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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the claimed method steps must be shown or the feature(s) canceled from the claim(s). For example, a flow chart may be used to provide a drawing of the steps disclosed in instant [0023]. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the limitation of claim 3 “advancing the dilator assembly through the puncture [of the septum wall] to dilate the puncture [of the septum wall]”, see below for interpretation details regarding puncture. It is noted that although the instant disclosure discloses advancing dilator assembly 10 into the left atrium after the stiff back end 38 of the guidewire is used to puncture the interatrial septum in instant [0023], the instant disclosure is silent to how the advancing the dilator assembly through the puncture to dilate the puncture made by the stiff back end 38. However, since the dilator assembly 10 is larger than stiff back end 38 of the guidewire, advancing the dilator assembly 10 into the left atrium would necessarily dilate the puncture made by the stiff back end 38. Therefore, it is suggested amending the following recitation in instant [0023] with: --The stiff back end 38 of the guidewire is then used to puncture the interatrial septum. Upon puncturing the septum, the stiff back end 38 of the guidewire is retracted, the dilator assembly 10 is advanced through the puncture in the septum to dilate the puncture and advanced into the left atrium, and then the floppy front end 36 of the guidewire is re-advanced into the left atrial via exit lumen 33, thus providing safe, guidewire access into the left atrium.-- to provide antecedent basis for the limitation.
Claim Objections
Claims 5-7 and 9 are objected to because of the following informalities:
Claim 5: the recitation of “before advancing the second end” is suggested to be recited as --before said advancing said second end of the said guidewire-- to avoid confusion of antecedent;
Claims 6 and 9: the recitation of “wherein puncturing of said septum wall” should be recited as --wherein said puncturing of said septum wall-- since this is referring to the step required in lines 10-11 of claim 1 so as to avoid confusion of antecedent basis; and
Claim 7: the recitation of “wherein providing a dilator assembly” should be recited as --wherein said providing the dilator assembly-- since this is referring to the step require on line 2 of claim 1 so as to avoid confusion of antecedent basis.
It is noted that the interchangeable recitation of “said” and “the” to avoid confusion.
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 3, 7, 10, 11, and 14 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.
Regarding claim 3, the recitation of “the puncture” lack antecedent basis since this is the first recitation of the limitation. It is unclear whether the recitation is referring to the puncture in the septum wall resulting from the puncturing said septum wall of lines 10-11 of claim 1 or another different puncture. However, for the purpose of continuous examination, the recitation is interpreted as referring to the puncture in the septum wall resulting from the puncturing said septum wall of lines 10-11 of claim 1. Therefore, it is suggested that the recitation is recited as --the puncture in the septum wall--.
Regarding claim 7, the recitation of “said dilator assembly with a joint lumen having a single exit lumen” is confusing because it is unclear whether 1) the claim is requiring another joint lumen for the dilator assembly since claim 1 already requires the dilator assembly with a joint lumen on line 5 or 2) further requiring that the joint lumen of the dilator assembly having a single exit lumen. However, as best understood for the purpose of continuous examination, the recitation is interpreted as requiring that the joint lumen of line 5 in claim 1 having a single exit lumen. Therefore, it is suggested that the recitation be amended to recite --said dilator assembly with the joint lumen having a single exit lumen-- to clarify the confusion. If applicant intends to require that the dilator assembly comprises another join lumen with a single exit lumen in addition to the joint lumen of claim 1, appropriate clarification is required with citation of support so as to avoid issues of new matter.
Regarding claim 10, the recitation of “providing the guidewire comprises providing a guidewire wherein said first end of said guidewire” is confusing because since it is unclear how many guidewires is required. Is the “providing the guidewire” requiring another step of providing a guidewire different from the guidewire that is part of the dilator assembly provided via providing a dilator on lines 2-7 of claim 1? The subsequent recitation of “providing a guidewire” is also confusing because it is unclear if this is referring back to the same guidewire in the “wherein providing the guidewire” or the same guidewire as line 7 of claim 1 (if the “providing the guidewire” is referring to the guidewire of line 7, claim 1 or another different guidewire. Moreover, the recitation of “said guidewire” may also be confusing because it appears that this should be referring to the guidewire of line 7 but guidewires are known to have at least two ends so if the claim requires one or two more guidewires, then this recitation could be referring to the first end of these other guidewires. However, as best understood for the purpose of continuous examination, the recitations are interpreted as referring the same guidewire of line 7, claim 1. Therefore, it is suggested that the recitation of “providing the guidewire comprises providing a guidewire wherein said first end of said guidewire” be amended to recite --wherein said first end of said guidewire-- to clarify the confusion. If applicant intends to require multiple guidewires, appropriate clarification is required with citation of support so as to avoid issues of new matter.
