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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 26, 2026 has been entered.
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) 1-6, 8, and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over DeVega (US 2011/0196312 A1) in view of Kahook (US 2018/0168863 A1), Perez (US 2011/0015575 A1), Green Jr. (US 2005/0080384 A1), and Berkman et al. (US 10,195,347 B1).
With regard to claims 1-3, 8, DeVega teaches a medical device, comprising: a head having a base (Fig. 3a member 330); a tube having a proximal end, a distal end, a first central channel extending from the proximal end to distal end, and a longitudinal axis extending substantially centrally through the first central channel (Fig. 3a member 310); a plunger slidably disposed at least partly within the first central channel of the tube (Fig. 3a member 350), the plunger defining a second central channel, and the longitudinal axis extending substantially centrally through the second central channel (Figs. 3a and 3b, channel within 340 where 348/349 are located); a cap removably attached to a distal end of the plunger (Fig. 3b, member 360 capable of being removed); and an optic assembly having a light source being disposed at least partly within the second central channel (Fig. 3b light 346) and being configured to: direct the radiation through the cap at the distal end of the plunger (Fig. 3a and 3b, light is directed through 360 which would then be directed to the distal end to illuminate the target).
In the embodiment of Figs. 3 DeVega does not disclose a piercing member or that the base is removably attachable to the tube. However, in Figs. 1 DeVega shows a needle may be used (Fig. 1a needle 132). Further, Kahook teaches a syringe for treatment which also directs light in which the needle is connectable to the syringe via known fastening means such as a luer or threads ([0049], [0066], [0077], Fig. 1 cannula 14 is attached via a known fastening mechanism). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to removably attach a piercing member in the embodiment of Figs. 3 of DeVega as DeVega teaches needles are effective for delivery and Kahook teaches removable fastening means are known in the art and would yield the same predictable result of delivering fluid from the syringe. Additionally, it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009. This provides a fluid tight seal between the base and the tube which are fluidly connected for delivery.
DeVega teaches a light source is provided within the plunger to illuminate the target but do not specifically disclose the optic assembly includes both alight source and a light pipe. However, Perez teaches a light guide which comprises a tube (a light pipe tube) which houses fiber optic strands (a light pipe of conductive material) to transmit light from an LED light source positioned proximally of the light tube which is beneficial in that the fiber optic bundles do not emit heat and the lighting arrangement may include a lens to disperse light as needed ([0023]-[0025]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a light pipe through a light tube to direct LED light in DeVega as Perez teaches such is effective for controlling the light delivered to the treatment area without generating heat and would still yield the same predictable result of illumination. DeVega does not disclose that a portion of the light pipe is encased within the cap. However, Green Jr. teaches a syringe with a light source routed through the plunger and states that the LED is attached to the seal ([0017]) and that the distal end is formed by the seal and light emitting diode ([0036]), however, the Figures are poor quality. Further, Berkman et al. teach an LED installed within a cavity of the plunger seal (Figs. 1-3, LED 124, cavity 114, Col. 3 lines 51-52). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to place a portion of the light pipe within the cap of DeVega as Green Jr. teach a similar syringe for directing light through a clear seal with the light attached to the seal and Berkman et al. show how a light may be within a cavity of the seal. Placing the light within the seal as opposed to just outside the seal yields the same result as light is still directed in the same direction through the seal for the same purpose. Additionally, Applicant has not disclosed that such an arrangement provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the Applicant's invention to perform equally well with the light and cap of DeVega as light is still provided in the same manner.
As combined the light pipe of Perez, which directs light from its proximal end distally through the light pipe, would extend through the plunger and into the seal to direct light out of the seal. The LED light source would be placed proximally to the light pipe placing it exterior to the plunger and cap. This would generally be in the area of 371 which is external to the plunger rod and cap. As combined with Green Jr. and Berkman et al. in order for the light to extend through the plunger and into the seal, the seal, considered as the cap, would necessarily include a third channel connected to the second channel.
