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 II, Species D, drawn to claims 22-34 and 37-38 in the reply filed on December 23, 2025 is acknowledged.
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.
Claims 22-34 and 37-38 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.
Claim 22 recites the limitation "the warpage is configured preoperatively so as to adapt the implant to be set onto and supported by at least a craniomaxillofacial bone and/or a soft tissue layer overlaying the craniomaxillofacial bone " in lines 2-5. If the implant is set onto and supported by at least a craniomaxillofacial bone, and not a soft tissue layer overlaying the craniomaxillofacial bone (only first option of “and/OR” clause), then there is not adequate support for “the soft tissue layer” described in lines 6 and 7. Appropriate clarification and correction is required.
Claim 22 recites the limitation "the elevation of the soft tissue layer" in line 7. There is insufficient antecedent basis for this limitation in the claim. Appropriate clarification and 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.
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 22-34 and 37-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Pub. No. 2018/0344464 to Engstrand et al.
As to Claim 22, Engstrand discloses a patient-specific craniomaxillofacial implant (110, [0046, 0068-0069], Figs. 2-5) formed into a plate that is rigid, warped, and of a substantially uniform thickness (Figs. 2-5, [0044, 0046-0048]). The warpage is configured preoperatively (patient-customized bending described in [0048]) so as to adapt the implant to be set onto and supported by at least a craniomaxillofacial bone and/or a soft tissue layer overlaying the craniomaxillofacial bone [0048-0049], and support the soft tissue layer in place of at least the craniomaxillofacial bone, thereby compensating or augmenting the elevation of the soft tissue layer (customizing bone defect [0046, 0048, 0051] and including deformation of support frame 120A, [0070]).
As to Claim 23, Engstrand discloses a patient-specific craniomaxillofacial implant wherein the warpage is configured preoperatively so as to also adapt the implant to support the soft tissue layer in place of at least the craniomaxillofacial bone (customizing bone defect [0046, 0048, 0051], and including deformation of support frame 120A, [0070]), thereby compensating or augmenting the elevation of the soft tissue layer, the support being asymmetrical to that provided by a contralateral portion of the craniomaxillofacial bone (configuration described in [0069-0070]).
As to Claim 24, Engstrand discloses a patient-specific craniomaxillofacial implant wherein the substantially uniform thickness is within a range of 0.2-0.8 mm [0074, 0113].
As to Claim 25, Engstrand discloses a patient-specific craniomaxillofacial implant, the soft tissue layer being one or more of muscle, fat, and skin (other tissues of [0050]).
As to Claim 26, Engstrand discloses a patient-specific craniomaxillofacial implant wherein the plate is also porous [0061].
As to Claim 27, Engstrand discloses a patient-specific craniomaxillofacial implant comprising further a preoperatively configured mechanical reinforcement (120A, [0068-0069]).
As to Claim 28, Engstrand discloses a patient-specific craniomaxillofacial implant wherein the mechanical reinforcement (120A) fills the porosity of the plate locally [0068-0069].
As to Claim 29, Engstrand discloses a patient-specific craniomaxillofacial implant wherein the mechanical reinforcement thickens the plate locally (fit described in [0069]).
As to Claim 30, Engstrand discloses a patient-specific craniomaxillofacial implant further including a means for fastening (screw inserted through 140A, 140B) and/or increasing stability of the implant upon the craniomaxillofacial bone [0067, 0071].
As to Claim 31, Engstrand discloses a patient-specific craniomaxillofacial implant wherein the warpage is configured preoperatively so as to adapt the implant to support the soft tissue layer by way of receiving the soft tissue layer in place of at least the craniomaxillofacial bone (modification described in [0048, 0050].
As to Claim 32, Engstrand discloses a patient-specific craniomaxillofacial implant wherein the warpage is configured preoperatively so as to adapt the implant to support the soft tissue layer by way of lifting the soft tissue layer over at least the craniomaxillofacial bone (e.g. fasteners driven through other tissue surrounding implantation site, [0050]).
As to Claim 33, Engstrand discloses a patient-specific craniomaxillofacial implant for reconstructing a defective craniomaxillofacial bone and a defective soft tissue layer overlaying the defective craniomaxillofacial bone [0066], wherein the warpage is configured preoperatively so as to adapt the implant to be set onto and supported by at least a non-defective part of the defective craniomaxillofacial bone [0068] and/or the defective part of the defective soft tissue layer [0068-0069], and support the defective soft tissue layer in place of the defective part of the defective craniomaxillofacial bone [0066, 0105], and the defective part of the defective soft tissue layer (via fasteners within 140A, 140B, [0069-0070]).
As to Claim 34, Engstrand discloses a patient-specific craniomaxillofacial implant wherein the defective craniomaxillofacial bone is a cranium [0045], and the defective soft tissue layer comprising overlaying temporalis muscle and fat [0045, 0051].
As to Claim 37, Engstrand discloses a patient-specific craniomaxillofacial implant for a cosmetic surgery [0045], wherein the warpage is configured preoperatively so as to adapt the implant to be set onto and supported by at least the craniomaxillofacial bone and/or the soft tissue layer [0051-0052], and support the soft tissue layer in place of at least craniomaxillofacial bone, thereby altering the apparent contours of the craniomaxillofacial bone [0051-0052, 0069].
As to Claim 38, Engstrand discloses a patient-specific craniomaxillofacial implant, the cosmetic surgery being operated upon a nasal bone [0049, 0051].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER J BECCIA whose telephone number is (571)270-7391. The examiner can normally be reached Mon - Fri 8:30-5:00.
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775