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
Applicant’s election without traverse of claims 1-14 in the reply filed on 12/23/2025 is acknowledged. Claims 1-14 are currently under examination and the subject of the present Office Action. Claims 15-20 are withdrawn from consideration without traverse.
As such, the restriction is made final.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 08/02/2024 has been considered here.
Claim Rejections - 35 USC § 103
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 1-10 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020210764 A1 (Naga, 2020) in view of Vieira (2010) as evidenced by Ak (2017).
In regards to claim 1, Naga teaches an implantable system for the controlled release of a therapeutic agent (see Naga, paragraph 0005). The implant is taught to comprise a polymer matrix (see Naga, paragraph 0198), and is in the form of an elongated rod or fiber that is flexible (see Naga, paragraphs 0127 and 0324). The therapeutic agent is taught to be an anti-inflammatory agent (see Naga, paragraphs 0359 and 0362). The release rate of the therapeutic agent is taught to be from 10 ng/day to 900µg/day (see Naga, paragraph 0410) for no less than 10 days (see Naga, paragraph 103). MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Further in regards to claims 1 and 14, specifically in regards to the concentration of therapeutic agent in the implant and the porosity of the implant, Naga teaches that the release kinetics of the implant are variables that can be modified, among others, by adjusting the concentration of the therapeutic agent and porosity of the implant (see Naga, paragraph 0104), the kinetics changing as the concentration is changed, the concentration of the therapeutic agent and porosity of the implant would have been considered result effective variables by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed concentration of the therapeutic agent and porosity of the implant cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, concentration and porosity in Naga to obtain the desired balance between the release kinetics of the implant as taught by Naga (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[W]here 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.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
In regards to claims 2 and 7-8, the therapeutic agent is taught to be tacrolimus or combinations of other immunosuppressants, like cyclosporine (i.e., a macrolactam) (see Naga, paragraph 0366).
In regards to claims 3-4, the polymer matrix is taught to comprise of poly(l-lactic acid) (PLLA) and polycaprolactone (PCL), specifically a copolymer of PLLA and PCL for a bioresorbable implant for drug release (see Naga, paragraphs 0165 and 0245). It is taught that the wt: wt ratio of PCL to PLLA is from 1:9 to 9:1 (see Naga, paragraph 0252). This overlaps with the molar ratio of the instant claims. For example if 5 g of PLLA and 6 g of PCL is used (i.e. a wt: wt ratio of 6:5), and converted into moles of lactic acid (molecular weight of 90.08g/mol) and caprolactone (molecular weight of 114.14g/mol), there are 0.055 mol of lactic acid and 0.053 mol of caprolactone to yield approximately a molar ratio of 51:49 lactic acid to caprolactone. MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
In regards to claims 5-6, it is taught in Naga that the therapeutic agent is released at a rate of 10ng/day to 25ng/day or any other incremental range therebetween (see Naga, paragraph 0410). It is also taught that the therapeutic agent is released over a period of time such as no less than 21 days (see Naga, paragraph 412). While Naga does not directly teach that the release rate of the therapeutic agent varies by no more than 10 ng/day over a period of at least 10 days, it is taught the therapeutic agent is released at a consistent rate for a period of time (e.g., from 1 day to 365 days) (see Naga, paragraph 0308). Further Figure 3A shows a constant release of the therapeutic agent over a period of 16 weeks (see Naga, figure 3A; paragraph 0099).
In regards to claim 9, Naga teaches various cross-sectional diameters of the implants including from about 0.01 to about 5 mm (i.e., from about 10µm to 5000 µm) (see Naga, paragraph 0124). MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Naga is silent on the implant being a suture specifically.
Vieira teaches sutures made of polylactic acid and polycaprolactone with a diameter of 150 µm and 400 µm (see Vieira, abstract; experimental procedure).
