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 .
Status of Claims
Claims 1-10 and 19-29 are currently pending and under examination. Claims 11-18 are canceled. As per the amendments filed on 07/23/2025, claims 1, 8-10, and 24 are amended. Claim 29 is newly added.
Response to Arguments
Applicant’s arguments, see Remarks page 8 (Rejection under 35 U.S.C. § 112), filed 07/23/2025, with respect to the rejections of claims 1-10 and 19-28 under 35 U.S.C. § 112(b) have been fully considered and are persuasive. Therefore, the rejections of claims 1-10 and 19-28 are withdrawn.
Applicant’s arguments, see Remarks pages 10-11 (With regard to claim 10), filed 07/23/2025, with respect to the rejections under 35 U.S.C. § 102 of claims 10, 19, and 21 over Lim (WO 2018/093097 A2) have been fully considered and are persuasive. With respect to claim 10, Applicant argues:
Claim 10 has been amended to clarify that the side hole has one or more side walls oriented in a direction intersecting the longitudinal axis and the side hole penetrates from an inner circumferential surface of the needle tube to an outer circumferential surface of the needle tube, and the side hole having one or more side walls defining an opening. Lim and Bays fail to disclose or suggest at least such features of claim 1. Specifically, Lam only discloses the needle tube being transparent (not providing a window penetrating from an inner circumferential surface of the needle tube to an outer circumferential surface of the needle tube and having side walls in the needle tube).
With regard to the rejection of claims 10, 19 and 21 under 35 U.S.C. § 102(a)(1), a puncture device having the features discussed above and as recited in independent claim 10, is nowhere disclosed in Lim. Since it has been decided that "anticipation requires the presence in a single prior art reference, disclosure of each and every element of the claimed invention, arranged as in the claim," independent claim 10 is not anticipated by Lim. Accordingly, independent claim 10 patentably distinguishes over Lim and is allowable. Claims 19 and 21, being dependent upon claim 1, are thus at least allowable therewith. Consequently, the Examiner is respectfully requested to withdraw the rejection of claims 10, 19 and 21 under 35 U.S.C. § 102(a)(1). (07/23/2025 Remarks, page 10-11)
The amended side-hole is not disclosed in Lim. Therefore, the 35 U.S.C. § 102 rejections of claims 10, 19, and 21 are withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Klubben (US PG Pub 2016/0278622 A1), see “Claim Rejections - 35 USC § 103” section.
Applicant’s arguments, see Remarks pages 10-12 (With regard to claim 1), filed 07/23/2025, with respect to the rejections under 35 U.S.C. § 103 of claims 1-9, 20, and 22-28 over Lim in view of Bays (WO 2014/068495 A2) have been fully considered and are persuasive. With respect to claim 1, Applicant argues:
Firstly, Applicant submits that the Examiner's combination of Lim and Bays to be unreasonable. That is, the Examiner considers the optical fiber to correspond to the tube (accommodated in the needle tube). The Examiner then argues that it would be obvious to modify Lin by splitting the needle tube into a proximal portion and a distal portion and connecting the distal portion of the needle tube to the distal end of the optical fiber and connecting the proximal portion of the needle tube to the proximal end of the optical fiber, citing Bays. However, those skilled in the art would not connect a fragile optical fiber in such a manner. (07/23/2025 Remarks, page 10)
The combination with Bays is obvious as a mechanism to cover the exposed optical fiber in Lim after puncturing the tissue (as illustrated below) in order to more purposefully time the application of phototherapy by incorporating a cover, via the teachings of Bays, to the transparent tube in Lim.
PNG
media_image1.png
867
1012
media_image1.png
Greyscale
Figures 9-10 in Lim (modified by examiner in red to show combination with Bays)
Additionally, Applicant argues:
Secondly, in the interests of advancing prosecution, claim 1 has been amended to clarify that "the needle tip further having a hollow portion at a proximal end of the needle tip for fixing the distal end of the tube to the hollow portion of the needle tip" (see e.g., Figures 4, 5, 13-18 and 22). Lim and Bays fail to disclose or suggest at least such features of claim 1. (07/23/2025 Remarks, page 10)
Neither Lim nor Bays disclose "the needle tip further having a hollow portion at a proximal end of the needle tip for fixing the distal end of the tube to the hollow portion of the needle tip.” Therefore, the rejections of claims 1-9, 20, and 22-28 are withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Baid (US PG Pub 2016/0235949 A1), see “Claim Rejections - 35 USC § 103” section.
