DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . The amendment of 12/19/25 has been entered in full. Claims 1-5 and 12-16 are canceled. Claims 6, 8-11 and 19 are amended. New claims 20-24 are added. Claims 6-11 and 17-24 are pending.
Election/Restrictions
New claims 20-24 are directed to a method comprising administering at least one anti-sclerostin antibody and at least one anti-dickkopf-1 antibody to a patient and therefore belong to inventive Group I.
Applicants' election with traverse of Group II, claims 6-11 and 17-19, in the reply filed on 12/19/25 is acknowledged.
The traversal is on the ground(s) that “new claim 20 depends directly from claim 6 so as to emphasize the shared inventive concept and shared technical feature”.
This is not found persuasive because, while it is acknowledged that the new method claims of Group II depend directly from the product claims of Group I, examination of the claims of Group I has identified prior art that anticipates independent claim 6 (see below). Therefore, the technical feature linking the inventions of Groups I and II currently does not constitute a special technical feature as defined by PCT rule 13.2, as it does not define a contribution over the prior art. Accordingly, the main invention remains the first product recited in the claims, Group I. Claims 20-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The election of platelet-rich fibrin as the species of additional component in the reply filed on 12/19/25 is also acknowledged. The elected species reads on each claim in the elected group.
Claims 6-11 and 17-19 are under consideration, as they read upon the elected species.
Specification
The disclosure is objected to because of the following informalities:
The title of the invention is not descriptive because it is directed to any form of therapeutic composition for increasing osseointegration, but the claims are limited to a composition comprising two active ingredients, an anti-sclerostin antibody and an anti-dickkopf-1 antibody. A new title is required that is clearly indicative of the invention to which the claims are directed. The following title is suggested: “Therapeutic Composition Combining Anti-Sclerostin and Anti-Dickkopf-1 Antibodies and Methods of Administration for Increasing Osseointegration with Dental Implants, Graft Materials and PRF”. Appropriate correction is required.
Claim Objections
Claims 6-11 and 17-19 are objected to because of the following informalities:
In claim 6, line 4, and claim 7, line 2, “anti dickkopf-1” should be “anti-dickkopf-1”. Compare with “anti-sclerostin” in the same line of each claim.
In claims 8 and 9, there should be a comma before the concluding clause; i.e., “a graft material, for local application… ” (claim 8) and “biomatrix, for localized delivery…”
In claim 19, line 5, the word “and” should be present before “the weight ratio”.
The remaining claim(s) are objected to for depending from an objected claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6-11 and 17-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Independent claim 6 is directed to a therapeutic composition, which is a product, but lines 6-11 limit the composition by way of a method step to be performed, i.e., “wherein the antibody combination is locally administered to a tooth extraction site or onto an implant’s surface, prior to implantation; wherein a total amount of said anti-sclerostin plus anti-dickkopf-1 antibodies per unit volume of void of extracted tooth of the patient or per unit volume of the implant to be applied is 0.001 to 50.0 mg/mm3, preferably 0.01 to 5 mg/mm3, and wherein the therapeutic composition provides rapid bone formation in the field of dental and jaw health”. This limitation renders the claim a single claim which claims both a product and a method step of using said product, which per MPEP 2173.05(p) is indefinite under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. Per MPEP 2173.05(p):
See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011). In Katz, a claim directed to "[a] system with an interface means for providing automated voice messages…to certain of said individual callers, wherein said certain of said individual callers digitally enter data" was determined to be indefinite because the italicized claim limitation is not directed to the system, but rather to actions of the individual callers, which creates confusion as to when direct infringement occurs. Katz, 639 F.3d at 1318 (citing IPXL Holdings v. Amazon.com, Inc., 430 F.3d 1377, 1384, 77 USPQ2d 1140, 1145 (Fed. Cir. 2005), in which a system claim that recited "an input means" and required a user to use the input means was found to be indefinite because it was unclear "whether infringement … occurs when one creates a system that allows the user [to use the input means], or whether infringement occurs when the user actually uses the input means.")
In the instant claim, the claim limitations directed to the antibody combination when locally administered, including the total amount used when applied, is not directed to the product (a therapeutic composition), but rather to an action (administering the composition) taken by a user to use the composition, which creates confusion as to when direct infringement occurs.
Claim 6 is also indefinite with regard to the use of the term “preferably” in line 10, because it is unclear whether the limitations following the term are part of the claimed invention. See MPEP § 2173.05(d). Specifically, it is unclear whether the limitation that recites the total amount of antibodies per unit volume is met by any an amount of “0.001 to 50.0 mg/mm3” or requires the preferred amount of “0.01 to 5 mg/mm3”.
