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 16 & 28-32) in the reply filed on 2/26/2026 is acknowledged.
Claims 19-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups II-III, there being no allowable generic or linking claim.
Information Disclosure Statement
The references cited by applicants in the information disclosure statements filed on 1/17/2024 & 1/13/2025 have been made of record. Examiner has considered the voluminous references to the best of her ability.
While the statements filed do not comply with the guidelines set forth in MPEP 2004 regarding both the number of references cited and the elimination of clearly irrelevant art and marginally cumulative information, compliance with these guidelines is not mandatory. Furthermore, 37 CFR 1.97 and 1.98 does not require that the information be material; rather, they allow for submission of information regardless of its pertinence to the claimed invention. Also, there is no requirement to explain the materiality of the submitted references. However, the cloaking of a clearly relevant reference by inclusion in a long list of citations may not comply with Applicant’s duty of disclosure. See Penn Yan Boats, Inc. v. Sea Lark boats Inc., 359 F. Supp. 948, aff’d 479 F. 2d. 1338.
Applicant is advised that the MPEP states the following with respect to large information disclosure statements:
Although a concise explanation of the relevance of information is not required for English language information, applicants are encouraged to provide a concise explanation of why the English-language information is being submitted. Concise explanations (especially those that point out the relevant pages and lines) are helpful to the Office, particularly where documents are lengthy and complex and applicant is aware of a section that is highly relevant to patentability or where a large number of documents are submitted and applicant is aware that one or more is highly relevant to patentability. MPEP § 609.04(a)(III).
This statement is in accord with dicta from Molins PLC v. Textron, Inc., 48 F.3d 1172 (Fed. Cir. 1995), states that forcing the Examiner to find “a needle in a haystack” is “probative of bad faith.” Id. at 1888. This case presented a situation where the disclosure was in excess of 700 pages and contained more than fifty references. Id. 1888.
The MPEP provides more support for this position. In a subsection entitled “Aids to Compliance With Duty of Disclosure,” item thirteen states:
It is desirable to avoid the submission of long lists of documents if it can be avoided. Eliminate clearly irrelevant information and marginally pertinent cumulative information. If a long list is submitted, highlight those documents which have been specifically brought to Applicant’s attention and/or are known to be of the most significance. See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F.Supp 948 (S.D. Fla. 1972) aff’d 479 F.2d 1338 (5th Cir 1974). See also MPEP § 2004.
Therefore, it is recommended that if any information that has been cited by Applicants in the previous disclosure statement is known to be material for patentability as defined by 37 CFR 1.56, Applicant should present a concise statement as to the relevance of that/those particular documents therein cited.
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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,795,724 in view of Hunt (US 2004/0030304). The patented claim 1 recites all of the current limitations, including an upstream layer having a hydrophilic side and a hydrophobic side, a sealing member adapted to cover the tissue site, the hydrophilic side facing the sealing member (because the hydrophobic side forms an exterior of the pouch that encloses an absorbent member), and the absorbent member between the upstream layer and the sealing member. The patented claim 1 is silent to being bonded to the sealing member. Hunt discloses a dressing having a pouch (elastomeric envelope) formed of an upstream layer (lower wall 30) and a downstream layer (upper wall 28, see Fig. 1), the two layers enclosing an absorbent member (36), the peripheral edge of the upstream layer being bonded ([0046], when the drape 4 is positioned over the envelope) to the sealing member (drape 4) via the downstream layer. It would have been obvious to one skilled in the art at the time of filing to modify with Hunt for easy removal of the pouch from the wound.
Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,045,594 in view of Hunt (US 2004/0030304). The patented claim 1 recites all of the current limitations, including an upstream layer having a hydrophilic side and a hydrophobic side, a sealing member adapted to cover the tissue site, the hydrophilic side facing the sealing member (because the hydrophobic side forms an exterior of the pouch that encloses an absorbent member), and the absorbent member between the upstream layer and the sealing member. The patented claim 1 is silent to being bonded to the sealing member. Hunt discloses a dressing having a pouch (elastomeric envelope) formed of an upstream layer (lower wall 30) and a downstream layer (upper wall 28, see Fig. 1), the two layers enclosing an absorbent member (36), the peripheral edge of the upstream layer being bonded ([0046], when the drape 4 is positioned over the envelope) to the sealing member (drape 4) via the downstream layer. It would have been obvious to one skilled in the art at the time of filing to modify with Hunt for easy removal of the pouch from the wound.
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.
Claims 16 & 32 are rejected under 35 U.S.C. 103 as being unpatentable over Hunt (US 2004/0030304) in view of MacMeccan et al. (US 2010/0030178).
