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 .
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 (i.e., changing from AIA to pre-AIA ) 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/06/2026 has been entered.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in EP on 04/25/2022. It is noted, however, that applicant has not filed a certified copy of the 22169675.0 application as required by 37 CFR 1.55.
Response to Amendment
The amendment filed 08/06/2026 has been entered. Claims 1-10 remain pending in the
application.
Response to Arguments
Applicant's arguments filed 08/06/2026 have been fully considered but they are not persuasive.
Regarding Applicant’s argument that the prior art does not read on the amended claim 1, the Examiner respectfully disagrees. The limitation “the annular cone having an outer diameter” is still read upon by the prior art, as the device of the primary reference has a round outer surface, therefore having a “diameter” (see Merriam Webster Online definition 2, defining “diameter” as “the length of a straight line through the center of an object or space”). The Examiner would like to make clear that the shape of the primary reference’s device is an irregular shape with a round outer surface, it is additionally possible to calculate an equivalent diameter by, for example through one method, taking many measurements, and finding an average to end up with an equivalent measurement representative of a “ true diameter”. Similarly the limitation “circumscribe the entire outer diameter of the annular cone thereby forming a closed ring” is still read upon by the reference, as the device of the primary reference (Sperling) has a closed rounded outer surface, with “ring” being given its broadest reasonable interpretation, being interpreted to mean “a circular line, figure, or object” (see Merriam Webster definition 3a) and circular to mean “round” (see Merriam Webster definition 1 of “circular”).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Applicant’s critique of Davies stating that the device does not create a “closed ring” is moot as Davies is a secondary reference brought in to teach the dimensions of the grooves. The “closed ring” limitation is already read upon by the primary reference, Sperling, as it has a closed profile outer surface that has grooves (where sides of steps meet) upon the entire circumference of the outer surface. Similarly, Applicant’s critique of Davies stating that the device does not have segments or is made of a grid/mesh material is moot under the new interpretation of the prior art references, as Davies is a secondary reference brought in to only teach the dimensions of said grooves, and does not need to have the segments (the segments and grooves are disclosed in Sperling). As mentioned previously, the limitation “the grooves… are configured as sawing guides that are configured to receive means for separating one or more cone segments in order to adapt a cone size of the cone” is functional and therefore the prior art is not required to disclose the function but is only required to be capable of the function, and since segments of Sperling have, grooves on the outer surface of the device, the segments and grooves would define clean perimeters that a saw could theoretically cut and therefore adapt the size of a cone, the apparatus, specifically the grooves, are capable of acting as “sawing guides” in order to “receive” means for separating the segments and adapting the size of the implant. Sperling therefore discloses the grooves bring configured as sawing guides that are configured to receive means for separating one or more cone segments in order to adapt a cone size of the cone (see paragraph [0187] denoting that surface of the shape of the cone can be modified by using blades, pointed structures, or machining lines, since this limitation is functional and therefore the prior art is not required to disclose the function but is only required to be capable of the function, and since the grooves define clean perimeters for a saw to cut and therefore adapt the size of a cone, the apparatus, specifically the grooves, are capable of acting as “sawing guides” in order to “receive” means for separating the segments and adapting the size of the implant).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3 and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over US 20240261109 A1 (hereafter --Sperling--), in view of US 11565021 B1 (hereafter --Davies--).
Regarding Claim 1, Sperling discloses an augmentation device comprising an annular cone surrounding a channel which extends from a proximal cone end to a distal cone end of the cone through said cone (see paragraph [0184], see also annotated distal and proximal ends as well as the channel in Figures 34C and 34D below), the annular cone having an outer diameter (see annotated device 3420 in Figures 34C and 34D, the device having a round outer surface, therefore having a “diameter” (see Merriam Webster Online definition 2, defining “diameter” as “the length of a straight line through the center of an object or space”), wherein the cone consists by at least 50 percent by volume, based on the total volume of the cone, of a biocompatible polymer (see paragraph [0200]), and is subdivided, by the at least three radially circumferential grooves in a cone lateral surface opposite the channel, into annular cone segments (see annotated circumferential grooves and segments in Figure 34C and 34D below), and wherein the grooves circumscribe the entire outer diameter of the annular cone thereby forming a closed ring (see annotated grooves in Figure 34D below, see also annotated device 3420 in Figures 34C and 34D, the device having a closed rounded outer surface, “ring” being given it’s broadest reasonable interpretation, being interpreted to mean “a circular line, figure, or object” (see Merriam Webster definition 3a) and circular to mean “round” (see Merriam Webster definition 1 of “circular”). Additionally, Sperling also discloses the grooves being configured as sawing guides that are configured to receive means for separating one or more cone segments in order to adapt a cone size of the cone (see paragraph [0187] denoting that surface of the shape of the cone can be modified by using blades, pointed structures, or machining lines, since this limitation is functional and therefore the prior art is not required to disclose the function but is only required to be capable of the function, and since the grooves define clean perimeters for a saw to cut and therefore adapt the size of a cone, the apparatus, specifically the grooves, are capable of acting as “sawing guides” in order to “receive” means for separating the segments and adapting the size of the implant).
