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 .
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 step of referencing one or more fiducial features on one or more components of the device (claim 47), the cannula tip comprising a detectable registration feature (claim 53), and the device comprising a mesh or balloon (claim 54) 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 § 102
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.
Claims 1-5, 7, 14, 15, 18, 19, 33, 41, 43, 48, 50, and 56 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ahn (U.S. Publication 2017/0312385).
Regarding claim 1:
Ahn discloses a method comprising:
(claim 1) acquiring image data of a wound site (paragraphs 159 and 162; imaging is used to determine the locations to perform the procedure)
(claim 1) positioning a device to deliver the adhesive composition to a wound site (paragraph 208)
(claim 1) delivering the adhesive composition to the wound site via the device (paragraph 208)
Regarding claims 2-5, 7, 14, 15, 18, 19, 24, 25, 33, 41, 43, 48, 50, and 56:
Ahn discloses a method comprising:
(claim 2) acquiring image data of a wound site (paragraphs 159 and 162)
(claim 14) wherein the acquiring includes acquiring a first set of image data of the wound site prior to delivering the adhesive composition to the wound site (paragraph 162) and acquiring a second set of image date of the wound site after delivering the adhesive compound to the wound site (paragraph 224)
(claim 15) further comprising acquiring a third set of image data of the wound site while delivering the adhesive composition to the wound site (paragraph 162)
(claim 18) wherein the acquiring the image data includes data related to the position of X-rays (paragraph 162; it is well known real-time fluoroscopy imaging is continuous use of X-ray pictures to create a movie like image)
(claim 19) wherein the acquiring of image date incudes X-ray (paragraph 162)
(claim 2) positioning a device constructed and arranged to deliver an adhesive composition to a wound site (paragraphs 25 and 208)
(claim 3) wherein the positioning of the device is responsive to the image data acquired (paragraph 162)
(claim 48) wherein the device comprises at least one cannula tip (the distal end of the cannula is a tip)
(claim 2) delivering the adhesive compound to the wound site via the device (paragraph 208)
(claim 4) wherein the delivering of the adhesive composition is responsive to the image data acquired (paragraph 162)
(claim 5) wherein delivering the adhesive compound further comprises controlling the location of delivery of the adhesive composition (paragraph 162)
(claim 7) wherein delivering the adhesive composition further comprises delivering an amount of the adhesive composition to prevent leakage from the wound site (paragraph 305)
(claim 33) wherein the adhesive composition has a viscosity between 100 cP and 10,000 cP (paragraph 39; 5 pascal-seconds is equal to 5000 cP)
(claim 56) wherein the adhesive composition is a therapeutic composition that stimulates bone regeneration (paragraph 181; the composition can be considered therapeutic since it stimulates bone remodeling, i.e. bone growth)
(claim 41) making an incision in a subject responsive to acquiring image data (paragraphs 58 and 221)
(claim 43) wherein the delivering of the adhesive composition occurs following making the incision (paragraphs 220-226)
(claim 50) controlling the direction of the adhesive composition (paragraph 208; the direction of cannula controls the direction of the composition delivery)
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.
Claims 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Ahn (U.S. Publication 2017/0312385) in view of Hess (U.S. Publication 2019/0022273).
The invention of Ahn discloses the method as discussed above including an adhesive composition in order to treat degenerate bone (abstract of Ahn). Hess teaches a method of delivering an adhesive composition, wherein the adhesive composition includes a multivalent metal salt (paragraphs 24 and 37), an organic compound, such as Formula (I) (paragraph 26), and an aqueous solution (paragraph 37) in order to treat degenerate bone (paragraph 49). Because both the invention of Ahn and the invention of Hess disclose inventions including an adhesive compound to treat degenerate bone, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to substitute one adhesive compound with the other adhesive compound in order to achieve the predictable results of treating degenerate bone.
Claims 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Ahn (U.S. Publication 2017/0312385) in view of Truckai (U.S. Publication 2009/0247664).
The invention of Ahn discloses the method as claimed, see above, except for the adhesive compound further including an agent, such as a contrast agent including barium, at an amount less than about 20% of the weight of the compound.
Regarding the adhesive compound further including an agent, Truckai teaches an invention including an adhesive compound, wherein the adhesive compound includes a contrast agent including barium (paragraph 134) less than about 50% weight in order to allow the adhesive compound to be seen in x-ray images. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the invention of Ahn wherein the adhesive compound further includes a contrast agent including barium in view of Truckai in order to allow the device to be seen in x-ray images.
Regarding the contrast agent being less than about 20% weight, it would have been obvious to one having ordinary skill in the art at the time the invention was filed provide the invention of Ahn as modified by Truckai wherein the contrast agent is provided at a weight less than about 20%, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 47 is rejected under 35 U.S.C. 103 as being unpatentable over Ahn (U.S. Publication 2017/0312385) in view of Terrill-Grisoni (U.S. Publication 2005/0124988).
The invention of Ahn discloses the method as claimed, see above, except for referencing one or more fiducial features on the device. Terrill-Grisoni teaches a device comprising a delivery device for bone cement (paragraphs 13, 14, and 53; the device is disclosed as being used with sleeves and injectors for bone cement, i.e. adhesive compound), wherein the device further comprises at least one or more fiducial features (10; modular portal 10 includes fiducial markers (22) that can be used in combination with a bone cement delivery device, wherein the fiducial markers (22) are referenced in order to register and track the delivery device with a computer-aided surgical navigation system (paragraph 9). It would have been obvious to one with ordinary skill in the art at the time the invention was filed to provide the delivery device with fiducial features and referencing the fiducial features in view of Terrill-Grisoni in order to register and track the delivery device with a computer-aided surgical navigation system.
Claim 53 is rejected under 35 U.S.C. 103 as being unpatentable over Ahn (U.S. Publication 2017/0312385) in view of Reiley (U.S. Patent 6,048,346).
The invention of Ahn discloses the method as claimed, see above, except for the tip of the cannula, i.e. the distal end of the delivery cannula, including a detectable registration feature. Reiley discloses a delivery device comprising a cannula (30) including a tip (34), wherein the tip includes a detectable registration feature (68) used to indicate the path of adhesive composition during delivery (column 9 lines 52-61) in order to visualize the tip of the delivery cannula within the treatment area. It would have been obvious to one having ordinary skill in the art at time the invention was filed to provide the invention of Ahn wherein the tip of the cannula includes a detectable registration feature in view of Reiley in order to visualize the tip of the delivery cannula within the treatment area.
Claim 54 is rejected under 35 U.S.C. 103 as being unpatentable over Ahn (U.S. Publication 2017/0312385) in view of Rabiner (U.S. Publication 2009/0054900).
The invention of Ahn discloses the method as claimed, see above, except for the invention further comprising a balloon. Rabiner teaches a device comprising a device for delivery an adhesive composition, wherein the device further includes a balloon in order to prevent damage to the bone and surrounding soft tissue. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the invention of Ahn wherein the device includes a balloon in view of Rabiner in order to prevent damage to the bone and surrounding soft tissue.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for cited references the examiner felt were relevant to the application.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicholas Woodall whose telephone number is (571) 272-5204. The examiner can normally be reached on Monday-Friday 8am to 5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICHOLAS W WOODALL/Primary Examiner, Art Unit 3775