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 .
Claim Status
Claims 1-17 were previously pending.
As a result of the 28 May 2024 Preliminary Amendment, claims 3-8 and 11-17 were amended, and claim 18 was added. No claims were cancelled.
Therefore, claims 1-18 are now pending and currently under examination.
Priority
Examiner acknowledges applicant’s claims for priority as follows:
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Information Disclosure Statement (IDS)
The IDS (1) filed on 31 July 2024 has been considered by the examiner. A signed copy is enclosed.
Applicant is reminded of their duty to disclose to the Office all information known to the
person to be material to patentability as defined in 37 CFR 1.56. As stated therein, “[e]ach
individual associated with the filing and prosecution of a patent application has a duty of candor
and good faith in dealing with the Office, which includes a duty to disclose to the Office all
information known to that individual to be material to patentability as defined in this section.”
Claim Objections
Claim 14 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 13.
Claims 13 and 14 both depend from claim 8 and recite “…the pharmaceutical preparation is an oral preparation…” Claims 13 and 14 contain different optional steps, however, these steps are exactly as claimed – optional – and not a required limitation. Therefore, the two claims without their optional limitation are identical.
When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 17 is objected to for a possible typographical error: “…wherein the composition comprising (comprises?) an inclusion complex…”
Claim Rejections - 35 USC § 112(a)
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.
Claim 18 is 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 depression by administering vilazodone hydrochloride, does not reasonably provide enablement for preventing depression by administering vilazodone hydrochloride. 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.
Enablement is considered in view of the Wands factors (MPEP 2164.01(A)).
These include:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based
on the content of the disclosure
All of the Wands factors have been considered with regard to the instant claims as discussed below:
(A)/(B) The breadth of the claims/The nature of the invention and (F)/(G) The amount of direction provided by the inventor/The existence of working examples:
Claim 18 is directed to a method of treating or preventing depression in a subject by administering a composition comprising an inclusion complex of vilazodone hydrochloride (active ingredient) wrapped in an inclusion material in a therapeutically effective amount. The amount of vilazodone hydrochloride in the composition is interpreted as a unit dose of 8 mg to 9 mg, 16 mg to 18 mg, or 32 mg to 36 mg (see rejection of claim 1 under 35 USC 112(b) below).
The specification does not define: treating or treatment; preventing or prevention; subject; depression; or therapeutically effective amount.
In order to practice the full scope of the invention, the claims require formulating an inclusion complex by: 1) selecting an inclusion material; 2) determining which unit dose of vilazodone hydrochloride to use; 3) determining a therapeutically effective amount of composition; and 4) administering this composition to prevent depression.
The limitation of “preventing depression” is substantially broader than treating an existing depressive disorder. Prevention may encompass administration to subjects who have never had depression, subjects at risk of developing depression, subjects with subclinical symptoms, subjects in remission, subjects with recurrent depression, subjects with genetic or familial predisposition, postpartum subjects, geriatric subjects, adolescent subjects, or subjects having different baseline risks and different etiologies.
The specification does not identify which populations are intended to be covered or provide sufficient guidance for determining which subjects would benefit from prophylactic administration. Nor does the specification provide objective criteria for determining whether depression has been prevented, as opposed to delayed, reduced in severity, reduced in recurrence, or merely treated after onset.
In addition, the specification does not identify which depressive disorder the composition is intended to target. The DSM-5 classifies depression into major depressive disorder (MDD) and persistent depressive disorder (PDD). Furthermore, the DSM-5 provides a method to classify depression based on duration, severity, symptom patterns, and context, allowing clinicians to tailor treatment plans effectively (e.g., MDD with seasonal pattern, MDD with psychotic features, MDD with psychotic features, Disruptive Mood Dysregulation Disorder (DMDD), Premenstrual Dysphoric Disorder (PMDD), Substance/Medication-Induced Depressive Disorder, Depressive Disorder due to another medical condition, etc.).
The aforementioned depressive disorders arise from a complex interplay of biological, psychological, and social pathways that affect mood, cognition and behavior.
