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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-13) and Species A (figs. 1a-c and figs. 1a-b) in the reply filed on 07/10/2026 is acknowledged.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed 03/08/2024 and 10/03/2024 has/have been considered by the Examiner.
Status of the Claims
Claims 1-13 and 24-35 are currently pending. Claims 24-35 are newly added. Claims 2 and 10-13 are currently withdrawn. Claims 14-23 are cancelled. Claims 1, 3-9, and 24-35 are currently rejected.
Claim Objections
Claims 30 and 34 are objected to because of the following informalities:
Claim 30 line 3 reads “and the height of the pillars are greater than the width”. This should read “and the height of the pillars is greater than the width”.
Claim 34 line 2 reads “a range of from”, and lines 3-4 similarly read “a range of from”. Both instances should read “a range .
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.
Claims 8-9, 24, 27-29, 32, and 34-35 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.
Claim 8 recites the limitation “laser-patterned metal mold insert” in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, this has been interpreted to read “a laser-patterned metal mold insert”.
Claim 9 recites the limitation “a liquid tissue adhesive” in line 3. Claim 1 already introduced “a liquid tissue adhesive” in the third to last line. It is unclear whether the instance of this limitation in the dependent claim is meant to introduce a new structure (in which case the naming convention should be altered to distinguish the structures) or refer back to the same structure earlier introduced (in which case the article should be changed to “the”). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 24 recites the limitation “droplets of adhesive” in line 2. Claim 1 already introduced “a liquid tissue adhesive” in the third to last line and “micro-droplets of the liquid tissue adhesive” in the last and second to last line. It is unclear whether the instance of this limitation in the dependent claim is meant to introduce a new structure (in which case the naming convention should be altered to distinguish the structures) or refer back to the same structure earlier introduced (in which case the article should be changed to “the” and the naming convention maintained throughout the claims). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claims 26, 27, 28, and 29 recite the limitation “the micro-patterned surface” on lines 1-2. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether these claims are meant to depend on claim 5 instead of claim 1, since claim 5 does introduce “an injection-molded, micro-patterned polymer surface”; whether the instances of “the micro-patterned surface” in claims 26, 27, 28, and 29 are instead meant to recite and refer back to “a micro-textured surface” as introduced in claim 1; or whether each of claims 26, 27, 28, and 29 is meant to separately introduce a “micro-patterned surface” (in which case “the” should be replaced with “a” in each instance). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 32 recites the limitation “a plurality of spaced pillars have a width at a top of the pillars than at a bottom of the pillars”. It is unclear what this limitation is supposed to convey. Is the width of the pillar consistent based on the height? Does the width of the pillar vary based on the height? If so, does the height increase or decrease with height? Do the pillars all share a single continuous top/bottom? Does each pillar have its own top/bottom? Is the width at the top of the pillars being compared to a width at the bottom of the pillars, or is the width at the top of the pillars being compared to some other metric? For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 34 recites the limitation “a plurality of pillars having a width in a range of from 2.5 to 80 µm and widths in a range of from 2.5 µm to 25 µm”. It is unclear whether “a width” and “widths” are meant to refer to the same width, widths at different points along the same structure, widths of different structures, or two different dimensions (such as length and width) of the same structure. It is further unclear whether “a width” has one range and “widths” has a second range, whether the second list of ranges is merely a suggested preferred sub-range of the first range, or whether only one range was meant to be listed at all. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 35 recites the limitation “the micro-textured the plurality of pillars having spacing”. There is insufficient antecedent basis for the limitation “the micro-textured”, and it is unclear whether this term is meant to introduce a new structure or refer back to the “micro-textured surface” of claim 1. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 35 recites the limitation “the micro-textured the plurality of pillars having spacing”. It is unclear how “the micro-textured” and “the plurality of pillars” are related. It is further unclear whether “the micro-textured” has spacing, “the plurality of pillars” has spacing, or there is spacing between these two limitations somehow. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 35 recites the limitation “spacing between individual pillar such as micro-pillars in a range of from 50 µm to 500 µm”. It is unclear whether “micro-pillars” is meant to introduce a new structure or further specify that the previously introduced “pillars” are “micro-pillars”. It is then further unclear whether the noted range refers to the size of the pillars, the size of the micro-pillars (if this is a separate limitation), or the size of an empty space formed between adjacent pillars and/or micro-pillars. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 35 recites the limitation “spacing between individual pillar such as micro-pillars in a range of from 50 µm to 500 µm”. It is unclear whether "spacing between individual pillar" is meant to refer to the width/length/height of a single pillar or whether this "spacing" refers to empty space between individual adjacent pillars, plural. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claims 9 and 35 are rejected at least for depending upon a claim rejected under 112(b), since claims inherit the deficiencies of those claims from which they depend.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The 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, 3-4, 24-25, and 33 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Rajendran et al (US 20140316327 A1).
