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 Application
The Amendments and Remarks filed on 03/05/26 are acknowledged.
Claims 2-3, 8-11, 13-16, 21-22, 27-28, 30-31, 33-34, 38, and 40 were previously cancelled.
Claims 1 and 37 were amended.
Claims 1, 4-7, 12, 17-20, 23-26, 29, 32, 35-37, and 39 are pending and included in the prosecution.
Response to Amendments/Arguments
Rejection of claim 37 under 35 USC § 112(a)
In light of the amendment of claim 37 to remove the term “prevention,” the rejection of this claim under 35 USC § 112(a) is withdrawn.
Notice for all US Patent Applications filed on or after March 16, 2013
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 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.
Maintained Rejections
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 at the time any inventions covered therein were effectively filed 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 at the time a later invention was effectively filed 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, 4-7, 12, 17-20, 23-26, 29, 32, 35-37, and 39 are again rejected under 35 U.S.C. 103 as being unpatentable over Ma et al. (US 2019/0307697 A1 – “Ma”) in view of Blumstock et al. (WO 2020/157569 A1 – “Blumstock”).
Instant claim 1 is drawn to a method for the pulsed delivery of a 5HT2A agonist to a subject comprising administering to the subject a device comprising a layer structure comprising components (a) – (f).
Instant claim 1 was amended to recite that the “entire” first side of the second layer is adjacent to the “entire” second side of the first layer in part (b); the “entire” first side of the third layer is adjacent to the “entire” second side of the second layer in part (c); the “entire” first side of the fourth layer is adjacent to the “entire” second side of the third layer in part (d); and the “entire” first side of the fifth layer is adjacent to the “entire” second side of the fourth layer in part (e).
Ma teaches a method for making a pulsatile delivery device, wherein “one type of charges are generated on a polymeric layer, and charges opposite the one type of charges are generated on a delivery layer including a film forming material and a predetermined substance dispersed throughout the film forming material. The charged polymeric and delivery layers are placed into contact to form a bi-layer structure. A stack with at least two bi-layer structures is formed so that the polymeric layers and the delivery layers are alternating throughout the stack. The stack is sealed so that one of the polymeric layers remains exposed” (Abstract, [0056]-[0071], claims 1-18). The method disclosed by Ma enables a large number of controlled release layers to be incorporated into the device, which improves the pulsatile release duration of the device ([0045]). The pulsatile device was preprogrammed to deliver daily pulse of bioactive parathyroid hormone (PTH) and the continuous device to deliver bioactive PTH in a linear manner for 3 weeks ([0128]). Fig. 1 shows that several bi-layer structures, for example 16, 16′, 16″, 16′″ may be positioned adjacent to one another to form a stack 18, and the bi-layer structures 16, 16′, 16″, 16′″ are positioned so that the polymeric layers 12 and the delivery layers 14 are alternating throughout the stack 18 ([0060]).
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Fig. 1 discloses a delivery layer 14, which includes drugs ([0053]), and the film forming material includes natural biodegradable polymers such as alginate, poly(ethylene glycol) (PEG), collagen, etc. ([0054]). Polymeric biodegradable materials used in the system also include a poly(ortho ester) or a heteropolymer of anhydrides of sebacic acid (SA), 1,3-bis (p-carboxyphenoxy) propane (CPP), and poly(ethylene glycol) (PEG) ([0071], [0091], [0137]), poly(L-lactic acid) (PLLA) ([0050], [0133], claim 14), polycaprolactone ([0050], [0063], [0066], [0077], [0080], [0099], and claim 14). The device may be implanted into a patient ([0082], [0088], [0118]-[0119]).
Ma does not expressly teach a 5HT2A agonist.
