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 § 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 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jones et al. (US 6,287,293; hereinafter “Jones”) in view of Watson et al. (US 5,662,600; hereinafter “Watson”), Hamilton (WO 2006/079905) and Hurwitz (US 4,764,948).
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In relation to claim 12, Jones shows in figures 5A, 5b, and 5c, radiographs of an access port implanted in a body taken by an X-ray machine showing radiopaque markers (22, 24). Figure 5A shows the letter “C” and the letter “O”. Additionally, Jones shows in figure 4, a venous access port assembly comprising: a housing comprising a housing base (112) defining at least one reservoir (118) with a passageway (114) extending from the at least one reservoir (118) through a stem of a discharge port (114), a septum (116), and wherein the housing base has a bottom outer surface having a radiopaque marker (24) on the bottom outer surface.
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With respect to the location of the radiopaque marker in relation to the reservoir and septum [directly beneath or in alignment with the longitudinal axis of the access port according to figure 8 of this application], Jones shows in figure 4, that radiopaque marker (24) is located directly below the septum and the reservoir, but not directly “beneath” [directly underneath] the septum and the reservoir [or in alignment with the longitudinal axis of the access port]. However, designing an access port with a radiopaque marker that is aligned with the longitudinal axis of the access port would have been considered conventional in the art as evidenced by the teachings of Watson.
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Watson shows in figure 2, a surgically implantable flow control device (10) having a reservoir (36), a septum portion (58), and a radiopaque marker (70) directly beneath reservoir (36) and septum portion (58) in alignment with the longitudinal axis of the device [see figure 2 above] and also in alignment with the reservoir (36) and the septum portion (58). Accordingly, for an artisan skilled in the art, modifying the location of the radiopaque marker in Jones with a location that is directly beneath a reservoir and a septum of an implant, as taught by Watson, would have been considered obvious in view of the demonstrated conventionality of this particular radiopaque marker location. Moreover, the artisan would have been motivated to make the modification because, after studying the teachings of Watson with respect to the location of the radiopaque marker, the artisan would have realized that the marker could have been located anywhere on the area of the bottom outer surface of Jones. The size of the C-shaped radiopaque marker in Jones [see Jones; figure 5a, radiopaque marker (24)] could have been reduced in size to a location directly beneath the reservoir and the septum, without interfering with radiopaque marker (22), and still perform its intended function. Therefore, the artisan could have experimented with the finite location possibilities in the bottom outer surface of Jones as long as the locations were recognizable by the X-ray scanner.
In relation to the limitation claiming that the housing comprises material that is at least one of radio-transparent or radio-translucent, as indicated above, figures 5A, 5B, and 5c are radiographs taken by an X-ray machine showing radiopaque markers (22, 24). In order for those radiographs to be taken, the material that is used to manufacture the housing of the implanted port must inherently have radio-transparent or radio-translucent properties. Otherwise, it would have been impossible for the X-ray machine to recognize the radiopaque markers because the images of the radiographs would have been blocked by the material used to manufacture the various parts of the housing. Moreover, in column 4, starting in line 5, Jones states:
“[t]he first locator ring 22 can be inserted during the welding process when the port top 12, the port septum 16 and the port base 15 are joined together. The second locator ring 24 can be placed on the bottom of port top 12 during an over-molding process when the bottom of drug port 10 is encapsulated in a silicone rubber material.”
Silicone rubber is a material that has radio-transparent or radio-translucent properties. To support this conclusion, Hamilton discloses on page 12, lines 26-28:
“[t]he medical grade silicone rubber, from which the cells (3) are manufactured, are normally relatively transparent, not only to the human eye but also to X-rays.”
Based on the teachings of Hamilton, used in this rejection to only establish that silicone rubber has transparent properties, for an artisan skilled in the art, manufacturing an access port such as the one disclosed by Jones with silicone rubber would have been considered obvious in view of the demonstrated conventionality of such use [transparency to X-rays]. Moreover, the artisan would have been motivated to make the modification because silicone rubber would have not blocked radiopaque markers during the process of obtaining radiographs using an X-ray machine.
In relation to the limitation claiming a radiopaque marker comprising letters in mirror image orientation, as discussed above, Jones shows in figure 5A, the radiograph of a radiopaque marker located on the bottom outer surface of an access port disclosing the letter “C” and the letter “O” within the letter “C”. Jones does not explicitly disclose markers or tags comprising of letters provided in a mirror-image orientation. However, the use of radiopaque markers having letters in mirror-image orientation would have been considered conventional in the art as evidenced by the teachings of Hurwitz.
