DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Allowable Subject Matter
Claim 18, 20-21 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art fails to fairly teach or suggest the features of claim 1 including less than about 5,000 uM/g of phospholipids, the features of claim 1 including less than about 25 ug/g of nucleic acid, and the features of claim 1 including calcium, less than about 50,000 ng/g of DNA, less than about 5,000 uM/g of phospholipids, less than about 2,000 ug/g of GAG, and less than about 25 ug/g of nucleic acid. The closest prior art is Murray (Pub. No.: US 2009/0306776) however Murray is silent as to these quantities.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the anchor, suture, and collagen implant must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 6, 8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification fails to describe an implant capable of absorbing at least 9 ml of blood. The specification fails to describe an implant configured to be indirectly coupled to an anchor via the suture.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-11, 13-16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Murray (Pub. No.: US 2009/0306776).
Murray discloses a device for repair of tissue exposed to synovial fluid (e.g., abstract), the device comprising:
a first anchor 8 capable of forming a stable attachment to a first bone;
a suture 12 attachable to a ruptured end of the tissue (e.g., fig. 1C) and
a collagen implant 14 positioned along the suture and adjacent to the ruptured end of the tissue (e.g., fig. 1C), the collagen implant comprising a self-assembly (e.g., para. 43) of collagen fibers (e.g., para. 41) and a bioabsorbable polymer (e.g., para. 41, 44) wherein the collagen implant is expandable and compressible (e.g., para. 45) and is capable of absorbing at least 3 ml (not disclosed) of blood (e.g., para. 9) and has resistance to degradation by synovial fluid (para. 41).
As provided in italicized text above, Murray does not specify the implant is capable of absorbing at least 3 ml of blood. Murray teaches the implant absorbs blood (e.g., para. 9), however, is silent as to the quantity. As the material is the same as the claimed material, it is fully expected that Murray is capable of absorbing at least 3 ml of blood, and it would have been obvious to one of ordinary skill in the art to have provided the implant as capable of implanting this volume of blood as an obvious expedient.
For claim 2, Murray does not specify the self-assembly of collagen fibers is obtained from a bovine knee. However, this limitation is a product-by-process limitation. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps (see MPEP 2113). Here, Murray discloses self-assembly collagen fibers, and thus includes the structure implied by the product-by-process limitation.
For claim 3, Murray teaches the device of claim 1, wherein the self-assembly of collagen fibers comprises soluble type I collagen (e.g., para. 46).
For claim 4, Murray teaches the device of claim 1, wherein the self-assembly of collagen fibers further comprises a therapeutic protein (e.g., para. 43).
For claim 5, Murray teaches the device of claim 1, wherein the collagen implant forms a generally cylindrical shape (e.g., fig. 1C).
For claim 6, Murray teaches the device of claim 1, wherein the collagen implant is capable of absorbing at least 9 ml (not disclosed) of blood (e.g., para. 9). As provided in italicized text above, Murray does not specify the implant is capable of absorbing at least 9 ml of blood. Murray teaches the implant absorbs blood (e.g., para. 9), however, is silent as to the quantity. As the material is the same as the claimed material, it is fully expected that Murray is capable of absorbing at least 9ml of blood, and it would have been obvious to one of ordinary skill in the art to have provided the implant as capable of implanting this volume of blood as an obvious expedient.
For claim 7, Murray teaches the device of claim 1, wherein the collagen implant is configured to permit a suture to pass therethrough (e.g., fig. 1C).
For claim 8, Murray teaches the device of claim 7, wherein the implant is configured to be indirectly coupled to an anchor via the suture (e.g., fig. 1C).
For claim 9, Murray teaches the device of claim 1, wherein the collagen implant is a sponge (e.g., para. 5).
For claims 10-11, Murray is silent as to 22 mm diameter or 30 mm length. However, as the implant is intended to repair a ruptured ligament, these dimensions are considered an obvious expedient to bridge a tear in the ACL and would have been obvious to one of ordinary skill in the art at the time the invention was filed. This selection would have occurred using known methods and would have yielded predictable results.
For claim 13, Murray teaches the device of claim 1, wherein the self-assembly of collagen fibers have a collagen concentration of greater than 10 mg/mL (para. 83).
For claim 14, Murray teaches the device of claim 1, further comprising a second anchor for direct contact with a second bone and being attachable to the suture (e.g., para. 8).
For claim 15, Murray teaches the device of claim 14, wherein the first anchor and the second anchor are selected from the group consisting of a screw, a barb, a helical anchor, a staple, a clip, a snap, and a rivet (e.g., para. 14).
For claim 16, Murray teaches the device of claim 1, wherein the self-assembly of collagen fibers includes calcium (e.g., para. 68).
Claims 12, 17, 19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Murray (Pub. No.: US 2009/0306776) in view of Smith et al. (Pub. No.: US 20070065943).
For claim 12 and 19 Murray lacks the self-assembly of collagen fibers include greater than 100 ug/g of GAG. Murray teaches collagen including GAG (e.g., para. 44), however, fails to specify the quantity of the GAG. Smith et al. (hereinafter, Smith) teaches a collagen construct with GAG content of greater than 100 ug/g and less than 2000 ug/g (e.g., fig. 7A, 8A). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have provided the collagen of Murray with GAG in the quantities taught by Smith as an obvious expedient. This selection would have occurred using known methods and would have yielded predictable results.
For claim 17, Murrya lacks the self-assembly of collagen fibers includes less than about 50,000 ng/g of DNA. Smith teaches less than 50000 ng/g DNA (fig. 7B, 8B) as a suitable amount of DNA within a collagen matrix. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have provided the collagen of Murray with DNA in the quantities taught by Smith as an obvious expedient. This selection would have occurred using known methods and would have yielded predictable results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUBA GANESAN whose telephone number is (571)272-3243. The examiner can normally be reached Monday-Friday, 8 AM - 5 PM Mountain Time.
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/SUBA GANESAN/Primary Examiner, Art Unit 3774