Regarding claim 1, Rajendran discloses a catheter adapter (apparatus 200, fig. 2a, [0224]) assembly comprising:
a catheter body (catheter 202, fig. 2a, [0224]) comprising a proximal end, a distal end, and a lumen (lumen 226, fig. 2b, [0227] “catheter 202 includes a lumen 226 extending from a proximal end to a distal end”) formed by an inner wall of the catheter body (see fig. 2b below which shows lumen 226 formed by inner wall of catheter body 202) that extends between the proximal end and the distal end along a longitudinal axis (see fig. 2b below);
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the catheter body further comprising an external surface that extends between the proximal end and the distal end (see fig. 2b above), the external surface comprising a first portion (echogenic region, fig. 2b, [0227] Referring now to FIG. 2B, the distal portion of the catheter 202 includes an echogenic region 222 including echogenic material to aid with ultrasound visualization of a distal tip of the catheter 202) and a second portion (frictional region 220, fig. 2a and 2b, [0226] frictional region 220, e.g., pebbled region, is optionally added to a proximal portion of the catheter 202); and
the second portion of the external surface including a micro-textured surface ([0226] “The frictional region 220 is configured to aid in sealing an insertion site in the tissue, minimize leakage of contrast and/or pharmacological agent, and minimize movement of the catheter 202.”) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to spread drops of a liquid tissue adhesive across the second portion of the external surface by capillary action to form a thin film and/or micro-droplets of the liquid tissue adhesive (Examiner notes that the liquid tissue adhesive is only functionally claimed, and the textured surface of the catheter body is capable of adhesion with adhesive, thus satisfying the functional limitation; [0226] “The frictional region 220 may include an adhesive material including a bioresorable material and non-bioresorable material.”).
Regarding claim 3, Rajendran discloses the catheter adapter assembly of claim 1, as described above, including wherein the liquid tissue adhesive comprises at least one liquid monomer having a viscosity of less than 200 cps at room temperature (Examiner notes that the liquid tissue adhesive is only functionally claimed, so the further limitation of the functionally claimed liquid tissue adhesive is met by the catheter body meeting the functional limitation in claim 1 above.).
Regarding claim 4, Rajendran as modified discloses the catheter adapter assembly of claim 3, as described above, including wherein the liquid monomer comprises at least one cyanoacrylate (Examiner notes that the liquid tissue adhesive is only functionally claimed, so the further limitation of the functionally claimed liquid tissue adhesive is met by the catheter body meeting the functional limitation in claim 1 above.).
Regarding claim 24, Rajendran as modified discloses the catheter adapter assembly of claim 1, as described above, including wherein the micro-textured surface is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to allow droplets of adhesive (see 112b interpretation above) to percolate through the micro-textured surface (Examiner notes that the liquid tissue adhesive is only functionally claimed, so the further limitation of the functionally claimed liquid tissue adhesive is met by the catheter body meeting the functional limitation in claim 1 above.).
Regarding claim 25, Rajendran as modified discloses the catheter adapter assembly of claim 3, as described above, including wherein the liquid monomer is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to undergo an exothermic reaction upon exposure to atmospheric moisture (Examiner notes that the liquid tissue adhesive is only functionally claimed, so the further limitation of the functionally claimed liquid tissue adhesive is met by the catheter body meeting the functional limitation in claim 1 above.).
Regarding claim 33, Rajendran as modified discloses the catheter adapter assembly of claim 1, as described above, including wherein the micro-textured surface comprises indentations (note claim 1 rejection above, surface is textured, any depression in the texture would meet the description of an “indentation”) that are configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to promote capillary action of a liquid adhesive when placed in contact with the micro-textured surface (Examiner notes that the liquid tissue adhesive is only functionally claimed, so the further limitation of the functionally claimed liquid tissue adhesive is met by the catheter body meeting the functional limitation in claim 1 above.).
