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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. JP 2020073803, filed on April 17, 2021.
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:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Moreci (US 7232429) in view of Dlugos (US 20060211913) in further view of Rabiner (US 20170128742).
Regarding claim 1, Moreci discloses an implantable medical instrument for use within a body (Fig. 1: 10), the medical instrument including a container (Fig. 1: cavity 30) that has an opening (Fig. 1: opening at top, which 20 covers) and holds a medicinal solution (Fig. 1: 42; col. 3, lines 60-63), and a soft portion that closes the opening (septum 20), the medical instrument comprising: a power receiver (Fig. 2: 54, 56, 58; col. 5, lines 2-3) that receives power transmitted (Fig. 2: power transmitted by 64 of 44 which is 34/38 in Fig. 1; col. 4, lines 54-55); and a light emitter (Fig. 2: lamp 50 of 44 which is 34/38 in Fig. 1; col. 4, lines 62-64) that emits light by way of the power received by the power receiver (col. 5, lines 1-3), wherein the light emitter includes at least one of a first light emitter (Fig. 1: lamp within 34 on the left, see annotated figure below), and a second light emitter (Fig. 1: lamp within 34 on the right, see annotated figure below) that emits light having a center wavelength of 400 nm or more and 480 nm or less (400nm; col. 3, lines 32-41). However, Moreci discloses the power transmitted by source 64 connected to the light sources 34 and 38, located on the implanted device, and does not disclose the power transmitted externally.
Dlugos teaches an analogous implanted medical port device (42), which receives power transmitted externally from an external power source (Fig. 12: power source 150 located in external control module 126, depicted as 64 in Fig. 1). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the internal transmitting power source of Moreci with the external power source taught by Dlugos in order to make the power source/transmitter accessible to allow for adjustments, troubleshooting, or recharging that may be needed without requiring removing the entire implanted device.
The Moreci-Dlugos device, however, does not teach the emitted wavelength range from the first light emitter as 600-1100nm, as the light emitters of Moreci are taught to emit light between 100-400nm for the purposes of killing bacterial and pathogens in the injected drug and/or container (col. 3, lines 32-41).
Rabiner teaches an analogous medical device for disinfecting in vivo via light emission wherein the light emitter emits light having a center wavelength of 600 nm or more and 1100 nm or less (para. [0046], second-to-last sentence, blue light wavelength between 350-770nm). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first light emitter of the Moreci-Dlugos device to emit light having a larger wavelength of up to 770nm as taught by Rabiner, in order to emit blue light in addition to ultra violet light to kill a larger range of pathogens. Furthermore, the wavelength of the light emitted is a result effective variable as both Moreci and Rabiner teach that certain ranges of wavelengths are effective in killing certain pathogens (Moreci: col. 3, lines 34-41; Rabiner: para. [0046], sentences 1-3). Therefore, one of ordinary skill in the art would have had a reasonable expectation of success in modifying the first light emitter taught by Moreci to increase the wavelength emitted to 600-1100nm in order to contribute to an overall larger range in wavelengths emitted (in combination with the second light emitter) to kill a larger range of pathogens, since it has been held that “where the general conditions of a claim are disclosed in prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See MPEP 2144.05(II).
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Annotated Fig. 1, Moreci
Regarding claim 2, Moreci in view of Dlugos in further view of Rabiner teaches the medical instrument according to claim 1, as described above, wherein the light emitter is provided around the soft portion, and irradiates at least a top surface of the soft portion (Moreci: col. 4, lines 36-38, 34 may be placed at the top of 30 around/near 20).
Regarding claim 3, Moreci in view of Dlugos in further view of Rabiner teaches the medical instrument according to claim 1, as described above, wherein the light emitter is disposed around a middle portion or a bottom portion of the container, and irradiates at least an interior of the container and the soft portion (Moreci: col. 4, lines 36-38, 34 may be placed at the base or middle of 30, as seen in Fig. 1).
