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 Amendment
This office action is responsive to the amendment filed on 6/15/2026. As directed by the amendment: claim(s) 1 has been amended, and claim 21 has been added. Thus, claims 1-21 are presently pending in this application. Claims 10-20 remain withdrawn from consideration.
Response to Arguments
Applicant's arguments filed 6/15/2026 have been fully considered but they are not persuasive.
Regarding applicant’s argument regarding the independent claims on page 1-3:
Applicant’s arguments with respect to the independent claim(s), particularly the arguments towards what is considered the broadest reasonable interpretation of the claim term filler, have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding applicant’s argument regarding dependent claims on page 3-4:
Applicant argues that their preceding arguments render the independent claims allowable, and consequently likewise the dependent claims including the new dependent claim 21 are allowable.
See examiner's rejection as necessitated by the amendment, below, detailing the prior art which discloses/teaches the limitations of the dependent claims.
Applicant argues that the prior art relied upon in the preceding office action does not teach the following limitations of the dependent claim 3:
“an actuator for deploying the needle from a retracted position within the lumen”
Examiner notes that in light of applicant’s disclosure, an actuator performing this function may be considered a shaft attached to an end of a needle such that an operator may manipulate an end of the tube to advance the needle, see page 6 line 2-3. See examiner's rejection as necessitated by the amendment, below, detailing that the proximal end of Chang’s injector 110 is considered an actuator. Further examiner notes the preceding and presented rejection of claim 8 demonstrating it would be obvious for the claimed needle of the prior art to be comprised of a shape memory material and thus also an actuator performing said claimed function.
If applicant were to amend the claim such that they incorporate some specific structure of the claimed actuator which can not be considered as being taught/disclosed by the prior art of record, then that claim may constitute allowable subject matter, however further search and consideration of such claims introducing new subject matter may be required to confirm or deny whether the amended claims overcome the prior art rejection of record or constitute allowable subject matter.
Applicant argues that the prior art relied upon in the preceding office action does not teach the following limitations of the dependent claim 4:
“wherein the shaft includes an inflation lumen, and the expandable elements comprise inflatable balloons in fluid communication with the inflation lumen”
Examiner notes that the teachings of Chang relied upon is clear in that its taught lumens may be connected to a pressure or fluid source and may support the translation of certain elements such as guidewires, cables, and the like, such as pressure or fluid from a source. It is unclear to examiner how applicant suggests the prior art of Chang is physically capable of performing its disclosed function of inflating the disclosed inflatable elements 114 without the inflatable elements receiving an inflating pressure or fluid, such as gas or liquid. Such that a modification of the prior art in view of Chang involving incorporating a lumen for inflating the inflatable balloons is obvious. In light of examiner's rejection of the independent claim as necessitated by the amendment incorporating new prior art of record, and in lieu of taking official notice that the claimed structure of a shaft of an inflation lumen in fluid communication with an inflatable balloon is exceedingly common knowledge in the art of balloon catheters, in addition to the present office action rejecting claim 4 from the teachings of Chang, examiner has also provided a rejection of claim 4 relying upon the prior art of WO 02055130 A2 provided in applicant’s Information Disclosure Statement filed 5/18/2026.
Applicant argues that the prior art relied upon in the preceding office action does not teach the following limitations of the dependent claim 6:
“a tip [of each of a plurality of needles is] located between the expandable elements”
Examiners notes that in the preceding office action and the present rejection as necessitated by the amendment, details that modifications to the prior art involving mere duplication of parts, such as a plurality of needles, especially where the prior art already discloses a needle having a tip disposed in the claimed region and teaches a modification involving a plurality of needles extending from the same region, are not considered to constitute allowable subject matter.
Further Examiner notes, that in the teachings of Chang which are relied upon for such claim limitations, the disclosure of paragraph 65 explicitly recites “In some variations, the injectors extend from the side of a distal portion of the injection catheter”. It is clear from this teaching that each of the plurality of the injectors extending from the side of the distal portion of the injection catheter, and not as applicant suggest from different portions/area of the injection catheter. Such a disposal of an injector extending from a side of a distal portion of the injection catheter, is seen in Chang’s figure 1. The preceding and present rejection of this claim limitation did not and does not rely upon the duplicating an injector of Chang other than the injector of 110 which extends its tip 122 between the inflatable balloons 114. Thus the modification to the prior art involves duplicating a needle having a tip between the expandable elements, wherein such duplication results in a plurality of similarly disposed needle tips.
See examiner's rejection as necessitated by the amendment and filed IDS, below, detailing the prior art which discloses/teaches the limitations of the dependent 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.
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:
“filler for forming a bridge among the blood vessel” in claim 1, and “actuator for deploying the needle” in claim 3.
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.
Regarding the claim term “filler for forming a bridge among the blood vessels”
Applicant discloses in page 8 that the claimed filler comprising a fluid material which cures/hardens performs the claimed function of forming a bridge among the blood vessels, such that the prior art having these structures or their structural equivalent can be considered to disclose/teach the claimed limitation.
