*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 .
Applicant’s response dated February 27, 2026 is acknowledged.
This application was transferred to Art Unit 1617.
Priority
This application claims benefit in provisional application 63/336,208 filed on 04/28/2022.
Claim Status
Claims 1, 43, 56, 111-120, 127, 166, 178, 188, 190, 214, 221, and 222 are pending. Claims 2-42, 44-55, 57-110, 121-126, 128-165, 167-177, 179-187, 189, 191-213, 215-220, and 223-232 were canceled. Claims 1, 43, 56, 120, 127, 166, 178, 188, 190, 214, 221, and 222 are withdrawn. Claims 111-119 are examined.
Election/Restriction
Applicant’s election without traverse of Group II (Claims 43, 111-119, and 178), drawn to a polymeric material in the reply filed on February 27, 2026, is acknowledged.
Applicant’s election without traverse of the species of polymeric composition (claims 111-119) in the reply filed on February 27, 2026, is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Accordingly, claims 1, 43, 56, 120, 127, 166, 178, 188, 190, 214, 221, and 222 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being withdrawn to a non-elected invention, and non-elected species of the invention, there being no allowable generic or linking claims.
Response to the restriction requirement of January 7, 2026 was timely filed.
Claims 111-119 are examined on the merits.
Claim Rejections – 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 111-119 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “smooth” in claims 111, 112, and 114, is a relative term which renders the claim indefinite. The term “smooth” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claims 113 and 115-119 are indefinite because the claims depend from an indefinite base claim and contain indefinite limitations.
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 111-119 are rejected under 35 U.S.C. 103 as being unpatentable over Wise (US 6,486,232 B1 Date of Patent November 26, 2002) and Mao (WO 2009/014718 A1 Published January 29, 2009).
The claims encompass a biodegradable surgical membrane.
The teachings of Wise are related to a bioerodable polymeric material, specifically a semi-interpenetrating network (semi-IPN) alloy. A multi-part bioerodible cement system, which, upon mixing of the system parts, forms a cured bioerodible cement, includes, in one part, a first bioerodible polymer (e.g., PLGA) capable of producing acidic products upon hydrolytic degradation, and, in another part, a second bioerodible scaffolding polymer (e.g., PPF) which upon crosslinking provides a biopolymeric scaffolding or internal reinforcement for the cured cement. In another aspect, a bone cement system includes a bioerodible scaffolding polymer (such as PPF), which when polymerized provides a hardened bone cement, the cement system further including a gas generating agent in stabilized form for providing the cured bone cement with pores for facilitating inward cell migration (Abstract). In preferred embodiments, the second bioerodible polymer comprises polypropylene fumarate crosslinked by a vinyl monomer to form the biopolymeric scaffolding which provides the semi-IPN with the requisite dimensional stability (column 3 lines 19-35). A semi-interpenetrating polymer network (semi-IPN) is defined herein as an intimate combination of two or more polymers, at least one of which is crosslinked (sometimes in the immediate presence of the other) to form a network ("scaffolding" in the present disclosure) in which the other polymer is enclosed, trapped or retained. As used herein, the term "bioerodible" is defined as the susceptibility of a biomaterial to degradation over time,
usually months (column 4 lines 57-65). The PLGA polymers have a lactide to glycolide ratio in the range of 0:100% to 100:0%, inclusive, i.e., the PLGA polymer can consist of 100% lactide, 100% glycolide, or any combination of lactide and glycolide residues. These polymers have the property of degrading hydrolytically to form lactic and glycolic acids (column 5 lines 14-20). In one embodiment, the first and second bioerodible polymers are dissolved in solvent and mixed to
homogeneity. The resulting mixture is cast into a desired form, e.g., a sheet, film, plate, screw, etc. The second bioerodible polymer is then treated to create the biopolymeric scaffolding, e.g., by crosslinking, and the solvent is evaporated while cure (crosslinking) progresses or after cure
to produce a (buffered) bioerodible implantable material. The product may be further processed, for example, compacted under pressure, extruded through a die, injection molded, or shaped further into a form useful for a specific bone repair application. This is best accomplished prior to complete cure while the mixture is still somewhat plastic (capable of flow) (column 8 lines 35-50). Table 2 describes component ranges, where first bioerodible polymer is present in a concentration of 0-50 wt. % and second bioerodible polymer is present in a concentration of 5-60 wt. % (column 10 lines 25-45). The porous article comprises an implant (page 17 fourth paragraph).
Wise does not teach a biphasic morphology of the implant, where the implant comprises a top smooth layer having a porosity less than about 40 % v/v and a bottom porous layer having a porosity higher than about 60% v/v.
