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 .
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.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 1917673.4, filed on 2019-12-04.
Response to Amendment
The amendment filed 08/13/2025 has been entered. Claims 2-3 and 16-17 are cancelled.
Claims 1, 4-15, and 18-22 remain pending.
Response to Arguments
Applicant's arguments filed 08/13/2025 have been fully considered but they are not persuasive.
Regarding Applicant’s argument that knitting is sufficiently different from weaving, and that since the Examiner has not shown that knitting specifically bone fibers together that it would not be obvious to knit the pieces together instead of weave the pieces together, the Examiner respectfully disagrees. The Applicant’s argument has a basis is on the presumption that “since knitted fabrics are generally less stable than woven fabrics, and that knitting would have increased complexity, time, and cost associated with producing a knitted product, that there would be no motivation to knit the fibers of the implant of Bindseil, and therefore it would not be obvious to do so.” The Examiner disagrees with this presumption, as knitting is a well know way of connecting fibers to each other, as well as is weaving, and there is no mention in the specification of the application that only knitting, and not also weaving, would “facilitate the creation of more complex 3-dimensinal implant products including, for example, bags, pouches and boat-like structures for carrying bone chips in spinal fusion surgery and bone augmentation procedures”. Due to the Instant Application not having a reason as to why knitting as opposed to weaving the bone fibers together would solves any problem or is for any particular purpose, nor does it place criticality on the limitation, nor does the specification state that knitting “much more challenging, time-consuming and expensive process than weaving,” as stated by the Applicant in the arguments, it would be obvious to switch out weaving for knitting, to make the pattern of connection of the bone fibers be knitted together in a regular and repeating knit, as an obvious matter of design choice within the skill of the art. Lastly, it does not state in the Instant Application’s specification that “knitted products are generally less structurally stable more readily deformable than woven products,” so there would be no reason to assume that the woven implant of Bindseil would not perform equally and function as intended if the connected of the fibers were of a knitted pattern as claimed.
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.
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.
Claims 1, 4-15, 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over US 20040249463 A1 (hereafter –Blindseil--).
Regarding Claim 1, Blindseil discloses a demineralized bone matrix (DBM) scaffold product (see annotated DBM scaffold product in Figures 2 and 3 below) comprising a plurality of elongate demineralised bone fibers (see paragraphs [0017] and [0022]) mechanically interconnected with one another in a regular and repeating pattern (see paragraph [0017], see also woven pattern in Figures 2 and 3 below).
This embodiment of Blindseil fails to disclose in which said plurality of elongate demineralised bone fibers are knitted together in a regular and repeating knit pattern.
As shown in the rejection above, the embodiment discloses a DBM scaffold product as claimed in claim 1 in which said plurality of elongate demineralised bone fibers are woven together in a regular and repeating weave pattern (see paragraph [0017] and Figures 2 and 3 above).
The Instant Application does not disclose having the bone fibers knitted instead of woven solves any problem or is for any particular purpose, nor does it place criticality on the limitation. Instead, the instant specification indicates weaving and knitting are known equivalents (see instant specification disclosing the strands may be woven or knitted together). It appears that Blindseil’s scaffold would perform equally and function as intended if the connected of the fibers were of a knitted pattern instead of a woven pattern.. Therefore, it would have been obvious to one having ordinary skill in the art to make the pattern of connection of the bone fibers be knitted together in a regular and repeating knit as an obvious matter of design choice within the skill of the art.
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Regarding Claim 4, Blindseil as modified discloses a DBM scaffold product as claimed in claim 1 in which said elongate demineralised bone fibers each comprise a single filament taken from a donor bone (see paragraph [0015], [0025], and [0032]).
Regarding Claim 5, Blindseil as modified discloses a DBM scaffold product as claimed in claim 1 in which said elongate demineralised bone fibers each comprise a composite strip comprising a plurality of filaments taken from donor bones which are connected together by an adhesive (see paragraph [0015] and [0025] regarding the donor bones, see also paragraph [0021] regarding the adhesive portion).
