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 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 20 is 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 20 recites the broad recitation about 10 mg to about 200 mg, and the claim also recites from about 20 mg to about 100 mg, or from about 25 mg to about 75 mg which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 102
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.
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:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3, 5, 7, 16-22, 25, 28, 32-33, 35, 38 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ferrillo (Ferrillo, Martin, Treatment of complex regional pain syndrome with stellate ganglion local anesthetic blockade: a case report of one patient’s experiences with traditional bupivacaine HCl and liposome bupivacaine, Clinical Case Reports 2016; 4(9): 861–865) as evidenced by Cleveland Clinic (Cleveland Clinic, Stellate Ganglion Block, 02/21/2023) and as evidenced by Qureshi (Qureshi et al., Long Acting Liposomal Bupivacaine for Percutaneous Sympathetic Stellate Ganglion Blockade: a Technical Note, Journal of Vascular and Interventional Neurology Vol. 9, No. 5, pp. 49–53. Published October, 2017).
The reference Ferrillo teaches “Treatment of complex regional pain syndrome with stellate ganglion local anesthetic blockade: a case report of one patient’s experiences with traditional bupivacaine HCl and liposome bupivacaine”(title) and “Liposome bupivacaine (bupivacaine liposome injectable suspension; EXPAREL , Pacira Pharmaceuticals, Inc., Parsippany, NJ) is a multivesicular formulation of bupivacaine indicated for single-dose administration into the surgical site to produce postsurgical analgesia [15]. Although liposome bupivacaine has been studied in a number of surgical settings [16–20], its use in SGB has not yet been reported. This case report describes the successful off-label use of liposome bupivacaine in SGB for refractory pain associated with CRPS”(page 862).
The reference Ferrillo also teaches “To the author’s knowledge, the current case report is the first published description of liposome bupivacaine use in SGB for patients with CRPS type I. The diagnosis of CRPS was strongly supported by clinical presentation, the main criterion to identify the condition [23–25]. The patient also responded to treatment for CRPS”(page 863) and “The onset of CRPS type I symptoms, also known as reflex sympathetic dystrophy, typically follows trauma to a limb or lesions in remote body areas [1, 4]”(page 861). SGB is stellate ganglion block see page 862, paragraph 2.
The Cleveland Clinic reference provides evidence of what is involved in a stellate ganglion block. The Cleveland Clinic teaches “A stellate ganglion block is an injection of medication into a collection of nerves at the bottom of the front side of your neck”(page 1) and “A stellate ganglion block (SGB) is an injection of anesthetic medication into a collection of nerves called the stellate ganglion. These nerves are located in your neck, on both sides of your voice box”(page 1). It also provides evidence of the injection site via a figure (page 1). It would have been inherent to the method to remove the needle.
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This anticipates claims 1, 7, 28, 35, 38.
The reference Ferrillo teaches “It has been hypothesized that the sympathetic nervous system is involved in the pathophysiology of CRPS in some patients [1, 4, 6, 8]. Therefore, interruption of the sympathetic supply to the painful area is one treatment approach used for CRPS”(page 862).
This anticipates claims 3 and 5.
Since the reference Ferrillo teaches the active step with the same exact composition (EXPAREL, page 862) as the instant specification (see examples 1-4, pages 16-18) the results of claim 16 (wherein the method causes a temporary reduction in the ability of the sympathetic nervous system to release neurotransmitters) would be inherent. “Products of identical chemical composition cannot have mutually exclusive properties.” Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F. 2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). This anticipates claim 16.
The reference Ferrillo teaches “About 4 months later, she received authorization for a left SGB with liposome bupivacaine. During the procedure, liposome bupivacaine 13.3 mg (1 mL) was injected” (page 863) and “Fourteen weeks later, she received authorization for four additional SGBs using liposome bupivacaine. The procedures were performed 3–5 weeks apart. Injections consisted of 2.0–2.5 mL of liposome bupivacaine (266 mg/20 mL [13.3 mg/mL])”( page 863). The reference Qureshi provides evidence that this concentration is the concentration of Bupivacaine in EXPAREL (pages 49-51) and that it is a phosphate salt.
This anticipates claims 18- 19, 21-22 and 25.
