DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Claim 6 was previously objected to and has been canceled.
Claims 1, 3, 5, and 7-8 have been amended, and claims 10-15 have been added. Claims 1-5 and 7-15 remain pending.
All claims were previously found to be indefinite; the amendments to the claims have overcome the previous indefinite rejections.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5 and 7-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 3, and 5 are considered to be indefinite where they are each rendered unclear where they refer to a light guide plate, light shielding plate, condensing portion, second condensing portion and notch portion as the respective claims are not clear as to whether each of those elements is required for each of the respective claims, or if one of the newly recited elements is required and the other elements are optional. Based on Applicant’s disclosure and Specification and the fact that each of the claims lists the elements or the final element, it appears that only one of the elements is required to satisfy the requirements of the claims. Further, it appears that a single embodiment requiring all of the elements is not disclosed or shown in the Drawings and would potentially be considered new matter should the claims be amended further to require each of a light guide plate, light shielding plate, condensing portion, and notch portion. Thus, and for the purposes of compact prosecution, Examiner has understood each of the independent claims to require only one of a first light guide plate, light shielding plate, condensing portion, and notch portion as appropriate.
Claim 11 is further considered to be indefinite where it recites “further including a second light shielding plate installed on an outer peripheral side of a second one of the light emitting portions, wherein the first light guide plate and the second light guide plate are oriented in different directions” as these do not appear to be referring to the same element, especially in view of claim 10 which claim 11 is dependent on further specifying and requiring the first light guide plate. For the purposes of compact prosecution, Examiner has understood the claim to require “further including a second light guide plate installed on an outer peripheral side of a second one of the light emitting portions, wherein the first light guide plate and the second light guide plate are oriented in different directions” to have the claim be consistent with itself and with claim 10.
Claims 2, 4, and 7-15 are indefinite due to their dependency on, and thus requirement of the indefinite limitations, of independent claims 1, 3, and 5, respectively.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 15 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 15 does not further limit claim 1 upon which it depends, as it simply repeats the same limitations placed on an optional notch portion which are already required in claim 1, and does not positively cite the requirement of the notch portion.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1-3, 5, and 7-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over McDonald et al. (US Pat. No. 5009644, henceforth McDonald) in view of Singh et al. (US 20200061362, henceforth Singh) and Wortley et al. (US 20070078391, previously made of record, henceforth Wortley).
Regarding claims 1 and 15, McDonald discloses a medical device (the combination of RF transmitter, access port 10, and syringe 30 as shown in fig. 1) comprising: a power transmission part (RF transmitter 34, fig. 1, transmits power as disclosed in Col. 2 lines 13-18) including a second coil (transmitting antenna 38, fig. 1, which is a coil as shown in the figure) that is configured to transmit power in a non-contact manner (see Col. 2 lines 13-18, power is transmitted via radiofrequency); and a medical instrument (access port 10, fig. 1) implanted for use in a body (see fig. 1, access port 10 is implanted into tissue 11 in a patient’s body where it is used), and including a power receiving part (coil 26, fig. 1) including a first coil (coil 26, fig. 1) that is configured to receive the power transmitted from the power transmission part (see Col. 2 lines 26-30), wherein the medical instrument includes: a housing (body 14, fig. 1); a container (reservoir 16, fig. 1) installed in the housing (see fig. 1, reservoir 16 is located inside of body 14); a notification part (beeper 46, fig. 1) that that are configured to operate based on use of the power received by the power receiving part (see Col. 2 lines 31-53) to notify that a predetermined state is reached (this is the state where the transmitting antenna 38 and needle 32 are in the proper position), when a relative positional relation between the power transmission part and the power receiving part reaches the predetermined state by moving the power transmission part (see Col. 2 lines 31-60, antenna 38 is moved into the proper position to provide power to beeper 46 as disclosed); and a soft part (septum 18, fig. 1) into which an injection needle is insertable (see fig. 1, needle 32 of syringe 30 is inserted into septum 18 as shown; note also that this limitation is only functional and thus the claimed soft part is only required to be capable of having a needle inserted into it, and such an insertion is not a requirement of the claim; the called out needle 32 of McDonald is pointed out as clarity of evidence), and the first coil is a coreless coil (see fig. 1, coil 26 is not shown as having a core) disposed to have an inner diameter (the distance from one edge of coil 26 to the opposite edge of coil 26 about the radial center of access port 10 is the claimed inner diameter of coil 26) larger than an outer diameter of the container (the claimed outer diameter is the distance from one radial outermost edge of reservoir 10 to the opposite radial outermost edge of reservoir 16 about the radial center of access port shown in fig. 1; since the inner diameter is larger than the outer diameter, this claim limitation is met), the power receiving part is installed on one plane (see Plane 1 called out in annotated fig. 1) of a substrate (see section S1 called out in annotated fig. 1; this section is considered to be a substrate as claimed where Merriam Webster defines a substrate to be “a substance acted upon” and the called out section is acted upon by the RF waves emitted from RF transmitter 34), and the notification part is installed on another plane (see Plane 2 called out in annotated fig. 1) of the substrate (see Plane 2 called out in annotated fig. 1).