The biological pathways include: neurotransmitter dysregulation (imbalances in one or more of serotonin, norepinephrine, and/or dopamine); neuroendocrine pathways through the hypothalamic-pituitary-adrenal axis; neuroinflammation; and genetic/epigenetic factors.
Psychological pathways include: cognitive mechanisms; behavioral mechanisms; and early childhood trauma/abuse/neglect.
Social pathways include environmental stressors and access to social support/resources.
The amount of guidance provided in the specification is insufficient for the full scope of claim 18. Although vilazodone is known as an antidepressant for treatment of major depressive disorder (specification, [0002]), knowledge that a compound can treat an existing type of depressive disorder does not, by itself, enable the use of that compound to prevent depression across the broad spectrum of depressive disorders and broad scope of subjects encompassed by claim 18. A POSITA would need to determine, among other things, appropriate prophylactic patient populations, dosing schedules, duration of administration, timing of administration relative to risk or symptom onset, clinical endpoints, and whether administration actually prevents depression rather than treats early or undiagnosed symptoms.
The specification also lacks representative examples commensurate with the scope of prevention claimed. Applicant has disclosed data pertaining to pharmacokinetic properties only. No prophylactic study is described in which the claimed composition is administered before onset of depression and shown to prevent development of depression. No animal model, clinical protocol, or human study is provided to demonstrate prevention of depression at a specific therapeutic amount. No data are provided showing reduced incidence of depression in a specific population. No biomarkers, diagnostic criteria, or validated prophylactic endpoints are provided. Therefore, the disclosure does not provide representative support for the breadth of the claimed preventive method.
(C)/(E) The state of the prior art/The level of predictability in the art:
The state of the art further supports a finding of non-enablement. As previously mentioned, vilazodone was approved to treat major depressive disorder. However, treatment does not correspond to prevention as evidenced by prior art references supporting only treatment, and not prevention, of MDD using vilazodone. Furthermore, depression is a complex psychiatric condition with multifactorial etiologies, including genetic, neurochemical, environmental, developmental, and psychosocial factors. Predicting prevention of depression in a subject who has not yet developed the disease would require substantial clinical investigation amounting to far more than routine pharmaceutical formulation. The specification’s disclosure of improved dissolution, inclusion complex formation, or reduced food effect does not establish the composition can prevent depression across the scope of the claim and prior art does not compensate for the lack of disclosure.
D) The level of one of ordinary skill:
One having ordinary skill in the art would have an advanced degree in biomedical
Research, drug development and/or pharmaceutical science such as a Ph.D. and/or an M.D., therefore the level of skill is high.
(H) The quantity of experimentation needed to make or use the invention based on the
content of the disclosure:
In view of the foregoing analysis, the quantity of experimentation required to practice the full scope of the prevention embodiment of claim 18 would be undue. A POSITA would need to conduct substantial and prolonged studies to identify appropriate prophylactic populations, determine effective preventive dosing regiments, establish safety for preventive administration, define endpoints for prevention, and demonstrate the claimed composition reduces the incidence or onset of depression. Such experimentation would far exceed routine optimization of a known formulation parameter; rather, it would require establishing a new prophylactic therapeutic use across a broad and clinically heterogenous disease area.
Accordingly, while the specification may provide information relevant to the preparation of vilazodone hydrochloride inclusion-complex compositions and supports administration for treatment of depression, the specification does not enable the full scope of claim 18 insofar as it encompasses preventing depression. Therefore, claim 18 is not enabled commensurate with its scope and is rejected under 35 USC 112(a) for lack of enablement.
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 1-18 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 are rejected under 35 U.S.C. 112(b) as being indefinite for the following reasons:
Claims 1 and 17 recite the limitation “the specification of the composition is 8mg~9mg, 16mg~18mg or 32~36mg.” Applicant’s disclosure provides examples whereby the unit dose of vilazodone hydrochloride is 8mg and states the specification of vilazodone coated tablets is 8mg ([00201-00202]). It is therefore assumed the terminology ‘specification of the composition’ is used to denote the unit dose of vilazodone hydrochloride in the composition. However, ‘specification of the composition’ is not clearly defined in the actual specification and has numerous possible meanings such as dosage strength, unit dose amount, total amount of vilazodone HCl per tablet/capsule, amount of inclusion complex, or amount administered per dose. Furthermore, as recited in claims 1 and 17, it is not entirely clear what component ‘specification of the composition’ is intended to modify.
