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
This office action is in response to applicant’s reply filed on July 24, 2026.
Status of Claims
Amendment of claims 1, 4, 7-8 and 17-18; and cancellation of claims 20-27 is acknowledged.
Claims 1-19 are currently pending and are the subject of this office action.
Claim 7-8 and 17-18 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 5, 2026.
Claims 1-6, 9-16 and 19 are under examination.
Priority
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Rejections and/or Objections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Rejections and/or Objections) or newly applied (New Rejections and/or Objections, Necessitated by Amendment or New Rejections and/or Objections not Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Responses to Applicant’s arguments have been addressed immediately after the corresponding rejections, or in the section: Withdrawn Rejections and/or Objections, if the rejection was withdrawn.
Claim Rejections - 35 USC § 102 (Modified Rejection Necessitated by Amendment).
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.
Claim(s) 1-6, 14-15 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nam et. al. (US 2019/0328721).
NOTE:
Claims 2-3 do not require “alleviating a symptom associated with impaired lymphatic drainage”, instead, claims 2-3 require an “amount” that has the potential to “alleviate a symptom associated with impaired lymphatic drainage”
Similarly, claims 4-6 do not require to rescue vascular barrier, but instead require an “amount” that has the potential to “rescue vascular barrier function”.
For claim 1, Nam teaches a method of treating cancer (which according to the instant specification cancer is considered a condition associated with impaired lymphatic drainage, see instant specification, page 8, lines 30-33) comprising administering to a subject suffering from cancer a composition comprising a therapeutically effective amount of a selective ROCK2 inhibitor (see abstract, [0017], [0166], Example 2 on page 11), and wherein ROCK2 inhibitors can be KD025 (See [0141], [0148] and [0167]).
For claims 2-3, Nam teaches the administration of “therapeutically effective amounts of ROCK inhibitors for the treatment of cancer” (see [0017] and [0166]), wherein the “therapeutically effective amounts” can be for example from 1 mg to about 50 mg (see [0144]).
The office does not have the facilities and resources to provide the factual evidence needed to establish that the “therapeutically effective amounts of ROCK2 inhibitors for the treatment of cancer” in the method of the prior art are not the same or similar to the “therapeutically effective amount for alleviating a symptom associated with impaired lymphatic drainage” of the instant claims.
The instant specification does not disclose any specific “effective amount for alleviating a symptom associated with impaired lymphatic drainage”.
In the absence of evidence to the contrary, the burden is on the applicant to prove that the “effective amount for alleviating a symptom associated with impaired lymphatic drainage” is different from the “therapeutically effective amounts” disclosed by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
For claim 4-6, Nam teaches a method of treating cancer comprising administering to a subject suffering from cancer (instant claims 4-6 are very broad since the subjects are not limited to any disease or condition, as such any subject, either suffering from any disease, including those suffering from cancer, or a healthy subject, are encompassed by claims 4-6) a composition comprising a therapeutically effective amount of a selective ROCK2 inhibitor (see abstract, [0017], [0166], Example 2 on page 11), and wherein ROCK2 inhibitors can be KD025 (See [0141], [0148], [0167]), and wherein the “therapeutically effective amounts” can be for example from 1 mg to about 50 mg (see [0144]).
The office does not have the facilities and resources to provide the factual evidence needed to establish that the “therapeutically effective amounts of ROCK2 inhibitors for the treatment of cancer” in the method of the prior art are not the same or similar to the “therapeutically effective amount effective to rescue vascular barrier function” of the instant claims.
The instant specification does not disclose any specific “effective amount effective to rescue vascular barrier function”.
In the absence of evidence to the contrary, the burden is on the applicant to prove that the “effective amount effective to rescue vascular barrier function” is different from the “therapeutically effective amounts” disclosed by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
For claim 14, Nam teaches the oral administration of the ROCK inhibitor (See [0143]).
For claim 15, Nam teaches the administration of tablets (see [0164]).
