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 .
Receipt is acknowledged for amendment and remarks filed 04/02/2026.
Claims 7-12 and 22-23 are canceled.
Claims 1 and 21 are amended.
New claims 26-30 are added.
Claims 1-3, 6, 13-17, 19-21 and 26-30 are pending.
Priority
This application is a 371 of PCT/CN2022/104726 filed 07/08/2022 and which claims benefit of CN application 202110780094.9 filed 07/09/2021.
Response to Arguments
On pages 7 of 10 to 9 of 10, applicant argues: a) that HANASOME ISAO and BORZACCIDELLO cannot be combined because HANASOME ISAO is used as ophthalmic eye drop while the composition of BORZACCIDELLO is used in surgical and dermo-esthetic field. b) that the skilled artisan would not expect that applying the component of BORZACCIDELLO to HANASOME ISAO or applying the component of HANASOME ISAO to BORZACCIDELLO will successfully achieve the effects described in the present application. That examples 1-8 of the as filed specification show long term stability, low impurity content, significant improvement effect on dry eye disease, small irritation and excellent clinical safety by combining loxoprofen sodium, sodium hyaluronate, polysorbate 80, disodium edetate, sodium chloride and benzalkonium chloride as recited in amended claim 1. That HANASOME ISAO and BORZACCIDELLO are in different technical fields and neither reference teaches the effects mentioned such that one of skill in the would not expect either composition of HANASOME ISAO and BORZACCIDELLO or combination of the compositions of HANASOME ISAO and BORZACCIDELLO to achieve the effects mentioned. c) The pharmaceutical ingredients in Kharazmi and Ostrow are different from the pharmaceutical ingredient in BORZACCIDELLO such that the ordinary skilled artisan would not be motivated to modify BORZACCIDELLO according to Kharazmi/Ostrow to arrive at the composition recited in amended claim 1. Therefore, applicant says that the amended claim 1 is non-obvious over BORZACCIDELLO in view of Kharazmi and further in view of Ostrow and HANASOME. d) For claim 6, applicant argues that the ratio calculated in the office action for loxoprofen: sodium hyaluronate: polysorbate of 10%:(25%):(15.5%) is 1:2.5:1.55 and not 1:0.4:0.6 calculated in the office action; BORZACCIDELLO has a different ratio which does not overlap with the ratio in claim 6; the composition of claim 6 has a mass ratio of loxoprofen sodium: sodium hyaluronate: polysorbate 80 of 1:(0.8-1.2): (0.2-0.5) while BORZACCIDELLO has a ratio of 1:2.5:1.55 or 1:0.4:0.6 such that claim 6 in not obvious over BORZACCIDELLO in view of Kharazmi and further in view of Ostrow and HANASOME. e) The composition of new claim 26 consists of loxoprofen sodium, sodium hyaluronate, polysorbate 80, disodium edetate, sodium chloride and benzalkonium chloride while the composition of BORZACCIDELLO contains one or more tocopherols or tocotrienols and mixtures thereof to achieve its invention such that new claim 26 provides significantly different technical solution. f) For claims 13-14 and new claim 27, the parts by weight of the components are important in achieving the effects mentioned above. Therefore, claims 13-14 and new claim 27 are non-obvious over and allowable over BORZACCIDELLO in view of Kharazmi and further in view of Ostrow and HANASOME. g) None of the prior art teaches the method of claims 21 and new claims 28-30 which recite method for treating dry eye disease/lacrimal gland dysfunction or ophthalmic disease manifested by reduced tear secretion/an ophthalmic disease manifested by poor tear film stability/local edema caused by corneal epithelial cell injury or eye injury in a subject in need thereof. h) Therefore, applicant states that based on the above arguments, claims 1-3, 6, 13-17, 19-21 and new claims 26-30 are allowable.
