DETAILED CORRESPONDENCE
Status of Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 10-15 are cancelled.
Claims 1-9 and 16-26 are pending.
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 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-9 and 16-26 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. ("Novel preparation of Au nanoparticles loaded Laponite nanoparticles/ECM injectable hydrogel on cardiac differentiation of resident cardiac stem cells to cardiomyocytes", Journal of Photochemistry and Photobiology B: Biology Volume 192, March 2019, Pages 49-54) hereinafter Zhang in view of Liebler et al. (WO2015086640A1) hereinafter Liebler.
Regarding claims 1-9 and 16-26, Zhang is drawn to injectable hydrogel fabricated from the electroactive gold (Au) and laponite (Lap) nanoparticles loaded myocardial extracellular matrix (ECM) to enhance the functional and biological properties of cardiomyocytes. The effects of nanoparticles onto the ECM were provided decreasing porous structure and interconnected pores in the hydrogel structure for the favorable environment of cardiac tissues. The biological analysis of cell survival and immunostaining studies of cardiomyocytes established that Au loaded Lap/ECM hydrogel improve cell compatibility and phenotypes maturation of cardiac specific proteins (abstract).
Zhang discloses the extra cellular matrix (ECM) was isolated and solutions were prepared ... ventricular tissue was crushed and decellularized. Zhang discloses the hydrogels were formed by adding Laponite trioctrahedal clay solution into the extracellular matrix (ECM) solution (page 9).
Zhang does not explicitly disclose bleeding disorders.
However, Liebler is drawn to methods for adhering tissue surfaces and materials and biomedical uses thereof. A method for adhering a first tissue surface to a second tissue surface in a subject in need thereof, comprising the steps of adsorbing a layer of nanoparticles on at least one of the tissue surfaces, and approximating the surfaces for a time sufficient for allowing the surfaces to adhere to each other. The present invention also relates to a method for adhering a material to a biological tissue in a subject in need thereof, comprising the steps of adsorbing a layer of nanoparticles on the surface of the material and/or the biological tissue and approximating the material and the biological tissue for a time sufficient for allowing the material and the biological tissue to adhere to each other (abstract).
Liebler discloses the material is a scaffold, in particular a hydrogel scaffold. Hydrogels represent an appealing scaffold material because they are structurally similar to the extracellular matrix of many tissues, can often be processed under relatively mild conditions, and may be delivered in a minimally invasive manner. Consequently, hydrogels, a class of highly hydrated polymer materials, are utilized as scaffold materials for drug and growth factor delivery, engineering tissue replacements, and a variety of other applications (page 9). Accordingly, materials, e.g. hydrogel, comprising amount of radiosensitizers are particularly suitable for the treatment of cancer (page 15). Liebler discloses the nanoparticles will act as contrast agents for imaging (radiopaque contrast agent) (page 26).
Liebler discloses among the mineral nanoparticles, one can mention clays such as laponite and montmorillonite (page 23). If drug or other delivery systems are used, they will typically include a pump and a catheter for dispensing the substances (page 22). Liebler discloses the method of the invention of the present invention is particularly suitable providing control of bleeding (page 35). Liebler discloses the method suitable in an aneurysm repair, an arteriovenous malformation repair (page 35).
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 Zhang, in bleeding disorders, as previously disclosed by Liebler, and arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Zhang and Liebler are in the field of hydrogels, and it would be obvious to use hydrogel as disclosed by Zhang in a bleeding disorder as Liebler discloses the method of the invention of the present invention is particularly suitable providing control of bleeding (page 35). Further, one having ordinary still in the art would reasonably expect success in combining prior art elements according to known methods to yield predictable results, see MPEP 2141.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation... 103 likely bars its patentability...if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions......the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
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/QUANGLONG N TRUONG/Examiner, Art Unit 1615