Regarding claim 24, the applicant further argues:
Furthermore, claim 24 has been amended to clarify that the tube has a single lumen accommodating the optical fiber in the single lumen, the lumen extending into the hollow portion of the needle tip. The Applicant further submits that at least claim 24 patentably distinguishes over Lim and Bays independently of its base claim and is allowable. In this regard, the Applicant submits that Lim and Bays fail to disclose or suggest the lumen of the tube extending into the hollow portion of the needle tip. (07/23/2025 Remarks, page 11-12)
Lim discloses the optical fiber as housed inside the needle and the lumen extending along the needle toward the needle tip (Figure 8, [0071] – “That is, a receiving space of a certain diameter can be formed inside the needle (500), and the optical fiber (600) can be manufactured with the receiving space embedded therein”). Lim and Bays were previously determined to not disclose the hollow portion of the needle tip in claim 1, where the rejection to claim 24 was withdrawn due to the dependency of claim 24 on claim 1. However, upon further consideration, a new ground(s) of rejection is made in view of Baid, see “Claim Rejections - 35 USC § 103” section.
Newly added claim 29 is evaluated in light of the above arguments and rejected under 35 U.S.C. § 103 over Lim in view of Bays and Baid (see “Claim Rejections - 35 USC § 103”).
Summary: The 35 U.S.C. § 102 rejections for claims 10, 19, and 21 and 35 U.S.C. § 103 rejections for claims 1-9, 20, and 22-28 are withdrawn. 35 U.S.C. § 103 rejections for claims 10, 18, and 21 newly in view of Klubben and claims 1-9, 20, and 22-28 newly in view of Baid are added. A new 35 U.S.C. § 103 rejection for claim 29 over Lim in view of Bays and Baid is added.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C.
103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 1-9, 20, and 22-29 are rejected under U.S.C 103 as being unpatentable over Lim (WO 2018/093097 A2, see previously cited) in view of Bays (WO 2014/068495 A2, see previously cited) and Baid (US PG Pub 2016/0235949 A1, see “Notice of References Cited”). Note machine translations via Espacenet (https://worldwide.espacenet.com) were used to interpret the disclosures in Lim and Bays - see previously attached for copies of translations.
Regarding Claim 1, Lim discloses a puncture device ([0017] - medical photodynamic therapy device with a needle for puncturing) comprising:
• a needle tube extending along a longitudinal axis (Fig 10, needle 500 extending along a longitudinal axis)
• a tube accommodated within the needle tube ([0017] – an optical fiber that emits laser light is embedded in the interior of the needle within a structure in a sealed state so as not to be exposed to the outside), the tube configured to accommodate an optical fiber (300 – optical fiber) extending along the longitudinal axis, the tube comprising a cylindrical optically-transparent material ([0020] – “In addition, the needle may be configured with a first needle portion made of a transparent material for a length along which the optical fiber is embedded” where the tube surrounding the fiber would necessarily need to be transparent as well).
• wherein the needle tube comprises a needle tip and a needle base (Figure 9, needle 500 contains a tip and a base section distinct from the tip) the needle tip being fixed to a distal end of the tube (Figs. 9-12 – the needle tip with a closed end fixes the optical fiber in a location), and having a blade surface at a distal end of the needle tip ([0019] – pointed tip of the needle equivalent to bladed surface) the needle tip further having a hollow portion at a proximal end of the needle tip ([0071] – needle connected to tip has a receiving space inside: “That is, a receiving space of a certain diameter can be formed inside the needle (500), and the optical fiber (600) can be manufactured with the receiving space embedded therein”);
• the needle base being disposed to cover a proximal portion of the tube relative to the needle tip and the needle base being movable along the longitudinal axis ([0017] – connection between tip and more-proximal base where the needle tube, made of the tip and base, as a whole is movable: “flexible hose formed to extend to a tip end of the base portion by a predetermined length; and a needle embedded in the flexible hose and protruding outward by a set length according to the movement of the moving portion”). Note the whole needle tube is moved to puncture the tissue and determine a position within the tissue. The optical fiber is uncovered when the needle tube is advanced out from the sheath when placed in tissue.
However, Lim does not disclose a distal end of the needle base is movable to abut on a proximal end of the needle tip, and to retract away from the proximal end of the needle tip in a longitudinal axis direction and the needle tip further having a hollow portion at a proximal end of the needle tip for fixing the distal end of the tube to the hollow portion of the needle tip.
Bays, in the same field of endeavor of a puncture device providing phototherapy ([0003], [0008]), teaches a movable base relative to the needle tip used to uncover the optical fiber for phototherapy (Figs. 3a-b, [0051] - shows a closed configuration in Fig 3a and an open configuration in Fig 3b due to the base moving away from the tip). Bays further teaches: “The concept of a movable outer tube placed around the flexible tube of the insertion catheter not only allows the flexible tube to be stiffened during insertion of the catheter, but this outer tube can also be used as a light shield and thus modify at will, by longitudinal movement, the illumination length along the insertion catheter (Fig.6)” ([0063]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Lim’s phototherapy puncture device with a movable needle by incorporating the needle base movable independent of the needle tip in Bays. This would have been obvious because both Lim and Bays discuss phototherapy applied to tissue as part of needle puncture devices and Bays provides a solution/improvement to preventing light from emitting into tissue prematurely until the needle base is moved. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Lim by incorporating the needle base movable independent of the needle tip in Bays.
