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 Amendment
This office action is responsive to the amendment filed on June 9, 2025. As directed by the amendment: claims 1, 10, 27, 32, 38, 77, 84, 85, 137 have been amended, claim 144 has been added, claims 3, 19, and 141 have been canceled. Thus claims 1, 10-11, 27, 32, 38, 41, 77, 84-85, 101, 117, 127, 137 and 142-144 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see Remarks, filed April 22, 2026, with respect to the rejections of independent claims 1 and 137 under 35 U.S.C. 102 and 103, respectively, have been fully considered and are persuasive. Orr fails to disclose the amended limitations of the independent claims, namely a pair of elongated shells extending from the proximal end to the distal end and being disposed on radially opposite sides of the main axis, the shells being resiliently urged radially relative to the main axis towards each other into a rest state and defining a main bore extending longitudinally therebetween from the proximal end thereof. Therefore, the rejections of claims 1 and 137 are withdrawn. Due to their dependency on claim 1, the rejections of claims 10-11 , 27, 32, 38, 41, 77, 84-85, 101, 117, 127, and 142-143 have been withdrawn. However, upon further consideration, in light of the amendments, a new ground(s) of rejection is made below.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim limitation(s) being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is/are:
“operating means” in claim 1.
“communicating means” in claim 1.
“fluid delivery means” in claim 32
“shielding means” in claim 84.
“operating means” in claim 137.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. “Operating means” is given the broadest reasonable interpretation of “a solid tubular member of substantially circular external transverse cross-section” (specification, [0144]), “an inflatable member, for example a balloon” (specification, [0196]), or equivalents thereof. “Communicating means” is given the broadest reasonable interpretation of “at least one chamber located in one of the carrier element and the operating means” (specification, [0025]) or equivalents thereof. “Fluid delivery means” is given the broadest reasonable interpretation of “an elongated fluid delivery needle” (specification, [0148]) or equivalents thereof. “Shielding means” is given the broadest reasonable interpretation of “an elongated tubular shield” (specification, [0057]), or equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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) 1, 11, 27, 32, 38, 84-85, 101, 127, and 144 are rejected under 35 U.S.C. 103 as being unpatentable over Orr (US 20110166516), in view of Kaplan et al. (US 5941868), hereinafter Kaplan.
Regarding claim 1, Orr discloses a microneedle device (Fig. 1, microneedle device 20) comprising: an elongated carrier element extending between a proximal end and a distal end and defining a longitudinally extending main axis (Fig. 1, catheter 40 and balloon 60 form carrier element longitudinally extending from a proximal end to a distal end), the carrier element comprising an elongated shell (Fig. 1, carrier element comprises balloon 60 which is an elongated shell), the shell being resiliently urged radially relative to the main axis towards itself into a rest state (Fig. 3 and [0039-0040], in the delivery/rest configuration the outer surface of balloon shell 60 is urged radially inwards towards itself/the main axis) and defining a main bore extending longitudinally within from the proximal end thereof (Fig. 1-2, balloon shell 60 defines a longitudinally extending main bore within from the proximal end) at least one microneedle defining a needle axis (Fig. 1, needles 80) carried on the shell with the needle axis extending substantially radially relative to the main axis (Fig. 1, needles 80 carried on balloon shell 60 with needle axis radially relative to main axis), an operating means (Fig. 1, operating means 50) co-urgeable through the main bore defined by the shell for urging the shell apart in opposite radial directions relative to the main axis from the rest state to an engagement state for in turn urging the at least one microneedle radially outwardly relative to the main axis from a rest state thereof to an engagement state for engaging tissue (Figs. 1-4 and [0040], operating means 50 extends through main bore of balloon shell 60 and urges shell 60 away from itself/main axis to an engagement state, in turn urging needles outwards to pierce target tissue), and a communicating means (Fig. 1, communicating means 64) comprising at least one main chamber located in the carrier element or in the operating means (Fig. 1-2, communicating means 64 comprises at last one main chamber/pocket 64 which is within the carrier element 40/60), the at least one main chamber being adapted for communicating the at least one microneedle with a source of a fluid to be delivered to a subject through the microneedle device for accommodating the fluid from the source to the at least one microneedle (Fig. 1-2 and 10 and [0065], main chamber 64 may communicate with a port connected to a source of therapeutic agent, for accommodating the fluid from the source to the needles 80).