McDonald does not disclose the medical device where the notification part includes a plurality of light emitting portions, especially where the plurality of light emitting portions are arranged along an outer edge of the soft part. Singh teaches a medical device (port 100, fig. 18) having a notification part (the section shown in fig. 18 is a notification part where it comprises the structures present in the claimed notification part) installed in a housing (body 102 and cap 104, figs. 18 and 20) of a medical instrument (port 100, figs. 18 and 20) which is powered in a non-contact manner (powered by electromagnetic field as in [0097]) by power transmitted from a second coil (second coil 342, fig. 18) of a power transmission part (external device 340, fig. 18) and received by a first coil (first coil 338, fig. 18) where the notification part includes a plurality of light emitting portions (LEDs 336, fig. 18) where the plurality of light emitting portions are arranged along an outer edge of a soft part (see [0097], LEDs 336 are arranged around opening 130 which is the boundary of septum 106 which is a soft part, see also figs. 18 and 20) which a needle is insertable into (see [0083] and [0084]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the plurality of light emitting portions of Singh to the notification port of McDonald for providing location aid to a clinician (Singh [0083]) and further to have arranged the plurality of light emitting portions around an outer edge of the soft part as is the arrangement of Singh for allowing light to transfer through the soft part and through the patient’s tissue to provide illumination through the tissue of the patient as in Singh ([0097]).
McDonald as modified by Singh does not disclose that the medical instrument further includes a first light guide plate installed on an outer peripheral side of one of the light emitting portions, the medical instrument further includes a light shielding plate installed on an outer peripheral side of one of the light emitting portions, the medical instrument further includes a condensing portion having a curved surface facing one of the light emitting portions, or a notch portion is formed over a circumferential direction on an outer peripheral side of an upper side of the container wherein the light emitting portions and the first coil are installed in the notch portion. Wortley teaches a medical instrument (vascular access port 10, fig. 4) comprising a plurality of light emitting portions (LEDs 28 and 30, fig. 4) disposed along an outer edge of a soft part (septum 14 is a soft part, and the LEDs 28 and 30 are disposed along the radial outer edge of the septum 14 where they are placed radially outside of septum 14) where the medical instrument further includes a first light guide plate (light guide 36, fig. 4) installed on an outer peripheral side of one of the light emitting portions (see fig. 4, light guide 36 is installed on top of the peripheral edges of LED 28 and thus it is on an outer peripheral side of LED 28 where it is stacked vertically on top of the edge of LED 28), the medical instrument further includes a condensing portion (the top of light guide 35 is a condensing portion as claimed, fig. 4) having a curved surface (see fig. 4, the top surface of light guide 35 is curved) facing one of the light emitting portions (see fig. 4, the inside of the top surface of light guide 35 is curved and is convex relative to, or facing, LED 30 as shown), or a notch portion (the spaces where light guides 35 and 36 and LEDs 28 and 30 are placed are notch portions as shown in fig. 4 where they are hollowed out spaces) is formed over a circumferential direction on an outer peripheral side of an upper side of a container (the container is the hollow inside space made by can 16, fig. 4, and the called out notch is formed as claimed where it is vertically above and radially surrounding the top of the container; “over a circumferential direction” as required in the claim means that the notch is formed in an orientation that could be considered to be above and radially outside of the claimed portion of the container) wherein the light emitting portions are installed in the notch portion (see fig. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have changed the arrangement of the plurality of light emitting portions of McDonald as modified by Singh to be the arrangement of the light emitting portions and light guides of Wortley as Wortley teaches this arrangement to be effective for providing a well-defined visual target for medical personnel to be able to identify the location of the port ([0055]). Such a modification would entail arranging the coils and plurality of light emitting portions of Singh which are added to McDonald into notches as in Wortley and filling the remainder of the notches with light guides as in Wortley.
{Examiner notes that the limitation “the medical instrument further includes a light shielding plate installed on an outer peripheral side of one of the light emitting portions” is optional as called out in the rejection above under 35 U.S.C. §112(b), and thus is not required to be anticipated for a proper rejection of art which is why it is omitted in the rejection of the claim above.}
Regarding claim 2, McDonald as modified by Singh and Wortley discloses the medical device of claim 1 wherein the plurality of light emitting portions share the power receiving part (see Singh fig. 18, multiple LEDs 336 share the same coil 338; this would also be the same in the modified device of McDonald since the arrangement of the LEDs is the same).
McDonald as modified does not explicitly discloses the medical device where the respective light emitting portions are electrically connected in parallel. Wortley teaches that parallel and series arrangements are both known arrangements for providing electrical power to multiple LEDs ([0059]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have connected the light emitting portions in parallel as Wortley teaches that parallel arrangements are easier to activate ([0059]).
