DETAILED ACTION
Examiner’s Note
This action is NON-FINAL.
Claim Status
As of the Non-Final Office Action mailed 4/22/2025, claims 1-8, 10-11, 13, and 16-22 were pending.
In Applicant's Response filed on 10/22/2025, claims 21-22 were amended.
As such, claims 1-8, 10-11, 13, and 16-22 are pending and have been examined herein.
Withdrawn Objections/Rejections
The objection of record to claim 22 for minor informalities has been withdrawn.
The rejection of record of claims 1, 3-8, 11, 13, 16, 18, and 21-22 under 35 USC § 103 as being unpatentable over Kallala (GB2559761 A) in view of Matuszewski et al (Bull Vet Inst Pulawy, 2013) and Hart et al (US 20190350843 A1) have been withdrawn.
The rejection of record of claim 2 under 35 USC § 103 as being unpatentable over Kallala in view of Matuszewski and Hart, and further in view of Baier et al (J Orthop Surg Res, 7 June 2013) have been withdrawn.
The rejection of record of claims 10, 17, and 19-20 under 35 USC § 103 as being unpatentable over Kallala in view of Matuszewski and Hart, and further in view of Li et al (US 7771755 A1, 10 Sept 2004) have been withdrawn.
New Grounds of Rejections
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.
Claim(s) 1, 3-8, 11, 13, 16, and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kallala (GB2559761 A; 16 Feb 2017; IDS FOR Reference 11 Feb 2021; previously cited) in view of Kamakura et al (US9968660B2, 8 Apr 2016; published 15 May 2018) and Li et al (Exp Ther Med. 2 May 2018; 15(6):5330-5336; of record).
Kallala teaches a formulation for use in acute bone fractures (p. 1, lines 1-2). The formulation includes an osteoclast inhibitor and a parathyroid hormone or derivative, which is combined with a delivery material for delivery in solid or liquid phase (p. 7, claim 1) (“i) a parathyroid hormone or a derivative thereof; ii) one or more osteoclast inhibitors” as in instant claim 1 in-part). The delivery material can be calcium sulphate, or mono-, di-, and tri-calcium phosphates, calcium carbonate, an autograft bone material, an allograft, a synthetic allograft, a ceramic, a bioglass, a collagen sponge, carboxymethylcellulose or a polymethyl methacrylate (PMMA) bone cement, or a or combination of any two or more thereof (i.e., bone void filler) (see p. 7 see claim 1 of Kallala) (“a bone void filler in a solid or liquid phase” as in instant claim 1 in-part; “wherein the bone void filler comprises (i) calcium sulphate, (ii) one or more of calcium sulphate, mono-, di-, and tri-calcium phosphates, calcium carbonate, an autograft bone material, an allograft, a synthetic allograft, a ceramic, a bioglass, a collagen sponge, carboxymethylcellulose or a polymethyl methacrylate (PMMA) bone cement, or a or combination of any two or more thereof, or (iii) (a) calcium sulphate and (b) one or more of , mono-, di-, and tri-calcium phosphates, calcium carbonate, an autograft bone material, an allograft, a synthetic allograft, a ceramic, a bioglass, a collagen sponge, carboxymethylcellulose or a polymethyl methacrylate (PMMA) bone cement” as in instant claim 22). The osteoclast inhibitor is a bisphosphonate (p.7, see claim 2 of Kallala) (“wherein the one or more osteoclast inhibitors comprise a bisphosphonate” as in instant claim 1 in-part). The parathyroid hormone, osteoclast inhibitors, and bone void fillers as described in Kallala reads on the “kit of parts” as in instant claim 16. The derivative of the parathyroid hormone is selected from PTHrP, 1-34 rhPTH, H05AA03 parathyroid hormone, teriparatide, and abaloparatide (p. 7, see claim 4 of Kallala), which reads on “wherein the derivative of the parathyroid hormone is selected from PTHrP, 1-34 rhPTH, H05AA03 parathyroid hormone, teriparatide, and abaloparatide” as in instant claim 6). The formulation also contains additives such as vitamin D, hydroxyapatite, vitamin E, selenium, zinc, magnesium, phosphate, or collagen (p. 7 claim 5), which reads on instant claim 7. The formulation also includes stem cells (p. 7, claim 6), which reads on instant claim 8. The reference also teaches that the formulation can be administered in a composition mixed with calcium sulfate paste for direct injection into a fracture site (p. 5, para 3, lines 11-14). This reads on instant claim 11 based on the claim interpretation from the instant specification (see instant specification, p. 8, lines 28-29). The formulation can be used in the treatment of bone fractures (p. 8 claim 9), specifically acute bone fractures and chronic bone injuries (p. 1 lines 1-6). This reads on instant claim 13.
