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 .
Response to Amendment
This office action is in response to the amendment filed on 6/11/2025. Currently claims 191-210 are pending with claims 195, 197, 199-200 and 208-209 withdrawn from consideration due to a previous restriction. Also, please note the set of claims received on 6/11/2025 indicate claims 195 and 197 are pending and claims 208-209 are pending. However, this indication is improper as claims 195 and 197 were withdrawn based on applicant’s election of claim 196 and claims 208-209 were withdrawn based on applicant’s election of claim 207 (see applicant’s response to requirement for restriction where applicant acknowledges these claims being withdrawn) received on 8/26/2024. The claim status of 195,197 and 208-209 listed on the set of claims received on 8/26/2024 appears to be a typo and is being treated as accidental mistake and so the claims as amended have been examined, but applicant should correct the status of these claims in the next set of claim amendments to avoid noncompliance.
Response to Arguments
Applicant’s arguments, see pg. 2, filed 6/11/2025, with respect to the previous rejections of claims 191-194, 196, 198, 201-207 and 210 under 35 USC 112(b) have been fully considered and are persuasive. The previous rejections of claims 191-194, 196, 198, 201-207 and 210 under 35 USC 112(b) has been withdrawn.
Applicant’s arguments, see pg. 2, filed 6/11/2025, with respect to the previous rejections of claims 198 and 201 under 35 USC 101 have been fully considered and are persuasive. The previous rejections of claims 198 and 201 under 35 USC 101 has been withdrawn.
Applicant’s arguments, see pg. 2, filed 6/11/2025, with respect to previous double patenting rejections of 191-194, 196, 198, 201 and 203-204 in view of US pat. 10583234 and US pat. 11331468 have been fully considered and are persuasive. The previous double patenting rejections of claims 191-194, 196, 198, 201 and 203-204 has been withdrawn.
Applicant’s arguments, see pgs. 3-4 filed 6/11/2025, with respect to the rejection(s) of claim(s) 191-194, 196, 198, 201-207 and 210 as being unpatentable under 103 in view of Shahinpoor in view of Kleinke have been fully considered and are persuasive based on applicant’s amendments to the claims. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the same prior art.
Since the same prior art is being used but under a different ground of rejection, applicant’s arguments will be briefly addressed to help advance compact prosecution.
The crux of applicant’s arguments appears to be directed to claim 191 with applicant appearing to argue that the newly added limitation “a respiration movement compensator placed between the first and second parts of the force transferring member, wherein the respiration movement compensator is reversibly compressible for compensating for movement of the heart in relation to the at least one bone caused by respiration of the patient” is not taught by Shahinpoor in view of Kleinke.
As applicant argues:
“Amended claim 191 defines a respiration movement compensator placed between [the] first and second parts of the force transferring member, wherein the respiration movement compensator is reversibly compressible for compensating for movement of the heart in relation to the at least one bone caused by respiration of the patient. Element 16 of Shahinpoor is a spring-loaded collar configured to upon compression of the heart, utilize the potential energy stored in the resilient collar to retract soft compression fingers upon completion of the compression cycle to allow the diastolic expansion of heart to proceed with no obstruction and to completely release heart from the soft compression fingers in case of any breakdown of the heart compression assembly.
However, the spring-loaded collar is not placed between a first and second part of the flexible stem. Instead, the flexible stem 10 is connected at one end to central platform via the spring-loaded collar 16. The spring-loaded collar of Shahinpoor is not configured to compensate for the movement bone and/or heart caused by the respiration of the patient. Since the guide stem 10of Shahinpoor is described as being longitudinally inflexible, and there is therefore no part of this flexible stem 10 that can be compressed due to the movement of the heart caused by the respiration of the patient. The mechanism of actuating the fingers of Shahinpoor is using the flexible stem to pull the central platform 7 to thereby cause the fingers to move. This mechanism would not function if the flexible stem 10 were to be flexible in the longitudinal direction, as a pulling action on the flexible stem would elongate the stem rather than moving the central platform 7. See. e.g. fig 1 in Shahinpoor and paragraphs 0037 and 0038 of Shahinpoor. Kleinke does not cure this deficiency since Kleinke fails to disclose a respiration movement compensator configured to be reversible compressible.
Consequently, it is submitted that claim 191 is non-obvious in view of the cited art. The dependent claims are non-obvious by virtue of the independent claim to which they refer.” [see pgs. 3-4 of applicant’s arguments received on 6/11/2025].
