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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 3, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1 – 29 are examined here-in.
Claim Objections
Claims 14 and 25 are objected to because of the following informalities:
In line 2 of claim 14, the linking verb “is” should be added between the phrases “effect of the analgesic” and “no longer effective” to read “effect of the analgesic is no longer effective”.
In claim 25, there is a period after PLGA. This period should be replaced with a comma.
In claim 25 “Anecortave” is capitalized although it is not a proper noun. Anecortave should not be capitalized.
In claim 25, it appears that there should be a comma between acetate and gelatin.
Appropriate correction is required.
Rejections of “Use” Claims - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 – 28 are directed to non-statutory subject matter. The claims does not fall within at least one of the four categories of patent eligible subject matter because "use of at formulation" is not a process, machine, manufacture, or composition of matter.
For the purposes of this examination, claims 1 – 27 are interpreted as method claims because independent claim 1 appears to include the active, positive step of “topically administering”. For claim 28, it is unclear if there is an active, positive step: Claim 28 is addressed below.
Rejections of “Use” Claims - 35 USC § 112(b)
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.
Claim 28 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. The claim is written as “use of formulation… in the manufacture of a medicament…” which is indefinite because it merely recites a use without any active, positive steps delimiting how the use is practiced. See MPEP 2173.05(q). For claim 28, it is unclear what the active, positive step is meant to be.
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.
Claim 25 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, 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 25 recites the broad recitation poly-2-hydroxyethylmetacrylate, then in parentheses p-HEMA hydrogels which is the narrower statement of the range/limitation. The use of the term “hydrogels” is the narrower statement of the limitation because a hydrogel is a specific form of polymer, rather than the broader range of any poly-2-hydroxyethylmetacrylate polymer. The claim is 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
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 – 6, and 21 – 27 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Wang (US 10,265,280 B2).
Wang teaches topical application of a composition containing ambroxol to the eye (column 1 lines 41 – 62, claim 1), anticipating instant claim 1. Wang teaches that the application of the composition alleviates irritation, itchiness, and burning (column 4 lines 13 – 16), reading on “nociceptive and/or neuropathic ocular pain” as recited in instant claim 1. The instant specification notes that nociceptive and/or neuropathic ocular pain may include a burning sensation (page 11 lines 4 -7), and that symptoms of chronic eye pain include discomfort, burning, and itching (page 25 lines 5 – 8).
Each of the functional limitations recited for claims 2 – 4 (i.e. provides partial preservation of sensation in the eye, wherein partial preservation of sensation in the eye comprises a preservation of at least 10% of corneal sensation, wherein partial preservation of sensation in the eye comprises a preservation of at least 20% of corneal sensation) are the result of topical application of a composition containing ambroxol as taught by Wang since it does not appear from the instant disclosure that additional elements are required to cause the functional limitations (instant specification pages 19 – 20, example 2). According to MPEP 2112(III) and 2163.07(a), an inherent feature of a composition or method does not need to be explicitly recognized in the prior art for the prior art to be applied. Said differently, “By disclosing in a patent application a device that inherently performs a function or has a property, operates according to a theory or has an advantage, a patent application necessarily discloses that function, theory or advantage, even though it says nothing explicit concerning it” MPEP 2163.07(a).
Since topical application of a composition containing ambroxol as taught by Wang appears to overlap with the instant claims, the skilled artisan would have expected that the composition and method of Wang would have had the same ability to provide partial preservation of sensation in the eye, wherein partial preservation of sensation in the eye comprises a preservation of at least 10% of corneal sensation, wherein partial preservation of sensation in the eye comprises a preservation of at least 20% of corneal sensation as that which is instantly claimed. Something which is old (e.g., the composition and method of Wang) does not become patentable upon the discovery of a new property (e.g., the ability to provide partial preservation of sensation in the eye, wherein partial preservation of sensation in the eye comprises a preservation of at least 10% of corneal sensation, wherein partial preservation of sensation in the eye comprises a preservation of at least 20% of corneal sensation), and this feature need not have been recognized at the time of the invention. See MPEP 2112(I) and 2112(II). Put another way, "When the claimed compositions are not novel they are not rendered patentable by recitation of properties, whether or not these properties are shown or suggested in the prior art." In re Spada, 911 F .2d 705, 709, (Fed. Cir. 1990). Therefore, since Wang’s prior art teachings recite the composition and method of administering ambroxol to the eye, the functional limitations of claims 2 – 4 are anticipated.
