DETAILED ACTION
Receipt is acknowledged of applicant’s Amendment/Remarks filed 9/27/2025.
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 .
Status of the Claims
Claims 1 and 8 have been amended. Claims 2, 4, 6, 7, 9, 11 and 13 are cancelled. No claims are newly added. Accordingly, claims 1, 3, 5, 8, 10, 12 and 14-20 remain pending in the application. Claims 8, 10, 12, 14-18 and 20 stand withdrawn from further consideration, without traverse. Claims 1, 3, 5 and 19 are currently under examination.
Withdrawn Rejections
Applicant’s amendment renders the rejection of claims 1, 3, 5 and 19 under 35 USC 103 over Gleeson, McKay and Lu moot. Specifically, the references teach a porous upper layer whereas the instant claims require “wherein the upper layer functions as a barrier membrane capable of inhibiting overgrowth of connective tissue by preventing the infiltration of connective tissue due to the absence of pores”. Thus, said rejection has been withdrawn. It is noted that the limitation regarding the absence of pores appears to be new matter (see new rejection below). Should the new matter be removed from the claims, the art rejection will be reconsidered and potentially reinstated.
New Rejections
In light of Applicant’s amendments, the following rejections have been newly added:
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, 5 and 19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
37 CFR §1.118 (a) states that "No amendment shall introduce new matter into the disclosure of an application after the filing date of the application".
Instant claim 1 recites, “wherein the upper layer functions as a barrier membrane capable of inhibiting overgrowth of connective tissue by preventing the filtration of connective tissue due to the absence of pores”. Applicant pointed to page 10, lines 7-12 of the specification as support which reads,
the upper layer enables the bone graft material to be stably maintained on a bone defect site and realizes a natural bone tissue environment at a graft site by preventing the infiltration of epithelial tissue or connective tissue, thereby maximizing bone tissue regeneration capacity.
However, there is no mention of an absence of pores. There is no explicit or implicit teaching in the original disclosure for a nonporous upper layer; the subject matter was not properly described as filed. Applicant is invited to identify the portion of the specification that teaches said limitation, as the examiner has not been able to locate the applicable disclosure. The claims within this rejection are examined as written by the applicant; at this time new matter must be considered as part of the claimed subject matter.
Dependent claims 3, 5 and 19 do not remedy the new matter issue and as such said dependent claims suffer from the same deficiency.
MPEP 2163.06 notes: "If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112, first paragraph - written description requirement. In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981)." MPEP 2163.02 teaches that "Whenever the issue arises, the fundamental factual inquiry is whether a claim defines an invention that is clearly conveyed to those skilled in the art at the time the application was filed...If a claim is amended to include subject matter, limitations, or terminology not present in the application as filed, involving a departure from, addition to, or deletion from the disclosure of the application as filed, the examiner should conclude that the claimed subject matter is not described in that application. MPEP 2163.06 further notes "When an amendment is filed in reply to an objection or rejection based on 35 U.S.C. 112, first paragraph, a study of the entire application is often necessary to determine whether or not "new matter" is involved. Applicant should therefore specifically point out the support for any amendments made to the disclosure".
This is a new matter rejection. Correction is respectfully requested.
Response to Arguments
The arguments filed 9/27/2025 regarding the 103 rejection over Gleeson, McKay and Lu are moot in view of the withdrawn rejection discussed above.
Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Yen et al. (US 2015/0230914 A1, Aug. 20, 2015, hereafter as “Yen”) teaches a dual layer composite material comprising a porous scaffold layer (lower layer) and a non-porous barrier film layer (upper layer), wherein the porous scaffold layer and the non-porous barrier film layer can both contain collagen (abstract; Fig. 1; [0007] and [0055]). However, Yen does not teach a bone mineral component or amount thereof; the collagen protein chains are aligned in the lower layer; 2-5 wt% collagen in the upper layer; a ratio of collagen in the upper layer to the lower layer being 0.5:1; and the collagen in the upper layer is cross-linked.
Conclusion
All claims have been rejected; no claims are allowed.
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY HAGOPIAN whose telephone number is (571)272-6097. The examiner can normally be reached on M-F 9:00 am - 3:30 pm.
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Casey S. Hagopian
Examiner, Art Unit 1617
/CARLOS A AZPURU/Primary Examiner, Art Unit 1617