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(s) 1, 3-4, 24-25, and 33 are alternatively rejected under 35 U.S.C. 103 as being unpatentable over Rajendran in view of Vogt et al (US-20140220310-A1) and the H.B. Fuller Engineering Adhesives Technical Data Sheet for 2028 (hereafter TDS). References are made to the pdf of the Technical Data Sheet for 2028 included as a Non-Patent Literature reference with this Office Action.
Alternatively regarding claim 1, Rajendran as applied to claim 1 above is silent to the second portion of the external surface including a micro-textured surface configured to spread drops of a liquid tissue adhesive across the second portion of the external surface by capillary action to form a thin film and/or micro-droplets of the liquid tissue adhesive.
TDS, in the art of engineering adhesives, teaches an adhesive 2028 that is a single component medium viscosity cyanoacrylate adhesive and is formulated for use in medical applications (see first paragraph of TDS).
Vogt, in the art of textured surfaces, teaches a micro-textured surface (microstructure 6 of edges 41 or 42, fig. 2, [0052]) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to spread drops of a liquid tissue adhesive (adhesive 7, fig. 2, [0052]) across the second portion of the external surface by capillary action to form a thin film and/or micro-droplets of the liquid tissue adhesive ([0052] describes adhesive 7 filling the micro-cracks 8 and fissures 9 by capillary action; [0044] describes various adhesives suitable for penetration into micro-cracks via capillary effect including cyanoacrylates).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the frictional region of Vogt to explicitly have microstructures configured to spread liquid adhesive by capillary action, and to have the liquid adhesive be cyanoacrylate, as taught by Vogt, since Vogt and Rajendran both deal with attaching surfaces using rough surfaces and adhesives (see Vogt fig. 2 and [0052]; see Rajendran [0226]). This modification would further have been obvious in view of TDS, which teaches cyanoacrylate as an adhesive for use in medical situations, and considering that Rajendran [0226] notes that “The frictional region 220 may include an adhesive material including a bioresorable material and non-bioresorable material.” One would have been motivated to make the modification because, as taught by Vogt [0052], the size of the microstructures allows for an adhesive (such as cyanoacrylate noted in Vogt [0044]) to fully penetrate the structures by capillary action, which would better ensure sealing of the catheter of Rajendran to the patient’s tissue.
Regarding claim 3, Rajendran as modified discloses the catheter adapter assembly of claim 1, as described above, including wherein the liquid tissue adhesive comprises at least one liquid monomer having a viscosity of less than 200 cps at room temperature (Vogt: [0052] “Adhesive 7 had a viscosity of 50 millipascal seconds”).
Regarding claim 4, Rajendran as modified discloses the catheter adapter assembly of claim 3, as described above, including wherein the liquid monomer comprises at least one cyanoacrylate (Vogt: [0044] describes various adhesives suitable for penetration into micro-cracks via capillary effect including cyanoacrylates; Examiner notes that since the liquid monomer is taught to be cyanoacrylate, and claim 4 depends from claim 3 which describes a viscosity of the liquid monomer, then cyanoacrylate must satisfy the limitations of claim 3).
Regarding claim 24, Rajendran as modified discloses the catheter adapter assembly of claim 1, as described above, including wherein the micro-textured surface is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to allow droplets of adhesive (see 112b interpretation above) to percolate through the micro-textured surface (Vogt: [0052] describes adhesive 7 filling the micro-cracks 8 and fissures 9 by capillary action; note instant specification [0026] describes percolation due to capillary action).
Regarding claim 25, Rajendran as modified discloses the catheter adapter assembly of claim 3, as described above, including wherein the liquid monomer (Vogt: [0044] describes various adhesives suitable for penetration into micro-cracks via capillary effect including cyanoacrylates) is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to undergo an exothermic reaction upon exposure to atmospheric moisture (TDS: “Ambient surface moisture initiates the curing process”).
Regarding claim 33, Rajendran as modified discloses the catheter adapter assembly of claim 1, as described above, including wherein the micro-textured surface comprises indentations that are configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to promote capillary action of a liquid adhesive when placed in contact with the micro-textured surface (Vogt: [0052] describes adhesive 7 filling the micro-cracks 8 and fissures 9 by capillary action).
Claim(s) 5-6 and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Rajendran in view of Lu et al (US 20150329743 A1; hereafter Lu), or alternatively over Rajendran modified by Vogt and further in view of Lu.
