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 .
DETAILED ACTION
Status of the Claims
Claims 9-16, 19-28 are currently pending.
Claims 1-8, 16-17 are canceled.
Claims 13-16 and 21-28 are withdrawn.
Claims 9-12 and 19-20 have been considered on the merits.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 9-12 and 19-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Pathak et al. (US 2009/0130162 A2) (cited in IDS dated 01/05/2024) as evidenced by Schulz et al (Rifampicin inhibition of RNA synthesis by destabilisation of DNA-RNA polymerase-oligonucleotide-complexes Nucleic Acids Res. 1981 Dec 21;9(24):6889–6906.)
Pathak discloses compositions for the preparation of biological tissues or extracellular matrices and their medical applications [0002].
Regarding claim 9, Pathak discloses a tissue prosthesis generated by decellularizing tissue to generate extracellular matrix suitable for implantation or medical use [0230]. The tissue or extracellular matrix is derived from a mammalian source (human, porcine pericardial sac) and includes bladder tissue, porcine submucosa tissue, placental tissue, and others [0097]. Pathak teaches a composite tissue-biodegradable composite material or coated tissue material that may be stapled or sutured to the surrounding tissue. [0223] Pathak teaches making the tissue into a biodegradable scaffold and several membrane like scaffolds may be stacked in a biotechnology tissue engineering reactor and seeded with mammalian cells to generate large quantity of engineered tissues [0227] Pathak teaches to manufacture bioprostheses thinner tissue may be combined or stacked and glued to make a thicker tissue for a particular medical device application. [0231] and examples. The tissue-based materials described by Pathak are taught to deliver biologically active compounds (compound that shows pharmacological activity [0081]) and combinations to achieve the desired therapeutic effect. Anti-inflammatory agents, antibiotics are taught [0217]. [217]. Specifically ,rifampin (an inhibitor of RNA synthesis- see evidentiary reference Schulz et al.), heparin (anticoagulant) are taught. [0357] and Examples.
Regarding claim 10, the tissue suitable for implantation may be treated to remove cells and cellular components or fragments (acellular) [0097; 0262]. The process of decellularization is described to make the tissue suitable for medical use. See Materials and Methods. Regarding claims 11 and 12, the mammalian tissue source is placental tissue, amniotic membrane tissue [0097]. Regarding claim 19, the tissue-based materials described by Pathak are taught to deliver biologically active compounds (compound that shows pharmacological activity [0081]) and combinations to achieve the desired therapeutic effect. Anti-inflammatory agents, antibiotics are taught [0217]. [217]. Regarding claim 20, the generated tissue is provided as a sheet [0097].
Therefore, Pathak anticipates the subject matter discussed above.
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are not persuasive. As discussed above, Pathak teaches all the new limitations claimed. As discussed above Pathak teaches rifampin, an inhibitor of RNA synthesis, and heparin (anticoagulant).
Conclusion
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.
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/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653