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 .
Status of Claims
Claims 1 and 10-19 are pending and examined on the merits.
Claims 1, 10, and 17 are currently amended.
Claims 2-9 and 20 are cancelled.
Allowable Subject Matter
Claims 18-19 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior arts of record are Ogihara (U.S. Pre Grant Pub. No. 2009/01175762 A1), Carpenter (U.S. Pre Grant Pub. No. 2007/0148037 A1), and Lindsay (U.S. Patent No. 6,468,473 B1)
As described below, Ogihara, in view of Carpenter, and further in view of Lindsay teaches the invention as recited below in claim 17. However, Ogihara, in view of Carpenter and further in view of Lindsay fails to disclose or reasonably suggest, alone or in combination, wherein at least one of said first protection means and second protection means is movable with respect to said load bearing body, as required by the claim. Further, one of ordinary skill in the art would not be motivated to make the first and/or second protection means movable at least because para. [0027] of Ogihara teaches that “the unit frame 5 is an integral, unitary, one-piece unit frame that is entirely formed of the same material and at one time.” Therefore, one of ordinary skill in the art would not have been reasonably motivated to make the first and/or second protection means movable without significantly modifying the device of Ogihara and without relying on impermissible hindsight (see MPEP 2141).
Claim 19 is objected to for being dependent on claim 18.
Claim Objections
Claim 1 objected to because of the following informalities: Line 18 recites “wherein and…”, this is grammatically incorrect. For the purposes of this Office Action, and in the interest in compact prosecution, Examiner will treat this claim as excluding “and”. Appropriate correction is required.
Response to Amendment
Applicant amendments filed 05/16/2025 have been fully considered.
Response to Arguments
Applicant provided amendments to independent claim 1 which necessitates a new ground of rejection. Accordingly, Applicant arguments filed 05/16/2025 have been fully considered. Ogihara (U.S. Pre Grant Pub. No. 2009/01175762 A1) is reintroduced as a primary reference in the present rejection for disclosing and rendering obvious the limitations presented via the amendments.
Regarding the arguments that Ogihara does not disclose features of claim 1 (see Remarks filed 05/16/2025 pages 8-12), as detailed in below, Examiner respectfully disagrees.
Regarding the argument that “the first and second supporting means 54, 53 are not removably attached…”, Lindsay teaches an analogous extracorporeal support circuit (see Abstract) comprising a pair of C-clips 137’ to fasten medical devices to a load-bearing body 82 (see at least Fig. 6D and col. 10, lines 17-27).
Therefore, Ogihara, in view of Carpenter, and further in view of Lindsay teaches the claim.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
In the instant case, claim 1 recites the limitations “hooking means” and “supporting means”, claim 10 recites the limitation “fixing means”, claims 13-15 recite the limitation “gripping element”, and claims 17-19 recite the limitation “protection means”; as such, these limitations are being be interpreted under 35 U.S.C. 112(f). “Hooking means” is interpreted as requiring “two hooking elements movable in a direction of mutual close/away movement”, or equivalents thereof (see Specification page 6, lines 13-15). “Supporting means” is interpreted as requiring a wall (such as walls 5 and 6 in Fig. 1) that are associated with a holding element 4 (see page 4, lines 19-21), that can be threaded (see page 6, lines 6-7), and that can be in the shape of a C-grip (see for example first supporting means 5 at least in Figs. 1, 3, and 4), or that can be a screw that is inserted into a medical device (see for example second supporting means 6 at least in Fig. 5). As broadly described in the spec (see page 6, lines 22-29), gripping element is considered a structural element onto which the hooking element can connect to, the gripping element is a feature unto which the hooking means engages. “Protection means” is interpreted as requiring a structure that is shaped to surround the medical device (see page 7, line 13 thru page 8, line 8).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
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.