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In figure 5, Hurwitz shows a radiopaque marker (20) comprising of a name [Jane Smith] in mirror image order. The radiopaque marker (20) is located on a cassette (16) that contains X-ray film (17) that is part of an X-ray machine used for mammograms.
Hurwitz discloses in column 9, lines 13-23:
“[t]his placement makes that the indicia 20 of the stencil appears as mirror image as viewed from above in FIG. 5. This mirror image is intended to be illustrated by the dashed line representation of such indicia in FIG. 5. In actuality, the indicia 20 is not visible when the label 15 is placed upon the cassette 16 in the indicated orientation. The resultant image upon an exposed x-ray assumes an appropriate orientation because the radiologist views an exposed mammogram produced from x-ray film 17 from the bottom side as the film appears in FIG. 5.”
Based on the information above, for an artisan skilled in the art, rearranging the radiopaque marker of Jones, which includes, inter alia, the letter “C” [as seen from the bottom outer surface of the housing base], with a mirror-image of this letter to create a final image (radiograph) displaying the letter in the correct reading order or configuration, as taught by Hurwitz, would have been considered obvious in view of the demonstrated conventionality of this radiopaque marker reading enhancement. The artisan would have been motivated to make the modification because the resultant image of the X-ray scan would have assumed the appropriate orientation of the letter(s) or symbol(s), facilitating the proper interpretation [reading] of the marker by the radiologist.
Up to this point in the rejection, the examiner of record has provided the necessary references to structure a solid section 103 Obviousness rejection. However, the examiner notes for the record that printed matter analysis must be incorporated into the rejection to evaluate the merits of the claim(s) in question following the procedural requirements of the Manual of Patent Examination Procedure (MPEP) and the legal roadmap used by the Court in C.R. Bard, Inc. v. Medical Components, 2:12-cv-00032-RJS-DAO. The scopes of the claims that were subject to invalidation in the cited court decision are substantially similar to the pending claims on this application. Therefore, particular attention must be given to the analysis in the court decision to avoid claiming unpatentable subject matter like non-functional printed matter.
Printed Matter Analysis
The first step in the printed matter analysis is to ascertain whether the limitation in question is in fact, directed toward printed matter. The MPEP and Federal Circuit cases establish a necessary condition for falling into the category of printed matter: a limitation is printed matter only if it claims the content of information. If this condition is met, the next step is to ascertain whether the printed matter is functionally related to the access port.
In the application at hand, the claim limitations in question are “at least one radiopaque marking” and “wherein the at least one radiopaque marking are letters provided in a mirror-image orientation.” The fact that the radiopaque marking comprises of letters, demonstrates a content of information in the marking whose sole function is to convey information. Accordingly, the claim language in question is considered printer matter. Having so found, the next step is to determine whether the printed matter should be given patentable weight. Printed matter is only given patentable weight if the matter is functionally or structurally related to the associated access port. Concerning the second condition, there is no relationship between the printed matter and the underlying access port upon which it is printed. In the application at hand, the printed matter does not change how the port works once it is implanted, does not affect or effect the functional and operational capabilities of the access port, and does not interrelate with the port to produce a new and useful product. Paragraph [0020] of the specification of this application supports the fact that there is no functional relationship between the printed matter and the underlying access port. The paragraph explicitly states:
“[t]he radiopaque markings and indicia would appear on an X-ray of the patient, and the indicia are provided in a mirror-image orientation on the bottom outer surface of the housing base (FIGS. 7 and 8) so that the indicia would appear as “CT” when the X-ray is viewed (FIG. 9), easily discerned by the radiologist or technologist.”
The paragraph discloses a relationship between the marking and an X-ray machine. Accordingly, the printed matter in no way depends on the access port, and the access port does not, depend on the printed matter. Therefore, the claim limitations in question are printed matter not entitled to patentable weight. Claim 12 without the printed matter limitations, should be considered obvious in view of the cited references.
Claims 14-15, 17-18, and 32-36 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jones et al. (US 6,287,293; hereinafter “Jones”) in view of Watson et al. (US 5,662,600; hereinafter “Watson”), Hamilton (WO 2006/079905), and Hurwitz (US 4,764,948), as discussed above, and in further view of Von Oepen et al. (US 2008/0027411; hereinafter “Von Oepen”), Lee (US 5,203,777), or Cioanta et al. (US 2002/0082610; hereinafter “Cioanta”).
