DETAILED ACTION
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 Objections
Claims 6, 7, 17, 18, are objected to because of the following informalities: In order to avoid any antecedent issues, “the spring constant” can be amended to “a spring constant” of the respective first and second biasing elements for clarity purposes. Appropriate correction is required.
Claims 7, 17, 18, are objected to because of the following informalities: In order to avoid any antecedent issues, “the compressive force” can be amended to “a compressive force” of the respect first and second biasing elements for clarity purposes. 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 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 recites the limitation "the spring" in line 12. There is insufficient antecedent basis for this limitation in the claim. A first biasing element and a second biasing element was previously claimed but not “a spring”. Therefore it is unclear what spring is being referred to. Therefore the limitation is considered to be indefinite.
Claim Rejections - 35 USC § 102
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.
Claims 11-20 are rejected under 35 U.S.C. 102(a) as being anticipated by U.S. Patent Publication 2011/0270191 to Paul.
As claim 11, Paul discloses a cardiac tissue piecing device (paragraph 25), the device comprising a tubular sheath (12) extending along a longitudinal axis, the tubular sheath having a proximal end (figure 1-3) and a distal end (figure 1) and comprising a hollow tube (paragraph 26, at least the “braided tube”) configured for flexible articulation through an artery or vein to a heart (paragraph 26); a needle (14) extending through the tubular sheath (figure 1-3, paragraph 27), the needle having a proximal end (24) and a sharp distal end (26) configured to pierce cardiac tissue (paragraph 27, 29); and a first biasing element (34) positioned to be in a compressed configuration when the distal end of the needle is held in a retractable configuration within the distal end of the tubular sheath (figure 1, paragraph 32, 33, the spring is compressed into the configuration of figure 1 by latch 30, at least one of the spring is compressed proximally, the retracted position can where the actuator more laterally based as seen in figure 1/3, where the torsion spring has a shorter dimension extending along the longitudinal axis of the device), and to be biased into an expanded configuration when the needle is released from being held in a retracted configuration when the needle is released from being held in a retracted configuration to move the needle distally out of the distal end of the tubular sheath (figure 1-3, paragraph 32-34), and a second biasing element (36) positioned to be compressed when the needle extends distally from the distal end of the tubular sheath (figure 1-2), and to automatically expand to return the spring to a retracted position within the tubular sheath upon the distal end of the needle extending distally out of the distal end of the tubular sheath (figure 2-3, paragraph 34-36, a spring can be returned to a retracted position based on the second biasing element automatic expansion).
As to claim 12, Paul discloses the first biasing element is configured to be biased into an axially expanded configuration when the needle is released from the being held in a retracted configuration when the needle is released from being held in a retracted configuration to move the needle distally out of the distal end of the tubular sheath (figure 2). The spring has a greater length along the longitudinal direction as the needle is released, which can read on the “axially expanded configuration”.
As to claim 13, Paul discloses the second biasing element is configured to be axially compressed by expansion of the first biasing element (figure 2).
As to claim 14, Paul discloses the second biasing element is configured to axially expand after the needle has been released from the locked configuration (figure 2-3).
As to claim 15, Paul discloses the second biasing element is configured to be axially compressed by the needle extending distally out of the distal end of the tubular sheath (figure 1-3, paragraph 34-36).
As to claim 16, Paul discloses the second biasing element is configured to expand axially automatically upon the distal end of the needle extending distally out of the distal end of the tubular sheath (figure 1-3, paragraph 34-36).
As to claim 17, Paul discloses the spring constant of the first biasing element is selected so that the compressive force of the first biasing element is sufficient to move the distal end of the needle to pierce cardiac tissue (figure 1-3, paragraph 34-36). The spring 34 can move the needle to pierce tissue, so the spring constant can be selected accordingly for the function.
As to claim 18, Paul discloses the spring constant of the second biasing element is selected so that the compressive force of the second biasing element is sufficient to move the distal end of the needle against the first biasing element to return the distal end of the needle into a retracted position within the tubular sheath (figure 1-3, paragraph 34-36). The spring 36 can move the needle back within the sheath, so the spring constant can be selected accordingly for the function.
As to claim 19, Paul discloses the distal end of the needle includes a tip formed by one or more tapers, bevels, chamfers, fillets, grooves, or at least two angles allowing piercing of the fossa ovalis (figure 2). The tip has at least a taper.