Wang teaches ambroxol in an amount of 0.01 to 2 weight percent of the composition (column 3 lines 4 – 14, claims 1, 5, 6, 10) anticipating instant claims 5 and 6. Prior art teachings that overlap the claimed range with sufficient specificity are anticipatory according to MPEP 2131.03(ii). In this case, Wang’s teaching for 0.01 to 2 weight percent falls within the claimed ranges of 0.001 to 10% and 0.05 to 2.0% as recited in claims 5 and 6, respectively.
Wang teaches the composition can be administered via a device such as an external pump or an ocular insert device, among others (column 4 lines 44 – 49) anticipating instant claim 21.
Wang teaches the composition includes at least one biocompatible polymer dissolved in the carrier or impregnated with ambroxol to provide extended release (column 1 lines 50 – 54, claim 7) anticipating instant claims 22 – 24.
Wang teaches the biocompatible polymer may be poly-2-hydroxyethylmethacrylate, poly(lactic-co-glycolic) acid, polycaprolactone, hydroxypropyl cellulose, anecortave acetate, gelatin, and/or collagen (column 3 lines 25 – 32, claim 8), anticipating instant claim 25.
Wang teaches the composition may include additives such as lubricants, preservatives, ionic species, or pH-adjusting agents, among others (column 1 lines 46 – 48), anticipating instant claim 26.
Wang’s teaching that application of the composition containing ambroxol alleviates irritation, itchiness, and burning (column 4 lines 13 – 16) anticipates instant claim 27 which recites “administration of the effective amount of the formulation results in a decrease in subjective symptoms”.
However, in the event that the previous does not have sufficient specificity to rise to anticipation, claims 1 – 6 and 21 – 27 are also rejected under 35 U.S.C. 103 below.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 1 – 6 and 21 – 27 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (as cited above).
For the purposes of this ground of rejection only, and purely arguendo, the Examiner will take the position that Wang does not teach a specific embodiment (i.e., preferred embodiment, working example, etc.) having all of the claimed elements arranged as required by the claims without resorting to some “picking and choosing” within the prior art disclosure. That being said, although Wang thus would not be anticipatory by this interpretation of the facts, it nevertheless does fairly suggest the claimed invention, as shown below.
Wang teaches topical application of a composition containing ambroxol to the eye (column 1 lines 41 – 62, claim 1) and that the application of the composition alleviates irritation, itchiness, and burning (column 4 lines 13 – 16).
Wang teaches ambroxol in an amount of 0.01 to 2 weight percent of the composition (column 3 lines 4 – 14, claims 1, 5, 6, 10).
Wang teaches the composition can be administered via a device such as an external pump or an ocular insert device, among others (column 4 lines 44 – 49).
Wang teaches the composition includes at least one biocompatible polymer dissolved in the carrier or impregnated with ambroxol to provide extended release (column 1 lines 50 – 54, claim 7). Wang teaches the biocompatible polymer may be poly-2-hydroxyethylmethacrylate, poly(lactic-co-glycolic) acid, polycaprolactone, hydroxypropyl cellulose, anecortave acetate, gelatin, and/or collagen (column 3 lines 25 – 32, claim 8).
Wang teaches the composition may include additives such as lubricants, preservatives, ionic species, or pH-adjusting agents, among others (column 1 lines 46 – 48).
As discussed above, for the purposes of this rejection and purely arguendo, the Examiner will take the position that Wang does not teach a specific embodiment having each of the claimed elements, however, claims 1 – 6 and 21 – 27 are rendered prima facie obvious over the teachings of Wang, because it is prima facie obvious to combine prior art elements according to known methods, in order to yield predictable results (MPEP 2143(i)(a)). In the instant case, all the claimed elements (e.g., ambroxol, additives, biocompatible polymers) were known in the prior art (e.g., ocular compositions) and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results (e.g., an ocular composition with ambroxol, additives, and biocompatible polymers) to one of ordinary skill in the art.
