Prosecution Insights
Last updated: April 19, 2026
Application No. 18/192,094

USE OF NERIDRONIC ACID OR OF ITS SALT FOR THE TREATMENT OF OSTEOARTHROSIS

Final Rejection §103§112
Filed
Mar 29, 2023
Examiner
OTTON, ALICIA L
Art Unit
1699
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Abiogen Pharma S P A
OA Round
2 (Final)
65%
Grant Probability
Moderate
3-4
OA Rounds
2y 9m
To Grant
74%
With Interview

Examiner Intelligence

Grants 65% of resolved cases
65%
Career Allow Rate
817 granted / 1260 resolved
+4.8% vs TC avg
Moderate +9% lift
Without
With
+9.1%
Interview Lift
resolved cases with interview
Typical timeline
2y 9m
Avg Prosecution
32 currently pending
Career history
1292
Total Applications
across all art units

Statute-Specific Performance

§101
1.3%
-38.7% vs TC avg
§103
24.5%
-15.5% vs TC avg
§102
24.9%
-15.1% vs TC avg
§112
28.8%
-11.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1260 resolved cases

Office Action

§103 §112
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 . Response to Remarks/Amendments Applicant’s amendments filed November 17, 2025 have been entered. All rejections and objections not explicitly maintained herein are withdrawn. The rejections below constitute the full set of rejections being applied to the instant claims. With respect to the rejection of claims 30-35 and 39-46 under 35 USC 103 as obvious over the ‘960 publication, it is noted that the rejection is withdrawn and replaced with a new rejection (the same publication in view of Varenna) as necessitated by Applicants’ claim amendment. Thus, the arguments presented by Applicants are addressed to the extent that the pertain to the amended grounds of rejection. Notably, the prior art rejections over claim 30 and any subsequent claim requiring a 200mg dosage of active ingredient have been withdrawn. The recited dosage is significantly higher than that suggested by the prior art. However, any claim requiring a lower dosage, or not reciting any dosage (such as claim 44) remain rejected for the reasons set forth herein. Applicants traverse the rejection on several grounds, each of which has been considered but was not found to be persuasive. Applicant’s first argue that the primary reference Du Mesnil only mentions neridronate in a list of several bisphosphonic acids but does not provide any specific examples utilizing neridronate for treatment. However, when considering all that a piece of prior art would have taught or suggested a skilled artisan, disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971) [emphasis added]. "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994) (The invention was directed to an epoxy impregnated fiber-reinforced printed circuit material. The applied prior art reference taught a printed circuit material similar to that of the claims but impregnated with polyester-imide resin instead of epoxy. The reference, however, disclosed that epoxy was known for this use, but that epoxy impregnated circuit boards have "relatively acceptable dimensional stability" and "some degree of flexibility," but are inferior to circuit boards impregnated with polyester-imide resins. The court upheld the rejection concluding that applicant’s argument that the reference teaches away from using epoxy was insufficient to overcome the rejection since "Gurley asserted no discovery beyond what was known in the art." Id. at 554, 31 USPQ2d at 1132.). Furthermore, "[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). Accordingly, even if no concrete data was provided for the neridronic acid currently claimed, the prior art’s disclosure that the compounds therein are useful for the treatment of lameness involving osteoarthrosis would have been expected to apply to all compounds disclosed therein as being exemplary of the invention. It is further noted that the provision of data is not a requirement for a prior art reference to teach or suggest a method of treatment. As set forth in MPEP 2123(I), A reference is not only relied upon as prior art for that which it explicitly teaches but also “may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art.” Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). Further, "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). Finally, it is respectfully submitted that the bar for establishing a prima facie case of obviousness only requires a reasonable expectation of success, not a guarantee of success. The examiner submits again, as in the original rejection, that an explicit suggestion that the compounds disclosed therein are effective for the treatment of lameness involving osteoarthrosis, and the further disclosure of neridronic acid as exemplary of the genus disclosed therein, would have been sufficient to establish the necessary “reasonable expectation” that the compounds exemplified therein would be capable of performing this function. Applicants go on to argue that Du Mesnil is silent as to the dosages presently claimed. This was not found persuasive because Du Mesnil teaches a typical dose range is from about 0.001 mg/kg of the patient's body weight (paragraph [0047]). In particular, an oral dosage form is most preferably 0.001 mg to 10g per dosage unit (paragraph [0053]) which fully encompasses the dosage of the instant claims, while an intravenous dosage most preferably ranges from 0.01 mg/kg/week to 1 mg/kg/week (paragraph [0056]). In addition, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In addition to the dosage ranges disclosed in DuMesnil, Varenna was relied upon for its teaching of more specific dosage and administration schedule pertaining to neridronate specifically. Applicants also argue that the use of an inherency rationale in the context of obviousness is improper because DuMesnil is silent as to the effect of administration on bone marrow lesions. However, as evidenced by WO 2015184003, the use of bisphosphonate