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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/31/2026 has been entered. Claims 20-27 are pending and examining below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/01/2026 is being considered by the examiner.
Drawings
The drawings are objected to because Applicant’s Figure 17B added on 12/17/2025 having 3 scoring spikes different from other scoring spikes (see Figure 17B below, it is possible as new matter).
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 given stamp pattern and the given scoring pattern in claims 20, 25 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.
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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.
Claims 20-27 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.
Claim 20 “the given scoring pattern” of the scoring portion lacks antecedent basis for the limitation in the claim. This recitation is indefinite because it is unclear whether the given scoring pattern refers to the given stamp pattern or a pattern of an entire of the scoring tool or the scoring portion. What are the given stamp pattern and the given scoring pattern in Figure 17B? Are both the given stamp pattern and the given scoring pattern the same, right? Claim 25 has the same issue.
For examination purposes, as best understood, Examiner is interpreting the “issues above” as below and all claims dependent from claims 20, 25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being dependent from the rejected parent claim.
Claim Rejections - 35 USC § 102
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.
(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 20-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Steelman et al (US 6311399) hereinafter Steelman.
Regarding claim 20, as best understood, Steelman shows a set of tools (Figures 1-6) configured to form a “domed shaped acellular dermal matrix (ADM) graft” having a thickness between 1mm and 2mm from an ADM graft (please note that this invention is directed to structures of a set of tools that is configured to form or shape of the domed ADM draft, therefore, the tools 10 or 110, Figures 1 and 4, has a domed shape handle 12 configured to form a “domed shaped acellular dermal matrix (ADM) graft” having a thickness between 1mm and 2mm from an ADM graft), the set of tools comprising:
a shaping tool having a domed shaping portion (emphasis added; see the handle 12 in Figures 1 and 4) upwardly extending from an edge providing including an overall given perimeter (see the peripheral edge or the perimeter of a face or tool 20 in Figures 1 and 4 that the handle protrudes thereon),
the “domed shaping portion” configured to shape the ADM graft into the “domed shaped ADM graft having an overall perimeter with a correspondence to the overall given perimeter” (see Figures 1 and 4 , the handle 12 having a domed shape is configured to shape the ADM graft into the “domed ADM graft having an overall perimeter with a correspondence to the overall given perimeter), and
the domed shaping portion (the handle 12, Figures 1 and 4) configured to shape the ADM graft to provide a perimeter edge with correspondence to the edge of the dome shaping portion (see MPEP 2112.01, under the heading "Product and Apparatus Claims - When the Structure Recited in the Reference is Substantially Identical to that of the Claims, Claimed Properties or Functions are Presumed to be Inherent"); and
a scoring tool (20) having a scoring portion (pins 30) within a scoring edge perimeter (see Figures 3A, 3B, the pins 30 are within the scoring tool or tool 20), the scoring portion (30) having a given stamp pattern corresponding to a desired mesh pattern (see Figure 2, the pins 30 are for penetrating a sheeting material), and a given scoring pattern (a pattern of pins 30 as seen in Figures 3A or 3B) of the scoring portion configured in the given stamp pattern to impart the desired mesh pattern into the “domed shaped ADM graft having the thickness between 1mm and 2mm” adjacent the perimeter edge (see Figure 2, the pins 30 are for penetrating a sheeting material).
Please note that the invention is directed to an apparatus (a set of tools including a shaping portion and a scoring portion), a recitation of the intended use of the sheeting material or the “domed shaped ADM graft having the thickness between 1mm and 2mm” is considered, however, only given weight inasmuch as it infers structure in the set of tools and see MPEP. 2112.01 “When the Structure Recited in the Reference is Substantially Identical to that of the Claims, Claimed Properties or Functions are Presumed to be Inherent”.
Regarding claim 21, Steelman shows that the shaping tool (12) and the scoring tool (20) are integrated in a single device (Figures 1, 4, both tools are assembled as a tool 10 or 110), wherein the domed shaping portion extends in a first direction (upwardly direction, Figures 1 and 4), wherein the scoring tool extends in a second direction (downward direction or an opposite direction), and wherein the first direction and the second direction are opposite to one another so as to form the domed shaped ADM graft with the given overall perimeter and the desired mesh pattern with a single placement of the ADM graft (Figures 1 and 4 and see the discussion in claim 20 above).
Regarding claim 22, Steelman shows that the shaping tool (12) and the scoring tool (20) are provided in devices separate from one another (Col. 5, lines 13-20 “the pins 30 are preferably removable if desired, such that the distribution of pins 30 can be tailored to a specific application…”).
Regarding claim 23, Steelman shows that the scoring edge perimeter is adjacent the edge of domed shaping portion (Figures 1 and 4, the bottom edge of the handle 12 is adjacent or at the edge of the tool 20).
Regarding claim 24, Steelman shows that the scoring edge perimeter is co-equal with the edge of domed shaping portion (see Figures 1 and 4, the joint between the handle 12 and the tool 20).
Regarding claims 25-27, Steelman shows all of the limitations as stated in claims 20-24 above.
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. See the new reference, Steelman above.
However, if Applicant still believes that the claimed invention’s apparatus/method different from the prior art’s apparatus/method or needs to discuss the rejections above or suggestion amendments that can be overcome the current rejections, especially, the ADM is positively claimed in the claimed invention. And if Applicant would like to float any amendments to positively include an ADM draft into the claims, Applicant should feel free to call the Examiner to schedule an interview.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Mork (US 0326160) shows a scoring tool with a handle (Figure 1)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NHAT CHIEU Q DO whose telephone number is (571)270-1522. The examiner can normally be reached 8AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Boyer Ashley can be reached at (571) 272-4502. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NHAT CHIEU Q DO/Primary Examiner, Art Unit 3724 9/3/2026
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