Regarding claim 3, McDonald discloses a medical instrument component (access port 10, fig. 1, except for conductive base plate 24, fig. 1) mounted on a medical instrument (access port 10 and conductive base plate 24, fig. 1) implanted for use in a body (see fig. 1, access port 10 is implanted into tissue 11 in a patient’s body where it is used), the medical instrument including: a power receiving part (coil 26, fig. 1) including a first coil (coil 26, fig. 1) that is configured to receive power transmitted from a power transmission part (see Col. 2 lines 26-30, where the power transmission part is RF transmitter 34, fig. 1, which transmits power as disclosed in Col. 2 lines 13-18) of an extracorporeal unit (the combination of antenna 38 and RF transmitter 34 make up an extracorporeal unit as claimed) in a non-contact manner (see Col. 2 lines 13-18, power is transmitted via radiofrequency); and a notification part (beeper 46, fig. 1) that is configured to operate based on use of the power which is configured to be received by the power receiving part (see Col. 2 lines 31-53) to notify that a predetermined state is reached (this is the state where the transmitting antenna 38 and needle 32 are in the proper position), when a relative positional relation between the power transmission part and the power receiving part reaches the predetermined state by moving the power transmission part (see Col. 2 lines 31-60, antenna 38 is moved into the proper position to provide power to beeper 46 as disclosed); wherein the first coil is a coreless coil (see fig. 1, coil 26 is not shown as having a core), the power receiving part is installed on one plane (see Plane 1 called out in annotated fig. 1) of a substrate (see section S1 called out in annotated fig. 1; this section is considered to be a substrate as claimed where Merriam Webster defines a substrate to be “a substance acted upon” and the called out section is acted upon by the RF waves emitted from RF transmitter 34), the notification part is installed on another plane (see Plane 2 called out in annotated fig. 1) of the substrate (see annotated fig. 1, Plane 2 is another plane within section S1 as claimed).
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Annotated fig. 1 from McDonald calling out the claimed planes and substrate
McDonald does not disclose the medical device where the notification part includes a plurality of light emitting portions, especially where the plurality of light emitting portions are arranged along an outer edge of the soft part. Singh teaches a medical device (port 100, fig. 18) having a notification part (the section shown in fig. 18 is a notification part where it comprises the structures present in the claimed notification part) installed in a housing (body 102 and cap 104, figs. 18 and 20) of a medical instrument (port 100, figs. 18 and 20) which is powered in a non-contact manner (powered by electromagnetic field as in [0097]) by power transmitted from a second coil (second coil 342, fig. 18) of a power transmission part (external device 340, fig. 18) and received by a first coil (first coil 338, fig. 18) where the notification part includes a plurality of light emitting portions (LEDs 336, fig. 18) where the plurality of light emitting portions are arranged along an outer edge of a soft part (see [0097], LEDs 336 are arranged around opening 130 which is the boundary of septum 106 which is a soft part, see also figs. 18 and 20) which a needle is insertable into (see [0083] and [0084]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the plurality of light emitting portions of Singh to the notification port of McDonald for providing location aid to a clinician (Singh [0083]) and further to have arranged the plurality of light emitting portions around an outer edge of the soft part as is the arrangement of Singh for allowing light to transfer through the soft part and through the patient’s tissue to provide illumination through the tissue of the patient as in Singh ([0097]).
McDonald as modified by Singh does not disclose that the medical instrument further includes a first light guide plate installed on an outer peripheral side of one of the light emitting portions, the medical instrument further includes a light shielding plate installed on an outer peripheral side of one of the light emitting portions, the medical instrument further includes a condensing portion having a curved surface facing one of the light emitting portions, or the medical instrument further includes a condensing portion provided on the substrate, the condensing portion configured to condense light emitted from at least one of the light emitting portions. Wortley teaches a medical instrument (vascular access port 10, fig. 4) comprising a plurality of light emitting portions (LEDs 28 and 30, fig. 4) disposed along an outer edge of a soft part (septum 14 is a soft part, and the LEDs 28 and 30 are disposed along the radial outer edge of the septum 14 where they are placed radially outside of septum 14) where the medical instrument further includes a first light guide plate (light guide 36, fig. 4, which is a guide plate because it guides light from the LED to the tissue) installed on an outer peripheral side of one of the light emitting portions (see fig. 4, light guide 36 is installed on top of the peripheral edges of LED 28 and thus it is on an outer peripheral side of LED 28 where it is stacked vertically on top of the edge of LED 28).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have changed the arrangement of the plurality of light emitting portions of McDonald as modified by Singh to be the arrangement of the light emitting portions and light guides of Wortley as Wortley teaches this arrangement to be effective for providing a well-defined visual target for medical personnel to be able to identify the location of the port ([0055]). Such a modification would entail arranging the coils and plurality of light emitting portions of Singh which are added to McDonald into notches as in Wortley and filling the remainder of the notches with light guides as in Wortley.
{Examiner notes that the limitations of “the medical instrument further includes a light shielding plate installed on an outer peripheral side of one of the light emitting portions”, “the medical instrument further includes a condensing portion having a curved surface facing one of the light emitting portions”, and “the medical instrument further includes a condensing portion provided on the substrate, the condensing portion configured to condense light emitted from at least one of the light emitting portions” are each optional as called out in the rejection above under 35 U.S.C. §112(b), and thus are not required to be anticipated for a proper rejection of art which is why they are omitted in the rejection of the claim above. Alternative rejections of claim 3 addressing each of the limitations individually are provided below for the rejection of respective dependent claims.}
Regarding claim 10, McDonald as modified discloses the medical instrument component of claim 3 further including the first light guide plate installed on the outer peripheral side of the first one of the light emitting portions (see fig. 4, light guide 36 is installed on top of the peripheral edges of LED 28 and thus it is on an outer peripheral side of LED 28 where it is stacked vertically on top of the edge of LED 28).
