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 .
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.
Claim 5 is 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 5 recites the limitation "the clear silicone layer" in line 3. There is insufficient antecedent basis for this limitation in the claim as no “clear silicone layer” had previously been recited in claim 5 or claim 1 from which it depends.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4, 6-8, 10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Magalich (US 2011/0288503) in view of Evans (US 2009/0156928).
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As to claim 1, Magalich teaches a method of manufacturing an indicia bearing septum (elastomeric region 20c) adapted to be assembled to an implantable port (port 200) having a cap (indicated in the exploded view of Fig 9, above, the cap is identified as housing 201) with an opening (the cap has an opening vertically therethrough as illustrated), comprising the steps of:(a) providing a one-piece integral unitary elastomeric septum (Magalich teaches septums 100-106 as shown in Figures 4 and 5A-5G as drop-in replacements of the septum 100 in Fig 9 and each of which include a second elastomeric region 20 which is considered here to be the claimed “septum.” This rejection relies on the embodiment shown in Magalich Fig. 5C. Elastomeric region 20c is one-piece, integral, and unitary. Evidence for this determination is from Fig 5C which illustrates the entire region having the same hatch lines) having a base with an elevated upper portion (region 20c may reasonably be divided into at least two portions: an upper portion and a lower portion. Everything above height D1c is considered the “elevated upper portion” while everything below height D1c is considered the “base.”1); (b) forming at least one depression (void 25 or 26 is a depression in region 20c which is filled with elastomeric material 36c as shown in Fig 5C, above. See also [0077].) of a given configuration (the voids 25, 26 are in the shape of “CT” as shown in Fig 4) into the top surface and the upper portion of the septum (the voids 25, 26 are depressed into the top surface of the region 20c as illustrated in Fig 5C, above.), the upper portion of the septum is exposed [open to view] (the manner in which the recited portion of the top surface of septum 20c will eventually be viewable after the septum is assembled into the port is through the opening of the cap. See Fig 9 which indicates the cap (housing 201) has an opening therethrough which exposes the septum 100, making the region 20c open to view through the opening in the housing 201 and through the clear portion 30c) and viewable [capable of being seen : visible] through the opening of the cap when the septum is assembled to the port (Even though the region 20c sits beneath the region 30c, the region 20c is considered viewable [capable of being seen : visible]. An artisan would have been motivated to have made region 30c clear based on the teachings of Magalich. See Magalich [0095]: “Optionally, one or more regions may be clear. For example, a top region (such as for example regions 20, 20b, 20c, 20d, 20e, 20/ and/or 20g), and/or other regions could be clear. This may allow human visualization of indicia, when such indicia is below or embedded in such region. Such human visualization may be in addition to medical imaging.” While Magalich doesn’t specify that that region 30c should be clear, a person having ordinary skill in the art at the time the invention was effectively filed would have found it prima facie obvious to have made region 30c clear since indicia 36c (intended to be viewed by a human as per [0095]) is below region 30c).
As acknowledged by the Board in the rejection of claim 9 of 15 July 2025, Magalich teaches a radiopaque insert (insert/indicia 36c) but does not explicitly disclose (c) forming one continuous solid radiopaque insert (insert/indicia 36c. Even though the insert is illustrated in Fig 4 as being separate letters “C” and “T,” Paragraph [0077] teaches the indicia may be “one or more” of items 35, 36.) having the given configuration in a mold; and (d) embedding the solid radiopaque insert into the depression at the upper portion of the septum such that the insert is viewable from the top surface of the upper portion through the opening of the cap when the septum is assembled to the port.
Nonetheless, Evans discloses port 10 having radiopaque indicator 1100 that is sized to fit cavity 1120 of port housing 20, is insertable, and is rigid/solid prior to being attached to port housing 20 via press-fitting or ultrasound welding (i.e., mounted into and embedded in the depression). See Evans paras. 56, 57, 60, 61, Figs. 11, 12A, 15. Hence, Evans discloses “forming” radiopaque insert 1120 as a “solid” having a given configuration and “mounting” radiopaque insert 1120 into depression (cavity) 1120.
