DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 12, 14, 15, 17, 18, 25, 27-34, 36, 38, 39, 40, 41, and 42 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.
Claim 12 recites the limitation “the at least one reservoir” in the phrases “with a passageway extending from the at least one reservoir” and “beneath at least a portion of the at least one reservoir and septum.” There is insufficient antecedent basis for this limitation in the claim.
Specifically, claim 12 earlier recites “a reservoir,” but does not previously introduce “at least one reservoir.” Because the claim later refers to “the at least one reservoir,” it is unclear whether the later-recited reservoir is the previously recited “a reservoir,” one of multiple reservoirs, or a different reservoir. This ambiguity is material because the specification expressly contemplates that the port may optionally have more than one reservoir and associated septum.
Claims 14, 15, 17, 18, 32–34, and 36 depend from claim 12 and therefore incorporate the indefinite limitation.
Claim 25 recites the limitation “the at least one reservoir” in the phrases “a passageway extending from the at least one reservoir to the discharge port” and “beneath the at least one reservoir.” There is insufficient antecedent basis for this limitation in the claim.
Specifically, claim 25 earlier recites “a reservoir” through the phrase “a housing base defining at least one wall of a reservoir,” but does not previously introduce “at least one reservoir.” Because the claim later refers to “the at least one reservoir,” it is unclear whether the later-recited reservoir is the previously recited reservoir, one of multiple reservoirs, or a different reservoir.
Claims 27–31 and 38–40 depend directly or indirectly from claim 25 and therefore incorporate the indefinite limitation.
Claim 30 recites the limitation “skirt” in the phrase “further comprising skirt over-molded about the housing base.” There is insufficient antecedent basis for this limitation in the claim.
Specifically, claim 30 does not positively introduce “a skirt” before later dependent claim31 recites “the skirt.” The omission of the indefinite article makes the claim unclear as to whether “skirt” is intended to be a separate structural component, a material, or a descriptive feature.
Claim 31 depends from claim 30 and recites “the skirt,” thereby incorporating the antecedent-basis defect.
Claim 39 recites the limitation “the at least one radiopaque marking” in the phrase “wherein the at least one radiopaque marking is centered within the region directly beneath at least one reservoir.” There is insufficient antecedent basis for this limitation in the claim.
Claim 25, from which claim 39 ultimately depends, recites “at least one marking” and later recites that “the at least one marking comprises radiopaque material,” but does not expressly introduce “at least one radiopaque marking.” Thus, it is unclear whether claim 39 refers to the previously recited “at least one marking,” a different radiopaque marking, or a subset of markings having radiopaque material.
Claim 41 recites the limitation “the at least one reservoir” in the phrase “a passageway extending from the at least one reservoir to the discharge port.” There is insufficient antecedent basis for this limitation in the claim because claim 41 earlier recites “a reservoir,” but does not previously introduce “at least one reservoir.”
Claim 41 also recites “said wall” in the phrase “wherein the at least one marking is provided in said wall of the housing base.” There is insufficient antecedent basis for “said wall” because the claim previously recites “at least one wall of a reservoir.” It is unclear whether “said wall” refers to a particular one of the at least one wall, every wall of the reservoir, the bottom wall, or another wall of the housing base. This ambiguity is significant because the specification describes a bottom floor/bottom wall and side walls as different structures.
Claim 42 depends from claim 41 and therefore incorporates the indefinite limitations.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 12, 25, 41, 27, 32-34, 36, 38, and 42 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sheetz et al. (US 2006/0247584A1) in view of Jones et al. (US 6,287,293; hereinafter “Jones”), Carter (US 4,863,470A), and Fabian (US 2007/0248256A1).
Independent claim 12 recites a venous access port assembly having a housing with a housing base and a septum, where the housing base defines at least one wall of a reservoir and a passageway extends from the reservoir through a stem of a discharge port. Claim 12 further recites that at least a portion of the housing is radiotransparent or radiolucent, that the housing base has a bottom outer surface, and that at least one radiopaque marking is beneath at least a portion of the reservoir and septum. The marking is formed within the bottom outer surface and comprises letters in mirror-image orientation as viewed from the bottom of the port assembly, such that an X-ray taken from above shows properly oriented letters that indicate both a property of the venous port assembly after implantation and the orientation of the port assembly.
