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 .
In view of the terminal disclaimer, previous double patenting rejections over claims of co-pending Application No. 17/489,349 are hereby withdrawn.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 14, 18, 20 and 22-35 are rejected under 35 U.S.C. 103 as being unpatentable over WAUGH (US 2017/0290778 A1) (with CHEN et al (US 2019/0389898 A1), which is being cited here merely to support the Examiner’s assertion that gabapentin and pregabalin have been well known to be effective to relieve neuropathy pain).
In claims 1, 13, 15 and 17, Waugh teaches a composition comprising (i) 0.1 - 25 wt.% of one or more active agents and (ii) 1.0 - 5.0 wt.% of decoy molecule selected from the group consisting of hyaluronic acid, collagen, fibronectin, elastin, lectin and fragment and combinations thereof (instant penetration enhancer). In claim 19, Waugh teaches that the active agent is selected from analgesic agents, antibacterial agents, antifungal agents, anesthetics, steroids, retinol, gabapentin, pregabalin, minocycline, salicylate, acetyl salicylic acid, cyclosporine, tacrolimus (FK 506), hydrocortisone, lidocaine, bimatoprost, botulinum toxin, tadalafil, an antibody or an antibody fragment. It would have been obvious to one skilled in the art to use gabapentin or pregabalin (instant active agent) as the active agent in Waugh’s composition with a reasonable expectation of success (besides, Waugh teaches delivery of gabapentin with hyaluronic acid (in the form of a saline solution) into skin in its Example 7). Waugh further teaches ([0052], claim 14, [0038]) that its composition can be topically administered to a skin surface tissue in the form of powders.
Based on Waugh’s teachings, it would have been obvious to one skilled in the art to topically administer to a skin surface tissue a powdered composition comprising 0.1-25 wt.% of an active agent, which is gabapentin or pregabalin (instant active agent), and 1.0-5.0 wt.% of decoy molecule selected from hyaluronic acid, collagen, fibronectin, elastin, lectin and fragment and combinations thereof (instant penetration enhancer) with a reasonable expectation of success. Furthermore, since a powder composition implies that ingredients making up the composition are also in powder form, Waugh’s composition in the form of powder also teaches instant powdered active agent and instant powdered penetration enhancer (Waugh’s powder composition also implies that such composition is substantially free of water as instantly recited in claim 18). Waugh further teaches ([0068]) that its composition can be used for treating nearly any condition including local pain relief or chronic pain relief. More specifically, gabapentin and pregabalin have been well known to be effective to relieve neuropathy pain, as evidenced by Chen et al ([0005]).
Thus, Waugh renders obvious instant claims 14, 18, 22-27.
With respect to instant claim 20, Waugh teaches ([0054]) that its composition may further include one or more pharmaceutically acceptable diluents, filler, disintegrants, binders, lubricants, surfactants, hydrophobic vehicles, emulsifiers, buffers, humectants, moisturizers, solubilizers, preservatives, colorants, plasticizers, carriers, excipients or combinations thereof. Furthermore, as discussed above, Waugh teaches or renders obvious instant powdered composition of claim 14, and since a powder composition implies that ingredients making up the composition are also in powder form, it would be obvious to one skilled in the art that those excipients listed above should also be in powder form. Thus, Waugh renders obvious instant claim 20.
With respect to instant claim 28, Waugh teaches (see [0067]) its composition can be applied to the (skin) surface tissue one or more times each day, for a period of at least 1 month. Thus, Waugh renders obvious instant claim 28.
With respect to instant claim 29, as already discussed above, gabapentin and pregabalin have been well known to be effective to relieve neuropathy pain (as evidenced by Chen et al ([0005])). Thus, it would be obvious to one skilled in the art to topically administer Waugh’s a powdered composition containing gabapentin or pregabalin to a skin surface tissue of a subject having neuropathy pain with a reasonable expectation of success. Thus, Waugh renders obvious instant claim 29.
With respect to instant claim 30, the Examiner already established above that it would be obvious to topically administer to a skin surface tissue a powdered composition comprising gabapentin or pregabalin (as an active agent), and decoy molecule selected from hyaluronic acid, collagen, fibronectin, elastin, lectin and fragment and combinations thereof. In claim 1, Waugh teaches that its composition comprises one or more active agents, and among the list for its active agent(s) (see claim 19), Waugh includes lidocaine as well as gabapentin or pregabalin. It would have been obvious to one skilled in the art to further include lidocaine (together with gabapentin or pregabalin) with a reasonable expectation of providing enhanced local pain relief or chronic pain relief. Thus, Waugh renders obvious instant claim 30.
