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 .
Response to Amendment
Applicant’s amendment, filed 12 March 2026, is acknowledged. Claims 15 and 21 are amended. Claims 36-38 are new. Claims 1-14 and 20 were previously cancelled.
Claims 15-19 and 21-38 are pending in the instant application.
Response to Arguments
Applicant’s arguments, filed 12 March 2026, with respect to the 35 USC 103 rejections of claims 15-19 have been fully considered and are persuasive in light of the amendment. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Arcand (US20130096371A1) and further in view of Merade (US20050101834A1) and Alinsod (US20080177132A1).
Applicant's arguments, with respect to the 35 USC 103 rejections of claims 21-35 have been fully considered but they are not persuasive. As the claim is written, the claim is not limited to only the biologic scaffold as part of an implantable device. The claim can be interpreted that there is additional structure to the biologic scaffold for implantation, as such the prior art previously applied Alinsod (US20080177132A1) in view of Brahm (US10583219B1) and further in view of Merade (US20050101834A1) is still applicable. Alinsod teaches the “shape” in claim 21 and the adjustment of the first lateral edge being the outermost edge of the shape would be an obvious design change.
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.
Claims 37 and 38 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.
Claim 37 recites the limitation "the biologic scaffold is an anterior pelvic organ prolapse biologic scaffold." in lines 1-2. The limitation renders the claim indefinite because it is unclear what is being claimed. The limitation can be interpreted as the tissue of the biologic scaffold comprises anterior pelvic organ prolapse. While it can be interpreted as intending to repair an anterior pelvic organ prolapse, that is not clear from the limitation. As claim 21 recites the limitation “a condition”, Examiner suggests verbiage similar to claim 19, --wherein the condition corresponds to an anterior pelvic organ prolapse--.
Claim 38 has a similar issue to claim 37, as claim 38 recites the limitation " the surgical implant is a posterior pelvic organ prolapse implant." in lines 1-2. The limitation renders the claim indefinite because it appears to be missing the term “repair”. As claim 15 recites the limitation “a condition”, Examiner suggests verbiage similar to claim 19, --wherein the condition corresponds to a posterior pelvic organ prolapse--.
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.
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) 15-19 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Arcand (US20130096371A1) in view of Merade (US20050101834A1) and further in view Alinsod (US20080177132A1).
Regarding claim 15, Arcand discloses a method of treating a patient with pelvic organ prolapse (Paragraph [0002]), the method comprising: selecting, based on a condition of a target tissue of the patient with pelvic organ prolapse (Paragraph [0008]), a surgical implant (Paragraph [0022]) and surgically implanting the surgical implant into the target tissue (Paragraph [0002]).
Arcand fails to explicitly disclose a surgical implant singularly made of tissues of biological origin, the surgical implant having a preconfigured shape suited for a pelvic organ prolapse specific surgical operation right out of its packaging wherein the shape comprises: a body portion extending along a central longitudinal axis of the shape from a first longitudinal end portion of the shape toward a second longitudinal end portion of the shape and extending along a transverse axis perpendicular to the central longitudinal axis, the body portion comprising: a first longitudinal end portion proximate to the first longitudinal end portion of the shape, wherein the first longitudinal end portion of the body portion comprises a longitudinal edge parallel to the transverse axis and a first lateral edge extending longitudinally from the longitudinal edge of the first longitudinal end portion of the body portion toward the second longitudinal end portion of the shape: and no more than two arms, the no more than two arms comprising: a first arm extending along a first axis angled relative to the central longitudinal axis and the transverse axis, and a second arm extending along a second axis angled relative to the central longitudinal axis and the transverse axis, wherein the first arm and the second arm define the second longitudinal end portion of the shape, and the shape is symmetrical about the central longitudinal axis. Merade discloses a surgical implant singularly made of tissues of biological origin (Paragraph [0020]), the surgical implant having a preconfigured shape suited for a pelvic organ prolapse (Paragraph [0020]) specific surgical operation right out of its packaging (Paragraph [0003]). Merade further discloses, in Figure 5 (see below) the shape comprises: a body portion extending along a central longitudinal axis of the shape from a first longitudinal end portion of the shape toward a second longitudinal end portion of the shape and extending along a transverse axis perpendicular to the central longitudinal axis, the body portion comprising: a first longitudinal end portion proximate to the first longitudinal end portion of the shape, wherein the first longitudinal end portion of the body portion comprises a longitudinal edge parallel to the transverse axis and a first lateral edge extending longitudinally from the longitudinal edge of the first longitudinal end portion of the body portion toward the second longitudinal end portion of the shape: and no more than two arms, the no more than two arms comprising: a first arm extending along a first axis relative to the central longitudinal axis and the transverse axis, and a second arm extending along a second axis relative to the central longitudinal axis and the transverse axis, wherein the first arm and the second arm define the second longitudinal end portion of the shape, and the shape is symmetrical about the central longitudinal axis.
