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 .
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
Response to Arguments
Applicant’s arguments, filed 6/23/2026, with respect to the claim rejections under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. In particular, the argument that Burshtein does not teach a composition comprising sodium starch glycolate at a concentration of at least 10 weight percent is found persuasive. The rejections have been withdrawn.
Applicant's preemptive arguments, filed 6/23/2026, with respect to potential claim rejections under 35 U.S.C. 103, have been fully considered but they are not persuasive.
Applicant’s position is that the claimed combination of teriparatide, a salt of NAC, and sodium starch or croscarmellose sodium unexpectedly provides significant enhanced acid-neutralizing effects (see Remarks, Pg 6, last paragraph - Pg 7, first paragraph).
MPEP 716.02(b)(I) states that the burden is on the Applicant to establish that the results are unexpected and significant: “The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992).” In the instant application, none of the data put forth demonstrate statistical significance, including Example 1 and Figures 3-5, as referenced in the Remarks. Thus, this requirement has not been met; see new rejections under 35 U.S.C. 103 below.
Consequently, the double patenting rejections have been modified/maintained herein.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 3-5, 7-8, 10-14, 16-17, and 21-24 in the reply filed on 4/20/2026 is acknowledged.
Applicant’s election of the species of sodium 8-N-(2-hydroxybenzoyl)aminocaprylate (SNAC) and sodium starch glycolate in the reply filed on 4/20/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Status
Claims 1, 8, 10-11, and 21-27 are pending and currently amended. Claims 25 and 26 are withdrawn. Claims 1, 8, 10-11, and 21-24 are currently amended. Claims 2-7, 9, and 12-20 are cancelled. Claim 27 is new.
Priority
The instant application is a continuation of 18/841,379, filed 8/25/2024, which claims priority to PCT/IL2023/050191, filed 2/23/2023, which claims priority to the provisional application 63/313,367, filed 2/24/2022. The priority date of 2/24/2022 is acknowledged.
Information Disclosure Statement
The IDS filed on 6/23/2026 is under consideration.
Claim Objections
Claim 22 is objected to because of the following informalities: The claim recites “the composition of claim 21… in the composition” (emphasis added). Remove the new limitation “in the composition” to reduce redundancy. Appropriate correction is required.
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.
Claim(s) 1, 8, 10-11, 21-24, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Burshtein et al. (CA 3033259 A1, published 2/22/2018), as evidenced by USCS (USA Chemical Suppliers, sodium starch glycolate suppliers USA, accessed from https://www.americanchemicalsuppliers.com/list/search?search=sodium+starch+glycolate on 7/1/2026), in view of Weibel et al. (US 10925896 B2, published 2/23/2021).
Burshtein teaches pharmaceutical compositions comprising a therapeutically active agent and an absorption enhancer such as NAC, NAD, 5-CNAC, 4-MOAC, 4-CNAB or a salt thereof, for use in the treatment of a condition treatable by said therapeutically active agent. The compositions are specifically formulated for oral administration (Title; Abstract).
Burshtein teaches that the therapeutically active agent can be PTH(1-34) (teriparatide; Pg 22, lines 30-32).
Burshtein also teaches the pharmaceutical composition comprises at least two discrete unit dosage forms bound to one another by a coating and/or matrix, each of which comprises a therapeutically active agent and an absorption enhancer, wherein the coating and/or matrix is formulated for immediate release of the unit dosage forms upon oral administration (Pg 25, lines 24-32). The coating and/or matrix comprises a disintegrant, which refers to a substance that expands and/or dissolves upon contact with moisture. Examples of disintegrants include crosslinked carboxymethyl cellulose (croscarmellose, e.g., sodium croscarmellose) and sodium starch glycolate (Pg 29, lines 3-14).
Burshtein does not expressly teach that the composition comprises at least 10 weight percent sodium starch glycolate.
