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 19 and 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 19, line 5, “a working lumen” lacks clear antecedent basis because “a working lumen” was previously set forth at line 3; therefore, it is unclear if the second instance refers to the first working lumen or another working lumen.
Claim 20 is rejected because it depends from and includes the limitations of rejected claim 19.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4 and 7-17, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ducharme et al. (2011/0152611; cited by Applicant) in view of Kraemer et al. (2014/0012248; cited by Applicant).
Regarding claim 1, Ducharme et al. disclose a medical system comprising:
a suture wire 710 (Figs. 5 and 14; paras. 0053, 0077 and 0081); and
a plurality of deployable assemblies 700 for engaging tissue (paras. 0079-0080) coupled to suture wire (Figs. 5 and 14; paras. 0053, 0077 and 0081), the plurality of assemblies each including one or more anchoring features, e.g., 2064 (Fig. 20F; paras. 0079-0080);
wherein, in a first configuration, e.g., prior to deployment from a deployment system 2100 (cf. Fig. 21 and paras. 0077, 0081 and 0082), a first assembly 700 of the plurality of assemblies is a first distance along the suture wire 710 from a second assembly 700 of the plurality of assemblies, and wherein, in a second configuration, upon deployment of the first assembly 700 into the patient, the first assembly is a second distance from the second assembly 700, wherein the second distance is greater than the first distance.
Thus, Ducharme et al. discloses the claimed invention except for the assemblies comprising a lighting element.
Kraemer et al. also disclose a medical system deploying a plurality of assemblies 308 (Fig. 18) for engaging tissue (para. 0072) and teach that the assemblies can be provided with an LED lighting element 314 to mark a surgical location and facilitate the procedure (id. and para. 0081).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the assemblies for engaging tissue of Ducharme et al. with LED lighting elements, in view of Kraemer et al., to mark a surgical location and facilitate the procedure.
Regarding claim 2, the anchoring features 264 are configured to affix the plurality of lighting assemblies of the combination (supra) to an anatomical surface (paras. 0079-0080 of Ducharme et al.).
Regarding claim 3, the suture wire 710 of the combination (supra) is configured to transition from an elongated configuration (e.g., taut) to a contracted configuration (e.g., loose and slack; e.g., Fig. 5 of Ducharme et al.).
Regarding claim 4, each of the plurality of lighting assemblies 700 of the combination (supra) is radially fixed with respect to the suture wire 710 (cf. Fig. 5 of Ducharme et al.).
Regarding claim 7, the plurality of lighting assemblies 700 of the combination (supra) are movably coupled to the suture wire 710.
Regarding claim 8, the medical system of the combination (supra) further comprises a driver 2100 configured to pull the second lighting 700 assembly proximally with respect to the first lighting assembly 700 (being deployed prior to the second; para. 0082 of Ducharme et al.) to transition from the first configuration to the second configuration.
Regarding claim 9, the lighting element of the combination (supra) comprises one or more light emitting diodes (LEDs) (Fig. 18 and para. 0081 of Kraemer et al.).
Regarding claim 10, the medical system of the combination (supra) includes a retention feature 712 that is distal of a distalmost of the plurality of lighting assemblies 700 of the combination (Fig. 5 of Ducharme et al.).
Regarding claim 11, the medical system of the combination (supra) can be used and characterized as a bronchoscope because it comprises a camera 1106 (Fig. 11A and para. 0065 of Ducharme et al.) allowing for visualization of anatomy (e.g., the lungs if desired), and wherein the suture wire 710 and the plurality of lighting assemblies 700 of the combination are configured to be inserted into a working lumen of the bronchoscope (Fig. 11A; supra).
Regarding claim 12, a first subset of the plurality of lighting assemblies 700 of the combination (supra) is configured to be removed from the working lumen in a configuration in which a second subset of the plurality of lighting assemblies 700 of the combination is affixed to an anatomical surface (i.e., a plurality of assemblies awaiting deployment are configured to be removed after a plurality of assemblies have been deployed and affixed to the anatomical surface (supra).
Regarding claim 13, the plurality of lighting assemblies of the combination (supra) includes at least an indication such as the LED light 314 (Fig. 18 and para. 0081 of Kraemer et al.).
Regarding claim 14, the anchoring features of the combination (supra) comprise at least barbs 2064 (Fig. 20F of Ducharme et al.).