Orr fails to disclose a pair of elongated shells extending from the proximal end to the distal end and being disposed on radially opposite sides of the main axis, the shells being resiliently urged towards each other into a rest state and a main bore extending longitudinally therebetween from the proximal end thereof, at least one microneedle on one of the shells, and an operating means for urging the shells apart in opposite radial directions relative to the main axis from the rest state to an engagement state. However, Kaplan discloses a pair of elongated shells (Fig. 1-3, opposing pair of infusion lumens 126 on infusion sleeve 112 (infusion sleeve 112 equivalent to carrier element 40/60 of Orr)) extending from the proximal end to the distal end and being disposed on radially opposite sides of the main axis (Fig. 1-3, the pair of infusion lumens 126 extend from the proximal end to the distal end of infusion sleeve 112 and are disposed on radially opposite sides of the main axis of infusion sleeve 112), the shells being resiliently urged towards each other into a rest state (Fig. 8 and Col. 6:59-65, opposite infusion lumens 126 are urged towards each other when balloon B is deflated/rest state) and a main bore extending longitudinally therebetween (Fig. 2-3, infusion lumens 126 define a main bore 124 extending longitudinally therebetween), at least one microneedle on one of the shells (Fig. 1 and Col. 3:20-26, infusion ports 128 on infusion lumens 126 may comprise needles), and an operating means for urging the shells apart in opposite radial directions relative to the main axis from the rest state to an engagement state (Fig. 8-9 and Col. 6:59-67, balloon B urges the opposing infusion lumens 126 in opposite radial directions relative to main axis from deflated/rest state to inflated/engaged state).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Orr to incorporate the disclosures of Kaplan and modify the shell to be a pair of elongated shells extending from the proximal end to the distal end and being disposed on radially opposite sides of the main axis, the shells being resiliently urged towards each other into a rest state and a main bore extending longitudinally therebetween from the proximal end thereof, at least one microneedle on one of the shells, and an operating means for urging the shells apart in opposite radial directions relative to the main axis from the rest state to an engagement state. Doing so would provide split portions between each infusion lumen for more easily permitting radial expansion of the device, thus enhancing its ability to engage the infusion region against the vessel wall to enhance transmural penetration (Kaplan, Col. 3:21-26; 6:43-45).
Regarding claim 11 and Orr, in view of Kaplan, Orr further discloses a microneedle device as claimed in Claim 1 in which the operating means comprises an expandable member of expandable transverse cross-section (Fig. 1 and [0031, 0039-0041], operating means is a balloon member with an expandable transverse cross-section).
Regarding claim 27, Orr, in view of Kaplan, discloses a microneedle device as claimed in Claim 1, as explained above. As noted above, Orr fails to disclose the pair of shells and is thus silent to in which the resilient urging of the shells into the rest state thereof resiliently urges the shells into sealing engagement with the operating means. However, Kaplan further discloses in which the resilient urging of the shells into the rest state thereof resiliently urges the shells into sealing engagement with the operating means (Fig. 8 and Col. 6:59-65, in rest/deflated state, the infusion lumens are collapsed and in a sealed engagement against the outer surface of balloon B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Orr to incorporate the disclosures of Kaplan and modify the shells such that t in which the resilient urging of the shells into the rest state thereof resiliently urges the shells into sealing engagement with the operating means. Doing so would provide shells/ lumens split portions between each infusion lumen for more easily permitting radial expansion/collapsing of the device, thus enhancing its ability to engage the device infusion region against the vessel wall to enhance transmural penetration (Kaplan, Col. 3:21-26; 6:43-45).
