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 .
Receipt is acknowledged of applicant’s amendment filed August 4, 2025. Claims 1-20 are pending with claims 1-10 withdrawn as being drawn to a non-elected invention.
Applicant’s arguments with respect to claims 11-20 have been considered but are moot in view of the new ground of rejection.
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.
Claims11-20 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 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. The “material capture region having a fixed notch shape” limitation in claim 1 does not appear to find support in the specification. Although the Examiner notes that the disclosure appears to provide support for a notched material capture region, there is nothing in the disclosure that describes the notch shape as a fixed notch shape nor is there anything in the disclosure that explains how the notch is fixed or what is necessary for a notch to be fixed. As such the limitation “material capture region having a fixed notch shape” fails to comply with the written description requirement.
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 11-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 11 states “a material capture region having a fixed notch shape” which is vague and indefinite because it is not fully understood what is meant by the term “fixed notch shape” and the specification does not provide guidance as to how to interpret what is meant by “fixed notch shape”. For example, the disclosure does not use the term “fixed notch shape” and the figures do not show what is meant by “fixed notch shape”. For example does “fixed notch shape” mean that the notch shape has a fixed/constant diameter, which does not appear to be the case since the shape appears to vary in size along the notch. Since there is no mention of the term “fixed notch shape” to provide guidance as to how to interpret the limitation and since the phrase is not clear what is required for a notch shape to have a fixed notch shape, the limitations is vague and indefinite. Correction is needed.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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(s) 11-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ischinger et al. WO 01/17434 (see English translation for relative descriptions of reference characters) in view of Arnett et al. (US 2012/0197282).
Regarding claim 11, Ischinger discloses an automated defect closure device (Figures 1, 13; Ref 1) comprising: a defect insertion region configured to be inserted into a defect in a material (Ref 4; where Ref 4 is capable of being inserted into a defect in a material); a material capture region having a fixed notch shape (Figure 13; Ref 5; where Figure 13 shows that the capture region has a fixed notch shape; additionally, where Figure 1 shows that the notch formed after Figure 1, Ref 5 rotates out of alignment with Ref 4, 3, will have a fixed height and therefore can be interpreted as a fixed notch shape), the notch shape formed by a cutout in a body portion of the automated defect closure device (Figure 1, 13; Ref 5; where Figure 13 shows that the notch shape is a cutout into the device, where the Examiner notes the limitation "formed by a cutout in a body portion" has been interpreted by the Examiner as a product-by-process limitation), the material capture region configured to capture a portion of the material adjacent to the defect when the defect insertion region is inserted into the defect (Ref 5; where Ref 5 rotates out of alignment with Ref 4, 3 and therefore forms a material capture region that is capable of capturing a portion of material adjacent to a defect when the defect insertion region is inserted into a defect; Figure 13; Ref 5; where Figure 13 shows a material capture region that is capable of capturing a portion of material adjacent to a defect when the defect insertion region when inserted into a defect); an automated fire and release (AFR) region to house a AFR assembly (Figure 1, 13; Ref 3; where Ref 3 houses part of an automatic fire and release assembly Ref 18, 19), wherein the material capture region is disposed between the defect insertion region and the AFR region (Figure 1, 13; where Ref 5 is between Ref 4 and Ref 3); an automated suture cartridge (ASC) assembly to house a first suture pin and a second suture pin (Ref 12, 13, 16, 17, 26, 27, 32, 33; where Ref 12 (labeled 9 in figure 13) is a first suture pin and Ref 13 is a second suture pin), each coupled to a respective end of a suture (Ref 12, 13, 14, 15; where Figure 1, 13 shows that each of the first suture pin and the second suture pin Ref 12 (labeled 9 in figure 13), 13 are coupled to a respective end of a suture Ref 14, 15); and a containment sub-assembly (Ref 4, 22, 23), wherein the AFR assembly is configured, upon activation, to force one of the suture pins to pass from a load location of the ASC assembly through the portion of the material captured in the material capture region and into the containment sub-assembly, such that the respective end of the suture coupled with the one of the suture pins is passed through the portion of the material (Figure 1, 13; Ref 2, 43; Ref 12, 13; where upon activation of Ref 2, 43; AFR assembly Ref 18, 19 force the suture pins Ref 12 (labeled 9 in figure 13), 13 from a load location within Ref 8, 9 through region Ref 5 and therefore the material captured within capture region Ref 5 and into containment sub-assembly Ref 22, 23 such that the suture Ref 14, 15 coupled with the suture pins Ref 12, 13 is passed through the portion of the material).