{Examiner notes that this is not a duplicate to claim 3 because it is considered to be a positive recitation of the previously optionally required first light guide plate.}
Regarding claim 11, McDonald as modified discloses the medical instrument component of claim 10 further including a second light guide plate (light guide 35, fig. 4) installed on an outer peripheral side of a second one of the light emitting portions (see fig. 4, light guide 35 is installed on top of the peripheral edges of LED 30 and thus it is on an outer peripheral side of LED 30 where it is stacked vertically on top of the edge of LED 30), wherein the first light guide plate and the second light guide plate are oriented in different directions (see fig. 2, relative to button 38, light guides 35 and 36 are oriented in different directions as claimed).
Under an alternative rejection requiring different optional subject matter in claim 3, claim 3 is additionally rejected as follows:
Regarding claim 3, McDonald discloses a medical instrument component (access port 10, fig. 1, except for conductive base plate 24, fig. 1) mounted on a medical instrument (access port 10 and conductive base plate 24, fig. 1) implanted for use in a body (see fig. 1, access port 10 is implanted into tissue 11 in a patient’s body where it is used), the medical instrument including: a power receiving part (coil 26, fig. 1) including a first coil (coil 26, fig. 1) that is configured to receive power transmitted from a power transmission part (see Col. 2 lines 26-30, where the power transmission part is RF transmitter 34, fig. 1, which transmits power as disclosed in Col. 2 lines 13-18) of an extracorporeal unit (the combination of antenna 38 and RF transmitter 34 make up an extracorporeal unit as claimed) in a non-contact manner (see Col. 2 lines 13-18, power is transmitted via radiofrequency); and a notification part (beeper 46, fig. 1) that is configured to operate based on use of the power which is configured to be received by the power receiving part (see Col. 2 lines 31-53) to notify that a predetermined state is reached (this is the state where the transmitting antenna 38 and needle 32 are in the proper position), when a relative positional relation between the power transmission part and the power receiving part reaches the predetermined state by moving the power transmission part (see Col. 2 lines 31-60, antenna 38 is moved into the proper position to provide power to beeper 46 as disclosed); wherein the first coil is a coreless coil (see fig. 1, coil 26 is not shown as having a core), the power receiving part is installed on one plane (see Plane 1 called out in annotated fig. 1) of a substrate (see section S1 called out in annotated fig. 1; this section is considered to be a substrate as claimed where Merriam Webster defines a substrate to be “a substance acted upon” and the called out section is acted upon by the RF waves emitted from RF transmitter 34), the notification part is installed on another plane (see Plane 2 called out in annotated fig. 1) of the substrate (see annotated fig. 1, Plane 2 is another plane within section S1 as claimed).
McDonald does not disclose the medical device where the notification part includes a plurality of light emitting portions, especially where the plurality of light emitting portions are arranged along an outer edge of the soft part. Singh teaches a medical device (port 100, fig. 18) having a notification part (the section shown in fig. 18 is a notification part where it comprises the structures present in the claimed notification part) installed in a housing (body 102 and cap 104, figs. 18 and 20) of a medical instrument (port 100, figs. 18 and 20) which is powered in a non-contact manner (powered by electromagnetic field as in [0097]) by power transmitted from a second coil (second coil 342, fig. 18) of a power transmission part (external device 340, fig. 18) and received by a first coil (first coil 338, fig. 18) where the notification part includes a plurality of light emitting portions (LEDs 336, fig. 18) where the plurality of light emitting portions are arranged along an outer edge of a soft part (see [0097], LEDs 336 are arranged around opening 130 which is the boundary of septum 106 which is a soft part, see also figs. 18 and 20) which a needle is insertable into (see [0083] and [0084]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the plurality of light emitting portions of Singh to the notification port of McDonald for providing location aid to a clinician (Singh [0083]) and further to have arranged the plurality of light emitting portions around an outer edge of the soft part as is the arrangement of Singh for allowing light to transfer through the soft part and through the patient’s tissue to provide illumination through the tissue of the patient as in Singh ([0097]).
McDonald as modified by Singh does not disclose that the medical instrument further includes a first light guide plate installed on an outer peripheral side of one of the light emitting portions, the medical instrument further includes a light shielding plate installed on an outer peripheral side of one of the light emitting portions, the medical instrument further includes a condensing portion having a curved surface facing one of the light emitting portions, or the medical instrument further includes a condensing portion provided on the substrate, the condensing portion configured to condense light emitted from at least one of the light emitting portions. Wortley teaches a medical instrument (vascular access port 10, fig. 4) comprising a plurality of light emitting portions (LEDs 28 and 30, fig. 4) disposed along an outer edge of a soft part (septum 14 is a soft part, and the LEDs 28 and 30 are disposed along the radial outer edge of the septum 14 where they are placed radially outside of septum 14) where the medical instrument further includes the medical instrument further includes a light shielding plate (light guide 36, fig. 4, which is a light shielding plate as it shields light from the LEDs from being exposed directly to tissue when the port 10 is implanted) installed on an outer peripheral side of one of the light emitting portions (see fig. 4, light guide 36 is installed on top of the peripheral edges of LED 28 and thus it is on an outer peripheral side of LED 28 where it is stacked vertically on top of the edge of LED 28).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have changed the arrangement of the plurality of light emitting portions of McDonald as modified by Singh to be the arrangement of the light emitting portions and light guides of Wortley as Wortley teaches this arrangement to be effective for providing a well-defined visual target for medical personnel to be able to identify the location of the port ([0055]). Such a modification would entail arranging the coils and plurality of light emitting portions of Singh which are added to McDonald into notches as in Wortley and filling the remainder of the notches with light guides as in Wortley.