2mL of liposome bupivacaine x 13.3 mg/mL =26.6 mg liposome bupivacaine
This anticipates claim 20.
The reference Ferrillo teaches “About 4 months later, she received authorization for a left SGB with liposome bupivacaine. During the procedure, liposome bupivacaine 13.3 mg (1 mL) was injected”(page 863). This anticipates claim 32-33.
The reference Ferrillo teaches “The patient continued to experience approximately 3 weeks (18–21 days) of pain relief with each SGB with liposome bupivacaine”(page 863). This anticipates claim 17.
Claim(s) 1, 3, 5, 7, 16-22, 25, 28-29, 32, 35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Qureshi (Qureshi et al., Long Acting Liposomal Bupivacaine for Percutaneous Sympathetic Stellate Ganglion Blockade: a Technical Note, Journal of Vascular and Interventional Neurology Vol. 9, No. 5, pp. 49–53. Published October, 2017) as evidenced by Cleveland Clinic (Cleveland Clinic, Stellate Ganglion Block, 02/21/2023).
The reference Qureshi teaches “Long Acting Liposomal Bupivacaine for Percutaneous Sympathetic Stellate Ganglion Blockade: a Technical Note”(title) and “Liposomal bupivacaine (Exparel, Pacira Pharmaceuticals, San Diego, CA, USA) is a long-acting formulation of bupivacaine loaded in multi-vesicular liposomes” (page 49). The reference Qureshi teaches “A 43-year-old female physician developed right-sided headache after right internal carotid artery dissection, involving the high cervical and petrous segments confirmed by cerebral angiography. The headache was initially accompanied by Horner’s syndrome, which resolved over the next few months”. The reference Cleveland Clinic provides evidence that Horner’s syndrome and chronic post-surgical pain (with unknown cause and that can be treated with SGB) are disorders associated with the sympathetic nervous system(pages 1, 2 and 4).
The reference Qureshi teaches “Percutaneous sympathetic blockade using local injection of anesthetic agent within the paravertebral muscle compartment, which contains the cervical sympathetic fibers and stellate ganglion, has been used for multiple indications”(page 49).
The Cleveland Clinic reference provides evidence of what is involved in a stellate ganglion block. The Cleveland Clinic teaches “A stellate ganglion block is an injection of medication into a collection of nerves at the bottom of the front side of your neck”(page 1) and “A stellate ganglion block (SGB) is an injection of anesthetic medication into a collection of nerves called the stellate ganglion. These nerves are located in your neck, on both sides of your voice box”(page 1). It also provides evidence of the injection site via a figure (page 1). It would have been inherent to the method to remove the needle.
This anticipates claims 1, 3, 5, 29 and 35.
Since claim 1 only requires someone at risk of a disorder of claim 7 this also anticipates claim 7.
Since the reference Qureshi teaches the active step with the same exact composition (EXPAREL, page 862) as the instant specification (see examples 1-4, pages 16-18) the results of claim 16 (wherein the method causes a temporary reduction in the ability of the sympathetic nervous system to release neurotransmitters) would be inherent. “Products of identical chemical composition cannot have mutually exclusive properties.” Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F. 2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). This anticipates claim 16.
The reference Qureshi teaches “After the stellate ganglion block with bupivacaine hydrochloride, patient was headache free immediately after the block but with recurrence of pain on Day 3 with return to peak intensity by Day 4. After the stellate ganglion blockade with liposomal bupivacaine hydrochloride, patient reported recurrence of pain on Day 15 post injection with return to peak intensity by Day 17. The patient reported an episode of aura which consisted of visual scintillations on Day 2 which lasted for five days and resolved spontaneously”(abstract). This anticipates claim 17.
