DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I, and Species A in the reply filed on 1/29/2026 is acknowledged.
Claims 25-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking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 1/29/2026.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “1320” in fig.2E is not mentioned in the description. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: “10”, “11”, and “12” are mentioned throughout the original specification (see for example par.187 where all three are mentioned), but are not shown in the drawings. 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. 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 Objections
Claim 1 is objected to because of the following informalities: In claim 1, line 8, “its fixated position” should recite --a fixated position-- (since the fixated position is not previously defined). Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that use the word “means,” coupled with functional language and are therefore being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Such claim limitation(s) is/are: “bone engaging means…adapted to extend into corresponding cavities” in claim 1; “guiding means adapted to guide the implant into its fixated position with the bone” in claim 1; “integration means adapted to promote integration of the implant with the bone” in claim 1; and “securing means adapted to secure the implant to the prepared surface of the bone” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The bone engaging means are interpreted to cover one or more of the guiding means, integration means, and securing means, guiding means are interpreted to cover guide projections extending from the bone facing surface, the integration means are interpreted to cover integration projections extending from the bone facing surface, and the securing means are interpreted to cover securing projections extending from the bone facing surface. Note that claims 2-17 recite sufficient structure to perform the recited function and are therefore not interpreted under 35 U.S.C. 112(f).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ferro et al. US 2017/0312084 (hereafter referred to as Ferro; cited in IDS).
Regarding claim 1, Ferro discloses an orthopaedic implant for use with or as part of an orthopaedic implant system, comprising: a body 102 having a bone facing surface 104 configured to mate with a prepared surface of a bone, and bone engaging means extending from the bone facing surface and being adapted to extend into corresponding cavities formed in the prepared surface of the bone when the body is mated with the bone (this is directed to the intended use/function of the bone engaging means; the bone engaging means therefore must be capable of extending into cavities formed in the bone when the body is mated with the bone), said bone engaging means comprising one or more of (only one of the following is required by the claim): guiding means adapted to guide the implant into its fixated position with the bone (can be considered any of projections 135, 146, 148, 150, 170, 190, 192, or 209 as shown in figs. 15-20, 23-32, and 35 since these projections can function to guide the implant into a fixated position within the bone); integration means adapted to promote integration of the implant with the bone (can be considered projections 106 shown throughout the figures, since the projections 106 encourage surrounding bone growth as discussed in par.100); and securing means adapted to secure the implant to the prepared surface of the bone (can be considered projections 106 as shown throughout the figures, since projections/ridges 106 are capable of securing the implant to the prepared surface of the bone as discussed in at least pars. 135 and 138). Note that projections 106 can be considered the integration means or the securing means since the claim does not require both integration and securing means and since the projections 106 function to both encourage bone growth and secure the implant to the prepared surface of the bone. The examiner also notes that par.270 of the instant application discloses the projections 1605 “act as both securing features 12 and integrating features 11”. Therefore, it is clear that projections can function as more than one type of bone engaging means.
Regarding claim 2, see figs. 15-20, 23-32, and 35 for guide projections 135, 146, 148, 150, 170, 190, 192, and 209 extending from the bone facing surface. The projections are capable of extending into corresponding guide cavities formed in the prepared surface of the bone.
Regarding claim 3, see fig.35 for guide projections 209 and 211 which have a “substantially” uniform width (they are substantially cylindrical) as they extend outwardly from the bone facing surface 216.
Regarding claims 4 and 5, see at least projections 135 in figs. 15-17 and projections 190, 192 in figs. 27-32 for guide projections having a tapered leading portion.
Regarding claim 6, see the integration projections 106 throughout the figures which extend from the bone facing surfaces and are capable of extending into cavities formed in the prepared surface of the bone. Par.100 discloses the protrusions 106 provide a shallow seating into bone and encourage gone growth surrounding the tapered protrusions. While the cavities formed in the prepared surface of the bone are directed to an intended use, Ferro discloses pre-punched holes for the protrusions in par.135.
Regarding claims 7-8, see figs. 5-14 for the tapered, three dimensional geometric shape of the integration projections 106.
Regarding claim 9, see par.72 for increased surface area provided by the protrusions.
Regarding claim 10, see par.78 and figs. 7-8 for a rectangular pyramid shape.
Regarding claim 11, the elongated shape of the projections 106 inherently resists transverse movement in use.
Regarding claim 12, see the securing projections 106 throughout the figures which extend from the bone facing surfaces and are capable of extending into cavities formed in the prepared surface of the bone. While the cavities formed in the prepared surface of the bone are directed to an intended use, Ferro discloses pre-punched undersized holes for the protrusions to form a tight press fit with the bone in par.135.
Regarding claim 13, see at least fig.24 which shows the long axis of the protrusions/ridges 106 on the distal surface being orthogonal to the vertical axis/axis of insertion, and shows the protrusions/ridges are parallel to the bone facing surfaces 104 (the ridges 106 have to be parallel to the surface from which they extend since they are connected to the surface).
Regarding claims 14-15, the claims are directed to an intended use of the implant since the claims discuss a substrate deforming joint between the ridges and the prepared surface of the bone (note: claims cannot positively recite such a joint since this would include positively claiming part of the body). The ridges 106 of Ferro are capable of forming a substrate deforming joint with the prepared surface of the bone, wherein the substrate deforming joint results from a resilient deformation of the bone, since Ferro discloses in par.135 that the ridges form a press-fit with the pre-punched undersized holes.
Regarding claim 16, the tapered leading end of the ridges biases the implant onto the prepared surface of the bone.
Regarding claim 17, see at least figs.23-26 which show tapered lateral sides of the ridges 106, which provides diminished/lessened height/projection of the ridges nearer lateral ends of the implant.
Regarding claim 18, securing means 106 are positioned adjacent/near guiding means 190, 192 in at least figs. 27-32.
Regarding claim 19, bone engaging means 106, 135, 190, and 192 are capable of resisting rotational and translational forces on the implant when the body is mated with the bone as least because they are tightly seated within cavities of the bone as discussed in par.135.
Regarding claims 20-23, see par.72 for 20%, 50%, and double, which is 100%. Since 100% is less than 1000%, this is considered “up to”/less than and including 1000%. The examiner notes that the claim compares the surface area of an arbitrary “orthopaedic implant with only planar bone facing surfaces” that is not positively claimed. As such, the implant of Ferro having increased surface area due to the bone engaging means is capable of having increased surface area of up to 20%, 50%, 100%, or 1000% of some arbitrary implant with planar surfaces.
Regarding claim 24, see figs. 23-32 and 35 for a femoral implant.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Each of US 2017/0304059, US 2014/0277549, GB 2388034, US 6,210,412, US 5,553,476, US 4,778,473, and US 4,714,473 disclose an implant comprising a body having a bone facing surface and bone engaging means capable of functioning as claimed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN Y WOLF whose telephone number is (571)270-3071. The examiner can normally be reached Mon-Fri 8am-2pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774 f