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 .
Response to Amendments
Applicant’s amendments, see page 9 of the remarks, filed 07/10/2025, with respect to the 112(a) and 112(b) rejection(s) of claim(s) 1-3 and 12-16 have been fully considered and overcome the previous 112(a)/112(b) rejections. However, upon further consideration, a new ground(s) of rejection is made in view of Morsi (US 20090254101) and Morsi (US 20090254101) in view of Arroyo (US 4630608).
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
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.
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:
“second anastomotic mechanism” in claim 1. The limitation describing the second anastomosis mechanism in claim 1 fails to include sufficient structure to perform the recited function of "anastomosing". In the specifications, the elected anastomosis mechanism is described as “one or more coupling pins”. Therefore, the second anastomosis mechanism is interpreted as a coupling pin or any structural equivalents thereof used to couple with a pin of the first anastomotic mechanism.
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 Rejections - 35 USC § 102
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 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.
Claim(s) 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Morsi (US 20090254101).
Regarding claim 1, Morsi discloses an anastomosis set (Figs. 1-3, para. 0027) for anastomosing a first end of a blood vessel to be anastomosed with a second end of a blood vessel to be anastomosed (Fig. 4, para. 0027, 0039), said anastomosis set comprising:
a first manipulator (interpreted as the surgical tool used to grip a handle 108 of a first suture ring 107, Fig. 3, para. 0035), with a first telescoping part (interpreted as the left suture ring 107) at a distal end thereof (Figs. 3, 7A, para. 0035, 0042), the first telescoping part 107 is used for telescoping toward the first end of the blood vessel to be anastomosed (Figs. 6, 7A, para. 0042-0043);
the first telescoping part comprising a first telescoping part half and a second telescoping part half (see annotated Fig. 3 below), the first telescoping part half and a second telescoping part half cooperatively defining a semi-circle with a first exit part defined as a gap between the first telescoping part half and the second telescoping part half (see annotated Fig. 3 below, para. 0034);
a second manipulator (interpreted as the surgical tool used to grip a handle 108 of a second suture ring 107, Fig. 3, para. 0035), with a second telescoping part (interpreted as the right suture ring 107) at a distal end thereof (Figs. 3, 7A, para. 0035, 0042), the second telescoping part 107 is used for telescoping toward the second end of the blood vessel to be anastomosed (Figs. 6, 7A, para. 0042-0043);
the second telescoping part comprising a third telescoping part half and a fourth telescoping part half (see annotated Fig. 3 below), the third telescoping part half and a fourth telescoping part half cooperatively defining a semi-circle with a second exit part defined as a gap between the third telescoping part half and the fourth telescoping part half (see annotated Fig. 3 below, para. 0034);
an anastomosis mechanism (interpreted as surgical clips 115) including a first anastomotic mechanism 120 and a second anastomotic mechanism 121, wherein the first anastomotic mechanism includes a pin which couples with the second anastomotic mechanism (Figs. 7B-10B, para. 0038);
an anastomotic auxiliary 113 having a first embedding end and a second embedding end (see annotated Fig. 5 below); wherein the first embedding end is configured to embed into the first end of the blood vessel to be anastomosed (Fig. 5, para. 0033), and the second embedding end is configured to embed into the second end of the blood vessel to be anastomosed (Fig. 5, para. 0033);
wherein the first end of the blood vessel to be anastomosed is folded toward the first telescoping part, the second end of the blood vessel to be anastomosed is folded toward the second telescoping part (see note below).
Note: The examiner notes that the claims are directed towards an apparatus not a method and the elements relied upon for the limitation i.e. “the first end to be anastomosed” and “the second end to be anastomosed” are introduced in the preamble of the claim and are not structural components of the device. Those elements are not positively recited and are a part of the body such that it falls under an intended use of the structural component of the device i.e. the first and second telescoping parts. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. As shown in Fig. 7A and described in para. 0034 of Morsi, the first and second telescoping parts 107 are intended to be positioned around the first and second ends of the blood vessel. Therefore, if the user were to position folded ends of the first and second blood vessel within the first and second telescoping parts such that the first/second ends of the blood vessels to be anastomosed is folded towards the first/second telescoping parts, the limitation would be met. Since, the device of Morsi meets the structural limitations required for the limitation in claim 1, the device of Morsi also meets the functional limitations required for the limitation in claim 1.
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Annotated Fig. 3 of Morsi
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Annotated Fig. 5 of Morsi
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2-3 and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Morsi (US 20090254101), as applied to claim 1 above, and further in view of Chin et al. (US 20030120291) [hereinafter Chin].
Regarding claims 2 and 3, Morsi discloses all of the limitations set forth above in claim 1. Morsi further discloses wherein the anastomotic auxiliary 113 comprises a fusiform body (see Fig. 2 which illustrates the anastomotic auxiliary 113 having a rounded body with tapered ends which is interpreted as a fusiform shape) having a recycle unit (interpreted as the surface of the fusiform body, Fig. 2 of Morsi), and an anastomotic auxiliary removal aid 103 includes a hollow tube (Fig. 2, para. 0027, 0041 of Morsi), said anastomotic auxiliary removal aid 103 is used to remove the anastomotic auxiliary 113 from the first and the second ends of the blood vessel to be anastomosed (para. 0043-0044 of Morsi).
