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 .
Claims 1-3, 5, 7, 10-13, 15-16, 20-21, 24-26, 31, and 33-43 are being examined in this office action
Claim 4, 6, 8-9, 14, 17-19, 22-23, 27-30, and 32 are cancelled
Claims 1, 3, 15, 16, 20, 21, 26, 38 and 43 are currently amended.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3-5, 7, 11, 15-17, 20-22, and 36-37 is/are rejected under 35 U.S.C. 102(1) as being anticipated by Takemoto et al. (US 20130296800 A1).
Regarding claim 1, Takemoto discloses a cannula assembly (needle tube 3, needling holding member 7, Fig. 2) comprising:
a cannula (needle tube 3, Fig. 2) having a proximal end (proximal section 3b, Fig. 4C) and a distal end (needle tip 3a, Fig. 4C);
polymeric support material (close contact portion 9, Fig. 2) substantially surrounding a portion of the cannula at or near the proximal end of the cannula ("… the needle holding member 7 … is formed integrally and coaxially with the needle tube 3 …" - Para [0038], "… the needle holding member 7 has a connecting part 8 … and a close portion part 9 ..." - Para [0039]), the polymeric support material having a proximal end and a distal end (See annotated Fig. 4CF); and
a hub (connecting part 8, Fig. 2) configured to be attached to a syringe (syringe 2, "the syringe 2 is provided with an outer tube 6 …" - Para [0031], Fig. 1)("… the needle holding member 7 has a connection part 8 to be joined to one axial-directional end of the outer tube 6 …" - Para [0039]);
wherein the polymeric support material is located between the cannula and the hub (Fig. 2), wherein the cannula, the polymeric support material and the hub are non-detachable ("… the needle holding member 7 … is formed integrally and coaxially with the needle tube 3 …" - Para [0038], "… the needle holding member 7 has a connecting part 8 … and a close portion part 9 continuous with the connecting section 8." - Para [0039]),
wherein the polymeric support material is continuously tapered inwardly from the proximal end of the polymeric support material to the distal end of the polymeric support material ("… the farther the connecting part 8 goes away from the outer tube 6, the thinner the connecting part 8 becomes …" - Para [0040], See annotated Fig. 4C).
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Regarding claim 3, Takemoto discloses the cannula assembly (needle tube 3, needling holding member 7, Fig. 2) as recited above, wherein
the polymeric support material (connecting part 8, Fig. 2) is continuously tapered inwardly from the proximal end of the polymeric support material to the distal end of the polymeric support material ("… the farther the connecting part 8 goes away from the outer tube 6, the thinner the connecting part 8 becomes …" - Para [0040], See annotated Fig. 4C above).
Regarding claim 5, Takemoto discloses the cannula assembly (needle tube 3, needling holding member 7, Fig. 2) as recited above, wherein
the polymeric support material (close contact portion 9, Fig. 2) comprises polytetrafluoroethylene (PTFE), polyamides, fluoropolymers, polyolefins, PVC (polyvinyl chlorides) ("… the material of the outer tube 6 … one of various resins is used. Examples of the resins include polyvinyl chloride …" - Para [0035]) ("The needle holding member 7 configured as above is composed of essentially the same material as the outer tube 6." - Para [0046])("… the needle holding member 7 has a connecting part 8 … and a close portion part 9 ..." - Para [0039]), polyimides, PEEK (polyetheretherketones), or combinations thereof.
Regarding claim 7, Takemoto discloses the cannula assembly (needle tube 3, needling holding member 7, Fig. 2) as recited above, wherein
the polymeric support material (close contact portion 9, Fig. 2) completely surrounds the cannula (Fig. 4B)("… the needle holding member 7 … is formed integrally and coaxially with the needle tube 3 …" - Para [0038], "… the needle holding member 7 has a connecting part 8 … and a close portion part 9 ..." - Para [0039]).
Regarding claim 11, Takemoto discloses the cannula assembly (needle tube 3, needling holding member 7, Fig. 2) as recited above, wherein
the polymeric support material (close contact portion 9, Fig. 2) and the hub (connecting part 8, Fig. 2) comprises transparent or translucent material ("… the material of the outer tube 6 is preferably transparent …" - Para [0035])("The needle holding member 7 configured as above is composed of essentially the same material as the outer tube 6." - Para [0046])("… the needle holding member 7 has a connecting part 8 … and a close portion part 9 ..." - Para [0039]).
