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 12/4/2025 . As directed by the amendment: claim(s) 1 and 10 has/have been amended. Thus, claims 1-20 are presently pending in this application.
Priority
Priority to the international application PCT/US2020/046073 has been acknowledged.
Election/Restriction
Applicant's election with traverse of Group I, claims 1-9 in the reply filed on 12/4/2025 is acknowledged. The traversal is on the ground(s) that the office action’s interpretation of the prior art of JP 200339874 as disclosing the shared technical feature is incorrect. This is not found persuasive.
Regarding applicant’s argument regarding the traversal of the restriction in their remarks section:
Applicant particularly argues the interpretation of the claim term "filler" should only be construed as "a composition, especially a semisolid that hardens on drying, used to fill pores, cracks, or holes." as provided by the American Heritage Dictionary of The English Language, and that the interpretation provided in the preceding office action was too broad as the prior art's filler allegedly could not harden/solidify to form an intravascular bridge.
However, examiner notes that this is an impermissibly narrow interpretation of the claim term "filler". Applicant neglects to provide that the American Heritage Dictionary of The English Language definition of the term "filler" in its entirety reads as:
"One that fills, as:
Something added to augment weight or size or fill space.
A composition, especially a semisolid that hardens on drying, used to fill pores, cracks, or holes in wood, plaster, or other construction surfaces before finishing.
Tobacco used to form the body of a cigar.
A short item used to fill space in a publication.
Something, such as a news item, public-service message, or music, used to fill time in a radio or television presentation.
A sheaf of loose papers used to fill a notebook or binder.
Architecture An element, such as a plate, used to fill the space between two supporting members."
It's clear that the meaning of the term "filler" is understood as "one that fills", and a filler being a specific material composition which hardens is merely a specific type of filler and constitutes too narrow an interpretation of the term, and further in view of the entire quotation of this specific filler term is clearly more specifically refer to construction surfaces like wood, concrete, or plaster, and not a blood vessel.
Examiner notes that broadest reasonable interpretation of the claim term " filler" to a person of ordinary skill in the art, not inconsistent with the disclosure, may be best provided by American Heritage Dictionary of The English Language's dictionary, as well as Merriam-Webster's and Oxford's English dictionaries: "one that fills ", or as otherwise written "one that takes up space". Such an interpretation is not inconsistent with the meaning of the term used throughout the disclosure, as the filler material M is disposed in the intervascular space to take up some amount of volume, see page 8 and fig 10 of Applicant's disclosure which details its disposal, and therein taking up volume, in the intervascular space. Thus for the reasons detailed in preceding office action, the prior art of JP 200339874, and as will be apparent in the present office action, the presently applied prior art of US 20060106338 A1 also discloses this feature.
Examiner notes for applicant that the present claims are absent certain functional features or specific materials which are disclosed by applicant as attributing to filler’s ability to form a solid/hardened structural bridge between two proximate blood vessels. If such features/functions were amended to the claims they may distinguish such claims from the prior art rejection presently of record.
Accordingly, for the reasons provided in the requirement for restriction mailed 10/20/2025, and the above remarks from examiner, applicant's traversing remarks are not persuasive and there remains a lack of unity between the inventions of Group I, II, and III.
The requirement is still deemed proper and is therefore made FINAL.
Claims 10 -20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/4/2025.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 7, and 9 are rejected under 35 U.S.C. 102(A)(1) as being anticipated by US 20060106338 A1, henceforth written as Chang.
Regarding claim 1, Chang discloses:
A catheter for relieving compression among blood vessels by introducing
(injection catheter 102; fig 1)
a filler into an intervascular space, comprising:
( fluid (not enumerated) is injected from injector 120; 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; expandable elements supported by the shaft; and
(paragraph 60-62;fig 1 illustrates balloons 114 114' being supported by a body (not enumerated) of catheter 102
a needle supported by the shaft, the needle, when deployed, including
(fluid delivery section 110 of injector 122; fig 1)
a tip located between the expandable elements for introducing the filler into the intervascular space.
(paragraph 51+58; fig 1e best illustrates injector 120's tip 122, extending from between balloons 114 114' and in a position 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, to deliver
Regarding claim 2, Chang discloses:
The catheter of claim 1, wherein the shaft includes a lumen, and the needle is hollow and in communication with the lumen.
(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)
Regarding claim 7, Chang discloses:
The catheter of claim 1, wherein the needle is curved when deployed between the expandable elements.
(fig 1d best demonstrates the manner that injector 120 is curved while it is deployed between balloons 114 114')
Regarding claim 9, Chang 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.
(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)
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 3-6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Chang, as applied to claim 1 above.
Regarding Claim 3,
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 2, further including an actuator for deploying the needle from a retracted position within the lumen.
However, Chang teaches in an alternative embodiment:
an actuator for deploying the needle from a retracted position within the lumen
(paragraph 66-69; a trigger (not enumerated/illustrated), therein the actuator, may be released to automatically deploy the injector from within the catheter)
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 means for automatically deploying an injector needle to the present catheter embodiment of Chang in order to advantageously arrive at an invention which may protect an needle prior to use and rapidly deploy the injector upon its fluid injecting function being desired, see paragraph 66 of Chang.
Regarding Claim 4,
Chang 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 --.
(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 present catheter embodiment of Chang 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 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 present catheter embodiment of Chang 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 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 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 catheter body proximal of/distal to/between the inflatable balloons in a desired direction)
Notably, MPEP 2144.04(VI)(B) provides that an modification of the prior 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 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.
Conclusion
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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/FORREST B DIPERT/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783