DETAILED ACTION
In Applicant’s Response filed 7/28/25, Applicant has amended claim 1; and added new claim 6. Claims 2-3 have been cancelled. Currently, claims 1 and 4-6 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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 and 4-6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. In particular, the new limitations in claim 1 which recite a base material being “a single layer plastic film” and recite that the base material is “a sole plastic film” are not supported by the disclosure as originally filed. Review of Applicant’s specification shows that the base material is described as being “film-like” but there is no disclosure of the base material being a single layer plastic film or a sole plastic film. Thus, these limitations constitute new matter and fail to comply with 35 USC 112(a). Claims 4-6 each depend from claim 1 and, therefore, include the same deficiencies.
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.
Claim(s) 1 and 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Busch (WO-2013101884-A1) in view of Taniguchi (JP-2015063671-A) and further in view of Brown (US 4643181).
With respect to claim 1, Busch discloses a surgical drape (100; fig 2a) comprising a tacky layer comprising at least one adhesive (adhesive layer 108; types of adhesives are disclosed in para [0085-0086]) configured to be incised or punctured with a surgical tool (incised with scalpel 33 – para [0054]), the tacky layer (108) having a tacky surface configured to be brought into contact with a region of a living body including a surgery site thereof (the adhesive layer is interpreted as being tacky and is in contact with a patient’s skin 20 to adhere the drape 100 to the skin 20 – para [0052]); and
a base material being a single layer plastic film and disposed by lamination onto a surface of the tacky surface of the tacky layer at a side opposite to the tacky surface thereof (a layer of adhesive 108 is provided on exterior surface 103 of the first film layer 101- para [0052]; while the opposite side of the drape includes a second film layer 102 that is laminated to film layer 101 (para [0051]; fig 2a); each film layer is a single layer of film material and is a “plastic” since it is preferably a polyurethane as described in para [0081]), and
the base material comprises a thermoplastic resin selected from the group consisting of polyurethane resin (paragraph [0081] discloses that the film used for forming the drape is preferably a polyurethane),
the base material is a sole plastic film (each film layer 101/102 is a single layer of film material and is a “plastic” since it is preferably a polyurethane as described in para [0081]) configured to be incised or punctured, in the surgical drape (the film is specifically configured to be incised, punctured or cut with a surgical device such as a scalpel to make an incision through the drape and into the patient’s skin during a procedure - para [0004; 0006-0007;0049]).
Busch does not, however, explicitly disclose that the surgical drape has a Young’s modulus of 10.0 MPa or less.
In paragraph [0081] of Busch, however, it is disclosed that the film used for forming the drape is preferably a polyurethane, polyether polyester, or polyether polyamide. Furthermore, Taniguchi teaches elastomeric materials that are used in medical applications (translation pg 2; para 2) such as polyurethane (translation pg 4; para 6) wherein the Young’s Modulus of the elastomeric material is preferably low for use in medical applications and, specifically, is “is 100 MPa or less, It is preferably 50 MPa or less, 10 MPa or less, 1 MPa or less, or 0.5 MPa or less” (translation pg 6 para 2). Thus, 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 polyurethane having a Young’s Modulus of 10 MPa or less as taught by Taniguchi as the polyurethane used for forming the drape of Busch since the drape in Busch is specifically intended to be used in medical applications and discovering the optimum or workable ranges involves only routine skill in the art.
Busch also does not explicitly disclose the drape having a piercing strength in a thickness direction of 4.0 N or less.
Busch does, however, teach that the film used for forming the drape is preferably formed from polyurethane (para [0081]) and that the film is specifically configured to be incised, punctured or cut with a surgical device such as a scalpel to make an incision through the drape and into the patient’s skin during a procedure (para [0004; 0006-0007;0049]). Thus, the polyurethane film used for the drape of Busch inherently must have a piercing strength in the thickness direction that is low enough to be capable of being incised with a scalpel as explicitly disclosed in Busch. Furthermore, Busch teaches that the film layer has a thickness, preferably, of between 13-52 microns (para [0081]). As indicated by Applicant’s own disclosure in table 1 (paragraph [0027] of the specification), polyurethane material having an average thickness of 30-45 microns has an average piercing strength of 0.67-1.52 N. Since the polyurethane film used for the drape of Busch is disclosed as having a thickness in the same range as the samples listed in table 1 of Applicant’s specification, this film is expected to therefore have the same piercing strength as those samples, which is within the claimed range of 0-4N. Furthermore, 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 material having a piercing strength in a thickness direction of, specifically, 4.0 N or less, not only to allow a physician to easily incise the drape but, also, because where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
Busch also does not explicitly disclose that the drape has an average score of peeling off resistance in a range from 4.3 to 5.0 wherein a score 5 indicates substantially no peeling off of the tacky surface of the tacky layer of the surgical drape at an incised site and a score 1 indicates complete peeling off of the tacky surface from the skin model at the incised site.
