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 .
Claims 1-20 are pending in the instant application and are examined on the merits herein.
Priority
The instant application is a 371 of PCT/KR2023/002064 filed 02/13/2023 which claims priority to KR10-2022-0045275 filed on 04/12/2022.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claims 1-20 receive priority to the prior-filed application, filed on 04/12/2022.
Drawings
The drawings are objected to under 37 CFR 1.83(a). Fig. 2 states “fowrad direction”. This should read “forward direction”. Fig. 3 states “pattered channel”. This should read “patterned channel”. 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.
Specification
The disclosure is objected to because of the following informalities:
Brachial lymph node is written as “branchial lymph node” in para. 0019.
Appropriate correction is required.
Claim Objections
Claims 3, 11-12, 16, and 20 are objected to because of the following informalities:
Claims 3 and 16 recites the limitation “poly(lactide-caprolactone” in ln. 4. This should read “poly(lactide-caprolactone)”.
Claims 11, 12, and 20 recite the limitation “branchial lymph node” in ln. 3, 2, and 2. In line with the specification (para. 0084), this should read “brachial lymph node”.
Claim 16 recites the limitation “wherein biocompatible polymer” in ln. 1-2. This should read “wherein the biocompatible polymer”.
Appropriate correction is required.
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.
Claim 6 is 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.
Claim 6 recites the limitation “wherein the artificial structure forms a lymphatic network” in ln. 1-2. This limitation is indefinite in that it is unclear how the artificial structure itself forms a lymphatic network. The applicant’s specification (para. 0071) notes that the artificial structure is configured to form a lymphatic network when it serves as a pathway for immune cells, lymph, tissue fluid, etc., to flow when implanted in vivo. For the sake of compact prosecution, the examiner is treating the claim as though it reads “wherein the artificial structure is configured to form a lymphatic network when it serves as a pathway for immune cells, lymph, tissue fluid, etc., to flow when implanted in vivo”.
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 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 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.
Claims 1-2, 5-6, 8-13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over US/2004/0254521 A1 to Simon in view of US/2025/0152421 A1 to Wang (citations from PGPUB and corresponding sections of machine translated foreign priority document CN/2022/10143155.5 filed 02/16/2022).
Regarding claims 1 and 8-10, Simon discloses
(Claim 1) an artificial structure (para. 0060; para. 0069; Fig. 4, glaucoma shunt 100D), comprising:
a first sheet (Fig. 4, first sheet 102a); and
a second sheet arranged on the first sheet and including at least two channels (Fig. 4, second sheet 102b comprising microchannels 110), each channel including
an inlet (Fig. 4, microchannels 110 comprising 112A inflow ports),
an outlet (Fig. 4, microchannels 110 comprising 112B outflow ports), and
a pattern on a first surface facing the first sheet (Fig. 4, microchannels 110 creating pattern on the first surface of the second sheet 102b facing the first sheet 102a).
Simon differs from the instantly claimed invention in that Simon fails to disclose
(Claim 1) a one-way channel structure configured to maintain a one-way flow of fluid from the inlet toward the outlet;
(Claim 8) wherein the at least two channels each comprise:
a primary channel connecting the inlet to the outlet and providing a direction of main flow of lymph; and
at least two anti-backflow channels, each of which is connected to the primary channel and has a structure configured to prevent backflow;
(Claim 9) wherein the primary channel has a zig-zagged linear structure, and
the at least two anti-backflow channels each have a curved structure; and
(Claim 10) wherein the at least two anti-backflow channels are staggered at regular intervals along the primary channel.
