DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/03/2026 has been entered.
Status of Application
The response filed 02/03/2026 has been received, entered and carefully considered. The response affects the instant application accordingly:
Claims 1, 3, 5, 10-11, 13 have been amended.
Claim 12 has been cancelled.
Claim 14 has been added.
Applicant has previously elected the species genera of benzoxazole based compounds (W=X=Y=Z=carbon, Q=V= oxygen, and U=N) with the specific species compound election of
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which was expanded to include
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where R1 is an alkyl with at least 5 carbons and now viewed as 5-7 carbons as addressed in the 112 rejection below, and R3 is a halogen and hydrogen.
Claims 1-11, 13-14 are pending.
Claims 1-3, 5-9, 11, 13-14 are present for examination at this time.
Applicant has requested to withdrawn from the PPH program. The request is denied as once a PPH request has been granted, the application is accorded special status with is retained through the prosecution of the application. If participation in the PPH program is no longer desired, Applicant may wish to consider filing a continuing application. See FAQ item 24 for the PPH program.
After consultation with a POC of the PPH program, the amendment of the compound formula for the independent claim is deemed further limiting of the OEE designated claim and examination of the claims is acceptable at this time. Applicant is reminded to comply with the PPH rules and FAQ’s to avoid non-compliance with the PPH program as withdrawal is not possible after Applicant’s initial request was granted.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
New grounds of rejection are set forth in the current office action as a result of amendment.
Current Grounds of Rejection
Due to the amendment of the claims the new grounds of rejection are applied:
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3, 5-8, 11, 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The independent claim and its dependent claims recite the method with the administration of a compound of Formula I wherein V=O,S or NR7 but does not define R7 anywhere in the claim, wherein it is unclear what is R7 and does not allow one to ascertain the metes and bounds of the claimed invention.
Claims 1-3, 5-9, 11, 13-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claims are directed to a method with the administration to a subject a compound of Formula I wherein
when Q is O or S, R6 is absent, and R1 is a linear or branched alkyl featuring a linear saturated chain of 5, 6 or 7 carbon atoms; and
when Q is N, one of R1 and R6 is a linear or branched alkyl featuring said linear saturated chain of 5, 6 or 7 carbon atoms and the other one of R1 and R6, is hydrogen or an alkyl of up to 3 carbon atoms in length.
This is indefinite as the recitation that R1 is a linear or branched alkyl featuring a linear saturated chain of 5, 6 or 7 carbon atoms (when Q=O or S) is unclear as it is unclear what is meant by “featuring” linear saturated chain of 5, 6 or 7 carbon atoms. Is the alkyl a linear saturated chain of 5, 6 or 7 carbon atoms? Is it more than a linear saturated chain of 5, 6 or 7 carbon atoms? Is the linear saturated chain of 5, 6 or 7 carbon atoms meant for only the branched alkyl and not the linear alkyl? Is it that one branch of the branched alkyl is a linear saturated chain of 5, 6 or 7 carbon atoms but other branches are not? It does not allow one to ascertain the metes and bounds of the claims as written.
The claim is also unclear as it recites R1 is a linear or branched alkyl featuring a linear saturated chain of 5, 6 or 7 carbon atoms; wherein how can a branched alkyl be a linear saturated chain of 5, 6 or 7 carbon atoms? A branched alkyl is not linear. It does not allow one to ascertain the metes and bounds of the claims as written. This is also the case with the recitation of when Q is N that “one of R1 and R6 is a linear or branched alkyl featuring said linear saturated chain of 5, 6 or 7 carbon atoms and the other one of R1 and R6, is hydrogen or an alkyl of up to 3 carbon atoms in length”, it is unclear what is mean by “said linear saturated chain of 5, 6 or 7 carbon atoms” as it is indefinite to what “said linear saturated chain” is it referring to as it is defining for a separate core and is the independent claim not a dependent claim.
