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 .
Status of Claims
Claims 1-20 are pending and examined on the merits.
Claim Objections
Claim 12 is objected to because of the following informalities:
Re Claim 12, given that polyester, spandex, and jersey are all generic terms, there is no need to capitalize any of these three words.
Appropriate correction is required.
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 1-20 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.
Re Claims 1 & 15, each claim recites “the torso pocket portion including a top edge disposed near the top edge joining together the inside material portion and an outside material portion between the right side and the left side” but earlier in the claim, “a top edge” and “an outside material portion” of the torso pocket portion are already recited, therefore it is confusing as to whether these two elements are in addition to what was already recited or referring back to the same elements recited earlier. For examination, Examiner interprets the quoted limitation to read “the top edge joining together the inside material portion and the outside material portion between the right side and the left side”.
Claims 2-14 and 16-20 are rejected for being dependent from Claim 1 or 15.
Additionally, it is not clear what Applicant intends to claim in Claim 11 because the claim language appears to have grammatical issues. The claim language seems to be claiming a location of the stoma of a patient being on the right side or on the left side and an ostomy bag may be oriented in both a vertical and horizontal direction within the inner pocket of the torso pocket portion. Examiner notes that there does not seem to be a relationship between the location of the stoma, i.e., the recitation of a stoma is irrelevant, and the orientation of the ostomy bag and suggests that Applicant simplify the claim language to just recite the orientation of the ostomy bag within the inner pocket.
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 1, 5, 7-8, 11, 14 are rejected under 35 U.S.C. 103 as being unpatentable over O’Hamill et al. (US 2020/0246178).
Re Claim 1, O’Hamill discloses an undergarment (hernia belt ostomy support system 10) comprising:
a torso pocket portion (curved portion of front body portion 12) shaped to surround a front torso area of a user, the torso pocket portion includes an inside material portion (back panel 16) and an outside material portion (front panel 14), the torso pocket portion also includes a top edge (top edge 20), a bottom edge (bottom edge 22), a right side (where the belt transitions from the curved portion to the first end 18, see e.g., FIG. 1), and a left side (where the belt transitions to second end 19), and the torso pocket portion includes a first end strap (18) coupled to the right side and a second end strap (19) coupled to the left side, the first end strap and the second end strap include complementary fasteners ([0040]) to join together around a back torso area of the user ([0040]), the top edge joining together the inside material portion and the outside material portion between the right side and the left side (evident from FIG. 1);
an inner pocket (interior compartment cavity 45, FIG. 4) formed in between the inside material portion and the outside material portion in the torso pocket portion around the front torso area of the user; and
an opening (stoma opening 24) formed along the inside material portion (FIG. 1).
O’Hamill does not explicitly disclose that the opening is a rectangular opening that extends substantially parallel to a top edge to provide access to the inner pocket, but instead discloses a circular opening. However, simple changes in the shape of an opening requires only routine skills in the art. It would have been obvious to one skilled in the art at the time of filing to modify O’Hamill because such a change simply yields different aesthetics.
Re Claim 5, O’Hamill discloses claim 1 but does not explicitly teach wherein a height of the rectangular opening is sized to fit a collar portion of an ostomy bag that couples with a stoma of the user. O’Hamill discloses that the opening is “appropriately … sized” to support an ostomy appliance ([0012]), thus providing guidance to one skilled in the art to size the opening such that a generic ostomy appliance can be supported and kept against the torso of a patient.
Re Claim 7, O’Hamill discloses claim 1, but does not explicitly disclose further comprising: a right side seam stitching along the right side, joining together the inside material portion and an outside material portion; and a left side seam along the left side, joining together the inside material portion and an outside material portion. The figures of O’Hamill shows dashed lines that are likely representative of stitching, combined with O’Hamill’s disclosure in [0048] of the presence of stitching (52) that are represented by the same dashed lines in the figures (e.g., see FIG. 6), thus it is likely that dashed lines shown at the right and left ends and along all peripheral edges of the belt/undergarment also represent stitching. A prima facie case of obviousness is established in view of O’Hamill’s disclosure.
Re Claim 8, O’Hamill discloses claim 7 but does not explicitly disclose that wherein the right side seam stitching and the left side seam stitching is a flatlock stitch. However, a flatlock stitch is simply one kind of well-known style of stitching often used in making clothing items. The selection of a specific type of stitch is obvious to one skilled in the art because it functions like other types of stitches in joining layers of fabric together.
Re Claim 9, O’Hamill discloses claim 1, and also suggests further comprising: a bottom seam forming the bottom edge, joins together the inside material portion and an outside material portion between the right side and the left side (see reasoning provided in the discussion in Claim 7 supra).