Regarding claim 15, the lighting assemblies 700 of the combination (supra) include a lumen through which the suture wire 710 and lighting assemblies 700 of the combination extend (Fig. 21 and cf. Fig. 14; para. 0077);
Regarding claim 16, the medical system of the combination (supra) comprises:
a suture wire 710;
a first lighting assembly 700 (supra) and a second lighting assembly 700 (id.) radially coupled to the suture wire, the first lighting assembly 700 and the second lighting assembly each including an LED lighting element 314 (Fig. 18 and para. 0081 of Kraemer et al.) and one or more anchoring features 2064 (Fig. 20F and paras. 0079-0080 of Ducharme et al.); and
a driver 2100 (Fig. 21 of Ducharme et al.) configured to move the second lighting assembly 700 proximally with respect to the first lighting assembly 700 (e.g., while deploying the first lighting assembly 700 (cf. para. 0082 of Ducharme et al.).
Regarding claim 17, the driver 2100 of the combination (supra) is configured to move the second lighting assembly 700 proximally in a configuration in which the first lighting assembly 700 is affixed to an anatomical surface via the one or more anchoring features 2064 of the first lighting assembly 700 (supra).
Regarding claim 19, the medical device of the combination (supra) comprises a method, comprising:
inserting a medical device 1100 and 2100 (Figs. 11C and 21 of Ducharme et al.; supra) into a subject, wherein the medical device includes a handle, e.g., 94 (cf. Fig. 19B), and a shaft 2102 extending distally from the handle (id.), the shaft having a working lumen (Fig. 21);
positioning a distal portion of the shaft at a target site (para. 0082);
deploying a first illumination device 700 of the combination (supra) from the working lumen (para. 0082);
affixing the first illumination device 700 to an internal surface of a subject (paras. 0079-0082); and
with the first illumination device 700 affixed to the internal surface (id.), retracting a subsequent illumination device 700 proximally within the working lumen relative to the first illumination device (id.) to dispense a second illumination device 700 (id.).
Regarding claim 20, the first illumination device 700 of the combination (supra) is coupled to the second illumination device 700 of the combination by a wire or a cable 710 (Fig. 5 of Ducharme et al.).
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Ducharme et al. (2011/0152611; cited by Applicant) in view of Kraemer et al. (2014/0012248; cited by Applicant), as applied to claim 1, further in view of Sauer, MD (2022/0313243).
Regarding claim 5, the medical system of the combination (supra) discloses the claimed invention including using the suture wire as a deployment line (supra), but do not explicitly recite the wire being a first wire and second wire that are twisted together.
Sauer, MD teaches that sutures can comprise many configurations including multifilament wires twisted together (para. 0023). This configuration provides an alternate effective suture wire for a medical system.
Therefore, it would have been further obvious to a person having ordinary skill in the art before the effective filing date to configure the suture wire of the combination (supra) with a first wire and second wire that are twisted together, in view of Sauer, MD, to provide an alternate effective suture wire for a medical system. As noted above, the twisted wire configuration forms the deployment line as combined.
Regarding claim 6, in a first configuration, a length of the deployment line has a first number of twists, and wherein, in the second elongated configuration, the length of the deployment line has a second number of twists, wherein the second number is less than the first number because as the twists are stretched and approaching a linear configuration the number of twists for a given length decreases.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Ducharme et al. (2011/0152611; cited by Applicant) in view of Kraemer et al. (2014/0012248; cited by Applicant), as applied to claim 1, further in view of Carroll et al. (2018/0325392).
Regarding claim 18, the medical system of the combination (supra) discloses the claimed invention except for at least one of the lighting assemblies including an orientation reference feature including: a liquid; and a gas bubble within the liquid.
Carroll et al. disclose a medical system comprising a lighting assembly including an orientation reference feature 590 (Fig. 12C and para. 0110) including: a liquid; and a gas bubble within the liquid, i.e., a bubble level, to facilitate orienting the medical device and ensure a desired direction for a light beam (id.).
It would have been further obvious to a person having ordinary skill in the art before the effective filing date to configure at least one of the lighting assemblies of the medical device of the combination (supra) with an orientation reference feature including a liquid and a gas bubble within the liquid, i.e., a bubble level, in view of Carroll et al., to facilitate orienting the medical device and ensure a desired direction for the light beam of the lighting assembly.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure (see attached PTO-892).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID C COMSTOCK whose telephone number is (571)272-4710. The examiner can normally be reached M-F 9:00-5:00 PST.
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, Eduardo Robert can be reached at 571-272-4719. 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.
DAVID C. COMSTOCK
Examiner
Art Unit 3773
/DAVID C COMSTOCK/Examiner, Art Unit 3773
/JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773
Prosecution Insights