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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/12/2016 has been entered.
Claim Rejections - 35 USC § 102/103
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-17 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by US 2017/0135688 A1 to Branthover et al. (hereinafter “Branthover”) (previously of record) or, in the alternative, under 35 U.S.C. 103 as obvious over Branthover in view of US 5,667,155 to Cerwin et al. (hereinafter “Cerwin”).
Note that a 102/103 rejection is permissible in instances where different interpretations of a claim term would result in different rejections. See MPEP 2158.01 at form paragraph 7.27.aia, note 2(a).
Regarding claim 1, Branthover discloses (see abstract; Figs. 1-29C; and [0043]-[0091]) a surgical instrument system (502, see Figs. 18-22 and Figs. 27A-B) comprising: a suture (14), a needle secured to the suture (910, Fig. 27B, see [0076] and [0089]), a surgical instrument ("suture anchor", see [0073], see also 112, Fig. 12), and a suture cartridge (506; see Figs. 18-20, see also [0076] referencing [0089] & Figs. 27A-B) wherein a portion of the suture extends proximally from a distal end of the surgical instrument (see [0073] and [0061]); wherein the suture cartridge receives a second portion of the suture and the needle (see [0073]-[0076]); and wherein the suture cartridge is removably connected to the surgical instrument (see Figs. 18-19 and [0073]), the suture cartridge including a first cavity (e.g, shown near #910 on first side of 904, Fig. 27B) to retain (hold) a proximal end of the needle and a second cavity (e.g., indicated by #912, Fig. 27B) to retain (hold) a distal end of the needle (see Fig. 27B), such that the suture cartridge can be removed from the surgical instrument with the needle and the suture retained (held) in the suture cartridge (see Figs. 18-20 and [0073]-[0076]).
Regarding claim 9, Branthover discloses (see abstract; Figs. 1-29C; and [0043]-[0091]) a surgical instrument system (502, see Figs. 18-22 and Figs. 27A-B) comprising: a suture (14), a first needle secured to a first end of the suture, a second needle secured to a second end of the suture (910, Fig. 27B, see [0076] and [0089], see also Fig. 12), a surgical instrument ("suture anchor", see [0073], see also 112, Fig. 12), and a suture cartridge (506; see Figs. 18-20, see also [0076] referencing [0089] & Figs. 27A-B) wherein a first portion of the suture extends proximally from a distal end of the surgical instrument to the first needle; wherein a second portion of the suture extends proximally from the distal end of the surgical instrument to the second needle (see [0073] and [0061], see also Fig. 12); wherein the suture cartridge receives the first and second needles and part of the first portion and part of the second portion of the suture (see [0073]-[0076]); and wherein the suture cartridge is removably connected to the surgical instrument (see Figs. 18-19 and [0073]), the suture cartridge including a first cavity (e.g, shown near #910 on first side of 904, Fig. 27B) to retain (hold) a proximal end of the first and second needles and a second cavity (e.g., indicated by #912, Fig. 27B) to retain (hold) a distal end of the first and second needles (see Fig. 27B), such that the suture cartridge can be removed from the surgical instrument with the first and second needles retained (held) in the suture cartridge (see Figs. 18-20 and [0073]-[0076]).
The rejection of claims 1/9 hinges on the interpretation of the term “hold/held”, which has replaced the terms “retain/retained”, and what the broadest reasonable interpretation of “hold/held” is in light of the specification as filed. The specification as filed discusses the “cavities” for the needle as follows: suture needles are held in cavities in the cartridge ([00149]) and that needles are insertable into the needle cavities for storage [00155]. The cavities are labeled as #822 and shown in Figs. 60-61. A review of the specification shows that there is no actual structure or mechanism in or within the cavities for actively holding the needles. Figures 60-61 show the needles as simply being located within cavities 822, but do not show any structure or mechanism within cavity 822 that holds, grasps, attaches to, secures, latches, etc. onto the needles. Further, there is no discussion that the needle is press-fit, friction fit, etc. into the cavity such that the cavity could hold or secure the needle within the cavity.
Dictionary.com defines several definitions for the term “hold”, with the most relevant ones to this application being (3) to bear, sustain, or support by any means, and (9) to contain or be capable of containing. Applicant appears to believe that definition (3) should be used to interpret the meaning of the term “hold” (see Applicant’s remarks on page 7, 1st paragraph: “the proximal end of the needles (of the reference)…is not held by any component of the suture holder”. However, as just discussed above, there is no structure that bears, sustains, or supports by any means the proximal/distal ends of the needle in cavities 822 in the application. Instead, the Examiner posits that definition (9) is more appropriately construed as the BRI of the term in light of the specification, in that cavities 822 contain or are capable of containing the ends of the suture needle. As discussed in the rejection above, there are cavities defined in Branthover’s device that “hold” the proximal and distal ends of the needle, because they “contain or are capable of containing” the ends of the needle, because the needle ends are contained within those cavities, irrespective of whether needle slots 906 hold the middle of the needle or not.
