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 . Claims 1-19 are pending examination below.
Claim Rejections - 35 USC § 102
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.
(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 1-19 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by WO 2006/045042 A1 (hereinafter, "Goldwasser").
In regards to claim 1, Goldwasser discloses a biological vaginal graft (Fig. 3, anterior implantable grafts, 10 and posterior implantable graft, 12, pg. 8 lines 3-8) comprising:
a central body (Fig. 2, body portion, 13, pg. 9 lines 3-16)
with a top portion (see below, annotated Fig. 1, CBT, pg. 9 lines 3-16)
and a bottom portion (see below, annotated Fig. 1, CBB, pg. 9 lines 3-16),
the central body having a trapezoidal dimension (Fig. 1, body portion, 13, pg. 9 lines 3-16, where rectangles are by definition trapezoidal);
and a plurality of extension members (see below, annotated Fig. 1, apical arms, 18-19, pg. 9 lines 7-14) extending outward from the bottom portion,
the plurality of extension members affixable (pg. 5 lines 20-25, states that the apical arms are affixed to the pubic symphysis)
via a grafting medical procedure (pg. 2-3, list vaginal procedure for the treatment of prolapse) to a vaginal canal of a patient;
wherein the plurality of extension members are disposed on opposing edges of the bottom portion (see below, annotated Fig. 1, BAA, apical arms, 18-19, in combination with CBB, pg. 5 lines 20-25);
wherein the central body and the plurality of extension members of the biological vaginal graft are composed of tissue graft material (pg. 16 lines 17-25, grafts can be composed of synthetic or non-synthetic material).
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In regards to claim 2, Goldwasser further discloses
wherein a top width of the top portion is less than a bottom width of the bottom portion (Table 1, pg. 23, see also, Fig. 1, perforations, 30, pg. 18 lines 15-19).
In regards to claim 6, Goldwasser teaches the biological vaginal graft further comprising:
a plurality of apical arms extending outward from the top portion (see above, annotated Fig. 1, proximal arms, 20-21, in combination with CBT, pg. 5 lines 20-25, Goldwasser teaches that the posterior graft may have two or more arms, and the anterior graft may have four or more arms),
the plurality of apical arms affixable via the grafting medical procedure (pg. 2-3 list vaginal procedures for the treatment of prolapse) to the vaginal canal of a patient.
In regards to claim 8, Goldwasser further discloses
wherein the tissue graft material is composed of decellularized dermal allograft (pg. 16 lines 17-25, grafts can be composed of both synthetic and non-synthetic material).
In regards to claim 9, Goldwasser further discloses
wherein the tissue graft material is composed of animal-based origin (pg. 16 lines 17-25, grafts can be composed of both synthetic and non-synthetic material, including xenografts).
In regards to claim 10, Goldwasser further discloses the biological vaginal graft available for surgical attachment to the patient using the grafting medical procedure (pg. 2-3, list vaginal procedure for the treatment of prolapse)
based on the existing central body (Fig. 1, body portion, 13, pg. 9 lines 3-16)
and the plurality of extension members (see above, annotated Fig. 1, apical arms, 18-19, pg. 9 lines 7-14)
without requiring modification of the vaginal graft within a surgical theater (pg. 11, lines 18-20, teach that modification can be completed before or during surgery).
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.
Claims 3-5, 7, 11-19 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2006/045042 A1 (hereinafter, "Goldwasser").
In regards to claim 3, Goldwasser further discloses,
wherein the top width is within a range (Table 2, pg. 25)
and the bottom width is within the range (Table 2, pg. 25).
However, Goldwasser does not explicitly disclose the top width is a range between of 3.5 centimeters to 4.5 centimeters or the bottom width is a range of 5.5 centimeters to 6.5 centimeters. Goldwasser teaches a top width of 4 centimeters to 5 centimeters and bottom width 4 centimeters to 5 centimeters.
