DETAILED ACTION
This Office Action is in response to the restriction response filed 2 January 2026.
Notice of Pre-AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Election/Restrictions
Applicant’s election without traverse of Group 1, Claims 1-15 in the reply filed on 2 January 2026 is acknowledged.
Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2 January 2026.
Claim Objections
Applicant is advised that should claim 4 be found allowable, claim 11 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
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 7-10, 12-15 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification fails to teach how to make and use the claimed invention without undue experimentation. Specifically, claim 7 recites:
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In order to determine compliance with the enablement requirement of 35 U.S.C. 112(a), the Federal Circuit developed a framework of factors in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), referred to as the Wands factors to assess whether any necessary experimentation required by the specification is "reasonable" or is "undue." These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The claim is analyzed below with respect to some of the Wands factors to show the experimentation required by make and use the claimed invention is undue.
(A) The breadth of the claims – The claims are directed towards a system for delivering a medical device including a retainer having a protrusion and a catheter having a lumen, such that the retainer is disposed within the lumen of the catheter. The catheter has an inner surface with an inwardly extending protrusion. The catheter protrusion and retainer protrusion are configured to engage to bump the medical device off the retainer.
(B) The nature of the invention – The claims are directed towards a delivery system for a medical device, such as a stent or heart valve. Specifically, the delivery system is disclosed as being configured for engaging with an eyelet of the medical device such that the eyelet is disposed around a retainer protrusion 124, shown in Figures 7a-7c. The specification discloses the retainer rotates relative to the medical device such that the eyelet of the medical device slides from the surface of the retainer 120 up the angled surface 132 so that the eyelet is no longer disposed around the retainer protrusion 124.
(C) State of the prior art – Delivery devices for medical implants, such as stents and valves, are well established in the art. These devices typically are designed for use in minimally invasive surgery such that the implant passes through the distal end of a catheter at a target location within the vasculature.
(D) The level of one of ordinary skill – A biomedical engineer or medical professional with sufficient skill and experience working with stents and valves or other implants delivered via a catheter advanced through blood vessels.
(F) The amount of direction provided by the inventor – The specification does not describe or show how the inwardly extending shaft protrusion in the catheter lumen engages with the outwardly extending retainer protrusion to bump the medical device off the retainer. Figures 7a and 7b show the retainer protrusion 124. However, it is unclear how this retainer protrusion engages with the catheter shaft protrusion 138 in Figure 7c to bump the medical device 122 off the retainer. The catheter shaft protrusion 138 must either:
(1) have a large enough height that it will intersect and be blocked from rotating past the retainer protrusion; or
(2) have a height such that it will extend to the exact height of the retainer protrusion; or
(3) have a smaller height such that it will not intersect with the retainer protrusion at all when the catheter shaft and retainer rotate relative to each other.
In scenario (1), it is unclear how the catheter shaft protrusion will allow the medical device to move off the retainer protrusion because the catheter shaft protrusion will block the medical device eyelet from passing over the retainer protrusion because it is in contact with a side wall of the retainer protrusion. The retainer protrusion will be unable to rotate past the catheter shaft protrusion because the two protrusions will intersect and block additional relative rotation between the retainer and the catheter.
In scenario (2), it is unclear how the catheter shaft protrusion and retainer protrusion will engage to bump the medical device to move off the retainer because there will be no clearance between the catheter shaft protrusion and retainer protrusion to allow the medical device to move over the top of the retainer protrusion, as needed to bump the medical device off the retainer protrusion. If the catheter shaft protrusion and retainer protrusion extend such that there is an exact clearance between them, it is unclear how they will engage to bump the medical device off the retainer protrusion.
In scenario (3), it is unclear that the catheter shaft protrusion and retainer protrusion will engage or intersect at all. Therefore, there is no engagement between the catheter shaft protrusion and retainer protrusion to bump the medical device off the retainer protrusion.
In Figure 7c, the retainer and the catheter shaft are not coaxially aligned. However, the claims recite the retainer is disposed within the catheter lumen. The specification and drawings do not explain how this works.
(G) The existence of working examples – The specification does not provide any drawings or description of how the catheter shaft protrusion and retainer protrusion engage to bump the medical device. It would not be obvious to one of ordinary skill in the art to understand how catheter shaft protrusion and retainer protrusion engage to bump the medical device off the retainer because, as described in section (F) above, in none of the three possible protrusion height scenarios is it physically possible for the catheter shaft protrusion and retainer protrusion to engage to bump the medical device off the retainer.
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure – The amount of experimentation to make and use the claimed invention is undue because the claimed invention appears to be physically impossible to build based on the provided disclosure. The specification does not provide additional description that would allow the device to function as disclosed. For example, is one or both of the protrusions soft or yieldable such that they change shape upon contact with a solid object?
For these reasons, claim 7 is not enabled by the specification.
