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 .
Response to Amendment
Applicant's amendment filed on July 24, 2025 has been received. Claims 22-30 are currently pending.
Response to Arguments
In view of Applicant's amendment, the search has been updated, and new prior art has been identified and applied. Applicant's arguments have been considered but are moot in view of the new ground(s) of rejection.
Claim Objections
Claim 1 is objected to because of the following informalities:
“first and second side seems” (line 6) should read “first and second side seams”
“a second portion width less than the pocket width” (line 13) should read “a second portion width smaller than the pocket width”
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 24-30 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.
Claims 24-30 each recite the limitation “The mastectomy brassiere of claim 1.” The limitation is indefinite, as claim 1 has been canceled in the present amendment. For purposes of examination, the Examiner will interpret the limitation as follows: “The mastectomy brassiere of claim 22.”
Claim 28 further recites the limitation “wherein the prosthetic breast form comprises a first cup, a second cup, and a gapping central portion.” As previously discussed on page 3 of the Non-Final Rejection mailed on March 5, 2024, the limitation is indefinite, as the term “gapping portion” is not regularly used in the art such that one of ordinary skill in the art would readily understand what structure(s) are included or excluded by the claimed phrase. The Examiner further notes that the specification does not appear to provide any specific definition or further explanation as to what the structure of the gapping portion includes/excludes. For purposes of examination, the Examiner will interpret the limitation as follows: “wherein the prosthetic breast form comprises a first cup, a second cup, and a central portion.”
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 27 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 27 recites the limitation “wherein: the prosthetic breast form comprises a compressible material such that a volume of the prosthetic breast form can be reduced while being inserted into the pocket.” This limitation, formerly recited in original claim 9, has been substantially imported into new independent claim 22, and therefore does not further limit claim 22.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 22-27, 29, and 30 (regarding claims 24-27, 29, and 30, as best as can be understood) are rejected under 35 U.S.C. 103 as being unpatentable over Rendone (US PG Pub 2020/0085113) in view of Rendone ‘904 (US PG Pub 2018/0332904) and Goff (US PG Pub 2017/0347729), further in view of McCusker (US Patent No. 4,607,640).
Regarding claim 22, Rendone discloses a mastectomy bra (100, see at least Figs. 1-4, 7, and 8, and note below), comprising:
a band sized to extend around a wearer's back (generally horizontally-extending portion of back panel 210);
a front panel permanently (110) affixed to the band to form a continuous loop lacking any means of bifurcation (see Figs. 1-2 and paragraphs 0031-0034), the front panel comprising:
an inner layer (126) defining a perimeter edge including an upper bust line (316), a lower bust line (bottom edge of 126 along lower margin 114, see at least Fig. 3) spaced from the upper bust line, first and second side seams (seams along lateral sides of 126, 128 that corresponding with first and second side portions 118, 120 of bra 100) extending between opposite ends of the upper and lower bust lines (see Figs. 1-3 and at least paragraphs 0034-0035);
an outer layer (128) overlaying the inner layer (see at least Fig. 3 and paragraphs 0033-0035);
a first portion (along the lower bust line and side seams) of the perimeter edge being permanently joined to the outer layer to define a pocket between the inner layer and the outer layer (see Figs. 1-3 and paragraphs 0033-0035), wherein the pocket defines a pocket width (width between first and second side seams);
a second portion of the perimeter edge (along upper bust line 316) located within the upper bust line and having a second portion width (width of pocket opening 132, see Figs. 1-3 and 7 and paragraphs 0036) to define an access slot (132) to the pocket (see at least paragraphs 0036 and 0046);
wherein the second portion has an open configuration in which the second portion is spaced from the outer layer to permit access to the pocket through the access slot (see at least Fig. 7 and paragraphs 0036 and 0046),
a first shoulder strap (first 116) extending from the front panel to the band and sized to receive a first shoulder of the wearer (see Figs. 1-2 and 7 and at least paragraph 0034);
a second shoulder strap (second 116) extending from the front panel to the band and sized to receive a second shoulder of the wearer (see Figs. 1-2 and 7 and at least paragraph 0034); and
a prosthetic breast form (400), constructed of a lightweight foam material (see at least paragraphs 0023 and 0030), having a breast form width substantially equal to the pocket width to retain the prosthetic breast form in place when disposed in the pocket (see at least Figs. 4, 7, and 8) wherein the prosthetic breast form is compressible to permit passage through the access slot (see paragraph 0039 of Rendone, prosthetic breast form 400 is made of a deformable material that is capable of being compressed/reduced in volume during insertion into pocket 130).
