DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Receipt is acknowledged of Applicants’ remarks, filed on 11/11/2025. No claims are amended.
Claims 1-5, 8-9, and 11-17 are pending and are examined on the merits herein.
Priority
The instant application is a 371 of PCT/KR2020/018648, filed on 12/18/2020, which claims foreign priority to KR-10-2019-0169734, filed on 12/18/2019.
Rejections Withdrawn
Applicant’s amendment and remarks, filed 11/11/2025, with respect that claims 8-9 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention has been fully considered and is persuasive, as dependent claims 8-9 recite the ratio of bulking agent for freeze-drying to Chemical Formula 1, while the independent claims limit the ratio of bulking agent for freeze-drying to cyclodextrin. This rejection has been withdrawn.
The following are maintained grounds of rejection.
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.
Claims 1-5, 8-9, and 11-17 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (WO 2017/164575 A1; PTO-892 11/18/2024) in view of Mehmood et al. (Open Science Journal of Pharmacy and Pharmacology, 2015; PTO-892 11/18/2024) Jameel et al. (Design of a formulation for freeze drying, 2010; PTO-892) and Mu et al. (WO 2018/133009; PTO-892 11/18/2024).
Kim discloses acid addition salts of 1-(5-(2,4-difluorophenyl)-1-((3-fluorophenyl) sulfonyl)-4-methoxy-1 H-pyrrol-3-yl)-N-methylmethanamine (page 1, lines 6-7), which is referred to as chemical formula 1, and the structure of which is shown below (page 2, line 22). Kim teaches the compound in pharmaceutical compositions for the treatment of gastrointestinal injury including gastric ulcers (page 5, lines 13-17 and claim 5). Kim teaches that the compound has the biological mechanism of inhibiting H+/K+-ATPase activity (page 12, line 7).
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Kim teaches that the compound may be formulated as a pharmaceutical composition including, among others, sterilized injection solutions (page 6, lines 8-14). The composition may include a suspending agent and a carrier selected from compounds including mannitol, sorbitol, and sucrose (page 5, lines 19-24). Kim teaches that the composition may be administered, among other routes, parenterally including intravenously (page 5, lines 28-30). Kim teaches a that the dosage may vary depending on formulation method, administration method, patient's age, body weight, sexually transmitted infection, diet, administration time, administration route, excretion rate or susceptibility (page 6, lines 4-6). The fumarate acid addition salt and the free base of the compound have comparatively poor solubility in water (Table 4 on page 16). Kim teaches that there is a continuing need for drug formulations that exhibit better bioavailability or better stability (page 1, lines 20-24).
Kim does not teach the compound of instant formula 1 formulated with cyclodextrin and a bulking agent (instant claim 1), amount of cyclodextrin (instant claims 4-5), the pH (instant claims 14-1) or the concentration of chemical formula 1 (instant claims 16-17) of the pharmaceutical composition.
Mehmood discusses the state of the art in excipients used in parenteral and lyophilized formulations (abstract). Water for injection is generally the preferred solvent in parenteral formulations (paragraph bridging pages 24-25). Mehmood teaches that complexation is used to improve the solubility of drug in the solvent, especially in water, and cyclodextrins have emerged as very effective additive compounds for solubilizing hydrophobic drugs (paragraph bridging pages 21-22). Cyclodextrins are being evaluated to improve solubility or stability of parenteral drugs. Gamma cyclodextrin appears in FDA approved parenteral products (page 26, paragraph 4). Mehmood also teaches that lyophilized formulations are used to improve the stability of injectable formulations (page 26, paragraph 6). Mehmood teaches that a bulking agent is added to the formulation matrix of lyophilized products and provide an adequate structure to the lyophilized cake. The structure of the lyophilized cake is important, since proper cake formation leads to proper pore formation that provides the means for vapor to escape from the product during the drying cycle (page 20, paragraph 2). Mehmood teaches that bulking agents – including compounds such as mannitol, sucrose, and glucose (Table 1) – are particularly important for lyophilized compositions when the total solid content is less than 2% to avoid melt back and collapse and to give improved dried product appearance (abstract and page 20, paragraph 2). Mehmood teaches that Mannitol is the most commonly and widely used excipient in lyophilized products (page 20, paragraph 3). Mehmood teaches that control of pH in lyophilized preparations is critical to avoid degradation of the drug during processing, storage and reconstitution (page 21, paragraph 1).
