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 .
Status of Application
Claims 1-16 are pending and examined on the merits.
Claims 1 and 5 are currently amended.
Response to Amendment
Applicant amendments filed 10/16/2025 have been fully considered.
Response to Arguments
Applicant provided amendments to the independent claim which necessitates a new ground of rejection. Accordingly, Applicant’s arguments filed 10/16/2025 have been fully considered but they are moot. Specifically, Larsson (US Pre-Grant Pub. No. 2010/0228206 A1) and Lin (US Pre-Grant Pub. No. 2002/0077584 A1) are reintroduced as primary and secondary references in the present rejection for disclosing and rendering obvious the limitations presented via the amendments. Matsudo (U.S. Pre Grant Pub. No. 2013/0041330 A1) is introduced as a secondary reference in the present rejection for disclosing and rendering obvious some of the limitations presented via the amendments.
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 (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 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.
Claims 1-8, and 10-16 are rejected under 35 U.S.C. 103 as being unpatentable over Larsson (US Pre-Grant Pub. No. 2010/0228206 A1) in view of Matsudo (U.S. Pre Grant Pub. No. 2013/0041330 A1).
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Regarding claim 1, Larsson, with reference to Image 1 above, teaches: A microneedle substrate for providing fluid communication to a tissue site through a cover (see at least Abstract), the microneedle substrate comprising:
a plurality of microneedles (see Image 1) coupled to the microneedle substrate (see at least para. [0038]) separate and distinct form the plurality of apertures (as broadly recited, Larsson teaches that the microneedles are separate and distinct from the plurality of apertures at least because the apertures are located at one side of the substrate while the microneedles are located on an opposite side of the substrate; see Image 1), each of the microneedles including a passage disposed through the microneedle (see Image 1; as broadly recited, the passages extend from a tip of the microneedles towards the substrate and does not extend through the substrate) that is in fluid communication with a corresponding through-hole extending through an entire thickness of the microneedle substrate (as broadly recited, a through-hole exists through the entire thickness of the substrate), wherein the through-hole is exposed to fluid communication with the passage through the microneedle along the entire thickness through the microneedle substrate (para. [0053-0054] teaches that fluid is moved through the through-channels 15, which include penetration elements 14 as well as the apertures of Image 1; therefore, the through-holes are exposed to fluid communication; as described above the microneedles go through the through-holes, therefore, the entire thickness of the through-hole through the substrate is exposed to fluid communication with the passage through the microneedle).
However, Larsson fails to explicitly teach a plurality of apertures disposed through the microneedle substrate, as required by the claim.
Matsudo teaches an analogous micro-needle device that includes micro-needles provided on a substrate (see Abstract). Matsudo further teaches a plurality of apertures disposed through the microneedle substrate (see for example through-hole 4 in Fig. 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Larsson to incorporate the teachings of Matsudo by including a plurality of apertures disposed through the microneedle substrate at least in order to allow for a physiologically active composition to be administered from the back face of the microneedle substrate, as taught by Matsudo (see para. [0030]).
Regarding claim 2, Larsson teaches the invention as discussed above in claim 1. Additionally, Larsson teaches wherein each of the microneedles is tapered (see Figs. 1-7; see also at least para. [0052] describing the penetration element as having a conical or pyramid-like shape and preferably having a sharp-pointed and/or cutting shape).
Regarding claim 3, Larsson teaches the invention as discussed above in claim 1. Additionally, Larsson teaches that the microneedles are tapered (see Figs. 1-7; see also at least para. [0052] describing the penetration element as having a conical or pyramid-like shape and preferably having a sharp-pointed and/or cutting shape) and are designed as hollow needles (see para. [0053]).
While Larsson fails to explicitly disclose that the passage of each of microneedles is tapered in a range of 0-45 degrees, as required by the claim, Larsson discloses that the shape of the penetration elements is a known alternative shape that comprises a conical or pyramid-like basic shape having a sharp-pointed and/or cutting shape (see at least para. [0052]). Therefore, one of ordinary skill in the art would have been motivated to include such shapes for the penetration elements at least in order for the penetration elements to have a sharp-pointed and/or cutting shape, as taught and desired by Larsson (see para. [0052]). Additionally, Larsson at least suggests that the channels 15 take the shape of the penetration elements (para. [0053] teaches that the elements 14 are designed as hollow needles). Therefore, the channels 15 can also have a conical or pyramid-like shape. Additionally, one of ordinary skill in the art would have reasonably recognized that the change in configuration of shape of a device is obvious absent persuasive evidence that the particular configuration is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966); see also MPEP 2144.04(IV)(B). Furthermore, since Larsson teaches that the penetration elements must have a sharp-pointed shape, one of ordinary skill would recognize that by optimizing the passage shape to taper in a range below 45 degrees, a sharper edge would be produced which would improve the penetration of the microneedles into a wound dressing cover layer and also improve the suction capabilities of the passages.