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As Arcand recites the common steps of selecting an implant based on the target tissue and implanting the implant to the target tissue, It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Arcand, with a surgical implant singularly made of tissues of biological origin, the surgical implant having a preconfigured shape (the shape of Merade, Figure 5) suited for a pelvic organ prolapse specific surgical operation right out of its packaging as taught by Merade, since such a modification would provide the predictable results of quick and easy surgical implementation (Merade, Paragraph [0007]).
Arcand, as modified by Merade, does not disclose the first arm extending along a first axis angled relative to the central longitudinal axis and the transverse axis, and a second arm extending along a second axis angled relative to the central longitudinal axis and the transverse axis. Alinsod discloses a surgical implant for anterior pelvic organ prolapse repair (Figure 1) a surgical implant for posterior pelvic organ prolapse repair (Figure 3). Both surgical implants comprise a first arm extending along a first axis angled relative to the central longitudinal axis and the transverse axis, and a second arm extending along a second axis angled relative to the central longitudinal axis and the transverse axis. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the surgical implant as taught by modified Arcand, with the first arm extending along a first axis angled relative to the central longitudinal axis and the transverse axis, and the second arm extending along a second axis angled relative to the central longitudinal axis and the transverse axis as taught by Alinsod, since such a modification would provide the predictable results of an effective design for the repair of anterior or posterior pelvic organ prolapse repair.
Regarding claim 16, Merade further discloses the tissues undergo a series of processing steps prior to final packaging (Paragraph [0009], the attachment structures are pre-attached).
Regarding claim 17, Merade further discloses tissues are derived from biological cells from human or animal (Paragraph [0020]).
Regarding claim 18, Merade further discloses partially trimming the surgical implant before implanting the surgical implant into the target tissue (Paragraph [0020], the sling is “fashioned” prior to packaging).
Regarding claim 19, Merade further discloses the condition corresponds to a pelvic condition (Paragraph [0020]).
Regarding claim 38, Arcand, as previously modified by Merade and Alinsod in claim 15, did not previously teach the implant is a posterior pelvic organ implant, Alinsod teaches a method when in the implant is a posterior pelvic organ implant (Alinsod, Paragraphs [0027]-[0038]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Arcand, with using the implant to treat a posterior pelvic organ prolapse as taught by Alinsod, since such a modification would provide the predictable results of known process to treat a posterior pelvic organ prolapse (Alinsod, Paragraphs [0027]-[0038]).
Claim(s) 21-26, 28-31, 33-35 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Alinsod (US20080177132A1) in view of Brahm (US10583219B1) and further in view of Merade (US20050101834A1).
Regarding claim 21, Alinsod discloses a method of treating a patient with pelvic organ prolapse (Abstract), the method comprising: selecting, based on a condition of a target tissue of the patient with pelvic organ prolapse (Paragraph [0005]), a biologic scaffold (Paragraph [0035]) wherein a shape of the biologic scaffold is preconfigured for addressing the condition of the target tissue (Figures 1 and 3), and wherein the shape comprises: a body portion extending along a central longitudinal axis of the shape from a first longitudinal end portion of the shape toward a second longitudinal end portion of the shape and extending along a transverse axis perpendicular to the central longitudinal axis (See annotated figure 3), the body portion comprising: a first longitudinal end portion proximate to the first longitudinal end portion of the shape (See annotated figure 3), wherein the first longitudinal end portion of the body portion comprises a longitudinal edge parallel to the transverse axis and a first lateral edge extending longitudinally from the longitudinal edge of the first longitudinal end portion of the body portion toward the second longitudinal end portion of the shape (See annotated figure 3): one or more arcuate edges connecting the first lateral edge to an intermediate portion of the body portion, the intermediate portion being positioned between the first longitudinal end portion of the shape and the second longitudinal end portion of the shape (See annotated figure 3), a first arm extending along a first axis angled relative to the central longitudinal axis and the transverse axis, and a second arm extending along a second axis angled relative to the central longitudinal axis and the transverse axis (See annotated figure 3), wherein the first arm and the second arm define the second longitudinal end portion of the shape (See annotated figure 3), and the shape is symmetrical about the central longitudinal axis (See annotated figure 3); opening the package containing the biologic scaffold and surgically implanting the surgical implant into the target tissue (Paragraph [0002]) to allow the target tissue to associate with the biologic scaffold (Paragraph [0004]).
