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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 14, 2026 has been entered. Currently claims 1-20 are pending in this application.
Response to Arguments
Applicant's arguments filed July 29, 2025 have been fully considered but they are not persuasive inasmuch as they apply to the amended rejections as applied to the amended claims.
As further stated below, the amendment to the claim to require “at a pitch angle of 60 up to 90 degrees” has necessitated new rejections under 35 U.S.C. 112(a).
Claim Rejections - 35 USC § 112 – Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Applicant does not have sufficient written description for the limitation “at a pitch angle of 60 up to 90 degrees”.
Applicant argues that the support for this limitation comes from paragraphs [0030] and [0160] of the specification. Examiner does not agree that these citations provide sufficient support for the claimed limitation.
Paragraph [0030] recites a “pitch angle up to 90 degrees.” Paragraph [0160] recites a pitch angle of between “15 degrees to and including 60 degrees”. These appear to be discussing two different embodiments of the invention, as the claimed invention, as shown in Figures 10-13B, only disclose a pitch angle of between “15 degrees to and including 60 degrees”. There is no support in the specification for a pitch angle between 60 and up to 90 degrees.
More significantly, neither of these citations provide sufficient specificity to show that Applicant had possession of the limitation of a pitch angle at “60 up to 90 degrees.” Applicant has provided no evidence that the specified angles between 60 and 90 degrees provides any sort of advantage or benefit over the angles specifically taught in the specification.
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 1, 9, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Griswold (US 2011/0251660).
Regarding claim 1, Griswold discloses the claimed biostimulator including: a housing having a longitudinal axis and including an electronics compartment (e.g. housing 108); and a fixation feature coupled to the housing (e.g. fixation feature 112 as shown in Figure 3) , wherein the fixation feature includes a cylindrical body and a plurality of arms extending distally from the cylindrical body longitudinally at a pitch angle of 60 degrees up to 90 degrees to respective distal tips, and wherein the pitch angle is measured proximally between the plurality of arms and the cylindrical body (e.g. fixation elements 114 as shown in Figure 2).
Regarding claim 9, Griswold discloses the claimed leadless pacemaker system comprising (e.g. as shown in Figure 1:
a transport catheter (e.g. containment sheath 124);
and a leadless cardiac pacemaker mounted on the transport catheter (e.g. implant 100), wherein the leadless cardiac pacemaker includes:
a housing having a longitudinal axis and including an electronics compartment (e.g. housing 108); and
a fixation feature coupled to the housing, wherein the fixation feature includes a plurality of arms extending longitudinally to respective distal tips (e.g. fixation features 112 including tines 114 as shown in Figures 2 and 3);
wherein the fixation feature includes a cylindrical body and a plurality of arms extending distally from the cylindrical body longitudinally at a pitch angle of 60 degrees up to 90 degrees to respective distal tips, and wherein the pitch angle is measured proximally between the plurality of arms and the cylindrical body (e.g. fixation elements 114 as shown in Figure 2).
Regarding claim 16, Griswold discloses the claimed method of manufacturing a leadless biostimulator (e.g. implant 100 as shown in Figures 1-3) comprising: forming a housing having a longitudinal axis and including an electronics compartment (e.g. housing 108); and forming a fixation feature on the housing, wherein the fixation feature includes a plurality of arms extending longitudinally to respective distal tips (e.g. fixation features 114 as shown in Figure 3); wherein the fixation feature includes a cylindrical body and a plurality of arms extending distally from the cylindrical body longitudinally at a pitch angle of 60 degrees up to 90 degrees to respective distal tips, and wherein the pitch angle is measured proximally between the plurality of arms and the cylindrical body (e.g. fixation elements 114 as shown in Figure 2).
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.
Claims 1-4, 7-12, 14-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Foster et al. (US 9,694,172, as previously cited) in view of Griswold (US 2011/0251660).
