Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Applicant’s election without traverse of Invention I, claims 1-7, in the reply filed on Apr. 16, 2024 is acknowledged.
Upon examination of the elected claims, claims 8-14 have been considered drawn to the elected subject matter. Therefore, the restriction requirement between Inventions I and II is withdrawn. Based on the results of the search, the species election requirement between the species of Group I, the enzymatically inactive tissue plasminogen activator (tPA) variant therapeutic agent, has been withdrawn.
Claims 1-14 have been considered on the merits.
Status of the Claims
Claims 1-14 are currently pending.
Claims 1-14 have been considered on the merits.
Drawings
The disclosure is objected to because of the following informalities:
The drawings are objected to because of the following informalities: illegible text in Figures 11-20, 22, and 23.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: the use of trademarks and containing an embedded hyperlinks in paras. 0167 and 0198 and the use of trademarks.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code. See MPEP § 608.01.
The use of the terms Neovastat® in 0019; TRIzol® in 0147, 0166, and 0198; RNeasy® Mini Kit in 0147; Nanodrop® in 0147, 0166, and 0198; Quantitect™ in 0148; SYBR® Green RT-PCR Reagents Kit in 0148; ABI PRISM™ 7900HT sequence detector in 0148; QuikChange® Lightning Multi Site Directed Mutagenesis Kit in 0157; Hamilton® syringe in 0160; RNAlater® in 0165 and 0198; QuantStudio™ 6 Flex thermal cycler in 0166 and 0198, which are a trade names or a marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Objections
The disclosure is objected to because of the following informalities: minor grammatical error in claims.
Claim 1 is objected to because of the following informalities: the first time an acronym is utilized in a claim-set, said acronym should be spelled out in its entirety followed by said acronym in parenthesis (e.g. tissue plasminogen activator (tPA)).
Appropriate corrections are appreciated.
Claim Rejections - 35 USC § 112(a)- written description
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 1-14 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 claims 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 pre-AIA the inventors, at the time the application was filed, had possession of the claimed invention.
The instant claims are drawn to a method of increasing outflow facility in a subject and a method of treatment for chronic elevated intraocular pressure (IOP) in a subject by administering an effective amount of an enzymatically inactive tissue plasminogen activator (tPA) variant therapeutic agent, which has a wide array of activities and/or effects. Thus, the claims are broadly drawn to any enzymatically inactive tPA variant therapeutic agent. Therefore, these claims are considered genus claims that encompass a wide array of compounds. The claims encompass any variant of any enzymatically inactive tPA which are not described by their function, structure or relation thereto, other than being enzymatically inactive. The genus is highly variant, inclusive to numerous structural variants because a significant number of structural differences between genus members is permitted. The specification describes non-enzymatically inactive, tPA includes all forms of tPA and variants that are proteolytically inactive or have significantly reduced activity and encompasses all structural conformations that are proteolytically inactive or have significantly reduced activity (0050 of published application). In addition, the specification states it can encompass all tPA including variants from all species (0050 of published application). The specification describes possible mutations that render the enzyme catalytically inactive (0051 of published application). However, the specification does not disclose the diverse genus. For instance, it is unclear how small of fragment of the tPA protein, which does not contain the catalytic domain or contains an inactive catalytic domain, which would be effective in increasing outflow facility or treating chronic elevated IOP. It is unclear what is encompassed by therapeutic agents as what molecules and compounds.
The specification does not place any structure, chemical or functional limitations on the embraced by genus “enzymatically inactive tPA variant therapeutic agent”. The recitation of “an enzymatically inactive tPA variant therapeutic agent” does not convey a common structure or function and is not so defined in the specification. In sum, specification and the claim do not provide any guidance on the structure of the “an enzymatically inactive tPA variant therapeutic agent”.
The MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that the claims are broad generics, with respect to all of the potential species of enzymatically inactive tPA variants that may exhibit one, all, of or any of the claimed activity. The possible variations of compounds are limitless with potentially thousands of variants that may exhibit the claimed activities. The purpose of the written description requirement is to ensure that the invention had possession, as of the filing date of the application, of the specific subject matter later claimed by him or her. A patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention. Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention."
The specification lacks sufficient variety of species of enzymatically inactive tPA variants to reflect this variance in the genus since the specification does not provide any examples of such a genus of compounds. Accordingly, the specification fails to provide adequate written description for the genus of “enzymatically inactive tPA variants” and does not reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed had possession of the entire scope of the claimed invention. Moreover, the specification neither describes the complete structure of a representative number of species, nor describes a representative number of species in terms of partial structure and relevant identifying characteristics. Absent of such teachings and guidance as to the structure and function of these compounds, the specification does not describe the claimed antagonist in such full, clear, concise and exact terms so as to indicate that Applicant had possession of these extracts at the time of filing of the present application. Thus, the written description requirement has not been satisfied.
