DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-5, 7-8, 10, 12-20, 22, 24, and 26-28 are pending and examined.
Claim Objections
Claim 13 is objected to because of the following informalities: In claim 13, line 5, “least” should read “at least.” Appropriate correction is required. Claim 27 is objected to because of the following informalities: In claim 27, line 6, “least” should read “at least.” Appropriate correction is required.
Note Regarding Examination
The examiner notes Applicant recites the phrase “CTLA-4 checkpoint related immunodeficiency” in claims 1, 2, 15 and 16. Examiner further notes Applicant’s definition of CTLA-4 checkpoint related immunodeficiency in the Specification, including the characterization of the sub-species of diseases, pathophysiology and primary symptomology. Upon consideration of Applicant’s definition and characterization in the Specification, the examiner finds Applicant provided sufficient written description to demonstrate possession of the invention as it relates to CTLA-4 checkpoint related immunodeficiency.
Additionally, based on the characterization of CTLA-4 checkpoint related immunodeficiency in the state of the prior art, the examiner finds sufficient scope of enablement as it relates to CTLA-4 checkpoint related immunodeficiency.
Claim Rejections - 35 USC § 112
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 1-2, 7, 13-16, 20, and 27-28 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.
Claim 1 recites the limitation, “the patient in need thereof.” There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not refer to a “patient in need thereof,” and it is unclear what patient in need thereof the applicant is referring to.
Claim 2 recites the limitation, “the group.” There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not refer to “a group,” and it is unclear what group the applicant is referring to.
Additionally, claim 2 and 16 recite “deficiency (LATAIE)” . The phrase “deficiency (LATAIE) is indefinite. It is unclear to the examiner what the applicant means by “deficiency (LATAIE).” The meaning of every term used in a claim should be apparent from the prior art or from the specification and drawings at the time the application is filed. Claim language may not be “ambiguous, vague, incoherent, opaque, or otherwise unclear in describing and defining the claimed invention.” In re Packard, 75 F.3d 1307, 1311, 110 USPQ2d 1785, 1787 (Fed. Cir.
2014). The examiner notes the specification defines LATAIE as “LRBA deficiency with autoantibodies, T-reg cell defects, auto-immune infiltration and enteropathy.” Thus, applicant proposes the following language if supported in the instant specification, “consisting of: CTLA-4 haploinsufficiency with autoimmune infiltration (CHAI), lipopolysaccharide-responsive beige-like anchor (LRBA) deficiency with autoantibodies, T-reg cell defects, auto-immune infiltration and enteropathy (LATAIE).
Claim 7 recites the limitation, “the set of polymers” There is insufficient antecedent basis for this limitation in the claim. It is unclear what set of polymers the applicant is referring to.
Additionally, claim 7 recites “Eudragit®.” The term “Eudragit®,” is indefinite as the examiner is not sure which Eudragit polymer the applicant is referring to. Eudragit® polymers can be Cationic (E series), Anionic (L, S, FS series), Neutral (RL, RS, NE, NMS series). Nikam et al., “A Systematic Overview of Eudragit® Based Copolymer for Smart Healthcare,” Pharmaceutics, 2023. Thus, the claim scope is indefinite since the trademark or trade name cannot be used to properly describe any particular material or product. See MPEP 2173.05(u). For examination purposes, the examiner interprets Eudragit as being any product sourced by Eudragit. It is suggested to change “Eudragit®” to further clarify which Eudragit polymers, which are supported in the instant Specification, that applicant intends by the term “Eudragit®.”
Claims 13 and 27 recite the phrase “at least about.” See, MPEP 2173.05(b). The phrase “at least about” is indefinite. See, Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991). Further, the term “about” provides no guidance on the permissible deviation of the claimed range such that a person of ordinary skill in the art can translate the definition into a meaningfully precise claim scope. See, Enviro Tech Chemical Services, Inc. v. Safe Foods Corp., 24-2160 (Fed. Cir. May 4, 2026) (Decision) (holding patent invalid where claim language recited “about” without guidance on how much below or above the pH would meet the limitation). For examination purposes, the examiner interprets “at least about” to mean at least.
Similarly, claim 14 recites the phrase “about 18 mg/kg.”
Additionally, claim 28 recites the phrase “about 2.25 mg/kg.”
