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 .
DETAILED ACTION
Claims 1, 3-4, 6, 8, 10-11, 14, 16, 18, 20, 22, 24-25, 27, 32, 41, 45-47 and 49 are pending and are under consideration in the instant office action.
Priority
This application claims priority to United States Provisional Application No.
63/189,947, filed May 18, 2021.
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:
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-4, 6, 8, 10-11, 14, 16, 18, 22, 24, 27, 32, 45-47 and 49 are rejected under 35 U.S.C. 102 (a) (1) and under 35 U.S.C 102(a)(2) as being anticipated by Gerber et al. (US 2022/0008384, priority date 03/28/2019)
Instant claims are drawn to a method of preparing a subject for surgery, comprising perineurally administering RTX to a subject in need of surgery.
Gerber et al. discloses method for postoperative pain control in a patient in need thereof, said method comprising administering a composition to a site intended for surgery in said patient at least one day before surgery is actually performed, wherein the composition comprises capsaicin or a capsacinoid such as resiniferatoxin (RTX) ([0007], [0030] reference Claim 1). Gerber discloses administration of 20-5000 ng of resiniferatoxin (reference Claim 7) and discloses wherein a dose of local anesthetic such as 0.1-5% bupivacaine is administered prior to, simultaneously with or posteriorly to the capsacinoid such as RTX administration (reference claim 8, reference claim 11, [0032-0033]). Gerber et al. discloses that particularly effective is the method to treat postoperative pain of orthopedic interventions and surgeries related to sports injuries, either from open, minimally invasive or arthroscopic surgery which may include joint replacement surgery, arthroplasty, debridement, cartilage repair, osteosynthesis, fracture treatment, treatment of ligament or tendon rupture or distortion (sprain), amputation, tumor or cancer surgery, in any joint, shoulder, elbow, hand, hip, knee, ankle or foot. [0009]. They disclose possible injection sites for RTX to include directly into the area of the surgical approach (skin incision, tissue preparation area) to the region of surgery, in the context of joint surgery around and or into (intraarticularly, into the synovial space) the joint space, to the sensory nerves connected to the area of surgery or as a regional or spinal anesthesia and they disclose that the site of infiltration may be defined by controlling of the needle position or the distribution of a contrast medium mixed with local anesthetics or RTX or being administered prior to this by means of fluoroscopy, radiographs, computer tomography or ultrasound. If the position of the injection needle or any suitable alternative administration tool (small catheter, tube) has been verified, it may be left in place to ensure the identical site of injection for a local anesthetic and the RTX solution. [0024-0026]. Gerber et al. discloses the volume of liquid to be injected into the intracapsular area may be from 0.1 to 150 ml. For a finger joint about max. 1 ml, for the shoulder joint max. 10 ml, for the knee joint max. about 30-50 ml, but preferably not over 20 ml [0023]. Gerber et al. further discloses compositions of the agents in a pharmaceutically acceptable vehicle, such as sodium chloride solution for injection, Ringer's solution for injection, isotonic dextrose, sterile water dextrose solution, Lactated Ringers injection solution, distilled water or mixtures thereof [0016] and discloses that RTX is preferably dissolved in a biocompatible solvent and is conveniently injected in an amount that corresponds to the available space in the joint to be treated so that it fills up easily to bulging and that the solvents may additionally contain permeation enhancer such as ethanol, phosphatidylcholines, propylene glycol dipelargonate (DPPG), or glycosylated glycerides [0020-0021], solubility enhancers such as benzyl alcohols, butylated hydroxytoluene’s, cremophores (EL, RH60), polyoxymethylene, sorbitanmonooleate or mannose to improve the activity of RTX. [0022]. They disclose buffering the solution with agents such as HEPES, phosphate, TRIS, Histidine, MOPS is required to establish the pH between 7.5 and 8.0 [0017].
It is noted that Gerber et al, does not use the term perineural administration, However, Perineural administration is a targeted technique that injects medications, such as local anesthetics or anti-inflammatory agents, directly around specific nerves or nerve clusters (plexuses) to block pain, reduce inflammation, and improve mobility. Often guided by ultrasound, this method provides precise, localized relief for chronic pain or surgical procedures with reduced systemic side effects. Gerber et al. explicitly discloses administering the RTX to the joint space or the sensory nerves connected to the area of surgery [0024] which is the same as perineural, absence of evidence to the contrary.
