DETAILED ACTION
Status of Application
The response filed 08/04/2025 has been received, entered and carefully considered. The response affects the instant application accordingly:
Claim 13 has been amended.
Claims 26-28 have been added.
Applicant had previously elected Group II and had previously canceled claims to the non-elected groups.
Claims 9-14, 26-28 are pending in the case.
Claims 9-14, 26-28 are present for examination.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
New grounds of rejection are set forth in the current office action as a result of claim amendment.
Priority
This application is a continuation-in-part of the prior application 16/650071, and adds disclosure not presented in the prior application.
The instant claims 9-12 are directed to a post-surgical ocular treatment method comprising topically administering to an eye of a subject that has undergone ocular surgery, a therapeutically effective amount of a pharmaceutical composition comprising of 0.01%-0.05% w/w betamethasone sodium phosphate; 0.05%-0.50% w/w mycophenolic acid; and a pharmaceutically acceptable carrier which is supported by the instant disclosure but not supported in the disclosure of the prior application wherein the instant claims are given the priority date of 03/24/2020 which is the filing date of the instant application.
Claims 13-14, 26-28 are subject the 112 rejections below for new matter.
New Grounds of Rejection and Objection
Due to the amendment of the claims the new grounds of rejection and objection are applied:
Claim Objections
Claim 28 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 14. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Claims 13-14, 26-28 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.
Claim 13 and its dependent claims are directed to a method of treatment comprising: topically administering to an eye of a subject that has undergone ocular surgery, a therapeutically effective amount of a pharmaceutical composition comprising betamethasone sodium phosphate at a concentration of 0.01% w/w to 0.05% w/w; mycophenolic acid at a concentration of 0.05% w/w to 0.50% w/w; and a pharmaceutically acceptable lubricating carrier for topical administration to the eye, wherein the composition maintains a viscosity about equal to water when exposed to body temperature.
This is new matter. The instant disclosure does not support for these claims as the specification does not provide any written description for a viscosity range nor value for the composition being administered. The specification does not provide written description for the viscosity of the composition under any specified condition, much less for it to be about equal to water when exposed to body temperature – there is no description for the viscosity of the composition when exposed to body temperature, nor what the duration is considered for the composition to maintain a viscosity about equal to water when exposed to body temperature – is it for seconds? Is it for minutes? There is no written description for what the duration is the maintenance period would be especially as the eye produces tears which would dilute the applied composition and the specification does not address what that duration of the maintenance period would be. Additionally the examples cited by Applicant and the instant disclosure describe the composition to contain Pluronic which is a poloxamer thickener and Methocel which is cellulose thickener, and the presence of chondroitin sulfate and dextran which are viscosity agents which is required in the dependent claims wherein the examples and specification does not support for the recitation that the composition to maintain for the non-specified duration a viscosity of about water when exposed to body temperature; as it describes the presence of viscosity agents (and present in dependent claims).
This is a new matter rejection.
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.
Claims 13-14, 26-28 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.
Claim 13 and its dependent claims are directed to a method of treatment comprising: topically administering to an eye of a subject that has undergone ocular surgery, a therapeutically effective amount of a pharmaceutical composition comprising betamethasone sodium phosphate at a concentration of 0.01% w/w to 0.05% w/w; mycophenolic acid at a concentration of 0.05% w/w to 0.50% w/w; and a pharmaceutically acceptable lubricating carrier for topical administration to the eye, wherein the composition maintains a viscosity about equal to water when exposed to body temperature.