Therefore, it would be obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the ranges of Goldwasser from between 4 to 5 to between 3.5 centimeters to 4.5 centimeters or 5.5 centimeters to 6.5 centimeters since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.”, see MPEP 2144.05(I)- In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
In regards to claim 4, Goldwasser further discloses,
wherein each of the plurality of extension members (see below, annotated Fig. 2, apical arms, 18-19, pg. 9 lines 7-14) has a length within a range (Tables 1-2, pg. 23, 25)
extending outward from the bottom portion (see below, annotated Fig. 2, BAA in combination with apical arms, 18-19).
However, Goldwasser does not explicitly disclose the extension members have a length of 3.5 centimeters to 6.5 centimeters. Goldwasser teaches extension members with a length 7 centimeters to 10 centimeters. Goldwasser teaches that the apical arms are trimmed based on patient specific measurements, based on measurements from the bony anatomy to the vaginal apex (pg. 25 lines 2-5).
Therefore, it would be obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to optimize the ranges of Goldwasser from between 7 centimeters to 10 centimeters to between 3.5 centimeters to 6.5 centimeters based on individual patent anatomy.
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In regards to claim 5, Goldwasser further discloses
wherein each of the plurality of extension members (see above, annotated Fig. 2, apical arms, 18-19, pg. 9 lines 7-14)
has a width within a range ( Table 2, pg. 25).
However, Goldwasser does not explicitly disclose the extension members have a width of 0.35 centimeters to 1.5 centimeters. Goldwasser teaches extension members with a width 1 centimeters to 2 centimeters with a bone anchored fixation. Goldwasser teaches that the width of the apical arms is based on patient anatomy (pg. 11 lines 3-5, 14-20) to allow for modification and maintain space for attachment as necessary.
Therefore, it would be obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the ranges of Goldwasser since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.”, see MPEP 2144.05(I)- In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
In regards to claim 7, Goldwasser further discloses
wherein each of the apical arms (see below, annotated Fig. 1, proximal arms, 20-21, in combination with CBT, pg. 5 lines 20-25, Goldwasser teaches that the posterior graft may have two or more arms, and the anterior graft may have four or more arms)
has a length within the range of centimeters (Table 1, pg. 23, D) and width within a range (Table 1, pg. 23, D).
However, Goldwasser does not explicitly disclose the extension members have a length of 3.5 to 6.5 centimeters and width of 0.35 centimeters to 1.5 centimeters. Goldwasser teaches apical arms with a width 1 centimeters to 2 centimeters. Therefore, it would be obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the ranges of Goldwasser from between 0.35 to 1 centimeter to a width of 1 to 2 centimeters since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.”, see MPEP 2144.05(I)-In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
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In regards to claim 11, Goldwasser discloses a biological vaginal graft (Fig. 3, anterior implantable grafts, 10 and posterior implantable graft, 12, pg. 8 lines 3-8) comprising:
a central body (Fig. 2, body portion, 13, pg. 9 lines 3-16)
with a top portion (see below, annotated Fig. 2, CBT)
and a bottom portion (see below, annotated Fig. 2, CBB),
the central body having a trapezoidal dimension (Fig. 2, body portion, 13, pg. 9 lines 3-16, where rectangles are by definition trapezoidal),
the top portion having a top width is within a range of centimeters (Table 2, pg. 25, body portion, 13)
and the bottom portion having a bottom width within a range of centimeters (Table 2, pg. 25, the preferred dimensions listed would give the body portion, 13, shape could be trapezoidal within the disclosed range);
and a plurality of extension members (see below, annotated Fig. 2, apical arms, 18-19, pg. 9 lines 7-14)
extending outward from the bottom portion (see below, annotated Fig. 2, CBB, pg. 5 lines 20-25 ),
the plurality of extension members affixable (pg. 5 lines 20-25, states that the apical arms are affixed to the pubic symphysis)
via a grafting medical procedure to a vaginal canal of a patient (pg. 2-3 list vaginal procedures for the treatment of prolapse);
wherein the plurality of extension members are disposed on opposing edges of the bottom portion (Fig. 6, apical arms, 18 and 19, pg. 6 lines 8-15),
each of the plurality of extension members has a length within a range centimeters extending outward from the bottom portion (Table 2, pg. 25);
wherein the central body and the plurality of extension members (see below, annotated Fig. 2, apical arms, 18-21, pg. 9 lines 7-14) of the biological vaginal graft
are composed of tissue graft material (pg. 16 lines 17-25, grafts can be composed of both synthetic and non-synthetic material).
