CTNF 18/962,477 CTNF 88735 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 07-29-01 AIA Claim 1 is objected to because of the following informalities: in line 6 the claim iterates the terms “receives” and “maintains” which should be drafted as “is configured to receive” and “is configured to maintain” respectively . Appropriate correction is required. 07-29-01 AIA Claim 15 is objected to because of the following informalities: in lines 6-7 the claim iterates the terms “receives” and “maintains” which should be drafted as “is configured to receive” and “is configured to maintain” respectively . Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 3-4, 10-11, and 17-18 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 3 recites the limitation "a distal end of the instrument" in line 2. This has improper antecedence and/or calls into question how many distal ends the instrument possess given the iteration of the same in line 8 of parent claim 1. For compact prosecution purposes the examiner recommends replacing “a distal end of the instrument” with “the distal end of the instrument”. Claim 4 is similarly affected, at least by virtue of dependency. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 10 recites the broader recitation “a single field of view greater than about 90 degrees”, and the claim also recites “or greater than about 180 degrees” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For compact prosecution purposes the examiner recommends either splitting the claim into two claims each containing only one range, or otherwise cancelling one of the ranges from the claim. The term “about” in claims 10-11 is a relative term which renders the claims indefinite. The term “about” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically, it is unclear as to the scope of what angular range is or is not bounded by the iterations of “about [number] degrees” in each instance within the claims. For compact prosecution purposes the examiner recommends removing the term “about”. Claim 17 recites the limitation "a distal end of the needle" in line 2. This has improper antecedence and/or calls into question how many distal ends the needle possess given the iteration of the same in lines 7-8 of parent claim 15. For compact prosecution purposes the examiner recommends replacing “a distal end of the needle” with “the distal end of the needle”. Claim 18 is similarly affected, at least by virtue of dependency. 07-36 AIA The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. In this instance the claim merely adds the clause “wherein the ultrasound sensor includes a single ultrasound sensor” which does not add any limitation to the scope of the claim as it neither requires something not already inherent, nor does it limit the number of sensors to “consisting of” only a single sensor. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. For compact prosecution purposes the examiner recommends replacing “includes” with “consists of” which would remedy the issue. Double Patenting 08-33 AIA 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. 08-34 AIA Claim s 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-18 of U.S. Patent No. US 12,186,129 B2 (hereinafter Chumo) . Although the claims at issue are not identical, they are not patentably distinct from each other because : Regarding claims 1 and 15 of the instant application and claims 1 and 16 of Chumo, respectively, the claims vary widely in their choice of wording yet recite nearly identical scope. For instance while Claims 1 and 15 of the instant application require the shaft possess both a US sensor and “an area having an echogenic signature distinct from a remainder of the shaft” which is not wording found in claims 1 and 16 of Chumo, claims 1 and 16 of Chumo have identically this same scope by way of having the US sensor incorporate “an area configured to indicate … in ultrasound images generated by the ultrasound sensor” which iterates the same scope as the echogenicity of the area is that which causes it to be distinguishable in the US image. Mutatis mutandis, it could be argued that each difference in the wording of the claim do not constitute differences in scope between claims 1 and 15 of the instant application and claims 1 and 16 of Chumo, with one exception. Specifically, the examiner notes that the instant claims 1 and 15 are broader than those of Chumo’s 1 and 16 as Chumo requires that the shaft’s working channel “includes a narrowed portion extending from the proximal end of the shaft to the distal end of the shaft” while the instant application’s claims 1 and 15 include the broader recitation “wherein the working channel [is configured to receive] the instrument and [is configured to maintain] an orientation of the instrument with respect to the shaft” without requiring a specific physical mechanism such as a narrowed or non-uniform cross sectional shape to enforce this orientation requirement. However, this is a prima facie obvious variant when one considers the legal precedent set forth in any of MPEP 2144.08, MPEP 2144.04(IV), and/or MPEP 2144.07 in light of the known use of channels having particular narrowing to orient channels as demonstrated by MPEP2144.03 and/or Jansen (of record in parent application and addressed below). That is this is a prima facie obvious variant for multiple reasons as narrowing the channel to bring about orientation of the instrument is a species of channels that are configured to orient an instrument, as narrowing the channel is a change in the shape of the channel without more as both serve to orient, and/or as narrowing the channel would be recognized in the art as a suitable way to maintain orientation either because this