DETAILED ACTION
Claims 12, 14-20, 24-28 and 31-36 are currently pending and under examination.
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 .
Withdrawn Rejections
The rejection of claim 12 under 112(b) is withdrawn as Applicant has amended instant claim 12 to limit the therapeutic agent to be other than the water-soluble agent.
Examiner’s Note
Applicant's amendments and arguments filed 09/04/2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 09/04/2025, it is noted that claims 12, 18-19 and 25 have been amended and no new matter or claims have been added.
Modified Rejections:
The following rejections have been modified based on Applicant’s claim amendments.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 12, 14-19, 24-28 and 32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lin (previously applied).
Regarding claim 12, the limitation of a biodegradable implant, the implant comprising a polymer matrix including a polymer having an acid degradation byproduct and a water-soluble non-active agent, wherein at least portion of the polymeric matrix has a volume with a minimum cross-sectional dimension of at least 400 um before degradation of the polymer beings, wherein the implant does not include a therapeutic agent is met by Lin teaching microporous biodegradable PLGA scaffolds with the use of mixed salts as porogen additives (title). Ammonium bicarbonate and sodium chloride particles were used as a porogen additive to fabricate highly microporous biodegradable PLGA scaffolds. Salt leaching was performed after the samples become semisolidifed. The polymer/salts/solvent mixture can be easily handled and molded into scaffolds of any specific shape, for ample thin sheet, cylindered or bone shaped, for special application in tissue engineering (abstract). Salt particle sizes are taught to be 150-710 microns to preparate the PLGA scaffolds (page 272, second column, last paragraph). The sheet is taught to be 1 mm thick, which is molded vacuum dried (page 273, first column, first paragraph). An active agent is not taught as included.
Regarding the limitation of when the implant is implanted at a treatment sight in the body, the water soluble non-active elutes out to form a porous micro structure, and when the implant is subjected to specific mass and then submerged in a buffer the pH of the surrounding buffer solution is within 0.5 units of a pH of the buffer before the implant was placed in the buffer is intended use limitations. Lin teaches an implantable structure containing the elected PLGA polymer, no active agent and a claimed non-active agent (salt) in the claimed size and thus would be capable of being implanted for the non-active to leach out and obtained the desired mass decrease and pH, absent factual evidence to the contrary.
Regarding claim 14, the limitation of wherein the implant is a biodegradable orthopedic implant is met by Lin teaching bone shaped implant (abstract).
Regarding claim 15, the limitation of wherein the implant is selected from the group consisting of a scaffold is met by Lin teaching scaffolds (abstract).
Regarding claims 16-17 and 32, the limitation of wherein the polymer is a PHA or at least one or more of PLA, PGA is met by Lin teaching the elected PLGA.
Regarding claims 18-19, the limitation of minimum cross sectional dimension is at least 800, at least 1 mm is met by Lin teaching the sheet is taught to be 1 mm thick, which is molded vacuum dried (page 273, first column, first paragraph).
Regarding claim 24, the limitation of wherein the porous microstructure is configured to facilitate tissue regeneration is met by Lin teaching scaffold exhibited good seeding efficiency and the scaffolds are promising for tissue engineering applications (abstract). Lin teaches the claimed structure of the device and thus would necessarily facilitate tissue regeneration.
Regarding claim 25, the limitation of wherein the water soluble non-active agent is configured to elute out of the polymer matrix at a rate faster than the degradation rate of the polymer is met by Lin teaching fast elution of the salt used as a prorogen and the elected PLGA polymer (abstract).
Regarding claims 26-28, the limitation of the implant is a tissue engineering scaffold and wherein the tissue engineering scaffold includes a plurality of interconnected pores is met by Lin teaching scaffold exhibited good seeding efficiency and the scaffolds are promising for tissue engineering applications (abstract). Lin teaches the claimed structure of the device and thus would necessarily facilitate tissue regeneration. Lin additionally demonstrates interconnected pores after removal of the porogen (page 274, figure 1). Lin teaches the structure of the scaffold and therefor would be capable of the intended use of specific tissue regeneration absent factual evidence to the contrary.
