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 .
Claims Status
The amendments and remarks filed 07/10/2026 are acknowledged.
Claims 1-20 are pending.
Claims 1, 3, 5-6, 8-9, 11-12, 14-15, 17-18, and 20 are amended.
Claims 9-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/15/2025.
Therefore, claims 1-8 are under examination.
Withdrawn
The objections to the drawings are withdrawn. Applicant has submitted replacement drawings and a substitute specification to overcome the objections.
The Improper Markush Grouping rejections of claims 1, 3, and 5 are withdrawn. Applicant has amended the claims to overcome the rejections.
The rejections of claims 5 and 8 under 35 U.S.C. 112(b) are withdrawn. Applicant has amended the claims to overcome the rejections.
Maintained Rejections
Claim Rejections - 35 USC § 112(a)
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 1-8 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Factors to be considered in determining whether undue experimentation is required, are set forth in In re Wands 8 USPQ2d 1400. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the
presence or absence of working examples, (4) the nature of the invention, (5) the state
of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art and (8) the breadth of the claims.
(4) The nature of the invention
The nature of the invention is a method of promoting bone growth in a subject, comprising administering to the subject an effective amount of a 14-3-3zeta protein to promote bone growth in the subject. Therefore, the nature of the invention is a chemical case, where there is natural unpredictability in performance. Accordingly, it is the Office’s position that undue experimentation would be required to use the claimed product, with a reasonable expectation of success, because it would not be predictable from the disclosure of any one particular embodiment what other embodiments may or may not work; see MPEP 2164.03.
(F) The amount of direction provided by the inventor, (G) The existence of working examples:
There is a lack of working examples in the specification. Applicant has not provided substantive evidence for promoting bone growth by administering the 14-3-3zeta protein as claimed. At best, Applicant appears to have provided evidence of inhibiting bone loss by administering the 14-3-3zeta protein [see 0087 and Figures 5A-H of the instant specification]. However, there is no evidence in the instant specification that the administration of 14-3-3 zeta protein promotes bone growth.
Given the lack of guidance and lack of working examples commensurate in scope to the claimed invention, the specification, as filed, does not provide enablement for the claimed method of promoting bone growth in a subject comprising administering to a subject an effective amount of a 14-3-3zeta protein to promote bone growth in the subject.
Applying the above test to the facts of record, it is determined that 1) no declaration under 37 C.F.R. 1.132 or other relevant evidence has been made of record establishing the amount of experimentation necessary, 2) insufficient direction or guidance is presented in the specification. One of skill in the art would require guidance in order to use the claimed 14-3-3-zeta protein in a manner reasonable in correlation with the scope of the claims. Without proper guidance, the experimentation to is undue.
Applicant has not provided sufficient guidance to enable one of skill in the art to use the claimed invention in a manner reasonably correlated with the scope of the claims. The scope of the claims must bear a reasonable correlation with the scope of enablement (In re Fisher, 166 USPQ 19 24 (CCPA 1970). Without such guidance, determining a function other than on-target activity is unpredictable and the experimentation left those skilled in the art is unnecessarily and improperly, extensive and undue. See Amgen Inc v Chugai Pharmaceutical Co Ltd. 927 F 2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991) at 18 USPQ2d 1026-1027 and Exparte Forman, 230 U.S.P.Q. 546(Bd. Pat=. App & int. 1986).
In view of all of the above, one of skill in the art would be forced into undue experimentation to practice the claimed invention, and thus, the claimed invention does not satisfy the requirements of 35 U.S.C. 112 first paragraph.
Claims 2-8, which depend from claim 1, are therefore rejected for the same reasons set forth above.
Response to Declarant’s Arguments
The declaration under 37 CFR 1.132 filed on 07/10/2026 is insufficient to overcome the rejections of claims 1-8 under 35 U.S.C. 112(a) enablement. Points 1-3 did not set forth any arguments. The Examiner acknowledges Declarant’s credentials. In point 4, Declarant states the Figure 3D of the instant application demonstrates that the administration of 14-3-3zeta protein promotes bone growth. This is not found persuasive because this is not commensurate in scope with the claims. The results of Figure 3D are directed to the combination of the 14-3-3zeta and incomplete Freund’s adjuvant (IFA), whereas the claims are only directed to the administration of the 14-3-3zeta protein. Additionally, the description of Figure 3D in the instant specification [see page 5] states that Figure 3D shows representative pictures of an inflamed joint.
Points 5 and 6 do not provide any arguments but state that collagen provides the structural framework, toughness, and flexibility of bones, is essential for bone formation, and is the structural scaffold that makes bone growth and bone repair possible by providing the framework on which new bone mineral is deposited, and that a reduction in available calcium can limit the mineral building blocks needed for bone formation and maintenance. The Examiner acknowledges the information about collagen and calcium.
