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 .
Status of Claims
Claims 1-30 are pending in the instant application. Claim 1 is amended and claims 17-30 are new via the amendment filed October 10th, 2025.
Priority
This is a 35 U.S.C. 371 National Stage filing of International Application No. PCT/EP2020/071044 filed July 24th, 2020, which claims priority under 35 U.S.C. 119(a-d) to, BE2019/5501 filed August 1st, 2019 .
Withdrawn Objections
Applicant’s arguments and amendments, filed October 10th, 2025, with respect to objection of claim 1 have been fully considered and are persuasive. The objection of claim 1 has been withdrawn.
Applicant has overcome the objection by way of amending claim 1 to recite “R6 is selected from the group consisting of..” in line 8 of the claim.
Withdrawn Rejections
Claim Rejections - 35 USC § 112(b)
Applicant’s arguments and amendments, filed October 10th, 2025, with respect to the 112(b) rejection of claims 1-15 have been fully considered and are persuasive. The 112(b) rejection of claims 1-15 has been withdrawn.
Applicant has overcome the 112(b) rejection by way of amending claim 1 to recite “when the substituents of said positions 20, 22, 24, 25, 26 or 27 are four different substituents”. The addition of this phrase clarifies that the limitation of R or S configuration only applies when there are four different substituents present.
Maintained Rejections - Response to Remarks
Non-Compliant Amendment
Applicant's arguments filed, October 10th, 2025, with respect to the non-compliant amendment have been fully considered but they are not persuasive.
On p. 11-13 of the remarks, Applicant argues that the method of treatment of a neuronal pathology recited in new claims 16-30 should be considered along with the composition as recited in instant claims 1-15. Applicant argues that the Examiner has not provided any evidence that there would be a serious burden to search both the composition and the method of the instant disclosure.
In response, had the method claims been provided earlier, unity would have been broken with the cited prior art, as under PCT Rule 13.1, the technical feature shared between the product and the method is not a special technical feature as it does not make a contribution over the prior art.
Additionally, the product as claimed can be used in a materially different process of using that product. See the prior art below. For instance, Medina teaches that compounds of instant formula (I) can be used in a method of treating hearing loss (paragraph [0009]).
As such, newly submitted claims 16-30 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
The product as instantly claimed can be used in a materially different process of using the product.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 16-30 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claims 16-30 are therefore withdrawn in view of the response above.
Response to Claim Rejections - 35 USC § 102
Applicant's arguments, filed October 10th, 2025, with respect to the 102(a)(1) and 102(a)(2) rejection of claims 1-3 and 6-14 under Poirot have been fully considered but they are not persuasive.
On p. 14-15 of the remarks, Applicant argues that claim 1, as amended, is not anticipated by Poirot because Poirot does not teach a composition for the treatment of neuronal pathology in a subject. Applicant argues that anticipation requires a single prior art reference that discloses each element of the claim. Applicant further argues that as Poirot does not teach that the compounds of formula (I) have a neuroprotective effect against a neuronal pathology upon administration to a subject, Poirot does not anticipate instant claim 1.
In response, the amendment to claim 1 does not overcome the rejection and still includes a phrase of intended use. The addition of the phrase “for treatment of a neuronal pathology in a subject…” is merely intended use and presumed met by a compound of formula (I). See MPEP 2111.02.
Further, the addition of the phrase “wherein the at least one compound of formula (I) has a neuroprotective effect against the neuronal pathology of the subject…” also fails to overcome the rejection under Poirot. This is a wherein clause, see MPEP 2111.04: Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) "adapted to" or "adapted for" clauses;
(B) "wherein" clauses; and
(C) "whereby" clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin v. Bertina, 285 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a "wherein" clause limited a process claim where the clause gave "meaning and purpose to the manipulative steps"). In In re Giannelli, 739 F.3d 1375, 1378, 109 USPQ2d 1333, 1336 (Fed. Cir. 2014), the court found that an "adapted to" clause limited a machine claim where "the written description makes clear that 'adapted to,' as used in the [patent] application, has a narrower meaning, viz., that the claimed machine is designed or constructed to be used as a rowing machine whereby a pulling force is exerted on the handles." In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a "‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention." Id. However, the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
Such clause does not overcome the rejection as the neuroprotective effect against the neuronal pathology is an inherent property of the compounds of instant formula (I). The prior art is silent regarding "neuroprotective effect”. However: “neuroprotective effect” will inevitably flow from the teachings of the prior art (see 102 rejection under Poirot), since the same compound (a compound of formula (I)) is taught by Poirot. In other words, products of identical or similar composition cannot exert mutually exclusive properties.
