DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/12/2025 has been entered.
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 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.
Claim(s) 1-19 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Criscione et al. (US Pub 2008/0021260).
With respect to claim 1, Criscione discloses a direct cardiac compression device (paragraph 108 see fig 6A-B and 11 below) for individualized support at different locations around the heart (paragraph 36), the device comprising: a housing (fig 6, 76) shaped to conform to the shape of the heart and to surround the heart (paragraph 126 “form a shape that is similar to the end diastolic shape of the heart”); two or more active chambers (fig 6, 52-74) positioned adjacent to the housing, wherein the two or more active comprise one or more right active chambers (figs 6B and 11 68-74, paragraph 120, four right ventricle chambers) positioned on the right ventricle side of the heart and one or more left active chambers positioned on the left ventricle side of the heart (figs 6B and 11 52-66, paragraph 120, eight left ventricle chambers), wherein the two or more active chambers are designed to conform to the shape of the heart (fig 11), each active chamber comprising an inner membrane sealingly (paragraph 27, two layers of material sealed and connected at a plurality of locations) attached along its periphery to the housing and an active fluid individually supplied thereto (fig 12 shows the two separate supplied areas and paragraph 28 discusses supplying the chambers separately); a right input connection (paragraphs 28 and 36, disclose separate fluid connections for each set of chambers) in fluid communication with the one or more right active chambers to ingress the active fluid into each of the one or more right active chambers; a left input connection (paragraphs 28 and 36, disclose separate fluid connections for each set of chambers) in fluid communication with the one or more left active chambers to ingress the active fluid into each of the one or more left active chambers, and a driver (paragraph 165 device driver) in fluid communication with both (paragraph 165 states that there is one driver. Paragraph 28 states there are multiple drive lines not multiple drivers) the right input connection and the left input connection to individually and periodically ingress and egress the active fluid therefrom, wherein the active fluid individually inflates the one or more right active chambers and the one or more left active chambers to compress the heart (paragraph 36, individually modulate the volume). With respect to claim 2, Criscione discloses wherein the driver is configured to ingress the active fluid into all active chambers during heart systole (paragraph 165 and paragraph 21). With respect to claim 3, Criscione discloses wherein the periodically ingress and egress of the active fluid within a single cardiac cycle is detected by an ECG signal (paragraph 165). With respect to claim 4, Criscione discloses wherein the housing is collapsible to allow minimally invasive insertion (fig 10 shows a minimally invasive insertion). With respect to claim 5, Criscione discloses wherein the device conforms to and is sized approximating an end-diastolic shape of the heart (paragraph 41, diastolic configuration). With respect to claim 6, Criscione discloses wherein the active fluid is supplied to the two or more active chambers at different pressures to provide individual support at different locations around the heart (fig 11 and paragraphs 28, 36 and 127). With respect to claim 7, Criscione discloses wherein the one or more right active chambers comprise 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 right active chambers positioned about the right ventricle side of the heart and the one or more left active chambers comprise 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 left active chambers positioned about the left ventricle side of the heart (Fig 6 shows 4 right chambers and 8 left chambers and paragraph 77 discloses the chambers can be 1-12 right chambers and 1-24 left chambers). With respect to claim 8, Criscione discloses wherein the one or more right active chambers and the one or more left active chambers are designed to individually ingress the active fluid into each of the one or more right active chambers and the one or more left active chambers independently (Paragraphs 36 and 127). With respect to claim 9, Criscione discloses wherein the one or more right active chambers comprise 1 right active chamber positioned on the right ventricle side of the heart and the one or more left active chambers comprise 2 left active chambers positioned on the left ventricle side of the heart (paragraph 77). With respect to claim 10, Criscione discloses wherein the one or more right active chambers comprise 2 right active chamber positioned on the right ventricle side of the heart and the one or more left active chambers comprise 2 left active chambers positioned on the left ventricle side of the heart (paragraph 77). With respect to claim 11, Criscione discloses wherein the one or more right active chambers comprise 1 right active chamber positioned on the right ventricle side of the heart and the one or more left active chambers comprise 3 left active chambers positioned on the left ventricle side of the heart (paragraph 77). With respect to claim 12, Criscione discloses wherein the one or more right active chambers comprise 2 right active chamber positioned on the right ventricle side of the heart and the one or more left active chambers comprise 3 left active chambers positioned on the left ventricle side of the heart (paragraph 77). With respect to claim 13, Criscione discloses wherein the device does not cause inversion of the natural curvature of the heart upon inflation of the active chambers (paragraph 25, non-inversion). With respect to claim 14, Criscione discloses further comprising at least one sensor (paragraph 174) in contact with the heart. With respect to claim 15, Criscione discloses wherein the at least one sensor comprises a right sensor on the right ventricle side of the heart and a left sensor on the left ventricle side of the heart (paragraph 174 and fig 10, ECG readings on both sides). With respect to claim 16, Criscione discloses wherein the sensor is an ECG sensor, an electrical sensor, or a sensor to detect the electrical activity of the heart in contact with the heart (paragraph 174 and paragraph 126, sensing ECG). With respect to claim 17, Criscione discloses further comprising a sensor in electrical communication with the heart (paragraph 174). With respect to claim 18, Criscione discloses wherein the direct cardiac compression device forms an intrinsic pneumatic attachment with the heart (paragraph 31 intrinsically contained). With respect to claim 19, Criscione discloses further comprising a first supply line connected to the one or more right active chambers and a second supply line connected to the one or more left active chambers (paragraph 28, individual drive lines for the right and left ventricles).
PNG
media_image1.png
790
713
media_image1.png
Greyscale
Response to Arguments
Applicant's arguments filed 6/12/2025 have been fully considered but they are not persuasive. The applicant argues that Criscione does not disclose individualized support at different locations of the heart stating it teaches a method of individually modulating the end diastolic heart volume and end systolic heart volume. The examiner respectfully disagrees. In response to applicant's argument that individualized support at different locations of the heart, 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. This the intended use of the claims and Criscione is capable of this intended use as it teaches a structure with different chambers that can be individually inflated at different times by drives, as disclosed in paragraph 28. Criscione does also disclose supporting the heart, paragraph 19 discloses the implanted device is contoured to support the heart and paragraph 74 states that the device inflates to support the heart.
The applicant argues that Criscione does not disclose an internal resilient layer. The examiner respectfully disagrees. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a resilient inner layer are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Additionally Criscione does disclose a resilient inner layer. The abstract discloses a resilient inner panel.
The applicant argues that Criscione does not disclose a single driver that that drives the left and right input lines. The examiner respectfully disagrees. Paragraph 165 discloses a single driver is used to drive the lines . Paragraph 170 additionally claims “a” device to inflate the bladders.
The applicant argues that Criscione does not disclose apply different pressures to the left and right sides. The examiner respectfully disagrees. Paragraph 127 states the right side has lower pressure. Additionally paragraph 28 discloses left and right sides can be inflated individually which would functionally lead to different pressures.
The rejection is deemed proper.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN J COTRONEO whose telephone number is (571)270-7388. The examiner can normally be reached Monday-Friday 9am-5pm 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, Eduardo Robert can be reached at (571) 272-4719. 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.
/S.J.C/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773