Accordingly, it would have been obvious for a skilled artisan to modify Magalich by forming insert/indicia 36c with a given “CT” configuration as a continuous solid radiopaque insert/indicia and mounting insert/indicia 36c into the depression 25, 26, as taught by Evans, in order to convey information regarding port 200 “including suitability of the port for power injectability . . . the number or reservoirs included in the port, and the orientation and position of the septa of the port.” See Evans para. 62. Modifying the molding process of insert/indicia 36c of Magalich with the forming process of Evans’ (pre-made) rigid radiopaque indicator, which is sized to fit the cavity (depression), is nothing more than the predictable use of prior art elements according to their established functions, which represents “the mere application of a known technique to a piece of prior art ready for the improvement.” KSR Int'l Co. v. Teleflex, Inc., 550 U.S. 398, 418 (2007).
Moreover, Magalich would suggest to a skilled artisan such a modification by disclosing molding of a first region (e.g., region 20c in Fig. 5C), setting in place a pre-molded, cured second region (e.g., region 36c in Fig. 5C), and over molding a third region (e.g., region 30c in Fig. 5C) on the assembly of the first and second regions, wherein over-molding includes “over-molding on a pre-cured element that has been stamped, cut or otherwise formed prior to the molding act 330” (emphasis added). See Magalich paras. 94, 97 (emphasis added).
Magalich in view of Evans further teaches: wherein the radiopaque insert (insert/indicia 36c) provides an indicia (“CT” configuration) to a viewer visually from the top surface of the upper portion of the septum and when the septum is viewed under x-ray or computer tomography imaging (see Magalich [0095] and [0093]: “For example, the indicia may comprise a medical imaging media around the shape of a letter and/or number.” Also, Evans’ indicator 1100 is radiopaque, see Evans Paragraphs [0056-0058]: “Because the indicator 1100 is radiopaque, the two portions 1111, 1112 will be visible through imaging techniques, such as radiographic (x-ray) imaging.”).
As to claim 2, Magalich in view of Evans teaches the method of claim 1, further comprising: covering the top of the septum (region 20c) with a clear silicone layer (region 30c is a transparent elastomeric layer. See the discussion of paragraph [0095] in the rejection of claim 1 above) after the insert is embedded into the depression at the upper portion to insulate the insert and the septum from the environment (this method step is explained in the rejection of claim 1, above: “Moreover, Magalich would suggest to a skilled artisan such a modification by disclosing molding of a first region (e.g., region 20c in Fig. 5C), setting in place a pre-molded, cured second region (e.g., region 36c in Fig. 5C), and over molding a third region (e.g., region 30c in Fig. 5C) on the assembly of the first and second regions, wherein over-molding includes “over-molding on a pre-cured element that has been stamped, cut or otherwise formed prior to the molding act 330” (emphasis added). See Magalich paras. 94, 97 (emphasis added).”).
As to claim 3, Magalich in view of Evans teaches the method of claim 1, but does not teach step (c) further comprises: configuring the mold to have at least one cavity shaped to form an insert having the given configuration; injecting a liquid radiopaque material into the mold cavity; and solidifying the liquid radiopaque material to form the one continuous solid radiopaque insert.
However, Magalich teaches [0081]: “Also, optionally wherein the second region may substantially cover said first region (see e.g. FIG. 5A-G) or not, and the first and second regions may be molded together, or not, with respect to each other.” Examiner previously took official notice, and now treats as fact that any molding process will include a step of configuring the mold to have at least one cavity shaped to form the item being molded having a given configuration.
It would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed to have performed this method step in the teachings of Magalich in order to adequately achieve the molded continuous indicia 36c or the radiopaque insert 1120 of Evans.
While Magalich doesn’t specify the molding process include a step of injecting a liquid, Magalich teaches the indicia 36d includes barium sulfate-loaded silicone (See [0082]. Examiner previously took official notice and now treats as fact that it was well known in the art for materials being molded to be injected as a liquid into a mold cavity. Thus, it would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed to have injected a liquid barium sulfate-loaded silicone mixture into the mold in order to ensure the mold is fully filled as in an injection molded process.
As to claim 4, Magalich in view of Evans teaches the method of claim 3, wherein the injecting step comprises injecting liquid Barium Sulfate (BaSO4) into the mold cavity (Magalich [0082]: “Optionally, the additive may be any of one or more materials. As but one example, such additive may include barium sulfate.”).
