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 4-5, 8-10, and 19-32 are pending and examined on the merits.
Claims 1-3, 6-7, and 11-18 are cancelled.
Response to Amendment
Applicant’s amendments filed 11/14/2025 have been fully considered. Regarding the objections to claims 22-23, Applicant amended the claims to correct a dependency issue. Accordingly, the objections to claims 22-23 are withdrawn.
Response to Arguments
Applicant provided amendments to the independent claim which necessitates a new ground of rejection. Accordingly, Applicant’s arguments filed 11/14/2025 have been fully considered but they are moot. Specifically, Kassab (U.S. Pre Grant Pub. No. 2010/0222738 A1) and Stamberg (U.S. Pre Grant Pub. No. 2014/0163601 A1) are introduced as new primary and secondary references in the present rejection for disclosing and rendering obvious the limitations presented via the amendments. Goldfarb (U.S. Pre Grant Pub. No. 2011/0004057 A1) and Salihoglu (U.S. Pre Grant Pub. No. 2020/0046892 A1) are reintroduced as secondary references in the present rejection for disclosing and rendering obvious some of the limitations presented in the claims.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “inflation means” in line 8 of claim 4, line 7 of claim 21, and line 9 of claim 24. This is interpreted as an inflation device for inflating the balloon (see page 4, lines 29-30), or equivalents thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 4-5, 19, and 21-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kassab (U.S. Pre Grant Pub. No. 2010/0222738 A1).
Regarding claim 4, Kassab teaches: A femoral arterial cannula (see Abstract and para. [0095]) comprising:
an elongated hollow cannula body (see catheter 10 in Fig. 1 and para. [0044]) having distal (14) and proximal open ends (12) and a lumen (18) extending therebetween configured to allow blood entering the proximal open end to flow through the lumen and exit the distal open end (see para. [0046]) and a taper extending from a position proximate to said proximal end and extending along a length of the hollow cannula body toward the distal end (see Fig. 1 and para. [0045]);
a balloon (32 in Fig. 1) situated on said body proximate to said distal end (see Fig. 1);
inflation means (see pores 34 in Fig. 1 and para. [0055]) connected to said balloon (as broadly recited, the pores 34 are considered to be fluidically connected to the balloon 32) for inflating said balloon (see para. [0055]);
a first plurality of blood flow exit ports (see plurality of orifices 20 in Fig. 1 between balloon 32 and distal end 14) situated in said cannula body (see Fig. 1) between said balloon and said distal end (see Fig. 1), each of the first plurality of blood flow exit ports being open to said lumen (see para. [0051]) so that a first portion of blood flowing through the lumen may exit one or more of the first plurality of blood flow exit ports (see para. [0051]), wherein the first plurality of blood flow exit ports allow for systemic blood flow (see para. [0051-0052]); and
a second plurality of blood flow exit ports (see plurality of orifices 20 in Fig. 1 between balloon 32 and balloon 30) situated in said cannula body between said balloon and said proximal end (see Fig. 1), each of the second plurality of blood flow exit ports being open to said lumen (see para. [0051]) so that a second portion of blood flowing through the lumen may exit one or more of the second plurality of blood flow exit ports (see para. [0051]), wherein the second plurality of blood flow exit ports allow for retrograde blood flow simultaneous with the systemic blood flow (see para. [0051-0052 and 0056]).
Regarding claim 5, Kassab teaches the invention as discussed above in claim 4. Additionally, Kassab teaches wherein said cannula body is an elongated hollow cylindrical body (see Fig. 1 and para. [0044]).
Regarding claim 19, Kassab teaches the invention as discussed above in claim 4. Additionally, Kassab teaches wherein the balloon is configured to remain substantially cylindrical along its length when inflated (as broadly recited, due to the cylindrical shape of the balloon 32 in the deflated state, the balloon will be substantially cylindrical when inflated; see Fig. 1).
Regarding claim 21, Kassab teaches A femoral arterial cannula (see Abstract and para. [0095]) comprising:
an elongated hollow cannula body (see catheter 10 in Fig. 1 and para. [0044]) having distal (14) and proximal (12) open ends and a lumen (18) extending therebetween configured to allow blood entering the proximal open end to flow through the lumen and exit the distal open end (see para. [0046]);
a balloon (32 in Fig. 1) situated on said body proximate to said distal end (see Fig. 1), the balloon being configured to remain substantially cylindrical along its length when inflated (as broadly recited, due to the cylindrical shape of the balloon 32 in the deflated state, the balloon will be substantially cylindrical when inflated; see Fig. 1);
inflation means (see pores 34 in Fig. 1 and para. [0055]) connected to said balloon (as broadly recited, the pores 34 are considered to be fluidically connected to the balloon 32) for inflating said balloon (see para. [0055]);
a first plurality of blood flow exit ports (see plurality of orifices 20 in Fig. 1 between balloon 32 and distal end 14) situated in said cannula body (see Fig. 1) between said balloon and said distal end (see Fig. 1), each of the first plurality of blood flow exit ports being open to said lumen (see para. [0051]) so that a first portion of blood flowing through the lumen may exit one or more of the first plurality of blood flow exit ports (see para. [0051]); and
a second plurality of blood flow exit ports (see plurality of orifices 20 in Fig. 1 between balloon 32 and balloon 30) situated in said cannula body between said balloon and said proximal end (see Fig. 1), each of the second plurality of blood flow exit ports being open to said lumen (see para. [0051]) so that a second portion of blood flowing through the lumen may exit one or more of the second plurality of blood flow exit ports (see para. [0051]).
