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 .
Detailed Action
This is in response to the non-provisional application filed 10/18/2024.
Claim Interpretation - 35 USC § 112(f)
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.
Allowable Subject Matter
Claims 3, 7, 8, 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Claim 3 recites wherein the first, second and third compliance control stitch patterns are the same. claim 7 recites each of the first and second compliance control stitch patterns interlock at vertices. The office agrees the art of record fail to teach or suggest these features. Claim 8 recites wherein each of the first, second and third compliance control stitch patterns comprise repeating vertices, wherein the vertices of the first compliance control stitch pattern are the same angles as the vertices of the second compliance control stitch pattern. Claim 14 recites wherein the first, second and third compliance control stitch patterns share vertices.
The Office agrees the art of record fail to teach or suggest these featues.
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.
Claim(s) 1, 2, 4, 5, 9, 10-12, 15, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2011/0166673 (Patel et al.) in view of U.S. Patent Publication Number 2005/0070930 (Kammerer)
Regarding claims 1, 4, 5, 9, 10 Patel et al. discloses as shown Figure 1, an implant for repairing or reconstructing soft tissue, the implant comprising: a substrate comprising a plurality of layers (multiple layers 12, see paragraph [0034]), wherein each layer comprises a biotextile or a medical textile; and a compliance control stitch (suture 14, see paragraph [0034]) pattern sewn or embroidered into the substrate.
Patel fails to disclose triaxial compliance control stitch pattern sewn or embroidered into the substrate, wherein the triaxial compliance control stitch pattern comprises a first compliance control stitch pattern, a second compliance control stitch pattern and a third compliance control stitch pattern that overlie each other to form the triaxial pattern.
Kammerer, from the same field of endeavor teaches a similar implant as shown in Figure 13, where a compliance control stitch pattern is triaxial wherein the triaxial compliance control stitch pattern comprises a first compliance control stitch pattern, a second compliance control stitch pattern and a third compliance control stitch pattern that overlie each other to form the triaxial pattern, wherein the first compliance control stitch pattern is different than the second and/or third compliance control stitch patterns, wherein the first compliance control stitch pattern is sewn into the second compliance control stitch pattern, wherein the first compliance control stitch pattern is oriented in a different direction than the second compliance control stitch pattern and the second third compliance control stitch pattern, wherein at least one of the first, second and third compliance control stitch patterns comprises a plurality of straight lines oriented along one or more axes of the substrate. See paragraph [0041].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the implant disclosed by Patel et al. substituting the compliance control stitch disclosed by Patel for the triaxial one taught by Kammerer because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Regarding claim 2, Patel fails to disclose the peak compliance strain is at a load of 16 Newtons per centimeter (N/cm) that is between 10% and 30%.
Patel recognizes that the amount of compliance is a result effective variable recognized for the purpose of preventing delamination of the implant and reinforce the implant. See paragraphs [0011], [0050].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method disclosed by Patel by altering the strength of the stitch formed by interweaving members 19 (by altering the shape of the stitch or its material, or the type of stitch see paragraphs [0042], [0044], [0045]) such that the peak compliance strain is at a load of 16 Newtons per centimeter (N/cm) that is between 10% and 30% in order to preventing delamination of the implant and reinforce the implant because it would only require the optimization of a result effective variable and it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 11, Patel et al. in view of Kammerer discloses wherein at least one of the first, second and third compliance control stitch patterns are resorbable by a human body so that the peak compliance strain of the implant changes over time while implanted in the subject. See paragraph [0012] and abstract.
Regarding claims 12, 15 Patel et al. discloses as shown Figure 1, an implant for repairing or reconstructing soft tissue, the implant comprising: a substrate comprising a plurality of layers layers (multiple layers 12, see paragraph [0034]) comprising a biotextile, a medical textile, or both a biotextile and a medical textile; and a first compliance control stitch pattern sewn or embroidered into the substrate.
Patel fails to disclose a second compliance control stitch pattern, and a third compliance control stitch pattern sewn or embroidered into the substrate, wherein the first, second and third compliance control stitch patterns form a triaxial pattern so that a peak compliance strain of the implant at 16 N/cm is between 10% and 30%.
Kammerer, from the same field of endeavor teaches a similar implant as shown in Figure 13, where a compliance control stitch pattern is triaxial wherein the triaxial compliance control stitch pattern comprises a first compliance control stitch pattern, a second compliance control stitch pattern and a third compliance control stitch pattern that overlie each other to form the triaxial pattern, wherein the first compliance control stitch pattern is different than the second and/or third compliance control stitch patterns, wherein the first compliance control stitch pattern is sewn into the second compliance control stitch pattern, wherein the first compliance control stitch pattern is oriented in a different direction than the second compliance control stitch pattern and the second third compliance control stitch pattern, wherein at least one of the first, second and third compliance control stitch patterns comprises a plurality of straight lines oriented along one or more axes of the substrate, wherein the first, second and third compliance control stitch patterns each comprise a plurality of straight lines oriented along one or more axes of the substrate. See paragraph [0041].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the implant disclosed by Patel et al. substituting the compliance control stitch disclosed by Patel for the triaxial one taught by Kammerer because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Patel recognizes that the amount of compliance is a result effective variable recognized for the purpose of preventing delamination of the implant and reinforce the implant. See paragraphs [0011], [0050].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method disclosed by Patel by altering the strength of the stitch formed by interweaving members 19 (by altering the shape of the stitch or its material, or the type of stitch see paragraphs [0042], [0044], [0045]) such that the peak compliance strain is at a load of 16 Newtons per centimeter (N/cm) that is between 10% and 30% in order to preventing delamination of the implant and reinforce the implant because it would only require the optimization of a result effective variable and it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 16, Patel et al. teaches in a related embodiment at least one of the first, second and third compliance control stitch patterns comprises a grid pattern. See Figure 7.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the implant disclosed by Patel in view of Kammerer by substituting the shape of at least one of the first, second and third compliance control stitch patterns for the grid shape taught by Figure 7 of Patel such that at least one of the first, second and third compliance control stitch patterns comprises a grid pattern because it would only require the simple substitution of one known alternative configuration for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2011/0166673 (Patel et al.) in view of U.S. Patent Publication Number 2005/0070930 (Kammerer) as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2010/0028396 (Ward et al.)