The teachings of Mao are related to porous polymeric articles (Abstract). The porous polymeric articles includes implants (page 3 last paragraph). The article has a porosity in the range of 20-60 % (page 4 first paragraph). In one embodiment, a laser sintered porous polymeric article having an average pore size ranging from about 10 μm to about 1 mm is provided. In some embodiments, a laser sintered porous polymeric article has an average pore size ranging from about 100 μm to about 400 μm, from about 150 μm to about 300 μm, or from about 200 μm to about 250 μm. In another embodiment, a laser sintered porous polymeric article has an average pore size ranging from about 300 μm to about 400 μm or from about 400 μm to about 600 μm (paragraph bridging pages 7-8). In some embodiments, a laser sintered porous polymeric article comprises a single sintered polymeric layer. In other embodiments, a laser sintered porous polymeric article comprises a plurality of sintered polymeric layers. In some embodiments, each of the plurality of layers of a laser sintered porous polymeric article is constructed independently of any other layer. As a result, layers of a laser sintered porous polymeric article, in some embodiments, demonstrate different polymers, average pore sizes, and/or porosities (page 8 second paragraph). The porous article is made from polyesters (page 8 third paragraph). In another embodiment, a laser sintered porous polymeric article comprising a first
layer and at least one additional layer comprises a porosity gradient. A porosity gradient is
established when the first layer of a laser sintered porous polymeric article has a porosity different than the at least one additional layer of the laser sintered porous polymeric article. In one embodiment, for example, the first layer has a porosity greater than the at least one additional layer. In another embodiment, the at least one additional layer has a porosity greater than the first layer. In some embodiments, the first layer and the at least one additional layer can independently demonstrate any of the porosities and pore sizes provided herein (page 12 first paragraph). In some embodiments, the first and/or any additional layer is non-porous or substantially non-porous. I one embodiment, for example, a laser sintered porous polymeric article comprises a porous surface layer and a non-porous or substantially non-porous second layer. A non-porous or substantially non-porous second layer, in some embodiments, is the core of the laser sintered article. In such embodiments, the porous surface layer envelopes the non-porous core. In other embodiments, the porous surface layer partially covers the nonporous core (page 12 second paragraph).
The teachings of Wise and Mao are related to porous implants made from polyester and it would have been obvious to have combined their teachings because they are in the same field of endeavor.
Regarding claim 111, 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 have formed a biodegradable surgical implant comprising a semi interpenetrating network comprising poly(lactide-co-glycolide) in a concentration of 0-50 wt. % and polypropylene fumarate in a concentration of 5-60 wt. % wherein the polypropylene fumarate is crosslinked with a vinyl monomer, with a reasonable expectation of success because Wise teaches a bioerodible implant comprising a first bioerodible polymer comprising poly(lactide-co-glycolide) and a second bioerodible polymer comprising polypropylene fumarate crosslinked with a vinyl monomer, wherein the first polymer is present in a concentration of 0-50 wt. % and the second polymer is present in a concentration of 5-60 wt. %, and wherein the implant is in the form of a film or a sheet. It would have been obvious to have varied the content of lactide to glycolide in a range of 0:100 to 100:0 because Wise teaches said range as suitable including embodiments of polylacide homopolymer and polyglycolide homopolymer.
A film or a sheet reads on a membrane.
The claimed range of weight ratios of the first polymer and the second polymer is obvious because it overlaps with the range of ratios taught by Wise. A composition that contains the first polymer in a concentration of 0-50 wt. % and a second polymer in a concentration of 5-60 wt. %, contains said first and second polymer in a range of weight ratios that overlaps with a range of 50:50 to 99:1.
Wise teaches a semi IPN which meets the limitation that requires the claimed membrane to have an interpenetrating polymer network between the first polymer chains and second polymer chains, and wherein the second polymer chains are interspersed throughout the first polymer chains.
Poly(lactide-co-glycolide) having a range of lactide and glycolide content from 0:100 to 100:0 meets the limitation of a first polymer because PLGA is linear, and as evidenced by instant specification paragraphs 0171-0172, PLGA and poly-lactic acid have a bulk crystallinity that is at least about 20%, which renders the claimed range because it overlaps with about 20-80% obvious.
Polypropylene fumarate crosslinked with vinyl monomer meets the limitation of a second polymer because polypropylene fumarate contains at least two functional groups that are coupled to each other to form crosslinks.
It would have been obvious to have formed the film or the sheet as a porous structure because Wise teaches that the structure is porous. It would have been obvious to have formed the porous film or sheet by combining two layers having different porosities where one layer is non-porous or substantially non-porous and the second layer is porous because Mao teaches a layered structure suitable for use as a surgical implant wherein the layered structure is formed from two distinct layers where one layer is non-porous or substantially non-porous and the second layer is porous. It would have been obvious to have formed the porous layer having a porosity that is greater than 60% v/v because Mao teaches that the porous polymeric article has a porosity greater than 60 % (paragraph bridging pages 11-12). Thus, the non-porous or substantially non-porous layer meets the limitation that requires a top smooth layer having a porosity of less than about 40 % v/v; and the porous layer having a porosity of greater than 60% v/v meets the limitation that requires a bottom porous layer having a porosity higher than about 60% v/v. The claimed porosity ranges are obvious because they overlap with the prior art ranges. It would have been reasonable to conclude that the non-porous or substantially non-porous layer has a porosity that overlaps with a range of less than about 40% v/v because the claimed range encompasses embodiments of non-porous or substantially non-porous structures. One of skill in the art would have been motivated to make Wise’s porous film or sheet having the configuration as taught by Mao because Mao teaches that the porous nature of polymeric articles is advantageous for implants as it can promote cellular in-growth. The porous polymeric articles demonstrate porosity gradients. Porosity gradients within a polymeric article can promote or assist cellular ingrowth in selected areas of the implant. An implant comprising a porous polymeric article, for example, may have a high porosity on surfaces where cellular ingrowth is desired and low or no porosity on surfaces where cellular in-growth is not desired. A porous polymeric article, in some embodiments, comprises porous layers and non-porous or substantially non-porous layers. As a result, porous polymeric articles can be constructed to have porosity in regions of the article where cellular in-growth is desired and low or no porosity in regions of the article wherein cellular in-growth is not desired (page 13 second paragraph).
