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 with traverse of Group I in the reply filed on 7/6/2026 is acknowledged. The traversal is on the ground(s) that there is no undue search burden to examine all the groups. This is not found persuasive because this is a unity of invention type restriction, and therefore search burden is not a consideration/factor in unity of invention. Search burden is only a consideration in US-type restrictions. Instead, unity of invention is based on shared/common technical features, which the examiner has properly addressed in the restriction requirement mailed 5/21/26.
The requirement is still deemed proper and is therefore made FINAL.
Claims 7-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/6/2026.
Claim Rejections - 35 USC § 102
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 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2017/0072191 to Ma et al. as evidenced by “What is nylon and what are its material properties?” by Protolabs Network or “20 Properties of Nylon” by Xometry, or in the alternative as obvious over Ma, as evidenced by Protolabs Network or Xometry
[Claim 1] An implantable medical device (Figs. 2B-7, 100, 11 and 13) comprising:
a body portion (102) extending between a distal body end and a proximal body end (Fig. 3B);
a fixation element (66) coupled to the distal body end (112) and extending away from the body portion, wherein the fixation element is configured to affix the body portion to a wall of a heart (Fig. 3A), wherein the fixation element defines a helical shape extending between a distal fixation end and a proximal fixation end along a direction of a helical axis (Figs. 3B, 13), wherein the proximal fixation end is coupled to the distal body end (Fig. 3B),
wherein the fixation element defines a proximal fixation section proximate the proximal fixation end, a distal fixation section proximate the distal fixation end, and a middle fixation section located between the proximal and distal fixation sections, wherein a cross-sectional dimension of the middle fixation section is smaller than a cross-sectional dimension of the proximal fixation section (provided by the “gradually tapering height transition” 254; Par 0084. See annotated Fig. 13 below); and
a flexible connector (continuous cylindrical wall portion 216, Fig. 6 or occlusion 230, Fig. 11) connected between adjacent portions of the fixation element spaced apart along the helical axis, wherein the connector comprises a same material as the fixation element (Pars 0074 and 0081). The examiner takes the position, that when a POSITA considers the Ma reference, as a whole, it is readily/necessarily apparent that the disclosure encompasses a single embodiment, i.e. a single helical winding, having both a tapered/smaller middle fixation portion (as shown in Fig. 13) and a flexible connector (as shown in Figs. 6 and 11). If applicant disagrees; see alternative 103 rejection below.
PNG
media_image1.png
851
1210
media_image1.png
Greyscale
Regarding the claimed “flexible” connector, it is emphasized that rigidity and flexibility are not binary properties, instead there is a spectrum/scale from completely rigid, i.e. non-flexible, to completely flexible, i.e. non-rigid. It is the examiner’s position that the connector of Ma, while disclosed as “rigid”, is at least somewhat flexible based on the disclosed materials. Specifically, the examiner interprets the disclosed rigidity to be rigid relative to the other portions of the helical winding that don’t include this connector, i.e. the connector portion of the helical winding is more rigid than the portion of the helical winding without the connector, and not completely/100% rigid. This is especially true when considering the materials for the helical winding disclosed by Ma, specifically nylon (Par 0064). As made clear by the evidentiary references, nylon is inherently flexible/compressible; “2. Nylon Is Elastic: Nylon demonstrates elastic and viscoelastic behavior, allowing it to partially or fully return toward its original shape after stretching within its elastic limit. The polymer chains possess flexibility that allows reversible deformation under applied stress within the material’s elastic region” (Xometry; see also “Nylon Is Resilient” and the 14 times that “flexibility” is mentioned); “Flexibility and resilience. Nylon is known for its flexibility, allowing it to be formed into various shapes without breaking. It also has a high degree of resilience, enabling it to return to its original shape after being deformed.” (Protolabs Network). Therefore, it is the examiner’s position that the connector portion taught by Ma is at least somewhat flexible, especially when it is made of nylon.
If it is determined that Ma fails to teach a single embodiment, i.e. a single fixation element, having both a tapered/smaller middle section and a flexible connector, as these features are never explicitly shown in the same figure, then such a modification would be obvious. Specifically, it would have been obvious to one of ordinary skill in the art to modify the embodiment of Fig. 13, i.e. a fixation element having a tapered/smaller middle section (as discussed above), to include/add the flexible coupler (as taught by either the continuous cylindrical wall portion 216 of Fig. 6 or the occlusion 230 of Fig. 11) as this coupler can “assist in assembling and securing the tube-cut helical anchor 66 to the body of the device” (Par 0075; Fig. 6) or it “can be used as a stop to prevent collapse of the helical arrangement of the anchor 66… Also, the occlusion 230 creates a functional stop that prevents further rotation/penetration of the tube-cut helical fixation anchor 66 into the tissue without pinching the tissue at that stopping point” (Par 0081; Fig. 11).
[Claims 2, 3 and 6] See annotated Fig. 13 above
[Claim 4] As shown in the annotated Fig. 6 below, the flexible connector (216, Fig. 6 or 230, Fig. 11) inherently define an opening; Specifically, the left and right sides of either flexible connector inherently defines an opening, i.e. the opening between the helical turns.
[Claim 5] As shown in the annotated Fig. 6 below, the flexible connector (216, Fig. 6) has a width defined by the helical pitch. Ma discloses that the helical pitch is between approximately 0.01 inches and approximately 0.1 inches (equivalent to 0.254 mm to 2.54 mm) which overlaps applicant’s claimed range. MPEP 2144.05 states “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.”. Therefore, it would have been obvious to choose/try any of the disclosed values for the helical pitch, i.e. width of the flexible connector, including 0.3 mm to 0.5 mm, as these are known distances/lengths/widths that function effectively in helical windings.
PNG
media_image2.png
743
931
media_image2.png
Greyscale
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lynsey C Eiseman whose telephone number is (571)270-7035. The examiner can normally be reached Monday-Thursday and alternating Fridays 7 to 4 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, David Hamaoui can be reached at 571-270-5625. 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.
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
Prosecution Insights