DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant's arguments filed 12/12/2025 have been fully considered but they are not persuasive.
Applicant argues: the rejection is improper, the office action uses “at least a portion of” several times, the record shows three OAs without specifics.
Response: the office is of the position that before each of the office actions, the office contacted the Applicant several times to discuss potential amendments to place the claims in condition of allowance, for the sake of compact prosecution to comply with the office policy. However, none of the telephonic interviews resulted in a timely agreement. Accordingly, an office action has to be issued.
With regards to the recitations of “at least a portion of”, the office is unclear as to how such recitation makes the rejection unclear or violates any rules, wherein an ordinary meaning of “at least a portion of” can be found on https://grammarvocab.com/atleast-or-at-least/ as “at least is a common English phrase used to indicate the minimum or a lower limit of something”. In this case, the claims call for “bone fixture”, “a structural component”, and “functional component”, without requiring a specific structure for each of the claimed components. Therefore, the office is of the position that a structure of at least a portion of the components disclosed by the cited reference(s) is sufficient to read on the structure of the claimed components, when a PHOSITA gives the claim its broadest reasonable interpretation in view of the MPEP 2111. Accordingly, a PHOSITA considering the office action in view of the cited reference(s) should understand that “at least a portion” can refer to a minimal part of or an entire of the component referred to in the office action. Applicant may clarify how the structure of the claimed components differ from the structure of the at least a portion of the component of the cited reference(s).
With regards to the rejection of claim 50 under 35 USC 112(a), the rejection is hereby withdrawn in view of Applicant’s argument.
With regards to the rejection of claim 56 under 35 USC 112(a), Applicant did not provide sufficient explanation as to how the original disclosure reasonably convey to a PHOSITA that the invention at the time the application was filed, had a possession of the claimed invention. Accordingly, the rejection is hereby maintained.
With regards to the rejections of claims 25, 46, 51 and 56 under 35 USC 112(b), the rejections are hereby withdrawn in view of Applicant’s argument.
Applicant argues: the office action refers to the bone fixture as “at least a portion of 10”, which is unspecific, at least a portion of an assembly means anything, making us guess.
Response: the office respectfully does not agree with Applicant’s interpretation of the reference to Wohrle, wherein #10 is described by Wohrle as being “implant” not “assembly”, see [¶71, a dental implant 10], Moreover, the implant 10 was defined as having a collar 16, body 12 and threads 18 to be implanted in patient’s jaw bone. Moreover, Wohrle in other figures, i.e. 13A, refers to the lower portion / component / part as #10 and Fig.1A of Wohrle does not specify that #10 refers to the combination of 10, 500, 502 and 522 to be referred to as assembly, Applicant is requested to direct the office as to where in Wohrle it was stated the #10 means the combination of 10, 500, 502 and 522 or assembly. Accordingly, a PHOSITA considering the entirety of Wohrle’s disclosure in view of MPEP 2141.02, would understand that at least a portion of 10, i.e. by body 12, is sufficient to read on the claimed bone fixture, and that #10 does not refer to the assembly having 10, 500, 502 and 522.
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Applicant argues: we rely on In re Mullin, wherein the USPTO cited an entire reference without explaining where exactly the alleged teachings were present. We submit that the broad references to Wohrle, establishes a prima facie case that the Examiner did not properly inform the Applicant why the claims were regarded as defective.
Response: the office respectfully does not agree with Applicant’s assertion, wherein it is unclear as to how a PHOSITA considering at least Figs. 1 or Fig. 13 to Wohrle above, can consider the reference to at least a portion of #10 being equivalent to a reference to an entire reference as In re Mullin, or does not properly inform the Applicant, as argued by the Applicant.
With regards to the recitations of “at least a portion of”, the office is unclear as to how such recitation makes the rejection unclear or violates any rules, wherein an ordinary meaning of “at least a portion of” can be found on https://grammarvocab.com/atleast-or-at-least/ as “at least is a common English phrase used to indicate the minimum or a lower limit of something”. In this case, the claims call for “bone fixture”, “a structural component”, and “functional component”, without requiring a specific structure for each of the claimed components. Therefore, the office is of the position that a structure of at least a portion of the components disclosed by the cited reference(s) is sufficient to read on the structure of the claimed components, when a PHOSITA gives the claim its broadest reasonable interpretation in view of the MPEP 2111. Accordingly, a PHOSITA considering the office action in view of the cited reference(s) should understand that “at least a portion” can refer to a minimal part of or an entire of the component referred to in the office action. Applicant may clarify how the structure of the claimed components differ from the structure of the at least a portion of the component of the cited reference(s).
Applicant argues: the reference to the structural component as “at least a portion of 502 and/or at least a portion of 500”, there are three different options, what portion, no figure is cited, none of the figures are part of 10.
