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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on February 12, 2025, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1 – 20 are examined here-in.
Claim Objections
Claims 5, 10, and 16 are objected to because of the following informalities:
Claims 5 and 16 do not have closing parentheses for “poly(lactic-co-glycolic) acid”.
Claim 10 currently recites “a third biodegradable of bioresorbable polymer”, which should be corrected to “a third biodegradable or bioresorbable polymer”.
Appropriate correction is required.
Claim 5 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n). For compact prosecution, the claim is being treated as dependent on claim 1.
Claim Interpretation
Claims 1, 10, 13, 18, and 20 include the phrase “is configured to” to describe release of an agent from the claimed layer comprising a biodegradable or bioresorbable polymer. As written, claims 1, 10, 13, 18, and 20, with the limitation “is configured to”, appear to recite sufficient structure and material (i.e. layer comprising a biodegradable or bioresorbable polymer and an active agent) to entirely perform the recited function (release of the active agent with polymer degradation). Further, the claim limitations in this application do not use the word “means” (or “step”) as a generic placeholder for performing the claimed function, and thus are not being interpreted under 35 U.S.C. 112(f).
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 5 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 5 recites the limitation "the surgical device" in the preamble of the claim. While “the surgical device” is likely referring to “the implantable medical device” of the preceding claims, there is insufficient antecedent basis for this limitation in the claim. Claim 5 should be corrected to “The implantable medical device…” or as otherwise appropriate.
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 non-obviousness.
Claims 1 – 7, 9, 12 – 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Goodman (US 2023/0077402 A1).
Goodman teaches a surgical device with a substrate, a first coating that includes a polymer, and a second coating that includes a polymer (abstract).
Goodman teaches the first coating comprises a polymer and an antibiotic or other active pharmaceutical ingredient (paragraphs 0004 – 0005). Goodman teaches that the antibiotic or other pharmaceutical ingredient is released as the polymer degrades (paragraphs 0004 – 0005).
Goodman teaches the second coating comprises a second polymer (paragraphs 0004 – 0005). Goodman teaches the second polymer is alginate (paragraphs 0004 – 0005).
Goodman teaches the substrate is a mesh (paragraph 0006).
Goodman teaches the first polymer is tyrosine-derived polyarylate (paragraph 0006).
Goodman teaches the antibiotics are selected from rifampin and minocycline, or a mixture thereof (paragraph 0006).
Goodman teaches the active pharmaceutical ingredient may be paclitaxel (paragraph 0062).
Goodman does not teach a specific embodiment having each of the claimed elements, however, claims 1 – 7, 9, 12 – 17, and 19 are rendered prima facie obvious over the teachings of Goodman, because it is prima facie obvious to combine prior art elements according to known methods, in order to yield predictable results (MPEP 2143(i)(a)). In the instant case, all the claimed elements (e.g., a substrate, a first layer, a second layer, biodegradable polymers, antibiotics, active pharmaceutical ingredients) were known in the prior art (e.g., implantable medical devices) and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results (e.g., an implantable device with a substrate and polymer layers that release active pharmaceutical ingredients) to one of ordinary skill in the art.
Goodman’s teaching for a surgical device which includes a substrate, a first polymer coating with an antibiotic or active pharmaceutical ingredient, and a second polymer coating with a hemostatic agent (abstract, paragraphs 0004 – 0006) reads on instant claim 1.
Goodman teaches the substrate is made of a biodegradable material (paragraph 0043) reading on the limitation “wherein the substrate comprises a biodegradable or bioresorbable material” as recited in claim 1.
Goodman teaches that the polymer releases antibiotic or active pharmaceutical ingredient as it degrades (abstract, paragraphs 0004 – 0006) and that the release of active agents can be controlled by the polymers that are in the coating (paragraph 0051), reading on the limitation of a biodegradable or bioresorbable polymer that releases an agent as the polymer degrades as recited in claim 1.
Goodman’s teaching that the first coating comprises a polymer and an antibiotic or other active pharmaceutical ingredient, wherein the other active pharmaceutical ingredient may be paclitaxel (paragraphs 0004 – 0005, 0062) reads on the chemotherapeutic agent dispersed in the first polymer as recited in claim 1.
Goodman’s teaching that the second coating comprises a second polymer (paragraphs 0004 – 0005) reads on “the second layer comprising a second biodegradable or bioresorbable polymer” as recited in claim 1.