Response: Claim 1 is amended to include the limitation of benzalkonium chloride, disodium edetate, and sodium chloride from canceled claim 12. In the office action mailed 01/23/2026, Ostrow was relied upon for teaching that benzalkonium chloride is a preservative as the primary reference, BORZACCIDELLO, teaches composition comprising preservatives, viscosity adjusting agent that includes chelating agent. EDTA is a known chelating agent and sodium chloride is a known tonicity agent. Kharazmi was relied upon for teaching that EDTA is a chelating agent and sodium chloride is a tonicity adjusting agent. HANASOME was relied upon for teaching that composition comprising loxoprofen sodium, polysorbate 80, boric acid, sodium chloride and benzalkonium chloride is used for treating ophthalmic conditions such that before the effective date of the invention, the ordinary skilled artisan would be motivated to administer the composition of BORZACCIDELLO to treat eye diseases. Therefore for a), HANASOME ISAO was relied upon for teaching that composition comprising loxoprofen sodium is used to treat eye disease such that composition of BORZACCIDELLO when administered would be expected to predictably treat eye disease. The rejection was not that the two compositions are combined to form a third composition. HANASOME ISAO was relied upon for claims 21-23 and not for claims 1 and 12. Therefore, the artisan would rely on the teaching of HANASOME ISAO that loxoprofen sodium and polysorbate 80 and sodium chloride composition of BORZACCIDELLO when administered to the eye would predictably treat eye disease as required by claims 21-23 --- it is noted that claims 22-23 are canceled in the amendment filed 04/02/2026. For b), the component of BORZACCIDELLO is not applied to HANASOME ISAO and the component of HANASOME ISAO is not applied to BORZACCIDELLO, rather it was presented in the office action mailed 01/23/2026 that one would reasonably expect that administering the composition of BORZACCIDELLO would predictably treat eye disease because the composition of HANASOME ISAO containing loxoprofen sodium and polysorbate 80 and sodium chloride when administered treats eye disease. There is no evidence that the composition of is not stable, has high impurity content, does not significantly improve effect on dry eye disease, has elevated irritation and not clinically safe. HANASOME ISAO was utilized for method claims 21-23 and not for the composition. Therefore, applicant’s argument that HANASOME ISAO cannot be relied upon for teaching that administering composition comprising loxoprofen sodium and polysorbate 80 and sodium chloride treats eye disease is not persuasive because same compositions would have the same effect. Hence the composition of BORZACCIDELLO comprising sodium salt of hyaluronic acid, and stabilizer comprising fatty acid and emulsifiers namely polysorbate 80, preservatives, viscosity adjusting agents, chelating agents, buffering agents, tonicity adjusting agents, antioxidants, ascorbic acid, vitamin C and loxoprofen as pharmaceutically active agent when administered would predictably treat eye disease. For c), Kharazmi and Ostrow were relied upon for teaching that EDTA is a chelating agent and sodium chloride is a tonicity adjusting agent (Kharazmi) and for teaching that benzalkonium chloride is a preservative (Ostrow). Kharazmi and Ostrow were not relied upon for reasons that applicant may be implying for relying on Kharazmi and Ostrow. For d), regarding claim 6, the calculation in the office action was reciprocal of the ratio it could have been because it was clearly stated in the office action at paragraph 18 on page 5 of the action---Hyaluronic acid is present at 0.01 to 25%, 0.01 to 10% or 0.1 to 10% in the composition (page 11, lines 3-4). Loxoprofen active agent is 10% or 10 mg/100 ml, the loxoprofen active agent is present at 0.1mg/mL or less (1 x 10-6 mg/ml-0.1 mg/mL) (page 16, lines 18 and 19). The emulsifier of polysorbate 80 is present at 0.1-0.0995 to 25 or 15 or 10%-9.5% =0.0005 to 15.5, 5.5, 0.5 (see page 15, lines 2-7).--- Thus a ratio of loxoprofen:sodium hyaluronate:polysorbate = 10%:(0.01-25 and using 5-25):(0.005-15.5 using 2-15.5) = 1:(0.5-2.5):(0.2-1.5). Thus for claim 6, the disclosed calculated ratios overlap the claimed ratio rendering the claimed ratio prima facie obvious. Adjustment will be made in rejection to address the appropriate ratios based on what is disclosed. For e), the composition of new claim 26 is newly added and the consisting of language excludes components outside of loxoprofen sodium, sodium hyaluronate, polysorbate 80, disodium edetate, sodium chloride and benzalkonium chloride and where the sodium hyaluronate has a molecular weight of 0.8 X 106-1.6x106. This composition appears to be new matter because the as filed specification does not envision composition that does not include at least water (See examples 1-4). For f), new claim 27 depends on new claim 26 and the rejection will be addressed separately. The examiner disagrees that the parts by weight of the components as claimed is not commensurate with the data in examples 1-4 and test in examples 5-8 because the data is produced from two specific parts by weight and does not represent the scope of the claimed parts by weight as exemplified by the disclosed amounts for the parts of the compositions in examples 1-4. There is no data from the placebo (see Example 8 and Examples 5-7). For example 8, the active agent loxoprofen sodium amounts are varied for the clinical trial. The data presented in Table 5 does not have results/data from the placebo/control. Applicant’s arguments with respect to dry eye effect, effect on irritation and stability of the claimed composition is not persuasive. Tables 1-4 has no data for control. For g), HANASOME ISAO et al (JP 2003160485 A, Eng Trans filed be applicant on form 1449) teaches that loxoprofen sodium is effective in treating eye diseases such that administration of composition comprising loxoprofen sodium would have the same effect. Therefore, for g), it would be reasonably expected that a composition having the effect of treating eye disease when administered would predictably treat eye disease. Therefore, for h), claims 1-3, 6, 13-17, 19-21 and new claims 28-30 are not patentable over the cited art. New claims 26-27 are being rejected below under new mater.