As to claim 20, Paul discloses the distal end of the tubular sheath is tapered and/or includes a beveled edge, a chamfered edge, a fillet, or a groove (figure 1). The end of the sheath is at least tapered.
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 1-5, 7, 11-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. U.S. Patent No. 11,219,743 in view of U.S. Patent Publication 2011/0270191 to Paul.
As to the instant application’s claim 1, the reference patent claims a cardiac tissue piecing device (claim 1), the device comprising a tubular sheath (claim 1) extending along a longitudinal axis, the tubular sheath having a proximal end (claim 1) and a distal end (claim 1) and comprising a hollow tube (claim 1) configured for flexible articulation through an artery or vein to a heart (claim 1); a flexible needle (claim 1) disposed coaxially in the tubular sheath and advanceable within the body along the longitudinal axis of the tubular sheath (claim 1), the needle having a proximal end and a distal end, the distal end of the needle being configured to pierce cardiac tissue within the body (claim 1); and a needle control mechanism including a piston (claim 1) operatively coupled with the needle; wherein: when the needle control mechanism is in a locked configuration (claim 1, first position), the piston compresses a first biasing element (claim 1), and the distal end of the needle is retracted within the tubular sheath (claim 1); when the needle control mechanism is released from the locked configuration (claim 1), the first biasing element expands to cause the distal end of the needle to extend out of the distal end of the tubular sheath to puncture cardiac tissue (claim 1); a second biasing element (claim 4, 8, return spring) is positioned relative to the piston to bias the piston proximally to retract the distal end of the needle into the distal end of the tubular sheath but is silent that the second biasing element biases the piston after the needle control mechanism has been released from the locked configuration and after the distal end of the needle has extended out of the distal end of the tubular sheath
If, however, it would not be known that the reference patent is configured for flexible articulation through an artery or vein to a heart and a distal end of a needle configured to puncture cardiac tissue, Paul teaches a similar device (heart piercing device, abstract) having a device with a sheath flexible articulation through an artery or vein to a heart (paragraph 26) and a distal end of a needle configured to puncture cardiac tissue (paragraph 27) in order to puncture a site in the heart as desired. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the reference patent be configured to articulate through an artery or vein to a heart to pierce cardiac tissue in order to puncture a site in the heart as desired. Further Paul teaches a second biasing spring (36) will retract the needle after the needle has been released from a locked configuration and after it has extended out of the sheath (figure 1-3, paragraph 34) for the purpose of providing a safety mechanism to withdraw the needle. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the second biasing element bias the needle proximally after the needle has extended out of the distal end of the sheath to provide a safety mechanism.
As to the instant application’s claim 2, see reference patent claim 6.
As to the instant application’s claim 3, see reference patent claim 8. Paul can further teach axial compression of the second biasing member (figure 1-3).
As to the instant application’s claim 4, 5, see reference patent claim 8. Paul can further teach the second biasing element expanding (figure 1-3).
As to the instant application’s claim 7, see reference patent claim 8. Paul can further teach the limitation (paragraph 35,36). The spring performs the function so the spring constant will be selected to perform the function.
As to the instant application’s claim 11, the reference patent claims a cardiac tissue piecing device (claim 1), the device comprising a tubular sheath (claim 1) extending along a longitudinal axis, the tubular sheath having a proximal end (claim 1) and a distal end (claim 1) and comprising a hollow tube (claim 1) configured for flexible articulation through an artery or vein to a heart (claim 1); a needle (claim 1) extending through the tubular sheath (claim 1), the needle having a proximal end and a sharp distal end configured to pierce cardiac tissue (claim 1); and a first biasing element (claim 1) positioned to be in a compressed configuration when the distal end of the needle is held in a retractable configuration within the distal end of the tubular sheath (claim 1), and to be biased into an expanded configuration when the needle is released from being held in a retracted configuration when the needle is released from being held in a retracted configuration to move the needle distally out of the distal end of the tubular sheath (claim 1), and a second biasing element (claim 4) positioned to be compressed when the needle extends distally from the distal end of the tubular sheath, but is silent about the second biasing element automatically expand to return the spring to a retracted position within the tubular sheath upon the distal end of the needle extending distally out of the distal end of the tubular sheath.
