Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 1-9 are currently pending and a preliminary amendment to the claims as filed on 02/06/2024 is acknowledged.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/06/2024 was filed before the mailing date of the instant first action on the merits. The submission thereof is in compliance with the provisions of 37 CFR 1.97. It is noted that the foreign references have only been considered to the extent that an English language abstract, translation or statement of relevance has been provided to the examiner. Accordingly, the information disclosure statement has been considered by the examiner, and signed and initialed copy is enclosed herewith.
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 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.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 nonobviousness.
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. As indicated above, the present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a medical/pharmaceutical/ophthalmic research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from medicine, pharmacy, physiology and chemistry— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Khopade et al. (US2018/0296571A1, IDS of 02/06/2024) in view of Lindstrom et al. (WO2014/160579A1) and further in view of Think Library, “Glossary: Agitation”, 2018-12-19, pp. 1-4, and Andrieux et al. (EP2661251B1).
Applicant claims the below claim 1 filed on 02/06/2024:
PNG
media_image1.png
572
842
media_image1.png
Greyscale
Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims (MPEP 2141.02); and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143)
Khopade further discloses a preparation of aqueous ophthalmic solution of difluprednate for the treatment of inflammatory disorder of the eye, comprising adding benzalkonium chloride and difluprednate in a container and then polyoxyl 35 castor oil (Cremophor El) is added wherein difluprednate was solubilized in the mixture to form drug preconcentrate which reads on the claimed step a) ([0058]); dissolving a polyvinyl alcohol in water for injection which reads on the claimed step b)i), separately dissolving boric acid, N-lauryl sarcosine, glycerin, acetic acid, sodium acetate, disodium edetate in water for injection which reads on the claimed step b)ii), and this phase was added to polyvinyl alcohol solution with stirring ([0059]) which reads on the claimed step b)iii); the drug preconcentrate was added to the above mixture and dissolved by mixing to get a solution ([0059]) which reads on the claimed step c); then polyhexamethylene biguanide was added to the solution ([0059]) which reads on the claimed step d) to produce the aqueous ophthalmic solution; and the obtained aqueous ophthalmic solution has a pH of about 5.0 to 6.0 ([0059]) which overlaps the instant range of pH 4.5 to 5.5 and osmolality of about 300 mOsm/kg ([0059]). MPEP 2144.05 states 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 re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) (instant claim 1, in part); the solution was filtered with 0.2 micron filter ([0059]) which is identical to the claimed filter size (instant claim 2); the solution comprises difluprednate 0.03%-0.04% that is within the claimed range of about 0.03 to about 0.04% (i); polyvinyl alcohol 1.4% that is within the claimed range of about 0.5 to about 3.0% (ii); benzalkonium chloride 0.02-0.025% that is within the claimed range of about 0.01 to about 0.05% (iii); and polyoxyl 35 castor oil 4.0-5.0% that is within the claimed range of about 1.5 to about 6.0% (iv) ([0058]-Table 1). MPEP 2144.05 noted above (instant claim 4); and this prior art further teaches that the osmolality is adjusted by addition of an osmotic/tonicity adjusting agent such as sodium chloride, potassium chloride, sodium bromide, calcium chloride, mannitol, glycerol, sorbitol, propylene glycol, dextrose, sucrose, mannose and the like and mixtures thereof ([0031]).
Khopade teaches high osmolality about 300 mOsm/kg, and but does not disclose the claimed lower osmolality of about 95 to about 150 mOsm/kg of instant claim 1. The deficiency is cured by Lindstrom.
Lindstrom discloses anti-inflammatory ophthalmic composition comprising NSAID and steroid such as difluprednate in an ophthalmically acceptable vehicle (claim 1 of prior art); the vehicle includes buffers to adjust the vehicle to an acceptable pH from about 3 to 6.5, and buffers include acetate buffer and borate buffers, and the vehicles can maintain proper intraocular pressure and provide solutions of medicaments that are isotonic or mildly hypotonic ([0012]); and the aqueous ophthalmic solution can have an osmolality from about 10mOsm/kg to about 400mOsm/kg by using salts such as sodium chloride, borate, and such range provides low viscosities which permit the solution to be easily administered to the eye in drop form, and hence be comfortably administrable in consistent accurate dosage ([0020] and [0055]) in which the osmolality range of the prior art overlaps the instant range of about 95 to about 150mOsm/kg. MPEP 2144.05 above.