In relation to claims 14 and 15, Jones does not disclose radiopaque markings comprising marking fluid imprinted onto the surface of the access port. However, Von Oepen explicitly discloses in paragraph 0061:
“[i]t is further contemplated that the radiopaque marker 100 in accordance with the present invention may be embodied in the form of a radiopaque ink. The radiopaque ink can be applied to the elongated body 11 surface using known printing methods such as pad printing. If desired, a protective layer may be disposed over the radiopaque ink, wherein the protective layer may be comprised of a curable adhesive or heat shrink material.”
In the above paragraph, Von Oepen demonstrates the conventionality of using marking fluid comprising radiopaque ink. Accordingly, for an artisan skilled in the art, using marking fluid [radiopaque ink] to imprint symbols on the surface of the access port via pad printing, as taught by Von Oepen, would have been considered obvious in view of the demonstrated conventionality of this marker enhancement. Moreover, the artisan would have been motivated to make the modification because, as explained above, the use of radiopaque ink would have been considered well-known at the time of the invention, and therefore, an obvious alternative process to print the radiopaque markers on the surface of the access port.
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In relation to claim 17, Jones does not disclose a radiopaque marking comprising foil. However, Lee shows in figure 2, radiopaque markers for tubular devices meant to be inserted into a body [see Lee; abstract]. In column 5, lines 5-14, Lee states:
“[p]referably, the markers 60 and 62 are rectangular in shape. If desired, the markers can be precisely square in shape. While the body 50 is made from a suitable material which is transparent to X-rays, such as a plastic or the like, the radiopaque markers can be made from a suitable conventional metal or the like. One such metal which is deemed to be particularly advantageous in a medical setting is the metal gold. To this end, the markers 60 and 62 can comprise squares of gold foil or the like.”
Accordingly, for an artisan skilled in the art, modifying the radiopaque marker disclosed by Jones with a radiopaque marking comprising foil, as taught by Lee, would have been considered obvious in view of the demonstrated conventionality of this radiopaque enhancement. Moreover, the artisan would have been motivated to make the modification because, at the time of the invention, the use of foil to make markings on implanted medical devices would have been considered well-known in the art, and therefore, an obvious alternative process to make the radiopaque marking.
In relation to claim 18, Jones does not disclose a radiopaque marking comprising film. However, Cioanta shows in figure 5a, a balloon catheter (20) having radiopaque markers (77a). In paragraph 0078, Cioanta states:
“[a]s shown in FIG. 5A, the radio-opaque markers 77 can be circumferentially arranged on the catheter either or both above 77u and below 771 (see also FIG. 1A) the sealing balloon 22 so that the balloon 22 can be more readily accentuated and confirmed in the X-ray as located in the membranous urethra, above the sphincter. Alternatively, or additionally, as shown in FIG. 5A, one or more longitudinally extending radiopaque markers 77a can be arranged to extend substantially along the length of the treatment balloon 15 at various radial positions (preferably at least 4 positions symmetrically separated and aligned about the cross-sectional width of the catheter, typically at 90 degree radial separation to allow for X-ray identification irrespective of the image angle). The radio-opaque markers are applied to block the transmission of X-ray for better contrast in images. The opacity, degree of contrast, and sharpness of the image may vary with material and type of process used to create the marker. The radio-opaque marker(s) may be arranged on the catheter by any suitable biocompatible marker, such as non-toxic radiopaque coatings, inks, thin-films, paints, tapes, strips, shrink tubing, and the like.”
Accordingly, for an artisan skilled in the art, modifying the access port disclosed by Jones with a radiopaque marking comprising film, as taught by Cioanta, would have been considered obvious in view of the demonstrated conventionality of this radiopaque enhancement. Moreover, the artisan would have been motivated to make the modification because, at the time of the invention, the use of film to make markings on implanted medical devices would have been considered well-known in the art, and therefore, an obvious alternative process to make the radiopaque marking.
In relation to claims 32, Jones discloses locator ring (24) shaped as a “C” having a discontinuity (25) to indicate an attribute of the access port comprising the location of the port stem (14) [see Jones; column 3, in lines 53-55].
In relation to claims 33, 34, and 36, Jones does not disclose an attribute comprising a “power injection” rating. However, as discussed above, Carter (US 4,863,470) shows in figures 1 and 2 above, an identification marker on an implant [breast prosthesis].
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In column 2, starting in line 30, Carter explicitly states:
“[t]he implant 10 includes within the shell 12 an identification marker or tab 16 which denotes the size of the implant 10. The tab 16 is made from material which is radiopaque, such as silicone with bismuth trioxide or silicone with barium sulfate. As shown most clearly in FIG. 1, the tab 16, which is formed preferably by molding, reads "SIZER 500" signifying that this prosthesis has a volume of 500 cubic centimeters. Clearly, this tab 16 can be molded or shaped, prior to insertion within the container, so as to provide other or additional identifying information, for example the manufacturer, year of manufacture, and type of prosthesis. Any information considered appropriate for retrieval prior to or after implantation can be coded into the tab 16. Information concerning the implanted prosthesis can subsequently be obtained by x-ray of the implanted prosthesis 10 without resorting to surgery or autopsy.”