This is indefinite. It is unclear what is the duration is considered for the composition to “maintain a viscosity about equal to water when exposed to body temperature” – is it for seconds? Is it for minutes? The eye produces tears which would dilute the applied composition when applied and over time. It does not allow one to ascertain the metes and bounds of the claim. Additionally, the claims “maintains a viscosity about equal to water when exposed to body temperature” which is unclear as body temperature is variable – wherein it is unclear what is the viscosity of water at body temperature (does it include with fever? Without fever? Some people are cooler, some are warmer). It does not allow one to ascertain the metes and bounds of the claim. Lastly, the dependent claims require the presence of chondroitin sulfate and dextran which are viscosity agents wherein it is unclear how the composition can maintain the viscosity of about equal to water when exposed to body temperature when there are thickeners present. The examples also require the presence of other viscosity agents like cellulose polymers and Pluronic/poloxamers. It does not allow one to ascertain the metes and bounds of the claims. For purposes of examination, the maintenance period can be any time period and is open to the inclusion to viscosity/thickening agents at any value.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 9, 12-14, 28 are rejected under 35 U.S.C. 103 as being unpatentable over Donnenfeld (Focus on Complications and Complexity: Dry Eye After LASIK) in view of Karolchyk et al. (U.S. Pat. Pub. 2017/0112936) and Koverech (WO 2012/084446).
Rejection:
Donnenfeld teaches that essentially all patients have dry eye at least transiently after LASIK, and that dry eye is the most common complication of LASIK surgery and ophthalmologist should take steps to minimize dry eye and employ postoperative therapeutic interventions (postoperative treatments from eye surgery, First paragraph and Conclusion).
Donnenfeld does not expressly teach the topical administration of a composition containing 0.01% to 0.05% w/w betamethasone sodium phosphate, 0.05% to 0.50% w/w mycophenolic acid, and a pharmaceutically acceptable carrier; but does establish that dry eye is the most common complication of LASIK surgery and ophthalmologists should take steps to minimize dry eye and employ postoperative treatments.
Karolchyk et al. teaches an ophthalmic composition for treating dry eye containing at least one corticosteroid and at least one immunosuppressant and a carrier (water). The corticosteroid includes betamethasone and be from about 0.01mg/ml-about 50mg/ml (about 0.001-5%) and about 0.1-about 40mg/ml (about 0.01-4%), the immunosuppressant including mycophenolic acid and be from about 0.01-50mg/ml (0.001-5%) and about 0.1-about 30mg/ml (0.01-3%). The composition can also have at least one medicament for dry eye (abstract, [8-9, 36, 39, 54, 60-61, 70-72, 78-79, 88, 115], claims 1,3, 5, 9). The composition can be delivered as an eyedrop and an eye spray (liquid forms) and can become gel-like as it arrives to the cul-de-sac or on the eye surface after seconds (maintained liquid for seconds).
Koverech teaches that known forms of betamethasone include betamethasone sodium phosphate, disodium phosphate, dipropionate and valerate; and are useful for the eye (Page 3 line 8-18).
Wherein it would be it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to treat the dry eye from LASIK with a dry eye formulation with betamethasone like betamethasone sodium phosphate as suggested by Karolchyk et al. and Koverech and produce the claimed invention; as it is it prima facie obvious to treat the dry eye from LASIK with a known formulation with an immunosuppressant like mycophenolic acid and a steroid like betamethasone for treating dry eye as presented with Karolchyk et al., and to utilize a known form of betamethasone like betamethasone sodium phosphate as taught by Koverech with a reasonable expectation of success. While Karolchyk et al. does not teach the exact claimed values for the betamethasone and mycophenolic acid, they are embraced by the taught range wherein it is prima facie obvious to optimize within the taught range and arrive at the claimed values as a means of attaining the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed range. It is noted that as composition is a fluid initially (maintained for seconds) wherein it is expected have a viscosity like water at body temperature being an eyedrop at that time as it contains viscosity agent like poloxamers of the instant specification, and then be gel-like but the composition gets diluted with tear fluid in the eye over time and will lower in viscosity over time and become like water.
Response to Arguments:
Applicant's arguments are centered on the assertion that Donnenfeld does not provide for a topical treatment containing betamethasone sodium phosphate and mycophenolic acid as claimed, that Koverech is to Bentelan on culture and does not have in vivo date, that Karolchyk is to numerous compounds and only formulated vancomycin with no data alleging a lack of expected results and expectation of success, the assertion of surprising results in the combination of a low dose of betamethasone sodium phosphate and a low dose of mycophenolic acid in a topical eye drop and reduced unwanted effects found with higher concentrations of compounds like betamethasone sodium phosphate citing [34] of the specification, that there the combination of mycophenolic acid and betamethasone sodium phosphate (.3% MPA with 0.01 BSP%) had surprising results compared to the actives alone (0.3% MPA alone, 0.01 BSP% alone) dosed twice daily for up to 12 weeks citing data in the CIP copending application of Figure 1-2, and that instant claim 13 maintains a viscosity about equal to water when exposed to body temperature and Karolchyk becomes gel-like in seconds compared to the instant claim 13.