Response: the office respectfully directs the Applicant to page 6 of the office action, wherein [Figs.1 – 14] was cited as a reference to Figures of Wohrle. Moreover, the three different options are equivalent to three different rejections using the same reference with different interpretations, which is believed to be not prohibited by the MPEP and therefore proper. With regards to Applicant arguments that none of the various figures with elements 502 and 500 being part of 10, the office respectfully directs the Applicant to at least Fig, 13A to Wohrle above, which shows all the components 10, 500, 502 and 522.
Applicant argues: the features of Wohrle identified in the office action are not arranged as in claim 21, and the Examiner does not point out where they are.
Response: the office respectfully asserts that the office action is sufficiently detailed that the pertinency and manner of applying the cited prior art to the claims in each rejection is clearly set forth therein, such that a PHOSITA considering the office action and the entirety of Wohrle should reasonably understand how the reference to Wohrle is interpreted as reading on the claimed components.
Applicant argues {P.18}: stuff about fig 13A and Fig.13B is in a final OA, and that is new grounds.
Response: the office is unclear of what Applicant is referring thereto, wherein the previous office action was a Non-Final OA. Moreover, the office action on page 8, refers to “FIGs.1 – 14” of Wohrle, which should be understood by a PHOSITA considering the office action as including Fig.13A and Fig.13B.
With regards to Applicant’s argument directed to citing the whole figures in the office action. The office respectfully directs the Applicant to MPEP 2141.02 (VI), wherein the MPEP at least in part states that “A prior art reference must be considered in its entirety, i.e., as a whole, including portions that would lead away from the claimed invention. W.L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983), cert. denied, 469 U.S. 851 (1984) .”. Accordingly, citing a reference to the figures of a reference is part of considering the entirety of the reference which must be considered as a whole.
Applicant argues: there is more of “at least a portion of” and the functional component can be the structural component.
Response: the office is of the position that the office action does not state that the functional component can be the structural component, wherein the structural component, according to some of the interpretations, can be interpreted as “at least a portion of 502” and the functional component can be interpreted as “at least a portion of 500”, alternatively, the structural component can be interpreted as “at least a portion of 500” and the functional component can be interpreted as “at least a portion of 502”, alternatively, the structural component can be interpreted as “at least a portion of 500 and 502” and the functional component can be interpreted as “at least a portion of 500 or 502”. The office would have agreed with the Applicant if, i.e. the office action refers to the structural component as “at least a portion of 500” and the functional component as “the same portion of 500”, which is not the case.
Applicant argues: the office actions refers to the sealing feature as least a portion of 500, which may or may not be the structural component or the functional component.
Response: the office respectfully directs the Applicant to MPEP 2111, which at least in part states that “During patent examination, the pending claims must be “given their broadest reasonable interpretation consistent with the specification.””. In this case, the office is of the position that the abstract of the publication of the current application, at least in part states that “wherein at least one of the bone fixture or the structural component includes a deformable element configured to deform to form an anti-microbial seal between the bone fixture and the structural component, and the at least one deformable element and the respective at least one bone fixture or structural component form a monolithic structure”, which is best understood that the sealing feature being part of the bone fixture or the structural component. Accordingly, interpreting the sealing feature as being portion of 500 which may be interpreted to be equivalent to the structural component is asserted to consistent with the MPEP and is therefore proper.
Applicant argues: the office refers to ¶123 - ¶124 of Wohrle. There exists a path for bacterial even after the use of the post 500, that is what these paragraphs say.
Response: the office respectfully disagrees with the Applicant and respectfully directs the Applicant to that Wohrle at least in part states in ¶124 that the arrangement described above may significantly reduce or prevent bacteria from entering the bore as the centering post 500 forms a tight seal with the abutment 502 and/or the implant 10. Accordingly, the office is unclear as to how the Applicant is considering the recitation of “prevent bacteria from entering” as being equivalent to “providing a path for bacteria”.
With regards to Applicant’s argument directed to “this is not sufficient to establish a prima facie case of anticipation. The office respectfully directs the Applicant to MPEP 2131, which at least in part states “A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference.” Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d 628, 631, 2 USPQ2d 1051, 1053 (Fed. Cir. 1987). “When a claim covers several structures or compositions, either generically or as alternatives, the claim is deemed anticipated if any of the structures or compositions within the scope of the claim is known in the prior art.” Brown v. 3M, 265 F.3d 1349, 1351, 60 USPQ2d 1375, 1376 (Fed. Cir. 2001) (claim to a system for setting a computer clock to an offset time to address the Year 2000 (Y2K) problem, applicable to records with year date data in “at least one of two-digit, three-digit, or four-digit” representations, was held anticipated by a system that offsets year dates in only two-digit formats).”.