With regards to claims 3-4, 6, 8, 10 and 49 these are functional properties of the RTX and will occur when it is administered to the surgical site in a patient in need of surgery. Gerber et al. discloses the administration of the same drug, to the same subject, at the same site for the same purpose as instantly claimed and as such these functional limitations of the treatment will inherently occur. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). It is also noted that, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430,433 (CCPA 1977). See also MPEP § 2112.01 with regard to inherency and product-by-process claims. In addition, it is also noted that “Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. 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).
Therefore the method disclosed by Gerber et al. fully anticipates instant claims 1, 3-4, 6, 8, 10-11, 14, 16, 18, 22, 24, 27, 32, 45-47 and 49.
Claims 1, 3-4, 6, 8, 10, 14, 16, 18, 20, 22, 24-25, 27, 32, 41, 45 and 49 are rejected under 35 U.S.C. 102 (a) (1) and under 35 U.S.C 102(a)(2) as being anticipated by Nahama et al. (US 20210393515, priority date of 12/21/2018)
Instant claims are drawn to a method of preparing a subject for surgery, comprising perineurally administering RTX to a subject in need of surgery.
Nahama et al. discloses administration of resiniferatoxin (RTX) perineurally in methods of treating maladaptive pain (claim 1). Nahama further discloses that during surgical or traumatic amputations, a substantial amount of trauma occurs in nerves and the surrounding tissue. This neural injury allows the sprouting of nerve endings, causing the terminals to become hyper-excitable, which is perpetuated and worsened by local inflammation. [0077]. Nahama et al. in addition disclose the inclusion criteria in their study wherein the cat has undergone surgery for treatment with RTX [0060-0061] Maladaptive pain is inclusive of chronic post-surgical pain which persists months after surgery beyond the healing time. Nahama et al. discloses where in the subject is a mammal such as a human or cat [0034], the subject is an amputee which would be a subject who has had surgery [0035], They disclose that RTX may be administered perineurally to one or more than one site [0038] (claim 5) at a dose of he RTX is administered at a dose of 0.1-100 μg perineurally or as a nerve block [0043]. Nahama et al. discloses formulations of RTX used comprising a pharmaceutically acceptable carrier comprising a) water; b) polysorbate 80; c) polyethylene glycol; d) a sugar or sugar alcohol; e) mannitol; f) dextrose; g) a pharmaceutically acceptable salt; and/or h) a pharmaceutically acceptable buffer (claim 14- 15) with a pH in the range of 6-7.6 (claim 23). They disclose that RTX is administered in an injection volume of 0.05-10 ml, optionally wherein the injection volume is in the range of 0.05-0.2 ml, 0.2-0.5 ml, 0.5-1 ml, 1-2 ml, 2-5 ml, or 5-10 ml (claim 32), They disclose wherein the concentration of RTX in the pharmaceutical formulation is in the range of 0.02-0.1 μg/ml, 0.1-1 μg/ml, 1-5 μg/ml, 5-10 μg/ml, 10-20 μg/ml, 20-50 μg/ml, 50-100 μg/ml, 100-150 μg/ml, 150-200 μg/ml, 200-250 μg/ml, or 250-300 μg/ml. (claim 29) and administering a dose of 0.1 μg to 100 μg of RTX, or a dose of RTX in the range of from 0.1-1 μg, 1-2 μg, 2-5 μg, 5-10 μg, 10-20 μg, 20-30 μg, 30-40 μg, 40-50 μg, 50-60 μg, 60-70 μg, 70-80 μg, 80-90 μg, or 90-100 μg.(claim 3)
With regards to claims 3-4, 6, 8, 10 and 49 these are functional properties of the RTX and will occur when it is administered to the surgical site in a patient in need of surgery. Nahama et al. discloses the administration of the same drug, to the same subject, at the same site for the same purpose as instantly claimed and as such these functional limitations of the treatment will inherently occur. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). It is also noted that, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430,433 (CCPA 1977). See also MPEP § 2112.01 with regard to inherency and product-by-process claims. In addition, it is also noted that “Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. 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).
Therefore the method disclosed by Nahama et al. fully anticipates instant claims 1, 3-4, 6, 8, 10, 14, 16, 18, 20, 22, 24-25, 27, 32, 41, 45 and 49
Conclusion
Claims 1, 3-4, 6, 8, 10-11, 14, 16, 18, 20, 22, 24-25, 27, 32, 41, 45-47 and 49 are rejected. No claims are allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAVITHA RAO whose telephone number is (571)270-5315. The examiner can normally be reached on Mon-Fri 7 am to 4 pm..
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dierdre (Renee) Claytor can be reached on (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAVITHA M RAO/Primary Examiner, Art Unit 1691
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