Wang’s teaching for the topical application of a composition containing ambroxol to the eye (column 1 lines 41 – 62, claim 1) and that the application of the composition alleviates irritation, itchiness, and burning (column 4 lines 13 – 16) reads on instant claim 1. Wang’s teaching that the application of the composition alleviates irritation, itchiness, and burning (column 4 lines 13 – 16), reads on “nociceptive and/or neuropathic ocular pain” as recited in instant claim 1 because the instant specification notes that nociceptive and/or neuropathic ocular pain may include a burning sensation (page 11 lines 4 -7), and that symptoms of chronic eye pain include discomfort, burning, and itching (page 25 lines 5 – 8). Furthermore, Wang’s teaching that the application of the composition alleviates irritation, itchiness, and burning (column 4 lines 13 – 16) reads on “a decrease in subjective symptoms” as recited in claim 27.
Each of the functional limitations recited for claims 2 – 4 (i.e. provides partial preservation of sensation in the eye, wherein partial preservation of sensation in the eye comprises a preservation of at least 10% of corneal sensation, wherein partial preservation of sensation in the eye comprises a preservation of at least 20% of corneal sensation) are the result of topical application of a composition containing ambroxol as taught by Wang since it does not appear from the instant disclosure that additional elements are required to cause the functional limitations (instant specification pages 19 – 20, example 2). According to MPEP 2112(III) and 2163.07(a), an inherent feature of a composition or method does not need to be explicitly recognized in the prior art for the prior art to be applied. Said differently, “By disclosing in a patent application a device that inherently performs a function or has a property, operates according to a theory or has an advantage, a patent application necessarily discloses that function, theory or advantage, even though it says nothing explicit concerning it” MPEP 2163.07(a).
Since topical application of a composition containing ambroxol as taught by Wang appears to overlap with the instant claims, the skilled artisan would have expected that the composition and method of Wang would have had the same ability to provide partial preservation of sensation in the eye, wherein partial preservation of sensation in the eye comprises a preservation of at least 10% of corneal sensation, wherein partial preservation of sensation in the eye comprises a preservation of at least 20% of corneal sensation as that which is instantly claimed. Something which is old (e.g., the composition and method of Wang) does not become patentable upon the discovery of a new property (e.g., the ability to provide partial preservation of sensation in the eye, wherein partial preservation of sensation in the eye comprises a preservation of at least 10% of corneal sensation, wherein partial preservation of sensation in the eye comprises a preservation of at least 20% of corneal sensation), and this feature need not have been recognized at the time of the invention. See MPEP 2112(I) and 2112(II). Put another way, "When the claimed compositions are not novel they are not rendered patentable by recitation of properties, whether or not these properties are shown or suggested in the prior art." In re Spada, 911 F .2d 705, 709, (Fed. Cir. 1990). Therefore, since Wang’s prior art teachings recite the composition and method of administering ambroxol to the eye, the functional limitations of claims 2 – 4 are obvious.
Wang’s teaching for ambroxol in an amount of 0.01 to 2 weight percent of the composition (column 3 lines 4 – 14, claims 1, 5, 6, 10) reads on instant claims 5 and 6 which recite 0.001 to 10% and 0.05 to 2.0%, respectively. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
Wang’s teaching that the composition can be administered via a device such as an external pump or an ocular insert device, among others (column 4 lines 44 – 49) reads on instant claim 21.
Wang’s teaching that the composition includes at least one biocompatible polymer dissolved in the carrier or impregnated with ambroxol to provide extended release (column 1 lines 50 – 54, claim 7) reads on instant claims 22 – 24.
Wang’s teaching that the biocompatible polymer may be poly-2-hydroxyethylmethacrylate, poly(lactic-co-glycolic) acid, polycaprolactone, hydroxypropyl cellulose, anecortave acetate, gelatin, and/or collagen (column 3 lines 25 – 32, claim 8) reads on instant claim 25.
Wang’s teaching that the composition may include additives such as lubricants, preservatives, ionic species, or pH-adjusting agents, among others (column 1 lines 46 – 48) reads on instant claim 26.
Claims 7, 8, 18 – 20, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (as cited above) and further in view of Milburn (US 2007/0014833 A1).
Wang’s teachings are discussed above.
Wang does not teach the inclusion of cyclodextrin.
Milburn teaches the missing elements of Wang.
Milburn teaches the treatment of ocular conditions or disorders with sirtuin modulators (abstract). Milburn teaches ambroxol as a sirtuin modulator (paragraph 0057).