Regarding claim 15, Takemoto discloses a cannula assembly (needle tube 3, needling holding member 7, Fig. 2) and a syringe (syringe 2, Fig. 1) combination comprising:
a cannula (needle tube 3, Fig. 2) having a proximal end (proximal section 3b, Fig. 4C) and a distal end (needle tip 3a, Fig. 4C), polymeric support material (close contact portion 9, Fig. 2) substantially surrounding a portion of the cannula (Fig. 4B)("… the needle holding member 7 … is formed integrally and coaxially with the needle tube 3 …" - Para [0038], "… the needle holding member 7 has a connecting part 8 … and a close portion part 9 ..." - Para [0039]) at or near the proximal end of the cannula (Fig. 4B), the polymeric support material having a proximal end and a distal end (See annotated Fig. 4C), the polymeric support material located between the cannula and a hub (Fig. 2), the polymeric support material and the hub being non-detachable ( "… the needle holding member 7 has a connecting part 8 … and a close portion part 9 continuous with the connecting section 8." - Para [0039]); and
the syringe (syringe 2, "the syringe 2 is provided with an outer tube 6 …" - Para [0031], Fig. 1),
wherein the hub attaches the cannula and the syringe ("… the needle holding member 7 has a connection part 8 to be joined to one axial-directional end of the outer tube 6 …" - Para [0039]) ("… the needle holding member 7 … is formed integrally and coaxially with the needle tube 3 …" - Para [0038], "… the needle holding member 7 has a connecting part 8 … and a close portion part 9 continuous with the connecting section 8." - Para [0039], Fig. 4C),
wherein the polymeric support material (connecting part 8, Fig. 2) is tapered inwardly from the proximal end of the polymeric support material to the distal end of the polymeric support material (See annotated Fig. 4C), in which the thickness of the polymeric support material is greater at the proximal end of the polymeric support material ("… the farther the connecting part 8 goes away from the outer tube 6, the thinner the connecting part 8 becomes …" - Para [0040], Fig. 4C).
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Regarding claim 16, Takemoto discloses the cannula assembly (needle tube 3, needling holding member 7, Fig. 2) and the syringe (syringe 2, Fig. 1) combination as recited above, wherein
the polymeric support material (connecting part 8, Fig. 2) is continuously tapered inwardly from the proximal end of the polymeric support material to the distal end of the polymeric support material ("… the farther the connecting part 8 goes away from the outer tube 6, the thinner the connecting part 8 becomes …" - Para [0040], See annotated Fig. 4C above).
Regarding claim 17, Takemoto discloses the cannula assembly (needle tube 3, needling holding member 7, Fig. 2) and the syringe (syringe 2, Fig. 1) combination as recited above, wherein
the polymeric support material (connecting part 8, Fig. 2) is tapered from the proximal end towards the distal end, in which the thickness of the polymeric support material is greater at the proximal end ("… the farther the connecting part 8 goes away from the outer tube 6, the thinner the connecting part 8 becomes …" - Para [0040], Fig. 2).
Regarding claim 20, Takemoto discloses a method ("… the method of forming the needle tube and the syringe …" - Para [0006]) for forming a cannula assembly (needle tube 3, needling holding member 7, Fig. 2), the method comprising:
providing a cannula (needle tube 3, Fig. 2)
having a proximal end (proximal section 3b, Fig. 4C) and a distal end (needle tip 3a, Fig. 4C), polymeric support material (close contact portion 9, Fig. 2), and a hub(connecting part 8, Fig. 2), the polymeric support material and the hub comprising transparent or translucent material ("… the material of the outer tube 6 is preferably transparent …" - Para [0035])("The needle holding member 7 configured as above is composed of essentially the same material as the outer tube 6." - Para [0046])("… the needle holding member 7 has a connecting part 8 … and a close portion part 9 ..." - Para [0039]);
locating the polymeric support material to substantially surround a portion of the cannula (Fig. 4B)("… the needle holding member 7 … is formed integrally and coaxially with the needle tube 3 …" - Para [0038], "… the needle holding member 7 has a connecting part 8 … and a close portion part 9 ..." - Para [0039]) at or near the proximal end of the cannula (Fig. 4B), the polymeric support material having a proximal end and a distal end (See annotated Fig. 4C above) the polymeric support material located between the cannula and the hub (Fig. 2); and
attaching the polymeric support material and the hub to the cannula to form a non- detachable, closed system (Fig. 4B)("… the needle holding member 7 … is formed integrally and coaxially with the needle tube 3 …" - Para [0038], "… the needle holding member 7 has a connecting part 8 … and a close portion part 9 ..." - Para [0039]),
wherein the polymeric support material (connecting part 8, Fig. 2) is tapered inwardly from the proximal end of the polymeric support material to the distal end of the polymeric support material (See annotated Fig. 4C above), in which the thickness of the polymeric support material is greater at the proximal end of the polymeric support material ("… the farther the connecting part 8 goes away from the outer tube 6, the thinner the connecting part 8 becomes …" - Para [0040], Fig. 2).
