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.
Election/Restrictions
Applicant elected group IV (method of growing bone) with SEQ ID 4 in a cleft palate without traverse in the reply filed on 27 Feb, 2024. Applicants have since amended the claims so their elected composition no longer reads on them.
Claims Status
Claims 8, 11, 16, 28, and 29 are pending.
Claims 8 has been amended.
Claims 28 and 29 have been withdrawn due to an election/restriction requirement.
Withdrawn Rejections
The rejection of claim(s) 8, 11, and 16 under 35 U.S.C. 103 as being unpatentable over Chen et al (Plast. Reconstr. Surg. (2015) 135 p1405-1412) in view of Shimp et al (US 9,034,356) is hereby withdrawn due to amendment.
New Rejections
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.
Claim(s) 8, 11, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Mauth et al (US 20170203008) in view of in view of Shimp et al (US 9,034,356, cited by applicants) and Chen et al (Plast. Reconstr. Surg. (2015) 135 p1405-1412, previously cited).
Mauth et al discuss a bone repair material (title), which is easy to handle and suitable for treatment of large oral bone defects (paragraph 13). This has a scaffold of a porous ceramic material, such as apatite (paragraph 30) which further comprises a cross linked polyethylene glycol hydrogel (paragraph 38) made by base catalyzed Michael type additions between a first precursor molecule and a second precursor molecule (paragraph 39). One of the two precursor molecules can be substituted by peptides with a cysteine on each end to produce enzymatically degradable gels (paragraph 39). Bioactive agents can be added for sustained release (paragraph 57), which can be covalently bound to the hydrogel and released during hydrolysis (paragraph 58) or entrapped or precipitated into the bone repair material and released by diffusion (paragraph 59).
The difference between this reference and the competing claims is that this reference does not discuss a TGF-β-type II receptor.
Similar to Mauth et al, Shimp et al discusses implants for bone growth (abstract). These can be made from bone particles (column 3, line 10-13), and can be used for cosmetic procedures in the bones of the face (column 4, line 4-26). Polymers may be added to the formulation (column 15, line 37-49), including polyethylene oxide (column 21, line 64), another name for PEG. Living cells, which may be genetically engineered can be added (column 28, line 48-51). The graft can contain a bioactive agent, such as betaglycan (a synonym for the TGFβ type III receptor) (column 33, line 61-62) and mesenchymal stem cells (column 34, line 11-12). The patient can be a human (column 4, line 57), which presumably will use the human proteins. This reference discusses synthetic implants similar to those of Mauth et al, and mentions using betaglycan in such constructs.
Chen et al discuss repair of dog alveolar cleft with a mix of autologous bone, mesenchymal stem cells, and platelet rich plasma (title). There were 4 groups; mesenchymal stem cells and platelet rich plasma plus bone, mesenchymal stem cells plus bone, platelet rich plasma plus bone, and just bone (p1407, 1st column, 3d paragraph). The stem cells and platelet rich plasma were part of the graft (p1407, 1st column, 4th paragraph). The combination of mesenchymal stem cells and platelet rich plasma both improved the repair, and the mixture was more potent than either alone (abstract). This reference discusses bone grafts to repair a cleft graft.
Therefore, it would be obvious to add the betaglycan of Shimp et al to the graft material of Mauth et al, as a simple substitution of one element (the additional compounds of Mauth et al) for another (the betaglycan of Shimp et al) yielding expected results (bone graft material which will heal bone defects). As Mauth et al discusses additional polypeptide components, an artisan in this field would attempt this material with a reasonable expectation of success.
Furthermore, it would be obvious to use the material of Mauth et al to heal the cleft grafts of Chen et al, as a substitution of one known element (the autologous bone of Chen et al) for another (the graft material of Mauth et al) yielding expected results (repaired cleft graft). As Mauth et al mention using the material for oral bone defects, an artisan in this field would attempt this substitution with a reasonable expectation of success.
Chen et al discusses surgical repair of cleft defects. Mauth et al renders obvious using a composition comprising a crosslinked hydrogel comprising an enzymatically cleavable peptide and PEG. Shimp et al renders obvious adding TGFβ type III receptor. Thus, the combination of references render obvious claims 8 and 11.
Shimp et al discusses treating humans, which will presumably use human proteins, rendering obvious claim 16.
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 FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658