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 . Claims 1-6 are pending and examined below.
Specification
The disclosure is objected to because of the following informalities:
Page 22 step 5 recites “…systema re placed…” It appears this is a typographical error.
Appropriate correction is required.
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.
Claim 5 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 5 recites the limitation "the group…" in line 2. There is insufficient antecedent basis for this limitation in the 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.
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.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Freyman et al. (US 20050013870 A1) hereinafter, Freyman.
Regarding claim 1, Freyman teaches
a method for preparing a genetically modified bioprosthetic heart valve (¶0001 & ¶0044), comprising:
- providing an aortic heart valve from an animal most suitable for an implantation (heart, ¶0044),
- treating the aortic heart valve by a molecular modification process (more than one conditioning process may be performed, ¶0048, the conditioned body tissue can be further processed before or after decellularization, ¶0052),
- performing a decellularization of the aortic heart valve (the conditioned body tissue may be decellularized, ¶0106),
- wherein the molecular modification process is applied preceding the decellularization (the conditioned body tissue can be further processed before or after decellularization, ¶0052, the conditioned body tissue may be decellularized, ¶0106).
Regarding claim 2, Freyman teaches
wherein the molecular modification process comprises an electroporation system (cells in the body tissue of an animal can be transfected in vivo or in vitro with genetic material using any appropriate means such as electroporation, ¶0055).
Regarding claim 3, Freyman teaches
wherein the molecular modification process comprises at least one small interfering RNA (siRNA) molecule (nucleic acid, ¶0053).
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 3-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freyman in view of Everaerts et al. (US 20070020248 A1) hereinafter, Everaerts.
Regarding claim 3, Freyman teaches
wherein the molecular modification process comprises at least one small interfering RNA (siRNA) molecule (nucleic acid, ¶0053, Freyman). Freyman is not specific in that the molecular modification process comprises at least one small interfering RNA (siRNA) molecule. However, Everaerts teaches an electrophoretic system, apparatus, and method of use thereof for the preparation of a tissue-derived bioprosthesis (abstract, Everaerts)
wherein the molecular modification process comprises at least one small interfering RNA (siRNA) molecule (siRNA, ¶0090, Everaerts).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Freyman by incorporating the teachings above as taught by Everaerts in order to modify cellular interactions, as well as agents that introduce, enhance, reduce, suppress or silence gene or messenger RNA (mRNA) expression, or protein expression (¶0090, Everaerts).
Regarding claim 4, Freyman teaches nucleic acid (¶0053, Freyman) but does not teach specifically wherein a target molecule of the at least one siRNA molecule is selected from molecules associated with a heart valve calcification problem. However, Everaerts teaches
wherein a target molecule of the at least one siRNA molecule is selected from molecules associated with a heart valve calcification problem (bioactive agents include agents that mitigate calcification, and agents include siRNA, ¶0090, Everaerts).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Freyman by incorporating the teachings above as taught by Everaerts in order to modify cellular interactions, as well as agents that introduce, enhance, reduce, suppress or silence gene or messenger RNA (mRNA) expression, or protein expression (¶0090, Everaerts).
Regarding claim 5, Freyman teaches
wherein the target molecule is at least one selected from the group consisting of receptor activator of the nuclear factor ƘB ligand (RANKL), Beta-catenin (β-catenin),Transforming Growth Factor-β(TGF-[[ ]]β) (transforming growth factor (TGF), ¶0071, Freyman), bone morphogenetic protein 2 (BMP2), Smad1, MSX2, ELN, FBN-1, COL I, COL II, ASCC3, ITK, CD28, LINS, Nox2, MMP-9, VCAM1, MMP9, ITGB2, RAC2,vWF, and ALDH2.
Regarding claim 6, Freyman teaches
wherein the target molecule is at least one selected from the group consisting of the RANKL, the β-catenin, and the TGF-[[ ]]β (transforming growth factor (TGF) (¶0071, Freyman).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIA XIONG WHITE whose telephone number is (703)756-4773. The examiner can normally be reached 0830-1630 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/K.X.W./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
Prosecution Insights