Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Receipt of arguments/remarks filed on September 10, 2025 is acknowledged. Claims 1-8, 11, 13-20 and 22 are pending.
Pertinent information
The compound recited in the claims is the active agent known as ripasudil, and is present in the eye drop formulation known as Glanatec®, which is used for the treatment of glaucoma, ocular hypertension and FECD. See the specification and cited art.
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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.
The factual inquiries 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.
Claim(s) 1-8, 11, 13-20 and 22 remain rejected under 35 U.S.C. 103 as being unpatentable over Kaneko et al. (Sci Rep. 2016 Jan 19;6:19640)-provided by Applicants in the IDS; further in view of Inoue et al. (Expert Opinion on Pharmacotherapy, 2017; vol. 18, no. 15, 1669-1673), Goldstein et al. (Journal of Ocular Pharmacology and Therapeutics, Vol. 34, no. 10, 2018) and Okumura et al. (Laboratory Investigation (2015) 95, 1291-1304) and Moloney et al. (Cornea Vol. 36, No. 6, June 2017; p.642-648)-previously cited.
Determination of the scope and content of the prior art (MPEP §2141.01)
Teachings of Kaneko et al.
Kaneko teaches that K-115 (Ripasudil hydrochloride hydrate) is a Rho-kinase (ROCK) inhibitor ophthalmic solution developed for the treatment of glaucoma and ocular hypertension. In a monkey experiment, 20 μL of 0.4% K-115 was instilled into one eye (for a dose of 80 μg/day) and intra-ocular pressure (IOP) was measured. 0.4% solution of K-115 had a significant IOP lowering effect (see page 7 and Figure 1).
Further, Kaneko teaches that K-115 has an IC50 of 0.051 µM for ROCK-1 and an IC50 of 0.019 µM for ROCK-2 (see page 3). Kaneko discloses the effects of K-115 at a concentration of 1 µM and 10 µM on Trabecular Meshwork (TM) cell morphology, and at a concentration of 5 µM and 25 µM on Schlemm’s endothelial (SCE) cells monolayer barrier function and molecules associated with cell-cell contact in Schlemm’s endothelial cells. At such low doses, it reduces actin bundles in TM cells, significantly decreases TEER and increases FITC-dextran permeability. See page 2 and an additional discussion at page 5:
“However, 1 μmol/L of K-115, enough to induce TM cell retraction, was found to have minimal inhibitory effect on PKC29. These results suggest that K-115 reduces outflow resistance and increases SCE cell permeability in association with tight junction disruption. Similar results were observed with the use of other ROCK inhibitors, Y-2763248. In addition, low concentrations of K-115 induced similar potential for monolayer cell permeability compared with higher concentrations of Y-27632 and fasudil. Therefore, promotion of aqueous outflow by K-115 is likely due to TM cytoskeletal changes, reduced outflow resistance and increased SCE permeability as a result of ROCK inhibitory activity.”
Teachings of Inoue et al.
Inoue teaches that ripasudil hydrochloride hydrate lowers IOP by a unique mechanism, namely inducing disruption of actin bundles in TM cells and Schlemm’s canal endothelial (SCE) cells and suppressing the production of extracellular matrix (ECM) by TM cells. See at least the abstract.
Teachings of Goldstein et al.
Goldstein teaches that 10 µM of ripasudil treatment on human corneal endothelial cells (HCECs) produces a protective effect against induced apoptosis, suggesting that ripasudil may help improve the integrity of the corneal endothelium.
Teachings of Okumura et al.
Fuchs endothelial corneal dystrophy (FECD) due to corneal endothelial cell degeneration is characterized by abnormal deposition of extracellular matrix (ECM), such as corneal guttae, accompanied by a loss of endothelial cells. Corneal endothelial cells in FECD have excessive production of ECM proteins, such as type I collagen and fibronectin .
Teachings of Moloney et al.
