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
The Amendments filed 07/15/2025 have been entered.
Claims 1-2, 4-10 and 12-18 have thereby been amended.
Claim 11 has been canceled.
Claims 1-10 and 12-18 are being examined in this office action.
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 “non-expendable mesh reservoir” limitation of claim 14 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 1-10 and 12-18 are objected to because of the following informalities: claim 1 recites “a ballon-based securement mechanism” and should instead read “a balloon-based securement mechanism”. Additionally, claims 2-18 should be included in the objection because any claims that depend on an objected claim inherit the problems of their parent claims. Appropriate correction is required.
Claim 1 recites “the reservoir” however, “a reservoir” is not previously referenced, and only “an expandable mesh reservoir” is previously referenced. Applicant is recommended to preplace “the reservoir” with “the expandable mesh reservoir” as it is interpreted to refer to and as referenced in independent claim 1 to maintain clarity and claim consistency.
Claim Rejections - 35 USC § 112
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.
Claims 1-10 and 12-18 are 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the phrase "balloon-based" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "-based" just as those by “-type”), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(b)(III)(E). It is unclear whether the “balloon-based” mechanism must encompass mechanisms that include a balloon, having air pressure blown expansion, or if this includes mechanisms that simply have the action of ballooning/expanding without the actual balloon structure. For the purposes of examination, “balloon-based securement mechanism” is interpreted broadly as a securement mechanism having a ballooning/expanding structure, or being coupled to and/or associated with a balloon (or expandable or inflatable structure) on the device.
Claim 14 recites the limitation "the non-expendable mesh reservoir". It is unclear what is meant by “the non-expendable mesh reservoir,” as only an “expandable mesh reservoir” and “expandable reservoir” is referred to in the claims, specification and drawings. Neither the drawings or specification provide further embodiment, definition or structure for "a non-expendable mesh reservoir" in the instant device. For the purposes of examination, the non-expendable mesh reservoir is interpreted as the expandable mesh reservoir as examined in claim 1.
Additionally, claims 2-10, 12-13, and 15-18 should be included in the rejection because any claims that depend on a rejected claim inherit the problems of their parent claims.
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.
Claims 1-4, 8-10, 12, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eidenschink (US 20130345796).
Regarding claim 1, Eidenschink discloses a device utilized for the administration of medications, fluids, or parenteral nutrition, the device comprising: an expandable mesh reservoir (Fig. 2A: 60) insertable under the skin in a collapsed form (page 5, para. [0065], first sentence), wherein the mesh is expanded (page 5, para. [0065], last sentence) after insertion to form an interstitial fluid chamber (Fig. 8A shows expansion within the vessel after insertion) and utilized with a stylet guided catheter (11: guided by pigtail stylet tip) securely connected to an infusion system; and a balloon-based securement mechanism to removably anchor the stylet guided catheter within the reservoir without external access (Figs. 2A and 2C: 11 inserted and removably anchored within 60 through lumen 28; page 3, para. [0044], sentence 3) utilized for administration of medications, a fluid, or parenteral nutrition.
Eidenschink fails to explicitly disclose that the device is used to administer fluids, medications or nutrition. However, the functional language of “a device utilized for the administration of medications, fluids, or parenteral nutrition” has been carefully considered but deemed not to impose any structural limitation on the claims distinguishable over the structure of the catheter (11) of Eidenschink. Since the catheter (11) of Eidenschink has the same structure as the catheter for administration of fluid and medications (para. [0011] from the instant application) as disclosed in the instant application, Eidenschink is able to be used in the same manner as set forth in the claim.
Eidenschink also fails to explicitly disclose that the device is used with a stylet connected to an infusion system. However, the functional language of “utilized with a stylet guided catheter securely connected to an infusion system” has been carefully considered but deemed not to impose any structural limitation on the claims distinguishable over the structure of the pigtail catheter (11) of Eidenschink. Since the catheter (11) of Eidenschink has the same structure as a stylet probe and of the catheter for administration of fluid and medications via infusion system as claimed, Eidenschink is able to be used in the same manner as set forth in the claim, as pigtail catheters are known in the art to be used to administer therapies via infusion systems.
Regarding claim 2, Eidenschink discloses the device of claim 1, as described above, wherein the expandable mesh reservoir is expanded (page 5, para. [0065], last sentence) and utilized with a needle guided catheter.