In relation to independent claim 12, Sheetz discloses the claimed venous access-port assembly structure. Sheetz states that “[a] typical port typically includes a housing assembly, a septum, and an outlet,” that “[t]he housing assembly and septum define a reservoir which is accessible through the septum,” and that “[t]he outlet of the housing may communicate with a catheter” (Sheetz ¶ [0003]).
Sheetz further discloses the recited housing base, septum, reservoir/cavity, passageway, and outlet stem arrangement, stating that “Access port 10 includes a housing or body 20 defined by a cap 14 and a base 16,” that “Cap 14 and base 16 ... may be configured for capturing therebetween a septum 18,” and that “cap 14, base 16, and septum 18 may collectively define a cavity 36 in fluid communication with a lumen 29 of outlet stem 31” (Sheetz ¶ [0044]). Sheetz further states that “[t]he outlet stem 31 may create a fluid-communicative passageway from the cavity 36 through the outlet stem 31 and into the interior of the patient” (Sheetz ¶ [0045]). Sheetz also discloses that an identifiable feature may convey a post-implant property of the access port. It states that “at least one identifiable feature of an access port contemplated by the instant disclosure may be further correlative with any information of interest, such as type of port, catheter type, date of manufacture, material lots, part numbers, etc.,” and further states that “at least one identifiable feature of an access port may be correlative with the access port being power injectable” (Sheetz ¶ [0042]). Sheetz also discloses that “at least one identifiable feature may be perceived via X-ray or ultrasound imaging” (Sheetz ¶ [0043]).
Sheetz does not expressly disclose that the property-identifying feature is a radiopaque letter marking formed within the bottom outer surface beneath the reservoir and septum in a mirror-image orientation. However, Jones supplies the port-specific bottom orientation marking. Jones discloses “radiopaque indicators to be placed on or in an implantable medical device so that the device can be viewed fluoroscopically” (Jones; col. 2, lines 36-39) and “locators that indicate the orientation of an implanted medical device as well as the orientation of particular features of the medical device” (Jones, col. 2, lines 45-49). Jones further states that “the locator on the bottom of the port preferably has a discontinuity or other indicator that is aligned with the axis of the stem to be used to identify the orientation of the port stem” (Jones, col. 2–3, starting in line 66). In the detailed embodiment, Jones discloses that “[a] Second locator ring 24 is fitted beneath the bottom lip of the port top 12 and has a discontinuity 25 disposed to indicate the location of the port stem 14,” (Jones, col. 3, lines 53-55) and that the locator rings are made from radiopaque materials including “gold, platinum, tungsten, tantalum, a barium compound, a medical grade titanium or Stainless Steel” (Jones, col. 3, lines 57-58).
Carter discloses the readable radiopaque letters and radiolucent/radiotransparent implant environment. Carter discloses an implant having “a radiolucent portion surrounding a radiopaque identification marker,” where the marker is “visible and easily readable by eye prior to implantation and readable from an x-ray photograph of the prosthesis after implantation” (Carter, col. 1, lines 53-57). Carter further discloses that the radiopaque tab reads “SIZER 500” and can be molded or shaped to provide “other or additional identifying information, for example the manufacturer, year of manufacture, and type of prosthesis,” and that “[a]ny information considered appropriate for retrieval prior to or after implantation can be coded into the tab 16” (Carter, col. 2, lines 36-43).
Finally, Fabian discloses the mirror-image orientation rationale. Fabian discloses “chirally asymmetric radiopaque and/or light-opaque letters or markings” for X-ray marking (Fabian ¶ [0008]). Fabian also teaches that radiographic images may appear as “reversals or mirror-images,” and explains that “an X-ray image of the left foot, if viewed from the back of the exposed film will look like a right foot” (Fabian ¶ [0004]). Fabian, referring to radiographic equipment and radiographic images, which are not claimed or supported by the specification of this application or parent applications, further states that a digital image may be “reversed to its mirror image” (Fabian ¶ [0010]). In summary, Fabian provides more specific evidence that mirror-image presentation was a known problem in radiography. Fabian explains that a digital radiographic image can be electronically manipulated, including being reversed to its mirror image (Fabian ¶ [0010]), and that such reversal can cause left/right or orientation confusion (Fabian ¶¶ [0006], [0047]). Fabian further teaches the use of chirally asymmetric notation, including letters, numbers, and symbols, so that when an image is reversed, the notation appears different, for example by causing lettering to read backwards (Fabian ¶ [0041]). Accordingly, Fabian teaches both the known mirror-image problem and a known solution using asymmetric lettering.