Jameel discusses the state of the art in designing pharmaceutical formulations for freeze drying. In discussing optimum levels of bulking agents, Jameel teaches that, in general, it is advantageous to freeze-dry a system whose solids content is between about 3% w/w and 10%. Less than 3% may provide less elegance and may risk “blowout,” but more than 10% may dry slowly because of high product resistance to vapor transport. Jameel suggests use of bulking agent to drug weight ratios ranging from 1:1 to 10:1 (paragraph bridging pages 481-482).
Mu teaches compositions containing Vonoprazan fumarate and cyclodextrins wherein the cyclodextrins can increase the solubility of Vonoprazan fumarate in water [0010]. Vonoprazan fumarate is used for treating gastric ulcers [0005] and has the biological mechanism of inhibiting H+/K+-ATPase activity [0002]. The structure of Vonoprazan fumarate is shown below [0004].
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The fumarate salt of Vonoprazan has poor solubility in water and is challenging to make into a suitable injection dosage form [0006]. The compositions of Mu comprise a cyclodextrin as a solubilizer to form an inclusion complex with Vonoprazan fumarate, thereby increasing its water solubility and provides a solution with good stability that meets the solubility requirements for preparing an injection [0019]. Mu discloses compositions comprising Vonoprazan fumarate and a cyclodextrin which are liquid preparations for injection (claim 4). Mu teaches that the compositions may have a weight ratio of Vonoprazan fumarate to the cyclodextrin that is, among others, 1:5 [0026]. Mu teaches that the compositions may have a pH ranging from 4.0 to 5.0 ([0039] and claim 14). Mu also teaches that the composition has a concentration of the active compound at 0.05% to 10% (w/v, g/mL) of the total volume of the injection solution, for example 0.4% [0032], which is a concentration of 4 mg/mL. Mu also teaches that suitable cyclodextrins include hydroxypropyl-β-cyclodextrin, sulfobutyl ether-β-cyclodextrin, hydroxyethyl-β-cyclodextrin, methyl-β-cyclodextrin or any combination thereof [0030].
It would have been prima facie obvious to combine the teachings of Kim, Mehmood, Jameel, and Mu before the effective filing date of the claimed invention by formulating the parenteral drug formulation of Kim using the cyclodextrin and bulking agents of Mehmood and to optimize the amount of bulking agent based on the teachings of Jameel and Mu, thus arriving at the instantly claimed invention. One of ordinary skill in the art would have been motivated to formulate the compound of Kim according to the teachings of Mehmood because Kim teaches that the composition may be administered parenterally and that the fumarate salt and the free base of the compound have poor solubility in water, and Mehmood teaches that cyclodextrins are effective additive compounds for solubilizing hydrophobic drugs and improving the stability of parenteral drugs. One of ordinary skill in the art would have furthermore been motivated to formulate the composition of Kim for lyophilization, which is freeze-drying, by further including a bulking agent because Mehmood teaches that lyophilized formulations are used to improve the stability of injectable formulations and that a bulking agent is added to the formulation to provide an adequate structure and improve the appearance of the cake. Jameel teaches use of bulking agent to drug weight ratios ranging from 1:1 to 10:1, and Mu teaches a weight ratio of active compound to cyclodextrin that is 1:5. Thus the combined teachings suggest a weight ratio of bulking agent to cyclodextrin that ranges from 0.2-2:1. One of ordinary skill in the art would have been motivated to use these approximate ratios to optimize the inclusion of bulking agent in the formulation using optimization that is routine in the art. MPEP 2144.05(II)(A) states that, generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Furthermore, it would have been prima facie obvious to formulate the composition suggested by Kim, Mehmood, and Jameel using the cyclodextrins, weight ratio of cyclodextrin, pH, and concentration of active compound taught by Mu because it is prima facia obvious to apply the known technique of formulating a composition of Vonoprazan fumarate to the formulation of the composition of Kim and Mehmood to yield the predictable result of a composition with improved solubility in water. Furthermore, it would have been prima facie obvious for one of ordinary skill in the art to optimize the type of cyclodextrin and amounts of the components in the composition taught by Kim and Mehmood beginning with the amounts suggested in the teaching of Mu such that the components are included in amounts suitable for the formulation of liquid preparations for injection (see MPEP 2144.05(II)(A)). Furthermore, it would have been obvious to try the finite number of predictable formulations provided by Mu for use in improving solubility of liquid compounds for injection taught by Kim. It would have been obvious to pursue the known formulation parameters of cyclodextrin type, weight ratio of cyclodextrin, pH, and concentration of active compound in the formulation of Kim compound with a reasonable expectation of success. One of ordinary skill in the art would have had a reasonable expectation of success in optimizing the components in the formulation taught by Kim and Mehmood using the starting values of Mu because both the compositions of Mu and the composition of Kim and Mehmood comprise small molecules and a cyclodextrin and are taught as being suitable for parenteral administration. Furthermore, the active compounds of Kim and Mu provide treatment of the same medical condition through the same biological mechanism and bear the distinct structural similarities of a pyrrole substituted with an aryl sulfone at the N position, a halogen substituted phenyl at the 2 position, and a CH2NHCH3 group at the 4 position.