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Sperling fails to disclose wherein the device wherein the grooves have a groove depth of at least 1mm and a groove width of at least 1mm.
Davies discloses an augmentation device comprising an annular cone surrounding a channel which extends from a proximal cone end to a distal cone end of the cone through said cone (see annotated channel, distal end, and proximal end in Figure 7 below), and teaches wherein the device has least three radially circumferential grooves in a cone lateral surface opposite the channel (see annotated circumferential grooves, lateral surface, and channel in Figure 7 below). Davies teaches wherein the grooves have a groove depth of at least 1mm and a groove width of at least 1mm (see column 11, lines 3-5 denoting that the square openings are about 2 mm deep and 6 mm in length, these sizes being at least 1 mm as they are both greater than 1 mm).
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The Instant Application does not disclose the grooves having a groove depth of at least 1mm and a groove width of at least 1mm being critical (see paragraph [0044] denoting that it is merely preferred that the groove width corresponds to not more than 5mm, preferably not more than 4mm, more preferably not more than 3mm, and paragraph [0043] denoting that it is preferred that the groove depth corresponds to not more than one quarter of the cone wall thickness, the wall thickness being disclosed to be in a range of 2 to 30mm, preferably 2 to 15mm, more preferably 2 to 10mm in paragraph [0036]). It appears that Sperling’s device would perform equally and function as intended with a different groove depth and width than exactly 1mm. Therefore, it would have been obvious to one having ordinary skill in the art to make the grooves have a groove depth of at least 1mm and a groove width of at least 1mm, as an obvious matter of design choice within the skill of the art, as well as by doing so could prevent warping and cracking problems in the implant by adding torsional rigidity and bending stiffness to the device (see column 18, lines 48-52) for a particular application.
Regarding Claim 2, Sperling as modified discloses the augmentation device according to claim 1, wherein the lateral cone surface is roughened or porous at least in portions (see paragraph [0186]).
Regarding Claim 3, Sperling as modified discloses the augmentation device according to claim 1, wherein the lateral cone surface is formed by at least 70 percent by area, based on the entire lateral cone surface, of tantalum, a tantalum alloy, titanium, a titanium alloy, or stainless steel (see paragraph [0200]).
Regarding Claim 6, Sperling as modified discloses the augmentation device according to claim 1.
Sperling as modified fails to disclose wherein the cone comprises radially circumferential inner grooves in a cone inner surface facing toward the channel, which inner grooves are arranged opposite the at least three radially circumferential grooves in the cone lateral surface.
Davies teaches wherein the cone comprises radially circumferential inner grooves in a cone inner surface facing toward the channel, which inner grooves are arranged opposite the circumferential grooves in the cone lateral surface (see annotated inner grooves 26 and inner surface in Figure 7 above).
Therefore, it would have been obvious to someone with ordinary skill in the art before the effective filing date of the invention to have the device of Sperling have radially circumferential inner grooves in a cone inner surface facing toward the channel opposite the at least three radially circumferential grooves in the cone lateral surface, as by doing so would provide additional room for positioning an artificial joint component within the interior of the porous implant, as taught by Davies (see column 6, lines 19-23).
Regarding Claim 7, Sperling as modified discloses the augmentation device according to claim 1, wherein the lateral cone surface comprises at least two axially extending axial grooves (see annotated axial grooves in Figure 34D above).
Sperling as modified fails to disclose the grooves having an axial groove depth of at least 1 mm and an axial groove width of at least 1 mm, each of which is connected at least to one of the grooves.
Davies teaches wherein the lateral cone surface comprises at least two axially extending axial grooves (see annotated axial grooves in Figure 7 above), with an axial groove depth of at least 1 mm and an axial groove width of at least 1 mm (see column 11, lines 3-5 denoting that the square openings are about 2 mm deep and 6 mm in length, these sizes being at least 1 mm as they are both greater than 1 mm), each of which is connected at least to one of the grooves (see annotated axial and circumferential grooves in Figure 7 above being connected to each other by the outer walls 46).