The phrase “about” is indefinite. See, MPEP 2173.05(b). The term “about” provides no guidance on the permissible deviation of the claimed range such that a person of ordinary skill in the art can translate the definition into a meaningfully precise claim scope. See, Enviro Tech Chemical Services, Inc. v. Safe Foods Corp., 24-2160 (Fed. Cir. May 4, 2026) (Decision) (holding patent invalid where claim language recited “about” without guidance on how much below or above the pH would meet the limitation). For examination purposes, the examiner interprets “about 18 mg/kg” and “about 2.25 mg/kg” to mean at least 18 mg/kg and at least 2.25 mg/kg respectively.
Claim 15 recites the limitation, “the patient in need thereof.” There is insufficient antecedent basis for this limitation in the claim. Claim 15 does not refer to a “patient in need thereof,” and it is unclear what patient in need thereof the applicant is referring to.
Claim 16 recites the limitation, “the group.” There is insufficient antecedent basis for this limitation in the claim. Claim 15 does not refer to “a group,” and it is unclear what group the applicant is referring to.
Claim 20 recites “a set of polymers.” The phrase “a set of polymers” is indefinite. It is unclear to the examiner what the applicant means by “a set of polymers.” The meaning of every term used in a claim should be apparent from the prior art or from the specification and drawings at the time the application is filed. Claim language may not be “ambiguous, vague, incoherent, opaque, or otherwise unclear in describing and defining the claimed invention.” In re Packard, 75 F.3d 1307, 1311, 110 USPQ2d 1785, 1787 (Fed. Cir. 2014). For examining purposes, the examiner interprets “a set of polymers” to mean a “plurality of polymers.”
Claim Rejections - 35 USC § 112
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.
Claim 7 is 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 is improperly dependent upon claim 6 which was canceled. 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 § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 7-8, 10, and 12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated, by Renga et al,. “Optimizing therapeutic outcomes of immune checkpoint blockade by a microbial tryptophan metabolite,” Journal for Immunotherapy of Cancer, 2022 (cited in IDS of December 9, 2024).
Regarding claim 1, Renga teaches a method of treating a CTLA-4 checkpoint related immunodeficiency in a patient comprising administering a therapeutically effective amount of a pharmaceutical composition comprising 1H-indole-3-carboxaldehye (3-IAld) to the patient in need thereof. See Results. Renga teaches a murine model of ICI-induced colitis to evaluate whether enteric formulated 3-IAld would rescue intestinal damage and toxicity in ICI-induced colitis. See Results, page 4-5, lines 1-4. Experimentation demonstrated administration of 3-IAld improved survival, prevented weight loss, ameliorated disease activity index and improved gross pathology in colitic mice. See Results, page 5, lines 3-8, Figures 1A-1E.
Regarding claim 2, Renga teaches the method of claim 1, wherein the CTLA-4 checkpoint related immunodeficiency is selected from the group consisting of: CTLA-4 haploinsufficiency with autoimmune infiltration (CHAI), lipopolysaccharide-responsive beige-like anchor (LRBA) deficiency (LATAIE), a regulatory T (Treg) cell defect, autoimmune infiltration, enteropathy disease, gut inflammation, immune mediated colitis, gastrointestinal disorder, and gastric atrophy. See Results. Renga teaches a murine model of ICI-induced colitis to evaluate whether enteric formulated 3-IAld would rescue intestinal damage and toxicity in ICI-induced colitis. See Results, page 4-5, lines 1-4. Experimentation demonstrated administration of 3-IAld improved survival, prevented weight loss, ameliorated disease activity index and improved gross pathology in colitic mice. See Results, page 5, lines 3-8, Figures 1A-1E.
Regarding claim 3, Renga teaches the method of claim 1, wherein the CTLA-4 checkpoint related immunodeficiency is immune mediated colitis. See Results. Renga teaches a murine model of ICI-induced colitis to evaluate whether enteric formulated 3-IAld would rescue intestinal damage and toxicity in ICI-induced colitis. See Results, page 4-5, lines 1-4. Experimentation demonstrated administration of 3-IAld improved survival, prevented weight loss, ameliorated disease activity index and improved gross pathology in colitic mice. See Results, page 5, lines 3-8, Figures 1A-1E.
Regarding claim 4, Renga teaches the method of claim 1, wherein the pharmaceutical composition comprises a pharmaceutically acceptable carrier. See Methods. Renga teaches 3-IAld and polymers were dissolved in ethanol at a feedstock concentration of 3% w/v. See Methods, Enteric Formulation Preparation, lines 6-8.