Regarding claim 21, Takemoto discloses the method ("… the method of forming the needle tube and the syringe …" - Para [0006]) as recited above, wherein
the polymeric support material (connecting part 8, Fig. 2) is continuously tapered inwardly from the proximal end of the polymeric support material to the distal end of the polymeric support material ("… the farther the connecting part 8 goes away from the outer tube 6, the thinner the connecting part 8 becomes …" - Para [0040], See annotated Fig. 4C above).
Regarding claim 22, Takemoto discloses the method ("… the method of forming the needle tube and the syringe …" - Para [0006]) as recited above, wherein
the polymeric support material (connecting part 8, Fig. 2) is tapered from the proximal end towards the distal end, in which the thickness of the polymeric support material is greater at the proximal end ("… the farther the connecting part 8 goes away from the outer tube 6, the thinner the connecting part 8 becomes …" - Para [0040], Fig. 2).
Regarding claim 36, Takemoto discloses the cannula assembly (needle tube 3, needling holding member 7, Fig. 2) as recited above, wherein
the cannula (needle tube 3, Fig. 2) is configured to extend sufficiently into the hub (needle holding member 7, Fig. 2) ("… the needle holding member 7 has a distal end and a proximal end, and is formed integrally and coaxially with the needle tube 3 …" - Para [0038], Fig. 4B) so as to receive the syringe ("… The proximal section 3b … of the needle tube 3 is inserted into the holding hole 6c." - Para [0032], Fig. 4C).
Regarding claim 37, Takemoto discloses the cannula assembly (needle tube 3, needling holding member 7, Fig. 2) as recited above, wherein
the cannula assembly (holding member 7, needle tube 3, Fig. 2) is a non- detachable, closed sterile system ("… the needle holding member 7 has a distal end and a proximal end, and is formed integrally and coaxially with the needle tube 3." - Para [0038]).
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.
Claim(s) 2, 12, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Takemoto et al. (US 20130296800 A1) in view of Wollbold (WO 2015144863 A1).
Regarding claim 2, Takemoto discloses the cannula assembly (needle tube 3, needling holding member 7, Fig. 2) as recited above, wherein
Takemoto does not expressly disclose that the cannula comprises glass fibers
Wollbold teaches that the cannula ("… the first body is a cannula …" - Para [0044]) comprises glass fibers ("The first body … may be formed from … glass …" - Para [0038]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the assembly of Takemoto to include that the cannula comprises glass fibers as taught by Wollbold for being configured for being transparent (Wollbold, Para [0039]).
Regarding claim 12, Takemoto discloses the cannula assembly (needle tube 3, needling holding member 7, Fig. 2) as recited above, wherein
the cannula (needle tube 3, Fig. 2), the polymeric support material (close contact portion 9, Fig. 2), and the hub (connecting part 8, Fig. 2) are non-detachably attached (Fig. 4B)("… the needle holding member 7 … is formed integrally and coaxially with the needle tube 3 …" - Para [0038], "… the needle holding member 7 has a connecting part 8 … and a close portion part 9 ..." - Para [0039])
Takemoto does not expressly disclose that the cannula, the polymeric support material, and the hub are non-detachably attached by a UV-sensitive adhesive.