Wang teaches an implantable glaucoma device (Fig. 2, glaucoma device 1; para. 0045-0051/pg. 4:13-6:4) comprising
(Claim 1) a one-way channel structure configured to maintain a one-way flow of fluid from the inlet toward the outlet (Fig. 2, one-way channel structure/Tesla valve 2 from inlet 13 to outlet 14; para. 0046-0051/pg. 4:17-6:4);
(Claim 8) wherein the channel comprises:
a primary channel connecting the inlet to the outlet and providing a direction of main flow of fluid (Fig. 6, primary channel in one-way channel structure/Tesla valve 2 is considered to be connected first channels 21 connecting inlet 13 to outlet 14; para. 0046-0051/pg. 4:17-6:4); and
at least two anti-backflow channels, each of which is connected to the primary channel and has a structure configured to prevent backflow (Fig. 6, backflow channels in one-way channel structure/Tesla valve 2 are considered to be second channels 22; para. 0046-0051/pg. 4:17-6:4);
(Claim 9) wherein the primary channel has a zig-zagged linear structure (Fig. 6, primary channel in one-way channel structure/Tesla valve 2 is considered to be connected first channels 21 in a zig-zagged linear structure), and
the at least two anti-backflow channels each have a curved structure (Fig. 6, backflow channels in one-way channel structure/Tesla valve 2 are considered to be curved second channels 22);
(Claim 10) wherein the at least two anti-backflow channels are staggered at regular intervals along the primary channel (Fig. 6, backflow channels in one-way channel structure/Tesla valve 2 are considered to be second channels 22 staggered along primary channel formed by connected first channels 21; para. 0046-0051/pg. 4:17-6:4); and
wherein the one-way channel structure effectively prevents backflow that affects therapeutic effect (para. 0044/pg. 4:13-16).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of Simon to comprise a one-way channel structure as taught by Wang, because Wang teaches that a one-way channel structure effectively prevents backflow that affects the therapeutic effect of the implant (para. 0044/pg. 4:13-16).
Further, the cited prior art fail to disclose the channel structure configured to maintain a flow of lymph. This is considered to be functional language (in view of the specific use case claimed- flow of lymph). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2114. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the channels of Simon and Wang are capable of allowing liquid flow (Simon: para. 0068, liquid flows through microchannels 110; Wang: para. 0045-0051/pg. 4:13-6:4). As such, the device is capable of performing the function as claimed (i.e. it is capable of being used for flow of lymph).
Regarding claim 2, the cited prior art suggests the invention of claim 1. Simon further discloses wherein the first sheet and the second sheet are each formed of a biocompatible polymer (para. 0060).
Regarding claim 5, the cited prior art suggests the invention of claim 1.
The cited prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the at least two channels are configured to be constricted by the skeletal muscle pressure when implanted into a subject.
Regarding the limitation “wherein the at least two channels are configured to be constricted by the skeletal muscle pressure when implanted into a subject”, the cited prior art does not explicitly disclose this limitation, but it follows naturally that the structure recited in Simon in view of Wang can be deformed in the manner claimed. As supported in MPEP 2112.01, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” Applicant’s specification notes that the artificial structure of their invention may have high elasticity to allow for constriction of the channels (para. 0055) and Simon discloses that the shunt of their invention can be made from a deformable material (para. 0060).
Regarding claim 7, the cited prior art suggests the invention of claim 1.
The cited prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the at least two channels each have a diameter of 200 to 1,000 microns.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the channels of Simon in view of Wang to have a diameter of 200 to 1,000 microns since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Simon in view of Wang would not operate differently with the claimed channel diameter and since Simon discloses that the characteristics of the microchannels can be changed based upon a given application (para. 0066) the device would function appropriately having the claimed channel diameter. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the channel diameter “may” be within the claimed ranges (specification para. 0056).
Regarding claims 6 and 11-12, the cited prior art suggests the invention of claim 1.
The prior art differs from the instantly claimed invention in that the prior art fails to disclose
(Claim 6) wherein the artificial structure is configured to form a lymphatic network when it serves as a pathway for immune cells, lymph, tissue fluid, etc., to flow when implanted in vivo;
(Claim 11) wherein the artificial structure is configured to be implanted in any at least one selected from the group consisting of a brachial lymph node (BLN), a superficial inguinal node, a deep inguinal node, and a popliteal lymph node;
(Claim 12) wherein the artificial structure is configured to be implanted in a brachial lymph node.
