DETAILED ACTION
This action is in response to applicant’s amendment received on April 28th, 2026.
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 one or more components of the device include one or more fiducial features (claim 47), the cannula tip having a detectable registration feature (claim 53), and a balloon or mesh containment device used to position the adhesive composition (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 § 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.
Claim 1 is 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).
Ahn discloses a method comprising:
(claim 1) acquiring image data of a wound site (paragraphs 159 and 162;l 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)
The invention of Ahn discloses the method as discussed above including an adhesive compound in order to treat degenerate bone (abstract of Ahn). Hess teaches a method of delivering an adhesive composition (for example see paragraphs 159, 160, 220, and 221), wherein the adhesive composition includes a multivalent metal salt (paragraphs 24 and 37), an organic compound, such as Formula (I) (paragraphs 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 2-4, 5, 7, 14, 15, 18, 19, 25, 33, 41, 43, 50, 56, and 61-63 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).
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 data 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 data includes an X-ray
(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 2) delivering the adhesive composition 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 composition 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 5,000 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)
The invention of Ahn discloses the method as discussed above including an adhesive compound in order to treat degenerate bone (abstract of Ahn). Hess teaches a method of delivering an adhesive composition (for example see paragraphs 159, 160, 220, and 221), wherein the adhesive composition includes a multivalent metal salt, such as tetracalcium phosphate (claim 25) (paragraphs 24 and 35-37), an organic compound, such as Formula (I) (paragraphs 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.
Regarding claim 61, the invention of Ahn as modified by Hess discloses the multivalent metal salt having a particle size between 1 micrometer and 250 micrometers (0.001 mm to 0.750 mm equals 1 micrometer to 750 micrometers; see paragraph 39). 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 as modified by Hess wherein multivalent metal salt having a particle size between 1 micrometer and 250 micrometers, 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 routing skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 62, the invention of Ahn as modified by Hess discloses the organic compound being about 10% to 90% w/w of the adhesive composition (see paragraph 142).
Regarding claim 63, the invention of Ahn as modified by Hess discloses the adhesive strength being at least 100 kPa upon curing (see paragraph 160).
Claims 34-37 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) further in view of Truckai (U.S. Publication 2009/0247664).
The invention of Ahn as modified by Hess discloses the invention as claimed except for adhesive composition further comprising an agent, Truckai teaches an invention including an adhesive composition, wherein the adhesive composition includes a contrast agent including barium (paragraph 134) less than about 50% weight in order to allow adhesive composition 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 as modified by Hess wherein the adhesive composition 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 to provide the invention of Ahn as modified by Hess as further 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 routing 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 Hess (U.S. Publication 2019/0022273) further in view of Terrill-Grisoni (U.S. Publication 2005/0124988).
The invention of Ahn as modified by Hess discloses the invention as claimed, see above, except for the 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 composition), 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 makers (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 having 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 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 Hess (U.S. Publication 2019/0022273) further in view of Reiley (U.S. Patent 6,048,346).
The invention of Ahn as modified by Hess discloses the invention 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 the time the invention was filed to provide the device of Ahn as modified by Hess 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 Hess (U.S. Publication 2019/0022273) further in view of Rabiner (U.S. Publication 2009/0054900).
The invention of Ahn as modified by Hess discloses the invention as claimed, see above, except for the invention further comprising a balloon. Rabiner teaches a device comprising a device for delivering 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 as modified by Hess wherein the device further includes a balloon in view of Rabiner in order to prevent damage to the bone and surrounding soft tissue.
Response to Arguments
Applicant's arguments filed April 28th, 2026 have been fully considered but they are not persuasive. The applicant’s arguments regarding the drawing objections are not persuasive. As discussed above, the drawings do not show claimed structural elements of the delivery device. The applicant’s argument that the examiner does not provide a prima facie case of obviousness is not persuasive. First, the examiner has provided the rational of substituting known equivalents for the same purpose, i.e. substituting one adhesive composition for another adhesive composition for treating degenerate bone. Second, the combination of references discloses the claims limitations as discussed above. Third, there is a reasonable expectation of success when substituting one adhesive composition for treating degenerate bone with another adhesive composition for treating degenerate bone. The applicant’s argument that the examiner has used improper hindsight is not persuasive. It must be recognized that any judgement on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. In re McLaughlin, 443 F.2d 1392; 170 USPQ 209 (CCPA 1971).
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 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)272-4705. 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
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