Milburn teaches that sirtuin modulators entrapped in cyclodextrin are advantageous because they are water soluble, have very low toxicity, and can be delivered by various techniques (paragraphs 1227 – 1228).
Milburn teaches that trauma or surgery are conditions for which sirtuin modulators are useful treatments (paragraphs 0038, 0053, 1094, 1097, 1103).
The combination of Wang and Milburn’s teachings renders claims 7, 8, 18 – 20, and 29 prima facie obvious as combining prior art elements according to known methods to yield predictable results (MPEP 2143(i)(a)). In the instant case, a person of ordinary skill in the art would have been motivated to combine Wang’s teachings for a composition containing ambroxol with Milburn’s teachings to encapsulate drug in cyclodextrin because Milburn teaches that entrapment in cyclodextrin makes the complex water soluble with very low toxicity (paragraphs 1227 – 1228). Furthermore, Milburn names ambroxol as a drug of interest for entrapping in cyclodextrin to treat ocular conditions (abstract, paragraph 0057). Therefore, the combination of Wang and Milburn’s teachings is prima facie obvious according to MPEP 2143(i)(a) as combining prior art elements (ambroxol, additives, biocompatible polymers, cyclodextrin) according to known methods to yield predictable results (an ocular composition with ambroxol encapsulated in cyclodextrin).
The combination of Wang’s teaching for the topical application of a composition containing ambroxol to the eye (column 1 lines 41 – 62, claim 1) with Milburn’s teaching to encapsulate ambroxol with cyclodextrin (abstract, paragraph 0057, 1227 – 1228) reads on instant claims 7 and 29. Wang’s teaching for ambroxol in an amount of 0.01 to 2 weight percent of the composition (column 3 lines 4 – 14, claims 1, 5, 6, 10) overlaps on the instantly claimed amount of 0.01 to 10% as recited in claim 29. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
Milburn’s teaching that trauma or surgery are conditions for which sirtuin modulators (of which ambroxol is one) are appropriate treatments (paragraphs 0038, 0053, 1094, 1097, 1103) reads on instant claims 8 and 18 - 20. Although Milburn doesn’t teach the specific times of 60, 20, and 5 minutes after trauma or surgery, identifying these administration time points is within the expertise of a person of ordinary skill in the art for optimization through routine experimentation, which is prima facie obvious according to MPEP 2144.04(ii)(a). A person of ordinary skill in the art would be motivated to experiment with time periods such as 5 minutes to efficiently evaluate time frames that efficacy of administration is impacted by: accordingly routine experimentation might include administering the composition at 0 min, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, and 60 min, which covers the claimed times recited in claims 18 – 20.
Claims 9 – 17 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (as cited above) and further in view of Gaida (US 2003/01713910 A1).
Wang’s teachings are discussed above.
Wang does not teach the inclusion of an analgesic.
Gaida teaches the missing elements of Wang.
Gaida teaches ambroxol has good activity for the treatment of chronic pain and neurological diseases (paragraphs 0002, 0009). Gaida teaches that ambroxol is antinociceptive because it blocks voltage-dependent sodium channels (paragraph 0021). Gaida teaches a composition with ambroxol and one or more active substances such as opiates or non-steroidal analgesics (paragraphs 0014 – 0017, claims 6, 7).
The combination of Wang and Gaida’s teachings renders claims 9 – 17 and 28 prima facie obvious as combining prior art elements according to known methods to yield predictable results. A person of ordinary skill in the art would be motivated to combine ambroxol with an opiate or non-steroidal analgesic as taught by Gaida with the expectation that a combination of drugs would address pain in more than one way. For example, Gaida teaches that ambroxol treats pain by blocking voltage-dependent sodium channels (paragraph 0021), and a person of ordinary skill in the art would recognize that opiates target pain through different mechanisms. As such, a person of ordinary skill in the art would be motivated to combine Wang’s teachings for ambroxol administration to the eye with Gaida’s teaching of ambroxol and other active substances to treat pain in order to make a composition of ambroxol, with an other active substance, for administration to the eye to treat pain. The combination of prior art elements according to known methods to yield predictable results is prima facie obvious according to MPEP 2143(i)(a).
The combination of Wang’s teaching for the topical application of a composition containing ambroxol to the eye (column 1 lines 41 – 62, claim 1) with Gaida’s teaching to combine ambroxol and one or more active substances such as opiates or non-steroidal analgesics (paragraphs 0014 – 0017) reads on instant claims 9, 16, and 17.
