DETAILED ACTION
In Applicant’s Response filed 4/10/26, Applicant has cancelled claims 1-19 and added new claims 20-30. Currently, claims 20-30 are pending.
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 .
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.
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 20 and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Propp (US 7294752) in view of Dicosmo (US 2016/0317699).
With respect to claim 20, Propp discloses a medical dressing (dressing 10; fig 1) comprising:
a backing layer (fabric layer 12; fig 1-3) comprising a first major surface (side 18; fig 3), a second major surface (side 20; fig 3), and a perimeter (outer perimeter of layer 12 shown in fig 1) defining a backing area on each of the first and second major surfaces (as shown in figs 2-3)
adhesive on at least a portion of the first major surface of the backing layer (side 18 includes adhesive – col 3 lines 62-64); and
a stiffening system (reinforcing structure 30; col 4 lines 5-67) fixedly attached to the backing layer (col 4 lines 5-10), and contained within a selected region of the backing layer wherein the selected region defines a region perimeter (as shown in fig 1);
wherein the stiffening system (30) comprises an array of a plurality of stiffening elements (ribs 38; figs 1-2) contained within the region perimeter of the selected region (as shown in fig 1) wherein each stiffening element (38) of the plurality of stiffening elements extends along a length from a first end to a second end (as shown in fig 1; one end is closer to opening 40 as shown in fig 1-2 and the other end is a terminal end 44) wherein the first end of each stiffening element is located closer to a center of the selected region than the second end (one end is closer to opening 40 as shown in fig 1-2), and wherein the second end (terminal end 44) is located closer to the region perimeter than the first end (as shown in figs 1-2 the terminal end 44 of each rib 38 is closer to the perimeter edge of the layer 12).
Propp does not, however, explicitly disclose that the backing layer and the adhesive form a substantially contact transparent adhesive composite.
Dicosmo, however, teaches use of “thin transparent polymer material such as a film backing material, woven or knitted fabric, a nonwoven fabric or a plastic or polymeric material such as cotton” for making IV dressings (para [0016]). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the woven or nonwoven fabric layer 12 of Propp from a transparent material since Dicosmo teaches that such materials are routinely used for forming IV dressings such as the one disclosed in Propp. Furthermore, one would have been motivated to make such a modification in order to provide a user with the ability to view the condition of an infusion site through the dressing and, also, because it is 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.
With respect to claim 25, Propp in view of Dicosmo discloses the dressing substantially as claimed (see rejection of claim 20) and Propp also discloses that at least a portion if the region perimeter is spaced inward from the perimeter of the backing layer (as shown in fig 2, at least a portion of backing 12 is configured as a frame where a portion of the region perimeter is spaced inward from the outer peripheral edge of layer 12 to define opening 22 at the center).
With respect to claim 26, Propp in view of Dicosmo discloses the dressing substantially as claimed (see rejection of claim 20) and Propp also discloses that the medical dressing comprises support material (member 48; figs 1-2) having an inner perimeter defining the selected region (as shown in figs 1-2), the support material attached to the backing layer outside of the selected region (as shown in fig 1).
With respect to claim 27, Propp in view of Dicosmo discloses the dressing substantially as claimed (see rejection of claim 20) and Propp also discloses that the stiffening system (30) further defines a gap occupying an arc about the center of the stiffening system that is free of stiffening elements (gap at the center of element 40 as shown in figs 1-2).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Propp (US 7294752) in view of Dicosmo (US 2016/0317699) and further in view of Fabo et al (US 2011/0098621).
With respect to claim 21, Propp in view of Dicosmo discloses the dressing substantially as claimed (see rejection of claim 20) but is silent with respect to whether one or more of the stiffening elements of the stiffening system comprise transparent stiffening elements.
Fabo, however, teaches a transparent dressing wherein all layers of the dressing, including the stiffening layer 4, are transparent (see claim 11). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed stiffening elements on the device of Propp in view of Dicosmo from a transparent material as taught by Fabo in order to provide a user with the ability to view the condition of an infusion site through the dressing and, also, because it is 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.
Claims 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Propp (US 7294752) in view of Dicosmo (US 2016/0317699) and further in view of Elsamahy et al (US 2014/0005607).
With respect to claim 22, Propp in view of Dicosmo discloses the dressing substantially as claimed (see rejection of claim 20) but is silent with respect to whether the stiffening elements comprise a colorant such that the transparent stiffening elements exhibit a color when exposed to white light.
Elsamahy, however, teaches an analogous dressing wherein the color of the reinforcing structure 34 may be provided with a distinctive color to be visible through the first layer 16 to aid in proper placement (para [0027]). Sunlight, incandescent bulbs and fluorescent lamps are all customarily used and known to be sources of white light – thus, the color visible to the user with customary light sources is interpreted as being provided by a colorant that exhibits the color when exposed to white light.
Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the stiffening elements on the device of Propp in view of Dicosmo to comprise a colorant such that the transparent stiffening elements exhibit a color when exposed to white light, as taught by Elsamahy, in order to assist with placement of the dressing with the reinforcement in the appropriate location with respect to a catheter.
With respect to claim 23, Propp in view of Dicosmo discloses the dressing substantially as claimed (see rejection of claim 20) but is silent with respect to whether the one or more of the stiffening elements of the stiffening system comprise opaque stiffening elements.
