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
Claims 12 and 17 have been amended. No new matter has been entered.
Claims 12-22 remain pending, with claims 13-15 remaining withdrawn.
Claim Rejections - 35 USC § 112
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 19 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 19 does not further limit claim 12 which it depends on as it requires all of the same limitations as amended claim 12 with no further specification.
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) 12 and 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zinn et al. (US 20070219510, henceforth Zinn) in view of Ko et al. (US 20130035648, henceforth Ko).
Regarding claims 12 and 19, Zinn discloses an access port (access port 100, fig. 1) to be connected to a catheter (entry cannula 190, fig. 10), the access port comprising: a port body (port body 102 and proximal cap 170, fig. 1) including a liquid storage portion (chamber 118, fig. 8); and a diaphragm body (the combination of septum 134 and support member 124 is the claimed diaphragm body, see figs. 4 and 8) held by the port body (see fig. 8, port body 102 contains and radially surrounds the diaphragm body) and covering the liquid storage portion (see fig. 8, septum 134 covers chamber 118 from above as shown), wherein the port body includes a connection passage (the combination proximal opening 172, proximal septum 174, and opening 116 make up the claimed connection passage, fig. 8) connected to the liquid storage portion (see fig. 8, opening 116 is directly connected to chamber 118) to allow the liquid storage portion to communicate with an inside of the catheter (see figs. 12 and 15, the connection allows cannula 190 to enter the chamber 118), and in a cross-section along an axial direction (the axial direction is the direction which extends along the line formed between opening 172 and passageway 154, see figs. 8 and 15 where fig. 15 shows cannula 190 extending along the axial direction) of the connection passage at a connection position (see annotated fig. 8 which calls out the connection position as being the point at which opening 116 meets chamber 118) where the connection passage is connected to the liquid storage portion (see annotated fig. 8), a length in a direction perpendicular to the axial direction between a surface of the diaphragm body opposite to the liquid storage portion (the surface of the diaphragm body opposite to the liquid storage portion is the top surface of septum 134 as shown in fig. 12) and an inner surface of the liquid storage portion (the inner surface of the liquid storage portion is the bottom surface of chamber 118 called out in annotated fig. 8; the length L between them as claimed is shown with a dashed line in the annotated fig. 8 as well) gradually decreases as it proceeds away from the connection position (see annotated fig. 8, the region R called out shows a gradual decrease in the length L as shown with second length L2 being shorter than L when viewed along the axial direction moving from opening 116 towards passageway 154) in an inclined region of the liquid storage portion along the axial direction (this is region R as called out in annotated fig. 8). Zinn additionally discloses a second inclined region (this is region R2, see annotated fig. 8) which exceeds half of the liquid storage portion along the axial direction (see annotated fig. 8, the length of region R2 along the axial direction appears to be greater than called out region R3 which is the length of the liquid storage portion which is not inclined and thus not in the inclined region).
Zinn does not disclose that the inclined region exceeds half of the liquid storage portion along the axial direction. Ko teaches an access port (hollow port 10, fig. 4) comprising a liquid storage portion (internal chamber 15, fig. 4) and a diaphragm body (the combination of arcuate surface 13 and receiving seat 17, fig. 1, make up the claimed diaphragm body) held by a port body (housing 11, fig. 1, which is considered to hold the diaphragm body as it includes it and/or extends around it to contain it) having a connection passage (connector 18, fig. 2) at a connection position (the point at which receiving seat 17 meets connector 18 is a connection position, see fig. 2; this is also where the tapered end of the needle 40 is shown in fig. 4) where the connection passage is connected to the liquid storage portion (see fig. 2), a length in a direction perpendicular to an axial direction (the axial direction is the direction which catheter 20 extends along, see fig. 4) between a surface of the diaphragm body opposite to the liquid storage portion (this is the top most surface of arcuate surface 13 as shown in fig. 4) and an inner surface of the liquid storage portion (this is the bottom most surface of receiving seat 17 as shown in fig. 4) gradually decreases as it proceeds away from the connection position (see the lengths L3 and L4 in provided annotated fig. 4; each extends along the claimed length between the called out surfaces, and L4 is shorter than L3 because the length gradually decreases as shown and as claimed as viewed along the axial direction moving away from the connection position) in an inclined region (see region R4, annotated fig. 4) exceeding half of the liquid storage portion along the axial direction (see region R5, annotated fig. 4, which shows the remainder of the length of the liquid storage portion along the axial direction; R4 is greater than R5 which means that R4 extends for more than half of the region, and since R4 is the inclined region, the claim limitation is met).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have extended the diaphragm body of Zinn such that it extended over the second inclined region such as make the inclined region extend for more than half of the length of the liquid storage portion along the axial direction as claimed and as in Ko as Ko teaches this extended angled arrangement to be beneficial for allowing a needle to be inserted into the liquid storage portion from various angles (see Ko [0017]). Such a modification would include changes to the shape of septum 134 of Zinn and the support member 124 to accommodate this change and allow for needle insertion from a greater variety of angles as in Ko.
