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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 3, 2026 has been entered.
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.
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 1-5, 9-13, 15, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Huitema et al (2015/0297228) in view of Gray (WO 86/07543) and further in view of the teaching of Heinrich et al (7,762,445).
Huitema et al disclose a device comprising a tissue manipulator comprising a fastener (i.e. staple). The staple includes a conductive coating disposed on at least a portion of the manipulator (para. [0301]). While Huitema et al disclose the device may also be used to deliver RF energy to tissue (para. [0379], for example), there is no express disclosure the energy is delivered directly to the staple. Huitema et al also fail to disclose providing an electrically insulating element between the conductive coating and the matter manipulator (i.e. staple).
Gray discloses a surgical staple and specifically teach the staple may comprise a matter manipulator (i.e. metal staple body 1) and a conductive coating (5,6) provided over the staple body. In particular, Gray teaches that it is known to provide an insulating element (4) between the conductive coating and the matter manipulator (i.e. staple 1).
To have provided the Huitema et al staple, which is taught to have a conductive coating over the staple body, with an insulative layer between the staple body and the conductive coating would have been an obvious design consideration for one of ordinary skill in the art at the time of the invention since Gray teach that it is fairly known to provide an insulative layer between a staple body and a conductive coating applied over the staple body.
Regarding energy delivery, Henrich et al provide another staple device comprising a conductive staple, and specifically disclose a means to deliver energy to the conductive staple via the anvil mechanism (col. 2, lines 52-63, for example) to alter tissue and prevent bleeding.
To have provided the Huitema et al device, as modified by the teaching of Gray, with an RF energy means to delivery energy directly to the staple to treat tissue during the stapling procedure would have been an obvious consideration for one of ordinary skill in the art since Huitema et al fairly teach the delivery of RF energy to tissue and further since Heinrich et al specifically teach it is known to provide electrical energy directly to the staple in an analogous device.
Regarding claims 2 and 3, Huitema et al disclose a conductive oxide coating that may include titanium oxide (para. [0301]). Regarding claims 4 and 5, Huitema et al discloses an RF power supply, and Heinrich et al specifically disclose a connector for connecting the RF energy source to the staple device. Regarding claim 9, the examiner maintains that one of ordinary skill in the art would recognize an acceptable thickness for the coating provided on the surgical staple. It is noted that applicant has provided no criticality or unexpected result associated with the particular thickness of the coating and any reasonable thickness is deemed an obvious design consideration.
Regarding claim 10, Huitema et al disclose contacting at least a portion of tissue (i.e. tissue to be stapled) with a manipulator comprising a fastener (i.e. staple). Huitema et al also disclose providing a coating on the staple as well as the use of RF energy to treat tissue, but fail to expressly disclose delivering the energy directly to the staple or an insulative coating between the staple and the conductive coating.
As asserted above, Henrich et al provide another staple device comprising a conductive staple, and specifically disclose a means to deliver energy to the conductive staple via the anvil mechanism (col. 2, lines 52-63, for example) to alter tissue and prevent bleeding. Also addressed previously, Gray teaches that it is known to provide an insulative layer between the staple body and a conductive outer coating.
To have provided the Huitema et al device with an RF energy means to delivery energy directly to the staple to treat tissue during the stapling procedure would have been an obvious consideration for one of ordinary skill in the art since Huitema et al fairly teach the delivery of RF energy to tissue and further since Heinrich et al specifically teach it is known to provide electrical energy directly to the staple in an analogous device. To have further provided an insulative layer between the staple body and the conductive outer coating would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Gray fairly teaches it is known to provide such an insulation layer between a staple body and a conductive outer coating.
Regarding claim 11, Heinrich et al specifically disclose heating tissue to reduce bleeding (col. 2, lines 39-45). Regarding 12, Heinrich et al disclose applying bipolar electrical energy (col. 4, lines 38-43). Regarding claim 13, Heinrich et al disclose cauterizing the tissue around the staple. Regarding claim 15, Huitema et al disclose viewing tissue during the procedure (para. [0411] and [0424], for example). Moreover, the examiner maintains one of ordinary skill in the art would recognize that tissue may be viewed as the device is located and actuated at a desired tissue site. Regarding claims 19 and 20, Huitema et al disclose a conductive titanium oxide coating as addressed previously.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Huitema et al (2015/0297228) and Gray (WO 86/07543) in view of the teaching of Heinrich et al (7,762,445) and further in view of the teaching of Knight et al (2006/0030844).