Regarding claim 5, Rajendran or Rajendran as modified discloses the catheter adapter assembly of claim 1, as described above.
Either alternative is silent to wherein the micro-textured surface comprises an injection molded, micro-patterned polymer surface.
Lu, in the art of adhesive surfaces for engaging with a patient’s body, teaches wherein the micro-textured surface (micropatterned surface including microfibrils 11, fig. 1, [0033]) comprises an injection molded ([0036] “soft-molding of elastomeric precursors on microfabricated templates”; [0037] “soft molding is preferred”), micro-patterned polymer ([0037] describes the use of polymeric materials to form the microstructures) surface ([0034] “FIGS. 3 and 4 show example designs of micropatterned structures comprising discrete microfibrils, and continuous microribbons which can be parallel to each other or form intersections. Any number of patterns may be used to form the patterned structures”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device to include a micro-textured surface being formed by injection molding, specifically soft molding with polymers, as taught by Lu, since Lu deals with surfaces for adhering to human tissue, as does Raj. One would have been motivated to make the modification because, as noted by Lu, [0033] “Soft materials improve the conformal contact to fairly rough surfaces” and [0034] “The combination of adhesion and friction can secure attachment to the skin or other surface, even under movement.”. Thus, modifying the textured surface of Rajendran to include the soft injection molded micro-patterned polymer surface of Lu would better facilitate the adhesion of the device of Rajendran to a patient’s tissue, preventing unnecessary trauma which may occur due to an insecure device.
Regarding claim 6, either alternative rejection discloses the catheter adapter assembly of claim 5, as described above, including wherein the injection molded (Lu: ([0036] “soft-molding of elastomeric precursors on microfabricated templates”), micro-patterned polymer (Lu: [0037] describes polymer materials) surface (Lu: micropatterned surface including microfibrils 11, fig. 1, [0033]) comprises a plurality of spaced pillars (discrete microfibrils 41, [0035], fig. 4 shows pillar structures of spaced apart features 41) that are configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to promote the capillary action when in contact with the liquid tissue adhesive (Note that the structure of Rajendran meets this functional limitation; Note that Vogt teaches microstructures appropriately spaced for capillary action of a liquid adhesive.).
Regarding claim 26, Rajendran or Rajendran as modified discloses the catheter adapter assembly of claim 1, as described above.
Either alternative is silent to wherein the micro-patterned surface (see 112b interpretation above) is in a grid pattern.
Lu, in the art of adhesive surfaces for engaging with a patient’s body, teaches wherein the micro-patterned surface (micropatterned surface including microfibrils 11, fig. 1, [0033]) is in a grid pattern (see fig. 4 which shows a grid pattern formed by the continuous microribbons, [0034] “FIGS. 3 and 4 show example designs of micropatterned structures comprising discrete microfibrils, and continuous microribbons which can be parallel to each other or form intersections. Any number of patterns may be used to form the patterned structures”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device to include a micro-textured surface being arranged in a grid pattern, as taught by Lu, since Lu deals with surfaces for adhering to human tissue, as does Raj. One would have been motivated to make the modification because, as noted by Lu, [0033] “the example design illustrated in FIG. 4 further increased the adhesion and friction of the micro-patterned structure, as every enclosed square formed by intersecting micro-ribbon acts similar to a suction cup, which locally improves the adhesion capacity.” Thus, modifying the textured surface of Rajendran to include the soft injection molded micro-patterned polymer surface of Lu would better facilitate the adhesion of the device of Rajendran to a patient’s tissue, preventing unnecessary trauma which may occur due to an insecure device.
Regarding claim 27, Rajendran or Rajendran as modified discloses the catheter adapter assembly of claim 1, as described above.
Either alternative is silent to wherein the micro-patterned surface (see 112b interpretation above) is in a regular polygonal array.