Regarding claim 4, Larsson teaches the invention as discussed above in claim 1. Additionally, Larsson teaches wherein each of the microneedles has a maximum width in a range of 200 micrometers to 2000 micrometers (which is 0.2mm to 2mm) (see para. [0056] teaching 0.5mm-1mm for the internal diameter of the channel and/or 1mm-2mm for the external diameter of the penetration elements 14).
However, while Larsson teaches that each of the microneedles has a length in a range of 0.2mm-5mm (see para. [0056]), Larsson fails to explicitly teach that each of the microneedles has a length in a range of 100 micrometers to 4000 micrometers (which is 0.1mm to 4mm), as required by the claim.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the length of each of the microneedles such that they each have a length in a range of 100 micrometers to 4000 micrometers at least since it has been held that a change in size (dimension) is generally recognized as being within the level of ordinary skill in the art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955); see also MPEP 2144.04(IV)(A). Where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device, and the device having the claimed dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device, Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). Therefore, one of ordinary skill in the art would have reasonably been motivated to make the length of each of the microneedles in a range of 100 micrometers to 4000 micrometers (0.1mm to 4mm) at least because such a change in length would not cause the device of Larsson to perform differently.
Regarding claim 5, Larsson teaches the invention as discussed above in claim 1. Additionally, Larsson teaches wherein the passage of each of the microneedles has a maximum width in a range of about 20 micrometers to 1800 micrometers (which is 0.02mm to 1.8mm) (see para. [0056] teaching 0.5mm-1mm for the internal diameter of the channel and/or 1mm-2mm for the external diameter of the penetration elements 14), and wherein the width of the passage through one or more of the microneedles at an end of the microneedle proximate to the microneedle substrate is the same as a width of the corresponding through-hole through the microneedle substrate (as shown in Fig. 1, and as broadly recited, the width of width of the passage directly adjacent the substrate is the same as the width of a corresponding through-hole through the substrate).
Regarding claim 6, Larsson teaches the invention as discussed above in claim 1. Additionally, Larsson teaches wherein the plurality of microneedles are arranged in an array (see for example para. [0026]).
Regarding claim 7, Larsson teaches the invention as discussed above in claim 1. Additionally, Larsson teaches wherein the plurality of apertures through the microneedle substrate are configured to increase a flexibility of the microneedle substrate (at least inherent; the plurality of apertures are configured to increase a flexibility of the substrate at least because having a perforated layer will necessarily have more flexibility than a non-perforated layer that has the same properties as the perforated layer).
Regarding claim 8, Larsson teaches the invention as discussed above in claim 1. Additionally, Larsson teaches wherein each of the microneedles is formed from a biocompatible material (para. [0052] teaches that the penetration elements 14 can be made of metal or plastic; since the penetration elements 14 pierce through and penetrate the cover 3, see para. [0051], the penetration elements 14 are in contact with the wound bed W, see Fig. 1; therefore, the penetration elements 14 are sufficiently biocompatible to be used in contact with a patient’s body, or a more specific body part, such as, an open wound bed).
Regarding claim 10, Larsson teaches the invention as discussed above in claim 1. Additionally, Larsson teaches that the penetration elements are arranged uniformly across the entire surface area of the main body (see para. [0026]). While Larsson fails to explicitly disclose that the microneedles are separated by a distance of about 1mm, as required by the claim, Larsson discloses that the penetration elements can be arranged uniformly across the entire surface of the main body (see para. [0026]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to arrange the penetration elements of Larsson uniformly across the surface of the main body such that they are separated by a distance of 1mm at least since it has been held that a change in size (dimension) is generally recognized as being within the level of ordinary skill in the art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955); see also MPEP 2144.04(IV)(A). Where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device, and the device having the claimed dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device, Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). Larsson discloses that several penetration elements are present (see para. [0049]), that the diameter of the main body 11 is 20mm-40mm (see para. [0056]), and that the external diameter of the penetration element 14 is 1mm-2mm (Id.). For example, Fig. 1 shows 19 penetration elements 14. If each penetration element has an outer diameter of 1mm-2mm, and if the spacing between each penetration element is 1mm, when the main body diameter is 40mm, the main body diameter must equal the total outer diameter of each penetration elements plus the total spacing between each penetration element, or 19*x + 20*1mm, meaning that the outer diameter of each penetration element is 1.05mm, which is within the ranges disclosed in para. [0056]. Therefore, one of ordinary skill in the art would have found it obvious to choose from a finite number of penetration elements to uniformly arrange on a main body, and could have reasonably chosen a diameter of the penetration elements which would cause the penetration elements to be separated by a distance of 1mm, with a reasonable expectation of enabling treatment of the wound that is as uniform and has as large a surface as possible, as desired by Larsson (see Abstract).