Regarding claim 1, as best the claim can be understood, Foster discloses the claimed biostimulator (e.g. heart stimulation system 400 as shown in Figures 4A-4B) comprising: a housing having a longitudinal axis and including an electronics compartment (e.g. housing 420); and a fixation feature coupled to the housing, wherein the fixation feature includes a plurality of arms extending longitudinally to respective distal tips, degrees (e.g. fixation features as shown in Figure 4A and labeled 214 in Figures 2B-2C. Examiner notes that the claims do not require that the stimulator and fixation portions are permanently attached.
Foster does not expressly disclose a fixation element wherein the pitch angle at a pitch angle of 60 degrees up to 90 degrees to respective distal tips, and wherein the pitch angle is measured proximally between the plurality of arms and the cylindrical body. Griswold discloses that it is well known in the art of fixation devices to include a fixation element with a cylindrical body and fixation elements at a pitch angle of 60 degrees up to 90 degrees to respective distal tips, and wherein the pitch angle is measured proximally between the plurality of arms and the cylindrical body (e.g. fixation elements 114 as shown in Figure 2). It would have been obvious to one having ordinary skill in the art to include the fixation elements of Griswold in the device of Foster in order to provide the predictable results of fixation elements capable of firmly gripping the desired implantation location.
Regarding claim 2, Foster additionally discloses where the plurality of arms extend in a first screwing direction such that rotation of the fixation feature in the first screwing direction affixes the fixation feature to a heart (e.g. active fixation members 214 as shown in Figures 2B-2C).
Regarding claim 3, Foster additionally discloses wherein the plurality of arms have respective anti-rotation features at the distal tips to resist rotation of the fixation feature in a second screwing direction opposite to the first screwing direction when the fixation feature is affixed to the heart (e.g. rotationally oriented barbs 215 as shown in Figures 2B-2C).
Regarding claim 4, Foster additionally discloses wherein the anti-rotation features include barbs extending in the second screwing direction (e.g. rotationally oriented barbs 215 as shown in Figures 2B-2C).
Regarding claim 7, Foster additionally discloses wherein the fixation feature includes a cylindrical body coupled to the housing (e.g. cylindrical body 310), and wherein the plurality of arms extend at a pitch angle from the cylindrical body (e.g. as shown in Figure 2B-2C).
Regarding claim 8, Foster additionally discloses wherein the cylindrical body and the plurality of arms are contained within a tubular profile (flat tubular profile as shown in Figure 4A).
Regarding claim 9, Foster discloses the claimed leadless pacemaker system comprising:
a transport catheter (e.g. insertion tool 600);
and a leadless cardiac pacemaker mounted on the transport catheter (e.g. heart stimulation system 400 as shown in Figures 4A-4B), wherein the leadless cardiac pacemaker includes:
a housing having a longitudinal axis and including an electronics compartment (e.g. housing 420); and
a fixation feature coupled to the housing, wherein the fixation feature includes a plurality of arms extending longitudinally to respective distal tips (e.g. fixation features as shown in Figure 4A and labeled 214 in Figures 2B-2C).
Foster does not expressly disclose a fixation element wherein the pitch angle at a pitch angle of 60 degrees up to 90 degrees to respective distal tips, and wherein the pitch angle is measured proximally between the plurality of arms and the cylindrical body. Griswold discloses that it is well known in the art of fixation devices to include a fixation element with a cylindrical body and fixation elements at a pitch angle of 60 degrees up to 90 degrees to respective distal tips, and wherein the pitch angle is measured proximally between the plurality of arms and the cylindrical body (e.g. fixation elements 114 as shown in Figure 2). It would have been obvious to one having ordinary skill in the art to include the fixation elements of Griswold in the device of Foster in order to provide the predictable results of fixation elements capable of firmly gripping the desired implantation location.
Regarding claim 10, Foster additionally discloses where the plurality of arms extend in a first screwing direction such that rotation of the fixation feature in the first screwing direction affixes the fixation feature to a heart (e.g. active fixation members 214 as shown in Figures 2B-2C).
Regarding claim 11, Foster additionally discloses wherein the plurality of arms have respective anti-rotation features at the distal tips to resist rotation of the fixation feature in a second screwing direction opposite to the first screwing direction when the fixation feature is affixed to the heart (e.g. rotationally oriented barbs 215 as shown in Figures 2B-2C).
