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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/21/2026 has been entered.
Response to Amendment
The amendment filed 07/21/2026 has been entered. Claims 1, 2, 4, 6-14, 17-22, and 60 remain
pending. Claims 61-62 has been added.
Response to Arguments
Applicant's arguments filed 07/21/2026 have been fully considered but they are not persuasive.
Regarding Applicant’s argument that the addition of the limitation “wherein the bone structure comprises a floor of an orbital bone structure” overcomes the prior art, the Examiner respectfully disagrees. The implant of the prior art sits on (and therefore “interfaces” with, as claimed) the inferior/bottom orbital rim, which is the anterior boundary/border of the orbital floor (see paragraph [0049] and Figure 6 denoting and illustrating that the implant is on the inferior/bottom orbital rim, which is the anterior boundary/border of the orbital floor). Regarding the argument that limitations “a distal edge positioned to sit underneath an eyeball during implantation of the implant, wherein the depression is near the distal edge and positioned to sit underneath the eyeball during implantation of the implant” overcome the previous rejection, the Examiner also respectfully disagrees. The limitation “underneath” is being interpreted broadly to mean “under an object” (see Merriam Webster definition 1, adverb). Since the implant is under the eyeball as it interfaces with the bottom orbital rim, the prior art still reads upon this claim. Further narrowing of the independent claim, or differing claim language, is recommended to differ the prior art’s device to the device of the Instant Application. Since the claim doesn’t clearly set forth a direction of “under” with respect to any other recited features of the implant, the term “underneath” is given its broadest reasonable interpretation to encompass a downward direction in a vertical axis of Fig. 6. Additionally, this limitation is able to be broadened even more, as any edge could be the “distal edge” as the term “distal” is not defined with respect to any other recited features. Further clarification is recommended.
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Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1-2, 4, 6-14, 17-19, 21-22, and 61-62 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 1, the limitation “distal” is not defined clearly as it does not define a direction with respect to any recited features of the implant. In the current form, any edge could be the “distal edge”. Further clarification is required. Claims 2, 6-14, 17-19, 21-22, and 61-62 depend from claim 1 and are rejected for the same reason.
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 1-2, 6-14, 17-19, 21-22, and 61-62 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2015/0105858 A1 (hereafter --Papay--).
Regarding Claim 1, Papay discloses an implant (100) for correcting a defect of a bone structure (see paragraph [0037]), comprising: a first surface comprising a shape configured to interface with a surface of the bone structure (see annotated first surface 204 in Figure 2 below, see paragraph [0039]), wherein the bone structure comprises a floor of an orbital bone structure (see paragraph [0049] and Figure 6 denoting and illustrating that the implant is on the inferior/bottom orbital rim, which is the anterior boundary/border of the orbital floor); and a second surface opposite the first surface and substantially conformal to the shape of the first surface (see annotated second surface 102 in Figure 1 below, see also paragraph [0039]), the second surface comprising: three or more point features on the second surface (see annotated point features in Figure 1 below), wherein the three or more point features comprise a first point feature, a second point feature, and a third point feature that form nodes of a triangle (see annotated first, second, and third point features 112 in Figure 1 below), wherein each of the three or more point features are recessed below the second surface (see paragraph [0042]), wherein at least one of the three or more point features comprises a depression (see paragraph [0042] denoting that point features 112 can extend partially or all the way through the implant, the descent of the extension into the implant being the depressions, depression being defined as “a place or part that is lower than the surrounding area” (see Merriam Webster online definition 3)), and an elevated ridge at least partially surrounding at least one of the three or more point features (see annotated elevated ridge 514 in Figure 1 below, see also paragraph [0048] denoting that elevated ridges 514 can be protruding above the implant), and a distal edge positioned to sit underneath an eyeball during implantation of the implant, wherein the depression is near the distal edge and positioned to sit underneath the eyeball during implantation of the implant (see annotated distal edge and depression in Figure 1 below, there being “depressions” (112) “near” the distal edge, see Figure 6 below showing that the entire implant is “underneath” the eyeball, so the distal edge and depression are both underneath the eyeball). Additionally, it is to be noted that since the claim doesn’t clearly set forth a direction of “under” with respect to any other recited features of the implant, the term “underneath” is given its broadest reasonable interpretation to encompass a downward direction in a vertical axis of Fig. 6. Additionally, this limitation is able to be broadened even more, as any edge could be the “distal edge” as the term “distal” is not defined with respect to any other recited features. Further clarification is recommended.