However, Morsi fails to disclose the anastomotic auxiliary comprises a tear line extending spirally on the fusiform body, wherein pulling the recycle unit causes the fusiform body to gradually turn into a linear body, and the anastomotic auxiliary removal aid comprises a removal device provided inside the hollow tube, and said removal device is attached to the anastomotic auxiliary.
Chin in the same field of endeavor teaches an anastomosis set (Figs. 6-9, para. 0023, 0026) comprising an anastomotic auxiliary 29 (Figs. 7-9, 17, para. 0026) comprising a recycle unit 29' and a tear line extending spirally on the fusiform body (Figs. 12, 17, para. 0028, 0030), wherein pulling the recycle unit 29’ causes a body of the anastomotic auxiliary 29 to gradually turn into a linear body (Figs. 12, 17, para. 0028, 0030) and an anastomotic auxiliary removal aid 43, 45 (Figs. 10-12, 18, para. 0030), said anastomotic auxiliary removal aid 43, 45 is used to remove the anastomotic auxiliary 29 from the first and the second end of the blood vessel to be anastomosed (para. 0030); the anastomotic auxiliary removal aid 43, 45 includes a hollow tube 43 and a removal device 45 provided inside the hollow tube (Figs. 10-12, 18, para. 0030), and said removal device is attached to the anastomotic auxiliary (Figs. 10-12, 18, para. 0030).
The substitution of one known anastomotic auxiliary and anastomotic auxiliary removal aid (anastomotic auxiliary having the tear line and anastomotic auxiliary removal aid comprising the hollow tube and the removal device disposed within the hollow tube as shown in Chin) for another (inflatable anastomotic auxiliary and the anastomotic auxiliary removal aid comprising the hollow tube as shown in Morsi) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the anastomotic auxiliary and anastomotic auxiliary removal aid shown in Chin would have yielded predictable results, namely, an alternative way to support the first and second blood vessels to be anastomosed via. the anastomotic auxiliary of Chin to allow the fusiform body of the anastomotic auxiliary to disassemble for convenient removal as a continuous strand (para. 0030 of Chin) via. the anastomotic auxiliary removal aid of Chin, thereby minimizing additional trauma or complication of the surgical procedure (para. 0034 of Chin).
Regarding claim 12, modified Morsi discloses wherein the fusiform body is not completely separated at the tear line (The examiner notes that during the initial stages of unraveling of the anastomotic auxiliary along the tear line, a portion of the anastomotic auxiliary is not completely separated at the tear line; Fig. 12, para. 0030 of Chin), wherein the fusiform body maintains a tubular shape before pulling the recycle unit (Chin discloses that the anastomotic auxiliary maintains its shape before pulling the recycle unit; Figs. 4-9, 12, 17, para. 0026, 0030; Fig. 2, para. 0031-0032 of Morsi discloses that the anastomotic auxiliary has a tubular shape).
Regarding claim 13, modified Morsi discloses wherein the fusiform body is completely separated at the tear line (Fig. 12, para. 0030 of Chin), wherein the fusiform body maintains a tubular shape before pulling the recycle unit (Chin discloses that the anastomotic auxiliary maintains its shape before pulling the recycle unit (see Figs. 4-9, 12, 17, para. 0026, 0030 of Chin); Fig. 2, para. 0031-0032 of Morsi discloses that the anastomotic auxiliary has a tubular shape).
Regarding claim 14, modified Morsi discloses wherein pulling one end of the removal device 45, will retract the anastomotic auxiliary within the hollow tube 43 (Figs. 10-12, 18, para. 0030 of Chin).
Regarding claim 15, modified Morsi discloses wherein:
the anastomotic auxiliary 29 is resilient (para. 0024, 0027 of Chin) and has a constrained diameter when the anastomotic auxiliary is situated within the hollow tube (Figs. 10-12, para. 0030-0031 of Chin), the anastomotic auxiliary expands to an unconstrained diameter which is larger than the constrained diameter when the anastomotic auxiliary is removed from the hollow tube (Figs. 7-11, para. 0026, 0028 of Chin).
Claim(s) 1 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over a variant interpretation of Morsi (US 20090254101) in view of Arroyo (US 4630608).
Regarding claim 1, Morsi discloses an anastomosis set (Figs. 1-3, para. 0027) for anastomosing a first end of a blood vessel to be anastomosed with a second end of a blood vessel to be anastomosed (Fig. 4, para. 0027, 0039), said anastomosis set comprising:
an anastomosis mechanism (interpreted as surgical clips 115) including a first anastomotic mechanism 120 and a second anastomotic mechanism 121, wherein the first anastomotic mechanism includes a pin which couples with the second anastomotic mechanism (Figs. 7B-10B, para. 0038);
an anastomotic auxiliary 113 having a first embedding end and a second embedding end (see annotated Fig. 5 above); wherein the first embedding end is configured to embed into the first end of the blood vessel to be anastomosed (Fig. 5, para. 0033), and the second embedding end is configured to embed into the second end of the blood vessel to be anastomosed (Fig. 5, para. 0033).