Regarding claim 32 and Orr, in view of Kaplan, Orr further discloses a microneedle device as claimed in Claim 1 in which the main chamber is configured to communicate with a fluid delivery means configured to deliver the fluid from a remote source to the main chamber (Fig. 1-2 and 10 and [0065], main chamber 64 may communicate with deliver channel 42 and a port connected to a remote source of therapeutic agent, for accommodating the fluid from the remote source to the needles 80).
Regarding claim 38, and Orr, in view of Kaplan, Orr further discloses a microneedle device as claimed in Claim 1 in which the one of the shells on which the at least one microneedle is carried and the operating means which comprises the main chamber comprises a fluid delivery needle accommodating duct for accommodating the fluid delivery needle therethrough to the main chamber (Fig. 10, device 20 can have at least one port 272 at the proximal end for receiving the therapeutic agent from the external source/needle, and is in fluid communication with the catheter40/balloon shell 60).
Regarding claim 84 and Orr, in view of Kaplan, Orr further discloses a microneedle device as claimed in Claim 1 further comprising a shielding means for protecting the at least one microneedle ([0039], device may comprise an outer sheath as a shielding means).
Regarding claim 85 and Orr, in view of Kaplan, Orr further discloses a microneedle device as claimed in Claim 84 in which the shielding means comprises a tubular shield having a carrier element accommodating bore extending therethrough for accommodating the carrier element and the at least one microneedle therein when the at least one microneedle is in the rest state thereof; and shielded therein ([0039], device may comprise an outer sheath shielding means which accommodates the apparatus 20 (including carrier element 40/60 and needles 80) within it to shield the needles 80 from the tissue).
Regarding claim 101 and Orr, in view of Kaplan, Orr further discloses a microneedle device as claimed in Claim 1 for use in a method for the treatment of a site in a human or animal body with an injectable fluid (Fig. 1-5, device 20 used for treating a human body site with an injectable fluid agent).
Regarding claim 127 and Orr, in view of Kaplan, Orr further discloses a method for treating a site in a lumen, vessel, cavity, organ or muscular organ comprising inserting a microneedle device as claimed in Claim 1 into the lumen, vessel, cavity, organ or muscular organ (Fig. 1 and 3 and [0038-0039], device 20 is inserted into the body and advanced to target site in a vessel), urging the at least one microneedle of the microneedle device into a wall or tissue of the lumen, vessel, cavity, organ or muscular organ adjacent the site thereof to be treated (Fig. 2 and 4 and [0040], needles 80 pierce into the tissue at/near target site), and delivering a therapeutic fluid through the at least one microneedle into the wall or tissue of the lumen, vessel, cavity, organ or muscular organ (Fig. 2 and 5 and [0040], therapeutic agent is delivered to target site via the needles).
Regarding claim 144, Orr, in view of Kaplan, discloses microneedle device as claimed in Claim 1, as explained above. As noted above, Orr fails to disclose a pair of shells, and is thus silent to in which at least one of the microneedles is located on each of the shells. However, Kaplan further discloses at least one of the microneedles is located on each of the shells (Fig. 1 and Col. 3:20-26, infusion ports 128 on each of infusion lumens 126 may comprise needles).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Orr, in view of Kaplan, to further incorporate the disclosures of Kaplan and modify the shells such that at least one of the microneedles is located on each of the shells. Doing so would provide a delivery device with split portions between each infusion lumen for more easily permitting radial expansion of the device, thus enhancing its ability to engage the infusion region against the vessel wall to enhance transmural penetration (Kaplan, Col. 3:21-26; 6:43-45).
Claim(s) 10 and 137 are rejected under 35 U.S.C. 103 as being unpatentable over Orr (US 20110166516), in view of Kaplan (US 5941868), and further in view of Braga (US 20140276621).
Regarding claim 10, Orr, in view of Kaplan, discloses a microneedle device as claimed in Claim 1.