Baid, in the same field of endeavor of a puncture device ([0002]), teaches a hollow needle wall 20 which extends from tip 14 (Figures 5-6, [0061]) where the distal end of tube 16 is fixed to the hollow needle wall by manipulating the inner diameter of the tubing to match the outer diameter of the hollow needle wall where fixing occurs (Figures 5-6, [0049]). Additionally, Baid teaches an engagement means for stopping a needle guard via crimped sections of the hollow needle wall which could be generally interpreted as a mechanism to prevent a slidable component from passing over a particularly portion of the hollow needle wall ([0050-0051]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Lim’s phototherapy puncture device with a movable needle by incorporating the hollow needle wall with adjustable outer diameter to restrain slidable elements (such as tubing) from passing too far toward the needle tip in Baid. This would have been obvious because both Lim and Baid discuss phototherapy applied to tissue as part of needle puncture devices and Baid provides a solution/improvement to fix slidable tubing in relation to the needle tip to prevent unwanted movement of the tubing beyond a particular point. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Lim by incorporating the hollow needle wall with adjustable outer diameter to restrain slidable elements (such as tubing) from passing too far toward the needle tip in Baid.
Therefore, Claim 1 is obvious over Lim in view of Bays and Baid.
Regarding Claim 2, the puncture device according to Claim 1 is obvious over Lim in view of Bays and Baid, as indicated hereinabove. Lim discloses further comprising:
• a sheath that movably accommodates the needle tube along the longitudinal axis ([0017] – “a flexible hose formed to extend to a tip end of the base portion by a predetermined length; and a needle embedded in the flexible hose and protruding outward by a set length according to the movement of the moving portion”);
• an operating body (position adjustment part 120 and moving part 130 are used to operate the sliding function) fixed to a proximal end of the sheath (Figure 1, [0043] - hose 140 connects to adjustment elements 120 and 130 and base 110); and
• a needle slider movable along the longitudinal axis relative to the operating body, the needle slider being connected to the tube ([0017] – “position adjusting portion capable of sliding or fixing with respect to the base portion; a moving portion capable of moving to the position fixing portion while the position fixing portion is fixed”).
Therefore, Claim 2 is obvious over Lim in view of Bays and Baid.
Regarding Claim 3, the puncture device according to Claim 1 is obvious over Lim in view of Bays and Baid, as indicated hereinabove. Lim discloses further comprising:
• a sheath that movably accommodates the needle tube along the longitudinal axis ([0017] – “a flexible hose formed to extend to a tip end of the base portion by a predetermined length; and a needle embedded in the flexible hose and protruding outward by a set length according to the movement of the moving portion”);
• an operating body (position adjustment part 120 and moving part 130 are used to operate the sliding function) fixed to a proximal end of the sheath (Figure 1, [0043] - hose 140 connects to adjustment elements 120 and 130 and base 110);
•a needle slider movable along the longitudinal axis relative to the operating body ([0017] – “position adjusting portion capable of sliding or fixing with respect to the base portion; a moving portion capable of moving to the position fixing portion while the position fixing portion is fixed”); and
• a connection member that connects the needle slider and the tube ([0017] – the needle tube and tube are moved by the slider relative to the sheath).
Therefore, Claim 3 is obvious over Lim in view of Bays and Baid.
Regarding Claim 4, the puncture device according to Claim 2 is obvious over Lim in view of Bays and Baid, as indicated hereinabove. Lim further discloses wherein the needle slider comprises a slider body fixed to the proximal end of the tube ([0017] – the needle is moved by the slider relative to a fixed hose/sheath) and a needle-tube operating section movably (position adjustment part 120 and moving part 130 are used to operate the sliding function) supported along the longitudinal axis relative to the slider body and fixed to a proximal end of the needle base ([0017] – “position adjusting portion capable of sliding or fixing with respect to the base portion; a moving portion capable of moving to the position fixing portion while the position fixing portion is fixed” where the base is connected to more proximal elements as seen in Figure 1). The slider body moves the needle relative to the outer sheath.
Therefore, Claim 4 is obvious over Lim in view of Bays and Baid.