Limitations from the specification cannot be imported into the claims and when applicant acts as their own lexicographer, the disclosure must clearly set forth a definition of the term. Typically, drug specification is most often used in the context of quality standards for a drug product and provides universal attributes critical to the quality of drug substance. However, its use in the context of claims 1 and 17 is unclear. Because of this, one of ordinary skill (POSITA) could not determine the metes and bounds of the claim and therefore, claims 1 and 17 are indefinite.
The limitation of claims 1 and 17 – “8mg~9mg, 16mg~18mg or 32~36mg” – is also problematic. A ‘~’ is not a standard method to modify a range and is most commonly used to denote approximate values. Is this intended to denote a range (e.g., 8mg-9mg)? Approximate values (e.g., about 8mg, about 9mg)? Approximate values within a range (about 8mg to about 9mg)? Therefore, claims 1 and 17 are indefinite because a POSITA could not determine the metes and bounds of the claim.
Finally, claim 1 recites that the active ingredient is wrapped in an inclusion material. Though the term ‘wrapped’ is not widely used in the field of pharmaceutical formulations, the specification seems to imply wrapping requires a 100% inclusion rate ([0069] for example). If this is not the case, clarification is required.
Separate from the preceding claims’ individual rejections, claims 2-18 are included in the rejection under 35 USC 112(b) because of their dependency on, and requiring every limitation of, independent claim 1 and failing to cure the defect.
Claim 6 and claim 7 are rejected under 112(b) for the following reason:
Both claim 6 and claim 7 recite method-of-use language in claims directed to a composition, thereby rendering the scope unclear. It is unclear whether the claims require a composition structurally formulated for oral administration, a method step of orally administering the composition, or if the claims are merely reciting an intended use of the composition. For purposes of examination, the claims have been interpreted as requiring that the composition be formulated for oral formulation.
Claim 11 is rejected under 112(b) for the following reasons:
Claim 11 also uses ‘~’ to modify a range. It is unclear whether ‘about 2.00% w/w~8.00% w/w’ means about 2.00% w/w to about 8.00% w/w or about 2.00% w/w to 8.00% w/w. Therefore, claim 11 is indefinite because a POSITA could not determine the metes and bounds of the claim.
Claim 11, which depends from claim 8, recites multiple optional limitations such as filler, disintegrant, and lubricant. However, claim 8 only supports the limitations of inclusion material and active ingredient in claim 11. Therefore, there is insufficient antecedent basis for limitations of filler, disintegrant, and lubricant in claim 11.
Claim 12 is rejected under 112(b) for the following reason:
Claim 12 recites the pharmaceutical preparation of claim 8 wherein the dissolution rate of the pharmaceutical preparation in a solution at pH 6 – pH 7 for 15 minutes is about 85% or more. Claim 12 further limits the dissolution rate of the pharmaceutical preparation in a solution at pH 6.8 for 15 minutes is about 85% or more. This claim limitation is unclear because there is a lack of ‘or’ between the two limitations (as in claim 5). Is this a typographical error? Or does the claim require both limitations to be true? Would one be infringing upon the claim if the solution was tested at pH 6.0, but not at pH 6.8? Therefore, claim 12 is indefinite because a POSITA could not determine the metes and bounds of the claim.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 7 and 8 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 7, which depends from claim 6, fails to further limit the subject matter of claim 6.
Claim 6 recites the limitation wherein the composition of claim 1 is administered orally and an optional limitation. Claim 7 recites the limitation wherein the composition of claim 6 is administered orally and an optional limitation. Since both limitations are optional, claim 7 does not further limit claim 6.
Claim 8, which depends from claim 1, fails to further limit the subject matter of claim 1.