Thus, under this interpretation, Branthover anticipates the claim under 102. Further, it would be inappropriate to read Applicant’s construction of the term “hold” into the specification, because as mentioned above there is no actual mechanism for actively holding or grasping the needle ends in the cavity, and thus interpreting the term “hold” to actively hold/grasp the needle would constitute new matter. However, in the interests of compact prosecution, an alternate 103 rejection is set forth below using Applicant’s interpretation.
It is noted that Branthover discusses that a plurality of mechanisms for retaining the needles can be used, including any suitable needle holder ([0076]). Cerwin discloses, in the same field of endeavor of suture/needle devices with needle holders, a mechanism for retaining a needle (see Fig. 1F and Col. 5, lines 35-48) comprising a first cavity (within 164 at proximal end of needle) for holding the proximal end of the needle and a distal cavity (within 162) for holding the distal end of the needle for the purpose of providing a snap block at the proximal end of the needle to accept the needle and retain it against movement during storage buy permit the needle to be easily removed due to its sufficient resiliency while also providing a tip block as the distal end of the needle to prevent the needle from twisting within the device (see Col. 5, lines 35-48). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Branthover’s device by providing the tip block and snap block to retain the ends of the needle, as taught by Cerwin, in order to accept the needle and retain it against movement or twisting during storage within the device but allow the needle to still be easily removed.
Branthover (alone or in combination with Cerwin) further discloses (claim 2) wherein the surgical instrument comprises a handle (504) and an elongated shaft (510) extending from the handle (see Fig. 19); (claim 3) wherein the suture extends proximally from a distal end of the elongated shaft and wherein the suture cartridge is removably connected to the handle (see [0073]); (claim 4) wherein the handle comprises a cavity (512), and wherein the suture cartridge is at least partially insertable into the cavity to removably connect the suture cartridge to the handle (see Fig. 19 and [0073]); (claim 5) wherein the needle and the second portion of the suture are located inside the cavity when the suture cartridge is at least partially inserted into the cavity (see [0076], [0089], Figs. 18 and 27A-B); (claim 6) wherein the second portion of the suture is in a coiled configuration when the suture cartridge is at least partially inserted into the cavity (see [0075]); (claim 7) wherein the suture cartridge comprises at least two posts, wherein the suture is wrapped around the posts when in the coiled configuration (see Fig. 12); (claim 8) wherein the suture cartridge comprises a needle cavity, wherein the needle is at least partially insertable into the needle cavity (see Figs. 27A-B and [0089]); (claim 10) further comprising an anchor connected to the distal end of the surgical instrument, wherein the suture is connected to the anchor ("suture anchor", see [0073], see also 112, Fig. 12); (claim 11) wherein the surgical instrument comprises a handle (504) and an elongated shaft (510) extending from the handle (see Fig. 19); (claim 12) wherein the suture cartridge is removably connected to the handle (see [0073]); (claim 13) wherein the handle comprises a cavity (512), and wherein the suture cartridge is at least partially insertable into the cavity to removably connect the suture cartridge to the handle (see Fig. 19 and [0073]); (claim 14) wherein the first and second needles and part of the first portion and the part of the second portion of the suture are located inside the cavity when the suture cartridge is at least partially inserted into the cavity (see [0076], [0089], Figs. 18 and 27A-B); (claim 15) wherein the parts of the first and second portions of the suture is in a coiled configuration when the suture cartridge is at least partially inserted into the cavity (see [0075]); (claim 16) wherein the suture cartridge comprises at least two posts, wherein the suture is wrapped around the posts when in the coiled configuration (see Fig. 12); and (claim 17) wherein the suture cartridge comprises a plurality of needle cavities, wherein the needles are at least partially insertable into the needle cavities (see Figs. 27A-B and [0089]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-17 have been considered but are not persuasive. As discussed in the rejection above, Examiner believes that Applicant is improperly construing the term “held” in a manner that is unsupported by the specification as filed. Specifically, while the specification does use the term “held”, the definition intended to be used by Applicant is not supported by the specification as filed, as set forth in the rejection above. Applicant states on page 8, last paragraph, that the present specification does specify that the needle ends are held by a structure and within the cavities (emphasis added by Examiner). Applicant has not stated nor shown any support for any alleged such “structure”. Nonetheless, in the interests of compact prosecution, an alternate 103 rejection has also been set forth to establish the non-patentability of the claims as currently recited.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771