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 .
Status of Claims
This office action is responsive to the amendment filed on 09/03/2025, wherein new claims 2-20 have been added. Thus, claims 1-20 are presently pending in this application, and currently examined in the Office Action.
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, 4, 9 and 11-20 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.
Regarding claim 3, which recites the limitation “the rectangular shape”, on line 1; there is insufficient antecedent basis for this limitation in the claim. In order to overcome this rejection, it is suggested the claim depend from claim 2 (which sets forth the limitation of “a rectangular shape”), instead of depending from claim 1.
Regarding claims 9 and 16, which recite the limitation(s) “the suture retention strength”, on line 1 and line 2 of both claims; there is insufficient antecedent basis for this/these limitation(s) in the claims. Additionally, it is unclear what additional structural limitations, if any, the parameter of these claims impart on the physical structure of the final product. Specifically, it is not clear what exact structure and/or material would be needed in order to meet the claimed limitation of “the suture retention strength of any hole of the group of holes is at least 80% of a suture retention strength of a region of the tissue matrix without holes”; and neither the claims, nor the originally filed specification, provide a specific structure, and/or material, which would be required to meet the claimed limitation. Thus, one of ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claims indefinite.
Regarding claim 11, which set forth the parameter of the holes being arranged in “a pattern such that a uniaxial tensile strength measured in any direction along the sheet is at least 60% of the uniaxial tensile strength of a sheet without the group of holes”, on the last 2 lines of the claim; however, this parameter is found to be confusing since it is not clear what exactly is meant by “a pattern”. Specifically, it is unclear what exact pattern/structure would be needed to meet the claim; and neither the claim, nor the originally filed specification provides a specific structure for “a pattern” such that a uniaxial tensile strength measured in any direction along the sheet is at least 60% of the uniaxial tensile strength of a sheet without the group of holes, as claimed. Thus, one of ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 12, which sets forth the parameter of the flexible sheet of tissue matrix with the group of holes has a uniaxial tensile strength “that is at least 70% of the uniaxial tensile strength of a sheet without the group of holes”; however, this parameter is found to be confusing since it is not clear what exactly, structurally, would be needed for the flexible sheet/tissue matrix product to meet the claimed parameter. Specifically, it is unclear what exact material, and/or structure and/or pattern would be needed to meet the claimed parameter; and neither the claim, nor the originally filed specification provides a specific structure such that the flexible sheet of tissue matrix with the group of holes has a uniaxial tensile strength that is at least 70% of the uniaxial tensile strength of a sheet without the group of holes, as claimed. Thus, one of ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Examiner’s Notes
It is to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Cahn (WO 97/06837), as disclosed in the IDS date 09/03/2024, in view of Ge et al. (Comparison of histological structure and biocompatibility between human acellular dermal matrix (ADM) and porcine ADM; Burns; 2009 Feb; 35(1); pg.46-50), as disclosed in the IDS date 09/03/2024, hereinafter Ge.
Regarding claim 1, Cahn discloses a tissue matrix product, illustrated in Figure 4, comprising a flexible sheet including a group of holes passing through the tissue matrix, wherein the holes are formed in a pattern comprising a repeating motif (M) of five holes, the motif (M) repeating in at least two columns (C1&C2), the flexible sheet including a perimeter region (P) where no holes are present, the perimeter region being sized to allow an area for passage of sutures/provide a non-perforated section for fixation to tissue, illustrated in Figure 4 and modified figure 4, below (pg. 15, Lines 14-15 & pg. 18, Lines 34-35); and though it is not specifically stated that a size of the perimeter region is in a range from 1.5 to 3 cm, this parameter is deemed to be a mere matter of normal design choice, not involving a novel inventive step; it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate size/proportion for the perimeter region, including in the range from 1.5 to 3 cm, based on the need of the patient and/or use of the product, and doing so amounts to a mere change/adjustment in size/proportion of the perimeter region; and it has been held that a change in size/proportion is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04); furthermore, it is to be noted that neither the claim(s), nor the originally filed specification gave any reason/benefit for, or criticality to the parameter of the perimeter region having the specific size range of 1.5 to 3 cm, as opposed to any other size, larger or smaller. But Cahn does not specifically disclose the flexible sheet comprises a tissue matrix.
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However, Ge teaches a flexible sheet product that comprises a tissue matrix (pg. 46, Column 1, Lines 2-4); wherein the flexible sheet product is effective in repairing/reconstructing different body tissues (pg. 46, Column 1, Lines 6-7 & pg. 49, Column 1, Last 3 Lines).