It would have been obvious to modify the osmolarity of Khopade with low osmolarity of Lindstrom as a matter of design or choice depending on type of the used osmotic/tonicity agent, as taught by Khopade ([0031]) and Lindstrom ([0020] and [0055]) because the osmolality range of about 10mOsm/kg to about 400mOsm/kg is generally used in the ophthalmic eye drop field for the patient compliance as taught by Lindstrom (instant claim 1 – osmolality).
Khopade teaches stirring regarding the claimed steps b)ii)-iii), and however, Khopade does not expressly specific stirring condition of instant claims 1 and 3. The deficiency is cured by Think Library and/or Andrieux.
Think Library discloses agitation is used for homogenizing, mixing, etc. (bridging paragraph pages 1-2); and agitation (=stirring) can control foaming(=bubble), and that is, by applying slow rotation that engulfs no bubbles (i.e., deaeration mode), bubbles that have risen to the liquid surface are destroyed by shearing force (see second Figure on page 3). It is clear from the teachings of Think Library that slow stirring rotation can reduce foaming.
Andrieux discloses a process for preparing an aqueous suspension of steroidal anti-inflammatory agent comprising a steroidal active agent, a dispersing agent, a suspension agent, and one or more excipients including antimicrobial agent (e.g., benzalkonium), and the process comprises (i) dissolution – dissolving in water the dispersing agent and all one or more excipients, (ii) dispersion – adding the steroidal anti-inflammatory agent to the solution of step (i), and (iii) homogenization – homogenizing the dispersion of step (ii), all steps are advantageously carried out at ambient temperature and under atmospheric pressure, wherein the dissolving step (i) is advantageously carried out under mixing at a speed of between 100 and 400 rpm, preferably approximately 250 rpm, step (ii) is performed at a stirring speed of 300 rpm without formation of foam, and step (iii) is performed with stirring with the same speed of 300 rpm (page 5, 7th para. and page 6, 8th para.). The stirring speed conditions in all the steps overlap or within the claimed ranges of 200-400 rpm or 200-600 rpm of instant claim 1 or 200-400rpm of instant claim 3. MPEP 2144.05 above.
It would have been obvious to further define the stirring condition of Khopade with low stirring speed (e.g., 200-600 rpm) during manufacturing pharmaceutical composition, in particular, in mixing the ingredients. One of the ordinary artisan would have motivated to do so because it is well known that foaming occurs at high stirring speed as it rapidly entrains air, creating vortex, increasing surface area, and thus, in order to avoid excessive foaming during manufacturing pharmaceutical solution, lowering stirring rate in mixing step would be necessary, as taught by Think Library and/or Andrieux (instant claims 1 and 3 – stirring condition).
In light of the foregoing, instant claims 1-4 are obvious over Khopade in view of Lindstrom and further in view of Think Library and Andrieux.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Khopade et al. (US2018/0296571A1, IDS of 02/06/2024) in view of Lindstrom et al. (WO2014/160579A1).
Applicant claims the below claim 5 filed on 02/06/2024:
PNG
media_image2.png
696
792
media_image2.png
Greyscale
For examination purpose, instant claim 5 is directed to an aqueous ophthalmic solution and recites product-by-process limitations of steps a)-d). However, such limitations are not structurally limiting the solution. With regard to this point, The M.P.E.P. § 2113 reads, “Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.” Therefore, instant claim 5 is seen as an ophthalmic solution comprising i)-iv) ingredients and having the claimed pH and osmolality.
Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
Khopade discloses an ophthalmic solution comprising a therapeutic effective concentration of difluprednate, polyvinyl alcohol, solubilizer comprising a mixture of quaternary ammonium and polyethyoxylated castor oil for the treatment of inflammatory disorder of the eye (abstract). In the below embodiment ([0038]), the ophthalmic solution is provides as follows:
PNG
media_image3.png
235
624
media_image3.png
Greyscale
In the above Table, difluprednate 0.03% is within the claimed range of about 0.013 to about 0.04% (i); polyvinyl alcohol 1.4% is within the claimed range of about 0.5 to about 3.0% (ii); benzalkonium chloride 0.02% is within the claimed range of about 0.01 to about 0.05% (iii); polyoxyl 35 castor oil 4.0% is within the claimed range of about 1.5 to about 6.0% (iv). The above solution has a pH of about 5.0 to 6.0 which overlaps the instant range of 4.5 to 5.5 and has osmolality of about 300 mOsm/kg ([0059]). MPEP 2144.05: “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 re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).” (instant claim 5, in part).