The limitation “configured to receive a tip of a stylus angled close to tangentially to the second surface” is treated as functional language, that is given limited patentable weight. The stylus is not positively recited as part of the claimed invention. The prior art is not required to disclose a stylus, but merely have the capability of performing the recited function. Due to the depression being a recess that is able to be touched by at least some existing stylus, it is therefore able to “receive a tip of a stylus angled close to the surface”.
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Regarding Claim 2, Papay as modified discloses the implant of claim 1, wherein at least another one of the three or more point features comprises a hole through the implant from the first surface to the second surface (see paragraph [0042] denoting that the apertures 112 can extend fully through both surfaces 102 and 204).
The limitation “configured to receive a tip of a stylus angled close to tangentially to the second surface” is treated as functional language, that is given limited patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to the hole being a recess that is able to be touched by a stylus, it is therefore able to “receive a tip of a stylus angled close to the surface”.
Regarding Claim 6, Papay discloses the implant of claim 1, wherein the elevated ridge surrounds the at least one or more of the three or more point features on a distal side (see annotated point features and elevated ridge in Figures 1 and 2 above).
Regarding Claim 7, Papay as modified discloses the implant of claim 1, wherein the elevated ridge is formed along the distal edge of the second surface (see annotated second surface and distal edge in Figure 1 above).
Regarding Claim 8, Papay as modified discloses the implant of claim 1, wherein the elevated ridge comprises at least one of a corner, a hook, a notch, or a gap at the one or more of the three or more point features (see annotated corner in Figure 1 above), wherein the at least one or the corner, the hook, the notch, or the gap is configured to trap the stylus at the one or more of the three or more point features (due to the corner of the protrusion having a space between the surface and the protruded surface, and the corner being near a “point feature”, the space is able to be touched by at least some existing stylus, and therefore “trap” a stylus from movement in at least one direction between the corner and point feature depending on the size and shape of the stylus).
Regarding Claim 9, Papay as modified discloses the implant of claim 8.
The limitation “wherein the corner, hook, notch, or gap is configured to receive the tip of the stylus angled substantially tangential to the second surface” is treated as functional language, that is given limited patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to the corner of the protrusion having a space between the surface and the protruded surface, the space is able to be touched by at least some existing stylus, and is therefore able to “receive a tip of a stylus angled close to the surface”.
Regarding Claim 10, Papay as modified discloses the implant of claim 1, wherein the elevated ridge extends from the first point feature of the three or more point features to the second point feature of the three or more point features (see annotated first and second point features, as well as the elevated ridges in Figure 1 above).
Regarding Claim 11, Papay as modified discloses the implant of claim 10, further comprising another elevated ridge on the second surface, the other elevated ridge extending from the second point feature to the third point feature of the three or more point features (see annotated elevated ridges in Figure 1 above, both of which extend from each point feature).
Regarding Claim 12, Papay as modified discloses the implant of claim 11, wherein the elevated ridge and the other elevated ridge form a continuous ridgeline on the second surface (see annotated elevated ridges in Figure 1 above).
Regarding Claim 13, Papay as modified discloses the implant of claim 1, wherein the implant further comprises a gradual transition at a side of the elevated ridge from a top of the elevated ridge to the second surface (see annotated gradual transition in Figure 5 below), wherein the gradual transition is configured to prevent the stylus being guided along the side of the elevated ridge (since the “elevated ridge” is elevated along the surface, depending on the force applied to the stylus the “gradual” transition, being the transition between the surface and the highest point of the elevated ridge, could “prevent” the stylus from going up along the side and over the ridge). “Gradual” transition is broad, and therefore is being given its broadest reasonable interpretation to encompass the structure disclosed by Papay.
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Regarding Claim 14, Papay as modified discloses the implant of claim 13, wherein the side is a distal side of the elevated ridge (see annotated distal side in Figure 5 above).
