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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Claims 8-11 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 6/5/26.
Applicant's election with traverse of Group I (claims 1-7 and 12-16) in the reply filed on 6/5/26 is acknowledged. The traversal is on the ground(s) that (1) the claims of Group II are directed to a wound dressing, surgical tape or plaster according to claim 1 and, thus, should not be separated from Group I since claim 8 incorporates all the limitations of claim 1 and only specifies a purpose for the dressing and (2) Applicant’s technical feature qualifies as a special technical feature because it makes a contribution over the cited prior art. This is not found persuasive for at least the following reasons:
The Office has noted Applicant’s arguments on page 4 of the Response that restriction between Groups I and II is not proper because claim 8 incorporates all the limitations of claim 1 by reference and additionally specifies a purpose for the wound dressing of claim 1 and, because, a proper examination of the claims of Group I requires full examination of the subject matter of the claims of Group II, so no undue burden is imposed on the Office by undertaking examination of the full set of claims as originally presented. The Office respectfully disagrees. Although it is true that claim 8 depends from claim 1 and, therefore, includes all the limitations of claim 1, the Office disagrees that this interdependence between the claims, alone, is sufficient to support withdrawing the requirement for restriction. Claim 8 specifies that the dressing, tape or plaster of claim 1 is a cannula dressing, not just that it is used as a cannula dressing. Thus, the claim is interpreted to mean that the dressing is structured or configured to cover a cannula. Taking into consideration Applicant’s disclosure and illustration of the cannula dressing embodiment of the invention in figure 4, it is clear that there are structural differences between the dressing shown in figures 1-3 and the cannula dressing shown in figure 4. For example, the cannula dressing in figure 4 includes an elongated bottom part (22) which is a structural feature that is needed for covering a cannula (24) (as described on page 6 of Applicant’s specification). This structure is not required or necessary, however, for the dressing shown in figures 1-3. Additionally, the cannula dressing shown in Applicant’s figure 4 includes a transparent part 28 which enables the cannula to be seen (Applicant’s specification page 6) which, again, would be unnecessary (and unwanted) in a dressing such as the one shown in Applicant’s figures 1-3. Thus, examination of the claims of Group II would require additional searches in order to take into consideration the specific structural features discussed above and the functional limitations associated with claims 8-11 which are specifically directed to a cannula dressing but are not applicable to the device of claims 1-7 and 12-16. Furthermore, the cannula dressing of Group II is classified in a different CPC area and therefore would require searches not only in the CPC areas related to the device of Group I, but, also in additional areas such as A61M25/0612 which relate to devices that are configured for holding or protecting a body-inserted needle. Thus, there would be a serious search and/or examination burden if restriction between Groups I and II was not required. Therefore, for at least the reasons provided above, the Office is not persuaded by Applicant’s arguments and, thus, maintains that the requirement for restriction is reasonable.
The Office has also noted Applicant’s arguments on pages 4-8 of the Response that Applicant’s technical feature qualifies as a special technical feature because it makes a contribution over the prior art. In particular, the Office has noted Applicant’s arguments that one of ordinary skill in the art would not have been motivated to modify the bandage of Bays to include a dissolvable adhesive, as taught by Grinstaff, as proposed by the Office in the Restriction Requirement dated 4/15/26. Although it may be true that it would be counterintuitive to provide a dissolvable adhesive on a bandage that has an absorbent pad with a liquid impermeable layer between the pad and the adhesive layer, the Office is not persuaded that Applicant’s technical feature qualifies as a special technical feature at least because it fails to make a contribution over the prior art in light of Kantner (US 2010/0272784) which discloses the invention as claimed (see claim rejections provided below). Thus, for at least this reason, the Office maintains that Groups I and II lack unity of invention because the shared technical feature does not make a contribution over the prior art.
Therefore, for at least the reasons provided above, the Office is not persuaded by Applicant’s arguments and the restriction requirement is still deemed proper and is therefore made FINAL.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it includes language which can be implied (i.e. “the present invention is directed to…”) and because it includes legal phraseology (i.e. “comprising”). Correction is required. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities which require appropriate correction:
Page 2 para [00010]: “embodiment the wound dressing” should be “embodiment of the wound dressing”.
Page 3 para [0012]: “procedure in process” should be “procedure or process”.