This is fully considered but not persuasive.
The argument to Donenfeld for not teaching the treatment is against the reference individually, and one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The argument that Koverech is to Bentelan on a culture and not being in vivo is not persuasive as the purpose of Koverech is to merely demonstrate that betamethasone sodium phosphate is a that known form of betamethasone and useful for the eye as seen by the limited section cited; it is also against the reference individually, and one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The argument to Karolchyk is not persuasive as while vancomycin is exemplified, the teachings of Karolchyk are not held solely to its examples when the general teaching is for a specific finite grouping of well-known actives for the ophthalmic composition for purpose of treating dry eye with a combination of actives which include a corticosteroid like betamethasone and immunosuppressant including mycophenolic acid with a reasonable expectation of success absent evidence of criticality for the specific corticosteroid and immunosuppressant.
As for the assertion of surprising results citing [34] of the specification that the combination of a low dose of betamethasone sodium phosphate (BSP) and a low dose of mycophenolic acid (MPA) in a topical eye drop and reduced unwanted effects found with higher concentrations of compounds like BSP, arguments without factual support are mere allegations and are not found persuasive.
As for the assertion that in the child CIP copending application Figure 1-2 the combination of 0.3% mycophenolic acid (MPA) and 0.01% betamethasone sodium phosphate (0.3% MPA with 0.01% BSP) had surprising results compared to the actives alone (0.3% MPA alone, 0.01 BSP% alone) dosed twice daily for up to 12 weeks, this is fully considered but not persuasive as any evidence submitted to traverse the rejection must be by way of an oath or declaration under 37 CFR 1.132. It is noted that the showing is not commensurate in scope with the claims as it is to a specific regimen of specific formulation, and in both Figure 1 and 2 there is not showing of statistical significance and the showing appear to demonstrate an additive effect which is not unexpected when two actives are combined rather than synergy.
As for the assertion that instant claim 13 maintains a viscosity about equal to water when exposed to body temperature and Karolchyk becomes gel-like in seconds, is not persuasive as addressed by the 112 issues above. Additionally, the instant specification exemplifies the composition with Pluronic/poloxamer, Methocel, dextran, and chondroitin sulfate which are all viscosity agents – and the examples have poloxamer at 0.2g/100ml=0.2%; and Karolchyk teaches the polymer like poloxamer from about 1.0mg/ml-about 500mg/ml (0.1g/100ml-50g/100ml=0.1-50%) where the instant examples fall within the range of Karolchyk and would be expected to have the same properties as those of Karolchyk as the instant examples contain viscosity polymers like poloxamer within the range of Karolchyk contrary to Applicant’s assertion.
Accordingly, the rejection stands.
Claims 10-11, 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Donnenfeld (Focus on Complications and Complexity: Dry Eye After LASIK) in view of Karolchyk et al. (U.S. Pat. Pub. 2017/0112936) and Koverech (WO 2012/084446) as applied to claims 9, 12-14, 28 above, further in view of Holgersson et al. (U.S. Pat. Pub. 2012/0165272).
The teachings of Donnenfeld in view of Karolchyk et al. and Koverech et al. are addressed above.
Donnenfeld in view of Karolchyk et al. and Koverech do not recite the presence of a chondroitin sulfate and dextran but does teach the inclusion of at least one medicament for dry eye like celluloses and polyvinyl alcohol which are known demulcents (demulcents relieve inflammation/irritation).
Holgersson et al. teaches that known demulcents for dry eye include chondroitin sulfate, dextran, polyvinyl alcohol, and celluloses like carboxymethylcellulose [114].
Wherein it would be it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the chondroitin sulfate and dextran as suggested by Holgersson et al. and produce the claimed invention; as it is it prima facie obvious to incorporate a known demulcent like chondroitin sulfate and dextran as inclusion of demulcents like celluloses and polyvinyl alcohol are taught with a reasonable expectation of success.
