DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
Claims 1-15 are pending and examined on the merits.
Information Disclosure Statement
The references cited by applicants in the information disclosure statements filed on 5/28/2024-5/27/2026 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.
Claims 12-13, 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 10,010,656 in view of Haggstrom (US 2007/0078366). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim 4 recites all of the limitations in current claims 12-13, including a cover, a seal layer to cooperate with the cover to provide a fluid seal, the seal layer being between the tissue site and the cover layer, an absorbent layer, a first manifold/porous layer, a second manifold/porous layer, and a pump. Patented claim 4 does not require that the pump be on-board the dressing. Haggstrom discloses a dressing with a micropump at the top of the dressing (Fig. 2). It would have been obvious to one skilled in the art at the time of filing to modify with an on-board micropump such that the patient can more easily move around.
Allowable Subject Matter
Claims 1-15 are allowed. Note the nonstatutory double patenting rejection of Claims 12-13 & 15.
The following is a statement of reasons for the indication of allowable subject matter:
The currently claimed inventions have an effective filing date of March 5, 2008.
Re Claim 1, closest prior art Hunt (US 2007/0030304) discloses a cover layer (patch 22, Fig. 1), a seal layer (drape 14) having an aperture (through which flange 20 of connector 16 extends), a first manifold (e.g., either one of top foam layer 40 and lower foam layer 42, Fig. 2), a second manifold (the other of 40 & 42), and an absorbent layer (upper foam layer 12). Hunt fails to disclose that that first manifold layer is fluidly exposed to the tissue site through the aperture in the seal layer and modifying Hunt to meet the claim would render the Hunt dressing inoperative. Additionally, the second manifold layer, which is closer to the wound than the absorbent layer in Hunt’s dressing, cannot be disposed between the absorbent layer and the cover because the Hunt dressing requires that the foam layers closer to the wound be non-absorbent so as to allow fluid to quickly reach the absorbent layer that is located farther away from the wound.
Re Claim 12, Hunt discloses a cover, a seal layer, an absorbent layer, a first porous layer and a second porous layer, but Hunt fails to disclose that the first porous layer is disposed between the seal layer and the absorbent layer or that the second porous layer is disposed between the absorbent layer and the cover. As discussed supra, Hunt’s layers serve a function that would be destroyed if they are rearranged as required by the claim.
Claims 2-11 & 13-15 are allowable at least for being dependent from Claim 1 or 12.
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 30 May 2026
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