In other words, even though the prior art is silent regarding "neuroprotective effect", by having a compound of instant formula (I) taught by the prior art, one will also have a compound that has a "neuroprotective effect,” even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage ("a neuroprotective effect") of the compound taught by the prior art ("a compound of instant formula (I)").
MPEP 2112 I states: “[T]he 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).”
Applicant's arguments, filed October 10th, 2025, with respect to the 102(a)(1) and 102(a)(2) rejection of claims 1-3, 5 and 10-15 under Medina have been fully considered but they are not persuasive.
On p. 15-16 of the remarks, Applicant argues that claim 1, as amended, is not anticipated by Medina because Medina does not teach a composition for the treatment of neuronal pathology in a subject. Applicant further argues that as Medina does not teach that the compounds of formula (I) have a neuroprotective effect against a neuronal pathology upon administration to a subject, Medina does not anticipate instant claim 1.
In response, the amendment to claim 1 does not overcome the rejection for the same reasons as stated above.
Double Patenting
Applicant's arguments, filed October 10th, 2025, with respect to the nonstatutory double patenting rejection of claims 1-8 and 10-15 over Application No. 18/875,115; claims 1 and 10-14 over Application No. 18/034,317; and claims 1 and 10-14 over Application No. 18/265,186 have been fully considered but they are not persuasive.
On p. 16-19 of the remarks, Applicant argues that claim 1, as amended, is not obvious over the copending applications because the copending applications do not teach a composition for the treatment of neuronal pathology in a subject.
In response, the amendment to claim 1 does not overcome the rejections for the same reasons as stated above.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. Claim 1 recites “for treatment of a neuronal pathology of a subject…” which is intended use and the claim limitation is presumed met by a compound of formula (I). The same interpretation is applied to claims 10-14, as these claims only further place limitations on the intended use of claim 1.
Maintained 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.
Claim(s) 1-3 and 6-14 stand rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Poirot et al (US 2014/0309417 A1).
Poirot teaches compounds of the following formula (claim 1):
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.
Poirot teaches the following compound (page 1, paragraph [0003]):
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This compound is embraced by formula (I) as R1 is OH, R2 is OH, R3 is NR5R6, wherein R5 is H and R6 is (CH2)3NH(CH2)4NHR7, R7 is H, R4 is H, Z1 is 1 and Z2 is 0, and T1-T4 are H. Note that “for treatment of a neuronal pathology” of instant claim 1 and other claims constitutes intended use limitation(s). The claims are interpreted as product claims, as statements of intended use are not accorded patentable weight.
The prior art is silent regarding "neuroprotective effect”. However: “neuroprotective effect” will inevitably flow from the teachings of the prior art (see 102 rejection under Poirot), since the same compound (a compound of formula (I)) is taught by Poirot. In other words, products of identical or similar composition cannot exert mutually exclusive properties.
In other words, even though the prior art is silent regarding "neuroprotective effect", by having a compound of instant formula (I) taught by the prior art, one will also have a compound that has a "neuroprotective effect,” even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage ("a neuroprotective effect") of the compound taught by the prior art ("a compound of instant formula (I)").
MPEP 2112 I states: “[T]he 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).”
Regarding claim 2, as seen above, Z2 is 0, R1 and R2 are OH, R4 is H, R5 is H, and T1-T4 are H.
Regarding claim 7, as seen above, Z1 is 1 and R5 is H.
Regarding claim 8, as seen above, R6 is (CH2)3NH(CH2)4NHR7 and R7 is H.
Poirot also teaches the following compound, 5α-hydroxy-6β[3-(4-aminobutylamino)propylamino]campestan-3β-ol (claim 9):
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This compound is embraced by formula (I) as R1 is OH, R2 is OH, R3 is NR5R6, wherein R5 is H and R6 is (CH2)3NH(CH2)4NHR7, R7 is H, R4 is H, Z1 and Z2 are 0, and T1-T4 are H. Note that “for treatment of a neuronal pathology” of instant claim 1 and other claims constitutes intended use limitation(s). The claims are interpreted as product claims, as statements of intended use are not accorded patentable weight.