Claim 1 recites a composition comprising an inclusion complex of vilazodone hydrochloride wrapped in an inclusion material. Claim 8 recites a pharmaceutical preparation comprising the composition of claim 1 and an optional component of at least one pharmaceutically acceptable adjuvant(s) or excipient(s). The addition of a pharmaceutically acceptable adjuvant or excipient to the composition of claim 1 would beget the pharmaceutical preparation of claim 8. However, this step is optional in claim 8 and therefore, claim 8 does not further limit the subject matter of claim 1 as both are directed to a composition comprising an inclusion complex of vilazodone hydrochloride wrapped in an inclusion material.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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 1-18 are rejected under 35 U.S.C. 103 as being obvious over Feng (US PGPub. No. 2020/0276191 A1; published 03 September 2020).
The applied reference has a common Applicant/Inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). However, because the applied reference was published more than 1 year before the claimed priority date of the instant application (30 November 2021), the applied reference also constitutes prior art under 35 U.S.C. 102(a)(1).
Feng discloses inclusion complexes comprising vilazodone and an inclusion material.
Regarding claim 1, Feng discloses an oral formulation ([0012]) of vilazodone hydrochloride ([0041]), whereby at least 90% is contained in an inclusion complex ([0005]). Feng further discloses the formulation comprises about 2% w/w to about 8% w/w of vilazodone based on the total weight of the formulation ([0015]).
Feng does not expressly teach the exact claimed unit dose of vilazodone hydrochloride of 8 mg to 9 mg, 16 mg to 18 mg, or 32 to 36 mg. However, more broadly Feng teaches formulations by weight percent rather than the claimed strengths ([0015]) and provides working examples where the dose of vilazodone hydrochloride is 4.6 mg ([0102]), 7.1 mg ([0104]), 9.8 mg ([0092], [0113]), 10 mg ([0094]), and 27 mg ([0106]). Furthermore, Feng teaches 10 mg ([0088]), 20 mg ([0040]), and 40 mg ([0110]) vilazodone hydrochloride VIIBRYD® tablets. The claimed ranges of 8 mg to 9 mg, 16 mg to 18 mg, or 32 to 36 mg are a modest reduction from the disclosed dosage amounts of 10 mg, 20 mg, and 40 mg.
Feng’s disclosed ranges are close to the claimed ranges and therefore, a prima facie case of obviousness exists. See MPEP 2144.05(I). See also Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. “The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.”).
Regarding claim 2, Feng discloses an oral formulation of vilazodone and an inclusion material, whereby the inclusion material is cyclodextrin or a derivative thereof ([0004]).
Regarding claim 3, Feng discloses an oral formulation of vilazodone and an inclusion material, whereby the weight ratio of the active ingredient to the inclusion material is about 1:2.4 to about 1:45.4, about 1:5 to about 1:45.4, about 1:6.5 to about 1:45.4, or about 1:8 to about 1:16.5 ([0006]). The range of weight ratios disclosed by Feng is identical to the instantly claimed range.
Regarding claim 4, Feng discloses a working example whereby the unit dose of vilazodone hydrochloride is 7.1 mg ([0104]), 9.8 mg ([0092], [0113]), and 10 mg ([0094]). As previously discussed, the amounts of vilazodone hydrochloride disclosed by Feng are virtually indistinguishable from the instantly claimed amount (e.g., 9.8 mg of Feng versus 9 mg of claim 4). A POSITA would expect the disclosed vilazodone hydrochloride amount would have the same properties as the claimed amount, especially provided both are directed to the API vilazodone hydrochloride is contained within cyclodextrin.
Regarding claims 5 and 12, Feng discloses the dissolution rate of various compositions containing vilazodone hydrochloride and cyclodextrin or derivatives thereof in pH 6.8 buffer ([0098], Table 7). The composition containing vilazodone hydrochloride and hydroxypropyl-β-cyclodextrin ([0105], Example 4) has a dissolution rate of 93 ± 1% at 15 minutes (Table 7).
Regarding claims 6 , 7, 13 and 14, Feng discloses the formulation is suitable for oral formulation ([0012] and [0068]).
Regarding claims 8 and 9, Feng discloses the formulation is a pharmaceutical formulation of an inclusion complex comprising vilazodone ([0011]). Embodiments of the formulation further comprise pharmaceutically acceptable excipients such as fillers, disintegrants, and lubricants ([0013]).
Regarding claim 10, Feng discloses the fillers of the aforementioned formulation embodiments can be selected from lactose ([0014]).
