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 .
Claims 1-46 are pending; claims 31-46 are withdrawn; claims 1-30 are examined.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-30 and 46, in the reply filed on 23 January 2026 is acknowledged. Since Applicant did not specifically present any specific ground(s) of traversal, this is not found persuasive. Accordingly, claims 31-45 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Additionally, upon further consideration, claim 46 is withdrawn from further consideration as being dependent upon a withdrawn invention/claim.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 112(a) – Scope of Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for antagonizing intestinal mucosal serotonin reuptake transporter (SERT) with limited passage through the intestinal epithelial barrier, does not reasonably provide enablement for antagonizing intestinal mucosal SERT with no passage through the intestinal epithelial barrier. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
The nature of the invention, state and predictability of the art, and relative
skill level
The invention relates to administering an effective amount of an agent that selectively antagonizes intestinal mucosal SERT with limited or no passage through the intestinal epithelial barrier. The relative skill of those in the art is high, that of an MD or PHD. That factor is outweighed, however, by the unpredictable nature of the art. As illustrative of the state of the art, the examiner cites Ageing Research Reviews, which discloses that intestinal epithelial barrier encompasses several elements that include the intestinal epithelium and mucus layer, antimicrobial peptides and secretory immunoglobulin (abs).
The breadth of the claims
Since the instant specification provides no limiting definition of the term “intestinal epithelial barrier”, the term will be interpreted expansively. The term “intestinal epithelial barrier” may vary widely in meaning, from the intestinal mucosal layer; antimicrobial peptides, to the intestinal epithelium.
The claims are broadly drawn to administering an agent that selectively antagonizes intestinal mucosal SERT with limited or no passage through the intestinal epithelial barrier, and thus the claims are very broad insofar as they suggest that the administration of an agent will not cross the intestinal mucus layer; that the agent will cross the intestinal epithelium; or that the agent will not cross the secretory immunoglobulins or antimicrobial peptides. Moreover, the claims do not disclose how the agent can antagonize the intestinal mucosal SERT without crossing the intestinal epithelial layer, which comprises the intestinal mucosal layer.
The amount of direction or guidance provided and the presence or absence of working examples
The specification provides no direction or guidance for practicing the claimed invention in its “full scope”. No reasonably specific guidance is provided concerning useful therapeutic protocols for no passage through the intestinal epithelial barrier (e.g., mucosa layer, antimicrobial peptides, immunoglobulins, and/or epithelium), other than antagonizing intestinal mucosal SERT. The latter is corroborated by the working examples.
The instant disclosure provides no evidence to suggest that this unique activity can be extrapolated to agents intended to cross the intestinal mucosal layer to exert its effects, and thus does not meet the “how to use” prong of 35 USC 112, first paragraph with regard thereto.
The quantity of experimentation necessary
Because of the known unpredictability of the art, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that the instantly claimed agents could be predictably used as inferred by the claim and contemplated by the specification. Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the claimed invention in its “full scope” a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
Claims 17-30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating or ameliorating the effect of a disorder in a pregnant subject, does not reasonably provide enablement for preventing a negative effect on the fetus. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
The nature of the invention, state and predictability of the art, and relative
skill level
The invention relates to treating or ameliorating the effect of a disorder in a pregnant subject while preventing a negative effect on the fetus. The relative skill of those in the art is high, that of an MD or PHD. That factor is outweighed, however, by the unpredictable nature of the art. As illustrative of the state of the art, the examiner cites Every Stage Health (from the American College of Obstetricians & Gynecologists), which discloses that most birth defects cannot be prevented because their cause is not known.
The breadth of the claims
Since the instant specification provides no limiting definition of the term “preventing negative effects”, the term will be interpreted expansively. The term “prevent” may vary widely in meaning, from “preventing” a negative effect from occurring to “preventing” it from progressing. Nor is the term limited by any time frame.
The claims are thus very broad insofar as they suggest that a fetus will not experience any negative effect during a term of pregnancy; that should a fetus get a negative effect, it will not worsen; or that following taking the claimed agent, a negative effect will not recur. While such “prevention” might theoretically be possible under strictly controlled laboratory conditions, as a practical matter it is nearly impossible to achieve in the “real world” in which patients live.
The amount of direction or guidance provided and the presence or absence of working examples
The specification provides no direction or guidance for practicing the claimed invention in its “full scope”. No reasonably specific guidance is provided concerning useful therapeutic protocols for preventing all possible negative effects on a fetus, other than administering an effective amount of an agent that selective antagonizes intestinal mucosal SERT. The latter is corroborated by the working examples.