In view of the teachings of Ge, it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention, to determine an appropriate material for the tissue matrix product of Cahn, including comparing a tissue matrix, since doing so amounts to mere substitution of one known material used in the art of artificial skin/tissue products for another known material, as taught by Ge; and it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use (see MPEP 2144.04).
Regarding claim 2, Cahn in view of Ge disclose the product of claim 1, wherein Cahn further teaches the repeating motif (M) has a rectangular shape that includes a hole positioned at each corner of the rectangular shape and one hole positioned at a center of the rectangular shape, illustrated in Figure 4 and modified figure 4, above.
Regarding claim 3, Cahn in view of Ge disclose the product of claim 2, wherein Cahn further teaches the rectangular shape, of the motif (M), has a first dimension (L) and a second dimension (W) such that the first dimension (L) is greater than the second dimension (W), illustrated in Figure 4 and modified figure 4, above.
Regarding claim 4, Cahn in view of Ge disclose the product of claim 3, wherein Cahn further teaches adjacent columns (C1&C2) are spaced apart from one another by a distance (D) different from the second dimension (W), wherein the distance (D) defines an area without holes, illustrated in Figure 4 and modified figure 4, above.
Regarding claim 5, Cahn in view of Ge disclose the product of claim 1, wherein Cahn further teaches the motif (M) is repeated in at least three columns (C1&C2&C3), illustrated in Figure 4 and modified figure 4, above.
Regarding claim 6, Cahn in view of Ge disclose the product of claim 1, wherein Cahn further teaches the motif (M) is repeated in at least two rows (R1&R2), illustrated in Figure 4 and modified figure 4, above.
Regarding claim 7, Cahn in view of Ge disclose the product of claim 6, wherein Cahn further teaches a distance (D) between each column (C1&C2) is greater than a distance between each row (R1&R2), illustrated in Figure 4 and modified figure 4, above.
Regarding claim 8, Cahn in view of Ge disclose the product of claim 1, wherein Cahn further teaches each hole has a maximum dimension between about 1.5 mm and 2.5 mm (Cahn: pg. 7, Lines 13-14).
Regarding claim 9, Cahn in view of Ge disclose the product of claim 1, and though it is not specifically stated that the suture retention strength of any hole of the group of holes is at least 80% of the suture retention strength of a region of the tissue matrix without the hole; this parameter is found to be an inherent property of the structure of the tissue matrix product/holes. Specifically, according to paragraph [0044] of the originally filed specification of the current application at hand, the size and shape of the holes can be configured to provide holes that will maintain suture retention strength of at least 80% of a suture retention strength of a region of the tissue matrix without a hole. Therefore, since the structure of the holes of the tissue matrix product of Cahn in view of Ge meet the optimal size/shape, i.e. having a maximum dimension between about 1.5 mm and 2.5 mm (Cahn: pg. 7, Lines 13-14) and being rounded/circular shape, as illustrated in Figure 4 of Cahn, it is obvious that the holes of the tissue matrix product of Cahn in view of Ge would also meet the limitation of having a suture retention strength of at least 80% of a suture retention strength of a region of the tissue matrix without holes.
Regarding claim 10, Cahn in view of Ge disclose the product of claim 1, wherein Cahn further teaches the motif (M) in a first column (C1), of the two columns, is not laterally aligned with the motif (M) in a second column (C2) of the two columns, illustrated in Figure 4 and modified figure 4, above.
Regarding claims 11, 12, 14, 15 and 17, Cahn discloses a tissue matrix product, illustrated in Figure 4, comprising a flexible sheet including a group of between 10 and 80 holes passing through the tissue matrix, wherein the flexible sheet comprises a rectangular shape, and the holes have a maximum dimension between about 1.8 mm and 2.5 mm (pg. 7, Lines 13-14), wherein the holes are arranged in a pattern, comprised of a repeating motif (M) of five holes arranged in a rectangular shape with a hole positioned at each corner of the rectangle and one hole positioned at the center of the rectangle, such that a uniaxial tensile strength measured in any direction along the sheet is at least 60%, or at least 70%, of the uniaxial tensile strength of a sheet without the group of holes, illustrated in Figure 4 and modified figure 4, above (To clarify, as best interpreted from the originally filed disclosure of the current application at hand, the “pattern” which produces at least 60%, or at least 70%, of the uniaxial tensile strength of a sheet without the group of holes is the pattern of repeating motifs (M) with a rectangular shape with a hole at each corner of the rectangle and one hole in the center of the rectangle, as illustrated in modified figure 4, above); and though it is not specifically stated that the flexible sheet has a width between 10-25 cm and a length between 15-30 cm, this parameter(s) is deemed to be a mere matter of normal design choice, not involving a novel inventive step; it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate size and/or dimensions/proportions for the flexible sheet, based on patient need, location of implantation, and/or use of the product, including having a width between 10-25 cm and a length between 15-30 cm, since doing so amounts to a mere change in size/proportion; and it has been held that a change in size/proportion is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04). But Cahn does not specifically disclose the flexible sheet comprises a tissue matrix.