Re Claim 16, Hunt discloses an apparatus (Figs. 1 & 3) for collecting fluid from a tissue site, the apparatus comprising:
an upstream layer (the upper layer of elastomeric material 38 of Fig. 1 or elastomeric material 38 of Fig. 3);
a sealing member (drape 14) adapted to cover the tissue site and the upstream layer (see figures), the sealing member being bonded to the upstream layer (see figures where the peripheries of the elastomeric material 38 and the drape 14 are joined); and
an absorbent member (foam layer 12, [0018] "absorbent polymer foam, e.g., a reticulated polyurethane foam" & [0041] "[t]he foam utilized is polyurethane") positioned between the upstream layer and the sealing member (see figures).
Hunt does not expressly teach that the upstream layer has a hydrophilic side and a hydrophobic side.
MacMeccan discloses a composite suitable for use as a wound dressing, wherein the composite comprises a layer (fluid transport layer 106, [0023]) upstream of an absorbent layer (fluid retentive layer 120, Fig. 5A), the layer having a hydrophilic side (second surface 110, [0019] "the second surface 110 of the fluid transport layer 106 exhibits a greater affinity for aqueous fluid than the first surface 108 of the fluid transport layer 106"; also see [0022] where at least some yarns used in the fluid transport layer 106 are hydrophilic) and a hydrophobic side (first surface 108, [0017] "hydrophobic layer 102 is applied to the first surface 108"; [0027] e.g., "the hydrophobic layer can be a discrete layer or a chemical coating or chemical treatment applied to the first surface 108"), the hydrophobic side facing the wound (Abstract, “the first surface of the fluid transport layer provides a skin-facing surface”) so as to improve fluid transport away from the wound (e.g., [0026] “any aqueous fluids absorbed by the composite article 100 will be transported or pumped from the hydrophobic layer 102 to the first surface 108 of the fluid transport layer 106”, also see [0019] "any aqueous fluids absorbed by the fluid transport layer 106 will be transported or pumped from the first surface 108 to the second surface 110 of the fluid transport layer 106").
It would have been obvious to one skilled in the art at the time of filing to modify Hunt with MacMeccan's upstream layer such that it has a hydrophilic side and a hydrophobic side so as to improve wound exudate/fluid management and subsequently leads to better wound healing ([0005] of MacMeccan). After the modification, the hydrophilic side (second surface 110) of the upstream layer (fluid transport layer 106) would face the sealing member since that is the side facing away from the wound/tissue site.
Re Claim 32, Hunt and MacMeccan combine to disclose claim 16 and Hunt further discloses a manifold (lower foam layer 36, Fig. 1), wherein the upstream layer (upper layer of elastomeric material 38) is adapted to be positioned between the absorbent member and the manifold.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Hunt and MacMeccan as applied to claim 16 above, and further in view of Lang et al. (US 4,753,231).
Re Claim 28, Hunt and MacMeccan combine to disclose claim 16 but they do not disclose that the upstream layer has a material density of about 80 gsm. Lang discloses a wound dressing having a layer that lies between an absorbent layer and a wound bed, wherein said layer has a weight of 10-80 gsm and serves to allow transfer of fluid to the absorbent layer to prevent wound fluid pooling in the wound (col. 4 lines 51-65). It would have been obvious to one skilled in the art to modify Hunt and MacMeccan with the knowledge from Lang, that a wound layer, one that can facilitate transfer of fluid from a wound to an absorbent layer within the dressing, may have a basis weight that matches what is currently claimed.
Claims 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Hunt and MacMeccan as applied to claim 16 above, and further in view of Mumby et al. (US 2014/0249495).
Re Claims 29-31, Hunt and MacMeccan combine to disclose claim 16 but do not disclose a non-adherent layer adapted to be positioned between the upstream layer and the tissue site, wherein the non-adherent layer comprises a perforated silicone and wherein the perforated silicone is pattern-coated with an acrylic adhesive adapted to face the tissue site. Mumby discloses an absorbent ([0223]) wound dressing having a wound-contacting layer (101, Fig. 1) that is formed of perforated silicone ([0222], “the wound contact layer may be formed from any suitable polymer, e.g. silicone”) and coated with an acrylic adhesive ([0222], “the wound contact layer 101 … is coated with a skin-compatible adhesive, such as pressure sensitive acrylic adhesive”), wherein the adhesive is provided in a pattern ([0222] “the adhesive may be coated in a semi-continuous layer such as in a pattern such as a chequerboard pattern, polka dot pattern, herring bone pattern, mesh pattern or other suitable pattern”). It would have been obvious to one skilled in the art at the time of filing to modify Hunt further by adding Mumby’s wound contacting silicone layer covered in patterned adhesive as such a layer is known to be beneficial for contacting wound tissue to prevent maceration.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN S SU whose telephone number is (408)918-7575. The examiner can normally be reached M-F 9:00 - 5:00 Pacific.
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/SUSAN S SU/Primary Examiner, Art Unit 3781 17 March 2026