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 .
Status of Application, Amendments and/or Claims
The amendment and Applicant’s arguments, filed 21 October 2025, have been entered in full. Claims 1-26, 29 and 35 are canceled. Claims 27, 28, 30-34 are amended. Claims 27, 28, 30-34 are under examination.
Withdrawn Objections And/Or Rejections
The rejection to claims 27, 28, 30-35 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, enablement, as set forth at pages 2-17 of the previous Office Action (21 April 2025), is withdrawn in view of the amendment and Applicant’s arguments that the claims are amended to recite the mechanism demonstrated by SEQ ID Nos: 3 and 4, as taught in the Specification (21 October 2025).
MATTER OF RECORD
All pending rejections are withdrawn in view of the amendment. Therefore, Applicant’s arguments will not be addressed. Please see the New rejections below.
NEW CLAIM REJECTIONS/OBJECTIONS
Claim Rejections-35 USC § 112(a) or 35 U.S.C. 112 (pre-AIA ), First paragraph, Scope of Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 27, 28, 30-34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for:
A method of treating a disease or condition in a human subject, wherein said disease or condition is characterized by excessive osteoclastogenesis and/or bone resorption, wherein said disease or condition is selected from the group consisting of osteoporosis, Paget’s disease and bone loss associated with cancer, comprising administering to the human subject a therapeutically-effective amount of an isolated or recombinant protein comprising or consisting of the amino acid sequence selected from SEQ ID NO: 3 or SEQ ID NO: 4, wherein administration reduces M-CSF signaling, reduces RANKL signaling and reduces activation of essential osteoclastogenic transcription factors NF-kB, c-Fos and NFATc1 in osteoclast precursors and reduces osteoclast differentiation and/or reduces bone resorptive activity in the human subject.
does not reasonably provide enablement for:
treating an osteolytic condition
inhibiting M-CSF or RANKL signaling
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to and/or use the invention commensurate in scope with these claims.
The instant claims are not enabled for the following reasons:
1. The instant specification fails to teach an “osteolytic condition” (please also see the New Matter Rejection below).
Because the specification fails to teach an “osteolytic condition”, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention and those conditions that fall under this genus. The effects of administering instant SEQ ID NO: 3 or SEQ ID NO: 4 to treat an unknown osteolytic condition would be unpredictable. The lack of guidance also induces a large quantity of experimentation because one of ordinary skill would need to discern which “osteolytic condition” is also “characterized by excessive osteoclastogenesis and/or bone resorption” that would be effective with SEQ ID NO:3 or SEQ ID NO:4 treatment.
2. The instant specification fails to teach wherein SEQ ID NO: 3 or SEQ ID NO: 4 inhibits M-CSF or RANKL signaling in osteoclast precursors. See for example Figure 15, which teaches a reduction.
3. The correlation between reduced osteoclast differentiation and/or reduced bone resorptive activity in a human subject and the in vitro mechanistic data of SEQ ID NO:3 does not rely solely on M-CSF or RANKL signaling.
The specification provides insight of a mechanism that occurs when SEQ ID NO: 3 is added to osteoclast precursors. Osteoclast precursors treated with SEQ ID NO: 3 reduces M-CSF signaling, reduces RANKL signaling and reduces activation of the essential osteoclastogenic transcription factors NF-κB, c-Fos and NFATc1, thereby reducing osteoclast differentiation and/or reducing bone resorptive activity in human subjects.
Due to the inherent unpredictability in the field and the lack of guidance in the
specification regarding administering SEQ ID NO:3 or SEQ ID NO:4 to treat an unknown osteolytic condition; the lack of guidance in the specification and the large quantity of experimentation necessary to discern unknown osteolytic conditions that are characterized by excessive osteoclastogenesis and/or bone resorption; the absence of working examples directed to same; the complex nature of the invention; and the breadth of the claims which fail to recite limitations regarding a correlation between the full in vitro mechanism of administered SEQ ID NO:3 or SEQ ID NO:4 in osteoclast precursors and reduced osteoclast differentiation and/or reduced bone resorptive activity in a human subject; undue experimentation would be required of the skilled artisan to make and/or use the claimed invention.
Claim Rejections-35 USC § 112(a) or 35 U.S.C. 112 (pre-AIA ), First paragraph, Written description requirement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 27, 28, 30-34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a New Matter Rejection.
The specification as originally filed does not provide support for the invention as now claimed:
“an osteolytic condition in a human subject, the condition being characterized by excessive osteoclastogenesis and/bone resorption..” (see claim 27).
Applicant's amendment, filed 21 October 2025, asserts that no new matter has been added and directs support to Figures 15A-15F, Example 3, Example 6 and Table 5.