Page 3 para [0013]: “resistance” should be “resistant”.
Page 3 para [0014]: “that intended topside” should be “the intended topside” and “as a corner” should be “has a corner”.
Page 4 para [0023]: “with either each section” should be “with each section”.
Page 4 para [0025]: “and so dissolves” should be “and dissolves”.
Page 5 para [0026]: “top side the plaster” should be “top side of the plaster”,
Page 6 para [0031]: “produce” should be “produced”.
Claim Objections
Claims 2-7 and 12-16 are objected to because of the following informalities which require appropriate correction:
In claim 2 line 1: “A wound dressing” should be “The wound dressing”.
In claim 2 line 2: “part” should be removed from “paper part”.
In claim 3 line 1: “A wound dressing” should be “The wound dressing”.
In claim 3 line 2: “its adhesive side” should be “an adhesive side”.
In claim 4 line 1: “A wound dressing” should be “The wound dressing”.
In claim 4, line 2 should be amended to recite: “…paper includes printed or written information or on one side conveys information.
In claim 5 line 1: “A wound dressing” should be “The wound dressing”.
In claim 5 line 2: “resistance” should be “resistant”.
In claim 5 line 1: a comma “,” should be added after “wound dressing” for improved readability.
In claim 6 line 1: a comma “,” should be added after “wound dressing” for improved readability.
In claim 6 line 1: “A wound dressing” should be “The wound dressing”.
In claim 6 line 2: “resistance” should be “resistant” and “the topside” should be “a topside”.
In claim 6 line 2: commas “,” should be added after “wound dressing” and “surgical tape” for improved readability.
In claim 7 line 1: “A wound dressing” should be “The wound dressing”.
In claim 7 line 1: a comma “,” should be added after “wound dressing” for improved readability.
In claim 7, line 2 should be amended to recite “…the absorbent pad
In claims 12-16, in line 1 of each claim: “A wound dressing” should be “The wound dressing”.
In claim 12 lines 1-2 and 3 (two separate corrections needed): “the dissolvable paper” should be “the adhesive dissolvable paper”.
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 1-7 and 12-16 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.
In particular, regarding claim 1, the limitation at line 2 reciting “…an adhesive dissolvable paper…” renders the claim indefinite because it is unclear what structure is being claimed. For example, it is unclear from this language whether the claim is reciting an adhesive that is dissolvable, a paper that is dissolvable, a dissolvable adhesive on a dissolvable paper, or if the adhesive causes a reaction with the paper to dissolve the paper (i.e. the adhesive dissolves the paper). Review of Applicant’s specification reveals that the disclosure provides support for claiming a dissolvable paper and/or a dissolvable adhesive (see i.e. specification page 5 para [0026]). However, such disclosure does not provide any guidance as to which of these options is intended by reciting “an adhesive dissolvable paper”. Since the limitation at issue recites that “the adhesive part is an adhesive dissolvable paper”, this limitation has been interpreted as being directed to or further defining adhesive, not paper. Thus, for purposes of examination, the claimed “adhesive dissolvable paper” has been interpreted as being a dissolvable adhesive applied to or provided on paper. Nevertheless, appropriate revision is required in order to clarify the language of the claims.
Regarding claim 2, the limitation at line 2 reciting “an adsorbent pad” renders the claim indefinite because it is unclear whether this limitation is directed to the “absorbent” pad recited in claim 1 or if it is directed to a different pad structure which is formed from an “adsorbent” material. Review of Applicant’s specification shows no disclosure of an “adsorbent” pad while all discussion refers to an “absorbent pad”. Additionally, Applicant’s drawings only illustrate a single pad 14 on the plaster 10 and refer to this pad as an “absorbent” pad. Therefore, it has been assumed that use of the term “adsorbent” in the claims is merely a typographical error. For purposes of examination, it has been assumed that Applicant intended for claim 2 to recite that the paper covers “the absorbent pad” but revision is nevertheless required in order to clarify the language of the claims.
Regarding claim 15, the limitation "e.g. – 87-89% hydrolyzed" renders the claim indefinite because it is unclear whether the values recited after “e.g.” are part of the claimed invention. See MPEP § 2173.05(d).
Claims 3-7, 12-14 and 16 depend directly or indirectly from rejected claim 1 and, therefore, contain the same deficiencies.
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 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.
