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 .
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.
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claim 1, 4, 6, 9, 11, 18-28, 31, drawn to an artificial support structure, classified in A61L27/3633.
II. Claim 32-34, drawn to a method of producing a scaffold, classified in A61L2420/02.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case the product as claimed can be made by another and materially different process. For example, instead of 3D printing the patterned polymeric substrate, the product can be produced by laser cutting or ablation casting.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with attorney on 6/29/26 a provisional election was made without traverse to prosecute the invention of group I, claims 1, 4, 6, 9, 11, 18-28, 31. Affirmation of this election must be made by applicant in replying to this Office action. Claims 32-34 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Objections
Claim 11 objected to because of the following informalities: Claim 11 is dependent on cancelled claim 10 and should be amended to depend from claim 9. For examination purposes, claim 11 is being treated as depending from claim 9. Appropriate correction is required.
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) 1, 4, 6, 9, 18-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Toro (20210369912).
With regards to claim 1, Toro discloses an artificial support structure (FIG 1A) comprising one or more biodegradable polymers ([0032], [0037]) and one or more extracellular matrix materials ([0011], [0037]), the support structure further comprising: a plurality of unit patterns (110), each unit pattern comprising a plurality of filaments (120), arranged continuously (FIG 1A), symmetrically (FIG 1A), and regularly thereon (FIG 1A), each unit pattern (110) being constituted of edges of a closed shape to thus form a pore at the inside thereof (140), wherein the plurality of unit patterns is connected to thus have intersection points with one another and the number of intersection points is the same as the number of edges passing the intersection points (FIG 1A).
With regards to claim 4, Toro discloses the artificial support structure of claim 1, wherein the plurality of connected unit patterns (110, FIG 1A) form a substantially planar sheet (FIG 1A) or wherein the plurality of connected unit patterns form a three-dimensional macrostructure (FIG 1D).
With regards to claim 6, Toro the artificial support structure of claim 1, wherein the artificial support structure comprises between 1 and 5 layers (FIG 1D shows three layers).
With regards to claim 9, Toro the artificial support according to claim 1, wherein four-unit patterns are connected to have four intersection points with one another (see annotated FIG 1A) and have four edges passing the four intersection points (see annotated FIG 1A), and a space surrounded with the four-unit patterns has the same or similar shape as or to each unit pattern (FIG 1A).
PNG
media_image1.png
499
556
media_image1.png
Greyscale
With regards to claim 18, Toro discloses an artificial support structure (FIG 1A) comprising one or more biodegradable polymers ([0032], [0037]) and one or more extracellular matrix materials ([0011], [0037]), the support structure further comprising: a plurality of unit patterns (110), each unit pattern comprising a plurality of filaments (120), arranged repeatedly to constitute columns or rows symmetrical to one another (FIG 1A), each unit pattern being constituted of edges of a closed shape to thus form a pore at the inside thereof (140), wherein the columns or rows along which the plurality of unit patterns are arranged repeatedly have an Eulerian trail (a square has an Eulerian trail).
With regards to claim 19, Toro discloses the artificial support according to claim 18, wherein columns or rows along which the plurality of unit patterns are arranged repeatedly are connected to allow the plurality of unit patterns to have intersection points with the plurality of unit patterns of the neighboring columns or rows (FIG 1A).
With regards to claim 20, Toro discloses the artificial support according to claim 19, wherein the plurality of unit patterns have the number of intersection points that is the same as the number of edges passing the intersection points (see annotated FIG 1A).
With regards to claim 21, Toro discloses the artificial support according to claim 20, wherein four neighboring unit patterns are connected to have four intersection points with one another and have four edges passing the four intersection points, and a space surrounded with the four-unit patterns has the same or similar shape as or to each unit pattern (see annotated FIG 1A).
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) 11, 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toro (20210369912) in view of Schwartz (20240382325).
With regards to claim 11, Toro discloses the artificial support according to claim 9, but fails to disclose wherein short edges of the edges of the closed shape of each unit pattern have the same length as one another, and long edges thereof have the same length as one another, so that the space surrounded with the four-unit patterns has the same shape as each unit pattern.
Schwartz also discloses an artificial support structure (200) comprising biodegradable polymers and extracellular matrix materials ([0047]), and formed of unit patterns (FIG 2B). Schwartz teaches short edges of the edges of the closed shape of each unit pattern have the same length as one another (FIG 2B, [0040], where diamond or rhombus shaped closed-cell patterns must have short edges with the same length), and long edges thereof have the same length as one another (FIG 2B, [0040], where diamond or rhombus shaped closed-cell patterns must have long edges with the same length), so that the space surrounded with the four-unit patterns has the same shape as each unit pattern (FIG 2B). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Toro’s artificial support to include that short edges of the edges of the closed shape of each unit pattern have the same length as one another, and long edges thereof have the same length as one another, so that the space surrounded with the four-unit patterns has the same shape as each unit pattern, as taught by Schwartz, in order to have a repeating pattern ([0040]).