However, Khopade teaches high osmolality 300 mOsm/kg, and but does not disclose the claimed osmolality range of about 95 to about 150 mOsm/kg. The deficiency is cured by Lindstrom.
Lindstrom discloses anti-inflammatory ophthalmic composition comprising NSAID and steroid such as difluprednate in an ophthalmically acceptable vehicle (claim 1 of prior art); the vehicle includes buffers to adjust the vehicle to an acceptable pH from about 3 to 6.5, and buffers include acetate buffer and borate buffers, and the vehicles can maintain proper intraocular pressure and provide solutions of medicaments that are isotonic or mildly hypotonic ([0012]); and the aqueous ophthalmic solution can have a osmolality from about 10mOsm/kg to about 400mOsm/kg by using salts such as sodium chloride, borate, and such range provides low viscosities which permit the solution to be easily administered to the eye in drop form, and hence be comfortably administrable in consistent accurate dosage ([0020] and [0055]) which overlaps the instant range of about 95 to about 150mOsm/kg. MPEP 2144.05.
It would have been obvious to modify the osmolarity of Khopade with low osmolarity of Lindstrom as a matter of design or choice depending on type of the used osmotic/tonicity agent, as taught by Khopade ([0031]) and Lindstrom ([0020] and [0055]) because the osmolality range of about 10mOsm/kg to about 400mOsm/kg is generally used in the ophthalmic eye drop field as taught by Lindstrom, and thus selection of lower or higher osmolality would have yielded no more than the predictable results.
In light of the foregoing, instant claim 5 is obvious over Khopade in view of Lindstrom.
Claims 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Lindstrom et al. (WO2014/160579A1).
Applicant claims the below claims 6 and 9 filed on 02/06/2024:
PNG
media_image4.png
68
773
media_image4.png
Greyscale
PNG
media_image5.png
535
813
media_image5.png
Greyscale
For examination purpose, instant claim 9 is directed to an aqueous ophthalmic solution and recites product-by-process limitations of steps a)-d). However, such limitations are not structurally limiting the solution. With regard to this point, The M.P.E.P. § 2113 reads, “Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.” Accordingly, instant claim 9 is seen as claim 6.
Prior Art
Lindstrom discloses an ophthalmic composition containing a difluprednate in an ophthalmically acceptable vehicle ([0009]); the composition has a pH of about 6.0 ([0020]) wherein the said pH of about 6.0 embraces 5.7-6.3 ([0028]: “about” refers to an approximation of a stated value within an acceptable range, such as plus or minus about 5%) and thus, the claimed pH 5.5 is close enough to the prior range of about 6.0. Please see MPEP 2144.05: A prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985). Such similar pH range would have yielded no more than predictable results, i.e., slightly acidic pH, in the absence of criticality evidence to the contrary; and further the composition has osmolality of about 100 to about 300 mOsm/kg ([0055]) which overlaps the instant range of about 95 to about 150 mOsm/kg. MPEP 2144.05 states 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 re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) (instant claims 6 and 9).
In light of the foregoing, instant claims 6 and 9 are obvious over Lindstrom.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Lindstrom et al. (WO2014/160579A1) in view of Khopade et al. (US2018/0296571A1, IDS of 02/06/2024).
Applicant claims the below claims 7-8 filed on 02/06/2024:
PNG
media_image6.png
201
772
media_image6.png
Greyscale
PNG
media_image7.png
223
777
media_image7.png
Greyscale
Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
Lindstrom was discussed with respect to instant claim 6.
Lindstrom discloses the ophthalmic composition contains 0.05% of difluprednate and further comprises benzalkonium chloride ([0058]), boric acid and glycerol (=glycerin) ([0012]), sodium edetate (Table 1), etc. for the treatment of eye inflammatory disorder or disease.
However, Lindstrom does not expressly embodiments of instant claims 7-8. The deficiency is cured by Khopade.
