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 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.
Claims 1-2 and 4-20 are rejected under 35 U.S.C. 103 as being unpatentable over Novak (WO2018017611A1, Cited pages are page numbers of the provided reference document and not those printed in the header) in view of Patel (US2011/0166673A1) and in view of Beaudry (WO2018/201116).
In regard to claim 1, Novak teaches a method for making an implantable medical product that includes extracellular matrix (ECM) material in sheet form (fig 5), the method comprising:
providing a first center seamed ECM sheet 12 and a second center seamed ECM sheet 14 (fig 4B),
superimposing the first 12 and second 14 center-seamed ECM sheets having the joined overlapped side edges;
joining together the first and second center-seamed ECM sheets by a continuous peripheral seam (see fig 3A, 5), that is provided along and that joins together the bottom edges of the first and second center-seamed ECM sheets (joints 12 and 14 as shown in fig 5) and that extends substantially completely along adjacent first side edges of the first and second center-seamed ECM sheets (extends around 12 and 14 in fig 6A) and only partially along adjacent second side edges of the first and second center-seamed ECM sheets to form a pouch structure that includes an internal region or cavity and an opening (fig 6A);
wherein the top edges of the first and second center-seamed ECM sheets are not joined together to form the opening (see fig 6A, top edge 22 is not joined), and wherein a portion of the first and second center-seamed ECM sheets at the peripheral seam had substantially the same properties as the remainder of the first and second center-seamed ECM sheets.(Fig 6a-b uniform material)
However, Novak does not teach that each the first second ECM sheets have multiple plies, a center lock stitched seam or are made of two parts of a sheet each.
Beaudry teaches the sheet is made by providing two sheets (figure 19, larger sheet made by first sheet 42 and second sheet 42’),
wherein the first and second sheets are each generally rectangular (see fig 19) having top, bottom and two side edges (fig 19);
overlapping only a first side edge of the first sheet 42 with only a first side edge of the second sheet 42’ such that remaining portions of the first and second ECM sheets are not overlapped (see fig 19)
joining together the overlapped side edges of the first and second sheets by a first stitched center seam 57 to create a first center-seamed sheet having two side edges, a top edge and a bottom edge (fig 19).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make the first center seamed ECM sheet and the second center seamed ECM sheet of Novak out of a first and second sheet and a third and fourth sheet as taught by Beaudry because this allows smaller sheets to be joined to form an enlarged sheet where larger sheets are not practical or available [0065].
Patel teaches the first and second ECM sheets include at least two ECM plies or layers and having top, bottom and two side edges. (see figure 4, 4 layers are present in a sheet; the two 2 layers can be considered the first ECM sheet and the bottom 2 layers can be considered the second ECM sheet);
And using a lock stitch seam [0045; 17] to secure a center seam and peripheral seam of a surgical graft (abstract; fig 2-3).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make the first and second ECM sheets of Novak out of at least two plies as taught by Patel because multiple layers have improved strength durability compared to a single layer [0004].
It would have been obvious to one of ordinary skill in the art of sewing and grafts at the time the invention was filed to use the lock-stitches of Patel in the seam of Novak and the seam of Novak in view of Beaudry because this can limit the possibility of ECM plies delaminating during implantation (see [0046]).
Regarding Claim 2, Novak teaches a method, wherein the first and second ECM sheets are provided by trimming larger ECM sheets to remove defects (see Page 28, Line 7-8, ECM materials harvested as intact sheets is the same as trimming sheets to remove defects),
with the ECM material comprising acellular ECM from a decellularized mammalian tissue source (see Page 26, Lines 23-27; also see Page 27, Lines 13-15),
selected from the group consisting of small intestine submucosa (SIS), urinary bladder submucosa, stomach submucosa, epithelium of mesodermal origin, dermal extracellular matrix, subcutaneous extracellular matrix, gastrointestinal extracellular matrix, tissue surrounding growing bone, placental extracellular matrix, omentum extracellular matrix, cardiac extracellular matrix, kidney extracellular matrix, pancreas extracellular matrix, lung extracellular matrix, urinary basement membrane, liver basement membrane, and combinations thereof (see Page 27, Lines 13-23).
Regarding Claim 4, Novak meets the claim limitations as discussed in the rejection of claim 1 but does not teach the first lock-stitched seam as claimed.
Beaudry further teaches the first stitched seam (center seam) extends substantially completely along the overlapped edges of the first and second sheets. (see seam 57 in figure 19; extends along the entire sheet).
However, Novak in view of Beaudry does not teach the first seam is lock-stitched.
As discussed in the rejection of claim 1, Patel further teaches the seam is a lock-stitched seam. [0047]
Regarding Claim 5, Novak teaches a method, further comprising inserting an electrical medical device into the internal region or cavity of the pouch structure (Fig. 1D, Medical device 200 is inserted in pouch product 10; also see Page 12, Lines 26-30).