The instant disclosure provides no evidence to suggest that this unique activity can be extrapolated to negative effects having unrelated or unknown cause from the agent, and thus does not meet the “how to use” prong of 35 USC 112, first paragraph with regard thereto.
The quantity of experimentation necessary
Because of the known unpredictability of the art, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that the instantly claimed agents could be predictably used as inferred by the claim and contemplated by the specification. Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the claimed invention in its “full scope” a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-30 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 17 recite treating or ameliorating the “effect” of “a disorder” in a “subject”. The claims are indefinite because the scope of the claims is unclear. It is not clear what is considered a disorder, or what is considered an effect of a disorder, such that one of ordinary skill in the art would know when a disorder or an effect infringes on the claimed invention.
It is further unclear whether the subject is otherwise healthy or in need of treatment (e.g., in the absence of a recitation of --- subject in need thereof ---, the subject may encompass any person.)
Claims 1 and 17 recites the limitation “the effect” in line 1. There is insufficient antecedent basis for this limitation in the claims. To obviate this issue, it is suggested for claims 1 and 17 to recite --- an effect ---.
Regarding claims 4 and 20, the phrase "e.g.," in line 3 of each claim render the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 13, 15, 27, and 29 recite the limitation "the nanoneedles" in line 1 of each claim. There is insufficient antecedent basis for this limitation in the claims. Claims 12 or 26, from which the claims depend, recite a plurality of nanoneedles. To obviate this issue, it is suggested for claims 13, 15, 27 and 29 to recite --- the plurality of nanoneedles ---.
Claim 17 recites the limitation “the fetus” in line 2. There is insufficient antecedent basis for this limitation in the claims. To obviate this issue, it is suggested for claim 17 to recite --- a fetus ---.
Claim 17 recites treating or ameliorating the effect of a disorder in a pregnant subject while “preventing” a “negative effect” on the fetus. The claim is indefinite because the scope of the claim is unclear. It is not clear whether the negative effect is caused by the administration of the agent or by other known and unknown causes in pregnancy. Moreover, it is further unclear what is considered “negative” for an effect, such that one of ordinary skill in the art would know when an effect on a fetus infringes on the claimed invention.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 1-11 and 17-25 are rejected under 35 U.S.C. 103 as being unpatentable over Jacobsen et al. (WO 2020/014334 A1, 01/16/2020) (hereinafter Jacobsen).
Jacobsen discloses methods for treating or ameliorating a gastrointestinal (GI) condition in a subject in need thereof, using a sustained release formulation of 5-hydroxytryptophan (5-HTP SR), and a kit comprising 5-HTP SR (abs). The kit further comprises a selective serotonin reuptake-inhibitor (SSRI), or another antidepressant (p. 5, lines 25-26). GI conditions include constipation, irritable bowel syndrome (IBS), and short gut syndrome (p. 4, lines 25-30). In the constipated state, dry and hard fecal matter accumulates in the colon, causing pain, bloatedness, and general discomfort (p. 10, lines 18-20). 5-HTP has been reported as an acute adjunct to enhance the effects of SSRI treatment in human models, to improve the efficacy of SSRI therapy. Such therapeutic approach can successfully treat both depression and GI abnormalities effectively and simultaneously (p. 25, lines 9-20). The subject in need includes a mammal such as human (p. 12, lines 24-25). The term “treatment” includes alleviation or prevention of symptoms (p. 11, lines 22-25). Various drug delivery systems will be appropriate to produce the desired intraluminal delivery profile, including but not limited to, matrix, particulate, biodegradable, pH-sensitive, and timed-release systems (p. 18, lines 29-31). Such delivery system formulations may provide selective augmentation of 5-HT function in the GI without, or with less, effect on the systemic periphery or CNS. This will be advantageous, as 5- HTP adverse effects related to systemic peripheral and CNS exposure will be minimized (p. 19, lines 1-3). Such delivery system may be formulated to include microparticle systems (p. 13, line 29 – p. 14, line 2).
Accordingly, Jacobsen discloses a method of treating/ameliorating the effect of a disorder, including GI disorders such as constipation (which causes abdominal pain) in a subject including humans, comprising administering an effective amount of an agent that selectively antagonizes serotonin reuptake transporter (SERT) (i.e. claimed selective serotonin reuptake inhibitor (SSRI)), in various drug delivery systems providing selective augmentation of 5-HT function in the GI (i.e. claimed selectively antagonizing intestinal mucosal SERT) without, or with less, effect/exposure on the systemic peripheral and central nervous system (CNS) (i.e. instantly claimed limited effect on SERT in CNS and ENS). Together these would provide a method as instantly claimed in claims 1-9 and 17-23. The prior art is not anticipatory insofar as this combination must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP § 2143 (I)(A).
