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 .
Response to Election/Restriction filed on March 27, 2026 is acknowledged.
Claims 1-25 are pending in this application.
Restriction
Applicant's election with traverse of the following species:
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in the reply filed on March 27, 2026 is acknowledged. The traversal is on the ground(s) that effective amount of abaloparatide, duration of administration, type of surgical intervention, and fracture healing confirmation are not mutually exclusive, do not have a separate status in the art, and do not require a different field of search. This is not found persuasive because the search for each of the species is not co-extensive particularly with regard to the literature search. Burden consists not only of specific searching of classes and subclasses, but also of searching multiple databases for foreign references and literature searches. Burden also resides in the examination of independent claim sets for clarity, enablement, and double patenting issues. Further, a reference that would anticipate the invention of one species would not necessarily anticipate or even make obvious another species. Thus, it would be an undue burden to examine all of the above species in one application and the restriction for examination purposes as indicated above is deemed proper.
The requirement is still deemed proper and is therefore made FINAL. Claims 13-14 and 20 are withdrawn from further consideration as being drawn to nonelected species. Claims 1-12, 15-19 and 21-25 are examined on the merits in this office action.
Objections
5. The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper (please see for example, paragraph [0023] of instant specification US 2023/0346892). Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
6. Claim 3 is objected to for the following minor informality: claim 3 contains the acronyms “CT” and “mRUST”, and an acronym in the first instance of claims should be expanded upon/spelled out with the acronym indicated in parentheses, i.e., modified Radiographic Union Score for Tibial Fractures (mRUST). The abbreviations can be used thereafter.
Rejections
U.S.C. 102
7. 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.
8. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
9. Claim(s) 1-10, 17 and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bernhardsson et al (Acta Orthopaedica, 2018, 89(6): 674-677, filed with IDS).
10. Bernhardsson et al teach administering a therapeutically effective amount of abaloparatide to a subject having a surgical intervention with a tibia fracture (seep. 675, left column “Animals”):
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. Bernhardsson et al teach the following:
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(see p. 675, left column “Drug treatment” to right column top). The active method steps of administering 2.2, 6.7, 20, 60 or 180 mg/kg of abaloparatide to a patient suffering from a tibia fracture is taught by Bernhardsson et al. This meets the limitation of instant claims 1-2 and 9-10. Bernhardsson et al teach that “given at 4 times the teriparatide dose in a human osteoporosis trial, abaloparatide increased bone density more than teriparatide, and both reduced fracture risk. We investigated in mice whether abaloparatide stimulates fracture healing, and if it does so with the suggested dose effect relation” (see abstract). Bernhardsson et al teach that “96 mice were randomly allocated to 11 groups: control (saline), teriparatide or abaloparatide, where teriparatide and abaloparatide were given at 5 different doses each…control (saline), teriparatide (15 mg/kg) or abaloparatide (60 mg/kg). Each treatment was given daily via subcutaneous injections…evaluated by mechanical testing and microCT” (see abstract, “Patients and methods”), meeting the limitation of instant claim 17.
With respect to the limitation in the preamble of claim 1, “A method of accelerating long bone fracture healing..”, please note that MPEP 2111.02 II states "a preamble generally is not limiting when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention." In the instant case, the preamble does not affect the method steps. The preamble in this case recites a statement of purpose or use, and therefore was not treated as a claim limitation.
Furthermore, with respect to “wherein facture healing, callus formation…is confirmed at 6, 12…” (claim 3); wherein union is accelerated, as determined by…” (claim 4); wherein bone quality is confirmed…(claim 5); wherein cartilaginous phase of fracture repair is confirmed…(claim 6); wherein fracture site stiffness is achieved at 6 weeks or 12 weeks (claim 7); wherein administering the therapeutically effective amount of abaloparatide elevates bone formation markers without elevating bone resorption markers (claim 8); wherein the healing time is decreased by…(claim 23)” according to MPEP 2111.04: "Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “adapted to” or “adapted for” clauses;
(B) “wherein” clauses; and
(C) “whereby” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Id. <”. In the instant case, it is not deemed that the “wherein” clause limits the claim to particular structural features.
Bernhardsson et al teach that the “left tibiae, with a hole in the proximal metaphysis, and the femurs were analyzed with microCT” (see p. 675, right column, “microCT”), meeting the limitation of instant claim 3. Bernhardsson et al teach the following:
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(see p. 676, bottom left column to top right column). Bernhardsson et al teach that “abaloparatide stimulated bone healing in both the diaphyseal and metaphyseal models” (see p. 676, right column, “Discussion”), meeting the limitation of instant claim 23.
Bernhardsson et al teach that the mean weight of the C57BL/6 mice were 26 g (see p. 675, left column). Thus, the mice were 0.026 kg each. The amount of abaloparatide was at 2.2, 6.7, 20, 60 or 180 mg/kg, this implies that at the highest dose of 180 mg/kg is 180 mg/kg x 0.026 kg = 4.68 mg.
Because Bernhardsson et al teach all of the active method steps, i.e., administering an effective amount of abaloparatide to a subject in need thereof, Bernhardsson et al anticipates instant claims 1-10, 17 and 23.
U.S.C. 103
11. 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.
12. 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.
13. 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.
14. 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.
15. Claim(s) 1-12, 15-19 and 21-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bernhardsson et al (Acta Orthopaedica, 2018, 89(6): 674-677, filed with IDS) in view of DOLHIN VOLODYMYR PROHOROVYCH (UA 84673, date published 10/2502013, English translation used and enclosed herein).