Although Goodman teaches that the second polymer coating includes a hemostatic agent, it is within the expertise of a person of ordinary skill in the art to substitute an antibiotic for the hemostatic agent. A person of ordinary skill in the art would have a reasonable expectation of success with this substitution because Goodman teaches that antibiotics are suitable for inclusion in a polymer coating layer (abstract, paragraphs 0004 – 0006). The substitution of one known element for another to obtain predictable results is prima facie obvious according to MPEP 2143(i)(b). Therefore, Goodman’s teachings for the inclusion of an antibiotic in a polymer coating read on an antibiotic in the second polymer, as recited in claim 1.
Goodman teaches that the choice of polymer will modulate the degradation of polymer and release of drug, providing examples of polymers degrading over periods of hours, days, or weeks (paragraphs 0050 – 0052). With this teaching, a person of ordinary skill in the art would have the necessary expertise to choose individual polymers or polymer combinations that release over a time period of at least 10 days and at least 1 day, as recited in instant claim 1. Goodman’s teachings show that biodegradable or bioresorbable polymers can be chosen so that drugs are released over a desired timeframe (paragraphs 0050 – 0052), thus a person of ordinary skill in the art would recognize the choice of polymer as a result-effective variable. As such, the presence of this result-effective variable would be motivation for a person of ordinary skill in the art to optimize the choice of polymer to obtain the desired result (i.e. a release time), which is prima facie obvious according to MPEP 2144.05(ii)(b). Thus the limitations for release over a time period of at least 10 days and at least 1 day as recited in claim 1 are prima facie obvious.
Goodman teaches the second polymer is tyrosine-derived polyarylate (claim 15, paragraphs 0072 – 0077) reading on instant claim 2.
Goodman’s teaching that the antibiotics included in a polymer coating are selected from rifampin and minocycline, or a mixture thereof (paragraph 0006) reads on instant claim 3. As discussed above, a person of ordinary skill in the art would have a reasonable expectation of success substituting an antibiotic for a hemostatic agent for inclusion in the second polymer layer because Goodman teaches that antibiotics are suitable for inclusion in a polymer coating layer (abstract, paragraphs 0004 – 0006) and the substitution of one known element for another to obtain predictable results is prima facie obvious according to MPEP 2143(i)(b).
As discussed above, Goodman teaches that the choice of polymer will modulate the degradation of polymer and release of drug, providing examples of polymers degrading over periods of hours, days, or weeks (paragraphs 0050 – 0052). With this teaching, a person of ordinary skill in the art would have the necessary expertise to choose individual polymers or polymer combinations that release over a time period of between 3 - 10 days and between 10 and 180 days, as recited in instant claims 4 and 7, respectively. Goodman’s teachings show that biodegradable or bioresorbable polymers can be chosen so that drugs are released over a desired timeframe (paragraphs 0050 – 0052), thus a person of ordinary skill in the art would recognize the choice of polymer as a result-effective variable. As such, the presence of this result-effective variable would be motivation for a person of ordinary skill in the art to optimize the choice of polymer to obtain the desired result (i.e. a release time), which is prima facie obvious according to MPEP 2144.05(ii)(b). Thus the limitations for release over a time period of between 3 - 10 days and between 10 and 180 days, as recited in instant claims 4 and 7 are prima facie obvious.
Goodman’s teaching that the first polymer is tyrosine-derived polyarylate (paragraph 0006) reads on instant claim 5. As discussed above, for the purposes of compact prosecution, claim 5 is being treated as dependent on claim 1.
Goodman’s teaching that the active pharmaceutical ingredient may be paclitaxel (paragraph 0062) reads on instant claim 6.
Goodman teaches the second coating is on the outer surface of the device (claims 10 and 11) reading on instant claim 9.
Goodman’s teaching that the substate is a mesh that is made of a biodegradable material (paragraphs 0006, 0043) reads on claim 12.
Goodman teaches that the layered biodegradable polymer system can be in the form of a sheet or pouch that surrounds or encloses a medical device, including various implantable stents, valves, monitors, defibrillators, and others (paragraphs 0032 – 0034, 0044, 0049), reading on the recitation for “a surgical system comprising: a surgical implant; and an implantable medical device in form of a sheet or pouch configured to at least partially surround the surgical implant,” as recited in claim 13.
Goodman’s teaching for a surgical device which includes a biodegradable substrate with a first biodegradable polymer coating and active pharmaceutical ingredient paclitaxel (abstract, paragraphs 0004 – 0006, 0043, 0051, 0062) reads on the substrate and first layer of claim 13.