Regarding Claim 5, the puncture device according to Claim 4 is obvious over Lim in view of Bays and Baid, as indicated hereinabove. Lim discloses further comprising: a positioning mechanism in which the slider body and the needle-tube operating section are configured to position the distal end of the needle base in abutment with the proximal end of the needle tip ([0055] – “For example, if the operator wants to make the needle (200) protrude 3 cm from the end of the flexible hose (140), the position adjustment part (120) is slid to the position 3 indicated on one side of the base part (110), the fixing screw (122) is tightened to fix it, and then the moving part (130) is pushed to the position adjustment part (120), so that the needle (200) protrudes 3 cm from the end of the flexible hose (140), as shown in FIGS. 3 and 6”). The needle tube, where the needle tip and base abut, is positioned at a length determined by the positioning mechanism.
Therefore, Claim 5 is obvious over Lim in view of Bays and Baid.
Regarding Claim 6, the puncture device according to Claim 5 is obvious over Lim in view of Bays and Baid, as indicated hereinabove. Lim further discloses a positioning mechanism to move the needle tube from the sheath into tissue ([0055]). However, Lim does not disclose the positioning mechanism is configured to perform the positioning in a switchable manner between a first state where the distal end of the needle base is in abutment with the proximal end of the needle tip and a second state where the distal end of the needle base is positioned away from the proximal end of the needle tip in the direction of the longitudinal axis.
Bays, in the same field of endeavor of a puncture device providing phototherapy ([0003], [0008]), teaches a movable base relative to the needle tip used to uncover the optical fiber for phototherapy (Figs. 3a-b, [0051] - shows a closed configuration in Fig 3a corresponding to the first state and an open configuration in Fig 3b due to the base moving away from the tip and corresponding to the second state).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Lim’s phototherapy puncture device with a movable needle by incorporating the needle base movable independent of the needle tip in Bays. This would have been obvious because both Lim and Bays discuss phototherapy applied to tissue as part of needle puncture devices and Bays provides a solution/improvement to preventing light from emitting into tissue prematurely until the needle base is moved. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Lim by incorporating the needle base movable independent of the needle tip in Bays.
Therefore, Claim 6 is obvious over Lim in view of Bays and Baid.
Regarding Claim 7, the puncture device according to Claim 1 is obvious over Lim in view of Bays and Baid, as indicated hereinabove. Lim further discloses a needle tube with a distinct tip and base (Figure 9, needle 500 contains a tip and portion within the base of the device). However, Lim fails to disclose wherein the distal end of the needle base and the proximal end of the needle tip overlap in a radial direction in a state where the distal end of the needle base is in abutment with the proximal end of the needle tip.
Bays, in the same field of endeavor of a puncture device providing phototherapy ([0003], [0008]), teaches a movable base relative to the needle tip used to uncover the optical fiber for phototherapy (Figs. 3a-b, [0051] - shows a closed configuration in Fig 3a and an open configuration in Fig 3b due to the base moving away from the tip). Bays further teaches: “The concept of a movable outer tube placed around the flexible tube of the insertion catheter not only allows the flexible tube to be stiffened during insertion of the catheter, but this outer tube can also be used as a light shield and thus modify at will, by longitudinal movement, the illumination length along the insertion catheter (Fig.6)” ([0063]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Lim’s phototherapy puncture device with a movable needle by incorporating the needle base movable independent of the needle tip in Bays. This would have been obvious because both Lim and Bays discuss phototherapy applied to tissue as part of needle puncture devices and Bays provides a solution/improvement to preventing light from emitting into tissue prematurely until the needle base is moved. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Lim by incorporating the needle base movable independent of the needle tip in Bays.
Baid, in the same field of endeavor of a puncture device ([0002]), teaches a hollow needle wall 20 which extends from tip 14 (Figures 5-6, [0061]) where the distal end of tube 16 is fixed to the hollow needle wall by manipulating the inner diameter of the tubing to match the outer diameter of the hollow needle wall where fixing occurs (Figures 5-6, [0049]). Additionally, Baid teaches an engagement means for stopping a needle guard via crimped sections of the hollow needle wall which could be generally interpreted as a mechanism to prevent a slidable component from passing over a particularly portion of the hollow needle wall ([0050-0051]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Lim’s phototherapy puncture device with a movable needle by incorporating the hollow needle wall with adjustable outer diameter to restrain slidable elements (such as tubing) from passing too far toward the needle tip in Baid. This would have been obvious because both Lim and Baid discuss phototherapy applied to tissue as part of needle puncture devices and Baid provides a solution/improvement to fix slidable tubing in relation to the needle tip to prevent unwanted movement of the tubing beyond a particular point in the proximal needle tip. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Lim by incorporating the hollow needle wall with adjustable outer diameter to restrain slidable elements (such as tubing) from passing too far toward the needle tip in Baid.
Therefore, Claim 7 is obvious over Lim in view of Bays and Baid.