Eidenschink fails to explicitly disclose that the device is used with a needle guided catheter. However, the functional language of “utilized with a needle guided catheter” has been carefully considered but deemed not to impose any structural limitation on the claims distinguishable over the structure of the catheter (11) of Eidenschink. Since the catheter (11) of Eidenschink has the same structure as the catheter for administration of fluid and medications (para. [0011] from the instant application) as disclosed in the instant application, Eidenschink is able to be used in the same manner as set forth in the claim, as its catheter is capable of being inserted and guided via a needle.
Regarding claim 3, Eidenschink discloses the device of claim 1, as described above, wherein the expandable mesh reservoir is expanded via a balloon (page 5, para. [0065], last sentence).
Regarding claim 4, Eidenschink discloses the device of claim 1, as described above, wherein the expandable mesh reservoir is constructed of a bare metal or metal mesh (page 3, para. [0041], last sentence; stiffening wires 68 of the mesh shown in Fig. 2A).
Regarding claim 8, Eidenschink discloses the device of claim 1, as described above, wherein the reservoir (Fig. 2A: reservoir space within mesh 60 upon its expansion) is used in conjunction with a patient-controlled anesthesia pump.
Eidenschink fails to explicitly disclose that the device is used with a patient-controlled anesthesia pump. However, the functional language of “the expandable mesh reservoir is used in conjunction with a patient-controlled anesthesia pump” has been carefully considered but deemed not to impose any structural limitation on the claims distinguishable over the structure of the catheter (11) of Eidenschink. Since the catheter (11) of Eidenschink has the same structure as the catheter for administration of fluid and medications (para. [0011] from the instant application) as disclosed in the instant application, Eidenschink is able to be used in the same manner as set forth in the claim, as its catheter is capable of being paired with administered anesthesia via a patient-controlled pump.
Regarding claim 9, Eidenschink discloses the device of claim 1, as described above, wherein the reservoir (Fig. 2A: reservoir space within mesh 60 upon its expansion) is used to treat dehydration.
Eidenschink fails to explicitly disclose that the device is used to treat dehydration. However, the functional language of “the expandable mesh reservoir is used to treat dehydration” has been carefully considered but deemed not to impose any structural limitation on the claims distinguishable over the structure of the catheter (11) of Eidenschink. Since the catheter (11) of Eidenschink has the same structure as the catheter for administration of fluid and medications (para. [0011] from the instant application) as disclosed in the instant application, Eidenschink is able to be used in the same manner as set forth in the claim, as its catheter is capable of delivering hydrating fluids or other medications for treating dehydration.
Regarding claim 10, Eidenschink discloses the device of claim 1, as described above, wherein the reservoir (Fig. 2A: reservoir space within mesh 60 upon its expansion) is used to treat hypovolemic shock.
Eidenschink fails to explicitly disclose that the device is used to treat hypovolemic shock. However, the functional language of “the expandable mesh reservoir is used to treat hypovolemic shock” has been carefully considered but deemed not to impose any structural limitation on the claims distinguishable over the structure of the catheter (11) of Eidenschink. Since the catheter (11) of Eidenschink has the same structure as the catheter for administration of fluid and medications (para. [0011] from the instant application) as disclosed in the instant application, Eidenschink is able to be used in the same manner as set forth in the claim, as its catheter is capable of delivering fluids, blood, or other medications for treating hypovolemic shock.
Regarding claim 12, Eidenschink discloses the device of claim 1, as described above, further comprising a needle-guided catheter secured by an inflatable balloon within the expandable mesh reservoir (Fig. 2A: catheter 20 secured to balloon 40 within 60).
Regarding claim 18, Eidenschink discloses the device of claim 1, as described above, wherein the expandable mesh reservoir and the catheter comprise a single device (Fig. 2A: shaft/catheter 20 and reservoir space within mesh 60 upon its expansion, are a single device).
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Eidenschink (US 201303455796) in view of Du (CN 111528986).
Regarding claim 5, Eidenschink discloses the device of claim 1, as described above, however, fails to disclose that the mesh eludes a drug to decrease the proliferation of interstitial tissue.
