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 .
Response to Arguments
Applicant's arguments filed 07/13/26 have been fully considered but they are not persuasive.
On pages 12-14 Applicant explains amendments made to the drawings, specification, and claims.
On page 14 Applicant describes amendments made to claims 9 and 13 to overcome 112 rejections.
On page 16 regarding prior art rejections, Applicant argues the Examiner’s use of Criscione is “openly speculative” since the Examiner explained the amount of tension present would depend on the method of inflation and how inflated the active pocket gets. Applicant appears to disagree that there is a state which is not so inflated that there is no tension applied, but fails to provide support or evidence for such a statement, making this unpersuasive.
On pages 16-17 Applicant describes the amendments made to claim 1.
On page 17 Applicant disagrees that three elements lying adjacent one another are connected, but then fails to support how the elements pointed out by the Examiner can be forming the single structure of the prior art unless they are connected. This accordingly makes this argument unpersuasive.
On pages 17-18 Applicant argues that the Examiner’s observation that the pockets overlap in a particular view is not adequate to teach “at least partially overlapping”, but then fails to state why or how this would be incorrect. This is accordingly unpersuasive.
On pages 18-19 Applicant describes Anstadt’s invention and states their item 122 cannot function as a frame, and argues it also cannot be the containment layer.
The Examiner respectfully disagrees, pointing out Applicant’s argument appears to assume there are two elements being represented by the same number, but the Examiner cannot locate any part of the rejection of record which labels two parts with the same number when addressing Anstadt. Arguments to claim 5 and 13 at the same time are equally unclear since these claims are not related to one another in any way.
On page 19 regarding claim 13, Applicant argues the prior art fails to teach a second support structure between the passive chambers and the active pockets as is claimed, and argues the nitinol scaffold is an intervening element in a two-layer laminate as opposed to being a discrete support structure separately in contact with the passive chambers on one side and the active pockets on the other as the claim requires.
The Examiner respectfully notes the claim does not appear to require the limitations Applicant is arguing, making this argument unpersuasive. The Examiner sees no requirement for a nitinol scaffold, a requirement for a second support structure to be between any chambers or pockets, a requirement for any scaffold (let alone a nitinol one) being an intervening element in a two-layer laminate, anything requiring “separate contact”, and there being “sides” of anything. It is unclear whether Applicant might be referring to another claim, or perhaps elements which are not claimed. Either way, the argument is not considered persuasive for these reasons. Further, and as was pointed out in the rejection of record previously, the Examiner is still unclear on what this second support structure is, where it is, and what/how it contacts anything in the claimed invention, since this structure is not shown anywhere in the figures of the invention, as would be required to understand the invention.
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 aperture, the apex, the ports, there being more than one passive chamber, [the element] that tapers 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”, the second support structure being in contact with one passive chamber, the second support structure being in contact with more than one passive chamber, the plurality of inflatable active pockets being in contact with the second support structure must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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:
-item “78” is used to represent “fiber reinforcement layer”, “mesh layer” , and “containment layer” in the specification .
-item “76” is used to represent both “passive layer” and “wireframe” (and “wire frame”) in the specification
-item 70a and 76 are both used to represent “wireframe”
-item “70” is used to represent “containment layer” and “frame”.
-specification pages 15-16 states that figure 16 shows the frame positioned over item 82 (chambers), but there is no item 82 in this figure
-the specification page 16 states that figure 17 shows the containment layer (which has no numeral and is not apparently in figure 17), positioned over the frame 70, but there is nothing positioned over item 70 in the figure
-the specification page 16 states figures 18-20 have a frame 70, but the figures show the figures having item 70a and 70b, and no item 8
-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 Objections
Claims 1, 3 are objected to because of the following informalities:
Claim 1 is objected to for referring to “any adjacent inflatable active pocket” when it is unclear how, if at all, this relates back to the previously claimed “plurality of inflatable active pockets”.
The claim is further unclear for claiming there are a plurality of passive chambers that taper “from an aperture to an apex” but it is unclear what has the aperture and the apex (e.g. the compression device, the chambers themselves, something else?). The figures do not describe or depict this apex or aperture, making this even more unclear.
