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 . 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 20 Nov, 2025 has been entered.
Claims Status
Claims 1, 3-6 and 10 are pending.
Claims 1 and 10 have been amended.
Maintained/Modified Rejections
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, 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) 1-6 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Cusano et al (J. Endocrinol. Invest. (2013) 36(11) p1121-1127, cited by applicants) in view of Kidron et al (US 20110142800, cited by applicants), and Hammerle et al (Bone (2012) 50 p965-973, cited by applicants).
Cusano et al discuss parathyroid hormones in the treatment of hypoparathyroidism (title). A number of studies show benefits of administering teriparatide to sufferers of this disorder (p3, 3d paragraph to p5, 2nd paragraph).
The difference between this reference and the instant claims is that this reference does not discuss oral administration using SNAC.
Kidron et al discuss oral administration of proteins (title) using an absorption enhancer and a protease inhibitor (abstract). Most polypeptides are dosed parenterally, although this typically leads to low patient compliance (paragraph 2). The oral dosage forms are effective for polypeptides up to 100 kDa (paragraph 13) and down to 1 kDa (paragraph 15), a size range that includes the teriparatide of Cusano et al. One formulation described lists SNAC, the active polypeptide, a protease inhibitor, and EDTA and/or an omega-3 fatty acid (paragraph 14). A number of polypeptides are discussed as useful in the invention, including parathyroid hormone (paragraph 33). The protease inhibitor can be a trypsin inhibitor, such as soybean trypsin inhibitor (paragraph 50). Dosage forms can include tablets (paragraph 116). The amount administered with the absorption enhancer at an amount sufficient to deliver the active agent for the desired effect (paragraph 67). Sustained release dosing forms, to allow frequency of treatment to be reduced to once or twice a day is discussed (paragraph 92). This reference teaches oral administration using SNAC and a soybean trypsin inhibitor.
Hammerle et al discuss a clinical trial examining the pharmacokinetics of orally administered teriparatide with an absorption enhancer (abstract). Dosages between 1 and 10 mg of teriparatide using 200 mg of CNAC (structurally very similar to SNAC of the instant claims), and 2.5-5 mg using 200 mg of CNAC were used (p967, 1st column, last paragraph, continues to 2nd column). Each patients received multiple treatments, which were measured separately (p966, 2nd column, 6th paragraph). Pharmacokinetics data shows generally increasing blood concentrations with dose, and similar timing of uptake and no significant differences between the 100 and 200 mg CNAC arms (table 2, p969, top of page). This reference shows that the pharmacokinetics claimed by applicants is similar to the known pharmacokinetics for a similar material.
Therefore, it would be obvious to use the oral formulations of Kidron et al to treat the hypoparathyroidism of Cusano et al, to increase the compliance, as discussed by Kidron et al. As Hammerle et al discuss a very similar formulation for a similar purpose, an artisan in this field would attempt this process with a reasonable expectation of success.
Cusano et al discusses using teriparatide to treat hypoparathyroidism. Kidron et al renders obvious oral formulations with SNAC, and discusses administration twice per day with extended release versions. Hammerle et al discusses how changing the formulation modifies the blood concentrations, measured after dosing, which will allow for obtaining a therapeutically effective dose; essentially, optimization of the dose (MPEP 2144.05(II)). Thus, the combination of references renders obvious claim 1.
Kidron et al discusses using a protease inhibitor, and specifically mention soybean trypsin inhibitor, rendering obvious claims 3-6.
Kidron et al discusses extended release formulations, allowing for dosing once or twice a day. Presumably, non-extended release formulations will require more frequent dosing. Thus, the combination of references renders obvious claim 10.
response to applicant’s arguments
Applicants argue that there is no reasonable expectation of success, that Kidron et al discusses insulin and exenatide, not teriparatide, that it is not possible to get to applicant’s invention via optimization of Kidron et al, that SNAC and CNAC would not be expected to give similar pharmacokinetics, that Hammerle et al teaches away from the invention, claim an unexpected result of variation of SNAC concentration provide improved bioavailability, and claim an unexpected result of the claimed formulation suitable for use. These arguments are supported by a declaration by Prof. Greg Burshtein, applicant.