Response to Arguments:
Applicant's arguments are to Donnenfeld in view of Karolchyk et al. and Koverech et al. which are addressed above.
Accordingly, the rejection stands.
Claims 9, 12-14, 28 are rejected under 35 U.S.C. 103 as being unpatentable over Donnenfeld (Focus on Complications and Complexity: Dry Eye After LASIK) in view of Hou et al. (U.S. Pat. Pub. 2017/0065552), Xia et al. (U.S. Pat. Pub. 2006/0148686), and Koverech (WO 2012/084446).
Rejection:
Donnenfeld teaches that essentially all patients have dry eye at least transiently after LASIK, and that dry eye is the most common complication of LASIK surgery and ophthalmologists should take steps to minimize dry eye and employ postoperative therapeutic interventions (postoperative treatments from eye surgery, First paragraph and Conclusion).
Donnenfeld does not expressly teach the topical administration of a composition containing 0.01% to 0.05% w/w betamethasone sodium phosphate, 0.05% to 0.50% w/w mycophenolic acid, and a pharmaceutically acceptable carrier; but does establish that dry eye is the most common complication of LASIK surgery and ophthalmologists should take steps to minimize dry eye and employ postoperative treatments.
Hou et al. teaches an aqueous ophthalmic composition for treating dry eye containing mycophenolic acid (0.1-0.5%), steroids, viscosity agent/modifier, wetting agent; the composition can be applied topically (abstract, Table 1A-1B, [9, 11-12, 16, 25, 40, 43, 60-64], claims 1, 5, 8,12, 26).
Xia et al. teaches that corticosteroids used for treating dry eye include betamethasone from 0.01-2% (abstract, [14], claim 2).
Koverech teaches that known forms of betamethasone include betamethasone sodium phosphate, disodium phosphate, dipropionate and valerate; and are useful for the eye (Page 3 line 8-18).
Wherein it would be it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to treat the dry eye from LASIK with a dry eye formulation with a steroid like betamethasone sodium phosphate as suggested by Hou et al. and Xia et al. and Koverech and produce the claimed invention; as it is it prima facie obvious to treat the dry eye from LASIK with a known formulation with mycophenolic acid and a steroid for treating dry eye as presented with Hou et al., and to utilize a known steroid like betamethasone in its known form as taught by Xia and Koverech with a reasonable expectation of success. While Xia et al. does not teach the exact claimed values for the betamethasone, they are embraced by the taught range wherein it is prima facie obvious to optimize within the taught range and arrive at the claimed values as a means of attaining the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed range; and as the composition for the method contains the same structural components as claimed as it contains the same actives in a vehicle, it would be expected to have the same properties as recited at body temperature as a composition and it’s properties cannot be separated.
Response to Arguments:
Applicant's arguments are centered on the assertion that Donnenfeld does not provide for a topical treatment containing betamethasone sodium phosphate and mycophenolic acid as claimed, that Hou lacks betamethasone, that Xia discloses a broad concentration range for the steroid and exemplifies loteprednol etabonate at 0.5-075% which is 10x more than the amount of betamethasone claimed, the assertion that Applicant’s results are unexpected.
This is fully considered but not persuasive.
The argument to Donnenfeld for not teaching the treatment and that Hou lacks betamethasone, are both against the references individually and one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Xia et al. teaches that corticosteroids used for treating dry eye include betamethasone from 0.01-2% (abstract, [14], claim 2).
The argument to Xia is a broad concentration range for the steroid and exemplifies loteprednol etabonate at 0.5-075% which is more than the amount of betamethasone claimed is not persuasive as the purpose of Xia is to merely demonstrate corticosteroids used for treating dry eye include betamethasone from 0.01-2% as seen by the limited section cited, and it is prima facie obvious to optimize within the taught range and arrive at the claimed values as a means of attaining the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed range which has not been presented.
Applicant’s assertion for unexpected results appear to be directed to the assertion for the child CIP copending application which is addressed above.
Accordingly, the rejection stands.
