DETAILED ACTION
This office action is in response to applicant’s filing dated June 18, 2026.
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, 2, 4-6, 15, and 17-20 are pending in the instant application. Acknowledgement is made of Applicant's remarks and amendments filed January 22, 2026. Acknowledgement is made of Applicant's amendment of claims 1, 4-6, 15, 17, 18, and 20; and cancelation of claims 3, 7-14, and 16.
Claims 1, 2, 4-6, 15, and 17-20 are presently under examination.
Priority
The present application claims benefit of US Provisional Application No. 63/636,022 filed on April 18, 2024.
Objections and/or Rejections 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Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 Objections and/or Rejections) or newly applied (New Objections and/or Rejections, Necessitated by Amendment or New Objections and/or Rejections, NOT Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Withdrawn Objections and/or Rejections
Claim Rejections - 35 USC § 102
The rejection of claims 1-7, 15, and 17-20 under 35 U.S.C. 102(a)(1) as being anticipated by Bazan et al (WO 2019/040122 A1, cited in the IDS filed April 30, 2025, hereinafter referred to as Bazan ‘122) has been rendered moot in view of the amendment of claim 1 and the cancelation of claims 3, 7, and 16. Thus, the rejection has been withdrawn.
New Objections and/or Rejections
Necessitated by Claim Amendment
Claim Rejections - 35 USC § 103
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.
Claims 1, 2, 4-6, 15, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Bazan et al (WO 2019/040122, cited in the IDS filed April 30, 2025, hereinafter referred to as Bazan ‘122) in view of Banach et al (WO 2018/115932 A1).
Regarding claim 1, Bazan ‘122 teaches novel ApAP (Acetaminophen) analogs were achieved by replacing the methyl group with saccharin creating 2-(1,1-dioxido-3-oxo-1,2-beuzisothiazol-2(3H)-yl)-N-(4-hydroxyphenyl)alkanecarboxamides, bearing a heterocyclic moiety linked to the p-acylaminophenol fragment (SCP-1); and the synthesis of novel analgesics, SRP-6D [00173]; and SRP-6d has the structure:
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This compound reads on SRP-001 as evidenced by the instant specification (see paragraph [0059]).
Bazan ‘122 teaches a method of ameliorating pain in a subject comprising administering to said subject afflicted with pain a therapeutically effective amount of the analgesic compound (claim 33) having the chemical structure (claim 9):
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Although the reference does not specifically identify that SRP-001 induces analgesia by generating a greater amount of N-arachidonoylphenolamine (AM404) in the midbrain periaqueductal gray (PAG) of the subject compared to an equivalent amount of ApAP, the method steps are the same. A chemical composition and its properties are inseparable. Thus, in practicing the methods of Bazan ‘122, (i.e. administering SRP-001 to ameliorate pain), SRP-001 would possess the characteristic of inducing analgesia by generating N-arachidonoylphenolamine (AM404) in the midbrain periaqueductal gray (PAG) of the subject. In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe includes functions and/or properties that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the Applicants to "prove that subject matter to be shown in the prior art does not possess the characteristic relied on" (205 USPQ 594, second column, first full paragraph). There is no requirement that a person of ordinary skill in the art would have recognized the newly cited function and/or property at the time of invention, so long as the function and/or property can be demonstrated to be reasonably expected to be present. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) ("[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention").
Regarding the limitation administering a therapeutic amount of a suspension of nanoparticles comprising SRP-001 wherein the nanoparticles have an average particle size of approximately 150 nm, Bazan ‘122 does not teach the amphetamine derivative compound, SRP-6D/SRP-001 is in a suspension of nanoparticles having the claimed size.
However, Banach teaches paracetamol, also known as acetaminophen or APAP, is a medication used to treat pain (page 1, 1st paragraph); preparation of stable water-in-oil nanoemulsions of paracetamol to improve their bioavailability and efficacy (page 3, last paragraph); and paracetamol particles with an average size of 119 nm (page 7, 2nd paragraph)
As such, since Bazan ‘122 teaches SRP-6D/SRP-001 is a derivative of acetaminophen and is useful in a method of ameliorating pain, and since Banach teaches that preparing nanoemulsions comprising acetaminophen improves bioavailability and efficacy, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to produce a composition comprising a suspension comprising nanoparticles of SRP-6D/SRP-001 is a derivative of acetaminophen with an expectation of success, since the prior art establishes that nanoemulsions improve bioavailability and efficacy of acetaminophen.
Regarding the claimed size, the cited references do not teach the claimed average nanoparticle size. However, Banach teaches paracetamol particles with an average size of 119 nm (page 7, 2nd paragraph).