Modified Rejections
Necessitated by Amendment
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 6, 15-17, 19-21 and 28-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over BORZACCHIELLO et al., (WO 2020025415 A1) in view of Kharazmi et al. (US 20030065039 A1) and further in view of Ostrow et al., (US 20150366854 A1) and HANASOME ISAO et al (JP 2003160485 A, Eng Trans filed be applicant on form 1449) for reasons of record and modified to address the claims as currently amended.
Claims 1-3 are directed to compositions comprising loxoprofen sodium which is sodium salt of loxoprofen, sodium hyaluronate and polysorbate 80; the hyaluronate has a molecular weight of 0.8 x 106-1.6x 106 (800,000 to 1,600,000 or 800 kDa to 1600 kDa). Currently amended claim 1 further comprises disodium edetate, sodium chloride and benzalkonium chloride The mass ratio or solution or ointment or gelling agent in claims 2 and 3 are in the alternative.
Thus for claims 1-3, BORZACCHIELLO teaches composition in the form of solution comprising sodium or potassium salt of hyaluronic acid (see the whole document with emphasis on the abstract, page 11, lines 16-25, page 12, lines 8-22; claims 1-4) and stabilizer comprising fatty acid and emulsifiers (page 13, lines 18, 23; page 14, lines 24-25); polysorbate 80 is identified as an emulsifier (page 15, lines 22-25; page 20, line 2) and loxoprofen as pharmaceutically active agent (abstract; page 16, line 14; page 21, line 5; claim 10). The molecular weight of the hyaluronan salt is 40 kDa to 4000 kDa (page 12, line 17; page19, line 11; claim 3).
BORZACCHIELLO differs from claims 1-3 by not teaching the molecular weight range for the sodium hyaluronate. However, the disclosed range of 40 kDa to 4000 kDa overlaps the claimed molecular weight range of 800 kDa to 1600 kDa or 800 kDa to 1400 kDa or 800 kDa to 1000 kDa or 1000 kDa to 1200 kDa or 1200 kDa to 1400 kDa. The disclosed range of 40 kDa to 4000 kDa allows for ranges of 800 kDa to 1600 kDa.
It has been settled in In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) that, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In the instant case, the disclosed range of 40 kDa to 4000 kDa overlaps the claimed molecular weight range of 800 kDa to 1600 kDa or 800 kDa to 1400 kDa or 800 kDa to 1000 kDa or 1000 kDa to 1200 kDa or 1200 kDa to 1400 kDa. The disclosed range of 40 kDa to 4000 kDa allows for ranges of 800 kDa to 1600 kDa.
The composition of BORZACCHIELLO contains chelating agent without naming the chelating agent to be EDTA and tonicity adjusting agent without naming one. While it is known that sodium EDTA is a chelating agent and sodium chloride is a tonicity adjusting agent, BORZACCHIELLO does not name specific chelating agent and tonicity adjusting agent. However, it is known that sodium EDTA is a chelating agent and sodium chloride is a tonicity adjusting agent (paragraphs [0250], [0261] of Kharazmi). Therefore, before the effective date of the invention, the artisan would use the specific chelating agent sodium EDTA with the expectation of predictably chelating metal ions, and use sodium chloride as the specific tonicity adjusting agent with the expectation of predictably adjusting the tonicity to the desired osmotic pressure.
The composition of BORZACCHIELLO contains preservatives, viscosity adjusting agents (thickening or fluidifying agents, emulsifiers, chelating agents, buffering agents, tonicity adjusting agents, antioxidants, ascorbic acid, vitamin C (page 17, lines 2-8) with at least the chelating agent meeting the metal complexing agent. BORZACCHIELLO does not name any specific preservative. However, Ostrow teaches that benzalkonium chloride is a preservative (paragraphs [0015], [0114], [0367], claim 13 and Tables 1-5).