Zinn as modified by Ko thus discloses the port wherein a surface of the diaphragm body opposite to the liquid storage portion (the top surface of septum 134; note that this surface extends forward in the modified device as the septum extends further forwards towards tapered surfaces 114A, 114B) has a first surface (the first surface is called out in the second annotated fig. 8 as F1) located on a side away from the connection position in the axial direction (see annotated fig. 8, surface F1 is located on the far side of septum 134 about the top most point of septum 134 from passageway 116 and the connection position), and a second surface (the second surface is called out in the second annotated fig. 8 as F2) located on a side closer to the connection position in the axial direction with respect to the first surface (see annotated fig. 8, surface F2 is located on the near side of septum 134 about the top most point of septum 134 from passageway 116 and the connection position) and inclined with respect to the first surface (see fig. 8, surface F2 is inclined relative to the axial direction and relative to surface F1 where it curves slightly upwards), wherein the first surface and the second surface intersect to create an angle therebetween (the first surface and the second surface intersect at the top of septum 134 as shown in second annotated fig. 8 from Zinn, the angle appears to be almost a 180 degree angle due to the curved nature of the septum 134 which defines part of the first surface and the second surface); a length of the first surface along the axial direction is longer than a length of the second surface along the axial direction (see annotated fig. 8, surface F1 is longer than surface F2 as the portion of the modified septum 134 which extends from the top most point of septum 134 towards passageway 154 is longer than the portion of the modified septum 134 which extends towards opening 116), the first surface is inclined with respect to the axial direction (see annotated fig. 8, the first surface F1 is inclined with respect to the horizontal axial direction where it slants and curves upwards) toward a side away from the inner surface of the liquid storage portion as it approaches the connection position in the axial direction (see fig. 8, this is the claimed inclination), and an inclination angle of the first surface with respect to the axial direction (this is the angle formed by the upward curving of surface F1 towards the top of septum 134 as shown as the angle of two dotted lines in annotated fig. 8) is larger than an inclination angle of the second surface with respect to the axial direction (this is the angle formed by the sloping of modified septum 134 shown as the angle of two dotted and dashed lines in annotated fig. 8 as measured against the horizontal axial direction; the different measurement locations provide the different inclination angles; as is visible in second annotated fig. 8, the angle between the dotted lines is larger than the angle between the dotted and dashed lines).
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Annotated fig. 8 from Zinn
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Second annotated fig. 8 from Zinn
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Annotated fig. 4 from Ko
Regarding claim 16, Zinn as modified discloses the port of claim 12 wherein the port body includes a surface layer member (the bottom of chamber 118 is formed by lower portion 102B of port body 102, which is considered to be a surface layer member as claimed) that forms an inner surface of the liquid storage portion and the connection passage (see fig. 8, power portion 102B is what forms the inner surface of chamber 118 and opening 116 as shown), and the surface layer member connects the inner surface of the liquid storage portion and the connection passage seamlessly (since lower portion 102B is shown as being continuously and integrally formed with itself at the portions forming the lower interior surfaces of chamber 118 and opening 116, it is considered to create a seamless connection between them since there is no seam between multiple structures as the power portion 102B is all one structure). Regarding claim 17, Zinn as modified discloses the port of claim 12 wherein, in a cross-section perpendicular to the axial direction of the connection passage (a cross section taken vertically such that it cuts across the entire port assembly as displayed in fig. 9), an inner surface of the port body (the interior surface of lower portion 102B of port body 102 which is shown as the edge separating chamber 118 and lower portion 102B, see annotated fig. 9) is inclined with respect to a lower surface of the diaphragm body (the claimed lower surface is the bottom of septum 134 as shown in annotated fig. 9; the called out edge of lower portion 102B is inclined with respect to this surface both where it curves upwards while the surface stays flat in the corners as called out with dotted circles and where the walls of the surface extend vertically in an inclination with respect to a horizontal surface) facing the inner surface of the port body (the called out surface of lower portion 102B faces the surface of septum 134 where the two surfaces are open to each other with only an open chamber separating them as shown in fig. 9) to approach the diaphragm body on both outer sides in a direction along the lower surface (the called out surface of lower portion 102B approaches septum 134 on both sides as shown in fig. 9 where it extends in a vertical direction towards septum 134).
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Annotated fig. 9 from Zinn
Regarding claim 18, Zinn as modified discloses the port of claim 17 wherein the inner surface extends in a U-shape in the cross-section perpendicular to the axial direction of the connection passage (see annotated fig. 9, the called out inner surface extends in a U-shape where it has a flat bottom portion and vertical extensions on the sides with curved corners as shown).
