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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “implantable medical port system… comprising: an implantable medical port coupled to an access port… and at least one contactless magnetic key configured to impart one or more magnetic fields upon a portion of the implantable medical port to manipulate the access valve” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 8-14 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 8 is unclear in light of the specification. Claim 8 requires “An implantable medical port system… comprising: an implantable medical port coupled to an access port… and at least one contactless magnetic key configured to impart one or more magnetic fields upon a portion of the implantable medical port to manipulate the access valve”. Firstly, the examiner notes that “an implantable medical port coupled to an access port” is inconsistent with the specification which recites “the implanted medical pump or implanted medical port including an access port” (emphasis added, instant para [0030]) and “The implantable medical port can include one or more fluid pathways that are coupled to an access port” (emphasis added, instant para [0018]). Additionally, while the instant Figures show a medical pump 102 in multiple figures, the Figures do not show a medical port (there is no corresponding reference numeral for a “medical port” or “medical port system”), so the scope of what constitutes a “medical port system” and a “medical port” is not made clear. This makes the limitations of claim 8 unclear because there is a significant lack of disclosure regarding an implantable medical port coupled to an access port, especially one where at least one contactless magnetic key is configured to impart one or more magnetic fields upon a portion of the implantable medical port to manipulate the access valve. For now, it will be assumed that the claim was intended to be written more consistently with the specification which refers to an access port being part of, rather than coupled to, the medical port.
Claims 9-14 are rejected as they depend from claim 8.
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 of this title, 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.
Claim(s) 1-5, and 8-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al. (US 2012/0053514 A1, cited previously and hereafter ‘Robinson’) in view of East (US 5,167,615).
As to claim 1, Robinson discloses an implantable medical pump system (see Figs. 1-3) configured to selectively permit access to a medicament reservoir, the implantable medical pump system comprising:
an implantable medical pump (12) including a medicament reservoir (34) fluidly coupled to an access port (42) via a first conduit (conduit between port 42 and reservoir 34 including 38), and an access valve (36); and
at least one contactless magnetic key (signals from programmer 20) configured to manipulate a portion of the implantable medical pump to manipulate the access valve among a first position and a third position, the first position fluidly coupling the medicament reservoir to the access port via the first conduit (see para 0055-0060), and the third position isolating the medicament reservoir from the access port (para 0063).
Robinson does not expressly recite the medicament reservoir fluidly coupled to the access port via a second conduit, and the at least one contactless key configured to manipulate the access valve to a second position fluidly coupling the medicament reservoir to the access port via the second conduit. However, Robinson does teach that the valve can be arranged in a wide variety of manners in the device 12 (see para 0029, 0055-0060), and teaches how the device can contain a plurality of different pathways (see para 0005, 0027, 0029). It would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention, based on the disclosure of Robinson, to have come up with a design wherein the medicament reservoir was fluidly coupled to a second conduit via the access valve, and the at least one contactless key configured to manipulate the access valve to a second position fluidly coupling the medicament reservoir to the access port via the second conduit. One having ordinary skill in the art would have seen the addition of a second conduit, as well as configuring the access valve to manipulate the access valve to a second position as claimed, as a matter of optimizing their device with an appropriate arrangement for the pathways and valve(s) for providing delivery of a particular fluid/number of fluids, which requires only a rearrangement and/or duplication of existing parts of Robinson (see para 0005, 0027, 0029, 0055-0060 of Robinson) (also see MPEP 2144 VI. Discussing duplication and/or rearrangement of parts).
Robinson is also silent to the at least one contactless key being magnetic and configured to impart one or more magnetic fields upon a portion of the implantable medical pump to manipulate the access valve.
East discloses at least one contactless key (polarized ring 128) configured to impart a magnetic field upon a portion of an implantable valve (10) to manipulate the valve, wherein the valve includes a magnetic element (magnet 116) configured to interact with the contactless key, thereby enabling the contactless key to directly manipulate the valve between multiple positions (see paragraphs beginning line 26 col. 10 and line 50 col. 10).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Robinson such that the at least one contactless key is magnetic and configured to impart a magnetic field upon a portion of the implantable medical pump to manipulate the access valve, thereby enabling the contactless key to directly manipulate the access valve between the first position, the second position, and the third position. One would have been motivated to do so as a way for a user to directly manipulate the access valve (rather than sending signals from programmer 20 to processor 26 and then to the access valve) and enable simple control over a position of the access valve (see paragraphs beginning line 26 col. 10 and line 50 col. 10 East disclosing manipulation of ring 128 to easily control positioning of valve).