Huitema et al provide a conductive titanium oxide coating on a surgical staple as addressed previously, but fail to expressly disclose the coating is optically transparent. Gray discloses an insulation layer between the staple body and an outer conductive coating, and Heinrich et al disclose the delivery of RF energy directly to the staple as addressed previously.
Knight provides the general teaching that it is known to provide a titanium oxide coating that is optically transparent as well as conductive (para. [0033], for example).
It is noted that applicant’s specification fails to provide any rationale for providing an optically transparent coating on a fastener, or staple. Rather, the optically transparent property appears to simply be a characteristic of the titanium oxide coating, which coating may have more logical need for optical transparency on some of the other disclosed devices. Surgical staplers are generally well known in the art, and applicant has not disclosed any particular structure for the surgical stapler leading one to believe the stapler disclosed would be one that is typically known in the art. While it is unclear why a surgical staple would have an optically transparent coating, the examiner maintains that Knight et al fairly teaches that it is generally known that conductive titanium oxide coatings are known to be optically transparent and, as such, use of such a coating on the Huitema et al device, which also has a conductive titanium oxide coating, would be an obvious design consideration for one of ordinary skill in the art.
Response to Arguments
Applicant's arguments filed February 3, 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.
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. In fact, the only discussion related to a staple addresses providing a conductive coating on the staple, with no discussion of providing an insulative element between the conductive coating and the 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.). As such, the drawing objection is maintained.
Regarding the 35 USC 112 rejection, applicant continues to argue that Figure 12 is a schematic view that applies equally to all embodiments. However, the discussion associated with Figure 12 makes no mention of a staple, and specifically discloses a resistor and/or a capacitor attached via terminals (300a, 300b) of the conductive material. It is not clear what would be terminals (300a, 300b) on a staple or why a staple would have two separate terminals, particularly given the prior art staple devices cited by applicant. Merely stating that an embodiment is “schematic” and asserting that it applies equally to all embodiments is not sufficient to support a combination of elements that would not apply equally to all disclosed embodiments. The discussion of Figure 12 also does not expressly state that the schematic applies equally to any disclosed matter manipulator. The examiner maintains the broad discussion associated with Figure 12, including the recitation of the various different types of energy sources (e.g. cryo, ultrasound, plasma) would not equally apply to all disclosed embodiments. Applicant has broadly proffered numerous different types of instruments and numerous different possible variations and is asserting that any feature may be combined with any type of matter manipulator, but has not provided any specific evidence that the contemplation of all these possible combinations have been in applicant’s possession at the time of invention.
The Declaration of Alan F. Doty is not deemed persuasive to overcome the 35 USC 112 rejection. While Mr. Doty has stated that paragraphs [0021-0048] of the instant specification describe general features of a “matter manipulator” intended to apply broadly to all disclosed manipulator embodiments. While that may be the intention, this does not support the conclusion that all possible combinations are adequately disclosed and were in possession by applicant at the time of filing. Also, while one of ordinary skill in the art may be capable of applying an insulating coating on any surgical device, including a staple, the mere suggestion that applicant’s device may have such a structure is not clear evidence that applicant has actually designed such a device or has had possession of such a device. Again, the numerous alternative arrangements suggested for the various types of matter manipulators are not necessarily properly and adequately described. For example, according the applicant’s and Mr. Doty’s line of reasoning, applicant could claim a staple for the delivery of cryogenic energy even though there is no discussion of how such a device would be designed or implemented. Perhaps one of ordinary skill in the art could read such a broad description and imagine a way in which such a device may be constructed, but there is certainly no clear description of such a device in the written specification. Likewise, an insulative layer provided between a staple and a conductive coating is merely a broad suggestion and lacks the necessary description and drawings to support such a claimed device. As such, the examiner maintains the Drawing Objection and the 35 USC 112, first paragraph rejection remain tenable.
Conclusion
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.
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/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/March 3, 2026