Regarding claims 112 and 119, it would have been obvious to have made each layer having a thickness greater than 10 um, with a reasonable expectation of success because Mao teaches that the first layer has a thickness greater than 10 um (page 14 second paragraph), and each additional layer has a thickness greater than 10 um (page 16 first paragraph). Claimed thickness range of the smooth layer is obvious because it overlaps with greater than 10 um, claimed thickness range of the bottom layer is obvious because it overlaps with greater than 10 um, and claimed membrane thickness range is obvious because it overlaps with greater than 20 um. The thickness range in claim 119 is obvious because it overlaps with greater than 20 microns. The claim 119 recites an intended use of the membrane. Prior art film comprising two layers could have been used as a periodontal membrane because it meets all of the structural requirements of the claimed membrane.
Regarding claim 113, it would have been obvious to have formed the porous layer having pore size in the range from 10 um to 1 mm, with a reasonable expectation of success because Mao teaches said pore size range as suitable for making the porous structure. The claimed pore size range is obvious because it overlaps with the prior art range.
Claim 114 describes degradation rates of the top smooth layer and the bottom porous layer. Considering that the two layers are made from the same material but have different porosities, where one layer is non-porous or substantially non-porous and the other layer has at least 60% porosity, it would have been reasonable to expect the two layers to have different degradation rates where the porous layer degrades faster than the non-porous layer because increased porosity in the porous layer would allow for the surrounding medium to infiltrate the body of the layer and expose more of the surface area of the porous layer to the medium that degrades the layer. Alternatively, the prior art layered structure meets all of the structural limitations of the instantly claimed structure, and it would have been reasonable to expect the prior art structure to have the same properties as the claimed structure when placed under identical conditions including higher degradation rate of the porous layer relative to the smooth layer. The instantly claimed degradation rate of the porous layer relative to the smooth top layer is obvious because it is at least close enough to the claimed degradation rate that the skilled artisan would have expected them to have the same properties when tested under the same conditions.
Regarding claim 115, it would have been obvious to have formed the crosslinked scaffold from a mixture of polymers including polypropylene fumarate and polycaprolactone, with a reasonable expectation of success because Wise teaches that the second bioerodible polymer of the semi-IPN alloy undergoes hydrolysis when exposed to an aqueous medium, such as polycaprolactone, polypropylene fumarate, other polymers capable of being crosslinked and combinations thereof (lines 28-53). It would have been obvious to have formed the crosslinked scaffold by crosslinking polycaprolactone polymer chains to each other, crosslinking polypropylene fumarate chains to each other, and by crosslinking polycaprolactone chains to polypropylene fumarate chains. Wise does not limit how the crosslinking is accomplished, and all three variations and their combinations would have been obvious. The resulting structure would have been an IPN of the three polymers where the crosslinked polycaprolactone and polypropylene fumarate and interspersed throughout PLGA.
Regarding claim 116, it would have been obvious to have crosslinked the polypropylene fumarate using EGDMA, with a reasonable expectation of success because Wise teaches using EGDMA as a crosslinker for the second erodible polymer polypropylene fumarate (paragraph bridging columns 5 and 6). EGDMA contains two vinyl groups that are capable of reacting two functional groups on the polymer in order to crosslink the polymer chains.
Regarding claims 117 and 118, it would have been obvious to have varied the degree of crosslinking from about 5% to 50% of the available crosslinking sites because Wise teaches that the degree of crosslinking necessary to form the scaffold will depend on the particular application and generally crosslinking of about 5-50% of the available crosslinking sites is acceptable (paragraph bridging columns 5 and 6). Wise does not teach crosslinking density. Considering the breadth of the claimed crosslinking density range and the degree of crosslinking range taught by the prior art, it would have been reasonable to expect the prior art structure to have a crosslinking density that is at least close enough to the claimed crosslinking density that the skilled artisan would have expected them to have the same properties.
The specification was reviewed and there is no evidence that any one the claimed ranges is critical. The claimed invention is obvious because combining prior art elements according to known methods to obtain predictable results supports obviousness.
Conclusion
No claims are allowed.
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/ALMA PIPIC/Primary Examiner, Art Unit 1617
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