Claim(s) 12, 15-20, 24-26, 28 and 32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2004/0054410 (previously applied).
Regarding claim 12, the limitation of a biodegradable implant, the implant comprising a polymer matrix including a polymer having an acid as a degradation byproduct and a water soluble non-active agent, wherein the implant does not include a therapeutic agent is met by the ‘410 publication teaching a porous, bioabsorbable scaffolds for tissue engineering (abstract). The scaffolds are formed of a bioabsorbable polymer such as polylactic acid, polyglycolic acid and copolymers ([0010], [0011]). The bioabsorbable material is taught to be PLGA and the pore forming substance is taught to be sodium chloride or glucose (Table 1). The porous structure can be in the form of a disk [0029]. The resultant scaffold is highly porous [0030]. Poly(ethylene oxide was extruded into a 1.0 mm diameter filament and cut into 2 CM lengths. This was dipped into sodium chloride crystals and allowed to dry. PLGA was dripped onto the salt encrusted PEO filament and the excessive solution allowed to run off. Additional powdered salt was springled onto the surface until it was covered [0043].
Regarding the limitation of when the implant is implanted at a treatment sight in the body, the water soluble non-active elutes out to form a porous micro structure, and when the implant is subjected to specific mass and then submerged in a buffer the pH of the surrounding buffer solution is within 0.5 units of a pH of the buffer before the implant was placed in the buffer is intended use limitations. The ‘410 publication teaches an implantable structure containing the elected PLGA polymer, no active agent and a claimed non-active agent (salt) in the claimed size and thus would be capable of being implanted for the non-active to leach out and obtained the desired mass decrease and pH, absent factual evidence to the contrary.
Regarding claim 15, the limitation of wherein the implant is a scaffold is met by the ‘410 publication teaching scaffolds (abstract).
Regarding claims 16-17 and 32, the limitation of wherein the polymer is the elected PLGA is met by the ‘410 publication teaching PLGA (Example 1).
Regarding claims 18-19, the limitation of wherein the minimum cross-sectional dimension is at least 800 um, at least 1mm is met by the ‘410 publication teaching poly(ethylene oxide was extruded into a 1.0 mm diameter filament and cut into 2 CM lengths. This was dipped into sodium chloride crystals and allowed to dry. PLGA was dripped onto the salt encrusted PEO filament and the excessive solution allowed to run off. Additional powdered salt was springled onto the surface until it was covered [0043].
Regarding claim 20, the limitation of further comprising a plasticizer is met by the ‘410 publication teaching PEO filament (Example 1). The instant specification teaches polyethylene oxide is a plasticizer [0283].
Regarding claim 24, 26 and 28, the limitation of wherein the porous microstructure is configured to facilitate tissue regeneration is met by the ‘410 publication teaching scaffolds for tissue engineering (abstract, [0043]). The ‘410 publication teaches the structure of the scaffold and therefor would be capable of the intended use of specific tissue regeneration absent factual evidence to the contrary.
Regarding claim 25, wherein the water soluble nonactive agent is configured to elute out of the polymer matrix at a faster rate than the degradation rate of the polymer is met by the ‘410 publication teaching the elected PLGA and sugar, and further teaching the sugar to be porogen that dissolves faster (Table 1, [0040], [0043]).
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.
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.
Claim(s) 12, 14-20, 25, 31-32 and 34-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0271696 (previously applied) in view of US 2003/0004564 (previously applied) and Lin (previously applied).
