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 .
Response to Amendment
The amendment filed 07/02/2025 has been entered. Claims 1, 3-10 and 12-21 remain pending in the application, claims 1 and 11 are cancelled, claims 10, 12-13, and 17-20 are withdrawn, and claim 22 is added. Applicant’s amendments to the claims have overcome the 112(b) rejections, however has not overcome the interpretation of the rejection previously set forth in the Non-Final Office Action mailed 03/07/2025.
Response to Arguments
Applicant's arguments filed 07/02/2025 have been fully considered but they are not persuasive.
Applicant states on pages 10-12 that Rosseau’s drawstring 16 is pulled and forces the segments into the circular configuration shown in figure 2, and straightens the prosthesis 28 into a flattened configuration positioned across the defect as opposed to wherein the holding portion (drawstring) is located on an outer peripheral surface of the biological organ as recited in claims 1 and 14. The Office respectfully disagrees. The term “outer peripheral surface” is relative and the outer peripheral surface can mean any outer surface relative to the biological organ. Paragraph 4 of Rousseau discloses the repair of abdominal wall hernias, and the area of the abdominal wall that is being bridged may be considered the outer peripheral surface. Therefore, the rejection is maintained.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “holding portion” in claims 1 and 14, and “pulling unit” in claim 5.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1, 3-9, 14-16, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Rousseau (US PGPub 2002/0173804) in view of Calabrese et al. (US PGPub 2010/0012703), and further in view of Bauman et al. (US PGPub 2005/0059996), hereinafter known as “Rousseau,” “Calabrese,” and “Bauman,” respectively.
With regards to claim 1, Rousseau discloses (Figures 1-2) a medical device 10 for joining a cut surface of a biological organ and an other biological organ (paragraphs 13-14 – functional limitation – surgical mesh 10 is for bridging a hernia (paragraph 1) and therefore “bridging” is referred to bridging two portions of cut tissue), the medical device 10 comprising:
an adhesion promotion sheet 28 including an adhesion promotion portion (central region of 28) configured to promote adhesion between a biological tissue of the cut surface of the biological organ and the other biological organ (paragraph 1 –“bridging a hernia”; paragraphs 14-15), the adhesion promotion portion being arranged in a central portion of the adhesion promotion sheet 28 and including a plurality of through-holes that pass through the adhesion promotion portion (figure 2; paragraphs 14-15 – adhesion promotion sheet is a mesh that has through-holes);
a frame portion (outer circumference of 28 where segments 18 lie) which is formed on the adhesion promotion sheet 28 and surrounds an outer periphery of the adhesion promotion portion;
a holding portion 18 (see Note below) disposed on the frame portion of the adhesion promotion sheet 28 and configured to hook and hold the adhesion promotion sheet 28 on the cut surface of the biological organ to be joined (paragraphs 13-14 – “used for reinforcing and occluding tissue defects”), and wherein the holding portion 18 is located on an outer peripheral surface of the biological organ (functional limitation - paragraph 18 – “Once the prosthesis 28 is positioned proximate to the defect, the drawstring 16 can be pulled, forcing the segments 18 into the circular configuration shown in FIG. 2 and straightening the prosthesis 28 into a flattened configuration positioned across the defect” – therefore also capable of positioning the holding portion 18 on an outer peripheral surface of a biological organ); and
wherein the holding portion 18 is configured to hold the adhesion promotion sheet 28 on the biological organ by elastic force of the holding portion 18 (paragraphs 13-14 – functional limitation – segments 18 are capable of imparting an elastic force by pressing down the adhesion promotion sheet 28 to the organ).
Note – 112(f) interpretation – Applicant’s holding portion is a material that can impart elastic force and is C-shaped configured to hook and hold the adhesion promotion sheet on a biological organ to be joined (Spec. [0006] and [0057-0058]); Rousseau’s holding portion 18 are a plurality of rigid, bead-like segments configured to shape/hold of the adhesion promotion sheet (paragraphs 13-14 and 18); therefore both holding portions are equivalent in holding the adhesion promotion sheet.