However, Ge teaches a flexible sheet product that comprises a tissue matrix (Pg. 46, Column 1, Lines 2-4); wherein the flexible sheet product is effective in repairing/reconstructing different body tissues (pg. 46, Column 1, Lines 6-7 & pg. 49, Column 1, Last 3 Lines).
In view of the teachings of Ge, it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention, to determine an appropriate material for the tissue matrix product of Cahn, including comparing a tissue matrix, since doing so amounts to mere substitution of one known material used in the art of artificial skin/tissue products for another known material, as taught by Ge; and it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use (see MPEP 2144.04).
Regarding claim 13, Cahn in view of Ge disclose the product of claim 11, and though it is not specifically stated that the flexible sheet specifically includes a group of between 14 and 64 holes, this parameter is deemed to be a mere matter of normal design choice, not involving a novel inventive step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate range/amount of holes in the flexible sheet, including a group of between 14 and 64 holes, based on the need of the patient and/or size of the product and/or use/implantation site of the product; additionally, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.05).
Regarding claim 16, Cahn in view of Ge disclose the product of claim 11, and though it is not specifically stated that the suture retention strength of any one of the holes is at least 80%, of the suture retention strength of a region of the tissue matrix without a hole; this parameter is found to be an inherent property of the structure of the tissue matrix product. Specifically, according to paragraph [0044] of the originally filed specification of the current application at hand, the size and shape of the holes can be configured to provide holes that will maintain suture retention strength of at least 80%, of a suture retention strength of a region of the tissue matrix without a hole. Therefore, since the structure of the holes of the tissue matrix product of Cahn in view of Ge meet the optimal size/shape, i.e. having a maximum dimension of between about 1.5 mm and 2.5 mm (Cahn: pg. 7, Lines 13-14) and being rounded/circular shape, as illustrated in Figure 4 of Cahn, it is obvious that the holes of the tissue matrix product of Cahn in view of Ge would also meet the limitation of having a suture retention strength of at least 80% of a suture retention strength of a region of the tissue matrix without holes.
Regarding claim 18, Cahn in view of Ge disclose the product of claim 17, wherein Chan further teaches the motif (M) is repeated in at least two columns (C1&C2), illustrated in Figure 4 and modified figure 4, above.
Regarding claim 19, Cahn in view of Ge disclose the product of claim 17, wherein Chan further teaches the motif (M) is repeated in at least two rows (R1&R2), illustrated in Figure 4 and modified figure 4, above.
Regarding claim 20, Cahn in view of Ge disclose the product of claim 19, wherein Chan further teaches a distance (D) between each column (C1&C2) is greater than a distance between each (R1&R2), illustrated in Figure 4 and modified figure 4, above.
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 11 and 16-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. 11,383,007. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims disclose a tissue matrix product comprising a flexible sheet comprising a tissue matrix, wherein the flexible sheet includes a group of between 10 and 80 holes passing through the tissue matrix, wherein the flexible sheet comprises a rectangular shape having a width between 10 cm and 30 cm and a length between 10 cm and 30 cm, and the holes have a maximum dimension between about 1.5 mm and 2.5 mm, wherein the holes are arranged in a pattern comprising a motif of five holes, the motif repeated in at least two columns such that a uniaxial tensile strength measured in any direction along the sheet is at least 60% of the uniaxial tensile strength of a sheet without the group of holes; and a suture retention strength of any one of the holes is at least 80% of the suture retention strength of a region of the tissue matrix without a hole.
Conclusion
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/DINAH BARIA/Primary Examiner, Art Unit 3774 06/17/2026
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