Goodman’s teaching that the second coating comprises a second biodegradable polymer (paragraphs 0004 – 0005) reads on claim 13. Although Goodman teaches that the second polymer coating includes a hemostatic agent, it is within the expertise of a person of ordinary skill in the art to substitute an antibiotic for the hemostatic agent. A person of ordinary skill in the art would have a reasonable expectation of success with this substitution because Goodman teaches that antibiotics are suitable for inclusion in a polymer coating layer (abstract, paragraphs 0004 – 0006). The substitution of one known element for another to obtain predictable results is prima facie obvious according to MPEP 2143(i)(b). Therefore, Goodman’s teachings for the inclusion of an antibiotic in a polymer coating read on an antibiotic in the second polymer, as recited in claim 13.
Goodman teaches that the choice of polymer will modulate the degradation of polymer and release of drug, providing examples of polymers degrading over periods of hours, days, or weeks (paragraphs 0050 – 0052). With this teaching, a person of ordinary skill in the art would have the necessary expertise to choose individual polymers or polymer combinations that release over a time period of at least 10 days and at least 1 day, as recited in instant claim 13. Goodman’s teachings show that biodegradable or bioresorbable polymers can be chosen so that drugs are released over a desired timeframe (paragraphs 0050 – 0052), thus a person of ordinary skill in the art would recognize the choice of polymer as a result-effective variable. As such, the presence of this result-effective variable would be motivation for a person of ordinary skill in the art to optimize the choice of polymer to obtain the desired result (i.e. a release time), which is prima facie obvious according to MPEP 2144.05(ii)(b). Thus the limitations for release over a time period of at least 10 days and at least 1 day as recited in claim 13 are prima facie obvious.
Goodman’s teaching that the second polymer is tyrosine-derived polyarylate (claim 15, paragraphs 0072 – 0077) and that the antibiotics included in a polymer coating are selected from rifampin and minocycline, or a mixture thereof (paragraph 0006) reads on instant claim 14. As discussed above, a person of ordinary skill in the art would have a reasonable expectation of success substituting an antibiotic for a hemostatic agent for inclusion in the second polymer layer because Goodman teaches that antibiotics are suitable for inclusion in a polymer coating layer (abstract, paragraphs 0004 – 0006) and the substitution of one known element for another to obtain predictable results is prima facie obvious according to MPEP 2143(i)(b).
As discussed above, Goodman teaches that the choice of polymer will modulate the degradation of polymer and release of drug, providing examples of polymers degrading over periods of hours, days, or weeks (paragraphs 0050 – 0052). With this teaching, a person of ordinary skill in the art would have the necessary expertise to choose individual polymers or polymer combinations that release over a time period of between 3 - 10 days and between 10 and 180 days, as recited in instant claim 15. Goodman’s teachings show that biodegradable or bioresorbable polymers can be chosen so that drugs are released over a desired timeframe (paragraphs 0050 – 0052), thus a person of ordinary skill in the art would recognize the choice of polymer as a result-effective variable. As such, the presence of this result-effective variable would be motivation for a person of ordinary skill in the art to optimize the choice of polymer to obtain the desired result (i.e. a release time), which is prima facie obvious according to MPEP 2144.05(ii)(b). Thus the limitations for release over a time period of between 3 - 10 days and between 10 and 180 days, as recited in instant claim 15 are prima facie obvious.
Goodman’s teaching that the first polymer is tyrosine-derived polyarylate (paragraph 0006) and that the active pharmaceutical ingredient may be paclitaxel (paragraph 0062) reads on instant claim 16.
Goodman’s teaching that the first polymer is on the inner surface of the pouch and the second polymer is on the outer surface (claim 10) reads on instant claim 17, because the pouch surrounds or encloses the medical device (paragraphs 0032 – 0034, 0044, 0049). In other words, the inner surface of the pouch is in contact with the surgical implant while the outer surface is positioned away from the implant, as recited in claim 17.
Goodman teaches that the substrate is completely biodegradable (paragraph 0054) and that implantable medical device may be a breast implant (paragraph 0034) reading on instant claim 19.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Goodman (US 2023/0077402 A1, as cited above) and further in view of Bonutti (US 2020/0230297 A1).
Goodman’s teachings are discussed above.
Goodman does not teach any differences in thickness for the layers or on different sides of the substrate.
Bonutti teaches a missing element of Goodman.
