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 .
Response to Amendment
2. Applicant’s amendment and response, filed on November 19, 2025 has been reviewed by the examiner and entered of record in the file.
3. Claims 68, and 89-91 are amended. No claim is canceled or added.
4. Claims 68, 74, 75, 80 and 85-91 are under examination and are the subject of this office action.
Previous Claim Rejections - 35 USC § 112(b)
5. Claims 68, 74, 75, 80, and 85-88 were previously 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.
6. (a) Claim 68 was previously rejected for reciting the antibiotic “fluoroquinolone,” and also reciting antibiotics within the fluoroquinolone class, i.e., “ofloxacin, moxifloxacin, ciprofloxacin, levofloxacin, besifloxacin,” which is the narrower statement of the limitation “fluoroquinolone.” In view of Applicant’s amendment to delete fluoroquinolone from the claim, the indefiniteness rejection is overcome.
(b) Claim 68 was also rejected for reciting the range of NSAID present “in an amount of 0.05% and 0.5% (weight/volume),” because it was not clear if Applicant intended the amount of NSAID be limited to 0.05% OR 0.5%, or a range of amounts. In view of Applicant’s amendment to change the amount of NSAID to “from 0.05% to 0.5%,” the previous indefiniteness rejection is overcome.
(c) Claim 68 was also rejected for reciting the range of corticosteroid present “in an amount of 0.05% and 2% (weight/volume),” because it was not clear if Applicant intended the amount of corticosteroid be limited to 0.05% OR 2%, or a range of amounts. In view of Applicant’s amendment to change the amount of corticosteroid to “from 0.05% to 2%,” the previous indefiniteness rejection is overcome.
(d) Claim 68 was also rejected for reciting the range of antibiotic present “in an amount of 0.1% and 1% (weight/volume),” because it is not clear if Applicant intended that the amount of antibiotic be limited to 0.1% OR 1%, or a range of amounts. In view of Applicant’s amendment to change the amount of antibiotic to “from 0.1% to 1%,” the previous indefiniteness rejection is overcome.
7. Accordingly, the previous indefiniteness rejection of claim 68 is withdrawn.
8. The previous indefiniteness rejection of claims 74, 75, 80, and 85-88 as being dependent upon and including all of the limitations of claim 68, is also withdrawn.
Previous Claim Rejections - 35 USC § 112(a)
9. Claims 68, 74, 75, 80, and 85-91 were previously rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
Claim 68 was previously rejected as lacking sufficient written description regarding the omission of the element of alcohol from the recited composition, i.e.: “wherein there is no alcohol present in the composition.”
In view of Applicant’s amendment to delete said recitation from the claim, the previous written description rejection is overcome and is withdrawn.
10. Claims 89 and 91 were previously rejected as lacking sufficient written description for a composition consisting of an NSAID, corticosteroid, antibiotic, and aqueous buffer.
In view of Applicant’s amendment to add the feature of a complexing agent to claims 88 and 89, the previous written description rejection is overcome and is withdrawn.
New Claim Rejections - 35 USC § 112(b)
11. 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.
12. Claims 90 and 91 are 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.
13. Claim 90 depends from claim 88 (which is dependent upon claim 68) and recites the limitation "wherein the antibiotic is the [sic] moxifloxacin" in line 2. However, there is insufficient antecedent basis for this limitation in the claim, because in Applicant’s amendment of November 19, 2025, the antibiotic “moxifloxacin” has been deleted from independent claim 68. Clarification is requested.
14. Claim 91 depends from claim 89 (which is dependent upon claim 68) and recites the limitation "wherein the antibiotic is the [sic] moxifloxacin" in line 2. However, there is insufficient antecedent basis for this limitation in the claim, because in Applicant’s amendment of November 19, 2025, the antibiotic “moxifloxacin” has been deleted from independent claim 68. Clarification is requested.