Du teaches an analogous balloon catheter with mesh, wherein the balloon surrounded by the mesh is coated in and eludes a drug to decrease proliferation of interstitial tissue (Translation: page 7, fourth paragraph from the bottom, first sentence). Therefore, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Eidenschink device with the Taxol drug coating taught by Du in order to prevent or treat intimal hyperplasia (Translation: page 7, fourth paragraph from the bottom, first sentence). Furthermore, although it would have been obvious for a person of ordinary skill in the art to have coated the expandable mesh reservoir surrounding the balloon in the drug in addition to the balloon itself to cover a greater surface area for delivery.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Eidenschink (US 201303455796) in view of Koike (WO 02068037).
Regarding claim 6, Eidenschink discloses the device of claim 1, as described above, wherein the expandable mesh reservoir is constructed from a polymer (page 3, para. [0040], second sentence). Eidenschink fails, however, to explicitly disclose that the polymer is biodegradable.
Koike teaches an analogous balloon catheter with a mesh stent made from a biodegradable polymer (Translation: page 9, fourth paragraph, sentences 1-3). Therefore, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the mesh of the Eidenschink with the biodegradable polymer mesh taught by Koike, in order to provide a biocompatible material and to degrade overtime in the body such as to slowly release embedded drugs.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Eidenschink (US 201303455796) in view of Koike (WO 02068037) in further view of Qiu (CN 105073173).
Regarding claim 7, Eidenschink discloses the device of claim 6, as best understood and described above, however, fails to disclose that the mesh eludes a drug to decrease the proliferation of interstitial tissue.
Qiu teaches an analogous ballooning/expanding, wherein the catheter expanding wings (analogous to the mesh of the instant invention) is covered by an enzyme hyaluronidase (Translation: page 12, second paragraph, second sentence). Therefore, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Eidenschink expandable mesh reservoir with the hyaluronidase coating taught by Qiu in order to prevent tissue fibrosis (Translation: page 12, second paragraph, first sentence). The limitation of the hyaluronidase to degrade extracellular matrix and enhance drug diffusion is an intended result limitation for the intended outcome of the hyaluronidase coating, and as such is given no patentable weight, as the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable (see MPEP 2112.I.).
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Eidenschink (US 201303455796) in view of Smith (US 4979955).
Regarding claim 13, Eidenschink discloses the device of claim 1, as described above, wherein the expandable mesh reservoir is attached to an implantable device (Figs. 8C and 8D: implantable valve device 7 attached to the reservoir within expandable mesh reservoir 560) to create an open space around the implantable device (543) to administer one or more medications.
Eidenschink discloses the implantable device being inserted as a prosthetic heart valve (page 5, para. [0063], sentences 1-2), but fails to explicitly disclose that the implantable device is rechargeable.
Smith teaches an analogous prosthetic heart valve (10) that has an integrated rechargeable implantable battery (102). Therefore, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implanted prosthetic heart valve of Eidenschink with the rechargeable prosthetic heart valve of Smith in order to work in tandem with a pacemaker (col. 8, lines 55-65).
Regarding claim 14 as best understood, Eidenschink discloses the device of claim 1, as described above, wherein the non-expendable mesh reservoir (interpreted as stated above in Claim Rejections - 35 USC § 112) is attached to an implantable device (Figs. 8C and 8D: implantable valve device 7 attached to the reservoir within balloon 540 and mesh 560) to create an open space around the implantable device (543) to administer one or more medications.
Eidenschink discloses the implantable device being inserted as a prosthetic heart valve (page 5, para. [0063], sentences 1-2), but fails to explicitly disclose that the implantable device is rechargeable.
Smith teaches an analogous prosthetic heart valve (10) that has an integrated rechargeable implantable battery (102). Therefore, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implanted prosthetic heart valve of Eidenschink with the rechargeable prosthetic heart valve of Smith in order to work in tandem with a pacemaker (col. 8, lines 55-65).
Regarding claim 15, Eidenschink in view of Smith teaches the device of claim 13, as described above, wherein the expandable mesh reservoir (Eidenschink Fig. 2A: reservoir space within mesh 60 upon its expansion) is used to administer one or more medications to treat substance use disorder.
Eidenschink fails to explicitly disclose that the device is used to treat substance use disorder. However, the functional language of “the reservoir is used to administer one or more medications to treat substance use disorder” has been carefully considered but deemed not to impose any structural limitation on the claims distinguishable over the structure of the catheter (11) of Eidenschink. Since the catheter (11) of Eidenschink has the same structure as the catheter for administration of fluid and medications (para. [0011] from the instant application) as disclosed in the instant application, Eidenschink is able to be used in the same manner as set forth in the claim, as its catheter is capable of delivering medications for the treatment of substance use disorder.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Eidenschink (US 201303455796) in view of Smith (US 4979955) in further view of Edelman (CN 104780952).