For claim 19, Nam teaches that the ROCK2 inhibitors bind to ROCK2 and inhibit serine/threonine kinase activity (see [0005] and [0134]).
Response to Applicant’s arguments related to the above rejection
Applicants’ arguments have been fully considered but are not persuasive.
Applicant argues that:
Nam is silent as to any effect on the lymphatic system.
Examiner’s response:
Nam does not have to mention any effect on the lymphatic system in order to anticipate claim 1. Claim 1 requires “a method of treating a condition associated with impaired lymphatic drainage in a subject in need thereof”. According to the instant specification (see instant specification, page 8, lines 30-33) a subject suffering from cancer is considered a subject in need thereof, or in other words, cancer is considered “a condition associated with impaired lymphatic drainage”. The fact that Nam did not recognize at that time that cancer is a “condition associated with impaired lymphatic drainage” is completely irrelevant, since apparently, Applicant discovered a new property or mechanism of action (cancer is associated with impaired lymphatic drainage) of a known disease (cancer).
Apparently, Applicant has discovered a new mechanism of action (cancer is associated with impaired lymphatic drainage) of a known disease (cancer). The explanation of an effect or mechanism of action of a known disease cannot confer novelty on a known process (administering a selective ROCK2 inhibitor to a patient suffering from cancer) if the skilled artisan was already aware of the occurrence of the desired therapeutic effect. Though new properties of a compound or their mechanism of action are no doubt important contributions to scientific and pharmaceutical development, the assessment of patentability is based upon the therapeutic applications and effects of the compounds, not the mechanism or properties by which they exert such a therapeutic effect.
MPEP 2145 states: “Mere recognition of latent properties in the prior art does not render non-obvious an otherwise known invention. In re Wiseman, 201 USPQ 658 (CCPA 1979). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991)”.
Applicant argues that:
To the extent this reasoning is meant to extend to claim 1, the Examiner's position as stated for claims 2-3 is that "[t]he office does not have the facilities and resources to provide the factual evidence needed to establish that the 'therapeutically effective amounts of ROCK2 inhibitors for the treatment of cancer' in the method of the prior art are not the same or similar to" the effective amount recited in the instant claims, and that "the burden is on the applicant to prove" a patentable difference, citing In re Best, 562 F.2d 1252 (CCPA 1977) and Ex parte Gray, 10 USPQ2d 1922 (PTO Bd. Pat. App. & Int. 1989). Applicant submits that Best and Gray require the Examiner first to establish a sound basis for believing the prior art's disclosed process is identical or substantially identical to the claimed one before the burden shifts to Applicant.
Examiner’s response:
Applicant did not disclose anywhere in the specification nor in the instant claims what a “therapeutically effective amount effective for alleviating a symptom associated with impaired lymphatic drainage is”. Unless Applicant defines the range of that “therapeutically effective amount’, any therapeutically effective amount in the prior art is going to be assumed to satisfy that requirement (to be effective for alleviating a symptom associated with impaired lymphatic drainage” until Applicant can demonstrate a patentable difference.
Applicant argues that:
Nam discloses no administration of the claimed compounds at all: KD025 is named only as one of roughly thirty alternative ROCK2 inhibitors listed in paragraph [0141] and is not used in any working example; and Nam does not name or disclose compound 175 or compound 497 anywhere in the reference. Nam also neither measures nor discusses any effect on the lymphatic system. Absent any disclosed administration event or effect in Nam bearing on lymphatic drainage, there is no basis on this record from which identity or substantial identity with the claimed process could be presumed, and the burden has not shifted to Applicant.
Examiner’s response:
First, Nam does not have to disclose compounds 175 and 497, since in order to anticipate the claim, Nam is required to anticipate just one species (KD025), not all of them.