Regarding claim 1, 16-17, 32 and 34-36, the limitation of a biodegradable implant, the implant comprising a polymer matrix including a polymer having an acid as a degradation byproduct and a water soluble non-active agent, wherein at least a portion of the polymer matrix has a volume with a minimum cross-sectional dimension of at least 400 um before degradation of the polymer begins, within the implant does not include therapeutic agent is met by the ‘696 publication teaching a medical device such as a coated stent (abstract). The polymeric coating is porous [005]. The coating is taught to include a polymer and a water soluble porogen to at least a portion of the surface of the device [007], thus the coating contains the porogen and PLGA and does not comprise an active agent. The porosity is taught to be interconnected [0012]. PLGA and citric acid is taught to be applied to the stents [0028]. Porogens are taught to include water soluble material such as citric acid, ascorbic acid and vitamin E [0040]. The medical device is taught to include a stent ([0057], Figure 1). The stent may be stainless steel [0061].
Regarding the limitation of when the implant is implanted at a treatment sight in the body, the water soluble non-active elutes out to form a porous micro structure, and when the implant is subjected to specific mass and then submerged in a buffer the pH of the surrounding buffer solution is within 0.5 units of a pH of the buffer before the implant was placed in the buffer is intended use limitations. The ‘696 publication teaches an implantable structure containing the elected PLGA polymer, no active agent and a claimed non-active agent (vitamin) in the claimed size and thus would be capable of being implanted for the non-active to leach out and obtained the desired mass decrease and pH, absent factual evidence to the contrary.
Regarding claims 14-15, the limitation of wherein the implant is selected form the group which includes bone graft and orthopedic implant is met by the ‘696 publication teaching grafts and bone implants (claim 10).
Regarding claim 20, the limitation of further comprising a plasticizer is met by the ‘696 publication teaching PLGA-PEG. The instant specification teaches polyethylene glycol is a plasticizer [0283].
Regarding claim 25, the limitation of wherein the water soluble non-active agent is configured to elute out of the polymer matrix at a rate faster than a degradation rate of the polymer is met by the ‘696 publication teaching the removal of the water soluble porogen from the porous polymeric coating [0007] through immersion in sterile water [0066].
Regarding claim 31, the limitation of further comprising an anti-adhesion barrier is met by the ‘696 publication teaching a stainless steel stent [0065], which absent a clear definition in the specification meets the limitation for anti-adhesion barrier.
The ’696 publication does not specifically teach wherein at least a portion of the polymer matrix has a volume with a minimum cross-sectional dimension of at least 400 um before degradation of the polymer begins (claim 12) at least 800 um, at least 1 mm (claim 18-19).
The ‘564 publication teaches stent design of a stainless steel stent of 1.6 mm in diameter and 10 mm in length [0090].
Lin teaching microporous biodegradable PLGA scaffolds with the use of mixed salts as porogen additives (title). Ammonium bicarbonate and sodium chloride particles were used as a porogen additive to fabricate highly microporous biodegradable PLGA scaffolds. Salt leaching was performed after the samples become semisolidifed. The polymer/salts/solvent mixture can be easily handled and molded into scaffolds of any specific shape, for ample thin sheet, cylindered or bone shaped, for special application in tissue engineering (abstract). Salt particle sizes are taught to be 150-710 microns to preparate the PLGA scaffolds (page 272, second column, last paragraph). The sheet is taught to be 1 mm thick, which is molded vacuum dried (page 273, first column, first paragraph). An active agent is not taught as included.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use a stainless-steel stent of a known length and diameter for the stainless-steel stent of the device of the ’696 publication because the ‘564 publication teaches known sizes of stainless-steel stents and the ‘696 publication teaches a stainless-steel stent. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the thickness taught by Lin for the ‘696 publication because the ’696 publication teaches the implant to be bone implants (claim 4) and Lin teaches known thickness of PLGA porous bone shaped implants. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use known thickness of PLGA porous compositions.
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin as applied to claims 12, 14-19, 24-28 and 32 above, and further in view of Martin-del-Campo (previously applied).
As mentioned in the above 102(a)(1) rejection, all the limitations of claims 12, 14-19, 24-28 and 32 are taught by Lin.
