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 § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 1, 3, 5-8, 10, 13, 16, 17, 19 and 21 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Sheetz et al (US 2006/0247584).
Regarding claim 1, Sheetz discloses an implantable venous access port assembly, the implantable venous access port assembly comprising: a needle-penetrable septum 18; a housing 14/16 securing the needle-penetrable septum (fig 1B); and a radiopaque material affixed to the housing wherein the radiopaque material produces a contrasting image under X-ray examination after implantation of the implantable venous access port assembly into a patient (¶73), wherein the radiopaque material comprises at least one cutout or at least one integrally molded marking (metal plate or other metal geometry - ¶73; an integrally molded marking is considered a product-by-process, a metal plate may be created by integrally molding said metal plate).
Regarding claim 3, wherein at least a portion of the radiopaque material indicates a characteristic of the implantable venous access port assembly when implanted into a patient and viewed by X-ray examination (¶42 and ¶73).
Regarding claim 5, wherein the characteristic is a pressure property of the implantable venous access port assembly (any shape can be associated with a pressure property, regardless see ¶42).
Regarding claim 6, wherein the pressure property is the implantable venous access port assembly is being rated for power injection (¶42).
Regarding claim 7, wherein the pressure property is the implantable venous access port assembly can withstand pressures for injection of contrast fluid (¶42).
Regarding claim 8, wherein the radiopaque material comprises titanium (¶46).
Regarding claim 10, wherein the housing further comprises a skirt formed from radiotransparent material molded about at least a portion of the housing (¶46, polysulfone is radiotransparent).
Regarding claim 13, wherein at least a portion of the housing is made of polysulfone resin (¶46).
Regarding claim 16, wherein the housing comprises a material (polysulfone - ¶46) of a different radiopacity from the radiopaque material (metal - ¶46).
Regarding claim 17, wherein the housing comprises a material of less radiopacity compared to the radiopaque material (see claim 16, polysulfone has less radiopacity than the radiopaque material).
Regarding claim 19, Sheetz discloses an implantable venous access port assembly, the implantable venous access port assembly comprising: a needle-penetrable septum 18; a housing 14/16 securing the needle-penetrable septum and at least partially defining at least one reservoir (fig 1B); and at least one of (i) a radiopaque material affixed to the housing or (ii) the housing is comprised at least partially of a radiopaque material (¶73 – metal feature), wherein the radiopaque material produces a contrasting image under X-ray examination after implantation of the implantable venous access port assembly into a patient (¶73) and wherein the radiopaque material comprises at least one cutout or at least one integrally molded marking (metal plate or other metal geometry - ¶73; an integrally molded marking is considered a product-by-process, a metal plate may be created by integrally molding said metal plate).
Regarding claim 21, Sheetz discloses method of using an implantable venous access port assembly, the assembly having a needle-penetrable septum 18, a housing 14/16 securing the needle-penetrable septum (fig 1B), and a radiopaque material affixed to the housing wherein the radiopaque material produces a contrasting image under X-ray examination (¶73), the method comprising: implanting the implantable venous access port assembly into a patient (fig 1B); performing an X-ray examination of the implanted implantable venous access port assembly and discerning the contrasting image visible under X-ray examination (¶73); and infusing fluid into the implanted implantable venous access port assembly based on the contrasting image discerned under X-ray examination (¶40, ¶42 – infusing based on port being power injectable).
Claim Rejections - 35 USC § 103
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 2, 4, 14, 18 and 20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sheetz et al (US 2006/0247584).
Regarding claims 2 and 20, while Sheetz substantially discloses the invention as claimed, it does not explicitly disclose wherein at least a portion of the radiopaque material is at least partially embedded within the housing.
Sheetz discloses the radiopaque material can be a plate or other metal geometry (¶73).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Sheetz by embedding a metal plate in the base (of the housing) as suggested by Sheetz itself as it is the largest area on the housing without any other feature and thus would most easily accommodate the metal plate.
