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 .
Applicant’s arguments, filed with the response of August 25, 2026, have been fully considered. The following is a complete response to the August 25, 2026 communication.
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 tissue manipulator including a staple including a conductive coating and an electrically insulating element disposed between the conductive coating and a portion of the manipulator 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 1-5, 8-13, 15, 19 and 20 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 claims 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. Applicant’s specification is decidedly vague in the application of a coating on the variety of different devices, in particular on a fastener such as a stapler. The only discussion of a coating on a staple is directed to prior art staples that may be coated with a conductive coating (para. [0050-0055] of the printed publication), and there is no discussion of providing an insulative coating. The only discussion of an insulating element is directed towards the embodiment of Figure 12. It is not clear how the embodiment of Figure 12 may be considered a fastener, or why a fastener would have a capacitor and resistor circuit. Applicant appears to be pulling different disclosed features into the claims, with no clear discussion of how these features are used together to create claimed invention.
Response to Arguments
Applicant's arguments filed August 25, 2026 have been fully considered but they are not persuasive. The examiner maintains that the drawings fail to show the claimed structure of an electrically insulating element disposed between a conductive coating and a portion of the tissue manipulator when the tissue manipulator is a staple. The examiner further maintains the position that the broad recitation of the use of an insulating element would not apply equally to all embodiments, and applicant’s failure to specifically address the manner and rationale for applying such an insulating coating on a staple makes the specification insufficient to comply with the written description requirement.
Initially, it is noted that the examiner has withdrawn the prior art rejections. As such, the Declaration of Michael J. Page, M.D. is moot as this declaration only addressed the prior art issues.
Applicant asserts that there is no legal requirement to show every claimed feature in the drawings, particularly when the feature is adequately described. As addressed with respect to the 35 USC 112 rejection above, the examiner maintains the feature is not adequately described. Paragraphs [0049-0056] of the printed publication (US 2021/0212749) provide the most comprehensive discussion of the use of surgical staples. This discussion is limited to providing a conductive coating on prior art staples, and makes no mention of the use of an insulating material, and specifically an insulating material disposed between a conductive coating and the tissue manipulator (i.e. staple). It is not clear which portion or portions of the staple would be provided with the insulative coating (e.g. the entire outer surface, only the top surface, the sides, etc.). Applicant’s citation of the MPEP states “the absence of a drawing illustrating a claimed feature is not, by itself, a sufficient basis for a drawing objection where the feature is adequately described in the specification” (emphasis added). As addressed in the 35 USC 112, first paragraph rejection (and extensively in previous Office actions), the examiner maintains this feature is not adequately described. That one of ordinary skill in the art may be able to arrive at the claimed combination does not negate the fact that there are numerous ways to arrive at such a combination and applicant’s specification has not addressed any of them specifically. As asserted in previous Office actions, the insulation could be applied in various manners (e.g. over the entire staple or only on select portions) and the conductive coating could likewise be applied in various manners. There is no discussion on the manner in which the claimed device would be derived.
Applicant’s argument that the Drawing Objection is improperly tethered to the 112(a) rejection is not persuasive. Clearly there is an independent basis for the rejection, namely that the features are not shown. The examiner’s “tethering” to the 35 USC 112(a) rejection is predicated on applicant’s continued arguments that a drawing is not necessary where a feature is adequately described in the specification. Clearly, the MPEP provides a basis to consider the specification when evaluating the drawings (as per applicant’s MPEP citation), and the examiner is merely responding to that argument.
The examiner also disagrees with applicant’s assertion that the examiner’s standard would require drawings for every species in every genus claim. If a feature is typically known and there is adequate disclosure in the specification, the examiner agrees that it would not be necessary to explicitly show every feature. However, the claimed features are not adequately described in the specification and there is no demonstrated “general knowledge” of the claimed limitations.
Regarding the 35 USC 112 arguments, specifically item (I), the examiner maintains that the wrong legal standard has not been applied. The examiner maintains there is insufficient description in the specification to reasonably convey to a POSITA that the inventor had possession of the claimed subject matter. This issue has been addressed extensively in previous Office actions. That the examiner may have entertained intuitive questions such as why or how the device is made is merely rhetoric addressing applicant’s many assertions that the device has been adequately disclosed, when in fact it has not. The most substantive discussion of using an insulative coating is at paragraphs [0076-0077] of the printed publication, which discussion is directed to the schematic drawing of Figure 12. The examiner sees no specific correlation between the schematic of Figure 12 and a surgical staple, nor is there any indication that the schematic of Figure 12 is representative of a surgical staple. The generic statement at paragraph [0037] that other coatings, including insulative coatings, may be used is deemed insufficient to support the specifically claimed combination.
Regarding item (II) of the 35 USC 112 arguments, the examiner maintains the specification does not clearly disclose the claimed combination. The generic statement that one or more other coatings, including an insulating material, may extend from the surface supporting layer is insufficient to support the claimed invention. Applicant’s specification defines “tissue manipulators” as a very broad array of devices including sutures, scalpels, wires, snares, mesh, stents, heart valves, defibrillators and pacemakers, and knee and hip replacements. The combination of a conductive coating in concert with an insulative coating may be intuitive in some of the devices, but not in others. The examiner maintains that surgical staples would fall into the category of devices that would not typically have a conductive coating and an insulative coating, and that if applicant found this to be a novel combination of elements then it should merit at least some level of specific discussion in the specification. Rather, applicant’s substantive discussion of staples having a coating only suggest that they may have a conductive coating with no discussion of the use of an insulative coating as claimed. It appears applicant has arrived at the claimed combination by combining broad recitations that were assembled piecemeal from the specification.
Regarding item (III) of the 35 USC 112 arguments, the examiner maintains that the point being made with the discussion of cryogenic energy was merely an illustration that clearly not all features and all elements are combinable equally. Again, the examiner maintains that there should be an express disclosure of critical, novel combinations of elements in order to provide adequate support in the specification. Merely listing a wide variety of devices and energy source and coatings and then assembling them in a specific manner is not sufficient, particularly when the combination of elements is not typically used together.
Regarding item (IV) of the 35 USC 112 arguments, the examiner maintains the Doty Declaration has been considered and addressed. It is not incumbent upon the examiner to counter the declarants assertions with expert testimony or to identify specific errors in the statements. Most importantly, the examiner has not disregarded the Doty Declaration. Rather, the examiner has considered all points asserted by Mr. Doty and has proffered a rational reason as to why those points were not deemed persuasive.
The examiner maintains the drawings fail to show the claimed invention as addressed above and in previous Office actions, and that the claims are properly rejected under 35 USC 112(a).
Conclusion
THIS ACTION IS MADE FINAL. 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 MICHAEL PEFFLEY whose telephone number is (571)272-4770. The examiner can normally be reached Mon-Fri 8 am-5 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/September 18, 2026
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