In response, this argument is not persuasive. Applicant appears to be interpreting the claims as requiring the first and second parts to be the flexible stem (element 10 of Shahinpoor) and that the flexible stem (i.e. the first and second parts) itself to be compressible or to experience some form of compensation. However, this is more specific than what is claimed under broadest reasonable interpretation. The claim only requires the respiration movement compensator be placed between the first and second parts of the transferring member, with no specific requirement for the first and second parts to be stems or their structural equivalents. Also, the claim never explicitly states that the first and second parts themselves need to be reversibly compressible or that they are compensated, only that the respiration movement compensator itself is reversibly compressed and that this reversibly compressible is for compensating movement of the heart in relation to the bone with no further specification as to what that compensating movement entails. Thus, applicant’s arguments are not commensurate to the scope of the claims because they include features not currently claimed. And as the claimed limitation is recited by Shahinpoor in view of Kleinke as outlined below, these arguments are not persuasive and the same prior art is being applied. However, it is noted that if applicant has support in their disclosure and can clarify the claims to include the features applicant appears to argue, applicant could potentially overcome the current grounds of rejection amending in this direction.
Claim Objections
Claim 191 is objected to because of the following informalities:
Claim 191 recites the limitation:
“a operation device comprising a motor adapted to create kinetic movement”
This should be changed to:
“an operation device comprising a motor adapted to create kinetic movement”
Appropriate correction is required.
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 193, 203-204 and 206 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 193 recites the limitation "said drive unit" in the limitation “wherein said drive unit is adapted to be placed at least partly in the abdomen”. There is insufficient antecedent basis for this limitation in the claim.
Claim 203 recites the limitation "the drive unit" in the limitation “an energy source adapted to be placed in the abdomen, for powering the drive unit”. There is insufficient antecedent basis for this limitation in the claim.
Claim 204 recites the limitation "the drive unit" in the limitation “wherein the force transferring member comprises at least one connecting arm, for connecting the drive unit to the element for improving the pump function of the heart”. There is insufficient antecedent basis for this limitation in the claim.
Claim 206 recites the limitation "said drive unit" in the limitation “wherein said drive unit comprises an implantable motor”. There is insufficient antecedent basis for this limitation in the claim.
There is no antecedent basis for “drive unit” as it has been changed to “operation device” in claim 191. This raises questions as to what is being claimed here, are limitations referring back to operation device with “drive unit” being a typo or is applicant claiming an additional component of a drive unit. For this examination “drive unit” in these claims is interpreted as referring to the “operation device” recited in claim 191. However, regardless if this is applicant’s interpretation or not, applicant should clarify what is being claimed here.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claim(s) 191-194, 196, 198, 201-207 and 210 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shahinpoor et al (US 6464655) in view of Kleinke et al (US 4583523) hereafter known as Kleinke.
Independent claim:
Regarding claim 191:
Shahinpoor discloses:
An implantable device for improving the pump function of the heart of a patient [see Figs. 1-2 and 7 element 30 and Col. 6 lines 65-67 and Col. 7 lines 1-5… “FIGS. 1 and 2 also show that the preferred heart compression assembly 30 is also equipped with support washers 15(a) and 15(b) to stabilize the laterally flexible but longitudinally inflexible cable guide 10 or the stem to allow free undulation of the stem in the presence of a resilient (spring-loaded) collar 16.”], the implantable device comprising:
a operation device comprising a motor adapted to create kinetic movement [see Figs. 1-2 element 11 and Col. 6 lines 60-65… “The actuation cable 9 is activated by robotic linear actuation mechanism 11 housed inside the abdomen base support assembly 12.”]
a force transferring member configured for transferring the kinetic movement from the operation device to a heart contacting member for improving the pump function of the heart [see Fig. 1-2 elements 14, 6, 7, 9, 10, 8, 9 (i.e. force transferring member as claimed), see Fig. 1-2 elements 3 and 4 (i.e. heart contacting member) and Col. 6 lines 50-65… “The preferred apparatus comprises a central platform 7 and a support column 2 mounted on a base platform 1 to enable soft compression fingers 3 to pivotally move in harmony about hinge 14, such pivoting actions are allowed by finger slot 6, the central platform slot 7(a) and central platform pin 7(b) as well as the pulling action of cable 9 inside a cable guide (the flexible stem) 10 linearly actuating the central platform stem 8 through the support platform cylindrical slot 13. The actuation cable 9 is activated by robotic linear actuation mechanism 11 housed inside the abdomen base support assembly 12.”],
wherein the force transferring member comprises a first part connected to the operation device and second part connected to the heart contacting member [see Fig. 1-2 elements 9,10 (i.e. first part) and Fig. 1-2 elements 7, 14 (i.e. second part)
a respiration movement compensator placed between the first and second parts of the force transferring member, wherein the respiration movement compensator is reversibly compressible for compensating for movement of the heart [see Figs. 1-2 element 16 and Col. 8 lines 50-67 and Col. 9 lines 1-12…. “thus causing the soft compression fingers 4 to close and compress the heart muscle 5 (systole) due to the action of resilient spring loaded collar 16.” And “When solenoid 12 is turned off, resilient spring loaded collar 16 quickly retracts the soft compression fingers 4 away from the heart muscle 5 allowing it to expand freely (diastole).”]