Instant claim 21 recites, inter alia, “wherein the composition is formulated such that the parathyroid hormone or derivative thereof and the one or more osteoclast inhibitors are released from the composition at a steady rate for at least approximately 7 weeks.” This claim expresses the outcome/consequence of using the instantly claimed composition in independent claim 1, making it an intended result (see also MPEP 2111.04). Thus, absent evidence to the contrary, the composition of Kallala would have the effect as claimed in instant claim 21.
Kallala differs from the instantly claimed invention in that it does not explicitly teaches that the amount of PTH is approximately 0.1 ng/mL to approximately 50 ng/mL or that the amount of bisphosphonate is approximately 50-300 ng/ml.
Kamakura teaches a means effective for bone regeneration or augmentation (abstract). The reference teaches that a porous composite is implanted at the site in need of bone regeneration and PTH or a derivative of PTH is administered topically to the site in need (see claims 1 and 3 of Kamakura). The amount of PTH can be suitably determined depending on the degree of bone defect, the body weight and age of the subject, etc. The PTH can be administered on the porous composite implanted in a site in need of bone regeneration or bone augmentation and the concentration of PTH in the liquid is 0.01 μg/mL to 500 μg/mL (i.e., at least 10 ng/mL). This range overlaps with (“a parathyroid hormone or a derivative thereof in an amount of approximately 0.1 ng/mL to approximately 50 g/mL” as in instant claim 1 in-part). The combined use of a calcium phosphate-containing porous composite and PTH allowed more effective bone regeneration or bone augmentation (“Solution to the Problem”, para 1). The composite can also contain calcium phosphate such as β-tricalcium phosphate (β-TCP), hydroxyapatite, and amorphous calcium phosphate. This shows that PTH at a concentration of at least 10 ng/mL can be used to regenerate bone.
Li describes minimally effective concentrations of zoledronic acid to suppress osteoclasts in vitro (title). The reference teaches that bisphosphonates have an important role in metabolic bone diseases and bone metastases and their anti-osteoclastic actions make them important candidates for, for example, the adjuvant treatment of giant cell tumors (Introduction, para 1). Relative to other bisphosphonates, zoledronic acid has the highest mineral binding affinity, indicating high potency and a long duration of action (same para). It also teaches that zoledronic acid was effective across all experimental concentrations according to the quantitative evaluation of cells stained with TRAP and directly suppressed osteoclast formation at all concentrations (“Osteoclast formation declines at 1x10-6 mol/L of zoledronic acid”; para 1). However, the effectiveness was not obvious at the concentrations of 1×10−8 and 1×10−7 mol/l and at the concentration of 1×10−6 mol/l (~272 ng/mL; overlaps with the instantly claimed “50-300 ng/mL” as in instant claim 1 in-part; “wherein the bisphosphonate comprises zoledronic acid . . . in an amount of from approximately 50 ng/mL to approximately 300 ng/mL” as in instant claim 4; “wherein the bisphosphonate comprises, or is, zoledronic acid” as in instant claim 5), the total area of mature mouse osteoclasts was significantly decreased (P<0.01) (same para). This inhibitory effect was further enhanced at the concentration of 1×10−5 mol/l. Furthermore, at the concentration of 1×10−4 mol/l, the suppressive effect was slightly greater compared with zoledronic acid at 1×10−5 mol/l (same para). It also teaches that zoledronic acid suppresses osteoclast adhesion, migration, and bone resorption of osteoclasts (Results, para 2-4).
Therefore, it would have been obvious prior to the effective filing date of the instantly claimed invention to create the bone formulation containing a parathyroid hormone, osteoclast inhibitor, as taught by Kallala, where the bone formulation contains parathyroid hormone in an amount of at least 10 ng/mL as taught by Kamakura, to arrive at the instantly claimed invention. Kamakura teaches that PTH can successfully be added to a bone regeneration composition in at least 10 ng/mL. One of ordinary skill would have been motivated to combine the composition containing PTH, bisphosphonate, and calcium phosphate as taught by Kallala (i.e., any amount of PTH is sufficient) with PTH concentration of Kamakura according to known methods to yield the predictable result of advantageously allowing more effective bone regeneration or bone augmentation. One of ordinary skill in the art would recognize that the improvements caused by the addition of PTH in an amount of at least 10 ng/mL would improve similar bone compositions in the same way.
