DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/21/2025 has been entered.
Status of Application
The response filed 10/21/2025 has been received, entered and carefully considered. The response affects the instant application accordingly:
Claims 1, 8, 10 have been amended.
Claims 1, 3, 7-11 are pending in the case.
Claims 1, 3, 7-11 are present for examination.
All grounds not addressed in the action are withdrawn or moot as a result of amendment.
New grounds of rejection are set forth in the current office action.
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
Due to the amendment of the claims the new grounds of rejection are applied:
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
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 1, 3, 7-11 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.
The term “derivative” is indefinite as it unclear is encompassed by the term. The specification recites some pharmaceutical salts but it is unclear what degree of derivation of the cysteamine is embraced by the claims and given the form any number of compounds given an infinite number of chemical reactions, the compounds and be anything and thereby it is unclear what is envisioned for the invention. For example, one could derivatize cysteamine to a hydroxylamine given any number of reactions. It does not allow one of skill in the art to know the metes and bounds of the invention. For purposes of examination to expedite prosecution, the phrase “cystamine or a derivative thereof” is treated as cysteamine or its pharmaceutically acceptable salt.
Claims 1, 3, 7-11 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.
The recitation that the cysteamine or a derivative thereof as a sole active ingredient is indefinite as it unclear what is encompassed by the phrase as many excipients have activity including the claimed glycerol (instant claim 11) and instant claims 8-9 which recites additional actives and are subject the indefinite rejection below. Antioxidants are active ingredients, preservatives are active ingredients, osmotic agents are active ingredients, and lubricants; wherein are they excluded or included in the composition? The instantly claimed glycerol is recited as an excipient but has activity as it can lower intraocular pressure in glaucoma (see Goswamy) and has properties of promoting epithelial cell growth and blunting the damaging effects of high osmolarity on the ocular surface and is considered an active ingredient (see Larson, Formularization of active Ingredients-Demulcents- Glycerin, Page 1 and 3-4); wherein it is unclear how the composition can only have cysteamine as the sole active ingredient as it is open to inclusion of glycerol which is an active ingredient. Is it directed to where the cysteamine is the sole therapeutic ingredient? This is also unclear as if cysteamine is a sole therapeutically active ingredient - the claimed glycerol is a therapeutic active ingredient as it can lower intraocular pressure in glaucoma and has properties of promoting epithelial cell growth and blunting the damaging effects of high osmolarity on the ocular surface wherein it is indefinite. It does not allow one to ascertain the metes and bounds of the claims as written. The indefinite issue for derivative is addressed above. For purposes of examination, the phrase is treated where the composition is open to other active components with cysteamine or a its pharmaceutically acceptable salt (i.e. glycerol, preservatives, lubricants), but not therapeutically conventional active drugs in the composition that comprises the method (i.e. omega 3 fatty acid, but the method is open to additional compositions and steps).
Claims 8-9 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.
The claims recite the method of claim 1 wherein the composition is further administered in combination with at least one additional active agent and wherein the at least one additional active agent is an MMP-9 inhibitor, but depends from independent claim 1 which states that the composition for the method has cysteamine as a sole active ingredient at 0.44% wherein it is unclear if the additional active agent is in the same composition which precludes any additional active other than cysteamine which broadens the claim from which it depends and indefinite, or if the additional active(s) are in a separate composition and a separate step from the 0.44% cysteamine composition where it is the sole active. It does not allow one to ascertain the metes and bounds of the claims as written. For purposes of examination, the claims are treated where the additional active(s) are in a separate composition being administered from the 0.44% cysteamine composition.
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 1, 3, 7-8, 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Matier et al. (WO 2005/051328) in view of American Academy of Ophthalmology (Evaluating MMP-9 levels may help diagnose dry eye).