Orr, in view of Kaplan, fails to disclose the operating means comprises an operating member, the operating member being of non-deformable transverse cross-section and having a transverse cross-sectional dimension greater than a corresponding transverse cross-sectional dimension of the main bore defined by the shells. However, Braga discloses the operating means comprises an operating member (Braga, Figs. 8-9, elongate wire 50), the operating member being of non-deformable transverse cross-section and having a transverse cross-sectional dimension greater than a corresponding transverse cross-sectional dimension of the main bore defined by the shells (Figs. 8-9 and [0049], elongate wire has a non-deformable transverse cross-section which has a dimension that is greater than the transverse cross-section of the deformable portions 30 at the treatment length 18 of the catheter).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Orr, in view of Kaplan, to incorporate the disclosures of Braga and modify the operating means to have an operating member of non-deformable transverse cross-section such that the operating member has a transverse cross-sectional dimension greater than a corresponding transverse cross-sectional dimension of the main bore defined by the shells. Doing so would provide an operating means for the catheter device which allows for smooth engagement between the operating means and the microneedle delivery region, and allows for an operating means which does not require fluid pressure buildup, thus allowing for a quicker delivery of more fluid (Braga, [0049]).
Regarding claim 137, Orr discloses a method for treating a site in a lumen, vessel, cavity, organ or muscular organ of a human or animal subject, the method comprising providing a microneedle device (Fig. 1, microneedle device 20), the microneedle device comprising an elongated carrier element extending between a proximal end and a distal end and defining a longitudinally extending main axis (Fig. 1, catheter 40 and balloon 60 form carrier element longitudinally extending from a proximal end to a distal end), the carrier element comprising an elongated shell (Fig. 1, carrier element comprises balloon 60 which is an elongated shell), the shell being resiliently urged radially relative to the main axis towards itself into a rest state (Fig. 3 and [0039-0040], in the delivery/rest configuration the outer surface of balloon shell 60 is urged radially inwards towards itself/the main axis) and defining a main bore extending longitudinally within from the proximal end thereof (Fig. 1-2, balloon shell 60 defines a longitudinally extending main bore within from the proximal end), at least one microneedle defining a needle axis (Fig. 1, needles 80), carried on the shell with the needle axis extending substantially radially relative to the main axis (Fig. 1, needles 80 carried on balloon shell 60 with needle axis radially relative to main axis), an operating means (Fig. 1, operating means 50) urgeable through the main bore defined by the shell for urging the shell apart in opposite radial directions relative to the main axis from the rest state to an engagement state for in turn urging the at least one microneedle radially outwardly relative to the main axis from a rest state thereof to an engagement state for engaging tissue (Figs. 1-4 and [0040], operating means 50 extends through main bore of balloon shell 60 and urges shell 60 away from itself/main axis to an engagement state, in turn urging needles outwards to pierce target tissue), and a communicating means (Fig. 1, communicating means 64) comprising at least one main chamber located in the carrier element or in the operating means (Fig. 1-2, communicating means 64 comprises at last one main chamber/pocket 64 which is within the carrier element 40/60), the at least one main chamber being adapted for communicating the at least one microneedle with a source of the fluid to be delivered to a subject through the microneedle device for accommodating the fluid from the source to the at least one microneedle (Fig. 1-2 and 10 and [0065], main chamber 64 may communicate with a port connected to a source of therapeutic agent, for accommodating the fluid from the source to the needles 80), providing an elongated tubular shield having a carrier element accommodating bore extending therethrough ([0039], device may comprise an outer sheath shielding means which has a bore that accommodates the apparatus 20 (including carrier element 40/60 and needles 80) within it), inserting the tubular shield with or without the carrier element located in the carrier element accommodating bore thereof from a location exteriorly of the subject through an orifice of the subject to the site in the lumen, vessel, cavity, organ or muscular organ to be treated until the distal end of the tubular shield is located adjacent the site to be treated, and the proximal end of the tubular shield is located exteriorly of the subject (Fig. 2, and [0038-0039], a distal end of an outer sheath may be inserted into a vessel or duct of a subject and advanced to a target site, while proximal end is kept exterior to subject), inserting the carrier element into the tubular shield from the proximal end thereof if the tubular shield is inserted into the subject without a carrier element located in the carrier element accommodating bore thereof , urging the carrier element to the distal end of the tubular shield until the carrier element is located in the carrier element accommodating bore of the tubular shield adjacent the distal end thereof ([0039], outer sheath may be inserted with the drug delivery apparatus 20, Therefore the carrier element 40/60 is inserted and accommodated within a lumen of the outer sheath at the distal end of the outer sheath and is therefore advanced within the lumen of the body until the carrier element 40/60 reaches the target site), partially withdrawing the tubular shield to expose the carrier element and the at least one microneedle adjacent the site to be treated in the lumen, vessel, cavity, organ or muscular organ ([0039], outer sheath may be at least partially retracted to expose the carrier element 40/60 and needles 80 to the target site), and injecting the therapeutic fluid into the wall or tissue of the lumen, vessel, cavity, organ or muscular organ through the at least one microneedle (Fig. 2 and 5 and [0040], therapeutic agent is delivered to target site tissue via the needles 80).