Re Claim 10, O’Hamill discloses claim 9 but does not disclose wherein the bottom seam is a shirring stitch to allow the outside material portion to extend outward away from the user. However, shirring stitching is a well-known sewing technique for making a garment fit better around curved contours. Given the belt of O’Hamill is designed to wrap around the waist and/or lower abdomen of a person, one skilled in the art at the time of filing would be encouraged to look at known sewing techniques to use at the bottom edge for creating an undergarment/belt that would be able to accommodate the wider/larger contours of a person (due to the buttocks).
Re Claim 11, O’Hamill discloses claim 1, and further discloses:
an ostomy bag (implied in e.g., [0012] because the belt supports an ostomy appliance) with a collar (inherent in an ostomy appliance).
While O’Hamill is silent to wherein the ostomy bag is configured to be positioned in the inner pocket in a substantially vertical orientation or a substantially horizontal orientation, such a recitation is functional language. Claims directed to a device must be distinguished from the prior art in terms of structure rather than function, because device claims cover what a device is, not what a device does. Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim. In this case, a user/patient can choose to orient the ostomy bag however one desires.
Re Claim 14, O’Hamill discloses claim 1 and further disclosing wherein a distance between a top edge and a bottom edge of the first end strap and the second end strap is less than a distance between the top edge and the bottom edge of the torso pocket portion (clearly shown in FIG. 1).
Claims 2-3, 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over O’Hamill in view of Berish et al. (US 2012/0283679).
Re Claim 2, O’Hamill discloses claim 1, and further disclosing wherein the complementary fasteners are hook and loop fasteners ([0040]) but does not disclose that they are disposed in a direction that is substantially perpendicular to the top edge. Berish discloses an ostomy belt wherein the right and left ends are fastened together by a series of fasteners (110 & 108) arranged in a direction perpendicular to a top edge of the belt (see FIG. 1), wherein the fasteners can be hook and look fasteners ([0033]). It would have been obvious to one skilled in the art at the time of filing to modify O’Hamill with Berish as this uses a smaller area of hook/loop fasteners but still ensures the right and left end edges are fully joined together.
Re Claim 3, O’Hamill discloses claim 1 but does not explicitly disclose wherein the inside material portion, the outside material portion, or both are treated with an anti-microbial treatment. Berish discloses an ostomy belt wherein the belt is made from material that underwent an antimicrobial treatment ([0030]). It would have been obvious to one skilled in the art at the time of filing to modify with Berish because the belt may come into contact with body waste material and an antimicrobial treatment helps to reduce the likelihood of infection.
Re Claim 12, O’Hamill discloses claim 1 but does not explicitly disclose that wherein the inside material portion, the outside material portion or both, are made from polyester spandex jersey in various grams per square meter weights. Berish discloses an ostomy belt made from a variety of fabrics including commercially available polyester spandex fabrics ([0030]). One skilled in the art at the time of filing would be guided by Berish to seek out such fabrics, such as polyester spandex that are suitable for forming a belt structure to hold an ostomy appliance.
Re Claim 13, O’Hamill and Berish combine to disclose claim 12 but neither explicitly discloses wherein the inside material portion, the outside material portion or both are made in a variety of flesh tone colors. However, given that O’Hamill discloses a desire for the belt/undergarment to be inconspicuous (Abstract), one skilled in the art at the time of filing would be encouraged to choose flesh tone colors for better hiding the presence of an ostomy appliance.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over O’Hamill in view of Miller (US 4,495,662).
Re Claim 4, O’Hamill discloses claim 1 but does not disclose wherein the bottom edge is longer in length than the top edge, thereby forming a contour on each of the right side and the left side to fit around the hips of the user. Miller discloses a garment for holding an ostomy appliance, wherein the garment is designed to cover from the waist down to the hips of a user, thereby providing a shorter top edge and a longer bottom edge (Fig. 2). It would have been obvious to one skilled in the art at the time of filing to modify with Miller’s shape such that it fits a typical person’s torso better.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over O’Hamill in view of Berg (US 2,688,327).
Re Claim 6, O’Hamill discloses claim 1, but does not explicitly disclose further comprising: an elastic binding formed around at least a portion of the rectangular opening. Berg discloses an undergarment for holding a colostomy device against the torso of a user, wherein the undergarment has a central opening (27) that allows the colostomy device to be secured and said opening has elastic reinforcement (col. 3 lines 4-10, “Furthermore, the central part of this side piece 25 is cut away to form a circular opening 27 which relieves the central, part of the pocket overlying the colostomy opening from pressure, while the elastic surround serves to hold the periphery of the pocket 7 firmly but gently against the body.”). It would have been obvious to one skilled in the art at the time of filing to glean from Berg for helping to fit the undergarment closer to the user’s body.
Claim 15, 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over O’Hamill in view of Miller.