Applicant's arguments filed 20 Nov, 2025 have been fully considered but they are not persuasive.
Applicants argue that there is no reasonable expectation of success, based on a reference published after applicant’s priority date discussing the difficulties in oral peptide availability and Prof. Burshtiein’s failed experiments with other polypeptide drugs. For the reference, it is not clear what an expectation of success is based on the reference; note that applicants have demonstrated vary low bioavailability and a large amount of variability (based on the large standard deviations of their experiment). Furthermore, Hammerle et al demonstrate success in getting physiologically relevant amounts into the bloodstream using a method vary similar to applicants. Applicants argue that the inventors have failed with other peptide drugs. However, it’s not clear what applicants consider a ‘success,’ it’s not clear how many different polypeptide drugs applicants have attempted to develop, it’s not clear if the data given is after optimization or not, it’s not clear if this data was developed just for this invention to show unpredictability. The MPEP states that the failure of experimenters who have no interest in succeeding should not be accorded great weight (MPEP 716.07). Nor is it clear that the failure is not an expected result of applicant’s prior experiments. It’s known in the art that SNAC works by reversibly binding to the peptide, rendering it more hydrophobic and able to pass more easily through gastrointestinal barriers (Malkov et al, Curr. Drug Deliv. (2005) 2 p191-197, p197, 1st column, 2nd paragraph). Logically, a more hydrophobic compound would benefit less, as it is already hydrophobic. But applicants have given no data on what peptides they failed with, or their hydrophobicity.
Applicants argue that Kidron et al discusses insulin and exenatide, not teriparatide. While the examples are directed to those two drugs, the disclosure of the reference is much broader, and explicitly mentions parathyroid hormone, a genus that includes teriparatide.
Applicants argue that it is not possible to get from Kidron et al to applicant’s invention. The reason is that the examples use a lower ratio of SNAC/peptide, and that the reference does not discuss ratios. However, the disclosure of Kidron et al is broader than just the examples, and allow for larger amounts of SNAC (MPEP 2123(I)). Applicants note that Kidron et al does not describe their invention in terms of ratios, as applicants do, but any formulation will have a ratio of SNAC and therapeutic. The fact that Kidron et al does not discuss their invention in those terms does not mean that optimization will not end up with similar values.
Applicants argue that SNAC and CNAC would be expected to give different pharmacokinetics. CNAC has the structure
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. SNAC has the structure
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. The ONLY difference is the chloride on CNAC that is not found on SNAC. Compounds with similar structures are expected to have similar properties (MPEP 2144.09(I)). These two compounds have similar structures, and are used for the same purpose. A person of skill in the art would expect them to work by a similar mechanism – weak absorption onto the therapeutic, increasing its lipophilicity to increase absorption from the digestive tract (Malkov et al, Curr. Drug Deliv. (2005) 2 p191-197). Applicants point to other differences in effect, but they do not say anything about the mechanism of uptake.
Applicants argue that Hammerle et al teaches away from the invention. This requires a mathematical transformation not suggested by any reference in the rejection, nor have applicants pointed to any prior art reference suggesting the transformation. It is not clear how this is a teaching away.
Applicants argue that increasing the ratio of SNAC to teriparatide increases bioavailability, an alleged unexpected result. There are a number of issues with the data underlying the argument. First, as the amount of SNAC is varied, the difference is made up with sodium starch glycolate, which applicants state can potentiate SNAC activity (paragraph 27 of Prof. Burshtein declaration). In other words, the different doses are not an apples to apples comparison. Second, applicants have previously demonstrated that varying the amount of SNAC can affect dissolution in related applications. It is not clear if applicants have optimized their tableting procedure for each formulation for optimum dissolution; the results applicants are demonstrating could just be differences in this parameter due to insufficient optimization. Third, it is the burden on applicants to show that the results are statistically significant (MPEP 716.02(b)). There is no mention of statistical significance in the declaration, but the means±SD overlap for most of the comparisons, strongly suggesting a lack of statistical significance. Finally, it is not clear why this is considered unexpected. The only evidence that applicants have given that a person of skill in the art would assume otherwise is an experiment of Hammerle et al, which has large error bars. But, Hammerle et al does not say that the concentration of absorption enhancer has no effect, just that it was not measured over a small range – if it was over all concentrations, it would have no effect and could be left out of the formulation. Furthermore, the mechanism of action is weakly binding to the protein to make it more lipophilic so it will diffuse out of the gastrointestinal tract and increase protease resistance (Malkov et al, Curr. Drug Deliv. (2005) 2 p191-197, p197, 1st column, 2nd paragraph). Given that this is a binding, it can be saturated, and a person of skill in the art would also appreciate that the soybean trypsin inhibitor, also a protein and included in a large excess over the therapeutic, would also be bound, requiring more of the absorption enhancer to saturate. In other words, a person of skill in the art would expect a non-linear saturable effect of varying the amount of SNAC.