Orr fails to disclose a pair of elongated shells extending from the proximal end to the distal end and being disposed on radially opposite sides of the main axis, the shells being resiliently urged towards each other into a rest state and a main bore extending longitudinally therebetween from the proximal end thereof, at least one microneedle on one of the shells, and an operating means for urging the shells apart in opposite radial directions relative to the main axis from the rest state to an engagement state. However, Kaplan discloses a pair of elongated shells (Fig. 1-3, opposing pair of infusion lumens 126 on infusion sleeve 112 (infusion sleeve 112 equivalent to carrier element 40/60 of Orr)) extending from the proximal end to the distal end and being disposed on radially opposite sides of the main axis (Fig. 1-3, the pair of infusion lumens 126 extend from the proximal end to the distal end of infusion sleeve 112 and are disposed on radially opposite sides of the main axis of infusion sleeve 112), the shells being resiliently urged towards each other into a rest state (Fig. 8 and Col. 6:59-65, opposite infusion lumens 126 are urged towards each other when balloon B is deflated/rest state) and a main bore extending longitudinally therebetween (Fig. 2-3, infusion lumens 126 define a main bore 124 extending longitudinally therebetween), at least one microneedle on one of the shells (Fig. 1 and Col. 3:20-26, infusion ports 128 on infusion lumens 126 may comprise needles), and an operating means for urging the shells apart in opposite radial directions relative to the main axis from the rest state to an engagement state (Fig. 8-9 and Col. 6:59-67, balloon B urges the opposing infusion lumens 126 in opposite radial directions relative to main axis from deflated/rest state to inflated/engaged state).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Orr to incorporate the disclosures of Kaplan and modify the method to have a pair of elongated shells extending from the proximal end to the distal end and being disposed on radially opposite sides of the main axis, the shells being resiliently urged towards each other into a rest state and a main bore extending longitudinally therebetween from the proximal end thereof, at least one microneedle on one of the shells, and an operating means for urging the shells apart in opposite radial directions relative to the main axis from the rest state to an engagement state. Doing so would provide split portions between each infusion lumen for more easily permitting radial expansion of the device, thus enhancing its ability to engage the infusion region against the vessel wall to enhance transmural penetration (Kaplan, Col. 3:21-26; 6:43-45).
