DETAILED ACTION
In Applicant’s Response filed 4/6/25, Applicant has amended claims 1 and 11; and amended the specification. Claims 4-7 and 13 have been cancelled. Currently, claims 1-3, 8-12 and 14-21 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 Objections
Claim 11 is objected to because of the following informalities: Claim 11 has been provided with an incorrect status identifier because the claim recites that it is “previously presented” but it includes strikethrough to the text to indicate that changes are being made by amendment. Thus, the status identifier should have been “currently amended”. It has been assumed for purposes of examination that Applicant intended for claim 11 to be treated as being “currently amended”. Thus, the amendments to claim 11 are being considered. Correction of the status identifier in future communications is necessary in order to clarify of the status of the claims. Appropriate correction is required.
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(s) 1-3, 8-9, 11, 14, 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Hathman (EP 0746291 B1) (hereinafter Hathman ‘291) in view of Mumby et al (US 2016/0361205) and further in view of Hathman (US 5086763) (hereinafter "Hathman '763")
Regarding claim 1, Hathman ‘ 291 discloses a bandage (Fig. 12, dressing 17) comprising:
a) a substantially planar, flexible substrate (Fig. 12, base member 27) having an upper surface and a lower surface (Fig. 12, base member 27 has an upper surface and lower surface), the upper surface (Fig. 12, the upper surface of the base member 27) of the substrate (Fig. 12, base member 27) having a raised portion (Fig. 12, standoff member 50) disposed in a midportion thereof (as shown in fig 12 the standoff member 50 is disposed at the center of base member 27);
b) a layer of adhesive attached to the lower surface of the substrate (Fig. 12, the lower surface of the base member 27 has an adhesive layer; para. [0025]);
c) an aperture (Fig. 12, aperture 21) formed through the substrate (Fig. 12, base member 27 includes aperture 21 at the center) and the raised portion (standoff member 50 includes an opening at the center as shown in fig 12); wherein the aperture has rectilinear borders (as shown in fig 12, the aperture 21 is square shaped with straight lines forming the four sides of the square shape); and
d) a substantially planar cap (Fig. 12, covering member 58) having boundaries and dimensions sufficient to cover the aperture (Fig. 12, covering member 58 covers aperture 21).
Hathman does not, however, explicitly disclose that the raised portion of the substrate comprises a quad lobe outline formed from shapes selected from a group of shapes consisting of circles and ovals.
Mumby is in the field of wound dressings (para. [0016]) and teaches a bandage (Fig. 2a, dressing 100), wherein the raised portion (Fig. 2b, region 114) of the substrate (Fig. 2a, layer 101) comprises a quad lobe outline (Fig. 2b, region 114 has a four lobe outline) formed from shapes selected from a group of shapes consisting of circles and ovals (Fig. 2b, the outline has 4 lobes wherein the lobe outline is formed from circles). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the dressing of Hathman ‘ 291 to include the four lobe outline raised portion where the outline is formed from shapes consisting of circles as taught by Mumby in order to maximize flexibility of the raised area (Mumby, para. [0281]-[0283]), thereby minimizing lifting of the bandage away from the skin (Mumby, para. [0281]).
Hathman ’29 also does not disclose that the cap is removable and wherein the cap is configured to be inserted into the aperture.
Hathman ‘ 763 is in the field of bandages (col. 1, Ins. 6-10) and teaches a bandage (Fig. 1, wound dressing 10), wherein the cap (Fig. 1, Fig. 3, pad 38 fits into the opening 20 and functions to close the opening as shown in fig 2) is removable (Fig. 1, Fig. 3, the flap 36 with pad 38 attached to it is removable; col. 5, Ins. 49-51) and wherein the cap is configured to be inserted into the aperture (pad 38 is attached to flap 36 as shown in fig 1 and is inserted into the aperture as shown in fig 2 – thus, the cap is configured to be inserted into the aperture). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify the dressing of Hathman ‘291 to include a cap that is removable and wherein the cap is configured to be inserted into the aperture, as taught by Hathman '763, in order to facilitate selective removal of the flap (Hathman ‘763, col. 5, Ins.49-51), thereby allowing a caretaker to view/inspect a wound without removing the entire dressing.