Regarding the claim term “actuator for deploying the needle”
Applicant discloses in page 5 line 20 to page 7 line 2 that the disclosed structures of an elongated tube connected to the needle, a post connected to a tube connected to a needle where the post slides in a slot, or a ratchet and pawl mechanism producing a linear motion of a tube connected to the needle, or a particularly shape-memory material of the needle performs the claimed function of deploying the needle, such that the prior art having these structures or their structural equivalent can be considered to disclose/teach the claimed limitation.
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 § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 1-9 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over US 20060106338 A1, henceforth written as Chang, in view of US 20210268271 A1, henceforth written as Bright.
Regarding Claim 1,
Chang discloses:
A catheter for relieving compression among blood vessels in an intervascular space, comprising:
(injection catheter 102; fig 1; fig 5b best illustrates the fluid being disposed into an intervascular space in another embodiment of the invention; fig 6b illustrates the fluid 625 being disposed in a subfascial layer 614 to produce a tumescence and consequently position the vessel away from other structures for treatment to proceed advantageously)
a shaft;
(see examiner's annotation of Chang's fig 1, below, denoting the claimed shaft )
expandable elements supported by the shaft;
(inflatable balloons 114 114’)
a [fluid filling an anatomical space between blood vessels] --; and
(paragraph 37+40; deploying anesthetic or therapeutic fluid)
a needle supported by the shaft,
(paragraph 57+73; injector 110 is considered to have a hollow needle shape for tissue penetration and fluid delivery; fig 1)
the needle, when deployed, including a tip located between the expandable elements for introducing the filler into the intervascular space.
(paragraph 51+57-58+73; fig 1d-e demonstrate tip 122 of injector 110 in a position between inflatable balloons 114 114’ for introducing fluid between vessel 100 & a target tissue structure 106 108, such as a tissue layer/fascia between vessels or body organs and thus an intervascular space; fig 5 also illustrating delivery of a similar embodiment to an intervascular space)
Chang discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
a filler for forming a bridge among the blood vessels;
However Bright teaches a system and method for introducing a filler among blood vessels comprising:
a filler for forming a bridge among the blood vessels
(a catheter delivers a hydrogel containing a therapeutic agent, such as an anesthetic or therapeutic agent, see paragraph 22+277, and containing an adhesive/adhering/glue medium, see paragraph 179+216+224+277, is dispensed into an intervascular space, see fig 1j-k and paragraph 71+112, such that the glue medium of the hydrogel conforms/adheres to structures of the target site/intervascular space, see paragraph 179+216+224, consequently the glue medium of the hydrogel hardens so as to stop flowing and adhere to the surrounding vasculature/tissue for a period, see paragraph 179+244-245+296-298, and thereby forms a structural bridge between the blood vessels spanning the target site which the hydrogel containing the glue medium has been dispensed to)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the anesthetic fluid dispensed by Chang’s disclosed invention with Bright’s teachings of a hydrogel containing an anesthetic agent and adhesive agent being dispensed into an intervascular space, such that Chang’s catheter dispense Bright’s filler which forms a structural bridge between vasculature at a target site, in order to advantageously arrive at an invention which provides for a sustained/controlled release of an anesthetic/therapeutic agent by the conforming and adhesion of the dispensed medium to target tissue - such as surrounding vasculature- such that there is a more effective means for local delivery to target tissue for an extended period, see paragraph 72+213+224+280 of Bright.
Regarding claim 2, modified invention of Chang in view of Bright discloses:
The catheter of claim 1, wherein the shaft includes a lumen, and the needle is hollow and in communication with the lumen.
Chang: (paragraph 61; injector 110 extends through a passage (not enumerated) to exit port 112, and is connector to a pressure/fluid source for dispensing via its tip, and thus hollow; see examiner's annotation of above, denoting the passage of Chang in communication with )
Regarding claim 3, modified invention of Chang in view of Bright discloses:
The catheter of claim 2, further including an actuator for deploying the needle from a retracted position within the lumen.
Chang: (paragraph 48+66; injector 110, the claimed needle, has a distal tissue penetrating tip 122 and a proximal end, see examiner's annotation of Chang's fig 1 above denoting the claimed proximal end, which may be manually manipulated by an operator for advancing/withdrawing the injector 110 within Chang’s passage, and thus the proximal end of injector 110 can be considered a structural equivalent of an elongated tube connected to a needle and thus interpreted as an actuator)
Examiner notes that Chang also discloses in paragraph 66-67 alternative embodiments of a triggering mechanism for advancing the injector comprising the injector being formed from a shape memory material for advancing/withdrawing the needle.
Regarding Claim 4,
Chang in view of Bright discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The catheter of claim 1, wherein --the expandable elements comprise inflatable balloons --.
Chang: (inflatable balloons 114 114’; fig 1)
However, Chang’s present embodiment is silent regarding:
The catheter of claim 1, wherein the shaft includes an inflation lumen, and the expandable elements comprise inflatable balloons in fluid communication with the inflation lumen.
However, Chang teaches in an alternative embodiment:
wherein the shaft includes a [fluid conveying] lumen.