It also would have been obvious prior to the effective filing date of the instantly claimed invention to create the bone formulation containing a parathyroid hormone, osteoclast inhibitor, and bisphosphonate as taught by Kallala, where the bone formulation contains 10-6 M zoledronic acid, as taught by Li, to arrive at the instantly claimed invention. Li shows that zoledronic acid’s effective concentration for anti-osteoclast activity is 10-6 M. One of ordinary skill in the art would have been motivated to modify the bisphosphonate-containing (zoledronic acid) bone formulation of Kallala (i.e., teaches any amount of zoledronic acid is sufficient) to include zoledronic acid in an amount of 10-6 M as taught by Li with a reasonable expectation of advantageously suppresses osteoclast adhesion, migration, and bone resorption of osteoclasts.
Regarding instant claims 3-5, Kallala teaches that the bisphosphonate can be zoledronic acid and/or alendronic acid (p. 7, see claim 3 of Kallala) (“wherein the bisphosphonate is selected from zoledronic acid, alendronic acid” as in instant claim 3; “wherein the bisphosphonate comprises zoledronic acid, alendronic acid” as in instant claim 4; “wherein the bisphosphonate comprises, or, is, zoledronic acid” as in instant claim 5), rendering the claims prima facie obvious.
Response to Arguments
Applicant’s arguments with respect to previously cited references Matuszewski et al and Hart et al have been considered but are moot because the new ground of rejection does not rely on any of the secondary references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The response to arguments will focus on the newly filed Declaration by Dr. Rami Kallala (“Kallala Declaration”) and Applicant’s arguments related to secondary indicia, purported unexpected results, etc.
On p. 10-11 of Remarks, Applicant argues that the first Kallala Declaration (“Declaration I”; filed 6/7/2024) demonstrated the criticality of the concentrations recited in claim 1. Applicant argues that concentrations of PTH between 0.01 ng/mL and 1.0 ng/mL purportedly result in increase in osteoblast viability and that concentration above 50 ng/mL caused decrease in cell viability. Applicant also argues that Fig. 3-4 of the specification show the optimal concentration of zoledronic acid to suppress bone resorption.
In response, the examiner reiterates that Declaration I was previously considered but insufficient to overcome the rejections, particularly in view of newly cited reference Kamakura et al as well as Li et al (of record; utilized in the above 103 rejection). First, the examiner notes that the Kallala reference teaches the combination of the components as instantly claimed such that it is prima facie obvious to create a composition containing any amount of PTH, bisphosphonate, and bone void filler (see MPEP 2144.05 and In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.")). Regardless, the Kamakura reference shows that PTH in at least 10 ng/mL can be added to a bone regeneration composition to allow for more effective bone regeneration. This overlaps with Applicant’s instantly claimed 0.1 to 50 ng/mL.
The examiner also notes that bisphosphonates claimed in at least independent claim 1 is broader than the argued criticality of zoledronic acid at the claimed range. Even if, arguendo, the purported criticality of the zoledronic acid applied to all of the bisphosphonates encompassed by at least independent claim 1, the 10-6M (272 ng/mL) of zoledronic acid is known in the prior art to have the same properties argued. The concentration produces a predictable result to a predictable extent rather than a new property dissimilar to the known properties of zoledronic acid as shown in the Li reference. Again, as stated above, zoledronic acid at the concentration of 1×10−6 mol/l significantly decreased the amount of osteoclasts and zoledronic acid suppresses osteoclast adhesion, migration, and bone resorption of osteoclasts (Results, para 2-4), which is exactly what Applicant argues to be the criticality of the claimed concentration.
Indeed, an obviousness rejection under 35 U.S.C 103 requires one of ordinary skill to balance each individual teaching of the prior art references with the totality of the references in combination. Applicant’s arguments must take into account the combination of teachings of the prior art references, and appreciate all of the evidence as a whole. Here, the combination of the Kallala, Kamakura, and Li references render prima facie obvious the composition components and the claimed concentrations. Neither the arguments nor Declaration I provide any evidence that the instantly claimed concentrations provide any benefits/unexpected results not previously contemplated by the prior art.
On p. 12-17 of Remarks, Applicant argues, inter alia, that the second Declaration (“Declaration II”) shows that the concentrations provide unpredictable results. Applicant argues that Declaration II states that “ … it was entirely unpredictable what concentration of PTH and bisphosphonate, if any, might be suitable for combined usage in the context of bone healing” and that the unpredictability derives at least in part from PTH and bisphosphonates individual capacity to “trigger both osteoclastic and osteoanabolic pathways . . . in a dose-dependent manner;” and that “the combined effects on these pathways are poorly understood.” Applicant further argues that it was “impossible to predict whether PTH and a bisphosphonate could be used in combination to beneficial effect and what doses of PTH and bisphosphonate might prove beneficial for bone healing.” Applicant also argues that the evidence of the declarations are unexpected at least because “they contravene the reasonable predictions of those of skill in the art at the time of the invention.” Applicant argues that its purportedly novel composition exhibits unexpected property of having improved bone healing properties at unexpectedly low concentrations of PTH.