Regarding claim 2, Hathman ‘ 291 in view of Mumby and further in view of Hathman ‘763 discloses the bandage substantially as claimed (see rejection of claim 1) and Hathman ‘291 also discloses that the bandage comprises:
e) a hinge (Fig. 12, hinge 56) attached to one boundary of the cap (Fig. 12, covering member 58) and to the substrate (Fig. 12, the hinge 56 is attached to the base member 27 via the standoff member 50; para. [0025)).
Regarding claim 3, Hathman ‘ 291 in view of Mumby and further in view of Hathman ‘763 discloses the bandage substantially as claimed (see rejection of claim 2) and Hathman ‘291 also discloses that the hinge (Fig. 12, hinge 56) is a living hinge (Fig. 12, hinge 56 is a living hinge since it is made from the same material as the frame and cap that it connects as shown in fig 12).
Regarding claim 8, Hathman ‘291 in view of Mumby and further in view of Hathman ‘763 discloses the bandage substantially as claimed (see rejection of claim 1) and Hathman '763 teaches a bandage (Fig. 1, wound dressing 10), wherein the cap (Fig. 1, Fig. 3, flap 36) is replaceable (Fig. 1, Fig. 3, the flap is replaceable; col. 5, Ins. 49-51). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the dressing of Hathman ‘ 291 in view of Mumby and further in view of Hathman ‘763 to include a replaceable flap as taught by Hathman ‘ 763 in order to facilitate replacement of dressing materials (Hathman ‘ 763, col. 2, Ins. 49-51), thereby facilitating wound healing.
Regarding claim 9, Hathman ‘ 291 in view of Mumby and further in view of Hathman ‘763 discloses the bandage substantially as claimed (see rejection of claim 1) and Hathman ‘291 also discloses that the cap (Fig. 12, covering member 58) is permanently mounted (Fig. 12, hinge 56 permanently mounts the covering member 58 to the standoff member 50) on the raised portion (Fig. 12, standoff member 50) of the substrate (Fig. 12, base member 27).
Regarding claim 11, Hathman ‘ 291 discloses a bandage (Fig. 12, dressing 17) comprising:
a) a substantially planar, flexible substrate (Fig. 12, base member 27) having an upper surface and a lower surface (Fig. 12, base member 27 has an upper surface and lower surface); the upper surface (Fig. 12, the upper surface of the base member 27) of the substrate (Fig. 12, base member 27) having a raised portion (Fig. 12, standoff member 50) disposed in a midportion thereof (as shown in fig 12 the standoff member 50 is disposed at the center of base member 27);
b) a layer of adhesive attached to the lower surface of the substrate (Fig. 12, the lower surface of the base member 27 has an adhesive layer; para. [0025]);
c) an aperture (Fig. 12, aperture 21) formed through the substrate (Fig. 12, base member 27 includes aperture 21 at the center) and the raised portion (standoff member 50 includes an opening at the center as shown in fig 12); wherein the aperture has rectilinear borders (as shown in fig 12, the aperture 21 is square shaped with straight lines forming the four sides of the square shape); and
d) a substantially planar cap (Fig. 12, covering member 58) having boundaries and dimensions sufficient to cover the aperture (Fig. 12, covering member 58 covers aperture 21).
Hathman does not, however, explicitly disclose that the raised portion of the substrate comprises a quad lobe outline formed from shapes selected from a group of shapes consisting of circles and ovals.