Based on the above teachings, it would have been obvious to a person of ordinary skill in the art to modify Sheetz’s property-identifying access port by providing Jones’s bottom-positioned radiopaque port orientation locator, by making the locator a readable radiopaque lettered implant attribute
indicator as taught by Carter, and by orienting the letters in mirror-image form as taught by Fabian so that radiographic viewing from the expected side would present the letters in readable orientation. The motivation would have been to provide a single post-implant X ray-visible feature that identifies a port property and confirms the orientation of the port/stem before clinical access, thereby reducing unsafe access of a flipped or misoriented port and improving clinical workflow.
Independent claim 25 recites a venous access port assembly having a housing with a housing base defining at least one wall of a reservoir, a discharge port extending from a portion of the housing, and a passageway extending from the reservoir to the discharge port. Claim 25 further recites at least one marking that is in a portion of the housing or discernible under X-ray examination, indicates the orientation of the port assembly and that the port assembly is rated for power injection, comprises radiopaque material, is provided in the bottom outer surface beneath the reservoir, and comprises letters provided in mirror-image orientation.
In relation to independent claim 25, Sheetz discloses the recited port assembly, including the housing/base, septum, reservoir/cavity, passageway, and outlet stem. Sheetz states that “[a]ccess port 10 includes a housing or body 20 defined by a cap 14 and a base 16,” that the cap and base may capture “a septum 18,” and that “cap 14, base 16, and septum 18 may collectively define a cavity 36 in fluid communication with a lumen 29 of outlet stem 31” (Sheetz ¶ [0044]). Sheetz also states that “[t]he outlet stem 31 may create a fluid-communicative passageway from the cavity 36 through the outlet stem 31 and into the interior of the patient” (Sheetz ¶ [0045]). Sheetz expressly discloses the power-injection rating and CT/contrast context required by claim 25. Sheetz states that “the access port may comprise at least one feature structured to identify the access port as being power injectable subsequent to subcutaneous implantation” (Sheetz ¶ [0010]). Sheetz further states that “[p]ower injectable ports may be employed in, among other processes, for example, computed tomography (‘CT’) scanning processes” and that a power injector system may be used “for injecting contrast media.” (Sheetz ¶ [0041]). Sheetz also teaches X-ray discernibility, stating that “at least one identifiable feature may be perceived via X-ray or ultrasound imaging” (Sheetz ¶ [0043]).
Sheetz does not expressly disclose that the power-injection marking is a radiopaque letter marking in a bottom outer surface beneath the reservoir and in mirror-image orientation. However, Jones discloses the bottom/beneath port-orientation feature. Jones teaches that “the locator on the bottom of the port preferably has a discontinuity or other indicator that is aligned with the axis of the stem to be used to identify the orientation of the port stem” (Jones, col. 2-3, starting in line 66). Jones further discloses that “[a] second locator ring 24 is fitted beneath the bottom lip of the port top 12 and has a discontinuity 25 disposed to indicate the location of the port stem 14” (Jones, col. 3, lines 53-55). The Jones locator rings are radiopaque and may be made from materials including “gold, platinum, tungsten, tantalum, a barium compound, a medical grade titanium or Stainless Steel” (Jones, col. 3, lines 55-59).
Carter discloses the readable radiopaque lettered marking for identifying implant information after implantation. Carter teaches that a radiopaque identification marker is “readable from an x-ray photograph of the prosthesis after implantation,” (Carter, col. 1, lines 56-57) and that “[a]ny information considered appropriate for retrieval prior to or after implantation can be coded into the tab 16” (Carter, col. 2, lines 41-43).