With regard to claims 4 and 5, the area at the proximal end 370 (Fig. 3b) is taken as the housing as it houses the electrical source, DeVega teaches circuitry and a power source are provided for the light source ([0023]) which as combined would be located proximally to direct light through the light pipe. DeVega teaches the LEDS may be programmable ([0023]). It would have been obvious to a person having ordinary skill in the art at the time the invention was made to include a processor in DeVega as this would be needed to carry out programming of the LEDs.
With regard to claim 6, see DeVega [0023] various colors, changing colors, intensities, and programming can be used for the light. The light pipe is a cylinder and thus has a curved distal end.
With regard to claim 9, DeVega teaches circuitry, a switch, and a power source are provided for the light source ([0020], [0023]).
Claim(s) 7 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over DeVega (US 2011/0196312 A1), Kahook (US 2018/0168863 A1), Perez (US 2011/0015575 A1), Green Jr. (US 2005/0080384 A1), and Berkman et al. (US 10,195,347 B1) as applied to claim 1 above, and further in view of Cowan et al. (US 2017/0290993 A1).
With regard to claims 7 and 10, DeVega teaches a device substantially as claimed. Perez teaches the material of the light pipe as noted above. DeVega does not disclose a sleeve. However, Cowan et al. teach a shield may be provided around the barrel of a syringe through which light is transmitted to increase the transmission of light through the barrel ([0111]). Cowan et al. teach depending on light transmission portions may be translucent and other portions opaque. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a shield in DeVega as Cowan et al. teach this is beneficial for controlling the transmission of light and to have such a shield be moveable so portions may be opaque or translucent as desired as Cowan et al. teach various arrangements may be desired based on desired transmission.
Claim(s) 1-6, 8, and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over DeVega (US 2011/0196312 A1) in view of Miller et al. (US 2007/0060896 A1), Kahook (US 2018/0168863 A1), Perez (US 2011/0015575 A1), Green Jr. (US 2005/0080384 A1), and Berkman et al. (US 10,195,347 B1).
With regard to claims 1-3, 8, DeVega teaches a medical device, comprising: a head having a base (Fig. 3a member 330); a tube having a proximal end, a distal end, a first central channel extending from the proximal end to distal end, and a longitudinal axis extending substantially centrally through the first central channel (Fig. 3a member 310); a plunger slidably disposed at least partly within the first central channel of the tube (Fig. 3a member 350), the plunger defining a second central channel, and the longitudinal axis extending substantially centrally through the second central channel (Figs. 3a and 3b, channel within 340 where 348/349 are located); a cap removably attached to a distal end of the plunger (Fig. 3b, member 360 capable of being removed); and an optic assembly having a light source being disposed at least partly within the second central channel (Fig. 3b light 346) and being configured to: direct the radiation through the cap at the distal end of the plunger (Fig. 3a and 3b, light is directed through 360 which would then be directed to the distal end to illuminate the target).
If DeVega is not found to teach a removable cap Miller et al. teach a plunger seal (cap) may be unitarily formed with a plunger rod or separately threaded ([0059], Figs. 7-11). If DeVega is not found to teach a removable cap it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a removable cap as Miller et al. teach such to be an equivalent construction. Further, it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin V. Erlicnman, 168 USPQ 177, 179.
In the embodiment of Figs. 3 DeVega does not disclose a piercing member or that the base is removably attachable to the tube. However, in Figs. 1 DeVega shows a needle may be used (Fig. 1a needle 132). Further, Kahook teaches a syringe for treatment which also directs light in which the needle is connectable to the syringe via known fastening means such as a luer or threads ([0049], [0066], [0077], Fig. 1 cannula 14 is attached via a known fastening mechanism). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to removably attach a piercing member in the embodiment of Figs. 3 of DeVega as DeVega teaches needles are effective for delivery and Kahook teaches removable fastening means are known in the art and would yield the same predictable result of delivering fluid from the syringe. Additionally, it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009. This provides a fluid tight seal between the base and the tube which are fluidly connected for delivery.