Claims 8-10, 12-15 are rejected based on their dependency from claim 7.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claims 1-6 and 11 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Kelly et al. (US Patent Publication 2011/0152997).
Claim 1: Kelly’997 discloses a retainer comprising:
a base (1) including an outer surface (Figures 3, 4, 13, 14);
a protrusion (10; Figure 15e) extending radially outwardly from the base (Figure 13 and 15 show this),
the protrusion configured to retain an eyelet of a medical device (Figure 19, 20, for example, however the medical device and eyelet are not positively recited elements of the claim), wherein the protrusion includes a surface at an obtuse angle relative to the outer surface of the base (side of protrusion 10 is obtuse relative to base 1; see annotated copy of Figure 15e below)) and configured to enable release of the eyelet from the protrusion via rotation of the base (the medical device is not claimed; a medical device could have eyelets shaped and designed such that they are released upon rotation of the base).
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Claim 2: Kelly’997 discloses the surface (see annotated copy of Figure 15e above) is a side surface of the protrusion in a rotational direction of the base (Figure 15e).
Claim 4, 11: Kelly’997 discloses the protrusion (10) includes multiple surfaces at an obtuse angle relative to the outer surface of the base (other side of the protrusion 10 in Figure 15e).
Claim 5: Kelly’997 discloses the base (1) is substantially circularly in cross-section (Figure 14), and wherein the surface is a side surface of the protrusion in a circumferential direction of the base (see annotate copy of Figure 15e in Figure 1 above).
Claim 6: Kelly’997 discloses the retainer comprises a plurality of protrusions (Figure 13), wherein each of the protrusions includes a surface at an obtuse angle relative to the outer surface of the base (Figure 15e) and configured to enable release of the eyelet from the protrusion via rotation of the base (the medical device is not claimed; a medical device could have eyelets shaped and designed such that they are released upon rotation of the base).
Claims 1, 3 and 6 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Melsheimer (US Patent Publication 2009/0171427).
Claim 1: Melsheimer’427 discloses a retainer comprising:
a base (12) including an outer surface (Figure 11);
a protrusion (26; Figure 11) extending radially outwardly from the base (Figure 11),
the protrusion configured to retain an eyelet of a medical device (the medical device and eyelet are not positively recited elements of the claim; the protrusion is capable of retaining an eyelet because it has a size and shape which could fit within an eyelet), wherein the protrusion includes a surface at an obtuse angle relative to the outer surface of the base (see annotated & truncated copy of Figure 11 below) and configured to enable release of the eyelet from the protrusion via rotation of the base (the medical device is not claimed; a medical device could have eyelets shaped and designed such that they are released upon rotation of the base).
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Claim 3: Melsheimer’427 discloses a longitudinal end of the protrusion (26; Figure 11) has a stepped surface configured to retain the eyelet of the medical device (see the annotated copy of Figure 11 below).
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Claim 6: Melsheimer’427 discloses the retainer (12) comprises a plurality of protrusions (Figure 11), wherein each of the protrusions includes a surface at an obtuse angle relative to the outer surface of the base (Figure 11) and configured to enable release of the eyelet from the protrusion via rotation of the base (the medical device is not claimed; a medical device could have eyelets shaped and designed such that they are released upon rotation of the base).
Claims 1, 4, 6 and 11 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Melsheimer (US Patent Publication 2012/0150272).
Claim 1: Melsheimer’272 discloses a retainer comprising:
a base (22) including an outer surface (Figure 2);
a protrusion (46) extending radially outwardly from the base (Figure 8 shows a different embodiment of the restraint member 26 shown in Figure 2),
the protrusion configured to retain an eyelet of a medical device (Figure 2, for example, however the medical device and eyelet are not positively recited elements of the claim), wherein the protrusion includes a surface at an obtuse angle relative to the outer surface of the base (side of the pyramid shaped protrusion 46 is obtuse relative to base 22; see annotated copy of Figure 8 below)) and configured to enable release of the eyelet from the protrusion via rotation of the base (the medical device is not claimed; a medical device could have eyelets shaped and designed such that they are released upon rotation of the base).
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Claim 4, 11: Melsheimer’272 discloses the protrusion (46) includes multiple surfaces at an obtuse angle relative to the outer surface of the base (other sides of the pyramid 46).
Claim 6: Melsheimer’272 discloses the retainer comprises a plurality of protrusions (Figure 8), wherein each of the protrusions includes a surface at an obtuse angle relative to the outer surface of the base (Figure 8) and configured to enable release of the eyelet from the protrusion via rotation of the base (the medical device is not claimed; a medical device could have eyelets shaped and designed such that they are released upon rotation of the base).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSEY BACHMAN whose telephone number is (571)272-6208. The examiner can normally be reached Monday-Friday 9am-5pm and alternating Fridays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Lindsey Bachman
/L.B./Examiner, Art Unit 3771 13 March 2026
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771