If, however, it would not be known that the reference patent is configured for flexible articulation through an artery or vein to a heart and a distal end of a needle configured to puncture cardiac tissue, Paul teaches a similar device (heart piercing device, abstract) having a device with a sheath flexible articulation through an artery or vein to a heart (paragraph 26) and a distal end of a needle configured to puncture cardiac tissue (paragraph 27) in order to puncture a site in the heart as desired. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the reference patent be configured to articulate through an artery or vein to a heart to pierce cardiac tissue in order to puncture a site in the heart as desired. Further Paul teaches a second biasing spring (36) will automatically expand to return the spring to a retracted position within the tubular sheath upon the distal end of the needle extending distally out of the distal end of the sheath (figure 1-3, paragraph 34) for the purpose of providing a safety mechanism to withdraw the needle. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the second biasing element automatically expand to return the spring to a retracted position within the tubular sheath upon the distal end of the needle extending distally out of the distal end of the sheath in order to provide a safety mechanism.
As to the instant application’s claim 12, see reference patent claim 1.
As to the instant application’s claim 13, 14, see reference patent claim 8. Paul can further teach axial compression of the second biasing member (figure 1-3).
As to the instant application’s claim 15, see reference patent claim 8. Paul can further teach the second biasing element expanding (figure 1-3).
As to the instant application’s claim 16, see reference patent claim 8. Paul can further teach the second biasing element expanding (figure 1-3).
As to the instant application’s claim 17, 18, see reference patent claim 8. Paul can further teach the limitation (paragraph 35,36). The spring performs the function so the spring constant will be selected to perform the function.
As to the instant application’s claim 19, 20, Paul can further teach the second the distal end of the needle includes a tip formed by one taper and the distal end of the sheath is tapered (figure 1) for the purpose of facilitating access and puncturing of the tissue. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the tip of the needle be formed by taper and the tubular sheath to be tapered in order for of facilitating access and puncturing of the tissue
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,219,743 in view of U.S. Patent Publication 2011/0270191 to Paul and further in view of U.S. Patent 5,474,539 to Costa.
As to claims 6, the reference patent as modified by Paul claims the device above but is silent about the spring constant of the second biasing element is different from the spring constant of the first biasing element.
Costa teaches a similar device (piercing device, abstract) comprising a spring constant of a second biasing element is different from a spring constant of a first biasing element (col. 2 ll. 28-39, col. 5 ll. 65-col. 6 ll. 35) for the purpose of selecting the spring forces for the particular function. The different springs have different functions and therefore can have different constants, as taught by Costa. It would have been obvious to one of ordinary skill in the art before the effective filing date for the claimed reference patent to have the spring constant of the second biasing element is different from the spring constant of the first biasing element in order for selecting different spring forces for the particular different functions.
Claim 8-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,219,743 in view of U.S. Patent Publication 2011/0270191 to Paul and further in view of U.S. Patent Publication 2008/0058836 to Moll.
As to claims 8-10, the reference patent as modified by Paul claims the device above but is silent about the one or more image/lighting devices, transparent balloon surrounding the one or more image/lighting devices, where the at least one or more image/lighting devices are positioned along the distal end of the tubular sheath, and irrigation orifices are defined along the distal end of the tubular sheath.
Moll teaches a similar device (flexible guide device, abstract) having one or more image/lighting devices (6604) and transparent balloon (6608, paragraph 179, 188 surrounding the one or more image/lighting devices (6604) or the at least one or more image/lighting devices are positioned along the distal end of the tubular sheath (figure 67), and irrigation orifices (6606) are defined along the distal end of the tubular sheath for the purpose of obtaining a clear working space for imaging the target location (paragraph 185). It would have been obvious to one of ordinary skill in the art before the effective filing date to use the imaging/lighting devices, transparent balloon or irrigation orifices in the reference patent in order for obtaining a clear working space for imaging the target location
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent Publication 2014/0371676 to Leeflang (as cited as Publication Reference 11 in the IDS filed 11/11/2024) and U.S. Patent 5,645,076 to Yoon (as cited as Patent Reference 5 in the IDS filed 11/11/2024) both disclose similar device capable of rendering obvious and/or providing evidence on the claims of record.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
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.
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.
/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771
Prosecution Insights