Lin does not specifically teach an elongated strip configured to be positioned along at least a partition of a patient’s dental arch (claim 33).
Martin-del-Campo teaches biomaterial for cleft lip and palate regeneration (title). Craniofacial bone defect anomalies affect both soft and hard tissue and can be caused by trauma, boner recession from tumors and cysts. Regeneration of cleft lip and palate regeneration (abstract). Biomimetic scaffolds are taught to be used for tissue engineering puzzle for clef/lip palate regeneration (Figure 1). Bone grafting in the dental arch and teeth alignment Is taught (page 5) wherein mimic bone architecture is taught (page 2).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the bone scaffold as taught by Lin in the form of a dental arch as taught by Martin-del-Campo as Lin teaches the formation of bone shaped implants and Martin-del-Campo teaches the desire to mimic natural oral bone in the form of scaffolds including the dental arch. It would have been prima facie obvious to one of ordinary skill in the art to use the scaffold of Lin to form a dental arch scaffold as Martin-del-Campo teaches the need for bone grafting in the dental arch and Lin teaches a bone growth scaffold.
New Rejection:
The following rejection is newly applied based on Applicant’s claim amendments.
Claim(s) 12, 14-20 and 24-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0191963.
Regarding claims 12, 16-19, the limitation of a biodegradable implant, the implant comprising a polymer matrix including a polymer having an acid degradation byproduct and a water-soluble non-active agent, wherein at least portion of the polymeric matrix has a volume with a minimum cross-sectional dimension of at least 400 um before degradation of the polymer beings, wherein the implant does not include a therapeutic agent is met by the ‘963 publication teaching an osteoimplant composite comprising a plurality of particles of an inorganic materials, a bone substitute material, a bone derived material or any combination thereof and a polymer material with the particle are combined. The composite is moldable or settable (abstract). The polymer is taught to be poly(D,L-lactide-co-glycolide) [0010]. The composite may comprise plasticizer and/or porogen. The porogen is taught to include salt, polymer, and diffuses, dissolved and/or degrades after impanation of the composite leaving a pore [0011]. The osteoimplant is taught not be limited in any shape, sizes or configurations and may be bone defect implants [0035]. Therapeutic is optionally added ([0011], [0128], claims 119-120) and thus would meet the limitation of no therapeutic agent other than the water soluble agent. The particle thickness is taught to be 0.05-2 mm [0052] included in the composition.
Regarding the limitation of when the implant is implanted at a treatment sight in the body, the water soluble non-active elutes out to form a porous micro structure, and when the implant is subjected to specific mass and then submerged in a buffer the pH of the surrounding buffer solution is within 0.5 units of a pH of the buffer before the implant was placed in the buffer is intended use limitations. The ‘963 publication teaches an implantable structure containing the elected PLGA polymer, no active agent and a claimed non-active agent (salt) and thus would be capable of being implanted for the non-active to leach out and obtained the desired mass decrease and pH, absent factual evidence to the contrary.
Regarding claims 14-15, the limitation of implant is an orthopedic implant selected from screws is met by the ‘963 publication teaching the implant being an osteoimplant such as a screw [0046].
Regarding claim 24-28, the limitation of wherein the porous microstructure is configured to facilitate tissue regeneration is met by the ‘963 publication teaching the porogen is taught to include salt, polymer, and diffuses, dissolved and/or degrades after impanation of the composite leaving a pore [0011] wherein the pores are connected [0116], thus teaching the porous structure capable or tissue regeneration absent factual evidence to the contrary.