As to claim 2, Robinson in view of East teaches the implantable medical pump system of claim 1 as described above. Robinson further discloses wherein the first conduit is adapted for refilling of the medicament reservoir (para 0025, 0060). While the references do not expressly recite the second conduit is adapted for aspiration of the medicament reservoir, the disclosure of Robinson makes it clear that any of various pathways can be adapted for aspiration (see para 0062 and 0065 disclosing withdrawing fluid from the reservoir, as well as para 0088 disclosing withdrawing fluids from pathways to different reservoirs). Thus, it would have been further obvious to one having ordinary skill in the art, if modifying Robinson as described above, to configure the second conduit so that it is adapted for aspiration of the medicament reservoir, as one having ordinary skill in the art would have been well aware of how to make the second conduit adapted for aspiration in order to optimize their device (see para 0025, 0060, 0062, 0065, 0088 of Robinson).
As to claim 3, Robinson in view of East teaches the implantable medical pump system of claim 1 as described above. Robinson further discloses wherein a first contactless key (first signals from programmer 20) is configured to manipulate the access valve to the first position, and a second contactless key (second signals from programmer 20) is configured to manipulate the access valve to the second position (see para 0055-0060, first contactless key and second contactless key being interpreted as different signals which communicate with processor 26 for performing actions by the valve). Robinson however is silent that the first contactless key and the second contactless key are magnetic. However, as noted in the rejection of claim 1 above, East teaches a magnetic contactless key in the form of ring 128. It follows that providing an additional magnetic key would constitute a mere duplication of parts (MPEP 2144.04 VI) (The examiner notes that the BRI of the claim includes having two magnetic keys each capable of manipulation of the valve to both the first position and to the second position as there is no mention of either key not being able to manipulate the valve into either position).
As to claim 4, Robinson in view of East teaches the implantable medical pump system of claim 1 as described above. Robinson further discloses wherein the access valve is biased to the third position isolating the medicament reservoir from the access port in the absence of the one or more magnetic fields imparted by the at least one contactless key (see para 0060 teaching “During operation of IMD 12, valve 36 may default to a normally closed position, thereby closing access to both reservoir fluid pathway 38 and catheter access fluid pathway 40”).
As to claim 5, Robinson in view of East teaches the implantable medical pump system of claim 1 as described above. In the modified version of Robinson, it can further be said that wherein the one or more magnetic fields of the at least one contactless key interact directly with the access valve (see paragraphs beginning line 26 col. 10 and line 50 col. 10 of East teaching direct manipulation of the valve).
As to claim 8, Robinson discloses an implantable medical port system (see Fig. 2) configured to selectively permit access to a fluid pathway (catheter 18 and/or any of internal pathways 48), the implantable medical port system comprising:
an implantable medical port (reservoir 34 and telemetry module 30 being interpreted as parts of the implantable medical port) coupled to an access port (42) via a first conduit (conduit between port 42 and reservoir 34 including 38) and an access valve (38); and
at least one contactless key (signals from programmer 20) configured to impart one or more signals upon a portion of the implantable medical port to manipulate the access valve among a first position and third position, the first position fluidly coupling the fluid pathway to the access port via the first conduit (see para 0055-0060), and the third position isolating the fluid pathway from the access port (para 0063).
Robinson does not expressly recite the implantable medical port coupled to the access port via a second conduit, and the at least one contactless key configured to manipulate the access valve to a second position fluidly coupling the fluid pathway to the access port via the second conduit. However, Robinson does teach that the valve can be arranged in a wide variety of manners in the device 12 (see para 0029, 0055-0060), and teaches how the device can contain a plurality of different pathways (see para 0005, 0027, 0029). It would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention, based on the disclosure of Robinson, to have come up with a design wherein the medicament reservoir was fluidly coupled to a second conduit via the access valve, and the at least one contactless key configured to manipulate the access valve to a second position fluidly coupling the medicament reservoir to the access port via the second conduit. One having ordinary skill in the art would have seen the addition of a second conduit, as well as configuring the access valve to manipulate the access valve to a second position as claimed, as a matter of optimizing their device with an appropriate arrangement for the pathways and valve(s) for providing delivery of a particular fluid/number of fluids, which requires only a rearrangement and/or duplication of existing parts of Robinson (see para 0005, 0027, 0029, 0055-0060 of Robinson) (also see MPEP 2144 VI. Discussing duplication and/or rearrangement of parts).
Robinson does not expressly recite the at least one contactless key being magnetic or being configured to impart one or more magnetic fields.
East discloses at least one contactless key (polarized ring 128) configured to impart a magnetic field upon a portion of an implantable valve (10) to manipulate the valve, wherein the valve includes a magnetic element (magnet 116) configured to interact with the contactless key, thereby enabling the contactless key to directly manipulate the valve between multiple positions (see paragraphs beginning line 26 col. 10 and line 50 col. 10).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Robinson such that the at least one contactless key is magnetic and configured to impart a magnetic field upon a portion of the implantable medical pump to manipulate the access valve, thereby enabling the contactless key to directly manipulate the access valve between the first position, the second position, and the third position. One would have been motivated to do so as a way for a user to directly manipulate the access valve (rather than sending signals from programmer 20 to processor 26 and then to the access valve) and enable simple control over a position of the access valve (see paragraphs beginning line 26 col. 10 and line 50 col. 10 East disclosing manipulation of ring 128 to easily control positioning of valve).
