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 .
Election/Restrictions
Applicant’s election of Group I, Species C, Figure 7A, Claims 1, 4-10 in the reply filed on May 26, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 2, 3, 11-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim.
Claim Objections
Claim 6 is objected to because of the following informalities: Claim 6 recites the limitation “the punch body” in line 6 of the claim. It is suggested this limitation be changed to “the cylindrical punch body” to consistently refer to the limitation “the cylindrical punch body” in lines 1-2 of the claim. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 6-10 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites the limitation "the circular distal end" in line 4 of the claim. There is insufficient antecedent basis for this limitation in the claim. The examiner interprets the limitation to be “the first end” for examination purposes.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 5-10 are rejected under 35 U.S.C. 103 as being unpatentable over Phung et al (US 20030069595) in view of Donohoe et al (US 8012164).
Regarding claim 1, Phung et al (hereafter Phung) discloses an aortic punch comprising: a cylindrical barrel (138); a cylindrical plunger (184, 162) movably mounted within the barrel; a blade shaft (192) movably mounted within a distal end of the barrel and having a first cutting tool (124, 194) at a distal end thereof; and a cylindrical punch body (120) movably mounted within a distal end of the barrel and about the blade shaft and having a second, circular cutting tool (120) configured to form a circular hole in the wall of a blood vessel around the first cut. Phung further teaches that the first cutting tool is inserted into an incision in the aortic wall, but does not specifically teach that the first cutting tool of the blade shaft is configured to form a first cut in a wall of a blood vessel. However, Donohoe et al (hereafter Donohoe) teaches an apparatus for creating an opening in the vessel wall comprising a cylindrical barrel, cylindrical plunger, blade shaft movably mounted within a distal end of the barrel and having a first cutting tool at a distal end thereof, the first cutting tool having a sharp distal end allow it to readily penetrate tissue (C:4, L: 34-40) in order to create an opening in the vessel wall without the need for a prior incision in the wall (abstract). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to make the distal end of the first cutting tool of Phung sharpened and configured to form a first cut in a wall of a blood vessel, as taught as known in the art by Donohoe, in order to allow it to readily penetrate tissue to create an opening in the vessel wall without the need for a prior incision in the wall.
Regarding claim 5, Phung in view of Donohoe teaches all of the limitations set forth in claim 1, wherein the barrel includes opposing pin holes (144) formed through a wall thereof.
Regarding claim 6, Phung in view of Donohoe teaches all of the limitations set forth in claim 5, wherein the cylindrical punch body has a first end, a second end, a first portion having a first diameter, and a second portion having a second diameter smaller than the first diameter, wherein a tapered portion extends between the first portion and the second portion (120, figures 4-5), and wherein an edge of the first end of the punch body defines the circular cutting tool (120, figure 6).
Regarding claim 7, Phung in view of Donohoe teaches all of the limitations set forth in claim 6, further including a coil spring (182) extending between a first end of the plunger and the second end of the punch body (figure 6).
Regarding claim 8, Phung in view of Donohoe teaches all of the limitations set forth in claim 7, further including a punch engagement member (116) having a cylindrical body and circular flange formed on a first end thereof, wherein the cylindrical body is configured to be inserted into a first end of the coil spring such that the flange engages the second end of the punch body (figure 5).
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Regarding claim 9, Phung in view of Donohoe teaches all of the limitations set forth in claim 8, wherein the cylindrical plunger (184) has a first end, a second end having a plunger flange (18) formed thereon, and opposing, longitudinally extending pin slots (170) formed through a wall of the plunger, wherein the plunger (162) has an outside diameter smaller than an inside diameter of the barrel and is configured for slidable mounting within the barrel (figure 5).
Regarding claim 10, Phung in view of Donohoe teaches all of the limitations set forth in claim 9, further including a locking pin (178) extending through the pin holes of the barrel and through the pin slots formed in the plunger (figure 5).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Phung et al (US 20030069595) in view of Donohoe et al (US 8012164), as applied to claim 1 above, and further in view of Bladen et al (US 20200205794).
Regarding claim 4, Phung in view of Donohoe teaches all of the limitations set forth in claim 1, but does not teach the first cutting tool is a blade that is rhino-shaped. Bladen et al (hereafter Bladen) teaches a tissue punch for forming a first cut in tissue, wherein it was known in the art at the time of the invention to make a rhino-shaped (the limitation “rhino-shaped” is sufficiently broad to encompass a curved profile such as the one shown in figure 8a) cutting tool in order to decrease the likelihood of tissue catching or snagging on the cutting surface as it passes by (paragraph 0169) for a tissue punch for forming a first cut in tissue. Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to make the first cutting tool of Phung in view of Donohoe further comprise a rhino-shaped blade, as taught as a known cutting tool shape in the art at the time of the invention by Bladen, in order to decrease the likelihood of tissue catching or snagging on the cutting surface as it passes into the tissue.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANH TIEU DANG whose telephone number is (571)270-3221. The examiner can normally be reached Monday-Thursday (9am-4pm EST).
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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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/ANH T DANG/ Primary Examiner, Art Unit 3771
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