DETAILED ACTION
Claims 1-4, 7, 9, 11-12, 14-16, 18-19, 21, 35-40 are currently pending. Claims 1-4, 7, 9, 11-12, 14, 36-39 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
Applicant's election with traverse of Group I in the reply filed on 11/05/2025 is acknowledged. The traversal is on the ground(s) that the ‘645 publication teaches scaffolds comprising protruding scaffold and supporting scaffold (abstract). Stiffness is taught to be an optimizable parameter [0097]. The Examiner has not shown in the cited ‘645 publication that a single biodegradable scaffold that has parts with different levels of stiffness as claimed. The ‘645 publication teaches optimization of stiffness but does not teach the same scaffold as parts in the scaffold with different levels of stiffness. This is not found persuasive because the ‘645 publication teaches two different parts to the same scaffold (protruding scaffold and supporting scaffold) and teaches the stiffness may be optimized ([0007], [0097]). The two different segments of the same scaffold are different in any minor amount would meet the limitations of the special technical features as “parts” and “different levels” are not defined, therefore any variation in stiffness between the protruding scaffold and supporting scaffold would meet the instant claim limitations and break unity.
The requirement is still deemed proper and is therefore made FINAL.
Claims 15-16, 18-19, 21, 35 and 40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 40 is properly placed in Group II as dependent on claim 15.
Priority
The instant case is a national stage entry of PCT/IL2022/050016, filed 01/04/2022 which claims priority to provisional application 63/133,453, filed 01/04/2021.
Information Disclosure Statement
Applicant’s Informational Disclosure Statement, filed on 09/06/2023, 12/24/2024 and 12/23/2025 has been considered. Please refer to Applicant's copy of the 1449 submitted herein.
Claim Rejections - 35 USC § 112 – New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 36-39 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 36 contains the newly added limitation “wherein said soft parts comprise openings filled with scaffold material, and wherein said opens are filled with less scaffold material compared to said stiff parts”. Support can be found for PCL, a scaffold material, to be used to fill openings in a mold, however support cannot be found for scaffold material to fill openings in a medical grade implant (page 24, last paragraph).
Alternatively, if Applicant believes that support for claim 36, drawn “wherein said soft parts comprise openings filled with scaffold material, and wherein said opens are filled with less scaffold material compared to said stiff parts”, is present and clearly envisaged in the instant application or earlier filed priority documents, applicant must, in responding to this Office Action, point out with particularity, where such support may be found.
Applicant does not indicate where these limitations are supported by the original specification, or how, as is Applicant's burden. See MPEP §714.02, last sentence of the third paragraph from the end and MPEP §2163.06 (I) last sentence.
Claim Rejections - 35 USC § 112 (b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
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 3-4, 7, 9, 11-12, 36-39 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.
Claim 3 contains the limitation of “high levels of stiffness”. High levels is not defined in the instant claims or instant specification. The term “high” in claim 3 is a relative term which renders the claim indefinite. The term “high” 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. Claim 3 contains the limitation of “more scaffold material”. It is unclear what “more scaffold material” is compared to, more than what? Claim 3 contains the limitation of “less openings”. It is unclear what “less openings is compared to, less than what? Parts with higher stiffness? No openings are required by instant claim 1. The relative term “high levels of stiffness” is being defined with relative terms “more scaffold” and “less openings”, and thus has unclear metes and bounds. Claim 9 is additionally rejected as being dependent on claim 3 and not clarifying the ambiguity of “more scaffold material” of claim 3. It is noted that claim 9 does resolve the ambiguity of “high levels of stiffness” of claim 3.
Claim 4 contains the limitation of “low levels of stiffness”. Low levels is not defined in the instant claims or instant specification. The term “low” in claim 4 is a relative term which renders the claim indefinite. The term “low” 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. Claim 4 contains the limitation of “less scaffold material”. It is unclear what “less scaffold material” is compared to, less than what? The relative term “low levels of stiffness” is being defined by another relative term “less scaffold” and thus has unclear metes and bounds. Claim 7 is additionally rejected as being dependent on claim 4 and not clarifying the ambiguity of “less scaffold material” of claim 4. It is noted that claim 7 does resolve the ambiguity of “low levels of stiffness” of claim 4.
Claim 11 contains the limitation “ultimate tensile strength of form about 10%PCL/0.25MPa to 30 30% PCL/2MPa”. The limitation of “30 30” is unclear as to what the numerical range is. Additionally, the limitation of 10%PCL and 30%PCL it is unclear if PCL is referring to a specific material amount to what that material is, as PCL is not previously required or defined in the instant claims.
Claim 12 contains the limitation “said parts that comprise more scaffold material” which does not antecedent basis. Claim 1, from which it dependents contains the limitation “parts with different levels of stiffness”. There is no antecedent basis for “said parts that comprise more scaffold material.
Claim 36 contains the limitation “wherein said soft parts comprise openings filled with scaffold material and wherein said opening are filled with less scaffold material compared to said stiff parts”. Instant claim 1, from which it depends, is a medical implant comprising a scaffold material and a plurality of seeded cells. It is unclear how the scaffold both forms the device which contains the openings and additionally fills in said openings, thus the instant claim has unclear metes and bounds. Claims 37-39 are additionally rejected as being dependent on claim 36 and not clarifying the ambiguity of claim 36.
Claim 39 contains the limitation of “low levels of stiffness”. Low levels is not defined in the instant claims or instant specification. The term “low” in claim 39 is a relative term which renders the claim indefinite. The term “low” 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. Claim 39 contains the limitation of “less scaffold material”. It is unclear what “less scaffold material” is compared to, less than what? The relative term “low levels of stiffness” is being defined by another relative term “less scaffold” and thus has unclear metes and bounds.
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) 1-4, 12, 14 and 36-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2002/0119177 in view of WO 2018/200816 (Applicant provided).
Regarding claims 1-4, 36, 38-39, 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 claim 37, 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 (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].
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.
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 as applied to claims 1-4, 12, 14 and 36-39 above, and further in view of US 2001/0021530.
As mentioned in the above 103 rejection, all of the limitations of claims 1-4, 12, 14 and 36-39 are taught by the combination of the ‘177 publication and the ‘816 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 as applied to claims 1-4, 12, 14 and 36-39 above, and further in view of US 2018/0117215.
As mentioned in the above 103 rejection, all of the limitations of claims 1-4, 12, 14 and 36-39 are taught by the combination of the ‘177 publication and the ‘816 publication.
The combination of references does not specifically teach wherein said scaffold comprises an ultimate tensile strength of form about 10%PCL/0.25 MPa to 30 30%PCL/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”.
Conclusion
No claims are allowed.
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