According to the above teachings, since “any information considered appropriate” about the characteristics of the access port or implant could have been displayed in the radiopaque marker, for an artisan skilled in the art, modifying the radiopaque marker disclosed by Jones with a marker having indicia showing a particular “power injection” rating or a location of a stem would have been considered obvious since this information is pertinent and necessary to inform medical personnel of all the necessary operational and manufacturing details of the access port or implant prior to surgery.
In relation to claim 35, as discussed above, Jones shows in figure 5A, the letter “C” and the letter “O”.
Claims 25, 27, 28-31 and 37-40 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jones et al. (US 6,287,293; hereinafter “Jones”) in view of Watson et al. (US 5662600; hereinafter “Watson”), Hamilton (WO 2006/079905) and Hurwitz (US 4,764,948), as discussed above, and in further view of Carter.
In relation to claim 25, Jones shows in figures 5A, 5b, and 5c, radiographs of an access port implanted in a body taken by an X-ray machine showing radiopaque markers (22, 24). Figure 5A shows the letter “C” and the letter “O”. Jones also shows in figure 4, a venous access port assembly comprising:
a housing comprising a housing base (112) defining at least one reservoir (118) with a passageway (114) extending from the at least one reservoir (118) through a stem of a discharge port (114),
a septum (116), and wherein the housing base has a bottom outer surface having a radiopaque marker (24) on the bottom outer surface;
radiopaque marker (24) is provided on a portion of the housing [see Jones; figure 4, marking (24)], and is discernible under x-ray examination [see Jones; column 4, lines 54-59] providing information regarding at least one of a location of the discharge port [see Jones; column 4, lines 35-37],
wherein radiopaque marker (24) comprises radiopaque material [see Jones; abstract],
wherein the housing base has a bottom outer surface and the at least one marking is provided on the bottom outer surface [see Jones; figure 4 above], and,
wherein the at least one marking are letters [see Jones; figure 5A…letter “C” and letter “O”].
Jones does not disclose (1) letters provided in a mirror image orientation or (2) information in the radiopaque marker indicating that the port is rated for power injection. However, these enhancements would have been considered conventional in the art at the time of the invention as evidenced by the teachings of Hurwitz and Carter.
In relation to the limitation claiming a radiopaque marker comprising letters in mirror image orientation, as discussed above, Jones shows in figure 5A, the radiograph of a radiopaque marker located on the bottom outer surface of an access port disclosing the letter “C” and the letter “O” within the letter “C”. Jones does not explicitly disclose markers or tags comprising of letters provided in a mirror-image orientation. However, the use of radiopaque markers having letters in mirror-image orientation would have been considered conventional in the art as evidenced by the teachings of Hurwitz.
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In figure 5, Hurwitz shows a radiopaque marker (20) comprising of a name [Jane Smith] in mirror image order. The radiopaque marker (20) is located on a cassette (16) that contains X-ray film (17) that is part of an X-ray machine used for mammograms.
Hurwitz discloses in column 9, lines 13-23:
“[t]his placement makes that the indicia 20 of the stencil appears as mirror image as viewed from above in FIG. 5. This mirror image is intended to be illustrated by the dashed line representation of such indicia in FIG. 5. In actuality, the indicia 20 is not visible when the label 15 is placed upon the cassette 16 in the indicated orientation. The resultant image upon an exposed x-ray assumes an appropriate orientation because the radiologist views an exposed mammogram produced from x-ray film 17 from the bottom side as the film appears in FIG. 5.”
Based on the information above, for an artisan skilled in the art, rearranging the radiopaque marker of Jones, which includes, inter alia, the letter “C” [as seen from the bottom outer surface of the housing base], with a mirror-image of this letter to create a final image [radiograph] displaying the letter in the correct reading order or configuration, as taught by Hurwitz, would have been considered obvious in view of the demonstrated conventionality of this marker reading enhancement. The artisan would have been motivated to make the modification because the resultant image of the X-ray scan would have assumed the appropriate orientation of the letter(s) or symbol(s) in the radiopaque marker, facilitating the proper interpretation [reading] of the marker by the radiologist.
In relation to the type of information that could be placed on a radiopaque marker, specifically, information indicating a rating for power injection, Carter (US 4,863,470) shows in figures 1 and 2 above, an identification marker on an implant [breast prosthesis].
