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 .
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 23-26 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 23 recites the limitation "the one or more wings" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 24 recites the limitation "the one or more wings" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 25 recites the limitation "the one or more wings" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 26 recites the limitation "the one or more wings" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Examiner notes in each of claims 23-26, this issue appears to be correctable if those claims are amended to depend from claim 22, instead of claim 1, as claim 22 first introduces the wings.
Claim Rejections - 35 USC § 102
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 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 21-37 and 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cox et al. (2008/0045924).
Regarding claim 21, Cox et al. disclose a device (see especially figures 1-1I, and additionally figures 11 and 13) comprising: a first tube (10b) comprising a first end, a second end, and a lumen (14); a second tube (10a) defining a first end, a second end, and a lumen (14), wherein the lumen of the second tube is configured to be in communication with the lumen of the first tube (see figure 1), wherein the first tube and the second tube are configured for collecting fluid from a cavity (see at least paragraph [0035]); and an anchoring mechanism (16) located proximate the second end of the first tube and the first end of the second tube (see at least figure 1), wherein the anchoring mechanism is configured for use in an open state and a collapsible state.
Regarding claim 22, the anchoring mechanism comprises one or more wings (16 is defined by Cox et al. as an acorn shape in at least paragraph [0034], which Examiner contends is analogous to a wing since applicant has not structurally defined what is meant by a wing).
Regarding claim 23, the one or more wings comprise a solid material (silicone; see at least paragraph [0034]).
Regarding claim 24, the one or more wings are configured to collapse for positioning of the device within the cavity (Examiner contends structure 16 is capable of collapsing in the claimed manner due to the structure and material it is made of.).
Regarding claim 25, the one or more wings are configured to hold the anchoring mechanism in place when in an open state (Examiner contends structure 16 is capable of holding in the claimed manner due to the structure and material it is made of.).
Regarding claim 26, the one or more wings are configured to collapse to allow for passage of the device from the cavity (Examiner contends structure 16 is capable of collapsing in the claimed manner due to the structure and material it is made of.).
Regarding claim 27, the first tube comprises one or more ports (18; see at least figure 1), wherein the one or more ports are configured for drawing the fluid from the cavity into the first tube.
Regarding claim 28, the one or more ports comprise a plurality of ports, the plurality of ports comprising at least one of round pores, slits, and oval pores (see at least figures 1-1I).
Regarding claim 29, the one or more ports are positioned in a spiral configuration around a center of the first tube (see at least figures 1-1I).
Regarding claim 30, the second tube is configured to be coupled to a collection vessel (via luer lock 12 as shown in figure 1; Examiner notes the collection vessel is not positively recited by this claim).
Regarding claim 31, at least one of the first tube and the second tube comprise volumetric indications (128; see at least figure 11 and paragraph [0052]), wherein the volumetric indications are configured for measurement of a volume of fluid within the first tube and/or the second tube for quantifying fluid loss from the cavity.
Regarding claim 32, the first tube comprises protection pores (the rounded distal end as shown in figure 1), wherein the protection pores protrude beyond an outer boundary of the first tube (Examiner notes applicant has not structurally defined what is meant by a protection pore.).
Regarding claim 33, the first end of the second tube extends from a base of the anchoring mechanism (see at least figure 1).
Regarding claim 34, the device of Cox et al. further comprises a stylet (140; see at least figure 13 where outer tube 124 is analogous to tubes 10a and 10b in figure 1).
Regarding claim 35, the stylet comprises a rod (140l see at least figure 13) placed inside the lumen of the second tube to add stiffness to device.
Regarding claim 36, the second tube comprises a semi-flexible catheter (see at least paragraph [0035]).
Regarding claim 37, the second end of the second tube comprises a semi-ridged end, wherein the semi-ridged end is configured for steerability and push-ability of the device (see at least paragraph [0035]).
Regarding claim 39, the device of Cox et al. further comprises a placement marker (128; see at least figure 11 and paragraph [0052]).
Claim Rejections - 35 USC § 103
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.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Cox et al. (2008/0045924).
Regarding claim 38, Cox et al. disclose the device substantially as described above with respect to claim 21, but fail to disclose the second end of the second tube is tapered. Rather, the tube in Cox et al. is not tapered, but straight. However, Examiner notes it has been held that absent persuasive evidence that the particular configuration of the claimed tube is significant, a person of ordinary skill in the art would have found it obvious to shape the prior art tube in the claimed shape/configuration. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Examiner notes it is well known in the art to taper tubes to allow the tubes to fit through smaller anatomical structures, and therefore Examiner ultimately contends it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have made the second end of the second tube of Cox et al. tapered as claimed.
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Cox et al. (2008/0045924) in view of Blake, III et al. (4,863,424).
Regarding claim 40, Cox et al. disclose the device substantially as described above with respect to claim 21, but fail to disclose the lumen of the first and second tubes has a hydrophilic coating. Attention is drawn to Blake, III et al., who teach it is known to include a hydrophilic coating (22) on the inner lumen (14) of a tube to reduce friction in said tube (see at least column 4, lines 51-53 and column 4, line 67 – column 5, line 7). Therefore, Examiner contends it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have placed a hydrophilic coating in the lumen of the tubes of Cox et al., per the teachings of Blake, III et al., to obtain the same advantage of reduced friction within the tubes.
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 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,839,408. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are more broad than, and thus anticipated by, the claims of the patent.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See the attached PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN J SEVERSON whose telephone number is (571)272-3142. The examiner can normally be reached Monday-Friday 6:00-4:00 central.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Ryan J. Severson/Primary Examiner, Art Unit 3771
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