Claims 7 and 19 are each indefinite with respect to the ratio of the two antibodies. In claim 7, “the ratio of said anti-sclerostin to said anti dickkopf-1 antibody is 10% to 99%” is unclear as to which component the percentage refers to. For example, if the ratio is “10%”, it is unclear whether the anti-sclerostin or anti-dickkopf-1 antibody is at 10%. In claim 19, the recitation in lines 5-6 is similarly indefinite.
Claim 7 is also indefinite with respect to use of the term “preferably” in line 3 for the same reason as for parent claim 6.
In claims 9-11 and 18, the recitations of “coating the surface of the dental implant site or orthognathic implant … prior to implantation” (claim 9), “the antibody combination is formulated into an application” (claim 10) or “the composition is used as a filler” (claim 11); “the dental implant is coated with…” (claim 18) are each an additional active method step that renders the respective claim indefinite for the same reason as for parent claim 6.
In claim 10, it is also unclear what is meant by “platelet-rich fibrin (PRF) a gel”, as it is unclear whether these words are missing a comma, i.e., “platelet-rich fibrin (PRF), a gel, graft material or biomatrix”, or include an extraneous “a”, i.e., “platelet-rich fibrin (PRF) gel, graft material or biomatrix”. If the latter, it is unclear whether the PRF is intended to modify each component of the group (gel, graft material, or biomatrix), or only the gel. If the former is intended, clarity could be achieved by amending the claim, for example to recite, “the group consisting of platelet-rich fibrin (PRF) gel, PRF graft material, or PRF biomatrix”. If the latter is intended, clarity could be achieved by amending the claim, for example to recite, “the group consisting of biomatrix, graft material, or platelet-rich fibrin (PRF) gel”. For purposes of advancing prosecution, the claim will be interpreted broadly as reading on any of these possibilities.
Claim 11 is indefinite with respect to “A kit comprising the antibody combination according to the therapeutic composition of claim 6, wherein the composition is used…” It is unclear whether the kit requires the composition of claim 6, or only the antibody combination; i.e., the combination of the two antibodies.
Claim 11 recites the limitations “the graft material” and “the platelet-rich fibrin (PRF) in lines 2-3. There is insufficient antecedent basis for these limitations in the claim. Specifically, claim 11 depends from claim 6, but there is no preceding recitation of a graft material or platelet-rich fibrin in the parent claim to provide antecedent basis for the recitations in the dependent claim.
Claim 19 is indefinite because the further limitations of the claim in lines 1-5 relate solely to a further limitation of the method step of parent claim 1.
Claim 19 is indefinite with regard to the use of the term “about” in the recitation "about 0.005 mg to about 50 mg, preferably about 0.05 mg to about 30 mg". Per MPEP 2173.05(b)(III)(A), “In determining the range encompassed by the term “about”, one must consider the context of the term as it is used in the specification and claims of the application”. In the instant case, the specification does not define the term, either generally, or in relation to weights, and instead merely uses the term in the same manner as the claim, e.g., at ¶ 16 and ¶ 49. The specification does not provide any guidance such that the skilled artisan would know which weights are encompassed by the claim. Thus, due to the use of the term "about", the claim is indefinite as to what degree of variation is encompassed; for example, "about 0.005 mg" could encompass a range of weights such as 0 mg, 0.001 mg, 0.0045 mg, 0.0055, or 0.01 mg, to list several of the many alternate possibilities. For purposes of advancing prosecution, the term is interpreted as encompassing each alternate possibility that the indefinite term reads on.
Claim 19 is also indefinite with respect to use of the term “preferably” in lines 2 and 6 for the same reason as for parent claim 6.
Claim 19 is also indefinite because the total amount of the antibody combination is unclear because a weight (e.g., 50 mg) is indicated per “unit volume” (line 4), but no units for the volume are provided.
The remaining claim(s) included in the rejection are dependent claims that depend from one of the claims rejected above, and encompass the same indefinite subject matter.
Claim Rejections - 35 USC § 112(d)
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 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], 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 9 and 18 are 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.
Per MPEP 608.01(n).III, “If the dependent claim does not comply with the requirements of 35 U.S.C. 112(d), the examiner should reject the dependent claim under 35 U.S.C. 112(d) rather than objecting to the claim” and “a dependent claim must be rejected under 35 U.S.C. 112(d) if it omits an element from the claim upon which it depends or it fails to add a limitation to the claim upon which it depends”.
Per MPEP 2111.04, “Claim scope is not limited … by claim language that does not limit a claim to a particular structure”.
