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 .
Claim Objections
Claim 21 is objected to because of the following informalities:
“comprising:” in line 1 should read “the adjunct comprising:”.
“is thereby” in line 4 should read “is”.
“and thereby adhere” in line 6 should read “and adhere”.
Claim 24 is objected to because of the following informality: “length and” in line 2 should read “length of the first layer and”.
Claim 31 is objected to because of the following informality: “sever tissue” in line 2 should read “sever the tissue”.
Claim 32 is objected to because of the following informalities:
“comprising:” in line 2 should read “the adjunct comprising:”.
“and thereby adhere” in line 8 should read “and adhere”.
Claim 33 is objected to because of the following informalities:
“where the” in line 1 should read “wherein the”.
“length and” in line 2 should read “length of the body layer and”.
Claim 36 is objected to because of the following informality: “a fifth layer” in line 1 should read “an additional layer” (because first, second, third, and fourth layers were not previously recited).
Claim 37 is objected to because of the following informality: “is thereby configured” in line 10 should read “is configured”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 29 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor, at the time the application was filed, had possession of the claimed invention. Claim 29 recites the limitation “the fifth layer and the second layer are separated by…the first layer” in lines 1-2. However, this limitation is not disclosed in any part of the instant application. Instead, it is clear when Figures 24-26 and Paragraph 0142 of the Patent Application Publication of the instant application are considered together that the fifth layer 3040 and the second layer 3030 are only separated by the third layer 3020+3022 and the adhesive layer 3050. Thus, the limitation constitutes new matter. The examiner suggests changing “the first layer, the third layer, or the adhesive layer” to “the third layer or the adhesive layer” in order to overcome this rejection.
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.
Claims 29-31, 35, 36, and 39 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 pre-AIA the applicant regards as the invention.
Claim 29 recites the limitation "the fifth layer" in line 1. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the examiner is interpreting the limitation as if it instead reads “the fourth layer”.
Claim 30 recites the limitation "the adjunct of claim 1" in line 5. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the examiner is interpreting the limitation as if it instead reads “the adjunct of claim 21”.
Claim 35 recites the limitation "the third layer" in line 1. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the examiner is interpreting the limitation as if it instead reads “the reinforcement layer”.
Claim 36 recites the limitation "the second layer" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the examiner is interpreting the limitation as if it instead reads “the supplemental layer”.
Claim 36 recites the limitation "the fourth layer" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the examiner is interpreting the limitation as if it instead reads “the adhesive layer”.
Claim 39 recites the limitation "at least a portion of the second layer is spaced apart from the first layer by the second layer" in lines 1-2. It is unclear from this limitation how the second layer can possibly be spaced apart from the first layer by itself. For examination purposes, the examiner is interpreting the limitation as if it instead reads “at least a portion of the third layer is spaced apart from the first layer by the second layer”.
Claim 31 is rejected as being indefinite because it depends from claim 30.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 21-24, 27-34, 36, 37, 39, and 40 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Schmid et al. (US 2013/0075448), hereinafter Schmid.
Regarding claim 21, Schmid discloses an adjunct (1010 in Figure 18A) configured for use with a surgical fastening device (10 in Figure 1; or 1030, 1040, and 1020 collectively in Figures 18A-18C), comprising:
(a) a first layer (1014 in Figure 18A) that comprises foam (Paragraph 0515 lines 20-21);
(b) a second layer (1013 in Figure 18A) that abuts the first layer (1014) (apparent from Figure 18A) and comprises polydioxanone (Paragraph 0515 lines 26-30);
(c) a third layer (1012 in Figure 18A) that spans across at least a portion of the first layer (1014) and is thereby configured to reinforce the first layer (clear from Figures 18A-18D, Paragraphs 0514 and 0515); and
(d) an adhesive layer (the “adhesive” described in Paragraph 0520 lines 8-11) configured to abut and thereby adhere the adjunct (1010) to a surgical fastening surface (1031 in Figure 18A) of the surgical fastening device (10; or 1030, 1040, and 1020 collectively) (clear when Paragraph 0520 lines 8-11 and Figure 18A are considered together),
wherein the adjunct (1010) is configured to be pierced by surgical fasteners (staples 1020 in Figures 18A-18D) of the surgical fastening device (10; or 1030, 1040, and 1020 collectively) (apparent when Figures 18A-18D are viewed in relation to one another, Paragraph 0515).
Regarding claim 22, Schmid discloses that the second layer (1013) overlies the first layer (1014) (apparent from Figure 18A).