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Alinsod does not disclose the first lateral edge is an outermost edge of the shape. As the lateral edges serve to provide a width between the two connection ends, the design decision to extend the lateral edge or shorten the arms in order for the design to meet the anatomical needs of posterior pelvic repair would have been obvious. As POSITA, identifying a lack of width between the two end points “55” of Figure 3, would be inclined to widen the main body shape since this would provide the greatest structural integrity to the device.
Modified Alinsod fails to disclose the method comprising a biologic scaffold disposed in a package and opening the package containing the biologic scaffold. Brahm discloses a method of treating pelvic organ prolapse (Col 2 lines 54-62) comprising implanting a multilayer bioabsorbable construct (Col 9, lines 23-35), wherein the multilayer bioabsorbable construct is stored in a package and is ready for implantation upon opening the package (Col 10, lines 18-33). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Alinsod, with the method comprising a biologic scaffold disposed in a package and opening the package containing the biologic scaffold as taught by Brahm, since such a modification would provide the predictable results of maintain the scaffold in a sterile place until it is ready for implantation ( Brahm, Col 8, lines 26-38).
Modified Alinsod fails to disclose the biologic scaffold consists of a single piece of tissue. Merade discloses a surgical implant that is singularly fabricated from natural tissues, such as tissues harvested from a donor or cadaver, or even the patient (Paragraph [0020]), with the surgical implant having a shape suited for a pelvic organ prolapse specific surgical operation (Paragraph [0020]). As Merade discloses the surgical implant may be fabricated into various shapes (Figures 5-7), it would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Alinsod, with the surgical implant consisting of a single piece fabricated from natural tissues, as taught by Merade, since such a modification would provide the predictable results of quick and easy surgical implementation (Merade, Paragraph [0007]).
Regarding claim 22, Alinsod, as modified in claim 21, discloses the body portion comprises a second longitudinal end portion proximate to the second longitudinal end portion of the shape (See annotated Figure 3 supra).
Regarding claim 23, Alinsod, as modified in claim 21, further discloses the second longitudinal end portion of the body portion comprises a longitudinal edge that is parallel to the transverse axis (See annotated Figure 3 supra).
Regarding claim 24, Alinsod, as modified in claim 21, further discloses the first arm comprises an edge connecting the longitudinal edge of the second longitudinal end portion of the body portion to a distal end portion of the first arm axis (See annotated Figure 3 supra).
Regarding claim 25, Alinsod, as modified in claim 21, further discloses the edge of the first arm is a second edge; and the first arm comprises a first edge connecting an intermediate portion of the body portion to the distal end portion of the first arm, the intermediate portion being positioned between the first longitudinal end portion of the body portion and the second longitudinal end portion of the body portion (See annotated Figure 3 supra).
Regarding claim 26, Alinsod, as modified in claim 21, further discloses the first edge of the first arm and the second edge of the first arm are linear and are parallel to one another (See annotated Figure 3 supra).
Regarding claim 28, Alinsod, as modified in claim 21, further discloses the first longitudinal end portion of the body portion has a first dimension along the transverse axis; the second longitudinal end portion of the body portion has a second dimension along the transverse axis; and the first dimension is greater than the second dimension (See annotated Figure 3 supra).
Regarding claim 29, Alinsod, as modified in claim 21, further discloses the first longitudinal end portion of the body portion comprises a second lateral edge extending longitudinally from the longitudinal edge of the first longitudinal end portion of the body portion toward the second longitudinal end portion of the shape; and the first lateral edge and the second lateral edge are parallel to one another (See annotated Figure 3 supra).
Regarding claim 30, Alinsod, as modified in claim 21, further discloses the intermediate portion is positioned between the first longitudinal end portion of the body portion and the second longitudinal end portion of the body portion, and comprises a third dimension less than the first dimension (See annotated Figure 3 supra).