compounds such as neridronic acid for the treatment of bone marrow lesions was known and documented (paragraphs [0056]-[0057], [0062], [0091], Embodiment 173). Thus, the examiner disagrees with the contention that this effect of the administration of neridronic acid would have been surprising or unexpected, as this conclusion is not supported by the evidence of record. To the extent in which Appellants argue that the Du Mesnil reference is nonanalogous art because it is not “reasonably pertinent” to the problem solved in the present invention, the problem solved in the present invention, as understood based on the claims interpreted in light of the specification, is the provision of an additional therapeutic option for the pain symptomology of osteoarthritis, which problem was solved in the description of neridronic acid or a salt thereof for this therapeutic purpose. In order for prior art to be analogous art, MPEP 2141.01(a) provides that “a reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention). See Bigio, 381 F.3d at 1325, 72 USPQ2d at 1212.” Here, the Du Mesnil reference is clearly in the same field of endeavor as it pertains to the use of bisphosphonate compounds (where neridronic acid is explicitly exemplified) for the purpose of treating lameness (irregular gait cause by the perception of pain) (col. 3, ll. 10-13). A reference contemplating the use of a compound in the same class of compounds as presently claimed, where the claimed neridronate is explicitly described, for the treatment of a painful joint condition must certainly be considered as being in the same field of endeavor as the claimed invention, if not at the very least reasonably pertinent. Finally, in response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, 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). For at least the reasons described above, as well as those set forth in the rejection herein, the examiner maintains that all features of the claimed invention would have been suggested to a person of ordinary skill in the art by the combination of prior art references. Status of the Claims Currently, claims 30-32 and 37-46 are pending and under consideration herein. Claim Objections Claim 32 is objected to for a typographical error. The text “claim 20” should be replaced with “claim 30.” Claim 46 is objected to for a typographical error. The text “neridro30-31nate” should be replaced with “neridronate.” 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(a) 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 37, 39, 41-42 and 44-46 are rejected under 35 U.S.C. 103 as being unpatentable over US 2001/0006960 (“the ‘960 publication”) in view of Varenna et al., Rheumatology 2013, 52: pp. 534-542. The instantly rejected claims are drawn to a method of treating bone marrow lesions thereby reducing joiny pain in a human patient comprising administering neridronic acid or a salt thereof intravenously at a dosage of 200 mg, at least 2 times over a period of 5-15 days, with at least one day between administrations, where claims dependent claims specify particular dosages for the pharmaceutical composition to be administered. Determining the scope and contents of the prior art The ‘960 publication teaches the treatment of lameness with an osseous, articular or osteoarticular component, comprising the administration, to a human or to an animal not suffering from arthritis or from fractures, of an effective amount of a bisphosphonic acid derivative of formula PNG media_image1.png 160 328 media_image1.png Greyscale (see Abstract), where lameness is defined as irregular gait caused by pain and resulting from painful lesions on the bone structure, cartilage, ligaments, synovial membrane or connective tissue, where osteoarthrosis is particularly exemplified as a particular condition in which lameness appears (see paragraph [0010] and claim 4). Thus, the art teaches that the patient to which the active is administered has painful bone lesions. Further Example 2 describes a clinical trial where osteoarthrosis is treated in a horse. Further relating to the instantly claimed method, the prior art teaches that the compound 6-amino-1-hydroxyhexylidenebisphosphonic acid or a salt thereof is preferable for the treatment method disclosed therein (see paragraph [0029]), where the above compound and neridronic acid are both chemical names for the same substance, CAS RN 79778-41-9: PNG media_image2.png 445 522 media_image2.png Greyscale . Notably, sodium salts of the compounds described therein are explicitly mentioned (paragraph [0020]). In addition, the features recited in claim 31 are considered to be inherent effects of an anticipatory administration. That is, administration of the same compound to the same patient population for the treatment of the same disease, as taught by the prior art, would necessarily have the same effect as claimed. Notably, MPEP 2131.02 provides that when the prior art teaches a genus (in this case a genus of compound and a genus of diseases to be treated), the claimed subject matter is anticipated if one of ordinary skill in the art is able to “at once envisage” the claimed embodiment. In re Petering, 301 F.2d 676, 133 USPQ 275 (CCPA 1962). Further, In In re Schauman, 572 F.2d 312, 197 USPQ 5 (CCPA 1978), claims to a specific compound were anticipated because the prior art taught a generic formula embracing a limited number of compounds closely related to each other in structure and the properties possessed by the compound class of the prior art was that disclosed for the claimed compound. The broad generic formula seemed to describe an infinite number of compounds but claim 1 was limited to a structure with only one variable substituent R. This substituent was limited to low alkyl radicals. One of ordinary skill in the art would at once envisage the subject matter within claim 1 of the reference.) Such