Rejection:
Matier et al. teaches treating eye conditions in patients including dry eye (keratoconjunctivitis sicca – including non-Sjogren’s presentations (does not recite Sjogren’s), the instant specification states that dysfunctional tear syndrome is the condition of having dry eyes [3]) with a composition comprising a hydroxylamine compound, a carrier/diluent, and further with a reducing agent that is preferably a sulfydryl compound such as β-mercaptoethylamine (also known as cysteamine) from about 0.1-about 5.0%w/v (claims 1, 13, 15-20; abstract, Page 4 paragraph 3-4, Page 7 paragraph 1 and 4, Page 8 last paragraph-Page 9 first line, Page 11 first paragraph). Administration can be by eye drop, wash or ointment (Page 8 paragraph 1, Page 10 paragraph 2, Page 13 first paragraph, claim 24). The reducing agent can be administered separately from the hydroxylamine or formulated together (claims 15-20, cysteamine/β-mercaptoethylamine in a separate composition from hydroxylamine-each therapeutic active in separate compositions (sole therapeutic active in their composition)). The composition can include tonicity agents and isotonic solutions such as 0.9% saline, viscosity agents like hydroxypropylcellulose and polyvinyl pyrrolidine, cosolvents like glycerin (glycerol, Page 11 paragraph 3-Page 12 first paragraph). The dose may be adjusted by the physician as needed and the dosing can be 1-4 times/day as long as needed and the dosing schedule may vary depending on the drug concentration and an ophthalmologist or one skilled in the art have the means to monitor the effectiveness of the dosage and dosage scheme and adjust accordingly (Page 10 last paragraph-Page 11 first paragraph, Page 17 last paragraph-Page 18 paragraph 2). Matier et al. teaches that the composition can have additional compounds known in the art for treating the disease (Page 17 paragraph 4, see full document specifically areas cited).
While Matier et al. does not expressly teach the exact claimed value of 0.44% for β-mercaptoethylamine (cysteamine), it is embraced by the taught range of Matier et al. (about 0.1-about 5.0%w/v ) wherein it would be prima facie obvious to optimize within the taught range to attain the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed values. It is implicit that the patient is diagnosed with the condition in order to be treated. It is also implicit if not prima facie obvious that the patient is human as the diseases are human diseases (i.e. glaucoma, dry eye, ERM is recited to be in people over 75). While Matier et al. does not expressly teach the exact claimed dosing regime, Matier does teach that dosing can be 1-4 times/day as long as needed and the dose and dosing schedule may be adjusted by the physician as needed for effectiveness, wherein to would be prima facie obvious to one of ordinary skill in the art to adjust/optimize the dosing schedule such as 4 times a day which is within the taught schedule - and to use the composition for the entire duration of the condition (i.e. dry eye for months, years) to attain the desired therapeutic/effective profile with a reasonable expectation of success absent evidence of criticality for a specific regimen schedule.
Matier does not expressly recite that the dry eye has elevated MMP activity, it does recite treating dry eye and MMP-9 is known to be elevated in the tears of patients with dry eyes as established by American Academy of Ophthalmology, wherein the dry eye is associated with increased MMP activity.
Response to Arguments:
Applicant’s arguments are centered on the assertions for unexpected results in Example 1 and that the amended claim 1 is commensurate in scope with the example asserting objective evidence of nonobviousness, that the Examiner failed to establish a prima facie case of obvious as the prior art do not teach/suggest the claim limitations, and that one would not have expected cysteamine to be useful for dry eye (dysfunctional tear syndrome).
This is fully considered but not persuasive.
Applicant’s argument that Example 1 presents with unexpected results and amended claim 1 which is to treating DTS associated with increased MMP activity with administering 0.44% cysteamine or a derivative thereof as a sole active ingredient four times daily for at least four weeks to ameliorate dry eye in a human is fully considered but not persuasive.
