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 .
Status of the Claims
Claims 1, 2, 5-11, and 14-23 are pending.
Claims 10, 11, and 14-23 are withdrawn from consideration as directed to non-elected inventions.
Claims 6-8 are withdrawn from consideration as directed to non-elected species of the elected invention.
Claims 1, 2, 5 and 9 are presented for examination and rejected as set forth below.
Claim Interpretation
The instant claims are directed to implantable compositions which combine erythropoietin (EPO) with a biopolymer matrix of type I collagen that is free of denatured collagens (which applicants indicate includes gelatin) such that the EPO is released in a biphasic manner over a period of 1 day, up to 12 weeks, with particular percentages of the active agent being released within the first day, and within three weeks of implantation. The examiner notes that the language specifying the manner in which such an implant may be used, here “for repairing a crushed peripheral nerve, recites an intended use, rather than affirmative structural limitation, of the composition otherwise fully set forth by the claim, and therefore is considered as contributing no patentable weight to the composition claimed. Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003) (Particularly, a recitation of an intended use will not limit the scope of the claim because it merely defines a context in which the invention may operate). The examiner further notes that no particular quantification of what is to constitute the “biphasic” rate of release is recited by the claims; art teaching or suggesting a medical device providing two distinct phases of drug release, such as a “burst” followed by a distinct sustained period of release of drug from the device, will be considered sufficient to address this newly added claim language. Claim 2 specifies that the matrix is semipermeable. The examiner notes that applicants have not provided a controlling definition of “semipermeable,” meaning that the ordinary meaning of the term, such as “a material permitting the movement of some materials but not others,” will control. Materials recited as permitting the release of materials such as drugs contained within a polymeric structure will be considered “semipermeable.” Claim 5 specifies that the EPO is to be released over a period of 1-7 days. Claim 9 specifies physical forms which the implant may take.
Response to Amendment
The Declaration of Inventor Li under 37 CFR 1.132 filed 9 December 2025 is insufficient to overcome the rejection of claims 1, 2, 5 and 9 based upon the teachings of Daniloff and Zhao as set forth in the last Office action because the declaration simply offers the inventor declarant’s opinion as to the obviousness of the invention claimed, without providing a scintilla of evidence to support their position.
Although factual evidence is preferable to opinion testimony, such testimony is entitled to consideration and some weight so long as the opinion is not on the ultimate legal conclusion at issue. While an opinion as to a legal conclusion is not entitled to any weight, the underlying basis for the opinion may be persuasive. In re Chilowsky, 306 F.2d 908, 134 USPQ 515 (CCPA 1962). In assessing the probative value of an expert opinion, the examiner must consider the nature of the matter sought to be established, the strength of any opposing evidence, the interest of the expert in the outcome of the case, and the presence or absence of factual support for the expert’s opinion. Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 227 USPQ 657 (Fed. Cir. 1985), cert. denied, 475 U.S. 1017 (1986). Here, the matter to be establishes is simply whether the record supports the examiner’s conclusion of obviousness. The inventor declarant offers no evidence of any kind, simply their perspective that it was not obvious to a person with ordinary skill in the art to design EPO release that can meet the optimal crushed nerve healing kinetics. As a named inventor of the application, the Declarant’s interest in the outcome of the case is straightforward. Since the art describes the manner in which biphasic release of active agents such as EPO from polymer matrices such as collagen are known to skilled artisans, as is the use of a Type I collagen matrix as part of a medical device to deliver drugs including EPO, the burden falls on applicants to provide evidence tending to rebut the presumption of operability of the prior art. This burden has not been met.
For at least these reasons, the Li declaration is unpersuasive.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 5 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Daniloff (WO2006/002332) in view of Zhao (AU2008201395).