In response, the examiner disagrees. In the first instance, the Kallala reference does in fact show that any combination of PTH and bisphosphonate can be predictably used in combination in a composition for bone fractures. The Kamakura and Li references render obvious the instantly claimed concentrations of PTH (10 ng/mL) and zoledronic acid (10-6M; ~272 ng/mL) (see 103 rejection above). Again, similarly to previously cited reference Hock (not relied upon for the above rejections), the Kamakura reference teaches that the amount of PTH utilized in the composition can be, for example, suitably determined depending on the degree of bone defect. It is not inventive to discover the optimum or workable ranges absent any unexpected results not previously contemplated by the prior art. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Second, the examiner notes that the argued concentration of PTH (1x, 2x, 5x, and 10x) in Declaration II is inconsistent with the instantly claimed range of concentrations (0.1 ng/mL to 50 ng/mL).
"A greater than expected result is an evidentiary factor pertinent to the legal conclusion of obviousness ... of the claims at issue." In re Corkill, 771 F.2d 1496, 226 USPQ 1005 (Fed. Cir. 1985). However, a greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected. Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. Ex parte The NutraSweet Co., 19 USPQ2d 1586 (Bd. Pat. App. & Inter. 1991) (see MPEP § 716.02(a)). The prior art discloses (1) PTH and bisphosphonate (such as zoledronic acid) can be combined to create a composition for bone fractures, (2) PTH can be added in an amount of at least 10 ng/mL to allow for mor effective bone regeneration, and (3) zoledronic acid at 10-6M performs Applicant’s instantly argued functions. This is similar to Applicant' s instantly claimed composition and argued criticality. The cited art taken as a whole demonstrates a reasonable probability that the combination of cited references Kallala, Kamakura, and Li create a composition sufficiently similar to the claimed composition that whatever differences exist, they are not patentably significant.
On p. 18-20 of Remarks, Applicant argues that the Examiner has approached the claimed invention as “multiple entirely independent elements, rather than in its entirety,” and that even if a particular concentration of one or both the PTH and bisphosphonate may be found in the prior art, it does not mean it would have been obvious to use that particular concentration in a composition as presently claimed. Applicant argues that this is particularly true given that the Declaration II demonstrates that the combined effect of zoledronic acid and PTH were unpredictable and that the fracture healing results would not have been predictable based on the understanding in the art. Applicant further argues that even if a prima facie case of obviousness could be made based on a new combination of references, the preponderance of the evidence would still weigh in favor of finding of non-obviousness because (1) the individual concentration ranges of PTH and bisphosphonate are critical, (2) the combination of PTH and bisphosphonate would not have been predictable at any concentration, and (3) the claim composition possesses unexpectedly beneficial results. Applicant argues that it was “entirely unpredictable what concentration of PTH and bisphosphonate, if any, might be suitable for combined usage in the context of bone healing.”
In response, the examiner disagrees. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (MPEP 2144.06). The prior art contemplates both the combination of PTH and bisphosphonate and the particular concentrations of both PTH and bisphosphonate as instantly claimed. It would have been obvious to use that particular concentration in the claimed composition because, in part, the Kallala reference already shows that PTH and bisphosphonate can be combined to form a composition for bone fracture healing. PTH in a concentration of at least 10 ng/mL is known to improve bone regeneration as shown by the Kamakura reference. Finally, the concentration of a bisphosphonate such as zoledronic acid is known in the prior art to have the same osteoclast inhibiting ability as argued by Applicant. It is the combination of the teachings of the prior art, not just what they teach in their individual capacity, that renders obvious the instant claims. Note that it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Thus, Applicant’s arguments are not persuasive.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kallala in view of Kamakura et al and Li et al as applied to claims 1, 3-8, 11, 13, 16, and 21-22 above, and further in view of Riman et al (US 20110008460 A1, 1/11/2008; published 1/13/2011).
The teachings of Kallala, Kamakura, and Li in combination were recited in the above 35 U.S.C. 103 rejection as applied to claim 1 of which claim 2 depends. The teachings will not be repeated here.
The difference between the combined teachings and the invention as instantly claimed is that they do not teach that the one or more osteoclast inhibitors further comprise strontium ranelate, denosumab, or romosozumab or a combination any two or more thereof.