With respect to instant claims 31-35, as discussed above, Waugh’s composition comprises 1.0 - 5.0 wt.% of decoy molecule (instant penetration enhancer) selected from the group consisting of hyaluronic acid, collagen, fibronectin, elastin, lectin and fragment and combinations thereof. Waugh’s range for the amount of decoy molecule overlaps with instant range of 0.1-6 wt.% of claim 31 or about 5 wt.% (which represents a range of 4.5 – 5.5 wt.% according to [0015] of present specification) of claim 32, thus rendering instant ranges prima facie obvious. In the case “where the [claimed] ranges overlap or lie inside ranges disclosed by the prior art,” a prima facie case of obviousness would exist which may be overcome by a showing of unexpected results, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Thus, Waugh renders obvious instant claims 31-35.
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over WAUGH (US 2017/0290778 A1) in view of Hendricus van Pinxteren et al (US 2016/0015792 A1) or JOSHI et al (US 2018/0116986 A1).
As discussed above, Waugh teaches or renders obvious topically administering to a skin surface tissue a powdered composition comprising powdered active agent (gabapentin or pregabalin) and a powdered decoy molecule (hyaluronic acid, collagen, fibronectin, elastin, lectin and fragment and combinations thereof). However, Waugh is silent as to the particle size for the powdered active agent or decoy molecule.
Hendricus van Pinxteren teaches (claims 1 and 10) a pharmaceutical composition comprising a sterile powder composition comprising powdered active agent (thrombin and fibrinogen powders) and pharmaceutically acceptable excipient in a powder form. Hendricus van Pinxteren also teaches ([0333]) that its composition can contain a binding agent such as hyaluronic acid. Hendricus van Pinxteren teaches (claim 28, [0082] and [0284]) that its powder composition can be topically applied to a skin external tissue to treat wound and teaches ([0104]) that the average particle size for its powder composition can range from 100 nm to 100 mm (i.e., 0.1mm – 100 mm). Another prior art, Joshi, teaches (claims 21 and 25, [0063]) a powder composition applied locally (topically) to mucosal or non-mucosal surfaces of a wound where the powder composition comprises an active agent, a local anesthetic (such as lidocaine) and hydrophilic polymers (such as hyaluronic acid or collagen). Joshi teaches ([0066] and [0003]) that for its invention, the wound can be any kinds of wounds including wounds on the skin. Joshi further teaches (claim 28) that the particle size of its powder composition can range from 0.1 micron to 200 microns. Under the guidelines given by Hendricus van Pinxteren or Joshi, instant range for the powdered active agent and the powdered penetration enhancer (decoy molecule) would have been obvious to one skilled in the art before the effective filing date of the claimed invention since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Thus, Waugh in view of Hendricus van Pinxteren or Joshi renders obvious instant claim 19.
Response to Arguments
Applicant argue that applicant unexpectedly discovered that the powder form of the active agent(s) and decoy molecule(s) could be topically applied for effective treatment. Applicant argue that of the 130-paragraph specification in Waugh, the term “powder” occurs one time in [0052] where it is listed in a general recitation of composition forms, along with other forms and also argue that Waugh further lists hundreds of active agents in 7 pages long paragraphs [0048]-[0051]. Applicant argue that the Examiner selects one particular composition form from Waugh for the particular active agent of applicant’s claimed invention and point to MPEP 2144.08 which states that the fact that a claimed species or subgenus is encompassed by a prior art genus is not sufficient by itself to establish a prima facie case of obviousness. In re Baird, 16 F.3d 380, 382, 29 USPQ2d 1550, 1552 (Fed. Cir. 1994) (“The fact that a claimed compound may be encompassed by a disclosed generic formula does not by itself render that compound obvious.”). Applicant argue that the fact that Waugh uses a saline solution for gabapentin with hyaluronic acid in Example 7 does not support the Examiner’s prima facie case of obviousness and strikes against an assumption that a powdered from can also be used. Applicant argue that [0052] of Waugh provides a general recitation of composition forms and that there is no guidance to one skilled in the art how to select a delivery form for a particular active agent. Applicant also argue that Waugh’s claim 14 does not recite a powdered composition and that there is no dependent claim to a powdered composition and argue that since claim 11 recites that the composition is formulated as a liquid, cream, ointment, gel or aerosol, it leads away from selecting a powdered composition. Applicant argue that Waugh’s examples and original claims lead one skilled in the art to liquid-based delivery and thus argue that the Examiner’s prima facie case of obviousness is not supported by Waugh’s disclosure but only based upon an improper level of hindsight. Applicant argue that the evidentiary reference, Chen, also strikes against one skilled in the art selecting powder from Waugh as the reference overall reflects the use of oral or liquid forms of gabapentin and pregabalin for pain therapy and does not lead one skilled in the art to select powder as a delivery form from Waugh’s disclosure. Thus, applicant conclude that neither prior art references discloses or suggests a powdered composition according to their claimed invention.