Daniloff describes compositions which utilize a biocompatible polymer to serve as a carrier for biologically active agents for delivery to damaged tissues. (Abs.). Daniloff indicates that various cytokines serve as exemplary active agents to be incorporated into such compositions, with the presently claimed erythropoietin recited as an exemplary cytokine. [0078]. Daniloff indicates that a particular form of the compositions according to the disclosure takes the form of a sheet for application to a surface a skilled artisan desires to be treat as is recited by instant Claim 9. [0113]. Daniloff indicates that the hydrophilic polymer serving as the matrix of the compositions is preferably Type I collagen recited by Claim 1. [0116-18; 0185-86]. Daniloff indicates that their implantable drug delivery systems suitably release the active agents, specifically including cytokines such as the erythropoietin recited and claimed over a period of 7 days as is required by Claim 5. [0229; 0234].
But for the description of a biphasic release profile, the specific combination of features claimed is disclosed within the breadth of knowledge provided by the Daniloff reference, but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). Where, as here, the reference does not provide any motivation to select this specific combination of a semipermeable sheet formed from a type I collagen matrix configured to deliver erythropoietin over a period of 7 days, anticipation cannot be found.
That being said, however, 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 prima facie obvious to have selected various combinations of semipermeable sheet formed from a type I collagen matrix configured to deliver erythropoietin over a period of 7 days from within the Daniloff disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
However, as set forth above, Daniloff does not describe providing these EPO eluting medical devices such that a biphasic rate of release is observed.
Attention is directed to the teachings of Zhao, which also describes drug-eluting implantable medical devices. (Abs.). Zhao describes the state of the art of drug elution from implantable polymer matrix devices over periods of weeks, normally two to six (pg.3), but in alternative embodiments 4-8 weeks, or even over the course of months, including complete drug release within any of six, or even within one week such as recited by Claim 5. (Pg.4-5). The erythropoietin of Daniloff as well as the present claims is exemplified as a particular active agent to be incorporated into such medical devices, with collagen a representative polymer which may be used as the matrix component. (pg.6; 22). Zhao indicates that medical devices which provide for an initial burst of drug released from devices followed by an even and sustained period of release of that drug from the device is positively correlated to desired therapeutic efficacy of the drug. (Pg.5). Zhao indicates that drug loading level may influence the rate and duration of drug release from the device, as will a variety of additional factors known to the skilled artisan. (Pg.20; 24-25). Zhao indicates that commonly less than 30% of the drug load is released within the first days, with the remainder being released over the next several weeks, the duration and rate of which will be varied by the skilled artisan according to the potency and toxicity of the drug. (Pg.23). By this, Zhao indicates that each of the release time, as well as rate of release, are result-effective variables suitable for optimization by nothing more than the routine experimentation of the skilled artisan invited by the teachings of Zhao, rendering the newly added limitations concerning the quantity of EPO released within the first 24 hours, as well as the first three weeks, prima facie obvious. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.).
It therefore would have been prima facie obvious for a skilled artisan to configure the Daniloff drug-releasing devices to provide for an initial burst of drug followed by a controlled and sustained period of release, thereby providing the biphasic rate of release now required by the amended claims according to the teachings of Zhao. This is because Zhao indicates that such a release profile is positively correlated to the desired therapeutic efficacy of drug for a given indication, and the strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. In re Sernaker, 702 F.2d 989, 994-95 (Fed. Cir. 1983). The particular parameters of release of Claim 1 also being an obvious modification of the teaching of Zhao concerning the desired modification of the rate at which drug are released from the devices described, applicants now bear the burden of establishing that the particular parameters claimed give rise to some unexpected result. “The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. . . . In such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range.” In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Response to Arguments
Applicant's arguments filed 9 December 2025 have been fully considered but they are not persuasive.
Applicants arguments reiterating the arguments presented in the Li declaration are unpersuasive for the reasons set forth above.
Applicants advance no arguments aside from a reiteration of the Li declaration. The rejection of record is therefore maintained.
Conclusion
No Claims are allowable.
THIS ACTION IS MADE FINAL. 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 SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614