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 .
Status of claims
Claims 1-6, 8-16, 22-26, and 28-31 are original. Claims 7, 27, and 32-81 are cancelled. Claims 17-21 are currently amended. Claims 14-26 and 28-31 are withdrawn by applicant. Claims 1-6, and 8-13 are pending and under examination.
Priority
This application claims the benefit of priority under U.S.C. § 119(e) of U.S. Provisional Application Serial No. 63/484,938, filed February 14, 2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/14/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election of Group I (Claims 1-6, and 8-13) filed on 05/19/2026 is acknowledged. All other pending claims are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, here being no allowable generic or linking claim. The election is treated as without traverse per applicant’s request.
Claims 14-26 and 28-31 to the method are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/19/2026.
Claim Objection
Claim 6 is objected to as it should say “the biopolymer scaffold further comprises…” as it is adding another component to what was included for the scaffold in claim 2.
Appropriate correction is required.
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.
Claim 9 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 9 states that “the biopolymer scaffold material has a porosity of greater than or equal to approximately 20% and less than or equal to approximately 70%”. However, it is uncertain what the percentage is relative to (e.g., pore volume relative to the total volume of the scaffold, pore area relative to the total surface or cross-sectional area being analyzed, etc.). These measurements represent different properties that may produce different porosity values for the same scaffold. This renders the claim indefinite.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Lauritzen et al. (US20110262515A1).
Lauritzen et al. discloses Fenestrated wound repair scaffolds and methods for forming scaffolds involve dispersing human collagen having a preserved number of native constituents in solution, depositing the human collagen dispersion in a tray, forming openings in the collagen dispersion and removing the liquid component to form a fenestrated wound repair scaffold [¶abstract].
Regarding claim 1:
Lauritzen et al. teaches that the scaffold may comprise a resulting foam-formed strand including a porous foam structure that may facilitate movement of biological materials within and through spaces of the reticulated cells of the collagen fiber walls, and that In various embodiments, reticulated cells are networked, communicating, or connected [¶105].
Lauritzen et al. teaches that in various embodiments, the collagen scaffolds are 3-6 mm thick [¶158].
Lauritzen et al. teaches that the scaffold may be fenestrated (i.e., have holes) and include a network of channels extending through the scaffold depth and providing fluid passageways (e.g., transverse or axial channel) through the thickness or width (end-to-end) of the scaffold [¶159-160, figures 4H-W].
Lauritzen et al. teaches that such fenestrations may have varying sizes, from about 0.56 mm to about 1.51 mm, and may extend in the x, y, and/or z direction [¶159, figures 4H-W].
Regarding claim 8, Lauritzen et al. teaches that the product may be in the form of a patch [¶119].
Regarding claim 9, Lauritzen et al. teaches that the ratio of openings within the collagen scaffold may be about 1%, about 5%, about 10%, about 20%, about 40%, about 50%, about 60%, or greater [¶147].
Regarding claim 10, Lauritzen et al. teaches embodiments wherein the scaffolds had an average tensile strength ranging from 1.496 to 5.951 MPa [¶184, table 1].
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to select and combine Lauritzen et al.’s disclosed porous, fenestrated collagen scaffold features, including the disclosed thickness, fenestration, fenestration dimensions, opening ratio, patch configuration, and tensile strength, because Lauritzen et al. teaches that interconnected pores and through-channels facilitate the movement of biological materials and fluids through the scaffolds. A person of ordinary skill in the art would have thus had a clear motivation to combine the disclosed scaffold features of Lauritzen et al. to achieve porous, fenestrated collagen patch that facilitates the movement of biological materials and fluids through the scaffold while maintaining suitable structural integrity for tissue repair, and would have had a reasonable expectation of success because Lauritzen et al. teaches such features for the same collagen scaffold system and their combinations would thus have had predictably preserved their respectively known functions.
Claims 2, 4-6, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Lauritzen et al. (US20110262515A1) in view of Cornwell et al. (US20180250441A1).
Lauritzen et al. teaches all required limitations of present claim 1.