Blumstock teaches methods and compositions for the treatment of psychological, cognitive, behavioral, and/or mood disorders, the composition comprising a 5HT agonist (e.g., psilocybin), and the compositions are administered in amounts or levels high enough to provide a therapeutic effect, but insufficient to provide an adverse effect (Abstract). The pharmaceutical compositions are formulated as a depot preparation and might be administered by implantation or transcutaneous delivery ([139]). Suitable 5HT agonists, e.g., 5HT2A agonists ([42]), include psilocybin (Abstract, [6], claims 1 and 13), an ergoline ([42]) or an ergoline derivative such as a lysergic acid amide ([44]) which is LSD (D-lysergic acid diethylamide) ([45]). Blumstock teaches that the pharmaceutical formulations include pulsatile release formulations ([140], [162]-[163]). Hydrophilic agents, including cellulose acetate phthalate (CAP) (e.g., Aquacoat CPD) ([94]) as well as polyglycol derivatives Poloxamer 188, Poloxamer 338, Poloxamer 407 ([93]) are disclosed. Any suitable dosage of 5HT2A agonists may be administered to an individual in need thereof, such as about 0.1 mg toa bout 10 mg or about 10 mg to about 50 mg is administered, and provides release of active over a period of at least 12 hours, at least 96 hours, or any suitable or desirous time period ([62]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method for making a pulsatile delivery device that may be implanted into a patient, wherein the device comprises a stack with at least two bi-layer structures so that polymeric layers and delivery layers comprising a drug are alternating throughout the stack, and wherein a large number of controlled release layers can be incorporated which improves the pulsatile release duration of the device, as taught by Ma, use the drug which is a 5HT2A agonist such as psilocybin and LSD, as taught by Blumstock, and produce the instant invention.
One of ordinary skill in the art would have been motivated to substitute the drug PTH of Ma with the 5HT2A agonist such as psilocybin and LSD, as taught by Blumstock in order to achieve pulsatile delivery of the 5HT2A agonists. Both references teach pulsatile delivery of the active agents incorporated therein. Since Ma teaches the advantage of improving the pulsatile release duration of the device based on the large number of controlled release layers ([0045]) and the continuous delivery of the active in a linear manner for 3 weeks ([0128]), one of ordinary skill in the art would have been motivated to incorporate the 5HT2A agonists of Blumstock in the method of Ma with a reasonable expectation of success in delivering the 5HT2A agonists over a desired time period by implanting the device in a subject in need of treatment of psychological, cognitive, behavioral, and/or mood disorders (Blumstock – Abstract).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claim 1, the limitation of a method for the pulsed delivery of a 5HT2A agonist would have been obvious over the pulsatile delivery device (Abstract, FIG. 1, [0056]-[0071], claims 1-18), as taught by Ma in view of the 5HT2A agonists ([42]), including psilocybin (Abstract, [6], claims 1 and 13), an ergoline ([42]) or an ergoline derivative such as a lysergic acid amide ([44]) which is LSD ([45]), wherein the 5HT2A agonists are included in pulsatile release pharmaceutical formulations ([140], [162]-[163]), as taught by Blumstock.
Regarding instant claim 1, the limitations of parts (a) – (f) would have been obvious over the pulsatile delivery device which comprises a stack with at least two bi-layer structures so that the polymeric layers and the delivery layers are alternating throughout the stack, wherein the stack is sealed so that one of the polymeric layers remains exposed (Abstract, FIG. 1, [0056]-[0071], claims 1-18), the large number of controlled release layers to be incorporated into the device, which improves the pulsatile release duration of the device ([0045]), as taught by Ma. One of ordinary skill in the art would have found it obvious to include several bi-layer structures based on the guidance by Ma (FIG. 1, [0060]) and include the 5HT2A agonists ([42]), including psilocybin (Abstract, [6], claims 1 and 13), an ergoline ([42]) or an ergoline derivative such as LSD ([45]), as taught by Blumstock.
Regarding instant claim 1, the newly added limitations of the “entire” first side of the second layer is adjacent to the “entire” second side of the first layer in part (b); the “entire” first side of the third layer is adjacent to the “entire” second side of the second layer in part (c); the “entire” first side of the fourth layer is adjacent to the “entire” second side of the third layer in part (d); and the “entire” first side of the fifth layer is adjacent to the “entire” second side of the fourth layer in part (e) would have been obvious over the teaching by Ma that: “Each of the polymeric layers 12, 12', etc. may have an area that is equal to or larger than an area of each of the delivery layers 14, 14' …” (emphasis added) ([0057]).
