Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claim 9 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 8. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 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 negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Publication No. 2011/0137150 to Connor et al. “Connor” in view of U.S. Publication No. 2004/0010229 to Houde et al. “Houde”
As for Claims 1-4 and 7, Connor discloses a contrast medium device comprising a first syringe and a second syringe each containing a fluid (202 and 204 Fig. 2 and corresponding descriptions); two components that can move the fluids in a simultaneous fashion (206 in Fig. 2 and corresponding descriptions); a contrast pattern generating chamber (e.g. static mixer 208) located where the two barrels are connected (e.g. first and second connections; Paragraph [0019]) and an exit port that connects the mixer to a catheter (Fig. 1) .
However, it is not clear if Connor’s system provides an air port as claimed.
Houde teaches from within a similar field of endeavor with respect to contrast medium devices adapted to employ first and second injectors (e.g. first and second containers) which may sequentially or simultaneously, inject first and second fluids into a patient via a catheter (Abstract). Houde explains "The first and second fluid lines 30,32 include distal ends 34,36, respectively, which may terminate at first and second inputs 38,40 respectively, of a Y-shaped fitting 42. The Y-shaped fitting 42 further includes an outlet 44 connected to an output conduit 46. An advantage of using such a fitting having multiple inlets and one outlet is that multiple fluids can be supplied under pressure from multiple sources and can be mixed in the fitting 42 prior to injection...Control valves 48 and 50 may be provided within the first and second fluid lines 30, 32 respectively...Moreover, the control values 48 and 50 may be provided in a variety of forms such as, but not limited to check valves, pinch valves, or any other type of valve contemplated by one skilled in the art” (Paragraph [0020]).
Accordingly, one skilled in the art would have been motivated to have modified the contrast medium generating and deliver device described by Connor to include fluid lines and valves (e.g. air valves/ports) for each syringe as described by Houde in order to selectively control delivery of fluids. Such a modification merely involves combing prior art elements according to known techniques to yield predictable results (MPEP 2143).
With respect to Claims 5, 8-9 and 11 Connor provides a luer lock or other type of lock to seal and store the contents of the first and second barrel (Paragraph [0020]). Such a component is configured to be a stop cock in its broadest reasonable interpretation.
As for Claims 6, 10 and 12, Connor explains that the contrast delivery device is connected to a catheter (Paragraph [0021]).
As for Claims 13-20, Connor and Houde disclose a contrast medium generation and delivery device coupled to a catheter as explained above. Connor explains that the catheter is configured to deliver mixed echogenic contrast to the uterus and the fallopian tubes to be viewed with ultrasound (Paragraph [0021]). Examiner notes that one skilled in the art would be able to determine the patency of the fallopian tube by observing the ultrasound image as described above in its broadest reasonable interpretation.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,070,888. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed toward a contrast generating device including two containers (e.g. syringes), first and second plungers for simultaneously injecting fluids, a contrast pattern generating chamber and a catheter. Examiner notes that the claimed features of an air port and fluid connections and are part of the patented devices (see Fig. 1).
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 9,554,826. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed toward using the same contrast generating device to create a contrast including two containers (e.g. syringes), first and second plungers for simultaneously injecting fluids, a contrast pattern generating chamber and a catheter. Examiner notes that the claimed features of an air port and fluid connections and are part of the patented devices (see Fig. 1).
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10,172,643. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed toward using the same contrast generating device to create a contrast including two containers (e.g. syringes), first and second plungers for simultaneously injecting fluids, a contrast pattern generating chamber and a catheter. Examiner notes that the claimed features of an air port and fluid connections and are part of the patented devices (see Fig. 1).
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,258,375. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed toward using the same contrast generating device to create a contrast including two containers (e.g. syringes), first and second plungers for simultaneously injecting fluids, a contrast pattern generating chamber and a catheter. Examiner notes that the claimed features of an air port and fluid connections and are part of the patented devices (see Fig. 1).
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,737,014. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed toward a device and method for delivering contrast that can be used to visualize a structure, the device having two containers (e.g. syringes), two plungers for simultaneously injecting fluid and gas. Examiner notes that the claimed features of an air port and fluid connections and are part of the patented devices (see Fig. 1).
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,154,326. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed toward methods of providing a contrast medium composition to a structure (e.g. fallopian tube and/or uterus) using a contrast generating device including two containers (e.g. syringes), first and second plungers for simultaneously injecting fluids, a contrast pattern generating chamber and a catheter. Examiner notes that the claimed features of an air port and fluid connections and are part of the patented devices (see Fig. 1).
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,648,033. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed toward methods of providing a contrast medium composition to a structure (e.g. fallopian tube and/or uterus) using a contrast generating device including two containers (e.g. syringes), first and second plungers for simultaneously injecting fluids, a contrast pattern generating chamber and a catheter. Examiner notes that the claimed features of an air port and fluid connections and are part of the patented devices (see Fig. 1).
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,171.463. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed toward methods of providing a contrast medium composition to a structure (e.g. fallopian tube and/or uterus) using a contrast generating device including two containers (e.g. syringes), first and second plungers for simultaneously injecting fluids, a contrast pattern generating chamber and a catheter. Examiner notes that the claimed features of an air port and fluid connections and are part of the patented devices (see Fig. 1).
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/031733. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed toward methods of providing a contrast medium composition to a structure (e.g. fallopian tube and/or uterus) using a contrast generating device including two containers (e.g. syringes), first and second plungers for simultaneously injecting fluids, a contrast pattern generating chamber and a catheter. Examiner notes that the claimed features of an air port and fluid connections and are part of the co-pending device (see Fig. 1).
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER L COOK whose telephone number is (571)270-7373. The examiner can normally be reached M-F approximately 8AM-5PM.
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/CHRISTOPHER L COOK/Primary Examiner, Art Unit 3797