The Examiner disagrees. Waugh first recognizes ([0002]) that a topical route of drug administration is desirable because (i) the risks and inconvenience of parenteral treatment and the variable absorption and metabolism associated with oral treatment can be avoided; (ii) drug administration can be continuous, thereby permitting the use of pharmacologically active agents with short biological half-lives; (iii) the gastrointestinal irritation associated with many compounds can be avoided; and (iv) cutaneous manifestations of diseases can be treated more effectively than by systemic approaches. Waugh then teaches ([0052]) that compositions for such topical administration can be in the form of solutions, powders, fluid emulsions, fluid suspensions, solids, semi-solids, ointments, pastes, creams, gels and jellies, foams or aerosol; thus, there is a finite number of identified, predictable potential solutions indicated in Waugh for the topical route of administration of its composition. Waugh’s composition contains an active agent and a decoy molecule, and Waugh teaches ([0038]) that the decoy molecule is capable of causing rearrangement of tissues that the composition contacts by temporarily disrupting cell-cell (intercellular) and cell-scaffold attachment allowing the active agent to pass through cell layers and passive intracellular crossing of the active agent into cells throughout the tissue. Waugh further teaches ([0038]) that its compositions and methods described therein can be used for (topically) administering any active agent (including small molecule drugs, macromolecular drugs, biologics, antibodies, chimeric antibodies, peptides, antioxidants, and the like) and that the compositions can be applied to any surface tissue, including skin. Based on Waugh’s teaching in [0038], one of ordinary skill in the art could have pursed topically administering Waugh’s composition in the form of powders (one of the known potential solutions as taught by Waugh) with a reasonable expectation that the decoy molecules (such as hyaluronic acid, collagen, fibronectin, elastin, lectin) would cause rearrangement of tissues that the powdered composition contacts by temporarily disrupting cell-cell and cell-scaffold attachment, thus allowing the active agent (such as gabapentin or pregabalin) to pass though cell layers and passive intracellular crossing of the active agent into cells throughout the tissue. Although applicant argue that applicant “unexpectedly” discovered that the powder form of the active agent(s) and decoy molecule(s) could be topically applied for effective treatment, applicant have not submitted any comparative experimental data that shows “unexpected” superior results of using the powder form of their composition (i.e., as the powder form is often considered an obvious alternative to the solution form (as used in Waugh’s Example 7), in order to show unexpected superior results, the change into powder form must result in a new, non-obvious and technically improved invention). As to applicant’s argument that the fact that the term “powder” occurs only one time in Waugh, the fact that Waugh uses a saline solution for gabapentin with hyaluronic acid in Example 7 and the fact that Waugh’s claim 11 recites that the composition is formulated as a liquid, cream, ointment, gel or aerosol all teach away from selecting a powdered composition, in In re Mills and Palmer 176 USPQ 196, it was held that non-preferred embodiments cannot be ignored, and even if the non-preferred embodiments are used, obviousness exists. Patentee, in the same manner as applicant, is not limited in his teachings to only the exemplified subject matter. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). See MPEP 2123(II). Applicant’s argument that the evidentiary reference, Chen, also strikes against one skilled in the art selecting powder from Waugh as the reference overall reflects the use of oral or liquid forms of gabapentin and pregabalin for pain therapy is not persuasive because Chen was used solely for the purpose of supporting the Examiner’s assertion (in relation to instant claim 29) that gabapentin and pregabalin have been well known to be effective to relieve neuropathy pain. Although applicant point out that Waugh lists hundreds of active agents in 7 pages long paragraphs [0048]-[0051], Waugh gives much narrower list of its active agent in its claim 7 (gabapentin and pregabalin are among the 20 examples listed in claim 7). Besides, as already discussed above, Waugh teaches a composition containing gabapentin (instant active agent) with hyaluronic acid (instant decoy molecule) in its Example 7. As to applicant’s argument of improper hindsight, "[a]ny judgment on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure, such a reconstruction is proper." In re McLaughlin, 443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA 1971).
For the reasons explained above, instant 103 rejections over Waugh still stand.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIN J. LEE whose telephone number is (571)272-1333. The examiner can normally be reached on M-F 9 am-5:30pm.
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/SIN J LEE/
Primary Examiner, Art Unit 1613
February 19, 2026