Wollbold teaches that the cannula, the polymeric support material, and the hub are non-detachably attached by a UV-sensitive adhesive ("… the curing step is performed in subjecting the curable adhesive composition to an electromagnetic radiation. Electromagnetic radiations in particular comprise … ultraviolet radiation …" - Para [0030]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the assembly of Takemoto to include that the cannula, the polymeric support material, and the hub are non-detachably attached by a UV-sensitive adhesive as taught by Wollbold for light curing of adhesive compositions (Wollbold, Para [0006]).
Regarding claim 24, Takemoto discloses the method ("… the method of forming the needle tube and the syringe …" - Para [0006]) as recited above, wherein
attaching the polymeric support material (needling holding member 7, Fig. 2) and the hub (needling holding member 7, Fig. 2) to the cannula (needle tube 3, Fig. 2) includes placing an adhesive on at least one of the cannula, the polymeric support material, and the hub (“… the needle tube has been fixed to the needle hub by use of an adhesive, in the state of being inserted and passed in an insertion hole in the needle hub.” – Para [0003]).
Takemoto does not expressly disclose that attaching the polymeric material and the hub to the cannula includes placing a UV adhesive on at least one of the cannula, the polymeric support material, and exposing the UV adhesive to UV light.
Wollbold teaches disclose that attaching the polymeric material and the hub to the cannula includes placing a UV adhesive ("… the curing step is performed in subjecting the curable adhesive composition to an electromagnetic radiation. Electromagnetic radiations in particular comprise … ultraviolet radiation …" - Para [0030]) on at least one of the cannula, the polymeric support material, and exposing the UV adhesive to UV light (“… a light having a wavelength within the UV and/or visible portion of the electromagnetic spectrum such as to ensure that this light can reach the curable adhesive composition.” – Para [0040]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Takemoto to include that attaching the polymeric material and the hub to the cannula includes placing a UV adhesive on at least one of the cannula, the polymeric support material, and exposing the UV adhesive to UV light as taught by Wollbold Wollbold for light curing of adhesive compositions (Wollbold, Para [0006]).
Claim(s) 10, 13, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Takemoto et al. (US 20130296800 A1) in view of Walker (WO 2019246435 A1).
Regarding claim 10, Takemoto discloses the cannula assembly (needle tube 3, needling holding member 7, Fig. 2) as recited above, further including
Takemoto does not expressly disclose a winged connection adapted to tighten the cannula assembly and the syringe.
Walker teaches a winged connection (assembly flange 236, Fig. 2M) adapted to tighten the cannula assembly and the syringe . ("… the user may apply axial force to the assembly flange 236 of the hub 230 an opposing axial force to the girl plate 222, causing a coupling or mating of the BFS vial 210 with the hub assembly 226 …" - Para [0044])
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the assembly of Takemoto to include a winged connection adapted to tighten the cannula assembly and the syringe as taught by Walker for the expelling of fluid (Walker, Para [0044]).
Regarding claim 13, Takemoto discloses the cannula assembly (needle tube 3, needling holding member 7, Fig. 2) as recited above, wherein
the cannula (needle tube 3, Fig. 2), the polymeric support material (close contact portion 9, Fig. 2), and the hub (connecting part 8, Fig. 2) are non- detachably attached
Takemoto does not expressly disclose that the cannula, the polymeric support material, and the hub are non-detachably attached by way of shrink wrap.
Walker teaches that the cannula, the polymeric support material, and the hub are non-detachably attached by way of shrink wrap by way of shrink wrap ("… the hub assembly 226 may generally be packaged and delivered in a fully assembled state … including a seal such as … shrink-wrap …" - Para [0036]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the assembly of Takemoto to that the cannula, the polymeric support material, and the hub are non-detachably attached by way of shrink wrap as taught by Walker to prevent contaminants from entering the hub (Walker, Para [0036]).
Regarding claim 25, Takemoto discloses the method ("… the method of forming the needle tube and the syringe …" - Para [0006]) as recited above, wherein
Takemoto does not expressly disclose that attaching the polymeric support material and hub to the cannula includes shrink-wrapping the hub and the polymeric support material to the cannula.