The phrase “one of R1 and R6 is a linear or branched alkyl featuring said linear saturated chain of 5, 6 or 7 carbon atoms and the other one of R1 and R6, is hydrogen or an alkyl of up to 3 carbon atoms in length” is also indefinite as it is unclear what is meant by “featuring” linear saturated chain of 5, 6 or 7 carbon atoms. Is the alkyl a linear saturated chain of 5, 6 or 7 carbon atoms? Is it more than a linear saturated chain of 5, 6 or 7 carbon atoms? Is the linear saturated chain of 5, 6 or 7 carbon atoms meant for only the branched alkyl and not the linear alkyl? Is it that one branch of the branched alkyl is a linear saturated chain of 5, 6 or 7 carbon atoms but other branches are not? It does not allow one to ascertain the metes and bounds of the claims as written. The claim is also unclear as it recites R1 or R6 as a linear or branched alkyl featuring a linear saturated chain of 5, 6 or 7 carbon atoms; wherein how can a branched alkyl be a linear saturated chain of 5, 6 or 7 carbon atoms? A branched alkyl is not linear. It does not allow one to ascertain the metes and bounds of the claims as written.
For purposes of examination, the claim is treated as
when Q is O or S, R6 is absent, and R1 is an C5-C7 alkyl that is linear or branched; and
when Q is N, one of R1 and R6 is C5-C7 alkyl that is linear or branched, and the other one of R1 and R6 is hydrogen or an alkyl of up to 3 carbon atoms in length.
Claim 14 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 14 recites the limitation "wherein each carbon atom in said linear saturated chain of 5, 6 or 7 carbon atoms is unsubstituted" in claim 1. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not recite the linear saturated chain of 5, 6 or 7 carbon atoms to be “substituted or unsubstituted”; only for the R1 (when Q=O or S) or for R1 or R6 (when Q=N) is a linear saturated chain of 5, 6 or 7 carbon atoms wherein it is unsubstituted (as it does not recite substitution or an alternative), wherein the limitation of claim 14 is unclear and lack antecedent basis and does not further limit the claim as addressed below.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 14 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 14 recites the limitation "wherein each carbon atom in said linear saturated chain of 5, 6 or 7 carbon atoms is unsubstituted" in claim 1; but claim 1 does not recite the linear saturated chain of 5, 6 or 7 carbon atoms to be “substituted or unsubstituted”; only for the R1 (when Q=O or S) or for R1 or R6 (when Q=N) is a linear saturated chain of 5, 6 or 7 carbon atoms wherein it is unsubstituted (as it does not recite substitution or an alternative), wherein the limitation of claim 14 does not further limit the claim.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 5-9, 11, 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Teuber et al. (U.S. Pat. Pub. 2004/0029937) as evidenced by Matschke et al. (Calcium-activated SK potassium channels are key modulators of the pacemaker frequency in locus coeruleus neurons).
Rejection:
Teuber et al. teaches a method of treating/alleviating a disease condition responsive to modulation of SKCa (calcium activated potassium channels) like cystic fibrosis in a living animal body including a human, with the administration of a compound of formula I. The modulating compounds of formula I may inhibit/block or activate the channels [29]. The compounds of formula I include
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(X=O), and R1 includes alkyl which is defined to be from 1-12 carbons and more preferred C1-6 alkyl [33, 64] and R5 includes hydrogen, halogen, and -CN [35]. Teuber et al. also exemplifies and claims compounds like
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(3-ethyl-5-chlorobenzoxazolone [133], R1=C2 and R5=chloride halogen), and that R5 can be absent (then R5 is hydrogen Example 1i). Teuber et al. teaches that the compounds can modulate SKCa (i.e. inhibit the calcium activated potassium channels) which as evidenced by Matschke et al. are SK1-SK4 (Page 331 first column 2nd paragraph (The SK channel family is composed of SK1 to SK4) and used to treat conditions like cystic fibrosis. Wherein it is implicit if not prima facie obvious to utilize the compounds taught to be utilized for the method of modulation/inhibition on any/all of the SKCa channels including SK4 as evidenced by Matschke et al. and taught by Teuber et al. to treat the taught conditions like cystic fibrosis ([7-8, 16-24, 29-39, 64, 122-125, 132], claims 1, 5 and 24-25).
