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 1 (claims 1 and 3-13), species 1k (the device includes an active chamber layer with eight active chambers which each connect to an anchoring tab that connects to a passive layer, so the chambers fold and collapse, but there is also a frame positioned over active chambers, and a containment layer positioned over the frame – figure 17), 2a (the pockets are arranged diagonally – figure 6), 3d (the wireframe is positioned outside the external cone), and 4b (the fiber reinforcement layer can be positioned inside the wireframe next to the active chamber) in the reply filed on 01/20/26 is acknowledged. The traversal is on the ground(s) that the species are all structurally and functionally overlapping, share the same core inventive concept, are variations of a single invention, and would not require materially different prior art searches. This is not found persuasive because the invention is restricted based on 371 rules, which indicates that restriction is proper if the inventions/species share a technical feature but it is not special, since it is known in the art as the Examiner demonstrated in the Election/Restriction mailed 07/17/25.
The requirement is still deemed proper and is therefore made FINAL.
Claim 2 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 01/20/26.
Claim Objections
Claims 1, 3, 6, 8-9, 11, 13 are objected to because of the following informalities:
Claim 1 is objected to for claiming “a plurality passive chambers” and “a plurality inflatable active pockets” when it appears a word (e.g. “of”) might be missing from both phrases.
“the a plurality inflatable active pockets is” and “the a plurality passive chambers” which are grammatically incorrect and also appear to have improper antecedent basis.
The claim is further objected to for claiming “the each of the a plurality inflatable active pockets does”, and “the adjacent a plurality inflatable active pockets”, which are also grammatically incorrect and appears to have improper antecedent basis.
The claim is further objected to for claiming “the one or more active pockets”. For the purposes of examination this will be understood to be referring to “the plurality inflatable active pockets”.
Claim 3 is objected to for referring to the plurality of “passive pocket” when it is believed this should reference passive chambers.
Claim 6 is objected to for having improper antecedent basis for “the support structure”.
Claim 11 is objected to for referring to “the one or more ports” with improper antecedent basis.
Claim 13 is objected to for referring to for referring to “the one or more passive chambers” and “the one or more inflatable active pockets” when there is improper antecedent basis for these in the claims.
Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the fibers intercalated in the frame, the aperture, the apex, the ports, there being more than one passive chamber, which taper from an aperture to an apex, the active pocket(s) being connected to the passive chamber(s) at least partially from the aperture to the apex, and the “second support structure” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Figures 1-2 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to because:
-items 55a, are present in the drawings, but not the specification.
-the specification refers to figure 6 showing “points 62 represent a chamber weld line” but figure 6 does not show an item 62.
-item “78” is used to represent “fiber reinforcement layer”, “mesh”, and “containment layer” in the specification .
-item “82” is used to represent both “electrodes” and “active chambers” in the specification.
-the specification page 13 describes figure 7 states that mesh 78 can expand fully or partially from the hub 40 to the top of the device, but figure 7 does not show a hub 40.
-item “76” is used to represent both “passive layer” and “wireframe” (and “wire frame”) in the specification
-item “80” is used to represent “hub”, “external portion of the containment layer”, and “active anchoring tab”.
-item “70” is used to represent “containment layer”, “frame”, and “passive layer”.
-the specification page 15 states that figure 11 shows the frame 70 in contact with the first securement cone 72a but figure 11 does not show a cone 72a.
-the figures appear to reference item 72, as well as items 72a-b. The specification defines “72” as the “internal portion”, but 72a-b as “first and second securement cone”. It is unclear if the figures, in pointing to 72, are referring to the structure that is meant, or not.
-specification pages 15-16 states that figures 12-13 and 16 shows item 82, but there is no item 82 in this figure, and the figure does not appear to show any chambers (which the specification described as item 82) at all
-item “82” is in the specification but not the drawings
-the specification page 16 states that figure 17 shows the device 10 (but item 10 is not in figure 17), with the containment layer (which has no numeral and is not apparently in figure 17), positioned over the frame 70 (item 70 is likewise not in figure 17).
-the specification page 16 states figures 18-20 have a frame 70, but there are no numerals in the figures.