Regarding Claim 6, Novak teaches a method, wherein the medical device is a subcutaneous implantable cardioverter-defibrillator, a pump, a pacemaker, synthetic heart valve, ventricular assist device, artificial heart, physiological sensor, catheter, or an associated component thereof (see Page 38, Lines 21- 30 and Page 29, Lines 1-3).
Regarding Claim 7, Novak teaches a method, further comprising closing the opening of the pouch structure by stitching or stapling after inserting the electrical device therein (see Page 26, Lines 16-18; also see Page 42, Lines 1-3).
Regarding Claim 8, Novak teaches a method further comprising providing a composition that is a pharmacological agent into the internal region or cavity of the pouch structure (see Page 32, Lines 1-13, Non-native bioactive substances are pharmacological agents and since they can be incorporated into the ECM material, they can also be found in the internal cavity of the pouch structure).
Regarding Claim 9, Novak teaches a method, wherein the pharmacological agent is or includes an antibiotic agent which is added prior to inserting the medical device into the pouch structure (see Page 32, Lines 8 - 16, Antibiotics are listed as a pharmacological agent that can be added prior to the procedure that involves inserting the medical device).
Regarding Claim 10, Novak teaches a method further comprising folding the edges of any or all of the sheets prior to stitching to provide a double thickness of the ECM sheets being stitched together (Figs. 2A and 2B, Flap 42, a section of wall 12, is folded over exterior of wall 14 to close opening 36; see Page 13, Lines 14-18; also see Page 26, Lines 10-18 ; also see Page 42, Lines 1-3).
Regarding Claim 11, Novak in view of Ward and Patel teaches a pouch product prepared by the method of claim 1 (see Claim 1 rejection; fig 6A-B).
Regarding Claim 12, Novak teaches an implantable pouch product for receiving a medical device (Abstract; figs 1, 5) and teaches an implantable medical product, comprising:
a pouch structure comprising extracellular matrix (ECM) material in sheet form (Fig. 1A, Pouch product 10 includes walls 12 and 14, which can be made of ECM material; See Page 26, lines 23-27 and Page 27, lines 13-15, Walls 12, 14 can be made of remodelable material such as ECM materials.),
wherein the ECM material comprises acellular ECM from a decellularized mammalian tissue source (see Page 26, Lines 23-27; also see Page 27, Lines 13-15),
selected from the group consisting of small intestine submucosa (SIS), urinary bladder submucosa, stomach submucosa, epithelium of mesodermal origin, dermal extracellular matrix, subcutaneous extracellular matrix, gastrointestinal extracellular matrix, tissue surrounding growing bone, placental extracellular matrix, omentum extracellular matrix, cardiac extracellular matrix, kidney extracellular matrix, pancreas extracellular matrix, lung extracellular matrix, urinary basement membrane, liver basement membrane, and combinations thereof (see Page 27, Lines 13-23),
wherein the pouch structure comprises an internal region or cavity (Figs. 1A and 1B, Walls 12 and 14 form an inner pocket) and an opening (Figs. 1A and 1B, Pouch product 10 has an upper opening 36; See Page 12, lines 26-28),
and is configured and sized to receive, encase and retain an electrical medical device inserted therein (see Page 39, Lines 20-28) (Fig. 1D, Medical device 200 is inserted in pouch product 10; also see Page 12, Lines 26-30);
wherein the pouch structure comprises a first ECM sheet and second ECM sheet, wherein the first and second ECM sheets are each generally rectangular ECM sheets (Figs. 1A and 1C, Walls 12 and 14 are generally rectangular) and include at least two ECM plies or layers (see Page 12, Lines 24-26) and having top, bottom and two side edges (Fig. 1A, Walls 12, 14 have a top side 22, bottom side 24, and lateral sides 18,20),
wherein the pair of first and second generally rectangular ECM sheets are superimposed upon each other (Figs. 1A and 1C, Walls 12 and 14 are superimposed; fig 5) and joined together with a continuous peripheral seam (Figs. 1A and 1C, Walls 12 and 14 are joined along flange 16, (A seam is a line where things join (Cambridge dictionary)), so the flange in this invention is considered a peripheral seam; figure 5, seam extends along the bottom and laterally sides fully)
that is provided along and that joins together the bottom edges of the sheets (Fig. 1A , Flange 16 is along the bottom side 24) and that extends substantially completely (defined in the instant disclosure as 75-100%) along adjacent first side edges of the first and second center seamed ECM sheets and only partially along adjacent second side edges of the sheets (Fig. 1A, Flange 16 extends along a portion of lateral sides 18,2, fig 5 extends around ¾ sides completely) to form the pouch structure;
and wherein the top edges of the first and second ECM sheets are not joined together to form the opening of the pouch structure (Fig. 1A, Walls 12 and 14 are not bonded together along distances 30, 32 and top side 20 to allow for device insertion; Fig. 1C, opening 36 is for device insertion, Opening 36 is on the top edges of sheets where the walls 12, 14 are not bonded; fig 5)
and are configured for closing by stitching or stapling after receiving the device (see Page 26, Lines 16-18; also see Page 42, Lines 1-3)
and wherein a portion of the first and second ECM sheets at the seam has substantially the same properties as the remainder of the first and second ECM sheets (Single layer wall material, therefore substantially the same material properties. The applicant has not specified which properties). pg 18 lines 15-29: fold or flange is made of any of the laminate wall materials describe herein. Since the flange is formed by folding the material of the ECM sheets, the flange is made of the same material and therefore has substantially the same (material) properties. The examiner suggests being more specific about which properties are being referred to.