However, Lauritzen et al. fails to teach the required limitations of present claims 2, 4-6, and 13.
Cornwell et al. discloses a tissue graft for soft tissue repair or reconstruction comprising a sheet of a biopolymer-based matrix having a plurality of small perforations and a plurality of large perforations [¶abstract].
Regarding claim 2, Cornwell et al. teaches that the tissue graft material may be an acellular collagen matrix [¶23], and that the present invention provides tissue grafts such as decellularized tissue products [¶8].
Regarding claims 4 and 5, Cornwell et al. teaches that the acellular collagen matrix may be derived from fetal or neonatal bovine dermis [¶23].
Regarding claim 6, Cornwell et al. teaches that the grafts of the invention may also serve as a carrier of bioactive agents, such as growth factors, to generate tissue [¶38]. Cornwell et al. teaches that the graft may be used for pericardial membrane repair [¶38].
Regarding claim 13, Cornwell et al. teaches that the perforation of the tissue graft is performed using a perforation machine that comprises a cutting die having a surface of desired dimensions. The cutting die has on its surface punches that have shapes and sizes that correspond to the predetermined shapes and sizes of the perforations on the tissue graft to be prepared [¶34].
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Lauritzen et al.’s fenestrated collagen scaffold to incorporate Cornwell et al.’s decellularized fetal or neonatal bovine acellular collagen matrix and predetermined perforation configurations carrying bioactive agents. A person of ordinary skill in the art would have had a clear motivation to combine these teachings to achieve a biocompatible, remodelable tissue-repair patch having controlled perforations that facilitate tissue integration, tissue generation, cell repopulation, revascularization, and fluid transport. A person of ordinary skill in the art would have had a reasonable expectation of success because Lauritzen et al. and Cornwell et al. both concerns perforated collagen-based scaffolds for tissue repair, and the proposed modifications would have predictably preserved the known functions of the disclosed scaffold materials and perforation features.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Lauritzen et al. (US20110262515A1) in view of Cornwell et al. (US20180250441A1) in further view of Mooney et al. (US20080044900A1).
Lauritzen et al. and Cornwell et al. collectively teach all required limitations of present claim 1 and 2.
However, Lauritzen et al. and Cornwell fail to teach the required limitations of present claim 3.
Mooney et al. Discloses a scaffold composition and a bioactive composition with the bioactive composition being incorporated into or coated onto the scaffold composition such that the scaffold composition and/or a bioactive composition controls egress of a resident cell or progeny thereof [¶abstract]. Mooney et al. teaches that the bioactive composition may be an extracellular matrix (ECM) component that is chemically crosslinked to the scaffold composition [¶8]. Mooney et al. teaches that cells are seeded ex vivo into the scaffold with autologous or allogeneic cells [¶92]. Mooney et al. teaches that the invention is particularly useful in regenerating heart tissue (ischemia lesions and scarring) [¶92].
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the decellularized collagen scaffold of Lauritzen et al. and Cornwell et al. by ex vivo seeding the scaffold with autologous cells, as taught by Mooney et al. A person of ordinary skill in the art would have had a clear motivation to make this modification to promote cellular repopulation, tissue integration, and regeneration of ischemic or scarred heart tissue, because Mooney et al. expressly teaches seeding scaffolds with autologous or allogeneic cells for regeneration of heart tissue affected by ischemic legions and scarring. A person of ordinary skill in the art would have had a reasonable expectation of success in doing so because Lauritzen et al., Cornwell et al., and Mooney et al. each concern biocompatible scaffold systems for tissue regeneration, and Mooney et al. expressly demonstrates that such scaffolds may be seeded ex vivo with therapeutic cells. Accordingly, incorporating Mooney et al.’s known cell-seeding technique into the decellularized scaffold of Lauritzen et al. and Cornwell et al. would have predictably provided a cell-populated scaffold suitable for cardiac tissue repair while preserving the known functions of the scaffold and seeded cells.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Lauritzen et al. (US20110262515A1) in view of Durdag et al. (US20140336557A1).
Lauritzen et al. teaches all required limitations of present claim 1.