Lu, in the art of adhesive surfaces for engaging with a patient’s body, teaches wherein the micro-patterned surface (micropatterned surface including microfibrils 11, fig. 1, [0033]) is in a regular polygonal array (see fig. 4 which shows a regular polygonal array formed by the continuous microribbons and the discrete microfibrils, [0034] “FIGS. 3 and 4 show example designs of micropatterned structures comprising discrete microfibrils, and continuous microribbons which can be parallel to each other or form intersections. Any number of patterns may be used to form the patterned structures”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device to include a micro-textured surface being arranged in a regular polygonal array, as taught by Lu, since Lu deals with surfaces for adhering to human tissue, as does Raj. One would have been motivated to make the modification because, as noted by Lu, [0033] “the example design illustrated in FIG. 4 further increased the adhesion and friction of the micro-patterned structure, as every enclosed square formed by intersecting micro-ribbon acts similar to a suction cup, which locally improves the adhesion capacity.” Thus, modifying the textured surface of Rajendran to include the soft injection molded micro-patterned polymer surface of Lu would better facilitate the adhesion of the device of Rajendran to a patient’s tissue, preventing unnecessary trauma which may occur due to an insecure device.
Regarding claim 28, Rajendran or Rajendran as modified discloses the catheter adapter assembly of claim 1, as described above
Either alternative is silent to wherein the micro-patterned surface (see 112b interpretation above) comprises individual elements that are in a uniform arrangement..
Lu, in the art of adhesive surfaces for engaging with a patient’s body, teaches wherein the micro-patterned surface (micropatterned surface including microfibrils 11, fig. 1, [0033]) comprises individual elements that are in a uniform arrangement. (see fig. 4 which shows a uniform arrangement of the continuous microribbons and the discrete microfibrils, [0034] “FIGS. 3 and 4 show example designs of micropatterned structures comprising discrete microfibrils, and continuous microribbons which can be parallel to each other or form intersections. Any number of patterns may be used to form the patterned structures”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device to include a micro-textured surface being arranged of individual elements that are arranged in a uniform arrangement, as taught by Lu, since Lu deals with surfaces for adhering to human tissue, as does Raj. One would have been motivated to make the modification because, as noted by Lu, [0033] “the example design illustrated in FIG. 4 further increased the adhesion and friction of the micro-patterned structure, as every enclosed square formed by intersecting micro-ribbon acts similar to a suction cup, which locally improves the adhesion capacity.” Thus, modifying the textured surface of Rajendran to include the soft injection molded micro-patterned polymer surface of Lu would better facilitate the adhesion of the device of Rajendran to a patient’s tissue, preventing unnecessary trauma which may occur due to an insecure device.
Claim(s) 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Rajendran in either alternative applied to claim 5 above further in view of Gale et al (US 20040032667 A1; hereafter Gale).
Regarding claim 7, Rajendran as modified discloses the catheter adapter assembly of claim 5, as described above.
Either alternative combination is silent to wherein the micro-textured surface is formed from a micro-machined metal mold insert.
This limitation amounts only to a difference in the process by which the device is made. As such, the device of claim 5 meets all structural limitations of the claim. See MPEP 2113 for Product-by-Process Claims.
Alternatively, Gale, in the art of molds for microstructures, teaches wherein the micro-textured surface is formed from a micro-machined metal mold insert ([0011] The mould insert is typically metal and is fabricated by conventional techniques such as high precision machining, diamond turning or electroforming.; [0037] The substrate is etched to the required depth. For etching high resolution microstructure, dry etching approaches are preferred. Typical substrate materials or mould insets are nickel or steel.).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to use the method taught by Gale to form the micro-textured surface of Rajendran as modified in either alternative, since Gale is specifically directed to forming microstructures. One would have been motivated to make the modification because the surface of Rajendran is curved and Gale [0018] notes that the methods taught by Gale “overcome the limitations of the prior art in which high resolution grating structure on curved mould surfaces cannot readily be fabricated.”. Additionally, using the methods of Gale facilitates replication of pattern and resolution between individual devices, ensuring reliability and predictability of quality within and between manufactured lots of devices.
Regarding claim 8, Rajendran as modified in either alternative discloses the catheter adapter assembly of claim 5.
Either alternative combination is silent to wherein the micro-textured surface is formed from laser-patterned metal mold insert (see 112b interpretation above).
This limitation amounts only to a difference in the process by which the device is made. As such, the device of claim 5 meets all structural limitations of the claim. See MPEP 2113 for Product-by-Process Claims.