Weibel teaches pharmaceutical compositions for oral administration that can be swallowed directly or disintegrate in the oral cavity (Abstract). Superdisintegrants may be added to a composition depending on the intended use of the tablet, i.e. whether it is for intact swallowing or rapid disintegration (in the oral cavity or in a small amount of liquid prior to ingestion). The term “superdisintegrant” as used herein refers to a group of disintegration agents well-known to a person skilled in the art, which can be used in a fractional amount of normal disintegrates to obtain the same effect of facilitating the disintegration or “breakup” of the dosage form after administration. Suitable examples include sodium starch glycolate (commercially available under the trade names Primojel® and Explotab®) and croscarmellose sodium (cross-linked sodium carboxymethylcellulose, commercially available under the trade name Ac-Di-Sol), which can be present in an amount of 0.1-10% (w/w) (Col. 7, lines 16-45).
In summary, Burshtein teaches a composition comprising teriparatide and a salt of NAC for oral administration; the composition can further comprise a disintegrant such as sodium starch glycolate. Weibel teaches adding superdisintegrants, such as sodium starch glycolate, to pharmaceutical compositions to facilitate the “breakup” of the composition after it is administered; superdisintegrants need only be present in a fractional amount to effect the same outcome as a typical disintegrant, for example, 0.1-10% w/w.
Based on these teachings, regarding claim 1, it would be prima facie obvious to add sodium starch glycolate to the composition taught by Burshtein in an amount of 10%. One skilled in the art would be motivated to do so in order to further improve the tablet’s ability to disintegrate quickly, thus releasing teriparatide more rapidly to the patient in need; moreover, Weibel teaches a useful starting point (0.1-10% w/w) from which one skilled in the art could optimize further. One would have a reasonable expectation of success given that Weibel teaches that superdisintegrants can help dissolve or “breakup” the pharmaceutical composition after it is orally administered.
Regarding claim 8, Burshtein teaches NAC or a salt thereof can be at least 50 weight percent of the total weight of the composition (SNAC, bottom of Pg 35; Pg 36, lines 4-29).
Regarding claim 10, Burshtein teaches NAC or a salt thereof can have 2.5-99.4 weight percents (Pg 36, lines 4-7). In light of the teachings of Weibel above, this reads on NAC or a salt thereof and sodium starch glycolate collectively amounting to at least 80 weight percent of the total composition.
Regarding claim 11, as stated above, Weibel teaches the inclusion of sodium starch glycolate from 0.1-10% w/w. Weibel teaches Explotab® is a type of sodium starch glycolate (Col. 7, lines 16-45). 10% by weight represents 10 grams of sodium starch glycolate/gram of the pharmaceutical composition. USCS evidences that sodium starch glycolate, such as Explotab®, has a molecular weight of 500,000-1,000,000 (Pg 1, third paragraph underneath “Sodium Starch Glycolate. CAS No: 9063-38-1”). Therefore, 10 grams of sodium starch glycolate/total grams is equivalent to 0.02 millimoles/gram (10g/500,000g/mol*1000millimol/mol = 0.02 millimoles). Because sodium starch glycolate has at least one carboxylate group per repeating unit, where there are 5 or more repeating units results in a concentration of alkaline groups in the composition of at least 0.1millimoles/gram (0.02millimoles/gram * 5 = 0.1millimoles/gram).
Regarding claim 21, Burshtein teaches the pharmaceutical composition in a unit dosage form (Abstract; Pg 2, lines 21-32), wherein a unit dosage form is defined as a physically discrete unit, each unit containing a predetermined quantity of one or more active ingredient(s) calculated to produce, either alone or in the context of a predetermined number of the unit dosage forms, a desired therapeutic effect, optionally in association with at least one pharmaceutically acceptable carrier, diluent, excipient, or a combination thereof (Pg 13, lines 13-17).
Regarding claim 22, as described above regarding claim 11, where there are 2 or more repeating units results in a concentration of alkaline groups in the composition of at least 0.0.04millimoles/gram (0.02millimoles/gram * 2 = 0.0.04millimoles/gram).
Regarding claim 23, Burshtein teaches the multi-unit dosage form comprise at total of at least 50mg of the absorption enhancer (NAC or salt thereof) in the at least two dosage forms (Pg 4, lines 22-24). Burshtein also teaches the total amount of absorption enhancer (NAC or salt thereof) in the at least two unit dosage forms described herein is at least about 100mg (Pg 38, lines 1-4), which reads on 50mg/unit dosage form.
Regarding claim 24, Burshtein teaches the unit dosage form can be a tablet (Pg 82, lines 26-28).