Claims 10-11, 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Donnenfeld (Focus on Complications and Complexity: Dry Eye After LASIK) in view of Hou et al. (U.S. Pat. Pub. 2017/0065552), Xia et al. (U.S. Pat. Pub. 2006/0148686), and Koverech (WO 2012/084446) as applied to claims 9, 12-14, 28 above, further in view of Zhu et al. (U.S. Pat. Pub. 2015/0157591).
The teachings of Donnenfeld in view of Hou et al., Xia et al., and Koverech are addressed above.
Donnenfeld in view of Hou et al., Xia et al., and Koverech do not recite the presence of a dextran or chondroitin sulfate but does teach the inclusion of viscosity agents.
Zhu et al. teaches that known viscosity agents include chondroitin sulfate and dextran and combinations thereof [98].
Wherein it would be it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate dextran and chondroitin sulfate as suggested by Zhu et al. and produce the claimed invention; as it is it prima facie obvious to incorporate known viscosity agents like dextran and chondroitin sulfate with a reasonable expectation of success absent evidence of criticality for the claimed agents.
Response to Arguments:
Applicant's arguments are those presented for Donnenfeld in view of Hou et al., Xia et al., and Koverech which are addressed above.
Accordingly, the rejection stands.
Claims 9, 11-14, 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Donnenfeld (Focus on Complications and Complexity: Dry Eye After LASIK) in view of Friedman et al. (U.S. Pat. Pub. 2010/0113416), Xia et al. (U.S. Pat. Pub. 2006/0148686), and Koverech (WO 2012/084446).
Rejection:
Donnenfeld teaches that essentially all patients have dry eye at least transiently after LASIK, and that dry eye is the most common complication of LASIK surgery and ophthalmologists should take steps to minimize dry eye and employ postoperative therapeutic interventions (postoperative treatments from eye surgery, First paragraph and Conclusion).
Donnenfeld does not expressly teach the topical administration of a composition containing 0.01% to 0.05% w/w betamethasone sodium phosphate, 0.05% to 0.50% w/w mycophenolic acid, and a pharmaceutically acceptable carrier; but does establish that dry eye is the most common complication of LASIK surgery and ophthalmologists should take steps to minimize dry eye and employ postoperative treatments.
Friedman et al. teaches a topical aqueous ophthalmic composition for treating dry eye containing a JAK inhibitor with at least one additional therapeutic agent including mycophenolic acid (0.01-5%) and corticosteroids (0.01-5%) like dexamethasone and prednisolone, viscosity agent/modifiers with a viscosity about 10-about 400 cps, suspending agents like dextrans (abstract, claim 1, 9-11, 17-18; [24, 27-28, 36, 41, 58-59]).
Xia et al. teaches that corticosteroids used for treating dry eye include steroids like betamethasone, dexamethasone, and prednisolone from 0.01-2% (abstract, [14], claim 2).
Koverech teaches that known forms of betamethasone include betamethasone sodium phosphate, disodium phosphate, dipropionate and valerate; and are useful for the eye (Page 3 line 8-18).
Wherein it would be it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to treat the dry eye from LASIK with a dry eye formulation with a JAK inhibitor and mycophenolic acid and a steroid like betamethasone sodium phosphate in topical aqueous carrier with excipients like dextran as suggested by Friedman et al. and Xia et al. and Koverech and produce the claimed invention; as it is it prima facie obvious to treat the dry eye from LASIK with a known formulation containing mycophenolic acid and a steroid along with the JAK inhibitor for treating dry eye as presented with Friedman et al., and to utilize a known steroid like betamethasone in its known form as taught by Xia and Koverech as simple substitution of one steroid for another is prima facie obvious with a reasonable expectation of success. While Friedman et al. and Xia et a. does not teach the exact claimed values for the mycophenolic acid and steroid/betamethasone, they are embraced by the taught range wherein it is prima facie obvious to optimize within the taught range and arrive at the claimed values as a means of attaining the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed range.
