DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claim 16 is objected to because of the following informalities: Claim 16 is objected to because fallopian is capitalized. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
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.
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 the 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, 9-11 and 14-16 is/are rejected under 35 U.S.C. 102(e) as being anticipated by U.S. Publication No. 2011/0137150 to Connor et al. “Connor”.
As for Claims 1-3, 9-11 and 14, 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 (e.g. syringe plungers) 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 (Paragraph [0019]) and an exit port that connects the aforementioned mixer to a catheter (Fig. 1).
Regarding Claim 12, Connor discloses wherein one syringe container can contain a microbubble contrast agent (e.g. contains a gas) and the other container contains saline (e.g. liquid) (Fig. 2).
As for Claims 15-16, Connor discloses 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.
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.
Claim(s) 4-8, 13 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Connor in view of U.S. Publication No. 2009/0028406 to Arditi et al. “Arditi”.
As for Claims 4-7, 13 and 18-20, Connor discloses a contrast medium device as described above but fails to specify the microbubble contrast agent container comprises a porous substance.
Arditi teaches from within a similar field of endeavor with respect to ultrasonic systems and methods to visualize a contrast agent (Abstract; Paragraph [0046]) where the contrast agent may include suspensions of gas bubbles in a liquid carrier where the gas bubbles are generally stabilized by entraining or encapsulating the gas or a precursor thereof into a variety of systems including emulsifiers, oils, thickeners, sugars, proteins or polymers and may involve a surfactant or other kinds of agents including suspension of porous microparticles or other solids (Paragraph [0046]).
Accordingly, one skilled in the art would have been motivated to have modified the microbubble contrast agent described by Connor to include other types of conventionally known ultrasound contrast agents described by Arditi in order to enhance the visualization. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Regarding Claim 8, Applicant explains the liquid may be foamed by shaking the container (Specification; Paragraph [0049]). Accordingly, the modified contrast agent described above could be foamed via shaking the container in its broadest reasonable interpretation.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Connor in view of U.S. Publication No. 2007/0128117 to Bettinger et al. “Bettinger”.
As for Claims 17, Connor discloses a contrast medium device as described above but fails to specify the microbubble contrast agent further comprises a therapeutic composition.
Bettinger teaches from within a similar field of endeavor with respect to ultrasound imaging with contrast agents where the contrast agent is combined with a therapeutic compound (Paragraph [0134]).
Accordingly, one skilled in the art would have been motivated to have modified the contrast medium device described by Connor to include other types of contrast agents combined with therapeutic compounds described by Bettinger in order to simultaneously diagnose and treat patient conditions. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
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 containers (e.g. syringes), plungers for simultaneously injecting fluids, a contrast pattern generating chamber and a catheter. The patented system is configured to generate and deliver the specific contrast medium specifics (e.g. gas, liquid, therapeutic composition, surfactant, emulsifier, other agents, etc.). Examiner notes that the presently pending claims represent an obvious broadening of the patented system.
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. The patented system is configured to generate and deliver the specific contrast medium specifics (e.g. gas, liquid, therapeutic composition, surfactant, emulsifier, other agents, etc.). Examiner notes that the presently pending claims represent an obvious broadening of the patented system.
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. The patented system is configured to generate and deliver the specific contrast medium specifics (e.g. gas, liquid, therapeutic composition, surfactant, emulsifier, other agents, etc.). Examiner notes that the presently pending claims represent an obvious broadening of the patented system.
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. The patented system is configured to generate and deliver the specific contrast medium specifics (e.g. gas, liquid, therapeutic composition, surfactant, emulsifier, other agents, etc.). Examiner notes that the presently pending claims represent an obvious broadening of the patented system.
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. The patented system is configured to generate and deliver the specific contrast medium specifics (e.g. gas, liquid, therapeutic composition, surfactant, emulsifier, other agents, etc.). Examiner notes that the presently pending claims represent an obvious broadening of the patented system.
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 containers (e.g. syringes), plungers for simultaneously injecting fluids, a contrast pattern generating chamber and a catheter. The patented system is configured to generate and deliver the specific contrast medium specifics (e.g. gas, liquid, therapeutic composition, surfactant, emulsifier, other agents, etc.). Examiner notes that the presently pending claims represent an obvious broadening of the patented system.
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 containers (e.g. syringes), plungers for simultaneously injecting fluids, a contrast pattern generating chamber and a catheter. The patented system is configured to generate and deliver the specific contrast medium specifics (e.g. gas, liquid, therapeutic composition, surfactant, emulsifier, other agents, etc.). Examiner notes that the presently pending claims represent an obvious broadening of the patented system.
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 containers (e.g. syringes), plungers for simultaneously injecting fluids, a contrast pattern generating chamber and a catheter. The patented system is configured to generate and deliver the specific contrast medium specifics (e.g. gas, liquid, therapeutic composition, surfactant, emulsifier, other agents, etc.). Examiner notes that the presently pending claims represent an obvious broadening of the patented system.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/032001. 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 containers (e.g. syringes), plungers for simultaneously injecting fluids, a contrast pattern generating chamber and a catheter. The patented system is configured to generate and deliver the specific contrast medium specifics (e.g. gas, liquid, therapeutic composition, surfactant, emulsifier, other agents, etc.). Examiner notes that the presently pending claims represent an obvious broadening of the patented system.
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