O’Hamill discloses an undergarment (hernia belt ostomy support system 10) comprising:
a torso pocket portion (curved portion of front body portion 12) shaped to surround a front torso area of a user, the torso pocket portion includes an inside material portion (back panel 16) and an outside material portion (front panel 14), the torso pocket portion also includes a top edge (top edge 20), a bottom edge (bottom edge 22), a right side (where the belt transitions from the curved portion to the first end 18, see e.g., FIG. 1), and a left side (where the belt transitions to second end 19), and the torso pocket portion includes a first end strap (18) coupled to the right side and a second end strap (19) coupled to the left side, the first end strap and the second end strap include complementary fasteners ([0040]) to join together around a back torso area of the user ([0040]), the top edge joining together the inside material portion and the outside material portion between the right side and the left side (evident from FIG. 1);
an inner pocket (interior compartment cavity 45, FIG. 4) formed in between the inside material portion and the outside material portion in the torso pocket portion around the front torso area of the user; and
an opening (stoma opening 24) formed along the inside material portion (FIG. 1).
O’Hamill does not explicitly disclose the top edge of the torso pocket portion is at substantially a same height as a top edge of the first end strap and as a top edge of the second end strap and a distance between the top edge and a bottom edge of the first end strap and the second end strap is less than a distance between the top edge and the bottom edge of the torso pocket portion. O’Hamill shows a belt/undergarment that is wider in the torso pocket portion than at the two end straps (18 & 19). Miller discloses a garment for holding an ostomy appliance wherein the garment’s top edge lines up with left and right fastening straps but the garment’s bottom edge extends lower than the lower edge of the fastening straps. It would have been obvious to one skilled in the art at the time of filing to modify with Miller for a different aesthetic for the belt/undergarment.
O’Hamill also does not explicitly disclose that the opening is a rectangular opening that extends substantially parallel to a top edge to provide access to the inner pocket, but instead discloses a circular opening. However, simple changes in the shape of an opening requires only routine skills in the art. It would have been obvious to one skilled in the art at the time of filing to modify O’Hamill because such a change simply yields different aesthetics.
Re Claim 18, O’Hamill and Miller combine to disclose claim 15. O’Hamill does not disclose wherein the bottom edge is longer in length than the top edge, thereby forming a contour on each of the right side and the left side to fit around the hips of the user. Miller discloses a garment for holding an ostomy appliance, wherein the garment is designed to cover from the waist down to the hips of a user, thereby providing a shorter top edge and a longer bottom edge (Fig. 2). It would have been obvious to one skilled in the art at the time of filing to modify with Miller’s shape such that it fits a typical person’s torso better.
Re Claim 19, O’Hamill and Miller disclose claim 15 but does not explicitly teach wherein a height of the rectangular opening is sized to fit a collar portion of an ostomy bag that couples with a stoma of the user. O’Hamill discloses that the opening is “appropriately … sized” to support an ostomy appliance ([0012]), thus providing guidance to one skilled in the art to size the opening such that a generic ostomy appliance can be supported and kept against the torso of a patient.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over O’Hamill and Miller as applied to claim 15 above, and further in view of Berish.
Re Claim 16, O’Hamill and Miller combine to disclose claim 15, O’Hamill further disclosing wherein the complementary fasteners are hook and loop fasteners ([0040]) but does not disclose that they are disposed in a direction that is substantially perpendicular to the top edge. Berish discloses an ostomy belt wherein the right and left ends are fastened together by a series of fasteners (110 & 108) arranged in a direction perpendicular to a top edge of the belt (see FIG. 1), wherein the fasteners can be hook and look fasteners ([0033]). It would have been obvious to one skilled in the art at the time of filing to modify O’Hamill with Berish as this uses a smaller area of hook/loop fasteners but still ensures the right and left end edges are fully joined together.
Re Claim 17, O’Hamill and Miller disclose claim 15 but they do not explicitly disclose wherein the inside material portion, the outside material portion, or both are treated with an anti-microbial treatment. Berish discloses an ostomy belt wherein the belt is made from material that underwent an antimicrobial treatment ([0030]). It would have been obvious to one skilled in the art at the time of filing to modify with Berish because the belt may come into contact with body waste material and an antimicrobial treatment helps to reduce the likelihood of infection.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over O’Hamill and Miller as applied to claim 15 above, and further in view of Berg.
Re Claim 20, O’Hamill and Miller disclose claim 15, but they do not explicitly disclose further comprising: an elastic binding formed around at least a portion of the rectangular opening. Berg discloses an undergarment for holding a colostomy device against the torso of a user, wherein the undergarment has a central opening (27) that allows the colostomy device to be secured and said opening has elastic reinforcement (col. 3 lines 4-10, “Furthermore, the central part of this side piece 25 is cut away to form a circular opening 27 which relieves the central, part of the pocket overlying the colostomy opening from pressure, while the elastic surround serves to hold the periphery of the pocket 7 firmly but gently against the body.”). It would have been obvious to one skilled in the art at the time of filing to glean from Berg for helping to fit the undergarment closer to the user’s body.
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 September 2026