Claims 1, 3, 7, 12-13, 15 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kantner (US 2010/0272784).
With respect to claim 1, Kantner discloses a wound dressing, surgical tape or plaster ( “devices for skin contacting application” - para [0010;0027]) comprising an absorbent pad (para [0010;0038]) and an adhesive part in which the adhesive part is an adhesive dissolvable paper (water-soluble PSA provided on a water-soluble backing – para [0010;0027-0038]; “paper” is defined by Merriam-Webster as being “a felted sheet of…vegetable fibers laid down on a fine screen from a water suspension” or “a similar sheet of other material (such as plastic)” (see attached PDF copy of the definition) - thus, the backing is interpreted as being a “paper” because Kantner discloses that it can be formed from “vegetable natural polymers” -para [0030] and be constructed from nonwoven techniques such as wet laying – para [0035]).
With respect to claim 3, Kantner discloses the invention as claimed (see rejection of claim 1) and also discloses a removable film or foil covering an adhesive side before use (film/foil support layer releasably attached to PSA – para [0040-0041]).
With respect to claim 7, Kantner discloses the invention as claimed (see rejection of claim 1) and also discloses that the absorbent pad is made of water soluble material (para [0010;0038]).
With respect to claim 12, Kantner discloses the invention as claimed (see rejection of claim 1) and also discloses a dissolvable polymer made from polyvinyl alcohol (PVA) (para [0031]).
With respect to claim 13, Kantner discloses the invention as claimed (see rejection of claim 12) and also discloses that said PVA is a cross laid fabric (the backings include nonwoven fibrous webs, woven fibrous webs, knits, foams, films and the like – para [0029;0035;0037]; cross laid fabrics are nonwoven fabric structures).
With respect to claim 15, Kantner discloses the invention as claimed (see rejection of claim 12) and also discloses that the PVA is partially hydrolyzed PVA (e.g. 87-89% hydrolyzed) (the device can be designed to dissolve in cold or warm water – para [0028]; hydrolysis greater than about 87% results in more crystalline polymers, thereby requiring higher temperatures to dissolve the polymer – para [0031] – thus, it is inherent that the PVA is partially hydrolyzed in order to be dissolvable in cold or warm water).
With respect to claim 16, Kantner discloses the invention as claimed (see rejection of claim 1) and also discloses that the device is sized and shaped to be applied to or about a body part (the device is designed as medical tape, bandages or wound dressings/patches specifically configured for application to the skin – para [0010]; with a specific example being a configuration sized/shaped for application to fingernails or toenails – para [0048]).
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 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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Kantner (US 2010/0272784) in view of Bays (US 6269820).
With respect to claim 2, Kantner discloses the invention as claimed (see rejection of claim 1) but does not explicitly disclose that the adhesive part covers the absorbent pad.
Bays, however, teaches a wound dressing (bandage 10; col 3 lines 45-57) comprising an absorbent pad (16; col 3 line 48) and an adhesive part (adhesive 14) in which the adhesive part is an adhesive coated paper (the adhesive 14 is applied to backing 12 which is formed from a porous material 22 such as paper – col 3 lines 58-67) wherein the adhesive coated paper covers the absorbent pad (as shown in figures 3 and 8, the backing 12 which is coated with adhesive 14 covers the absorbent pad 16; pad 16 is described as being “absorbent” in col 3 line 48). 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 adhesive part of the device of Kantner to be larger than the absorbent pad to cover the absorbent pad like the backing 12 covers pad 16 in Bays figure 8 in order to provide an adhesive margin around the pad for attachment to the skin (Bays col 7 lines 20-27).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Kantner (US 2010/0272784) in view of Bowman (US 2015/0257935).
With respect to claim 4, Kantner discloses the invention as claimed (see rejection of claim 1) but does not explicitly disclose that the adhesive dissolvable paper is printed or written or on one side conveying information.
Bowman, however, teaches bandages 1401 and 1500 that are customizable (figs 14-15; para [0061-0061]) wherein, specifically, bandage 1401 includes a writing surface 1402 on a major face of the bandage wherein stickers 1403 are applied to surface 1402 to convey information (such as i.e. the patient’s name as shown on the writing surface of bandage 1500 in figure 15; para [0060-0061]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have added stickers with writing conveying information as taught by Bowman to the major face of the adhesive dissolvable paper of the device of Kantner in order to customize the device to meet the specific needs of a given user.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Kantner (US 2010/0272784) in view of McEntire et al (US 2007/0259029).