Regarding claim 11, Feng discloses the formulation comprises about 2% w/w to about 8% w/w of vilazodone based on the total weight of the formulation ([0015]).
Regarding claim 15, Feng discloses a method of preparing the formulation by dissolving the active ingredient and the inclusion material to form an inclusion complex ([0022]).
Regarding claim 16, Feng discloses the method of preparing further discloses drying the inclusion solution to form solid granules ([0022]).
Regarding claim 17, Feng discloses a method of preparing comprising mixing the inclusion complex with a pharmaceutically acceptable excipient ([0019]).
Regarding claim 18, Feng discloses vilazodone is administered for the treatment of major depressive disorder ([0003]). Feng further discloses administration of vilazodone ([0042]).
Feng therefore teaches embodiments of formulations containing an inclusion complex, whereby active ingredient vilazodone hydrochloride is wrapped in an inclusion material to form the inclusion complex. The difference between the applied reference and the claimed invention is that the applied reference may not teach the instantly claimed method with particularity so as to amount to anticipation. See MPEP “[t]he identical invention must be shown in as complete detail as is contained in the ... claim.” Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).
Feng discloses various embodiments of the vilazodone hydrochloride inclusion complex formulation comprising fillers, disintegrants, and lubricants, methods of preparing such formulation, and methods of treatment using such formulation. These disclosures require the skilled artisan choose from those embodiments to arrive at the currently claimed invention. A skilled artisan would have reasonable expectation of success in doing so because both Feng and the currently claimed invention purport to address the same issue of administering vilazodone to a fasting subject. With that said, the applied reference discloses the elements of the claimed composition and methods with sufficient guidance, particularity, and with a reasonable expectation of success for the skilled artisan, that the invention would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date. Therefore, Feng makes obvious that which is currently claimed in instant claims 1-18.
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.
US Patent No. 10,688,090 B2 (patent date: 23 June 2020)
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 9-12, 14, and 18 of U.S. Patent No. 10,688,090 B2 (hereinafter ‘090) in further view of VIIBRYD® label insert (2011).
Although the claims at issue are not identical, they are not patentably distinct from each other because both ‘090 and the instantly claimed invention are drawn to a formulation comprising an inclusion complex of vilazodone hydrochloride and a cyclodextrin inclusion material.
Claim mapping:
Instant Claim
‘090 Claim
Rationale
1 and 4
1 and 3
Both claims are drawn to an inclusion complex comprising an active ingredient contained in an inclusion material, wherein the active material is vilazodone hydrochloride.
The dose of vilazodone is made obvious by VIIBRYD® label insert, which provides the recommended dose of vilazodone hydrochloride is 10 mg, 20 mg, and 40 mg (p. 1). The claimed doses of 9 mg, 20 mg, and 36 mg do not overlap with the prior art, but are close enough to assume similar properties, especially in light of the broadly claimed w/w % of vilazodone in ‘090 (see ‘090 claim 13).
2
4
The inclusion material comprises cyclodextrin or a derivative thereof.
3
1, 2, 5
The weight ratio of the active ingredient to the inclusion material is from 1:5 to 1:45.4 or 1:6.5 to 1:45.4.
5
N/A
This is an inherent property that would flow naturally from identical formulations as claimed in ‘090 and the instantly claimed invention. See MPEP 2112.
6, 7, 13, and 14
N/A
The instant claims are made obvious over ‘090 in further view of VIIBRYD® label insert, which discloses vilazodone hydrochloride tablets for oral administration (p. 1). Oral administration would be obvious to a POSITA as use of a known technique (oral administration) to improve similar products in the same way.
8
9
A pharmaceutical formulation comprising the inclusion complex (cyclodextrin derivative) and at least one pharmaceutically acceptable excipient.
9
10
The pharmaceutically acceptable excipients of the pharmaceutical formulation further comprise one or more of fillers, disintegrants, and lubricants.
10
11
The filler comprising the pharmaceutically acceptable excipient is chosen from: lactose, sucrose, fructose, etc.
11
12 and 14
The formulation comprises 2% w/w to 8% w/w of vilazodone hydrochloride.