Regarding Claim 6, Blindseil as modified discloses a DBM scaffold product as claimed in claim 5 in which said adhesive comprises a liquid or gel tissue adhesive comprising one or more of a fibrin glue, cyanoacrylate based product, polyethylene glycol-PE-sealant or glutaraldehyde albumin-derived product (see paragraph [0021]).
Regarding Claim 7, Blindseil as modified discloses a DBM scaffold product as claimed in claim 6 in which said adhesive further comprises a hemostatic component (see paragraph [0021] denoting that the adhesive could be a fibrin glue or a cyanoacrylate product, both options that are known to be helpful with hemostasis and stopping bleeding as they can seal a wound).
Regarding Claim 8, Blindseil as modified discloses a DBM scaffold product as claimed in claim 5 in which said filaments comprise flat sides, in which said filaments are arranged with end portions thereof overlapping (see annotated flat sides and end portions overlapping in Figures 2 and 3 above), and with said adhesive located between said overlapped end portions (see paragraphs [0023] denoting that the layers can be secured together through one or more of the interconnection mechanisms, the two being using an adhesive and using weaving).
Regarding Claim 9, Blindseil as modified discloses a DBM scaffold product as claimed in claim 5 in which said product is formed into a sheet (see Figures 2 and 3 above). “Sheet” is being interpreted as “a broad stretch or surface of something” (see definition 3 on Merriam Webster online).
Regarding Claim 10, Blindseil as modified discloses a DBM scaffold product as claimed in claim 5 in which said product is formed into a three-dimensional shape defining an inner area (see Figures 2 and 3 above denoting the DBM scaffold product that is a three-dimensional structure that defines an “inner area,” the inner area being the area of the piece of the scaffold product).
Regarding Claim 11, Blindseil as modified discloses a DBM scaffold product as claimed in claim 1 in which said product comprises a plurality of elongate synthetic fibers mechanically interconnected with said plurality of elongate demineralised bone fibers in a regular and repeating pattern (see paragraph [0019] and [0020] denoting that a resorbable, nonresorbable polymer, or collagen can be the elongate and flexible material threaded through the layers of the implant to further assist in connecting them securely).
Regarding Claim 12, Blindseil as modified discloses a DBM scaffold product as claimed in claim 11 in which said synthetic fibers comprises one or more of a polylactic acid, polyglycolic acid, collagen or chitosan (see paragraph [0020] denoting that collagen is one of the material options).
Regarding Claim 13, Blindseil as modified discloses a DBM scaffold product as claimed in claim 1 in which said product further comprises a gel or viscous liquid applied to said plurality of elongate demineralised bone fibers (see paragraph [0021] denoting that gelatin-based adhesives are an option to connect the layers together).
Regarding Claim 14, Blindseil as modified discloses a DBM scaffold product as claimed in claim 13 in which said gel or viscous liquid comprises one or more of glycerol, collagen, gelatin, hyaluronic acid, lecithin, calcium sulphate, poloxamer, calcium phosphate or carboxymethyl cellulose (CMC) (see paragraph [0021] denoting that gelatin-based adhesives and calcium phosphate are an option to connect the layers together).
Regarding Claim 15, Blindseil discloses a method of manufacturing a DBM scaffold product comprising a plurality of elongate demineralised bone fibers, said method comprising the step of mechanically interconnecting said plurality of elongate demineralised bone fibers with one another in a regular and repeating pattern (see paragraph [0017], see also woven pattern in Figures 2 and 3 above).
This embodiment of Blindseil fails to disclose in which said plurality of elongate demineralised bone fibers are knitted together in a regular and repeating knit pattern.
As shown in the rejection above, the embodiment discloses a DBM scaffold product as claimed in claim 1 in which said plurality of elongate demineralised bone fibers are woven together in a regular and repeating weave pattern (see paragraph [0017] and Figures 2 and 3 above).