Regarding Claim 8, the puncture device according to Claim 23 is obvious over Lim in view of Bays and Baid, as indicated hereinabove. Lim further discloses a diffuser in the optical fiber 600 where therapeutic light is emitted when the needle tube is pushed from the sheath (Figure 10, [0063]) where a range or diffuser is apparent in the shaded section of the optical fiber in Figures 9-12. However, Lim does not disclose a light radiation range in which light is emitted from the optical fiber is wider in the longitudinal axis direction than a light radiation range in which the tube is exposed from the needle tube when the distal end of the needle base is positioned maximally away from the proximal end of the needle tip in the longitudinal axis direction.
Bays, in the same field of endeavor of a puncture device providing phototherapy ([0003], [0008]), teaches a movable base relative to the needle tip used to uncover the optical fiber for phototherapy (Figs. 3a-b, [0051] - shows a closed configuration in Fig 3a and an open configuration in Fig 3b due to the base moving away from the tip). The thicker sections at the end of the optical fibers in Figures 2, 3, and 6 which emit light are interpreted as diffusers. The length of these diffusers appears to be highly variably in Figure 2 depending on the application, which could be interpreted as being longer than the distance the needle base can be moved.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Lim’s phototherapy puncture device with a movable needle by incorporating the needle base movable independent of the needle tip in Bays. This would have been obvious because both Lim and Bays discuss phototherapy applied to tissue as part of needle puncture devices and Bays provides a solution/improvement to preventing light from emitting into tissue prematurely until the needle base is moved. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Lim by incorporating the needle base movable independent of the needle tip in Bays.
Therefore, Claim 8 is obvious over Lim in view of Bays and Baid.
Regarding Claim 9, the puncture device according to Claim 8 is obvious over Lim in view of Bays and Baid, as indicated hereinabove. Lim further discloses a diffuser in the optical fiber 600 where therapeutic light is emitted when the needle tube is pushed from the sheath (Figure 10, [0063]). Lim does not disclose wherein, in the state where the distal end of the needle base is positioned maximally away from the proximal end of the needle tip in the longitudinal axis direction, a distal end of the light radiation range in the longitudinal axis direction is positioned toward the distal end of the needle tube and a proximal end of the light radiation range in the longitudinal axis direction is positioned toward the proximal end of the needle tube.
Bays, in the same field of endeavor of a puncture device providing phototherapy ([0003], [0008]), teaches a movable base relative to the needle tip used to uncover the optical fiber for phototherapy (Figs. 3a-b, [0051] - shows a closed configuration in Fig 3a and an open configuration in Fig 3b due to the base moving away from the tip). The thicker sections at the end of the optical fibers in Figures 2, 3, and 6 which emit light are interpreted as diffusers. The diffuser is represented in these figures as having a distal end positioned toward the needle tip and a proximal end positioned in the direction of the base toward the proximal end of the needle tube.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Lim’s phototherapy puncture device with a movable needle by incorporating the needle base movable independent of the needle tip in Bays. This would have been obvious because both Lim and Bays discuss phototherapy applied to tissue as part of needle puncture devices and Bays provides a solution/improvement to preventing light from emitting into tissue prematurely until the needle base is moved. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Lim by incorporating the needle base movable independent of the needle tip in Bays.
Therefore, Claim 9 is obvious over Lim in view of Bays and Baid.
Regarding Claim 20, the puncture device according to Claim 1 is obvious over Lim in view of Bays, as indicated hereinabove. Lim discloses further comprising:
• a sheath that movably accommodates the needle tube along the longitudinal axis ([0017] – “a flexible hose formed to extend to a tip end of the base portion by a predetermined length; and a needle embedded in the flexible hose and protruding outward by a set length according to the movement of the moving portion”);
• an operating body (position adjustment part 120 and moving part 130 are used to operate the sliding function) fixed to a proximal end of the sheath (Figure 1, [0043] - hose 140 connects to adjustment elements 120 and 130 and base 110);
• a needle slider movable along the longitudinal axis relative to the operating body ([0017] – “position adjusting portion capable of sliding or fixing with respect to the base portion; a moving portion capable of moving to the position fixing portion while the position fixing portion is fixed”) and
• a connection member that connects the needle slider and the tube ([0017] – the needle tube and tube are moved by the slider relative to the sheath).
Therefore, Claim 20 is obvious over Lim in view of Bays and Baid.
Regarding Claim 22, the puncture device according to Claim 1 is obvious over Lim in view of Bays and Baid, as indicated hereinabove. Lim further discloses wherein the needle tube comprises a metallic needle tube ([0073] – part of the needle tube is soft iron: “That is, among the entire length of the needle (500), a first needle part made of a transparent material may be formed for a length in which the optical fiber (600) is embedded, and a second needle part made of soft iron may be formed for a length in which the optical fiber (600) is not embedded, and they may be connected to each other”).