However, Shahinpoor fails to disclose “a fixation device connected to the operation device, wherein the fixation device is adapted to be mounted to at least one bone in the patient’s body to fixate the operation device to human bone” or compensating for the respiratory movement of the heart specifically “in relation to the at least one bone.”
Kleinke discloses in the analogous art of heart assist devices [see abstract… “The implantable heart assist device includes an elongated assembly extending transversely between the ribs of a person from the rib cage to the aorta of the heart to be assisted.”] a known way to attach a heart assist device to the user’s body includes attaching the device to two ribs (i.e. bone(s)) using two base plates and screws (i.e. fixation device) [see Fig. 1-2 elements 39 and 41 (base plates), elements 12 and 14 (ribs) elements 43 and 45 (screws) and Col. 5 lines 5-15… in particular “Considering now the heart assist device in greater detail with particular reference to FIGS. 1 and 2 of the drawings, a pair of upright, spaced-apart mounting or base plates 39 and 41 extend vertically between the ribs 12 and 14 to support the device 10 therefrom. A pair of mounting screws 43 and 45 fasten the upper portion of the plate 39 to the upper rib 12. A pair of similar screws (not shown) fasten the lower portion of the plate 39 to the lower rib 14.”].
Since Shahinpoor is silent as to exactly how the heart assist device is attached to the chest and Kleinke discloses a known way to attach the device is via connecting the device to two ribs using base plates and screws, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Shahinpoor by connecting the entire whole device to the ribs via base plates and screws similarly to Kleinke as this is a known way to secure a heart assist device (i.e. reciting “a fixation device connected to the operation device, wherein the fixation device is adapted to be mounted to at least one bone in the patient’s body to fixate the operation device to human bone”).
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Shahinpoor in view of Kleinke by fixing the base plates and screws (i.e. the fixation device) to ribs above the respiration movement compensator (i.e. thereby reciting capability of compensating movement of the heart specifically “in relation to the at least one bone caused by respiration of the patient.” as claimed) because there are a limited number of places to fix the fixation device to the body (i.e. ribs above the respiration movement compensator, ribs below the respiration movement compensator, and ribs even with the respiration movement compensator) and ribs above the respiration movement compensator are one of those limited number of places.
Dependent claims
Regarding claim 192, see rejection to claim 191 which cites Col. 8 lines 50-67 and Col. 9 lines 1-12 of Shahinpoor…. “thus causing the soft compression fingers 4 to close and compress the heart muscle 5 (systole) due to the action of resilient spring loaded collar 16.” And “When solenoid 12 is turned off, resilient spring loaded collar 16 quickly retracts the soft compression fingers 4 away from the heart muscle 5 allowing it to expand freely (diastole).” Which describes element 16 (i.e. the respiration movement compensator) as being spring loaded (i.e. mechanical construction) as recited by claim 192.
Regarding claims 193-194, see Fig. 7 and Col. 8 lines 28-39 Shahinpoor [see “FIG. 7 depicts the general arrangement of the compression assembly 30 implanted inside a human body 42 such that the base support assembly 12 is housed in the base of the abdomen 44 with flexible stem 10 extending to the soft compression fingers 3 and the compression assembly in the chest 46.”] which shows a configuration where the operation device (i.e. element 11) is in the abdomen and the force transferring member are at least capable to travel from the abdomen to the thorax as claimed.
Regarding claim 196, see rejection to claim 191 which discloses how Shahinpoor in view of Kleinke has the fixation device connected to two ribs (i.e. fixation device is adapted to be mounted to at least one rib) which recites claim 196.
Regarding claim 198: see Figs. 1-2 element 16 and Col. 8 lines 50-67 and Col. 9 lines 1-12 of Shahinpoor [see… “thus causing the soft compression fingers 4 to close and compress the heart muscle 5 (systole)”] which show and describe elements 3-4 (i.e. heart contacting member) that at the very least is capable to exert a force as claimed]
Regarding claim 201, Shahinpoor in view of Kleinke discloses the heart contacting member (i.e. Fig. 1-2 elements 3-4 of Shahinpoor) as being attached to hinges (elements 14 of Shahinpoor) [see Figs. 1-2 and Col. 6 lines 54-65… “The preferred apparatus comprises a central platform 7 and a support column 2 mounted on a base platform 1 to enable soft compression fingers 3 to pivotally move in harmony about hinge 14, such pivoting actions are allowed by finger slot 6, the central platform slot 7(a) and central platform pin 7(b) as well as the pulling action of cable 9 inside a cable guide (the flexible stem) 10 linearly actuating the central platform stem 8 through the support platform cylindrical slot 13.”] to allow pivoting move which makes the heart contacting organ be capable of changing areas on the heart through which force is exerted and thereby reciting the heart contacting organ is configured to change from exerting force to a first area of the heart to exerting force to a second area of the heart, after said implantable device has been implanted in said human patient.