Ischinger fails to explicitly disclose a tip protruding from a portion of the material capture region.
However Arnett in a similar field of endeavor (i.e. a device to puncture tissue with a needle) teaches a similar device that includes either a flat bottom portion of a material capture region (Figure 6C; Ref 12, 12B) or alternatively a tip protruding from a bottom portion of a material capture region when viewed from a side of the device (Figures 6B; Ref 12, 12B); where the tip is proximate to the insertion region when the material capture region is viewed from a front of the device (Figure 6B; Ref 12, 12B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the bottom portion of a material capture region to include a tip protruding from the bottom portion of the material capture region when viewed from a side of the device, where the tip is proximate the insertion region when the material capture region is viewed from a front of the device as suggested by Arnett, since such a modification provides a well-known alternate capture region shape that would have yielded predictable results, namely, allowing a tissue to be captured by the notch.
Regarding claim 12, Ischinger discloses the body portion comprising the defect insertion region, the material capture region and the AFR region (Ref 4, 5, 3; Figures 1, 13; where Ref 4, 5, 3 form the body portion); and a handle portion coupled with the body portion at a coupling region (Ref 43; Figure 1), wherein the handle portion extends from the coupling region generally in a first direction defining a first axis (Figure 1; Ref 43; where the curved end portion of Ref 43 defines a first axis), the body portion extends from the coupling region generally in a second direction defining a second axis, and the first and second axes form an obtuse angle (Ref 3, 4, 5; where the second axis is the longitudinal axis that runs through Ref 3, 4, 5; where Figure 1 shows that the curved end portion of Ref 43 has a first axis that forms an obtuse angle with respect to the longitudinal axis of the device).
Regarding claim 13, Ischinger discloses that the AFR assembly is configured: upon first activation, to force the first suture pin (Ref 12) to pass from the load location of the ASC assembly (Figure 1; Ref 12, 8; where Figure 1, 13 shows first suture pin within Ref 8 (i.e. the load location)) through a first portion of the material captured in the material capture region and into the containment sub-assembly (Ref 43, 12; where upon first activation Ref 12 moves from within Ref 8 through Ref 5 and therefore the material captured within region Ref 5 and into containment sub-assembly Ref 22), such that the first end of the suture is passed through the first portion of the material (Ref 14; Figure 1, 13; where upon activation of Ref 43, the suture pin Ref 12 (labeled 9 in figure 13) and therefore the suture attached Ref 14 passes through the first portion of material in region Ref 5); and upon second activation, subsequent to the automated defect closure device being rotated within the defect to capture, in the material capture region, a second portion of the material adjacent to the defect apart from the first portion of the material, to force the second suture pin to pass from the load location of the ASC assembly through the second portion of the material and into the containment sub-assembly, such that the second end of the suture is passed through the second portion of the material (Ref 43, 13, 26; Figure 1, 9; where Figure 9 shows that the device can be rotated; where upon activation Ref 26 moves from within Ref 8 through Ref 5 and therefore the material captured within region Ref 5 and into containment sub-assembly Ref 22; where the device is capable of being rotated within a defect to capture in the material capture region, a second portion of the material adjacent to the defect apart from the first portion of material).
Regarding claim 14, Ischinger discloses that the AFR assembly is configured: upon the first activation (Ref 18, 43), to force the first suture pin (Ref 12) into a pin capture structure of the containment sub-assembly (Ref 22); and upon the second activation, to force the second suture pin (Ref 26) into the pin capture structure (Ref 22; where the first part of Ref 22 is the pin capture structure), thereby forcing the first suture pin out of the pin capture structure and into a pin container structure of the containment sub-assembly (Ref 12, 26; where Ref 22 has a length to accommodate two needles one after another and therefore the second suture pin Ref 26 is capable upon second activation of forcing the first suture pin Ref 12 out of the first section of Ref 22 (i.e. the pin capture structure) and into the bottom section of Ref 22 (i.e. a pin container structure).