Rousseau is silent in wherein the plurality of through-holes of the adhesion promotion sheet is not formed in the frame portion.
However, in a similar field of endeavor of promoting adhesion between biological tissue, Calabrese teaches (Figure 2A) in wherein the plurality of through-holes 120 of the adhesion promotion sheet 100 is not formed on the frame portion 128 (paragraph 46).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the frame portion of Rousseau to include not forming the plurality of through-holes from the adhesion promotion sheet as taught by Calabrese for the purpose of preventing the leakage of fluids (e.g., body fluids) in the radial outward direction (paragraph 46 of Calabrese).
Rousseau/Calabrese are further silent to the frame portion having a higher rigidity than the adhesion promotion portion.
However, in a similar field of endeavor of promoting adhesion between biological tissue, Bauman teaches (Figure 4C) the frame portion 46 having a higher rigidity than the adhesion promotion portion 42 (paragraph 60 – “The buttress 12 can be made of a constant thickness or can be made of varying thickness, densities or materials of construction through their cross sections… thicker, more dense or stronger material could be constructed into the buttress 12 so as to coincide with the areas where the staples are placed with thinner, less dense or weaker material used in other areas”; paragraph 64 – “A perimeter area 46 of the buttress 12 as depicted can also be made with a thicker or higher density material to increase the strength of the material for staple reinforcement”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the medical device of Rousseau/Calabrese to include the frame portion having a higher rigidity than the adhesion promotion portion as taught by Bauman for the purpose of helping to prevent deformation of the medical device (paragraph 60 of Bauman).
With regards to claim 3, Rousseau discloses wherein the holding portion 18 is integrally attached to the adhesion promotion sheet 28 (definition of integral according to Merriam-Webster is “formed as a unit with another part”, therefore the holding portion 18 and the adhesion promotion sheet 28 are formed together as a unit).
With regards to claim 4, Rousseau discloses wherein the holding portion 18 is disposed only in a portion of the adhesion promotion sheet 28 along a circumferential direction (figure 2; paragraph 14 – “segments 18 are pulled together as closely as possible, forcing the loop 22 with segments 18 into a generally circular configuration”).
With regards to claim 5, Rousseau discloses further comprising:
a pulling unit 16 (see Note below) configured to perform a pulling operation of the adhesion promotion sheet 28 toward a side facing a position where the holding portion 18 is disposed (paragraphs 13-14 – functional limitation – “The slipknot 20 is preferably larger than the lumen 14, such that when the drawstring 16 is pulled in a proximal direction, the slipknot 20 encounters the rod 12 and the loop 22 is reduced in circumference” - therefore the drawstring 16 must be pulled in order to maintain the knot, the knot 20 is shown in figure 1 in line with the circumference of the holding portion 18, and therefore the pulling operation of the adhesion promotion sheet 28 takes place where the holding portion 18 is disposed).
Note – 112(f) interpretation – Applicant’s pulling unit is a string or strip shaped member that enables a pulling operation of the adhesion promotion sheet (spec. [0063-0064]); Rousseau’s pulling unit is a drawstring that forms a knot to pull taut the adhesion promotion sheet (paragraphs 13-14); therefore both pulling units are equivalent in pulling/tensioning the adhesion promotion sheet.
With regards to claim 6, Rousseau discloses wherein the pulling unit 16 is a string-shaped member (paragraphs 13-14 – drawstring).
With regards to claim 7, Rousseau discloses wherein the pulling unit 16 is a strip-shaped member connected to the adhesion promotion sheet 28 (paragraphs 13-14 – drawstring).
With regards to claim 8, Rousseau discloses wherein the adhesion promotion portion 28 is made of a biodegradable sheet (paragraph 15 – absorbable materials) having the plurality of through- holes that pass through the adhesion promotion portion 28 (figure 2; paragraphs 14-15 – adhesion promotion sheet is a mesh that has through-holes).