Orr, in view of Kaplan, fails to disclose urging the operating means through the tubular shield until the operating means is adjacent the proximal end of the carrier element while retaining the carrier element in position at the site to be treated, urging the operating means into a main bore defined by the shells for urging the shells from the rest state to the engagement state for in turn urging the at least one microneedle radially outwardly relative to the main axis defined by the carrier element from the rest state to the engagement state into the wall or tissue defining the lumen, vessel, cavity, organ or muscular organ. However, Braga discloses urging an operating means through the tubular shield until the operating means is adjacent the proximal end of the carrier element while retaining the carrier element in position at the site to be treated (Figs. 8 and [0049], elongate wire 50 may be inserted into the catheter 10 and advanced towards the treatment portion 18 of the catheter, while the treatment portion is positioned ate the target site), urging the operating means into a main bore defined by the shells for urging the shells from the rest state to the engagement state for in turn urging the at least one microneedle radially outwardly relative to the main axis defined by the carrier element from the rest state to the engagement state into the wall or tissue defining the lumen, vessel, cavity, organ or muscular organ (Figs. 8-9 and [0045, 0049], elongate wire 50 may be further urged through the bore of the treatment portion 18 in order to urge deformable portions 30 of treatment portion 18 outwards into the extended position such that the microneedles 36 penetrate the tissue wall).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Orr, in view of Kaplan, to incorporate the disclosures of Braga and modify the method to include urging an operating means through the tubular shield until the operating means is adjacent the proximal end of the carrier element while retaining the carrier element in position at the site to be treated, urging the operating means into a main bore defined by the carrier element for in turn urging the at least one microneedle transversely outwardly of the main axis defined by the carrier element from the rest state to the engagement state into the wall or tissue defining the lumen, vessel, cavity, organ or muscular organ. Doing so would provide an operating means for the catheter device which allows for smooth engagement between the operating means and the microneedle delivery region, and allows for an operating means which does not require fluid pressure buildup, thus allowing for a quicker delivery of more fluid (Braga, [0049]).
Claim(s) 41 and 143 are rejected under 35 U.S.C. 103 as being unpatentable over Orr (US 20110166516), in view of Kaplan (US 5941868), as applied to claim 38 above, and further in view of Asai (US 20110071502).
Regarding claim 41, and Orr, in view of Kaplan, Orr further discloses a microneedle device as claimed in Claim 38 in which a plurality of the main chambers are provided (Fig. 1, plurality of main chambers 64 are provided), and the fluid delivery needle accommodating duct is configured to communicate with each one of the main chambers (Fig. 1 and 10, port 272 communicates with its respective delivery channel and main chambers 64 (see fig. 1, embodiment only has one delivery channel 42 which communicates with all main chambers 64)).
Orr, in view of Kaplan, fails to disclose each main chamber is isolated from the fluid delivery needle accommodating duct by a first sealing element, and each first sealing element is configured to sealably accommodate the fluid delivery needle therethrough to the corresponding one of the main chambers. However, Ray discloses each main chamber is isolated from the fluid delivery needle accommodating duct by a first sealing element (Fig. 2 and 4, port 42 is isolated from the downstream components of device via hemostatic valve 44), and each first sealing element is configured to sealably accommodate the fluid delivery needle therethrough to the corresponding one of the main chambers (Fig. 4-5 and [0044], hemostatic valve sealingly accommodates a component to pass therethrough yet still has high liquid tightness).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Orr, in view of Kaplan, to incorporate the disclosures of Asai and modify the fluid delivery needle accommodating duct to have a first sealing element, and each first sealing element is configured to sealably accommodate the fluid delivery needle therethrough to the corresponding one of the main chambers. Doing so would maintain the port opening as liquid tight (Asai, [0043-0044]).
Regarding claim 143, Orr, in view of Kaplan and Asai, discloses a microneedle device as claimed in Claim 41, as explained above. As noted above, Orr and Kaplan fail to disclose the first sealing element and are thus silent to in which each first sealing element comprises a self-resealing sealing element configured to reseal itself on withdrawal of the fluid delivery needle. However, Asai further discloses in which each first sealing element comprises a self-resealing sealing element configured to reseal itself on withdrawal of the fluid delivery needle (Fig. 4-5 and [0043], hemostatic valve maintains the liquid tight seal when the component is no longer fitted in the port).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Orr, in view of Kaplan and Asai, to further incorporate the disclosures of Asai and modify the first sealing element to comprise a self-resealing sealing element configured to reseal itself on withdrawal of the fluid delivery needle. Doing so would maintain the port opening as liquid tight (Asai, [0043-0044]).