is the case here. Further, the art teaches pharmaceutical compositions comprising the substances described therein for administration to a human patient, where the composition contains the active ingredient and may also include “ingredients usually used in pharmacy for the preparation of oral forms” (paragraph [0058], which reads on the “vehicles” encompassed by the pharmaceutical compositions in the present claims). Modes of administration for the prior art formulations are disclosed throughout the reference, for example at paragraph [0049] where parenteral, oral, rectal, intra-articular, cutaneous, transcutaneous and transdermal modes are all explicitly described. Regarding the claimed vial or bottle containing the composition to be administered, it is noted that any container comprising the composition would read on this limitation, including the container from which an injection is given in the parenteral administration as in the Examples. With respect to the claimed unit doses, the prior art teaches that the exact formulation, route of administration and dosage for the pharmaceutical compositions can be chosen based on the severity of patient's condition and other factors such as age and weight (paragraph [0050]), where a typical dose range is from about 0.001 mg/kg of the patient's body weight (paragraph [0047]). In particular, an oral dosage form is most preferably 0.001 mg to 10g per dosage unit (paragraph [0053]) which fully encompasses the dosage of the instant claims, while an intravenous dosage most preferably ranges from 0.01 mg/kg/week to 1 mg/kg/week (paragraph [0056]). Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02) The difference between the prior art and the instant claims is that the ‘960 publication does not explicitly describe an example wherein an anticipatory compound is actually administered to a patient for the treatment of bone marrow lesions, as claimed, and that the ‘960 publication does not explicitly teach the amount of the doses as presently claimed or the particular intervals at which the intravenous dosage is to be administered. Further, as it pertains to claims 39, 41-42 and 45-46, the prior art does not explicitly teach the amount present in the unit doses as presently claimed. Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2141.02) As an initial matter, with respect to the requirement that bone marrow lesions are treated, it is noted that a compound and its properties are inseparable and the administration of an anticipatory compound (i.e. neridronic acid) would necessarily have the recited effect (i.e. reduction of bone marrow lesions). To this end, MPEP 2112 provides that the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003) (rejecting the contention that inherent anticipation requires recognition by a person of ordinary skill in the art before the critical date and allowing expert testimony with respect to post-critical date clinical trials to show inherency); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) (“[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention.” Such is the case here, since the claimed effects (i.e. alleviation of pain symptomology and reduction in size and extent of bone marrow lesions) is a necessary result of the prior art administration of a compound specifically disclosed in the art as for treatment of osteoarthritis. The fact that this effect was not recognized or assayed in the prior art does not render the instant claims patentable over the prior art disclosure. Further regarding the differences described in paragraph 13 above, MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.’" KSR, 550 U.S. at ___, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention." Further, MPEP 2144.06 states that it is obvious to substitute art-recognized equivalents which are known for the same purpose. In the present case, the skilled artisan conducting the method of the instantly claimed invention would merely be carrying out the explicit teaching or suggestion of the prior art as in rationale (G) above. The prior art explicitly teaches the administration of the described illustrative compounds including the anticipatory species in a method for treating cancer which is encompassed by the instantly claimed scope. In addition to the explicit suggestion for treating osteoarthritis patients having pain caused by bone lesions throughout the reference, the prior art provides data showing evidence of in vivo utility of a related bisphosphonate compound in a clinical trial (Example 3), as well as explicit suggestions that the compound of the instant claims be used for the same purpose. To this end, it is noted that an improvement in the art would have been obvious if “it is likely the product not of innovation but of ordinary skill and common sense.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007). Finding workable or optimal ranges is generally understood as within the capabilities of the ordinary artisan. See Pfizer Inc. v. Apotex Inc., 82 USPQ2d 1321 (Fed. Cir. 2007) (discovery of an optimum value of a variable in a known process is usually obvious.). The idea that optimizing an ordinary variable does not by itself constitute a patentable advance was also stated in In re Geisler, 43 USPQ2d 1362: “…“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). Only if the “results of optimizing a variable” are “unexpectedly good” can a patent be obtained for the claimed critical range. In re Antonie, 559 F.2d 618, 620, 195 USPQ 6, 8 (CCPA 1977); see also In re Dillon , 919 F.2d 688, 692, 16 USPQ2d 1897, 1901 (Fed.Cir. 1990) (in banc).” Note MPEP §2144.05(II)(A) on this issue. Likewise, optimization of a range or other variable within the claims flows from the “normal desire of scientists or artisans to improve upon what is already generally known.” In re Peterson, 65 USPQ2d 1379, 1382. See also In re Boesch, 