Regarding claim 22, Kassab teaches the invention as discussed above in claim 21. Additionally, Kassab teaches wherein an elongated hollow cannula body has a taper extending from a position proximate to said proximal end and extending along a length of the hollow cannula body toward the distal end (see Fig. 1 and para. [0045]).
Regarding claim 27, Kassab teaches the invention as discussed above in claim 4. Additionally, Kassab teaches wherein the first plurality of blood flow exit ports situated in said cannula body between said balloon and said distal end comprises two blood flow exit ports located 180 degrees circumferentially and longitudinally offset (see at least Fig. 1).
Regarding claim 29, Kassab teaches the invention as discussed above in claim 4. Additionally, Kassab teaches wherein the second plurality of blood flow exit ports situated in said cannula body between said balloon and said distal end comprises two blood flow exit ports located 180 degrees circumferentially and longitudinally offset (see at least Fig. 1).
Regarding claim 31, Kassab teaches the invention as discussed above in claim 4. Additionally, Kassab teaches wherein the second plurality of blood flow exit ports situated in said cannula body between said balloon and said proximal end comprises at least four blood flow exit ports (see Fig. 1).
Regarding claim 32, Kassab teaches the invention as discussed above in claim 4. Additionally, Kassab teaches wherein the balloon comprises a drug eluting coating (para. [0044] teaches that the catheter 10, which includes balloon 32 may be coated with heparin or any other suitable anti-coagulant).
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 8-9, 20, and 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Kassab (U.S. Pre Grant Pub. No. 2010/0222738 A1) in view of Goldfarb (U.S. Pre Grant Pub. No. 2011/0004057 A1).
Regarding claims 8-9, Kassab teaches the invention as discussed above in claim 4. However, Kassab fails to explicitly teach radio-opaque markers, as required by the claims.
Goldfarb teaches an analogous balloon catheter to be inserted into a human body (see at least para. [0002]) comprising a cannula body (see shaft 122 in Fig. 12 and para. [0131]) that comprises a distal single radio-opaque marker (see marker 114; as applied to claim 8, [0127] the markers are radiographic) and a proximal double radio-opaque marker (116; para. [0131] discloses that the third marker is a double marker; as shown in Fig. 12, the third marker 116 is proximal the second marker 114; as applied to claim 9).
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 Kassab to incorporate the teachings of Goldfarb by including a distal single radio-opaque marker and a proximal double radio-opaque marker at least because Goldfarb teaches that such markers help with indicating the distance the balloon has been advanced and retracted and/or can approximate a location of the balloon relative to a patient’s anatomy (see Goldfarb, at least para. [0131]).
Regarding claims 20 and 23, Kassab teaches the invention as discussed above in claims 4 and 21, respectively. However, Kassab fails to explicitly teach a leur lock connector or wire bound tubing, as required by the claim.
Goldfarb teaches wherein the hollow cannula body further comprises a leur lock connector positioned at the proximal open end (see at least para. [0050]), wherein a portion of the hollow cannula body extending from a distal side of the leur lock connector to a position proximate to a balloon comprises wire wound tubing (see at least para. [0053]).
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 Kassab to incorporate the teachings of Goldfarb by including a Luer lock connector and wire wound tubing at least to reinforce the cannula and to enable quick attachment and detachment of tubes and other medical instruments, as taught by Goldfarb (see at least para. [0050 and 0053]).
Regarding claim 24, Kassab teaches: A femoral arterial cannula (see Abstract and para. [0095]) comprising:
an elongated hollow cannula body (see catheter 10 in Fig. 1 and para. [0044]) having distal (14) and proximal open ends (14) and a lumen (18) extending therebetween configured to allow blood entering the proximal open end to flow through the lumen and exit the distal open end (see para. [0046]) and a taper extending from a position proximate to said proximal end and extending along a length of the hollow cannula body toward the distal end (see Fig. 1 and para. [0045]);
a balloon (32 in Fig. 1) situated on said body proximate to said distal end (see Fig. 1);
inflation means (see pores 34 in Fig. 1 and para. [0055]) connected to said balloon (as broadly recited, the pores 34 are considered to be fluidically connected to the balloon 32) for inflating said balloon (see para. [0055]);
a first plurality of blood flow exit ports (see plurality of orifices 20 in Fig. 1 between balloon 32 and distal end 14) situated in said cannula body (see Fig. 1) between said balloon and said distal end (see Fig. 1), each of the first plurality of blood flow exit ports being open to said lumen (see para. [0051]) so that a first portion of blood flowing through the lumen may exit one or more of the first plurality of blood flow exit ports (see para. [0051]), wherein the first plurality of blood flow exit ports allow for systemic blood flow (see para. [0051-0052]); and
a second plurality of blood flow exit ports (see plurality of orifices 20 in Fig. 1 between balloon 32 and balloon 30) situated in said cannula body between said balloon and said proximal end (see Fig. 1), each of the second plurality of blood flow exit ports being open to said lumen (see para. [0051]) so that a second portion of blood flowing through the lumen may exit one or more of the second plurality of blood flow exit ports (see para. [0051]), wherein the second plurality of blood flow exit ports allow for retrograde blood flow simultaneous with the systemic blood flow (see para. [0051-0052 and 0056]).