Claim Rejections - 35 USC § 112(a) -scope of enablement
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 1-14 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 increasing outflow facility in a subject and the treatment for chronic elevated intraocular pressure (IOP) by administering an effective amount of adenoviral vector by periocular injection where the vector encodes for human tPA with an active site mutation (S468A) where serine replaces alanine in the catalytic site and is driven by the CMV promoter or by administrating human tPA protein with the S468A mutation by intravitreal injection, does not reasonably provide enablement for the administration of all potential sequences encoding all enzymatically inactive variants, all enzymatically inactive variants of the tPA proteins, all potential enzymatically inactive tPA variant therapeutic agents, all modes or routes of administration of the vector or protein, and all potential vectors and gene promoters. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, the enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
(1) The nature of the invention and (2) the breadth of the claims:
The claims are drawn to a method of increasing outflow facility in a subject and a method of treatment for chronic elevated intraocular pressure (IOP) by administering an effect amount of an enzymatically inactive tPA variant therapeutic agent. Thus, the claims taken together with the specification imply that any subject can be treated to increase outflow facility or for chronic IOP by the administration of all potential sequences encoding for any enzymatically inactive variant, all enzymatically inactive variants of the tPA protein, all potential enzymatically inactive tPA variant therapeutic agents (e.g. 20 amino acid protein fragments of tPA), all modes of administration of the vector or protein (e.g. subretinal, intravenous, intradermal, intrathecal, intraperitoneal, or intratracheal administration or topical application), and all potential vectors and gene promoters.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
The prior art in general teaches the difficulties in treating ocular diseases including glaucoma with gene therapy and other therapeutics. For instance, Tawfik et al. (Naunyn-schmiedeberg's Archives of Pharmacology, 2022) reports “despite the ease of accessibility of delivering drugs via the ocular surface, the delivery of drugs to the retina is still challenging due to anatomic and physiologic barriers” (abstract). Lin et al. (Frontiers in Pharmacology, 2025) reports that “the core challenge of intravitreal injection in glaucoma treatment lies in the limitations of the drug delivery systems” (pg. 5 Col. 1 last para.). Additionally, Lin reports that the relationship between the dynamic changes of aqueous humor cytokines and drug responsiveness is unclear and this complex regulatory network is a technical challenge for formulation individualized drug delivery schemes (pg. 5 Col. 2 para. 1). Lin teaches another challenge is that drug efficacy depends on the control of primary disease and the risk of carrier displacement (pg. 6 Col. 2 para. 1). In addition, Bennett et al. (Molecular Therapy, 2000) states explicitly "Systemic delivery of gene therapy agents does not result in gene delivery to ocular structures" (pg. 501 Col. 1 para. 1), and "As with any gene therapy experiment, success in the eye is dictated by the ability of efficiently transfer genetic material to target cells and to achieve long-term expression at appropriate levels" (pg. 501 Col. 2 para. 1). Bennett further reports that vectors that target dividing cells have limited utility in the eye, since most of the cells are terminally differentiated and nonreplicating (pg. 501 Col. 2 para. 1). As further evidence, Anton et al. (International Journal of Molecular Sciences, 2024) reports the primary limitation of gene therapy is its safety concerns such as off-target effects, viral vector toxicity, immune and inflammatory responses, challenges in regulating gene expression, and delivering sufficient quantity of modified genes to the target tissue (pg. 12 para. 3-5).
Thus, as the state of the art stands, the method would be unpredictable depending on the mode of delivery, the vehicle of delivery, and the condition of the subject.
(5) The relative skill of those in the art:
The relative skill of those in the art is high.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The instant specification provides working examples and guidance for the use of the instantly claimed method for increasing outflow facility in a subject and the treatment for chronic elevated intraocular pressure (IOP) by administering an effective amount of adenoviral vector by periocular injection where the vector encodes for human tPA with an active site mutation (S468A) where serine replaces alanine in the catalytic site and is driven by the CMV promoter or by administrating human tPA protein with the S468A mutation by intravitreal injection (Example 9 and 12-14). However, the specification does not provide any guidance for the use of the instantly claimed method for additional enzymatically inactive tPA variant therapeutic agents. The applicants have provided no additional data demonstrating the claimed method with other variants, other vectors, and other modes of administering to give the skilled artisan any reason to expect that the method would be effective with all potential enzymatically inactive tPA variants. The specification does not describe or suggest what portion of the tPA protein is necessary to result in an increase in outflow facility in a subject or treat chronic elevated IOP in a subject.