Applicant argues: with regards to the rejection based on Westerkull, Applicant traverse on the ground detailed above with respect to the “at least a portion of”.
Response: the office respectfully directs the Applicant MPEP 2131, which at least in part states ““A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference.” Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d 628, 631, 2 USPQ2d 1051, 1053 (Fed. Cir. 1987).”. There is no indication that the use of “at least a portion of” before the element from the reference that is equivalent to that claimed is prohibited. Accordingly, the office respectfully asserts that the rejection is consistent with the MPEP and is therefore proper.
Applicant argues: the office points to element 24 as seen above, and paragraph 41 details 24. There is nothing in paragraph 41 that expressly or inherently discloses the sealing feature of the claim.
Response: the office respectfully directs the Applicant to that P.9 of the office action, which referred to ¶14 - ¶15 and ¶41, not only to ¶41. A PHOSITA considering the entirety of Westerkull would understand from at least ¶41 that element 24 defines an elastic seal between components of the implant [Fig.5], and ¶14 - ¶15 describe the purpose of the seal, which is to avoid having a path for bacteria, by saying “a sealing is achieved closest to the skin which further reduces the risk for gaps in the interface where bacteria could be accommodated and then interfere with the skin tissue.”, and “the sealing will be located to a more peripheral portion of the interface between the fixture and the abutment without offering gaps for bacteria.”.
In view of the preceding explanations, the several telephonic interviews conducted with the Applicant to ensure that the Applicant does not have specific questions related to the cited reference and how they are applied to the claims to be addressed, and in view of the feedback received from the participants of the appeal conference that were previously made a decision that the office action is clear to a PHOSITA to understand when considering the entirety of the cited references and that the rejections are proper, the rejections are asserted to be consistent with the MPEP and are therefore proper.
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 21 and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. 9271092 B2, claim 1 of U.S. Patent No. 11166752 B2, and claim 1 of U.S. Patent No. 8787607 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims lies in the fact that the patent claims include more elements and are thus much specific. Thus the invention of the patent claims are in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “all portions of the bone fixture and all portions of the structural component lying on the respective planes are either on an inside or on an outside of the other of all portions of the bone fixture and all portions of the structural component lying on the respective planes” of claim 56 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
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.
Claim 56 is 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.
In claim 56, the recitation directed to “all portions of the bone fixture and all portions of the structural component lying on the respective planes are either on an inside or on an outside of the other of all portions of the bone fixture and all portions of the structural component lying on the respective planes” does not have description in the original description in such a way to reasonably convey to a PHOSITA that the inventor(s) at the time the application was filed, had a possession of the claimed invention. Applicant may amend the claim or cancel the claim to overcome this rejection.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 21 – 23, 25, 28, 33 – 34, 42, 53 and 58 – 59 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Wohrle et al. (US Pub. 2005/0014108 A1).
Claim 21, Wohrle discloses an implant [Abstract, Figs. 1 – 14], comprising:
a bone fixture configured to anchor to bone of a recipient [at least a portion of 10];
a structural component [at least a portion of 502, at least a portion of 500, or a combination of at least portion of 502 and at least portion of 500] configured to be connected to the bone fixture and connect a functional component of the implant to the bone fixture [the functional component is defined by at least a portion of 502 which is configured to connect with at least a portion of 500, at least a portion of 500 which is configured to connect with at least a portion of 502, at least a portion of a driving tool, or at least a portion of the prosthetic tooth / final restoration, ¶120]; and
a screw [522] configured to bolt the structural component to the bone fixture [Figs. 14], wherein a path for microorganisms would extend from, with respect to a longitudinal axis of the implant, an outboard interface of the screw and the structural component and, with respect to the longitudinal axis of the implant, an outboard interface of the bone fixture with the structural component, but for one or more sealing features of the implant [wherein bacteria / microorganisms can be located on an outside portion(s) of the screw, structural component and the bone fixture, with respect to an imaginary longitudinal axis of the implant, but for sealing feature defined by at least a portion of 500, ¶123 - ¶124].