Regarding the limitations “mastectomy bra” and “prosthetic breast form,” Rendone discloses a substantially breast-shaped pad insert (400) of varying thickness that is configured to cover the wearer’s breasts and provide modesty, shaping, and support (see Figs. 1-6A and 7 and paragraphs 0002, 0023, and 0029) and is therefore capable of being used as a prosthetic breast form, based on the size/shape of the removed breast and how much of the breast tissue was removed (e.g., partial mastectomy vs. total mastectomy). Accordingly, Rendone’s bra (100) is also capable of being used as a mastectomy bra. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987). See MPEP 2114 (II).
The Examiner further notes that new claim 22 removes previously presented limitations that structurally defined the claimed prosthetic breast form over a conventional brassiere pad (e.g., the prosthetic breast form having a flat rear side configured to face inward toward the user’s body), and Rendone’s breast-shaped pad insert (400) meets the broader structural requirements of the prosthetic breast form as currently claimed.
Rendone discloses wherein the prosthetic breast form (400) is constructed from a lightweight foam material (see at least paragraphs 0023 and 0030), as discussed above, but fails to specifically teach a polyester foam material.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have chosen a polyester foam material for Rendone’s lightweight foam material, as polyester foams are commonly used in the art and would provide properties such as compressibility, resilience, and dimensional stability. It has been held to be 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. See MPEP 2144.07.
Rendone also fails to specifically disclose wherein the second portion width (width of pocket opening 132) is smaller than the pocket width.
However, Rendone ‘904 teaches a similar pocket (154) for a bra (100), wherein the pocket is formed from inner and outer layers of material (710, 712) that are joined along their bottom edges (718, 716) and side edges (714, 722, 716, 724; see at least Fig. 7 and paragraphs 0025 and 0035-0038), and unaffixed along either an entire length or a partial length of their top edges (720, 728), so as to form a larger or smaller pocket opening (155) as desired (see at least Figs. 1, 4, 7, and paragraph 0038). The Examiner notes that providing a smaller pocket opening would allow the contents of the pocket to be more securely retained within the pocket during use of the bra.
Furthermore, Goff teaches wherein it is known in the art to vary the size of a pocket opening, such that the pocket opening width would measure about 50%, 70-90%, or greater than 90% of the width of the pocket itself (see at least Fig. 1 and paragraphs 0016-0017 and 0024), such that the pocket opening width is smaller than the pocket width. Again, the Examiner notes that providing a smaller pocket opening would allow the contents of the pocket to be more securely retained within the pocket during use of the bra.
Therefore, based on Rendone ‘904’s and Goff’s teachings, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have joined together at least a portion of the top edges of Rendone’s inner and outer layers to provide a smaller access opening width that is smaller than the pocket width, as such a configuration is known in the art, and doing so would allow Rendone’s prosthetic breast form to be more securely retained within the pocket during use of the bra.
Furthermore, such a modification would have involved a mere change in the size of a component. A change in size or proportion is generally recognized as being within the level of ordinary skill in the art. See MPEP 2144.04 (IV)(A).
Rendone further fails to disclose wherein the second portion is releasably joined to the outer layer and includes a closed configuration in which the second portion is joined to the outer layer to restrict access to the pocket through the access slot; the bra further including a fastener for releasably holding the second portion in the closed configuration.
However, McCusker teaches a brassiere (11) including at least one pad insert (21R, 21L) configured to be removably received in at least one pocket (14R, 14L) of the brassiere (see Figs. 1-6 and column 3, lines 3-32), wherein each pocket includes an access slot (18) and a corresponding fastener (19) so as to allow outer and inner layers of the pocket to be selectively and releasably fastenable along the access slot to define an open configuration in which the inner layer is spaced from the outer layer to permit access to the pocket through the access slot, and a closed configuration in which the inner layer is joined to the outer layer to restrict access to the pocket through the access slot (see Figs. 1 and 3 and column 3, lines 3-27), to increase the security of the pocket by allowing the access slot to be closed after the pad insert(s) is/are inserted (see column 3, lines 3-27).
Therefore, based on McCusker’s teachings, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have modified Rendone’s pocket to further include a fastener along the access slot, such that the second portion would be releasably joined to the outer layer and would include a closed configuration in which the second portion is joined to the outer layer to restrict access to the pocket through the access slot, as doing so would further increase the security of the pocket by allowing the access slot to be closed after the prosthetic breast form is inserted.
Regarding claim 23, Rendone, Rendone ‘904, Goff, and McCusker together teach the limitations of claim 22, as discussed above, but fail to explicitly teach wherein: the prosthetic breast form comprises a percent mass of the total brassiere and said percent mass is 50%-70%. Rendone, Rendone ‘904, Goff, and McCusker are silent as to the exact percent mass of the prosthetic breast form in relation to the brassiere.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to experiment with different ranges of prosthetic mass/weight and different ranges of mass/weight of other components of the brassiere (e.g., fabric, foam, fasteners), such that the prosthetic breast form would comprise a percent mass of the total brassiere and said percent mass is 50%-70%, in order to achieve an optimal configuration to provide a desired amount of breast tissue simulation, modesty, shaping, and/or support, since discovering the optimum or workable ranges of radii involves only routine skill in the art. See MPEP 2144.05.