Mumby is in the field of wound dressings (para. [0016]) and teaches a bandage (Fig. 2a, dressing 100), wherein the raised portion (Fig. 2b, region 114) of the substrate (Fig. 2a, layer 101) comprises a quad lobe outline (Fig. 2b, region 114 has a four lobe outline) formed from shapes selected from a group of shapes consisting of circles and ovals (Fig. 2b, the outline has 4 lobes wherein the lobe outline is formed from circles). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the dressing of Hathman ‘ 291 to include the four lobe outline raised portion where the outline is formed from shapes consisting of circles as taught by Mumby in order to maximize flexibility of the raised area (Mumby, para. [0281]-[0283]), thereby minimizing lifting of the bandage away from the skin (Mumby, para. [0281]).
Hathman ’29 also does not disclose that the cap is configured to be inserted into the aperture.
Hathman ‘ 763 is in the field of bandages (col. 1, Ins. 6-10) and teaches a bandage (Fig. 1, wound dressing 10), wherein the cap (Fig. 1, Fig. 3, pad 38 fits into the opening 20 and functions to close the opening as shown in fig 2) is inserted into the aperture (pad 38 is attached to flap 36 as shown in fig 1 and is inserted into the aperture as shown in fig 2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify the dressing of Hathman ‘291 to include a cap that is configured to be inserted into the aperture, as taught by Hathman '763 in order to facilitate selective removal of the flap (Hathman ‘763, col. 5, Ins.49-51), thereby allowing a caretaker to view/inspect a wound without removing the entire dressing.
Regarding claim 14, Hathman ‘ 291 in view of Mumby discloses the bandage substantially as claimed (see rejection of claim 11) but does not disclose that the cap is removable.
Hathman ‘ 763 is in the field of bandages (col. 1, Ins. 6-10) and teaches a bandage (Fig. 1, wound dressing 10), wherein the cap (Fig. 1, Fig. 3, flap 36) is removable (Fig. 1, Fig. 3, the flap is removable; col. 5, Ins. 49-51). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the dressing of Hathman ‘291 in view of Mumby to include a removable cap as taught by Hathman '763 in order to facilitate selective removal of the flap (Hathman ‘ 763, col. 5, Ins.49-51), thereby facilitating replacement of dressing materials.
Regarding claim 16, Hathman ‘ 291 in view of Mumby discloses the bandage substantially as claimed (see rejection of claim 11) and Hathman ‘291 also discloses that the cap (Fig. 12, covering member 58) is permanently mounted (Fig. 12, hinge 56 permanently mounts the covering member 58 to the standoff member 50) on the raised portion (Fig. 12, standoff member 50) of the substrate (Fig. 12, base member 27).
Regarding claim 18, Hathman ‘ 291 in view of Mumby discloses the bandage substantially as claimed (see rejection of claim 11) and Hathman ‘291 also discloses that the substrate (Fig. 12, base member 27) has a shape chosen from a set of shapes consisting of: irregular, square, circular, regular polygonal, and irregular polygonal (Fig. 12, base member 27 has an irregular shape).
Claims 10 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Hathman (EP 0746291 B1) (hereinafter Hathman ‘291) in view of Mumby et al (US 2016/0361205) and Hathman (US 5086763) (hereinafter "Hathman '763") and further in view of Dardenne et al (US 2014/0336533).
Regarding claim 10, Hathman ‘291 in view of Mumby and further in view of Hathman ‘763 discloses the bandage substantially as claimed (see rejection of claim 1) but does not disclose that the cap is adapted to slide from an original position on the raised portion of the substrate.
Dardenne is in the field of devices for covering wounds (para. [0001}) and teaches a device (Fig. 1, device 1), wherein the cap (Fig. 1, means 8) is adapted to slide from an original position (Fig. 1, the means 8 slides along side wall 3 from a closed position to an open position; para. [0042]) on the raised portion (Fig. 1, side wall 3) of the substrate (Fig. 1, flange 6). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the bandage of Hathman ‘291 in view of Mumby and further in view of Hathman ‘763 to include a sliding cap means as taught by Dardenne in order to facilitate fitted closure of a wound, thereby minimizing contamination of the wound.