Claims 1 and 10-17 are rejected under 35 U.S.C. 103 as being unpatentable over Ogihara (U.S. Pre Grant Pub. No. 2009/0175762 A1), in view of Carpenter (U.S. Pre Grant Pub. No. 2007/0148037 A1), and further in view of Lindsay (U.S. Patent No. 6,468,473 B1).
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Regarding claim 1, Ogihara, with reference to Image 1 above, teaches: An appliance (see Image 1) for the support of biomedical devices during extracorporeal circulation (see at least para. [0007]), the appliance comprising:
an oxygenator (see 4 in Fig. 2);
a pumping assembly (see pump 3 in Fig. 2); and
at least one load-bearing body (see Image 1), at least one holding element (Id.) provided with at least first supporting means (Id.) of the oxygenator (see Figs. 1-2) and with second supporting means (see Image 1) of the pumping assembly (see Figs. 1-2), wherein
said first supporting means and said second supporting means are locked to each other (para. [0027] teaches that frame 5 is an integrally formed unit; therefore, the first and second supporting means are locked to each other), and
said holding element comprises removable hooking means to said load- bearing body (para. [0048] and Fig. 4 teach an operation part 82 that moves nail part 84 away from a forward position to release oxygenator unit; nail part 84 is considered to be a removable hooking means),
wherein said holding element is made in a single body piece (see para. [0027]),
wherein said holding element has at least a first holding wall (see Image 1) with which said first supporting means are associated and at least a second holding wall (Id.) with which said second supporting means are associated, said first and second holding walls being arranged transversely to each other (see Image 1),
said first and second holding walls being arranged, in use, vertically and horizontally (see Image 1), respectively,
wherein said holding element comprises at least one intermediate wall directly adjacent to said first holding wall (see Image 1) and arranged substantially transverse thereto (Id.), said intermediate wall being adapted to be arranged, in use, below the oxygenator (as shown in Fig. 2; the intermediate wall is below the oxygenator),
wherein said intermediate wall is arranged parallel to said second holding wall and at a greater height with respect thereto (see Image 1; as broadly recited, the intermediate wall is considered to be parallel to the second holding wall) so that, in use, the oxygenator is arranged on top of the pumping assembly (see Fig. 2), thus facilitating, from a fluid-dynamic point of view, the transfer of blood from the pumping assembly to the oxygenator (since the structure is disclosed by Ogihara, the device will necessarily function as claimed),
wherein said intermediate wall and said second holding wall are vertically staggered to each other (see Image 1);
wherein said first supporting means comprises at least one housing seat of the oxygenator and configured to keep the oxygenator in suspension on said first holding wall (see for example Fig. 2 showing the oxygenator suspended on the first holding wall);
and wherein the intermediate wall is spaced from the oxygenator (as broadly recited, the intermediate wall is spaced from the oxygenator at least because said intermediate wall is separate from the oxygenator).
However, Ogihara fails to explicitly teach at least one command and control unit connectable to at least one biomedical device or wherein and said first supporting means are removably attached from said first holding wall and wherein said second supporting means are removably attached from said second holding wall, as required by the claim.
Carpenter teaches an analogous appliance for the support of biomedical devices during extracorporeal circulation (see Abstract) comprising at least one load-bearing body (see support arm assembly 330 in Fig. 6), at least one command and control unit (see for example AAR controller described in para. [0074]) connectable to at least one biomedical device (see at least para. [0074] disclosing that the AAR controller is coupled to a VARD 130), at least one holding element (see Image 1) provided with at least first supporting means (Id.) of a first biomedical device (see arterial blood filter 180 in Fig. 6) and with second supporting means (see Image 1) of a second biomedical device (see VARD 130 in Fig. 6).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Ogihara to incorporate the teachings of Carpenter by including at least one command and control unit connectable to at least one biomedical device at least because Venous Air Removal Devices (VARD) and active air removal controllers (AAR) are well known in the art, as evidenced by their disclosure in Carpenter (see at least para. [0023]), and one of ordinary skill in the art would have reasonably been motivated to include such command and control units at least in order to detect the presence of air within the extracorporeal device to be evacuated from the chamber, as taught by Carpenter (see at least para. [0069]).