Regarding claim 4, Moreci in view of Dlugos in further view of Rabiner teaches the medical instrument according to claim 1, as described above, wherein the light emitter includes at least the first light emitter (Moreci: Fig. 1: lamp within 34 on the left, see annotated figure above), and wherein a radiant exposure of the light emitted from the first light emitter is in a range from 1.0 to 100.0 J/cm2 at an irradiation target site (Rabiner: para. [0134], last two sentence, target of 36 J/cm2). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have also incorporated the value of the energy emitted by the first light emitter taught by Rabiner in order to deliver a dose of light needed to be bactericidal (Rabiner: para. [0134], last two sentence, target of 36 J/cm2).
Regarding claim 5, Moreci in view of Dlugos in further view of Rabiner teaches the medical instrument according to claim 1, as described above, wherein the light emitter includes at least the first light emitter (Moreci: Fig. 1: lamp within 34 on the left, see annotated figure above), and wherein the first light emitter emits light having a center wavelength of 620 nm, 660 nm, 680 nm, 760 nm, or 820 nm (Rabiner: para. [0046], second-to-last sentence, blue light wavelength between 350-770nm). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first light emitter of the Moreci-Dlugos-Rabiner device to emit light having a larger wavelength of 760nm as taught by the Rabiner range, in order to emit blue light in addition to ultra violet light to kill a larger range of pathogens. Furthermore, the wavelength of the light emitted is a result effective variable as both Moreci and Rabiner teach that certain ranges of wavelengths are effective in killing certain pathogens (Moreci: col. 3, lines 34-41; Rabiner: para. [0046], sentences 1-3). Therefore, one of ordinary skill in the art would have had a reasonable expectation of success in modifying the first light emitter taught by Moreci to increase the wavelength emitted to 600-1100nm in order to contribute to an overall larger range in wavelengths emitted (in combination with the second light emitter) to kill a larger range of pathogens, since it has been held that “where the general conditions of a claim are disclosed in prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See MPEP 2144.05(II).
Regarding claim 6, Moreci in view of Dlugos in further view of Rabiner teaches the medical instrument according to claim 1, as described above, wherein the light emitter includes at least the second light emitter (Moreci: Fig. 1: lamp within 34 on the right, see annotated figure above), and wherein a radiant exposure of the light emitted from the second light emitter is in a range from 32 to 125 J/cm2 at an irradiation target site (Rabiner: para. [0134], last two sentence, target of 36 J/cm2). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the value of the energy emitted taught by Rabiner into the second light emitter in order to deliver a dose of light needed to be bactericidal (Rabiner: para. [0134], last two sentence, target of 36 J/cm2).
Regarding claim 7, Moreci in view of Dlugos in further view of Rabiner teaches a medical device comprising: a medical instrument according to claim 1 as described above; and a power transmitter that transmits predetermined power (Dlugos: Fig. 12: power transmitter 150 located in external control module 126, depicted as 64 in Fig. 1), wherein the medical instrument further includes a power receiver that receives power transmitted from the power transmitter (Moreci: power receiver Fig. 2: 54, 56, 58; col. 5, lines 2-3).
Regarding claim 8, Moreci in view of Dlugos in further view of Rabiner teaches the medical instrument according to claim 2, as described above, wherein the light emitter includes at least the first light emitter (Moreci: Fig. 1: lamp within 34 on the left, see annotated figure above), and wherein a radiant exposure of the light emitted from the first light emitter is in a range from 1.0 to 100.0 J/cm2 at an irradiation target site (Rabiner: para. [0134], last two sentence, target of 36 J/cm2). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have also incorporated the value of the energy emitted by the first light emitter taught by Rabiner in order to deliver a dose of light needed to be bactericidal (Rabiner: para. [0134], last two sentence, target of 36 J/cm2).