The indefinite issues are addressed above. The claims are also not commensurate in scope with Example 1 which is only to a single concentration of 0.44% of cysteamine eyedrop four times/day as the only compound in the method of treatment of dry eye for 30-37 days which is not commensurate in scope with the instant claims which is to any means of administration and a broader range of time, and allows for the inclusion of other components and other steps (“comprising”). Additionally, the example demonstrates that the 0.44% cysteamine eye drop four times a day for 30-37 day was useful for the treatment - it does not demonstrate any unexpected results nor comparative to show evidence of criticality for the claimed value and regimen which falls within the taught range of the prior art wherein it is prima facie obvious to optimize within the taught values with a reasonable expectation of success absent evidence of criticality which has not been presented. The claims are also broader than the example as the claims are open the inclusion of other components, other compositions, and other steps (as well as the indefiniteness issues addressed above). Applicant’s assertion that a person would have accepted the evidence as evidence as a showing of unexpected results even though it might not satisfy a statistician-that would be enough. This is not persuasive as the cases law Applicant cites (In re Kollman), this is fully considered but not persuasive as the merits of the cases are not the same as those in the instant case particularly as the art and predictability of the art is different (i.e. UV screening agents) and Applicant takes it out of context as it addresses that there was unexpected results in the specification and demonstrated hydrogen bonding present would allow one to ascertain a trend in the exemplified data which is not the instant case which is to a single concentration that is embraced by the prior art for the method taught and claimed. The prior art addresses treating dry eye with cysteamine (β-mercaptoethylamine, claimed) from about 0.1-about 5.0%w/v with hydroxylamine in separate compositions (sole active) where dosing can be 1-4 times/day as long as needed and the dose and dosing schedule may be adjusted by the physician as needed for effectiveness; wherein it is prima facie obvious to optimize within the taught range to attain the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed values of 0.44% at 4 times daily for at least 4 weeks which has not been presented (MPEP 2144.05 IIIA).
With regards to Applicant’s assertion that the Examiner failed to establish a prima facie case of obvious as the prior art do not teach/suggest the claim limitations, this is not persuasive as the prior art meets the claimed limitations and the basis for obviousness is articulated in the rejection above. The prior art teaches a method of treating dry eye (is DTS as addressed by the specification, and presents with elevated MMP as established by American Academy of Ophthalmology) including non-Sjogren presentations (does not recite Sjogren’s) with a composition comprising cysteamine in a range embracing the claimed value (0.44% falls within 0.1-about 5.0%w/v) and dosing (4x/day falls within. 1-4 times/day) wherein optimization within a taught range is prima facie obvious and arrive at the claimed values as a means to attain the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality which has not been presented, and to administer the composition for as long as the patient has the condition (i.e. for years when chronic) absent evidence of criticality for a specific concentration/regimen which has not been presented.
As for the assertion that the instant claims are for a new and unexpected use of cysteamine for treating DTS as the prevailing knowledge was that cysteamine was not known to be effective for dry eye but for cystinosis, this is not persuasive as the use is not new as addressed above, the prior art teaches treating dry eye (and presents with elevated MMP) with a composition that contains cysteamine including non-Sjogren presentations (does not recite Sjogren’s) in a range embracing the claimed values and dosing wherein optimization within a taught range is prima facie obvious and arrive at the claimed values as a means to attain the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality which has not been presented, and to administer the composition for as long as the patient has the condition (i.e. for years when chronic) absent evidence of criticality for a specific regimen which has not been presented.
Applicant also reiterates the assertion that it is the burden of the examiner to show that achieving the claimed invention would have been obvious to one of skill in the art citing case law (In re Stepan) and that the Examiner failed to explain why it would be obvious to select and optimize the cysteamine. This is not persuasive as addressed previously the merits of the cases are not the same as those in the instant case particularly as the art and predictability of the art is different (i.e. cloud point on aqueous glyphosate salt with surfactant systems comprising dialkoxylated alkylamine, water miscible solubilizer and amine oxide allow for formulation of ultra-high loaded ('high-strength') glyphosate salt concentrates possessing high or no cloud points of Applicant’s arguments), prosecution of previous cases have no bearing on the instant case as each application is to be treated on its own merits. Additionally with regards to In re Stepan - there was evidence showing criticality for the surfactant systems comprising dialkoxylated alkylamine, water miscible solubilizer and amine oxide to allow for the formulation of ultra-high loaded ('high-strength') glyphosate salt concentrates possessing high or no cloud points; as there was evidence presented that the claimed surfactants in the Pallas reference had failed in the experiments establishing evidence of criticality for the surfactant systems comprising dialkoxylated alkylamine, water miscible solubilizer and amine oxide to yield a formulation of ultra-high loaded ('high-strength') glyphosate salt concentrates with high or no cloud points.
This is not the case in the instant application.