Busch does, however, teach that the adhesive used is an acrylic adhesive (para [0085]) and further teaches that “strength of the adhesive can be selected to permit removable adhesion of the incise drape to the surface of a surgical drape, without causing the surgical drape to peel away from a patient's body on removal of the incise drape from the surgical drape” (para [0084]). Furthermore, as shown in figures 2b and 2c of Busch, the drape remains attached to the skin and does not peel away when an incision is made. As indicated by Applicant’s own disclosure, a tacky layer including an acrylic-based tackiness agent (para [0016;0031]; table 2) has a peeling resistance that ranges from 1 to 5 (para [0031]; table 2) wherein a score of 5 indicates that the tacky layer was hardly peeled (para [0030]) and a score of 1 indicates that the tacky layer was peeled completely (para [0030]). Since the adhesive used for the drape of Busch is an acrylic, which is the same as the tackiness agent disclosed in Applicant’s specification and used in the comparative examples in table 2, this adhesive is therefore expected to have the same peel resistance as the tackiness agent used in the comparative examples, which is from 1 to 5 and, therefore, encompasses the claimed range of 4.3-5. Additionally, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have used an adhesive that is capable of functioning so that there is substantially no peeling off of the tacky surface of the tacky layer of the surgical drape at an incised site since Busch explicitly teaches that the strength of the adhesive can be selected to meet the intended end use, which is for the drape to remain attached to the skin and not peel away when an incision is made as shown in figures 2b and 2c of Busch. Furthermore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have used an adhesive that has an average score of peeling off resistance that, specifically, is in a range from 4.3 to 5.0, because where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
Busch also does not explicitly disclose that peeling off of the surgical drape from a skin model for practicing surgery is measured and scored, wherein when the tacky surface of the tacky layer of the surgical drape is pasted onto the skin model, the skin model is bent into a columnar shape so that the drape faces outside, then three incisions having a length in a range from 3 to 4 cm and a thickness in a range from 6 to 8 mm are made with a surgical scalpel into the surgical drape and further into the skin model so as to reach a layer of the skin model corresponding to a subcutaneous skin layer, and the peeling off of the tacky layer is observed visually at each of the incised sites. However, with regard to these limitations which are directed to a method of measuring peeling off resistance, it is noted that the method steps are not germane to the issue of patentability of the surgical drape itself. Therefore, these limitations have not been given patentable weight.
Busch also does not disclose that the tacky layer has a thickness in a range from 1-1200µm.
Brown, however, teaches an incise drape which includes an adhesive layer having a thickness that is no greater than about 60 microns and, more specifically, is between about 30 and 60 microns and preferably between 40 and 50 microns – col 3 lines 45-50). 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 layer on the drape of Busch in view of Taniguchi having a thickness in the range of 1-1200µm, as taught by Brown, in order to provide the desired adhesion properties in the drape and, furthermore, because where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
With respect to claim 4, Busch in view of Taniguchi and further in view of Brown discloses the invention substantially as claimed (see rejection of claim 1) but Busch does not, however, explicitly disclose that the surgical drape has a Young’s modulus in a range of 0.1MPa to 10.0 MPa.
In paragraph [0081] of Busch, however, it is disclosed that the film used for forming the drape is preferably a polyurethane, polyether polyester, or polyether polyamide. Furthermore, Taniguchi teaches elastomeric materials that are used in medical applications (translation pg 2; para 2) such as polyurethane (translation pg 4; para 6) wherein the Young’s Modulus of the elastomeric material is preferably low for use in medical applications and, specifically, is “is 100 MPa or less, It is preferably 50 MPa or less, 10 MPa or less, 1 MPa or less, or 0.5 MPa or less” (translation pg 6 para 2; the range of 10Mpa or less includes the values within the range of 0.1-10Mpa). Thus, 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 polyurethane having a Young’s Modulus in a range of 0.1MPa to 10.0 MPa as taught by Taniguchi as the polyurethane used for forming the drape of Busch since the drape in Busch is specifically intended to be used in medical applications and discovering the optimum or workable ranges involves only routine skill in the art.
With respect to claim 5, Busch in view of Taniguchi and further in view of Brown discloses the invention substantially as claimed (see rejection of claim 1) but Busch does not explicitly disclose the drape having a piercing strength in a range of 0.5N to 4.0 N.