With regards to claim 9, Rousseau discloses wherein the holding portion 18 does not have any of the plurality of through-holes (figure 2; paragraphs 14 and 23 – the plurality of through-holes formed by the mesh 28 are part of the mesh 28; the holding portion, or segments, 18 do not have the same plurality of through-holes formed within the holding portion 18).
With regards to claim 21, the combination discloses the medical device of claim 1. Rousseau further discloses wherein the adhesion promotion sheet 28 is made of a biodegradable material (paragraph 15 – “absorbable materials”), and the frame portion extends to an outer edge of the adhesion promotion sheet 28 (figure 2 – frame portion is the outer circumference of the adhesion promotion sheet 28 starting from where the holding portion 18 lies and extending to the edge of the adhesion promotion sheet 28). The combination is silent to the frame portion is compressed in a thickness direction.
However, Bauman further teaches the formation of a medical device, wherein the medical device 12 can be made of varying thickness, densities or materials of construction through their cross sections (paragraph 60). Thus, it can be interpreted that by forming the medical device with varying thicknesses, the frame portion is compressed (less thick, more dense) relative to the central region of the medical device. Additionally, this claim is a product-by-process limitation, as the instant application describes compression in a thickness direction “to crush the through-hole 112” (specification [0052]). Therefore, since the combination discloses no formation of the through-hole on the frame portion of the medical device, the process of compression to crush the through-hole is given no patentable weight.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Rousseau/Calabrese/Bauman to include compressing the frame portion in a thickness direction as taught by Bauman for the purpose of helping to prevent deformation of the medical device (paragraph 60 of Bauman).
With regards to claim 14, Rousseau discloses (Figures 1-2) a medical device 10 that promotes adhesion between biological tissue (paragraphs 1 and 13-14), the medical device 10 comprising:
an adhesion promotion sheet 28 including an adhesion promotion portion (central region of 28) made of a biodegradable sheet (paragraph 15 – absorbable material) configured to join biological tissues (paragraph 1 – “bridging a hernia”) and promote the adhesion between a cut surface of one joint target site and an other joint target site (paragraphs 13-14 – functional limitation – surgical mesh 10 is for bridging a hernia (paragraph 1) and therefore “bridging” is referred to bridging two portions of cut tissue), the adhesion promotion portion (central region of 28) being arranged in a central portion of the adhesion promotion sheet 28 and including a plurality of through-holes that pass through the adhesion promotion portion (figure 2; paragraphs 14-15 – adhesion promotion sheet is a mesh that has through-holes);
a frame portion (outer circumference of 28 where segments 18 lie) which is formed on the adhesion promotion sheet 28 so as to surround a periphery of the adhesion promotion sheet 28, wherein the frame portion is made of a biodegradable sheet (paragraph 15 – absorbable material); and
a holding portion 18 (see Note below) disposed on the frame portion of the adhesion promotion sheet 28 and configured to hook and hold the adhesion promotion sheet 28 on a biological organ to be joined (paragraphs 13-14 – “used for reinforcing and occluding tissue defects”), the holding portion 18 being located on an outer peripheral surface of the cut surface of the one joint target site of the biological organ (functional limitation - paragraph 18 – “Once the prosthesis 28 is positioned proximate to the defect, the drawstring 16 can be pulled, forcing the segments 18 into the circular configuration shown in FIG. 2 and straightening the prosthesis 28 into a flattened configuration positioned across the defect” – therefore also capable of positioning the holding portion 18 on an outer peripheral surface of a biological organ) and wherein the holding portion 18 is configured to hold the adhesion promotion sheet 28 on the biological organ by elastic force of the holding portion 18 (paragraphs 13-14 – functional limitation – segments 18 are capable of imparting an elastic force by pressing down the adhesion promotion sheet 28 to the organ).