Claims 22, 23, 25, 28, 33 – 34, 42, 53 and 58 – 59, Wohrle discloses the limitations of claim 21, as above, and further, Wohrle discloses (claim 22) wherein: the sealing feature(s) is established by at least a deformed portion of the bone fixture, a deformed portion of the structural component or a deformed portion of the screw [wherein at least a portion of 500, defining at least a portion of the structural components is configured to be deformed to form the seal, ¶117, ¶123 - ¶124]; (claim 23) wherein: the sealing feature(s) is established by at least two of a deformed portion of the bone fixture, a deformed portion of the structural component or a deformed portion of the screw [wherein at least two portions of 500, i.e. Fig.14A portion on the right side and a portion on the left side, defining at least two portions of the structural components are configured to be deformed to form the seal, ¶117, ¶123 - ¶124]; (claim 25) wherein: the sealing feature(s) is established by at least a deformed portion at an interface of the bone fixture and the structural component [wherein at least a portion of 500 at an interface of the bone fixture 10 and the structural component is configured for deforming, ¶117, ¶123 - ¶124] and at least a deformed portion of the bone fixture or a deformed portion of the structural component [wherein at least a portion of 500 defines at least a portion of the structural component and is configured for deforming to form a seal]; (claim 28) wherein: the sealing feature(s) is established by at least a deformed portion of the bone fixture or a deformed portion of the structural component, wherein the deformation was established via rotation of the screw that drove the bone fixture and the structural component towards each other [wherein at least a portion of 500 defines at least a portion of the structural component and is configured for deforming to form a seal via tightening screw 522, ¶117, ¶123 - ¶124]; (claim 33) wherein: the sealing feature(s) is established by a deformable element that is monolithic with one of the structural component or the fixture and deformed against a corresponding contact surface of the other of the structural component or the fixture [wherein at least a portion of 500, defining at least a portion of the structural components “monolithic” is configured to be deformed to form the seal, ¶117, ¶123 - ¶124]; (claim 34) wherein: the sealing feature(s) is established by deformation of structure of the implant, and all or substantially all of an overall deformation occurs in one of the structural component or the bone fixture [wherein at least a portion of 500, defining at least a portion of the structural components “monolithic” is configured to be deformed to form the seal, ¶117, ¶123 - ¶124]; (claim 42) wherein the implant consists of three parts, the parts being the bone fixture, the structural component and the screw [Figs.14, “10” bone fixture, “500 or 500 + 502” structural component and “522” screw]; (claim 58) wherein: the structural component establishes a most proximal portion of the implant, and the bone fixture establishes a most distal portion of the implant, when the structural component is completely screwed to the bone fixture by the screw [Fig.14B, wherein at least a portion of the combination of 500 and 502, defining the structural component of the implant, establishes a most proximal portion of the implant, and wherein at least a portion of 10 defining the bone fixture of the implant, establishes a most distal portion of the implant, when screwed together]; (claim 59) wherein: the structural component is a percutaneous abutment of a percutaneous bone conduction device configured for attachment of a removable unit with a vibrator of the percutaneous bone conduction device thereto [Figs.14, wherein at least a portion of the combination of 500 and 502, defining the structural component of the implant, exhibits substantially identical structure to the claimed structure of the structural component and is therefore inherently capable of performing the claimed functions, wherein the abutment is connected to an implantable titanium screw, ¶71, and is capable of attaching to a unit with vibrator].
Claim 53, Wohrle discloses an implant [Abstract, Figs. 1 – 14], comprising:
means for anchoring to bone of the recipient [at least a portion of 10];
means for connecting to the means for anchoring to another component of the implant [at least a portion of 502, at least a portion of 500, or a combination of at least portion of 502 and at least portion of 500, wherein at least a portion of 500 is configured to connect with at least a portion of 502 to at least a portion of 10, or at least a portion of 502 and 500 is configured to connect at least a portion of a driving tool, or at least a portion of the prosthetic tooth / final restoration to at least a portion of 10, ¶120];
means for bolting the means for connecting to the means for anchoring to bone [522]; and
means for preventing a path for microorganisms from an outboard interface of the means for anchoring to bone with the means for connecting [wherein bacteria / microorganisms can be located on an outside portion(s) of the screw, structural component and the bone fixture, but for sealing feature defined by at least a portion of 500, ¶123 - ¶124].
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Claim(s) 21 – 22, 28, 40 – 44, 47, 49, 53 and 56 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Westerkull (US Pub. 2006/0050913 A1).
Claim 21, Westerkull discloses an implant [Abstract, Figs. 1 – 8], comprising:
a bone fixture configured to anchor to bone of a recipient [at least a portion of 92];
a structural component [at least a portion of 90] configured to be connected to the bone fixture and connect a functional component of the implant to the bone fixture [the functional component is defined by at least a portion of 1]; and
a screw [16] configured to bolt the structural component to the bone fixture [Fig. 5], wherein a path for microorganisms would extend from, with respect to a longitudinal axis of the implant, an outboard interface of the screw and the structural component and, with respect to the longitudinal axis of the implant, an outboard interface of the bone fixture with the structural component, but for one or more sealing features of the implant [wherein bacteria / microorganisms can be located on an outside portion of the screw, structural component and the bone fixture, with respect to a longitudinal axis of the implant, but for sealing feature defined by at least a portion of 24, ¶14 - ¶15 and ¶41].