Second, KD025 is named in several paragraphs (See [0141], [0148] and [0167]) and more important, according to MPEP 2131.02 II:
“A genus does not always anticipate a claim to a species within the genus. However, when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named. See Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990) (The claimed compound was named in a reference which also disclosed 45 other compounds. The Board held that the comprehensiveness of the listing did not negate the fact that the compound claimed was specifically taught. The Board compared the facts to the situation in which the compound was found in the Merck Index, saying that "the tenth edition of the Merck Index lists ten thousand compounds. In our view, each and every one of those compounds is ‘described’ as that term is used in [pre-AIA ] 35 U.S.C. 102(a), in that publication."). Id. at 1718.
Third, Nam does not have to provide a working example for compound KD025 in order to enable for the treatment of cancer comprising the administration of the selective ROCK2 inhibitor KD025. Nam provides several examples of selective ROCK2 inhibitors that are effective in treating cancer (see Example 2 on page 11), as such, Nam enables for the treatment of other selective ROCK2 inhibitors, like KD025, for the treatment of cancer.
Fourth, as discussed previously, the fact that Nam is silent regarding “impaired lymphatic drainage” is irrelevant. Apparently, Applicant has discovered a new mechanism of action (cancer is associated with impaired lymphatic drainage) of a known disease (cancer). The explanation of an effect or mechanism of action of a known disease cannot confer novelty on a known process (administering a selective ROCK2 inhibitor to a patient suffering from cancer) if the skilled artisan was already aware of the occurrence of the desired therapeutic effect. Though new properties of a compound or their mechanism of action are no doubt important contributions to scientific and pharmaceutical development, the assessment of patentability is based upon the therapeutic applications and effects of the compounds, not the mechanism or properties by which they exert such a therapeutic effect.
MPEP 2145 states: “Mere recognition of latent properties in the prior art does not render non-obvious an otherwise known invention. In re Wiseman, 201 USPQ 658 (CCPA 1979). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991)”.
Claim Rejections - 35 USC § 103 (Modified Rejection Necessitated by Amendment).
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nam et. al. (US 2019/0328721).
Nam teaches all the limitations of claim 16, except for the administration of 200-400 mg of ROCK2 inhibitor.
However, Nam further teaches the administration of 0.010 mg to about 500 mg of active ingredient (see [0144]) which overlaps with the instantly claimed range.
MPEP 2144.05 states: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
"A prior art reference that discloses a range encompassing a somewhat narrower
claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). >See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005).
All this will result in the practice of claim 16 with a reasonable expectation of success.
Applicant argues that:
Unexpected results for the compound KD025.
Examiner’s response:
Apparently, Applicant discovered a new mechanism of action of the method anticipated and made obvious by Nam: a method of treating cancer comprising administering to a subject suffering from cancer a composition comprising a therapeutically effective amount od the selective ROCK2 inhibitor KD025.
Apparently, Applicant has discovered a new mechanism of action (cancer is associated with impaired lymphatic drainage) of a known disease (cancer). The explanation of an effect or mechanism of action of a known disease cannot confer novelty on a known process (administering a selective ROCK2 inhibitor to a patient suffering from cancer) if the skilled artisan was already aware of the occurrence of the desired therapeutic effect. Though new properties of a compound or their mechanism of action are no doubt important contributions to scientific and pharmaceutical development, the assessment of patentability is based upon the therapeutic applications and effects of the compounds, not the mechanism or properties by which they exert such a therapeutic effect.
MPEP 2145 states: “Mere recognition of latent properties in the prior art does not render non-obvious an otherwise known invention. In re Wiseman, 201 USPQ 658 (CCPA 1979). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991)”.
Claim Rejections - 35 USC § 103 (New Rejection Necessitated by Amendment).
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-6, 9-10, 14-16 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lampe et. al. (US 2010/0008968) in view of Zhao et. al. (US 2019/0276440).
For claims 1 and 9-10, Lampe teaches a method of treating edema (a condition associated with impaired lymphatic drainage) comprising the administration of a ROCK2 inhibitor (see [0003], [0091] and [0305]-[0306]) to a subject suffering from edema. Lampe does not teach the ROCK2 inhibitor KD025. However, Nam teaches that KD025 is a ROCK2 inhibitor (see [0141]).
