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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-12, in the reply filed on 05/19/2026 is acknowledged.
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/19/2026.
Status of the Claims
Claims 1-20 are currently pending.
Claims 13-20 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 1-12 have been considered on the merits.
Claim Objections
Claim 8 is objected to because of the following informalities: a space is needed in “10,000rpm” in line 3. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: “comprised” should be amended to “comprises”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3 and 6 is 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 6 recites the limitation "the tendon neotissue" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation "said population of tenocyte-like cells" in line 13. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 5-6, and 9-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Taguchi et al (American Journal of Vet Research, 2021).
Regarding claim 1, Taguchi teaches a method of inducing tenogenic differentiation in adipose derived stem cells (ASC) in a bioreactor comprising applying ASCs onto a porous biopolymer-based scaffold to form a cell-scaffold construct (pg. 925, col. 2, para 5; pg. 926, col. 2, para 2), culturing the cell-scaffold construct in a medium for a period of time to produce a population of tenocyte-like cells (pg. 925, col. 2, para 5). The culturing step comprises contacting the cell-scaffold construct with at least one tenogenic differentiation driver (pg. 925, col. 2, para 5) and applying controlled mechanical stimulations to said cell-scaffold construct comprising flow shear stress and static tensile strain (pg. 925, col. 1, para 3; pg. 927, col. 1, para 2). Taguchi teaches that these steps produce a population of differentiated cells expressing a tendon specific extracellular matrix gene (Col1 and Col3 see Fig. 5). Taguchi teaches maturing the population of differentiated cells to produce tenocyte-like cells (pg. 930, col. 1, last para) wherein said population of tenocyte-like cells express at least one tendon marker gene (Fig. 5 Tenomodulin).
With regards to claim 2, Taguchi teaches that the population of differentiated cells comprise a population of tenoblast-like cells (pg. 929, col. 1, para 1; pg. 930, col. 1, last para).
With regards to claim 5, Taguchi teaches wherein the porous biopolymer scaffold is ligated by a filament or net and shaped as a column along a longitudinal axis (see Fig. 1).
Regarding claim 6, Taguchi teaches wherein the tendon neotissue comprises the population of tenocyte like cells embedded within a fibrous extracellular matrix attached to the biopolymer-based scaffold and are organized parallel to each other along the longitudinal axis (Fig. 1) and wherein the population of tenocyte like cells have an elongated rod-like nucleus (pg. 929, col. 1, para 1) and express ECM components (Fig. 5).
Regarding claim 9, Taguchi teaches that the static tensile strain is continuous with an amplitude of 15%, which falls within the range of 1-75% (pg. 926, Fig. 1 description).
Regarding claim 10, Taguchi teaches that the porous scaffold comprised at least 5% collagen type 1 (Fig. 4 and pg. 929, col. 2, para 1) and is infused with a population of ASC at a density of 3.3 x 10^6 (pg. 927, col. 1, para 2).
Regarding claim 11, Taguchi teaches that the at least one tenogenic differentiation driver is a TGF family member (pg. 925, col. 2, para 5).
Regarding claim 12, Taguchi teaches that one tendon-ECM gene is collagen I and collagen 3 (See Fig. 5). Taguchi is silent to whether or not the produced cells express one of the claimed tendon marker genes or tenogenic transcription factor gene of claim 12, however Taguchi teaches the active steps of the method of claim 1 which would inherently result in cells which express the claimed genes. Claim 12 contains a wherein clause that recites the intended result of the method rather than requiring an additional step be performed. MPEP 2111.04 states “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed” and that a such a clause ‘"in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Therefore, since these claims only recite the results of the steps, then art reading on claim 1 will also read on these results since performing the same steps will inherently lead to the same results in the absence of evidence to the contrary including unexpected results.
Therefore, Taguchi anticipates the claims.
Claims 3 and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Taguchi et al (American Journal of Vet Research, 2021).
Regarding claim 3, Taguchi teaches a method of producing a tendon neotissue from a population of adipose derived stem cells (ASC) in a bioreactor comprising applying ASCs onto a porous biopolymer-based scaffold to form a cell-scaffold construct (pg. 925, col. 2, para 5; pg. 926, col. 2, para 2), culturing the cell-scaffold construct in a medium for a period of time to produce a population of tenocyte-like cells (pg. 925, col. 2, para 5). The culturing step comprises contacting the cell-scaffold construct with at least one tenogenic differentiation driver (pg. 925, col. 2, para 5) and applying controlled mechanical stimulations to said cell-scaffold construct comprising flow shear stress and static tensile strain (pg. 925, col. 1, para 3; pg. 927, col. 1, para 2). Taguchi teaches that these steps produce a population of differentiated cells expressing a tendon specific extracellular matrix gene (Col1 and Col3 see Fig. 5). Taguchi teaches maturing the population of differentiated cells to produce tenocyte-like cells (pg. 930, col. 1, last para) wherein said population of tenocyte-like cells express at least one tendon marker gene (Fig. 5 Tenomodulin) and organize to form the tendon neotissue (Fig. 3).