Regarding instant claims 4-7, the limitations of the mixture of cellulose acetate phthalate (CAP) and a poloxamer would have been obvious over the hydrophilic agents, including cellulose acetate phthalate (CAP) (e.g., Aquacoat CPD) used in an amount of from about 0.1% to about 10% by weight ([94]), as well as polyglycol derivatives Poloxamer 188, Poloxamer 338, Poloxamer 407 used in an amount of from about 0.1% to about 10% by weight ([92]), as taught by Blumstock. One of ordinary skill in the art would have found the mol% ranges recited in instant claim 7 obvious variants over the weight % ranges taught by Blumstock unless there is evidence of criticality or unexpected results. One of ordinary skill in the art would have found it obvious to calculate the mol% based on the total weight % of the CAP and poloxamer and modify the ranges based on the desired pulsatile release rate.
Regarding instant claim 12, the limitation of a thickness of each of the second layer and the fourth layer that is greater than a thickness of each of the first layer, the third layer, and the fifth layer would have been obvious over the isolation layers with varying thicknesses ([0018]), and the teaching that the thickness of each isolation layer may be adjusted to achieve desired time intervals between adjacent pulses of drug release from the formed device ([0093]) by Ma. One of ordinary skill in the art would have found it obvious to vary the thickness of the layers based on the desired pulsatile release rate.
Regarding instant claims 17-18, the limitations of the second layer and the fourth layer each independently eroding over a period of from about 48 hours to about 96 hours (instant claim 17) and the first layer, the third layer, and the fifth layer each independently eroding over a period of from about 30 minutes to about 48 hours would have been obvious over the release of the active from the pulsatile delivery device on day 1, day 10, and day 20 (FIGS. 30A through 30C, [0035]), as taught by Ma in view of the release of active over a period of at least 12 hours, at least 96 hours, or any suitable or desirous time period ([62]), as taught by Blumstock. One of ordinary skill in the art would have found it obvious to modify the layers in order to achieve the desired release rate from each layer, and the recited time period would have been an obvious variant over the teaching of Ma unless there is evidence of criticality or unexpected results.
Regarding instant claim 19, the limitation of the sixth biodegradable polymer comprising poly(sebacic acid), polycaprolactone, polylactic acid (PLA) or any combination thereof would have been obvious over the poly(ortho ester) or a heteropolymer of anhydrides of sebacic acid (SA), ([0071], [0091], [0137]), poly(L-lactic acid) (PLLA) ([0050], [0133], claim 14), and polycaprolactone ([0050], [0063], [0066], [0077], [0080], [0099], and claim 14), as taught by Ma. One of ordinary skill in the art would have found it obvious to include the polymers taught by Ma in different layers of the delivery device based on the desired pulsatile release.
Regarding instant claim 20, the limitation of a seventh layer and a seventh biodegradable polymer would have been obvious over the multiple bi-layer structures ([0060]), as taught by Ma. One of ordinary skill in the art would have found it obvious to include additional layers and polymers based on the teaching by Ma in order to achieve the desired pulsatile release.
Regarding instant claim 23, the limitations of the additional pairs of layers would have been obvious over the multiple bi-layer structures ([0060]), as taught by Ma in view of the 5HT2A agonists ([42]), including psilocybin (Abstract, [6], claims 1 and 13), an ergoline ([42]) or an ergoline derivative such as a lysergic acid amide ([44]) which is LSD ([45]), wherein the 5HT2A agonists are included in pulsatile release pharmaceutical formulations ([140], [162]-[163]), as taught by Blumstock. One of ordinary skill in the art would have found it obvious to include additional layers and polymers based on the teaching by Ma in order to achieve the desired pulsatile release.
Regarding instant claim 24, the limitation of the drug-releasing biodegradable polymer would have been obvious over the poly(ortho ester) or a heteropolymer of anhydrides of sebacic acid (SA), ([0071], [0091], [0137]), poly(L-lactic acid) (PLLA) ([0050], [0133], claim 14), and polycaprolactone ([0050], [0063], [0066], [0077], [0080], [0099], and claim 14), as taught by Ma. One of ordinary skill in the art would have found it obvious to include the polymers taught by Ma in different layers of the delivery device based on the desired pulsatile release.
Regarding instant claim 25, the limitation of the interface biodegradable polymer would have been obvious over the poly(ortho ester) or a heteropolymer of anhydrides of sebacic acid (SA), ([0071], [0091], [0137]), poly(L-lactic acid) (PLLA) ([0050], [0133], claim 14), and polycaprolactone ([0050], [0063], [0066], [0077], [0080], [0099], and claim 14), as taught by Ma.