Before the effective filing date of the claimed invention, it would have been prima facie obvious for a person of ordinary skill in the art to substitute one functional equivalence (any ROCK2 inhibitor) for another (KD025) with an expectation of success, since the prior art establishes that both function in similar manner, thus resulting in the practice of claims 1 and 9-10, with a reasonable expectation of success.
For claims 2-3, Lampe teaches dosage levels about 0.01-140 mg/kg (see [0213]).
The office does not have the facilities and resources to provide the factual evidence needed to establish that the dosages in the method of the prior art are not the same or similar to the “therapeutically effective amount for alleviating a symptom associated with impaired lymphatic drainage” of the instant claims.
The instant specification does not disclose any specific “effective amount for alleviating a symptom associated with impaired lymphatic drainage”.
In the absence of evidence to the contrary, the burden is on the applicant to prove that the “effective amount for alleviating a symptom associated with impaired lymphatic drainage” is different from the “effective amounts” disclosed by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
For claim 4-6, Lampe teaches the administration of a composition comprising a ROCK2 inhibitor to a subject suffering from several diseases (see abstract, see [0091] and [0305]-[0306]), (claims 4-6 are very broad since the subjects are not limited to any disease or condition, as such any subject, either suffering from any disease, or a healthy subject are encompassed by claims 4-6).
Lampe does not teach the ROCK2 inhibitor KD025. However, Nam teaches that KD025 is a ROCK2 inhibitor (see [0141]).
Before the effective filing date of the claimed invention, it would have been prima facie obvious for a person of ordinary skill in the art to substitute one functional equivalence (any ROCK2 inhibitor) for another (KD025) with an expectation of success, since the prior art establishes that both function in similar manner.
Further, Lampe teaches dosage levels about 0.01-140 mg/kg (see [0213]).
The office does not have the facilities and resources to provide the factual evidence needed to establish that the “dosage level amounts” in the method of the prior art are not the same or similar to the “therapeutically effective amount effective to rescue vascular barrier function” of the instant claims.
The instant specification does not disclose any specific “effective amount effective to rescue vascular barrier function”.
In the absence of evidence to the contrary, the burden is on the applicant to prove that the “effective amount effective to rescue vascular barrier function” is different from the “dosage level amounts” disclosed by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
All this will result in the practice of claims 4-6 with a reasonable expectation of success.
For claim 14, Lampe teaches the oral administration of ROCK2 inhibitors (see for example [0340]).
All this will result in the practice of claim 14 with a reasonable expectation of success.
For claim 15, Lampe teaches the administration of tablets (see [0160]).
All this will result in the practice of claim 15 with a reasonable expectation of success.
Lampe teaches all the limitations of claim 16, except for the administration of 200-400 mg of ROCK2 inhibitor.
However, Lampe further teaches the administration of 1 mg to about 500 mg of active ingredient (see [0213]) which overlaps with the instantly claimed range.
MPEP 2144.05 states: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
"A prior art reference that discloses a range encompassing a somewhat narrower
claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). >See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005).
All this will result in the practice of claim 16 with a reasonable expectation of success.
For claim 19, Lampe teaches that the ROCK2 inhibitors bind to ROCK2 and inhibit serine/threonine kinase activity (see [0003]).
All this will result in the practice of claim 19 with a reasonable expectation of success.
Response to Applicant’s arguments
Since a new rejection was issued (see above), it is the Examiner’s belief that most of the arguments presented by Applicant are no longer applicable or have been considered/answered in the rejection itself.
Claim Rejections - 35 USC § 102 (New Rejection Necessitated by Amendment).
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)(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.
Claim(s) 1-6, 9-10, 14-16 and 19 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kuznetova et. al. (US 2023/0172944).