Applicant has not demonstrated evidence of criticality for the claimed value and regimen which falls within the taught range of the prior art. As the prior art teaches and claims β-mercaptoethylamine (cysteamine) in the taught and claimed method of treating dry eye with the administration of a composition comprising a hydroxylamine compound and β-mercaptoethylamine in separate compositions (cysteamine) with clear ranges and regimens, optimization within the taught range and to treat the condition for the duration of the condition to attain the desired therapeutic profile is prima facie obvious with a reasonable expectation of success absent evidence of criticality which has not been presented (2144.05 IIA).
As for Applicants arguments that there is no motivation to combine AAO with Matier is not persuasive as Matier recites treating dry eye and American Academy of Ophthalmology is presented merely to show and established that MMP-9 is known to be elevated in the tears of patients with dry eyes wherein the dry eye is associated with increased MMP activity.
As for the assertion that the instant claims are for a new and unexpected use of cysteamine for treating DTS as the prevailing knowledge was that cysteamine was not known to be effective for dry eye but for cystinosis, this is not persuasive as the use is not new as addressed above, the prior art teaches treating dry eye (and presents with elevated MMP) with a composition that contains cysteamine including non-Sjogren presentations (does not recite Sjogren's) in a range embracing the claimed values and dosing wherein optimization within a taught range is prima facie obvious and arrive at the claimed values as a means to attain the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality which has not been presented, and to administer the composition for as long as the patient has the condition (i.e. for years when chronic) absent evidence of criticality for a specific regimen which has not been presented.
Accordingly, the rejection stands.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Matier et al. (WO 2005/051328) in view of American Academy of Ophthalmology (Evaluating MMP-9 levels may help diagnose dry eye) as applied to claims 1, 3, 7-8, 10-11 above, in view of Hong et al. (U.S. Pat. Pub. 2009/0131303).
Rejection:
The teachings of Matier et al. in view of American Academy of Ophthalmology are addressed above.
Matier et al. in view of American Academy of Ophthalmology does not teach the inclusion of an MMP-9 inhibitor but does teach that the composition can have additional compounds known in the art for treating the disease.
Hong et al. teaches protease-inhibiting peptide substrates that are MMP-9 inhibitors which are useful for treating dry eye (abstract, [2, 5], claims 7 and 9-10).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate an MMP-9 inhibitor like the disclosed protease-inhibiting peptide substrates as suggested by Hong et al. and produce the claimed invention, as it is prima facie obvious to combine actives useful for the same condition as their additive effect with a reasonable expectation of success and the prior art of Matier et al. teaches combination of actives with hydroxylamine administered separately or together for the treatment.
Response to Arguments:
Applicant’s arguments are those presented with Matier and AAO which are addressed above. Applicant also asserts that Hong does not teach the claimed method. Applicant’s remaining arguments that Hong does not teach the claimed method is not persuasive as this is an argument against the reference individually, 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).
Accordingly, the rejection stands.
Claims 1, 3 are rejected under 35 U.S.C. 103(a) as being unpatentable over Matossian (Improve the Diagnosis, Management and Treatment of Inflammatory Dry Eye) in view of Rubin (U.S. Pat. Pub. 2008/0242735).
Matossian teaches that dry eye (keratoconjunctivitis, including non-Sjogren’s presentations (does not recite Sjogren’s) is known to a multifactorial disease of the tears and ocular surface and presents with elevated MMP-9 (Page 1, see full document specifically areas cited).
Matossian does not expressly teach treatment with cysteamine but does teach that dry eye presents with elevated MMP-9.