Therefore, Claim 22 is obvious over Lim in view of Bays and Baid.
Regarding Claim 23, the puncture device according to Claim 1 is obvious over Lim in view of Bays, as indicated hereinabove. Lim discloses further comprising the optical fiber disposed in the tube ([0017] – an optical fiber that emits laser light is embedded in the interior of the needle within a structure in a sealed state so as not to be exposed to the outside).
Therefore, Claim 23 is obvious over Lim in view of Bays and Baid.
Regarding Claim 24, the puncture device according to Claim 1 is obvious over Lim in view of Bays and Baid, as indicated hereinabove. Lim further discloses wherein the tube has a single lumen accommodating the optical fiber in the single lumen (Figure 8, [0071] – the optical fiber is depicted inside a sealed container housed inside the needle: “That is, a receiving space of a certain diameter can be formed inside the needle (500), and the optical fiber (600) can be manufactured with the receiving space embedded therein”). However, Lim does not disclose the lumen extending into the hollow portion of the needle tip.
Baid, in the same field of endeavor of a puncture device ([0002]), teaches a hollow needle wall 20 which extends from tip 14 (Figures 5-6, [0061]) where the distal end of tube 16 is fixed to the hollow needle wall by manipulating the inner diameter of the tubing to match the outer diameter of the hollow needle wall where fixing occurs (Figures 5-6, [0049]). Additionally, Baid teaches an engagement means for stopping a needle guard via crimped sections of the hollow needle wall which could be generally interpreted as a mechanism to prevent a slidable component from passing over a particularly portion of the hollow needle wall ([0050-0051]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Lim’s phototherapy puncture device with a movable needle by incorporating the hollow needle wall with adjustable outer diameter to restrain slidable elements (such as tubing) from passing too far toward the needle tip in Baid. This would have been obvious because both Lim and Baid discuss phototherapy applied to tissue as part of needle puncture devices and Baid provides a solution/improvement to fix slidable tubing in relation to the needle tip to prevent unwanted movement of the tubing beyond a particular point. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Lim by incorporating the hollow needle wall with adjustable outer diameter to restrain slidable elements (such as tubing) from passing too far toward the needle tip in Baid.
Therefore, Claim 24 is obvious over Lim in view of Bays and Baid.
Regarding Claim 25, the puncture device according to Claim 1 is obvious over Lim in view of Bays and Baid, as indicated hereinabove. Lim further discloses the optical fiber 600 where therapeutic light is emitted when the needle tube is pushed from the sheath (Figure 10, [0063]). However, Lim does not disclose wherein each of the distal end of the needle base and the proximal end of the needle tip have abutting annular surfaces (because the tip and base are connected in Lim).
Bays, in the same field of endeavor of a puncture device providing phototherapy ([0003], [0008]), teaches a movable base relative to the needle tip used to uncover the optical fiber for phototherapy (Figs. 3a-b, [0051] - shows a closed configuration in Fig 3a and an open configuration in Fig 3b due to the base moving away from the tip). Bays further teaches: “The concept of a movable outer tube placed around the flexible tube of the insertion catheter not only allows the flexible tube to be stiffened during insertion of the catheter, but this outer tube can also be used as a light shield and thus modify at will, by longitudinal movement, the illumination length along the insertion catheter (Fig.6)” ([0063]). The annular surfaces of the tip and needle would abut when the base and tip are in contact with each other.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Lim’s phototherapy puncture device with a movable needle by incorporating the needle base movable independent of the needle tip in Bays. This would have been obvious because both Lim and Bays discuss phototherapy applied to tissue as part of needle puncture devices and Bays provides a solution/improvement to preventing light from emitting into tissue prematurely until the needle base is moved. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Lim by incorporating the needle base movable independent of the needle tip in Bays.
Therefore, Claim 25 is obvious over Lim in view of Bays and Baid.
Regarding Claim 26, the puncture device according to Claim 1 is obvious over Lim in view of Bays and Baid, as indicated hereinabove. Lim further discloses the optical fiber 600 where therapeutic light is emitted when the needle tube is pushed from the sheath (Figure 10, [0063]). However, Lim does not disclose wherein the needle tube comprises a needle tip, and the needle base is separably formed from the needle tip (because the tip and base are connected in Lim).
