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 .
CLAIM INTERPRETATION
2. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
3. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
4. expandable and contractible control member in claim 1, 13, and 19
5. piercing device in claim 8.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
6. Claim(s) 7 is objected to because of the following informalities: please change “the distal side” to “a distal side”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
7. 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.
8. 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.
9. Claim(s) 1, 2, 6 and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McGuckin, JR. (US 2016/0100971A1, “McGuckin”).
10. Regarding claim 1, McGuckin discloses an apparatus for placement of a compression anastomosis device. The apparatus includes a delivery device (10; Fig. 15) having distal and proximal ends, one or more compression anastomosis devices (42, 48) deployable from the distal end, and an expandable and contractible control member (52; [0064, 0057]) independently deployable from the distal end (Figs. 15-20). The control member is capable of being manipulated by the user to align one or more compression anastomosis devices with a deployment channel (Fig. 18). It is noted that the deployment channel is interpreted as a channel between two lumens as disclosed in the instant specification [0013].
11. Regarding claim 2, McGuckin discloses that the control member is capable of being expanded to a diameter greater than that of the deployment channel to dilate a created enterotomy and capable of being contracted to a diameter equal to or less than the deployment channel to be removed from the enterotomy [0064]. It is known that a stent may be collapsed or contracted within a removal sheath.
12. Regarding claim 6, McGuckin discloses that the control member is capable of being deployed between distal and proximal lumens to capture a formed enterotomy. It is noted that the limitation is written as function language and the claims have not stated where the distal and proximal lumens are located. The apparatus must only be capable of performing the claimed function.
13. Regarding claim 8, McGuckin discloses a piercing device (32) capable of cutting, dissecting and or dilating tissue to create a deployment channel between two lumens.
14. Claim(s) 19, 21 and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bakos et al. (US 2008/0200933A1, “Bakos”).
15. Regarding claim 19, Bakos discloses an apparatus for placement of a compression anastomosis device. The apparatus includes a delivery device (30; Fig. 5-16; [0043-0045]) having distal and proximal ends. The distal end (32) includes capabilities to dilate or dissect tissue between adjacent lumens to create an enterotomy (Fig. 5-16). An expandable and contractible control member (80; [0064, 0057]) is independently deployable from the distal end when the delivery device is withdrawn (Figs. 5-16). The control member is capable of being expanded to a diameter greater than that of the enterotomy to dilate the enterotomy [0040]. The control member is capable of being rotationally manipulated so as to engage with a distally deployed anastomosis device and align it with a proximal anastomosis device. It is noted that distal and proximal anastomosis devices are not positively recited. The control member is capable of being laterally manipulable so as to bring the distal anastomosis device toward the proximal anastomosis device and pair them. It is further noted that distal and proximal anastomosis devices are not positively recited. The control member is capable of being contracted to a diameter equal to or less than that of the delivery device [0040]. The control member is capable of being retracted into the delivery device once deflated and grasped by a snare or forceps device.
16. Regarding claim 21, Bakos discloses that the control member is a balloon cuff (Fig. 16).
17. Regarding claim 23, Bakos discloses that the control member is capable of being deployed to the distal side of a distal anastomosis device as a backstop (Fig. 16). It is noted that distal and proximal anastomosis devices are not positively recited.
18. Claim(s) 1, 2, 6, 7, 19 and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arevalos et al. (US 2019/0374254A1, “Arevalos”).
19. Regarding claim 1, Arevalos discloses an apparatus for placement of a compression anastomosis device. The apparatus includes a delivery device (110; Fig. 1; [0151]) having distal and proximal ends, one or more compression anastomosis devices (104) deployable from the distal end, and an expandable and contractible control member (108) independently deployable from the distal end (Figs. 1). The control member is capable of being manipulated by the user to align one or more compression anastomosis devices with a deployment channel. It is noted that the deployment channel is interpreted as a channel between two lumens as disclosed in the instant specification [0013].
20. Regarding claim 2, Arevalos discloses that the control member is capable of being expanded to a diameter greater than that of the deployment channel to dilate a created enterotomy and capable of being contracted to a diameter equal to or less than the deployment channel to be removed from the enterotomy [0179].
21. Regarding claim 6, Arevalos discloses that the control member is capable of being deployed between distal and proximal lumens to capture a formed enterotomy. It is noted that the limitation is written as function language and the claims have not stated where the distal and proximal lumens are located. The apparatus must only be capable of performing the claimed function.
22. Regarding claim 7, Arevalos discloses that the control member is capable of being deployed to the distal side of a distal anastomosis device as a backstop (Fig. 10). It is noted that distal and proximal anastomosis devices are not positively recited.