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In column 2, starting in line 30, Carter explicitly states:
“[t]he implant 10 includes within the shell 12 an identification marker or tab 16 which denotes the size of the implant 10. The tab 16 is made from material which is radiopaque, such as silicone with bismuth trioxide or silicone with barium sulfate. As shown most clearly in FIG. 1, the tab 16, which is formed preferably by molding, reads "SIZER 500" signifying that this prosthesis has a volume of 500 cubic centimeters. Clearly, this tab 16 can be molded or shaped, prior to insertion within the container, so as to provide other or additional identifying information, for example the manufacturer, year of manufacture, and type of prosthesis. Any information considered appropriate for retrieval prior to or after implantation can be coded into the tab 16. Information concerning the implanted prosthesis can subsequently be obtained by x-ray of the implanted prosthesis 10 without resorting to surgery or autopsy.”
According to the above teachings, since “any information considered appropriate” about the characteristics of the access port or implant could have been displayed in the radiopaque marker, for an artisan skilled in the art, modifying the radiopaque marker disclosed by Jones with a marker having indicia showing a particular rating or a location of a stem would have been considered obvious since this information is pertinent and necessary to inform medical personnel of all the necessary operational and manufacturing details of the access port or implant prior to surgery.
Up to this point in the rejection, the examiner of record has provided the necessary references to structure a solid section 103 Obviousness rejection. However, the examiner notes for the record that printed matter analysis must be incorporated into the rejection to evaluate the merits of the claim(s) in question following the procedural requirements of the Manual of Patent Examination Procedure (MPEP) and the legal roadmap used by the Court in C.R. Bard, Inc. v. Medical Components, 2:12-cv-00032-RJS-DAO. The scopes of the claims that were subject to invalidation in the cited court decision are substantially similar to the pending claims on this application. Therefore, particular attention must be given to the analysis in the court decision to avoid claiming unpatentable subject matter like non-functional printed matter.
Printed Matter Analysis
The first step in the printed matter analysis is to ascertain whether the limitation in question is in fact, directed toward printed matter. The MPEP and Federal Circuit cases establish a necessary condition for falling into the category of printed matter: a limitation is printed matter only if it claims the content of information. If this condition is met, the next step is to ascertain whether the printed matter is functionally related to the access port.
In the application at hand, the claim limitations in question are “at least one marking”, “being discernible under X-ray examination and providing information regarding at least one location of the discharge port and wherein the access port assembly is rated for power injection”, and “wherein the at least one marking are letters provided in a mirror-image orientation.” The fact that the radiopaque marking comprises of letters, demonstrates a content of information in the marking whose sole function is to convey information. Accordingly, the claim language in question is considered printer matter. Having so found, the next step is to determine whether the printed matter should be given patentable weight. Printed matter is only given patentable weight if the matter is functionally or structurally related to the associated access port. Concerning the second condition, there is no relationship between the printed matter and the underlying access port upon which it is printed. In the application at hand, the printed matter does not change how the port works once it is implanted, does not affect or effect the functional and operational capabilities of the access port, and does not interrelate with the port to produce a new and useful product. Paragraph [0020] of the specification of this application supports the fact that there is no functional relationship between the printed matter and the underlying access port. The paragraph explicitly states:
“[t]he radiopaque markings and indicia would appear on an X-ray of the patient, and the indicia are provided in a mirror-image orientation on the bottom outer surface of the housing base (FIGS. 7 and 8) so that the indicia would appear as “CT” when the X-ray is viewed (FIG. 9), easily discerned by the radiologist or technologist.”
The paragraph discloses a relationship between the marking and an X-ray machine. Accordingly, the printed matter in no way depends on the access port, and the access port does not, depend on the printed matter. Therefore, the claim limitations in question are printed matter not entitled to patentable weight. Claim 25, without the printed matter limitations, should be considered obvious in view of the cited references.
In relation to claims 27 and 31, as discussed above, Jones shows in figures 5A, 5B, and 5c radiographs taken by an X-ray machine showing radiopaque markers (22, 24). In order for those radiographs to be taken, the material that is used to manufacture the housing of the implanted port must inherently have radio-transparent or radio-translucent properties. Otherwise, it would have been impossible for the X-ray machine to recognize the radiopaque markers because the images of the radiographs would have been blocked by the material used to manufacture the various parts of the housing. Moreover, in column 4, starting in line 5, Jones states:
“[t]he first locator ring 22 can be inserted during the welding process when the port top 12, the port septum 16 and the port base 15 are joined together. The second locator ring 24 can be placed on the bottom of port top 12 during an over-molding process when the bottom of drug port 10 is encapsulated in a silicone rubber material.”