Regarding claim 31, Alinsod, as modified in claim 21, further discloses the edge of the first arm is a second edge, and the first arm comprises a first edge connecting the first longitudinal end portion of the body portion to the distal end portion of the first arm; and the first edge of the first arm and the second edge of the first arm are arcuate. (See annotated Figure 3 below).
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Regarding claim 33, Alinsod, as modified in claim 21, further discloses adjusting the shape of the biologic scaffold after opening the package (Alinsod, Paragraph [0023], modified Alinsod disclosed the package, and the package would have to be open in order to modify the shape), wherein adjusting the shape of the biologic scaffold comprises removing a portion from the biologic scaffold by cutting across the first longitudinal end portion of the shape (Alinsod, Paragraph [0023]).
Regarding claim 34, Alinsod, as modified in claim 21, further discloses implanting the biologic scaffold comprises implanting the biologic scaffold such that the biologic scaffold directly contacts the target tissue (Both Alinsod and Merade cite in-growth of the target tissue onto the implant. Alinsod (Paragraph [0033]), Merade (Paragraph [0025]).
Regarding claim 35, Alinsod, as modified in claim 21, further discloses treating a vaginal prolapse condition by implanting the biologic scaffold into the target tissue (Alinsod, Abstract).
Regarding claim 37, Alinsod, as modified in claim 21, teaches a method when in the implant is an anterior pelvic organ prolapse implant (Alinsod, Paragraphs [0040]-[0054]).
Claim(s) 27 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Alinsod (US20080177132A1) in view of Brahm (US10583219B1) and Merade (US20050101834A1), as applied to claims 26 and 31 above, and further in view of Poucher (US20150297333A1).
Regarding claims 27 and 32, modified Alinsod does not disclose the distal end portion of the first arm comprises a third edge, a fourth edge, and a fifth edge, the third edge being linear and connecting the first edge to the fourth edge, the fourth edge being rounded and connecting the third edge to the fifth edge, and the fifth edge being linear and connecting the second edge to the fourth edge. Examiner notes that as the body comprises the limitations of claim 32, it does not prevent claim 32 from having a 5th edge similar to claim 27 to connect the 4th edge to the 2nd edge. Poucher discloses a device and a method for implantable devices for the treatment for treatment of urinary incontinence and pelvic organ prolapse (Paragraphs [0002] and [0003]). Poucher further discloses the device comprises autograft material, allograft material or xenograft material (Paragraph [0188]). Poucher illustrates in Figures 1 and 10B, the distal ends of the device comprise a third edge, a fourth edge, and a fifth edge, the third edge being linear and connecting the first edge to the fourth edge, the fourth edge being rounded and connecting the third edge to the fifth edge, and the fifth edge being linear and connecting the second edge to the fourth edge (Figures 1 and 10B). As Poucher shows that the distal end design is effective for anchor attachment and the instant application does not provide a reasoning for the limitations of claims 27 and 32 beyond a design choice, it would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Alinsod, with the distal end portion of the first arm comprises a third edge, a fourth edge, and a fifth edge, the third edge being linear and connecting the first edge to the fourth edge, the fourth edge being rounded and connecting the third edge to the fifth edge, and the fifth edge being linear and connecting the second edge to the fourth edge, as taught by Poucher, since such a modification would provide the predictable results of any effective design for anchor attachment (Poucher, Figures 1 and 10B).
Claim 36 are rejected under 35 U.S.C. 103 as being unpatentable over Alinsod (US20080177132A1) in view of Brahm (US10583219B1) and Merade (US20050101834A1), as applied to claim 21 above, and further in view of LoPresti (US20200360564A1).
Modified Alinsod does not disclose the single piece of tissue is derived from extracellular matrix (ECM) material. LoPresti discloses an ECM product (Abstract), that can be produced as a sheet and formed into a suitable shape, wherein the product can consist of ECM alone (Paragraph [0060]). LoPresti further discloses the product can be used to treat pelvic organ reconstruction (Paragraph [0083]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Alinsod, with the single piece of tissue being derived from ECM material as taught by LoPresti, since extracellular matrix (ECM) biomaterials have been shown to promote constructive remodeling by increasing the anti-inflammatory (M2) phenotype (LoPresti, Paragraphs [0003]-[0004]).
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 Marc D Honrath whose telephone number is (571)272-6219. The examiner can normally be reached M-F 7:30-5:00.
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, Charles A Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/M.D.H./Examiner, Art Unit 3791
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