However, neither Ogihara nor Carpenter explicitly teach wherein and said first supporting means are removably attached from said first holding wall and wherein said second supporting means are removably attached from said second holding wall, as required by the claim.
Lindsay teaches an analogous extracorporeal support circuit (see Abstract) comprising a pair of C-clips 137’ to fasten medical devices to a load-bearing body 82 (see at least Fig. 6D and col. 10, lines 17-27).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Ogihara in view of Carpenter to incorporate the teachings of Lindsay by including a pair of C-clips to fasten each of the first and second biomedical devices to the load-bearing body at least in order to prevent unwanted or accidental removal of the biomedical devices, as taught by Lindsay (see col. 10, lines 20-21). Additionally, the clips are removably attached to the first and second holding walls (see Fig. 6D).
Regarding claim 10, Ogihara, in view of Carpenter, and further in view of Lindsay teaches the invention as described above in claim 1. Additionally, Ogihara, in view of Carpenter, and further in view of Lindsay further teaches wherein said first supporting means comprise removable fixing means to said holding element (see col. 10, lines 20-21 and Fig. 6D of Lindsay).
Regarding claim 11, Ogihara, in view of Carpenter, and further in view of Lindsay teaches the invention as described above in claim 10. Additionally, Ogihara, in view of Carpenter, and further in view of Lindsay further teaches wherein said second supporting means are configured to keep the second biomedical device in position on said second holding wall (see col. 10, lines 20-21 and Fig. 6D of Lindsay).
Regarding claim 12, Ogihara, in view of Carpenter, and further in view of Lindsay teaches the invention as described above in claim 11. Additionally, Ogihara, in view of Carpenter, and further in view of Lindsay further teaches wherein said hooking means are movable from at least one engagement configuration to a release configuration with said load-bearing body (see at least para. [0048] of Ogihara).
Regarding claim 13, Ogihara, in view of Carpenter, and further in view of Lindsay teaches the invention as described above in claim 12. Additionally, Ogihara, in view of Carpenter, and further in view of Lindsay teaches further comprising: at least one gripping element (see element 58 in Fig. 3) associated with said load-bearing body and wherein said hooking means are adapted to engage in a removable manner with said gripping element (see para. [0048]).
Regarding claim 14, Ogihara, in view of Carpenter, and further in view of Lindsay teaches the invention as described above in claim 13. Additionally, Ogihara, in view of Carpenter, and further in view of Lindsay further teaches wherein said gripping element is of the joined type (see para. [0048]).
Regarding claim 15, Ogihara, in view of Carpenter, and further in view of Lindsay teaches the invention as described above in claim 14. Additionally, Ogihara, in view of Carpenter, and further in view of Lindsay teaches further comprising: at least two of said gripping elements which are separate from each other (see for example elements 59 and 58 in Fig. 3).
Regarding claim 16, Ogihara, in view of Carpenter, and further in view of Lindsay teaches the invention as described above in claim 15. Additionally, Ogihara, in view of Carpenter, and further in view of Lindsay teaches wherein said load-bearing body comprises at least one front portion and at least two lateral portions arranged transversely with respect to said front portion (see for example element 59 in Fig. 3), said gripping elements being associated with at least said front portion and with at least one of said lateral portions (see Fig. 3).
Regarding claim 17, Ogihara, in view of Carpenter, and further in view of Lindsay teaches the invention as described above in claim 16. Additionally, Ogihara, in view of Carpenter, and further in view of Lindsay teaches further comprising: at least one of first protection means of the oxygenator and second protection means of the pumping assembly associated with said load-bearing body (see Image 1).
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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/JIHAD DAKKAK/ Examiner, Art Unit 3781 /JESSICA ARBLE/Primary Examiner, Art Unit 3781