Note – 112(f) interpretation – Applicant’s holding portion is a material that can impart elastic force and is C-shaped configured to hook and hold the adhesion promotion sheet on a biological organ to be joined (Spec. [0006] and [0057-0058]); Rousseau’s holding portion 18 are a plurality of rigid, bead-like segments configured to shape/hold of the adhesion promotion sheet (paragraphs 13-14 and 18); therefore both holding portions are equivalent in holding the adhesion promotion sheet.
Rousseau is silent in which the frame portion does not include any of the plurality of through-holes.
However, in a similar field of endeavor of promoting adhesion between biological tissue, Calabrese teaches (Figure 2A) in which the frame portion 120 does not include any of the plurality of through-holes 120 (paragraph 46).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the frame portion of Rousseau to not include any of the plurality of through-holes as taught by Calabrese for the purpose of preventing the leakage of fluids (e.g., body fluids) in the radial outward direction (paragraph 46 of Calabrese).
Rousseau/Calabrese are further silent to the frame portion having a higher rigidity than the adhesion promotion portion.
However, in a similar field of endeavor of promoting adhesion between biological tissue, Bauman teaches (Figure 4C) the frame portion 46 having a higher rigidity than the adhesion promotion portion 42 (paragraph 60 – “The buttress 12 can be made of a constant thickness or can be made of varying thickness, densities or materials of construction through their cross sections… thicker, more dense or stronger material could be constructed into the buttress 12 so as to coincide with the areas where the staples are placed with thinner, less dense or weaker material used in other areas”; paragraph 64 – “A perimeter area 46 of the buttress 12 as depicted can also be made with a thicker or higher density material to increase the strength of the material for staple reinforcement”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the medical device of Rousseau/Calabrese to include the frame portion having a higher rigidity than the adhesion promotion portion as taught by Bauman for the purpose of helping to prevent deformation of the medical device (paragraph 60 of Bauman).
With regards to claim 15, Rousseau further discloses wherein the holding portion 18 is integrally attached to the adhesion promotion sheet 28 (definition of integral according to Merriam-Webster is “formed as a unit with another part”, therefore the holding portion 18 and the adhesion promotion sheet 28 are formed together as a unit).
With regards to claim 16, Rousseau further discloses wherein the holding portion 18 is disposed only in a portion of the adhesion promotion sheet 28 along a circumferential direction (figure 2; paragraph 14 – “segments 18 are pulled together as closely as possible, forcing the loop 22 with segments 18 into a generally circular configuration”).
With regards to claim 22, the combination discloses the medical device of claim 14. Rousseau further discloses wherein the adhesion promotion sheet 28 is made of a biodegradable material (paragraph 15 – “absorbable materials”), and the frame portion extends to an outer edge of the adhesion promotion sheet 28 (figure 2 – frame portion is the outer circumference of the adhesion promotion sheet 28 starting from where the holding portion 18 lies and extending to the edge of the adhesion promotion sheet 28). The combination is silent to the frame portion is compressed in a thickness direction.
However, Bauman further teaches the formation of a medical device, wherein the medical device 12 can be made of varying thickness, densities or materials of construction through their cross sections (paragraph 60). Thus, it can be interpreted that by forming the medical device with varying thicknesses, the frame portion is compressed (less thick, more dense) relative to the central region of the medical device. Additionally, this claim is a product-by-process limitation, as the instant application describes compression in a thickness direction “to crush the through-hole 112” (specification [0052]). Therefore, since the combination discloses no formation of the through-hole on the frame portion of the medical device, the process of compression to crush the through-hole is given no patentable weight.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Rousseau/Calabrese/Bauman to include compressing the frame portion in a thickness direction as taught by Bauman for the purpose of helping to prevent deformation of the medical device (paragraph 60 of Bauman).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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/MOHAMMED S ADAM/Examiner, Art Unit 3771 08/04/2025
/KATHERINE SHI/Primary Examiner, Art Unit 3771