Moloney teaches the administration of ripasudil hydrochloride hydrate (Glanatec® ophthalmic solution 0.4%) onto the eyes of patients with Fuchs Endothelial Dystrophy (FECD), 6 times daily.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
Regarding claims 1-3, 5, 7, 8, 11, 13-14, 17-18 and 22, Kaneko administers 1 µM, 5 µM, 10 µM and 25 µM concentrations of ripasudil to the trabecular meshwork (TM) ex vivo, while the claims recite administration to an eye of a subject a dose having a concentration of from 30 µM and 100 µM. Goldstein also administers 10 µM of ripasudil to human corneal endothelial cells (HCECs) ex vivo. ---The difference is the dose concentration.
Regarding claims 4, 6, 15-16, 19-20, Kaneko administers 1 µM, 5 µM, 10 µM and 25 µM concentrations of ripasudil to the trabecular meshwork (TM) ex vivo, while the claims recite administration to an FECD patient. ---The additional difference is the patient to be treated.
Finding of prima facie obviousness--rational and motivation (MPEP §2142-
2413)
The references are in the same field of endeavor. A person of ordinary skill in the art is a person with the level of skill of the authors of the references cited in this action. While Kaneko and the other references do not disclose a concentration from 30 µM to 100 µM of ripasudil as claimed, Kaneko teaches concentrations of 1 µM, 5 µM, 10 µM and 25 µM for reducing actin bundles and for suppressing the production of extracellular matrix (ECM) as Inoue; and Goldstein teaches a 10 µM concentration of ripasudil to improve the integrity of the corneal endothelium and for protective effects. Thus, the ordinary skilled artisan would have been motivated to optimize the low concentration solutions of ripasudil for the benefits taught by the references (reduction of actin bundles, suppression of production of extracellular matrix (ECM) in TM cells, improvement in the integrity of the corneal endothelium and production of a protective effect against induced apoptosis).
Differences in result-effective variables will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating the value of the result-effective variable is critical. See MPEP 2144.05. In the instant case, the dose/concentration of ripasudil is considered a result-effective variable that impacts the effectiveness of the treatment and the risk of side effects. Absent a showing of criticality, optimizing result-effective variables is deemed routine optimization. Kaneko provides a teaching that a skilled artisan can optimize the concentration of ripasudil to 1 µM, 5 µM, 10 µM and 25 µM. The claimed concentration of 30 µM is very close to Kaneko’s 25 µM concentration, and thus, the effects would be expected to be similar.
Therefore, it would have been prima facie obvious to administer a solution of ripasudil (K-115) at a concentration of from 30 µM to 100 µM to an eye of a subject and to the damaged cornea of a FECD patient.
Regarding the intended use/result “for modulating an expression of an extracellular matrix protein by corneal endothelial cells in a subject…, and the extracellular matrix protein is at least one selected from the group consisting of agrin, α-smooth muscle actin, and β-actin” in claims 1-2, 7-8, 11 and 22, claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. MPEP 2111.04. The preamble of these claims merely states the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations. Therefore, the preamble in this case is not considered a limitation and is of no significance to claim construction. See MPEP 2111.02. Note that the only physical step required in the claims is to administer ripasudil to an eye of the subject at a concentration of from 30 µM to 100 µM at least one time per day.
Regarding the intended use/result “for preventing and/or suppressing guttae formation by modulating an expression of an extracellular matrix protein by corneal endothelial cells in a subject…such that an expression of an extracellular matrix protein by corneal endothelial cells is modulated, and the extracellular matrix protein is at least one selected from the group consisting of agrin, α-smooth muscle actin, and β-actin” in claims 3-4 and 13-16, claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. MPEP 2111.04. The preamble of these claims merely states the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations. Therefore, the preamble in this case is not considered a limitation and is of no significance to claim construction. See MPEP 2111.02. Note that the only physical step required in the claims is to administer ripasudil to an eye of the subject at a concentration of from 30 µM to 100 µM at least one time per day.