Applicants argue that the formulation works is unexpected, and that it has superior pharmacokinetics over SC administration, as it has faster uptake. It is not clear how a formulation working much as the rejection suggests is unexpected. But it is known that SC administration leads to relatively slow uptake (Richter et al, Drug Metab. Dispos. (2014) 42 p1881-1889, abstract), and oral uptake can be rapid (Teja-Isavadharm et al, Br. J. Clin. Pharmacol. (1996) 42 p599-604).
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.
first rejection
Claims 1, 3-6 and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 15/549,394 (US 20180036382 in view of Cusano et al (J. Endocrinol. Invest. (2013) 36(11) p1121-1127, cited by applicants) and Kidron et al (US 20110142800, cited by applicants).
Competing claim 1 describes a formulation comprising teriparatide, SNAC, and soybean trypsin inhibitor.
The difference between the competing claims and the examined claims is that the competing claims do not describe using the material to treat hypoparathyroidism, nor some details of the formulation in the dependent claims.
Cusano et al discuss parathyroid hormones in the treatment of hypoparathyroidism (title). A number of studies show benefits of administering teriparatide to sufferers of this disorder (p3, 3d paragraph to p5, 2nd paragraph). This reference teaches using teriparatide to treat hypoparathyroidism.
Kidron et al discuss oral administration of proteins (title) using an absorption enhancer and a protease inhibitor (abstract). Most polypeptides are dosed parenterally, although this typically leads to low patient compliance (paragraph 2). The oral dosage forms are effective for polypeptides up to 100 kDa (paragraph 13) and down to 1 kDa (paragraph 15), a size range that includes the teriparatide of Cusano et al. One formulation described lists SNAC, the active polypeptide, a protease inhibitor, and EDTA and/or an omega-3 fatty acid (paragraph 14). A number of polypeptides are discussed as useful in the invention, including parathyroid hormone (paragraph 33). The protease inhibitor can be a trypsin inhibitor, such as soybean trypsin inhibitor (paragraph 50). Dosage forms can include tablets (paragraph 116). The amount administered with the absorption enhancer at an amount sufficient to deliver the active agent for the desired effect (paragraph 67). Sustained release dosing forms, to allow frequency of treatment to be reduced to once or twice a day is discussed (paragraph 92). This reference teaches more details about formulation with SNAC and a protease inhibitor.
Therefore, it would be obvious to use the formulation of the competing claims to treat the hypoparathyroidism of Cusano et al, to provide the benefits of this therapy to that population. As this is a known therapy for this disorder, an artisan in this field would attempt this therapy with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
response to applicant’s arguments
Applicants request that addressing these rejections be deferred until indication of allowable subject matter. However, until this rejection is overcome, it will remain valid.
second rejection
Claims 1, 3-6 and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 45 and 16 of copending Application No. 15/549,425 (US 20180028622) in view of Cusano et al (J. Endocrinol. Invest. (2013) 36(11) p1121-1127) and Kidron et al (US 20110142800, cited by applicants).
Competing claim 15 describes a method of treating osteoporosis comprising oral administration of PTH, SNAC, and soybean trypsin inhibitor, with concentration ranges very similar to that of the instant claims. Competing claim 16 requires teriparatide. While the competing claims do not use the same dose schedule, this is considered mere optimization, and not a patentable distinction.