As to claim 9, Robinson in view of East teaches the implantable medical puort system of claim 8 as described above. Robinson further discloses wherein the first conduit is adapted for refilling of the fluid pathway (para 0025, 0060). While the references do not expressly recite the second conduit is adapted for aspiration of the fluid pathway, the disclosure of Robinson makes it clear that any of various pathways can be adapted for aspiration (see para 0062 and 0065 disclosing withdrawing fluid from the reservoir, as well as para 0088 disclosing withdrawing fluids from pathways to different reservoirs). Thus, it would have been further obvious to one having ordinary skill in the art, if modifying Robinson as described above, to configure the second conduit so that it is adapted for aspiration of the fluid pathway, as one having ordinary skill in the art would have been well aware of how to make the second conduit adapted for aspiration in order to optimize their device (see para 0025, 0060, 0062, 0065, 0088 of Robinson).
As to claim 10, Robinson in view of East teaches the implantable medical port system of claim 8 as described above. Robinson further discloses wherein a first contactless key (first signals from programmer 20) is configured to manipulate the access valve to the first position, and a second contactless key (second signals from programmer 20) is configured to manipulate the access valve to a second position (see para 0055-0060, first contactless key and second contactless key being interpreted as different signals which communicate with processor 26 for performing actions by the valve). Robinson however is silent that the first contactless key and the second contactless key are magnetic. However, as noted in the rejection of claim 1 above, East teaches a magnetic contactless key in the form of ring 128. It follows that providing an additional magnetic key would constitute a mere duplication of parts (MPEP 2144.04 VI) (The examiner notes that the BRI of the claim includes having two magnetic keys each capable of manipulation of the valve to both the first position and to the second position as there is no mention of either key not being able to manipulate the valve into either position).
As to claim 11, Robinson in view of East teaches the implantable medical port system of claim 8 as described above. Robinson further discloses wherein the access valve is biased to the third position isolating the medicament reservoir from the access port in the absence of the one or more magnetic fields imparted by the at least one contactless key (see para 0060 teaching “During operation of IMD 12, valve 36 may default to a normally closed position, thereby closing access to both reservoir fluid pathway 38 and catheter access fluid pathway 40”).
As to claim 12, Robinson in view of East teaches the implantable medical port system of claim 8 as described above. In the modified version of Robinson, it can further be said that wherein the one or more magnetic fields of the at least one contactless key interact directly with the access valve (see paragraphs beginning line 26 col. 10 and line 50 col. 10 of East teaching direct manipulation of the valve).
Claim(s) 6 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robinson in view of East as applied to claims 1 and 8, respectively above, and further in view of DeCant et al. (US 4,447,224, hereafter “DeCant”).
As to claim 6, Robinson in view of East teaches the implantable medical pump system of claim 1 as described above. Robinson additionally discloses a processor (26) but does not expressly recite wherein the one or more magnetic fields of the at least one contactless key interact indirectly with the access valve via a magnetic sensing element in communication with the processor.
However, DeCant discloses a processor (68) in communication with a valve (42) and teaches “Valve 42 can also be designed to have a manual actuation capability with the valve being closed by a subcutaneous electrical switch mounted in the top wall of housing 12 as shown in dotted lines at 80 in FIG. 1. The switch is connected electrically to processor 68 and actuated by pressing against the skin or by a magnet positioned outside the patient's body opposite the switch” (para beginning line 3 col. 8 and Fig. 1).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Robinson further (as already modified above) such that wherein the one or more magnetic fields of the at least one contactless key interact indirectly with the access valve via a magnetic sensing element in communication with the processor. One would have been motivated to do so as an alternative means for triggering movement of the valve (see para beginning line 3 col. 8 and Fig. 1 of DeCant).
As to claim 13, Robinson in view of East teaches the implantable medical port system of claim 8 as described above. Robinson additionally discloses a processor (26) but does not expressly recite wherein the one or more magnetic fields of the at least one contactless key interact indirectly with the access valve via a magnetic sensing element in communication with the processor.
However, DeCant discloses a processor (68) in communication with a valve (42) and teaches “Valve 42 can also be designed to have a manual actuation capability with the valve being closed by a subcutaneous electrical switch mounted in the top wall of housing 12 as shown in dotted lines at 80 in FIG. 1. The switch is connected electrically to processor 68 and actuated by pressing against the skin or by a magnet positioned outside the patient's body opposite the switch” (para beginning line 3 col. 8 and Fig. 1).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Robinson further (as already modified above) such that wherein the one or more magnetic fields of the at least one contactless key interact indirectly with the access valve via a magnetic sensing element in communication with the processor. One would have been motivated to do so as an alternative means for triggering movement of the valve (see para beginning line 3 col. 8 and Fig. 1 of DeCant).