Bonutti teaches a polymeric implantable mesh with a pharmaceutical agent (abstract).
Bonutti teaches the implant is made with biodegradable materials, and the biodegradable coating enables the release of pharmaceutical agent (paragraphs 0010 – 0011).
Bonutti teaches the release rate of a pharmaceutical agent is proportional to the thickness of the polymer coating, and that the thickness of the polymer coating may be varied to control the release rate of the pharmaceutical agent (paragraphs 0062, 0066, 0073, 0093).
The combination of Goodman and Bonutti’s teachings renders claim 8 prima facie obvious as combining prior art elements according to known methods to yield predictable results. A person of ordinary skill in the art would be motivated to modify the implant of Goodman to have differing polymer layer thickness because Bonutti teaches that the release rate of a pharmaceutical agent is proportional to the thickness of the polymer coating, and therefore the thickness of the polymer coating can be intentionally modulated to control the release rate of the pharmaceutical agent (paragraphs 0062, 0066, 0073, 0093). In other words, a person of ordinary skill in the art would be motivated to apply Bonutti’s teachings to Goodman’s implant because Bonutti teaches layer thickness controls the rate of drug release. Modifying Goodman’s implant with Bonutti’s teachings would yield the predictable result of controlled drug release. Therefore, claim 8 is prima facie obvious according to MPEP 2143(i)(a).
Goodman’s teaching for a surgical device which includes a biodegradable substrate with a first biodegradable polymer coating and active pharmaceutical ingredient, and a second coating with a second biodegradable polymer (abstract, paragraphs 0004 – 0006, 0043, 0051, 0062) in combination with Bonutti’s teaching for an implant with biodegradable polymeric materials, wherein the thickness of the polymer coating may be varied to control the release rate of the pharmaceutical agent (abstract, paragraphs 0010 – 0011, 0062, 0066, 0073, 0093) reads on instant claim 8. A person of ordinary skill in the art would be motivated to make the first layer thicker on one side of the substrate compared to the other, as recited in claim 8, so that the polymer degradation would take longer and drug would release more slowly, as taught by Bonutti.
Claims 10, 11, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Goodman (US 2023/0077402 A1, as cited above) and further in view of Fang (US 2009/0112315 A1).
Goodman’s teachings are discussed above.
Goodman does not teach a third layer.
Fang teaches the missing element of Goodman.
Fang teaches a medical implant with layers of biodegradable materials carrying biologically active agents (abstract, paragraph 0006). Fang teaches the layers of biodegradable materials enable the sequential and timed release of biologically active agent into the surrounding tissue (abstract, paragraph 0006).
Fang teaches that a third layer can be added in the same manner as the first and second layers (paragraph 0034).
The combination of Goodman and Fang’s teachings renders claims 10, 11, 18, and 20 prima facie obvious as combining prior art elements according to known methods to yield predictable results. A person of ordinary skill in the art would be motivated to modify the implant of Goodman to have multiple layers as taught by Fang because Fang teaches that each layers of biodegradable material enables the sequential and timed release of biologically active agent into the surrounding tissue (abstract, paragraph 0006). In other words, including multiple layers allows for the inclusion of more biologically active agents to be released in a controlled manner. The modification of Goodman’s implant to include multiple layers as taught by Fang teachings would yield the predictable result of sequential and/or timed release for multiple biological agents. Therefore, claims 10, 11, 18, and 20 are prima facie obvious according to MPEP 2143(i)(a).
Goodman’s teaching for a surgical device which includes a biodegradable substrate with a first biodegradable polymer coating and active pharmaceutical ingredient, and a second coating with a second biodegradable polymer (abstract, paragraphs 0004 – 0006, 0043, 0051, 0062) in combination with Fang’s teaching for multiple layers of biodegradable materials (abstract, paragraph 0006) wherein a third layer can be added in the same manner as the first and second layers (paragraph 0034) reads on instant claim 10.
As discussed above, Goodman teaches a polymer layer contains a hemostatic agent (abstract, paragraphs 0004 – 0006). Although Goodman teaches the hemostatic agent in the second polymer layer, a person of ordinary skill in the art would be motivated to put the hemostatic agent in the third polymer layer (rather than the second) so that the layer promoting hemostasis would be dissolved and therefore the drug released, sooner than the other layers. A person of skill in the art would be motivated to arrange for hemostatic agent release prior to antibiotic or chemotherapeutic release to ensure that the patient’s blood clots adequately, thus preventing excessive bleeding and blood loss. Therefore, the combination of Goodman and Fang’s teachings would motivate a person of skill in the art to include a third layer that has a hemostatic agent, as recited in claim 10.