While Teuber et al. does not expressly exemplify where R1 is at 5-7 carbons, it does expressly defines the alkyl to be from 1-12 carbons including a more preferred C1-6 alkyl and exemplifies it with an alkyl (ethyl); wherein it would be prima facie obvious to exemplify the compound with the taught alkyl groups as defined such as C5 and C6 with a reasonable expectation of success absent evidence of criticality. It is also prima facie obvious to exemplify where R5 is hydrogen as R5 can be hydrogen, halogen, and -CN; and is exemplified without R5 substituent (R5 is then hydrogen) with a reasonable expectation of success absent evidence of criticality for the substituent. As the Teuber compounds defines the alkyl to be from 1-12 carbons and includes the alkyl to be from C5-C12 which falls within the claimed formula, the mechanism of activity of the compound (i.e. interacting with calmodulin PIP2 binding domain and inhibiting the SK4 channel) to treat these disease is responsive to modulation of SKCa naturally flows from the compound upon administration to the subject as the prior art teaches the method of treatment of diseases responsive to modulation of SKCa (calcium activated potassium channels) which includes SK4 like cystic fibrosis which is a condition of the instant specification, with the administration of compounds of formula I which includes
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like
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(exemplified/claimed) and
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(alkyl is C5 within the instant claims) and
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(alkyl is C6 with chloride falling within instant claims) and
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(alkyl is C6 falling within the instant formula) where the same activity and mechanism of action is present as it naturally flows from the compounds are being administered for treatment of conditions like cystic fibrosis as taught by Teuber et al. which is a condition of SK4 as established by the instant specification; wherein the same activity and mechanism of action is present and 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 it patentably new to the discoverer. The claiming of a new use, new function or unknown property which is 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).
Response to Arguments:
Applicant's arguments are centered on the assertion that the inventors identified a previously untargeted region of SK4 channels with the amended instantly claimed compounds of Formula I, the calmodiulin-PEP2 binding domain, that Teuber does not suggest selecting an alkyl chain of 5-7 carbons as instantly claimed and does not teach the selection of C5-C7 alkyl to result in SK4 inhibition, that Matschke et al. does not teach the instant claimed method, the assertion of criticality for the alkyl substituent asserting that the 132 declaration of Attali and the Tables 2-3 of the specification demonstrate that the position and alkyl length exhibit different level of SK4 inhibition.
This is fully considered but not persuasive.
With regards to the assertion that inventors identified a previously untargeted region of SK4 channels with the instant claimed formula, and the calmodiulin-PEP2 binding domain; this is not persuasive as the prior art of Teuber teaches method of treating/alleviating a disease condition like cystic fibrosis where the disease condition is responsive to modulation of SKCa (calcium activated potassium channels) with the administration of a compound of formula I including
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that may inhibit/block or activate the channels, where the alkyl for R1 is from 1-12 carbons which includes the alkyl to be from C5-C12 falling within the claimed formula.
The mechanism of activity of the compound (i.e. interacting with calmodulin PIP2 binding domain and inhibiting the SK4 channel) to treat the diseases responsive to modulation of SKCa like cystic fibrosis (a SK4 condition of the instant specification) - naturally flows from the compound upon administration to the subject. The prior art teaches the method of treatment of diseases responsive to modulation of SKCa (calcium activated potassium channels) which includes cystic fibrosis which is a SK4 condition as established by the instant specification, the administration of compounds of formula I that have the alkyl to be from C1-C12 with the preferred grouping of C1-C6 which includes
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(alkyl is C5 within the instant claimed formula) and
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(alkyl is C6 and R3 with chloride falling within the instant formula) and
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(alkyl is C6 falling within the instant formula) and wherein the same activity and mechanism of action is present as it naturally flows from the compounds are being administered for treatment of conditions like cystic fibrosis as taught by Teuber et al. which is a condition of SK4 as established by the instant specification; wherein the same activity and mechanism of action is present and 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 intrinsically 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). An intrinsic feature need not be recognized at the time of the invention. There is no requirement that a person of ordinary skill in the art would have recognized the disclosure at the time of invention, but only that the subject matter is in fact present in the prior art reference. As if the compounds are physically the same it must have the same properties “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). The Examiner’s finding on the principle that product of identical chemical composition cannot have mutually exclusive properties which is a well settled principle in patent law. Therefore where the claimed and prior art compounds and their utility are identical or substantially identical, the USPTO can require an applicant to prove that the prior art product do not necessarily possess the characteristic of the claims for targeting SK4 channels and the calmodiulin-PEP2 binding domain to act as allosteric SK4 blocker by interfering with this domain.