Regarding Claim 17, Papay as modified discloses the implant of claim 1, wherein the elevated ridge comprises a concave side (see annotated concave side in Figure 5 above).
The limitation “for receiving the tip of the stylus” is treated as functional language, that is given limited patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to the side of the protrusion having a space between the surface and the protruded surface, the space is able to be touched by at least some existing stylus, and is therefore able to “receive a tip of a stylus”.
Regarding Claim 18, Papay as modified discloses the implant of claim 17, wherein the concave side is a proximal side of the elevated ridge (see annotated proximal side in Figure 5 above).
Regarding Claim 19, Papay as modified discloses the implant of claim 1, wherein the elevated ridge extends along a path between the first point feature of the three or more point features and the second point feature of the three or more point features, wherein each of the one or more elevated ridge is located on a first side of the path and no elevated ridge is located on a second side of the path (see annotated path, first side of path, and second side of path in Figure 5 above), wherein the first side of the path is a distal side of the path (see annotated first side of the path in Figure 5 above).
Regarding Claim 21, Papay discloses the implant of claim 1, further comprising a plurality of perforations through the implant from the first surface to the second surface (see paragraph [0042] denoting that the apertures 112 can extend fully through both surfaces 102 and 204).
Regarding Claim 22, Papay discloses the implant of claim 21, wherein a path between the first point feature of the three or more point features and the second point feature of the three or more point features does not include the plurality of perforations (see annotated path in Figure 5 above).
Regarding Claim 61, Papay discloses the implant of claim 1, wherein the one or more of the three or more point features at least partially surrounded by the elevated ridge comprise the depression (see annotated point features and depression 112 being “partially surrounded” by the elevated ridge).
Regarding Claim 62, Papay as modified discloses the implant of claim 1, wherein the one or more of the three or more point features at least partially surrounded by the elevated ridge comprise a most distal point feature of the three or more point features (see annotated point features and depression 112 being “partially surrounded” by the elevated ridge. The most distal point feature being the closest 112 to the ridge (see annotated first point feature being the closest to the ridge in Figure 1 above)).
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 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 4 and 60 are rejected under 35 U.S.C. 103 as being unpatentable over US 20150105858 A1 (hereafter --Papay--), in view of US 20200100894 A1 (hereafter --Woodburn--).
Regarding Claim 4, Papay as modified discloses the implant of claim 1.
Papay discloses wherein the depression could be any shape (see paragraph [0045] denoting that 112 can be any shape or size), however fails to specifically disclose wherein the depression is a wedge-shaped depression.
Woodburn discloses an orbital implant for implantation in the eye of a patient, wherein the implant comprises of a first surface, a second surface, and depressions (see annotated depressions in Figure 1 below). Woodburn teaches a depression that is wedge shaped (see annotated depressions in Figure 1 below being “wedge-shaped).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date for the depression of Papay to be an elongated depression that is wedge shaped, the substitution of one known element (depression shape of Papay) for another (wedge shaped depression of Woodburn) would have been obvious to one of ordinary skill in the art at the time of the invention since the substitution of the depression shapes shown in Woodburn would have yielded predictable results, namely, a depression with a wedge shape, as disclosed in Woodburn.
Regarding Claim 60, Papay as modified discloses the implant of claim 1.
wherein the depression is the elongated depression.
Papay discloses wherein the depression could be any shape (see paragraph [0045] denoting that 112 can be any shape or size), however fails to specifically disclose wherein the depression is the elongated depression.
Woodburn discloses an orbital implant for implantation in the eye of a patient, wherein the implant comprises of a first surface, a second surface, and depressions (see annotated depressions in Figure 1 below). Woodburn teaches elongated depression that is elongated in shape along the second surface (see annotated depressions in Figure 1 below being both “elongated”).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date for the depression of Papay to be an elongated depression that is elongated in shape along the second surface, the substitution of one known element (depression shape of Papay) for another (elongated depression shape of Woodburn) would have been obvious to one of ordinary skill in the art at the time of the invention since the substitution of the depression shapes shown in Woodburn would have yielded predictable results, namely, a depression with an elongated shape, as disclosed in Woodburn.
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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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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