The prior art is silent regarding "neuroprotective effect”. However: “neuroprotective effect” will inevitably flow from the teachings of the prior art (see 102 rejection under Poirot), since the same compound (a compound of formula (I)) is taught by Poirot. In other words, products of identical or similar composition cannot exert mutually exclusive properties.
In other words, even though the prior art is silent regarding "neuroprotective effect", by having a compound of instant formula (I) taught by the prior art, one will also have a compound that has a "neuroprotective effect,” even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage ("a neuroprotective effect") of the compound taught by the prior art ("a compound of instant formula (I)").
MPEP 2112 I states: “[T]he 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).”
Regarding claim 2, as seen above, Z2 is 0, R1 and R2 are OH, R4 is H, R5 is H, and T1-T4 are H.
Regarding claim 3, as seen above, Z1 is 0 and R5 is H.
Regarding claim 6, R6 is (CH2)3NH(CH2)4NHR7 and R7 is H.
Poirot also teaches the following compound, 3β-acetoxy-5α -hydroxy-6β-[3-(4-aminobutylamino)propylamino]cholest-7-ene (claim 9):
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This compound is embraced by formula (I) as R1 is R-COO, R is CH3, R2 is OH, R3 is NR5R6, wherein R5 is H and R6 is (CH2)3NH(CH2)4NHR7, R7 is H, R4 is H, Z1 is 1 and Z2 is 0, and T1-T4 are H. Note that “for treatment of a neuronal pathology” of instant claim 1 and other claims constitutes intended use limitation(s). The claims are interpreted as product claims, as statements of intended use are not accorded patentable weight.
The prior art is silent regarding "neuroprotective effect”. However: “neuroprotective effect” will inevitably flow from the teachings of the prior art (see 102 rejection under Poirot), since the same compound (a compound of formula (I)) is taught by Poirot. In other words, products of identical or similar composition cannot exert mutually exclusive properties.
In other words, even though the prior art is silent regarding "neuroprotective effect", by having a compound of instant formula (I) taught by the prior art, one will also have a compound that has a "neuroprotective effect,” even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage ("a neuroprotective effect") of the compound taught by the prior art ("a compound of instant formula (I)").
MPEP 2112 I states: “[T]he 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).”
Regarding claim 9, R1 is R-COO, R is CH3, R2 is OH, R5 is H, R6 is (CH2)3NH(CH2)4NHR7, Z1 is 1 and Z2 is 0.
Claim(s) 1-3, 5 and 10-15 stand rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Medina et al (US 2017/0209465).
Medina teaches a solution of 6β-[2-(1H-imidazol-4-yl)-ethylamino]-cholestane-3β,5α-diol (I μM) (page 3, paragraph [0056]). 6β -[2-(1H-imidazol-4-yl)-ethylamino]-cholestane-3 β,5α-diol is the following compound
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This compound is embraced by formula (I) as R1 is OH, R2 is OH, R3 is NR5R6, wherein R5 is H and R6 is –(CH2)2-imidazol-4-yl, R4 is H, Z1 and Z2 are 0, and T1-T4 are H. Note that “for treatment of a neuronal pathology” of instant claim 1 and other claims constitutes intended use limitation(s). The claims are interpreted as product claims, as statements of intended use are not accorded patentable weight.
The prior art is silent regarding "neuroprotective effect”. However: “neuroprotective effect” will inevitably flow from the teachings of the prior art (see 102 rejection under Medina), since the same compound (a compound of formula (I)) is taught by Medina. In other words, products of identical or similar composition cannot exert mutually exclusive properties.
In other words, even though the prior art is silent regarding "neuroprotective effect", by having a compound of instant formula (I) taught by the prior art, one will also have a compound that has a "neuroprotective effect,” even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage ("a neuroprotective effect") of the compound taught by the prior art ("a compound of instant formula (I)").
MPEP 2112 I states: “[T]he 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).”
Regarding claim 2, as seen above, Z2 is 0, R1 and R2 are OH, R4 is H, R5 is H, and T1-T4 are H.
Regarding claim 3, as seen above, Z1 is 0 and R5 is H.