The Instant Application does not disclose having the bone fibers knitted instead of woven solves any problem or is for any particular purpose, nor does it place criticality on the limitation. Instead, the instant specification indicates weaving and knitting are known equivalents (see instant specification disclosing the strands may be woven or knitted together). It appears that Blindseil’s scaffold would perform equally and function as intended if the connected of the fibers were of a knitted pattern instead of a woven pattern.. Therefore, it would have been obvious to one having ordinary skill in the art to make the pattern of connection of the bone fibers be knitted together in a regular and repeating knit as an obvious matter of design choice within the skill of the art.
Regarding Claim 18, Blindseil as modified discloses a method of manufacturing a DBM scaffold product as claimed in claim 15 in which prior to said step of mechanically interconnecting said plurality of elongate demineralised bone fibers with one another in a regular and repeating pattern said method comprises the step of forming each of said elongate demineralised bone fibers by connecting a plurality of filaments taken from donor bones together with adhesive to form a composite strip (see paragraph [0015] and [0025] regarding the donor bones, see also paragraph [0021] regarding the adhesive portion).
Regarding Claim 19, Blindseil as modified discloses a method of manufacturing a DBM scaffold product as claimed in claim 18 in which said filaments comprise flat sides, and in which said step of forming each of said elongate demineralised bone fibers as a composite strip comprises arranging adjacent filaments with end portions thereof overlapping (see paragraph [0017], see also woven pattern in Figures 2 and 3 above), said adhesive being between said overlapped end portions (see paragraph [0021] denoting that an adhesive can be applied to interlock fibers).
Regarding Claim 20, Blindseil as modified discloses a method of manufacturing a DBM scaffold product as claimed in claim 15 in which said step of mechanically interconnecting said plurality of elongate demineralised bone fibers with one another in a regular and repeating pattern comprises forming said product as a sheet (see paragraph [0017], see also woven pattern in Figures 2 and 3 above). “Sheet” is being interpreted as “a broad stretch or surface of something” (see definition 3 on Merriam Webster online).
Regarding Claim 21, Blindseil as modified discloses a method of manufacturing a DBM scaffold product as claimed in claim 15 in which said step of mechanically interconnecting said plurality of elongate demineralised bone fibers with one another in a regular and repeating pattern comprises forming said product as a three-dimensional shape defining an inner area (see Figures 2 and 3 above denoting the DBM scaffold product that is a three dimensional structure that defines an “inner area,” the inner area being the area of the piece of the scaffold product).
Claims 22 is rejected under 35 U.S.C. 103 as being unpatentable over US 20040249463 A1 (hereafter –Blindseil--), as applied to claim 15 above, in view of US 20140314822 A1 (hereafter –Carter--).
Regarding Claim 22, Blindseil as modified discloses a method of manufacturing a DBM scaffold product as claimed in claim 15.
Blindseil as modified fails to disclose in which said method comprises the further step of placing said product into a mold of a pre-determined shape and size and applying a pressure thereto in order to form said product into a pre-determined shape.
Carter discloses a method of manufacturing a DBM scaffold product (see Figure 21 below) comprising a plurality of elongate demineralised bone fibers (see Abstract, see also paragraph [0005]), said method comprising the step of mechanically interconnecting said plurality of elongate demineralised bone fibers with one another in a regular and repeating pattern (see paragraphs [0101], [0102], and Claim 8). Carter teaches wherein the method comprises the further step of placing said product into a mold of a pre-determined shape and size and applying a pressure thereto in order to form said product into a pre-determined shape (see paragraph [0134]).
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Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the method of Blindseil comprise of the further step of placing said product into a mold of a pre-determined shape and size and applying a pressure thereto in order to form said product into a pre-determined shape, as by doing so would enable the fibers to be compressed to a defined thickness and shape as taught by Carter (see paragraph [0089]).
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 PARIS MARIE BLASS whose telephone number is (703)756-5375. The examiner can normally be reached Monday - Thursday 9 a.m. - 7 p.m. ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774