It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to optimize the osteoimplant thickness as the ‘963 publication teaches any size and the size of particles included in the implant, thus teaching an optimizable parameter. As MPEP 2144.05 recites “where 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 optimization”.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
102:
Lin:
Applicant argues Lin fail to disclose or suggest each and every feature of claim 12 including a biodegradable implant configured to be implanted at a treatment site in a body with the water-soluble agent present and after the implant is implanted at the treatment site the water-soluble agent is confused to elute out of the polymer matrix to form a porous microstructure. Lin use of ammonium-bicarbonate and sodium chloride particles in PLGA scaffolds are removed prior to implantation and thus are not present when the scaffold is implanted and are not suitable for implantation as they would lack pores needed to support cell seeding for tissue engineering.
In response, Lin teaches a PLGA scaffold containing NaCl porogens (abstract) and thus is structurally indistinguishable from the claimed implant. Lin contains further processing steps, however while the PLGA implant and NaCl porogens are present the structure in Lin and that claimed is identical and thus meets the instant claim limitations. The instant claims are product claims and thus do not require implantation, and the Lin structure containing NaCl porogens would be capable of being implanted absent factual evidence to the contrary. The desire for removal before implantation is not a teaching of implantation containing the porogen not being capable, but rather not preferred.
The ‘410 publication:
Applicant argues the ‘410 publication states that the pore forming substance is removed from the scaffold as part of the manufacturing process prior to implantation and thus are not present when the scaffold is implanted.
In response, the ‘410 publication teaches a PLGA scaffold containing NaCl or glucose porogens (abstract, [0010]-[0011], Table 1) and thus is structurally indistinguishable from the claimed implant. The ‘410 publication contains further processing steps, however while the PLGA implant and NaCl porogens are present the structure in the ‘410 publication and that claimed is identical and thus meets the instant claim limitations. The instant claims are product claims and thus do not require implantation, and the ‘410 publication structure containing NaCl porogens would be capable of being implanted absent factual evidence to the contrary. The desire for removal before implantation is not a teaching of implantation containing the porogen not being capable, but rather not preferred.
103:
The ‘696 publication and the ‘564 publication
Applicant argues the ‘696 publication and the ‘564 publication fails to disclose or suggest each and every feature of claim 12 including a biodegradable implant configured to be implanted at a treatment site in a body with the water-soluble agent present and after the implant is implanted at the treatment site the water-soluble agent is confused to elute out of the polymer matrix to form a porous microstructure. The ‘696 publication and the ‘564 publication use of porogen particles in PLGA scaffolds are removed prior to implantation and thus are not present when the scaffold is implanted and are not suitable for implantation as they would lack pores needed to support cell seeding for tissue engineering.
In response, the ‘696 publication teaches a PLGA scaffold containing NaCl or glucose porogens (abstract, [007], Table 1) and thus is structurally indistinguishable from the claimed implant. The ‘564 publication teaches stent design of a stainless steel stent of 1.6 mm in diameter and 10 mm in length [0090]. The ‘564 publication contains further processing steps, however while the PLGA implant and vitamin porogens are present the structure in the ‘696 publication and that claimed is identical and thus meets the instant claim limitations. The instant claims are product claims and thus do not require implantation, and the ‘696 publication structure containing porogens would be capable of being implanted absent factual evidence to the contrary. The desire for removal before implantation is not a teaching of implantation containing the porogen not being capable, but rather not preferred.
Applicant argues the ‘696 publication and the ‘564 publication do not specifically teach a minimum thickness of at least 400 um. The claimed implant exhibit substantially no core acidification compared to polymer only samples of the same thickness.
In response, Applicant is referred to the modified rejection above wherein Lin teaches known thickness of PLGA porogen containing implants. Further Applicant compares PLGA implants to porogen containing implants. The ‘696 publication teaches a composition containing PLGA and porogens and thus would have the same results of no core acidification.
Applicant argues Martin-del-Campo does not cure the deficiencies of Lin.
In response, Applicant’s arguments regarding Lin are addressed above as first presented.
Conclusion
No claims are 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.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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/LYNDSEY M BECKHARDT/ Examiner, Art Unit 1613
/BRIAN-YONG S KWON/ Supervisory Patent Examiner, Art Unit 1613