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 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.
Claims Status
Claims 1-3, 10, 11, 17, 18, 24, 32, 33, 35, 39-41, 43, and 45-48 are pending.
Claims 1, 3, 18, 24, 39, 40, and 43 have been amended.
Claims 32, 33, and 35 have been withdrawn due to an election/restriction requirement.
Maintained/Modified Rejections
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 18 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for bioavailability in the low single digit percentages, does not reasonably provide enablement for higher bioavailability. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The MPEP states “There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is ‘undue.’ These factors include, but are not limited to: 1) the breadth of the claims; 2) the nature of the invention; 3) the state of the prior art; 4) the level of one of ordinary skill; 5) the level of predictability in the art; 6) the amount of direction provided by the inventor; 7) the existence of working examples; and 8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure” (MPEP 2164.01(a).
1 and 2) the breadth of the claims and the nature of the invention: Applicants are claiming an orally available formulation of PTH, with the rejected claim allowing for a bioavailability of up to 5%.
3) the state of the prior art: Hammerle et al (Bone (2012) 50 p965-973, cited by applicants), using CNAC and PTH, finds a bioavailability of less than 1%, with high levels of variability (p972, 2nd column, 3d paragraph). This reference shows that similar embodiments to those of applicants have very low bioavailability.
Peng et al (Expert Opin. Drug Delv. (2023) 20(10 p1349-1369) explicitly states that, well after applicant’s priority date, one of the problems of orally dosing polypeptides is weak absorption (abstract). Successes show relatively small improvements over free polypeptide (note 14th page, 2nd paragraph, for example, which describes an experiment with a bioavailability of 29.6% greater than that of free polypeptide). This reference shows that, well after applicant’s priority date, bioavailability is still a major issue with orally available polypeptide formulations.
4) the level of one of ordinary skill: The level of skill in the art is high.
5) the level of predictability in the art: As noted previously, Peng et al, well after applicant’s priority date, shows that bioavailability is an issue, showing a low level of predictability in the art.
6 and 7) the amount of direction provided by the inventor and the existence of working examples: The disclosure merely gives different prospective ranges of bioavailability, and that SNAC will increase bioavailability (p42, 1st paragraph). Aside from the permeation enhancer, there is no discussion of how to increase bioavailability. A declaration filed on 5 Feb, 2024 shows that the bioavailability of the formulations of Hammerle et al are around 0.25%, while those of applicant’s claimed invention are somewhat less than 1% (table A and table B, 9th page), although how these numbers were calculated is not given.
8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure: The prior art shows low bioavailability from similar formulations. Applicant’s formulations, which presumably have been optimized, have a bioavailability of less than 1% in a clinical trial in humans. A reference published well after applicant’s priority date states that bioavailability is an issue in this field. This shows that it would take undue experimentation to match the entire range of bioavailability claimed by applicants.
response to applicant’s arguments
Applicants have amended the claim to narrow the range, and state that this is enabled.
Applicant's arguments filed 20 Nov, 2025 have been fully considered but they are not persuasive.
Applicants have provided no evidence that they can achieve an average bioavailability above 1%. Their declarations, which presumably use their best mode after optimization, all show bioavailability below 1%. There is no guidance given by applicants on how to increase this parameter, and have clearly done all the optimization discussed by Kidron et al. Given that this is known to be a difficult problem, the invention is not enabled for more than 5x applicant’s best results.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 10, 11, 17, 18, 24, 39, 40, 41, 43, and 45-48 are rejected under 35 U.S.C. 103 as being unpatentable over Hammerle et al (Bone (2012) 50 p965-973) in view of Kidron et al (US 20110142800, previously cited)
Hammerle et al discuss a clinical trial examining the pharmacokinetics of orally administered teriparatide with an absorption enhancer, and discuss its applications in the treatment of osteoporosis (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). 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). Note that the Cmax (74.1-1624 pg/mL) and AUC/Cmax (0.386-0.449h) from table 2 are, within the error of the measurements, in the range claimed by applicants, and that the Cmax of the more standard administration route was 149 pg/ml (table 2, p969, top of page). In other words, the dosages used were within the range of the therapeutic dosages, however, uncertainty is very large in all measurements.
