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
Claims 1-21 are pending in the application. Claims 7-21 are withdrawn. Claim 1 has been amended. Claims 1-6 are rejected.
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 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) 1-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wrenstrom, Jr. (US Pat No. 6,152,928) in view of Shluzas et al (US Pat No. 6,146,406).
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Regarding claim 1, Wrenstrom teaches a surgical fixation device (10), comprising:
a central portion1 (see annotated Fig. above, note the portion where the arms and legs extend from is deemed to be a “central portion”)
a pronged upper portion (above top most horizontal dashed line) having two or more arms (30) extending proximally from the central portion to a top surface (See annotated Fig. 1 above) of the upper portion, each of the two or more arms comprising a side of the upper portion (See Fig. 1);
wherein the sides of at least two of the two or more arms are opposing sides (note each arm is on an opposing side of the device);
a flange (tip of 30; see annotated Fig. 1 above) extending outwardly around each of the opposing sides; and
a pronged lower portion (see annotated Fig. 1 above) having two or more legs (18) extending distally2 from the central portion with a space (36) between at least two of the two or more legs.
Wrenstrom does not explicitly teach each of the two or more legs has a concave outer surface facing away from the space. Wrenstrom teaches the legs have a straight, linear outer surface.
Shluzas teaches an analogous surgical fixation (anchor) device (10) with a pronged lower portion (near reference number 50) having two legs (12 and 14) extending therefrom with a space between at least two of the legs (Note open space between legs 12 and 14 as seen in Fig. 2A). Shluzas further teaches each of the two legs has a concave outer surface (46 and 48) facing away from the space. (See Fig. 2A, 2B; Col. 2, lines 60-63). Shluzas also teaches an alternate embodiment where each of the legs has a straight linear outer surface (See Figs. 4A and 4B).
It would have been obvious as a matter of design choice to one of ordinary skill in the art at the time of filing to modify the anchoring device of Wrenstrom with the teachings of Shluzas such that each leg member has a concave outer surface since both straight linear and concave (curved) outer surfaces of the legs are known in the art to be art equivalent shapes which work equally well. It is noted a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. Additionally, a person of ordinary skill in the art would have recognized the interchangeability of the element shown in the prior art for the corresponding element disclosed in the specification. (See MPEP §2183)
Regarding claim 2, modified Wrenstrom further teaches the flange is between3 the top surface and the lower portion (note the flange is directly adjacent the top surface and extends towards the lower portion).
Regarding claim 3, modified Wrenstrom further teaches each of the two or more legs (18) terminates in a sharp edge (point 34). (See Fig. 1; Col. 4, lines 7-10)
Regarding claim 4, modified Wrenstrom further teaches the upper portion4 is wider than the lower portion. (See annotated Fig. 1 above; note that the width of the lower portion between the two horizontal dashed lines is smaller in width than the rounded upper portion. Dash marks provided to aid in visualization)
Regarding claim 5, modified Wrenstrom further teaches a slot (22) extending through the top surface of the upper portion, separating the two of the two or more arms. (See annotated Fig. 1 above; Col. 4, lines 46-50).
Regarding claim 6, modified Wrenstrom further teaches at least one relief feature5 on a side of the upper portion adjacent to at least one of the two or more arms. (See annotated Fig. 1 above).
Response to Arguments
Applicant's arguments filed July 25, 2025 have been fully considered but they are not persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant’s only specific argument is that the Shluzas reference (US Pat. No. 6,146,406) fails to teach the legs extend distally from the central portion and instead teach the legs extend proximally. Firstly, it is noted that the rejection does not rely upon Shluzas to teach the legs extending distally from the central portion. As clearly seen above, Wrenstrom, Jr. (US Pat No. 6,152,928) teaches the legs extend distally from the central portion of the device. Shluzas is relied upon for the teaching that legs in a surgical fixation (anchor) device can either be curved or straight. Wrenstrom is relied upon for all other features of the claim.
Secondly, it is noted that “proximal” and “distal” are relative terms. It is further noted that while "distal" is often used to describe the portion of a device farthest from the operator, it is also used in the medical art to describe the portion closest to the operator. Further, “proximal” and “distal” are defined by Merriam-Webster in relation to the center of the body. Thus, the legs of Shluzas could reasonably be interpreted as extending distally since there are no other specific relative structural limitations which prevent such an interpretation. However, this point is moot since Shluzas is not being relied upon to teach this feature. Examiner’s comments regarding the structure of Shluzas are included to highlight the analogous nature of the two anchoring devices.
It is noted the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
The remainder of applicant’s arguments amount to an allegation of patentability based on the alleged deficiencies of the primary reference. For the reasons set forth above, this is unpersuasive.
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 RACHEL S. HIGHLAND whose telephone number is (571)270-3254. The examiner can normally be reached on Monday through Thursday between 9:30am and 2:30pm .
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/R.S.H/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
1 MPEP §2111 requires claim limitations be given their “broadest reasonable interpretation in light of the specification”. Additionally, claim terms are given their “plain meaning” unless applicant has provided a special definition. However, it is improper to import claim limitations from the specification into the claims. “Portion” is defined as “part of the whole” and thus only requires a part of the device to meet the claimed limitation. As seen in annotated Fig. 1 above, there is a part of the device that is in the middle (central) which meets the present claim limitations.
2 It is noted that “proximal” and “distal” are relative terms. It is further noted that while "distal" is often used to describe the portion of a device farthest from the operator, it is also used in the medical art to describe the portion closest to the operator. Further, “proximal” and “distal” are defined by Merriam-Webster in relation to the center of the body. In the instant case, the top of the device is deemed to be proximal and the bottom of the device is deemed to be distal which is the interpretation consistent with the specification. Additionally, other than the arms extending proximally and the legs extending distally, the claims do not require any other particular orientations of specific structures.
3 MPEP §2111 requires claim limitations be given their “broadest reasonable interpretation in light of the specification”. Additionally, claim terms are given their “plain meaning” unless applicant has provided a special definition. However, it is improper to import claim limitations from the specification into the claims. Merriam-Webster Dictionary provides multiple definitions for “between” including: “1a: by the common action of, jointly engaging; 1b: in common to, shared by; 2a in the time, space, or interval that separates; 2b in intermediate relation to; 3a from one to another of; 3b serving to connect or unite in a relationship (such as difference, likeness, or proportion)”. It is the examiner’s position that the flange as seen in Fig. 1 of Wenstrom satisfies many of these definitions.
4 Under the “broadest reasonable interpretation” standard, “portion” is defined as “part of the whole” and thus only requires a part of the device to meet the claimed limitation. As seen in annotated Fig. 1 above, the lower portion between the two horizontal lines has a smaller width than the upper portion. Note there are no limitations in the claims which preclude this interpretation.
5 MPEP §2111 requires claim limitations be given their “broadest reasonable interpretation in light of the specification”. Additionally, claim terms are given their “plain meaning” unless applicant has provided a special definition. However, it is improper to import claim limitations from the specification into the claims. Applicant’s specification describes the “relief feature” as slots on opposing sides of the aperture (See paragraph [0048] as published). It is the examiner’s position that the chamfered inner edges see in Fig. 1 are sufficient to meet this limitation as currently claimed.