Regarding claim 12, McDonald as modified discloses the medical instrument component of claim 3 further including the light shielding plate installed on the outer peripheral side of the one of the light emitting portions (see fig. 4, light guide 36 is installed on top of the peripheral edges of LED 28 and thus it is on an outer peripheral side of LED 28 where it is stacked vertically on top of the edge of LED 28).
{Examiner notes that this is not a duplicate to claim 3 because it is considered to be a positive recitation of the previously optionally required first light shielding plate.}
Under an alternative rejection requiring different optional subject matter in claim 3, claim 3 is additionally rejected as follows:
Regarding claim 3, McDonald discloses a medical instrument component (access port 10, fig. 1, except for conductive base plate 24, fig. 1) mounted on a medical instrument (access port 10 and conductive base plate 24, fig. 1) implanted for use in a body (see fig. 1, access port 10 is implanted into tissue 11 in a patient’s body where it is used), the medical instrument including: a power receiving part (coil 26, fig. 1) including a first coil (coil 26, fig. 1) that is configured to receive power transmitted from a power transmission part (see Col. 2 lines 26-30, where the power transmission part is RF transmitter 34, fig. 1, which transmits power as disclosed in Col. 2 lines 13-18) of an extracorporeal unit (the combination of antenna 38 and RF transmitter 34 make up an extracorporeal unit as claimed) in a non-contact manner (see Col. 2 lines 13-18, power is transmitted via radiofrequency); and a notification part (beeper 46, fig. 1) that is configured to operate based on use of the power which is configured to be received by the power receiving part (see Col. 2 lines 31-53) to notify that a predetermined state is reached (this is the state where the transmitting antenna 38 and needle 32 are in the proper position), when a relative positional relation between the power transmission part and the power receiving part reaches the predetermined state by moving the power transmission part (see Col. 2 lines 31-60, antenna 38 is moved into the proper position to provide power to beeper 46 as disclosed); wherein the first coil is a coreless coil (see fig. 1, coil 26 is not shown as having a core), the power receiving part is installed on one plane (see Plane 1 called out in annotated fig. 1) of a substrate (see section S1 called out in annotated fig. 1; this section is considered to be a substrate as claimed where Merriam Webster defines a substrate to be “a substance acted upon” and the called out section is acted upon by the RF waves emitted from RF transmitter 34), the notification part is installed on another plane (see Plane 2 called out in annotated fig. 1) of the substrate (see annotated fig. 1, Plane 2 is another plane within section S1 as claimed).
McDonald does not disclose the medical device where the notification part includes a plurality of light emitting portions, especially where the plurality of light emitting portions are arranged along an outer edge of the soft part. Singh teaches a medical device (port 100, fig. 18) having a notification part (the section shown in fig. 18 is a notification part where it comprises the structures present in the claimed notification part) installed in a housing (body 102 and cap 104, figs. 18 and 20) of a medical instrument (port 100, figs. 18 and 20) which is powered in a non-contact manner (powered by electromagnetic field as in [0097]) by power transmitted from a second coil (second coil 342, fig. 18) of a power transmission part (external device 340, fig. 18) and received by a first coil (first coil 338, fig. 18) where the notification part includes a plurality of light emitting portions (LEDs 336, fig. 18) where the plurality of light emitting portions are arranged along an outer edge of a soft part (see [0097], LEDs 336 are arranged around opening 130 which is the boundary of septum 106 which is a soft part, see also figs. 18 and 20) which a needle is insertable into (see [0083] and [0084]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the plurality of light emitting portions of Singh to the notification port of McDonald for providing location aid to a clinician (Singh [0083]) and further to have arranged the plurality of light emitting portions around an outer edge of the soft part as is the arrangement of Singh for allowing light to transfer through the soft part and through the patient’s tissue to provide illumination through the tissue of the patient as in Singh ([0097]).
McDonald as modified by Singh does not disclose that the medical instrument further includes a first light guide plate installed on an outer peripheral side of one of the light emitting portions, the medical instrument further includes a light shielding plate installed on an outer peripheral side of one of the light emitting portions, the medical instrument further includes a condensing portion having a curved surface facing one of the light emitting portions, or the medical instrument further includes a condensing portion provided on the substrate, the condensing portion configured to condense light emitted from at least one of the light emitting portions. Wortley teaches a medical instrument (vascular access port 10, fig. 4) comprising a plurality of light emitting portions (LEDs 28 and 30, fig. 4) disposed along an outer edge of a soft part (septum 14 is a soft part, and the LEDs 28 and 30 are disposed along the radial outer edge of the septum 14 where they are placed radially outside of septum 14) the medical instrument further includes a condensing portion (the top surface of light guide 35 is a condensing portion as claimed, fig. 4) having a curved surface (see fig. 4, the top surface of light guide 35 is curved) facing one of the light emitting portions (see fig. 4, the inside of the top surface of light guide 35 is curved and is convex relative to, or facing, LED 30 as shown).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have changed the arrangement of the plurality of light emitting portions of McDonald as modified by Singh to be the arrangement of the light emitting portions and light guides of Wortley as Wortley teaches this arrangement to be effective for providing a well-defined visual target for medical personnel to be able to identify the location of the port ([0055]). Such a modification would entail arranging the coils and plurality of light emitting portions of Singh which are added to McDonald into notches as in Wortley and filling the remainder of the notches with light guides as in Wortley.