Rubin teaches treatment of MMP pathologies with elevated MMP such as MMP-9 with the administration of cysteamine including eye drops forms for pathologies affecting the eyes (abstract, claim 1, 9-11, 13-14, [11, 15-18]). The amount of cysteamine is about 0.1-about 0.5% like about 0.5% (embraces 0.44%) and given between about 2-12 times/day (claim 9-11 and 13-14, [11]). Rubin teaches that the amount of cysteamine for effective therapy depend on many factors and dosages can be titrated to optimize safety and efficacy as aminal testing is used for predictive indication of a human therapeutic dosage (for a human patient, [21-22], see full document specifically areas cited).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to treat dry eye with cysteamine as suggested by Rubin and produce the claimed invention, as it is prima facie obvious to use a composition useful for elevated MMP eye conditions for an eye condition with elevated MMP-9 with a reasonable expectation of success. It is implicit that the patient is diagnosed with the condition in order to be treated. While the prior art does not expressly teach the exact claimed amount of cysteamine and dosing regime, it is embraced by the prior art as Rubin does teach that amount of cysteamine is from about 0.1-about 0.5% and dosing can be given between about 2-12 times/day and that it can be titrated to optimize safety and efficacy; wherein to would be prima facie obvious to one of ordinary skill in the art to adjust/optimize the amount of cysteamine and dosing schedule within the taught range and to use the composition for the duration of the condition to attain the desired therapeutic/effective profile with a reasonable expectation of success absent evidence of criticality for a specific range or regimen schedule.
Response to Arguments:
Applicant’s arguments centered on the assertion that Rubin is silent on the treatment of dry eye, that there is no examples for treating dry eye with cysteamine in Rubin, there is no examples for treating dry eye with cysteamine in Matossian, and alleges that the Examiner asserts that the Applicant provide a comparison to the composition combination of reference to support unexpected results is improper, and that the Examiner did not meet the burden of obviousness to shift the burden to Applicant.
This is fully considered but not persuasives.
With regards to the assertion that Rubin is silent on the treatment of dry eye, that there is no examples for treating dry eye with cysteamine in Rubin, and there is no examples for treating dry eye with cysteamine in Matossian; this is not persuasive as it is against the reference individually or examples 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). Applicant’s argument appears to want that the instant method be in a single teaching or anticipatory which is not the basis for a prima facie case of obviousness.
With regards to the assertion that the Examiner did not meet the burden of obviousness to shift the burden to Applicant. This is not persuasive as addressed by the prima facie case of obviousness presented above.
With regards to the assertion that the Examiner is requiring a comparison of the claimed invention to the prior art and one is not required to do a comparative, Applicant is not required to do a comparison but Applicant can rebut a prima facie case of obviousness by showing criticality of the range (MPEP 2144.05 IIIA) but this has not been presented. The prior art rejection presented above establishes that dry eye presents with elevated MMP-9 and Rubin teaches a method of treating MMP pathologies with elevated MMP such as MMP-9 with the administration of cysteamine including eye drops forms with cysteamine from about 0.1-about 0.5% (embracing 0.44%) and given between about 2-12 times/day (embracing 4x/day) it is prima facie obvious to use a composition useful for elevated MMP eye conditions for an eye condition with elevated MMP-9 with a reasonable expectation of success absent evidence of criticality for the claimed concentration/regimen which has not been presented. Applicant’s assertion that the treatment for non-Sjogren’s dry eye and Sjogren’s dry eye are different is not persuasive as the prior art establishes that dry eye has elevated MMP-9 regardless of the form (embracing non-Sjogren’s) wherein it is obvious as addressed above to utilize a treatment useful for treating MMP pathologies such as elevated MMP-9 with the administration of cysteamine eyedrops as addressed above absent evidence of criticality for the claimed concentration/regimen.
Applicant also reiterates the assertion that it is the burden of the examiner to show that achieving the claimed invention would have been obvious to one of skill in the art citing case law (In re Stepan) and that the Examiner failed to explain why it would be obvious to select and optimize the cysteamine. This is not persuasive as addressed above, the merits of the cases are not the same as those in the instant case particularly as the art and predictability of the art is different (i.e. cloud point on aqueous glyphosate salt with surfactant systems comprising dialkoxylated alkylamine), prosecution of previous cases have no bearing on the instant case as each application is to be treated on its own merits. Additionally with regards to In re Stepan - there was evidence showing criticality for the surfactant systems comprising dialkoxylated alkylamine, water miscible solubilizer and amine oxide to allow for the formulation of ultra-high loaded ('high-strength') glyphosate salt concentrates possessing high or no cloud points; as there was evidence presented that the claimed surfactants in the Pallas reference had failed in the experiments establishing evidence of criticality for the surfactant systems comprising dialkoxylated alkylamine, water miscible solubilizer and amine oxide to yield a formulation of ultra-high loaded ('high-strength') glyphosate salt concentrates with high or no cloud points. This is not the case in the instant application. Applicant has not demonstrated evidence of criticality for the claimed value and regimen which falls within the taught range of the prior art as addressed above - cysteamine from about 0.1-about 0.5% (embracing 0.44%) and given between about 2-12 times/day (embracing 4x/day) and it is prima facie obvious to use a composition useful for elevated MMP eye conditions for an eye condition with elevated MMP-9 with a reasonable expectation of success absent evidence of criticality for the claimed concentration/regimen which again has not been presented to overcome the case of prima facie obviousness (2144.05 IIA).
