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 .
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because use of legal phraseology, "herein", "wherein", and "thereby' and "disclose[ ]". A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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.
Claim(s) 1 and 3-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over HIORTH et al. WO 2020109599 A1, here in referred to as Hiorth, in view of Dyneema fact sheet (furnished with this Office Action).
Re. Claim 1, Hiorth discloses a method for repairing a cardiac valve (pg 1, lines 1-5), the method comprising: attaching a high strength cord (Fig 10, artificial chordae lines 14, pg 53, lines 26-40) to targeted tissue of a heart (pg 1, lines 1-5), the high strength cord including a distal anchor (Fig 10, self-expandable leaflet anchor 10) and a suture (Fig 16, suture 68.) extending proximally from the distal anchor implant, and anchoring a proximal end of the high strength cord to the heart (pg 53, lines 26-40 & pg 54, lines 1-11).
But does not disclose the high strength cord having a tensile strength of at least 2000MPa.
But a Dyneema fact sheet discloses a similar high strength medical cord. The Dyneema fact sheet teaches the high strength cord having a tensile strength of at least 2000MPa (pg 65, 35-40; Dyneema fact sheet).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the cardial repair method of Hiorth to incorporate the high strength cord having a tensile strength of at least 2000MPa, as taught and suggested by the Dyneema fact sheet to be sufficient strong cord material [table of physical properties].
Re. Claim 3, the combination of Hiorth and the Dyneema fact sheet discloses wherein the high strength cord comprises braided or twisted strands of a synthetic aramid polymer (Pg 69, lines19-20).
Re. Claim 4, the combination of Hiorth and the Dyneema fact sheet discloses wherein the braided or twisted strands of the synthetic aramid polymer surround a core structure (Pg 69, lines19-20).
Re. Claim 5, the combination of Hiorth and the Dyneema fact sheet discloses wherein the synthetic aramid strands cover at least 50% of the core structure (Pg 50 33-37, main portion of chord interpreted as at least 50%).
Re. Claim 6, the combination of Hiorth and the Dyneema fact sheet discloses wherein the high strength cord comprises a core portion (Pg 69, lines19-20) of a high-strength material and a coating material coating the core portion, the coating material configured to improve biostability (Pg 50, lines 33-37).
Re. Claim 7, the combination of Hiorth and the Dyneema fact sheet discloses wherein the high-strength material comprises a high-strength polymer (pg 65, 35-40; Dyneema fact sheet).
Re. Claim 8, the combination of Hiorth and the Dyneema fact sheet discloses wherein the high-strength material comprises a metal (pg 50, lines 21-22).
Re. Claim 9, the combination of Hiorth and the Dyneema fact sheet discloses wherein the high-strength material comprises a ceramic (Pg 10, lines 7-8, glass is a ceramic material).
Re. Claim 10, the combination of Hiorth and the Dyneema fact sheet discloses wherein the coating material comprises expanded polytetrafluoroethylene (pg 40, lines 27-37).
Re. Claim 11, the combination of Hiorth and the Dyneema fact sheet discloses wherein the high strength cord comprises a core portion (Pg 69, lines19-20) of a high strength material and a jacket portion surrounding the core portion (Pg 50, lines 33-37).
Re. Claim 12, the combination of Hiorth and the Dyneema fact sheet wherein the high strength material comprises a high strength polymer (pg 65, 35-40; Dyneema fact sheet).
Re. Claim 13, the combination of Hiorth and the Dyneema fact sheet discloses wherein the high strength material comprises a metal pg 50, lines 21-22).
Re. Claim 14, the combination of Hiorth and the Dyneema fact sheet discloses wherein the high strength material comprises a ceramic (Pg 10, lines 7-8, glass is a ceramic material).
Re. Claim 15, the combination of Hiorth and the Dyneema fact sheet discloses wherein the jacket portion comprises expanded polytetrafluoroethylene (pg 52, 7-23).
Re. Claim 17, the combination of Hiorth and the Dyneema fact sheet discloses wherein anchoring the proximal end includes securing the proximal end to an external wall of the heart (pg 59, lines 1-5).
Re. Claim 18, the combination of Hiorth and the Dyneema fact sheet discloses wherein anchoring (Fig 38, papillary anchor 9) the proximal end includes securing the proximal end to a papillary muscle of the heart Annotated Fig 38 below, pg 2, lines 7-9).
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Annotated Figure 38, Hiorth et al.
Re. Claim 19, the combination of Hiorth and the Dyneema fact sheet discloses wherein the targeted tissue includes a leaflet of a mitral valve (Fig 15, pg 65, 8-19).
Re. Claim 20, the combination of Hiorth and the Dyneema fact sheet discloses wherein the distal anchor is a bulky (Fig 47, 65, pg 80, 30-31) knot formed using the high strength cord ((pg 65, 35-40; Dyneema fact sheet).
Re. Claim 16, the combination of Hiorth and the Dyneema fact sheet discloses the invention substantially as claimed and as discussed above with respect to claim 1, but does not disclose wherein the jacket portion is formed from ribbons of flattened expanded polytetrafluoroethylene.
However, in another embodiment Hiorth discloses a similar method of cardiac repair. Hiorth also teaches wherein the jacket portion is formed from ribbons (pgs 28, lines 24-37 and 1-2) of flattened expanded polytetrafluoroethylene (pg 52, 7-23).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the base cardiac repair method of Hiorth and the Dyneema fact sheet to incorporate wherein the jacket portion is formed from ribbons of flattened expanded polytetrafluoroethylene as taught and suggested by Hiorth In order to allow more reliable adjustments (pgs 28, lines 24-37).
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over HIORTH in view of the Dyneema fact sheet, and further in view of Sogard US 20070173930 A1, herein referred to as Sogard.
Re. Claim 2, the combination of Hiorth and the Dyneema fact sheet does not discloses wherein the high strength cord consists of synthetic aramid polymer fibers.
But Sogard discloses a similar method for cardiovascular repair using a strength cord. Sogard teaches wherein the high strength cord consists of synthetic aramid polymer fibers (Fig 3, cord 330, [0035]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the base cardiac repair method of Hiorth and the Dyneema fact sheet to incorporate wherein the high strength cord consists of synthetic aramid polymer fiber, as taught and suggested by Sogard in order to make the cord autologous with the grafting area [0035]
Conclusion
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/A.F./ /THOMAS C BARRETT/Patent Examiner, Art Unit 3774 SPE, Art Unit 3799