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 .
Priority
The instant application is the national stage entry of PCT/US22/3396 filed 17 June 2022. Acknowledgement is made of the Applicant’s claim of domestic priority to provisional application 63/212,474 filed 18 June 2021.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 2 January 2026 is acknowledged. The Applicant has canceled claims 18-34. No claims have been withdrawn. New claims 35-44 fall within Group I and will be examined.
Status of the Claims
Claims 1-17 and 35-44 are pending.
Claims 1-17 are rejected.
Claims 35-44 are allowable.
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.
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.
Claims 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Samia et al. (US 2021/0106708) in view of Skardal et al. (US 2020/0108172) as evidenced by DattaLab (https://www.dattalab.caltech.edu/porous-hydrogels).
Samia teaches a nanocomposite [0003] that can comprise at least one polymer wherein the polymer can be selected from starch, collagen, and gelatin [0084]. The polymer can be present in amounts ranging from about 1% to about 10% wt/vol [0084]. In addition, the nanocomposite can be a hydrogel [0084]. The nanocomposite can be formulated for application to a specific medical implant or prevention or disruption of a biofilm [0099]. Samia teaches that the viscosity of the nanocomposite can have varying viscosity based on the temperature so that the nanocomposite can readily flow over a surface but without washing completely away after application [0080-0081].
Samia does not teach the gelatin in the form of nanoparticles nor does it teach the specifically claimed concentrations of agents.
Skardal teaches gelatin nanoparticles for use in a composition such as a hydrogel [0007]. The nanoparticles can range in size from about 150 nm to about 500 nm [0007] and can be present in compositions in amounts from about 10 mg/mL to about 250 mg/mL [0008]. The gelatin nanoparticles are used to modify one or more properties of the composition including thixotrophy and stiffness [0051].
Dattalab provides evidence that hydrogels are defined as porous, cross-linked networks of hydrophilic polymers (pg 1).
It would have been prima facie obvious to the person of ordinary skill in the art to prepare the nanocomposite hydrogel of Samia comprising at least one polymer for application to a specific medical implant. Hydrogels, by definition, are interconnected, porous structures. Starch, collagen, and gelatin are provided in a list of suitable polymers however it would have been obvious to combine all three together in the composition of Samia. It must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. Consistent with this reasoning, it would have been obvious to have selected various combinations of polymers from within Samia, to arrive at compositions “yielding no more than one would expect from such an arrangement.” The resulting composition would comprise starch, collagen, and gelatin wherein each polymer can be present in amounts ranging from about 1% to about 10% wt/vol.
Since Samia teaches the benefit of variable viscosity, it would have been obvious to look to Skardal which teaches that thixotrophy can be adjusted by using hydrogels comprising gelatin nanoparticles. Thixotrophy is a property of compositions wherein viscous materials like hydrogels flow when stirred or stressed and thicken when left to rest. Although this is not temperature dependent such as the viscosity changes in Samia, the teaching in Samia that different viscosity gradients are beneficial can be applied to the property of thixotrophy as well. The resulting composition comprises the biocompatible and biodegradable components of starch, collagen, and gelatin nanoparticles (about 150 nm to about 500 nm) in about 1% to about 10% wt/vol each wherein the formulation has thixotrophy, thus rendering obvious instant claims 1-2, 5-7, 12, and 14-17.
Regarding the amounts of each agent polymer, the concentration of gelatin particles, and the peak particle size of the nanoparticles, each property is optimizable based on the teachings in the prior art. The polymer, which is known for being important in forming a hydrogel, can be varied to any desired concentration by the skilled artisan in order to prepare said hydrogel. The amount of gelatin nanoparticles, which are known for imparting thixotrophy to the hydrogel, can be adjusted to achieve the desired level of thixotrophy. The particle size does not particularly matter in the prior art and Skardal’s range of 150-500 nm is for average diameter, thus adjusting to a lower size of 40 nm would have been obvious based on optimization of the hydrogel. That being said and in lieu of objective evidence of unexpected results, the concentrations of polymer and gelatin and the particle size of the gelatin can be viewed as variables which achieve the recognized results of a nanocomposite with desired hydrogel properties and thixotrophy. The optimum or workable range of concentration and particle size can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980).
It is noted that the limitation in instant claim 1 that reads, “for three-dimensional printing” is an intended use of the claimed composition, does not result in a structural difference over the prior art, and is thus given minimal patentable weight (See MPEP 2111.02 (II)).
Claims 1-17 are accordingly rejected as obvious in view of the prior art.
Claims 1-17 and 35-44 are rejected under 35 U.S.C. 103 as being unpatentable over Samia et al. (US 2021/0106708) in view of Skardal et al. (US 2020/0108172) in view of Ramirez et al. (Drug Delivery 27(1), 2020, 1308-1318) as evidenced by DattaLab (https://www.dattalab.caltech.edu/porous-hydrogels).
Samia, Skardal, and DattaLab, as applied supra, are herein applied in their entirety for the teachings of a composition comprising starch, collagen, and gelatin nanoparticles (about 150 nm to about 500 nm) in about 1% to about 10% wt/vol each wherein the formulation has thixotrophy.
Samia does not teach further including extracellular vesicles or exosomes in the composition.
Ramirez teaches that extracellular vesicles (EVs) have become increasingly popular in regenerative medicine and, recently, royal jelly EVs were shown to display wound healing properties and inhibition of biofilms (abstract). Moreover, when released from collagen gels, royal jelly EVs significantly decreased S. aureus biofilm formation (pg 1315, col 2; Fig 7).
It would have been prima facie obvious to prepare the composition of Samia, Skardal, and DattaLab comprising starch, collagen, and gelatin nanoparticles and further include royal jelly EVs. Both Samia and Ramirez are towards inhibiting biofilms, therefore combination would have been obvious. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07). The resulting composition would be a biofilm inhibitor comprising starch, collagen, gelatin nanoparticles, and royal jelly EVs and would render obvious instant claims 35-44. Claims 1-17 and 35-44 are accordingly obvious in view of the prior art.
Conclusion
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/ANDREW S ROSENTHAL/ Primary Examiner, Art Unit 1613