However, Goldwasser does not explicitly disclose the top portion having a top width is within a range of 3.5 centimeters to 4.5 centimeters, the bottom portion having a bottom width within a range of 5.5 centimeters to 6.5 centimeters, each of the plurality of extension members has a length within a range of 3.5 centimeters to 6.5 centimeters. Goldwasser teaches a top width of 4 centimeters to 5 centimeters and bottom width 4 centimeters to 5 centimeters.
Therefore, it would be obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the ranges of Goldwasser from between 3.5 centimeters to 4.5 centimeters for the top width, and 5.5 centimeters to 6.5 centimeters for the bottom width, since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.”, see MPEP 2144.05(I)- In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Goldwasser discloses each of the plurality of extension members has a length within a range of 7 centimeter to 10 centimeters. Goldwasser teaches that the apical arms are trimmed based on patient specific measurements, based on measurements from the bony anatomy to the vaginal apex (pg. 25 lines 2-5). Therefore, it would be obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to optimize the ranges of Goldwasser from between 7 centimeters to 10 centimeters to between 3.5 centimeters to 6.5 centimeters based on individual patent anatomy.
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In regards to claim 12, Goldwasser further discloses the biological vaginal graft (Fig. 3, anterior implantable grafts, 10, pg. 8 lines 3-8) of claim 11,
wherein the tissue graft material is composed of decellularized dermal allograft (pg. 16 lines 17-25, grafts can be composed of both synthetic and non-synthetic material).
In regards to claim 13, Goldwasser further discloses
wherein the tissue graft material is composed of animal-based origin (pg. 16 lines 17-25, grafts can be composed of both synthetic and non-synthetic material, including xenografts).
In regards to claim 14, Goldwasser further discloses the graft
available for surgical attachment to the patient (Fig. 6, fixation device, 60, pg. 11, lines 3-9)
using the grafting medical procedure (pg. 2-3, list vaginal procedure for the treatment of prolapse)
based on the existing central body (Fig. 2, body portion, 13, pg. 9 lines 3-16)
and the plurality of extension members (see above, annotated Fig. 2, apical arms, 18-19, pg. 9 lines 7-14)
without requiring modification of the vaginal graft within a surgical theater (pg. 11, lines 18-20, teach that modification can be completed before or during surgery).
In regards to claim 15, Goldwasser discloses a biological vaginal graft (Fig. 3, anterior implantable grafts, 10 and posterior implantable graft, 12, pg. 8 lines 3-8) comprising:
a central body with a top portion (see below, annotated Fig. 1, CBT, pg. 9 lines 3-16)
and a bottom portion (see below, annotated Fig. 1, CBB, pg. 9 lines 3-16),
the central body having a trapezoidal dimension (Fig. 1, body portion, 13, pg. 9 lines 3-16, where rectangles are by definition trapezoidal);
a plurality of extension members (Fig. 1, apical arms, 18-19, pg. 9 lines 7-14)
extending outward from the bottom portion (Fig. 5, apical arms, 18 and 19, pg. 9 lines 7-14),
the plurality of extension members affixable via a grafting medical procedure to a vaginal canal of a patient (pg. 5 lines 20-25, states that the apical arms are affixed to the pubic symphysis);
and a plurality of apical arms extending outward from the top portion (see below, Fig. 1, proximal arms, 20-21, pg. 9 lines 7-14),
wherein each of the apical arms has a length range in centimeters (Table 1, pg. 23)
and width range in centimeters (Table 1, pg. 23),
the plurality of apical arms affixable via the grafting medical procedure (pg. 2-3, list vaginal procedure for the treatment of prolapse) to the vaginal canal of the patient (pg. 5 lines 20-25, states that the apical arms are affixed to the pubic symphysis);
wherein the plurality of extension members (see below, annotated Fig. 2, apical arms, 18-19pg. 9 lines 7-14)
are disposed on opposing edges of the bottom portion (Fig. 5, pg. 12 lines 13-16);
wherein the central body and the plurality of extension members of the biological vaginal graft are composed of tissue graft material (pg. 16 lines 17-25, grafts can be composed of both synthetic and non-synthetic material).