Khopade discloses the below embodiment for the treatment of eye inflammatory disorder:
PNG
media_image8.png
568
602
media_image8.png
Greyscale
PNG
media_image9.png
74
578
media_image9.png
Greyscale
In the above Table ([0057] – Example 4), difluprednate 0.04% is within the claimed range of about 0.03 to about 0.04% (i); polyvinyl alcohol 1.40% is within the claimed range of about 0.5 to about 3.0% (ii); benzalkonium chloride 0.025% is within the claimed range of about 0.01 to about 0.05% (iii); polyoxyl 35 castor oil 5.0% is within the claimed range of about 1.5 to about 6.0% (iv); polyhexamethylene biguanide 0.005% is within the claimed amount of about 0.002 to about 0.02% (v); N-lauroyl sarcosine sodium 0.03% is within the claimed range of about 0.02 to about 0.05% (vi); boric acid 0.6% is within the claimed range of about 0.05 to about 1.5% (vii); disodium edetate 0.05% is within the claimed range of about 0.01 to about 0.1% (viii); and glycerin 1.60% is within the claimed range of about 1.0 to about 3.0% (ix)(instant claims 7-8). MPEP 2144.05 above.
It would have been obvious to modify the ophthalmic formulation of Lindstrom with the formulation of Khopade in order to provide lower concentration of difluprednate with enhanced patient compliance and without unwanted side effects such as blurred vision, irritation, foreign body sensation etc., upon instillation as taught by Khopade e.g., [0045]-[0046] (instant claims 7-8).
Therefore, instant claims 7-8 are obvious over Lindstrom in view of Khopade.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory 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 nonstatutory double patenting rejection is appropriate where the claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 5-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of US patent no. 11,000,475B2 in view of Lindstrom et al. (WO2014/160579A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets require difluprednate, crystal growth inhibitor such as polyvinyl alcohol, quaternary ammonium compound such as benzalkonium chloride, polyethyoxylated castor oil and same or inside amounts. The difference between them is that the claimed invention further requires product-by-process limitations, and pH/osmolality features. However, the product-by-limitations are not considered because the claimed invention is directed to a product not a process. Further, pH and osmolality are found in Lindstrom.
Lindstrom discloses anti-inflammatory ophthalmic composition comprising NSAID and steroid such as difluprednate in an ophthalmically acceptable vehicle (claim 1 of prior art); the vehicle includes buffers to adjust the vehicle to an acceptable pH from about 3 to 6.5, and buffers include acetate buffer and borate buffers, and the vehicles can maintain proper intraocular pressure and provide solutions of medicaments that are isotonic or mildly hypotonic ([0012]); and the aqueous ophthalmic solution can have a osmolality from about 10mOsm/kg to about 400mOsm/kg by using salts such as sodium chloride, borate, and such range provides low viscosities which permit the solution to be easily administered to the eye in drop form, and hence be comfortably administrable in consistent accurate dosage ([0020] and [0055]) which overlaps the instant range of about 95 to about 150mOsm/kg. Further the composition can have a pH of about 3to 6.5 ([0012]) which overlaps the instant range of 4.5 to 5.5.
It would have been obvious to modify the teachings of patent ‘475 with low osmolarity and overlapping pH of Lindstrom as a matter of design or choice depending on type of the used osmotic/tonicity agent, as taught by Lindstrom ([0012], [0020] and [0055]) because the range of osmolality of about 10mOsm/kg to about 400mOsm/kg and pH of about 3 to 6.5 are generally used in the ophthalmic eye drop field as taught by Lindstrom.
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patent ‘375 subject matter.
Claims 5-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of US patent no. 11,103,451B2 in view of Lindstrom et al. (WO2014/160579A1).
Although the claims at issue are not identical(product (instant) vs. method of use (patent ‘475)), they are not patentably distinct from each other because both claim sets require difluprednate, polyvinyl alcohol, quaternary ammonium compound such as benzalkonium chloride, polyoxylated castor oil and same or inside amounts. The difference between them is that the claimed invention further requires product-by-process limitations and pH and osmolality. However, the product-by-limitations are not considered because the claimed invention is directed to a product not a process. Further, pH and osmolality are found in Lindstrom.
Lindstrom discloses anti-inflammatory ophthalmic composition comprising NSAID and steroid such as difluprednate in an ophthalmically acceptable vehicle (claim 1 of prior art); the vehicle includes buffers to adjust the vehicle to an acceptable pH from about 3 to 6.5, and buffers include acetate buffer and borate buffers, and the vehicles can maintain proper intraocular pressure and provide solutions of medicaments that are isotonic or mildly hypotonic ([0012]); and the aqueous ophthalmic solution can have a osmolality from about 10mOsm/kg to about 400mOsm/kg by using salts such as sodium chloride, borate, and such range provides low viscosities which permit the solution to be easily administered to the eye in drop form, and hence be comfortably administrable in consistent accurate dosage ([0020] and [0055]) which overlaps the instant range of about 95 to about 150mOsm/kg. Further the composition can have a pH of about 3 to 6.5 ([0012]) which overlaps the instant range of 4.5 to 5.5.
