-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 August 31, 2026 is acknowledged.
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 previously canceled. Claims 1, 43, 56, 120, 127, 166, 178, 188, 190, 214, 221, and 222 remain withdrawn. Claims 111-119 are examined.
Maintained Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. l 12(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. l 12(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.
In the remarks dated August 31, 2026, applicant argued that “smooth” in “a top smooth layer” is definite because the claim also describes the top layer as having a porosity that is less than about 40% v/v; and cited paragraphs in the specification that refer to the degree of porosity of the smooth layer.
Applicant’s argument regarding “smooth” is not persuasive because porosity and smoothness of a layer are independent properties and the specification does not provide a nexus between the two. The claims do not limit where the pores in the top layer are located. Thus, the claims encompass embodiments where the pores are located internally and the surface of the layer is free of pores; and embodiments where pores are located on the surface of the top layer. Porosity of a polymer layer does not necessarily affect the smoothness of the layer because the pores can be located exclusively internally and in the instant case it is not clear whether the porosity is what contributes to the smoothness of the layer or some other unrecited feature. The specification does not provide a definition of “smooth” and does not provide a correlation between “smooth” and “porosity”. The examiner disagrees with applicant’s assertion that the specification expressly defines “smooth layer” as an air-inhibited layer. The top layer is described as having a certain degree of porosity and as being smooth. The terms in paragraph 0281 that are used interchangeably with “top smooth layer” were considered, however alternative names of “top smooth layer” are not sufficient to make the scope of “smooth” clear.
Maintained 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 Bl Date of Patent November 26, 2002) and Mao (WO 2009/014718 Al 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 include 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. In 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 nonporous 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 nonporous 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. 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.
Response to Arguments
Applicant’s arguments submitted in the remarks dated August 31, 2026, were fully considered but are not persuasive for the following reasons.
Arguments on in the paragraph bridging pages 12-13 related to porosity teachings in Mao are not persuasive because Mao teaches an embodiment of an article comprising a porous surface layer and a non-porous or substantially non-porous second layer. The non-porous or substantially non-porous layer meets the instantly claimed top smooth layer having a porosity less than about 40% v/v. The porous layer meets the instantly claimed bottom porous layer having a porosity higher than about 60% v/v because Mao teaches the polymer article has a porosity greater than 60 % v/v. It would have been reasonable to expect the porous layer to have a porosity greater than 60% v/v because the article as a whole is described as having a porosity greater than 60% v/v. Thus, an article that has a non-porous layer and a porous layer and has a total porosity greater than 60% v/v is expected to have a porous layer that has a porosity that is greater than 60% v/v. A prior art reference is not required to teach the exact same porosity range as claimed for an obviousness rejection to be proper. The claimed porosity ranges are obvious because they overlap with the prior art ranges.
Arguments in the first full paragraph on page 13 are not persuasive because Mao’s teachings on page 12 are not limited to a core/shell geometry that requires a non-porous layer sandwiched between two porous layers. Mao teaches “In some embodiments, the first and/or any additional layer is non-porous or substantially non-porous. In 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 person skilled in the art would have interpreted this teaching to mean that the article comprises two layers, where one layer is a porous surface layer and the second layer is non-porous or substantially non-porous. Applicant’s arguments are based on an embodiment that requires a non-porous layer sandwiched between two porous layers described on page 12, however the rejection of instant claims does not rely on that embodiment.
Second full paragraph on page 13 teaches “An implant comprising a laser sintered 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.”. The paragraph does not limit this teaching to any particular arrangement of the layers. Thus, applicant’s argument that the teachings are relevant to an article having a non-porous layer sandwiched between two porous layers is not persuasive.
Argument’s on page 14 are not persuasive because there is nothing in Wise that would have led the skilled artisan to conclude that a biphasic two-layer sheet or film would not function for Wise’s purpose. Applicant provided unsupported conclusions as to why Mao’s biphasic arrangement of layers would not work in Wise’s implant, however that is not sufficient to overcome the rejection.
Arguments on page 15 are not persuasive because a person skilled in the art would have been capable of determining how to form pores in Wise’s implant through routine experimentation.
Arguments bridging pages 15-16 related to layer thickness are not persuasive because the cited passages in Mao teach the first layer of particles of a first polymer material has a thickness of greater than about 10 micron (second paragraph on page 14), and each additional layer of particles has a thickness greater than about 10 microns and greater than about 50 microns (first paragraph on page 16). It is apparent from the paragraph bridging pages 19-20 that the first polymer layer of the implant has a thickness greater than about 10 micron and each additional layer has a thickness greater than about 50 micron, which matches the ranges of thicknesses of polymer particles used to make each layer.
Arguments directed to claim 114 are not persuasive because the applicant did not show that the prior art implant would not have properties that overlap instantly claimed properties. The Office does not have the means to test prior art products in order to determine if they have properties required by the instant claims. The burden is on the applicant. The Office has relied on the prior art structure and a rationale that since all structural limitations of the claimed product are met by the prior art, the structure in the prior art would have been expected to have the same properties as claimed product.
Arguments directed to claim 119 are not persuasive because prior art implant meets all of the instantly claimed limitations and it could have been used as a periodontal membrane, absent evidenced to the contrary.
Conclusion
No claims are allowed.
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.
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/ALMA PIPIC/Primary Examiner, Art Unit 1617
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