DETAILED ACTION
This Office Action is in response to Applicant’s amendment filed 18 June 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 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.
Response to Arguments
Kelly’997
In the response filed 18 June 2026, claim 1 was amended to recite “the base is rotatable”. Applicant argues this overcomes the rejection under Kelly’997 because Kelly’997’s base 1 not disclosed as rotatable and does not teach that rotation of the base 1 will release an eyelet of a medical device. This argument is not persuasive. In Applicant’s own invention, the specification discloses the base rotates, but does not disclose what initiates or causes the rotation or that it needs to rotate relative to any other element. Examiner assumes it rotates via rotation of a proximal handle.
In the same way, Kelly’997’s base 1 is capable of being rotated by rotating a proximal end or handle. The claim does not require the base to rotate relative to anything else. The “medical device” is recited functionally and not a positively recited element of the invention. Therefore, the medical device could be specially designed such that rotation of Kelly’s base 1 would enable release of an eyelet of a medical device.
Applicant argues “the eyelet and medical device do not need to be positively recited for the “configured to” language to be given patentable weight” (6-18-2026 response at page 6). Examiner agrees and gave the limitation patentable weight; however, the limitation is very broad because the medical device is not a positively claimed element.
Melsheimer’427
Applicant argues the amendment to claim 1 reciting “the base is rotatable” overcomes Melsheimer’427 because Melsheimer’427 does not disclose base 12 is rotatable and does not teach that rotation of the base 12 will release an eyelet of a medical device. This argument is not persuasive. In In Applicant’s own invention, the specification discloses the base rotates, but does not disclose what initiates or causes the rotation or that it needs to rotate relative to any other element. Examiner assumes it rotates via rotation of a proximal handle.
In the same way, Melsheimer’427’s base 12 is capable of being rotated by rotating a proximal end or handle. The claim does not require the base to rotate relative to anything else. The “medical device” is recited functionally and not a positively recited element of the invention. Therefore, the medical device could be specially designed such that rotation of Melsheimer’427’s base 12 would enable release of an eyelet of a medical device.
Melsheimer’272
Applicant argues the amendment to claim 1 reciting “the base is rotatable” overcomes Melsheimer’272 because Melsheimer’272 does not disclose base 26 is rotatable and does not teach that rotation of the base 22 will release an eyelet of a medical device. This argument is not persuasive. In In Applicant’s own invention, the specification discloses the base rotates, but does not disclose what initiates or causes the rotation or that it needs to rotate relative to any other element. Examiner assumes it rotates via rotation of a proximal handle.
In the same way, Melsheimer’272’s base 22 is capable of being rotated by rotating a proximal end or handle. The claim does not require the base to rotate relative to anything else. The “medical device” is recited functionally and not a positively recited element of the invention. Therefore, the medical device could be specially designed such that rotation of Melsheimer’272’s base 22 would enable release of an eyelet of a medical device.
The rejections were updated to reflect the newly recited claim language, but otherwise maintained.
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 24 and 27 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 pre-AIA the applicant regards as the invention.
Claims 24 and 27 recites the limitation "the eyelet”. There is insufficient antecedent basis for this limitation in the claims.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 –
the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(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.
Claims 1-6 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), the base is rotatable (i.e it can be rotated by hand via rotation of the handle/proximal end of the catheter);
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).
PNG
media_image1.png
74
144
media_image1.png
Greyscale
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: 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), wherein the base is rotatable (i.e it can be rotated by hand via rotation of the handle/proximal end of the catheter);
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).
PNG
media_image2.png
216
344
media_image2.png
Greyscale
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).
PNG
media_image3.png
224
440
media_image3.png
Greyscale
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 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), wherein the base is rotatable (i.e. it can be rotated by hand via rotation of the handle/proximal end of the catheter);
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).
PNG
media_image4.png
454
248
media_image4.png
Greyscale
Claim 4: 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).
Claims 21-24, 26 and 27 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Dwork et al. (US Patent Publication 2012/0022628).
Claim 21: Dwork’628 discloses a medical device delivery system (paragraph [0002]) comprising:
a retainer (120) comprising a base (202) including an outer surface, the base being rotatable (202 rotates about axle 204, as shown in Figures 6, 7 and described in paragraph [0035]); and
a heart valve prosthesis (“stent”, paragraph [0026]) including a frame (“frame”, paragraph [0034]) and a valve body coupled to the frame (paragraph [0024] discloses “a stent may include…a prosthetic heart valve coupled to a frame);
wherein in a delivery configuration a coupling portion (“loops”, paragraph [0034]) of the frame of the heart valve prosthesis is coupled to the retainer (paragraph [0029]), and
wherein rotation of the rotatable base is configured to release the coupling portion of the frame of the heart valve prosthesis from the retainer (paragraph [0035]) .
Dwork’628 does not teach the prosthesis is a heart valve prothesis with a valve body.
Claim 22: Dwork’628 discloses the retainer further comprises a protrusion (222) extending radially outwardly from the base, wherein in the delivery configuration the protrusion retains the coupling portion of the frame of the heart valve prosthesis (paragraph [0034]).
Claim 23: Dwork’628 discloses the protrusion (222) includes a surface (front/distal surface of the protrusion, see annotated copy of Figure 2 below) at an obtuse angle relative to the outer surface of the base (202).
PNG
media_image5.png
246
312
media_image5.png
Greyscale
Claim 24: Dwork’628 discloses a longitudinal end of the protrusion comprises a stepped surface (proximal/back surface of the protrusion; see annotated copy of Figure 3 below) configured to retain the eyelet of the medical device.
PNG
media_image6.png
176
316
media_image6.png
Greyscale
Claim 26: Dwork’628 discloses the base (202) is substantially circular in cross-section (substantially circular when looking at a cross-section as identified below); and
Wherein the surface is a side surface of the protrusion in a circumferential direction of the base (see Figures 2-3).
PNG
media_image7.png
224
256
media_image7.png
Greyscale
Claim 27: Dwork’628 discloses the retainer (202) comprises a plurality of protrusions (222, 224), wherein each of the protrusions includes a surface at an obtuse angle relative to the outer surface of the base (see annotated copy of Figure 2 in the rejection to claim 23 above; protrusion 224 is shaped similarly to 222) and configured to enable release of the eyelet from the protrusion via rotation of the base (paragraph [0035]).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim 25 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Dwork’628, as applied to claim 23, further in view of Melsheimer’272.
Claim 25: Dwork’628 teaches the limitations of claim 25 except the protrusion includes multiple surfaces at an obtuse angle relative to the base.
Like Dwork’628, Melsheimer’272 teaches a device for delivering a self-expanding prosthetic valve with eyelets (paragraph [0003] with eyelets (openings 38 defined by bends 20). Like Dwork’628, Melsheimer’272’s eyelets are fitted over a protrusion (46).
Melsheimer’272 teaches providing the protrusions with multiple surfaces at an obtuse angle relative to an outer surface of the base (44) (Figure 8) in order to allow a smooth release of the prosthesis while still providing sufficient retention of the prosthesis (paragraph [0057]).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the device taught by Dwork’628w with multiple surfaces at an obtuse angle relative to the base, as taught by Melsheimer’272, to allow a smooth release of the prosthesis while still providing sufficient retention of the prosthesis (paragraph [0057]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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.
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, Elizabeth Houston can be reached on 571-272-7134. 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.
Lindsey Bachman
/L.B./Examiner, Art Unit 3771 6 July 2026
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
Prosecution Insights