Claim 3 is objected to for claiming each of the inflatable active pockets “are connected to the plurality of passive chambers by an anchoring tab”, when it appears this is claiming that each active pocket is connected to every single one of the passive chambers through one anchoring tab, but this does not appear to be accurate to what is depicted.
Appropriate correction is required.
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 1 and 3-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 is rejected for having new matter for claiming “each of the plurality of inflatable active pockets is connected to the plurality of passive chambers” when there does not appear to be support in the invention as is originally filed for each of the plurality of pockets to be attached to all of the plurality of passive chambers from the aperture to the apex. This is accordingly new matter.
Claim 13 is rejected for having new matter for claiming there is a “second support structure” in contact with the one or more passive chamber(s) and being in contact with the plurality of inflatable active pockets, at the same time as there being a “support structure”. Notably, while the specification generally refers to such a “second support structure”, there isn’t any detailed description or depiction of where this second support structure is in relation to the “support structure”, or whether or not it is even capable of being present within the invention at the same time as the “support structure”, let alone being able to “contact” the passive chambers and “contact” the active pockets at the same time as the active pockets and passive chambers are “separately attached to a support structure”.
Remaining claims are rejected for depending on a claim with new matter.
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.
Claim 1, 3-13 is 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 1 is indefinite for claiming “each of the plurality of inflatable active pockets is connected to the plurality of passive chambers”, when it is unclear how each of the pockets can be attached to all of the passive chambers as the claim requires.
The claim is further indefinite for claiming “wherein each of the plurality of active inflatable pockets is separately attached to a support structure”, when it is unclear what it means to be “separately attached” to something, since “separate” and “attach” appear to mean the opposite thing. Clarification is required.
Claim 13 is indefinite for claiming there is a “second support structure” in contact with the one or more passive chamber(s) and being in contact with the plurality of inflatable active pockets. Notably, while the specification generally refers to such a “second support structure”, there isn’t any detailed description or depiction of what this second structure might be or entail, or how it could be in contact with multiple passive chambers (which are not depicted), or how it could be in contact with a plurality of inflatable active pockets (since the second support structure is also not depicted). The specification also only supports this second support structure’s presence, without indicating what embodiment(s) this second support structure might be present in. This makes it unclear whether or not it is possible to have the second support structure and the support structure present in one embodiment as is required by claim 13, and if so, how. The Examiner is unable to reject the claim with prior art at this time, but notes if the drawing objections related to the “second support structure”, 112a rejections, and 112b rejections are clarified, a prior art rejection may yet be applied.
Remaining claims are rejected for depending on a rejected claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 plurality of 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. See also [0044] each of the active and passive layers are formed of chambers, and the chambers are mounted to the nitinol scaffold. This connection is understood to inherently occur at least at some location from the aperture to apex since the structure exists in three dimensions and the aperture to apex is where the structures co-extend according to figure 2b), wherein each of the plurality of active inflatable pockets is separately attached to a support structure ([0044] the “inner passive layer containing six fluid chambers and an outer active layer containing six fluid chambers”, wherein “the chambers…were mounted on a nitinol wire scaffold”. “Mounted” is defined by Merriam-Webster as “to attach to a support”.) and not directly joined to any adjacent inflatable active pocket in a tension-transmitting manner, such that each 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 some level where 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 structure 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 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.
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 plurality of 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. See also [0044] each of the active and passive layers are formed of chambers, and the chambers are mounted to the nitinol scaffold. This connection is understood to inherently occur at least at some location from the aperture to apex since the structure exists in three dimensions and the aperture to apex is where the structures co-extend according to figure 2b), wherein each of the plurality of active inflatable pockets is separately attached to a support structure ([0044] the “inner passive layer containing six fluid chambers and an outer active layer containing six fluid chambers”, wherein “the chambers…were mounted on a nitinol wire scaffold”. “Mounted” is defined by Merriam-Webster as “to attach to a support”.) and not directly joined to any adjacent inflatable active pocket in a tension-transmitting manner, such that each 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 some level where inflation of the active pockets is occurring where there is not enough fluid in the chambers to tension adjacent pockets),
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 a fiber reinforcement layer 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 a reinforcement layer 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
THIS ACTION IS MADE FINAL. 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 mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 07/20/26
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