Regarding claim 27, in addition to multiunit dosage forms, Burshtein also teaches single unit dosage forms or a single tablet (Pg 31, lines 27-32).
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, 8, 10-11, and 21-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 9, 11-15, 18, 24, and 26-28 of U.S. Patent No. 12,239,691 B2 (US ‘691) in view of Weibel et al. (US 10925896 B2, published 2/23/2021). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 of US ‘691 recites a pharmaceutical composition multi-unit dosage form comprising at least three discrete unit dosage forms bound to one another by a coating and/or matrix, each of said unit dosage forms comprising a therapeutically active agent and an absorption enhancer, said therapeutically active agent having a molecular weight in a range of 1 kDa to 100 kDa and/or being a BCS Class III agent, said unit dosage forms together comprising a therapeutically effective amount of said therapeutically active agent and an effective amount of said absorption enhancer, wherein said coating and/or matrix is formulated for immediate release of said unit dosage forms upon oral administration, such that the multi-unit dosage form disintegrates in gastric fluid and/or in saliva within no more than 5 minutes to thereby release said unit dosage forms, wherein said absorption enhancer is selected from the group consisting of NAC (8-N-(2-hydroxybenzoyl)aminocaprylate), NAD (10-N-(2-hydroxybenzoyl)aminodecanoic acid), 5-CNAC (8-N-(5-chlorosalicyloyl)aminocaprylic acid), 4-MOAC (8-N-(2-hydroxy-4-methoxybenzoyl)aminocaprylic acid), 4-CNAB (4-N-(2-hydroxy-4-chlorobenzoyl)aminobutanoic acid) and salts thereof, and wherein at least 50 weight percents of the unit dosage forms consists of said absorption enhancer.
Additional independent and dependent claims include additional characteristics of the coating and/or matrix (claim 2), the therapeutically active peptide (claims 9, 11-13, 24, 26-28), a method of treating a condition (claims 14 and 18), and a kit comprising thereof (claim 15). Regarding the method of treatment, the instant specification teaches the instant invention can be used in a method of treatment for osteoporosis, conditions associated with a bone fracture or bone defect, osteoarthritis, and hypoparathyroidism (instant Pg 31, lines 3-5).
The difference between copending US ‘691 and the instant claims is that US ‘691 does not expressly teach sodium glycolate or croscarmellose sodium that is at least 10 weight percent of the total weight of the composition.
Weibel teaches adding superdisintegrants, such as sodium starch glycolate or croscarmellose sodium, to orally administered pharmaceutical compositions to facilitate the “breakup” of the composition after it is administered; superdisintegrants need only be present in a fractional amount to effect the same outcome as a typical disintegrant, for example, 0.1-10% w/w.
Based upon these teachings, it would prima facie obvious to incorporate the teachings of Weibel into US ‘691, thereby arriving at the instant claims. One would be motivated to do so and have a reasonable expectation of success in order to improve the tablet’s ability to disintegrate quickly, thereby releasing teriparatide more rapidly to the patient in need thereof, and because Weibel teaches inclusion of said superdisintegrants for pharmaceutical compositions delivered orally. Thus, the claims are rendered obvious.
Claims 1, 8, 10-11, 21-24, and 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 7-14, 16, 19, and 21-26 of copending Application No. 18/841,379 (‘379 reference application; claim set filed 8/25/2024). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 of copending Application No. ‘379 recites a pharmaceutical composition comprising, as a therapeutically active agent, a parathyroid hormone; and an absorption enhancer, and a polymer comprising a plurality of alkaline groups, wherein a concentration of said polymer in the composition is at least 10 weight percent of the total weight of the composition, said absorption enhancer being a substituted or non-substituted fatty acid or salt thereof.