The difference between the competing claims and the instant claims is that the disorder is different.
Cusano et al discuss parathyroid hormones in the treatment of hypoparathyroidism (title). A number of studies show benefits of administering teriparatide to sufferers of this disorder (p3, 3d paragraph to p5, 2nd paragraph). This reference teaches using teriparatide to treat hypoparathyroidism.
Kidron et al discuss oral administration of proteins (title) using an absorption enhancer and a protease inhibitor (abstract). Most polypeptides are dosed parenterally, although this typically leads to low patient compliance (paragraph 2). The oral dosage forms are effective for polypeptides up to 100 kDa (paragraph 13) and down to 1 kDa (paragraph 15), a size range that includes the teriparatide of Cusano et al. One formulation described lists SNAC, the active polypeptide, a protease inhibitor, and EDTA and/or an omega-3 fatty acid (paragraph 14). A number of polypeptides are discussed as useful in the invention, including parathyroid hormone (paragraph 33). The protease inhibitor can be a trypsin inhibitor, such as soybean trypsin inhibitor (paragraph 50). Dosage forms can include tablets (paragraph 116). The amount administered with the absorption enhancer at an amount sufficient to deliver the active agent for the desired effect (paragraph 67). Sustained release dosing forms, to allow frequency of treatment to be reduced to once or twice a day is discussed (paragraph 92). This reference teaches more details about formulation with SNAC and a protease inhibitor.
Therefore, it would be obvious to use the formulation of the competing claims to treat the hypoparathyroidism of Cusano et al, to provide the benefits of this therapy to that population. As this is a known therapy for this disorder, an artisan in this field would attempt this therapy with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
response to applicant’s arguments
Applicants request that addressing these rejections be deferred until indication of allowable subject matter. However, until this rejection is overcome, it will remain valid.
third rejection
Claims 1, 3-6 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12, 14, 20, 21, and 23 of US Patent No. 10,583,177 in view of Cusano et al (J. Endocrinol. Invest. (2013) 36(11) p1121-1127) and Kidron et al (US 20110142800, cited by applicants).
Competing claim 12 describes a formulation comprising an active agent and SNAC for oral administration. Competing claim 14 specifies that the formulation comprises a protease inhibitor. Competing claims 20 and 21 specify a polypeptide, with a Markush group that includes a PTH. Competing claim 23 describes a method of treating a disorder that can be treated with the oral formulation of competing claim 12.
The difference between the competing claims and the instant claims is that the competing claims do not specify the PTH is teriparatide or the disorder is hypoparathyroidism, and some limitations of the dependent claims.
Cusano et al discuss parathyroid hormones in the treatment of hypoparathyroidism (title). A number of studies show benefits of administering teriparatide to sufferers of this disorder (p3, 3d paragraph to p5, 2nd paragraph). This reference teaches using teriparatide to treat hypoparathyroidism.
Kidron et al discuss oral administration of proteins (title) using an absorption enhancer and a protease inhibitor (abstract). Most polypeptides are dosed parenterally, although this typically leads to low patient compliance (paragraph 2). The oral dosage forms are effective for polypeptides up to 100 kDa (paragraph 13) and down to 1 kDa (paragraph 15), a size range that includes the teriparatide of Cusano et al. One formulation described lists SNAC, the active polypeptide, a protease inhibitor, and EDTA and/or an omega-3 fatty acid (paragraph 14). A number of polypeptides are discussed as useful in the invention, including parathyroid hormone (paragraph 33). The protease inhibitor can be a trypsin inhibitor, such as soybean trypsin inhibitor (paragraph 50). Dosage forms can include tablets (paragraph 116). The amount administered with the absorption enhancer at an amount sufficient to deliver the active agent for the desired effect (paragraph 67). Sustained release dosing forms, to allow frequency of treatment to be reduced to once or twice a day is discussed (paragraph 92). This reference teaches more details about formulation with SNAC and a protease inhibitor.