Response to Arguments
Applicant's arguments filed 11/11/2025 have been fully considered but they are not persuasive.
Applicant argues that the combined teachings of the references do not teach the specific combination and ratio that produces the unpredictable effect of improving the lyophilized cake characteristics (Remarks, page 7, paragraph 4). Specifically, the particular content ratio of "cyclodextrin" to "bulking agent for freeze-drying" (0.5-5.0:1) yields superior lyophilized cake morphology and enhanced stability during the freeze-drying process (Remarks, page 7, paragraph 5). Applicant points to the particular example 6 of the instant specification as showing that when the ratio of cyclodextrin to the bulking agent falls below the claimed range, quality deterioration such as the formation of cracks in the lyophilized cake occurs (Remarks, page 7, paragraph 6). This amounts to an argument from unexpected results. This is not persuasive.
Applicant does not demonstrate the criticality of the claimed the content ratio. Example 6 of the instant specification (beginning on page 13 of the instant specification), is the only example which provides a comparison of the ratio of a bulking agent, in this case D-mannitol) to cyclodextrin. Example 6 provides only ratios of up to 3:1, and thus does not show that the effect occurs throughout the entirety of the claimed range and that the effect is limited to the claimed range. Also, Example 6 indicates that sample 6-3, which has a ratio of D-mannitol to cyclodextrin of 25 mg:50 mg or 0.5:1, does not possess the “good properties.” MPEP 2144.05(II)(A) states that, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. MPEP 716.02(d) states that to establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. Furthermore, MPEP 716.02(d) states that the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. Thus the instant specification does not provide evidence that this claimed content ratio is critical.
Furthermore, independent claim 1 does not limit the bulking agent to any specific agent. Example 6 provides only an analysis of D-mannitol as a bulking agent. MPEP 716.02(d) states that the objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support. Thus the scope of any unexpected result based on Example 6 would not be commensurate with the scope of the instant claims.
Applicant further argues that the prior art KR 10-1829705 B1 (hereafter Oh et al., provided in IDS filed 12/08/2022. Machine translation included in PTO-892) further supports the argument that Mu is not combinable with Kim because Vonoprazan has a different structure than the instant active such that it will have completely different properties. Applicant states that Oh teaches an injectable composition comprising Tegoprazan (which is a third, distinct active) and teaches the use of cyclodextrin as a stabilizer. Applicant indicates that when mannitol is used in such a composition, the active ingredient may precipitate, leading to reduced stability and impaired physical properties. Applicant argues that combining cyclodextrin and mannitol in the instantly claimed invention would thus not be obvious over the prior art (Remarks, page 9, paragraphs 1-4). This is not persuasive.
Oh evaluates cyclodextrin and cyclodextrin derivatives as stabilizers for an injectable composition comprising Tegoprazan. Other stabilizers, such as trehalose and mannitol, are evaluated as comparative examples and are used instead of cyclodextrin [0034] and [0080]. Thus the teachings of Oh regarding mannitol suggest that mannitol alone is not suitable for stabilization of Tegoprazan because when mannitol alone, without cyclodextrin, is used there is precipitation of the active agent [0094], but Oh does not teach that it is the presence of mannitol that causes precipitation rather than merely the absence of cyclodextrin. This does not teach away from combining both cyclodextrin and mannitol in the composition of Kim, nor does it provide support that Tegoprazan has completely different properties as compared to Vonoprazan or the instantly claimed active.