Regarding instant claim 26, the limitations of a first sub-layer and a second sub-layer each comprising the second biodegradable polymer would have been obvious over the multiple bi-layer structures ([0060]), and the poly(ortho ester) or a heteropolymer of anhydrides of sebacic acid (SA), ([0071], [0091], [0137]), poly(L-lactic acid) (PLLA) ([0050], [0133], claim 14), and polycaprolactone ([0050], [0063], [0066], [0077], [0080], [0099], and claim 14), as taught by Ma.
Regarding instant claim 29, the limitation of the third sub-layer and the fourth sub-layer each comprising the fourth biodegradable polymer would have been obvious over the multiple bi-layer structures ([0060]), and the poly(ortho ester) or a heteropolymer of anhydrides of sebacic acid (SA), ([0071], [0091], [0137]), poly(L-lactic acid) (PLLA) ([0050], [0133], claim 14), and polycaprolactone ([0050], [0063], [0066], [0077], [0080], [0099], and claim 14), as taught by Ma.
Regarding instant claim 32, the limitation of the fifth sub-layer and the sixth sub-layer each comprising the seventh biodegradable polymer would have been obvious over the multiple bi-layer structures ([0060]), and the poly(ortho ester) or a heteropolymer of anhydrides of sebacic acid (SA), ([0071], [0091], [0137]), poly(L-lactic acid) (PLLA) ([0050], [0133], claim 14), and polycaprolactone ([0050], [0063], [0066], [0077], [0080], [0099], and claim 14), as taught by Ma.
Regarding instant claim 35, the limitation of the device which is a film having a thickness of from about 0.05 mm to about 2 mm would have been obvious over the overlapping thickness of the scaffold which may be 0.5 mm or more ([0085]), as taught by Ma. According to MPEP 2144.05, “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.”
Regarding instant claim 36, the limitation of the 5HT2A agonist would have been obvious over the 5HT2A agonists ([42]), including psilocybin (Abstract, [6], claims 1 and 13), an ergoline ([42]) or an ergoline derivative such as a lysergic acid amide ([44]) which is LSD ([45]), as taught by Blumstock.
Regarding instant claim 37, the limitation of the subject in need of treatment or prevention of neuropsychiatric disease would have been obvious over the method of managing a neurological condition or one or more symptoms thereof in a subject in need thereof (Abstract and claim 1), and a method of treating the symptoms of a neurological condition in a subject (claim 2), wherein the treatment includes the treatment of depression, anxiety, obsessive compulsive disorder ([7], [41]), as well as managing and treating addiction disorders ([177], [199]), as taught by Blumstock.
Regarding instant claim 39, the limitation of the device that is implanted into the subject or injected into the subject would have been obvious over the device which may be implanted into a patient ([0082], [0088], [0118]-[0119]), as taught by Ma, and the pharmaceutical compositions which are administered by implantation or transcutaneous delivery ([139]), as taught by Blumstock.
Response to Arguments
Applicant’s arguments (Pages 6-9, filed 03/05/26) with respect to the rejection of claims 1, 4-7, 12, 17-20, 23-26, 29, 32, 35-37, and 39 under 35 U.S.C. 103 as being unpatentable over Ma in view of Blumstock have been fully considered but are not persuasive.
Applicant argues that Ma teaches a different structure from claim 1, refers to FIG. 1 of Ma, argues that the alternating positively charged and negatively charged layers of Ma are not the same size, the entire first side of one layer is not adjacent to an entire side of the next layer, and refers to [0057], Example 1 and [0094]-[0096] of Ma.
This is not persuasive because Ma clearly teaches that: “Each of the polymeric layers 12, 12', etc. may have an area that is equal to or larger than an area of each of the delivery layers 14, 14' …” (emphasis added) ([0057]). The entire first side of each of the second, third, fourth, and fifth layers would therefore be adjacent to the corresponding entire second sides of the first, second, third, and fourth layers, respectively.
Applicant argues that although Ma uses “equal to larger” language in the written description, in reduction to practice, it is clear that different surface areas with overhangs are required.
This is not persuasive because the teaching by Ma that: “Each of the polymeric layers 12, 12', etc. may have an area that is equal to or larger than an area of each of the delivery layers 14, 14' …” (emphasis added) ([0057]) is presumed enabled. According to MPEP 2121, “When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to provide facts rebutting the presumption of operability.” Applicant has not provided any evidence that the polymeric layers of Ma would not include the equal areas. All embodiments disclosed by Ma are presumed enabled even if the examples that are reduced to practice don’t expressly teach the equal areas.