Finally, Fabian discloses the mirror-image orientation rationale. Fabian discloses “chirally asymmetric radiopaque and/or light-opaque letters or markings” for X-ray marking (Fabian ¶ [0008]). Fabian also teaches that radiographic images may appear as “reversals or mirror-images,” and explains that “an X-ray image of the left foot, if viewed from the back of the exposed film will look like a right foot” (Fabian ¶ [0004]). Fabian, referring to radiographic equipment and radiographic images, which are not claimed or supported by the specification of this application or parent applications, further states that a digital image may be “reversed to its mirror image” (Fabian ¶ [0010]). In summary, Fabian provides more specific evidence that mirror-image presentation was a known problem in radiography. Fabian explains that a digital radiographic image can be electronically manipulated, including being reversed to its mirror image (Fabian ¶ [0010]), and that such reversal can cause left/right or orientation confusion (Fabian ¶¶ [0006], [0047]). Fabian further teaches the use of chirally asymmetric notation, including letters, numbers, and symbols, so that when an image is reversed, the notation appears different, for example by causing lettering to read backwards (Fabian ¶ [0041]). Accordingly, Fabian teaches both the known mirror-image problem and a known solution using asymmetric lettering.
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to combine Sheetz’s X-ray-perceivable power-injectable access-port identifier with Jones’s radiopaque bottom port-orientation locator, Carter’s radiopaque readable implant letters, and Fabian’s mirror-image radiographic teaching. The motivation to combine would have been to make the Sheetz power-injection rating discernible by X-ray while also indicating port orientation from the bottom/beneath-reservoir position taught by Jones, using radiopaque letters that can be correctly read on the X-ray image as taught by Carter and Fabian.
Independent claim 41 recites a venous access port assembly comprising a housing base defining at least one wall of a reservoir, a discharge port extending from the housing base, and a passageway extending from the reservoir to the discharge port. Claim 41 further recites at least one marking within 0044the region beneath the reservoir that is discernible under X-ray examination and indicates both the orientation of the port assembly and that the access port assembly is rated for power injection, where the marking comprises radiopaque material, is provided in the wall of the housing base, and comprises mirror-image letters indicating orientation when viewed by X-ray examination.
In relation to independent claim 41, Sheetz discloses the housing-base, reservoir, discharge-port, and passageway structure. It states that “[a]ccess port 10 includes a housing or body 20 defined by a cap 14 and a base 16,” that “cap 14, base 16, and septum 18 may collectively define a cavity 36 in fluid communication with a lumen 29 of outlet stem 31,” and that “[t]he outlet stem 31 may create a fluid-communicative passageway from the cavity 36 through the outlet stem 31 and into the interior of the patient” (Sheetz ¶¶ [0044]–[0045]). Sheetz also teaches that the access port may have “at least one feature structured to identify the access port as being power injectable subsequent to subcutaneous implantation” (Sheetz ¶ [0010]).
Sheetz further teaches that power-injectable access ports are used in “computed tomography (‘CT’) scanning processes” and with a power injector system “for injecting contrast media” (Sheetz ¶ [0041]). Sheetz also teaches that the feature can be imaged after implantation because “at least one identifiable feature may be perceived via X-ray or ultrasound imaging” (Sheetz ¶ [0043]). Sheetz does not expressly disclose that the X-ray-discernible power-injection marking is a radiopaque mirror-image letter marking within a wall of the housing base in the region beneath the reservoir. However, Jones discloses the port-specific beneath/bottom orientation marking, teaching that “radiopaque indicators” can be placed “on or in an implantable medical device so that the device can be viewed fluoroscopically,” (Jones, col. 2, lines 36-39) and that the locators indicate “the orientation of an implanted medical device as well as the orientation of particular features of the medical device” (Jones, col. 2, lines 45-49). Jones further teaches that the lower locator is fitted beneath the bottom lip of the port and includes a discontinuity “disposed to indicate the location of the port stem 14” (Jones, col. 3, line 55).