Therefore, there is no conclusive evidence in the instant disclosure to indicate that the instantly claimed method can be used to increase outflow facility or treat chronic IOP in a subject by administering any enzymatically inactive tPA variant therapeutic agent.
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed above and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to use the claimed invention within the broad scope as instantly claimed.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 7-10 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gindina et al. (Experimental Eye Research, 2020).
With respect to claims 1, 2, 8, and 9, Gindina teaches a method of increasing outflow facility in mouse model of juvenile open angle glaucoma (a subject), by administering an effective amount of an enzymatically inactive tPA (pg. 2 Col. 1 last para.).
Gindina does not explicitly teach the method for the treatment of chronic elevated intra ocular pressure (IOP) in a subject as recited in claim 8. However, Gindina teaches the claimed method of administering an effective amount of an enzymatically inactive tPA. Once administered to the subject the enzymatically inactive tPA would treat whatever conditions are present. Thus, the claimed treatment of chronic elevated IOP must be inherent to the method as taught by Gindina and a necessary effect of practicing the method.
Similarly, Gindina does not measure the intra ocular pressure (IOP) in the mice when administered the enzymatically inactive tPA protein and does not teach administering the enzymatically inactive tPA variant therapeutic agent reduces intra ocular pressure (IOP) in said subject for a period of at least one day to a year or more, relative to IOP measurements in said subject prior to administration of the enzymatically inactive tPA variant therapeutic agent as recited claims 3 and 10. Claims 3 and 10 contain wherein clauses that recites the intended result of the method rather than requiring an additional step be performed. MPEP 2111.04 states “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed” and that a such a clause ‘"in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Therefore since these claims only recite the results of the steps, then art reading on claims 1 and 8 from which these claims depend from will also read on these results since performing the same steps will inherently lead to the same results in the absence of evidence to the contrary including unexpected results.
With respect to claims 7 and 14, Gindina teaches administering the enzymatically inactive tPA variant by intravitreal injections (pg. 2 Col. 1 last para.).
Therefore, the reference anticipates the claimed subject matter.
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.
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Gindina et al. (Experimental Eye Research, 2020) in view of Danias et al. (US 2015/0366953 A1).
With respect to claims 1, 2, 6, 8, 9 and 13, Gindina teaches a method of increasing outflow facility in mouse model of juvenile open angle glaucoma (a subject), by administering an effective amount an enzymatically inactive tPA (pg. 2 Col. 1 last para.).
With respect to claims 1, 2, 8, and 9, Gindina teaches a method of increasing outflow facility in mouse model of juvenile open angle glaucoma (a subject), by administering an effective amount of an enzymatically inactive tPA (pg. 2 Col. 1 last para.).
Gindina does not explicitly teach the method for the treatment of chronic elevated intra ocular pressure (IOP) in a subject as recited in claim 8. However, Gindina teaches the claimed method of administering an effective amount of an enzymatically inactive tPA. Once administered to the subject the enzymatically inactive tPA would treat whatever conditions are present. Thus, the claimed treatment of chronic elevated IOP must be inherent to the method as taught by Gindina and a necessary effect of practicing the method.
Similarly, Gindina does not measure the intra ocular pressure (IOP) in the mice when administered the enzymatically inactive tPA protein and does not teach administering the enzymatically inactive tPA variant therapeutic agent reduces intra ocular pressure (IOP) in said subject for a period of at least one day to a year or more, relative to IOP measurements in said subject prior to administration of the enzymatically inactive tPA variant therapeutic agent as recited claims 3 and 10. Claims 3 and 10 contain wherein clauses that recites the intended result of the method rather than requiring an additional step be performed. MPEP 2111.04 states “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed” and that a such a clause ‘"in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Therefore since these claims only recite the results of the steps, then art reading on claims 1 and 8 from which these claims depend from will also read on these results since performing the same steps will inherently lead to the same results in the absence of evidence to the contrary including unexpected results.
With respect to claims 7 and 14, Gindina teaches administering the enzymatically inactive tPA variant by intravitreal injections (pg. 2 Col. 1 last para.).
Gindina does not teach the method where the enzymatically inactive tPA variant therapeutic agent is a vector encoding an enzymatically inactive tPA variant as recited in claims 2 and 9.