Riman teaches a biomimetic hydroxyapatite composition to be used as bone implant, bone powders and grafts (see abstract and para 61). The reference teaches that the composition can also contain bisphosphonates, teriparatide, and strontium ranelate (para 62) (“wherein the one or more osteoclast inhibitors further comprise strontium ranelate” as in instant claim 2). The composition can be used as an osseous cement to treat bone disease (para 62 and 72).
Therefore, it would have been obvious prior to the effective filing date of the instantly claimed invention to create the bone formulation containing a parathyroid hormone, osteoclast inhibitor, and bisphosphonate as taught by Kallala, Kamakura, and Li in combination, where the bone formulation contains strontium ranelate as taught by Riman to arrive at the instantly claimed invention. Riman shows that strontium ranelate can be added to a bone composition. One of ordinary skill would have been motivated to combine the bone composition of Kallala, Kamakura, and Li in combination with strontium ranelate according to known methods to yield the predictable result of advantageously treat bone disease as taught by the prior art. One of ordinary skill in the art would recognize that the improvements caused by the addition of strontium ranelate would improve similar bone compositions in the same way.
Response to Arguments
Applicant’s arguments with respect to claim(s) 2 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim(s) 10 and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kallala in view of Kamakura et al and Li et al as applied to claims 1, 3-8, 11, 13, 16, and 21-22 above, and further in view of Li et al (US 7,771,755 A1, 10 Sept 2004; Published 10 Aug 2010; previously cited).
The teachings of Kallala, Kamakura, and Li in combination were recited in the above 35 U.S.C. 103 rejection as applied to claim 1 of which claims 10, 17, 19, and 20 depend. The teachings will not be repeated here.
The difference between the combined teachings and the invention as instantly claimed is that they do not teach that the formulation is in solid form (claim 10), or that the one or more osteoclast inhibitor comprises an etidronate (claim 17), risedronate (claim 19), or a clodronate (claim 20).
Li teaches osteogenic proteins that can be delivered via an injectable solid or hardenable paste (abstract) (“wherein the composition is in a solid form” as in instant claim 10). The formulation contains an osteogenic protein and a poorly crystalline apatitic calcium phosphate, wherein the composition is in the form of a solid rod suitable for intraosseous injection in solid state, further comprising a bone resorption inhibitor (see claim 20 of Li). The bone resorption inhibitor is a bisphosphonate (see claim 21 of Li) and the bisphosphonate is selected from alendronate, cimadronate, clodronate, etidronates, ibandronate, neridronate, olpadronate, pamidronate, risedronate, tiludronate, YH 529, and zoledronate (see claim 22 of Li) (“one or more osteoclast inhibitors comprises an etidronate” as in instant claim 17; “wherein the one or more osteoclast inhibitors comprises a pamidronate” as in instant claim 18; “one or more osteoclast inhibitors comprises risedronate” as in instant claim 19; “one or more osteoclast inhibitors comprises a clodronate” as in instant claim 20). The bisphosphonates dramatically reduces indices of bone turnover, increases bone mineral density, as well as reduces hip and spine fracture in osteopenic women (“Additional active agents” para 4).
Therefore, it would have been obvious prior to the effective filing date of the instantly claimed invention to create the bone formulation containing a parathyroid hormone, osteoclast inhibitor, and bisphosphonate as taught by Kallala, Kamakura, and Li in combination, where the composition is in solid form and the bisphosphonate is etidronate, clodronate, or risedronate as taught by Li, to arrive at the instantly claimed invention. As Li shows that etidronate, risedronate, and clodronate can be used in a bone composition, one of ordinary skill would have been motivated to simply substitute one known element [bisphosphonate of Kallala, Kamakura, and Li in combination] for another [etidronate, risedronate, and clodronate of Li] to obtain the predictable result of advantageously reducing indices of bone turnover and increasing bone mineral density as taught by the prior art.
Furthermore, it also would have been prima facie obvious to try, from a finite number of identifiable, predictable solutions, to make the formulation into an injectable solid with a reasonable expectation of success as taught by the prior art.
Finally, it also would have been prima facie obvious to try, from a finite number of identifiable, predictable solutions, to use any bisphosphonate, including those instantly claimed, to create a bone composition with a reasonable expectation of success as taught by the prior art.
Response to Arguments
Applicant has not provided any arguments challenging the specific teachings of cited reference Li nor has Applicant attempted to distinguish the instantly claimed invention from what is taught in the prior art reference.
Conclusion
No claim is allowed.
THIS ACTION IS NON-FINAL.
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/G.R./Examiner, Art Unit 1632
/KARA D JOHNSON/Primary Examiner, Art Unit 1632