Regarding claims 10 and 17 reciting administering to a pregnant subject, this is merely a recitation of the intended use of the composition. Since the composition of the prior art comprises substantially the same active ingredients as the claimed invention (i.e. SSRI), and the prior art discloses administering to humans, the composition of the prior art would be usable to be administered to a pregnant subject, whether the prior art recognizes such use or not.
Regarding claims 17 and 24 reciting preventing a negative effect on the fetus, this limitation does not require any negative effect to actually be present to render the claimed subject matter obvious. This limitation requires only that the negative effect could occur to the fetus. As discussed above, Jacobsen discloses wherein “treatment” includes alleviation or prevention of symptoms. Thus, since Jacobsen discloses methods of treating a GI condition, and treatment includes prevention of symptoms, comprising orally administering a composition comprising SSRI, an agent that would selectively antagonize SERT, one would reasonably expect the method of Jacobsen, comprising substantially the same administration of an agent including SSRI, to demonstrate substantially the same effects as intended by the instant Specification, such as preventing a negative effect on a fetus as instantly claimed.
Regarding claims 11 and 25, as noted by para. [0016] of the instant Specification, drug delivery systems that limit systemic absorption (e.g., to the ENS and CNS) are gut epithelial-restricted drug delivery systems. Accordingly, as discussed above, the drug delivery system of Jacobsen, limiting delivery to the intestines, meets the limitations of a gut epithelial restricted delivery system as instantly claimed.
Claims 12, 15-16, 26, and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Jacobsen et al. (WO 2020/014334 A1, 01/16/2020) (hereinafter Jacobsen) in view of Yang et al. (CN 106495232 A, 03/15/2017, IDS reference submitted 04/14/2025) (hereinafter Yang).
The disclosure of Jacobsen is discussed in detail above, and differs from the instant claims insofar as not explicitly disclosing wherein the delivery system comprises a spherical, hollow core having a surface, and a plurality of nanoneedles secured to the surface of the core and extending outwardly therefrom.
Yang discloses a hollow sea urchin-type nano-composite drug-carrying system comprising a hollow spherical center and ZnO nanorods structure (abs) capable of targeted drug delivery ([0005], [0007]). The overall particle size of the system may be about 1-1.5 µm, while the hollow center may be about 450-650 nm ([0008]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have included a hollow sea urchin-type drug-carrying system of Yang in the drug delivery system of Jacobsen, since it is a known and effective dry delivery system suitable for targeted drug delivery as taught by Yang.
Regarding claims 15 and 29, although Yang does not explicitly disclose an average length of the nanorods, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed range (i.e. about 1-100 nm) through routine experimentation based on the desired particle size of the system. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP § 2144.05(II)(A).
Regarding claims 16 and 30, as discussed above, Yang discloses wherein the overall particle size of the system is about 1-1.5 µm. The claimed size (i.e. about 1-5µm) would have been obvious to one of ordinary skill in the art since they overlap with the ranges of the prior art. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Claims 12-13, 15-16, 26-27, and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Jacobsen et al. (WO 2020/014334 A1, 01/16/2020) (hereinafter Jacobsen) in view of Wang et al. (CN 110104689 A, 08/09/2019) (hereinafter Wang).
The disclosure of Jacobsen is discussed in detail above, and differs from the instant claims insofar as not explicitly disclosing wherein the delivery system comprises a spherical, hollow core having a surface, and a plurality of nanoneedles secured to the surface of the core and extending outwardly therefrom.
Wang discloses hollow manganese dioxide (MnO2) nanoparticles having stable properties, controllable size and uniform structure, and can be used as a targeted drug carrier (abs). The shapes of the nanoparticle includes spherical sea urchin-shaped (¶ Ex. 4). The nanoparticle is low toxicity and has a high theoretical capacity (§ Background, ¶1).
Accordingly, it would have been obvious to one of ordinary skill in the art to have included hollow manganese dioxide (MnO2) nanoparticles in the delivery system of Jacobsen, since the nanoparticles have stable structural properties and controllable size and structure as a known and effective drug delivery system suitable for targeted drug delivery as taught by Wang.
Regarding claims 15 and 29, although Wang does not explicitly disclose an average length of the nanorods, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed range (i.e. about 1-100 nm) through routine experimentation based on the desired particle size of the delivery system. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP § 2144.05(II)(A).
Regarding claims 16 and 30, although Wang does not explicitly disclose a size of the hollow MnO2 nanoparticles, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed range (i.e. about 1-1.5 µm) through routine experimentation based on the desired particle size of the delivery system. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP § 2144.05(II)(A).