Regarding claim 13, McDonald as modified discloses the medical instrument component of claim 3 further including the condensing portion having a curved surface (see fig. 4, the top surface of light guide 35 is curved) facing one of the light emitting portions (see fig. 4, the inside of the top surface of light guide 35 is curved and is convex relative to, or facing, LED 30 as shown).
{Examiner notes that this is not a duplicate to claim 3 because it is considered to be a positive recitation of the previously optionally required first condensing portion.}
Under an alternative rejection requiring different optional subject matter in claim 3, claim 3 is additionally rejected as follows:
Regarding claim 3, McDonald discloses a medical instrument component (access port 10, fig. 1, except for conductive base plate 24, fig. 1) mounted on a medical instrument (access port 10 and conductive base plate 24, fig. 1) implanted for use in a body (see fig. 1, access port 10 is implanted into tissue 11 in a patient’s body where it is used), the medical instrument including: a power receiving part (coil 26, fig. 1) including a first coil (coil 26, fig. 1) that is configured to receive power transmitted from a power transmission part (see Col. 2 lines 26-30, where the power transmission part is RF transmitter 34, fig. 1, which transmits power as disclosed in Col. 2 lines 13-18) of an extracorporeal unit (the combination of antenna 38 and RF transmitter 34 make up an extracorporeal unit as claimed) in a non-contact manner (see Col. 2 lines 13-18, power is transmitted via radiofrequency); and a notification part (beeper 46, fig. 1) that is configured to operate based on use of the power which is configured to be received by the power receiving part (see Col. 2 lines 31-53) to notify that a predetermined state is reached (this is the state where the transmitting antenna 38 and needle 32 are in the proper position), when a relative positional relation between the power transmission part and the power receiving part reaches the predetermined state by moving the power transmission part (see Col. 2 lines 31-60, antenna 38 is moved into the proper position to provide power to beeper 46 as disclosed); wherein the first coil is a coreless coil (see fig. 1, coil 26 is not shown as having a core), the power receiving part is installed on one plane (see Plane 1 called out in annotated fig. 1) of a substrate (see section S1 called out in annotated fig. 1; this section is considered to be a substrate as claimed where Merriam Webster defines a substrate to be “a substance acted upon” and the called out section is acted upon by the RF waves emitted from RF transmitter 34), the notification part is installed on another plane (see Plane 2 called out in annotated fig. 1) of the substrate (see annotated fig. 1, Plane 2 is another plane within section S1 as claimed).
McDonald does not disclose the medical device where the notification part includes a plurality of light emitting portions, especially where the plurality of light emitting portions are arranged along an outer edge of the soft part. Singh teaches a medical device (port 100, fig. 18) having a notification part (the section shown in fig. 18 is a notification part where it comprises the structures present in the claimed notification part) installed in a housing (body 102 and cap 104, figs. 18 and 20) of a medical instrument (port 100, figs. 18 and 20) which is powered in a non-contact manner (powered by electromagnetic field as in [0097]) by power transmitted from a second coil (second coil 342, fig. 18) of a power transmission part (external device 340, fig. 18) and received by a first coil (first coil 338, fig. 18) where the notification part includes a plurality of light emitting portions (LEDs 336, fig. 18) where the plurality of light emitting portions are arranged along an outer edge of a soft part (see [0097], LEDs 336 are arranged around opening 130 which is the boundary of septum 106 which is a soft part, see also figs. 18 and 20) which a needle is insertable into (see [0083] and [0084]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the plurality of light emitting portions of Singh to the notification port of McDonald for providing location aid to a clinician (Singh [0083]) and further to have arranged the plurality of light emitting portions around an outer edge of the soft part as is the arrangement of Singh for allowing light to transfer through the soft part and through the patient’s tissue to provide illumination through the tissue of the patient as in Singh ([0097]).
McDonald as modified by Singh does not disclose that the medical instrument further includes a first light guide plate installed on an outer peripheral side of one of the light emitting portions, the medical instrument further includes a light shielding plate installed on an outer peripheral side of one of the light emitting portions, the medical instrument further includes a condensing portion having a curved surface facing one of the light emitting portions, or the medical instrument further includes a condensing portion provided on the substrate, the condensing portion configured to condense light emitted from at least one of the light emitting portions. Wortley teaches a medical instrument (vascular access port 10, fig. 4) comprising a plurality of light emitting portions (LEDs 28 and 30, fig. 4) disposed along an outer edge of a soft part (septum 14 is a soft part, and the LEDs 28 and 30 are disposed along the radial outer edge of the septum 14 where they are placed radially outside of septum 14) where the medical instrument further includes a condensing portion (light guide 36, fig. 4) provided on a substrate (lower housing 24, fig. 4; light guide 36 is provided on lower housing 24 as claimed where it is adjacent to it), the condensing portion configured to condense light emitted from at least one of the light emitting portions (note that this is a functional limitation which means that the structure must only be functionally capable of condensing light emitted from at least one of the light emitting portions; light guide 36 meets this limitation where it is a guide configured to gather light emitted from LED 28 and transfer it out of the port 10 vertically which it does by condensing light).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have changed the arrangement of the plurality of light emitting portions of McDonald as modified by Singh to be the arrangement of the light emitting portions and light guides of Wortley as Wortley teaches this arrangement to be effective for providing a well-defined visual target for medical personnel to be able to identify the location of the port ([0055]). Such a modification would entail arranging the coils and plurality of light emitting portions of Singh which are added to McDonald into notches as in Wortley and filling the remainder of the notches with light guides as in Wortley.