With respect to claims 5-6, Kantner discloses the invention as claimed (see rejection of claim 1) and also discloses a second support layer formed from film material that is adhered to the backing to provide rigidity during application when a first support layer is removed from the adhesive (para [0040-0041]). Kantner does not, however, explicitly disclose that the second support layer is a removable water resistance film that is secured to the topside of the wound dressing, surgical tape, or plaster via adhesive.
McEntire, however, teaches a dermal patch 10 (the term patch is disclosed as including adhesive dressings – para [0039]) comprising a polymeric matrix layer 30 and an adhesive layer 25 (fig 1; para [0040-0045]) that is configured for attachment to a user’s skin (para [0045]), a removable protective covering 15 covering the adhesive layer 25 prior to use (fig 1; para [0045]) and a protective covering 20 formed of elastic film that is water-resistant (para [0042]) and weakly bonded to the layer 30 such that after adhesive layer 25 is pressed onto the skin by applying pressure on the release layer 20, layer 20 is grasped and peeled from the composite film to expose the outer surface 40 of layer 30 (para [0045]; the bonding between layers 20 and 30 is interpreted as being via adhesive having a bonding strength that is less than the bonding strength of the adhesive of layer 25 to layer 30 as disclosed in para [0045]). 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 second support layer in Kantner as a removable water resistance film that is secured via adhesive to the topside of the dressing as taught by McEntire in order to prevent contamination of the device and provide support during application (McEntire para [0040-0041;0045]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Kantner (US 2010/0272784) in view of Franklin (CA 2665529).
With respect to claim 12, Kantner discloses the invention as claimed (see rejection of claim 1) and also discloses that the dissolvable paper is made from cellulose derivatives (para [0030]) but does not explicitly disclose that the dissolvable paper is made from Sodium Carboxy Methyl Cellulose and wood/wooden pulp.
Franklin, however, teaches an adhesive article which includes a layer formed from Aquasol™ paper which is a water-dissolvable paper made of sodium carboxy methyl cellulose and wooden pulp (pg 4; paragraph 3). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have used a dissolvable paper made from Sodium Carboxy Methyl Cellulose and wooden pulp, as taught by Franklin, as the dissolvable paper in the device of Kantner, since 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.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Kantner (US 2010/0272784) in view of Fang et al (WO 2007109353).
With respect to claim 14, Kantner discloses the invention as claimed (see rejection of claim 13) but does not explicitly disclose that the fabric is about 38 gsm.
Fang, however, teaches a medical article formed from a fabric that is formed from PVA and is a cross-lapped, spun- laced nonwoven fabric having a basis weight of from about 30 to about 35 gsm (see claims 32-33). Although Fang does not disclose that the basis weight is exactly 38 gsm, the claim requires that the weight is “about” 38 gsm, which is interpreted to mean that the weight can be slightly less or slightly more than 38 gsm and, additionally, Fang teaches that the basis weight is “about” 30-35 gsm, meaning that the weight can be slightly less than 30gsm or slightly more than 35gsm. The difference between 35 and 38gsm is only 3 gsm and is interpreted to be such a small, insignificant difference that it is not expected to result in a change in structure or physical characteristics that would likely be noticed by a user of the device. Furthermore, the teaching of the range of “about” 30-35gsm is interpreted as including values that are “about 38gsm” since such values are only slightly higher than the upper limit of 35gsm. Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have configured the device of Kantner comprising a PVA cross-laid fabric that is about 38gsm, as taught by Fang, in order to provide a fabric having a weight that is appropriate for use in medical applications on the body and, additionally, because discovering an optimum value of a result effective variable involves only routine skill in the art.
Citation of Pertinent Prior art
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US2003/0012910 discloses a dissolvable adhesive article; US2009/0226116 discloses water dissolvable paper with adhesive; US8636708 discloses an adhesive article including a water dissolvable layer 30 and printed information on one side providing identification or surgical information about a patient; WO 2015/002888 teaches a dissolvable hydrogel composition which is capable of being adhered to a wound surface and controllably dissolved to release the composition from the surface at a later time (see abstract lines 3-5).
Conclusion
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.
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786
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