The limitations of claims 6 and 11-12 are considered to comprise functional language (in view of the specific use case claimed-implantable in any of the nodes claimed). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2114. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the artificial structure of Simon is capable of allowing liquid flow when implanted within the body (para. 0002; para. 0009; para. 0022; para. 0068, liquid flows through microchannels 110). As such, the device is capable of performing the function as claimed (i.e. it is capable of being implanted within any of the nodes claimed while allowing for liquid flow to form a lymphatic network).
Regarding claim 13, Simon discloses a method of forming an artificial structure (para. 0060; para. 0069; Fig. 4, glaucoma shunt 100D), the method comprising:
preparing a first sheet and a second sheet from a polymer (para. 0060; Fig. 4, first and second sheets 102a/102b); and
adhering the first sheet and the second sheet to position a pattern present on the a first side of the second sheet to face inwardly toward the first sheet (para. 0069; Fig. 4, microchannels 110 creating pattern on the first surface of the second sheet 102b facing inwardly toward the first sheet 102a), wherein
the artificial structure (para. 0060; para. 0069; Fig. 4, glaucoma shunt 100D) comprises
a first sheet (Fig. 4, first sheet 102a); and
a second sheet arranged on the first sheet and including at least two channels (Fig. 4, second sheet 102b comprising microchannels 110), each channel including
an inlet (Fig. 4, microchannels 110 comprising 112A inflow ports),
an outlet (Fig. 4, microchannels 110 comprising 112B outflow ports), and
a pattern on a first surface facing the first sheet (Fig. 4, microchannels 110 creating pattern on the first surface of the second sheet 102b facing the first sheet 102a).
Simon differs from the instantly claimed invention in that Simon fails to disclose a one-way channel structure configured to maintain a one-way flow of fluid from the inlet toward the outlet.
Wang teaches an implantable glaucoma device comprising a one-way channel structure configured to maintain a one-way flow of fluid from the inlet toward the outlet (Fig. 2, glaucoma device 1 comprising one-way channel structure/Tesla valve 2 from inlet 13 to outlet 14; para. 0045-0051/pg. 4:13-6:4).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of Simon to comprise a one-way channel structure as taught by Wang, because Wang teaches that the one-way channel structure effectively prevents backflow that affects the therapeutic effect (para. 0044/pg. 4:13-16).
Further, the cited prior art fail to disclose the channel structure configured to maintain a flow of lymph. This is considered to be functional language (in view of the specific use case claimed- flow of lymph). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2114. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the channels of Simon and Wang are capable of allowing liquid flow (Simon: para. 0068, liquid flows through microchannels 110; Wang: para. 0045-0051/pg. 4:13-6:4). As such, the device is capable of performing the function as claimed (i.e. it is capable of being used for flow of lymph).
Regarding claim 15, the cited prior art suggests the invention of claim 13. Simon further discloses wherein the artificial structure is formed of a biocompatible polymer (para. 0060).
Claims 3, 14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Simon and Wang as applied above, and further in view of US/2007/0293872 A1 to Peyman.
Regarding claims 3, 14, and 16, the cited prior art suggests the invention of claims 2, 13, or 15.
The cited prior art differs from the instantly claimed invention in that the prior art fails to disclose
(Claims 3 and 16) wherein the biocompatible polymer is at least one selected from the group consisting of polylactic acid (PLA), polyglycolic acid (PGA), poly-e-caprolactone (PCL), poly-L-lactic acid (PLLA), a poly(lactide-co-glycolic acid) (PLGA) copolymer, a poly(lactide-caprolactone (PLCL) copolymer, biodegradable polycarbonate, and a copolymer thereof; and
(Claim 14) wherein the polymer is polydimethylsiloxane (PDMS).
Peyman teaches a glaucoma shunt that can be made from polydimethylsiloxane, polylactic acid (PLA), polyglycolic acid (PGA), poly-e-caprolactone (PCL), poly-L-lactic acid (PLLA), a poly(lactide-co-glycolic acid) (PLGA) copolymer, and a copolymer thereof (para. 0028-0031; Fig. 2, shunt 46).