is well known and/or because of the art of record that teaches as much. Therefore and for the foregoing reasons the examiner concludes that claims 1 and 15 of the instant application are obvious variants to claims 1 and 16, respectively, of Chumo. Having addressed the independent claims, the examiner notes that the dependent claims are obvious variants due to dependency and due to the following factors of each particular claim: Claim 2 of the instant application recites the same scope as claim 4 of Chumo. Claim 3 of the instant application recites the same scope as claim 3 of Chumo. Claim 4 of the instant application reiterates that same scope of claim 3 of Chumo, wherein claim 3 of Chumo teaches the preset curved configuration and parent claim 1 of Chumo teaches the alignment. Claim 5 of the instant application recites the same scope as claim 5 of Chumo. Claim 6 of the instant application recites the same scope as claim 6 of Chumo. Claim 7 of the instant application recites the same scope as claim 9 of Chumo. Claim 8 of the instant application recites the same scope as claim 10 of Chumo. Claims 9-10 of the instant application, as best understood, recites the same scope as claim 7 of Chumo. Claim 11 of the instant application recites the same scope as claim 8 of Chumo. Claim 12 of the instant application recites the same scope as claim 11 of Chumo. Claim 13 of the instant application recites the same scope as claim 17 of Chumo except the genus-species relationship of instrument and needle, where such relationship is obvious as addressed above. Claim 14 of the instant application recites the same scope as claim 16 of Chumo where the species needle teaches the grouping of needle or brush. Claim 16 of the instant application recites the same scope as claim 16 or alternatively 4 of Chumo, where in regards to Chumo’s claim 16 a channel that narrows is a species of channels that are non-uniform and where with regards to Chumo’s claim 4, this is taught except the genus-species relationship of instrument and needle, where such relationship is obvious as addressed above. Claim 17-18 of the instant application recites the same scope as claim 3 of Chumo except the genus-species relationship of instrument and needle, where such relationship is obvious as addressed above. Claims 19-20 of the instant application recite the same scope as claim 6 of Chumo except the genus-species relationship of instrument and needle, where such relationship is obvious as addressed above . Allowable Subject Matter Claims 1-20 would be allowable if rewritten or amended to overcome the objections and/or rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), 2nd paragraph, set forth in this Office action and if also amended to overcome or otherwise terminally disclaimed to overcome the double patenting rejection. 07-43-03 AIA As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a). 13-03-01 AIA The following is a statement of reasons for the indication of allowable subject matter: It is clear to the examiner that the invention iterated in the independent claims is new and novel compared to the prior art; however, the individual components of the invention are demonstrated in the prior art with WO 2009/029639 A1 (hereafter Jansen), US 20140276615 A1 (hereafter Laroya), and US 20120095404 A1 (hereafter Massengale) each being exemplary for showing the various individual components of the independent claims. However, and in light of the review by the Patent Trial and Appeal Board provided for this same subject matter in parent application 15/073749, it is clear that while the individual components of the invention may be known there is not any reasonable grounds hold the instant invention to be obvious, with the relative alignment of claimed elements in particular being unobvious as iterated in the Board’s opinion on page 8 of the 06/18/2024 decision. That is, while the claims at issue are drafted slightly more broadly than those of the parent application, they still fundamentally contain a shaft having a radially disposed US sensor thereon, an instrument (or needle, for claim 15) which has a specific radial orientation when exiting the shaft, and the echogenic area of the shaft configured to indicate the orientation of the instrument (or needle, for claim 15) in the images and thus contain the same the subject matter which the courts previously addressed. Therefore, the claims are held to be both novel and unobvious over the prior art in view of status of the prior art and in view of the Patent Trial and Appeal Board decision in the parent application. Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.” Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael S Kellogg whose telephone number is (571)270-7278. The examiner can normally be reached M-F 9am-1pm. 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, Keith Raymond can be reached at (571)270-1790. 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. /MICHAEL S KELLOGG/ Examiner, Art Unit 3798 /KEITH M RAYMOND/ Supervisory Patent Examiner, Art Unit 3798 Application/Control Number: 18/962,477 Page 2 Art Unit: 3798 Application/Control Number: 18/962,477 Page 3 Art Unit: 3798 Application/Control Number: 18/962,477 Page 4 Art Unit: 3798 Application/Control Number: 18/962,477 Page 5 Art Unit: 3798 Application/Control Number: 18/962,477 Page 6 Art Unit: 3798 Application/Control Number: 18/962,477 Page 7 Art Unit: 3798 Application/Control Number: 18/962,477 Page 8 Art Unit: 3798 Application/Control Number: 18/962,477 Page 9 Art Unit: 3798 Application/Control Number: 18/962,477 Page 10 Art Unit: 3798 Application/Control Number: 18/962,477 Page 11 Art Unit: 3798
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