Therefore, it would be obvious to use the formulation of the competing claims to treat the hypoparathyroidism of Cusano et al, to provide the benefits of this therapy to that population. As this is a known therapy for this disorder, an artisan in this field would attempt this therapy with a reasonable expectation of success.
response to applicant’s arguments
Applicants request that addressing these rejections be deferred until indication of allowable subject matter. However, until this rejection is overcome, it will remain valid.
fourth rejection
Claims 1, 3-6 and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21 and 38 of copending Application No. 15/549,418 (US 20180036234) in view of Cusano et al (J. Endocrinol. Invest. (2013) 36(11) p1121-1127) and Kidron et al (US 20110142800, cited by applicants).
Competing claim 21 describes a method of treating bone fractures, comprising orally administering PTH, specifically teriparatide, with SNAC and a soybean trypsin inhibitor and a dose that overlaps with that of the instant claims. Competing claim 38 describes a dosing schedule that overlaps with that of the instant claims.
The difference between the competing claims and the examined claims is that the competing claims are treating a different disorder, and some limitations in the dependent claims.
Cusano et al discuss parathyroid hormones in the treatment of hypoparathyroidism (title). A number of studies show benefits of administering teriparatide to sufferers of this disorder (p3, 3d paragraph to p5, 2nd paragraph). This reference teaches using teriparatide to treat hypoparathyroidism.
Kidron et al discuss oral administration of proteins (title) using an absorption enhancer and a protease inhibitor (abstract). Most polypeptides are dosed parenterally, although this typically leads to low patient compliance (paragraph 2). The oral dosage forms are effective for polypeptides up to 100 kDa (paragraph 13) and down to 1 kDa (paragraph 15), a size range that includes the teriparatide of Cusano et al. One formulation described lists SNAC, the active polypeptide, a protease inhibitor, and EDTA and/or an omega-3 fatty acid (paragraph 14). A number of polypeptides are discussed as useful in the invention, including parathyroid hormone (paragraph 33). The protease inhibitor can be a trypsin inhibitor, such as soybean trypsin inhibitor (paragraph 50). Dosage forms can include tablets (paragraph 116). The amount administered with the absorption enhancer at an amount sufficient to deliver the active agent for the desired effect (paragraph 67). Sustained release dosing forms, to allow frequency of treatment to be reduced to once or twice a day is discussed (paragraph 92). This reference teaches more details about formulation with SNAC and a protease inhibitor.
Therefore, it would be obvious to use the formulation of the competing claims to treat the hypoparathyroidism of Cusano et al, to provide the benefits of this therapy to that population. As this is a known therapy for this disorder, an artisan in this field would attempt this therapy with a reasonable expectation of success.
response to applicant’s arguments
Applicants request that addressing these rejections be deferred until indication of allowable subject matter. However, until this rejection is overcome, it will remain valid.
fifth rejection
Claims 1, 3-6 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 15-17, and 19 of US Patent No. 12,239,691 in view of Cusano et al (J. Endocrinol. Invest. (2013) 36(11) p1121-1127) and Kidron et al (US 20110142800, cited by applicants).
Competing claim 1 describes formulations of a therapeutically active agent and a genus of compounds including the free acid of SNAC (which is considered equivalent to SNAC) as an absorption enhancer. Competing claims15-17 together describe the therapeutically active agent as teriparatide. Competing claim 39 is a method of treating a condition treatable by parathyroid hormone.
The difference between the competing claims and the instant claims is that the competing claims do not specify the disorder, nor do they give the dose and schedule of the instant claims.
Cusano et al discuss parathyroid hormones in the treatment of hypoparathyroidism (title). A number of studies show benefits of administering teriparatide to sufferers of this disorder (p3, 3d paragraph to p5, 2nd paragraph). This reference teaches using teriparatide to treat hypoparathyroidism.