Therefore, before the effective date of the invention the artisan would use specific preservative such as benzalkonium chloride in the composition of BORZACCHIELLO with the expectation of predictably preserving the composition as contemplated by BORZACCHIELLO.
For claim 6, Hyaluronic acid is present at 0.01 to 25%, 0.01 to 10% or 0.1 to 10% in the composition (page 11, lines 3-4). Loxoprofen active agent is 10% or 10 mg/100 ml, the loxoprofen active agent is present at 0.1mg/mL or less (1 x 10-6 mg/ml-0.1 mg/mL) (page 16, lines 18 and 19). The emulsifier of polysorbate 80 is present at 0.1-0.0995 to 25 or 15 or 10%-9.5% =0.0005 to 15.5, 5.5, 0.5 (see page 15, lines 2-7). Thus a ratio of loxoprofen:sodium hyaluronate:polysorbate = 10%:(0.01-25 and using 5-25):(0.005-15.5 using 2-15.5) = 1:(0.5-2.5):(0.2-1.5). Thus for claim 6, the disclosed calculated ratios overlap the claimed ratio rendering the claimed ratio prima facie obvious.
For claims 13 and 14, HANASOME ISAO teaches eye drop composition comprising loxoprofen, polysorbate 80 solubilizers, sodium edetate as a stabilizer, pH adjusters, isotonicity agents, preservatives (see the whole document with emphasis on paragraphs [0021]-[0028]). In paragraph [0034], example 6, teaches an ophthalmic solution that comprises 0.1 g loxoprofen, 1 g boric acid, 0.35 g sodium chloride tonicity agent, 0.005 g benzalkonium chloride preservative, 0.01 g polysorbate 80. Also, BORZACCHIELLO teaches composition in the form of solution comprising sodium or potassium salt of hyaluronic acid (see the whole document with emphasis on the abstract, page 11, lines 16-25, page 12, lines 8-22; claims 1-4) and stabilizer comprising fatty acid and emulsifiers (page 13, lines 18, 23; page 14, lines 24-25); polysorbate 80 is identified as an emulsifier (page 15, lines 22-25; page 20, line 2) and loxoprofen as pharmaceutically active agent (abstract; page 16, line 14; page 21, line 5; claim 10). The molecular weight of the hyaluronan salt is 40 kDa to 4000 kDa (page 12, line 17; page19, line 11; claim 3).
BORZACCHIELLO teaches that hyaluronic acid is present at 0.01 to 25%, 0.01 to 10% or 0.1 to 10% in the composition (page 11, lines 3-4). Loxoprofen active agent is 10% or 10 mg/100 ml, the loxoprofen active agent is present at 0.1mg/mL or less (1 x 10-6 mg/ml-0.1 mg/mL) (page 16, lines 18 and 19). The emulsifier of polysorbate 80 is present at 0.1-0.0995 to 25 or 15 or 10%-9.5% =0.0005 to 15.5, 5.5, 0.5 (see page 15, lines 2-7). Thus a ratio of loxoprofen:sodium hyaluronate:polysorbate = 10%:(0.01-25 and using 5-25):(0.005-15.5 using 2-15.5) = 1:(0.5-2.5):(0.2-1.5). BORZACCHIELLO does not teach amounts of sodium chloride tonicity agent and benzalkonium chloride preservative. But HANASOME ISAO teaches 0.35 g sodium chloride tonicity agent, 0.005 g benzalkonium chloride preservative, 0.01 g polysorbate 80.
However, differences in concentration, and in this case, parts by weight of the components, will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parts by weight of the components is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382, it was decided that “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” The artisan would be motivated to optimize the composition of BORZACCHIELLO using the tonicity agent and the preservative of HANASOME ISAO in amounts/parts per weight that would be expected to be predictably preserve the composition and to have effective tonicity.
For claim 15, the form of the composition in BORZACCHIELLO is an aqueous solution (abstract, page 8, line 20; page 10, lines 10, 15).
For claims 16 and 17, BORZACCHIELLO teaches that the active agent is present at 0.0001 to 10% by weight of the solution (page 16, lines 18 and 19) such that when the loxoprofen active agent is 10% or 10 mg/100 ml, the loxoprofen active agent is present at 0.1 mg/mL or less (1 x 10-6 mg/ml-0.1 mg/mL). The 0.1 mg/mL meets claim 16. For claim 17, generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382, it was decided that “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” The artisan would be motivated to optimize the composition of BORZACCHIELLO to use amount loxoprofen in amounts that would be expected to provide the desired effect.