However, Novak does not teach ECM sheets are joined by lock stitching or the first and second ECM sheets are center seamed each having at least two ECM plies with overlapped side edges joined together by a second center seam such that only a first side edge of the first sheet overlaps only with a first side edge of the second sheet such that remaining portions are not overlapped.
Beaudry teaches the sheet is made by providing two sheets (figure 19, larger sheet made by first sheet 42 and second sheet 42’),
wherein the first and second sheets are each generally rectangular (see fig 19) having top, bottom and two side edges (fig 19);
overlapping only a first side edge of the first sheet 42 with only a first side edge of the second sheet 42’ such that remaining portions of the first and second ECM sheets are not overlapped (see fig 19)
joining together the overlapped side edges of the first and second sheets by a first stitched center seam 57 to create a first center-seamed sheet having two side edges, a top edge and a bottom edge (fig 19).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make the first center seamed ECM sheet and the second center seamed ECM sheet of Novak out of a first and second sheet as taught by Beaudry because this allows smaller sheets to be joined to form an enlarged sheet where larger sheets are not practical or available [0065].
Patel teaches the first and second ECM sheets include at least two ECM plies or layers and having top, bottom and two side edges. (see figure 4, 4 layers are present in a sheet; the two 2 layers can be considered the first ECM sheet and the bottom 2 layers can be considered the second ECM sheet);
And using a lock stitch seam [0045; 17] to secure a center seam and peripheral seam of a surgical graft (abstract; fig 2-3).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make the first and second ECM sheets of Novak out of at least two plies as taught by Patel because multiple layers have improved strength durability compared to a single layer [0004].
It would have been obvious to one of ordinary skill in the art of sewing and grafts at the time the invention was filed to use the lock-stitches of Patel in the seam of Novak and the seam of Novak in view of Beaudry because this can limit the possibility of ECM plies delaminating during implantation (see [0046]).
Regarding Claim 13, Novak teaches a medical product,
wherein the first and second ECM sheets each have a rounded corner located within the peripheral seam (As best understood, Fig. 1A, Walls 12, 14 have rounded corners 28, 26 that are along flange 16, a seam is a line where things join (Cambridge dictionary) so the flange in this invention is considered a peripheral seam).
However, Novak does not teach ECM sheets joined by lock-stitching or that the first and second ECM sheets are center seamed.
Patel further teaches a peripheral lock-stitched seam (Fig. 2, Suture line 19 on the periphery 25 further secures multiple layers 12; Fig. 4, Shows a cross section of the lock-stitch with sutures 30,31 through layers 12; see [0045] and [0046]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a lock-stitch as taught by Patel to on the seam of Novak in order to limit the possibility of ECM plies delaminating during implantation (see [0046]) and to be able to resize the pouch structure without unjoining the ECM sheets (see [0045]).
As discussed in the rejection of claim 12, Beaudry teaches the first and second sheets are center-seamed.
Regarding Claim 14, Novak meets the claim limitations as discussed in the rejection of claim 12 but does not teach the first lock-stitched seam extends substantially completely along the overlapped edges of the first and second ECM sheets.
Beaudry further teaches the first stitched seam (center seam) extends substantially completely along the overlapped edges of the first and second sheets. (see seam 57 in figure 19; extends along the entire sheet).
However, Novak in view of Beaudry does not teach the first seam is lock-stitched.
As discussed in the rejection of claim 12, Patel further teaches the seam is a lock-stitched seam. [0047]
Regarding Claim 15, Novak teaches a medical product, wherein the first and second ECM sheet each includes a plurality of holes in a spaced pattern (Figs. 1A and 1C, Walls 12 and 14 have a plurality of through openings 34 in a spaced pattern).’
However, Novak does not teach the ECM sheets are center seamed.
As discussed in the rejection of claim 12, Beaudry teaches the ECM sheets are center seamed (fig 19).