Regarding claim 11, the recitation of “providing the guidewire comprises providing a guidewire” is confusing because it is unclear whether the claim is requiring additional steps of providing a guidewire and how many guidewires are required by the claim, see explanation for claim 10 above for additional details. The recitations of “the second end” and “the first rigidity” also lack antecedent basis. First, the recitation of “the second end” is confusing because it is unclear whether this second end is referring to the second end of the guidewire recited in line 7 of claim 1 or if this is referring to a second end of another structure in the claims. Second, it is noted that this is the first recitation of a first rigidity since the claim depends from claim 1 but the first rigidity is required in claim 10 so it is unclear whether the claim is intended to be dependent from claim 10 or if the first rigidity is referring to another first rigidity. However, for the purpose of continuous examination, the recitations of “the second end” and “the first rigidity” are interpreted as referring to the same second end of the guidewire in line 7, claim 1 and the first rigidity of the first end of the guidewire, where the guidewire is the same as the guidewire of line 7, claim 1, respectively. If applicant intends to require multiple guidewires, a different second end, or a different first rigidity, appropriate clarification is required with citation of support so as to avoid issues of new matter.
Regarding claim 14, the recitation of “interchangeably advancing and retracting a first end of a guidewire and a second end of said guidewire out of a single exit lumen at said distal end of said dilator assembly” is confusing because it is unclear whether the claim is requiring interchangeably advancing and retracting another different guidewire from that of claim 14 or if the claim is further requiring additional specifics to the step of claim 13. For the purpose of continuous examination, the recitation is interpreted as further defining the step of interchangeably advancing and retracting of claim 13. Therefore, it is suggested that the recitation be amended to recite --said interchangeably advancing and retracting said first end of said guidewire and said second end of said guidewire out of said distal end of said dilator assembly is through a single exit lumen at said distal end of said dilator assembly--. If applicant intends to require multiple steps of interchangeably advancing and retracting or multiple guidewires, appropriate clarification is required with citation of support so as to avoid issues of new matter.
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 13 and 14, as best understood (see above for interpretation details for the claim), are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Whiting (US Pub. No. 2012/0035590 A1).
Claim 13. Whiting discloses a method for puncturing a septum wall, said method comprising:
interchangeably advancing and retracting a first end (21) of a guidewire (10) and a second end (12) of said guidewire out of a distal end (18) of a dilator assembly (3) ([0049]) for puncturing a septum wall ([0045]; i.e., since guidewire 10 is used in part of the procedure for transseptal puncture via the transseptal needle, the interchangeably advancing and retracting of the two ends of guidewire 10 is used in a procedure with the transeptal needle for puncturing the atrial septum wall).
Claim 14. Whiting discloses the method of claim 13, comprising interchangeably advancing and retracting a first end of a guidewire and a second end of said guidewire out of a single exit lumen (i.e., exit of sheath 3 at distal end 18) at said distal end of said dilator assembly (Fig. 4).
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, and 4-15, as best understood (see above for interpretation details for the respective claims), are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,130,276.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are designed to be performed by the steps required in the instant claims as further explained:
Re instant claims 1, 4, 6, 9-11, and 15: the functional limitations of how the first and second ends of the guidewire being slidably received in the respective first and second lumen (the steps of inserting, advancing of the instant claims) and how the second end is adapted to puncturing the interatrial septum wall (the steps of puncturing of the instant claims); and the limitation of relative rigidity of the first and second ends of the guidewire (first and second rigidity of instant claims 10 and 11) of patented claims 1, 6, and 10;
Re instant claims 2, 5, 7, and 12-14: the limitation that the joint lumen being sized so that only one of the first end and the second end of the guidewire being extendable therethrough (the single exit lumen of instant claim 7) at a time of patented claims 10-16 requires that the patented device be used by advancing only one of the first end and the second end of the guidewire through the joint lumen thereby requiring retracting of said second end of instant claim 2; before advancing the second end, the first end of the guidewire is required to be retracted of instant claim 5; and the interchangeably advancing and retracting of instant claims 12-14.
Re instant claim 8, although the patented claims do not explicitly require not requiring removal or reinsertion of multiple guidewires or needles, it is noted that the requirement of patented claims 1, 6, and 10 for the second end of the guidewire to be adapted to puncture an interatrial septum during a procedure is requiring that the during the procedure the puncturing of the interatrial septum can be performed without requiring removal or reinsertion of multiple guidewires or needles since the guidewire of the dilator assembly punctures the interatrial septum with the second end.
Claim 3, as best understood (see above for interpretation details), is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,130,276 in view of Davies (US Pub. No. 2016/0175009 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are designed to be performed by the steps required in the instant claim 1 via the functional limitations of how the first and second ends of the guidewire being slidably received in the respective first and second lumen of patented claims 1, 6, and 10. The patented claims do not explicitly require advancing the dilator assembly through the puncture of the septum wall to dilate the puncture of the septum wall. However, Davies discloses devices for puncturing interatrial septum wall using a dilator assembly (100) with a guidewire (200) (Figs. 6A-6D), wherein after the septum wall is punctured, the dilator assembly is advanced from the position of Fig. 6C through the puncture in the septum wall to the position of Fig. 6D to dilate the puncture in the septum wall. Therefore, since both the patented claims and Davies are drawn to a method for puncturing an interatrial septum wall with a dilator assembly with a guidewire, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the patented claims with the step of advancing the dilator assembly through the puncture to dilate the puncture for providing access to the left atrium during the procedure.
Conclusion
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/JENNA ZHANG/Primary Examiner, Art Unit 3783