NOTE:
Claims 2-3 do not require “alleviating a symptom associated with impaired lymphatic drainage”, instead, claims 2-3 require an “amount” that has the potential to “alleviate a symptom associated with impaired lymphatic drainage”
Similarly, claims 4-6 do not require to rescue vascular barrier, but instead require an “amount” that has the potential to “rescue vascular barrier function”.
For claims 1 and 9-10, Kuznetova teaches a method of treating pulmonary edema comprising the administration to a subject suffering from pulmonary edema a composition comprising a therapeutically effective amount (See [0175]) of a ROCK 2 inhibitor (see abstract, [0001], [0006], [0071] and claim 1), wherein the ROCK inhibitor is SLX-2119 (KD025) (see [0059], [0060], Table 1 on page 6 compound 9, [0062]-[0063] and claim 3).
For claims 2-3, Kuznetova teaches the administration of “therapeutically effective amounts of ROCK inhibitors for the treatment of cancer” (see [0175]).
The office does not have the facilities and resources to provide the factual evidence needed to establish that the “therapeutically effective amounts of ROCK2 inhibitors for the treatment of pulmonary edema” in the method of the prior art are not the same or similar to the “therapeutically effective amount for alleviating a symptom associated with impaired lymphatic drainage” of the instant claims.
The instant specification does not disclose any specific “effective amount for alleviating a symptom associated with impaired lymphatic drainage”.
In the absence of evidence to the contrary, the burden is on the applicant to prove that the “effective amount for alleviating a symptom associated with impaired lymphatic drainage” is different from the “therapeutically effective amounts” disclosed by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
For claims 4-6, Kuznetova teaches a method of treating pulmonary edema comprising the administration to a subject suffering from pulmonary edema (instant claims 4-6 are very broad since the subjects are not limited to any disease or condition, as such any subject, either suffering from any disease, including those suffering from pulmonary edema, or a healthy subject are encompassed by claims 4-6) a composition comprising a therapeutically effective amount (See [0175]) of a ROCK 2 inhibitor (see abstract, [0001], [0006], [0071] and claim 1), wherein the ROCK inhibitor is SLX-2119 (KD025) (see [0059], [0060], Table 1 on page 6 compound 9, [0062]-[0063] and claim 3).
The office does not have the facilities and resources to provide the factual evidence needed to establish that the “therapeutically effective amounts of ROCK2 inhibitors for the treatment of pulmonary edema” in the method of the prior art are not the same or similar to the “therapeutically effective amount effective to rescue vascular barrier function” of the instant claims.
The instant specification does not disclose any specific “effective amount effective to rescue vascular barrier function”.
In the absence of evidence to the contrary, the burden is on the applicant to prove that the “effective amount effective to rescue vascular barrier function” is different from the “therapeutically effective amounts” disclosed by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
For claim 14, Kuznetsova teaches the oral administration of ROCK inhibitors (see [0175]).
For claim 15, Kuznetsova teaches the administration of ROCK inhibitor in the form of tablets (see [0175]).
For claim 19, Kuznetsova does not explicitly teach that the selective ROCK2 inhibitor binds to ROCK2 and inhibits ROCK2 serine/threonine kinase activity. However, Kuznetsova teaches that ROCKs consist of an amino-terminal protein serine/threonine kinase domain. Further “binding to ROCK2 and inhibition of ROCK2 serine/threonine kinase activity” is considered an inherent property of ROCK2 selective inhibitors like KD025 as evidenced by the instant specification (see page 2, lines 31-32).
MPEP 2112 I states:
“The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
MPEP 2112.01 II states:
"Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty."
Double Patenting (Maintained Rejection).
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6, 9-16 and 19 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 135 of copending Application No. 18/292,051 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and the co-pending application teach methods of treating diseases associated with Rock2 in subjects in need thereof, wherein the disease can be edema among others (see specification [0003]).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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 extension fee 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 date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
July 29, 2026.
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