Similarly, the cited references do not teach administering a therapeutic amount of a composition comprising SRP-001 or a pharmaceutically acceptable salt thereof at equimolar dosing relative to acetaminophen (ApAP). However, Bazan ‘122 teaches the therapeutically effective amount comprises a dose of about 10 µM to about 10 mM of the composition is administered to the subject (claim 39). The instant specification teaches a therapeutically effective amount of the analgesic compound or composition administered to a subject comprises a dose of about 10 µM to about 10 mM (see paragraph [0066].
It would have been prima facie obvious to one of ordinary skill in the art to utilize the amount of SRP-3D (DA)/SRP-100 taught by Bazan ‘122 and the nanoparticle sizes taught by Banach as a starting point for optimizing the amount and nanoparticle size of SRP-3D (DA)/SRP-100 utilized to treat pain, since Bazan ‘122 teaches SRP-3D (DA)/SRP-100 is an acetaminophen analog useful for treating ameliorating pain and Banach teach nanoparticle formulations of acetaminophen improve bioavailability and efficacy of acetaminophen and because dosage and treatment regimen are result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Regarding the limitation assessing the intensity of the pain in the subject, Bazan ‘122 teaches two different assays were utilized to quantify the analgesic effects of the compounds [00196]; acetic acid-induced abdominal writhing assay [00197] and tail-flick assay [00198]. As noted by Applicant in the response citing paragraphs [0111] and [0112] as support for the limitation assessing the intensity of the pain in the subject, which disclose antinociception assessment using two pain models, the tail flick and acetic acid writhing assays, quantifying the analgesic effects of the compounds utilizing the tail flick and acetic acid writhing assays reads on assessing the intensity of the pain in the subject.
Regarding the limitation wherein SRP 001 achieves a statistically lower ED 50 (p ≤ 0.05) than ApAP in at least one in vivo assay, Bazan ‘122 teaches a method of ameliorating pain in a subject comprising administering to said subject afflicted with pain a therapeutically effective amount of SRP-001 in amounts that anticipate the instantly claimed amounts. Moreover, Bazan ‘122 teaches two different assays were utilized to quantify the analgesic effects of the compounds [00196]; acetic acid-induced abdominal writhing assay [00197] and tail-flick assay [00198] in male mice. In performing the active step (i.e. administering an effective amount of the composition comprising SRP-001 taught by Bazan ‘122 to a subject with pain and assessing the pain with the assays taught by Bazan ‘122), the SRP 001 would necessarily result in a statistically lower ED 50 (p ≤ 0.05) than ApAP in at least one in vivo assay.
In regard to "wherein” clauses, MPEP 2111.04 states:
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, 283 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 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 (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) 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. In the instant case, the wherein clause is directed to the intended result (i.e. achieving a statistically lower ED 50 (p ≤ 0.05) than ApAP in at least one in vivo assay) of the process step positively recited (i.e. administering SRP-001 to a subject suffering from pain in an in vivo assay such as tail-flic or acetic acid-induced writhing).
Regarding claim 2, Bazan ‘122 teaches the term “pain” can refer to all types of pain; the term can refer to visceral pain; the term can also refer to nociceptive pain or nociception, such as somatic pain (normal nerve response to a noxious pain) [0088].
Regarding claim 4, Bazan ‘122 teaches the composition is administered in a single dose (claim 42).
Regarding claim 5, Bazan ‘122 teaches the composition is administered at intervals of about 4 hours, 12 hours or 24 hours (claim 43).
Regarding claim 6, Bazan ‘122 teaches the composition is administered orally (claim 44).
Regarding claim 15, Bazan ‘122 teaches the composition is administered in the form of a capsule or aqueous solution (claim 45).
Regarding claim 17, Bazan ‘122 teaches the composition exhibits analgesia, antipyresis, or a combination thereof (claim 46).
Regarding claim 18, the cited art does not explicitly teach the suspension of nanoparticles lacks hepatotoxicity, the method steps are the same. A chemical composition and its properties are inseparable. Thus, in practicing the method of ameliorating pain comprising administering a suspension comprising nanoparticles of SRP-001, the nanoparticles of SRP-001 would possess the characteristic of lacking hepatotoxicity.
Regarding claim 19, Bazan ‘122 teaches wherein the composition is not metabolized to NAPQI (claim 49).