Regarding claim 5, Renga teaches the method of claim 4, wherein the pharmaceutically acceptable carrier is at least one polymer. See Methods. Renga teaches 3-IAld and polymers were dissolved in ethanol at a feedstock concentration of 3% w/v. See Methods, Enteric Formulation Preparation, lines 6-8.
Regarding claim 7, Renga teaches the method of claim 6, wherein the set of polymers are Eudragit® polymers. See Methods. Renga teaches enteric microparticles (MPs) were prepared using Eudragit L100 to S100 at a ratio of 1:2, with the addition EC as described in Puccetti et al., and that 3-IAld and the polymers were dissolved in ethanol at a feedstock concentration of 3% w/v. See Methods, Enteric Formulation Preparation, lines 1-8.
Regarding claim 8, Renga teaches the method of claim 1, wherein the pharmaceutical composition is formulated for enteric delivery or is orally administered. See Results and Methods. Renga teaches enteric formulation preparation. See methods, page 3. Experimentation evaluated whether enteric formulated 3-IAld would rescue from intestinal damage and toxicity in ICI-induced colitis. See results, page 4, line 1.
Regarding claim 10, Renga teaches the method of claim 1, wherein the pharmaceutical composition is in a form selected from a capsule, tablet, get tablet, gel capsule, gel liquid and gummy. See Introduction. Renga teaches administration of an enteric formulation of 3-IAld recently shown to increase its efficacy while minimizing unwanted toxicity through localized delivery in the small intestine. See Introduction, page 2, paragraph 4, lines 4-9.
Regarding claim 12, Renga teaches the method of claim 1, wherein the pharmaceutical composition is administered at an interval of every other day (q.o.d). See Methods. Renga teaches 3-IAld was administered every other day at a dose of 18 mg/kg. See Methods, page 2, paragraph 1, lines 39-41.
Regarding claim 13, Renga teaches the method of claim 1, wherein the pharmaceutical composition is administered at a 3-IAld dosage of at least about 3 mg/kg, at least about 4 mg/kg, at least about 5 mg/kg, at least about 6 mg/kg, at least about 7 mg/kg, at least about 8 mg/kg, at least about 9 mg/kg, at least about 10 mg/kg, at least about 11 mg/kg, at least about 12 mg/kg, at least about 13 mg/kg, at least about 14 mg/kg, at least about 15 mg/kg, least about 16 mg/kg, at least about 17 mg/kg, or at least about 18 mg/kg. See Methods. Renga teaches 3-IAld was administered at a dose of 18 mg/kg. See Methods, page 2, paragraph 1, line 40.
Regarding claim 14, Renga teaches the method of claim 1, wherein the 3-IAld is about 18 mg/kg. See Methods. Renga teaches 3-IAld was administered at a dose of 18 mg/kg. See Methods, page 2, paragraph 1, line 40.
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.
Claims 15-20, 22, 24, and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Renga, and further in view of Matern et al, “A substrate of the ABC transporter PEN3 stimulates bacterial flagellin (flg22)-induced callose deposition in Arabidopsis thaliana,” J. Biol. Chem., 2019.
Regarding claim 15, Renga teaches a method of treating CTLA-4 related immunodeficiency in a patient comprising administering a therapeutically effective amount of a pharmaceutical composition to a patient in need thereof. See Results. Renga teaches a murine model of ICI-induced colitis to evaluate whether enteric formulated 3-IAld would rescue intestinal damage and toxicity in ICI-induced colitis. See Results, page 4-5, lines 1-4. Experimentation demonstrated administration of 3-IAld improved survival, prevented weight loss, ameliorated disease activity index and improved gross pathology in colitic mice. See Results, page 5, lines 3-8, Figures 1A-1E. Renga fails to teach a pharmaceutical composition comprising 1-methylindole-3-carboxylic acid.
Regarding claim 28, Renga teaches the method of claim 1, wherein the pharmaceutical composition is administered at a dosage of about 2.25 mg/kg. See Methods. Renga teaches 3-IAld was administered at a dose of 18 mg/kg. See Methods, page 2, paragraph 1, line 40. Renga fails to teach a 1-methylindole-3-carboxylic acid dosage.
However, Matern teaches 1-methylindole-3-carboxylic acid. See Figure 1 and Table 2. Matern teaches that 1-methylindole-3-carboxylic acid is a microbial tryptophan-based metabolite produced in bacteria by direct metabolism of 3-IAld. This is shown in part below.
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Renga and Matern are analogous to the claimed invention because both are in the same field of microbial tryptophan-based indole compounds.