15. Accordingly, claims 90 and 91 have not been further treated on the merits. In re Steele, 305 F.2d 859,134 USPQ 292 (CCPA 1962) (it is improper to rely on speculative assumptions regarding the meaning of a claim and then base a rejection under 35 U.S.C. 103 on these assumptions).
Previous Claim Rejections - 35 USC § 103
16. Claims 68, 74, 75, 85-91 were previously rejected under 35 U.S.C. 103 as being unpatentable over Barman et al., U.S. 20170049697 A1, in view of Sampietro, U.S. 20180318319 A1.
17. Claim 80 was previously rejected under 35 U.S.C. 103 as being unpatentable over Barman et al., U.S. 20170049697 A1, as applied to claims 68, 74, 75, and 85-91 above, in view of Sampietro, U.S. 20180318319 A1, further in view of Lushchyk et al., (Acta Ophthalmol 2013).
18. In view of Applicant’s amendatory changes to claim 68 to delete the limitation requiring that “there is no alcohol present in the composition,” the previous obviousness rejections are withdrawn. However, upon further consideration, claims 68, 74, 75, 80 and 85-91 are again rejected over Barman et al., U.S. 20170049697 A1, please see below.
New Claim Rejections - 35 USC § 103
19. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
20. Claims 68, 74, and 85-87 are rejected under 35 U.S.C. 103 as being unpatentable over Barman et al., U.S. 20170049697 A1.
Claim 68, as amended, is drawn to a method of treating and/or preventing age related macular degeneration in a subject, comprising topically administering an effective amount of an aqueous composition to the eye of a subject in need thereof, wherein the composition comprises:
(a) an NSAID present in an amount of 0.05% and 0.5% (weight/volume) of the total volume of the composition (more specifically, wherein the NSAID is diclofenac), and
(b) a corticosteroid present in an amount of 0.05% and 2% of the total amount of the composition (more specifically, wherein the corticosteroid is prednisolone), and
(c) an antibiotic present in an amount of 0.1% and 1% of the total volume of the composition (more specifically, ofloxacin, ciprofloxacin or levofloxacin).
21. Barman et al. teach and recite a method for treating an ocular disorder in a subject, wherein the ocular disorder is age-related macular degeneration (see Claim 23), the method comprising identifying a subject having an ocular disorder and administering to an eye of the subject a liquid drug delivery system, wherein said drug liquid delivery system is aqueous and comprises a combination of APIs including the NSAID diclofenac, the corticosteroid prednisolone acetate (i.e., a salt of prednisolone), and the antibiotic moxifloxacin, and mixtures thereof (see Claims 16 and 17).
22. While Barman et al. do not disclose the specific recited combination of API’s, as recognized by In re Schaumann, 572 F.2d 312 (CCPA 1978), claims to a species are anticipated where the prior art teaches a genus embracing a limited number of members closely related to each other such that one of ordinary skill in the art could immediately envisage each member. Notably, in In re Petering, 301 F.2d 676 (CCPA 1962) the court determined that a prior art genus containing only 20 compounds anticipated a claimed species within the genus because "one skilled in [the] art would... envisage each member" of the genus (emphasis in original)). Thus, considering that the genus of APIs disclosed and recited by Barman et al. in Claim 17 comprises only ten corticosteroids, only four antibiotics, and only two NSAIDS, the skilled artisan would have immediately envisaged selecting the combination of diclofenac, a salt of prednisolone and moxifloxacin, for the treatment of age-related macular degeneration in a subject in need thereof.
23. Barman et al. teach that said liquid crystalline drug delivery system can be administered to the eye by daily eye-drops (paragraph [0051]).
24. Thus, Barman et al. teach and recite a method of treating age-related macular degeneration in a subject comprising administering to the eye of the subject a composition comprising a combination of APIs including the NSAID diclofenac, the corticosteroid prednisolone acetate, and the fluoroquinolone antibiotic moxifloxacin, but do not teach the inclusion of the fluoroquinolones ofloxacin, ciprofloxacin or levofloxacin.