The difference between this reference and the instant claims is that this reference uses a different permeation enhancer, and does not discuss soybean trypsin inhibitor.
Kidron et al discuss compositions for the oral administration of proteins (title), including parathyroid hormone (paragraph 33). Using oral dosing, the low patient compliance with injected dosage forms can be avoided (paragraph 2). This is accomplished using a protease inhibitor and an absorption enhancer (paragraph 13). The protease inhibitor can be soybean trypsin inhibitor (paragraph 50), applicant’s elected species of protease inhibitor. The protease inhibitor can be around 0.2 to 10 mg/dosage unit, or more (paragraph 56). The absorption enhancer can be SNAC (paragraph 65). The absorption enhancer can be almost all of the composition (99.4% w/w) (paragraph 68), or 70 mg or more per dosage unit (paragraph 70). Various dosage forms, including tablets, are discussed (paragraph 120). Magnesium stearate, applicant’s elected lubricant, is mentioned as useful for that purpose (paragraph 114). The composition can be formulated to achieve a particular release profile, as known by one skilled in the art (paragraph 115). Note that the protease inhibitor is synergistic with the permeation enhancer (paragraph 124); this means that, with the protease inhibitor, a lower pharmaceutical dose can be used. Examples are given with 2.5 mg aprotinin (protease inhibitor) and 6 mg insulin (paragraph 123). Optimizing the amount of the protease inhibitor (paragraph 128) and the uptake enhancer (paragraph 129) is mentioned.
Therefore, it would be obvious to use the SNAC of Kidron et al for the CNAC of Hammerle et al, as Kidron et al discuss both uptake inhibitors, and discuss optimizing the uptake inhibitor and the amount of the material. As this is standard pharmaceutical development, an artisan in this field would attempt this modification with a reasonable expectation of success.
Furthermore, it would be obvious to add soybean trypsin inhibitor as described by Kidron et al, to increase the amount of the peptide absorbed. As the reference clearly states that this will benefit uptake, an artisan in this field would attempt this addition with a reasonable expectation of success.
Finally, it would be obvious to optimize the concentrations of the elements in the tablet to reduce the amount of drug used while maintaining a pharmacologically appropriate dosage (as described by Hammerle et al). As Hammerle et al show that the uptake increases with increasing dosage, and Kidron et al describe ranges that overlap with applicant’s claimed formulations, an artisan in this field would attempt this modification with a reasonable expectation of success. Note that, absent secondary considerations, differences in concentration are not considered a patentable distinction (MPEP 2144.05(II)(A) and MPEP 2144.05(II)).
Hammerle et al discuss a very similar uptake enhancer to that claimed by applicants using teriparatide, showing pharmacokinetics very similar to that claimed by applicants. Kidron et al renders obvious optimizing the amount of teriparatide and soybean trypsin inhibitor, rendering obvious claims 1-3, 17, 24, and 39-41.
Kidron et al discuss adding magnesium stearate, a lubricant, rendering obvious claims 10, 11, and 45-47.
Hammerle et al show a bioavailability of around 1% (based on the comparison of Cmax values vs. SC injection) or 0.25% (based on applicant’s calculations in their dec, and optimizing the formulation would not be expected to decrease these values. Thus, the combination of references renders obvious claim 18.
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 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, claim an unexpected result of the claimed formulation suitable for use, and claim an unexpected result of reduced bone resorption. 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, the primary reference demonstrates 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. The mechanism of action of SNAC is to weakly bind to the drug and render it more hydrophobic, allowing easier penetration through the digestive tract (Malkov et al, Curr. Drug Deliv. (2005) 2 p191-197). Logically, this means that it will be more effective for hydrophilic drugs, as hydrophobic drugs will already be hydrophobic. Applicants have not provided any information as to the identity of the peptides that they failed to achieve success with, making it unclear if this would be unexpected or not. 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).
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 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 23 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 (declaration of 4 March, 2021). 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 not be surprised by 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).