Claim(s) 7 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robinson in view of East as applied to claim 1 or claim 8, respectively above, and further in view of Fullerton et al. (US 2011/006885 A1, hereafter “Fullerton”).
As to claim 7, Robinson in view of East teaches the implantable medical pump system of claim 1 as described above, but does not expressly recite wherein the at least one contactless magnetic key is coded to include two or more maxels.
Fullerton teaches "Specifically, magnet designers can now use patterns of grouped and/or alternating magnetic elements--or maxels-that behave individually like dipole magnets, but can exhibit many different behaviors as a whole. The shape of a force profile is controlled by a number of design parameters, including the total number of magnetic elements, polarity, amplitude, and the size,
shape and location of the maxels (field emission sources). The amount of maxel polarity variation per
unit area (code density) on a magnet surface affects the level of the peak force at contact. The code
density also affects the residual level of force at the far-field and the rate of decay, or slope, of the
force curve. As the code density increases, so does the peak attraction force. However, the attraction
force decays more rapidly, and the far-field force is significantly reduced. Thus, in stark contrast to the
conventional magnets, the custom designed magnetic fields employing correlated magnetics
technology can exhibit a stronger peak force with a very short `throw,` rendering a much safer
magnetic device." (para 0181).
It would have been obvious to one having ordinary skill in the art before the effective filing
date of the present invention to have modified Robinson (as already modified above) further in view of
Fullerton such that the at least one contactless key includes two or more maxels. One would have
been motivated to do so as Fullerton demonstrates how use of multiple maxels can be used to create
safer magnetic devices that can exhibit many different behaviors (see para 0181 of Fullerton).
As to claim 14, Robinson in view of East teaches the implantable medical port system of claim 8 as described above, but does not expressly recite wherein the at least one contactless magnetic key is coded to include two or more maxels.
Fullerton teaches "Specifically, magnet designers can now use patterns of grouped and/or alternating magnetic elements--or maxels-that behave individually like dipole magnets, but can exhibit many different behaviors as a whole. The shape of a force profile is controlled by a number of design parameters, including the total number of magnetic elements, polarity, amplitude, and the size,
shape and location of the maxels (field emission sources). The amount of maxel polarity variation per
unit area (code density) on a magnet surface affects the level of the peak force at contact. The code
density also affects the residual level of force at the far-field and the rate of decay, or slope, of the
force curve. As the code density increases, so does the peak attraction force. However, the attraction
force decays more rapidly, and the far-field force is significantly reduced. Thus, in stark contrast to the
conventional magnets, the custom designed magnetic fields employing correlated magnetics
technology can exhibit a stronger peak force with a very short `throw,` rendering a much safer
magnetic device." (para 0181).
It would have been obvious to one having ordinary skill in the art before the effective filing
date of the present invention to have modified Robinson (as already modified above) further in view of
Fullerton such that the at least one contactless key includes two or more maxels. One would have
been motivated to do so as Fullerton demonstrates how use of multiple maxels can be used to create
safer magnetic devices that can exhibit many different behaviors (see para 0181 of Fullerton).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,083,316. Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to the same subject matter of an implantable medical pump system comprising an implantable medical pump including a medicament reservoir fluidly coupled to an access port via a first conduit, a second conduit and an access valve, and at least one contactless key. The differences between the instant claim 1 and claim 1 of the patent are that instant claim 1 is broader in that it does not require limitations regarding an access template. Additionally, while the instant claim 1 specifically refers to at least one magnetic contactless key, claim 1 of the patent requires that the at least one magnetic contactless key is “configured to impart a magnetic field” and therefore it can be inferred that the at least one magnetic contactless key of the patent is magnetic.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 12,083,316. Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to the same subject matter of an implantable medical pump system comprising an implantable medical pump including a medicament reservoir fluidly coupled to an access port via a first conduit, a second conduit and an access valve, and at least one contactless key. The differences between the instant claim 1 and claim 2 of the patent are that instant claim 1 is broader in that it does not require limitations regarding an access template. Additionally, while the instant claim 1 specifically refers to at least one magnetic contactless key, claim 2 of the patent requires that the at least one magnetic contactless key is “configured to impart a magnetic field” and therefore it can be inferred that the at least one magnetic contactless key of the patent is magnetic.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James D Ponton whose telephone number is (571)272-1001. The examiner can normally be reached M-F 9am-5pm.
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/James D Ponton/Primary Examiner, Art Unit 3783
Prosecution Insights