23. Regarding claim 19, Arevalos discloses an apparatus for placement of a compression anastomosis device. The apparatus includes a delivery device (1006; Fig. 10) having a distal end and a proximal end. The distal end (1008) includes capabilities to dilate or dissect tissue between adjacent lumens to create an enterotomy (Fig. 10). An expandable and contractible control member (1004; [0179]) is independently deployable from the distal end via lumen of catheter (1002;Figs. 10). The control member is capable of being expanded to a diameter greater than that of the enterotomy to dilate the enterotomy (Figs. 10B; [0179]). The control member is capable of being rotationally manipulated so as to engage with a distally deployed anastomosis device and align it with a proximal anastomosis device. It is noted that distal and proximal anastomosis devices are not positively recited. The control member is capable of being laterally manipulable so as to bring the distal anastomosis device toward the proximal anastomosis device and pair them. It is noted that distal and proximal anastomosis devices are not positively recited. The control member is capable of being contracted to a diameter equal to or less than that of the delivery device [0040]. The control member is capable of being retracted into the delivery device.
24. Regarding claim 23, Arevalos discloses that the control member is capable of being deployed to the distal side of a distal anastomosis device as a backstop (Fig. 10). It is noted that distal and proximal anastomosis devices are not positively recited.
Claim Rejections - 35 USC § 103
25. 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.
26. Claim(s) 3-5 and 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arevalos.
27. Regarding claims 3-5 and 20-22, embodiment of Arevalos does not disclose that the control member is capable of being a basket, however, Arevalos discloses a control member in the form of a basket (Fig. 61), balloon cuff (2604) and a wire jaw (Fig. 58). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the control member of Arevalos with a basket, balloon cuff or wire jaw, as taught by Arevalos, as this modification involves the simple substitution of one type of control member for another for the predictable result of providing means for stabilization.
28. Claim(s) 9, 10 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGuckin in view of Seddon et al. (US 2021/0100554A1, “Seddon”).
29. Regarding claims 9, 10 and 12, McGuckin discloses that the piercing device is a needle (32) but does not disclose that it is a hot needle. In the same field of endeavor, anastomosis procedures, Seddon teaches a hot needle that emits monopolar energy and a corkscrew needle [0027]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the needle of McGuckin with means to emit monopolar energy, as taught by Seddon, for the predictable result of providing means for piercing tissue. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the needle of McGuckin with a corkscrew needle, as taught by Seddon, as this modification involves the simple substitution of one type of needle for another for the predictable result of providing means for piercing tissue.
30. Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGuckin in view of Saadat et al. (US 2006/0036267A1, “Saadat”).
31. Regarding claim 11, McGuckin discloses that the piercing device is a needle (32) but does not disclose that it is a coring needle. In the same field of endeavor, anastomosis procedures, Saadat teaches a coring needle [0034]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the needle of McGuckin with a coring needle, as taught by Saadat, as this modification involves the simple substitution of one type of needle for another for the predictable result of providing means for piercing tissue.
32. Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGuckin in view of Jahns et al. (US 2005/0165427A1, “Jahns”).
33. Regarding claim 12, McGuckin discloses that the piercing device is a needle (32) but does not disclose that it is a corkscrew needle. In the same field of endeavor, anastomosis procedures, Jahns teaches a corkscrew needle [0034]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the needle of McGuckin with a corkscrew needle, as taught by Jahns, as this modification involves the simple substitution of one type of needle for another for the predictable result of providing means for piercing tissue.
Allowable Subject Matter
34. Claim(s) 13-18 is/are allowed.
35. Regarding claim 13, the prior art does not disclose or suggest a method for positioning compression anastomosis devices including deploying a first compression anastomosis device from a distal end of a delivery device into a proximal lumen, piercing the tissue wall to create an enterotomy between adjacent lumens, deploying a second anastomosis device through the enterotomy into a distal lumen, independently deploying an expandable and contractible control member into the enterotomy, expanding the control member to dilate the enterotomy, engaging the control member with the second anastomosis device, manipulating the control member rotationally and laterally with the distal anastomosis device to align the two anastomosis devices, bring the anastomosis devices together, contracting the control member to a diameter equal or less than that of the delivery device and retracting the control member into the delivery device, in combination with the other claimed limitations.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Fox (US 2008/0200934A1) discloses an apparatus that includes a compression anastomosis device and a control member.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOCELIN C TANNER whose telephone number is (571)270-5202. The examiner can normally be reached M-F 8am-4pm.
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, Jackie Ho can be reached at (571)272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOCELIN C TANNER/Primary Examiner, Art Unit 3771