The reference Qureshi teaches “Liposomal bupivacaine (EXPAREL) 13.3 mg/mL (1.3%) solution diluted with preservative-free normal saline: a total solution of 20 ml (52 mg of bupivacaine) was injected at the level of the lower portion of body of the sixth cervical vertebra, medial to the right internal carotid artery. The response to sympathetic block was assessed by a neurologist not involved in the procedure”(abstract) and “The procedure was performed under conscious sedation. A total of 3 ml of 1% lidocaine was infiltrated to anesthetize the skin and superficial subcutaneous tissues. A 22-gauge × 3.5-inch BD Quincke spinal needle was introduced at the level of the lower portion of body of the sixth cervical vertebra, medial to the right internal carotid artery. The needle was advanced until it reached the junction between the body and the transverse process of the sixth cervical vertebra [Figure 1(A) and (B)]. The position of the needle was confirmed by contrast injection, which demonstrated the needle anterior to the para vertebral muscles, with spread along the axis of the interfascial compartment (see Figure 2). Liposomal bupivacaine was injected over 10 min in each procedure with monitoring of blood pressure and heart rate.”(page 50). It would have been inherent to the method to remove the needle.
The reference Qureshi teaches “Bupivacaine is encapsulated in a liposomal formulation as phosphate salt, but concentration is expressed as bupivacaine free base”(page 51).
This anticipates claims 18-22, 25, 28, 32.
Claim(s) 1, 3, 7, 16, 18-21, 23, 25, 28, 32-35 and 38 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lador (Lador et al., Stellate ganglion instrumentation for pharmacological blockade, nerve recording, and stimulation in patients with ventricular arrhythmias: Preliminary experience, Heart Rhythm, Vol 20, No 6, June 2023, pages 797-805) as evidenced by Cleveland Clinic (Cleveland Clinic, Stellate Ganglion Block, 02/21/2023) and as evidenced by Qureshi (Qureshi et al., Long Acting Liposomal Bupivacaine for Percutaneous Sympathetic Stellate Ganglion Blockade: a Technical Note, Journal of Vascular and Interventional Neurology Vol. 9, No. 5, pp. 49–53. Published October, 2017).
The reference Lador teaches “Specifically, activation of the sympathetic nervous system has been linked to ventricular arrhythmogenesis. The stellate ganglion (SG) contains a significant clustering of cardiac sympathetic innervation, and SG blockade (SGB) with anesthetic drugs is being increasingly used for controlling ventricular arrhythmias (VAs)”(page 797) and “Two patient cohorts were included—group 1: patients undergoing SGB for drug-refractory VAs. SGB was performed by injection of liposomal bupivacaine”(abstract).
The reference Lador teaches “All structures were identified by ultrasonography (carotid artery, left internal jugular vein, longus colli muscle, vertebral artery, anterior scalene muscle, and brachial plexus). The skin was first an esthetized with 2mL of 1% lidocaine. Then, a 22-G, 4-in needle (Micropuncture needle, Cook Medical, Bloomington, IN) was advanced under continuous ultrasound guidance lateral to or through the in ternal jugular vein, lateral to the carotid artery toward the SG, identified as an echogenic bight structure below the common carotid artery, anterior to the C7 tubercle. Visualization of the needle and vessels allowed to avoid vascular puncture, which was ruled out by aspiration. Then, 10 mL of 0.25% liposomal bupivacaine injectable suspension (EXPAREL, Pacira Pharmaceuticals, Tampa, FL) was injected. The procedure was performed on both sides using the outlined technique similar to what other groups have described.2,3,1”(page 798). The reference Qureshi provides evidence that this concentration is the concentration of Bupivacaine in EXPAREL (pages 49-51) and that it is a phosphate salt of bupivacaine loaded in multi-vesicular liposomes. It would have been inherent to the method to remove the needle. This anticipates claims 18-21, 25, 28, 32-33 and 38.
The Cleveland Clinic reference provides evidence of what is involved in a stellate ganglion block. The Cleveland Clinic teaches “A stellate ganglion block is an injection of medication into a collection of nerves at the bottom of the front side of your neck”(page 1) and “A stellate ganglion block (SGB) is an injection of anesthetic medication into a collection of nerves called the stellate ganglion. These nerves are located in your neck, on both sides of your voice box”(page 1). It also provides evidence of the injection site via a figure (page 1). It would have been inherent to the method to remove the needle.
This anticipates claims 1, 3 and 35.
Since claim 1 only requires someone at risk of a disorder of claim 7 this also anticipates claim 7.
The reference Lador teaches Bilateral SGB (table 1, page 801).
This anticipates claims 23 and 34.