Claims 22, 28, 40 – 42, 44, 47, 49, 53 and 56, Westerkull discloses the limitations of claim 21, as above, and further, Westerkull discloses (claim 22) wherein the sealing feature(s) is established by at least a deformed portion of the bone fixture, a deformed portion of the structural component or a deformed portion of the screw [elastic sealing 24, included on / attached to at least a portion of 90 or 92, forming a unitary construct, defines a deformable portion of the bone fixture and/or the structural component to establish the sealing feature]; (claim 28) wherein the sealing feature(s) is established by at least a deformed portion of the bone fixture or a deformed portion of the structural component [elastic sealing 24, included on / attached to at least a portion of 90 or 92, forming a unitary construct, defines a deformable portion of the bone fixture to establish the sealing feature], wherein the deformation was established via rotation of the screw that drove the bone fixture and the structural component towards each other [¶18 and ¶41, wherein tightening the screw 16 forces the abutment 90 towards the fixture 92 deforming the elastic sealing 24]; (claim 40) wherein the sealing feature(s) is established by at least the deformed portion of the bone fixture [elastic sealing 24, included on / attached to at least a portion of 92, forming a unitary construct, defines a deformable portion of the bone fixture to establish the sealing feature]; (claim 41) wherein: the sealing feature(s) is established by at least a deformed portion at an interface of the bone fixture and the structural component [elastic sealing 24, included at an interface of at least a portion of 90 and 92, defines a deformable portion to establish the sealing feature]; and the structural component is a monolithic component that extends from a topmost portion of the implant to the bone fixture, the top most portion of the implant is furthest away from the bone fixture [Fig.5, wherein abutment 90, defining the structural component, is of a single piece and extends from bone fixture 92 to a topmost portion away from the bone fixture, towards the top of the page]; (claim 42) wherein the implant consists of three parts, the parts being the bone fixture, the structural component and the screw [Fig.5, 92, 90 and 16]; (claim 44) an assembly [Abstract, Figs. 1 – 8] comprising the implant of claim 22, and the functional component [1, Fig.1], wherein the functional component is attached to the structural component [1, Fig.1, ¶34], and the functional component is a removable device that transforms sound into mechanical vibrations [¶34, functional component 1 is connectable to the implantable device]; (claim 47) wherein the structural component is a means for penetrating skin of the recipient [¶34, and claim 1, a skin-penetrating hearing aid abutment]; (claim 49) wherein the screw is in direct contact with planar flat surface of the structural component, the planar flat surface extending normal to a longitudinal axis of the screw [Fig.5 to Westerkull, below]; (claim 56) wherein: with respect to any plane normal to the longitudinal axis of the implant that extends through the bone fixture and the structural component, all portions of the bone fixture and all portions of the structural component lying on the respective planes are either on an inside or on an outside of the other of all portions of the bone fixture and all portions of the structural component lying on the respective planes [Fig.5].
Claim 53, Westerkull discloses an implant [Abstract, Figs. 1 – 8], comprising:
means for anchoring to bone of the recipient [at least a portion of 92];
means for connecting to the means for anchoring to another component of the implant [at least a portion of 90 is capable of connecting at least a portion of 1 to 92];
means for bolting the means for connecting to the means for anchoring to bone [16]; and
means for preventing a path for microorganisms from an outboard interface of the means for anchoring to bone with the means for connecting [wherein bacteria / microorganisms can be located on an outside portion of the screw, structural component and the bone fixture, but for sealing feature defined by at least a portion of 24, ¶14 - ¶15 and ¶41].
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 30 – 32, 35 – 37, 48 and 52 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wohrle et al. (US Pub. 2005/0014108 A1).
Claim 30, Wohrle discloses the limitations of claim 21, as above, and further, Wohrle discloses wherein: the sealing feature(s) is established by an annular ring that had a dimension in an undeformed state [wherein at least a portion of 500, i.e. by 506, defines an annular ring, Fig.11, and being dimensioned, in an undeformed state, to fit in portion 50, to then be deformed to fill a gap 511, ¶116 - ¶117].
Wohrle does not explicitly disclose wherein the at least a portion of 506, defining the annular ring, had a dimension of between 0.01 mm to about 0.1 mm in an undeformed state.
It would have been an obvious matter of design choice to construct at least a portion of 506 having a desired undeformed dimension of between 0.01 mm to about 0.1 mm to correspond to a desired dimension of the implant, into which to be seated and to expand therein forming a tight seal to prevent penetration of bacteria into the implant, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Claims 31 – 32, Wohrle discloses the limitations of claim 21, as above.
Wohrle does not explicitly disclose in the preferred embodiment wherein: a surface of the structural component is coated to improve skin tissue integration.
