DETAILED ACTION
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 .
Applicant’s amendment and reply filed October 14, 2025 have been received and entered into the case. Claims 2 – 5 are canceled; claims 1, 6 – 16 and 48 are pending and have been considered on the merits. All arguments have been fully considered.
Claim Rejections - 35 USC § 112
Previous rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn due to the amendments filed on October 14, 2025.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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, 10, 15 are rejected under 35 U.S.C. 102a1 and 102a2 as being anticipated by Ny et al. (US 2003/0147879).
Regarding claim 1, Ny teaches a method for treating wounds in a patient (one in need thereof), the method comprising intravenous administration of effective amounts of plasmin (a fibrinogenase) (abstract, 0023 – 0024).
Regarding claim 10, the patient may have a diabetic ulcer or bed sores (pressure ulcer) (0022, 0023, 0029, 0054).
Regarding claim 15, Ny teaches the plasmin is administered as pharmaceutical in a pharmaceutical carrier (0024).
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.
Claims 1, 8 – 9, 11 – 14 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Ny et al. (US 2003/0147879) as evidenced by Kazmi et al. (2012).
Regarding claim 1, Ny teaches a method for treating wounds in a patient (one in need thereof), the method comprising intravenous administration of effective amounts of plasmin (a fibrinogenase) (abstract, 0023 – 0024).
Regarding claims 8 – 9, Ny does not teach the method where in the patient’s plasma viscosity decreases as claimed. However, Ny teaches administering effective amounts that enhance wound healing and increase systemic levels of plasminogen 10, 50 or 100% more than prior to administration of the actives (0038). In this regard, increased levels of plasminogen (and plasmin) would inherently result in decreased plasma viscosity as it functions to break down fibrin (See Kazmi et al. for support). Moreover, at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to optimize the amount of plasmin administered in the methods of Ny as a matter of routine experimentation and procedure, in order to obtain results effective to treat wounds and ulcers.
Regarding claims 11 – 14 and 48, Ny does not teach the method wherein administration dose and regimen is as claimed. However, Ny states that the plasmin may be formulated into pharmaceutical compositions for administration to subjects in an amount effective, at dosages and for periods of time necessary to achieve the desired result. Specifically, that a therapeutically active amount of a substance may vary according to factors such as the disease state, age, sex, and weight of the individual; dosage regimen may be adjusted to provide the optimum therapeutic response; and that more than one divided dose may be administered daily or the dose may be proportionally reduced as indicated by the exigencies of the therapeutic situation (0061). Moreover, Ny specifically teaches one practicing the methods to optimize the therapeutic amount, dosage and dosage administrations when practicing the methods of treating wounds and ulcers.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Claims 1, and 6 – 7 are rejected under 35 U.S.C. 103 as being unpatentable over Ny et al. (US 2003/0147879) in view of Zwaal (WO 2013/024074).
Regarding claim 1, Ny teaches a method for treating wounds in a patient (one in need thereof), the method comprising intravenous administration of effective amounts of plasmin (a fibrinogenase) (abstract, 0023 – 0024).
Regarding claims 6 – 7, Ny does not teach the method wherein the plasmin is one of the recited types. However, Ny teaches the plasmin includes allelic plasmin, function-conservative derivatives of plasmin, functionally active plasmin fragments, derivatives, or homologs of plasmin (0032). At the time the claims were filed, the various claimed fragments, derivatives and homologs were known in the art as therapeutic equivalents that can be interchanged and substituted for one another and with a reasonable expectation for obtaining predictable results. In support, Zwaal teaches therapeutic plasmin variants and derivatives Glu-plasmin, Lys-plasmin, midiplasmin, miniplasmin, microplasmin and deltaplasmin as functional alternatives for each other (p.5, 9, 11). As such, at the time the claims were filed, it would have been obvious to use any of the instant fragments, derivatives and variants of plasmin in the methods of Ny for the express direction thereby and since they were all well known and used therapeutic equivalents.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Claims 1, 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Ny et al. (US 2003/0147879) in view of Novokhatny et al. (2003).
Regarding claim 1, Ny teaches a method for treating wounds in a patient (one in need thereof), the method comprising intravenous administration of effective amounts of plasmin (a fibrinogenase) (abstract, 0023 – 0024).
Regarding claim 15, Ny teaches the plasmin is administered as pharmaceutical in a pharmaceutical carrier (0024).
Regarding claim 16, Ny does not teach the pharmaceutical composition having an acidic pH. However, Novokhatny teaches acidification of plasmin formulations remarkably stabilize the plasmin against auto-degradation, is equivalent to neutral pH formulations (abstract, p. 1037 right col.) and exhibits efficacy for long term activity in vivo (p.1037 right col). At the time the claims were filed, one of ordinary skill in the art would have been motivated to acidify the compositions of Ny for the advantages of long term stability and efficacy in vivo, as disclosed by Novokhatny, and with a reasonable expectation for successfully treating wounds and ulcers.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant argues that Ny does not specifically teach administering plasmin intravenously and that one in the art would not practice this because the reference teaches many routes of administration and possible actives; that effects of intravenous plasmin are speculative only; and that one would not substitute plasminogen with plasmin for intravenous administration. Applicant argues that the instant specification explains that systemic therapy with plasmin was known to be ineffective for achieving thrombolysis and as such would not administer it to other conditions such as wounds and as such, the claimed method exhibits unexpected results in wound healing.
Applicant argues the secondary references do not overcome the deficiencies of Ny in that Kazmi does not teach plasmin is effective in wound healing; Zwaal does not administer plasmin variants intravenously; and Novokhatny does not teach administering plasmin intravenously.
Regarding the argument that Ny does not teach administering plasmin intravenously, Ny specifically teaches administering plasmin intravenously (0023 – 0024). Further, Ny specifically identifies administering plasmin as the active (abstract, claims) and intravenous administration as the preferred method (0024, 0063, 0082 examples).
Regarding the argument that intravenous plasmin is taught only speculatively, the reference clearly teaches the method administering plasmin intravenously (0023, 0024, 0032, 0060 - 0062, 0082). In this regard the reference anticipates the claimed subject matter. Please note that the prior art is not required to exemplify all embodiments of the disclosure to anticipate a claim (MPEP 2123).
Regarding the argument that one would not substitute plasminogen with plasmin for intravenous administration, it is iterated that the prior art teaches administering plasmin intravenously (0023 – 0024).
Regarding the argument that plasmin was known to be ineffective for achieving thrombolysis and as such would not administer it to other conditions such as wounds, Ny specifically teaches treating wounds by administering plasmin intravenously (0023 – 0024), thus the argument fails to persuade.
Regarding the argued unexpected results, it is iterated that the prior art teaches administering plasmin intravenously for treating wounds (0023 – 0024). In this regard, unexpected results are irrelevant to 35 U.S.C. 102 rejections and thus cannot overcome a rejection so based (MPEP 2131.04). Notwithstanding, the prior art specifically teaches the argued unexpected result. Further, applicant has not provided any evidence of an unexpected result.
Regarding the secondary references, it is maintained that Ny teaches administering intravenous plasmin and the secondary references are relied upon to demonstrate increased levels of plasminogen and plasmin inherently result in decrease plasma viscosity; that the claimed plasmin fragments were known equivalents in the art; and acidifying plasmin formulations was known to stabilize the plasmin. Since applicant fails to rebut these points, they are considered points of agreement.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
No claims are allowed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
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/RUTH A DAVIS/ Primary Examiner, Art Unit 1699
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