Regarding the intended use/result “for preventing and/or suppressing recurrence of guttae formation in a subject…such that an expression of an extracellular matrix protein by corneal endothelial cells is modulated, and the extracellular matrix protein is at least one selected from the group consisting of agrin, α-smooth muscle actin, and β-actin” in claims 5-6 and 17-20, claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. MPEP 2111.04. The preamble of these claims merely states the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations. Therefore, the preamble in this case is not considered a limitation and is of no significance to claim construction. See MPEP 2111.02. Note that the only physical step required in the claims is to administer ripasudil to an eye of the subject at a concentration of from 30 µM to 100 µM at least one time per day.
Nevertheless, if the preamble would be considered a claim limitation in this case, the characteristics disclosed would have necessarily happened upon administration of ripasudil to an eye of the subject at a concentration of from 30 µM to 100 µM. The newly added limitation “such that an expression of an extracellular matrix protein by corneal endothelial cells is modulated, and the extracellular matrix protein is at least one selected from the group consisting of agrin, α-smooth muscle actin, and β-actin” is not considered to further limit the administration or patient population of the claims because it is merely a feature of the method that necessarily flows from administering ripasudil to an eye of the subject at a concentration of from 30 µM to 100 µM, which is taught by the combination of references.
Note MPEP 2112: The express, implicit, and inherent disclosures of a prior art reference may be relied upon in the rejection of claims under 35 U.S.C. 102 or 103."The inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness." In re Napier, 55 F.3d 610, 613, 34 USPQ2d 1782, 1784 (Fed. Cir. 1995) (affirmed a 35 U.S.C. 103 rejection based in part on inherent disclosure in one of the references). See also In re Grasselli, 713 F.2d 731, 739, 218 USPQ 769, 775 (Fed. Cir. 1983).
MPEP 2112: “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.” Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004).
Applicant’s arguments have been carefully considered but were not found persuasive.
Applicant argues that none of the cited references disclose a relationship/nexus between the administration of ripasudil and the decrease in expression of agrin, α-SMA, and β-actin. Applicant further argues that the references do not teach or suggest the effect of administering ripasudil for modulating an expression of an extracellular matrix protein by corneal endothelial cells in a subject, for preventing and/or suppressing guttae formation by modulating an expression of an extracellular matrix protein, for preventing and/or suppressing recurrence of guttae formation in a subject, where the extracellular matrix protein is at least one of agrin, α-SMA, and β-actin.
In response, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). See also MPEP 2145 II in this regard:
“Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979) (Claims were directed to grooved carbon disc brakes wherein the grooves were provided to vent steam or vapor during a braking action. A prior art reference taught noncarbon disc brakes which were grooved for the purpose of cooling the faces of the braking members and eliminating dust. The court held the prior art references when combined would overcome the problems of dust and overheating solved by the prior art and would inherently overcome the steam or vapor cause of the problem relied upon for patentability by applicants. Granting a patent on the discovery of an unknown but inherent function (here venting steam or vapor) "would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art." 596 F.2d at 1022, 201 USPQ at 661.); In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991) (Appellant argued that the presence of DEHP as the plasticizer in a blood collection bag unexpectedly suppressed hemolysis and therefore rebutted any prima facie showing of obviousness. However, the closest prior art utilizing a DEHP plasticized blood collection bag inherently achieved same result, although this fact was unknown in the prior art.).”
Applicant additionally states that the mere discussion on actin bundles in Kaneko and Inoue would not provide reasonable expectation that the claimed agent would have the same effect on all actin within the body. In response, the examiner is not saying that ripasudil would have the same effect on all actin within the body. The examiner is asserting that since the prior art teaches the same claimed agent being administered to the eye of the same subject, the properties applicant discloses and claims are necessarily present. Administration of ripasudil to the eye will necessarily modulate expression of at least one of agrin, α-SMA, and β-actin by corneal endothelial cells. This is because a chemical composition and its properties are inseparable. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Applicant submits that the cited references do not provide sufficient disclosure, and it would require undue experimentation. The examiner disagrees because the references teach administering a solution of ripasudil (K-115) at various concentrations to the eye of a subject and to the damaged cornea of a FECD patient.
