DETAILED ACTION
Claims 1, 3, 7, 9, 11-12, 14-16, 18-19, 21, 35-38, 40-45 are currently pending. Claims 1, 3, 7, 9, 11-12, 14, 36-38, 41-43 are currently 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 .
Election/Restrictions
Claims 44-45 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/05/2025. It is noted that newly added claim 44-45 are properly placed in Group II as it is a method of manufacturing.
Withdrawn Rejections
The prior rejection of claims 36-39 under 112(a) for new matter is withdrawn based on Applicant’s claim amendment to limitations directed to opening filled with scaffold material, which Examiner finder persuasive.
The prior rejection of claims 3-4, 7, 9, 11-12, 36-39 under 35 U.S.C. 112(b) are withdrawn as a result of Applicant’s claim amendments.
Examiner’s Note
Applicant's amendments and arguments filed 05/28/2026 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 05/28/2026, it is noted that claims 1, 3, 7, 9, 11-12, 36-38 have been amended and claims 41-43 are newly added. No new matter or claims have been added.
Newly Applied Rejections:
The following rejections are newly applied based on Applicant’s claim amendments.
Claim Rejections - 35 USC § 112 (d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 3 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 3 depends from independent claim 1, wherein instant claim 3 contains the limitation of “one or more of: a) more scaffold material compared to said soft parts; and b) less opening or no openings at all” wherein instant claim 1 requires soft parts to have less scaffold material compared to said stiff parts and therefore is not further limiting. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 1, 3, 12, 14, 36-38 and 41-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2002/0119177 (previously applied) in view of WO 2018/200816 (Applicant provided), US 2019/0374336 and WO 01/87575.
Regarding claims 1, 3, 36, 38, the limitation of a medical grade implant comprising a biodegradable scaffold and a plurality of seeded cells on the surface of said scaffold wherein said biodegradable scaffold comprises parts with different levels of stiffness is met by the ‘177 publication teaching biocompatible tissue repair stimulating implant or scaffold device that includes one or more layers of bioabsorbable polymeric foam having pores with an open cell pore structure (abstract). The bioabsorbable, biocompatible elastomer includes but are not limited to caprolactone and glycolide [0031]. The implant is taught to have multiple layers of foam components and the outer layers have a lower pore density then the inner layers thereof (claim 45). The implant is taught to contain suitable cells types [0046]. The active agent is taught to be applied by places the foam scaffold in a container containing the biological component to impregnate it [0067], which would meet the limitation of cells on the surface of said scaffold and wherein cell seeding is taught ([0111]-[0113]) and additionally a bioactive agent is taught as incorporated into the pores (abstract).
Regarding claim 12, the limitation of wherein said parts that comprise more scaffold material comprise from about 5% to about 80% more scaffold material than parts comprising less scaffold material is met by the ‘177 publication teaching density or openness of material wherein the density is between 12-80%. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to optimize the density and openness of the implant material in the provided range as the ‘177 publication teaches a range of desired density and additionally teaches lower pore density in the inner layers than the outer layers, thus providing a reason to optimize the pore density in the inner and outer layers. 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”.
Regarding claim 14, the limitation of wherein the implant allows cell growth and regeneration of cartilage tissue at the implant site is met by the ‘177 publication teaching the structure as discussed above. The ‘177 publication teaches the claimed structure and thus would be capable of allowing cell growth and regeneration of cartilage absent factual evidence to the contrary. Additionally, the ‘177 publication teaches the desire for tissue ingrowth [0023] including cartilage [0035].
Regarding claims 37 and 41, the limitation of wherein said micropores have a pore size between 10 and 100 um is met by the ‘177 publication teaches pores having a range of about 100 to 1000 microns [0023].
The ‘252 patent does not specifically recite parts with different levels of stiffness, wherein said stiff parts and said soft parts comprise micropores, and wherein said soft parts comprise opening larger than said micropores and less scaffold material compared to said stiff parts, wherein said opening are distributed in said soft parts according to a predetermined pattern (claim 1).