Silicone rubber is a material that has radio-transparent or radio-translucent properties. To support this conclusion, Hamilton discloses on page 12, lines 26-28:
“[t]he medical grade silicone rubber, from which the cells (3) are manufactured, are normally relatively transparent, not only to the human eye but also to X-rays.”
Based on the clarification stating that silicone rubber has transparent properties, for an artisan skilled in the art, manufacturing an access port such as the one disclosed by Jones with silicone rubber would have been considered obvious in view of the demonstrated conventionality of such use. Moreover, the artisan would have been motivated to make the modification because silicone rubber would have not blocked radiopaque markers during the process of obtaining radiographs using an X-ray machine.
In relation to claim 28, Jones shows in figure 4, a housing having a septum seat (22).
In relation to claim 29, Jones shows in figure 4, a needle-penetrable septum (116).
In relation to claim 30, Jones shows in figure 1, a skirt (12).
In relation to claim 37, as discussed above, Jones shows in figure 5A, the letter “C” and the letter “O”.
In relation to claim 38, Jones does not disclose an attribute comprising a “power injection” rating. However, as discussed above, Carter (US 4,863,470) shows in figures 1 and 2 above, an identification marker on an implant [breast prosthesis].
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In column 2, starting in line 30, Carter explicitly states:
“[t]he implant 10 includes within the shell 12 an identification marker or tab 16 which denotes the size of the implant 10. The tab 16 is made from material which is radiopaque, such as silicone with bismuth trioxide or silicone with barium sulfate. As shown most clearly in FIG. 1, the tab 16, which is formed preferably by molding, reads "SIZER 500" signifying that this prosthesis has a volume of 500 cubic centimeters. Clearly, this tab 16 can be molded or shaped, prior to insertion within the container, so as to provide other or additional identifying information, for example the manufacturer, year of manufacture, and type of prosthesis. Any information considered appropriate for retrieval prior to or after implantation can be coded into the tab 16. Information concerning the implanted prosthesis can subsequently be obtained by x-ray of the implanted prosthesis 10 without resorting to surgery or autopsy.”
According to the above teachings, since “any information considered appropriate” about the characteristics of the access port or implant could have been displayed in the radiopaque marker, for an artisan skilled in the art, modifying the radiopaque marker disclosed by Jones with a marker having indicia showing a particular “power injection” rating or a location of a stem would have been considered obvious since this information is pertinent and necessary to inform medical personnel of all the necessary operational and manufacturing details of the access port or implant prior to surgery.
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In relation to claims 39 and 40, as discussed above, Jones shows in figure 4 [see above], that radiopaque marker (24) is located directly below the septum and the reservoir, but not directly “beneath” [directly underneath] the septum and the reservoir [or in alignment with the longitudinal axis of the access port]. However, designing an access port with a radiopaque marker that is aligned with the longitudinal axis of the access port would have been considered conventional in the art as evidenced by the teachings of Watson.
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Watson shows in figure 2, a surgically implantable flow control device (10) having a reservoir (36), a septum portion (58), and a radiopaque marker (70) directly beneath reservoir (36) and septum portion (58) in alignment with the longitudinal axis of the device [see figure 2 above] and also in alignment with the reservoir (36) and the septum portion (58). Accordingly, for an artisan skilled in the art, modifying the location of the radiopaque marker in Jones with a location that is directly beneath a reservoir and a septum of an implant, as taught by Watson, would have been considered obvious in view of the demonstrated conventionality of this particular radiopaque marker location. Moreover, the artisan would have been motivated to make the modification because, after studying the teachings of Watson with respect to the location of the radiopaque marker, the artisan would have realized that the marker could have been located anywhere on the area of the bottom outer surface of Jones. Therefore, the artisan could have experimented with the finite location possibilities in the bottom outer surface of Jones to come up with a location to make the marker most recognizable by the X-ray scanner.
New Claims 41 and 42
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 41 and 42 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In relation to claims 41 and 42, there is no support in the specification for the limitation:
“wherein the at least one marking is at least one of (a) provided in the bottom floor or (b) provided on a surface of the bottom floor.” The only paragraph in the specification where the phrase “bottom floor” is disclosed appears to be paragraph [0016]. Paragraph [0016] discloses:
[0016] “[w]ith reference now to FIGS. 3 to 7, the interior of the port assembly 10 is shown to provide an interior reservoir 22. Housing 12 is shown to include a housing base 28 of needle-impenetrable material that includes a well 30 having a bottom floor 32 and side walls 34 that define the interior reservoir 22 beneath septum 14. Bottom floor 32 may be convex or elevated (not shown) toward the center of the reservoir, if desired. Housing base 28 includes a base flange 36 extending radially outwardly from the bottom of well 30, and base flange 36 includes openings 38, 40 that serve to enable suturing to the patient upon placement of the venous access port and the attached catheter into the patient.”