Regarding claim 14, McDonald as modified discloses the medical instrument component of claim 3 further comprising the condensing portion provided on the substrate (the substrate is lower housing 24, fig. 4; light guide 36 is provided on lower housing 24 as claimed where it is adjacent to it), the condensing portion configured to condense light emitted from at least one of the light emitting portions (note that this is a functional limitation which means that the structure must only be functionally capable of condensing light emitted from at least one of the light emitting portions; light guide 36 meets this limitation where it is a guide configured to gather light emitted from LED 28 and transfer it out of the port 10 vertically which it does by condensing light).
{Examiner notes that this is not a duplicate to claim 3 because it is considered to be a positive recitation of the previously optionally required second condensing portion.}
Regarding claim 5, McDonald discloses a medical instrument (access port 10, fig. 1) implanted for use in a body (see fig. 1, access port 10 is implanted into tissue 11 in a patient’s body where it is used), and comprising: a power receiving part (coil 26, fig. 1) including a first coil (coil 26, fig. 1) that is configured to receive power transmitted from a power transmission part (see Col. 2 lines 26-30) of an extracorporeal unit (RF transmitter 34, fig. 1, which transmits power as disclosed in Col. 2 lines 13-18) in a non-contact manner (see Col. 2 lines 13-18, power is transmitted via radiofrequency); a notification part (beeper 46, fig. 1) that is configured to operate based on use of the power which is configured to be received by the power receiving part (see Col. 2 lines 31-53) to notify that a predetermined state is reached (this is the state where the transmitting antenna 38 and needle 32 are in the proper position), when a relative positional relation between the power transmission part and the power receiving part reaches the predetermined state by moving the power transmission part (see Col. 2 lines 31-60, antenna 38 is moved into the proper position to provide power to beeper 46 as disclosed); a housing (body 14, fig. 1); a container (reservoir 16, fig. 1) installed in the housing (see fig. 1, reservoir 16 is located inside of body 14); and a soft part (septum 18, fig. 1) into which an injection needle is insertable (see fig. 1, needle 32 of syringe 30 is inserted into septum 18 as shown; note also that this limitation is functional and thus the claimed soft part is only required to be capable of having a needle inserted into it, and such an insertion is not a requirement of the claim; the called out needle 32 of McDonald is pointed out as clarity of evidence); a first exterior part (the combination of reservoir 16, contact plate 20, and circuit 22 is the first exterior part, see fig. 1, as it is radially exterior relative to the tapered point of needle 32 as shown) comprising the container (see fig. 1, the called out exterior part includes container 16); a second exterior part (the combination of body 14 and common plate 24, fig. 1, is the second exterior part which is also radially exterior relative to the tapered point of needle 32) comprising an insertion part (the combination of body 14 and common plate 24 is an insertion part as claimed) into which the first exterior part is inserted (see fig. 1, reservoir 16 and contact plate 20 are inserted into body 14 as claimed); and a medical instrument component (circuit 22, fig. 1) disposed between the second exterior part and the first exterior part (see fig. 1, circuit 22 is arranged axially between contact plate 20 and common plate 24 as shown), wherein the power receiving part is installed on one plane (see Plane 1 called out in annotated fig. 1) of a substrate (see section S1 called out in annotated fig. 1; this section is considered to be a substrate as claimed where Merriam Webster defines a substrate to be “a substance acted upon” and the called out section is acted upon by the RF waves emitted from RF transmitter 34), and the notification part is installed on another plane (see Plane 2 called out in annotated fig. 1) of the substrate (see Plane 2 called out in annotated fig. 1), wherein the first coil is a coreless coil (see fig. 1, coil 26 is not shown as having a core) disposed to have an inner diameter (the distance from one edge of coil 26 to the opposite edge of coil 26 about the radial center of access port 10 is the claimed inner diameter of coil 26) larger than an outer diameter of the container (the claimed outer diameter is the distance from one radial outermost edge of reservoir 10 to the opposite radial outermost edge of reservoir 16 about the radial center of access port shown in fig. 1; since the inner diameter is larger than the outer diameter, this claim limitation is met).
McDonald does not disclose the medical device where the notification part includes a plurality of light emitting portions, especially where the plurality of light emitting portions are arranged along an outer edge of the soft part. Singh teaches a medical device (port 100, fig. 18) having a notification part (the section shown in fig. 18 is a notification part where it comprises the structures present in the claimed notification part) installed in a housing (body 102 and cap 104, figs. 18 and 20) of a medical instrument (port 100, figs. 18 and 20) which is powered in a non-contact manner (powered by electromagnetic field as in [0097]) by power transmitted from a second coil (second coil 342, fig. 18) of a power transmission part (external device 340, fig. 18) and received by a first coil (first coil 338, fig. 18) where the notification part includes a plurality of light emitting portions (LEDs 336, fig. 18) where the plurality of light emitting portions are arranged along an outer edge of a soft part (see [0097], LEDs 336 are arranged around opening 130 which is the boundary of septum 106 which is a soft part, see also figs. 18 and 20) which a needle is insertable into (see [0083] and [0084]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the plurality of light emitting portions of Singh to the notification port of McDonald for providing location aid to a clinician (Singh [0083]) and further to have arranged the plurality of light emitting portions around an outer edge of the soft part as is the arrangement of Singh for allowing light to transfer through the soft part and through the patient’s tissue to provide illumination through the tissue of the patient as in Singh ([0097]).