Furthermore, according to MPEP § 2123, “a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments” and “disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure of preferred embodiments.”
Applicant argues that Blumstock suggests but does not produce or use oral dosage forms; that Blumstock does not seem to have actually enabled oral dosage forms, and that Blumstock had clearly not settled on optimal effective concentrations of components to be delivered orally.
This is not persuasive because Blumstock is not relied upon for teaching oral dosage forms. Blumstock is relied upon to cure the deficiency of a 5HT2A agonist in Ma. One of ordinary skill in the art would have been motivated to substitute the drug PTH of Ma with the 5HT2A agonist such as psilocybin and LSD, as taught by Blumstock in order to achieve pulsatile delivery of the 5HT2A agonists. Both references teach pulsatile delivery of the active agents incorporated therein. Since Ma teaches the advantage of improving the pulsatile release duration of the device based on the large number of controlled release layers ([0045]) and the continuous delivery of the active in a linear manner for 3 weeks ([0128]), one of ordinary skill in the art would have been motivated to incorporate the 5HT2A agonists of Blumstock in the method of Ma with a reasonable expectation of success in delivering the 5HT2A agonists over a desired time period by implanting the device in a subject in need of treatment of psychological, cognitive, behavioral, and/or mood disorders (Blumstock – Abstract). Both references, i.e., Ma and Blumstock, teach implantable pharmaceutical formulations.
Applicant argues that Blumstock administers single subcutaneous doses of psilocybin to rats, and that solubility, reactivity, non-covalent interactions, migration through different layers of polymers, and the like, were not discussed or disclosed, while dosages were speculated about broadly but not specifically evaluated for 5HT agonists dispersed in any dissolving polymers. Applicant argues that Blumstock can be construed as demonstrating the effectiveness of repeated doses of a drug administered in a medical or veterinary setting, while the present specification teaches repeated visits to receive a dosage of a drug are associated with reduced patient compliance (see instant specification, paragraph [0004]).
This is not persuasive because instant claims are silent with respect to any specific subject, medical/veterinary setting, or repeated doses to whom the pulsed delivery of a 5HT2A agonist is administered. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., repeated visits to receive a dosage of a drug are associated with reduced patient compliance) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Also, one of ordinary skill in the art would have had a reasonable expectation of successfully treating the same conditions taught by the prior art in different subjects.
Applicant argues that Blumstock does not demonstrate pulsatile delivery of 5HT agonists, that Blumstock uses the term “pulsatile release dosage forms” in a laundry list of many dosage forms that are not elaborated on (paragraph [162], inter alia), and that Blumstock does not use pulsatile release in any Examples and does not elaborate on the meaning of pulsatile. Applicant argues that the ordinarily skilled artisan, following the teachings of Blumstock, would look to the examples of Blumstock to determine what formulation from the list had actually been demonstrated and could reasonably be believed to function without additional experimentation.
This is not persuasive because Blumstock clearly teaches pulsatile release formulations ([140], [162]-[163]), which are presumed enabled based on MPEP 2121. Even if Blumstock does not exemplify pulsatile release formulations since this reference discloses pulsatile release formulations, one of ordinary skill in the art when reading the disclosure of Blumstock in its entirety, in combination with the disclosure of the primary reference, Ma, would have found it obvious to prepare pulsatile release formulations. Furthermore, according to MPEP § 2123, “a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments” and “disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure of preferred embodiments.” The disclosure of Blumstock is not limited to just the examples.
One of ordinary skill in the art would have known the meaning of pulsatile release or pulsatile delivery based on the teaching of the primary reference Ma. Moreover, instant claims only recite “pulsed delivery.” Instant claims do not recite any parameters regarding a specific pulsed release amount or time period. In the absence of such a specific claimed limitation, the prior art references Ma and Blumstock that clearly teach pulsatile release formulations render obvious the pulsed delivery limitation of instant claims.
Applicant argues that Ma cannot be modified by Blumstock without undue experimentation; the primary substance release by the device of Ma is parathyroid hormone; the primary 5HT2A agonist of Blumstock is psilocybin; and that one would not expect success in delivering the psilocybin of Blumstock in the same polymer system as described by Ma, since these two vary widely in terms of structure, size, and the like.