Kidron et al discuss oral administration of proteins (title) using an absorption enhancer and a protease inhibitor (abstract). Most polypeptides are dosed parenterally, although this typically leads to low patient compliance (paragraph 2). The oral dosage forms are effective for polypeptides up to 100 kDa (paragraph 13) and down to 1 kDa (paragraph 15), a size range that includes the teriparatide of Cusano et al. One formulation described lists SNAC, the active polypeptide, a protease inhibitor, and EDTA and/or an omega-3 fatty acid (paragraph 14). A number of polypeptides are discussed as useful in the invention, including parathyroid hormone (paragraph 33). The protease inhibitor can be a trypsin inhibitor, such as soybean trypsin inhibitor (paragraph 50). Dosage forms can include tablets (paragraph 116). The amount administered with the absorption enhancer at an amount sufficient to deliver the active agent for the desired effect (paragraph 67). Sustained release dosing forms, to allow frequency of treatment to be reduced to once or twice a day is discussed (paragraph 92). This reference teaches more details about formulation with SNAC and a protease inhibitor.
Therefore, it would be obvious to use the formulation of the competing claims to treat the hypoparathyroidism of Cusano et al, to provide the benefits of this therapy to that population. As this is a known therapy for this disorder, an artisan in this field would attempt this therapy with a reasonable expectation of success.
response to applicant’s arguments
Applicants request that addressing these rejections be deferred until indication of allowable subject matter. However, until this rejection is overcome, it will remain valid.
sixth rejection
Claims 1, 3-6 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6, and 10 of US 12,076,373 in view of Cusano et al (J. Endocrinol. Invest. (2013) 36(11) p1121-1127) and Kidron et al (US 20110142800, cited by applicants).
Competing claim 1 describes a formulation of a therapeutic for oral administration with SNAC, while competing claims 2 and 3 describe addition of soybean trypsin inhibitor. Competing claim 10 specifies using the formulation to treat a disorder treated by the therapeutic.
The difference between the competing claims and the instant claims is that the competing claims do not specify the ratios of the compounds in the tablet, nor the dosage or the disorder treated.
Cusano et al discuss parathyroid hormones in the treatment of hypoparathyroidism (title). A number of studies show benefits of administering teriparatide to sufferers of this disorder (p3, 3d paragraph to p5, 2nd paragraph). This reference teaches using teriparatide to treat hypoparathyroidism.
Kidron et al discuss oral administration of proteins (title) using an absorption enhancer and a protease inhibitor (abstract). Most polypeptides are dosed parenterally, although this typically leads to low patient compliance (paragraph 2). The oral dosage forms are effective for polypeptides up to 100 kDa (paragraph 13) and down to 1 kDa (paragraph 15), a size range that includes the teriparatide of Cusano et al. One formulation described lists SNAC, the active polypeptide, a protease inhibitor, and EDTA and/or an omega-3 fatty acid (paragraph 14). A number of polypeptides are discussed as useful in the invention, including parathyroid hormone (paragraph 33). The protease inhibitor can be a trypsin inhibitor, such as soybean trypsin inhibitor (paragraph 50). Dosage forms can include tablets (paragraph 116). The amount administered with the absorption enhancer at an amount sufficient to deliver the active agent for the desired effect (paragraph 67). Sustained release dosing forms, to allow frequency of treatment to be reduced to once or twice a day is discussed (paragraph 92). This reference teaches more details about formulation with SNAC and a protease inhibitor.
Therefore, it would be obvious to use the formulation of the competing claims to treat the hypoparathyroidism of Cusano et al, to provide the benefits of this therapy to that population. As this is a known therapy for this disorder, an artisan in this field would attempt this therapy with a reasonable expectation of success.
response to applicant’s arguments
Applicants request that addressing these rejections be deferred until indication of allowable subject matter. However, until this rejection is overcome, it will remain valid.
seventh rejection
Claims 1, 3-6 and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 9 of copending Application No. 18/798,864 in view of Cusano et al (J. Endocrinol. Invest. (2013) 36(11) p1121-1127) and Kidron et al (US 20110142800, cited by applicants).
Competing claim 1 describes formulations of a therapeutically active agent and SNAC for oral administration of therapeutically active polypeptides. Competing claim 2 adds a protease inhibitor, while competing claim 9 is a method of treating a condition treatable by the polypeptide of claim 1.
The difference between the competing claims and the instant claims is that the competing claims do not specify the disorder, the polypeptide, nor do they give the dose and schedule of the instant claims.
Cusano et al discuss parathyroid hormones in the treatment of hypoparathyroidism (title). A number of studies show benefits of administering teriparatide to sufferers of this disorder (p3, 3d paragraph to p5, 2nd paragraph). This reference teaches using teriparatide to treat hypoparathyroidism.