617 F.2d 272, 276 (C.C.P.A. 1980): “[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.”; In re Esterhoy, 440 F.2d 1386, 1389 (C.C.P.A. 1971): “The conditions recited in the claims appear to us to be only optimum and easily ascertained by routine experimentation.”; In re Swentzel, 219 F.2d 216, 219 (C.C.P.A. 1955): “the determination of that desired size under the present circumstances involves nothing more than routine experimentation and exercise of the judgment of one skilled in the art.”; In re Swain, 156 F.2d 246, 247-48 (C.C.P.A. 1946): “In the absence of a proper showing of an unexpected and superior result over the disclosure of the prior art, no invention is involved in a result obtained by experimentation.” See also In re Kulling, 14 USPQ2d 1056 and In re Malagari, 182 USPQ 549, 553. As is stated in Iron Grip Barbell Co. v. USA Sports, Inc., 73 USPQ2d 1225, 1228 “[W]here there is a range disclosed in the prior art, and the claimed invention falls within that range, there is a presumption of obviousness.” Note similar language in In re Cooper, 57 USPQ 117, 119-120 and Ormco Corp. v. Align Tech., Inc., 79 U.S.P.Q.2d 1931, 1940. To overcome this prima facie case of obviousness applicants must show “that the claimed range achieves unexpected results relative to the prior art range.” (Peterson). Moreover, this showing must be commensurate in scope with the claimed range or, in other words, an applicant must show that the unexpected result occurs throughout the entire claimed range. See In re Harris, 74 USPQ2d 1951 (“Harris needed to show results covering the scope of the claimed range”). The showing must also present enough data points within the prior art range, but outside the claimed range, to establish that the unexpected property does not occur outside the claimed range. In re Hill, 284 F.2d 955, 958-59 (CCPA 1960). See MPEP §716.02(d)(II). Moreover, In re Huang, 40 USPQ2d 1685, 1688 states that even if the “modification results in great improvement and utility over the prior art, it may still not be patentable if the modification was within the capabilities of one skilled in the art, unless the claimed ranges “produce a new and unexpected result which is different in kind and not merely in degree from the results of the prior art.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (C.C.P.A. 1955); see In re Woodruff, 919 F.2d 1575, 1578, 16 USPQ2d 1934, 1936-37 (Fed.Cir. 1990).” Note similar language in In re Waymouth and Koury, 182 USPQ 290 (“a difference in kind, rather than in degree.”) "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005)(claimed alloy held obvious over prior art alloy that taught ranges of weight percentages overlapping, and in most instances completely encompassing, claimed ranges; furthermore, narrower ranges taught by reference overlapped all but one range in claimed invention). See MPEP 2144.05(I). Further, it is noted that 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). The above case law is especially applicable here, as the prior art discloses that dosage amount and interval are result effective variables which may be tailored to the individual patient. With respect to the particular dosages selected for the instant claims, as well as the intervals selected for intravenous administration, this information was already known in the art for neridronate as evidenced by Varenna et al. The Varenna reference teaches an i.v. infusion of 100 mg neridronate given four times over 10 days being effective for treating pain (see Abstract). Notably, regarding instant claim 38, the neridronate was diluted in a 500 mL saline isotonic solution which reads on the composition of claim 38. The treatment was administered every third day four times (page 535). Thus, all of the elements of claims were known to one of ordinary skill in the art at the time the invention was made and one skilled in the art could have practiced the claimed invention as described by the prior art which would have yielded nothing more than predictable results to one of ordinary skill in the art at the time of invention. Therefore, the claimed invention, as a whole, would have been obvious to one of ordinary skill in that art at the time the invention was made. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claims 37, 39 and 41-42 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 30, from which the claims depend, require 200 mg of neridronic acid or a salt thereof. Claims 37 and 42 require an amount of sodium neridronate which would deliver 100mg equivalent of neridronic acid; based on the percent by weight, this limitation would require 185 mg sodium neridronate, which falls outside the limitations of the independent claim. Similarly, other dependent claims require a vial with a unit dose of 70-150 mg, which does not equate to the required 200 mg administered dose in the independent claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Conclusion Claims 30-31, 38, 40 and 43 are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alicia L. Otton whose telephone number is (571)270-7683. The examiner can normally be reached on Monday - Thursday, 8:00-6:00. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Fereydoun Sajjadi can be reached on 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. 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 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. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ALICIA L OTTON/Primary Examiner, Art Unit 1699
Read full office action

Prosecution Timeline

Mar 29, 2023
Application Filed
Sep 06, 2025
Non-Final Rejection — §103, §112
Nov 17, 2025
Response Filed
Mar 17, 2026
Final Rejection — §103, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
65%
Grant Probability
74%
With Interview (+9.1%)
2y 9m
Median Time to Grant
Moderate
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