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 amendment filed 07/24/2024.
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.
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) 1-8, 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 5,782,864 (Lizardi) in view of U.S. Patent Publication Number 2009/0306711 (Stone et al.)
Regarding claims 1-3, Lizardi discloses as shown in Figure 1, a suture system, comprising: a strand of suture (first suture loop 14, see col.3, lines 6-14) ; and a needle (suture needle 16, see col.3, lines 6-14) having a loading loop (second suture loop 18, see col.3, lines 6-14); wherein the strand of suture is threaded over the loading loop, wherein at least a second portion of the strand of suture is configured to form a bridge connecting a first proximal body and second distal body when in use.
Lizardi fails to disclose a flexible backstop having two ends, and the needle passes through the flexible backstop such that at least a first portion of the strand of suture is positioned through the flexible backstop.
Stone et al., from a related field of endeavor teaches a similar suture system as shown in Figure 1C wherein the system includes a flexible backstop (connector device 101, see paragraph [0030]), at least a first portion of the strand of suture is positioned through the flexible backstop, for the purpose of allowing tissue to tissue attachment in multiple locations without the need of individual knots for each location, wherein when a needle is pulled through the flexible backstop, the loading loop and the strand of suture are capable of being pulled through the flexible backstop, wherein the flexible backstop is capable of comprising a first state in which the flexible backstop is uncompressed and extends along a first longitudinal axis; and a second state in which the flexible backstop is compressed and expanded in a direction perpendicular to the longitudinal axis. see paragraph [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 suture system disclosed by Lizardi to include the suture backstop taught by Stone et al. such that the system included a flexible backstop having two ends a first portion of the strand of suture is positioned through the flexible backstop.
Regarding the limitations “the needle passes through the flexible backstop such that at least a first portion of the strand of suture is positioned through the flexible backstop”, the Office is interpreting these limitations are product by process.
"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)
"The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983).
In this case, the needle passing through the flexible backstop is how the suture system is assembled into its final form before use. There does not appear to be any structure implied by these steps that would be absent the combination of Lizardi and Stone.
Alternatively, it would have been further obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the suture disclosed by Lizardi in view of Stone et al. such that the needle passes through the flexible backstop such that at least a first portion of the strand of suture is positioned through the flexible backstop as obvious to try because it represents choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
In this case, since the prior art teaches a strand of suture is positioned through the flexible backstop and a needle attached the suture, it follows that passing the needle through the flexible backstop such that at least a first portion of the strand of suture is positioned through the flexible backstop represents choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success and is obvious to try. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Regarding claim 5, Lizardi discloses an anchoring body (anchor 12, see col. 3, lines 14-28) having at least a portion of the strand of suture positioned through the anchoring body.
Regarding claims 6, 7 Lizardi in view of Stone et al. wherein the anchoring body and the flexible backstop are held in relative position to each other via the strand of suture (because they are all connected with one another via the suture), wherein a portion of the anchoring body is capable of being positioned on a distal surface of the second distal body and a portion of the flexible backstop is capable of being positioned on a proximal surface of the first proximal body in the deployed configuration. see col.3, lines 6-14 of Lizardi.
Regarding claim 8, Lizardi in view of Stone et al. wherein the flexible backstop is an all-suture backstop. See paragraph [0030].
Regarding claim 10, Lizardi discloses wherein the at least second portion of the strand of suture is capable of being positioned through a single hole formed in at least one of the first proximal body and the second distal body.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 5,782,864 (Lizardi) in view of U.S. Patent Publication Number 2009/0306711 (Stone et al.) as applied to claim 5 above, and further in view of U.S. Patent Publication Number 2010/0152752 (Denove et al.)
Regarding claim 9, Lizardi fails to disclose wherein the anchoring body is an all-suture button or a metal button.
Denove, from the same field of endeavor teaches a similar suture system as shown in Figure 1 with a similar anchoring body (button) used for the same purpose of securing a suture, where the anchoring body is the form of a metal body. See claim 26.
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 system disclosed by Lizardi by substituting the anchoring body disclosed by Lizardi for the anchoring body taught by Denove 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).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 5,782,864 (Lizardi) in view of U.S. Patent Publication Number 2009/0306711 (Stone et al.) as applied to claim 5 above, and further in view of U.S. Patent Publication Number 2006/0030884 (Yeung et al.) and U.S. Patent Publication Number 2009/0209909 (Tanaka et al.)
Regarding claim 11, Lizardi fails to disclose wherein at least one of the flexible backstop and the anchoring body is comprised of radiopaque fiber.
Yeung et al., from the same field of endeavor discloses as similar suture system as shown in Figure 1, where anchoring body is comprised of radiopaque material. See paragraph [0206].
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 suture system disclosed by Lizardi by incorporating the radiopaque material taught by Yueng into the anchoring body disclosed by Lizardi in order to configure the anchoring body to be tracked by a surgeon.
Tanaka, from a related field of endeavor teaches a similar use of radiopaque material, where the radiopaque material is the form of a radiopaque fiber. See paragraph [0118].
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 stem disclosed by Lizardi in view of Stone and Yueng by substituting the radiopaque materials disclosed by Lizardi in view of Stone and Yueng for the radiopaque fiber taught by Tanaka because it would only require the simple substitution of 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).
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.
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/RICHARD G LOUIS/Primary Examiner, Art Unit 3771