The ‘816 publication teaches ear implant may be a tissue scaffold multicomponent assembly for reconstruction of auricular tissue. The first and second tissue scaffold component are taught with a plurality of open pores configured to support cell growth (abstract). The plurality of open pores it he first tissue scaffold component has a first pore density in a first region. The pore density thus translates to a first rigidity level. The first tissue scaffold component also has a second region having a second pore density distinct from the first pore density. The second pore density thus relates to a second region having a second rigidity level distinct from the first rigidity level. The implant thus has a tailored scaffold porosity which provides the capability of forming hybrid or gradate scaffold pores within the era scaffold implant. The pore density and/or pores architecture imparts strength and rigidity in desired regions of the implant, wherein pore density imparts flexibility in the desired regions. The implant scaffold stiffness can be mediated by the microstructure design. The ‘816 publication teaching ear implants for tissue reconstruction in a patient where the assembly includes a first and second tissue scaffold component each comprise a biocompatible polymeric material and plurality of open pores (abstract). The first plurality of open pores in the first tissue scaffold has first pore density in a first region which translates to a first rigidity level. The first tissue scaffold has a second region having a second pore density distinct from the first pore density and a second rigidity. The implant devices have a tailored scaffold porosity which proves a graduated scaffold pores within the ear scaffold implant wherein the pore density and/or pore architecture imparts strength and rigidity in desired regions of the implant. The implant scaffold stiffness can be mediated by the microstructure design [0075], thus teaching two distinct regions of rigidity which is connected to the stiffness of the material. Cells are taught as seeded onto the scaffolds [0097].
The ‘336 publication teaches a nasal tissue implant for tissue engineering and reconstruction comprising a biocompatible polymeric material having plurality of open pores configured to support cell growth (abstract). The scaffold is taught to have a combination of small pores and large pores [0010]. Tailored scaffold porosity provides a capability of hybrid or gradated scaffold pores. Pore placement can form a scaffold having strength and rigidity at the foundational subunits while porous architecture imparts flexibility at subunits adjacent to soft tissue interface. The size and/or density of pores may be smaller or less at regions of the implant corresponding to foundational subunits so as to achieve a stiffer material and the pores may be larger or there is a higher pore density at subunits adjacent to soft tissue to provide greater flexibility [0048].
The ‘575 publication teaches fabrication of porous material (title). The 3D biodegradable porous polymer scaffolds with well-controlled interconnected pores and method of forming the porous material is taught. The hydrophobic porogen material were fabricated into 3D negative replicas of desired microporous architecture before PLLA and PLGA were dissolved in solvent and cast onto the negative replica. The porogen is dissolved out leaving a porous scaffold. The skeletal structure of PLLA foams consisted of small platelets or nanofibers. To improve the tissue organization, 3D macroporous architecture are built in the nanofibrous matrices wherein the polymer scaffold is tailored to a variety of potential tissue engineering applications (abstract). The microporous walls are taught to have macropores [0101] wherein 3d printing is taught to form the macropores and freeze drying is taught to form foam ([0114], [0055]). Regarding claims 42-43, the limitations of formation of the micropores and openings are product by process limitations. The ‘575 publication teaches microporous walls and macropores (holes) meeting the structural limitations. MPEP 2113 - “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention that the higher and lower pore density in the scaffold taught by the ‘177 publication would result in differing stiffness of the regions as the ‘816 publication teaches the connection between pore density, rigidity and stiffness of scaffold materials in scaffolds which comprise two distinct areas of different porosity and stiffness. It would have been prima facie obvious to one of ordinary skill in the art to optimize the pore density in the scaffold as taught by the ‘177 publication to obtain the desired stiffness as the ‘177 publication teaches regions with different pore density in tissue scaffolds and the ‘816 publication connects pore density and stiffness in tissue scaffolds, thus rendering it obvious. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to optimize the porous structure as the ‘336 publication teaches the desire for stiffer less porous material for a rigid foundation and a more porous flexible upper layer for tissue interface. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘575 publication teaches a method of forming a controlled porous structure for a tissue scaffold comprising microporous walls and microporous structure. One of ordinary skill in the art before the filing date of the claimed invention would have the desire to use the microporous walls and controlled microporous structure in the outer layers to obtain an optimized tissue scaffolding based on the teachings of the ‘336 publication and the ‘575 publication for the tissue scaffold of the ‘177 publication.
Claim(s) 7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2002/0119177 in view of WO 2018/200816, US 2019/0374336 and WO 01/87575 as applied to claims 1, 3, 12, 14, 36-38 and 41-43 above, and further in view of US 2001/0021530 (previously applied).
As mentioned in the above 103 rejection, all of the limitations of claims 1, 3, 12, 12, 14, 36-38 and 41-43 are taught by the combination of the ‘177 publication, the ‘816 publication, the ‘336 publication and the ‘575 publication.
