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
Status of Claims
The amendments and arguments filed on 07/08/2026 are acknowledged and have been fully considered. Claims 1-9 and 11-20 are now pending. Claim 10 is canceled; claims 1, 12, 14-15, and 19 are amended; claims 15-20 are withdrawn.
Claims 1-9 and 11-14 will be examined on the merits herein.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 12-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification describes the use of anti-adherent agents but does not teach the anti-adherent agents being incorporated into the polymer matrix directly as claimed in claim 12. For example, in paragraph 0038 of the instant specification it is taught that anti-adherent agents aid in effective manufacture of the suture and that the polymer powders tend to form clumps with the anti-inflammatory agent but it is not taught that the anti-adherent agent is incorporated into the polymer matrix. As this is not taught directly in the specification, it would be considered new matter. Claim 13 depends from claim 12 and as such is rejected as well.
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 1-9 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).
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.
Further in regards to claim 1, specifically to the suture being solvent extruded, a product-by-process claim drawn to a composition directed towards the suture, the patentability of a product does not depend on its method of production. The combination of Naga and Vieira teach the instantly claimed suture. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). "The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by- process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing a nonobvious difference between the claimed product and the prior art product. The teachings of Naga and Vieira teach the suture as instantly claimed, thus the burden shifts to the applicant to come forward with evidence showing that the process of making the suture as instantly claimed produces a materially different product than the suture of Naga and Vieira. 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 and porosity of the suture, 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.
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.).
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 1-9 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 1-9 and 14 above, and further in view of US PGPUB 20140142225 A1 (Bond, 2014) and WO 9604942 (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 incorporated into the polymer matrix.
Bond teaches a composition for sutures (see Bond, paragraph 0149) comprising a thermoplastic polymer, such as polylactic acid (see Bond, paragraph 0012), and magnesium stearate (see Bond, paragraph 0023). The suture is taught to be made via extrusion (see Bond, paragraphs 0029, 0089-0102). The polymer and the magnesium stearate are taught to be combine before extrusion (see Bond, paragraphs 0086-0088).
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 of 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 Bond and 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). Further it would be within the purview of with ordinary skill in the art to use the teaching of Bond to add the magnesium stearate into the polymer before extrusion to work as a compatibilizer with other polymers (see Bond, paragraph 0017). One with ordinary skill in the art would be motivated to combine the magnesium stearate of Bond and 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.
Response to Arguments
Applicant's arguments filed 07/08/2026 have been fully considered but they are not persuasive in view of the modified grounds of rejection as necessitated by amendment.
In regard to applicant’s argument against the optimization of the porosity and that it is not explained why it routine optimization is used to arrive to the porosity as claimed, 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. It is taught in the art that adjusting the porosity affects the release kinetics of the implant and as such it would be within the purview of one with ordinary skill to use routine optimization to provide specific release kinetics by modifying the variables that are known to affect them as taught in the art. Applicant also argues that the a skilled person in the art could not have predicted the benefits of using a solvent-extruded suture to increase porosity without offsetting tensile strength, it is noted that the fact that applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In the instant case, the compositional limitations of the claims are met and as such, one with ordinary skill in the art would reasonably expect the properties, such as the uniaxial tensile strength and porosity of the suture, 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.
Applicant points to figures 2C and 4 to show unexpected results, however applicant is reminded that whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). In the instant case, the data is not enough to establish unexpected results. First, the data presented is only for a specific polymer (i.e., PLLA-PCL), where the claim is much broader. Second, looking figure 4, the data is not statistically significant as there is overlap with the placebo and drug PLLA-PCL lines for the tension. It is not clear how these are unexpected results as they are showing that the tension is the same as the control. Further looking at figure 2C, it is not clear whether the porosity is being just measured and presented or if it is a variable that is being changed between the control and experimental sutures (as taught in the art). Either way, it is noted that the end result for the tension is not very different as shown in figure 4. Overall, the data presented is not commensurate with the scope of the limitations in the claims and is not presented in a manner in which it is clear in order to establish the unexpected results that applicant is arguing. The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration."); Ex parte C, 27 USPQ2d 1492 (Bd. Pat. App. & Inter. 1992) (Applicant alleged unexpected results with regard to the claimed soybean plant, however there was no basis for judging the practical significance of data with regard to maturity date, flowering date, flower color, or height of the plant.). See also In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977) and In re Eli Lilly, 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) as discussed in MPEP § 716.02(c). "[A]ppellants have the burden of explaining the data in any declaration they proffer as evidence of non-obviousness." Ex parte Ishizaka, 24 USPQ2d 1621, 1624 (Bd. Pat. App. & Inter. 1992).
In regard to applicant’s argument against the rejection of claims 12-13, it is noted that the rejection has been modified as necessitated by amendment to be over Naga in view of Vieira, Bond, and Lee. Bond teaches that the magnesium stearate is added to the polymer before extrusion as discussed in the rejection above. One with ordinary skill in the art would be motivated to combine the magnesium stearate of Bond and 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.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611
/A.A.A./Examiner, Art Unit 1611
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