Regarding claim 17, Hathman ‘291 in view of Mumby and further in view of Hathman ‘763 discloses the bandage substantially as claimed (see rejection of claim 11) but does not disclose that the cap is adapted to slide from an original position on the raised portion of the substrate.
Dardenne is in the field of devices for covering wounds (para. [0001}) and teaches a device (Fig. 1, device 1), wherein the cap (Fig. 1, means 8) is adapted to slide from an original position (Fig. 1, the means 8 slides along side wall 3 from a closed position to an open position; para. [0042]) on the raised portion (Fig. 1, side wall 3) of the substrate (Fig. 1, flange 6). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the bandage of Hathman ‘291 in view of Mumby and further in view of Hathman ‘763 to include a sliding cap means as taught by Dardenne in order to facilitate fitted closure of a wound, thereby minimizing contamination of the wound.
Claim(s) 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hathman (EP 0746291 B1) (hereinafter Hathman ‘291) in view of Mumby et al (US 2016/0361205).
Regarding claim 19, Hathman ‘ 291 discloses a bandage (Fig. 12, dressing 17) comprising:
a) a substantially planar, flexible substrate (Fig. 12, base member 27) having an upper surface and a lower surface (Fig. 12, base member 27 has an upper surface and lower surface), the upper surface (Fig. 12, the upper surface of the base member 27) of the substrate (Fig. 12, base member 27) having a raised portion (Fig. 12, standoff member 50);
b) a layer of adhesive attached to the lower surface of the substrate (Fig. 12, the lower surface of the base member 27 has an adhesive layer; para. [0025]); and wherein the substrate (Fig. 12, base member 27) has a shape chosen from a set of shapes consisting of: irregular, square, circular, regular polygonal, and irregular polygonal (Fig. 12, base member 27 has an irregular shape).
Hathman ‘291 does not, however, disclose that the raised portion of the substrate comprises a quad lobe outline formed from shapes selected from a group of shapes consisting of circles and ovals.
Mumby is in the field of wound dressings (para. [0016]) and teaches a bandage (Fig. 2a, dressing 100), wherein the raised portion (Fig. 2b, region 114) of the substrate (Fig. 2a, layer 101) comprises a quad lobe outline (Fig. 2b, region 114 has a four lobe outline) wherein the quad lobe outline is formed from shapes selected from a group of shapes consisting of circles and ovals (Fig. 2b, the outline has 4 lobes wherein the lobe outline is formed from circles). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the dressing of Hathman ‘ 291 to include a four lobe outline raised portion where the outline is formed from shapes consisting of circles as taught by Mumby to maximize flexibility of the raised area (Mumby, para. [0281]-[0283]), thereby minimizing lifting of the bandage away from the skin (Mumby, para. [0281]).
Regarding claim 20, Hathman ‘ 291 in view of Mumby discloses the bandage as claimed (see rejection of claim 19) and Mumby further teaches that the circles and ovals of the quad lobe outline are at least partially overlapping (Fig. 2b, the circles of the lobe outline overlap. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the dressing of Hathman ‘291 in view of Mumby to include the four lobe outline raised portion having circles and ovals of the quad lobe outline that are at least partially overlapping as taught by Mumby to maximize flexibility of the raised area (Mumby, para. {0281]-[0283]), thereby minimizing lifting of the bandage away from the skin (Mumby, para. [0281)).
Claim(s) 12 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hathman (EP 0746291 B1) (hereinafter Hathman ‘291) in view of Mumby et al (US 2016/0361205) and Hathman (US 5086763) (hereinafter "Hathman '763") and further in view of Vogel (US 2509462).
Regarding claim 12, Hathman ‘ 291 in view of Mumby and further in view of Hathman ‘763 discloses the bandage substantially as claimed (see rejection of claim 11) and Hathman ‘291 also discloses that the bandage comprises:
e) a hinge (Fig. 12, hinge 56) attached to one boundary of the cap (Fig. 12, covering member 58) and to the substrate (Fig. 12, the hinge 56 is attached to the base member 27 via the standoff member 50; para. [0025)).