Regarding claim 5, as seen above, R6 is –(CH2)2-imidazol-4-yl.
Regarding claim 15, as seen above, the compound of formula (I) is in a solution in a concentration of between 1 pmol/L and 1 mmol/L. As this range is 1x10-12 M to 0.001 M and Medina teaches that the above compound is in a solution in a concentration of 1x10-6 M, the teachings anticipate the claim.
Maintained Double Patenting
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 1-8 and 10-15 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18/875,115 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The copending application teaches a compound of formula (I):
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The copending application also teaches that R1-R7, Z1-Z2 and T1-T4 are embraced by formula (I) of the instant application. The copending application also teaches, regarding instant claim 15, wherein the composition is in the form of an aqueous solution and has a concentration of a compound of formula (I) of between 10 pmol/L and 1 mmol/L.
The copending application also teaches the following compound (claim 4):
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This compound is embraced by formula (I) and claim 4 as R1 is OH, R2 is OH, R3 is NR5R6, wherein R5 is H and R6 is (CH2)3NH(CH)4NHR7, R7 is C(O)CH3, R4 is H, Z1 and Z2 are 0, and T1-T4 are H. Note that “for treatment of a neuronal pathology” of instant claim 1 and other claims constitutes intended use limitation(s). The claims are interpreted as product claims, as statements of intended use are not accorded patentable weight.
The copending application is silent regarding "neuroprotective effect”. However: “neuroprotective effect” will inevitably flow from the claims of the copending application, since the same compound (a compound of formula (I)) is claimed. In other words, products of identical or similar composition cannot exert mutually exclusive properties.
In other words, even though the copending application is silent regarding "neuroprotective effect", by having a compound of instant formula (I) claimed by the copending application, one will also have a compound that has a "neuroprotective effect,” even though copending applications was not aware of it.
Apparently, Applicant has discovered a new property or advantage ("a neuroprotective effect") of the compound claimed in the copending application ("a compound of instant formula (I)").
MPEP 2112 I states: “[T]he 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).”
Regarding claim 2, as seen above, Z2 is 0, R1 and R2 are OH, R4 is H, R5 is H, and T1-T4 are H.
Regarding claim 3, as seen above, Z1 is 0 and R5 is H.
Regarding claim 4, R6 is (CH2)3NH(CH)4NHR7 and R7 is C(O)CH3.
The copending application also teaches the following compound (claim 6):
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This compound is embraced by formula (I) as R1 is OH, R2 is OH, R3 is NR5R6, wherein R5 is H and R6 is (CH2)3NH(CH2)4NHR7, R7 is H, R4 is H, Z1 and Z2 are 0, and T1-T4 are H.
Regarding claim 2, as seen above, Z2 is 0, R1 and R2 are OH, R4 is H, R5 is H, and T1-T4 are H.
Regarding claim 3, as seen above, Z1 is 0 and R5 is H.
Regarding claim 6, R6 is (CH2)3NH(CH2)4NHR7 and R7 is H.
The copending application also teaches the following compound (claim 5):
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This compound is embraced by formula (I) as R1 is OH, R2 is OH, R3 is NR5R6, wherein R5 is H and R6 is –(CH2)2-imidazol-4-yl, R4 is H, Z1 and Z2 are 0, and T1-T4 are H. Note that “for treatment of a neuronal pathology” of instant claim 1 and other claims constitutes intended use limitation(s). The claims are interpreted as product claims, as statements of intended use are not accorded patentable weight.
The copending application is silent regarding "neuroprotective effect”. However: “neuroprotective effect” will inevitably flow from the claims of the copending application, since the same compound (a compound of formula (I)) is claimed. In other words, products of identical or similar composition cannot exert mutually exclusive properties.
In other words, even though the copending application is silent regarding "neuroprotective effect", by having a compound of instant formula (I) claimed by the copending application, one will also have a compound that has a "neuroprotective effect,” even though copending applications was not aware of it.
Apparently, Applicant has discovered a new property or advantage ("a neuroprotective effect") of the compound claimed in the copending application ("a compound of instant formula (I)").
MPEP 2112 I states: “[T]he 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).”
Regarding claim 2, as seen above, Z2 is 0, R1 and R2 are OH, R4 is H, R5 is H, and T1-T4 are H.