Claim(s) 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zinn et al. (US 20070219510, henceforth Zinn) in view of Ko et al. (US 20130035648, henceforth Ko) as applied to claim 12 above, and further in view of McIntyre et al. (US 20090105688, henceforth McIntyre, previously made of record).
Regarding claim 20, Zinn as modified discloses the port of claim 12.
Zinn as modified does not disclose the port wherein the port body has a built-in metal coil. McIntyre teaches an access port (port 100, fig. 1) comprising a port body (housing 102 which defines the exterior boundaries of port 100, fig. 1) with a metal coil built into it (coil 254, fig. 3) which is connected to a light emitter (LED 250, fig. 1) which acts as a light source (see light source 110, fig. 1, and see [0017]). Note that the metal coil is considered to be built into the port body as claimed where it is provided within the exterior boundaries formed by the port body (see fig. 1).
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 metal coil and light emitter of McIntyre to the port body of Zinn for the benefit providing a guiding light which can be used to identify and determine the location of the port body (see McIntyre [0009] and [0010]).
Regarding claim 21, Zinn as modified discloses the port of claim 12.
Zinn as modified does not disclose the port wherein the port body includes at least two metal coils provided to be spaced apart from each other at positions around the liquid storage portion, and at least two light emitters electrically connected to the metal coils. McIntyre teaches an access port (port 100, fig. 1) comprising a port body (housing 102 which defines the exterior boundaries of port 100, fig. 1) with a metal coil built into it (coil 254, fig. 3) which is connected to a light emitter (LED 250, fig. 3) which acts as a light source (see light source 110, fig. 1, and see [0017]) and is connected to the metal coil (see fig. 3). McIntyre additionally teaches that multiple light emitters can be used (see [0013], multiple light sources can be used) at different locations (different locations in the port, [0013]) such that light can pass through a septum of the port ([0012]). McIntyre additionally teaches that the medical coil is directly connected to the terminals of the light emitter (see fig. 3).
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 multiple light emitters as in McIntyre to the port body of Zinn at different positions spaced apart from each other around the port for the benefit providing a guiding light which can be used to identify and determine the location of the port body (see McIntyre [0009] and [0010]), and further to have provided multiple metal coils for these multiple lights as McIntyre teaches that one coil connects directly to one light source and thus multiple light sources would require multiple coils (see fig. 3).
Regarding claim 22, Zinn as modified discloses the port of claim 21 wherein the port body includes a bottom wall portion (see the bottom wall of lower portion 102B as shown in the orientation of fig. 8) that forms a bottom surface of the liquid storage portion (see fig. 8) and a side wall portion (see the radial exterior edges of lower portion 102B as shown in the orientation of fig. 9) that forms a side surface of the liquid storage portion (see fig. 9). McIntyre additionally teaches that the light sources can be placed in different locations about the port body (see [0013]) and integrally with the housing ([0013]).
Zinn as modified does not explicitly disclose that the at least two metal coils are incorporated in the side wall portion. However, there are a limited number of options available for the placement of the at least two metal coils which would allow the metal coils to be integrally formed in the housing and would allow the directly attached light sources to shine through skin covering the port and/or shine through the septum of the device as taught in McIntyre (see [0012]-[0014]), with any such possible arrangement having a predictable expectation of success as any such arrangement which satisfies the design criteria set forth in McIntrye could reasonably be made to work. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have tried arranging the at least two metal coils to be in the side wall portion of the port body as claimed as this is one of a limited set of options which includes the coils being formed into the housing and would allow the light from the light source to shine through the septum of the modified device and to shine through a user’s skin once implanted and activated.
Response to Arguments
Applicant's arguments filed 12/04/2025 have been fully considered but they are not persuasive.
Applicant first argues that the bend forming an angle is different from the curved surface of Zinn as modified by Ko; Examiner notes that the claim does not require any such bend, however for the sake of clarification, a bend can also be interpreted as “a curved part of a path” as per Merriam-Webster, and a curve would meet this definition as the curved top of the septum of Zinn forms part of the path outlining the tip silhouette of Zinn, such as is viewed in fig. 8 of Zinn.
Applicant also argues that Zinn as modified does not disclose an angle being formed between the first and second surfaces as newly claimed. Examiner respectfully disagrees. The first and second surfaces meet (and thus create an intersection) at the top of septum 134 as called out in second annotated fig. 8 provided above. The claim does not specify the angle which is required or that the surfaces extend along a flat plane such as to create the desired angle, and thus a curved surface which creates an angle of just under 180 degrees at its topmost vertex would still apply to meet the claim language.
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