With regards to claim 4, Taguchi teaches that the population of differentiated cells comprise a population of tenoblast-like cells (pg. 929, col. 1, para 1; pg. 930, col. 1, last para).
Therefore, Taguchi anticipates the claims.
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.
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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Taguchi et al (American Journal of Vet Research, 2021), as applied to claims 1-2, 5-6, and 9-12, and in view of Erlandson et al (US 20200255785 A1).
Regarding claim 7, the limitations of the independent claim 1 are taught above.
Regarding claim 7, Taguchi teaches that the flow shear stress is induced by a perfusion flow (pg. 925, col. 1, para 3) and pg. 927, col. 1, para 2).
Taguchi does not teach that the flow shear stress is also caused by an additional centrifugal flow motion of the medium as required by claim 7.
However, Erlandson teaches a cell culture bioreactor system which combines both a perfusion flow bioreactor system with a centrifugal flow motion bioreactor system to result in a combination bioreactor (See Fig. 1 and [0095]). Erlandson teaches that the combination perfusion system provides the benefit of fully utilizing the nutrients provided in media with less waste than systems with high media perfusion rates ([0002]).
One of ordinary skill in the art would find it obvious at the effective filling date of the instant invention to combine the method of producing tenocyte-like cells taught by Taguchi with the combination perfusion and centrifugation bioreactor system taught by Erlandson to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because Taguchi teaches the use of a perfusion bioreactor system and Erlandson teaches that the combination perfusion system provides the benefit of fully utilizing the nutrients provided in media with less waste than systems with high media perfusion rates ([0002]). One of ordinary skill in the art would have a reasonable expectation of success when combining Taguchi with Erlandson because Taguchi teaches all the necessary steps to perform the method and Erlandson teaches a more beneficial perfusion centrifugation bioreactor system.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Taguchi et al (American Journal of Vet Research, 2021) and Erlandson et al (US 20200255785 A1), as applied to claim 7 above, and in further view of Cannon et al (US20020146817A1).
Regarding claim 8, the limitations of the independent claim 1 are taught above.
Regarding claim 8, Taguchi teaches that the flow shear stress is induced by a perfusion flow (pg. 925, col. 1, para 3) and pg. 927, col. 1, para 2) at 1 ml/min flow rate and in a bidirectional manner (pg. 927, col. 1, para 2).
Regarding claim 8, Erlandson teaches that the impeller which renders the centrifugal flow is agitating the medium at a speed range of 80-110 rpm ([0096]) and 240 rpm ([0095]).
Taguchi and Erlandson do not teach that the perfusion flow is at a rate of between 2-50 ml/minute as required by claim 8.
However, Cannon teaches a bioreactor system which is used to allow mechanical forces to be translated through the biochamber which is expressly important for cells which are typically exposed to large levels of force in vivo like tendon and ligament tissues ([0063]).
Regarding claim 8, Cannon teaches that the perfusion flow of the system can be within the range of 4-40 mL/min ([0061]).
One of ordinary skill in the art would find it obvious at the effective filling date of the instant invention to combine the method of producing tenocyte-like cells taught by Taguchi and Erlandson with the perfusion rate taught by Cannon to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because Taguchi teaches the use of a perfusion bioreactor system and Cannon teaches a bioreactor system which is used to allow mechanical forces to be translated through the biochamber which is expressly important for cells which are typically exposed to large levels of force in vivo like tendon and ligament tissues ([0063]). One of ordinary skill in the art would have a reasonable expectation of success when combining Taguchi and Erlandson with Cannon because Taguchi teaches all the necessary steps to perform the method and Cannon teaches that tendon cells benefit from a stronger level of force in flow rate.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONSTANTINA E STAVROU whose telephone number is (571)272-9899. The examiner can normally be reached M-F 8:00-5:00.
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CONSTANTINA E. STAVROU
Examiner
Art Unit 1632
/TITILAYO MOLOYE/Primary Examiner, Art Unit 1632
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