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.
Claim 8 is 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.
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 8 recites the broad recitation at least 2 channels, and the claim also recites at least 5 channels, at least 10 channels, and at least 15 channels 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.
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.
Claim(s) 1 – 52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pellinen et al. (US PGPUB 2019/028993 – in IDS) in view of Schouenborg et al. (US PGPUB 2018/0369572).
Regarding claims 1 – 3, Pellinen discloses microfilament guiding structure (e.g. 12) comprising channels (e.g. 14) providing a continuous lumen through the structure configured to allow accommodation, and axial movement of microfilaments (e.g. ¶ 6-8), wherein at least some of the channels have a three dimensional spatial (three dimensional) configuration that said channels have an angular spatial arrangement with an acute angle a from about 2 deg up to about 20 deg, where the angle a of a channel is given by the acute angle a of a right angled triangle with sides defined by the straight line between the center of the proximal and distal exit of a channel, the straight line parallel to the central axis of the guiding structure and intersecting the center of the proximal channel exit and the straight line perpendicular to the central axis of the guiding structure intersecting the center of the distal exit if the channel and angle a being the angle between the two longest sides (e.g. ¶ 39), but fails to teach the structure gradually disintegrating and/or dissolving when contacted by tissue fluids
Schouenborg teaches it is known to use dissolvable/transient supports for microelectrodes and using channel lining materials that gradually disintegrate and/or dissolve (e.g. ABSTRACT). It would have been obvious to one having ordinary skill in the art to modify the structure as taught by Pellinen with the dissolving structure as taught by Schouenborg, since such a modification would provide the predictable results of having better vessel protection and reduced chronic response.
Regarding claims 4 – 6, Pellinen discloses the claimed dimensions of the guiding structure (e.g. ¶ 47).
Regarding claim 7, Pellinen discloses the invention as previously described, but fails to teach materials selected from the group consisting of low molecular carbohydrates, proteinaceous materials, and mixtures thereof, preferably gelatin. Schouenborg teaches it is known to use the claimed materials (e.g. ¶ 28). It would have been obvious to one having ordinary skill in the art to modify the structure as taught by Pellinen with the dissolving claimed materials as taught by Schouenborg, since such a modification would provide the predictable results of having better vessel protection and reduced chronic response.
Regarding claim 8, Pellinen discloses at least 2 channels (e.g. Fig. 3A, 14).
Regarding claim 9 and 10, Pellinen discloses the microfilaments are selected from electrically conductive microelectrodes, hollow microfilaments, microfilaments comprising sensing means such as photon sensing means, and any combination of the three types of microfilaments (e.g. ¶ 6).
Regarding claims 11 and 12, Pellinen discloses the proximal section comprising from one channel up to a number of channels equaling the number of channels comprised in the distal section wherein the channel or channels of the proximal section has or have a combined cross-section area capable of allowing insertion of a number of microfilaments equaling the number of channels in the distal structure and accommodating the microfilaments and wherein the channels of the distal and the channel or channels of the proximal sections are so configured that individual, microfilaments in the proximal section of the guiding structure can be moved in an axial direction (e.g. Figs. 3-4).
Regarding claims 14 – 20, Pellinen teaches a push rod (e.g. 50) that is an actuator for deploying the probes (e.g. ¶ 53-56). The push rod reads on the pin as it is used for the same purpose and is slidably located in a proximal part of the elongated hollow guiding member.
Regarding claim 21¸ Pellinen discloses the microfilament guiding structure comprises at least two regions, a distal region and a proximal region where the area of the cross-section of the proximal region is greater than the area of the cross-section of the distal region (e.g. Fig. 6).
Regarding claim 22, Pellinen discloses the microfilament guiding structure is essentially rotationally symmetric (e.g. Fig. 6).
Regarding claims 23 – 31, Pellinen discloses a distal and a proximal region/parts, wherein at least a part of the distal region, or the distal part, comprises comprises an elliptical cross-section, preferably circular cross-section and at least a part of the proximal region, or distal part, comprises a di-elliptical cross-section, preferably di-circular cross-section (e.g. Figs. 6, 8; the annular guide tube with partion/gaps; deployment channels create effective radial variations).
Regarding claims 32, Pellinen discloses a distal and proximal region, the guiding member comprising an annular cross-section with an inner diameter (Di) and an outer diameter (Do), where Di is from about 102% up to about 110% of Rnd and Do is from about 90 up to about 100% of Rpw, wherein the elongated hollow guiding member has a lateral partition of the annular cross-section over the entire axial length of the guiding member, wherein the proximal partition is wider than the distal partition (e.g. Fig. 6).
Regarding claims 33 – 37, Pellinen discloses the distal region of the guiding structure comprises a protrusion (e.g. Fig. 8; guide tube sidewall features and channel exits create protrusions).
Regarding claims 38 – 40, Pellinen discloses the pin guiding structure accommodates a rigid pin and the individual microfilaments, the rigid pin and the individual microfilaments extending from the pin guiding structure in proximal direction, the pin guiding structure comprising a rotationally symmetric cross-section with a radial extension to be accommodated in the proximal region of the elongated hollow guiding member, wherein the pin guiding structure is positioned at a distance from the microfilament guiding structure sufficient for moving the individual microfilaments through the distal section of the guiding system (e.g. ¶ 53-56).
Regarding claims 41 - 43, Pellinen discloses the pin guiding structure as previously mentioned, but fails to teach it has the characteristics of gradually disintegrating and/or dissolving.
Schouenborg teaches it is known to use dissolvable/transient supports for microelectrodes and using materials that gradually disintegrate and/or dissolve (e.g. ABSTRACT). It would have been obvious to one having ordinary skill in the art to modify the structure as taught by Pellinen with the dissolving structure as taught by Schouenborg, since such a modification would provide the predictable results of having better vessel protection and reduced chronic response.
Regarding claims 44 – 49, Pellinen discloses the claimed dimensions of the guiding structure (e.g. ¶ 47).
Regarding claims 50 – 52, Pellinen discloses the microfilaments are electrically conductive and comprise a material selected from the group consisting of microelectrode comprises a metal, metal alloy, carbon such as graphite and graphene, an electrically conductive polymer, and or a mixture thereof (e.g. ¶ 62).
Regarding claims 53 – 57, Pellinen discloses a method of manufacture for the device described above (e.g. ¶ 69-75).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH M DIETRICH whose telephone number is (571)270-1895. The examiner can normally be reached Mon - Fri 8:00-5:00.
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, Jennifer McDonald can be reached at 571-270-3061. 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.
/JOSEPH M DIETRICH/Primary Examiner, Art Unit 3796
Prosecution Insights