Because Applicant’s arguments are not persuasive, the instant claims are rejected for the reasons of record.
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 1-5, 8-9, and 11-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 18/560,968 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 1 of ‘968 claims an injectable composition at a pH of 4.0-6.0 comprising a compound of the same Chemical Formula 1, cyclodextrin, and an isotonizing agent. Claim 2 further limits the composition in which the cyclodextrin is (2-hydroxypropyl)-beta-cyclodextrin or sulfobutyl ether-betacyclodextrin. Claim 3 further limits cyclodextrin contained in an amount of 4.5 to 15.0 parts by weight based on 1 part by weight of the compound represented by Chemical Formula 1. Claim 8 further limits the composition further comprising a freeze drying aid which is selected from D-mannitol, sucrose, sorbitol, or trehalose. Claim 9 further limits the freeze drying aid may be contained in an amount of 3.0 to 25.0 parts by weight based on 1 part by weight of the compound represented by Chemical Formula 1. Claim 10 further limits the solvent of the formulation for injection is distilled water, water for injection, acetate buffer, or physiological saline. Claim 11 further limits the compound represented by Chemical Formula 1 having a concentration of 1-8 mg/mL in the formulation for injection.
‘968 does not claim the compounds having a bulking agent contained in an amount of 0.5 to 5.0 parts by weight based on 1 part by weight of the cyclodextrin.
The claims of ‘968 recite the composition further comprising a freeze drying aid which is selected from D-mannitol, sucrose, sorbitol, or trehalose and may be contained in an amount of 3.0 to 25.0 parts by weight based on 1 part by weight of the compound represented by Chemical Formula 1, and that cyclodextrin is contained in an amount of 4.5 to 15.0 parts by weight based on 1 part by weight of the compound represented by Chemical Formula 1. Thus suggests that the freeze drying aid is contained in an amount of 0.7 to 1.7 parts by weight based on 1 part by weight cyclodextrin, which overlaps with the range of cyclodextrin in the instant claims. In the case where the claimed ranges overlap or lie inside ranges discloses by the prior art, a prima facie case of obviousness exits (see MPEP 2144.05). Thus it would have been prima facie obvious for one of ordinary skill in the art to select a bulking agent content of the instant claims.
The claims of ‘968 recite cyclodextrin contained in an amount of 4.5 to 15.0 parts by weight based on 1 part by weight of the compound, which overlaps with the range of cyclodextrin in the instant claims. In the case where the claimed ranges overlap or lie inside ranges discloses by the prior art, a prima facie case of obviousness exits (see MPEP 2144.05). Thus it would have been prima facie obvious for one of ordinary skill in the art to select a cyclodextrin content of the instant claims.
Regarding instant claims 16-17, ‘968 does not claim the composition in which concentration of chemical formula 1 is 5 to 25 mg/mL. However, the claims of ‘968 recite a concentration of 1-8 mg/mL, which overlaps with the range of cyclodextrin in the instant claims. In the case where the claimed ranges overlap or lie inside ranges discloses by the prior art, a prima facie case of obviousness exits (see MPEP 2144.05). Thus it would have been prima facie obvious for one of ordinary skill in the art to select a concentration of chemical formula 1 of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-5, 8-9, and 11-17 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 18/560,955 in view of Kim et al. (WO 2017/164575 A1; PTO-892 11/18/2024), Mehmood et al. (Open Science Journal of Pharmacy and Pharmacology, 2015; PTO-892 11/18/2024), and Mu et al. (WO 2018/133009; PTO-892 11/18/2024).
Claim 1 of ‘955 claims a liquid pharmaceutical composition comprising the same chemical formula 1 as the instant claims. Claim 2 further limits the composition having a cyclodextrin and an isotonizing agent. Claim 3 further limits the cyclodextrin is (2-hydroxypropyl)-beta-cyclodextrin and the isotonizing agent is D-mannitol. Claim 4 further limits that the pH is 4.0-6.0.