As Peyman discloses a glaucoma shunt that may use the materials claimed, it would have been obvious to one having ordinary skill in the art at the time the invention was made to use the materials claimed as disclosed by Peyman in the glaucoma shunt suggested by the prior art, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP § 2144.07.
Claims 4 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Simon and Wang as applied above, and further in view of US/2014/0343476 A1 to Penhasi.
Regarding claims 4 and 17, the cited prior art suggests the invention of claims 2 or 13.
The cited prior art differs from the instantly claimed invention in that the cited prior art fails to disclose
(Claims 4 and 17) wherein the biocompatible polymer is hydrophobic.
Penhasi teaches a glaucoma shunt that can be made from biocompatible hydrophobic polymers (para. 0002-0003; para. 0062; para. 0119; Fig. 1, shunt 102).
As Penhasi discloses a glaucoma shunt that may use the materials claimed, it would have been obvious to one having ordinary skill in the art at the time the invention was made to use the materials claimed as disclosed by Penhasi in the glaucoma shunt suggested by the prior art, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP § 2144.07.
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Simon and Wang as applied above, and further in view of US/2017/0340430 A1 to Moore.
Regarding claims 18-20, the cited prior art suggests the invention of claim 1.
The prior art differs from the instantly claimed invention in that the prior art fails to disclose
(Claim 18) method of treating a lymphedema-related condition, the method comprising implanting, into a patient in need of treatment, an artificial structure
(Claim 19) wherein the lymphedema-related condition is at least one selected from the group consisting of Milroy disease, Meige lymphedema, lymphedematarda, secondary lymphedema, and lipedema;
(Claim 20) wherein the artificial structure is implanted at at least one selected from the group consisting of a brachial lymph node (BLN), a superficial inguinal node, a deep inguinal node, and a popliteal lymph node.
Moore teaches a
(Claim 18) method of treating a lymphedema-related condition, the method comprising implanting, into a patient in need of treatment, an artificial structure (para. 0003-0004; para. 0040-0043; para. 0085-0086; Fig. 15-16, artificial lymph structure 310);
(Claim 19) wherein the lymphedema-related condition is at least one selected from the group consisting of Milroy disease, Meige lymphedema, lymphedematarda, secondary lymphedema, and lipedema (para. 0003-0004, secondary lymphedema from the removal of lymph nodes under the arm in mastectomy; para. 0040-0043; para. 0085-0086; Fig. 15-16, artificial lymph structure 310);
(Claim 20) wherein the artificial structure is implanted at at least one selected from the group consisting of a brachial lymph node (BLN), a superficial inguinal node, a deep inguinal node, and a popliteal lymph node (para. 0003-0004, secondary lymphedema from the removal of lymph nodes under the arm [brachial lymph nodes are present under the arm] in mastectomy; para. 0040-0043; para. 0085-0086; Fig. 15-16, artificial lymph structure 310).
The shunt of Moore is considered to be functionally equivalent to the shunt of Simon in view of Wang in that Moore’s shunt (Fig. 15-16, artificial lymph structure 310) comprises multiple channels (Fig. 15-16, channels 333), each channel comprising an inlet (para. 0085-0086; Fig. 15-16, inlets 324/326), an outlet (para. 0085-0086; Fig. 15-16, outlets 330), and a one-way channel structure configured to maintain a flow of lymph from the inlet toward the outlet (para. 0025; para. 0077, unidirectional valve structure having no moving parts [US1329559]; para. 0085-0086). As Moore teaches a functionally equivalent structure to that of Simon in view of Wang that can be used in the methods claimed, it would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize the shunt of Simon in view of Wang in the methods claimed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. WO/2021/262176 A1 to Garland discloses a lymph conduction implant. WO/2017/015571 A1 to Labib discloses a lymphatic implant comprising hollow fibers. WO/2016/174379 A1 to Bateman discloses a tracheostomy tube comprising a one-way channel structure. U.S. Patent no. 1,329,559 A to Tesla discloses a one-way channel structure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm.
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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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/Linnae E. Raymond/Examiner, Art Unit 3781
/LESLIE R DEAK/Primary Examiner, Art Unit 3799
10 July 2026
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