As to claim 6, Magalich in view of Evans teaches the method of claim 1, wherein step (b) comprises forming the depression from the top surface of the upper portion to a predetermined depth into the upper portion of the septum (as discussed at [0074] and illustrated in Fig 5C, the indicia 36c is depressed a depth of (D2c - D1c) into the septum 20c.).
As to claim 7, Magalich in view of Evans teaches the method of claim 1, wherein step (b) comprises forming the given configuration of the depression as a readable indicia that is adapted to convey information to a viewer (see Magalich [0073] which teaches the indicia is formed by voids in the form of letters or symbols useful for conveying “the flow rate rating of the port” for example.).
As to claim 8, Magalich in view of Evans teaches the method of claim 3, but does not teach the liquid radiopaque material injected into the mold cavity is compacted to provide a compacted solid insert. However, Applicant’s disclosure at [0037] teaches “Mold 20 has a cover (not shown for sake of clarity) that covers mold 20 so that the liquid barium is injected into the different molding cavities and is compacted separately in each of the cavities, as is conventionally known in injection molding.”
It would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed to have performed a step of compacting to provide a compacted solid insert in the method of Magalich because such a step is admitted to be conventionally known in injection molding.
As to claim 12, Magalich teaches a method of manufacturing a septum (elastomeric region 20c) adapted to be used with a port (port 200. See the Exploded Fig 9 above) having a housing (the lower portion of the port as illustrated) and a cap (the upper portion of the port as illustrated) with respective in alignment openings (the vertical opening through the cap is in alignment with the vertical opening of the housing of the port, as illustrated), comprising providing a one-piece integral unitary elastomeric septum (Magalich teaches septums 100-106 as shown in Figures 4 and 5A-5G as drop-in replacements of the septum 100 in Fig 9 and each of which include a second elastomeric region 20 which is considered here to be the claimed “septum.” This rejection relies on the embodiment shown in Magalich Fig. 5C. Elastomeric region 20c is one-piece, integral, and unitary. Evidence for this determination is from Fig 5C which illustrates the entire region having the same hatch lines) having a base with an elevated upper portion (region 20c may reasonably be divided into at least two portions: an upper portion and a lower portion. Everything above height D1c is considered the “elevated upper portion” while everything below height D1c is considered the “base.”2) having a top surface adapted to expose3 [open to view] (the manner in which the recited portion of the top surface of septum 20c will eventually be viewable after the septum is assembled into the port is through the opening of the cap. See Fig 9 which indicates the cap (housing 201) has an opening therethrough which exposes the septum 100, making the region 20c viewable through the opening in the housing 201 and through the clear portion 30c) and viewable [capable of being seen : visible] through the openings of the cap and the housing (Even though the region 20c sits beneath the region 30c, the region 20c is considered viewable [capable of being seen : visible]. An artisan would have been motivated to have made region 30c clear based on the teachings of Magalich. See Magalich [0095]: “Optionally, one or more regions may be clear. For example, a top region (such as for example regions 20, 20b, 20c, 20d, 20e, 20/ and/or 20g), and/or other regions could be clear. This may allow human visualization of indicia, when such indicia is below or embedded in such region. Such human visualization may be in addition to medical imaging.” While Magalich doesn’t specify that that region 30c should be clear, a person having ordinary skill in the art at the time the invention was effectively filed would have found it prima facie obvious to have made region 30c clear since indicia 36c (intended to be viewed by a human as per [0095]) is below region 30c); forming a depression of a given configuration onto the top surface and into the upper portion of the septum (voids 25, 26), the depression being viewable from the top surface of the upper portion of the septum (as indicated above).
As acknowledged by the Board in the rejection of claim 9 of 15 July 2025, Magalich teaches a radiopaque insert (insert/indicia 36c) but does not explicitly disclose forming one continuous piece solid radiopaque indicia with the given configuration from a mold (insert/indicia 36c. Even though the insert is illustrated in Fig 4 as being separate letters “C” and “T,” Paragraph [0077] teaches the indicia may be “one or more” of items 35, 36.) and embedding the solid indicia into the depression from the top surface of the upper portion into the upper portion of the septum.
