inflatable body is inflated or contracted (as seen in comparison of Fig 3A and Fig 4; Para 25). The motivation set forth in the rejection of claim 114 also applies to this claim.
Re claim 129, Seward (as modified by Vigil 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 Vigil 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 Vigil 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 Vigil 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 Vigil 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).
Response to Arguments
Applicant's arguments filed 5/22/2026 have been fully considered but are moot in view of the present rejections that utilize the above-cited Vigil reference. It is noted that the addition of both now-cancelled claims 125 and 128 into independent claim 114 changed the scope of the invention (since claims 125 and 128 did not previously depend on each other), resulting in a new combination of references being the closest prior art of record for the present claims.
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 KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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