The combination of references does not specifically teach a low level of stiffness are form about 1.5 MPa to about 5 MPa (claim 7) and a high level of stiffness from about 15 MPa to about 30 MPa (claim 9).
The ‘530 publication teaches scaffold materials may comprise polymers such as polycaprolactone. Mechanical properties of the scaffold may be obtained by polymer blends, filler materials, processing tools or combinations thereof. Compressive strength is between 1 and 280 MPa and tensile strength between 1 and 160 MPa [0032].
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to optimize the stiffness of the scaffold as taught by the ‘177 publication as the ‘177 publication teaches that the higher and lower pore density in the scaffold taught by the ‘177 publication would result in differing stiffness of the regions as the ‘816 publication teaches the connection between pore density, rigidity and stiffness of scaffold materials. It would have been prima facie obvious to one of ordinary skill in the art to optimize the pore density in the scaffold as taught by the ‘177 publication to obtain the desired stiffness as the ‘177 publication teaches regions with different pore density in tissue scaffolds and the ‘816 publication connects pore density and stiffness in tissue scaffolds, thus rendering it obvious, thus teaching the stiffness is an optimizable parameter. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘530 publication teaches ranges of compressive strength and tensile strength and elasticity in a scaffold comprising polycaprolactone for use in tissue engineering and the ‘177 publication teaches a tissue scaffold formed of polycaprolactone, thus providing a reasonable expectation of success in the ranges taught by the ‘530 publication in the ’177 publication tissue scaffold. 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”.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2002/0119177 in view of WO 2018/200816, US 2019/0374336 and WO 01/87575 as applied to claims 1, 3, 12, 14, 36-38 and 41-43 above, and further in view of US 2018/0117215.
As mentioned in the above 103 rejection, all of the limitations of claims 1, 3, 12, 12, 14, 36-38 and 41-43 are taught by the combination of the ‘177 publication, the ‘816 publication, the ‘336 publication and the ‘575 publication.
The combination of references does not specifically teach wherein said scaffold comprises an ultimate tensile strength of from about 10%PCL/ having a stiffness level of 0.25 MPa to 2MPa (claim 11).
The ‘215 publication teaches the ultimate tensile strength of 1.2 in PCL scaffold material (Fig 7B, [0103]). Composite scaffolds are taught for skin tissue regeneration comprise poly(caprolactone) scaffolds are synthesized. A plurality of physicochemical characteristics of the composite scaffold comprising hydrogel and poly(glycerol sebacate) -poly(caprolactone) is analyzed for physiochemical characteristics and mechanical properties (abstract). Highly porous structure retains desirable mechanical properties such as direction tensile loads which maintain mechanical flexibility and are seeded with cells [0015].
It would have been prima facie obvious to one of ordinary skill in the art to optimize the pore density in the scaffold as taught by the ‘177 publication to obtain the desired stiffness as the ‘177 publication teaches regions with different pore density in tissue scaffolds and the ‘816 publication connects pore density and stiffness in tissue scaffolds, thus rendering it obvious, thus teaching the stiffness is an optimizable parameter. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘215 publication teaches ranges of ultimate tensile strength in a scaffold comprising polycaprolactone for use in tissue engineering and the ‘177 publication teaches a tissue scaffold formed of polycaprolactone, thus providing a reasonable expectation of success in the ranges taught by the ‘215 publication in the ’177 publication tissue scaffold. 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 but are not deemed to be persuasive.
103:
Applicant argues the Examiner has not shown in any of the cited art “wherein said soft parts comprise openings larger than said micropores and less scaffold material compared to said stiff parts, wherein said opening are distributed in said soft parts according to a predetermined pattern.
In response, Applicant is referred to the modified rejection applied above. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to optimize the porous structure as the ‘336 publication teaches the desire for stiffer less porous material for a rigid foundation and a more porous flexible upper layer for tissue interface. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘575 publication teaches a method of forming a controlled porous structure for a tissue scaffold comprising microporous walls and microporous structure. One of ordinary skill in the art before the filing date of the claimed invention would have the desire to use the microporous walls and controlled microporous structure in the outer layers to obtain an optimized tissue scaffolding based on the teachings of the ‘336 publication and the ‘575 publication for the tissue scaffold of the ‘177 publication.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
/BRIAN-YONG S KWON/Supervisory Patent Examiner, Art Unit 1613
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