Walker teaches that attaching the polymeric support material and hub (hub assembly 226, Fig. 2) to the cannula (needle 284, Fig. 2) includes shrink-wrapping the hub and the polymeric support material to the cannula)(“… the hub assembly 226 may generally be packaged and delivered … including the cap 228 provided over the needle 284 and/or including a seal … such as … shrink-wrap seal …” – Para [0036]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Takemoto to include that attaching the polymeric support material and hub to the cannula includes shrink-wrapping the hub and the polymeric support material to the cannula as taught by Walker to prevent contaminants from entering the hub (Walker, Para [0036]).
Claim(s) 26, 31, 33-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tieu et al. (US Pub No. 20140155471 A1) in view of Takemoto et al. (US 20130296800 A1).
Regarding claim 26, Tieu discloses a method of delivering a viral vector to a central nervous system of a subject, the method (“method … for delivery of viral vectors.” – Para [0037]) comprising:
providing a syringe containing a solution including a viral vector ("A viral vector can be delivered via a catheter, cannula or other injection device that is inserted into CNS tissue …" - Para [0037])
administering the solution including the viral vector to the central nervous system of the subject via the cannula assembly and the syringe ("A viral vector can be delivered via a catheter, cannula or other injection device that is inserted into CNS tissue …" - Para [0037]).
Tieu does not expressly disclose the cannula assembly of claim 1 and attaching the syringe to the hub of the cannula.
Takemoto teaches the cannula assembly of claim 1 (needle tube 3,close contact portion 9, connecting part 8, Fig. 2) and attaching the syringe (syringe 2, "the syringe 2 is provided with an outer tube 6 …" - Para [0031], Fig. 1) to the hub (connection part 8, Fig. 2) of the cannula (needle tube 3, Fig. 2) ("… the needle holding member 7 has a connection part 8 to be joined to one axial-directional end of the outer tube 6 …" - Para [0039]) ("… the needle holding member 7 … is formed integrally and coaxially with the needle tube 3 …" - Para [0038]).
Therefore, it would have been obvious, before the effective filing date of the invention to modify the method of Tieu to include the cannula assembly of claim 1 and attaching the syringe to the hub of the cannula as taught by Tieu for treating neurological disease (Tieu, Para [0023]).
Regarding claim 31, Tieu discloses the method (“method … for delivery of viral vectors.” – Para [0037]) as recited above, wherein
the central nervous system is a brain tissue ("One of skill in the art can readily determine which general area of the CNS is an appropriate target. For example, and not to be limiting, when treating PD, the striatum or substantia nigra are suitable areas of the brain to target." - Para [0037]) or a spinal cord.
Regarding claim 33, Tieu discloses the method (“method … for delivery of viral vectors.” – Para [0037]) as recited above, wherein
the subject has a neurological disorder (“… a method of treating a neurological disease or injury in a subject …” – Para [0004]).
Regarding claim 34, Tieu discloses the method (“method … for delivery of viral vectors.” – Para [0037]) as recited above, wherein
the neurological disorder is meningitis, encephalitis, multiple sclerosis (MS), stroke, brain tumors, epilepsy, Alzheimer's disease, AIDS- related dementia, Parkinson's disease or Huntington's disease the neurological disorder is meningitis, encephalitis, multiple sclerosis (MS), stroke, brain tumors, epilepsy, Alzheimer's disease, AIDS- related dementia, Parkinson's disease or Huntington's disease ("… the neurological disease or injury can be, but is not limited to, Parkinson's disease, Alzheimer's disease, Huntington's disease … " - Para [0027]).
Regarding claim 35, Tieu discloses the method (“method … for delivery of viral vectors.” – Para [0037]) as recited above, wherein
the neurological disorder is Alzheimer's disease, Parkinson's disease or Huntington's disease ("… the neurological disease or injury can be, but is not limited to, Parkinson's disease, Alzheimer's disease, Huntington's disease … " - Para [0027]).
Claim(s) 38-39, and 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Takemoto et al. (US 20130296800 A1) in view of Steube (US Pub No. 20030040720 A1).