Regarding claim 9, Moreci in view of Dlugos in further view of Rabiner teaches the medical instrument according to claim 2, as described above, wherein the light emitter includes at least the first light emitter (Moreci: Fig. 1: lamp within 34 on the left, see annotated figure above), and wherein the first light emitter emits light having a center wavelength of 620 nm, 660 nm, 680 nm, 760 nm, or 820 nm (Rabiner: para. [0046], second-to-last sentence, blue light wavelength between 350-770nm). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first light emitter of the Moreci-Dlugos-Rabiner device to emit light having a larger wavelength of 760nm as taught by the Rabiner range, in order to emit blue light in addition to ultra violet light to kill a larger range of pathogens. Furthermore, the wavelength of the light emitted is a result effective variable as both Moreci and Rabiner teach that certain ranges of wavelengths are effective in killing certain pathogens (Moreci: col. 3, lines 34-41; Rabiner: para. [0046], sentences 1-3). Therefore, one of ordinary skill in the art would have had a reasonable expectation of success in modifying the first light emitter taught by Moreci to increase the wavelength emitted to 600-1100nm in order to contribute to an overall larger range in wavelengths emitted (in combination with the second light emitter) to kill a larger range of pathogens, since it has been held that “where the general conditions of a claim are disclosed in prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See MPEP 2144.05(II).
Regarding claim 10, Moreci in view of Dlugos in further view of Rabiner teaches the medical instrument according to claim 2, as described above, wherein the light emitter includes at least the second light emitter (Moreci: Fig. 1: lamp within 34 on the right, see annotated figure above), and wherein a radiant exposure of the light emitted from the second light emitter is in a range from 32 to 125 J/cm2 at an irradiation target site (Rabiner: para. [0134], last two sentence, target of 36 J/cm2). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the value of the energy emitted taught by Rabiner into the second light emitter in order to deliver a dose of light needed to be bactericidal (Rabiner: para. [0134], last two sentence, target of 36 J/cm2).
Regarding claim 11, Moreci in view of Dlugos in further view of Rabiner teaches a medical device comprising: a medical instrument according to claim 2 as described above; and a power transmitter that transmits predetermined power (Dlugos: Fig. 12: power transmitter 150 located in external control module 126, depicted as 64 in Fig. 1), wherein the medical instrument further includes a power receiver that receives power transmitted from the power transmitter (Moreci: power receiver Fig. 2: 54, 56, 58; col. 5, lines 2-3).
Regarding claim 12, Moreci in view of Dlugos in further view of Rabiner teaches the medical instrument according to claim 3, as described above, wherein the light emitter includes at least the first light emitter (Moreci: Fig. 1: lamp within 34 on the left, see annotated figure above), and wherein a radiant exposure of the light emitted from the first light emitter is in a range from 1.0 to 100.0 J/cm2 at an irradiation target site (Rabiner: para. [0134], last two sentence, target of 36 J/cm2). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have also incorporated the value of the energy emitted by the first light emitter taught by Rabiner in order to deliver a dose of light needed to be bactericidal (Rabiner: para. [0134], last two sentence, target of 36 J/cm2).
Regarding claim 13, Moreci in view of Dlugos in further view of Rabiner teaches the medical instrument according to claim 3, as described above, wherein the light emitter includes at least the first light emitter (Moreci: Fig. 1: lamp within 34 on the left, see annotated figure above), and wherein the first light emitter emits light having a center wavelength of 620 nm, 660 nm, 680 nm, 760 nm, or 820 nm (Rabiner: para. [0046], second-to-last sentence, blue light wavelength between 350-770nm). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first light emitter of the Moreci-Dlugos-Rabiner device to emit light having a larger wavelength of 760nm as taught by the Rabiner range, in order to emit blue light in addition to ultra violet light to kill a larger range of pathogens. Furthermore, the wavelength of the light emitted is a result effective variable as both Moreci and Rabiner teach that certain ranges of wavelengths are effective in killing certain pathogens (Moreci: col. 3, lines 34-41; Rabiner: para. [0046], sentences 1-3). Therefore, one of ordinary skill in the art would have had a reasonable expectation of success in modifying the first light emitter taught by Moreci to increase the wavelength emitted to 600-1100nm in order to contribute to an overall larger range in wavelengths emitted (in combination with the second light emitter) to kill a larger range of pathogens, since it has been held that “where the general conditions of a claim are disclosed in prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See MPEP 2144.05(II).