McDonald as modified by Singh does not disclose that the medical instrument further includes a first light guide plate installed on an outer peripheral side of one of the light emitting portions, the medical instrument further includes a light shielding plate installed on an outer peripheral side of one of the light emitting portions, the medical instrument further includes a condensing portion having a curved surface facing one of the light emitting portions, or a notch portion is formed over a circumferential direction on an outer peripheral side of an upper side of the container wherein the light emitting portions and the first coil are installed in the notch portion. Wortley teaches a medical instrument (vascular access port 10, fig. 4) comprising a plurality of light emitting portions (LEDs 28 and 30, fig. 4) disposed along an outer edge of a soft part (septum 14 is a soft part, and the LEDs 28 and 30 are disposed along the radial outer edge of the septum 14 where they are placed radially outside of septum 14) where the medical instrument further includes a first light guide plate (light guide 36, fig. 4) installed on an outer peripheral side of one of the light emitting portions (see fig. 4, light guide 36 is installed on top of the peripheral edges of LED 28 and thus it is on an outer peripheral side of LED 28 where it is stacked vertically on top of the edge of LED 28), the medical instrument further includes a condensing portion (the top of light guide 35 is a condensing portion as claimed, fig. 4) having a curved surface (see fig. 4, the top surface of light guide 35 is curved) facing one of the light emitting portions (see fig. 4, the inside of the top surface of light guide 35 is curved and is convex relative to, or facing, LED 30 as shown), or a notch portion (the spaces where light guides 35 and 36 and LEDs 28 and 30 are placed are notch portions as shown in fig. 4 where they are hollowed out spaces) is formed over a circumferential direction on an outer peripheral side of an upper side of a container (the container is the hollow inside space made by can 16, fig. 4, and the called out notch is formed as claimed where it is vertically above and radially surrounding the top of the container) wherein the light emitting portions are installed in the notch portion (see fig. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have changed the arrangement of the plurality of light emitting portions of McDonald as modified by Singh to be the arrangement of the light emitting portions and light guides of Wortley as Wortley teaches this arrangement to be effective for providing a well-defined visual target for medical personnel to be able to identify the location of the port ([0055]). Such a modification would entail arranging the coils and plurality of light emitting portions of Singh which are added to McDonald into notches as in Wortley and filling the remainder of the notches with light guides as in Wortley.
{Examiner notes that the limitation “the medical instrument further includes a light shielding plate installed on an outer peripheral side of one of the light emitting portions” is optional as called out in the rejection above under 35 U.S.C. §112(b), and thus is not required to be anticipated for a proper rejection of art which is why it is omitted in the rejection of the claim above.}
Regarding claim 7, McDonald as modified discloses the instrument of claim 5 wherein the light emitting portions are configured to emit light from the first exterior part toward the second exterior part (in the modified device of claim 5, the light emitting portions which are added from Singh emit light from within reservoir 16 towards the top of reservoir 16 and the top of body 14 out of the tissue 11 of the patient, and thus the light is configured to be emitted from the first exterior part, especially from contact plate 20, towards the top of body 14 which is a part of the second exterior part as claimed).
Regarding claim 8, McDonald as modified discloses the instrument of claim 5 wherein the medical instrument component is installed in the first exterior part (since circuit 22 is a part of the first exterior part, it is installed in it).
Regarding claim 9, McDonald as modified discloses the instrument of claim 7 wherein the medical instrument component is installed in the first exterior part (since circuit 22 is a part of the first exterior part, it is installed in it).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over McDonald et al. (US Pat. No. 5009644, henceforth McDonald) in view of Singh et al. (US 20200061362, henceforth Singh) and Wortley et al. (US 20070078391, henceforth Wortley) as initially applied to claim 3 above, and further in view of Wiley et al. (US 20130338494, henceforth Wiley).
{Examiner notes that the relied upon rejection of claim 3 is the initial rejection, however, each of the rejections of claim 3 provided above could be used for the rejection of claim 4.}
Regarding claim 4, McDonald as modified by Singh discloses the medical instrument component of claim 3 wherein the other plane of the substrate, together with the notification part, is covered with a material (see fig. 1, Plane 2 of substrate section S1 and the beeper 46 of circuit 22 as well as the added plurality of lights in the reservoir 16 in the modified device are all covered with material from body 14 as shown).
McDonald as modified by Singh does not explicitly disclose that the material is a resin material as claimed. Wiley teaches that exterior bodies of access ports are known in the art to be made with resin ([0086]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the body of McDonald out of resin as claimed as Wiley teaches that resins are known to be materials used for the bodies of access ports for their biocompatibility properties (see [0086]), moldability, and ease of manufacturing ([0164] and [0170]-[0171]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 3, and 5 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.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783