Applicant further argues that the cited references do not provide sufficient insights on various extracellular matrix proteins and extracellular matrix-associated proteins in the extracellular matrix of a human eye; and it would require testing on each protein to deduce the effect of ripasudil on the target’s expression, which would consist of testing over 300 possible targets resulting in undue experimentation.
In response, what is currently claimed is administration of ripasudil to the eye of a subject for modulating an expression of an extracellular matrix protein by corneal endothelial cells, for preventing and/or suppressing guttae formation or recurrence of guttae formation, wherein the extracellular matrix protein is at least one of agrin, α-SMA, and β-actin. Testing each actin protein to deduce the effect of ripasudil is not a limitation of the claims. Other “various extracellular matrix proteins” are also not limitations of the claims. The claimed method is performed by administering a concentration of from 30 µM to 100 µM of ripasudil to the eye of a subject. The prior art references teach administering various dose concentrations of ripasudil. Administering a concentration of from 30 µM to 100 µM of ripasudil to the eye of a subject as claimed could not possibly require undue experimentation. Testing the effects of particular extracellular matrix proteins of interest to the artisan could not possibly require undue experimentation.
Applicant additionally argues that the ranges in Kaneko and the present claims do not overlap and there is no evidence that the concentrations outside the range of the prior art would achieve the results desired in the prior art. In response, the examiner has not argued that there are overlapping ranges. The examiner has stated that Kaneko teaches concentrations of 1 µM, 5 µM, 10 µM and 25 µM for reducing actin bundles and for suppressing the production of extracellular matrix (ECM) as Inoue; and Goldstein teaches a 10 µM concentration of ripasudil to improve the integrity of the corneal endothelium and for protective effects. The ordinary skilled artisan would have been motivated to optimize the low concentration solutions of ripasudil for the benefits taught by the references (reduction of actin bundles, suppression of production of extracellular matrix (ECM) in TM cells, improvement in the integrity of the corneal endothelium and production of a protective effect against induced apoptosis).
Applicant states that “the prior art need to recognize that a property is affected by a variable in order for it to be result effective”. In response, at least Kaneko provides evidence that the concentration of ripasudil is a result-effective variable that impacts the effectiveness of the treatment and the risk of side effects. See Kaneko’s experimentation with the concentration of ripasudil.
Applicant states that the references do not recognize that the range outside the described concentrations in Kaneko would have reasonably achieved the desired benefits. In response, Kaneko recognized that concentrations of 1 µM, 5 µM, 10 µM and 25 µM were useful for reducing actin bundles and for suppressing the production of extracellular matrix (ECM) as Inoue; and Goldstein taught a 10 µM concentration of ripasudil to improve the integrity of the corneal endothelium and for protective effects. Optimizing the concentration of ripasudil to outside of the concentrations in Kaneko would be deemed routine optimization. See MPEP 2144.05. Moreover, the claimed concentration of 30 µM is very close to Kaneko’s 25 µM concentration, and thus, the effects would be expected to be similar.
It is the examiner’s position that the administration of ripasudil at the optimized concentrations claimed would have necessarily resulted in said desired benefits. Applicant has not provided evidence that the prior art compositions disclosed in the examples of the references do not possess said desired benefits. MPEP 2112.V states:
Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the examiner presents evidence or reasoning to show inherency, the burden of production shifts to the applicant. "[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same." In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255).