Regarding claim 6, Patel et al. fails to disclose wherein at least one of the first, second and third compliance control stitch patterns have a zig-zag pattern comprising repeating vertices.
Ward et al. from a related field of endeavor teaches a similar implant with a compliance control stitch patterns have a zig-zag pattern comprising repeating vertices. See paragraph [0088].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify at least one of the first, second and third compliance control stitch patterns disclosed by Patel et al. in view of Kammerer by substituting one of them for the zig-zag pattern taught by Ward et al. such that at least one of the first, second and third compliance control stitch patterns have a zig-zag pattern comprising repeating vertices because it would only require the simple substitution of one known alternative configuration for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2011/0166673 (Patel et al.) in view of U.S. Patent Publication Number 2005/0070930 (Kammerer) as applied to claim 12 above, and further in view of U.S. Patent Publication Number 2010/0028396 (Ward et al.)
Regarding claim 13, Patel fails to disclose wherein the triaxial pattern has a high density in which the first, second and third compliance control stitch patterns comprise about 0.5 mm to about 12 mm per stitch.
Ward et al. from a related field of endeavor teaches a similar implant with a compliance control stitch patterns comprise about 0.5 mm to about 12 mm per stitch. See paragraph [0144].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify at least one of the first, second and third compliance control stitch patterns disclosed by Patel et al. in view of Kammerer by substituting the distance between the stitches taught by Patel et al. in view of Kammerer for the 5 mm taught by Ward because it would only require the simple substitution of one known alternative configuration for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Alternatively, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify at least one of the first, second and third compliance control stitch patterns disclosed by Patel et al. in view of Kammerer such that the triaxial pattern has a high density in which the first, second and third compliance control stitch patterns comprise about 0.5 mm to about 12 mm per stitch as matter of engineering design choice.
Applicant has not disclosed that spacing the spacing of the stitches apart provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Patel in view of Kammerer’s stitches, and applicant’s invention, to perform equally well with either the spacing taught by Patel in view of Kammerer or the claimed 0.5 mm to about 12 mm spacing because both spacing dimensions would perform the same function of holding layers of the substrate together equally well considering the relative dimensions disclosed.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2011/0166673 (Patel et al.) in view of U.S. Patent Publication Number 2005/0070930 (Kammerer), U.S. Patent Publication Number 2010/0028396 (Ward et al.)
Regarding claim 17 Patel et al. discloses as shown Figure 1, an implant for repairing or reconstructing soft tissue, the implant comprising: a substrate comprising a plurality of layers (multiple layers 12, see paragraph [0034]), wherein each layer comprises a biotextile or a medical textile; and a compliance control stitch (suture 14, see paragraph [0034]) pattern sewn or embroidered into the substrate.
Patel fails to disclose triaxial compliance control stitch pattern sewn or embroidered into the substrate, wherein the triaxial compliance control stitch pattern comprises a first compliance control stitch pattern, a second compliance control stitch pattern and a third compliance control stitch pattern that overlie each other to form the triaxial pattern.
Kammerer, from the same field of endeavor teaches a similar implant as shown in Figure 13, where a compliance control stitch pattern is triaxial wherein the triaxial compliance control stitch pattern comprises a first compliance control stitch pattern, a second compliance control stitch pattern and a third compliance control stitch pattern that overlie each other to form the triaxial pattern, wherein the first compliance control stitch pattern is different than the second and/or third compliance control stitch patterns, wherein the first compliance control stitch pattern is sewn into the second compliance control stitch pattern, wherein the first compliance control stitch pattern is oriented in a different direction than the second compliance control stitch pattern and the second third compliance control stitch pattern, wherein at least one of the first, second and third compliance control stitch patterns comprises a plurality of straight lines oriented along one or more axes of the substrate. See paragraph [0041].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the implant disclosed by Patel et al. substituting the compliance control stitch disclosed by Patel for the triaxial one taught by Kammerer because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Alternatively, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify at least one of the first, second and third compliance control stitch patterns disclosed by Patel et al. in view of Kammerer such that the triaxial pattern has a high density in which the first, second and third compliance control stitch patterns comprise about 0.5 mm to about 12 mm per stitch as matter of engineering design choice.
Applicant has not disclosed that spacing the spacing of the stitches apart provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Patel in view of Kammerer’s stitches, and applicant’s invention, to perform equally well with either the spacing taught by Patel in view of Kammerer or the claimed 0.5 mm to about 12 mm spacing because both spacing dimensions would perform the same function of holding layers of the substrate together equally well considering the relative dimensions disclosed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is 571-270-1965. The examiner can normally be reached on Monday – Friday, 9:30 – 6:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
If there are any inquiries that are not being addressed by first contacting the Examiner or the Supervisor, you may send an email inquiry to TC3700_Workgroup_D_Inquiries@uspto.gov.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RICHARD G LOUIS/Primary Examiner, Art Unit 3771