Since the reference Lador teaches the active step with the same exact composition (EXPAREL, page 862) as the instant specification (see examples 1-4, pages 16-18) the results of claim 16 (wherein the method causes a temporary reduction in the ability of the sympathetic nervous system to release neurotransmitters) would be inherent. “Products of identical chemical composition cannot have mutually exclusive properties.” Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F. 2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). This anticipates claim 16.
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, 3, 5, 7, 16-23, 25, 28-29, 32-35 and 38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 11, 16-18, 20-22, 24-26, 28-29, 33, 45, 47-48 and 51 of copending Application No. 18/503,474 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Application ‘474 claims:
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This anticipates claims 1, 3, 5.
Since claim 1 only requires someone at risk of a disorder of claim 7 this also anticipates claim 7.
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This anticipates claims 16-17 and 32.
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This anticipates claims 18-23, and 28-29, 33-35 and 38.
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This anticipates claim 25.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3, 5, 7, 16-23, 25, 28-29, 32-35 and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-38 of U.S. Patent No. 12285419 B2 in view of Ferrillo (Ferrillo, Martin, Treatment of complex regional pain syndrome with stellate ganglion local anesthetic blockade: a case report of one patient’s experiences with traditional bupivacaine HCl and liposome bupivacaine in view of Lador (Lador et al., Stellate ganglion instrumentation for pharmacological blockade, nerve recording, and stimulation in patients with ventricular arrhythmias: Preliminary experience, Heart Rhythm, Vol 20, No 6, June 2023, pages 797-805) as evidenced by Cleveland Clinic (Cleveland Clinic, Stellate Ganglion Block, 02/21/2023) and in view of Qureshi (Qureshi et al., Long Acting Liposomal Bupivacaine for Percutaneous Sympathetic Stellate Ganglion Blockade: a Technical Note, Journal of Vascular and Interventional Neurology Vol. 9, No. 5, pp. 49–53. Published October, 2017).
Patent ‘419 claims:
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This helps to teach claims 1, 3, 5, 7, 16-23, 25, 28-29, 32-35 and 38.
The patent ‘419 does not teach a disorder associated with sympathetic nervous system (all claims), the specific concentration of 13.3mg/mL (claim 19) or amounts (claims 20-23), or left or right injection claims (33-34) or the nerves of claim 38.
The secondary references further teach that all needed changes would be obvious as outlined in the 102 rejections (which are incorporated herein by reference).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have modified patent ‘419 with Ferrillo, Lador and Qureshi because they all teach liposome bupivacaine for the purpose of stellate ganglion blockade. Thus one would be motivated to use the composition described in patent ‘419 because it is suggested for pain treatment for the purpose of stellate ganglion blockade in the methods of Ferrillo, Lador and Qureshi. One would have a reasonable expectation of success because the compositions and methods are very similar.
Claims 1, 3, 5, 7, 16-23, 25, 28-29, 32-35 and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12433878 B2 as evidenced by Lador (Lador et al., Stellate ganglion instrumentation for pharmacological blockade, nerve recording, and stimulation in patients with ventricular arrhythmias: Preliminary experience, Heart Rhythm, Vol 20, No 6, June 2023, pages 797-805).
The patent ‘878 claims:
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The reference Lador provides evidence that ventricular arrhythmia is a disorder associated with sympathetic nervous system, “Specifically, activation of the sympathetic nervous system has been linked to ventricular arrhythmogenesis. The stellate ganglion (SG) contains a significant clustering of cardiac sympathetic innervation, and SG blockade (SGB) with anesthetic drugs is being increasingly used for controlling ventricular arrhythmias (VAs)”(page 797).
This anticipates claims 1, 3, 5, 16-22.
Since claim 1 only requires someone at risk of a disorder of claim 7 this also anticipates claim 7.
The patent ‘878 claims:
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This anticipates claims 23, 25, 28-29, 32-35, and 38.
Conclusion
Claims 1, 3, 5, 7, 16-23, 25, 28-29, 32-35 and 38 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISON AZAR HASTINGS whose telephone number is (703)756-4584. The examiner can normally be reached Mon-Thurs 7:30am-5pm EST Friday 7:30-4pm EST (every other Friday off).
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/ALISON AZAR HASTINGS/ Examiner, Art Unit 1627
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