Wohrle teaches in another embodiment of the same invention coating an outer surface of at least a portion of the implant with hydroxyapatite (HA) to increase a surface area of the implantable portion and promote, enhance or maintain soft-tissue attachment [¶79].
It would have been obvious to one of ordinary skill in the art at the time of the invention was made to combine the teachings of Wohrle, and coat at least a surface portion of 502 with HA in order to increase its surface area and promote, enhance or maintain soft-tissue attachment [¶79].
Claim 48, Wohrle discloses the limitations of claim 32, as above, and further, Wohrle discloses (claim 48) wherein at least one of the one or more sealing features is a monolithic part of the structural component, the at least one of the one or more sealing features being a deformed portion of the structural component [wherein at least a portion of 500, defining at least a portion of the structural components “monolithic” is configured to be deformed to form the sealing feature].
Claims 35 – 37, Wohrle discloses the limitations of claim 21, as above, and further, Wohrle discloses wherein the sealing feature(s) is established by deformation of structure of the implant resulting from an application of a torque onto the screw [¶123 - ¶124].
Wohrle does not explicitly disclose wherein the torque being greater than about 15 Ncm, 20 Ncm, or 15 Ncm to about 30 Ncm.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to apply a desired torque on the screw, being greater than about 15 Ncm, 20 Ncm, or 15 Ncm to about 30 Ncm in order to apply a sufficient torque to the screw to cause deformation of the seal to prevent the entry of bacteria inside the implant, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 52, Wohrle discloses the limitations of claim 31, as above, and further, Wohrle discloses (claim 52) wherein: the sealing feature(s) is established by at least a deformed portion of at least one of the bone fixture or the structural component [wherein at least a portion of 500, defining at least a portion of the structural components “monolithic” is configured to be deformed to form the sealing feature].
Claims 23 and 39 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wohrle et al. (US Pub. 2005/0014108 A1) in view of Shaw (US Pat. 5447434).
Alternative interpretation for claim 23:
Claim 23, Wohrle discloses the limitations of claim 21, as above, and further, Wohrle discloses wherein: the sealing feature(s) is established by at least two of a deformed portion of the bone fixture, a deformed portion of the structural component or a deformed portion of the screw [wherein at least a portion of 500, defining at least a portion of the structural components is configured to be deformed to form the seal].
Wohrle does not explicitly disclose a sealing feature established by a deformed portion of the screw.
Shaw teaches an analogous implant [Abstract, Figs. 1 - 8] comprising a sealing feature established by a deformed portion of the screw [col.3 / Lines 1 – 17, wherein a sealing feature, by 328, is established by screw 210 relative to implantable component 212].
It would have been obvious to one of ordinary skill in the art at the time of the invention was made to combine the teachings of Wohrle and Shaw, and construct the screw 522 of Wohrle to establish a sealing feature by a deformed portion relative to the structural component 502 in view of Shaw. One would have been motivated to do so in order to provide seal between components of the implant that prevent penetration of bacteria and micro-organisms into the implant.
Claim 39, Wohrle discloses the limitations of claim 22, as above, except for explicitly disclosing wherein the screw is a metal screw “which should be inherent in Wohrle disclosure”.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the screw of metallic material, wherein metallic material known in the medical art with its high strength, toughness, hardness, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Moreover, Wohrle does not disclose wherein the screw includes an annular angled ring extending outward, and the annular angled ring is configured to deform against a contact surface of the structural component, thereby forming a seal.
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Shaw teaches an analogous implant [abstract, Figs. 1 – 3] comprising a screw having head and threaded shaft (10), wherein the head includes at least one deformable element in the form of an annular ring / annular angled ring extending outward and downward from a screw head / deformable flange (defined by at least a portion by 28) located at an interface between the screw head and another component (at least a portion of 12), and forming a monolithic structure with the screw [Fig.2].
It would have been obvious to one of ordinary skill in the art at the time of the invention was made to combine the teachings of Wohrle and Shaw, and construct the screw of Wohrle in view of Shaw, having a monolithic deformable annular ring / annular angled ring extending outward and downward from a screw head / flange located at an interface between the screw and another structure, and configured to deform upon tightening the screw relative to the other structure forming antimicrobial seal. One would have been motivated to do so in order to provide the implant of Wohrle with an anti-microbial seal between the screw and the structural component [col.1/II.47-56] to prevent microorganisms from penetrating into the implant and/or human body.
Claim(s) 38 and 55 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Westerkull (US Pub. 2006/0050913 A1) in view of Jinton et al. (US Pub. 2009/0082817 A1).
