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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/20/2025 has been entered.
Claim Status
Claims 1-2, 7-9, 11-17, 22-23, 28-38 and 43-49 are pending. Claims 1-2, 16-17 and 49 have been amended. Claims 1-2, 7-9, 11-14, 16-17 and 49 are being examined in this application. In the response to the restriction requirement, Applicants elected Group I, rhPTH(1-84), poloxamer, sodium chloride, methionine, m-cresol, and acetate buffer. Claims 15, 22-23, 28-38 and 43-48 are withdrawn as being drawn to a nonelected species/invention.
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.
This rejection has been modified.
Claims 1-2, 7-9, 11-14, 16-17 and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Loer Linderoth et al. (WO 2009/053106).
With respect to claims 1, 11-12, 16 and 49, Loer Linderoth et al. teach a pharmaceutical composition comprising, when dissolved in a suitable vehicle, PTH at a concentration of 1 mg/ml to 10 mg/ml, methionine provided at a concentration of 1 mg/ml to 10 mg/ml, at least one Poloxamer surfactant provided at a concentration from 0.02 mg/ml to 1 mg/ml, and a physiologically acceptable buffering agent that maintains the pH of the formulation at a pH of 5 to 6.5 (claim 1), wherein the PTH is recombinant human PTH(1-84) (page 19, line 24), wherein the composition is in the form of a stable solution formulation (claim 2), wherein the composition further comprises at least one tonicity modifier (claim 19), wherein the composition further comprises at least one pharmaceutically acceptable preservative (claim 27), wherein the composition is suitable for administration by injection (claim 36), wherein the physiologically acceptable buffering agent is acetate (claim 16); and wherein the suitable vehicle is water (page 3, lines 24-25).
Loer Linderoth et al. do not teach the claimed amounts.
However, Loer Linderoth et al. teach that: a) the rhPTH(1-84) is present at a concentration of 1 mg/ml to 2 mg/ml (claim 10); b) the poloxamer surfactant is present at a concentration of 0.05 mg/ml to 0.5 mg/ml (i.e. 0.05% to 0.5%) (claim 10); c) the tonicity modifier (sodium chloride) is present at a concentration of 1 mg/ml to 10 mg/ml (i.e. 1% to 10%); d) the antioxidant (methionine) is present at a concentration of 1 mg/ml to 4 mg/ml (i.e. 1% to 4%) (page 5, lines 27-28); e) the preservative (m-cresol) is present at a concentration of 1 mg/ml to 5 mg/ml (i.e. 1% to 5%) (claim 28); and f) the pharmaceutically acceptable buffer include acetate and citrate, wherein the citrate is present at a concentration of 5 mM to 30 mM, and wherein “[o]ther buffers are also suitable, for example at similar concentration and/or pH ranges as described above for the citrate buffer”.
A prima facie case of obviousness necessarily exists when the prior art range overlaps or touches a claimed range, such as in the instant rejection (MPEP § 2144.05).
With respect to the limitation “wherein the formulation is physically stable and remains clear, colorless, and free of visible particle for at least 48 hours”, it is noted that such property is inherent to the composition. Furthermore, Loer Linderoth et al. teach that the composition is stable for 60 days (page 2, lines 16-38; page 3, lines 1-13), and further teach that the composition is clear after 12 months (page 30, lines 25-26; Table 21).
With respect to claim 2, Loer Linderoth et al. teach that the composition is stable for 60 days (page 2, lines 16-38; page 3, lines 1-13).
With respect to claim 7, Loer Linderoth et al. teach that the poloxamer surfactant is poloxamer 188 (claim 3).
With respect to claim 8, Loer Linderoth et al. teach that the tonicity modifier is sodium chloride (claim 19).
With respect to claim 9, Loer Linderoth et al. teach that the preservative in m-cresol (claims 27-28).
With respect to claims 13-14, Loer Linderoth et al. teach that pH of the formulation is 5.5 (claims 11-14).
With respect to claim 17, Loer Linderoth et al. teach that the composition is stable for 60 days (page 2, lines 16-38; page 3, lines 1-13).
Response to Arguments
Applicant’s arguments filed on 10/20/2025 have been fully considered but they are not persuasive.
Applicant argues that “[t]hat the formulations encompassed by the present claims, as amended, are patentable in view of the disclosure of WO 2009/053106 because they show surprising and unexpected clarity and stability results by remaining clear, colorless, and free of visible particles for at least 3 months at 25°C”.
Applicant also argues that “[a]ny long-term (3 months and longer) storage of the compositions of WO 2009/053106 requires refrigeration at 50C, see Example 11, p. 30-31 of WO 2009/053106. In contrast, the currently claimed formulations are stable for at least 3 months, and in most cases for 6 months, at 25°C. See Table 8. This property is important for shelf-life of the commercial formulations and provides clear benefits over the formulations of WO 2009/053106”.
Applicant’s arguments are not persuasive because the claimed properties are inherent to the composition of Loer Linderoth et al.
Moreover, as previously discussed, Loer Linderoth et al. teach that the composition is stable for 60 days (page 2, lines 16-38; page 3, lines 1-13), and further teach that the composition is clear after 12 months (page 30, lines 25-26; Table 21).
Additionally, the MPEP 716.02(e) states that “[A]n affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979). "A comparison of the claimed invention with the disclosure of each cited reference to determine the number of claim limitations in common with each reference, bearing in mind the relative importance of particular limitations, will usually yield the closest single prior art reference." In re Merchant, 575 F.2d 865, 868, 197 USPQ 785, 787 (CCPA 1978) (emphasis in original)”.
In the instant case, Applicant should compare the claimed formulation with the formulation of Loer Linderoth et al. in order to demonstrate that the formulation of Loer Linderoth et al. differs from the instantly claimed formulation.
Since the Office does not have the facilities for examining and comparing Applicant’s formulation with the formulation of the prior art, the burden is on the applicant to show a novel or unobvious difference between the claimed formulation and the formulation of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
For the reasons stated above the rejection is maintained.
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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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658