Claim 9 depends from claim 6 and limits the therapeutic composition by means of a further “wherein” clause stating that “wherein osseointegration is promoted by coating the surface of the dental implant site or orthognathic implant with the antibody combination to promote osseointegration prior to implantation”. This wherein clause is solely directed to a further step that must be taken because meeting the limitation requires that the claimed antibody combination of claim 6 is coated onto the surface of a dental implant site or orthognathic implant. The claim is still solely directed to the composition itself, which has merely been applied to a site, and not changed in structure in any form. Thus, the limitation does not further limit the structure of therapeutic composition itself. As such, this wherein clause fails to further limit the claimed therapeutic composition of parent claim 6.
Claim 18 depends from claim 17, which in turn depends from independent claim 6. Claim 18 further recites a wherein clause reading, “wherein the dental implant is coated with lyophilized SCL-AB and dry DKK1-AB antibodies”. The dental implant refers to the intended use for the composition recited in parent claim 6, i.e., that the composition is “for increasing osseointegration of a patient’s dental implant site and/or orthognathic implant site”, and further to lines 6-7, which recite a method step to perform that is directed to locally administering the antibody combination “onto an implant’s surface”. The form of lyophilized for the SCL-AB and dried for the DKK1-AB is present in parent claim 17. Thus, the further recitation of claim 18 is directed solely to coating the claimed composition onto a dental implant, which is directed to a method step. As such, claim 8 fails to further limit the composition of parent claim 17.
Therefore, dependent claims 9 and 18 are of improper dependent form because each fails to further limit the subject matter of the respective parent 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.
Note on Prior Art Rejection(s)
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 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.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 6-7 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu et al, 2018 Apr 4, Journal of Dental Research. 97(9): 1031-1038 (cited on 1/20/26 IDS). The earliest date to which the instant application claims priority is 12/15/19.
In independent claim 6, the following recitations do not distinguish the claimed composition from a prior art composition comprising the same components:
---Lines 1-2: the recitation “for increasing osseointegration of a patient’s dental implant site and/or orthognathic implant site” has been considered in the context of the entire claim, and is interpreted as an intended use that does not result in a structural difference between the product as and a prior art product having the same structure. See MPEP 2111.02.
---Lines 6-10: The first two “wherein” clauses are directed to a method step (see the rejection of the claim under 35 USC § 112(b) set forth above), and thus relate to a use of the composition, rather than distinguishing the composition in and of itself from the prior art. Per MPEP 2111.04, “Claim scope is not limited … by claim language that does not limit a claim to a particular structure”.
---Lines 10-11: The third “wherein” clause is directed to an intended result for the administration of the therapeutic composition. Per MPEP 2111.04, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited”.
Thus, with respect to anticipatory prior art, claim 6 is interpreted broadly as encompassing a therapeutic composition comprising an antibody combination of anti-sclerostin plus anti-dickkopf (DKK1) antibodies.
Liu teaches a therapeutic comprising an antibody combination of anti-sclerostin and anti-DKK1 antibodies (page 1032, right column). As such, the teachings of Liu anticipate claim 6.
Claim 7 further limits the ratio of the two antibodies “in the said local administration”, which refers solely to the method step recited in the parent claim; i.e., it only limits the ratio when the composition is administered. However, for purposes of advancing prosecution, the claim is broadly interpreted as a composition in and of itself that has a ratio of anti-sclerostin antibody to the anti-DKK1 antibody at 50% to 50%, i.e., 1:1. Liu further teaches that the composition combining anti-sclerostin and anti-DKK1 antibodies has each antibody at equal amounts, which is a 1:1 ratio. As such, the teachings of Liu also anticipate claim 7.
Claim 9 fails to further limit the therapeutic composition of parent claim 6 for the reasons set forth above in the section titled, “Claim Rejections – 35 U.S.C. 112(d)”. As such, the teachings of Liu that anticipate claim 6 also anticipate claim 9.
Claims 6-11 and 17-19 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO2019/213285, published 11/7/2019, filed 5/1/19, and claiming priority to 5/2/18 (cited on 4/21/25 IDS). The earliest date to which the instant application claims priority is 12/15/19.
Claim 6, for the same reasons set forth above, is interpreted as encompassing a therapeutic composition comprising an antibody combination of anti-sclerostin plus anti-dickkopf (DKK1) antibodies.
‘285 teaches a composition that includes a pharmaceutical composition that includes (1) an anti-DKK1 agent, e.g., an anti-DKK1 antibody and/or other promoters of Wnt signaling” (¶ 85, page 40). ‘285 further specifically teaches that examples of “Promoters of Wnt signaling” include antibodies directed against sclerostin (¶ 52). ‘285 further specifically teaches that “[i]n some embodiments, the composition includes more than one agent capable of promoting and/or potentiating Wnt signaling”, with exemplary agents including an anti-DKK1 agent and an anti-sclerostin antibody (¶ 84, page 40). As such, the teachings of ‘285 anticipate claim 6.