12
N/A
This is an inherent property that would flow naturally from identical formulations as claimed in ‘090 and the instantly claimed invention. See MPEP 2112.
15, 17
18
A method of preparation comprising: dissolving the active ingredient and an inclusion material to form an inclusion solution.
As recited in instant claim 17, a POSITA would use this method to also include a pharmaceutically acceptable excipient when preparing a pharmaceutical formulation.
16
N/A
The instant claim is made obvious over ‘090 in further view of VIIBRYD® label insert, which discloses vilazodone hydrochloride in a solid tablet formulation. A solid dosage form would be obvious to a POSITA as use of a known technique (solid dosage form) to improve similar products in the same way.
18
N/A
The instant claim is made obvious over ‘090 in further view of VIIBRYD® label insert, which discloses vilazodone hydrochloride is used to treat MDD (p. 1).
Therefore, claims 1-5, 9-12, 14, and 18 of ‘090 in further view of VIIBRYD® label insert make obvious that which is currently claimed in instant claims 1-18.
US Patent No. 11,517,569 B2 (patent date: 06 December 2022)
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7, and 11-13 of U.S. Patent No. 11,517,569 B2 (hereinafter ‘569) in further view of VIIBRYD® label insert (2011).
Although the claims at issue are not identical, they are not patentably distinct from each other because both ‘569 and the instantly claimed invention are drawn to a formulation comprising an inclusion complex of a cyclodextrin inclusion material and vilazodone hydrochloride.
Claim mapping:
Instant Claim
‘569 Claim
Rationale
1 and 4
1
Both claims are drawn to an inclusion complex comprising an active ingredient contained in an inclusion material, wherein the active material is vilazodone hydrochloride.
The dose of vilazodone is made obvious by VIIBRYD® label insert, which provides the recommended dose of vilazodone hydrochloride is 10 mg, 20 mg, and 40 mg (p. 1). The claimed doses of 9 mg, 20 mg, and 36 mg do not overlap with the prior art, but are close enough to assume similar properties, especially in light of the broadly claimed w/w % of vilazodone in ‘569 (see ‘569 claim 13).
2
1, 2
The inclusion material comprises cyclodextrin or a derivative thereof.
3
1, 3
The weight ratio of the active ingredient to the inclusion material is from 1:5 to 1:45.4 or 1:6.5 to 1:45.4.
5
N/A
This is an inherent property that would flow naturally from identical formulations as claimed in ‘569 and the instantly claimed invention. See MPEP 2112.
6, 7, 13, and 14
N/A
The instant claims are made obvious over ‘569 in further view of VIIBRYD® label insert, which discloses vilazodone hydrochloride tablets for oral administration (p. 1). Oral administration would be obvious to a POSITA as use of a known technique (oral administration) to improve similar products in the same way.
8
11
A pharmaceutical formulation comprising the inclusion complex (cyclodextrin derivative) and at least one pharmaceutically acceptable excipient.
9
12
The pharmaceutically acceptable excipients of the pharmaceutical formulation further comprise one or more of fillers, disintegrants, and lubricants.
10
N/A
The instant claim is made obvious over ‘569 in further view of VIIBRYD® label insert, which discloses vilazodone hydrochloride as an active ingredient formulated in a tablet with lactose monohydrate, microcrystalline cellulose, and polyethylene glycol (p. 10). Substitution of the species of fillers and lubricants into the genus of fillers and lubricants disclosed by ‘569 would be obvious to a POSITA as a simple substitution of one known element for another to obtain predictable results.
11
13
The formulation comprises 2% w/w to 8% w/w of vilazodone hydrochloride.
12
N/A
This is an inherent property that would flow naturally from identical formulations as claimed in ‘569 and the instantly claimed invention. See MPEP 2112.
15, 17
7
A method of preparation comprising: dissolving the active ingredient and an inclusion material to form an inclusion solution.
As recited in instant claim 17, a POSITA would use this method to also include a pharmaceutically acceptable excipient when preparing a pharmaceutical formulation.
16
N/A
The instant claim is made obvious over ‘569 in further view of VIIBRYD® label insert, which discloses vilazodone hydrochloride in a solid tablet formulation. A solid dosage form would be obvious to a POSITA as use of a known technique (solid dosage form) to improve similar products in the same way.