Gaida names lidocaine specifically as an active substance to include in a composition with ambroxol (paragraphs 0014 – 0015), reading on instant claim 15.
Instant claims 10 – 13 are directed to administering the additional active substance before, after, or at the same time as ambroxol. Gaida’s teachings of a composition with ambroxol with one or more active substances (paragraphs 0014 – 0017) suggest that ambroxol and the other active substance are administered at the same time, reading on instant claim 11. According to MPEP 2144.04(iv)(c), selection of any order of performing steps or mixing ingredients is prima facie obvious in the absence of new or unexpected results, reading on claims 10, 12, and 13.
The functional limitations recited for claim 14 (i.e. “wherein the formulation continues to treat nociceptive and neuropathic ocular pain after the effect of the analgesic is no longer effective”) appear to be the result of topical application of a composition containing ambroxol and an other active agent as taught by the combination of Wang and Gaida since it does not appear from the instant disclosure that additional elements are required to cause the functional limitations (example 3). According to MPEP 2112(III) and 2163.07(a), an inherent feature of a composition or method does not need to be explicitly recognized in the prior art for the prior art to be applied. Said differently, “By disclosing in a patent application a device that inherently performs a function or has a property, operates according to a theory or has an advantage, a patent application necessarily discloses that function, theory or advantage, even though it says nothing explicit concerning it” MPEP 2163.07(a).
Since topical application of a composition containing ambroxol and an other active agent as taught by the combination of Wang and Gaida appears to overlap with the instant claims, the skilled artisan would have expected that the composition and method of Wang would have had the same ability to continue to treat nociceptive and neuropathic ocular pain after the effect of the analgesic is no longer effective as that which is instantly claimed. Something which is old (e.g., a composition containing ambroxol and an other active agent as taught by the combination of Wang and Gaida) does not become patentable upon the discovery of a new property (e.g., to continue to treat nociceptive and neuropathic ocular pain after the effect of the analgesic is no longer effective), and this feature need not have been recognized at the time of the invention. See MPEP 2112(I) and 2112(II). Put another way, "When the claimed compositions are not novel they are not rendered patentable by recitation of properties, whether or not these properties are shown or suggested in the prior art." In re Spada, 911 F .2d 705, 709, (Fed. Cir. 1990). Therefore, since the combination of Wang and Gaida’s prior art teachings recite the topical application of a composition containing ambroxol and an other active agent, the functional limitation of claim 14 is obvious.
The combination of a composition containing ambroxol with one or more active substances to treat pain (paragraphs 0014 – 0017) reads on “manufacture of a medicament” as recited in claim 28.
Double Patenting
The non-statutory 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 non-statutory 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 non-statutory 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 non-statutory 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.
Double Patenting over U.S. Patent No. 10,625,280
Claims 1 – 29 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1 – 10 of U.S. Patent No. 10,625,280.
Although the claims at issue are not identical, they are not patentably distinct from each other because: instant claim 1 is drawn to use of a formulation for treating nociceptive and/or neuropathic ocular pain in a subject comprising topically administering an effective amount of ambroxol and/or a derivative of ambroxol.
Conflicting claim 1 is drawn to a method of treating dry eye disease comprising topically administering to an ocular surface a formulation comprising ambroxol and/or a salt form of ambroxol in a weight percent of 0.01 to 20%.
The instant and conflicting claims differ because conflicting claim 1 recites treating dry eye disease and ambroxol in the amount of 0.01 to 20%. One symptom of dry eye disease is pain, therefore treating dry eye disease reads on treating ocular pain as recited in instant claim 1.
Conflicting claim 1’s requirement for ambroxol in the amount of 0.01 to 20% reads on the amounts of 0.001 to 10%, 0.05 to 2%, and 0.01 to 10% as recited in instant claims 5, 6, and 29.
The dependent conflicting claims overlap with the dependent instant claims in a similar manner.
Conclusion
All claims are rejected. No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Toriana N. Vigil whose telephone number is (571)270-7549. The examiner can normally be reached Monday - Friday 9:00 a.m. - 5:00 p.m. EST.
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/TORIANA N. VIGIL/ Examiner, Art Unit 1612
/SAHANA S KAUP/ Supervisory Primary Examiner, Art Unit 1612
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