Dependent claims include additional characteristics of the polymer (claims 3, 4, 12, 13, 14, 16), the identity of the absorption enhancer (claim 7), the concentration of the absorption enhancer (claim 8), the concentration of the polymer (claim 9), the combined concentration of the absorption enhancer and the polymer (claim 10), the concentration of the alkaline groups (claim 11), the identity of the parathyroid hormone (claim 19), the composition as a unit dosage form and characteristics thereof (claims 21-24), and methods of treatment thereof (claims 25-26). The instant specification teaches the instant invention can be used in a method of treatment for osteoporosis, conditions associated with a bone fracture or bone defect, osteoarthritis, and hypoparathyroidism (instant Pg 31, lines 3-5).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 8, 10-11, 21-24, and 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 7-13, 15-17, 19, 21, 25, 26, 28, and 29 of copending Application No. 18/841,377 (‘377 reference application; claim set filed 8/25/2024). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 of copending Application No. ‘377 recites a pharmaceutical composition comprising a therapeutically active agent, an absorption enhancer, and a polymer comprising a plurality of alkaline groups, wherein a concentration of said polymer in the composition is at least 10 weight percent of the total weight of the composition, said absorption enhancer being a substituted or non-substituted fatty acid or a salt thereof.
Dependent claims include additional characteristics of the polymer (claims 3, 4, 12, 13, 15-17), the identity of the absorption enhancer (claim 7), the concentration of the absorption enhancer (claim 8), the concentration of the polymer (claim 9), the combined concentration of the absorption enhancer and the polymer (claim 10), the concentration of the alkaline groups (claims 11 and 26), characteristics of the therapeutically active compound (claims 19 and 21), the composition as a unit dosage form and characteristics thereof (claims 25 and 28), and methods of treatment thereof (claims 29). The instant specification teaches the instant invention can be used in a method of treatment for osteoporosis, conditions associated with a bone fracture or bone defect, osteoarthritis, and hypoparathyroidism (instant Pg 31, lines 3-5).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 8, 10-11, 21-24, and 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 7-16, 20-21, and 23-24 of copending Application No. 18/841,378 (‘378 reference application; claim set filed 8/25/2024) in view of Burshtein et al. (CA 3033259 A1, published 2/22/2018). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 of copending Application No. ‘378 recites a pharmaceutical composition comprising, as a therapeutically active agent, a glucagon-like peptide-2; and an absorption enhancer, and a polymer in the composition comprising a plurality of alkaline groups, wherein a concentration of said polymer in the composition is at least 10 weight percent of the total weight of the composition, said absorption enhancer being a substituted or non-substituted fatty acid or a salt thereof.
Dependent claims include additional characteristics of the polymer (claims 3, 4, 12, 13, 14-16), the identity of the absorption enhancer (claim 7), the concentration of the absorption enhancer (claim 8), the concentration of the polymer (claim 9), the combined concentration of the absorption enhancer and the polymer (claim 10), the concentration of the alkaline groups (claims 11 and 21), the composition as a unit dosage form and characteristics thereof (claims 20 and 23), and methods of treatment thereof (claims 24). The instant specification teaches the instant invention can be used in a method of treatment for osteoporosis, conditions associated with a bone fracture or bone defect, osteoarthritis, and hypoparathyroidism (instant Pg 31, lines 3-5).
The difference between copending Application No. ‘378 and the instant claims is that the active agent is a GLP2 instead of PTH(1-34).
Burshtein teaches pharmaceutical compositions comprising a therapeutically active agent, an absorption enhancer, and a disintegrant polymer. Burshtein teaches that therapeutically active agents can include PTH(1-34) as well as GLP2 (Pg 64, lines 21-26; Pg 65, lines 24-27). Based upon these teachings, it would prima facie obvious to substitute GLP2 for PTH(1-34). One would be motivated to do so and have a reasonable expectation of success given that Burshtein teaches similar pharmaceutical compositions wherein the active agent can be either PTH(1-34) or GLP2. Thus, the claims are rendered obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 8, 10-11, 21-24, and 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 and 21-25 of copending Application No. 18/841,375 (‘375 reference application; claim set filed 8/25/2024) in view of Burshtein et al. (CA 3033259 A1, published 2/22/2018). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 of copending Application No. ‘375 recites a pharmaceutical composition comprising a therapeutically active agent, an absorption enhancer, and a comprising a plurality of alkaline groups, wherein a concentration of said polymer in the composition is at least 10 weight percent of the total weight of the composition, said absorption enhancer being a substituted or non-substituted fatty acid or a salt thereof, wherein said therapeutically active agent is a polypeptide selected from a glucagon-like peptide-1 and a glucagon-like peptide-1 receptor agonist.