Regarding claim 23, Schmid discloses that at least a portion of the third layer (1012) is spaced apart from the first layer (1014) by the second layer (1013) (apparent from Figure 18A).
Regarding claim 24, Schmid discloses that the third layer (1012) spans across at least a majority of a length and at least a majority of a width of the first layer (1014) (clear from Figures 18A-18D).
Regarding claim 27, Schmid discloses a fourth layer (1011 in Figure 18A).
Regarding claim 28, Schmid discloses that the fourth layer (1011) overlies the second layer (1013) and the adhesive layer (the “adhesive” described in Paragraph 0520 lines 8-11) (clear when Figure 18A and Paragraph 0520 lines 8-11 are considered together).
Regarding claim 29, Schmid discloses that the fifth layer (1011) and the second layer (1013) are separated by the third layer (1012) (apparent from Figure 18A).
Regarding claim 30, Schmid discloses a surgical fastening device (10 in Figure 1; or 1040, 1030, and 1010 collectively in Figure 18A), comprising:
(a) a first jaw (1040 in Figure 18A);
(b) a second jaw (1030 in Figure 18A) configured to cooperate with the first jaw (1040) to clamp and fasten tissue (T in Figures 18A-18D) with a plurality of surgical fasteners (staples 1020 in Figures 18A-18D) (Paragraphs 0517 and 0518); and
(c) the adjunct (1010) of claim 1 (see 102(a)(2) rejection of claim 21 above) adhered to a fastening surface (1031 in Figure 18A) of the second jaw (1030) by the adhesive layer (the “adhesive” described in Paragraph 0520 lines 8-11) (clear when Paragraph 0520 lines 8-11 and Figure 18A are considered together),
wherein the surgical fastening device (10; or 1040, 1030, and 1010 collectively) is operable to drive the surgical fasteners (staples 1020) through the adjunct (1010) and into the tissue (T) such that the adjunct (1010) supports the surgical fasteners (staples 1020) relative to the tissue (apparent when Figures 18A-18D are viewed in relation to one another, Paragraphs 0517 and 0518).
Regarding claim 31, Schmid discloses a knife (172 in Figure 1) actuatable to sever tissue (T) and at least a portion of the adjunct (1010) (clear when Paragraphs 0493 and 0496 and Figures 18A-18D are considered together).
Regarding claim 32, Schmid discloses an adjunct (1010 in Figure 18A) configured for use with a surgical fastening device (10 in Figure 1; or 1030, 1040, and 1020 collectively in Figures 18A-18C), comprising:
(a) a body layer (1014 in Figure 18A) that comprises foam (Paragraph 0515 lines 20-21);
(b) a supplemental layer (1013 in Figure 18A) that abuts the body layer (1014) (apparent from Figure 18A) and comprises polydioxanone (Paragraph 0515 lines 26-30);
(c) a reinforcement layer (1012 in Figure 18A) that spans across at least a portion of the body layer (1014) and is configured to reinforce the body layer (clear from Figures 18A-18D, Paragraphs 0514 and 0515); and
(d) an adhesive layer (the “adhesive” described in Paragraph 0520 lines 8-11) configured to abut and thereby adhere the adjunct (1010) to a surgical fastening surface (1031 in Figure 18A) of the surgical fastening device (10; or 1030, 1040, and 1020 collectively) (clear when Paragraph 0520 lines 8-11 and Figure 18A are considered together),
wherein the adjunct (1010) is configured to be pierced by surgical fasteners (staples 1020 in Figures 18A-18D) of the surgical fastening device (10; or 1030, 1040, and 1020 collectively) (apparent when Figures 18A-18D are viewed in relation to one another, Paragraph 0515).
Regarding claim 33, Schmid discloses that the reinforcement layer (1012) spans across at least a majority of a length and at least a majority of a width of the body layer (1014) (clear from Figures 18A-18D).
Regarding claim 34, Schmid discloses that at least a portion of the reinforcement layer (1012) is spaced apart from the body layer (1014) by the supplemental layer (1013) (apparent from Figure 18A).
Regarding claim 36, Schmid discloses a fifth layer (1011 in Figure 18A) that overlies the second layer (1013) and the fourth layer (the “adhesive” described in Paragraph 0520 lines 8-11) (clear when Figure 18A and Paragraph 0520 lines 8-11 are considered together).