As for the assertion that Teuber does not suggest selecting an alkyl chain of 5-7 carbons as instantly claimed and does not teach the selection of C5-C7 alkyl to result in SK4 inhibition, this is fully considered but not persuasive. Contrary to the assertion, Teuber et al. teaches the compounds to be useful for treating conditions responsive to modulation of SKCa (calcium activated potassium channels) like cystic fibrosis which is a SK4 condition as established by the instant specification with the administration of a compound of formula I including
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where R1 can be an alkyl of C1-12 with exemplification of C2 wherein there is an explicit teaching for alkyl from C1-C12 wherein it is prima facie obvious to exemplify the compounds including C5 and C6 and C7 with a reasonable expectation of success absent evidence of criticality for the alkyl length which has not been provided as addressed below, and as addressed above the recited compounds are used for treating conditions like cystic fibrosis which is a SK4 condition cited by the specification, the same activity and mechanism of action is present and 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).
Applicant’s arguments that Matschke et al. does not teach the instant claimed method is to the reference individually and one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Matschke et al. is presented merely as evidence that calcium activated potassium channels are SK1-SK4.
As for the assertion of evidence of criticality citing the declaration of Attali and Tables 2-3 of the specification are evidence that compounds comprising an alkyl chain of 5-7 carbons in length in the instant claimed formula for inhibition activity; this is fully considered but not persuasive. The compounds of Tables 2-3 are not commensurate in scope with what Applicant elected or what is claimed as Applicant’s election/expansion is for
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and there is no compound that is present as a comparative in Tables 2-3 within the elected/expanded genus to demonstrate that the prior art compounds presented above do not possess the SK4 or evidence of criticality for the specific formula being examined over the prior art. The compounds of Table 2-3 are for the non-elected genus/core wherein while there appears to have three tested compounds with the recited alkyl length that have inhibitory activity (Q=U=N, V=O, W=X=Y=Z=C, R2=R3=R4=R5=R6=H, R1 is C5-C7 linear alkyl)– they are not the elected genus present for examination and also not commensurate in scope with the claims (the three compounds are to the same limited configuration which is not the breath claimed). There are not any compounds in Table 2 or 3 to the elected/expanded compound genus to establish evidence of criticality for the alkyl length for the elected genus. There is a 132 declaration of Attali that asserts that the position of the C8 alkyl have a change in SK4 inhibition and that the variable of Q among O,S, or N is not material alter the steric interaction. This is fully considered but not persuasive. The argument that the position of the C8 alkyl impacts the SK4 inhibition is to ring walking but the prior art rejection does not involve ring walking. The prior art of Teuber has the compound with the substituent is in the same position as the instant compounds wherein it is not persuasive. Additionally it is noted that the alkyl presented is C8 is outside the instant claimed formula wherein it is confusing how that is supposed to be evidence of criticality of the alkyl substituent as it is out the C5-C7 length instantly claimed going against the assertion of criticality. As for the statement that variable of Q among O,S, or N does not material alter the steric interaction where the data of where Y and Q are nitrogen is indicative for compounds of benzoxazolone skeleton (U=N and Q=O), this is not persuasive as the allegation is not supported by nor a substitute for evidence - and in fact is not accurate as seen by the separation of the core and substituents establishes that there is a distinctive difference especially as R6 is not present when Q=O or S but is present when Q=N wherein there is a difference in the steric structure within the formula contrary to the allegation. Additionally, there is a search burden wherein there was an election of species and Applicant had the opportunity to elect their desired genus and compound species – Applicant had elected the species genera of benzoxazole based compounds (W=X=Y=Z=carbon, Q=V= oxygen, and U=N) with the specific species compound election of
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which was expanded to include
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where R1 is an alkyl with at least 5 carbons and now viewed as 5-7 carbons, and R3 is a halogen and hydrogen; where examination is held.
Applicant has not presented any evidence of criticality for the length of the alkyl substituent for the elected chemical core for inhibitory activity to distinguish it from the prior art. If Applicant had evidence of criticality for the alkyl length for the elected genus for inhibitory activity for SK4, it is highly encouraged to present it to distinguish it from the prior art; but as it stands there is no evidence currently presented.
Accordingly, the rejection stands.
Conclusion
Claims 1-3, 5-9, 11, 13-14 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GIGI GEORGIANA HUANG whose telephone number is (571)272-9073. The examiner can normally be reached Monday-Thursday 9:00-5:00pm.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613
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