Carter discloses the radiopaque lettered implant-information marking, teaching a marker “readable from an x-ray photograph of the prosthesis after implantation” (Carter, col. 1, lines 56-57) and coding of “[a]ny information considered appropriate for retrieval prior to or after implantation” into a radiopaque tab. (Carter, col. 2, 41-43).
Finally, Fabian discloses the mirror-image orientation rationale. Fabian discloses “chirally asymmetric radiopaque and/or light-opaque letters or markings” for X-ray marking (Fabian ¶ [0008]). Fabian also teaches that radiographic images may appear as “reversals or mirror-images,” and explains that “an X-ray image of the left foot, if viewed from the back of the exposed film will look like a right foot” (Fabian ¶ [0004]). Fabian, referring to radiographic equipment and radiographic images, which are not claimed or supported by the specification of this application or parent applications, further states that a digital image may be “reversed to its mirror image” (Fabian ¶ [0010]). In summary, Fabian provides more specific evidence that mirror-image presentation was a known problem in radiography. Fabian explains that a digital radiographic image can be electronically manipulated, including being reversed to its mirror image (Fabian ¶ [0010]), and that such reversal can cause left/right or orientation confusion (Fabian ¶¶ [0006], [0047]). Fabian further teaches the use of chirally asymmetric notation, including letters, numbers, and symbols, so that when an image is reversed, the notation appears different, for example by causing lettering to read backwards (Fabian ¶ [0041]). Accordingly, Fabian teaches both the known mirror-image problem and a known solution using asymmetric lettering.
Based on the above teachings, for an artisan skilled in the art, it would have been obvious to provide Sheetz’s X-ray-discernible power-injection identifier as a radiopaque mirror-image letter marking in the housing-base wall beneath the reservoir, as taught by Jones’s port-orientation bottom locator and Carter’s readable radiopaque implant information, with the letter orientation adjusted in view of Fabian’s mirror-image radiographic teaching. The motivation to combine would have been to permit a practitioner to determine from X-ray examination both that the implanted port is power injection rated and that the port is oriented correctly before access or contrast injection.
In relation to claim 27, this claim depends from claim 25 and recites that at least a portion of the housing base comprises material that is radiotransparent or radiolucent. The rejection of claim 25 is
incorporated here. Sheetz teaches that the body of the access port may be formed from “a bio-compatible plastic material” (Sheetz ¶ [0046]). Carter teaches a radiolucent implant environment, stating that the shell is “made of a radiolucent material” and that the gel is “also radiolucent” (Carter, col. 2, lines 18-23). Based on the above teachings, for an artisan skilled in the art, it would have been obvious to select a radiolucent plastic for the housing base so that the radiopaque bottom indicia would be visible on X-ray without being obscured by the port housing.
In relation to claim 32, this claim depends from claim 12 and recites that the radiopaque marking identifies an attribute of the assembly. Sheetz discloses that an identifiable feature may be correlated with “type of port, catheter type, date of manufacture, material lots, part numbers,
etc.,” and may also be correlated with the access port “being power injectable” (Sheetz ¶ [0042]). Carter similarly discloses that any information appropriate for retrieval before or after implantation can be coded into a radiopaque tab (Carter, col. 2, lines 41-43). Thus, in view of the demonstrated conventionality of the attribute-identification limitation, its implementation in the invention of this application would have been considered an obvious alternative in the design of the port assembly.
In relation to claim 33, this claim depends from claim 12 and recites that the property is the assembly being rated for power injection. Sheetz expressly discloses an access port feature structured to identify the port “as being power injectable subsequent to subcutaneous implantation” (Sheetz ¶ [0010]). In view of the demonstrated conventionality of this enhancement, its implementation in the invention of this application would have been considered an obvious alternative in the design of the port assembly.
In relation to claim 34, this claim depends from claim 12 and recites that the property is power injection of contrast fluid. Sheetz states that power-injectable ports may be used in CT scanning and that a power-injector system may be used “for injecting contrast media” (Sheetz ¶ [0041]). In view of the demonstrated conventionality of this enhancement, its implementation in the invention of this application would have been considered an obvious alternative in the design of the port assembly.