Regarding Claim 16, Novak teaches a medical product, further comprising the electrical medical device inserted in the internal region or cavity (Fig. 1D, Medical device 200 is inserted in pouch product 10; also see Page 12, Lines 26-30).
Regarding Claim 17, Novak meets the claim limitations as discussed in the rejection of claim 16 and further teaches the electrical medical device is selected from the group consisting of a subcutaneous implantable cardioverter-defibrillator, a pump, a pacemaker, a synthetic heart valve, ventricular assist device, artificial heart, physiological sensor, catheter, and an associated component thereof (see Page 38, Lines 21- 30 and Page 29, Lines 1-3).
Regarding Claim 18, Novak meets the claim limitations as discussed in the rejection of claim 12 and further teaches the internal region or cavity of the pouch structure contains a pharmacological agent (see Page 32, Lines 1-13, Non-native bioactive substances are pharmacological agents and since they can be incorporated into the ECM material, they can also be found in the internal cavity of the pouch structure).
Regarding Claim 19, Novak meets the claim limitations as discussed in the rejection of claim 18 and further teaches the pharmacological agent comprises an antibiotic agent (see Page 32, Lines 8 - 16, Antibiotics are listed as a pharmacological agent that can be added prior to the procedure that involves inserting the medical device).
Regarding Claim 20, Novak meets the claim limitations as discussed in the rejection of claim 12 and further teaches the edges of any or all of the first and second ECM sheets are folded to provide a double thickness of the first and second ECM sheets joined by stitched seams (Figs. 2A and 2B, Flap 42, a section of wall 12, is folded over exterior of wall 14 to close opening 36; see Page 13, Lines 14-18; also see Page 26, Lines 10-18; also see Page 42, Lines 1-3).
However, Novak does not teach ECM sheets joined by lock-stitching or that the first and second ECM sheets are center seamed.
As discussed in the rejection of claim 12, Beaudry teaches the first and second sheets are center seamed (seam 57 in figure 19).
Patel further teaches ECM sheets joined by the lock-stitched seams (Fig. 2, suture line 19 on the periphery 25 further secures multiple layers 12; Fig. 4, shows the cross section of a lock-stitch with sutures 30,31 through layers 12; see [0045] and [0046]) and a center seamed ECM sheet as discussed in the rejection of claim 12 (see fig 4).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a lock-stitch as taught by Patel to secure the flange/seam of Novak and of Novak in view of Beaudry in order to limit the possibility of ECM plies delaminating during implantation (see [0046]) and to be able to resize the pouch structure without unjoining the ECM sheets (see [0045]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Novak (WO2018017611A1, Cited pages are page numbers of the provided reference document and not those printed in the header) in view of Patel (US20110166673A1), and further in view of Lee (US20180098836A1).
Regarding Claim 3, Novak teaches a method, which further comprises,
die cutting the first and second ECM sheets to provide a plurality of holes (see Page 18, Lines 20-22, Stamping or otherwise cutting would include die cutting as a method to create the plurality of openings).
However, Novak does not teach ECM sheets that are center seamed or the ECM sheets joined by lock stitching or die cutting ECM sheets to create rounded corners.
Patel further teaches using a lock-stitched seam (Fig. 4, Shows a cross section of the lock-stitch with sutures 30,31 through layers 12; see [0045]; also see [0043], A useful pattern can have one stitch line.)
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a lock-stitch on ECM sheets as taught by Patel on the seam/flange of Novak in order to limit the possibility of ECM plies delaminating.
Lee teaches tissue matrices with holes and further teaches die cutting the first and second ECM sheets to provide rounded corners and a plurality of holes prior to joining the pair of first and second ECM sheets by the peripheral lock-stitched seam (Figs. 1A and 1C, depicts an ECM sheet 10 produced by die cutting to have rounded corners 15 and a plurality of holes 20; see [0067], ECM sheet is not joined to another sheet when cut).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to die cut the ECM sheet as taught by Lee to form rounded corners and a plurality of holes as taught by Novak in order to save processing time by simultaneously shaping the perimeter of the ECM sheet and making holes (see [0067]).
As discussed in the rejection of claim 1, Beaudry teaches the first and second sheets are center seamed (fig 19, seam 57).
Response to Arguments
In regard to the 103(a) rejection of claims 1, 2, 4-20 as unpatentable over Novak (WO2018/017611A1) in view of Patel (2011/0166673A1), the applicant’s arguments have been fully considered. The remainder of the arguments are directed towards new claim limitations which have been addressed above.
In regard to the 103(a) rejection of claim 3 as unpatentable over Novak (WO2018/017611A1) in view of Patel (2011/0166673A1) and further in view of Lee (2018/0098836A1), no further arguments have been submitted.
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 CHRISTIE BAHENA whose telephone number is (571)270-3206. The examiner can normally be reached M-F 9-3.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774
Prosecution Insights