Kidron et al discuss oral administration of proteins (title) using an absorption enhancer and a protease inhibitor (abstract). Most polypeptides are dosed parenterally, although this typically leads to low patient compliance (paragraph 2). The oral dosage forms are effective for polypeptides up to 100 kDa (paragraph 13) and down to 1 kDa (paragraph 15), a size range that includes the teriparatide of Cusano et al. One formulation described lists SNAC, the active polypeptide, a protease inhibitor, and EDTA and/or an omega-3 fatty acid (paragraph 14). A number of polypeptides are discussed as useful in the invention, including parathyroid hormone (paragraph 33). The protease inhibitor can be a trypsin inhibitor, such as soybean trypsin inhibitor (paragraph 50). Dosage forms can include tablets (paragraph 116). The amount administered with the absorption enhancer at an amount sufficient to deliver the active agent for the desired effect (paragraph 67). Sustained release dosing forms, to allow frequency of treatment to be reduced to once or twice a day is discussed (paragraph 92). This reference teaches more details about formulation with SNAC and a protease inhibitor.
Therefore, it would be obvious to use the formulation of the competing claims to treat the hypoparathyroidism of Cusano et al, to provide the benefits of this therapy to that population. As this is a known therapy for this disorder, an artisan in this field would attempt this therapy with a reasonable expectation of success.
response to applicant’s arguments
Applicants request that addressing these rejections be deferred until indication of allowable subject matter. However, until this rejection is overcome, it will remain valid.
eighth rejection
Claims 1, 3-6 and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 25 and 26 of copending Application No. 18/841,379 in view of Cusano et al (J. Endocrinol. Invest. (2013) 36(11) p1121-1127) and Kidron et al (US 20110142800, cited by applicants).
Competing claim 1 describes formulations of a parathyroid hormone and an absorption enhancer. Competing claim 7 specifies that the absorption enhancer is NAC (the acid form of SNAC, and considered equivalent). Competing claim 25 is a method of treating a condition treatable by the formulation of claim 1, while claim 26 specifies a Markush group of disorders, including hypoparathyroidism.
The difference between the competing claims and the instant claims is that the competing claims do not specify teriparatide and a protease inhibitor, nor do they give the dose and schedule of the instant claims.
Cusano et al discuss parathyroid hormones in the treatment of hypoparathyroidism (title). A number of studies show benefits of administering teriparatide to sufferers of this disorder (p3, 3d paragraph to p5, 2nd paragraph). This reference teaches using teriparatide to treat hypoparathyroidism.
Kidron et al discuss oral administration of proteins (title) using an absorption enhancer and a protease inhibitor (abstract). Most polypeptides are dosed parenterally, although this typically leads to low patient compliance (paragraph 2). The oral dosage forms are effective for polypeptides up to 100 kDa (paragraph 13) and down to 1 kDa (paragraph 15), a size range that includes the teriparatide of Cusano et al. One formulation described lists SNAC, the active polypeptide, a protease inhibitor, and EDTA and/or an omega-3 fatty acid (paragraph 14). A number of polypeptides are discussed as useful in the invention, including parathyroid hormone (paragraph 33). The protease inhibitor can be a trypsin inhibitor, such as soybean trypsin inhibitor (paragraph 50). Dosage forms can include tablets (paragraph 116). The amount administered with the absorption enhancer at an amount sufficient to deliver the active agent for the desired effect (paragraph 67). Sustained release dosing forms, to allow frequency of treatment to be reduced to once or twice a day is discussed (paragraph 92). This reference teaches more details about formulation with SNAC and a protease inhibitor.
Therefore, it would be obvious to use the teriparatide of Cusano et al as the parathyroid hormone, as a species of the genus of parathyroid hormone of the competing claims. As Cusano et al shows that this fragment is effective, an artisan in this field would attempt this therapy with a reasonable expectation of success.
response to applicant’s arguments
Applicants request that addressing these rejections be deferred until indication of allowable subject matter. However, until this rejection is overcome, it will remain valid.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658