Claim 7, for the same reasons set forth above, is interpreted as a composition in and of itself that has a ratio of anti-sclerostin antibody to anti-DKK1 antibody at 50% to 50%, i.e., 1:1. ‘285 further teaches that the anti-DKK1 agent or other promoter of Wnt signaling can be present at various “wt/wt%”, e.g., 5% (¶ 83). Thus, ‘285 teaches the same “wt/wt%” for each of the two components in the composition; e.g., the exemplary anti-DKK1 antibody and the anti-sclerostin antibody. Thus, each is present in a 1:1 ratio, which would be ratio of 50%. As such, the teachings of ‘285 also anticipate claim 7.
Claims 8 and 10 each encompass a composition of claim 6 that further comprises platelet-rich fibrin (PRF) (claim 8) or is formulated into PRF (claim 10). The claims conclude that such a composition is “for local application” (claim 8) or “localized delivery” (claim 10)” to the implantation site prior to implantation”, but these recitation are interpreted as being directed to an intended use for the composition, as each does not further limit the structure of the composition. ‘285 further teaches that a composition of the invention may also include “platelet-rich fibrin” or PRF (¶ 29, page 15). As such, the teachings of ‘285 also anticipate claims 8 and 10.
Claim 9 fails to further limit the therapeutic composition of parent claim 6 for the reasons set forth above in the section titled, “Claim Rejections – 35 U.S.C. 112(d)”. As such, the teachings of ‘285 that anticipate claim 6 also anticipate claim 9.
Claim 11 is indefinite with regard to “the composition is used as a filler to the graft material and/or the platelet-rich fibrin (PRF)” for the reasons set forth above in the section titled, “Claim Rejections – 35 U.S.C. 112(b)”; specifically, while the claim is directed to a product, this limitation is directed to a method step, and the terms “the graft material” and “the platelet-rich fibrin (PRF)” lack antecedent basis in the parent claim. As such, this limitation is interpreted as an intended use for the composition in the kit, and as such does not render it patentably distinct from a prior art kit having the same components. As such, the claim is interpreted as encompassing a kit comprising the antibody combination of claim 6, and instructions for use. MPEP 2111.05 provides guidance for consideration of claim limitations directed to printed matter. In the instant case, the “instructions for use” are distinguished from prior art instructions only by the content of information; specifically, instructions for the use. As such, the instructions are considered printed matter. Furthermore, the instructions are not functionally related to the associated compositions, because they do not perform any function with respect to the composition. This is in accord with the following example given in MPEP 2111.05, "For example, in a kit containing a set of chemicals and a printed set of instructions for using the chemicals, the instructions are not related to that particular set of chemicals". As such, the “instructions for use” are owed no patentable weight with respect to the prior art. As such, claim 6 encompasses a kit comprising the antibody combination of claim 6. ‘285 further teaches kit comprising the promoters of Wnt signaling of the invention (¶ 95). As such, the teachings of ‘285 anticipate claim 11.
Claim 17 encompasses a composition of claim 6 wherein the anti-sclerostin antibody (SCL-AB) is lyophilized and the anti-dickkopf antibody (DKK1-AB) is dried. Lyophilization is freezing drying, as such, the term “dried” encompasses “lyophilized”. Thus, claim 17 encompasses a composition of claim 6 wherein both antibodies are lyophilized, i.e., freeze-dried. ‘285 further teaches that the composition of the invention may lyophilized (¶ 86), and that each promoter of Wnt signaling can be in lyophilized form (¶ 88). As such, the teachings of ‘285 also anticipate claim 17.
Claim 18 fails to further limit the therapeutic composition of parent claim 6 for the reasons set forth above in the section titled, “Claim Rejections – 35 U.S.C. 112(d)”. As such, the teachings of ‘285 that anticipate claim 17 also anticipate claim 18.
In claim 19, the wherein clause recited in lines 1-5 is solely directed to further limiting the wherein clause of lines 7-10 of parent claim 6; i.e. solely limiting the total amount of the antibodies that is to be applied when the antibody combination is locally administered. As such, this limitation is directed to a method step, which is interpreted as an intended use for the composition and does not further limit the structure of the composition in and of itself. As such, the therapeutic composition of claim 19 is interpreted as composition in and of itself that has a ratio of anti-sclerostin antibody to anti-DKK1 antibody at 50% to 50%, i.e., 1:1. This further limitation is met by the teachings of ‘285 for the same reasons as for claim 7, set forth above.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/patents/uspto-automated-interview-request-air-form.
/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674