Regarding claim 12, Foster additionally discloses wherein the anti-rotation features include barbs extending in the second screwing direction (e.g. rotationally oriented barbs 215 as shown in Figures 2B-2C).
Regarding claim 14, Foster additionally discloses wherein the fixation feature includes a cylindrical body coupled to the housing (e.g. cylindrical body 310), and wherein the plurality of arms extend at a pitch angle from the cylindrical body (e.g. as shown in Figure 2B-2C).
Regarding claim 15, Foster additionally discloses wherein the cylindrical body and the plurality of arms are contained within a tubular profile (flat tubular profile as shown in Figure 4A).
Regarding claim 16, Foster discloses the claimed method of manufacturing a leadless biostimulator (e.g. heart stimulation system 400 as shown in Figures 4A-4B) comprising: forming a housing having a longitudinal axis and including an electronics compartment (e.g. housing 420); and forming a fixation feature on the housing, wherein the fixation feature includes a plurality of arms extending longitudinally to respective distal tips (e.g. fixation features as shown in Figure 4A and labeled 214 in Figures 2B-2C).
Foster does not expressly disclose a fixation element wherein the pitch angle at a pitch angle of 60 degrees up to 90 degrees to respective distal tips, and wherein the pitch angle is measured proximally between the plurality of arms and the cylindrical body. Griswold discloses that it is well known in the art of fixation devices to include a fixation element with a cylindrical body and fixation elements at a pitch angle of 60 degrees up to 90 degrees to respective distal tips, and wherein the pitch angle is measured proximally between the plurality of arms and the cylindrical body (e.g. fixation elements 114 as shown in Figure 2). It would have been obvious to one having ordinary skill in the art to include the fixation elements of Griswold in the device of Foster in order to provide the predictable results of fixation elements capable of firmly gripping the desired implantation location.
Regarding claim 17, Foster additionally discloses where the plurality of arms extend in a first screwing direction such that rotation of the fixation feature in the first screwing direction affixes the fixation feature to a heart (e.g. active fixation members 214 as shown in Figures 2B-2C).
Regarding claim 19, Foster additionally discloses wherein the fixation feature includes a cylindrical body coupled to the housing (e.g. cylindrical body 310), and wherein the plurality of arms extend at a pitch angle from the cylindrical body (e.g. as shown in Figure 2B-2C).
Regarding claim 20, Foster additionally discloses wherein the cylindrical body and the plurality of arms are contained within a tubular profile (flat tubular profile as shown in Figure 4A).
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.
Claims 5-6, 13, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Foster and Griswold in view of Khairkhahan et al. (US 2012/0116489, as previously cited).
Regarding claims 5, 13, and 18, Foster discloses a claimed invention except the express mention of barbs that are formed from a material configured to yield to a predetermined counter torque to cause the fixation feature to disengage from the heart. Khairkhahan discloses that it is well known in the art of leadless biostimulators to include barbs (e.g. barbs 214) that are formed from a material configured to yield to a predetermined counter torque to cause the fixation feature to disengage from the heart (e.g. Figure 2a, torque requirements as discussed in [0053])
Regarding claim 6, Foster and Khairkhahan disclose the claimed invention but does not disclose expressly wherein the predetermined counter torque is greater than 0.5 oz-in. It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the device as taught by Foster and Khairkhahan with the specific torque requirement, because Applicant has not disclosed that such a torque requirement provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the two torque requirements as taught by Foster and Khairkhahan, because it provides a reliable lead fixation device and since it appears to be an arbitrary design consideration which fails to patentably distinguish over the prior art. Therefore, it would have been an obvious matter of design choice to modify Foster and Khairkhahan to obtain the invention as specified in the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amanda K Hulbert whose telephone number is (571)270-1912. The examiner can normally be reached Monday - Friday 9:00-5:00.
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, Unsu Jung can be reached on 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.
/Amanda K Hulbert/Primary Examiner, Art Unit 3792