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 .
Election/Restrictions
Applicant’s election without traverse of Species C (electrical therapy and pharmacological agent/fluid delivery) in the reply filed on 6/25/2026 is acknowledged.
As noted in Applicant’s response, Claims 1-13, 15, 17 and 18 are hereby elected as reading on the elected species. Claims 14, 16 and 19-21 are withdrawn from consideration.
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 1-13, 15, 17 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,771,897. Although the claims at issue are not identical, they are not patentably distinct from each other because the current claim set requires a system and method of use wherein the system comprises a catheter with push wires as an action member (claims 1 and 6) configured to be moveable through blood vessels of an endovascular route into the sinus cavernosus and out of the catheter through a perforation in a medial wall of the sinus cavernosus and wherein the system is adapted to actively bend between 20-120 degrees.
Claim Interpretation
The Examiner notes Claims 1-13 and 15 are system claims that recite various structures configured to perform various functions. For instance, Claim 1 states “…a distal end of which is configured to be movable distally within the catheter…”. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Therefore, the Examiner notes that each system claim will be examined based on the structure claimed and thus it will be understood that any structure incorporating the positively recited features would be capable of the claimed function. In each instance, if there are structural features not claimed that would result in the claimed function, the Examiner notes such features should be incorporated into the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 8 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 8 includes the language “…so that the distal surfaces of the annular collar are projected distally form the distal end of the catheter, enclosing a volume around the distal end of the catheter, around the perforation in the medial wall of the cavernous sinus to close a space around the opening in the distal end of the catheter between the distal end of the catheter and the perforation.”(emphasis added). The bolded portion positively recites a connection of the device to a human organism thus effectively claiming the human organism. The Examiner suggest amending the claim to read “…so that the distal surfaces of the annular collar are projected distally from the distal end of the catheter, and configured to enclose distal end of the catheter, around the perforation in the medial wall of the cavernous sinus to close a space around the opening in the distal end of the catheter between the distal end of the catheter and the perforation “ or some variant thereof.
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 8, 12 and 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.
Regarding 8, the term “good contact” is a relative term which renders the claim indefinite. The term “good” is not defined by the claim, 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. It is unclear what level of contact Applicant deems to be “good” versus “not good”..
Furthermore, Claim 8 recites the limitation "the exterior of the distal end" in line 4 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Additionally, Claim 8 includes the language “otherwise deployed”. It is unclear what type of deployment this term encompasses. The Examiner suggests amending the claim to remove the term “otherwise”. The metes and bounds of the term are unclear.
Claim 12 recites the limitation “a distal part of the catheter has a peel-away configuration…”. Claim 1, from which claim1 2 depends already recites “a distal end”. It is unclear if this is the same distal part claimed in claim 12 or a different portion of the catheter. Furtehrmore, it is unclear what portion of the catheter is peelable and/or it is unclear what particular configuration is implied by “peel-away configuration.” Is the outer coating of the catheter peelable or is there some sort of sheath that is able to be peeled away or is this some other configuration? The metes and bounds are unclear.
Claim 18 states : “moving the distal end of a catheter of a system according to claim 1 through an endovascular route…”. The use of the terms “a catheter” and “a system” implies a new catheter and a new system other than what is claimed in claim 1. As such, it is unclear what features of claim 1 are associated with the newly claimed catheter and system. Additionally, the use of “the distal end” would lack proper antecedent support coupled with the use of “a catheter” since a distal end of the new catheter has not been previously claimed. If Applicant intends for all of the structure of Claim 1 to be incorporated into Claim 18, the Examiner suggests amending the claim to read “moving the distal end of the catheter of the system according to claim 1”. If Applicant only wants some portions or substructure of the system of Claim 1 to be incorporated into the claim, the Examiner suggests deleting the reference to claim 1 and then only including the specific structure in claim 18 that Applicant deems pertinent to the claim. If Applicant chooses the latter option, the claims could be subject to an election by original presentation and could potentially be withdrawn since this would change the scope of the claim. For purposes of examination, the Examiner is interpreting Claims 18-21 as requiring all of the stricture of claim 1.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 7, 9, 13, 15 and 17 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Williams et al. (2007/0255379).