However, Lauritzen et al. fails to teach the required limitations of present claim 11.
Durdag et al. discloses novel wound healing absorbent scaffolds and dressing based on natural and naturally-derived material and fibers, preferentially poly (lactic) acid fibers and alginate materials [¶abstract]. Durdag et al. teaches a method for forming a moist, cross-linked gelled biopolymer composite to satisfy a still existing need for a soft, pliable, highly absorbent dressing to deliver moisture [¶23]. In one non-limiting embodiment [¶¶ 224-226, 252-258, example 18], Durdag et al. teaches that such products may have a water absorbency capacity of 26.59 g/100 cm2 (i.e., 0.2659 mL/cm2).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Lauritzen et al.’s collagen wound-repair scaffolds to incorporate the fluid absorptive characteristics taught by Durdag et al. such that the scaffold exhibits an area liquid-absorption capacity within the claimed range. A person of ordinary skill in the art would have had a clear motivation to make this modification to improve fluid uptake and retention at the tissue repair site and thereby provide enhanced local fluid management, as Durdag et al. expressly teaches highly absorbent biopolymer scaffolds for absorbing and retaining moisture. A person of ordinary skill in the art would have had a reasonable expectation of success in doing so because Lauritzen et al. and Durdag et al. both concern biopolymer-based scaffolds for tissue repair, and Durdag et al. demonstrates that known biopolymer scaffold materials can reproducibly achieve an area water absorption capacity of approximately 0.2659 mL/cm2, which falls within the claimed range. Accordingly, applying Durdag et al.’s known fluid-absorption characteristic to Lauritzen et al.’s scaffolds would have predictably yielded tissue-repair scaffolds having the claimed absorption capacity while preserving the scaffold’s intended structural and tissue-repair functions.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Lauritzen et al. (US20110262515A1) in view of Dai et al. (US20090162452A1).
Lauritzen et al. teaches all required limitations of present claim 1.
However, Lauritzen et al. fails to teach the required limitations of present claim 12.
Dai et al. discloses a method of forming and preserving a bio-remodelable, biopolymer scaffold (matrix) material by subjecting animal tissue to chemical and mechanical processing [¶abstract]. Dai et al. teaches biopolymer-based matrix (EBM) produced from fetal or neo-natal animal skins (e.g., bovine skin) can be used for pericardial repair [¶20]. Dai et al. teaches that it may be drapable (i.e., flexible) and has single suture-pullout strength of more than 20 Newtons. [¶20].
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Lauritzen et al.’s collagen wound-repair scaffold to possess the suture-retention characteristic taught by Dai et al. A person of ordinary skill in the art would have been motivated to make this modification in order to provide sufficient mechanical strength for secure suturing and fixation of the scaffold at a tissue-repair site, particularly because Dai et al. teaches a drapable biopolymer matrix suitable for pericardial repair having a single suture-pullout strength greater than 20 N. A person of ordinary skill in the art would have had a reasonable expectation of success because Lauritzen et al. and Dai et al. both concern biopolymer-based tissue-repair scaffolds, and Dai et al. demonstrates that such scaffold materials can achieve sufficient suture strength while retaining flexibility and handling characteristics desirable for surgical implantation. Accordingly, incorporating Dai et al.’s known suture strength characteristics into Lauritzen et al.’s scaffold would have predictably yielded a tissue-repair scaffold having a suture-retention strength within the claimed range while maintaining suitability for implantation and tissue repair.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 4-6, and 9-12 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over the following claims of co-pending U.S. Patent application No. 18/849,162 (referred to as co-pending ‘162): 1, 8, 12 (for present claim 1); 9 (for present claim 2); 10 (for present claim 4); 9, 10 (for present claim 5); 19 (for present claim 6); 14 (for present claim 9); 15 (for present claim 10); 17 (for present claim 11); 16 (for present claim 12)––In view of Lauritzen et al. (US20110262515A1).