Claim(s) 77 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orr (US 20110166516), in view of Kaplan (US 5941868), as applied to claim 1 above, and further in view of Krulevitch et al. (US 20050273049), hereinafter Krulevitch.
Regarding claim 77, Orr, in view of Kaplan, discloses a microneedle device as claimed in Claim 1.
Orr, in view of Kaplan, fails to disclose in which each main chamber is located in the operating means, and the operating means is alignable with the shells, for aligning the at least one main chamber with a corresponding one or more of the microneedles for communicating the main chamber with the one or more microneedles corresponding to the main chamber. However, Krulevitch discloses in which each main chamber is located in the operating means (Fig. 2, main chamber 235 is located in a portion of the operating means 230), and the operating means is alignable with the shells, for aligning the at least one main chamber with a corresponding one or more of the microneedles for communicating the main chamber with the one or more microneedles corresponding to the main chamber (Fig. 1-2 and [0079], operating means 230 is aligned with carrier element 245 which comprises needles 250, such that the main chambers 235 is aligned with and communicate with the corresponding needles 250).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Orr, in view of Kaplan, to incorporate the disclosures of Krulevitch and modify the device such that each main chamber is located in the operating means, and the operating means is alignable with the shells, for aligning the at least one main chamber with a corresponding one or more of the microneedles for communicating the main chamber with the one or more microneedles corresponding to the main chamber. Doing so would create a fluid delivery system pierces the tissue and delivers therapeutic fluid based on the operating means/main chamber's interactions, thus ensuring a specific ratio of therapeutic fluid is dispensed during use (Krulevitch, [0077]).
Claim(s) 117 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orr (US 20110166516), in view of Kaplan (US 5941868), as applied to claim 1 above, and further in view of Tankovich (US 20160287668).
Regarding claim 117 and Orr, in view of Kaplan, Orr further discloses a method for treating a target body site comprising inserting a microneedle device as claimed in Claim 1 into the target (see claim 1 rejection above and Fig. 1 and 3 and [0038-0039], device 20 is inserted into the body and advanced to target site in a vessel), urging the at least one microneedle of the microneedle device into tissue adjacent the target site (Fig. 2 and 4 and [0040], needles 80 pierce into the tissue at/near target site), and delivering a therapeutic fluid through the at least one microneedle into the tissue (Fig. 2 and 5 and [0040], therapeutic agent is delivered to target site via the needles).
Orr, in view of Kaplan, fails to disclose that the target site is a fistula. However, Tankovich discloses the target site is a fistula ([0113], microneedle treatment device for treatment of arteriovenous fistula).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Orr, in view of Kaplan, to incorporate the disclosures of Tankovich to modify the device to be used for treatment of a target site which is a fistula. Doing so would allow for use of the device in the treatment of vascular disorders (Tankovich, [0113]).
Claim(s) 142 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orr (US 20110166516), in view of Kaplan (US 5941868), as applied to claim 32 above, and further in view of Ash (US 20200368493).
Regarding claim 142, Orr, in view of Kaplan, discloses a microneedle device as claimed in Claim 32.
Orr, in view of Kaplan, fails to disclose the fluid delivery means comprises an elongated fluid delivery needle having a fluid accommodating bore extending therethrough to a distal end thereof. However, Ash discloses the fluid delivery means comprises an elongated fluid delivery needle having a fluid accommodating bore extending therethrough to a distal end thereof (Fig. 1 and [0035], fluid can be delivered to the bores of the device through a needle, which would comprise a fluid accommodating bore extending therethrough to a distal end thereof).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Orr, in view of Kaplan, to incorporate the disclosures of Ash and modify the fluid delivery means to be an elongated fluid delivery needle having a fluid accommodating bore extending therethrough to a distal end thereof. Doing so would provide an advantageous method to provide fluid to the ports/lumens of catheter device (Ash, [0054]).
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.
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/SARAH DYMPNA GRASMEDER/Examiner, Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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