Finally, applicants argue that the formulation unexpectedly leads to lower bone resorption. Applicants have stated (declaration of 20 Nov, 2025) that it is known in the art that intermittent high doses leads to increase in bone mass, while prolonged exposure leads to resorption (paragraph 45). So the more rapid oral uptake compared to the slow SC uptake would be expected to produce this effect. In addition, it is not clear if this is different than the closest prior art (MPEP 716.02(e)), which uses CNAC in oral uptake, or if it is statistically significant compared to the SC administration (MPEP 716.02(b)(I)).
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
first rejection
Claims 1-3, 6, 10, 11, 15, 17, 18, 20-24, and 39-44 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21 of copending Application No. 15/549418 (US 20180036234, cited by applicants) (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the competing claims render obvious the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Competing claim 21 is a method using a tablet formulation of teriparatide and SNAC orally administered, with similar pharmacokinetics and dosages.
response to applicant’s arguments
Applicants request that this rejection be deferred until a determination of allowable subject matter is made. However, until the rejection is overcome, it will remain valid.
second rejection
Claims 1-3, 6, 10, 11, 15, 17, 18, 20-24, and 39-44 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15 and 16 of copending Application No. 15/549425 (US 20180028622, cited by applicants) (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the competing claims anticipate or render obvious the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The teachings of the competing claims are similar to the first double patenting rejection, as is the logic behind the rejection.
response to applicant’s arguments
Applicants request that this rejection be deferred until a determination of allowable subject matter is made. However, until the rejection is overcome, it will remain valid.
third rejection
Claims 1-3, 6, 10, 11, 15, 17, 18, 20-24, and 39-44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, and 6-9 of U.S. Patent No. 10,010,503 (previously cited) in view of Kidron et al (US 20110142800, previously cited). Please note that this rejection is necessitated by amendment.
The teachings of the competing claims are similar to the previous rejections under this basis, save that the competing claims do not discuss a tablet formulation.
Kidron et al discuss compositions for the oral administration of proteins (title), including parathyroid hormone (paragraph 33). Using oral dosing, the low patient compliance with injected dosage forms can be avoided (paragraph 2). This is accomplished using a protease inhibitor and an absorption enhancer (paragraph 13). The absorption enhancer can be SNAC (paragraph 65). The absorption enhancer can be 40-60% (w/w) of the composition (paragraph 68), or 50 mg or more per dosage unit (paragraph 70). Various dosage forms, including tablets, are discussed (paragraph 120).
Therefore, it would be obvious to use a tablet formulation, as Kidron et al teach that this can be used for similar formulations. As Kidron et al discuss much the same formulations, an artisan in this field would attempt this variation with a reasonable expectation of success. Note that this is a simple substitution of one known element (the unnamed dosage form of the competing claims) for another (the dosage forms of Kidron et al) yielding expected results (a usable dosage form).
response to applicant’s arguments:
Applicants repeat the same arguments that were presented with respect to the rejection under 35 USC 103, above, which were answered there. Applicants also argue that the scope of the reference is more limited, due to the lack of the specification in a double patenting rejection.
Applicant's arguments filed 10 March, 2025 have been fully considered but they are not persuasive.
The arguments that are duplicative with those with respect to the rejection under 35 USC 103 were answered with that rejection. It is not clear how the fact that the specification of the competing application cannot be used in an obvious type double patenting rejection renders the rejection invalid; applicants have not pointed to a portion of the rejection that refers to the competing specification.
fourth rejection
Claims 1-3, 6, 10, 11, 15, 17, 18, 20-24, and 39-44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 6, and 10 of US Patent No. 12,076,373.
The teachings of the competing claims and the logic of the rejection are similar to that of the first ODP rejection, and will not be repeated here.
response to applicant’s arguments:
Applicants request that this rejection be deferred until a determination of allowable subject matter is made. However, until the rejection is overcome, it will remain valid.
fifth rejection
Claims 1-3, 10, 11, 17, 18, 24, 39, 40, 41, 43, and 45-48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 6 of Application No. 18/432,185 (US 20240181020).
Competing claim 1 describes a method of treatment using oral dosing of parathyroid hormone and SNAC, so that the plasma concentration (Cmax) is between 25-1000 pg/mL. Competing claims 2-4 and 6 describe protease inhibitors, narrowing down to soybean trypsin inhibitor.