Claims 10, 26 are rejected under 35 U.S.C. 103 as being unpatentable over Donnenfeld (Focus on Complications and Complexity: Dry Eye After LASIK) in view of Friedman et al. (U.S. Pat. Pub. 2010/0113416), Xia et al. (U.S. Pat. Pub. 2006/0148686), and Koverech (WO 2012/084446) as applied to claims 9, 11-14, 27-28 above, further in view of Zhu et al. (U.S. Pat. Pub. 2015/0157591).
The teachings of Donnenfeld in view of Friedman et al., Xia et al., and Koverech are addressed above.
Donnenfeld in view of Friedman et al., Xia et al., and Koverech do not recite the presence of a chondroitin sulfate but does teach the inclusion of viscosity/wetting agents.
Zhu et al. teaches that known viscosity agents include chondroitin sulfate and dextran and combinations thereof [98].
Wherein it would be it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate chondroitin sulfate as suggested by Zhu et al. and produce the claimed invention; as it is it prima facie obvious to incorporate known viscosity agents like chondroitin sulfate with a reasonable expectation of success absent evidence of criticality for the claimed agent.
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 conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 9, 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10-12, 17 of copending Application No. 18/100505 (reference application) in view of Koverech (WO 2012/084446).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims are directed to the same method with the same active components of betamethasone and mycophenolic acid with ranges that embrace the instant ranges, wherein it would be prima facie obvious to optimize within the copending ranges as a means of attaining the desired therapeutic profile and arrive at the instant claimed values absent evidence of criticality for the recited range.
The copending claims do not recite the betamethasone to be betamethasone sodium phosphate but does recite the inclusion of betamethasone or its pharmaceutically acceptable salt.
Koverech teaches that known forms of betamethasone include betamethasone sodium phosphate, disodium phosphate, dipropionate and valerate (all salt forms); and are useful for the eye (Page 3 line 8-18).
Wherein it would be it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize betamethasone sodium phosphate as suggested by Koverech and produce the claimed invention; as it is it prima facie obvious to utilize a known betamethasone salt form with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments:
There are no arguments or terminal disclaimer.
Accordingly, the rejection stands.
Claims 12, 14, 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10-12, 17 of copending Application No. 18/100505 (reference application) in view of Koverech (WO 2012/084446) as applied to claims 9 and 13 above, further in view of Donnenfeld (Focus on Complications and Complexity: Dry Eye After LASIK).
The teachings of the copending claims in view of Koverech are addressed above.
The copending claims in view of Koverech do not recite the presence or risk of dry eye but is directed to post surgical ocular treatment (treatment after ocular surgery).
Donnenfeld teaches that essentially all patients have dry eye at least transiently after LASIK, and that dry eye is the most common complication of LASIK surgery and ophthalmologists should take steps to minimize dry eye and employ postoperative therapeutic interventions (postoperative treatments, First paragraph and Conclusion).
Wherein it would be it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that there the patient would have or is at risk of dry eye after ocular surgery such as LASIK as suggested by Donnenfeld and produce the claimed invention; as it is it prima facie obvious to utilize a known means of ocular post-surgical treatment for patients that had LASIK (a ocular surgery) with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments:
There are no arguments or terminal disclaimer.
Accordingly, the rejection stands.
Claims 10-11, 26-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-12, 17 of copending Application No. 18/100505 (reference application) in view of Koverech (WO 2012/084446) as applied to claims 9 and 13 above, further in view of Zhu et al. (U.S. Pat. Pub. 2015/0157591).
The teachings of the copending claims in view of Koverech are addressed above.
The copending claims in view of Koverech do not recite the presence of dextran or chondroitin sulfate but does teach the topical administration of the composition.
Zhu et al. teaches that it is known that agents can be added to increase the viscosity of ophthalmic compositions which include chondroitin sulfate and dextran and combinations thereof [98].
Wherein it would be it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate dextran and chondroitin sulfate as suggested by Zhu et al. and produce the claimed invention; as it is it prima facie obvious to incorporate known viscosity agents like dextran and chondroitin sulfate to increase the viscosity of the composition (i.e. improved handling, less runoff) with a reasonable expectation of success absent evidence of criticality for the claimed agents.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments:
There are no arguments or terminal disclaimer.
Accordingly, the rejection stands.
Conclusion
Claims 9-14, 26-28 are rejected.
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.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613