Each of the above claims (or claim groups) of co-pending ‘162 teach all limitations of
their corresponding claim(s) listed in the present application, except for the following difference: present claim 1 specifies such pores to be interconnected and extend from one side of a surface through to the opposing surface. The specifications of co-pending ‘162 remedies this deficiency by stating that the pores of such scaffold materials may be interconnected and also connect a first surface to the second opposing surface [¶56]. Additionally, present claim 1 teaches that the thickness of the pores have an average maximum transverse dimension that is less than or equal to 1 mm. Lauritzen et al. remedies this deficiency by teaching that fenestrations of such scaffoldings may have varying sizes, from about 0.56 mm to about 1.51 mm, and may extend in the x, y, and/or z direction, and may extend from one surface to another [¶159-160, figures 4H-W]. In view of Lauritzen et al., such variations in pore morphology are a matter of routine optimization of result-effective variables to enhance efficacy of the scaffold for purposes of tissue regeneration, obvious to a person of ordinary skill in the art. Accordingly, the present claims differ from the claims of co-pending ‘162 only by an obvious variation that does not impart a patentable distinction.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims of co-pending ‘162 have not yet in fact been patented.
Claims 1-2, 4-6, and 8-12 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over the following claims of co-pending U.S. Patent application No. 18/967,982 (referred to as co-pending ‘982): 1 (for present claim 1, 9, 10); 2 (for present claim 2, 4); 3 (for present claim 5); 7 (for present claim 6); 4 (for present claim 8); 5 (for present claim 11); 10 (for present claim 12)––In view of Lauritzen et al. (US20110262515A1).
Each of the above claims (or claim groups) of co-pending ‘982 teach all limitations of
their corresponding claim(s) listed in the present application, except for the following difference: present claim 1 specifies such pores to be interconnected and extend from one side of a surface through to the opposing surface. Additionally, present claim 1 teaches that the thickness of the pores has an average maximum transverse dimension that is less than or equal to 1 mm. Lauritzen et al. remedies this deficiency by teaching that fenestrations of such scaffoldings may have varying sizes, from about 0.56 mm to about 1.51 mm, and may extend in the x, y, and/or z direction, and may extend from one surface to another [¶159-160, figures 4H-W]. In view of Lauritzen et al., such variations in pore morphology are a matter of routine optimization of result-effective variables to enhance efficacy of the scaffold for purposes of tissue regeneration, obvious to a person of ordinary skill in the art. Accordingly, the present claims differ from the claims of co-pending ‘982 only by an obvious variation that does not impart a patentable distinction.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims of co-pending ‘982 have not yet in fact been patented.
Claims 1-2, 4-6, and 8-12 are rejected on the ground of non-statutory double patenting as being unpatentable over the following claims of granted U.S. Patent No. 12,194,017 B2 (referred to as patent ‘017): 14, 23, 42 (for present claim 1,2, 4-5, 8-9); 21, 47 (for present claim 6); 14 (for present claim 8); 26,42 (for present claim 10); 14, 42 (for present claim 11); 27, 50 (for present claim 12)––In view of Lauritzen et al. (US20110262515A1).
Each of the above claims (or claim groups) of patent ‘017 teach all limitations of
their corresponding claim(s) listed in the present application, except for the following difference: present claim 1 specifies such pores to be interconnected and extend from one side of a surface through to the opposing surface. Additionally, present claim 1 teaches that the thickness of the pores have an average maximum transverse dimension that is less than or equal to 1 mm. Lauritzen et al. remedies this deficiency by teaching that fenestrations of such scaffoldings may have varying sizes, from about 0.56 mm to about 1.51 mm, and may extend in the x, y, and/or z direction, and may extend from one surface to another [¶159-160, figures 4H-W]. In view of Lauritzen et al., such variations in pore morphology are a matter of routine optimization of result-effective variables to enhance efficacy of the scaffold for purposes of tissue regeneration, obvious to a person of ordinary skill in the art. Accordingly, the present claims differ from the claims of patent ‘017 only by an obvious variation that does not impart a patentable distinction.
Conclusions
No claim is found allowable.
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Arya A. Bazargani, Ph.D.
Patent Examiner
Art Unit 1613
/MARK V STEVENS/Primary Examiner, Art Unit 1613
Prosecution Insights