However, Morsi fails to disclose a first manipulator, with a first telescoping part at a distal end thereof, the first telescoping part is used for telescoping toward the first end of the blood vessel to be anastomosed; the first telescoping part comprising a first telescoping part half and a second telescoping part half, the first telescoping part half and a second telescoping part half cooperatively defining a semi-circle with a first exit part defined as a gap between the first telescoping part half and the second telescoping part half; a second manipulator, with a second telescoping part at a distal end thereof, the second telescoping part is used for telescoping toward the second end of the blood vessel to be anastomosed; the second telescoping part comprising a third telescoping part half and a fourth telescoping part half, the third telescoping part half and a fourth telescoping part half cooperatively defining a semi-circle with a second exit part defined as a gap between the third telescoping part half and the fourth telescoping part half; wherein the first end of the blood vessel to be anastomosed is folded toward the first telescoping part, the second end of the blood vessel to be anastomosed is folded toward the second telescoping part.
Arroyo in the same field of endeavor of anastomosis sets 10 (Fig. 1, col. 3 lines 28-35) teaches a first manipulator 30 (Fig. 1, col. 4 lines 3-6), with a first telescoping part 33 at a distal end thereof (Figs. 1-2, 4, col. 4 lines 7-14), the first telescoping part 33 is used for telescoping toward a first end of a blood vessel 12 to be anastomosed (Figs. 1-2, col. 4 lines 7-14);
the first telescoping part 33 comprising a first telescoping part 33’ and a second telescoping part half 33” (Fig. 4, col. 4 lines 20-29), the first telescoping part half 33’ and a second telescoping part half 33” cooperatively defining a semi-circle (see Fig. 4 which illustrates the first and second telescoping part halves 33’, 33” cooperatively defining an incomplete circle; The examiner notes that the “semi-circle” defined by the instant applications first and second telescoping part halves in the elected embodiment of Figs. 1A-B, define an incomplete circle and not the plain definition of semi-circle i.e. a half circle) with a first exit part defined as a gap (see small gap between the first and second telescoping part halves 33’, 33” in Fig, 4) between the first telescoping part half and the second telescoping part half (Fig. 4, col. 4 lines 7-14 and lines 39-47);
a second manipulator 32 (Fig. 1, col. 4 lines 3-6), with a second telescoping part 34 at a distal end thereof (Fig. 1, col. 4 lines 20-29), the second telescoping part is used for telescoping toward the second end of the blood vessel to be anastomosed; the second telescoping part 34 comprising a third telescoping part 33’ and a fourth telescoping part half 33” (Figs. 1, 4, col. 4 lines 20-29), the third telescoping part half 33’ and a fourth telescoping part half 33” cooperatively defining a semi-circle (see Fig. 4 which illustrates the second and third telescoping part halves 33’, 33” cooperatively defining an incomplete circle; The examiner notes that the “semi-circle” defined by the instant applications third and fourth telescoping part halves in the elected embodiment of Figs. 1A-B, define an incomplete circle and not the plain definition of semi-circle i.e. a half circle) with a second exit part defined as a gap (see small gap between the first and second telescoping part halves 33’, 33” in Fig, 4) between the third telescoping part half and the fourth telescoping part half (Fig. 4, col. 4 lines 7-14 and lines 39-47);
wherein the first end of the blood vessel to be anastomosed is folded toward the first telescoping part, the second end of the blood vessel to be anastomosed is folded toward the second telescoping part (see note above in regards to functional language; The examiner notes that since Arroyo references teaches the structure i.e. first and second telescoping parts to necessitate the functional language, Arroyo meets the limitation.).
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 anastomosis set in Morsi to include the first and second manipulators comprising first and second telescoping parts at their distal ends as taught by Arroyo in order to provide additional vessel stabilization during anastomosis (col. 2 lines 44-46 and col. 4 lines 3-14 of Arroyo)
Regarding claim 16, modified Morsi discloses wherein: said first manipulator 30 includes a first joint part 39 (Figs. 1-2, col. 4 lines 22-29 of Arroyo); said second manipulator 32 includes a second joint part 39 (Figs. 1-2, col. 4 lines 22-29 of Arroyo); and at least one of said first joint part and said second joint part are attached to an anastomotic device 50 in a manner permitting relative movement between the second joint part and the anastomotic device 50 (Figs. 1-2, col. 5 lines 17-24 of Arroyo).
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 LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Thursday 7:30am-5:30 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, Elizabeth Houston can be reached on 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN DUBOSE/Examiner, Art Unit 3771 /KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
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