Additionally, Applicant does not provide any criticality for the claimed range, and paragraph 0045 of the instant specification states that the percentage may range anywhere from 25% to 70%.
Regarding claim 24, Rendone, Rendone ‘904, Goff, and McCusker together teach the limitations of claim 22, as discussed above, but fail to explicitly teach wherein: a length of the access slot is between 4.0 inches and 7.0 inches. Rendone depicts an access slot (126) that appears to be reasonably within the claimed range (see Figs. 1 and 7) but is silent as to the exact measurements of the access slot.
However, absent a teaching of criticality for the particular claimed range of 4-7 inches, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have experimented with different ranges of access slot length such that access slot would be between 4.0 inches and 7.0 inches, in order to achieve an optimal configuration to accommodate a desired wearer size, proportion, or chest width, since discovering the optimum or workable ranges of slot lengths involves only routine skill in the art. See MPEP 2144.05. Furthermore, a change in size or proportion is generally recognized as being within the level of ordinary skill in the art. See MPEP 2144.04 (IV)(A).
Regarding claim 25, the modified brassiere of Rendone (i.e., Rendone in view of Rendone ‘904, Goff, and McCusker) is further disclosed wherein: the front panel (110 of Rendone), the first shoulder strap (first 116 of Rendone), the second shoulder strap (second 116 of Rendone), and the band (lower band of 210 of Rendone) comprise a textile material (see paragraphs 0031-0034 of Rendone); and the textile material is the same for each the front panel, the first shoulder strap, the second shoulder strap, and the band (see paragraph 0034 of Rendone, bra 100 can be integrally manufactured through a single knitting event such that each portion would comprise the same textile material).
Regarding claim 26, the modified brassiere of Rendone (i.e., Rendone in view of Rendone ‘904, Goff, and McCusker) is further disclosed wherein: the prosthetic breast form (400 of Rendone) can be inserted into the pocket (130 of Rendone) while the brassiere is being worn by the user (see at least Fig. 7 and paragraph 0046 of Rendone).
Regarding claim 27, the modified brassiere of Rendone (i.e., Rendone in view of Rendone ‘904, Goff, and McCusker) is further disclosed wherein: the prosthetic breast form (400 of Rendone) comprises a compressible material such that a volume of the prosthetic breast form can be reduced while being inserted into the pocket (see paragraph 0039 of Rendone, prosthetic breast form 400 is made of a deformable material that is capable of being compressed/reduced in volume during insertion into pocket 130).
Regarding claim 29, the modified brassiere of Rendone (i.e., Rendone in view of Rendone ‘904, Goff, and McCusker) is further disclosed wherein: the prosthetic breast form (400 of Rendone) comprises a single cup (at least one of 434 or 436 of Rendone; see Figs. 4-6A and paragraphs 0037-0041 of Rendone; the Examiner notes that claim 29 is an open-ended comprising claim, and Rendone’s breast form comprises a single cup, in addition to other structures).
Regarding claim 30, the modified brassiere of Rendone (i.e., Rendone in view of Rendone ‘904, Goff, and McCusker) is further disclosed wherein: the prosthetic breast form (400 of Rendone) comprises a first cup (434), a second cup (436), and a gapping central portion (424) connecting the first cup to the second cup (see Figs. 4-6A and paragraphs 0037-0041 of Rendone).
Claim 28, as best as can be understood, is rejected under 35 U.S.C. 103 as being unpatentable over Rendone, Rendone ‘904, Goff, and McCusker, as applied claim 22 above, in view of Murphy et al. (herein Murphy)(US PG Pub 2012/0220191).
Regarding claim 28, Rendone, Rendone ‘904, Goff, and McCusker together teach the limitations of claim 22, as discussed above, but fail to further teach wherein the front panel further comprises a lace panel.
However, Murphy teaches a prosthetic brassiere (502, see Fig. 5 and paragraph 0039) comprising a lace panel (510, see Fig. 5 and paragraphs 0035-0039), to provide additional modesty coverage and/or to enhance the aesthetic appearance of the bra (see Abstract and paragraph 00009-0012 and 0039-0041).
Therefore, based on Murphy’s teachings, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have modified Rendone’s front panel to further comprise a lace panel, as doing so would provide additional modesty coverage and/or enhance the aesthetic appearance of the bra.
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 JOCELYN BRAVO whose telephone number is (571)270-0581. The examiner can normally be reached Mon - Fri 9:30am - 6:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Ostrup, can be reached at (571) 272-5559. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOCELYN BRAVO/ Primary Examiner, Art Unit 3732