25. Yet, Barman et al. additionally teach alternative anti-microbials, wherein the antimicrobial is selected from a small subgenus including the fluoroquinolone antibiotics ciprofloxacin, levofloxacin, moxifloxacin hydrochloride, and ofloxacin (see paragraph [0054]).
26. Thus, it would have been obvious to one of skill in the art before the effective filing date of the claimed invention to substitute any of the instantly recited fluoroquinolones ofloxacin, ciprofloxacin or levofloxacin for the fluoroquinolone moxifloxacin in the treatment of age-related macular degeneration, with a reasonable expectation of success. And, as noted by the court in In re Font, 675 F.2d 297 (CCPA 1982), an express suggestion to substitute one equivalent component (i.e., an equivalent fluoroquinolone) for another is not necessary to render such substitution obvious. In the instant case, (1) the prior art element of Barman et al. performs the function specified in the claim with only insubstantial differences; (2) the claimed component(s) (i.e., ofloxacin, ciprofloxacin or levofloxacin) and its function was known in the art (i.e., known fluoroquinolone antimicrobials for inclusion in ophthalmic preparations); (3) a person of ordinary skill in the art would have recognized the interchangeability of the elements and could have substituted one known element for another; and (4) the results of the substitution would have been predictable, i.e., a reasonable expectation of success in the treatment of AMD in a subject in need thereof.
27. As such, one of skill in the art would have been motivated to combine the same API’s taught by Barman et al., in an ocular pharmaceutical composition and administer to a subject for treating age-related macular degeneration in said subject, and would have had a reasonable expectation of success in said treatment.
As such, claim 68 is prima facie obvious.
Claim 74 is drawn to claim 68, and limits wherein the subject:
k) was previously diagnosed with, or had symptoms of, age-related macular degeneration (claim 86).
28. Regarding claims 74 and 86, the method recited by Barman et al. comprises a first step of identifying a subject having an ocular disorder, wherein the disorder is age-related macular degeneration (see Claims 22-23), which meets the limitation of being diagnosed with age-related macular degeneration. And, one of skill in the art would have reasonably expected that a subject identified and diagnosed with the ocular disorder age-related macular degeneration by a medical professional would have been suffering from symptoms of AMD. As such, it would have been obvious to one skilled in the art before the effective filing date of the claimed invention to topically administer to an eye of a subject suffering from AMD and having been diagnosed with AMD, the ophthalmic composition previously taught by Barman et al. comprising the NSAID diclofenac, the corticosteroid prednisolone, and a fluoroquinolone antibiotic selected from ofloxacin, ciprofloxacin, or levofloxacin.
As such, claims 74 and 86 are prima face obvious.
Claim 85 is drawn to claim 68, wherein the AMD is wet AMD.
Claim 87 is drawn to claim 86, wherein the AMD is wet AMD.
29. Barman et al. additionally teach and recite that the ocular disorder to be treated is choroidal neovascularization, aka “wet” age-related macular degeneration (see Claim 44). Thus, one of skill in the art would have been motivated before the effective filing date of the claimed invention to employ the ophthalmic composition previously taught by Barman et al., comprising diclofenac, prednisolone, and a fluoroquinolone antibiotic selected from ofloxacin, ciprofloxacin, or levofloxacin, for treating AMD in a subject in need thereof, wherein the AMD is choroidal neovascularization, and would have had a reasonable expectation of success.
As such, claims 85 and 87 are prima facie obvious.
30. Claim 75 is rejected under 35 U.S.C. 103 as being unpatentable over Barman et al., U.S. 20170049697 A1, as applied to claims 68, 74, and 85-87 above, further in view of Russo et al., Mediators of Inflammation (2013).
Claim 68 is addressed in detail, above.
Claim 75 is drawn to claim 68, and limits wherein the composition is administered at a dose of one drop 1 to 6 times per day.