For claims 19 and 20, BORZACCHIELLO prepares the composition by forming aqueous solution of glycosaminoglycan such as hyaluronic acid salt, stabilizer that comprises fatty acid and emulsifier such as polysorbate 80; the composition is sterilized using dry heat, wet heat (page 17, line 9 to page 19, line 4). Ambient temperature (page 18, lines 4 and 5) is less than 40 oC meeting the requirement of claim 20. BORZACCHIELLO does not teach the exact order of adding the components that make up the composition. However, it was established in In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) that selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results; and In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) that selection of any order of mixing ingredients is prima facie obvious.
For claim 21, BORZACCHIELLO teaches composition in the form of solution comprising sodium or potassium salt of hyaluronic acid (see the whole document with emphasis on the abstract, page 11, lines 16-25, page 12, lines 8-22; claims 1-4) and stabilizer comprising fatty acid and emulsifiers (page 13, lines 18, 23; page 14, lines 24-25); polysorbate 80 is identified as an emulsifier (page 15, lines 22-25; page 20, line 2) and loxoprofen as pharmaceutically active agent (abstract; page 16, line 14; page 21, line 5; claim 10). The molecular weight of the hyaluronan salt is 40 kDa to 4000 kDa (page 12, line 17; page19, line 11; claim 3). The composition of BORZACCHIELLO contains preservatives, viscosity adjusting agents (thickening or fluidifying agents, emulsifiers, chelating agents, buffering agents, tonicity adjusting agents, antioxidants, ascorbic acid, vitamin C (page 17, lines 2-8) with at least the chelating agent meeting the metal complexing agent of claim 7 and tonicity adjusting agent.
BORZACCHIELLO differs from claim 21 by not teaching treating ophthalmic diseases. However, HANASOME ISAO (JP 2003160485 A) teaches composition comprising loxoprofen sodium, polysorbate 80, boric acid, sodium chloride and benzalkonium chloride for treating ophthalmic conditions (see the whole Eng Trans document filed by applicant, with emphasis of paragraph [0034]) by administering the composition (paragraphs [0020], [0050], [0051]). Therefore, because loxoprofen composition comprising polysorbate 80 and sodium chloride have been administered as eye drops to treat ophthalmic conditions, before the effective date of the invention, the artisan would have been motivated to administer the composition of BORZACCHIELLO to the eyes with the expectation of predictably effectively treating eye conditions.
For claims 28-30, lacrimal gland dysfunction or ophthalmic disease manifested by reduced tear secretion in a subject (claim 28), ophthalmic disease manifested by poor tear film stability (claim 29), or local edema caused by corneal epithelial cell injury or eye injury in a subject (claim 30) are all eye conditions. It is the administered composition that results in treating the conditions listed in claims 21 and 28-30. Thus administering a composition, of BORZACCHIELLO in view of Kharazmi and Ostrow and HANASOME ISAO, comprising sodium salt of loxoprofen, sodium hyaluronate and polysorbate 80; the hyaluronate has a molecular weight of 0.8 x 106-1.6x 106 (800,000 to 1,600,000 or 800 kDa to 1600 kDa), disodium edetate, sodium chloride and benzalkonium chloride to a subject would be expected to predictably treat ophthalmic conditions (claim 21) including lacrimal gland dysfunction or ophthalmic disease manifested by reduced tear secretion in a subject (claim 28), ophthalmic disease manifested by poor tear film stability (claim 29), or local edema caused by corneal epithelial cell injury or eye injury (claim 30).
Therefore, BORZACCHIELLO in view of Kharazmi and Ostrow and HANASOME ISAO renders claims 1-3, 6, 15-17, 19-21 and 28-30 prima facie obvious.
New Rejection
Based on the Amendment
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
New claims 26 and 27 are 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is New Matter rejection.
New claims 26 and 27 are directed to compositions that consist of loxoprofen sodium, sodium hyaluronate, polysorbate 80, disodium edetate, sodium chloride and benzalkonium chloride and where the sodium hyaluronate has a molecular weight of 0.8 X 106-1.6x106. However, all the exemplified compositions, examples 1-4 contain water. The consisting language limits the composition to loxoprofen sodium, sodium hyaluronate, polysorbate 80, disodium edetate, sodium chloride and benzalkonium chloride and where the sodium hyaluronate has a molecular weight of 0.8 X 106-1.6x106. Composition that does not contain at least water is not envisioned by the specification as filed.
No claim is allowed.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
Conclusion
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/BLESSING M FUBARA/Primary Examiner, Art Unit 1613
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