Regarding claim 37, Schmid discloses a surgical fastener cartridge (1030, 1020, and 1010 collectively in Figure 18A), comprising:
(a) a body (1030 in Figures 18A-18D) having a deck (upper surface of 1030 in Figures 18A-18D) configured to compress tissue (T in Figures 18A-18D), the deck (upper surface of 1030 in Figures 18A-18D) having a plurality of openings (grooves 1032 in Figures 18A-18D) (Paragraph 0517);
(b) a plurality of surgical fasteners (stapes 1020 in Figures 18A-18D) housed within the openings (grooves 1032) (as shown in Figures 18A-18D, Paragraph 0517); and
(c) an adjunct (1010 in Figure 18A) secured to the deck (upper surface of 1030 in Figures 18A-18D) (Paragraph 0520 lines 8-11), wherein the adjunct (1010) includes:
(i) a first layer (1014 in Figure 18A) that comprises foam (Paragraph 0515 lines 20-21),
(ii) a second layer (1013 in Figure 18A) that abuts the first layer (1014) (apparent from Figure 18A) and comprises polydioxanone (Paragraph 0515 lines 26-30),
(iii) a third layer (1012 in Figure 18A) that spans across at least a portion of the first layer (1014) and is thereby configured to reinforce the first layer (clear from Figures 18A-18D, Paragraphs 0514 and 0515), and
(iv) a fourth layer (the “adhesive” described in Paragraph 0520 lines 8-11) that adheres the adjunct (1010) to the deck (upper surface of 1030 in Figures 18A-18D) (clear when Paragraph 0520 lines 8-11 and Figure 18A are considered together),
wherein the adjunct (1010) is configured to be pierced by the surgical fasteners (staples 1020) (apparent when Figures 18A-18D are viewed in relation to one another, Paragraph 0515).
Regarding claim 39, Schmid discloses that at least a portion of the second layer (1012) is spaced apart from the first layer (1014) by the second layer (1013) (apparent from Figure 18A).
Regarding claim 40, Schmid discloses a fifth layer (1011 in Figure 18A) that overlies the second layer (1013) and the fourth layer (the “adhesive” described in Paragraph 0520 lines 8-11) (clear when Figure 18A and Paragraph 0520 lines 8-11 are considered together).
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 of this title, 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.
Claims 25, 35, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Schmid in view of Prommersberger et al. (US 2007/0175235), hereinafter Prommersberger.
Regarding claims 25, 35, and 38, Schmid discloses all the limitations of the claim as stated above except: the third layer includes a plurality of reinforcement strands.
Prommersberger teaches that it was known to provide a layer (360 in Figure 3C) of an adjunct (350 in Figure 3C) with a plurality of reinforcement strands (strands 381 in Figure 3C) (Col. 7 lines 15-19), in order to provide additional support to the adjunct (350) and assist in preventing tears during stapling (Col. 2 lines 30-34).
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to have modified Schmid to incorporate the teachings of Prommersberger by providing the third layer (1012) of Schmid with a plurality of reinforcement strands, because doing so would provide additional support to the adjunct and assist in preventing tears during stapling.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Schmid in view of Prommersberger in further view of Erneta et al. (US 2013/0315963), hereinafter Erneta.
Regarding claim 26, Schmid in view of Prommersberger teaches all the limitations of the claim as stated above but does not expressly teach: the reinforcement strands comprise polyglactin 910.
Erneta teaches that it was known to provide reinforcement strands (the “sutures” described in Paragraph 0011) comprising polyglactin 910 (Paragraph 0011), in order to make the reinforcement strands (“sutures”) commercially available, fast absorbing, and high strength (Paragraph 0011).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have modified Schmid in view of Prommersberger to incorporate the teachings of Erneta by modifying the the reinforcement strands of Schmid in view of Prommersberger to comprise polyglactin 910, because doing so would make the reinforcement strands commercially available, fast absorbing, and high strength.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Shelton, IV (US 2012/0080344) teaches an adjunct (6670 in Figure 212) having a first layer (6671 in Figure 212) that comprises foam (Paragraph 0509 lines 1-4), and a second layer (6672 in Figure 212) that abuts the first layer (6671) (apparent from Figure 212) and comprises polydioxanone (Paragraph 0509 lines 5-7). However, the adjunct (6670) of Shelton, IV does not have any other layers.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TANZIM IMAM whose telephone number is (571)272-2216. The examiner can normally be reached on Mon - Fri 8:00AM - 4:00PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shelley Self can be reached on 571-272-4524. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TANZIM IMAM/Primary Examiner, Art Unit 3731
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