31. Barman et al. teach the treatment of age-related macular degeneration in a subject in need thereof, comprising topically administering to an eye of the subject an ophthalmic composition comprises a combination of APIs including the NSAID diclofenac, the corticosteroid prednisolone, and a fluoroquinolone antibiotic selected from ofloxacin, ciprofloxacin, or levofloxacin, but do not teach wherein the composition is administered at a dose of one drop 1 to 6 times per day.
32. Yet, Russo et al. teach the administration of topical ophthalmic formulations comprising commercially available NSAIDs for reducing eye inflammation, pain, and reduction of exudation secondary to age-related macular degeneration, for example (see abstract). In Table 1, Russo et al. disclose the administration frequency of commercially available NSAIDs, wherein diclofenac is administered 4 times per day (Table 1, page 2).
A dose of one drop dose 4 times per day falls within the range of 1 to 6 times per day, required by claim 75. And, dose regimen optimization is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize given the guidance of the prior art.
33. Thus, one of skill in the art would have been motivated before the effective filing date of the claimed invention to treat age-related macular degeneration in a subject in need thereof by topically administering to the eye of said subject the ophthalmic composition comprising diclofenac previously taught by Barman et al., at a frequency of 4 times per day, and would have had a reasonable expectation of success.
As such, claim 75 is prima facie obvious.
34. Claim 80 is rejected under 35 U.S.C. 103 as being unpatentable over Barman et al., U.S. 20170049697 A1, as applied to claims 68, 74, and 85-87 above, further in view of Lushchyk et al., Acta Ophthalmol (2013), (previously cited in the office action of August 22, 2025).
Claim 68 is addressed in detail, above.
Claim 80 is drawn to claim 68 and limits wherein the composition is administered concurrently with an intravitreal injection of bevacizumab.
35. Barman et al. teaches the treatment of age-related macular degeneration in a subject in need thereof, comprising topically administering to an eye of the subject an ophthalmic composition comprises a combination of APIs including the NSAID diclofenac, the corticosteroid prednisolone, and a fluoroquinolone antibiotic selected from ofloxacin, ciprofloxacin, or levofloxacin, but do not teach the concurrent administration of bevacizumab.
36. Yet, Barman et al. additionally suggest that the liquid crystalline drug delivery system described above can be formulated with a hydrophobic drug, including VEGFR/PDGFR inhibitors, (see paragraph [0055]).
37. And, Lushchyk et al. teach that bevacizumab is one of the most frequently used anti-VEGF drugs (i.e., a VEGF inhibitor) in the treatment of age-related macular degeneration (page e456, first paragraph under “Introduction”), and demonstrate that intravitreal bevacizumab injection improves visual acuity in patients suffering from age-related macular degeneration (see abstract).
38. Thus, one skilled in the art before the effective filing date of the claimed invention would have been motivated to combine the known ophthalmic therapies commonly employed in the treatment of age-related macular degeneration as taught by Barman et al. and Lushchyk et al., in order to achieve an improved therapeutic strategy for the treatment of AMD in a patient in need thereof, with a reasonable expectation of success. And, the rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law, please see In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). See also In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forth test for implicit teachings); In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) (discussion of reliance on legal precedent); In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed. Cir. 1988) (references do not have to explicitly suggest combining teachings). Furthermore, MPEP 2144 teaches that the strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination.
39. Please refer to MPEP 2144.06 “I. COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE” wherein Kerkhoven is specifically referenced:
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious).
40. As stated by the Court in KSR International Co., v. Teleflex Inc., 127 US 1727 (2007), “when a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious” (quoting Sakraida v. AG Pro, Inc., 425 US 273 (1976); see also: Merck v. Biocraft (874 F.2d 804, 807 (Fed. Cir. 1989), indicating that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands; Sundance, Inc. v. DeMonte Fabricated, Ltd., 550 F.3d 1356 (Fed. Cir. 2008): a claimed invention is obvious is it is a combination of known prior art elements that would reasonably have been expected to maintain their respective properties or functions after they had been combined; Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327 (1945): indicating that “[r]eading a list and selecting a known component to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle”.