It would have been obvious to modify the teachings of patent ‘451 with low osmolarity and overlapping pH of Lindstrom as a matter of design or choice depending on type of the used osmotic/tonicity agent, as taught by Lindstrom ([0012], [0020] and [0055]) because the ranges of osmolality of about 10mOsm/kg to about 400mOsm/kg and pH of about 3 to 6.5 are generally used in the ophthalmic eye drop field as taught by Lindstrom.
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patent ‘451 subject matter.
Claims 5-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21of US patent no. 11,890,375B2 in view of Lindstrom et al. (WO2014/160579A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets require difluprednate, polyvinyl alcohol, quaternary ammonium compound such as benzalkonium chloride, polyethyoxylated castor oil and same or inside amounts. The difference between them is that the claimed invention further requires product-by-process limitations and pH and osmolality. However, the product-by-limitations are not considered because the claimed invention is directed to a product not a process. Further, pH and osmolality are found in Lindstrom.
Lindstrom discloses anti-inflammatory ophthalmic composition comprising NSAID and steroid such as difluprednate in an ophthalmically acceptable vehicle (claim 1 of prior art); the vehicle includes buffers to adjust the vehicle to an acceptable pH from about 3 to 6.5, and buffers include acetate buffer and borate buffers, and the vehicles can maintain proper intraocular pressure and provide solutions of medicaments that are isotonic or mildly hypotonic ([0012]); and the aqueous ophthalmic solution can have a osmolality from about 10mOsm/kg to about 400mOsm/kg by using salts such as sodium chloride, borate, and such range provides low viscosities which permit the solution to be easily administered to the eye in drop form, and hence be comfortably administrable in consistent accurate dosage ([0020] and [0055]) which overlaps the instant range of about 95 to about 150mOsm/kg. Further the composition can have a pH of about 3 to 6.5 ([0012]) which overlaps the instant range of 4.5 to 5.5.
It would have been obvious to modify the teachings of patent ‘375 with low osmolarity and overlapping pH of Lindstrom as a matter of design or choice depending on type of the used osmotic/tonicity agent, as taught by Lindstrom ([0012], [0020] and [0055]) because the ranges of osmolality of about 10mOsm/kg to about 400mOsm/kg and pH of about 3 to 6.5 are generally used in the ophthalmic eye drop field as taught by Lindstrom.
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patent ‘375 subject matter.
Claims 5-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of US patent no. 12,383,496B2 in view of Lindstrom et al. (WO2014/160579A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets require difluprednate, polyvinyl alcohol, quaternary ammonium compound such as benzalkonium chloride, polyethyoxylated castor oil and same or inside amounts. The difference between them is that the claimed invention further requires product-by-process limitations and pH and osmolality. However, the product-by-limitations are not considered because the claimed invention is directed to a product not a process. Further, pH and lower osmolality are found in Lindstrom.
Lindstrom discloses anti-inflammatory ophthalmic composition comprising NSAID and steroid such as difluprednate in an ophthalmically acceptable vehicle (claim 1 of prior art); the vehicle includes buffers to adjust the vehicle to an acceptable pH from about 3 to 6.5, and buffers include acetate buffer and borate buffers, and the vehicles can maintain proper intraocular pressure and provide solutions of medicaments that are isotonic or mildly hypotonic ([0012]); and the aqueous ophthalmic solution can have a osmolality from about 10mOsm/kg to about 400mOsm/kg by using salts such as sodium chloride, borate, and such range provides low viscosities which permit the solution to be easily administered to the eye in drop form, and hence be comfortably administrable in consistent accurate dosage ([0020] and [0055]) which overlaps the instant range of about 95 to about 150mOsm/kg. Further the composition can have a pH of about 3 to 6.5 ([0012]) which overlaps the instant range of 4.5 to 5.5.
It would have been obvious to modify the teachings of patent ‘496 with low osmolarity and overlapping pH of Lindstrom as a matter of design or choice depending on type of the used osmotic/tonicity agent, as taught by Lindstrom ([0012], [0020] and [0055]) because osmolality of about 10mOsm/kg to about 400mOsm/kg and pH about 3 to 6.5 are used in the ophthalmic eye drop field as taught by Lindstrom, and it would have been obvious to modify the teachings of patent ‘496 with overlapping pH
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patent ‘496 subject matter.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KYUNG S CHANG/ Primary Examiner, Art Unit 1613