Claims 38 and 55, Westerkull discloses the limitations of claim 22, as above, and further, Westerkull discloses wherein the screw comprises two opposite ends, with at least one end having male threads [wherein screw 16 has a shaft portion defining an end having external threads for engaging internal threads of at least a portion of 92, defining the bone fixture, i.e. Fig.5, and an opposite end of the screw 16 is defined by the head, as shown in Fig.5 to Westerkull, below].
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Westerkull does not explicitly disclose that the screw, defining an end opposite to at least a portion of the screw shaft, having male threads.
Jinton teaches an analogous implant [abstract, Figs. 1 – 7] comprising
a bone fixture configured to anchor to bone of a recipient (defined by at least a portion of 1); a structural component configured to be connected to the bone fixture and connect a functional component of the implant to the bone fixture (since neither the claims nor the specification specify the structural equivalency for the structural and functional components, the office takes an interpretation that member 2 defines at least two portions defining the claimed structural and functional components, or member 2 defines the structural component which is capable of connecting to a component i.e. 37, shown in Figs. 7, according to an alternative interpretation); and a screw configured to bolt the structural component to the bone fixture (defined by at least a portion of screw 3); wherein the screw has male threads by the head for engaging with a tool for torque application [wherein at least a portion of the head has external threads, paras.31 – 32].
It would have been obvious to one of ordinary skill in the art at the time of the invention was made to combine the teachings of Westerkull and Jinton, and construct the head of the screw of Westerkull having male threads in view of Jinton. One would have been motivated to do so in order to provide the screw head of Westerkull with a functionally equivalent mechanism for connecting with a tool to inhibit undesired separation or relative rotation between the screw and the tool when in use and to facilitate remote positioning, manipulating and/or torquing the screw in a desired place [Jinton, paras.31 – 32].
Claims 38 and 55 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wohrle et al. (US Pub. 2005/0014108 A1) in view of Abdu (US Pub. 2004/0133207 A1).
Claims 38 and 55, Wohrle discloses the limitations of claim 22, as above, and further, Wohrle discloses wherein the screw comprises two opposite ends, with at least one end having male threads [wherein screw 522 has a shaft portion defining an end having external threads for engaging internal threads of at least a portion of 10, defining the bone fixture, i.e. Figs.14, and an opposite end of the screw 522 is defined by the head 564, Fig.13A].
Wohrle does not explicitly disclose that the screw, defining an end opposite to at least a portion of the screw shaft, having male threads.
Abdou teaches an analogous implant [abstract, Figs. 1 – 16] comprising a screw [at least a portion by 120, Fig. 8b] having an end by head [160] having male threads [157, ¶62].
It would have been obvious to one of ordinary skill in the art at the time of the invention was made to combine the teachings of Wohrle and Abdu, and construct the head of the screw of Wohrle having male threads in view of Abdu. One would have been motivated to do so in order to provide the screw head of Wohrle with a functionally equivalent mechanism for connecting with a tool to inhibit relative rotation between the screw and the tool when in use and to facilitate remote positioning and/or torquing the screw in a desired place [Abdu, para.8].
Claim(s) 33, 45 – 46 and 57 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Westerkull (US Pub. 2006/0050913 A1) in view of Shaw (US Pat. 5447434).
Claims 33 and 45, Westerkull discloses the limitations of claim 22, as above, and further, Westerkull discloses (claim 33) wherein the sealing feature(s) is established by a deformable element attached to one of the structural component or the fixture and deformed against a corresponding contact surface of the other of the structural component or the fixture [¶41 and Fig.5]; (claim 45) wherein the structural component is a skin penetrating abutment of a percutaneous bone conduction device [¶34, and claim 1, a skin-penetrating hearing aid abutment].
Westerkull does not explicitly disclose wherein the deformable element is monolithic with one of the structural component or the fixture.
Shaw teaches an analogous implant [abstract, Figs. 1 – 3] comprising a micromechanical seal and a component of the implant being monolithically formed [Figs. 2 – 3, defined by deformable element 22 and screw 10 and/or deformable element 24 and abutment 12, which form seal 26].
It would have been obvious to one of ordinary skill in the art at the time of the invention was made to combine the teachings of Westerkull and Shaw, and construct the structural component and/or the fixture of Westerkull having a monolithic deformable sealing element in view of Shaw. One would have been motivated to do so in order to provide the implant of Westerkull with an anti-microbial seal between the implantable components [col.1/II.47-56] to prevent microorganisms from penetrating into the implant and/or human body.