-the specification page 16 states that figures 19-20 have “supports” connecting the frame 70 but there aren’t any “supports” labeled in the figures.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 9 and 13 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.
Claim 9 is indefinite for referring to the active pockets including 3-15 active pockets, but “preferably” 5-10, and “more preferably” 7-9 active pockets when it is unclear whether the claim actually requires there to be 7-9 active pockets or not.
The claim is further indefinite for referring to “the plurality of inflatable active pockets” multiple times, when the claim from which this depends actually describes the pockets as being “individually independently inflatable” pockets. It is unclear if this is simply a mistake in recalling proper antecedent basis, or whether the claim is now claiming that the pockets just be “individual” and inflatable, in addition to being “individually independently inflatable”.
Claim 13 is indefinite for claiming there is a “second support structure” positioned between the passive chamber(s) and the active pocket(s). Notably, while the specification generally refers to such a structure, there isn’t any detailed description or depiction of what this second structure might be or entail, or how it could be positioned between one pocket and one chamber, let alone multiple pockets and one chamber, multiple chamber and one pocket, and multiple chambers and multiple pockets. The Examiner notes that the scope of the claim appears to cover all possibilities, although the description and figures do not appear to address or account for all these possibilities. For all the above reasons, it is unclear whether this is new matter, not enabled, or simply describing something in the specification which is enabled/supported but not clear, since the terminology is different and the figures do not show it.
Remaining claims are rejected for depending on a rejected claim.
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 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 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 6-7, 9, 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Criscione et al. (US 20130102849 A1) hereinafter known as Criscione in view of Criscione et al. (US 20170368246 A1) hereinafter known as Criscione ‘246.
Regarding claim 1 Criscione discloses a direct cardiac compression device (Abstract) comprising:
a plurality of passive chambers ([0044]-[0045] inner passive component includes six fluid chambers) that taper from an aperture to an apex (Figure 2b shows the chamber(s) that extend from an open top aperture to a bottom apex; see also [0055] the chambers are tapered);
a plurality of inflatable active pockets ([0044]-[0045] outer active layer containing six fluid chambers; inflatable with air), wherein each of the active pockets is connected to the passive chamber(s) at least partially from the aperture to the apex (see figure 2b which shows the inner passive component and outer active component connected at least partially through the nitinol scaffold lying therebetween. This is considered to be an inherent connection or the device would be simply layers which fall apart when in use.), and wherein the active pockets does not tension an adjacent pocket upon inflation (this would appear to depend on the method of inflation and how inflated the active pockets get. There is at least a small margin when inflation of the active pockets is occurring where there is not enough fluid in the chambers to tension adjacent pockets), and
a frame (Figure 2b the nitinol scaffold) in contact with the active pocket(s) to at least partially surround the pockets (Figure 2b; the frame is seen partially enclose the active pocket on the inner side),
but is silent with regards to the active pockets being configured to be individually inflated.
However, regarding claim 1 Criscione ‘246 teaches that a direct cardiac compression device (Abstract) can have active pockets which are configured to be individually inflatable ([0034]). Criscione and Criscione ‘246 are involved in the same field of endeavor, namely direct cardiac compression devices. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of Criscione so that the bladders are individually inflatable as is taught by Criscione ‘246 in order to allow the device precise control over which areas of the heart can receive compression, thus allowing patient-specific cardiac support.
Regarding claim 6 the Criscione Criscione ‘246 Combination teaches the device of claim 1 substantially as is claimed,
wherein Criscione further discloses each of the active pockets are connected to the support structure at the aperture, or at both the aperture and apex (Figure 2b shows the active pockets connected to the support structure along their length.). Alternatively, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of the Criscione Criscione ‘246 Combination so the pockets are connected to the support structure along the length of the contact of the pockets and support sturcture in order to ensure the device does not laminate when in use.
Regarding claim 7 the Criscione Criscione ‘246 Combination teaches the device of claim 1 substantially as is claimed,
wherein Criscione further discloses each of the active pockets at least partially overlap (see at least Figures 2a-3 which shows the three-dimensional composition of the device as a whole. When viewed from the perspective shown by the these figures, the active pockets overlap.).