In relation to claim 36, this claim depends from claim 12 and recites that the letters comprise CT. Sheetz expressly links power injection to “computed tomography (‘CT’) scanning processes.” (Sheetz ¶ [0041]). Carter teaches radiopaque implant letters readable after implantation (Carter, col. 2, lines 30-43). It would therefore have been obvious to use CT as the lettered radiopaque property indicator for a port rated for power injection in CT contrast-media procedures.
In relation to claim 38, this claim depends from claim 25 and recites that the letters comprise CT. The rejection of claim 25 is incorporated here. Sheetz expressly states that power-injectable ports may be used in “computed tomography (‘CT’) scanning processes” and for power-injector injection of contrast media (Sheetz ¶ [0041]). Carter teaches forming radiopaque letters in an implant to encode implant information readable after implantation (Carter, col. 2, lines 30-43). Therefore, for an artisan skilled in the art, it would have been obvious to use the letters CT as the lettered indicia for a port whose identifiable feature indicates power-injection suitability in CT/contrast procedures.
In relation to claim 42, the rejection of claim 41 is incorporated here. Jones teaches that the bottom locator identifies orientation, stating that “the locator on the bottom of the port preferably has
a discontinuity or other indicator that is aligned with the axis of the stem” (Jones, col. 2–3, starting in line 66). Jones further teaches that locators may be “painted onto the drug port with radiopaque paint” or formed in holes or grooves with resin and powdered radiopaque material (Jones, col. 4, lines 14-18). Moreover, as discussed above, Carter teaches X-ray-readable radiopaque lettered implant information, and Fabian teaches mirror-image radiographic orientation concerns. Based on the above teachings, it would have been obvious to place the mirror-image radiopaque CT/property/orientation letters on the bottom outer surface of the housing base because Jones expressly teaches bottom port locators for orientation and because bottom placement would have located the marking in the X-ray path beneath the port reservoir while minimizing interference with septum puncture and upper port access.
Claim 14, 15, 17, and 18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sheetz et al. (US 2006/0247584A1) in view of Jones et al. (US 6,287,293; hereinafter “Jones”), Carter (US 4,863,470A), and Fabian (US 2007/0248256A1), as discussed above, and in further view of Hurwitz (US 4764948A) and Von Oepen et al. (US 2008/0027411A1; hereinafter “Von Oepen”).
In relation to claim 14, this claim depends from claim 12 and further recites that the radiopaque marking comprises marking fluid applied onto a surface of the housing base. The rejection of claim 12 is incorporated here. The combination of Sheetz, Jones, Carter, and Fabian render obvious the venous access port, bottom/beneath radiopaque marking, X-ray readability, attribute indication, orientation indication, and mirror-image letter orientation. The base combination does not expressly require that the radiopaque marking be a marking fluid applied onto a surface of the housing base. However, Jones discloses a port-specific applied marking-fluid teaching because it discloses that “the locators could be painted onto the drug port with radiopaque paint” (Jones, col. 4, lines 15-16). Hurwitz similarly discloses a marking structure in which “a layer of printable material which is transparent to x-rays, nominally titanium based white paint, is optionally applied over the layer of blocker material” (Hurwitz, col. 4, lines 10-13). Von Oepen discloses radiopaque ink: “the radiopaque marker ... may be embodied in the form of a radiopaque ink,” and “[t]he radiopaque ink can be applied to the elongated body ... surface using known printing methods such as pad printing” (Von Oepen ¶ [0061]). Based on the above teachings, for an artisan skilled in the art, it would have been obvious to use radiopaque paint or ink as the marking fluid for the bottom-surface radiopaque letters because paint/ink provides a known way to apply X-ray discernible information to a medical device surface without requiring separate metal hardware, while preserving the X-ray-readable property and orientation functions taught by the combination of Sheetz, Jones, Carter, and Fabian.