Hathman ‘291 in view of Mumby does not, however, disclose that the hinge is formed in the shape of a helical coil.
Vogel, however, teaches a spring hinge which includes a helical coil portion (col 1 lines 1-5). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have incorporated a spring hinge that includes a helical coil portion as taught by Vogel into the hinge structure on the bandage of Hathman ‘291 in view of Mumby and further in view of Hathman ‘763 since Vogel explicitly teaches that such hinges can be incorporated into any suitable type of hinged structure (col 4 lines 52-56).
Regarding claim 15, Hathman ‘291 in view of Mumby and Hathman ‘763 and further in view of Vogel discloses the bandage as claimed (see rejection of claim 12) but does not disclose that the cap is replaceable.
Hathman '763 is in the field of bandages (col. 1, Ins. 6-10) and teaches a bandage (Fig. 1, wound dressing 10), wherein the cap (Fig. 1, Fig. 3, pad 38 on flap 36) is replaceable (Fig. 1, Fig. 3, the flap is replaceable; col. 5, Ins. 49-51). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the dressing of Hathman ‘ 291 in view of Mumby and Hathman ‘763 and further in view of Vogel to include a replaceable flap as taught by Hathman ‘ 763 in order to facilitate replacement of dressing materials (Hathman ‘763, col. 2, Ins. 49-51), thereby facilitating wound healing.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Hathman (EP 0746291 B1) (hereinafter Hathman ‘291) in view of Mumby et al (US 2016/0361205) and Hathman (US 5086763) (hereinafter "Hathman '763") and further in view of Locke et al (US 2014/0277454).
Regarding claim 21, Hathman ‘291 in view of Mumby and further in view of Hathman ‘763 discloses the bandage substantially as claimed (see rejection of claim 11) but does not disclose that the aperture is formed in the shape of a cross.
Locke, however, teaches a dressing which includes a base layer provided with a network of lines or cross-shaped incisions or openings (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 aperture in the device of Hathman ‘291 in view of Mumby and further in view of Hathman ‘763 such that it is in the shape of a cross like the openings in the device of Locke since applicant has not disclosed that such a design solves any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing an aperture in a bandage.
Response to Amendments/Arguments
Applicant’s amendments and arguments filed 4/6/25 have been fully considered as follows:
Regarding the objections to the specification, Applicant’s amendments to the specification and the amendments to the claims have been fully considered and are sufficient to overcome the objections which, accordingly, have been withdrawn.
Regarding the claim rejections under 35 USC 112, Applicant’s amendments to the claims have been fully considered and are sufficient to overcome the rejections which, accordingly, have been withdrawn.
Regarding the claim rejections under 35 USC 103, Applicant’s arguments on pages 7-10 of the Response have been fully considered but are not persuasive.
In particular, the Office has noted Applicant’s arguments on page 7 that there would be no motivation to combine Hathman and Mumby because the standoff member in Hathman extends above the surface and would form an obstruction that could catch against a surface whereas the device of Mumby is a solid bandage. The Office respectfully disagrees since Mumby teaches a raised portion (Fig. 2b, region 114) and thus has a portion that extends above the surface like the standoff member in Hathman.
The Office has also noted Applicant’s arguments on page 8 that Vogel is non-analogous art and a person of ordinary skill in the field of bandages and dressings would not look to a lid for a lighter to address the instant problem. The Office respectfully disagrees. In response to applicant's argument that Vogel is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor' s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Vogel has been cited for its teachings related to hinges for modifying the hinge of Hathman ‘291 in view of Mumby and Hathman ‘763. Thus, Vogel is reasonably pertinent to the problem of providing a hinged element on a structure.
The Office has also noted Applicant’s arguments on pages 8-10, but in response to applicant's arguments that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Since the present rejections rely on knowledge that was within the level of ordinary skill in the art before the effective filing date of the invention, the Office maintains that the rejections are proper.
Therefore, for at least the reasons provided above, the Office maintains and reaffirms 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.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786