However, Goldwasser does not explicitly discloses each of the apical arms has a length within the range of 3.5 to 6.5 centimeters and width within the range of 0.35 centimeters to 1.5 centimeters. Goldwasser teaches extension members with a width 1 centimeters to 2 centimeters with a length 7 centimeters to 10 centimeters. Goldwasser teaches that the apical arms are trimmed based on patient specific measurements, based on measurements from the bony anatomy to the vaginal apex (pg. 25 lines 2-5).
Therefore, it would be obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to optimize the ranges of Goldwasser from between 7 centimeters to 10 centimeters to between 3.5 centimeters to 6.5 centimeters based on individual patent anatomy. In addition, to modify the ranges of Goldwasser from between 0.35 to 1 centimeter to a width of 1 to 2 centimeters since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.”, see MPEP 2144.05(I)-In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
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In regards to claim 16, Goldwasser further discloses the biological vaginal graft comprising:
a top width of the top portion is less than a bottom width of the bottom portion (Fig. 5, where central body can be trimmed at perforations, 30, pg. 11 line 10-14 ),
such that the top width is within the range in centimeters (Table 1, pg. 23)
and the bottom width is within the range in centimeters (Table 1, pg. 23);
and each of the plurality of extension members has a length within a range in centimeters (Table 1, pg. 23, C and D, 18-21, pg. 23)
extending outward from the bottom portion (Fig. 5, apical arms, 18-19, pg. 12 lines 18-29)
and each of the plurality of extension members has a width within a range in centimeters (Table 1, pg. 23, C and D arms, 18-21).
However, Goldwasser does not explicitly discloses that the top width is within the range of 3.5 centimeters to 4.5 centimeters, the bottom width is within the range of 5.5 centimeters to 6.5 centimeters, each of the plurality of extension members has a length within a range of 3.5 centimeters to 6.5 centimeters and each of the plurality of extension members has a width within a range of 0.35 centimeters to 1.5 centimeters.
Goldwasser teaches a top width of 4 centimeters to 5 centimeters and bottom width 4 centimeters to 5 centimeters. Goldwasser further teaches extension members with a width 1 centimeters to 2 centimeters with a bone anchored fixation. Goldwasser teaches that the width of the apical arms is based on patient anatomy (pg. 11 lines 3-5, 14-20) to allow for modification and maintain space for attachment as necessary. Further, Goldwasser discloses extension members with a length between 7 centimeters to 10 centimeters for arms C and between 2 centimeters to 6 centimeters for arms D.
Therefore, it would be obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the ranges of Goldwasser as necessary since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.”, see MPEP 2144.05(I)-In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
In regards to claim 17, Goldwasser further discloses
wherein the tissue graft material is composed of decellularized dermal allograft (pg. 16 lines 17-25, grafts can be composed of both synthetic and non-synthetic material).
In regards to claim 18, Goldwasser further discloses
wherein the tissue graft material is composed of animal-based origin (pg. 16 lines 17-25, grafts can be composed of both synthetic and non-synthetic material, including xenografts).
In regards to claim 19, Goldwasser further discloses the biological vaginal graft available for surgical attachment to the patient using the grafting medical procedure (pg. 2-3, list vaginal procedure for the treatment of prolapse)
based on the existing central body,
the plurality of extension members (see below, annotated Fig. 2, apical arms, 18-19, pg. 9 lines 7-14),
and the apical arms (Fig. 2, apical arms, 18-19, pg. 9 lines 7-14)
without requiring modification of the vaginal graft within a surgical theater (pg. 11, lines 18-20, teach that modification can be completed before or during surgery).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JICHELE MONIQUE SANDERS whose telephone number is (571)272-2240. The examiner can normally be reached M-Thu 6:30-5:15.
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/J.M.S./Examiner, Art Unit 3774
/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700