Regarding claim 4, the planar portion including the at least one cutout or at least integrally molded marking (shape of plate - ¶73). While Sheetz substantially discloses the invention as claimed, it does not disclose wherein the radiopaque material further comprises a planar portion recessed into a bottom surface of a bottom wall of the housing.
Sheetz discloses the radiopaque material can be a plate or other metal geometry (¶73).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Sheetz by placing the metal plate/planar portion recessed into a bottom surface of a bottom wall of the housing as suggested by Sheetz itself as it is the largest area on the housing without any other feature and thus would most easily accommodate the metal plate.
Regarding claim 14, while Sheetz substantially discloses the invention as claimed, it does not disclose wherein the at least a portion of the radiopaque material is centered within the region directly beneath the septum.
Sheetz discloses the radiopaque material can be a plate or other metal geometry (¶73).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Sheetz such that at least a portion of the radiopaque material is centered within the region directly beneath the septum as suggested by Sheetz itself as it is the largest area on the housing without any other feature and thus would most easily accommodate the metal plate.
Regarding claim 18, while Sheetz substantially discloses the invention as claimed, it does not disclose wherein the housing comprises a material of the same radiopacity as the radiopaque material.
Sheetz discloses using titanium for the housing (¶46) and a metal plate for the radiopaque material (¶73).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Sheetz such that the housing comprises a material of the same radiopacity as the radiopaque material (titanium) as titanium is the only identified metal in Sheetz and as part of Sheetz’s desire to indicate properties of the device by rearranging the various physical features of the device to make its appearance distinct and thus identifiable.
Claim 9, 11, 12, 15, 22 and 23 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sheetz et al (US 2006/0247584) in view of Jones et al (US 6,287,293).
Regarding claim 9, while Sheetz substantially discloses the invention as claimed, it does not disclose wherein the radiopaque material comprises a polymer with a radiopaque filler.
Jones disclose using either titanium (similar to Sheetz) or silicone with a barium sulfate filler as a radiopaque material (Col.1 ll 46-49 and Col.3 ll 58).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Sheetz such that the radiopaque material comprises a polymer with a radiopaque filler as taught by Jones since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197. 125 USPQ 416 (CCPA 1960).
Regarding claims 11, 12, 22 and 23, while Sheetz substantially discloses the invention as claimed, it does not disclose the at least one cutout or the least one integrally molded marking is formed in a shape of at least one alphabetical letter.
Jones shows the radiopaque material in the shape of a C (fig 5a).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Sheetz such that the at least one cutout or the least one integrally molded marking is formed in a shape of at least one alphabetical letter as taught by Jones as it is another way to customize the image of the port (as Sheetz teaches desirable).
As can be seen from Jones, the at least one alphabetical letter comprises a “C” in mirror-image orientation (especially as a C can change orientation depending on how stands with respect to it).
Regarding claim 15, while Sheetz substantially discloses the invention as claimed, it does not disclose wherein the housing and the septum define a reservoir, and at least a portion of the radiopaque material is projecting outward of a periphery of the reservoir.
Jones discloses an implantable venous access device where the radiopaque material 24 is projecting outward of a periphery of the reservoir (figs 1 and 4).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Sheetz such that the housing and the septum define a reservoir, and at least a portion of the radiopaque material is projecting outward of a periphery of the reservoir as taught by Jones as it is another way to customize the image of the port (as Sheetz teaches desirable).
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.
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 8,257,325. Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variants of either the patented claims or the patented claims in view of the references used in the rejections above.
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 8,852,160. Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variants of either the patented claims or the patented claims in view of the references used in the rejections above.
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 9,533,133. Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variants of either the patented claims or the patented claims in view of the references used in the rejections above.
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of U.S. Patent No. 9,517,329. Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variants of either the patented claims or the patented claims in view of the references used in the rejections above.
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of U.S. Patent No. 10,874,842. Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variants of either the patented claims or the patented claims in view of the references used in the rejections above.
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,878,137. Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variants of either the patented claims or the patented claims in view of the references used in the rejections above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783
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