Regarding claim 14, Moreci in view of Dlugos in further view of Rabiner teaches the medical instrument according to claim 3, as described above, wherein the light emitter includes at least the second light emitter (Moreci: Fig. 1: lamp within 34 on the right, see annotated figure above), and wherein a radiant exposure of the light emitted from the second light emitter is in a range from 32 to 125 J/cm2 at an irradiation target site (Rabiner: para. [0134], last two sentence, target of 36 J/cm2). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the value of the energy emitted taught by Rabiner into the second light emitter in order to deliver a dose of light needed to be bactericidal (Rabiner: para. [0134], last two sentence, target of 36 J/cm2).
Regarding claim 15, Moreci in view of Dlugos in further view of Rabiner teaches a medical device comprising: a medical instrument according to claim 3 as described above; and a power transmitter that transmits predetermined power (Dlugos: Fig. 12: power transmitter 150 located in external control module 126, depicted as 64 in Fig. 1), wherein the medical instrument further includes a power receiver that receives power transmitted from the power transmitter (Moreci: power receiver Fig. 2: 54, 56, 58; col. 5, lines 2-3).
Regarding claim 16, Moreci in view of Dlugos in further view of Rabiner teaches the medical instrument according to claim 4, as described above, wherein the light emitter includes at least the first light emitter (Moreci: Fig. 1: lamp within 34 on the left, see annotated figure above), and wherein the first light emitter emits light having a center wavelength of 620 nm, 660 nm, 680 nm, 760 nm, or 820 nm (Rabiner: para. [0046], second-to-last sentence, blue light wavelength between 350-770nm). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first light emitter of the Moreci-Dlugos-Rabiner device to emit light having a larger wavelength of 760nm as taught by the Rabiner range, in order to emit blue light in addition to ultra violet light to kill a larger range of pathogens. Furthermore, the wavelength of the light emitted is a result effective variable as both Moreci and Rabiner teach that certain ranges of wavelengths are effective in killing certain pathogens (Moreci: col. 3, lines 34-41; Rabiner: para. [0046], sentences 1-3). Therefore, one of ordinary skill in the art would have had a reasonable expectation of success in modifying the first light emitter taught by Moreci to increase the wavelength emitted to 600-1100nm in order to contribute to an overall larger range in wavelengths emitted (in combination with the second light emitter) to kill a larger range of pathogens, since it has been held that “where the general conditions of a claim are disclosed in prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See MPEP 2144.05(II).
Regarding claim 17, Moreci in view of Dlugos in further view of Rabiner teaches a medical device comprising: a medical instrument according to claim 4 as described above; and a power transmitter that transmits predetermined power (Dlugos: Fig. 12: power transmitter 150 located in external control module 126, depicted as 64 in Fig. 1), wherein the medical instrument further includes a power receiver that receives power transmitted from the power transmitter (Moreci: power receiver Fig. 2: 54, 56, 58; col. 5, lines 2-3).
Regarding claim 18, Moreci in view of Dlugos in further view of Rabiner teaches a medical device comprising: a medical instrument according to claim 5 as described above; and a power transmitter that transmits predetermined power (Dlugos: Fig. 12: power transmitter 150 located in external control module 126, depicted as 64 in Fig. 1), wherein the medical instrument further includes a power receiver that receives power transmitted from the power transmitter (Moreci: power receiver Fig. 2: 54, 56, 58; col. 5, lines 2-3).
Regarding claim 19, Moreci in view of Dlugos in further view of Rabiner teaches a medical device comprising: a medical instrument according to claim 6 as described above; and a power transmitter that transmits predetermined power (Dlugos: Fig. 12: power transmitter 150 located in external control module 126, depicted as 64 in Fig. 1), wherein the medical instrument further includes a power receiver that receives power transmitted from the power transmitter (Moreci: power receiver Fig. 2: 54, 56, 58; col. 5, lines 2-3).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATERINA ANNA WITTLIFF whose telephone number is (703)756-4772. The examiner can normally be reached M-Th: 9-7ET.
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/K.A.W./Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783