Regarding claim 38, Takemoto discloses a cannula assembly (holding member 7, needle tube 3, Fig. 2) comprising:
a cannula (needle tube 3, Fig. 2) having a proximal end (proximal section 3b, Fig. 4C) and a distal end (needle tip 3a, Fig. 4C); and
a hub (connecting part 8, Fig. 2) configured to be attached to a syringe (syringe 2, "the syringe 2 is provided with an outer tube 6 …" - Para [0031], Fig. 1)("… the needle holding member 7 has a connection part 8 to be joined to one axial-directional end of the outer tube 6 …" - Para [0039]),
polymeric support material (close contact portion 9, Fig. 2) substantially surrounding a portion of the cannula at or near the proximal end of the cannula (See annotated Fig. 4C), the polymeric support material having a proximal end and a distal end (See annotated Fig. 4C), the polymeric support material being located between the cannula and the hub (Fig. 2),
wherein the cannula is configured to extend into the hub (Fig. 4B), and
wherein the cannula and the hub are non-detachable ("… the needle holding member 7 … is formed integrally and coaxially with the needle tube 3 …" - Para [0038], "… the needle holding member 7 has a connecting part 8 … and a close portion part 9 ..." - Para [0039]),
wherein the polymeric support material (connecting part 8, Fig. 2) is tapered inwardly from the proximal end of the polymeric support material to the distal end of the polymeric support material (See annotated Fig. 4C), in which the thickness of the polymeric support material is greater at the proximal end of the polymeric support material ("… the farther the connecting part 8 goes away from the outer tube 6, the thinner the connecting part 8 becomes …" - Para [0040], Fig. 2).
Takemoto does not expressly disclose that when a syringe is attached, the cannula is extended sufficiently to be received by the syringe so as to reduce the dead space relative to when the cannula is not extended sufficiently to be received by the syringe.
Steube teaches that when a syringe is attached, the cannula is extended sufficiently to be received by the syringe (“Needle cannula 120 is mounted within needle cavity 121 …” – Para [0028]) so as to reduce the dead space relative to when the cannula is not extended sufficiently to be received by the syringe ("One of the advantages of this configuration is the reduction of total dead space, which may include space 137, typically due to a barrel and needle hub connection." - Para [0028]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the assembly of Takemoto to include that when a syringe is attached, the cannula is extended sufficiently to be received by the syringe so as to reduce the dead space relative to when the cannula is not extended sufficiently to be received by the syringe as taught by Steube to reduce dead space within which medication can be wasted (Steuebe, Abstract).
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Regarding claim 39, Takemoto discloses the cannula assembly (holding member 7, needle tube 3, Fig. 2) as recited above, further including
a syringe (syringe 2, "the syringe 2 is provided with an outer tube 6 …" - Para [0031], Fig. 1) to form a cannula assembly and syringe combination, the cannula extending into the hub and the syringe ("… the needle holding member 7 has a connection part 8 to be joined to one axial-directional end of the outer tube 6 …" - Para [0039]) ("… the needle holding member 7 … is formed integrally and coaxially with the needle tube 3 …" - Para [0038], Fig. 4C).
Regarding claim 43, Takemoto discloses the cannula assembly (holding member 7, needle tube 3, Fig. 2) as recited above, further including
wherein the polymeric support material (connecting part 8, Fig. 2) is continuously tapered inwardly from the proximal end of the polymeric support material to the distal end of the polymeric support material ("… the farther the connecting part 8 goes away from the outer tube 6, the thinner the connecting part 8 becomes …" - Para [0040], See annotated Fig. 4C above)
Claim(s) 40 and 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Takemoto et al. (US 20130296800 A1) in view of Steube (US Pub No. 20030040720 A1) and in further view of Wollbold (WO 2015144863 A1).
Regarding claim 40, Takemoto discloses the cannula assembly (holding member 7, needle tube 3, Fig. 2) as recited above, wherein
the cannula (needle tube 3, Fig. 2) and the hub (holding member 7, Fig. 2) are attached ("… the needle holding member 7 … is formed integrally and coaxially with the needle tube 3 …" - Para [0038])
Takemoto does not expressly disclose that the cannula and the hub are attached by an adhesive.
Wollbold teaches that the cannula and the hub are attached by an adhesive ("… the curing step is performed in subjecting the curable adhesive composition to an electromagnetic radiation. Electromagnetic radiations in particular comprise … ultraviolet radiation …" - Para [0030]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the assembly of Takemoto to include that the cannula, the polymeric support material, and the hub are non-detachably attached by an adhesive as taught by Wollbold for light curing of adhesive compositions (Wollbold, Para [0006]).
