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 .
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 Roefs (US 2006/0042101 A1).
Regarding claim 20, Roefs shows a set of tools 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 a domed ADM draft, therefore, a device, Figures 1-6 and 7-13, 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- 6 and Para. 23 “The handle 12 is formed to be held in the hand of a user and has a smooth, circular convex top surface 16”) upwardly extending from an edge providing including an overall given perimeter (there are many edges in this device, see a perimeter edge between the upper and lower portions 16, 26 in Figures 1-2 or a perimeter edge of a bottom portion 30 in Figures 10, 12),
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” (Figures 4A-4D and Para. 36 “the shape and overall design of the dome portion 12” configured to shape the ADM graft into the “hemispherical domed ADM graft having an overall perimeter with a correspondence to the overall given perimeter), and
the domed shaping portion 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 (as it is written, it is extremity broad that makes unclear what structure of the scoring tool is, therefore, see Figures 1-2 and 7-13, the sharp point 14 meets this limitation) having a scoring portion (emphasis added, see the tip where the reference “14” in Figure 13) within a scoring edge perimeter (the perimeter edge of the bottom portion 30 or the edge of the end 38), and
the scoring portion configured to impart a desired mesh pattern into the domed shaped ADM graft having the thickness between 1mm and 2mm adjacent the perimeter edge (see Figures 7-12; the point 14 can be configured to impart a desired mesh pattern into the domed shaped ADM graft having the thickness between 1mm and 2mm adjacent the perimeter edge because Para. 24 discusses that the point 14 is 1/16 inch = 1.5875mm and Para. 29 “the handle and shank can be formed of the same…materials…stainless steel” that means the point 14 is stainless steel, therefore, the point 14 is configured to impart a desired mesh pattern into the domed shaped ADM graft).
Regarding claim 21, Roefs shows that the shaping tool (12) and the scoring tool (14) are integrated in a single device (Figures 7-12), wherein the domed shaping portion (16) extends in a first direction (upwardly direction, Figures 7-12), 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 7-12 and see the discussion in claim 20 above).
Regarding claim 22, Roefs shows that the shaping tool (12) and the scoring tool (14) are provided in devices separate from one another (see Figures 9-13 and Para. 27 discus that the point 14 is screwed into the handle for easily replaced if needed).
Regarding claim 23, Roefs shows that the scoring edge perimeter is adjacent the edge of domed shaping portion (Figures 10, 12, the edge of the bottom portion 30 is adjacent the edge of domed shaping portion or the handle).
Regarding claim 24, Roefs shows that the scoring edge perimeter is co-equal with the edge of domed shaping portion (see the joint between the handle and the top portion of the portion 30 in Figures 10 and 12).
Regarding claims 25-27, Roefs 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, Roefs above.
With regards to claim 20, Applicant has amended the claim, therefore, the new art, Roefs having the point 14 that is made of stainless steel and 1.5875 mm long which can be performed or imparted a desired mesh pattern of any tissue materials.
With regards to MPEP§ 2131 “a scoring tool configured to impart a desired mesh pattern into an ADM…as claimed…well-known terms in the biomedical arts” in the section 1 in page 10 of the remarks, the MPEP§ 2131 states that “A claimed invention may be rejected under 35 U.S.C. 102 when the invention is anticipated (or is "not novel") over a disclosure that is available as prior art. To reject a claim as anticipated by a reference, the disclosure must teach every element required by the claim under its broadest reasonable interpretation.”. As claim 20 is written, it is directed to structures of a set of tools” that is configured to impart or act on a workpiece (ADM); claim 20 is NOT a combination of a set of tools and an (ADM) draft. What are structures of the set of tools Applicant trying to claim?
It appears that the structures are a domed shaped portion of a shaping tool integrated with a scoring tool. Therefore, many art can be read on it. See the example art Roefs above.
With regards to the section 2, see the rejection by the art, Roefs 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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/NHAT CHIEU Q DO/Primary Examiner, Art Unit 3724 5/26/2026
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