Goodman teaches that the orientation of the layers can be manipulated according to the desired drug release, for example, Goodman teaches an outer surface with hemostatic agent so that the hemostatic agent is released prior to the antibiotic agent (paragraph 0048). With Goodman and Fang’s teachings, a person of ordinary skill in the art has the necessary expertise to orient the layers such that the third layer with hemostatic agent is the outermost layer, reading on instant claim 11.
The combination of Goodman and Fang’s teachings with regards to claims 10 and 11, as discussed above, read on instant claim 18.
Goodman’s teaching for a surgical device which includes a biodegradable substrate with a first biodegradable polymer coating and active pharmaceutical ingredient, and a second coating with a second biodegradable polymer (abstract, paragraphs 0004 – 0006, 0043, 0051, 0062) in combination with Fang’s teaching for multiple layers of biodegradable materials (abstract, paragraph 0006) wherein a third layer can be added in the same manner as the first and second layers (paragraph 0034) reads on instant claim 20.
Goodman’s teaching that the substrate is made of a biodegradable mesh (paragraphs 0006, 0043) reads on the limitation of “a bioresorbable mesh substrate” as recited in claim 20.
Goodman’s teaching that the first coating comprises a polymer and an antibiotic or other active pharmaceutical ingredient, wherein the other active pharmaceutical ingredient may be paclitaxel (paragraphs 0004 – 0005, 0062) and the polymer releases antibiotic or active pharmaceutical ingredient as it degrades (abstract, paragraphs 0004 – 0006) reads on the first coating as recited in claim 20.
Goodman’s teaching that the second coating comprises a second polymer (paragraphs 0004 – 0005) reads on “the second layer comprising a second biodegradable or bioresorbable polymer” as recited in claim 20. Although Goodman teaches that the second polymer coating includes a hemostatic agent, it is within the expertise of a person of ordinary skill in the art to substitute an antibiotic for the hemostatic agent. A person of ordinary skill in the art would have a reasonable expectation of success with this substitution because Goodman teaches that antibiotics are suitable for inclusion in a polymer coating layer (abstract, paragraphs 0004 – 0006). The substitution of one known element for another to obtain predictable results is prima facie obvious according to MPEP 2143(i)(b). Therefore, Goodman’s teachings for the inclusion of an antibiotic in a polymer coating read on an antibiotic in the second polymer, as recited in claim 20.
As discussed with regards to claim 10, the combination of Goodman and Fang’s teachings would motivate a person of skill in the art to include a third polymer layer and to allocate a hemostatic agent to the third layer. A person of ordinary skill in the art would be motivated to put the hemostatic agent in the third polymer layer (rather than the second) so that the layer promoting hemostasis would be dissolved and therefore the drug released, sooner than the other layers. A person of skill in the art would be motivated to arrange for hemostatic agent release prior to antibiotic or chemotherapeutic release to ensure that the patient’s blood clots adequately, thus preventing excessive bleeding and blood loss. Therefore, the combination of Goodman and Fang’s teachings would motivate a person of skill in the art to include a third layer that has a hemostatic agent, as recited in claim 20.
Goodman teaches that the choice of polymer will modulate the degradation of polymer and release of drug, providing examples of polymers degrading over periods of hours, days, or weeks (paragraphs 0050 – 0052). With this teaching, a person of ordinary skill in the art would have the necessary expertise to choose individual polymers or polymer combinations that release over a time period of more than 10 days, at least 3 days, and less than 3 days as recited in instant claim 20. Goodman’s teachings show that biodegradable or bioresorbable polymers can be chosen so that drugs are released over a desired timeframe (paragraphs 0050 – 0052), thus a person of ordinary skill in the art would recognize the choice of polymer as a result-effective variable. As such, the presence of this result-effective variable would be motivation for a person of ordinary skill in the art to optimize the choice of polymer to obtain the desired result (i.e. a release time), which is prima facie obvious according to MPEP 2144.05(ii)(b). Thus the limitations for release over a time period of more than 10 days, at least 3 days, and less than 3 days as recited in instant claim 20 are prima facie obvious.
Conclusion
All claims are rejected. No claims are allowed.
Correspondence
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/TORIANA N. VIGIL/Examiner, Art Unit 1612
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