As such, claim 80 is prima facie obvious.
41. Claims 88 and 89 are rejected under 35 U.S.C. 103 as being unpatentable over Barman et al., U.S. 20170049697 A1, as applied to claims 68, 74, and 85-87 above, and further in view of Loftsson and Stefansson, Acta Ophthalmologica Scandinavica (2002).
Claim 68 is addressed in detail, above.
Claim 88, as amended, is drawn to claim 68, wherein the composition consists essentially of the NSAID, the corticosteroid, the antibiotic, an aqueous buffer, and a complexing agent. Claim 89, as amended, is drawn to claim 68, wherein the composition consists of the NSAID, the corticosteroid, the antibiotic, an aqueous buffer, and a complexing agent.
42. Barman et al. suggest a method of treating age-related macular degeneration (AMD) in a subject, comprising topically administering an effective amount of an aqueous composition to the eye of a subject in need thereof, wherein the composition comprises diclofenac, prednisolone, and a fluoroquinolone antibiotic including ofloxacin, ciprofloxacin or levofloxacin, but do not disclose a single composition comprising diclofenac, prednisolone, an antibiotic, an aqueous buffer, and a cyclodextrin.
43. Yet, Loftsson teaches that cyclodextrins: “can be used to form aqueous eye drop solutions with lipophilic drugs, such as steroids,… [and] increase the water solubility of the drug, enhance drug absorption into the eye, improve aqueous stability and reduce local irritation. Cyclodextrins are useful excipients in eye drop formulations of various drugs, including steroids of any kind.” (see abstract). Loftsson go on to teach that cylcodextrins are chemically stable adjuvants that enhance the bioavailability of ophthalmic drugs, (page 146, left column, second paragraph), and teaches a topical formulation for ocular drug delivery comprising diclofenac and 2-hydroxypropyl-b-cyclodextrin (HPCD) in Table 1 (page 145).
44. Accordingly, one skilled in the art before the effective filing date of the claimed invention would have been motivated to add the complexing agent cyclodextrin to the topical ophthalmic composition taught by Barman et al. in order to obtain an improved composition for treating AMD in a subject in need thereof. And, as stated by the Court in KSR International Co., v. Teleflex Inc., 127 US 1727 (2007), “when a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious” (quoting Sakraida v. AG Pro, Inc., 425 US 273 (1976); see also: Merck v. Biocraft (874 F.2d 804, 807 (Fed. Cir. 1989), indicating that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands; Sundance, Inc. v. DeMonte Fabricated, Ltd., 550 F.3d 1356 (Fed. Cir. 2008): a claimed invention is obvious is it is a combination of known prior art elements that would reasonably have been expected to maintain their respective properties or functions after they had been combined; Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327 (1945): indicating that “[r]eading a list and selecting a known component to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.”
45. Regarding the aqueous buffer, Barman et al. additionally teach that “[t]he aqueous solution also contains a buffer. The buffer can be, but is not limited to, sodium acetate, sodium dihydrogen phosphate, disodium hydrogen phosphate, potassium dihydrogen phosphate, dipotassium hydrogen phosphate, ε-aminocaproic acid; amino acid salts such as sodium glutamate, boric acid, and citric acid,” (paragraph [0027]). Accordingly, one skilled in the art before the effective filing date of the claimed invention would have been motivated to incorporate an aqueous buffer to the topical ophthalmic composition taught by Barman et al. in order to obtain an improved composition for treating AMD in a subject in need thereof.