Gut microbiota signatures predict toxicity associated with CTLA-4 checkpoint related immunodeficiencies. Andrews et al., “Gut microbiota signatures are associated with toxicity to combine CTLA-4 and PD-1 blockade,” Nat. Med., 2021. Further, the expression of microbial metabolites can be predictive biomarkers of the efficacy of CTLA-4 therapy. Renga et al., 2022. Microbiota-dependent tryptophan catabolites are abundantly produced within the gastrointestinal tract and are known to exert profound effects on host physiology including the maintenance of epithelial barrier function and immune homeostasis. Agus et al., “Gut microbiota regulation of tryptophan metabolism in health and disease,” Cell Host Microbe, 2018. By binding to the host aryl hydrocarbon receptor, tryptophan catabolites, such as 3-IAld, activate interleukin pathways that affect the composition and function of gut microbiota. Renga et al., 2022.
Research by Matern demonstrates that, in bacteria, 1-methylindole-3-carboxylic acid is a metabolite of tryptophan-derived 3-IAld. Tryptophan is first metabolized by CYP79B2 or CYP79B3 to produce IAOx. IAOx is further metabolized by CYP71A12 or CYP71A3 into IAN. Further metabolism of IAN by CYP71B6 or CYP71A12 produces 3-IAld. Aldehyde oxidase-1 metabolizes 3-IAld into 1-methylindole-3-carboxylic acid. Thus, 1-methylindole-3-carboxylic acid is a direct metabolite of 3-IAld in bacteria.
Indeed, Renga teaches that 3-IAld is a microbial tryptophan catabolite known to contribute to epithelial barrier function and immune homeostasis in the gut via the aryl hydrocarbon receptor. 1-methylindole-3-carboxylic acid is a direct metabolite of 3-IAld with a very similar structure, where the carbonyl group is replaced with a carboxylic acid.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of administering 3-IAld for the treatment of CTLA-4 checkpoint related immunodeficiency of Renga by substituting the 3-IAld indole compound for the 1-methylindole-3-carboxylic acid indole compound. The simple substitution of known elements is likely to be obvious when predictable results are achieved. See, KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395-97 (2007) (see MPEP § 2143, B.).
See MPEP 2143(I)(b). Obviousness of a chemical compound in view of its structural similarity to a prior art compound may be shown by identifying some line of reasoning that would have led one of ordinary skill in the art to select and modify the prior art compound in a particular way to produce the claimed compound. See, Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Circ. 2007). In Aventis Pharma Deutschland, the court stated that an expectation of similar properties in light of the prior art can be sufficient, even without an explicit teaching that the compound will have a particular activity. Given 1-methylindole-3-carboxylic acid is a direct metabolite of 3-IAld with structural similarity to 3-IAld,
Thus, it would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the instant application that 1-methylindole-3-carboxylic acid would be an effective indole based pharmaceutical composition for the treatment of CTLA-4 checkpoint related immunodeficiency. One would be motivated to do so because there is a need to identify novel ligands of the aryl hydrocarbon receptor. There is also a motivation to identify novel compounds with efficacy in treating bacterial infections, inflammatory diseases and immune related disorders, such as CTLA-4 checkpoint related immunodeficiency. Further, the claimed compounds are taught to independently play a role in bacterial function, which directly contributes to the pathophysiology of the primary symptomology in CTLA-4 checkpoint related immunodeficiencies. As such, there is a reasonable and predictable expectation of success in arriving at the administration of 1-methylindole-3-carboxylic acid to treat CTLA-4 checkpoint related immunodeficiency in view of the teachings in the cited prior art.
Regarding claim 16, Renga further teaches the method of claim 15, wherein the CTLA-4 checkpoint related immunodeficiency is selected from the group consisting of: CTLA-4 haploinsufficiency with autoimmune infiltration (CHAI), lipopolysaccharide-responsive beige-like anchor (LRBA) deficiency (LATAIE), a regulatory T (Treg) cell defect, autoimmune infiltration, enteropathy disease, gut inflammation, immune mediated colitis, gastrointestinal disorder, and gastric atrophy. See Results. Experimentation demonstrated administration of 3-IAld improved survival, prevented weight loss, ameliorated disease activity index and improved gross pathology in colitic mice. See Results, page 5, lines 3-8, Figures 1A-1E.