Regarding claim 16, Eidenschink discloses the device of claim 15, as described above, wherein the implantable device is used to administer naltrexone. Eidenschink discloses the implantable device being inserted as a prosthetic heart valve (page 5, para. [0063], sentences 1-2), but fails to explicitly disclose that the implantable device is rechargeable.
Smith teaches an analogous prosthetic heart valve (10) that has an integrated rechargeable implantable battery (102). Therefore, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implanted prosthetic heart valve of Eidenschink with the rechargeable prosthetic heart valve of Smith in order to work in tandem with a pacemaker (col. 8, lines 55-65).
Eidenschink fails to explicitly disclose that the implantable device is used to administer naltrexone. However, the functional language of “used to administer naltrexone” has been carefully considered but deemed not to impose any structural limitation on the claims distinguishable over the structure of the implantable valve devices of both Eidenschink and Smith, since these valve devices have a structure that allows them to administer drugs, as evidenced but the drug eluting prosthetic heart valve taught by Edelman (Translation: page 4, lines 1-4). Eidenschink is able to be used in the same manner as set forth in the claim, as it is structurally capable of eluting the drug naltrexone.
Regarding claim 17, Eidenschink discloses the device of claim 15, as described above, wherein the implantable device is used to administer disulfiram. Eidenschink discloses the implantable device being inserted as a prosthetic heart valve (page 5, para. [0063], sentences 1-2), but fails to explicitly disclose that the implantable device is rechargeable.
Smith teaches an analogous prosthetic heart valve (10) that has an integrated rechargeable implantable battery (102). Therefore, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implanted prosthetic heart valve of Eidenschink with the rechargeable prosthetic heart valve of Smith in order to work in tandem with a pacemaker (col. 8, lines 55-65).
Eidenschink fails to explicitly disclose that the implantable device is used to administer disulfiram. However, the functional language of “used to administer disulfiram” has been carefully considered but deemed not to impose any structural limitation on the claims distinguishable over the structure of the implantable valve devices of both Eidenschink and Smith, since these valve devices have a structure that allows them to administer drugs, as evidenced but the drug eluting prosthetic heart valve taught by Edelman (Translation: page 4, lines 1-4). Eidenschink is able to be used in the same manner as set forth in the claim, as it is structurally capable of eluting the drug disulfiram.
Response to Arguments
Applicant's arguments filed 07/15/2025 have been fully considered but they are not persuasive.
The amendments made to claims 13 and 14 resulted in the drawing objection to claim 13 to be withdrawn. However, claim 14 remains rejected to for the “non-expandable mesh reservoir” not being depicted and labeled in the drawings.
The amendments made to claims 6, 12-14 and 16-17 resulted in the respective 112(b) rejections to be withdrawn, however, the amendments resulted in new 112(b) rejections described above regarding claims 1 and 14.
Applicant argues that Eidenschink does not anticipate independent claim 1 and depending claims 2-4, 8-10, 12 and 18 because the Eidenschink device is used for applying magnetic field therapy within vasculature, different from the intended use of the instant application. However, even though the Eidenschink device discloses additional structures and features not claimed in the instant application, and is disclosed to be used for a therapy different than that of the instant application, as described in the rejections above, Eidenschink does disclose the claimed limitations as they are currently written, and is capable to be used for the same use of delivering medications, fluids or parenteral nutrition in the same manner as the claimed invention. Therefore, Examiner maintains that claims 1-4, 8-10, 12 and 18 are not novel over Eidenschink.
Applicant argues that in light of the amendments filed 07/15/2025, independent claim 1 is unsupported by Eidenschink. However, as cited in the rejection above, Eidenschink does disclose the expandable mesh reservoir, the stylet guided catheter, and the balloon-based securement mechanism, given its broadest reasonable interpretation. Applicant asserts that the amendment of “expandable mesh reservoir” of claims 2 and 7 is unsupported by Eidenschink, however, the mesh (60) of Eidenschink does expand and does create a reservoir within it.
Therefore, dependent claims 5-7, 13-17 are not considered allowable for the same reasons as claim 1 and by virtue of their dependency from claim 1, as Applicant argues. For these reasons, the rejections as recited above are maintained.
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 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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/K.A.W./Examiner, Art Unit 3783 /MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783