Reference application ‘955 does not teach the amount bulking agent (claims 1, 8-9, and 11) or cyclodextrin (instant claims 4-5), that the composition is injectable (instant claim 12), the solvent (instant claim 13), or the concentration of Chemical Formula 1 in the solution (instant claims 16-17).
The teachings of Kim, Mehmood, Jameel, and Mu are as discussed above.
It would have been prima facie obvious to combine the claims of ‘955 with the teachings of Kim, Mehmood, Jameel, and Mu before the effective filing date of the claimed invention by formulating the composition of ‘955 as a parenteral drug formulation of Kim using the cyclodextrin and bulking agents of Mehmood and to optimize the amount of bulking agent as taught by Jameel and Mu, thus arriving at the instantly claimed invention. One of ordinary skill in the art would have been motivated to formulate the compound of Kim according to the teachings of Mehmood because Kim teaches that the composition may be administered parenterally and that the fumarate salt and the free base of the compound of ‘955 have poor solubility in water, and Mehmood teaches that cyclodextrins are effective additive compounds for solubilizing hydrophobic drugs and improving the stability of parenteral drugs. One of ordinary skill in the art would have furthermore been motivated to formulate the composition of ‘955 as a lyophilized preparation with a bulking agent and to optimize the amount of bulking agent because Mehmood teaches that lyophilized formulations are used to improve the stability of injectable formulations and that a bulking agent is added to the formulation to provide an adequate structure and appearance to the cake. In addition, one of ordinary skill in the art would have been motivated to optimize the inclusion of bulking agent in the formulation because Mehmood teaches that the total solid content is a result effect variable such that one of ordinary skill in the art would be motivated to optimize the amount of bulking agent in order to improve the appearance and stability of the lyophilized cakes in the process of the formulation of the parenteral pharmaceuticals.
Furthermore, it would have been prima facie obvious to formulate the composition suggested by ‘955, Kim and Mehmood using the weight ratio of cyclodextrin and bulking agent, pH, and concentration of active compound taught by Mu because it is prima facia obvious to apply the known technique of formulating a composition of Vonoprazan fumarate to the formulation of the composition of ‘955, to yield the predictable result of a composition with improved solubility in water. One of ordinary skill in the art would have had a reasonable expectation of success because both the Vonoprazan fumarate of Mu and the compound of ‘955 are small molecules taught as being useful for parenteral administration of a drug for treating gastric ulcers.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 11/11/2025 have been fully considered but are not persuasive.
Applicant argues that the unpredictable and significant effect central to the claimed composition is that a "good" crack-free lyophilized cake is obtained only when the ratio of the freeze-drying aid (D-mannitol) to cyclodextrin (HP-β-CD) meets a specific value (Remarks, page 10, paragraph 4). Similarly, Applicant states that there is no reasonable basis in the references to conclude that such a combination would lead to the unpredictable effect observed in the present invention - namely, the formation of a high-quality lyophilized cake at a specific composition ratio (Remarks, page 11, paragraph 1). This amounts to an argument from unexpected results. This is not persuasive.
As discussed above in response to Applicant’s arguments regarding the 103 rejection, Applicant does not demonstrate the criticality of the claimed the content ratio. MPEP 2144.05(II)(A) states that, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Furthermore, MPEP 716.02(d) states that the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. Example 6 of the instant specification (beginning on page 13 of the instant specification), is the only example which provides a comparison of the ratio of a bulking agent, in this case D-mannitol) to cyclodextrin. Example 6 provides only ratios of up to 3:1, and thus does not allow analysis of the criticality of the upper end of the ratio. Also, Example 6 indicates that sample 6-3, which has a ratio of D-mannitol to cyclodextrin of 25 mg:50 mg or 0.5:1, does not possess the “good properties” which are the purported unexpected results. Thus the instant specification does not provide evidence that this claimed content ratio is critical.
Furthermore, MPEP 716.02(d) states that the objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support. Independent claim 1 does not limit the bulking agent to any specific agent. Example 6 provides only an analysis of D-mannitol as a bulking agent. Thus the scope of any unexpected result would not be commensurate with the scope of the instant claims.
Thus the rejections are maintained for the reasons of record.
Conclusion
No claims are 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 extension fee 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 date of this final action.
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/S.G.H./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693