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 1-8, 11, 13-20 and 22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for downregulating or a downregulated expression of an extracellular matrix protein wherein the extracellular matrix protein is at least one at least one selected from the group consisting of agrin, α-smooth muscle actin, and β-actin, does not reasonably provide enablement for upregulation within the claimed “modulating” or “modulated”. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
The instant specification does not provide enablement for upregulating the extracellular matrix protein claimed with the compound of the claims because the compound of the claims is a suppressor or downregulator of the expression of extracellular matrix proteins agrin, α-smooth muscle actin, and β-actin by corneal endothelial cells. The specification reported this, particularly at Figure 4.
As a general rule, enablement must be commensurate with the scope of claim language. MPEP 2164.08 states, “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)” (emphasis added). The “make and use the full scope of the invention without undue experimentation” language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: “A lack of enablement for the full scope of a claim, however, is a legitimate rejection.” The principle was explicitly affirmed most recently in Liebel-Flarsheim Co. v. Medrad, Inc. 481 F.3d 1371, 82 USPQ2d 1113; Auto. Tech. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 84 USPQ2d 1108 (Fed. Cir. 2007), Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 84 U.S.P.Q.2d 1705 (Fed. Cir. 2007), and Sitrick v. Dreamworks, LLC, 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008).
Enablement is considered in view of the Wands factors (MPEP 2164.01 (A)). These include: nature of the invention, breadth of the claims, guidance of the specification, the existence of working examples, state of the art, predictability of the art and the amount of experimentation necessary. All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
Nature of the invention and Breadth of claims:
The claims recite the administration to an eye of a subject the compound 1-(4-fluoro-5-isoquinolinesulfonyl)-2-methyl- 1,4-homopiperazine or a salt thereof, or a solvate thereof for modulating the expression of an extracellular matrix protein wherein the extracellular matrix protein is at least one selected from the group consisting of agrin, α-smooth muscle actin, and β-actin. Modulation encompasses both downregulation and upregulation. These are opposite effects.
The state of the art and predictability in the art: The art is unpredictable. Pharmacological activity in general is a very unpredictable area. Note that in cases involving physiological activity such as the instant case, “the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.” See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
The art knows that if a particular compound downregulates agrin, α-smooth muscle actin, and β-actin, it cannot also upregulate the same.
The prior art taught that the claimed compound suppresses the production of extracellular matrix (ECM) by TM cells. See above references.
The skill of those in the art: The artisan would know how to follow and apply standard and known operating procedures.
Working Examples and Direction or Guidance : There is no working example or direction of upregulation of agrin, α-smooth muscle actin, and β-actin with the claimed compound because the instant specification discloses that the claimed compound is a downregulator.
The quantity of experimentation needed: One of ordinary skill would not know how to practice the full scope of the claimed invention, that is, upregulating/upregulation of the expression of an extracellular matrix protein wherein the extracellular matrix protein is at least one selected from the group consisting of agrin, α-smooth muscle actin, and β-actin with the claimed compound since the results in the instant specification disclose that the compound downregulates the expression.
MPEP 2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here.
Applicant’s arguments were considered but were found unpersuasive.
It is unclear how applicant’s arguments “provide sufficient evidence as to how to make and use the claimed invention for the full scope of the claims without undue experimentation”. The parts of the specification at paragraphs [0022], [0023], [0024] and [0025] cited by Applicants do not provide support for the compound to be used for upregulating the extracellular matrix protein claimed with the compound of the claims. The term “modulating” used in the claims encompasses upregulating. However, the compound of the claims is a downregulator (suppressor) of the expression of extracellular matrix proteins agrin, α-smooth muscle actin, and β-actin by corneal endothelial cells. The specification reported this, particularly at Figure 4.
Conclusion
Claims 1-8, 11, 13-20 and 22 are rejected. No claim is allowable.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE RODRIGUEZ-GARCIA whose telephone number is (571)270-5865. The examiner can normally be reached Monday-Friday 9:30am-4:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph K McKane can be reached at 571-272-0699. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VALERIE RODRIGUEZ-GARCIA/Primary Examiner, Art Unit 1621