46. And, it is noted that the transitional phrase “consisting essentially of” limits the scope of a claim to the specified materials or steps “and those that do not materially affect the basic and novel characteristic(s)” of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976) (emphasis in original) (Prior art hydraulic fluid required a dispersant which appellants argued was excluded from claims limited to a functional fluid “consisting essentially of” certain components. In finding the claims did not exclude the prior art dispersant, the court noted that appellants’ specification indicated the claimed composition can contain any well-known additive such as a dispersant, and there was no evidence that the presence of a dispersant would materially affect the basic and novel characteristic of the claimed invention. The prior art composition had the same basic and novel characteristic (increased oxidation resistance) as well as additional enhanced detergent and dispersant characteristics.). “A ‘consisting essentially of’ claim occupies a middle ground between closed claims that are written in a ‘consisting of’ format and fully open claims that are drafted in a ‘comprising’ format.” PPG Industries v. Guardian Industries, 156 F.3d 1351, 1354, 48 USPQ2d 1351, 1353-54 (Fed. Cir. 1998). See also Atlas Powder v. E.I. duPont de Nemours & Co., 750 F.2d 1569, 224 USPQ 409 (Fed. Cir. 1984); In re Janakirama-Rao, 317 F.2d 951, 137 USPQ 893 (CCPA 1963); Water Technologies Corp. vs. Calco, Ltd., 850 F.2d 660, 7 USPQ2d 1097 (Fed. Cir. 1988). Therefore, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, “consisting essentially of” will be construed as equivalent to “comprising.” See, e.g., PPG, 156 F.3d at 1355, 48 USPQ2d at 1355 (“PPG could have defined the scope of the phrase ‘consisting essentially of’ for purposes of its patent by making clear in its specification what it regarded as constituting a material change in the basic and novel characteristics of the invention.”). See also AK Steel Corp. v. Sollac, 344 F.3d 1234, 1240-41, 68 USPQ2d 1280, 1283-84.
As such, claims 88 and 89 are prima facie obvious.
Response to Arguments
47. Applicant traverses the previous obviousness rejection of claims 68, 74, 75, and 85-87 over Barman et al., and the rejection of claim 80 over Barman et al. and further in view of Sampietro in view of Lushchyk et al. Applicant argues that the amendment to claim 68 removing the proviso statement precluding alcohol from the composition cures their priority claim, and therefore Sampietro is not available as prior art.
Applicant argues that the amendment to claim 68 removes the species ketorolac, dexamethasone, bromfenac, and moxifloxacin, and therefore the office is not able to establish the prima facie case of obviousness with respect to Barman et al. because the elements previously relied upon in that disclosure are no longer recited in claim 68 as amended.
48. Applicant's arguments have been fully considered but they are not persuasive. While the amendment to claim 68 deletes the NSAID species ketorolac and bromfenac, the corticosteroid species dexamethasone, and the antibiotic moxifloxacin, it is noted that Barman et al. recite a method of treating an ocular disorder that can be age-related macular degeneration in a subject (see Claim 23) comprising administering to the eye of the subject a composition comprising the NSAIDs diclofenac and the corticosteroid prednisolone (see Claim 17). While Barman et al. recite the fluoroquinolone antibiotic moxifloxacin in Claim 17, Barman et al. additionally teach alternative quinolone antibiotics including ofloxacin, ciprofloxacin and levofloxacin in paragraph [0054]. Thus, one skilled in the art would have reasonably considered substituting one of the fluoroquinolones specifically named in paragraph [0054] for moxifloxacin, with a reasonable expectation of success. See also Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356 (Fed. Cir. 2012): finding a “strong case of obviousness based on the prior art references of record [wherein the claim] recites a combination of elements that were all known in the prior art, and all that was required to obtain that combination was to substitute one well-known…agent for another”).
As such, a prima facie case is established. Since Applicant has not demonstrated otherwise, Applicant's argument is not considered persuasive.
Conclusion
49. Claims 68, 74, 75, 80, and 85-91 are pending in the instant application. Claims 68, 74, 75, 80 and 85-91 are rejected. No claim is presently allowed.
50. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANET L COPPINS whose telephone number is (571)272-0680. The examiner can normally be reached on Monday-Friday 8:30AM-5PM EST.
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/JANET L COPPINS/Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628