Regarding claim 41, Takemoto discloses the cannula assembly (holding member 7, needle tube 3, Fig. 2) as recited above, wherein
Takemoto does not expressly disclose that the adhesive is an UV-sensitive adhesive
Wollbold teaches that the adhesive is a UV-sensitive adhesive ("… the curing step is performed in subjecting the curable adhesive composition to an electromagnetic radiation. Electromagnetic radiations in particular comprise … ultraviolet radiation …" - Para [0030]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the assembly of Takemoto to include that the adhesive is an UV-sensitive adhesive as taught by Wollbold for light curing of adhesive compositions (Wollbold, Para [0006]).
Claim(s) 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Takemoto et al. (US 20130296800 A1) in view of Steube (US Pub No. 20030040720 A1) and in further view of Walker (WO 2019246435 A1).
Regarding claim 42, Takemoto discloses the cannula assembly (holding member 7, needle tube 3, Fig. 2) as recited above, wherein
the cannula (needle tube 3, Fig. 2) and the hub (holding member 7, Fig. 2) are attached ("… the needle holding member 7 … is formed integrally and coaxially with the needle tube 3 …" - Para [0038]) by shrink wrap.
Takemoto does not expressly disclose that the cannula and the hub are attached by shrink wrap.
Walker teaches that the cannula and the hub are attached by shrink wrap ("… the hub assembly 226 may generally be packaged and delivered in a fully assembled state … including a seal such as … shrink-wrap …" - Para [0036]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the assembly of Takemoto to include that the cannula and the hub are attached by shrink wrap as taught by Wollbold to prevent contaminants from entering the hub (Walker, Para [0036]).
Response to Arguments
Applicant’s arguments, see pages 8-12, filed 6/22/2026, with respect to the rejection(s) of claim(s) 1-3, 5, 7, 10-13, 15, 16, 20, 21, 24-26, 31, and 33-43 under 35 USC 102 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Takemoto.
102 Independent Claim 1
Applicant argues that Takemoto does not disclose teach or suggest “wherein the polymeric support material is tapered inwardly from the proximal end of the polymeric support material to the distal end of the polymeric support material, in which the thickness of the polymeric support material is greater at the proximal end of the polymeric support material" recited in independent claim 1. Rather, as shown best in FIG. 4B of Takemoto above, the needle holding member 7 has a proximal end beginning at connecting part 8 that tapers initially inwardly, then tapers outwardly and then turns into a flat section near the close contact point 9. The needle holding member 7 is not tapered inwardly at its proximal end, which is the further end of the close contact point 9 from the syringe 2.
Examiner interprets Takemoto teaches “wherein the polymeric support material is tapered inwardly from the proximal end of the polymeric support material to the distal end of the polymeric support material, in which the thickness of the polymeric support material is greater at the proximal end of the polymeric support material" of claim 1 as recited in the rejection above, because connecting part 8 is interpreted only as the part that tapers initially inward. The part that tapers outward is interpreted to be a part of the close contact point 9. See annotated Figure 4C below.
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103 Dependent claims 2, 3, 5, 7, 10-13, 26, 31, and 33-36
Applicant argues that Wollbold, Walker or Tieu, however, do not address the deficiencies in Takemoto discussed above with respect to independent claim 1. Therefore, dependent claims 2, 3, 5, 7, 10-13, 26, 31 and 33-36 are not anticipated by or rendered obvious over Takemoto, Wollbold, Walker, Tieu, or any combination thereof for at least these reasons and should be allowable.
Refer to the above rejection and response to arguments.
103 Independent claims 15, 20, and 38
Applicant argues that for at least the same reasons as discussed above with respect to independent claim 1, independent claims 15 and 20 are not anticipated by or rendered obvious over Takemoto.
Refer to the above rejection and response to arguments.
103 Dependent claims 16, 21, 24, 25, and 39-43
Applicant argues that neither Wollbold nor Walker, however, addresses the deficiencies in Takemoto discussed above with respect to independent claims 15, 20 and 38
Refer to the above rejection and response to arguments.
With respect to the applicant’s argument the rejection above teaches the claimed limitations. The rejection above is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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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/ESHA PRAKASH KASHYAP/ Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783
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