Since there is no support in the specification for the claim language disclosing “a marking in the bottom floor or on a surface of the bottom floor”, this claim language will not be afforded any weight in the evaluation of claims 41 and 42 under sections 102 and 103.
Claims 41 and 42 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jones et al. (US 6,287,293; hereinafter “Jones”) in view of Watson et al. (US 5662600; hereinafter “Watson”), Hamilton (WO 2006/079905) and Hurwitz (US 4,764,948), as discussed above, and in further view of Carter.
In relation to claims 41 and 42, Jones shows in figures 5A, 5b, and 5c, radiographs of an access port implanted in a body taken by an X-ray machine showing radiopaque markers (22, 24). Figure 5A shows the letter “C” and the letter “O”. Jones also shows in figure 4, a venous access port assembly comprising:
a housing comprising a housing base (112) defining at least one reservoir (118) with a bottom floor and a passageway (114) extending from the at least one reservoir (118) through a stem of a discharge port (114),
a septum (116), and wherein the housing base has a bottom outer surface having a radiopaque marker (24) on the bottom outer surface;
radiopaque marker (24) is provided on a portion of the housing [see Jones; figure 4, marking (24)], and is discernible under x-ray examination [see Jones; column 4, lines 54-59] providing information regarding at least one of a location of the discharge port [see Jones; column 4, lines 35-37],
wherein radiopaque marker (24) comprises radiopaque material [see Jones; abstract],
wherein the housing base has a bottom outer surface and the at least one marking is provided on the bottom outer surface [see Jones; figure 4 above], and,
wherein the at least one marking are letters [see Jones; figure 5A…letter “C” and letter “O”].
Jones does not disclose (1) letters provided in a mirror image orientation or (2) information in the radiopaque marker indicating that the port is rated for power injection. However, these enhancements would have been considered conventional in the art at the time of the invention as evidenced by the teachings of Hurwitz and Carter.
In relation to the limitation claiming a radiopaque marker comprising letters in mirror image orientation, as discussed above, Jones shows in figure 5A, the radiograph of a radiopaque marker located on the bottom outer surface of an access port disclosing the letter “C” and the letter “O” within the letter “C”. Jones does not explicitly disclose markers or tags comprising of letters provided in a mirror-image orientation. However, the use of radiopaque markers having letters in mirror-image orientation would have been considered conventional in the art as evidenced by the teachings of Hurwitz.
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In figure 5, Hurwitz shows a radiopaque marker (20) comprising of a name [Jane Smith] in mirror image order. The radiopaque marker (20) is located on a cassette (16) that contains X-ray film (17) that is part of an X-ray machine used for mammograms.
Hurwitz discloses in column 9, lines 13-23:
“[t]his placement makes that the indicia 20 of the stencil appears as mirror image as viewed from above in FIG. 5. This mirror image is intended to be illustrated by the dashed line representation of such indicia in FIG. 5. In actuality, the indicia 20 is not visible when the label 15 is placed upon the cassette 16 in the indicated orientation. The resultant image upon an exposed x-ray assumes an appropriate orientation because the radiologist views an exposed mammogram produced from x-ray film 17 from the bottom side as the film appears in FIG. 5.”
Based on the information above, for an artisan skilled in the art, rearranging the radiopaque marker of Jones, which includes, inter alia, the letter “C” [as seen from the bottom outer surface of the housing base], with a mirror-image of this letter to create a final image [radiograph] displaying the letter in the correct reading order or configuration, as taught by Hurwitz, would have been considered obvious in view of the demonstrated conventionality of this marker reading enhancement. The artisan would have been motivated to make the modification because the resultant image of the X-ray scan would have assumed the appropriate orientation of the letter(s) or symbol(s) in the radiopaque marker, facilitating the proper interpretation [reading] of the marker by the radiologist.
In relation to the type of information that could be placed on a radiopaque marker, specifically, information indicating a rating for power injection, Carter (US 4,863,470) shows in figures 1 and 2 above, an identification marker on an implant [breast prosthesis].