The Examiner cannot find the limitation “osteolytic condition”.
The instant claims result in New Matter because the limitation ““osteolytic condition” cannot be found in the specification. The claims also broaden the original disclosure because they include diseases and/or conditions that were not originally contemplated.
The specification as filed does not provide a written description or set forth the metes and bounds of this "limitation". The instant claims now recite limitations which were not disclosed in the specification as filed, and now change the scope of the instant disclosure as-filed.
Applicant is required to cancel the new matter in the response to this Office action. Alternatively, Applicant is invited to provide specific written support for the “limitations” indicated above or rely upon the limitations set forth in the specification as filed.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 27, 31-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5 and 11 of U.S. Patent No. 10,858,409 in view of Miller et al. (RBP-J-Regulated mirR-182 proteins TNF-alpha induces osteoclastogenesis. ABSTRACT. Journal of Immunology, Vol. 196/No. 12, pages 4977-86, 2016).
The instant claims are drawn to a method of treating an osteolytic condition in a human subject, the condition being characterized by excessive osteoclastogenesis and/or bone resorption, the method comprising administering to the subject a therapeutically-effective amount of an isolated or recombinant protein comprising or consisting of the amino acid sequence selected from SEQ ID NO: 3 or SEQ ID: NO: 4, wherein administration inhibits M-CSF and/or RANKL signaling in osteoclast precursors and reduces osteoclast differentiation and/or bone resorptive activity in the subject. The claims are further drawn to wherein the administration reduces expression of c-Fms and/or RANK in osteoclast precursors. The claims are further drawn to wherein administration inhibits nuclear translocation of NF-kB p65 and/or p52 in osteoclast precursors.
The claims of U.S. Patent No. 10,858,409 teach a method of treating rheumatoid arthritis in a patient comprising administering SEQ ID NO:4. The claims further teach a method of treating rheumatoid arthritis in a patient comprising administering SEQ ID NO:3.
The claims of U.S. Patent No. 10,858,409 teach rheumatoid arthritis as an osteolytic condition characterized by excessive osteoclastogenesis and/or bone resorption.
Miller et al. teach increased osteoclastogenesis is responsible for osteolysis, which is a severe consequence of inflammatory diseases associated with bone destruction, such as rheumatoid arthritis and periodontitis.
It would have been obvious for one of ordinary skill in the art before the effective filling date to modify a method of treating rheumatoid arthritis in a patient comprising administering SEQ ID NO:3 or SEQ ID NO:4, as taught by the claims of U.S. Patent No. 10,858,409, by treating an osteolytic condition characterized by excessive osteoclastogenesis and/or bone resorption, wherein the osteolytic condition characterized by excessive osteoclastogenesis and/or bone resorption is rheumatoid arthritis, as taught by Miller et al.
One of ordinary skill in the art before the effective filing date, would have been motivated to make such modifications and expect success because Miller et al. teach increased osteoclastogenesis is responsible for osteolysis, which is a severe consequence of inflammatory diseases associated with bone destruction, such as rheumatoid arthritis and periodontists. The species of treating rheumatoid arthritis comprising administering SEQ ID NO:3 or SEQ ID NO:4, as taught by the claims of U.S. Patent No. 10,858,409, renders obvious the genus of treating an osteolytic condition characterized by excessive osteoclastogenesis and/or bone resorption comprising administering SEQ ID NO:3 or SEQ ID NO:4, as recited in the instant claims.
The mechanism of inhibition of M-CSF and/or RANKL signaling in osteoclast precursors, reduced expression of c-Fms and/or RANK in osteoclast precursors and inhibition of nuclear translocation of NF-kB p65 and/or p52 in osteoclast precursors, would inherently occur when SEQ ID NO:3 or SEQ ID NO:4 is added to osteoclast precursors.
MPEP 2112 teaches: Requirements of Rejection Based on Inherency; Burden of Proof [R-10.2019]. The express, implicit, and inherent disclosures of a prior art reference may be relied upon in the rejection of claims under 35 U.S.C. 102 or 103. "The inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness." In re Napier, 55 F.8d 610, 613, 34 USPQ2d 1782, 1784 (Fed. Cir. 1995) (affirmed a 35 U.S.C. 103 rejection based in part on inherent disclosure in one of the references). See also In re Grasselli, 713 F.2d 731, 739, 218 USPQ 769, 775 (Fed. Cir. 1983).
Case law has established that the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer. Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Also, case law has established that chemical compounds and their properties are inseparable (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA1963)), as are their processes and yields (In re Von Schickh, 362 F.2d 821, 150 USPQ 300 (CCPA 1966)).
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any 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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/R.M.D/Examiner, Art Unit 1647 1/14/2026
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647