Regarding claim 202,
Shahinpoor in view of Kleinke discloses the invention substantially as claimed including all the limitations of claim 191 as outlined above. Also, Shahinpoor in view of Kleinke discloses a rechargeable battery in the abdomen (i.e. an energy receiver adapted to be placed in the abdomen) being recharged transcutaneously (i.e. outside the skin) [see Fig. 7 and Col. 7 lines 20-32 of Shahinpoor… “Base support assembly 12 houses a power source for the device, such as at least one long lasting battery 12(a), which can be transcutaneously recharged from outside the patient's body (not shown). Within the base support assembly 12 is control circuitry 12(b) which preferably includes a microprocessor for the robotic actuations of the linear actuator 11,”].
However, Shahinpoor in view of Kleinke is silent as to whether this charging is wireless or not. Thus, Shahinpoor in view of Kleinke fails to fully disclose “an energy receiver adapted to be placed in the abdomen, for receiving wirelessly transmitted energy”.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Shahinpoor in view of Kleinke by transcutaneously recharging wirelessly (i.e. thereby fully reciting “an energy receiver adapted to be placed in the abdomen, for receiving wirelessly transmitted energy”) because there are a limited number of ways to transcutaneously recharge (i.e. with wires or wirelessly) and wirelessly is one of those limited number of ways.
Regarding claim 203, see Figs. 2 and 7 and Col. 7 lines 20-32 of Shahinpoor [see… “Base support assembly 12 houses a power source for the device, such as at least one long lasting battery 12(a), which can be transcutaneously recharged from outside the patient's body (not shown). Within the base support assembly 12 is control circuitry 12(b) which preferably includes a microprocessor for the robotic actuations of the linear actuator 11,”] which discloses a rechargeable battery in the abdomen which is an energy source as claimed.
Regarding claims 204-205, see Figs. 1-2 element 10 (i.e. part of the force transferring member as claimed) and Col. 6 lines 50-65 of Shahinpoor [see… “The preferred apparatus comprises a central platform 7 and a support column 2 mounted on a base platform 1 to enable soft compression fingers 3 to pivotally move in harmony about hinge 14, such pivoting actions are allowed by finger slot 6, the central platform slot 7(a) and central platform pin 7(b) as well as the pulling action of cable 9 inside a cable guide (the flexible stem) 10 linearly actuating the central platform stem 8 through the support platform cylindrical slot 13. The actuation cable 9 is activated by robotic linear actuation mechanism 11 housed inside the abdomen base support assembly 12.”] which describes a flexible stem which is at least a connecting arm as recited in claim 204 and as it is flexible while the fixating member is mounted to a bone, this arm is displaceable in relation to displace the element for improving the pump function as recited in claim 205.
Regarding claims 206-207: see Col. 4 lines 50-55 [see “linear motors or robotic actuators as well as robotic metal hydride actuators and polymeric artificial muscles can also be used.”] which describe linear motors (a type of electric motor) being used. Thus, the linear actuation mechanism (i.e. the operation device) is understood to include electric motors as recited by claims 206-207.
Regarding claim 210:
Shahinpoor in view of Kleinke discloses the invention substantially as claimed including all the limitations of claim 191 and receiver(s) that non-invasively receive control signals outside the body to control the implantable device [see of Col. 4 lines 44-65 of Shahinpoor… “The power supply for the implanted apparatus can be long lasting batteries that can be recharged transcutaneously, and various other components of the apparatus can be noninvasively computer-programmed and interrogated by external circuits.”]
However, Shahinpoor in view of Kleinke is silent as to whether this control signal is provided wirelessly and thus Shahinpoor in view of Kleinke fails to fully disclose “a receiver for wirelessly receiving control signals transmitted from outside the body of the patient, such that the implantable device can be non-invasively controlled”
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Shahinpoor in view of Kleinke by transcutaneously communicate wirelessly because there are a limited number of ways to transcutaneously communicate (i.e. with wires or wirelessly) and wirelessly is one of those limited number of ways.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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SEBASTIAN X LUKJAN
/SXL/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792