In regards to claims 1-9 and 14, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to use the teachings of Naga and Vieira to formulate a drug eluting suture as instantly claimed because Naga teaches an implant comprised of PLLA and PCL that releases a therapeutic agent, such as an anti-inflammatory agent, and Vieira teaches that sutures made of polylactic acid and polycaprolactone are known in the art. It would be within the purview of one with ordinary skill in the art to envisage the composition of Naga as a suture because Naga teaches that it is an elongated fiber that is flexible, which is very similar to a suture in description. Further the cross-dimensional diameter of the composition overlaps with diameters that are known to be used for sutures of polylactic acid and polycaprolactone (i.e., 150 µm and 400 µm) (see Vieira, abstract; experimental procedure). It is noted Ak teaches that drug-eluting sutures are known in the art, specifically with tacrolimus (see Ak, page 1, objective/background; conclusion) and as such, it is not outside of the realm of one with ordinary skill in the art before the effective filing date of the claimed invention to envisage such a suture. One with ordinary skill in the art would be motivated to combine the suture of Vieira with the drug-eluting implant of Naga according to known methods of making drug-eluting devices (see Naga, paragraphs 0284-0295) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results with a reasonable expectation of success.
In regards to claim 10, as the combination of teachings of Naga and Vieira would yield an identical composition as instantly claimed, the properties, such as the uniaxial tensile strength, of the composition would be the same. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658. As the prior art renders obvious the instant composition, a person of ordinary skill in the art would reasonably expect the same composition to have the same properties as instantly claimed.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2020210764 A1 (Naga, 2020) in view of Vieira (2010) as applied to claims 1-10 and 14 above, and further in view of WO 2007110609 A1 (Dagger, 2007) as evidenced by Ak (2017).
The teachings of Naga and Vieira have been described supra.
The teachings of Naga and Vieira are silent on the polymer matrix being annealed.
Dagger teaches that annealing the fibers in a polymer matrix increases the strength and tensile modulus of the fibers in a suture (see Dagger, paragraphs 0010-0011).
In regards to claim 11, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to use the teachings of Naga and Vieira with Dagger to formulate a drug eluting suture as instantly claimed as it is known that the mechanical properties of fibers in a polymer matrix are enhanced through the annealing process. One with ordinary skill in the art would be motivated to combine the sutures of Naga and Vieira and Dagger according to the known method of enhancing mechanical properties through annealing (see Dagger, paragraphs 0010-0011) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Further, as the combination of teachings of Naga, Vieira, and Dagger would yield an identical composition as instantly claimed, the properties, such as the uniaxial tensile strength, of the composition would be the same. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658. As the prior art renders obvious the instant composition, a person of ordinary skill in the art would reasonably expect the same composition to have the same properties as instantly claimed.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020210764 A1 (Naga, 2020) in view of Vieira (2010) as applied to claims 1-10 and 14 above, and further in view of WO 9604942 A1 (Lee, 1996) as evidenced by Ak (2017).
The teachings of Naga and Vieira have been described supra.
The teachings of Naga and Vieira are silent on the composition comprising an anti-adherent agent.
Lee teaches a coating composition for sutures comprising a powdered lubricant in an amount of 50 wt.% of the composition (see Lee, abstract). The lubricant is taught to be magnesium stearate (see Lee, page 4, lines 24-27). It is taught that the coating composition remains on the suture in an amount of 6 to 18wt% based on the weight o the uncoated suture (see Lee, page 5, lines 23-34). With 6 wt% being split into a 50% composition, the amount of magnesium stearate would be about 3 wt% based on the weight of the uncoated suture. “A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.").” One with ordinary skill in the art would reasonably expect that a composition comprising 3 wt% of magnesium stearate would have the same properties as a composition comprising 2.5 wt% of magnesium stearate.
In regards to claims 12-13, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to use the teachings of Naga and Vieira with Lee to formulate a drug eluting suture as instantly claimed as the coating composition of Lee is taught to provide both improved knot slipdown property and knot security to the surgical suture (see Lee, abstract). One with ordinary skill in the art would be motivated to combine the coating of Lee with the suture of Naga and Vieira according to the known method of applying a coating to a suture (see Lee, page 6, lines 15-26) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Conclusion
No claims allowed.
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/Isis A Ghali/Primary Examiner, Art Unit 1611
/A.A.A./Examiner, Art Unit 1611