Regarding claim 15, Ischinger discloses that the AFR assembly comprises a trigger structure (Ref 43), a pin deployment structure coupled with the trigger structure (Ref 18; where Ref 18 is coupled with Ref 43); and the AFR assembly is configured, upon activation of the trigger structure, to engage the pin deployment structure with the one of the suture pins in the load location of the ASC assembly, such that the pin deployment structure forces the one of the suture pins from the load location, through the portion of the material, and into the containment sub-assembly (Ref 43, 18, 12; where upon activation of Ref 43, pin deployment structure Ref 18 engages with suture pin Ref 12 in the load location Ref 8 such that the pin deployment structure Ref 18 forces suture pin Ref 12 from the load location in Ref 8, through the material captured in region Ref 5 and into Ref 22).
Regarding claim 16, Ischinger discloses that the AFR assembly further comprises a release structure configured, upon de-activation of the trigger structure, to disengage the pin deployment structure from the one of the suture pins, thereby leaving the one of the suture pins contained by the containment sub-assembly; and return the trigger structure and the pin deployment structure at least partially to a reset position (Ref 20; Figure 1; where upon de-activation of Ref 43, Ref 20 disengages the pin deployment structure Ref 18 from suture pin Ref 12, thereby leaving suture pin in Ref 22 and returning the trigger structure and pin deployment structure at least partially to a reset position Ref 43, 18).
Regarding claim 17, Ischinger discloses that the trigger structure comprises a plunger structure that is activated by depressing (Ref 43; where Ref 43 is depressed and is therefore interpreted as a plunger structure); the pin deployment structure comprises a pushing rod (Ref 18); and the release structure comprises a spring (Ref 20; Figure 1).
Regarding claim 18, Ischinger discloses that the release structure is further configured, upon de-activation of the trigger structure, automatically to chamber the second suture pin in the load location of the ASC assembly (Ref 43, 20, 30, 26; Figure 1; where automatically upon de-activation of the trigger structure Ref 20, 18 retracts to automatically chamber second suture pin Ref 26 by means of Ref 30).
Regarding claim 19, Ischinger discloses that the ASC assembly comprises: a suture pin cartridge configured to hold a plurality of suture pins including the first and second suture pins (Ref 8, 9, 28, 29; where suture pins Ref 12, 13, 26, 27 are held); and a suture pin advancement structure configured to interface with the suture pin cartridge to selectively advance each of the plurality of suture pins into the load position (Ref 18, 19; Ref 30, 31; where suture pin advancement structure Ref 18, 19, 30,3 1 selectively advance each suture pin into the load position).
Regarding claim 20, Ischinger discloses that the suture pin cartridge is configured to hold a plurality of pairs of suture pins, each pair of suture pins having a respective first and second suture pins coupled together by a respective suture (Ref 12, 13, 26, 27; 14, 15, 24, 25).
Response to Arguments
Applicant’s arguments with respect to claims 11-20 have been considered but are moot in view of the new ground of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 7,211,093; US 5,527,322; WO94/13211; WO95/13021 – Fixed cutout notch in a suturing tool
US7,749,250, US 2023/0329694; US11,510,666- Fixed cutout notch in a suturing tool that includes a hooked end .
(US 2004/0181238) – Figures 15-18; where the Examiner notes a rejection similar to the rejection above could be made using the ‘238 reference.
(WO2007/050941) cited on the IDS- Figures 2-3; where the Examiner notes a rejection similar to the rejection above could be made using the ‘941 reference; where the reference additionally teaches using a single suture line which forms a loop
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 ERIN L COLELLO whose telephone number is (571)270-3212. The examiner can normally be reached Mondays 8-5pm, Tuesday-Thursdays 10-2pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.L.C/Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771