The Instant Application does not disclose the axially grooves having a groove depth of at least 1mm and a groove width of at least 1mm being critical (see paragraph [0071] denoting that it is preferred that the axial groove width corresponds to not more than 5mm, preferably not more than 4mm, more preferably not more than 3mm, see paragraph [0070] denoting it is preferred that the axial groove depth corresponds to not more than one quarter of the cone wall thickness, the wall thickness being disclosed to be in a range of 2 to 30mm, preferably 2 to 15mm, more preferably 2 to 10mm in paragraph [0036]). It appears that Sperling’s device would perform equally and function as intended with a different groove depth and width than exactly 1mm. Therefore, it would have been obvious to one having ordinary skill in the art to make the axial grooves have a groove depth of at least 1mm and a groove width of at least 1mm, as an obvious matter of design choice within the skill of the art, as well as by doing so could prevent warping and cracking problems in the implant by adding torsional rigidity and bending stiffness to the device (see column 18, lines 48-52) for a particular application.
Regarding Claim 8, Sperling as modified discloses the augmentation device according to claim 1, wherein the cone segments are separated from one another in a stepped manner (see annotated segments in Figures 34C and 34D above).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over US 20240261109 A1 (hereafter --Sperling--), in view of US 11565021 B1 (hereafter --Davies--), in even further view of US 20200222196 A1 (hereafter –Vogt--).
Regarding Claim 4, Sperling as modified discloses the augmentation device according to claim 1.
Sperling as modified fails to disclose wherein the biocompatible polymer is a PMMA bone cement.
Vogt discloses an implant configured to be implanted into a bone canal (see annotated implant Figure 1 below, see paragraph [0027]). Jones teaches wherein the biocompatible polymer is a PMMA bone cement that contains an antibiotic (see paragraphs [0031], [0128]).
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Therefore, it would have been obvious to someone with ordinary skill in the art before the effective filing date of the invention to have the biocompatible polymer of the device of Sperling be a PMMA bone cement that contains an antibiotic as taught by Vogt, 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 design choice. In re Leshin, 125 USPQ 416.
Regarding Claim 5, Sperling as modified discloses the augmentation device according to claim 4, wherein the PMMA bone cement contains at least one antibiotic (see claim 4 rejection above, see also paragraph [0031] of Vogt).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over US 20240261109 A1 (hereafter --Sperling--), in view of US 11565021 B1 (hereafter --Davies--), in even further view of US 20200100894 (hereafter –Woodburn--).
Regarding Claim 9, Sperling as modified discloses a method for adapting a cone size of an augmentation device according to claim 1 (see paragraph [0187] denoting that surface of the shape of the cone can be modified by using blades, pointed structures, or machining lines).
Sperling as modified fails to disclose comprising a step of separating one or more cone segments at the proximal cone end by and/or at the distal cone end by utilizing the radially circumferential groove or grooves as sawing guides to saw, cut, or break along the radially circumferential groove or grooves.
Woodburn discloses an implant with grooves (see annotated grooves in Figure 1 below). Woodburn teaches comprising a step of separating one or more implant segments at implant ends by utilizing the radially circumferential groove or grooves as sawing guides to saw, cut, or break along the radially circumferential groove or grooves (see paragraphs [0029] denoting the physician can “sever” along the potions 7).
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Therefore, it would have been obvious to someone with ordinary skill in the art before the effective filing date of the invention to have the method of adapting a cone size of an augmentation device of Sperling to further comprise a step of separating one or more cone segments at the proximal cone end and/or at the distal cone end by sawing, cutting, or breaking along the radially circumferential groove or grooves, as by doing so would allow the physician to sever various portions of the implant as needed to adapt the implant to the particular portions of the portion of the body that the implant is being implanted to be supported, as taught by Woodburn (see paragraph [0029]).
Regarding Claim 10, Sperling as modified discloses the method according to claim 9 for adapting an augmentation device comprising: an annular cone surrounding a channel which extends from a proximal cone end to a distal cone end of the cone through said cone, (see paragraph [0184], see also annotated distal and proximal ends as well as the channel in Figures 34C and 34D above), wherein the cone consists by at least 50 percent by volume, based on the total volume of the cone, of a biocompatible polymer (see paragraph [0200]), and is subdivided, by at least three radially circumferential grooves in a cone lateral surface opposite the channel, into annular cone segments, wherein the grooves have a groove depth of at least 1 mm and a groove width of at least 1 mm (see claim 1 rejection above), and form sawing guides in order to adapt a cone size of the cone by separating one or more cone segments, comprising a step of separating a conical part from the cone by sawing, cutting, or breaking along two of the axially extending axial grooves (see claim 9 rejection above).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PARIS MARIE BLASS whose telephone number is (703)756-5375. The examiner can normally be reached Monday - Thursday 9 a.m. - 7 p.m. ET.
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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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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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