(paragraph 56+61; the injection catheter may have a number of additional passages for supporting various structures, such as guidewires, endoscopes, cables, and these lumens may be connected to pressure/fluid source)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to implement Chang’s further teachings of lumens within a catheter conveying media to the modified catheter embodiment of Chang in view of Bright in order to advantageously arrive at a catheter which can convey inflating media to an inflatable element within a catheter from a fluid source, see paragraph 56+61 of Chang, improving the operability of the invention to inflate its inflatable balloons as desired to support its medical application.
Regarding Claim 5,
Chang in view of Bright discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Chang’s present embodiment is silent regarding:
The catheter of claim 4, wherein the shaft comprises a guidewire lumen.
However, Chang teaches in an alternative embodiment:
wherein the shaft comprises a guidewire lumen.
(paragraph 56+61; the injection catheter may have a number of additional passages for supporting various structures, such as guidewires, endoscopes, cables, and these lumens may be connected to pressure/fluid source)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to implement Chang’s further teachings of lumens within a catheter conveying a guidewire to the modified catheter embodiment of Chang in view of Bright in order to advantageously arrive at a catheter which can be delivered over a guidewire and thus improves its ability to track through the vasculature of a patient, see paragraph 61 of Chang.
Regarding Claim 6,
Chang in view of Bright discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The catheter of claim 1, -- a tip [ of the needle] located between the expandable elements.
(fig 1; tip 122)
However, Chang’s present embodiment is silent regarding:
The catheter of claim 1, wherein a plurality of needles are provided, each having a tip located between the expandable elements.
However, Chang teaches in an alternative embodiment:
wherein a plurality of needles are provided
(paragraph 61+65-66+68; multiple injectors may be used for injecting fluid to a target tissue, and multiple injectors may extend from the side of the catheter body; examiner notes in the present embodiment of Chang)
Notably, MPEP 2144.04(VI)(B) provides that a modification of the prior art amounting to a mere duplication of parts has no patentable significance unless a new and unexpected result is produced. Accordingly, duplicating needles of Chang such that there are multiple needles extending from between the expandable elements would similarly lack patentable significance as a new and unexpected result is not produced by such a modification.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to implement Chang’s further teachings of utilizing multiple injectors to the present catheter embodiment of Chang in order to advantageously arrive at a catheter which can simultaneously deliver fluid to the extraluminal/intervascular space immediately adjacent the vessel the catheter is deployed within, see paragraph 68 of Chang.
Regarding claim 7, Chang in view of Bright discloses:
The catheter of claim 1, wherein the needle is curved when deployed between the expandable elements.
Chang: (fig 1d best demonstrates the manner that injector 120 is curved while it is deployed between balloons 114 114')
Regarding Claim 8,
Chang discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Chang’s present embodiment is silent regarding:
The catheter of claim 1, wherein the needle comprises a shape memory material.
However, Chang teaches in an alternative embodiment:
wherein the needle comprises a shape memory material.
(paragraph 66; the injector may be formed from a shape memory material)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to implement Chang’s further injector material teachings to the present catheter embodiment of Chang in order to advantageously arrive at a needle which may change its shape to deploy and extend from the catheter, see paragraph 66 of Chang.
Regarding claim 9, Chang in view of Bright discloses:
The catheter of claim 1, wherein the needle is adapted for delivering the filler from a remote source to a location in the intervascular space.
Chang: (paragraph 53+61; fluid dispensed from the fluid delivery section 110 of injector 120 is conveyed from pressure/fluid space to the target site where the tip 122 is positioned)
Regarding claim 21, Chang in view of Bright discloses:
The catheter of claim 1, wherein the filler comprises an adhesive.
Bright: (paragraph 179+216+224; hydrogel dispensed by the modified invention of Chang in view of Bright comprises a glue medium and therein an adhesive)
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Chang, as applied to claim 1 above, in view of WO 02055130 A2, henceforth written as Hiblar.
Regarding Claim 4,
Chang in view of Bright discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The catheter of claim 1, wherein --the expandable elements comprise inflatable balloons --.
Chang: (inflatable balloons 114 114’; fig 1)
However, only for the sake of applicant’s arguments regarding disagreement of Chang’s teachings such that Chang’s is silent regarding:
The catheter of claim 1, wherein the shaft includes an inflation lumen, and the expandable elements comprise inflatable balloons in fluid communication with the inflation lumen.
However, Hiblar teaches in a balloon catheter:
wherein the shaft includes an inflation lumen, and - inflatable balloons in fluid communication with the inflation lumen
(catheter 66 has balloon inflation lumen 38 to inflate balloon 20 and balloon 120; fig 1+7)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to implement Hiblar’s teachings of a lumen within a catheter conveying balloon inflating media to the modified catheter embodiment of Chang in view of Bright in order to advantageously arrive at a catheter which can convey inflating media to an inflatable element within a catheter from a fluid source improving the operability of the invention to inflate its inflatable balloons as desired to support its medical application.
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 FORREST DIPERT whose telephone number is (703)756-1704. The examiner can normally be reached M-F 8:30am-5pm eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FORREST B DIPERT/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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