DETAILED ACTION
The following is a First Action, Non-Final Office Action on the merits.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 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.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120, 121 & 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application Nos. 15/254646, 14/096973, 13/161182, 61/480486 & 61/354903 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Application Nos. 15/254646, 14/096973, 13/161182, 61/480486 & 61/354903 fail to provide adequate support for claims 6-7 and the range claimed.
Accordingly, claims 1-5 & 8-10 are given the priority date of 6/15/2010.
Accordingly, claims 6-7 are given the priority date of 7/24/2020.
Specification
The disclosure is objected to because of the following informalities: amend the first paragraph of the specification to reflect appropriate patent numbers for the issued applications.
Appropriate correction is required.
Claim Objections
Claim 5 is objected to because of the following informalities: amend “wherein the first body lumen is coupled to the second body lumen with at least one of” to –wherein the energy source couples the first body lumen to the second body lumen with at least one of- in ll. 1-2 to avoid a 35 USC 112(b)/second paragraph rejection since claim 1 recites “energy source”, and the “thermal resistance”, “radiofrequency (RF) energy” and “ultrasonic energy” are from the energy source. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: amend “grams of force” to -gram-force- in ll. 5 (twice). Appropriate correction is required.
Claim 8 is objected to because of the following informalities: amend “the measurement of the distance” to -the measured distance- in ll. 2 to provide proper antecedent basis for “the measurement” in ll. 3. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: amend “the measurement of the distance” to -the sensed distance- in ll. 2 to provide proper antecedent basis for “the measurement” in ll. 3. 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.
Claim 7 is 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 7 recites the limitation “applying a pressure…in the range of about 100 to about 1000 g”. It is unclear how the unit of measurement “gram” can be a “pressure” since pressure is an applied force per unit area and the claim fails to provide the unit of area. The originally filed disclosure provides no other information and recites the same language. For purposes of examination, the claim will be interpreted as a pressure range with the units as gram-force per square centimeter, but notes that there is no support in the originally filed disclosure for this range.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1 & 3-4 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by LeMole (5,893,369).
Concerning claim 1, as illustrated in Figs. 14-20, Le Mole discloses a method (method for bypassing an occluded artery between a natural graft blood vessel 14 and an artery or vein blood vessel 12; Col. 2, ll. 5-13), comprising:
inserting a guidewire through a first body lumen and into a second body lumen adjacent to the first body lumen (guide wire 52 is passed through vessel 14 to vessel 12; Col. 1, ll. 39-58, Col. 2, ll. 5-13, Col. 9, ll. 20-33);
advancing over the guidewire a medical device into the first body lumen, the medical device having a first portion and a second portion slidably coupled to the first portion, the second portion including a shaft and a non-expandable member, the medical device movable between a first configuration and a second configuration (punch 64, first portion and block 66/ block handle 70, second portion, are advanced over guide wire 52, where block 66/block handle 70 are slidably coupled to punch 64 and include block handle shaft 70 and non-expandable block 66, punch 64 & block 66/shaft 70 being movable between first and second configurations; Col. 9-11, ll. 58-9);
moving the medical device from its first configuration to its second configuration such that the second portion of the medical device moves into a second body lumen (block 66/ block handle 70 is initially parallel to guide wire 52 to insert into vessel 12 and then manipulated to pivot at pivot attachment 72 such that block 66 surface 66s is substantially parallel to the interior surface of the vessel wall 12 Col. 9-11, ll. 58-9); and
activating an energy source associated with at least one of the first portion or the second portion of the medical device such that a concentric opening is created between the first body lumen and the second body lumen (block 66 is translated with mechanical energy (i.e., mechanical energy source is operator of the device) toward punch 64 and the vessel walls between the punch 64 and block 66 are sheared off to create an opening between vessels 12, 14; Col. 10-11, ll. 13-9).
Concerning claim 3, LeMole discloses the second portion (66/70) of the medical device is moving in a first direction (i.e., parallel to guidewire 52) when moving from its first configuration to its second configuration, the method further comprising moving the second portion of the medical device in a second direction (i.e., pivoting 66 and drawing 66 closer to the vessel walls) opposite the first direction before the activating (Col. 10-11, ll. 13-9; Fig. 18-20).
Concerning claim 4, LeMole discloses activating the energy source (mechanical energy) associated with the at least one of the first portion (64) or the second portion (66) of the medical device (64/66/70) such that the first body lumen (14) is coupled to the second body lumen (12) (opening between the two is created upon shearing of vessel walls such that lumens are connected) (Col. 10-11, ll. 13-9; Fig. 18-20).
The Examiner notes to Applicant that claim 50 fails to recite that the vessel walls are coupled together with the energy from the energy source after the activating forms the opening.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 2 & 5 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over LeMole (5,893,369), as applied to claims 1 & 4, in further view of Clague et al. (2004/0082945).