Regarding claim 3, as seen above, Z1 is 0 and R5 is H.
Regarding claim 5, as seen above, R6 is –(CH2)2-imidazol-4-yl.
The copending application also teaches the following compound (claim 9):
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This compound is embraced by formula (I) as R1 is OH, R2 is OH, R3 is NR5R6, wherein R5 is H and R6 is (CH2)3NH(CH2)4NHR7, R7 is H, R4 is H, Z1 is 1 and Z2 is 0, and T1-T4 are H. Note that “for treatment of a neuronal pathology” of instant claim 1 and other claims constitutes intended use limitation(s). The claims are interpreted as product claims, as statements of intended use are not accorded patentable weight.
The copending application is silent regarding "neuroprotective effect”. However: “neuroprotective effect” will inevitably flow from the claims of the copending application, since the same compound (a compound of formula (I)) is claimed. In other words, products of identical or similar composition cannot exert mutually exclusive properties.
In other words, even though the copending application is silent regarding "neuroprotective effect", by having a compound of instant formula (I) claimed by the copending application, one will also have a compound that has a "neuroprotective effect,” even though copending applications was not aware of it.
Apparently, Applicant has discovered a new property or advantage ("a neuroprotective effect") of the compound claimed in the copending application ("a compound of instant formula (I)").
MPEP 2112 I states: “[T]he 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).”
Regarding claim 2, as seen above, Z2 is 0, R1 and R2 are OH, R4 is H, R5 is H, and T1-T4 are H.
Regarding claim 7, as seen above, Z1 is 1 and R5 is H.
Regarding claim 8, as seen above, R6 is (CH2)3NH(CH2)4NHR7 and R7 is H.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 10-14 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4 and 7-23 of copending Application No. 18/034,317 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The copending application teaches a compound of formula (I):
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The copending application further teaches the following compound (claim 7):
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This compound is embraced by formula (I) R1 is OCnH2n+1, R2 is OH, R3 is NR5R6, wherein R5 is H and R6 is –(CH2)2-imidazol-4-yl, R4 is H, Z1 and Z2 are 0, and T1-T4 are H. Note that “for treatment of a neuronal pathology” of instant claim 1 and other claims constitutes intended use limitation(s). The claims are interpreted as product claims, as statements of intended use are not accorded patentable weight.
The copending application is silent regarding "neuroprotective effect”. However: “neuroprotective effect” will inevitably flow from the claims of the copending application, since the same compound (a compound of formula (I)) is claimed. In other words, products of identical or similar composition cannot exert mutually exclusive properties.
In other words, even though the copending application is silent regarding "neuroprotective effect", by having a compound of instant formula (I) claimed by the copending application, one will also have a compound that has a "neuroprotective effect,” even though copending applications was not aware of it.
Apparently, Applicant has discovered a new property or advantage ("a neuroprotective effect") of the compound claimed in the copending application ("a compound of instant formula (I)").
MPEP 2112 I states: “[T]he 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).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 10-14 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 18/265,186 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The copending application teaches a compound of formula (I):
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214
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The copending application further teaches the following compound (claim 6):
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This compound is embraced by formula (I) R1 is R-COO, R is C2H5, R2 is OH, R3 is NR5R6, wherein R5 is H and R6 is –(CH2)2-imidazol-4-yl, R4 is H, Z1 and Z2 are 0, and T1-T4 are H. Note that “for treatment of a neuronal pathology” of instant claim 1 and other claims constitutes intended use limitation(s). The claims are interpreted as product claims, as statements of intended use are not accorded patentable weight.
The copending application is silent regarding "neuroprotective effect”. However: “neuroprotective effect” will inevitably flow from the claims of the copending application, since the same compound (a compound of formula (I)) is claimed. In other words, products of identical or similar composition cannot exert mutually exclusive properties.
In other words, even though the copending application is silent regarding "neuroprotective effect", by having a compound of instant formula (I) claimed by the copending application, one will also have a compound that has a "neuroprotective effect,” even though copending applications was not aware of it.
Apparently, Applicant has discovered a new property or advantage ("a neuroprotective effect") of the compound claimed in the copending application ("a compound of instant formula (I)").
MPEP 2112 I states: “[T]he 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).”
Correspondence
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/A.G.K./Examiner, Art Unit 1626
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699