Regarding claim 20, the prior art does not explicitly teach the specific neuronal target of the composition is one or more of CB1, FAAH or TRPV1, which underlies the analgesia; or wherein SRP-001 has a half-life in said subject of about 4.9 to about 9.8 hours; or wherein in a direct comparison of SRP-001 vs. ApAP at equimolar doses reveals no mortality for SRP-001,whereas ApAP shows a dose-dependent increase in mortality. However, the above pharmacokinetic parameters depend, among other things, from the specific components, relative amounts, type of formulation, and pH of the formulation etc., all of which seem to be the same or very similar to the composition taught by the prior art (see above rejection).
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the formulations if SRP-001 that will result from the teachings of the prior art does not possess the same material, structural and functional characteristics of the formulation claimed in the instant application. In the absence of evidence to the contrary, the burden is on the applicant to prove that the formulation used in the instantly claimed method is different from those taught 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).
Taken together, all this would result in the practice of the method of claims 1, 2, 4-6, 15, and 17-20 with a reasonable expectation of success.
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, 2, 4-6, 15, and 17-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 7, and 10-23 of U.S. Patent No. 11,458,142 B2 in view of Bazan et al (WO 2019/040122 A1, cited in the IDS filed April 30, 2025, hereinafter referred to as Bazan ‘122) and Banach et al (WO 2018/115932 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The present claims are directed to a method for ameliorating a pain in a subject in need thereof comprising administering a therapeutic amount of a suspension of nanoparticles comprising SRP-001 or a pharmaceutically acceptable salt thereof, wherein SRP-001 induces analgesia by generating N-arachidonoylphenolamine (AM404) in the midbrain periaqueductal gray (PAG) of the subject, to thereby ameliorate the pain.
The previously allowed claims are directed to a method of ameliorating pain in a subject comprising administering to said subject afflicted with pain a therapeutically effective amount of the analgesic composition of formula (I) wherein the composition of formula (I) has the structure:
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This compound reads on SRP-001 as evidenced by the instant specification (see paragraph [0059]).
Although the previously allowed claims do not specifically identify analgesia by generating a greater amount of N-arachidonoylphenolamine (AM404) in the midbrain periaqueductal gray (PAG) of the subject compared to an equivalent amount of ApAP, the method steps are the same. A chemical composition and its properties are inseparable. Thus, in practicing the methods of previously allowed claims, (i.e. administering SRP-001 to ameliorate pain), SRP-001 would possess the characteristic of inducing analgesia by generating N-arachidonoylphenolamine (AM404) in the midbrain periaqueductal gray (PAG) of the subject. In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe includes functions and/or properties that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the Applicants to "prove that subject matter to be shown in the prior art does not possess the characteristic relied on" (205 USPQ 594, second column, first full paragraph). There is no requirement that a person of ordinary skill in the art would have recognized the newly cited function and/or property at the time of invention, so long as the function and/or property can be demonstrated to be reasonably expected to be present. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) ("[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention").
The previously allowed claims do not teach the claimed compound is in a suspension of nanoparticles having the claimed size. However, Bazan ‘122 teaches novel ApAP (Acetaminophen) analogs were achieved by replacing the methyl group with saccharin creating 2-(1,1-dioxido-3-oxo-1,2-beuzisothiazol-2(3H)-yl)-N-(4-hydroxyphenyl)alkanecarboxamides, bearing a heterocyclic moiety linked to the p-acylaminophenol fragment (SCP-1); and the synthesis of novel analgesics, SRP-6D [00173]; and SRP-6d has the structure:
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This compound reads on SRP-001 as evidenced by the instant specification (see paragraph [0059]).
Moreover, Banach teaches paracetamol, also known as acetaminophen or APAP, is a medication used to treat pain (page 1, 1st paragraph); preparation of stable water-in-oil nanoemulsions of paracetamol to improve their bioavailability and efficacy (page 3, last paragraph); and paracetamol particles with an average size of 119 nm (page 7, 2nd paragraph)
As such, since Bazan ‘122 teaches SRP-6D/SRP-001 is a derivative of acetaminophen and is useful in a method of ameliorating pain, and since Banach teaches that preparing nanoemulsions comprising acetaminophen improves bioavailability and efficacy, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to produce a composition comprising a suspension comprising nanoparticles of SRP-6D/SRP-001 is a derivative of acetaminophen with an expectation of success, since the prior art establishes that nanoemulsions improve bioavailability and efficacy of acetaminophen.
Regarding the claimed size, Banach teaches paracetamol particles with an average size of 119 nm (page 7, 2nd paragraph).
Regarding the limitation wherein the therapeutic amount of SRP-001 is less than or equivalent to a dose of acetaminophen (ApAP) effective to treat the pain intensity of the subject, the previously allowed claims are directed to wherein the therapeutically effective amount comprises a dose of about 10 µM to about 10 mM. The instant specification teaches a therapeutically effective amount of the analgesic compound or composition administered to a subject comprises a dose of about 10 µM to about 10 mM (see paragraph [0066].