With regards to claim 22, Toro the artificial support according to claim 21, but fails to disclose wherein short edges of the edges of the closed shape of each unit pattern have the same length as one another, and long edges thereof have the same length as one another, so that the space surrounded with the four-unit patterns has the same shape as each unit pattern.
Schwartz also discloses an artificial support structure (200) comprising biodegradable polymers and extracellular matrix materials ([0047]), and formed of unit patterns (FIG 2B). Schwartz teaches short edges of the edges of the closed shape of each unit pattern have the same length as one another (FIG 2B, [0040], where diamond or rhombus shaped closed-cell patterns must have short edges with the same length), and long edges thereof have the same length as one another (FIG 2B, [0040], where diamond or rhombus shaped closed-cell patterns must have long edges with the same length), so that the space surrounded with the four-unit patterns has the same shape as each unit pattern (FIG 2B). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Toro’s artificial support to include that short edges of the edges of the closed shape of each unit pattern have the same length as one another, and long edges thereof have the same length as one another, so that the space surrounded with the four-unit patterns has the same shape as each unit pattern, as taught by Schwartz, in order to have a repeating pattern ([0040]).
Claim(s) 23-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toro (20210369912) in view of Knight (12465475).
With regards to claim 23, Toro discloses a scaffold (FIG 1A), comprising a patterned polymeric substrate (FIG 1A) having a coating of one or more extracellular matrix ([0011]) materials thereon, but fails to disclose wherein the pattern of the polymeric substrate comprises adjacent rows of a series of unit cell structures each generally in the shape of the letter "I", the unit cell structures aligned in the rows of the patterned polymeric substrate in a perpendicularly alternating pattern of the unit cell structures.
Knight discloses an artificial support structure formed of unit patterns (FIG 10). Knight teaches the pattern of the polymeric substrate comprises adjacent rows of a series of unit cell structures each generally in the shape of the letter "I" (bottom right of FIG 10), the unit cell structures aligned in the rows of the patterned polymeric substrate in a perpendicularly alternating pattern of the unit cell structures (bottom right of FIG 10). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Toro’s artificial support to include that wherein the pattern of the polymeric substrate comprises adjacent rows of a series of unit cell structures each generally in the shape of the letter "I", the unit cell structures aligned in the rows of the patterned polymeric substrate in a perpendicularly alternating pattern of the unit cell structures, as taught by Knight, in order to maximize pore expansion (col 6, line 58).
With regards to claim 24, Toro as modified by Knight discloses the scaffold of claim 23 wherein the unit cell structures of the series are further defined as comprising a pore shaped as a central line greater in length than two substantially equal-length lines each perpendicular to opposite ends of the central line (bottom right of FIG 10), and wherein the alternating pattern is configured such that each of the ends of the central line of the pore are generally perpendicular to a central line of a pore of an adjacent unit cell structure (bottom right of FIG 10).
With regards to claim 25, Toro as modified by Knight discloses the scaffold of claim 23, wherein the scaffold is configured as one or more sheets (FIG 1D), each comprising a first planar side (the top side of each layer) and a second planar side (the bottom side of each layer).
With regards to claim 26, Toro as modified by Knight discloses the scaffold of claim 25, wherein the scaffold comprises 1, 2, 3, 4, or 5 sheets (FIG 1D shows 3 layers), or comprises at least or no more than 1, 2, 3, 4, or 5 sheets (FIG 1D shows 3 layers).
With regards to claim 27, Toro as modified by Knight discloses the scaffold of claim 25, wherein the multiple sheets are configured such that a planar side of one sheet is adjacent to a planar side of another sheet (FIG 1D).
With regards to claim 28, Toro as modified by Knight discloses the scaffold of claim 23, wherein the scaffold comprises one or more of a defined shape (FIG 1A, where a planar sheet is a defined shape).
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toro (20210369912) in view of Knight (12465475), as applied to claim 23 above, and further in view of Zavala (20260061094).
With regards to claim 31, Toro as modified by Schwartz discloses the scaffold of claim 23, but fails to disclose wherein the scaffold further comprises one or more therapeutic agents.
Zavala discloses a biocompatible scaffold ([0006]). Zavala teaches that the scaffold further comprises one or more therapeutic agents ([0007]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Toro’s scaffold to include that it further comprises one or more therapeutic agents, as taught by Zavala in order to enhance the regeneration repair of the target tissues ([0007]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE FLORENCIA NERENBERG whose telephone number is (571)272-9599. The examiner can normally be reached M-F 7:30-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/R.F.N./
Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
Prosecution Insights