Regarding claim 17, Renga teaches the method of claim 15, wherein the CTLA-4 checkpoint related immunodeficiency immune-mediated colitis. See Results. Renga teaches a murine model of ICI-induced colitis to evaluate whether enteric formulated 3-IAld would rescue intestinal damage and toxicity in ICI-induced colitis. See Results, page 4-5, lines 1-4. Experimentation demonstrated administration of 3-IAld improved survival, prevented weight loss, ameliorated disease activity index and improved gross pathology in colitic mice. See Results, page 5, lines 3-8, Figures 1A-1E.
Regarding claim 18, Renga teaches the method of claim 15, wherein the pharmaceutical composition comprises a pharmaceutically acceptable carrier. See Methods. Renga teaches 3-IAld, and polymers were dissolved in ethanol at a feedstock concentration of 3% w/v. See Methods, Enteric Formulation Preparation, lines 6-8.
Regarding claim 19, Renga teaches the methods of claim 18, wherein the pharmaceutically acceptable carrier is at least one polymer. See Methods. Renga teaches 3-IAld and polymers were dissolved in ethanol at a feedstock concentration of 3% w/v. See Methods, Enteric Formulation Preparation, lines 6-8.
Regarding claim 20, Renga teaches the methods of claim 18, wherein the pharmaceutically acceptable carrier is a set of polymers. See methods. Renga teaches enteric microparticles prepared using two Eudragit polymers, L100 to S100, at a ratio of 1:2 and that 3-IAld and the polymers were dissolved in ethanol at feedstock concentration of 3% w/v. See methods, Enteric Formulation Preparation, lines 1-8.
Regarding claim 22, Renga teaches the methods of claim 15, wherein the pharmaceutical composition is formulated for enteric delivery or is orally administered. See Results and Methods. Renga teaches enteric formulation preparation. See methods, page 3. Experimentation evaluated whether enteric formulated 3-IAld would rescue from intestinal damage and toxicity in ICI-induced colitis. See results, page 4, line 1.
Regarding claim 24, Renga teaches the methods of claim 15, wherein the pharmaceutical composition is in a form selected from a capsule, tablet, get tablet, gel capsule, gel liquid and gummy. See Introduction. Renga teaches administration of an enteric formulation of 3-IAld recently shown to increase its efficacy while minimizing unwanted toxicity through localized delivery in the small intestine. See Introduction, page 2, paragraph 4, lines 4-9.
Regarding claim 26, Renga teaches the method of claim 1, wherein the pharmaceutical composition is administered at an interval of every other day (q.o.d). See Methods. Renga teaches 3-IAld was administered every other day at a dose of 18 mg/kg. See Methods, page 2, paragraph 1, lines 39-41.
Regarding claim 27, Renga teaches the method of claim 1, wherein the pharmaceutical composition is administered at a 3-IAld dosage of at least about 2 mg/kg, at least 3 mg/kg, at least about 4 mg/kg, at least about 5 mg/kg, at least about 6 mg/kg, at least about 7 mg/kg, at least about 8 mg/kg, at least about 9 mg/kg, at least about 10 mg/kg, at least about 11 mg/kg, at least about 12 mg/kg, at least about 13 mg/kg, at least about 14 mg/kg, at least about 15 mg/kg, least about 16 mg/kg, at least about 17 mg/kg, or at least about 18 mg/kg. See Methods. Renga teaches 3-IAld was administered at a dose of 18 mg/kg. See Methods, page 2, paragraph 1, line 40.
Double Patenting (Statutory)
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1, 2, 15 and 16 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of copending Application No. 19/494,556 (same applicant and same inventors). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented. Claim 1 in the current application is verbatim identical to claim 1 of the copending Application No. 19/494,556.
Double Patenting (Nonstatutory)
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 3-5, 7, 8, 10, 12-20, 22, 24, and 26-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 22 of copending Application No. 19/494,556 (same applicant and same inventors). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 22 in the present application is obvious over claim 22 of copending Application No. 19/494,556 in view of the instant Specification.
Claims 3-5, 7, 8, 10, 12-20, 22, 24, and 26-28 of the instant application teaches a method of administering the same APIs to a same subject population at a same dosage. While the breadth of the claims is not identical because the claims of the ‘556 application are broader and include numerous proper and improper multiple dependent claims, they are nonetheless substantially overlapping in scope. As such, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pharmaceutical composition of the instant application to include oral administration as taught by the instant Specification in order to provide an additional means of enteric delivery.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Correspondence
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/JARED BARSKY/Primary Examiner, Art Unit 1628
Prosecution Insights