Alternatively, Gale, in the art of molds for microstructures, teaches wherein the micro-textured surface is formed from laser-patterned metal mold insert ([0011] The mould insert is typically metal and is fabricated by conventional techniques such as high precision machining, diamond turning or electroforming.; [0028-0031] describes using a laser to acquire the desired pattern).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to use the method taught by Gale to form the micro-textured surface of Rajendran as modified in either alternative, since Gale is specifically directed to forming microstructures. One would have been motivated to make the modification because the surface of Rajendran is curved and Gale [0018] notes that the methods taught by Gale “overcome the limitations of the prior art in which high resolution grating structure on curved mould surfaces cannot readily be fabricated.”. Additionally, using the methods of Gale facilitates replication of pattern and resolution between individual devices, ensuring reliability and predictability of quality within and between manufactured lots of devices.
Regarding claim 9, Rajendran as modified in either alternative discloses the catheter adapter assembly of claim 8, as described above, including wherein the injection molded (Lu: ([0036] “soft-molding of elastomeric precursors on microfabricated templates”), micro-patterned polymer (Lu: [0037] describes polymer materials) surface (Lu: micropatterned surface including microfibrils 11, fig. 1, [0033]) comprises a plurality of spaced pillars (discrete microfibrils 41, [0035], fig. 4 shows pillar structures of spaced apart features 41) that promote the capillary action (Examiner notes that “that promote the capillary action” is a functional limitation.) when in contact with the liquid tissue adhesive (Note that the structure of Rajendran meets this functional limitation; Note that Vogt teaches microstructures appropriately spaced for capillary action of a liquid adhesive.).
Claim(s) 29 is rejected under 35 U.S.C. 103 as being unpatentable over Rajendran further in view of Wang et al (CN 111544170 A; hereafter Wang), or alternatively over Rajendran modified by Vogt further in view of Wang. Text references are made to the Espacenet English Translation of Wang included with this Office Action.
Regarding claim 29, Rajendran or Rajendran as modified discloses the catheter adapter assembly of claim 1, as described above.
Either alternative is silent to wherein the micro-patterned surface (see 112b interpretation above) comprises individual elements that are in a random arrangement.
Wang, in the art of medical devices with micro-patterned surfaces for preventing sliding against human tissue, teaches wherein the micro-patterned surface (see 112b interpretation above) comprises individual elements that are in a random arrangement (Paragraph#27 “the frictional resistance generated by the random micro-patterns formed on the outer surface of the stent graft can effectively prevent slippage”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the micro-textured surface of Rajendran or Rajendran as modified and applied to claim 1 above to include individual elements randomly arranged, as taught by Wang, since Wang also deals with frictional interactions between human tissue and medical devices. One would have been motivated to make the modification because, as noted by Wang Paragraph#27, the random micro-patterns can help to effectively prevent slippage of the medical device against the tissue of the patient.
Claim(s) 30-32 are rejected under 35 U.S.C. 103 as being unpatentable over Rajendran modified by Lu and further in view of Guler et al (US 20150282955 A1; hereafter Guler), or alternatively over Rajendran modified by Vogt and Lu and further in view of Guler.
Regarding claim 30, Rajendran as modified in either alternative discloses the catheter adapter assembly of claim 5, as described above.
Guler, in the art of micropatterns for tissue adhesion, teaches wherein the micro-patterned polymer surface comprises a plurality of spaced pillars (adhesion elements 54, see fig. 3 and fig. 5a, [0052]) having a height (80 μm, see annotated fig. 5a and calculation table below) and a width (see annotated fig. 5a and calculation table below; note that the Examiner interprets the “width” in the claim to be db, the width at the bottom of the pillar noted in fig. 5a below)and the height of the pillars are greater than the width (see calculation table and annotated fig. 5a below) ([0041] In at least one embodiment, the outwardly extending adhesion elements are truncated cones with a width d selected from the range of 50 μm to 500 μm; a height h that is 20-50% of the width d; a concave surface depth δ that is 10-20% of the width d; and an angle θ selected from the range of 30 degrees to 75 degrees).
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Calculations Corresponding to Guler Annotated Fig. 5A
Variable
Value
Calculation if Applicable
Width at top in micrometers (d)
160
“width d selected from the range of 50 μm to 500 μm” [0041]
Height in micrometers (h)
80
“height h that is 20-50% of the width d”
h=(0.5)*(d)=(0.5)*(160)=80
Angle in degrees (θ)
49
“θ selected from the range of 30 degrees to 75 degrees” [0041]
Lateral distance from top edge to bottom edge in micrometers (x)
70
x=h/tan(θ)=80/tan(49)=69.54294 [Wingdings font/0xE0]=70
Width at bottom in micrometers (db)
20
db= d -(2)*(x) = 160-2*70=20
Ratio of height to width at bottom (r)
4
r=h/db=80/20=4
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the pillars of Rajendran modified by Lu or Rajendran modified by Vogt and Lu to include the dimensions noted in the table above and in accordance with the teachings of Guler since Guler also teaches surface patterns suitable for adhesion with human tissues. One would have been motivated to make the modification because, as noted by Guler, [0031] the shape of the pillars can help to promote adhesion to the human tissue.