Concerning claim 2, LeMole fails to disclose the concentric opening is formed using radiofrequency (RF) energy. However, Clague et al. disclose a device (60, 40) for creating an opening comprising a first portion (62) positioned on one side of a vessel wall and a second portion (52) positioned on the other side of the vessel wall, the first and second members (62, 52) being operable to mechanically cut, and also electrically cut an opening in the vessel wall via bipolar RF cutting between the first and second members (62, 52). At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of LeMole such that a source of RF energy is applied to the third toggle member in order to provide the benefit of enhancing the mechanical cutting, inhibiting blood loss and making a clean incision as taught by Clague et al. ([0024], [0028-0029], [0098-0101]; Fig. 6).
Concerning claim 5, LeMole fails to disclose the first body lumen is coupled to the second body lumen with at least one of a thermal resistance, a radiofrequency (RF) energy or an ultrasonic energy. However, Clague et al. disclose a device (60, 40) for creating an opening and coupling two interior areas comprising a first portion (62) positioned on one side of a vessel wall and a second portion (52) positioned on the other side of the vessel wall, the first and second members (62, 52) being operable to mechanically cut, and also electrically cut an opening in the vessel wall via bipolar RF cutting between the first and second members (62, 52). At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of LeMole such that the first body lumen is coupled to the second body lumen with at least one of a thermal resistance, a radiofrequency (RF) energy or an ultrasonic energy in order to provide the benefit of enhancing the mechanical cutting, inhibiting blood loss and making a clean incision as taught by Clague et al. ([0024], [0028-0029], [0098-0101]; Fig. 6).
Claims 6-7 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over LeMole (5,893,369), as applied to claim 1.
Concerning claim 6, LeMole discloses moving the non-expandable member (66) of the second portion (66/70) of the medical device (64/66/70) towards the first portion (64) of the medical device (64/66/70) before the activating (block 66 is translated toward the punch 64 before applying sufficient mechanical pressure to shear off vessel walls); and maintaining the second portion in a position proximate the first portion with an applied force (occurs at an infinitesimal amount of time since no specified time period is claimed) (Col. 10-11, ll. 13-9; Fig. 18-20). LeMole fails to specifically disclose the force range for maintaining the second portion in the position proximate the first portion to be a force in the range of about 100 grams of force to about 1000 grams of force. However, LeMole discloses that some forces are required to maintain the second portion in a position proximate the first portion before puncturing the body lumens (Col. 9, ll. 20-33). It would have been obvious to one having ordinary skill in the art at the time of the invention to modify the invention of LeMole such that the actual force range applied is a force in the range of about 100 grams of force to about 1000 grams of force, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Further, Applicant has placed no criticality on the claimed range, and merely states the same language as the claim.
Concerning claim 7, LeMole discloses moving the non-expandable member (66) of the second portion (66/70) of the medical device (64/66/70) towards the first portion (64) of the medical device (64/66/70) before the activating (block 66 is translated toward the punch 64 before applying sufficient mechanical pressure to shear off vessel walls); and applying a pressure between the first portion and the second portion (occurs at an infinitesimal amount of time since no specified time period is claimed) (Col. 10-11, ll. 13-9; Fig. 18-20). LeMole fails to specifically disclose the pressure range applied between the first portion and the second to be in the range of about 100 to about 1000 gf/cm2. However, LeMole discloses that some forces, and inherent pressures, are required to maintain the second portion in a position proximate the first portion before puncturing the body lumens (Col. 9, ll. 20-33). It would have been obvious to one having ordinary skill in the art at the time of the invention to modify the invention of LeMole such that the actual pressure range applied is a pressure in the range of about 100 to about 1000 gf/cm2, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Further, Applicant has placed no criticality on the claimed range, and merely states the same language as the claim.
Claims 8-9 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over LeMole (5,893,369), as applied to claim 1, in further view of Timm (2012/0016413).
Concerning claims 8-9, LeMole fail to disclose measuring/sensing a distance between the first portion and the second portion; and outputting an indication associated with the measurement of the distance. However, Timm et al. disclose a method of creating a connection between two vessels comprising a medical device (10) having a first portion (26) and a second portion (28) slidably coupled to the first portion (26) and a position sensor (27) that provides the surgeon with feedback of the distance between the first portion (26) and the second portion (28). At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of LeMole to further comprise measuring/sensing a distance between the first portion and the second portion; and outputting an indication associated with the measurement of the distance in order to provide the benefit of determining thickness of tissue between the first and second portions as taught by Timm et al. ([0110], [0204])
Claim(s) 10 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over LeMole (5,893,369, previously cited) in view of Flaherty et al. (6,544,230).
