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 Objections
Claim 11 is objected to because of the following informalities: claim 11 recites the limitation “a portion of the quantity or additional quantity through the medical device” should read “a portion of the quantity or additional quantity of biocompatible fluid through the medical device”. Appropriate correction is required.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-10 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-10 of prior U.S. Patent No. 12,144,563. This is a statutory double patenting rejection.
Co-pending application
U.S. Patent No. 12,144,563
Claim 1: A method of performing an ultrasound-guided procedure, the method comprising: providing a medical device, the medical device comprising (i) a therapeutic distal tip configured to percutaneously alter internal tissue or bone at a treatment site of a patient; (ii) a source of biocompatible fluid; and (iii) a delivery system configured to selectively deliver a quantity of the biocompatible fluid, with echogenic microbubbles therein, to an area external and adjacent to the therapeutic distal tip; subcutaneously advancing the therapeutic distal tip toward the treatment site; delivering a quantity of biocompatible fluid with echogenic microbubbles to the area; observing, via ultrasound, an anatomic structure proximate the treatment site and dispersion of the echogenic microbubbles at the area; and based on a nature and location of the dispersion, steering the therapeutic distal tip relative to the anatomic structure, and continuing to advance the therapeutic distal tip toward the treatment site.
Claim 1: A method of performing an ultrasound-guided procedure, the method comprising: providing a medical device, the medical device comprising (i) a therapeutic distal tip configured to percutaneously alter internal tissue or bone at a treatment site of a patient; (ii) a source of biocompatible fluid; and (iii) a delivery system configured to selectively deliver a quantity of the biocompatible fluid, with echogenic microbubbles therein, to an area external and adjacent to the therapeutic distal tip; subcutaneously advancing the therapeutic distal tip toward the treatment site; delivering a quantity of biocompatible fluid with echogenic microbubbles to the area; observing, via ultrasound, an anatomic structure proximate the treatment site and dispersion of the echogenic microbubbles at the area; and based on a nature and location of the dispersion, steering the therapeutic distal tip relative to the anatomic structure, and continuing to advance the therapeutic distal tip toward the treatment site.
Claim 2: The method of claim 1, wherein the therapeutic distal tip comprises one of a blade, a trochar, a grinding tip, a source of ultrasonic energy, a source of radio frequency energy, and a source of pressurized fluid.
Claim 2: The method of claim 1, wherein the therapeutic distal tip comprises one of a blade, a trochar, a grinding tip, a source of ultrasonic energy, a source of radio frequency energy, and a source of pressurized fluid.
Claim 3: The method of claim 1, wherein the treatment site comprises a finger, a wrist, an elbow, a shoulder, a back, a hip, a knee, an ankle, a foot, a toe, or a joint.
Claim 3: The method of claim 1, wherein the treatment site comprises a finger, a wrist, an elbow, a shoulder, a back, a hip, a knee, an ankle, a foot, a toe, or a joint.
Claim 4: The method of claim 1, wherein the anatomic structure comprises a ligament, a tendon, a bone, a band of muscle, a portion of fat, a nerve, a vessel, a duct, a lymph node or a gland.
Claim 4: The method of claim 1, wherein the anatomic structure comprises a ligament, a tendon, a bone, a band of muscle, a portion of fat, a nerve, a vessel, a duct, a lymph node or a gland.
Claim 5: The method of claim 1, wherein steering the therapeutic distal tip relative to the anatomic structure comprises steering the therapeutic distal tip away from a blood vessel or a nerve.
Claim 5: The method of claim 1, wherein steering the therapeutic distal tip relative to the anatomic structure comprises steering the therapeutic distal tip away from a blood vessel or a nerve.
Claim 6: The method of claim 1, wherein observing the dispersion of the echogenic microbubbles comprises observing a lateral dispersion of the echogenic microbubbles parallel to a plane of tissue.
Claim 6: The method of claim 1, wherein observing the dispersion of the echogenic microbubbles comprises observing a lateral dispersion of the echogenic microbubbles parallel to a plane of tissue.
Claim 7: The method of claim 6, wherein steering the therapeutic distal tip comprises steering the therapeutic distal tip along the plane of tissue.
Claim 7: The method of claim 6, wherein steering the therapeutic distal tip comprises steering the therapeutic distal tip along the plane of tissue.
Claim 8: The method of claim 6, wherein steering the therapeutic distal tip comprises steering the therapeutic distal tip through the plane of tissue.
Claim 8: The method of claim 6, wherein steering the therapeutic distal tip comprises steering the therapeutic distal tip through the plane of tissue.
Claim 9: The method of claim 6, further comprising delivering an additional quantity of biocompatible fluid to hydrodissect the plane of tissue from other tissue adjacent the plane.
Claim 9: The method of claim 6, further comprising delivering an additional quantity of biocompatible fluid to hydrodissect the plane of tissue from other tissue adjacent the plane.
Claim 10: The method of claim 1, wherein observing the dispersion of the echogenic microbubbles comprises observing a diffuse dispersion of echogenic microbubbles.
Claim 10: The method of claim 1, wherein observing the dispersion of the echogenic microbubbles comprises observing a diffuse dispersion of echogenic microbubbles.
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 11 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 12,144,563. Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variation of each other.
Co-pending application
U.S. Patent No. 12,144,563
Claim 11: The method of claim 1, further comprising evacuating a portion of the quantity or additional quantity through the medical device.
Claim 11: The method of claim 9, further comprising evacuating a portion of the quantity or additional quantity of biocompatible fluid through the medical device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZAINAB M ALDARRAJI whose telephone number is (571)272-8726. The examiner can normally be reached Monday-Thursday7AM-5PM EST.
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/ZAINAB MOHAMMED ALDARRAJI/ Patent Examiner, Art Unit 3797