Regarding Claims 1 and 2, Williams discloses a system having a device 12c having microelectrodes thereon and fluid reservoirs therein for allowing the delivery of fluids to the vasculature (Abstract; par. [0017, 0047] Fig. 3) and Williams further discloses the system is capable of bending approximately 90 degrees (see Fig 3; par. [0048]) which falls within the claimed range of 30-120 degrees and is not less than 75 degrees. The Examiner notes that the intended use language “a distal end configured to be moveably distally within the catheter….and then into or around the pituitary gland” does not further limit the claim and that since Williams discloses all of the claimed structure and the claimed flexibility of said structure, Williams is capable of the claimed function. If there are other structural considerations that make the claimed function possible, the Examiner suggests amending the claims to positively recite such structure.
Regarding claim 7, William discloses wherein the catheter comprises a tip containing a sharp, preferably pointed, element that can be projected distally from the opening in the distal end of the catheter to form the perforation in the medial wall of the cavernous sinus (e.g. paragraph [0040], needle tips).
Regarding claim 9, Williams discloses wherein the action member comprises at least a first guide wire for pivoting or steering the distal end of the catheter in a desired direction, preferably by remote control, for controlling its distal movement through the endovascular route and then into and through the sinus cavernosus (e.g. guidewires 21 described in paragraph [0046]; alternatively mandrel 18 as described in [0035]-[0036]).
Regarding claim 13, Williams discloses wherein the system comprises an electrode or electrode array, the distal end of which has one or more contact points for electrical stimulation of endocrine tissue of the pituitary gland, the pituitary stalk or the hypothalamus (e.g. electrodes 25 or 26; paragraphs [0038]-[0040]; and/or - the system comprises a microcannula, the distal end of which has one or more central hollow channels, each with one or more side openings, through which small volumes of a fluid or gel can flow into the pituitary gland, the pituitary stalk or the hypothalamus, preferably with side openings that can be opened and closed by remote control.
Regarding claim 15, Williams discloses wherein a distal portion of the electrode or electrode array and/or microcannula has a shape memory and thus can form a three-dimensional shape, preferably a coil shape, within or about the pituitary gland, preferably when triggered by remote control (e.g. paragraph [0051]).
Regarding claim 17, Williams discloses wherein the catheter annular wall section is removable while leaving the microcannula and/or the electrode or electrode array in place (e.g. paragraphs [0029], [0054], wherein sheaths 17 and 19 are removable), and optionally, further comprising an optionally subcutaneously provided reservoir and/or control or pump unit for controlling and providing electrical pulses and/or therapeutic or diagnostic liquids directly to a pituitary gland via the microcannula or electrode, and/or measuring of currents in the electrode or electrode array.
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 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Williams et al. (2007/0255379) in view of Sinelknikov et al. (2015/0257779)..
Regarding claims 3 and 5, Williams discloses the invention substantially as claimed, but does not expressly disclose first and second annular walls with a working channels incorporated into at least one of the first and second annular walls and an interior lumen disposed inside at least one of the first and second annular walls. In the same problem-solving area, Sinelknikov teaches that it is known to use multiple pull wires passing through lumens in a catheter shaft to provide multiple points of articulation in order to facilitate positioning the catheter through controllable deflection (e.g. paragraph [0178]). The plurality of lumens for the pull wires described in e.g. paragraph [0178] reasonably read on working channels incorporated int the wall of the catheter to meet the claim.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Williams, with multiple pullwires located in lumens of the catheter shaft as taught by Sinelnikov, since such a modification would provide the predictable results of improving the controllable deflection of the catheter to facilitate better positioning in alignment with a target tissue.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Williams et al. (2007/0255379) in view of Newell et al. (2014/0200648). Williams discloses all of the claimed invention except for including a radiopaque marker. However, Newell, in the same field of endeavor of catheter implantation, discloses including radiopaque markers on the catheter for the purpose of allowing for precise image guidance of the catheter through the vasculature (par. [0134]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Williams reference to include radiopaque markers, as taught and suggested by Newell, for the purpose of allowing for precise image guidance of the catheter through the vasculature.
Allowable Subject Matter
Claims 4, 6, 8, 11, 12 and 18 do not have prior art applied against them but are not in condition for allowance due to the 35 USC 101 and 112 rejections as well as the applied doble patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALLEN PORTER whose telephone number is (571)270-5419. The examiner can normally be reached Mon - Fri 9:00-6:00 EST.
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, Unsu Jung can be reached at 571-272-8506. 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.
/ALLEN PORTER/Primary Examiner, Art Unit 3796
Prosecution Insights