However, Danias teaches a similar a method of increasing outflow facility in a subject and a method of treatment for chronic elevated IOP in a subject by administering an effective amount of a tPA therapeutic agent that is a tPA protein or a vector encoding an enzymatically inactive tPA variant (abstract, 0007, 0009, 0027 and 0082). Danias teaches the tPA variant therapeutic agent can be a vector encoding a tPA gene or a tPA gene derivative (0009, 0025 and 0070). Danias teaches vectors can provide long term expression of proteins in the TM (trabecular meshwork) without adverse effects (0069).
Accordingly, at the effective time of filing of the claimed invention, one of ordinary skill in the art would have been motivated to modify the method of Gindina so that the enzymatically inactive tPA protein is delivered via gene therapy in a vector encoding the enzymatically inactive tPA protein to provide long term expression of proteins in the TM (trabecular meshwork) of the eye as taught by Danias. It would have been obvious to one of ordinary skill to modify the method of Gindina to deliver a vector encoding the enzymatically inactive tPA protein, since similar methods of treating subjects to increase outflow facility and treat elevated IOP by administering an effective amount of a vector encoding tPA protein were known to be effective as taught by Danias. Furthermore, one of ordinary skill in the art would have had a reasonable expectation of success in making such a modification to Gindina, since Gindina teaches enzymatically inactive tPA is effective in increasing outflow facility in subjects and Danias teaches vectors encoding tPA protein are also effective in increasing outflow facility in subjects.
Gindina does not teach administering the enzymatically inactive tPA variant therapeutic agent to said subject for a period of at least two weeks as recited claims 4 and 11.
However, Danias teaches administering the tPA variant therapeutic agent to the subject for a period of at least two weeks (0078). Danias teaches that recurrent administration allows for a long-term solution to the problem of chronic elevated IOP even where excess fibrin accumulation is not apparent.
Accordingly, at the effective time of filing of the claimed invention, one of ordinary skill in the art would have been motivated to modify the method of Gindina so that the enzymatically inactive tPA therapeutic agent is administered for a period of at least two weeks for the benefit of long-term management of chronic elevated IOP and treatment of the subject as taught by Danias. It would have been obvious to one of ordinary skill to modify the method of Gindina to administer for a period of at least two weeks, since similar methods of treating subjects to increase outflow facility and treat elevated IOP by administering an effective amount of a tPA therapeutic agent were known to be effective when administered for a period of time of at least two weeks as taught by Danias. Furthermore, one of ordinary skill in the art would have had a reasonable expectation of success in making such a modification to Gindina, since Gindina teaches enzymatically inactive tPA is effective in increasing outflow facility in subjects and Danias teaches tPA is effective in increasing outflow facility and treating chronic elevated IOP in subjects when administered for a period of greater than two weeks.
Gindina does not teach the subject is human as recited in claims 6 and 13.
However, Danias teaches a similar a method of increasing outflow facility in a subject and a method of treatment for chronic elevated IOP in a subject by administering an effective amount of a tPA therapeutic agent that is a tPA protein or a vector encoding an enzymatically inactive tPA variant (abstract, 0007, 0009, 0027 and 0082). Danias further teaches the subject has open angle glaucoma and where the subject is preferably mammal and preferably a human (0024 and 0080).
Accordingly, at the effective time of filing of the claimed invention, one of ordinary skill in the art would have been motivated to modify the method of Gindina so that the subject is human for the benefit of treating additional subjects as taught by Danias. It would have been obvious to one of ordinary skill to modify the method of Gindina to treat additional species of animals including humans, since similar methods of treating subjects to increase outflow facility and treat elevated IOP by administering an effective amount of a tPA therapeutic agent were known to treat humans as taught by Danias. Furthermore, one of ordinary skill in the art would have had a reasonable expectation of success in making such a modification to Gindina, since Danias teaches tPA is effective in increasing outflow facility and treating chronic elevated IOP in human subjects.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Higazi et al. (US 2011/0008313 A1)
With respect to claim 1, Higazi teaches a method of treating a pathologic condition involving a neurological injury or an ischemic disease or condition by administering tPA containing a Ser to Ala mutation at 481 which is devoid of protease activity (abstract and 0001). Higazi teaches the NMDA-R (N-methyl-D-aspartate receptor) disorder may include glaucoma (0074). Higazi teaches administering an effective amount of a mutated tPA molecule devoid of serine protease activity (0075).
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY ANN CORDAS whose telephone number is (571)272-2905. The examiner can normally be reached on M-F 9:00-5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached on 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY A CORDAS/Primary Examiner, Art Unit 1632
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