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 .
Claim Objections
Claim 10 is objected to because of the following informalities:
Claim 10 recites “needle couples to a suture” which is a typo; a suggested edit is “needle couple[[s]]d to a suture”; this is how the claim will be interpreted for examination purposes below.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 4-10 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 4-10 each recites the limitation "The device of claim…" in preamble. There is insufficient antecedent basis for this limitation in the claim. Claims 1-3 on which these claims depend from recite “system”; claim 1 recites “A marking system” and claims 2-3 recite “The system of claim…”. It is unclear and thus indefinite whether “device” is the same as “system”. For examination purposes below, it will be assumed that the instant claims recite “The system of claim…”; claim terms should be consistent throughout the claim set.
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.
Claim(s) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Opperman (US 20160331485 A1; 11/17/2016; issued patent cited in IDS) in view of Selis (US 20050277871 A1; 12/15/2005).
Regarding claim 1, Opperman teaches a marking system (Abstract; Fig. 4; [0012]) comprising:
a central specimen marker to be inserted within mass tissue (Fig. 3A-3E; [0015]; [0016] “deep location”; [0016] “placed on a mass”; claim 6 “deep location”; claim 7; claim 16 “deep location”; claim 17 “placed on the specimen mass”).
Opperman does not explicitly teach to identify a center of the mass tissue. For the purposes of examination, Applicant is reminded that this is a product claim. Intended use/functional language does not require that reference specifically teach the intended use of the element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Opperman’s teaching of clip being placed on mass to mark tissue would structurally meet the claim limitation.
However, for the sake of compact prosecution and to avoid doubt, Selis teaches in the same field of endeavor (Abstract; [0003]) a central specimen marker to be inserted within mass tissue to identify a center of the mass tissue (Fig. 1A-2; [0024] “deploying the clip to the central region…marking clip and insures proper securing and placement of the clip at a predetermined location, particular a central region of the tissue of interest”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Opperman to include this feature as taught by Selis because this enables marking central tissue of interest with marking clip ([0015]-[0016]; [0024]).
In the combination of Opperman and Selis, Opperman teaches a first set of specimen markers be inserted within the mass tissue to provide a mapping for removing the mass tissue (Fig. 2-4; [0015]-[0018]; claim 1; claim 9; claim 11; claim 19).
Regarding claim 2, in the combination of Opperman and Selis, Opperman teaches a second set of specimen markers to be inserted in tissue surrounding the mass tissue at locations adjacent to the first set of specimen markers (Fig. 2-4; [0015]-[0018]; claim 2; claim 7; claim 12; claim 17).
Regarding claim 3, in the combination of Opperman and Selis, Opperman teaches wherein the first set of specimen markers and the second set of specimen markers provide a mapping between the mass tissue and the surrounding tissue (Fig. 2-4; [0015]-[0018]; claim 1; claim 4; claim 9; claim 11; claim 14; claim 19).
Regarding claim 4, in the combination of Opperman and Selis, Opperman teaches wherein the first set of specimen markers comprise:
a second specimen marker located at a first location within the mass tissue; and
a third specimen marker located at a second location within the mass tissue (Fig. 2-4; [0015]-[0018]; claim 1 “one or more marking clips attached to a specimen mass”; claim 11).
Regarding claim 5, in the combination of Opperman and Selis, Opperman teaches wherein the second set of specimen markers comprise:
a fourth specimen marker located at a first location within the surrounding tissue; and
a fifth specimen marker located at a second location within the surrounding tissue (Fig. 2-4; [0015]-[0018]; claim 2; claim 12).
Regarding claim 6, in the combination of Opperman and Selis, Opperman teaches wherein the first location of the surrounding tissue is adjacent to the first location of the mass tissue and the second location of the surrounding tissue is adjacent to the second location of the mass tissue (Fig. 3A-4; [0015]-[0018]; claims 1-2; claim 4; claim 7; claims 11-12; claim 14; claim 17).
Regarding claim 7, in the combination of Opperman and Selis, Opperman teaches wherein the specimen marker comprises a first color, the second and fourth specimen markers comprise a second color and the third and fifth specimen markers clips comprise a third color (Fig. 4; [0015]-[0018]; claims 4-7; claims 14-17).
Regarding claim 8, in the combination of Opperman and Selis, Opperman teaches wherein the second set of specimen markers provide a mapping for removing portions of the surrounding tissue (Fig. 3A-4; [0015]-[0018]; claim 9; claim 19).
Regarding claim 9, in the combination of Opperman and Selis, Opperman teaches wherein a specimen marker comprises a marking clip (Fig. 2-4; [0014] “marking clip”).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Opperman and Selis as applied to claim 1 above, and further in view of Mikkaichi (US 20070157937 A1; 7/12/2007).
Regarding claim 10, the combination of Opperman and Selis does not teach wherein a specimen marker comprises a needle coupled to a suture. Note that Opperman teaches specimen marker comprises clip coupled to a suture (Fig. 2-4; [0018]; claim 3) and Selis teaches “a needle having an opening and a clip delivery device within the needle” (claim 14). However, Mikkaichi teaches in the same field of endeavor (Fig. 2, S51; [0045]) that “it is also acceptable to carry out marking of the tissue using a clip, needle or the like.” ([0085]). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Opperman and Selis to substitute a needle for a clip in Opperman’s teaching of clip coupled to a suture (Fig. 4; [0018]; claim 3) such that the specimen marker comprises a needle coupled to a suture because this is simple substitution with predictable results; MPEP 2144.06 art recognized equivalence for the same purpose.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wright (US 20060229529 A1) teaches marking tissue with pins and clips that are labeled and/or colored (Fig. 1; Fig. 3-11; Fig. 14-18; [0037]).
Philips (US 20240008860 A1) teaches “tissue orientation clip and a delivery device that delivers one or more tissue orientation clips to a tissue site” (Abstract) that are colored (Fig. 2-3; [0011]; [0049]; [0058]) and can identify margin of a tissue ([0081]).
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/JONATHAN T KUO/Primary Examiner, Art Unit 3792