Claims 12-13, 15-16, 26-27, and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Jacobsen et al. (WO 2020/014334 A1, 01/16/2020) (hereinafter Jacobsen) in view of Lee and Kim (US 2008/0241262 A1, 10/02/2008, IDS reference submitted 04/14/2025) (hereinafter Lee).
The disclosure of Jacobsen is discussed in detail above, and differs from the instant claims insofar as not explicitly disclosing wherein the delivery system comprises a spherical, hollow core having a surface, and a plurality of nanoneedles secured to the surface of the core and extending outwardly therefrom.
Lee discloses nano-structures suitable for drug delivery systems, including metal oxide nano-particles and nano-rods deposited on the surface of the nano-particles (abs). The nano-rods are grown on or from the outer surface, assuming uniform and/or non-uniform sizes and/or directions and/or orientations on the outer surface providing for a different format for achieving light-to-heat energy transfer, and are suited for drug delivery systems ([0052]). The diameter of the nano-particle and the dimensions of the nano-rods deposited or formed on the surface of the nano-particles may be controlled based on desired plasmon resonance ([0063]). The nano-particles may be impregnated with at least one pharmaceutically active agent ([0062]). The nano-shells and polymer together form microparticles, nano-particles, or vesicles. The nano-particles core may be between about 1 nm to slight less than 5 µm in diameter ([0188]). Metals capable of forming nano-particles include transition metals such as titanium (Ti), manganese (Mn), iron (Fe), zinc (Zn), their alloys or mixtures and combinations thereof ([0324]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have included the metal oxide nano-particles and nano-rods structure of Lee in the delivery system of Jacobsen, since it is a known and effective drug delivery system suitable for achieving targeted drug delivery as taught by Lee.
Regarding claims 13 and 27, as discussed above, Lee discloses manganese as a suitable metal to form metal oxide nanoparticles and nanorods (i.e. MnO2).
Regarding claims 15-16 and 29-30, although Lee does not explicitly disclose an average length of nanorods, or a specific size of the nano-structure, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed range of nano-rods (i.e. about 1-100 nm); or the claimed range of nano-particle (i.e. about 1-5 µm) through routine experimentation based on the desired plasmon resonance as taught by Lee. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP § 2144.05(II)(A).
Claims 14 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Jacobsen et al. (WO 2020/014334 A1, 01/16/2020) (hereinafter Jacobsen) in view of Yang et al. (CN 106495232 A, 03/15/2017, IDS reference submitted 4/14/2025) (hereinafter Yang), further in view of Li (US 2018/0177887 A1, 06/28/2018) (hereinafter Li).
The disclosures of Jacobsen and Yang are discussed above, and differs from the instant claim insofar as not explicitly disclosing wherein the core of the nanoparticle is loaded with SSRI encapsulated mesoporous silica nanoparticles.
Li discloses a method of treating a disease condition in a subject that is in need of such treatment, comprising administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of a compound comprising a targeting moiety and a pharmaceutical acceptable carrier ([0033]). The compounds may be administered singly or in combination with other therapeutic agents, using administration routes including oral and intestinal administration ([0262], [0264]). Other compounds that may be administered include tricyclic and non-tricyclic antidepressants, such as citalopram and sertraline ([0267]). The targeting moiety may comprise a particle such as a nanoparticle ([0135]) or microparticle ([0142]). The particle may be porous, such as a porous silica particle, e.g., a mesoporous silica nanoparticle ([0144]). The particles can also be non-polymeric particles (e.g., metal particles). The therapeutic agent may be encapsulated within the nanoparticle ([0136], [0147]).
Accordingly, it would have been obvious to one of ordinary skill in the art to encapsulate a therapeutic agent such as SSRI inside a mesoporous silica nanoparticle contained within a nanoparticle delivery system of Yang, since it is a known and effective material for delivering agents such as SSRI as taught by Li. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP § 2144.07.
Claims 14 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Jacobsen et al. (WO 2020/014334 A1, 01/16/2020) (hereinafter Jacobsen) in view of Wang et al. (CN 110104689 A, 08/09/2019) (hereinafter Wang), further in view of Li (US 2018/0177887 A1, 06/28/2018) (hereinafter Li).
The disclosures of Jacobsen and Wang are discussed above, and differs from the instant claim insofar as not explicitly disclosing wherein the core of the nanoparticle is loaded with SSRI encapsulated mesoporous silica nanoparticles.