Applicant’s additional assertion that Rubin is to treating a pterygium which is different that dry eye (DTS) 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). Additionally, Rubin is not only to pterygium as asserted by Applicant - but to treating a pathology in which increased production of MMP is implicated with an eye drop composition comprising cysteamine from about 0.1%-about 0.5% - and Matossian establishes that dry eye is a that presents with increased MMP-9 wherein it is a pathology with increased production of MMP is implicated and it would be obvious to utilize the treatment taught by Rubin for the condition in which increased production of MMP is implicated with a reasonable expectation of success.
Accordingly, the rejection stands.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Matossian (Improve the Diagnosis, Management and Treatment of Inflammatory Dry Eye) in view of Rubin (U.S. Pat. Pub. 2008/0242735) as applied to claims 1, 3 above, in view of Hong et al. (U.S. Pat. Pub. 2009/0131303).
Rejection:
The teachings of Matossian in view of Rubin are addressed above.
Matossian in view of Rubin does not teach the inclusion of an MMP-9 inhibitor but does teach treating eye diseases like dry eye with elevated MMP with cysteamine.
Hong et al. teaches protease-inhibiting peptide substrates that are MMP-9 inhibitors which are useful for treating dry eye (abstract, [2, 5], claims 7 and 9-10).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate an MMP-9 inhibitor like the disclosed protease-inhibiting peptide substrates as suggested by Hong et al. and produce the claimed invention, as it is prima facie obvious to combine actives useful for the same condition as their additive effect with a reasonable expectation of success.
Response to Arguments:
Applicant’s arguments are those presented in Matossian in view of Rubin which are addressed above. Applicant’s remaining arguments are to assertion that Hong does not cure the deficiencies of Matossian and Rubin as it is silent regarding the treatment instantly claimed which is not persuasive as it 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).
Accordingly, the rejection stands.
Claims 7 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Matossian (Improve the Diagnosis, Management and Treatment of Inflammatory Dry Eye) in view of Rubin (U.S. Pat. Pub. 2008/0242735) as applied to claims 1, 3 above, in view of Matier et al. (WO 2005/051328).
Rejection:
The teachings of Matossian in view of Rubin are addressed above.
Matossian in view of Rubin does not expressly teach the inclusion of certain excipients like glycerin (glycerol) but does teach the method of treating dry eye with a cysteamine eyedrop solution.
Matier et al. teaches compositions for treating eye conditions in patients like dry eye can contain excipients like tonicity agents such as sodium chloride for isotonic solutions such as 0.9% saline, viscosity agents (thickener helps alleviate symptoms), and cosolvents like glycerin (glycerol, Page 11 paragraph 3-Page 12 first paragraph).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate saline as suggested by Matier et al. and produce the claimed invention, as it is prima facie obvious to incorporate known conventional ophthalmic excipients in ophthalmic solutions for their known purpose with a reasonable expectation of success.
Response to Arguments:
Applicant’s arguments are those presented in Matossian in view of Rubin which are addressed above. Applicant’s remaining arguments are to assertion that Matier does not cure the deficiencies of Matossian and Rubin as it does not teach/suggest all the claim limitations which is not persuasive as it 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).
Accordingly, the rejection stands.
Conclusion
Claims 1, 3, 7-11 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GIGI GEORGIANA HUANG whose telephone number is (571)272-9073. The examiner can normally be reached Monday-Thursday 9:00-5:00pm.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613