Bays, in the same field of endeavor of a puncture device providing phototherapy ([0003], [0008]), teaches a movable base relative to the needle tip used to uncover the optical fiber for phototherapy (Figs. 3a-b, [0051] - shows a closed configuration in Fig 3a and an open configuration in Fig 3b due to the base moving away from the tip). Bays further teaches: “The concept of a movable outer tube placed around the flexible tube of the insertion catheter not only allows the flexible tube to be stiffened during insertion of the catheter, but this outer tube can also be used as a light shield and thus modify at will, by longitudinal movement, the illumination length along the insertion catheter (Fig.6)” ([0063]). The base and tip are separable in Bays and are therefore separably formed.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Lim’s phototherapy puncture device with a movable needle by incorporating the needle base movable independent of the needle tip in Bays. This would have been obvious because both Lim and Bays discuss phototherapy applied to tissue as part of needle puncture devices and Bays provides a solution/improvement to preventing light from emitting into tissue prematurely until the needle base is moved. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Lim by incorporating the needle base movable independent of the needle tip in Bays.
Therefore, Claim 26 is obvious over Lim in view of Bays and Baid.
Regarding Claim 27, the puncture device according to Claim 6 is obvious over Lim in view of Bays and Baid, as indicated hereinabove. Lim further discloses wherein the positioning mechanism comprises a plurality of protrusions (Figure 1, positioning elements 120, 122, and 150 jut out from the structure and would be classified as protrusions based on the broadest reasonable interpretation of the claim). The definition of protrude, according to Merriam-Webster (www.merriam-webster.com), is “to jut out from the surrounding surface or context.” The claim can be broadly interpreted as the positioning mechanism having any number of elements which jut out. The examiner recognizes the intent may be to claim protrusions 25 in the instant specification ([0030], Figures 8 and 9), but the use of “protrusions” does not adequately narrow the claim language to address this embodiment.
Therefore, Claim 27 is obvious over Lim in view of Bays and Baid.
Regarding Claim 28, the puncture device according to Claim 27 is obvious over Lim in view of Bays and Baid, as indicated hereinabove. Lim further discloses, with respect to the needle tube positioning mechanism, wherein:
• the needle-tube operating section comprises a lock member ([0049] – locking mechanism described: “In addition, a fixing screw (122) is rotatably positioned on one end of the position adjusting part (120), so that when the fixing screw (122) is tightened, the position adjusting part (120) is fixed so that it does not slide relative to the base part (110), and when the fixing screw (122) is loosened, the position adjusting part (120) is able to slide relative to the base part (110)”); and
• the lock member is configured to be moved to a locking position engaged between the plurality of protrusions and moved to an unlocked position not engaged with the plurality of protrusions ([0055] – “For example, if the operator wants to make the needle (200) protrude 3 cm from the end of the flexible hose (140), the position adjustment part (120) is slid to the position 3 indicated on one side of the base part (110), the fixing screw (122) is tightened to fix it, and then the moving part (130) is pushed to the position adjustment part (120), so that the needle (200) protrudes 3 cm from the end of the flexible hose (140), as shown in FIGS. 3 and 6”). The locking mechanism is fixed at the desired length location. The broadness of the interpretation of protrusions (from the positioning mechanism) is inherited from Claim 27 where locking requires the manipulation of protrusions such as 120, 122, and 150.
Therefore, Claim 28 is obvious over Lim in view of Bays and Baid.
Regarding Claim 29, the puncture device according to Claim 1 is obvious over Lim in view of Bays and Baid, as indicated hereinabove. Lim further discloses a sheath that movably accommodates the needle base along the longitudinal axis ([0017] - a flexible hose which could be moved because it is not attached to the underlying needle tube). However, Lim does not disclose wherein the sheath, the tube and the needle tube are independently movable relative to each other.
Bays, in the same field of endeavor of a puncture device providing phototherapy ([0003], [0008]), teaches a movable base (in this case analogous to the tube in the claim language) relative to the needle tip used to uncover the optical fiber for phototherapy (Figs. 3a-b, [0051] - shows a closed configuration in Fig 3a and an open configuration in Fig 3b due to the base moving away from the tip). Bays further teaches: “The concept of a movable outer tube placed around the flexible tube of the insertion catheter not only allows the flexible tube to be stiffened during insertion of the catheter, but this outer tube can also be used as a light shield and thus modify at will, by longitudinal movement, the illumination length along the insertion catheter (Fig.6)” ([0063]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Lim’s phototherapy puncture device with a movable needle by incorporating the needle base movable independent of the needle tip in Bays. This would have been obvious because both Lim and Bays discuss phototherapy applied to tissue as part of needle puncture devices and Bays provides a solution/improvement to preventing light from emitting into tissue prematurely until the needle base is moved. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Lim by incorporating the needle base movable independent of the needle tip in Bays.
Therefore, Claim 29 is obvious over Lim in view of Bays and Baid.