16. Bernhardsson et al teach administering a therapeutically effective amount of abaloparatide to a subject having a surgical intervention with a tibia fracture (seep. 675, left column “Animals”):
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. Bernhardsson et al teach the following:
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(see p. 675, left column “Drug treatment” to right column top). The active method steps of administering 2.2, 6.7, 20, 60 or 180 mg/kg of abaloparatide to a patient suffering from a tibia fracture is taught by Bernhardsson et al. This meets the limitation of instant claims 1-2 and 9-10. Bernhardsson et al teach that “given at 4 times the teriparatide dose in a human osteoporosis trial, abaloparatide increased bone density more than teriparatide, and both reduced fracture risk. We investigated in mice whether abaloparatide stimulates fracture healing, and if it does so with the suggested dose effect relation” (see abstract). Bernhardsson et al teach that “96 mice were randomly allocated to 11 groups: control (saline), teriparatide or abaloparatide, where teriparatide and abaloparatide were given at 5 different doses each…control (saline), teriparatide (15 mg/kg) or abaloparatide (60 mg/kg). Each treatment was given daily via subcutaneous injections…evaluated by mechanical testing and microCT” (see abstract, “Patients and methods”), meeting the limitation of instant claim 17.
With respect to the limitation in the preamble of claim 1, “A method of accelerating long bone fracture healing..”, please note that MPEP 2111.02 II states "a preamble generally is not limiting when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention." In the instant case, the preamble does not affect the method steps. The preamble in this case recites a statement of purpose or use, and therefore was not treated as a claim limitation.
Furthermore, with respect to “wherein facture healing, callus formation…is confirmed at 6, 12…” (claim 3); wherein union is accelerated, as determined by…” (claim 4); wherein bone quality is confirmed…(claim 5); wherein cartilaginous phase of fracture repair is confirmed…(claim 6); wherein fracture site stiffness is achieved at 6 weeks or 12 weeks (claim 7); wherein administering the therapeutically effective amount of abaloparatide elevates bone formation markers without elevating bone resorption markers (claim 8)” according to MPEP 2111.04: "Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “adapted to” or “adapted for” clauses;
(B) “wherein” clauses; and
(C) “whereby” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Id. <”. In the instant case, it is not deemed that the “wherein” clause limits the claim to particular structural features.
Bernhardsson et al teach that the “left tibiae, with a hole in the proximal metaphysis, and the femurs were analyzed with microCT” (see p. 675, right column, “microCT”), meeting the limitation of instant claim 3. Bernhardsson et al teach the following:
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(see p. 676, bottom left column to top right column). Bernhardsson et al teach that “abaloparatide stimulated bone healing in both the diaphyseal and metaphyseal models” (see p. 676, right column, “Discussion”), meeting the limitation of instant claim 23.
Bernhardsson et al teach that the mean weight of the C57BL/6 mice were 26 g (see p. 675, left column). Thus, the mice were 0.026 kg each. The amount of abaloparatide was at 2.2, 6.7, 20, 60 or 180 mg/kg, this implies that at the highest dose of 180 mg/kg is 180 mg/kg x 0.026 kg = 4.68 mg.
Because Bernhardsson et al teach all of the active method steps, i.e., administering an effective amount of abaloparatide to a subject in need thereof, Bernhardsson et al anticipates instant claims 1-10, 17 and 23.
The difference between the reference and the instant claims is that the reference does not teach that the subject is at a high risk for fracture (e.g., diabetes), and the amount of 80 mg and administered daily for 3 months.
17. However, DOLHIN VOLODYMYR PROHOROVYCH et al teach treating the factures of long bones in the patients with diabetes mellitus (see for example, abstract).
18. Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Bernhardsson et al and DOLHIN VOLODYMYR PROHOROVYCH et al since both references teach treating fractures of long bones (such as tibia). One of ordinary skill in the art would have been motivated to combine and optimize the amount and the duration of the treatment because Bernhardsson et al teach that “abaloparatide stimulated bone healing in both the diaphyseal and metaphyseal models” (see p. 676, right column, “Discussion”), and Bernhardsson et al teach that the mean weight of the C57BL/6 mice were 26 g (see p. 675, left column). Thus, the mice were 0.026 kg each. The amount of abaloparatide was at 2.2, 6.7, 20, 60 or 180 mg/kg, this implies that at the highest dose of 180 mg/kg is 180 mg/kg x 0.026 kg = 4.68 mg. Bernhardsson et al teach that the treatment was given daily via subcutaneous injections and the table shows for 28 days. One of ordinary skill in the art would have optimized the conditions for the optimal treatment methods. The MPEP 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. “[W]here 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
Furthermore, with respect to “wherein the healing time is decreased…” (claim 25)” according to MPEP 2111.04: "Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “adapted to” or “adapted for” clauses;
(B) “wherein” clauses; and
(C) “whereby” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Id. <”. In the instant case, it is not deemed that the “wherein” clause limits the claim to particular structural features.
Therefore, the combined art is prima facie obvious over instant claims 1-12, 15-19 and 21-25.
CONCLUSION
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE HA whose telephone number is (571)272-5982. The examiner can normally be reached Monday-Thursday 5:00 am- 4:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LIANKO GARYU can be reached at 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIE HA/Primary Examiner, Art Unit 1654
5/28/2026
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