The Examiner acknowledges that the PTH taught by Ma and the 5HT2A agonist such as psilocybin and LSD taught by Blumstock are not the same. However, Applicant’s argument is not persuasive because the simple substitution of one known element for another to obtain predictable results is obvious. Please see MPEP 2141(III)(B).
Also, according to MPEP 2141(III)(G), one of the rationales for supporting a conclusion of obviousness is: Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to substitute the drug PTH of Ma with the 5HT2A agonist such as psilocybin and LSD, as taught by Blumstock in order to achieve pulsatile delivery of the 5HT2A agonists. The motivation to make the substitution is provided by the fact that both references teach pulsatile delivery of the active agents incorporated therein. Since Ma teaches the advantage of improving the pulsatile release duration of the device based on the large number of controlled release layers ([0045]) and the continuous delivery of the active in a linear manner for 3 weeks ([0128]), one of ordinary skill in the art would have been motivated to incorporate the 5HT2A agonists of Blumstock in the method of Ma with a reasonable expectation of success in delivering the 5HT2A agonists over a desired time period by implanting the device in a subject in need of treatment of psychological, cognitive, behavioral, and/or mood disorders (Blumstock – Abstract).
Since both the prior art references teach pulsatile delivery of the active ingredients one of ordinary skill in the art would not have to undertake undue experimentation.
Therefore, the rejection of 12/31/25 is 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, 4-7, 12, 17-20, 23-26, 29, 32, 35-37, and 39 are again provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-5, 7-15, 18, 21-22, 25, and 28-29 of copending Application No. 19/129,443 (“the ‘443 Application”).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a method for the pulsed delivery of a 5HT2A agonist to a subject comprising administering to the subject a device comprising a layer structure comprising components (a) – (f), and therefore, encompass overlapping or coextensive subject matter.
One difference is that claim 1 is drawn to a method for the pulsed delivery of a 5HT2A agonist to a subject comprising administering to the subject a device comprising a layer structure comprising components (a) – (f) whereas claim 1 of the ‘443 Application recites a device for delivering one more bioactive agents to a subject. However, claim 28 of the ‘443 Application recites a method for pulsed delivery of one or more bioactive agents to a subject, thereby rendering instant claims obvious.
Another difference is that instant claim 1 specifically recites a 5HT2A agonist whereas claims of the ‘443 Application do not recite this specific active. However, the 5HT2A agonist of instant claims is a species of the receptor agonist recited in claim 12 of the ‘443 Application and renders it obvious.
Yet another difference is that claim 1 of the ‘443 Application recites a plurality of reservoirs whereas instant claims are silent with respect to this limitation. However, since instant claims also recite various layers which contain the active agent one of ordinary skill in the art would have found it obvious to include the active agent in the layers in different forms, like matrix, depot, or a plurality or reservoirs. Therefore, this limitation is also rendered obvious over instant claims.
The additional bioactive agent recited in claim 25 of the ‘443 Application would have been obvious over the combination of actives recited in instant claim 36.
The subject in need of treatment or prevention of neuropsychiatric disease recited in instant claim 37 is a species of the subject population recited in claim 28 of the ‘443 Application and renders it obvious.
Therefore, instant claims are obvious over claims of the ‘443 Application, and they are not patentably distinct over each other.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Response to Arguments
Applicant’s arguments (Page 9, filed 03/05/26) with respect to the provisional rejection of claims 1, 4-7, 12, 17-20, 23-26, 29, 32, 35-37, and 39 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-5, 7-15, 18, 21-22, 25, and 28-29 of copending Application No. 19/129,443 (“the ‘443 Application”) have been fully considered but are not persuasive.
Applicant states that they will address the double patenting rejection to the extent that it still applies once all other substantive issues have been resolved.
The obviousness rejection of record is maintained for the reasons explained above. Applicant has not provided any deficiencies in the provisional double patenting rejection. Until such time that a terminal disclaimer is filed the provisional double patenting rejection will be maintained for the reasons given above.
Conclusion
No claims are 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 extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARADHANA SASAN whose telephone number is (571)272-9022. The examiner can normally be reached Monday to Friday from 6:30 am to 3:00 pm.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615
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