Dependent claims include additional characteristics of the polymer (claims 2-5, 12-17), the identity of the absorption enhancer (claims 6 and 7), the concentration of the absorption enhancer (claim 8), the concentration of the polymer (claim 9), the combined concentration of the absorption enhancer and the polymer (claim 10), the concentration of the alkaline groups (claims 11 and 22), the composition as a unit dosage form and characteristics thereof (claims 21 and 23-24), and methods of treatment thereof (claims 25). The instant specification teaches the instant invention can be used in a method of treatment for osteoporosis, conditions associated with a bone fracture or bone defect, osteoarthritis, and hypoparathyroidism (instant Pg 31, lines 3-5).
The difference between copending Application No. ‘378 and the instant claims is that the active agent is a GLP1 instead of PTH(1-34).
Burshtein teaches pharmaceutical compositions comprising a therapeutically active agent, an absorption enhancer, and a disintegrant polymer. Burshtein teaches that therapeutically active agents can include PTH(1-34) as well as GLP1 (Pg 64, lines 21-26; Pg 65, lines 24-27). Based upon these teachings, it would prima facie obvious to substitute GLP1 for PTH(1-34). One would be motivated to do so and have a reasonable expectation of success given that Burshtein teaches similar pharmaceutical compositions wherein the active agent can be either PTH(1-34) or GLP1. Thus, the claims are rendered obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 8, 10-11, and 21-24 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 7-9, 13, 16-17, 20, and 22-23 of copending Application No. 18/818,691 (‘691 reference application; claim set filed 8/29/2024) in view of Weibel et al. (US 10925896 B2, published 2/23/2021). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 of copending Application No. ‘691 recites a method of treating a condition treatable by parathyroid hormone or a fragment thereof in a subject in need thereof, the method comprising orally administering to the subject concomitantly from 3 to 10 pharmaceutical composition unit dosage forms, each of said unit dosage forms comprising said parathyroid hormone or a fragment thereof and an absorption enhancer, wherein said from 3 to 10 pharmaceutical composition unit dosage forms are not comprised by a multi-unit dosage form and together comprise a therapeutically effective amount of said parathyroid hormone or a fragment thereof and an effective amount of said absorption enhancer, wherein said absorption enhancer is selected from the group consisting of NAC (8-N-(2-hydroxybenzoyl)aminocaprylate), NAD (10-N-(2-hydroxybenzoyl)aminodecanoic acid), 5-CNAC (8-N-(5-chlorosalicyloyl)aminocaprylic acid), 4-MOAC (8-N-(2-hydroxy-4-methoxybenzoyl)aminocaprylic acid), 4-CNAB (4-N-(2-hydroxy-4-chlorobenzoyl)aminobutanoic acid) and salts thereof.
Additional claims include the concentration of the absorption enhancer (claims 2 and claim 20), species of the parathyroid hormone (claims 4 and 13), the species of the absorption enhancer (claim 7 and 16), the medical condition to be treated (claim 8), a kit thereof (claim 9), a pharmaceutical composition thereof (claim 17). Claims 22 and 23 also recites a method of treating.
The difference between copending copending Application No. ‘691 and the instant claims is that copending Application ‘691 not expressly teach sodium glycolate or croscarmellose sodium that is at least 10 weight percent of the total weight of the composition.
Weibel teaches adding superdisintegrants, such as sodium starch glycolate or croscarmellose sodium, to orally administered pharmaceutical compositions to facilitate the “breakup” of the composition after it is administered; superdisintegrants need only be present in a fractional amount to effect the same outcome as a typical disintegrant, for example, 0.1-10% w/w.
Based upon these teachings, it would prima facie obvious to incorporate the teachings of Weibel into copending Application No. ‘691, thereby arriving at the instant claims. One would be motivated to do so and have a reasonable expectation of success in order to improve the tablet’s ability to disintegrate quickly, thereby releasing teriparatide more rapidly to the patient in need thereof, and because Weibel teaches inclusion of said superdisintegrants for pharmaceutical compositions delivered orally. Thus, the claims are rendered obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sara Konopelski Snavely whose telephone number is (571)272-1841. The examiner can normally be reached Monday - Friday 9-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa L Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARA E KONOPELSKI SNAVELY/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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