It would have been prima facie obvious to one of ordinary skill in the art to utilize the amount of previously allowed claims and the nanoparticle sizes taught by Banach as a starting point for optimizing the amount and nanoparticle size of nanoparticle comprising SRP-001 utilized to treat pain, since Bazan ‘122 teaches SRP-100 is an acetaminophen analog useful for treating ameliorating pain and Banach teach nanoparticle formulations of acetaminophen improve bioavailability and efficacy of acetaminophen and because dosage and treatment regimen are result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Regarding the limitation assessing the intensity of the pain in the subject, although the previously allowed claims do not explicitly teach assessing the intensity of pain in the subject. However, Bazan ‘122 teaches two different assays were utilized to quantify the analgesic effects of the compounds [00196]; acetic acid-induced abdominal writhing assay [00197] and tail-flick assay [00198]. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to assess analgesic effect or nociception of SRP-001 in the method of the previously allowed claims utilizing acetic acid-induced abdominal writhing assay, since the prior art teaches these are useful methods to determine efficacy of compounds for treating pain.
Regarding the limitation wherein SRP 001 achieves a statistically lower ED 50 (p ≤ 0.05) than ApAP in at least one in vivo assay, the previously allowed claims and Bazan ‘122 teach a method of ameliorating pain in a subject comprising administering to said subject afflicted with pain a therapeutically effective amount of SRP-001 in amounts that render the instantly claimed amounts obvious where subjects are assayed in tail-flick and acetic acid-induced writhing assays. In performing the active step (i.e. administering an effective amount of the composition comprising SRP-001 taught by Bazan ‘122 to a subject with pain and assessing the pain with the assays taught by Bazan ‘122), the SRP 001 would necessarily result in a statistically lower ED 50 (p ≤ 0.05) than ApAP in at least one in vivo assay.
In regard to "wherein” clauses, MPEP 2111.04 states:
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, 283 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 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 (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) 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. In the instant case, the wherein clause is directed to the intended result (i.e. achieving a statistically lower ED 50 (p ≤ 0.05) than ApAP in at least one in vivo assay) of the process step positively recited (i.e. administering SRP-001 to a subject suffering from pain in an in vivo assay such as tail-flic or acetic acid-induced writhing).
Furthermore, the previously allowed claims are directed to wherein pain is nociceptive pain; the therapeutically effective amount comprises a dose of about 10 µM to about 10 mM of the composition is administered to the subject; the composition is administered in a single dose; the composition is administered at intervals of about 4 hours, 12 hours or 24 hours; the composition is administered orally , parentally, transdermally, or nasally; the composition is administered in the form of a pill, capsule, cream, spray, lotion, or aqueous solution; the composition exhibits analgesia, antipyresis, or a combination thereof; the composition reduces the risk of hepatotoxicity by at least about 20%; and the composition is not metabolized to NAPQI.
Moreover, the previously allowed claims are directed a composition administered in the form of an aqueous solution. This reads on a composition comprising an excipient, wherein the excipient is water.
Regarding claim 20, the previously allowed claims do not explicitly teach the specific neuronal target of the composition is one or more of CB1, FAAH or TRPV1, which underlies the analgesia; or wherein SRP-001 has a half-life in said subject of about 4.9 to about 9.8 hours; or wherein in a direct comparison of SRP-001 vs. ApAP at equimolar doses reveals no mortality for SRP-001,whereas ApAP shows a dose-dependent increase in mortality. However, the above pharmacokinetic parameters depend, among other things, from the specific components, relative amounts, type of formulation, and pH of the formulation etc., all of which seem to be the same or very similar to the composition taught by the prior art (see above rejection).
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the formulations if SRP-001 that will result from the teachings of the prior art does not possess the same material, structural and functional characteristics of the formulation claimed in the instant application. In the absence of evidence to the contrary, the burden is on the applicant to prove that the formulation used in the instantly claimed method is different from those taught 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).
Thus, It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to arrive at the method of the instant claims from the method of the previously allowed claims in view of the cited art.
Response to Arguments
Since a new rejection was issued (see above), it is the Examiner’s belief that most of the arguments presented by Applicant have been considered/answered in the rejection itself.
Conclusion
Claims 1, 2, 4-6, 15, and 17-20 are rejected.
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm, Monday - Thursday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Rayna Rodriguez/ Primary Examiner, Art Unit 1628
Prosecution Insights