Concerning claim 62, as illustrated in Figs. 14-20, Le Mole discloses a method (method for bypassing an occluded artery between a natural graft blood vessel 14 and an artery or vein blood vessel 12; Col. 2, ll. 5-13), comprising:
inserting a guidewire into the first vessel and the second vessel using a needle (guide wire 52 is passed through vessel 14 to vessel 12 via needle 50; Col. 1, ll. 39-58, Col. 2, ll. 5-13, Col. 9, ll. 20-33);
advancing over the guidewire a fistula creation device having a main body having a first tissue contacting surface, a shaft slidably coupled to the main body, and a non-expandable member coupled to the shaft and movable relative to the main body, the non-expandable member having a second tissue contacting surface (punch 64, main body having first tissue contacting surface, and block 66/block handle 70, shaft and non-expandable member, are advanced over guide wire 52, where block 66/block handle 70 are slidably coupled and movable relative to punch 64, non-expandable block 66 has a second tissue contacting surface; Col. 9-11, ll. 58-9);
positioning the main body in the first vessel (punch 64 is positioned in vessel 14; Col. 10-11, ll. 13-9);
moving the shaft such that the non-expandable member is positioned in the second vessel (block 66/block handle 70 is initially parallel to guide wire 52 to insert into vessel 12 and then manipulated to pivot at pivot attachment 72 such that block 66 surface 66s is substantially parallel to the interior surface of the vessel wall 12 Col. 10-11, ll. 13-9);
moving the non-expandable member relative to the main body to contact a side wall of the second vessel (block 66 is translated toward punch 64 to contact vessel side walls 12; Col. 10-11, ll. 13-9); and
creating an aperture through the first vessel and the second vessel between the first tissue contacting surface and the second tissue contacting surface (bock 66 is translated with mechanical energy (i.e., mechanical energy source is operator of the device) toward punch 64 and the vessel walls between the punch 64 and block 66 are sheared off to create an opening between vessels 12, 14; Col. 10-11, ll. 13-9).
LeMole fails to disclose positioning an access sheath within the first vessel and the second vessel over said guidewire. However, Flaherty et al. disclose a device for creating a fistula comprising a vessel access sheath (200) having a hollow interior (202) and an exit port through which a needle (10) and device (30) are inserted. At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of LeMole to further comprise positioning an access sheath within the first vessel and the second vessel over said guidewire in order to provide the benefit of having a guide catheter/introducer to provide access to the target treatment from the initial entry into a body (i.e., femoral vein) as taught by Flaherty et al. (Col. 18-20, II. 36-3; Fig. 13a-g).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 4-5 & 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8-10 of U.S. Patent No. 10,751,461. Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a method (method of creating an arteriovenous (AV) fistula between adjacent first and second blood vessels), comprising: inserting a guidewire through a first body lumen and into a second body lumen adjacent to the first body lumen (inserting a second guidewire through the needle from the first vessel into the second vessel); advancing over the guidewire a medical device into the first body lumen, the medical device having a first portion and a second portion slidably coupled to the first portion, the second portion including a shaft and a non-expandable member, the medical device movable between a first configuration and a second configuration (inserting a toggle delivery catheter into the sheath over the second guidewire; advancing a toggle apparatus comprising a shaft and a pivotable toggle member attached to a distal end of the shaft over the second guidewire so that the toggle member is disposed within the second vessel); moving the medical device from its first configuration to its second configuration such that the second portion of the medical device moves into a second body lumen (moving the toggle member proximally to contact the side wall of the second vessel); and activating an energy source associated with at least one of the first portion or the second portion of the medical device such that a concentric opening is created between the first body lumen and the second body lumen (creating an aperture through the side wall of one of the first vessel or the second vessel, wherein creating the aperture comprises using an energized member to apply a cutting force to the side wall). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a method (method of creating an arteriovenous (AV) fistula between adjacent first and second vessels), comprising: inserting a guidewire into the first vessel and the second vessel using a needle (inserting a first guidewire into the first vessel); positioning an access sheath within the first vessel and the second vessel over said first guidewire (positioning a hollow vessel access sheath within the first vessel over said first guidewire); advancing over the guidewire a fistula creation device having a main body having a first tissue contacting surface, a shaft slidably coupled to the main body, and a non-expandable member coupled to the shaft and movable relative to the main body, the non-expandable member having a second tissue contacting surface and positioning the main body in the first vessel (inserting a toggle delivery catheter into the sheath over the second guidewire); moving the shaft such that the non-expandable member is positioned in the second vessel (advancing a toggle apparatus comprising a shaft and a pivotable toggle member attached to a distal end of the shaft over the second guidewire so that the toggle member is disposed within the second vessel); moving the non-expandable member relative to the main body to contact a side wall of the second vessel (moving the toggle member proximally to contact the side wall of the second vessel); and creating an aperture through the first vessel and the second vessel between the first tissue contacting surface and the second tissue contacting surface (creating an aperture through the side wall of one of the first vessel or the second vessel.). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Makower (6,068,638) teach welding electrodes to weld vessels together without the need for additional mechanical attachment devices (Col.6-7, ll. 62-23; Fig. 8).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAYMI E DELLA whose telephone number is (571)270-1429. The examiner can normally be reached on M-Th 6:00 am - 4:45 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, Joanne Rodden can be reached on (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794