Regarding claim 31, Rajendran as modified in either alternative discloses the catheter adapter assembly of claim 30, as described above, including wherein the spaced pillars have an aspect ratio defined by a ratio of the height to the width which is greater than 2 (see calculation table above, ratio of height to the width is 4 which is greater than 2).
Regarding claim 32, Rajendran as modified in either alternative discloses the catheter adapter assembly of claim 5, as described above.
Either alternative is silent to wherein the micro-patterned polymer surface comprises a plurality of spaced pillars have a width at a top of the pillars than at a bottom of the pillars (see 112b interpretation above).
Guler, in the art of micropatterns for tissue adhesion, teaches wherein the micro-patterned polymer surface comprises a plurality of spaced pillars (adhesion elements 54, see fig. 3 and fig. 5a, [0052]) have a width at a top of the pillars than at a bottom of the pillars (see 112b interpretation above) (see fig. 5a, [0035] As shown for example in FIGS. 5A and 5B, each outwardly extending adhesion element 54a is a truncated cone with a concave end 58.).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the pillars of Rajendran modified by Lu or Rajendran modified by Vogt and Lu to include the dimensions noted in the table above and in accordance with the teachings of Guler since Guler also teaches surface patterns suitable for adhesion with human tissues. One would have been motivated to make the modification because, as noted by Guler, [0035] the truncated cone and concave end shape of the pillars can help to promote adhesion to the human tissue.
Claim(s) 34-35 are rejected under 35 U.S.C. 103 as being unpatentable over Rajendran in view of Guler, or alternatively over Rajendran modified by Vogt and further in view of Guler.
Regarding claim 34, Rajendran or Rajendran modified by Vogt discloses the catheter adapter assembly of claim 1, as described above.
Eiether alternative is silent to wherein the micro-textured surface comprises a plurality of pillars having a width in a range of from 2.5 to 80 μm and widths (see 112b interpretation above) in a range of from 2.5 μm to 25 μm (see 112b interpretation above).
Guler, in the art of micropatterns for tissue adhesion, teaches wherein the micro-textured surface comprises a plurality of spaced pillars (adhesion elements 54, see fig. 3 and fig. 5a, [0052]) having a width in a range of from 2.5 to 80 μm and widths (see 112b interpretation above) in a range of from 2.5 μm to 25 μm (width at the bottom of the pillar is 20 μm as shown in Calculation Table above) (see Calculation Table and annotated fig. 5a above, note that the first range is interpreted to apply to the height, and the second range is interpreted to refer to the width at the bottom of the pillar).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the pillars of Rajendran modified by Lu or Rajendran modified by Vogt and Lu to include the dimensions noted in the table above and in accordance with the teachings of Guler since Guler also teaches surface patterns suitable for adhesion with human tissues. One would have been motivated to make the modification because, as noted by Guler, [0035] the truncated cone and concave end shape of the pillars can help to promote adhesion to the human tissue.
Regarding claim 35, Rajendran as modified in either alternative applied above discloses the catheter adapter assembly of claim 34, including wherein the micro-textured (see 112b interpretation above) the plurality of pillars having spacing between individual pillar (see fig. 4 of Guler) (see 112b interpretation above) such as micro-pillars (Guler: adhesion elements 54, fig. 4) in a range of from 50 μm to 500 μm (Guler: [0052] In at least one embodiment, two adjacent adhesion elements 54 in a micropattern are spaced apart by a distance s measured between the centers 57 of two adjacent adhesion elements (shown in FIGS. 3 and 4)… the spacing s is 120 μm, 130 μm, 140 μm, or 150 μm.).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the pillars of Rajendran as modified to include the spacing dimensions in accordance with the teachings of Guler since Guler also teaches surface patterns suitable for adhesion with human tissues. One would have been motivated to make the modification because, as noted by Guler, [0052] the spacing of the adhesion elements influences the overall adhesion of the surface to the tissue.
Conclusion
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 09/21/2026
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