Elsamahy, however, teaches an analogous dressing wherein the color of the reinforcing structure 34 may be provided with a distinctive color to be visible through the first layer 16 to aid in proper placement (para [0027]). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the stiffening elements on the device of Propp in view of Dicosmo to be opaque (have color) as taught by Elsamahy in order to assist with placement of the dressing with the reinforcement in the appropriate location with respect to a catheter.
With respect to claim 24, Propp in view of Dicosmo discloses the dressing substantially as claimed (see rejection of claim 23) but is silent with respect to whether the stiffening elements comprise a colorant such that the opaque stiffening elements exhibit a color when exposed to white light.
Elsamahy, however, teaches an analogous dressing wherein the color of the reinforcing structure 34 may be provided with a distinctive color to be visible through the first layer 16 to aid in proper placement (para [0027]). Sunlight, incandescent bulbs and fluorescent lamps are all customarily used and known to be sources of white light – thus, the color visible to the user with customary light sources is interpreted as being provided by a colorant that exhibits the color when exposed to white light.
Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the stiffening elements on the device of Propp in view of Dicosmo to comprise a colorant such that the stiffening elements exhibit a color when exposed to white light, as taught by Elsamahy, in order to assist with placement of the dressing with the reinforcement in the appropriate location with respect to a catheter.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Propp (US 7294752) in view of Dicosmo (US 2016/0317699) with extrinsic evidence from “Polypropylene Properties & Polypropylene Characteristics Explained” (www.palmetto-industries.com).
With respect to claim 30, Propp in view of Dicosmo discloses the dressing substantially as claimed (see rejection of claim 20) but does not explicitly disclose that the stiffening system has an elongation at break of between 200-800%. Propp, however, discloses that the stiffening system is made from polypropylene (col 4 lines 10-14) which, inherently, has an elongation at break of between 200-700% (as taught by “Polypropylene Properties & Polypropylene Characteristics Explained”; see page 3). Thus, the stiffening system (30) of Propp, which is formed from polypropylene, is interpreted as having an elongation at break of between 200-800%.
Double Patenting
NON-STATUTORY DOUBLE PATENTING
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 20-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 12201501.
Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims are a broader recitation of the invention than that of the patented application.
Specifically, claim 20 of the present application and claim 1 of US Patent No. 12202501 (the ‘501 patent) differ in that the patented claims include more elements than the claims in the present application and, therefore, are more narrow and specific. Thus, claim 1 of the ‘501 Patent is in effect a “species” of the broader, “generic” invention recited in claim 20 of the present application. It has been held that a generic invention is anticipated by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Thus, claim 20 of the present application is anticipated by claim 1 of the ‘501 patent and, therefore, are not patentably distinct from claim 1 of the ‘501 patent.
All of the limitations of claims 21 and 22 can be found in claim 2 of the ‘501 Patent; All of the limitations of claim 23 and 24 can be found in claim 3 of the ‘501 Patent; All of the limitations of claim 25 can be found in claim 4 of the ‘501 Patent.
Allowable Subject Matter
Claims 28 and 29 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The subject matter of claims 28 and 29 could either not be found or was not suggested in the prior art of record.
With respect to claim 28, the subject matter not found was a medical dressing comprising a stiffening system which defines a gap occupying an arc about the center of the stiffening system that is free of stiffening elements, wherein the stiffening system further comprises a central support proximate the center of the stiffening system and a perimeter support extending between second ends of adjacent stiffening elements, and wherein the gap is formed in both the central support and the perimeter support, in combination with the other elements in the claims.
The closest prior art of record is Propp which discloses the medical dressing substantially as claimed and, also, discloses a stiffening system (30) that defines a gap occupying an arc about the center of the stiffening system that is free of stiffening elements (gap at the center of element 40 as shown in figs 1-2) and wherein the stiffening system comprises a central support (reinforcing structure at opening 40) proximate the center (as shown in fig 1). Propp does not, however, further disclose a perimeter support extending between second ends of adjacent stiffening elements, and wherein the gap is formed in both the central support and the perimeter support as recited in claim 28. For at least this reason, the prior art of record fails to disclose or suggest the subject matter of claim 28.
With respect to claim 29, the subject matter not found was a medical dressing comprising a stiffening system which has a flexural rigidity of 5 or more, in combination with the other elements in the claims.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Response to Amendments/Arguments
Applicant’s amendments and arguments filed 4/10/26 have been fully considered as follows:
Regarding the objections to the claims: Applicant has cancelled claims 1-19 thereby obviating the basis for the objections. Therefore, the objections have been withdrawn.
Regarding the claim rejections under 35 USC 103: Applicant has cancelled claims 1-19 thereby obviating the basis for the rejections. Therefore, the rejections have been withdrawn. New rejections have been given for new claims 20-30, however, as necessitated by Applicant’s amendments to the claims.
Regarding the Double Patenting Rejections: Applicant has cancelled claims 1-19 thereby obviating the basis for the rejections. Therefore, the rejections have been withdrawn. New rejections have been given, however, as necessitated by Applicant’s amendments to the claims.
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 CAITLIN CARREIRO whose telephone number is (571)270-7234. The examiner can normally be reached M-F 7:30am-4pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael Bredefeld can be reached at 571-270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786
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