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In column 2, starting in line 30, Carter explicitly states:
“[t]he implant 10 includes within the shell 12 an identification marker or tab 16 which denotes the size of the implant 10. The tab 16 is made from material which is radiopaque, such as silicone with bismuth trioxide or silicone with barium sulfate. As shown most clearly in FIG. 1, the tab 16, which is formed preferably by molding, reads "SIZER 500" signifying that this prosthesis has a volume of 500 cubic centimeters. Clearly, this tab 16 can be molded or shaped, prior to insertion within the container, so as to provide other or additional identifying information, for example the manufacturer, year of manufacture, and type of prosthesis. Any information considered appropriate for retrieval prior to or after implantation can be coded into the tab 16. Information concerning the implanted prosthesis can subsequently be obtained by x-ray of the implanted prosthesis 10 without resorting to surgery or autopsy.”
According to the above teachings, since “any information considered appropriate” about the characteristics of the access port or implant could have been displayed in the radiopaque marker, for an artisan skilled in the art, modifying the radiopaque marker disclosed by Jones with a marker having indicia showing a particular rating or a location of a stem would have been considered obvious since this information is pertinent and necessary to inform medical personnel of all the necessary operational and manufacturing details of the access port or implant prior to surgery.
Up to this point in the rejection, the examiner of record has provided the necessary references to structure a solid section 103 Obviousness rejection. However, the examiner notes for the record that printed matter analysis must be incorporated into the rejection to evaluate the merits of the claim(s) in question following the procedural requirements of the Manual of Patent Examination Procedure (MPEP) and the legal roadmap used by the Court in C.R. Bard, Inc. v. Medical Components, 2:12-cv-00032-RJS-DAO. The scopes of the claims that were subject to invalidation in the cited court decision are substantially similar to the pending claims on this application. Therefore, particular attention must be given to the analysis in the court decision to avoid claiming unpatentable subject matter like non-functional printed matter.
Printed Matter Analysis
The first step in the printed matter analysis is to ascertain whether the limitation in question is in fact, directed toward printed matter. The MPEP and Federal Circuit cases establish a necessary condition for falling into the category of printed matter: a limitation is printed matter only if it claims the content of information. If this condition is met, the next step is to ascertain whether the printed matter is functionally related to the access port.
In the application at hand, the claim limitations in question are “at least one marking” and “providing information regarding at least one of a location of the discharge port and wherein the access port assembly is rated for power injection”, and “wherein the at least one marking are letters provided in a mirror-image orientation.” The fact that the radiopaque marking comprises of letters, demonstrates a content of information in the marking whose sole function is to convey information. Accordingly, the claim language in question is considered printer matter. Having so found, the next step is to determine whether the printed matter should be given patentable weight. Printed matter is only given patentable weight if the matter is functionally or structurally related to the associated access port. Concerning the second condition, there is no relationship between the printed matter and the underlying access port upon which it is printed. In the application at hand, the printed matter does not change how the port works once it is implanted, does not affect or effect the functional and operational capabilities of the access port, and does not interrelate with the port to produce a new and useful product. Paragraph [0020] of the specification of this application supports the fact that there is no functional relationship between the printed matter and the underlying access port. The paragraph explicitly states:
“[t]he radiopaque markings and indicia would appear on an X-ray of the patient, and the indicia are provided in a mirror-image orientation on the bottom outer surface of the housing base (FIGS. 7 and 8) so that the indicia would appear as “CT” when the X-ray is viewed (FIG. 9), easily discerned by the radiologist or technologist.”
The paragraph discloses a relationship between the marking and an X-ray machine. Accordingly, the printed matter in no way depends on the access port, and the access port does not, depend on the printed matter. Therefore, the claim limitations in question are printed matter not entitled to patentable weight. Claims 41 and 42, without the printed matter limitations, should be considered obvious in view of the cited references.
Response to Arguments
Applicant’s arguments with respect to the pending claims have been considered but are moot because of the new grounds of rejection which include printed matter analysis incorporated to all the pending section 103 rejections.
The examiner of record would like to take this opportunity to [again] address the non-analogous art argument that is repeatedly used to seek to invalidate the use of the following references in the pending rejections:
Hamilton-used in the pending rejections to only provide evidence that a material such as medical grade silicone rubber is transparent to X-rays;
Tanaka- [removed from pending rejections],
Von Oepen-used in the pending rejections to demonstrate the conventionality of making radiopaque indicia of radiopaque ink using the process of pad printing;
Lee-used in the pending rejections to demonstrate the conventionality of making radiopaque markers of foil material;
Cionanta- used in the pending rejections to demonstrate the conventionality of making radiopaque markers of film material; and
Carter- used in the pending rejections to demonstrate that any information considered appropriate and necessary to inform medical