18
N/A
The instant claim is made obvious over ‘569 in further view of VIIBRYD® label insert, which discloses vilazodone hydrochloride is used to treat MDD (p. 1).
Therefore, claims 1-3, 7, and 11-13 of ‘569 in further view of VIIBRYD® label insert make obvious that which is currently claimed in instant claims 1-18.
US Patent No. 12,171,761 B2 (patent date: 24 December 2024)
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6, 12, 14, 18-19, and 24 of U.S. Patent No. 12,171,761 B2 (hereinafter ‘761) in further view of VIIBRYD® label insert (2011).
Although the claims at issue are not identical, they are not patentably distinct from each other because both ‘761 and the instantly claimed invention are drawn to a formulation comprising an inclusion complex of vilazodone hydrochloride and a cyclodextrin inclusion material.
Claim mapping:
Instant Claim
‘761 Claim
Rationale
1 and 4
1
Both claims are drawn to an inclusion complex comprising an active ingredient contained in an inclusion material, wherein the active material is vilazodone hydrochloride.
The dose of vilazodone is made obvious by VIIBRYD® label insert, which provides the recommended dose of vilazodone hydrochloride is 10 mg, 20 mg, and 40 mg (p. 1). The claimed doses of 9 mg, 20 mg, and 36 mg do not overlap with the prior art, but are close enough to assume similar properties.
2
1, 2
The inclusion material comprises cyclodextrin or a derivative thereof.
3
1, 2
The weight ratio of the active ingredient to the inclusion material is from 1:5 to 1:45.4 or 1:6.5 to 1:45.4.
5
N/A
This is an inherent property that would flow naturally from identical formulations as claimed in ‘761 and the instantly claimed invention. See MPEP 2112.
6, 7, 13, and 14
24
Oral administration of a composition comprising an active ingredient, vilazodone hydrochloride, in a cyclodextrin derivative inclusion material.
8
6, 18
A pharmaceutical formulation comprising the inclusion complex (cyclodextrin derivative) and at least one pharmaceutically acceptable excipient.
9
19
The pharmaceutically acceptable excipients of the pharmaceutical formulation further comprise one or more of fillers, disintegrants, and lubricants.
10
N/A
The instant claim is made obvious over ‘761 in further view of VIIBRYD® label insert, which discloses vilazodone hydrochloride as an active ingredient formulated in a tablet with lactose monohydrate, microcrystalline cellulose, and polyethylene glycol (p. 10). Substitution of the species of fillers and lubricants into the genus of fillers and lubricants disclosed by ‘761 would be obvious to a POSITA as a simple substitution of one known element for another to obtain predictable results.
11
12 and 14
The formulation comprises 2% w/w to 8% w/w of vilazodone hydrochloride.
12
N/A
This is an inherent property that would flow naturally from identical formulations as claimed in ‘090 and the instantly claimed invention. See MPEP 2112.
15, 17
18
A method of preparation comprising: dissolving the active ingredient and an inclusion material to form an inclusion solution.
As recited in instant claim 17, a POSITA would use this method to also include a pharmaceutically acceptable excipient when preparing a pharmaceutical formulation.
16
N/A
The instant claim is made obvious over ‘090 in further view of VIIBRYD® label insert, which discloses vilazodone hydrochloride in a solid tablet formulation. A solid dosage form would be obvious to a POSITA as use of a known technique (solid dosage form) to improve similar products in the same way.
18
N/A
The instant claim is made obvious over ‘090 in further view of VIIBRYD® label insert, which discloses vilazodone hydrochloride is used to treat MDD (p. 1).
Therefore, claims 1-2, 6, 12, 14, 18-19, and 24 of ‘761 in further view of VIIBRYD® label insert make obvious that which is currently claimed in instant claims 1-18.
Conclusion
Claims 1-18 are rejected. Claims 14 and 17 are objected to. No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Julia A. Rossi whose telephone number is (571)272-0138. The examiner can normally be reached M-Th 7:30-5:30 (MST).
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/JULIA A. ROSSI/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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