Nonetheless, Evans discloses port 10 having radiopaque indicator 1100 that is sized to fit cavity 1120 of port housing 20, is insertable, and is rigid/solid prior to being attached to port housing 20 via press-fitting or ultrasound welding (i.e., mounted into and embedded in the depression). See Evans paras. 56, 57, 60, 61, Figs. 11, 12A, 15. Hence, Evans discloses “forming” radiopaque insert 1120 as a “solid” having a given configuration and “mounting” radiopaque insert 1120 into depression (cavity) 1120.
Accordingly, it would have been obvious for a skilled artisan to modify Magalich by forming insert/indicia 36c with a given “CT” configuration as a solid radiopaque insert/indicia and mounting insert/indicia 36c into the depression 25, 26, as taught by Evans, in order to convey information regarding port 200 “including suitability of the port for power injectability . . . the number or reservoirs included in the port, and the orientation and position of the septa of the port.” See Evans para. 62. Modifying the molding process of insert/indicia 36c of Magalich with the forming process of Evans’ (pre-made) rigid radiopaque indicator, which is sized to fit the cavity (depression), is nothing more than the predictable use of prior art elements according to their established functions, which represents “the mere application of a known technique to a piece of prior art ready for the improvement.” KSR Int'l Co. v. Teleflex, Inc., 550 U.S. 398, 418 (2007).
Moreover, Magalich would suggest to a skilled artisan such a modification by disclosing molding of a first region (e.g., region 20c in Fig. 5C), setting in place a pre-molded, cured second region (e.g., region 36c in Fig. 5C), and over molding a third region (e.g., region 30c in Fig. 5C) on the assembly of the first and second regions, wherein over-molding includes “over-molding on a pre-cured element that has been stamped, cut or otherwise formed prior to the molding act 330” (emphasis added). See Magalich paras. 94, 97 (emphasis added).
Magalich in view of Evans further teaches: the indicia (insert/indicia 36c) is viewable visually from the top surface of the upper portion of the septum and is viewable under radiographic imaging (see Magalich [0095] and [0093]: “For example, the indicia may comprise a medical imaging media around the shape of a letter and/or number.” Also, Evans’ indicator 1100 is radiopaque, see Evans Paragraphs [0056-0058]: “Because the indicator 1100 is radiopaque, the two portions 1111, 1112 will be visible through imaging techniques, such as radiographic (x-ray) imaging.”); the indicia adapted to convey information to the viewer (see Magalich [0073] which teaches the indicia is formed by voids in the form of letters or symbols useful for conveying “the flow rate rating of the port” for example.); wherein the elastomeric septum is formed from a silicone gum stock or a liquid injection molding material (Magalich [0054] teaches the materials of the septum are liquid before being cured in a mold).
As to claim 10, Magalich in view of Evans teaches the method of claim 12, but does not teach the indicia is formed by: providing a mold having a mold cavity with the given configuration; injecting a liquid radiopaque material into the mold cavity; solidifying the liquid radiopaque material in the mold cavity; and extracting the solidified one continuous piece of solid radiopaque indicia from the mold cavity.
Rather, Magalich teaches generally at [0054]: “The term “molding” means to cure a liquid in a mold.” Examiner previously took official notice and now treats as fact that any molding process will include a step of configuring the mold to have at least one cavity shaped to form the item being molded “having a given configuration.” Thus, it would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed to have performed this method step in the teachings of Magalich in view of Evans in order to adequately achieve the molded indicia 36c or Evans’ radiopaque insert 1120.
While Magalich doesn’t specify the molding process includes a step of injecting a liquid, Magalich teaches a radiopaque material includes silicone. Examiner previously took official notice and now treat as fact that it was well known in the art for materials being molded to be injected as a liquid into a mold cavity. Thus, it would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed to have injected a liquid radiopaque-loaded silicone mixture into the mold in order to ensure the mold is fully filled as in an injection molded process.
Magalich teaches the material is solidified by being cured in a mold.
Even though Magalich doesn’t specify the extraction of the solidified one piece solid radiopaque insert from the mold cavity, this is considered to be an obvious matter of common sense since the indicia is to be inserted into a septum, and thus must be removed from a first mold in order to be inserted into the region 20c as shown in Fig 5C.
Last, even though the insert is illustrated in Magalich Fig 4 as being separate letters “C” and “T” (and therefore not “one continuous piece”), Paragraph [0077] teaches the indicia may be “one or more” of items 35, 36. Which meets the “one continuous piece” limitation.)
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Magalich in view of Evans as applied to claim 1 above, and further in view of Beling (US 8,092,435).