Claim 46, Westerkull discloses the limitations of claim 22, as above, and further, Westerkull discloses wherein the bone fixture is a means for anchoring to bone of the recipient [at least a portion of 92, claim 1], the structural component is a means for connecting to the bone fixture and connecting the functional component of the implant to the means for anchoring to bone [at least a portion of 90 connects to at least a portion of 92 and 1, Fig. 1 and claim 1], and the screw is a means for bolting the means for connecting to the means for anchoring to bone [at least a portion of 16, Fig. 5 and claim 9], wherein the implant has a means for substantially preventing a path for microorganism from, with respect to a longitudinal axis of the implant, an outboard interface of the means for bolting and the means for connecting [inherently, due to the tight connection between the head of screw 16 and the corresponding shoulder of structural component 90], and, with respect to the longitudinal axis of the implant, an outboard interface of the means for anchoring to bone with the means for connecting [wherein bacteria / microorganisms can be located on an outside portion of the screw, structural component and the bone fixture, with respect to a longitudinal axis of the implant, but for sealing feature defined by at least a portion of 24, ¶14 - ¶15 and ¶41].
Assuming Applicant does not agree with the preceding inherent interpretation, the office takes alternative interpretation in view of Shaw, wherein, Shaw teaches an analogous implant [abstract, Figs. 1 – 3] comprising a screw having head and threaded shaft (10), wherein the head includes at least one deformable element in the form of an annular ring / annular angled ring extending outward and downward from a screw head / deformable flange (defined by at least a portion by 28) located at an interface between the screw head and another component (at least a portion of 12), and forming a monolithic structure with the screw [Fig.2].
It would have been obvious to one of ordinary skill in the art at the time of the invention was made to combine the teachings of Westerkull and Shaw, and construct the screw of Westerkull in view of Shaw, having a monolithic deformable annular ring / annular angled ring extending outward and downward from a screw head / flange located at an interface between the screw and another structure, and configured to deform upon tightening the screw relative to the other structure forming antimicrobial seal. One would have been motivated to do so in order to provide the implant of Westerkull with an anti-microbial seal between the screw and the structural component [col.1/II.47-56] to prevent microorganisms from penetrating into the implant and/or human body.
Claim 57, wherein: the implant is configured so that the structural component directly abuts skin tissue of the recipient when the implant is implanted in the recipient [wherein at least portion of 90 defining the structural component of the implant is configured to abut skin tissue when the implant is implanted. Note: the structure of the implant of Westerkull exhibits substantially identical structure to that claimed and is therefore inherently capable of performing the claimed functions].
Claim(s) 50 – 51 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Westerkull (US Pub. 2006/0050913 A1) in view of Niznick (US Pat. 5,622,500).
Westerkull discloses the limitations of claim 21, as above, and further, Westerkull discloses wherein: the structural component includes an internal through passage [defined by the passage extending through 90, Fig.5 to Westerkull above]; the screw is threaded [¶39, Figs.3 - 6, wherein the screw 16 is configured to be screwed into threaded bore of bone fixture 92]; the screw completely extends from a location outside the internal through passage on a first side of the structural component to a location outside the internal through passage on a second side of the structural component opposite the first side [Fig.5 to Westerkull above]; and all thread of the screw is located away from a substantially central portion of the structural component [Fig.5 to Westerkull above].
Westerkull does not disclose wherein only a portion of the through passage is threaded.
Niznick teaches an analogous implant [abstract, Figs. 1 – 3] comprising a bone fixture, a structural component, and a screw, and wherein only a portion of an internal through passage of the structural component is threaded [Fig.1 below to Niznick].
It would have been obvious to one of ordinary skill in the art at the time of the invention was made to combine the teachings of Westerkull and Niznick, and construct the internal through passage of the structural component of Westerkull having a threaded portion in view of Niznick. One would have been motivated to do so in order to provide the structural component with a connection for connecting to a removal tool [Col.4/II.51-58].
Claim 51, Westerkull discloses the limitations of claim 22, as above, and further, Westerkull discloses wherein: the thread of the screw is located as far away from a substantially central portion of the structural component as possible [Fig.5 to Westerkull, wherein at least a threaded portion of the screw 16 is located far from a central portion of structural component 90].
Westerkull does not disclose wherein the substantially central portion is threaded.
Niznick teaches an analogous implant [abstract, Figs. 1 – 3] comprising a bone fixture, a structural component, and a screw, and wherein only a portion of an internal through passage of the structural component is threaded [Fig.1 below to Niznick].
It would have been obvious to one of ordinary skill in the art at the time of the invention was made to combine the teachings of Westerkull and Niznick, and construct the internal through passage of the structural component of Westerkull having a threaded portion in view of Niznick. One would have been motivated to do so in order to provide the structural component with a connection for connecting to a removal tool [Col.4/II.51-58].
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Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL S. HANNA whose telephone number is (571)270-3248. The examiner can normally be reached 8-5 M-F.
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/SAMUEL S HANNA/Primary Examiner, Art Unit 3775