Li discloses a method of treating a disease condition in a subject that is in need of such treatment, comprising administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of a compound comprising a targeting moiety and a pharmaceutical acceptable carrier ([0033]). The compounds may be administered singly or in combination with other therapeutic agents, using administration routes including oral and intestinal administration ([0262], [0264]). Other compounds that may be administered include tricyclic and non-tricyclic antidepressants, such as citalopram and sertraline ([0267]). The targeting moiety may comprise a particle such as a nanoparticle ([0135]) or microparticle ([0142]). The particle may be porous, such as a porous silica particle, e.g., a mesoporous silica nanoparticle ([0144]). The particles can also be non-polymeric particles (e.g., metal particles). The therapeutic agent may be encapsulated within the nanoparticle ([0136], [0147]).
Accordingly, it would have been obvious to one of ordinary skill in the art to encapsulate a therapeutic agent such as SSRI inside a mesoporous silica nanoparticle contained within the nanoparticles of Wang, since it is a known and effective material for delivering agents such as SSRI as taught by Li. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP § 2144.07.
Claims 14 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Jacobsen et al. (WO 2020/014334 A1, 01/16/2020) (hereinafter Jacobsen) in view of Lee and Kim (US 2008/0241262 A1, 10/02/2008, IDS reference submitted 4/14/2025) (hereinafter Lee), further in view of Li (US 2018/0177887 A1, 06/28/2018) (hereinafter Li).
The disclosures of Jacobsen and Wang are discussed above, and differs from the instant claim insofar as not explicitly disclosing wherein the core of the nanoparticle is loaded with SSRI encapsulated mesoporous silica nanoparticles.
Li discloses a method of treating a disease condition in a subject that is in need of such treatment, comprising administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of a compound comprising a targeting moiety and a pharmaceutical acceptable carrier ([0033]). The compounds may be administered singly or in combination with other therapeutic agents, using administration routes including oral and intestinal administration ([0262], [0264]). Other compounds that may be administered include tricyclic and non-tricyclic antidepressants, such as citalopram and sertraline ([0267]). The targeting moiety may comprise a particle such as a nanoparticle ([0135]) or microparticle ([0142]). The particle may be porous, such as a porous silica particle, e.g., a mesoporous silica nanoparticle ([0144]). The particles can also be non-polymeric particles (e.g., metal particles). The therapeutic agent may be encapsulated within the nanoparticle ([0136], [0147]).
Accordingly, it would have been obvious to one of ordinary skill in the art to encapsulate a therapeutic agent such as SSRI inside a mesoporous silica nanoparticle impregnated in the nano-structure of Lee, since it is a known and effective material for delivering agents such as SSRI as taught by Li. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP § 2144.07.
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 1-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/516,772 in view of Jacobsen et al. (WO 2020/014334 A1, 01/16/2020) (hereinafter Jacobsen), Yang et al. (CN 106495232 A, 03/15/2017, IDS reference submitted 4/14/2025) (hereinafter Yang), Wang et al. (CN 110104689 A, 08/09/2019) (hereinafter Wang), Lee and Kim (US 2008/0241262 A1, 10/02/2008, IDS reference submitted 4/14/2025) (hereinafter Lee), and Li (US 2018/0177887 A1, 06/28/2018) (hereinafter Li).
The pending claims differ from the copending claims insofar as reciting a method of treating or ameliorating the effect of a disorder in a subject. However, these feature are known in the art. As noted in the current rejections, the teachings of Jacobsen render obvious claims 1-11 and 17-25; the combined teachings of Jacobsen and Yang render obvious claims 12, 15-16, 26, and 29-30; the combined teachings of Jacobsen and Wang render obvious claims 12-13, 15-16, 26-27, and 29-30; the combined teachings of Jacobsen and Lee render obvious claims 12-13, 15-16, 26-27, and 29-30; and the combined teachings of Jacobsen, Yang/Wang/Lee and Li render obvious claims 14 and 28.
Therefore, as claims 1-20 of copending Application No. 18/516,772, Jacobsen, Yang, Wang, Lee, and Li all disclose methods of treating or ameliorating the effect of a disorder in a subject, it would have been prima facie obvious to one of ordinary skill in the art to have modified the copending application and to include the teachings of Van Haren and Yoshino as discussed in the rejections above, because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as instantly claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." See MPEP 2144.06(I).
This is a provisional nonstatutory double patenting rejection.
Citation of the State of the Art and Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Shah et al. (“Serotonin as a mitogen in the gastrointestinal tract”, 05/18/2021), directed to serotonin potentiation in the gastrointestinal (GI) system results in enhanced intestinal epithelial proliferation and decreased injury from intestinal inflammation.
Conclusion
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/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612