Claims 10, 19, and 21 are rejected under U.S.C 103 as being unpatentable over Lim (WO 2018/093097 A2, see previously cited) in view of Klubben III, to be referred to as Klubben, (US PG Pub 2016/0278622 A1, see “Notice of References Cited”). Note a machine translations via Espacenet (https://worldwide.espacenet.com) was used to interpret the disclosure in Lim - see previously attached for copy of disclosure translation.
Regarding Claim 10, Lim discloses a puncture device ([0017] - medical photodynamic therapy device with a needle for puncturing) comprising:
• a needle tube having a blade surface at a distal end of the needle tube ([0019] – pointed tip of the needle equivalent to bladed surface);
• an optical fiber accommodated within the needle tube, the optical fiber extending along a longitudinal axis of the needle tube ([0020] – “In addition, the needle may be configured with a first needle portion made of a transparent material for a length along which the optical fiber is embedded, and a second needle portion made of wrought iron for a length along which the optical fiber is not embedded, and the first needle portion and the second needle portion may be configured by being combined”);
• wherein the distal end of the needle tube is provided with a side hole ([0017] – a window where light can be emitted as the needle tube emerges from sheath: “wherein the needle is made of a transparent material, but is sealed with the transparent material up to an end, and an optical fiber that irradiates laser light is embedded in the interior of the needle in a sealed state so as not to be exposed to the outside, and laser light generated from the optical fiber can be irradiated to the outside through the needle made of a transparent material”),
• light is irradiated from the side hole in the direction intersecting the longitudinal axis from a distal end of the side hole to a proximal end of the side hole (Figure 10, [0017] – light can be emitted as the needle tube emerges from the sheath, where the light is emitted in different directions which intersect the longitudinal axis after leaving the optical fiber).
However, Lim does not disclose (1) the side hole having one or more side wall defining an opening, the one or more side walls being oriented in a direction intersecting the longitudinal axis and (2) the side hole penetrates from an inner circumferential surface of the needle tube to an outer circumferential surface of the needle tube.
Klubben, in the same field of endeavor of photodynamic therapy ([0005]), teaches customizable windows for light transmission defined by transparent sections within the opaque walls of a sheath ([0044] – “A sheath 302 is positioned in slidable relation over light diffusing fiber 102, similar to the manner in which sheath 104 is positioned over light diffusing fiber 102 in illuminating device 100. Sheath 302, however, includes transparent areas 304, as well as visibly opaque (and radio opaque) areas 306. Thus, light energy diffused from fiber 102 will also be diffused through transparent areas 304 but will be blocked by visibly opaque areas 306. Such a patterned sheath 02 may be useful when needing to illuminate a uniquely shaped area of tissue”, see Figure 4). To be transparent, the side hole in Klubben would need to be transparent though the thickness of the tube.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Lim’s phototherapy puncture device with a transparent movable needle by incorporating transparent windows through an opaque tube in Klubben. This would have been obvious because both Lim and Klubben discuss phototherapy applied to tissue and Klubben provides a solution/improvement to providing localized photodynamic therapy only to select tissue near the transparent windows. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Lim by incorporating transparent windows through an opaque tube in Klubben.
Therefore, Claim 10 is obvious over Lim in view of Klubben.
Regarding Claim 19, the puncture device according to Claim 10 is obvious over Lim in view of Klubben, as indicated hereinabove. Lim further discloses further comprising:
• a sheath that movably accommodates the needle tube along the longitudinal axis ([0017] – a flexible hose formed to extend to a tip end of the base portion by a predetermined length; and a needle embedded in the flexible hose and protruding outward by a set length according to the movement of the moving portion);
• an operating body (position adjustment part 120 and moving part 130 are used to operate the sliding function) fixed to a proximal end of the sheath (Figure 1, [0043] - hose 140 connects to adjustment elements 120 and 130 and base 110); and
• a needle slider movable along the longitudinal axis relative to the operating body, the needle slider being connected to the tube ([0017] – “position adjusting portion capable of sliding or fixing with respect to the base portion; a moving portion capable of moving to the position fixing portion while the position fixing portion is fixed”).
Therefore, Claim 19 is obvious over Lim in view of Klubben.
Regarding Claim 21, the puncture device according to Claim 10 is obvious over Lim in view of Klubben, as indicated hereinabove. Lim further discloses wherein the needle tube comprises a metallic needle tube ([0073] – part of the needle tube is soft iron: “That is, among the entire length of the needle (500), a first needle part made of a transparent material may be formed for a length in which the optical fiber (600) is embedded, and a second needle part made of soft iron may be formed for a length in which the optical fiber (600) is not embedded, and they may be connected to each other”).
Therefore, Claim 21 is obvious over Lim in view of Klubben.
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Benjamin Schmitt, whose telephone number is 703-756-1345. The examiner can normally be reached on Monday-Friday from 9:00 am to 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached on 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional qu