In relation to claim 15, this claim depends from claim 14 and further recites that the marking fluid is embossed or imprinted onto the surface of the housing base. The rejections of claims 12 and 14 are incorporated here. The base combination, as supplemented by Jones, Hurwitz, and Von Oepen, teaches radiopaque paint or ink applied to a medical device surface. Hurwitz supplies the impressing/embossing concept, stating that “[t]he actual process of stencilizing the layer of blocker material is the reverse of embossment and is best described as impressing.” (Hurwitz, col. 3, lines 38-40). Von Oepen supplies imprinting/printing, stating that radiopaque ink may be applied
by “known printing methods such as pad printing.” (Von Oepen ¶ [0061]. Based on the above teachings, for an artisan skilled in the art, it would have been obvious to imprint, pad-print, impress, or emboss the radiopaque marking fluid onto the housing-base surface because those are known and predictable techniques for placing machine-readable or human-readable X-ray markings on a medical device surface. The reason to use such a technique would have been to ensure repeatable placement and legibility of the mirror-image CT/attribute letters on the bottom housing surface.
In relation to claim 17, this claim depends from claim 12 and further recites that the radiopaque marking comprises foil. The rejection of claim 12 is incorporated here. The base combination teaches the access port structure and renders obvious the bottom/beneath radiopaque mirror-image lettered
indicia. The base combination does not expressly require foil. However, Hurwitz discloses a thin X-ray blocking metal layer, stating that the blocker material is “nominally metal and preferably lead or tin,” overlies a soft material layer, and is “opaque to x-rays” (Hurwitz, col. 3, lines 32-34). Hurwitz also identifies the X-ray marking system as laminated layers on a substrate, with the blocker material being fractured or stencilized to provide X-ray data marking (Hurwitz, col. 3, lines 20-37). Based on the above teachings, for an artisan skilled in the art, it would have been obvious to form the radiopaque letters from a thin metal foil or foil-like layer because foil provides a predictable, thin, radiopaque medium for forming X-ray readable letters. Using such a material on or within the bottom of the port would have predictably achieved the same X-ray visibility taught by Jones and Carter while maintaining a low-profile port structure.
In relation to claim 18, this claim depends from claim 12 and further recites that the radiopaque marking comprises film. The rejection of claim 12 is incorporated here. Hurwitz discloses that the soft material in the X-ray data marking system is “nominally plastic and preferably polyester film” (Hurwitz, col. 3, lines 28-29). Von Oepen discloses that, over radiopaque ink, “[t]he protective layer may also be a film secured over the radiopaque ink by an adhesive or heat welding process” (Von Oepen ¶ [0061]). Based on the above teachings, for an artisan skilled in the art, it would have been obvious to implement the bottom radiopaque marking as a film or a film-supported radiopaque ink/letter structure because films are known thin carriers or protective layers for device markings. The motivation would have been to provide durable, accurately positioned X-ray-readable letters on the port’s bottom surface while protecting the marking from wear during handling and implantation.
Claim 28, 29, 30, 31, 39, and 40 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sheetz et al. (US 2006/0247584A1) in view of Jones et al. (US 6,287,293; hereinafter “Jones”), Carter (US 4,863,470A), and Fabian (US 2007/0248256A1), as discussed above, and in further view of Schneiter (US 2007/0073250A1).
In relation to claims 28 and 29, claim 28 depends from claim 25 and recites that the housing base comprises a septum seat. Claim 29 depends from claim 28 and recites a needle-penetrable septum placed within the septum seat. The rejection of claim 25 is incorporated here. Sheetz discloses that the cap and base capture a septum between them, and that the septum is repeatedly punctured to access the cavity (Sheetz ¶¶ [0044]–[0045]). Schneiter further discloses an implantable port having “a base 20, a central housing 22 and a septum 24,” that the “septum 24 closes off an interior reservoir 44,” and that the septum is “molded from a medical grade silicone that provides access to the interior reservoir 44 through the use of a non-coring needle” (Schneiter ¶ [0027]). Based on the above teachings, for an artisan skilled in the art, it would have been obvious to provide a seat or receiving structure in the housing/base for the septum because a septum must be held in a stable, sealed position over the reservoir to permit repeated needle penetration without leakage.