The difference between the competing claims and the examined claims is that the competing claims do not describe the ratios of the claims. However, differences in concentration are not considered a patentable distinction, as these are commonly optimized (MPEP 2144.05(II)(A)). Alternatively, Kidron et al (US 20110142800, previously cited), discussing similar inventions, describes optimizing the concentration of the protease inhibitor and the absorption enhancer (paragraphs 128-129); presumably, the amount of the pharmaceutical would be appropriate for a pharmacological effect.
response to applicant’s arguments:
Applicants request that this rejection be deferred until a determination of allowable subject matter is made. However, until the rejection is overcome, it will remain valid.
sixth rejection
Claims 1-3, 10, 11, 17, 18, 24, 39, 40, 41, 43, and 45-48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 10, and 19 of Application No. 18/841,379 in view of Kidron et al (US 20110142800, previously cited).
Competing claim 1 describes a formulation with a parathyroid hormone and an absorption enhancer. Competing claim 7 specifies that the absorption enhancer is NAC, the free acid of SNAC, and assumed to be equivalent. Competing claim 10 specifies that the absorption enhancer be at least a large percentage of the total, while competing claim 19 states that the parathyroid hormone is selected from a small group including teriparatide.
The difference between the competing claims and the examined claims is that the competing claims do not give the ratios of the examined claims, nor does it describe a protease inhibitor.
Kidron et al describes similar formulations to the competing claims, comprising a polypeptide and SNAC, along with a protease inhibitor (paragraph 8). The protease inhibitor protects the protein of the formulation from cleavage (paragraph 48). Soybean trypsin inhibitor is suggested as an appropriate protease inhibitor (paragraph 50). PTH is listed as a polypeptide that can be used in the invention (paragraph 33).
Therefore, it would be obvious to include soybean trypsin inhibitor to the formulation of the competing claims, as Kidron et al states that this will prevent cleavage of the polypeptide. As this reference describes formulations similar to those of the competing claims, an artisan in this field would attempt this modification with a reasonable expectation of success. Note that differences in concentration are not considered a patentable distinction
response to applicant’s arguments:
Applicants request that this rejection be deferred until a determination of allowable subject matter is made. However, until the rejection is overcome, it will remain valid.
seventh rejection
Claims 1-3, 10, 11, 17, 18, 24, 39, 40, 41, 43, and 45-48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9, 11, and 13 of Application No. 18/818,691 in view of Kidron et al (US 20110142800, previously cited).
Competing claim 9 describes a kit with a parathyroid hormone and NAC, the free acid of SNAC, and assumed to be equivalent. Competing claim 11 specifies that the absorption enhancer be at least a large percentage of the total, while competing claim 13 states that the parathyroid hormone is selected from a small group including teriparatide.
The difference between the competing claims and the examined claims is that the competing claims do not give the ratios of the examined claims, nor does it describe a protease inhibitor.
Kidron et al describes similar formulations to the competing claims, comprising a polypeptide and SNAC, along with a protease inhibitor (paragraph 8). The protease inhibitor protects the protein of the formulation from cleavage (paragraph 48). Soybean trypsin inhibitor is suggested as an appropriate protease inhibitor (paragraph 50). PTH is listed as a polypeptide that can be used in the invention (paragraph 33).
Therefore, it would be obvious to include soybean trypsin inhibitor to the formulation of the competing claims, as Kidron et al states that this will prevent cleavage of the polypeptide. As this reference describes formulations similar to those of the competing claims, an artisan in this field would attempt this modification with a reasonable expectation of success.
Note that differences in concentration are not considered a patentable distinction, as these are commonly optimized (MPEP 2144.05(II)(A)). Alternatively, Kidron et al describes optimizing the concentration of the protease inhibitor and the absorption enhancer (paragraphs 128-129); presumably, the amount of the pharmaceutical would be appropriate for a pharmacological effect.
response to applicant’s arguments:
Applicants request that this rejection be deferred until a determination of allowable subject matter is made. However, until the rejection is overcome, it will remain valid.
Conclusion
THIS ACTION IS MADE FINAL. 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 FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658