Regarding claim 9 the Criscione Criscione ‘246 Combination teaches the device of claim 1 substantially as is claimed,
wherein Criscione further discloses there are 3-15 active pockets ([0044]).
Regarding claim 11 the Criscione Criscione ‘246 Combination teaches the device of claim 1 substantially as is claimed,
wherein Criscione further discloses a hub positioned at the apex (Figure 3 shows a hub (“central part of a circular object” – Merriam-Webster) at the apex of the device) which is in operable communication with ports ([0075] the compartments are operably connected to ports; and Figure 3 shows the compartments likewise operably connected to the hub).
Regarding claim 12 the Criscione Criscione ‘246 Combination teaches the device of claim 11 substantially as is claimed,
wherein Criscione further discloses the frame comprises a wire, polymer, shape memory material, metal, alloy, composite, or a combination (Figure 2b the scaffold is Nitinol (a shape memory material)).
Claims 3-5 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Criscione and Criscione ‘246 as is applied above, further in view of Anstadt et al. (US 20040267086 A1) hereinafter known as Anstadt.
Regarding claim 3 the Criscione Criscione ‘246 Combination teaches the device of claim 1 substantially as is claimed,
but is silent with regards to each of the active pockets being connected to the passive pockets by an anchoring tab.
However, regarding claim 3 Anstadt teaches a cardiac compression device which includes anchoring tabs (Figure 4a, at items 570, 520) that connect two parts of the device to one another. Criscione and Anstadt are involved in the same field of endeavor, namely cardiac compression devices. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of the Criscione Criscione ‘246 Combination so that the active and passive pockets are connected to one another via anchoring tabs as is taught by Anstadt since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the use of any known connection or anchoring mechanism would have been obvious to try in order to eliminate stresses between the pockets that might otherwise result.
Regarding claim 4 the Criscione Criscione ‘246 Anstadt Combination teaches discloses the device of claim 3 substantially as is claimed,
wherein Anstadt further teaches the anchoring tabs extends at least partially from an aperture to an apex (this is considered to be inherent since the tabs are three-dimensional objections).
Regarding claim 5 the Criscione Criscione ‘246 Combination teaches the device of claim 1 substantially as is claimed,
but is silent with regard to there being a containment layer at least partially disposed around the device.
However, regarding claim 5 Anstadt teaches a direct cardiac compression device which includes a containment layer at least partially disposed around the device (Figure 4a item 112). Criscione and Anstadt are involved in the same field of endeavor, namely direct cardiac compression devices. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of the Criscione Criscione ‘246 Combination so that there is a containment layer as is taught by Anstadt in order to ensure the outer wall does not over-extend in a radially outward direction thus acting to help prevent dilation of the heart.
Regarding claim 13 Criscione discloses a direct cardiac compression device (Abstract) comprising:
a plurality of passive chambers ([0044]-[0045] inner passive component includes six fluid chambers) that taper from an aperture to an apex (Figure 2b shows the chamber(s) that extend from an open top aperture to a bottom apex; see also [0055] the chambers are tapered);
a plurality of inflatable active pockets ([0044]-[0045] outer active layer containing six fluid chambers; inflatable with air), wherein each of the active pockets is connected to the passive chamber(s) at least partially from the aperture to the apex (see figure 2b which shows the inner passive component and outer active component connected at least partially through the nitinol scaffold lying therebetween), and wherein the active pockets does not tension an adjacent pocket upon inflation (this would appear to depend on the method of inflation and how inflated the active pockets get. There is at least a small margin when inflation of the active pockets is occurring where there is not enough fluid in the chambers to tension adjacent pockets), and
a second support structure positioned between the passive chambers and active pockets (claim 13) (Figure 2b the nitinol scaffold),
but is silent with regards to the active pockets being configured to be individually inflated,
and there being a frame in contact with the active pockets to at least partially surround the pockets.
However, regarding claim 13 Criscione ‘246 teaches that a direct cardiac compression device (Abstract) can have active pockets which are configured to be individually inflatable ([0034]). Criscione and Criscione ‘246 are involved in the same field of endeavor, namely direct cardiac compression devices. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of Criscione so that the bladders are individually inflatable as is taught by Criscione ‘246 in order to allow the device precise control over which areas of the heart can receive compression, thus allowing patient-specific cardiac support.