Regarding claim 11, Larsson in view of Matsudo teaches the invention as discussed above in claim 1. Additionally, Larsson teaches wherein the plurality of microneedles provide an effective area for fluid flow of at least 125 square millimeters (para. [0056] teaches that the diameter of the main body 11 is 20-40mm; with a uniform distribution of the penetration elements, as described in para. [0026], which have an outer diameter of 1mm-2mm and an internal diameter of 0.5mm-1mm, if, for example, 40 penetration elements were located on the main body 11, each penetration element having an inner diameter of 1mm, the effective area for fluid flow from the plurality of microneedles would be equal to (40 microneedles x 1mm2 x pi) or about 125 mm2).
Regarding claim 12, Larsson in view of Matsudo teaches the invention as discussed above in claim 1. Additionally, Larsson teaches wherein the plurality of microneedles are configured to pierce the cover (see for example para. [0021]).
Regarding claim 13, Larsson in view of Matsudo teaches the invention as discussed above in claim 1. Additionally, Larsson teaches A system for treating a tissue site with negative pressure (see for example connecting device 1 in Fig. 1), the system comprising:
a manifold configured to be applied to the tissue site (see wound cover 3 applied to wound W at least in Fig. 1);
a cover configured to be disposed over the manifold (see main body 11 disposed over cover 3 at least in Fig. 1); and
the microneedle substrate of claim 1 (see above).
Regarding claim 14, Larsson in view of Matsudo teaches the invention as discussed above in claim 13. Additionally, Larsson teaches: further comprising a negative-pressure source (see at least para. [0054]) configured to be fluidly coupled to the to the manifold through the cover and the microneedle substrate (as taught in at least para. [0054], with reference to Fig. 1, the suction source is connected to attachment piece 10 which is in turn connected to the manifold 3 via the cover 11 and the substrate 17).
Regarding claim 15, Larsson in view of Matsudo teaches the invention as discussed above in claim 1. Additionally, Larsson teaches: A method for treating a tissue site with negative pressure (see for example para. [0016]), the method comprising:
applying a manifold to a tissue site (Fig. 1 shows the connecting device 1 applied to a wound; see also for example para. [0014]);
sealing a cover over the manifold around the tissue site (see for example para. [0036]);
disposing the microneedle substrate of claim 1 on the cover (see for example para. [0037]);
piercing the cover with the plurality of microneedles (see for example para. [0021 and 0051] and Image 1);
fluidly coupling a negative-pressure source to the manifold through the cover and the microneedle substrate (see for example para. [0054]); and
applying a therapeutic level of negative pressure from the negative-pressure source to the manifold (see for example para. [0054]).
Regarding claim 16, Larsson in view of Matsudo teaches the invention as discussed above in claim 1. Additionally Larsson teaches that each of the microneedles has a length in a range of 0.2mm-5mm (see para. [0056]), Larsson fails to explicitly teach that each of the microneedles has a length in a range of 1000 micrometers to 2000 micrometers (which is 1mm to 2mm). However, it has been held that in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); see also MPEP 2144.05(I). Therefore, It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made each of the microneedles have a length in a range of 1000 micrometers to 2000 micrometers, as required by the claim.
Additionally, Larsson teaches wherein the passage disposed through the microneedle and the through-hole through the microneedle substrate provide a separate pathway from the plurality of apertures through the microneedle substrate (as broadly recited, and as shown in Fig. 1, the substrate comprises a plurality of microneedles, a plurality of through-holes, and a plurality of apertures, one or more of the microneedles, through-holes, and apertures provide for separate pathways through the substrate).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Larsson (US Pre-Grant Pub. No. 2010/0228206 A1) in view of Matsudo (U.S. Pre Grant Pub. No. 2013/0041330 A1), as applied above to claim 1, and further in view of Lin (US Pre-Grant Pub. No. 2002/0077584 A1).
Regarding claim 9, Larsson teaches the invention as discussed above in claim 1. Additionally, Larsson teaches that the penetration elements are made of metal or plastic. However, while Larsson fails to explicitly teach that the microneedles are formed from stainless steel, titanium, aluminum, polycarbonate, polyethylene terephthalate, polyetherketone, polyimide, or polyphenylsulfone, as required by the claim, such materials are well known in the art and one of ordinary skill in the art would have been motivated to form the microneedles of Larsson out of one of the claimed materials at least in order to provide stability to the microneedles and ensure that the tip is strong enough to pierce a wound dressing cover layer. Such a modification is reasonably within the capability of one of ordinary skill in the art. In addition, prior art references exist which teach the claimed materials.
Lin teaches an analogous medical device for use with transdermal applications (Abstract) comprising a plurality of microblades for piercing a patient’s skin (Id.). Lin further teaches that the microblades can be made from materials such as stainless steel, titanium, aluminum, polyethylene, or other rigid materials (see para. [0058]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Larsson to incorporate the teachings of Lin by forming the microneedles out of one of the claimed materials at least in order for the piercing members to have sufficient strength and manufacturability, as taught by Lin (see para. [0058]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIHAD DAKKAK whose telephone number is (571)272-0567. The examiner can normally be reached Mon-Fri: 9AM - 5PM ET.
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/JIHAD DAKKAK/ Examiner, Art Unit 3781
/JESSICA ARBLE/ Primary Examiner, Art Unit 3781