DeVega teaches a light source is provided within the plunger to illuminate the target but do not specifically disclose the optic assembly includes both alight source and a light pipe. However, Perez teaches a light guide which comprises a tube (a light pipe tube) which houses fiber optic strands (a light pipe of conductive material) to transmit light from an LED light source positioned proximally of the light tube which is beneficial in that the fiber optic bundles do not emit heat and the lighting arrangement may include a lens to disperse light as needed ([0023]-[0025]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a light pipe through a light tube to direct LED light in DeVega as Perez teaches such is effective for controlling the light delivered to the treatment area without generating heat and would still yield the same predictable result of illumination. DeVega does not disclose that a portion of the light pipe is encased within the cap. However, Green Jr. teaches a syringe with a light source routed through the plunger and states that the LED is attached to the seal ([0017]) and that the distal end is formed by the seal and light emitting diode ([0036]), however, the Figures are poor quality. Further, Berkman et al. teach an LED installed within a cavity of the plunger seal (Figs. 1-3, LED 124, cavity 114, Col. 3 lines 51-52). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to place a portion of the light pipe within the cap of DeVega as Green Jr. teach a similar syringe for directing light through a clear seal with the light attached to the seal and Berkman et al. show how a light may be within a cavity of the seal. Placing the light within the seal as opposed to just outside the seal yields the same result as light is still directed in the same direction through the seal for the same purpose. Additionally, Applicant has not disclosed that such an arrangement provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the Applicant's invention to perform equally well with the light and cap of DeVega as light is still provided in the same manner.
As combined the light pipe of Perez, which directs light from its proximal end distally through the light pipe, would extend through the plunger and into the seal to direct light out of the seal. The LED light source would be placed proximally to the light pipe placing it exterior to the plunger and cap. This would generally be in the area of 371 which is external to the plunger rod and cap. As combined with Green Jr. and Berkman et al. in order for the light to extend through the plunger and into the seal, the seal, considered as the cap, would necessarily include a third channel connected to the second channel.
With regard to claims 4 and 5, the area at the proximal end 370 (Fig. 3b) is taken as the housing as it houses the electrical source, DeVega teaches circuitry and a power source are provided for the light source ([0023]) which as combined would be located proximally to direct light through the light pipe. DeVega teaches the LEDS may be programmable ([0023]). It would have been obvious to a person having ordinary skill in the art at the time the invention was made to include a processor in DeVega as this would be needed to carry out programming of the LEDs.
With regard to claim 6, see DeVega [0023] various colors, changing colors, intensities, and programming can be used for the light. The light pipe is a cylinder and thus has a curved distal end.
With regard to claim 9, DeVega teaches circuitry, a switch, and a power source are provided for the light source ([0020], [0023]).
Claim(s) 7 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over DeVega (US 2011/0196312 A1), Miller et al. (US 2007/0060896 A1), Kahook (US 2018/0168863 A1), Perez (US 2011/0015575 A1), Green Jr. (US 2005/0080384 A1), and Berkman et al. (US 10,195,347 B1) as applied to claim 1 above, and further in view of Cowan et al. (US 2017/0290993 A1).
With regard to claims 7 and 10, DeVega teaches a device substantially as claimed. Perez teaches the material of the light pipe as noted above. DeVega does not disclose a sleeve. However, Cowan et al. teach a shield may be provided around the barrel of a syringe through which light is transmitted to increase the transmission of light through the barrel ([0111]). Cowan et al. teach depending on light transmission portions may be translucent and other portions opaque. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a shield in DeVega as Cowan et al. teach this is beneficial for controlling the transmission of light and to have such a shield be moveable so portions may be opaque or translucent as desired as Cowan et al. teach various arrangements may be desired based on desired transmission.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The new limitations are rejected as above. Perez is not solely relied upon to teach the light extending through the cap. The Examiner maintains the cap of DeVega is removable as there is no particular structure recited to a connection for removal. The components may be physically separated. The Examiner has also made an additional rejection to the removable limitation.
Conclusion
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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