In relation to claim 30, this claim depends from claim 29 and recites a skirt over-molded about the housing base. The rejections of claims 25, 28, and 29 are incorporated here. Jones teaches an over-molding operation for the port bottom, stating that the second locator ring can be placed “during an over-molding process when the bottom of drug port 10 is encapsulated in a Silicone rubber material” (Jones, col. 4, lines 8-10). Based on the above teachings for an artisan skilled in the art, it would have been obvious to over-mold a silicone skirt or encapsulating structure about the housing base to provide a biocompatible exterior, assist securement, and integrate the radiopaque locator with the port body.
In relation to claim 31, this claim depends from claim 30 and recites that at least one of the housing base, septum, and skirt is radiotransparent or radiolucent. The rejections of claims 25, 28, 29, and 30 are incorporated here. As discussed previously, Sheetz teaches a biocompatible plastic port body, Carter teaches radiolucent implant materials, and Jones teaches silicone rubber encapsulation during over-molding. Therefore, for an artisan skilled in the art, it would have been obvious to use radiolucent or radiotransparent polymers or silicone for the base, septum, or skirt so that X-ray-readable radiopaque indicia remain discernible.
In relation to claims 39 and 40, claim 39 depends from claim 29 and recites that the radiopaque marking is centered within the region directly beneath at least one reservoir. Claim 40 depends from claim 29 and recites that the marking is directly beneath at least one reservoir and the septum. The rejections of claims 25, 28, and 29 are incorporated here. Jones teaches port locators above the septum and beneath the bottom lip, with the lower locator used to identify port-stem orientation and the port orientation under fluoroscopy (Jones, col. 3, lines 47-55). Carter teaches positioning radiopaque lettered information inside a radiolucent implanted device in an orientation readily recordable on an X-ray plate (Carter, col. 2, lines 47-52). Based on the above teachings, for an artisan skilled in the art, it would have been obvious to center the lettered radiopaque marking beneath the reservoir and septum to maximize readability through the radiolucent housing and avoid obscuration by the stem or other port structures, while preserving Jones’s orientation function.
Response to Arguments
The examiner of record acknowledges receipt of the amendment filed on 4/1/2026. Applicant’s arguments with respect to the pending claims have been considered but are moot because of the new ground of rejection. In order to expedite prosecution of this application and afford the Applicant the opportunity to reply to the new ground of rejection, this office action will not be classified as a final office action.
Clarification and Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure to provide evidence of the general level of ordinary skill in the radiography art before the effective filing date:
Physics Overview of Screen-Film Radiography. Ritenour ER. Radiographics: A Review Publication of the Radiological Society of North America, Inc. 1996;16(4):903-16. Doi:10.1148/radiographics.16.4.8835979.
Ritenour provides evidence of the general level of ordinary skill in the radiography art before the effective filing date. Ritenour explains that screen-film radiography involves an imaging chain including the X-ray source, the patient or object being radiographed, the image receptor, the processor, the view box, and the observer. Thus, persons of ordinary skill in the radiography art understood that the final radiographic image depends on the geometry of the X-ray beam, the position of the image receptor, processing, and the side or manner in which the image is viewed.
Fabian [used in the rejections of the pending claims] provides more specific evidence that mirror-image presentation was a known problem in radiography. Fabian explains that a digital radiographic image can be electronically manipulated, including being reversed to its mirror image, and that such reversal can cause left/right or orientation confusion. Fabian further teaches the use of chirally asymmetric notation, including letters, numbers, and symbols, so that when an image is reversed, the notation appears different, for example by causing lettering to read backwards. Accordingly, Fabian teaches both the known mirror-image problem and a known solution using asymmetric lettering.
In view of Ritenour [to establish the general level of ordinary skill in the radiography art] and Fabian [used in the rejections of the pending claims], a person of ordinary skill in the art would have recognized that the orientation of radiopaque letters on an object to be X-rayed must be selected based on the expected viewing orientation of the resulting radiographic image of a radiographic system that is not claimed, described, or supported in the specification of this application. It would therefore have been an obvious design choice to place letters in reverse or mirror-image orientation on or within the bottom surface of an implantable port so that, when the port is imaged from above and the resulting radiograph is viewed in the intended orientation, the letters appear properly oriented to the viewer. This use of reverse lettering merely applies a known radiographic marking technique to achieve the predictable result of readable radiographic indicia.
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783
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