However, Kassab fails to explicitly teach a leur lock connector positioned at the proximal open end, or wherein a portion of the hollow cannula body extending from a distal side of the leur lock connector to a position proximate to a balloon comprises wire wound tubing, as required by the claim.
Goldfarb teaches wherein the hollow cannula body further comprises a leur lock connector positioned at the proximal open end (see at least para. [0050]), wherein a portion of the hollow cannula body extending from a distal side of the leur lock connector to a position proximate to a balloon comprises wire wound tubing (see at least para. [0053]).
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 Kassab to incorporate the teachings of Goldfarb by including a Leur lock connector and wire wound tubing at least to reinforce the cannula and to enable quick attachment and detachment of tubes and other medical instruments, as taught by Goldfarb (see at least para. [0050 and 0053]).
Regarding claim 25, Kassab in view of Goldfarb teaches the invention as discussed above in claim 24. Additionally, Kassab teaches wherein the balloon is configured to remain substantially cylindrical along its length when inflated (as broadly recited, due to the cylindrical shape of the balloon 32 in the deflated state, the balloon will be substantially cylindrical when inflated; see Fig. 1).
Regarding claim 26, Kassab in view of Goldfarb teaches the invention as discussed above in claim 24. Additionally, Kassab teaches wherein an elongated hollow cannula body has a taper extending from a position proximate to said proximal end and extending along a length of the hollow cannula body toward the distal end (see Fig. 1 and para. [0045]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kassab (U.S. Pre Grant Pub. No. 2010/0222738 A1) in view of Salihoglu (U.S. Pre Grant Pub. No. 2020/0046892 A1).
Regarding claim 10, Kassab teaches the invention as discussed above in claim 4. However, Kassab fails to teach that the inflation means comprises a small bore tubing connected to said balloon at a first end, a balloon cuff connected to a second end of said small bore tubing, a two-way valve connected to said balloon cuff, or a female luer port connected to said two-way valve, as required by the claim.
Salihoglu teaches an analogous femoral arterial balloon catheter (see at least para. [0038] and Fig. 1) comprising a balloon (6) and an inflations means (see balloon pilot 7 and bidirectional valve 9 in Fig. 1 and para. [0038]), wherein the balloon pilot (7) comprises:
a small bore tubing connected to said balloon at a first end (see balloon inflation path 10 in Fig. 1 and para. [0038]);
a balloon cuff connected to a second end of said small bore tubing (see balloon pilot 7 in Fig. 1 and para. [0038]);
a two-way valve connected to said balloon cuff (bidirectional valve 9 in Fig. 1 and para. [0038]); and
a female luer port connected to said two-way valve (see luer connection 11 in Fig. 1 and para. [0038]).
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 Kassab to incorporate the teachings of Salihoglu by replacing the inflation means of Kassab with the inflation means of Salihoglu at least in order to manually control the inflation of the balloon by transmitting balloon inflation fluid (as taught by Salihoglu in para. [0053]) as opposed to letting the balloon automatically inflate and deflate depending on arterial pressure (as taught by Kassab in para. [0055]). Additionally, one of ordinary skill in the art would have reasonably included a two-way valve and a female luer port at least because such structures are well known in the art, as evidenced by their disclosure in Salihoglu (see at least para. [0038]). Additionally, one of ordinary skill in the art would have been reasonably motivated to connect the two-way valve and the female luer port at least to enable quick and easy attachment and detachment of the inflation device of Kassab.
Claims 28 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Kassab (U.S. Pre Grant Pub. No. 2010/0222738 A1) in view of Stamberg (U.S. Pre Grant Pub. No. 2014/0163601 A1).
Regarding claims 28 and 30, Kassab teaches the invention as discussed above in claims 22 and 4, respectively. However, Kassab fails to teach wherein the two blood flow exit ports are longitudinally offset by 5 mm, as required by the claims.
Stamberg teaches an analogous cannula for treating ischemia (see para. [0041]) comprising openings that are spaced apart by 5 mm (see para. [0043]).
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 Kassab to incorporate the teachings of Stamberg by longitudinally offsetting the two blood flow exit ports by 5 mm at least in order for the cannula to be able to deliver any therapeutic agent within a blood vessel of a patient, as taught by Stamberg (see para. [0006]).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIHAD DAKKAK whose telephone number is (571)272-0567. The examiner can normally be reached Mon-Fri: 9AM - 5PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JIHAD DAKKAK/ Examiner, Art Unit 3781
/SARAH AL HASHIMI/ Supervisory Patent Examiner, Art Unit 3781