Point 7 sets forth a journal article referred to as “Exhibit A” that Declarant states demonstrates that 14-3-3zeta protein inhibits bone loss. This is not found persuasive because this is not commensurate in scope with the instant claims. The claims are directed to a method of promoting bone growth and not to a method of inhibiting bone loss. Point 8 sets forth data referred to as “Exhibit B” that Declarant states shows that the administration of 14-3-3 zeta protein promotes bone growth with the fluorescent green labeled bone layers indicating net bone formation. This is not found persuasive because Exhibit B is not in color so the Examiner cannot interpret the figures.
Point 9 does not provide any arguments. Declarant states that the article entitled "14-3-ζ A suppressor of inflammatory arthritis", PNAS 2021 Vol. 118 No. 34, by Joshua Kim, et al., is a disclosure made by members of their laboratory group and themselves, and Declarant also states that they are an author on this article, as is the co-inventor on the above-identified application, Saurabh Chattopadhyay. The Examiner acknowledges this article and its author information.
Response to Arguments
The rejections of claims 1-8 under 35 U.S.C. 112(a) enablement are maintained. On pages 7-8 of the remarks, Applicant argues that the claimed subject matter is described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention without undue experimentation, pointing to various parts of the instant specification which the Examiner will address individually below. In regards to Figure 3D, this is not found persuasive because this is not commensurate in scope with the claims. The results of Figure 3D are directed to the combination of the 14-3-3zeta and incomplete Freund’s adjuvant (IFA), whereas the claims are only directed to the administration of the 14-3-3zeta protein. Additionally, the description of the Figure 3D in the instant specification [see page 5] states that Figure 3D shows representative pictures of an inflamed joint.
In regards to paragraph 87 which references Figures 5A-H, this is not found persuasive because these Figures are not commensurate in scope with the claims. The results of Figures 5A-H are directed to the combination of the 14-3-3zeta and incomplete Freund’s adjuvant (IFA), whereas the claims are only directed to the administration of the 14-3-3zeta protein. Additionally, Paragraph 87 references “14-3-3zeta immunization” indicating that an immune response against 14-3-3zeta is occurring. Incomplete Freund’s adjuvant is known in the art to induce an immune response and stimulate antibody-producing cells [see InvivoGen; instant PTO-892]. Thus, it is inferred that administering the combination of 14-3-3zeta and IFA would induce an immune response against 14-3-3zeta, which would be in opposition to instant claim 1 requiring administering the 14-3-3zeta protein to promote bone growth.
In regard to Figures 6A-6N, this is not found persuasive because this is not commensurate in scope with the claims. Figures 6A-6B are directed to the combination of the 14-3-3zeta and incomplete Freund’s adjuvant (IFA), whereas the claims are only directed to the administration of the 14-3-3zeta protein. Further, 6A-6N relate to 14-3-3zeta promoting collagen synthesis. While collagen relates to and may improve bone density, Figures 6A-6B do not indicate that 14-3-3zeta promotes bone growth.
In regards to Figures 7A-7G, this is not found persuasive because this is not commensurate in scope with the claims. Figures 7A-7G demonstrate that the 14-3-3zeta protein causes bone remodeling by promoting collagen synthesis. However, Figures 7A-7G do not indicate that 4-3-3zeta promotes bone growth.
In regards to Figures 8A-8D and 12A-12B, this is not found persuasive because this is not commensurate in scope with the claims. Figures 8A-8D demonstrate that 14-3-3zeta knockout has less bone formation compared to wild type mouse and Figures 12A-12B demonstrate that 14-3-3zeta knockout animals have reduced calcium deposits, but the claims are directed to the administration of the 14-3-3zeta protein in order to promote bone growth. Applicant further argues the Chakravarti declaration and that it provides additional data showing that administration of 14-3-3zeta protein promotes bone growth. The declaration has been addressed above and the response thereto will not be reiterated.
In summary, many of the examples Applicant points to for support for enablement are not commensurate in scope with the instant claims. A majority of the examples and Figures in the instant specification are directed to the combination of 14-3-3zeta and incomplete Freund’s adjuvant (IFA). As stated above, incomplete Freund’s adjuvant is known in the art to induce an immune response and stimulate antibody-producing cells and so, it is inferred that administering the combination of 14-3-3zeta and IFA would induce an immune response against 14-3-3zeta, and this would be in opposition to instant claim 1 requiring administering the 14-3-3zeta protein to promote bone growth. The Examiner cannot determine if it is the administration of the 14-3-3zeta protein itself or if it is an immune response against 14-3-3zeta due to the administration of the combination of 14-3-3zeta and IFA that is the cause of the results in the instant specification.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brittney E Donoghue whose telephone number is (571)272-9883. The examiner can normally be reached Mon - Fri 7:30 - 3:30.
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/B.E.D./Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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