As to claim 5, Magalich in view of Evans teaches the method of claim 1,but does not teach forming two channels at the base of the septum to provide inflow and outflow of liquid silicone to form the clear silicone layer over the upper portion and the base of the septum.
Magalich is silent as to inflow and outflow channels to form the clear silicone layer over the upper portion and the base of the septum, However, in the art of manufacturing septums, such a feature was known at the time the invention was effectively filed. See Beling which teaches an implantable portal including a septum having a base and an upper portion having radiopaque elements. Beling further teaches a clear silicone layer 28b which is analogous to Magalich’s layer 30C. Beling further teaches channels 28a1 and 28a2 which provide inflow and outflow of liquid silicone. See Col 3 line 66- Col 4 line 9.
It would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed to a person having ordinary skill in the art at the time the invention was effectively filed to provide for the channels of Beling in the device of Magalich in view of Evans. Such a person would have been motivated to do so in order to achieve the benefits of Beling’s channels, such increasing the bonding surface between the base and cover layers of the septum.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Magalich in view of Evans as applied to claim 12 above, and further in view of Beling (US 8,092,435).
As to claim 11, Magalich in view of Evans teaches the method of claim 12, but does not teach: forming inflow and outflow channels at the base of the septum to enable inflow and outflow of liquid silicone to the septum; channeling a liquid silicone through the inflow and outflow channels to form a clear silicone layer that overs the septum.
Magalich is silent as to inflow and outflow channels to form the clear silicone layer over the upper portion and the base of the septum, However, in the art of manufacturing septums, such a feature was known at the time the invention was effectively filed. See Beling which teaches an implantable portal including a septum having a base and an upper portion having radiopaque elements. Beling further teaches a clear silicone layer 28b which is analogous to Magalich’s layer 30C. Beling further teaches channels 28a1 and 28a2 which provide inflow and outflow of liquid silicone. See Col 3 line 66- Col 4 line 9.
It would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed to a person having ordinary skill in the art at the time the invention was effectively filed to provide for the channels of Beling in the device of Magalich in view of Evans. Such a person would have been motivated to do so in order to achieve the benefits of Beling’s channels, such increasing the bonding surface between the base and cover layers of the septum.
Response to Arguments
Applicant's arguments filed 28 April 2026 have been fully considered but they are not persuasive.
Applicant argues that neither Magalich nor Evans teaches the “elevated upper portion into which the depression of a given configuration is formed.” Examiner disagrees. Magalich teaches upper and lower portions of the septum 20c. See the rejection of claim 1 above for further details of Examiner’s interpretation of Magalich’s “upper portion.” It is the upper portion into which the radiopaque portion is inserted.
Applicant argues that Magalich in view of Evans does not teach dependent claims 5 and 11. Examiner agrees. Beling is cited as evidence that such channels were known at the time the invention was effectively filed.
Applicant continues to argue that Magalich teaches overmolding the upper layer over the lower layer instead of inserting a separately-molded, solid, radiopaque component into the void. Examiner continues to assert that Magalich does not teach only overmolding, and also teaches the claimed limitation of embedding a separately-molded solid radiopaque insert into the one-piece integral unitary elastomeric septum.
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 JACOB JAMES CIGNA whose telephone number is (571)270-5262. The examiner can normally be reached 9am-5pm Monday-Friday.
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/JACOB J CIGNA/Primary Examiner, Art Unit 3726 6 August 2026
1 Examiner recognizes that in general examiners are discouraged from wantonly sub-dividing unitary regions into smaller portions in order to designate them as various claimed elements. However, the subdivision of the unitary region 20c is provided via Magalich’s teachings. See paragraphs [0074-0075] which describe that the region 20c may be said to have “top, middle and/or bottom” depths, and further teaches variations in which the additive is provided at different heights of the region.
2 Examiner recognizes that in general examiners are discouraged from wantonly sub-dividing unitary regions into smaller portions in order to designate them as various claimed elements. However, the subdivision of the unitary region 20c is provided via Magalich’s teachings. See paragraphs [0074-0075] which describe that the region 20c may be said to have “top, middle and/or bottom” depths, and further teaches variations in which the additive is provided at different heights of the region.
3 Examiner interprets this limitation as “to be exposed”.
Prosecution Insights