Further, regarding claim 13 Anstadt teaches a frame (Figure 4a item 112 semi-rigid shell) in contact with inner pockets to at least partially surround them (Figure 4a). Criscione and Anstadt are involved in the same field of endeavor, namely direct cardiac compression devices. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of the Criscione Criscione ‘246 Combination so that there is a frame in contact with the active pockets as is taught by Anstadt in order to ensure the outer wall does not over-extend in a radially outward direction thus acting to help prevent dilation of the heart.
Claim 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Criscione and Criscione ‘246 as is applied above, further in view of Criscione et al. (US 20080021260 A1) hereinafter known as Criscione ‘260.
Regarding claim 8 the Criscione Criscione ‘246 Combination teaches the device of claim 1 substantially as is claimed,
but is silent with regards to the active pockets being connected with a spot weld, seam weld, weld line, or a combination thereof.
However, regarding claim 8 Criscione ‘260 teaches that pockets within a direct cardiac compression device can be connected via a spot/seam/weld line ([0132]). Criscione and Criscione ‘260 are involved in the same field of endeavor, namely direct cardiac compression devices. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of the Criscione Criscione ‘246 Combination to have the pockets connected via a weld as is taught by Criscione ‘260 since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, any known method of connection is considered obvious to try.
Claim 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Criscione, Criscione ‘246, and Anstadt as is applied above, further in view of Macdonald et al. (WO 2007062239 A2) hereinafter known as Macdonald.
Regarding claim 10 Criscione discloses a direct cardiac compression device (Abstract) comprising:
a plurality of passive chambers ([0044]-[0045] inner passive component includes six fluid chambers) that taper from an aperture to an apex (Figure 2b shows the chamber(s) that extend from an open top aperture to a bottom apex; see also [0055] the chambers are tapered);
a plurality of inflatable active pockets ([0044]-[0045] outer active layer containing six fluid chambers; inflatable with air), wherein each of the active pockets is connected to the passive chamber(s) at least partially from the aperture to the apex (see figure 2b which shows the inner passive component and outer active component connected at least partially through the nitinol scaffold lying therebetween), and wherein the active pockets does not tension an adjacent pocket upon inflation (this would appear to depend on the method of inflation and how inflated the active pockets get. There is at least a small margin when inflation of the active pockets is occurring where there is not enough fluid in the chambers to tension adjacent pockets), and
but is silent with regards to the active pockets being configured to be individually inflated,
and there being a frame in contact with the active pockets to at least partially surround the pockets which has one or more fibers intercalated in the frame to provide support.
However, regarding claim 10 Criscione ‘246 teaches that a direct cardiac compression device (Abstract) can have active pockets which are configured to be individually inflatable ([0034]). Criscione and Criscione ‘246 are involved in the same field of endeavor, namely direct cardiac compression devices. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of Criscione so that the bladders are individually inflatable as is taught by Criscione ‘246 in order to allow the device precise control over which areas of the heart can receive compression, thus allowing patient-specific cardiac support.
Further, regarding claim 10 Anstadt teaches a frame (Figure 4a item 112 semi-rigid shell) in contact with inner pockets to at least partially surround them (Figure 4a). Criscione and Anstadt are involved in the same field of endeavor, namely direct cardiac compression devices. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of the Criscione Criscione ‘246 Combination so that there is a frame in contact with the active pockets as is taught by Anstadt in order to ensure the outer wall does not over-extend in a radially outward direction thus acting to help prevent dilation of the heart.
Further, regarding claim 10 Macdonald teaches a direct cardiac compression device that includes one or more fibers intercalated in a frame to provide support ([0085]). Criscione and Macdonald are involved in the same field of endeavor, namely direct cardiac compression devices. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of the Criscione Criscione ‘246 Anstadt Combination to have fibers intercalated in the frame as is taught by Macdonald in order to provide a support mechanism to support the cardiac compression device which is flexible yet strong.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 02/19/26