Busch does, however, teach that the film used for forming the drape is preferably formed from polyurethane (para [0081]) and that the film is specifically configured to be incised, punctured or cut with a surgical device such as a scalpel to make an incision through the drape and into the patient’s skin during a procedure (para [0004; 0006-0007;0049]). Thus, the polyurethane film used for the drape of Busch inherently must have a piercing strength in the thickness direction that is low enough to be capable of being incised with a scalpel as explicitly disclosed in Busch. Furthermore, Busch teaches that the film layer has a thickness, preferably, of between 13-52 microns (para [0081]). As indicated by Applicant’s own disclosure in table 1 in paragraph [0027] of the specification, polyurethane material having an average thickness of 30-45 microns was found to have an average piercing strength of 0.67-1.52 N. Since the polyurethane film used for the drape of Busch is disclosed as having a thickness in the same range as the samples listed in table 1 of Applicant’s specification, this film is expected to therefore have the same piercing strength as those samples, which is within the claimed range of 0.5N to 4.0 N. Furthermore, 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 material having a piercing strength in a thickness direction of, specifically, 0.5N to 4.0 N, not only to allow a physician to easily incise the drape but, also, because where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
With respect to claim 6, Busch in view of Taniguchi and further in view of Brown discloses the invention substantially as claimed (see rejection of claim 1) but Busch does not disclose that the tacky layer has a thickness in a range from 5-300µm.
Brown, however, teaches an incise drape which includes an adhesive layer having a thickness that is no greater than about 60 microns and, more specifically, is between about 30 and 60 microns and preferably between 40 and 50 microns – col 3 lines 45-50). 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 layer on the drape of Busch in view of Taniguchi having a thickness in the range of 5-300µm, as taught by Brown, in order to provide the desired adhesion properties in the drape and, furthermore, because where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
Response to Amendments/Arguments
Applicant’s amendments and arguments filed 7/28/25 have been fully considered as follows:
Regarding the claim rejections under 35 USC 103, Applicant’s arguments on pages 4-7 of the Response have been fully considered but are not persuasive.
Specifically, the Office has noted Applicant’s arguments on pages 4-5 that the drape of Busch differs from the claimed invention because it has two films sealed together to form a cavity therebetween as compared to the claimed invention which includes a single layer plastic film that is a sole plastic film. The Office is not persuaded by these arguments, however, because the mere fact that a prior art reference includes elements in addition to the specific elements listed in a claim does not, alone, differentiate the prior art device from a claimed invention where the claim includes “comprising” language, such as in the pending claims in this case. As recited in MPEP § 2111.03, “[t]he transitional term “comprising”, which is synonymous with “including,” “containing,” or “characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps”. (See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004)). Therefore, the mere fact that the device of Busch includes two film layers (each of which is a single film layer) instead of just one does not automatically differentiate the device from that of the claimed invention.
The Office has also noted Applicant’s arguments on pages 5-6 that the Busch reference fails to disclose the claimed thickness of the adhesive layer or the same drape structure as recited in claim 1 but the Office is not persuaded by these arguments in view of the modified grounds of rejection presented above which were necessitated by Applicant’s amendments to the claims.
The Office has also noted Applicant’s arguments on pages 6-7 that the products/uses taught in Taniguchi do not involve bringing a product into contact with a region of a living body such as a surgical site of skin and then being incised or punctured with a scalpel as recited in claim 1 of the present application. The Office is not persuaded by these arguments, however, because in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the present case, Taniguchi has been cited merely for teaching that polyurethane materials used in medical applications (like the polyurethane used for forming the drape of Busch) preferably have a low Young’s Modulus - specifically, a Young’s Modulus that is “is 100 MPa or less…preferably 50 MPa or less, 10 MPa or less, 1 MPa or less, or 0.5 MPa or less” (translation pg 6 para 2). The Busch reference has been cited for disclosing a surgical drape (100; fig 2a) configured to be incised or punctured with a surgical tool (incised with scalpel 33 – para [0054]), and being configured to be brought into contact with a region of a living body including a surgery site thereof (the adhesive layer is interpreted as being tacky and is in contact with a patient’s skin 20 to adhere the drape 100 to the skin 20 – para [0052]) (see rejection of claim 1 above). Thus, the Office is not persuaded by Applicant’s arguments because the combination of Taniguchi with Busch discloses a drape substantially as recited in claim 1 of the present application.
Thus, for at least the reasons outlined above, the Office is not persuaded by Applicant’s arguments and therefore maintains that the prior art of record reads on the claims substantially as recited in the present application.
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.
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786