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 .
Drawings
The drawings are objected to because Figs. 1-13 include grayscale that is not ordinarily permitted in utility and design patent applications (see 37 CFR 1.84(B)). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Additionally, Figs. 12 and 13 are objected to for impermissible shading. Per MPEP §608.01(f) quoting 37 C.F.R. 1.84(b):
(b) Photographs.—
(1) Black and white. Photographs, including photocopies of photographs, are not ordinarily permitted in utility and design patent applications. The Office will accept photographs in utility and design patent applications, however, if photographs are the only practicable medium for illustrating the claimed invention. For example, photographs or photomicrographs of: electrophoresis gels, blots (e.g., immunological, western, Southern, and northern), auto-radiographs, cell cultures (stained and unstained), histological tissue cross sections (stained and unstained), animals, plants, in vivo imaging, thin layer chromatography plates, crystalline structures, and, in a design patent application, ornamental effects, are acceptable. If the subject matter of the application admits of illustration by a drawing, the examiner may require a drawing in place of the photograph. The photographs must be of sufficient quality so that all details in the photographs are reproducible in the printed patent.
In the instant case, photographs are not appropriate since the claimed invention can be sufficiently illustrated with convention black ink line drawings. Corrected drawings are required. The objection to the drawings will not be held in abeyance.
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 17-20 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 17 recites “a clothing article” in line 2. It is unclear if this is the same or a separate and distinct clothing article from the clothing article recited in claim 1 line 3. Examiner recommends amending claim 17 to recite “the clothing article” to overcome this rejection. Dependent claims 18-20 are likewise rejected.
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.
Claim(s) 1-2, 4-7, 11-12, 14 and 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dehlin (US 3,706,104 A) in view of Nelson (US 2021/0113352 A1).
Regarding claim 1, Dehlin discloses an artificial breast (abstract) comprising a shell (2, 3, 5, casing, fig. 2) and a filler removably disposed within the shell (col 3, lines 25-42); said artificial breast being shaped and configured to fit securely within a clothing article by compression between a wearer and the clothing article to inhibit movement of the artificial breast relative to the clothing article (abstract); wherein: the shell comprises a distal side (see annotated fig. 3, below) defining a curved bra cup and a proximal side (see annotated fig. 3, below) configured to conform to contours of a body (col 3, lines 25-42) and configured to expand (col 3, lines 25-42), the distal side of the shell comprising an inner felt layer (inner layer 8, first layer, fig. 3) configured to form the bra cup and an outer cloth layer (7, outer fabric casing layer, fig. 3) for facing the clothing article when worn, and the filler is removably disposed within the shell in an amount configured to provide form and firmness to the artificial breast and in an amount adequate to cause compression of the artificial breast when worn (col 3, lines 25-42); wherein the proximal side of the shell defines a flexible opening (6, opening, fig. 2) for disposing the filler within the shell (col 2 lines 30-42), and said shell flexibly accommodates different amounts of filler (col 2, lines 48-61).
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Dehlin fails to teach the use of non-synthetic material and the use of felt. However, Nelson discloses an external breast prosthesis that includes said artificial breast comprising non-synthetic material (alpaca felt, ¶ [0069]) and the use of felt (¶ [0069]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Dehlin to include the use of non-synthetic material and the use of felt as taught by Nelson in order for the materials to be taught and give shape yet offer softness (¶ [0057], Nelson).
Regarding claim 2, Dehlin fails to teach the non-synthetic material. However, Nelson further discloses the non-synthetic material has anti-bacterial, hypoallergenic, moisture wicking, biodegradable, breathable, or thermal regulating properties, or a combination thereof (¶ [0069], the instant application states cotton, wool and alpaca fulfill the descriptors in ¶ [0038] of the specification), wherein: the felt layer of the shell comprises felted Alpaca fiber, wool fiber, rayon fiber, or a combination thereof (¶ [0069]); and the filler comprises Alpaca fiber, hemp fiber, wool fiber, cotton fiber, bamboo fiber, silk fiber, rayon fiber, or a combination thereof (It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use alpaca fiber, since it has been held to be within 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). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Dehlin to include the use of alpaca felt and fiber as the non-synthetic material as taught by Nelson in order for the materials to be taught and give shape yet offer softness (¶ [0057], Nelson).
Regarding claim 4, the phrase “the proximal side of the shell is configured to expand relative to the amount of filler disposed within the shell to conform the proximal side of the shell to the contours of a body” is a functional recitation that is not given full patentable weight. The prior art is not required to explicitly disclose the recited function, but merely have the capability of perform [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the Dehlin device discloses all the claimed structural features and is considered to be capable of expanding relative to the amount of filler disposed within the shell to conform the proximal side of the shell to the contours of a body.
Regarding claim 5, Dehlin fails to teach the filler comprises Alpaca fiber. However, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to use alpaca fiber, since it has been held to be within 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 (¶ [0069] points to the use of alpaca batting, Nelson). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Dehlin to include the filler comprises Alpaca fiber as taught by Nelson in order for the materials to be taught and give shape yet offer softness (¶ [0057], Nelson).
Regarding claim 6, Dehlin fails to teach felted Alpaca fiber. However, Nelson further discloses the inner felt layer of the shell comprises felted Alpaca fiber (¶ [0069]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Dehlin to include felted Alpaca fiber as taught by Nelson in order for the materials to be taught and give shape yet offer softness (¶ [0057], Nelson).
Regarding claim 7, Dehlin fails to teach the proximal side of the shell comprises bamboo and/or cotton. However, Nelson further discloses the proximal side of the shell comprises bamboo and/or cotton (the cover/shell can be made of a cotton fabric, ¶ [0038]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Dehlin to include the proximal side of the shell comprises bamboo and/or cotton as taught by Nelson in order for the materials to be taught and give shape yet offer softness (¶ [0057], Nelson).
Regarding claim 11, Dehlin further discloses the bra cup size and shape is suited to the wearer who has had a full mastectomy, a partial mastectomy, and/or who wishes to supplement existing breast volume (col 2, lines 48-61).
Regarding claim 14, Dehlin further discloses a weight (col 4, lines 3-13) disposed within the shell.
Regarding claim 16, Dehlin further discloses the clothing article within which the artificial breast is to be worn comprises a top, a bra, a top, a dress, lingerie, a bralette, or a swimsuit (col 1, lines 2-6).
Regarding claim 17, Dehlin fails to teach at least two fastening straps. However, Nelson further discloses at least two fastening straps (102, 120, 130, strap, fig. 1A) for securing the artificial breast within a clothing article having loops (110, loop, fig. 1A, the loops being placed within a clothing article is obvious to try as they will either be on the breast or on the clothing in order to attach the implant to in the intended breast area) configured to receive said fastening straps (fig. 14), wherein said fastening straps comprise a ribbon (102, strap, fig. 1A) having a first end (104, first end) and a second end (106, second end, fig. 1A), the first end coupling to the shell of the artificial breast (fig. 1A); and the second end comprising a feed tab (108, hook, fig. 1A) and a fastener (108, hook, fig. 1A), the feed tab being configured for feeding the second end of each of the fastening straps through the respective loop of the clothing article (fig. 14). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Dehlin to include at least two fastening straps as taught by Nelson in order for the materials to be taught and give shape yet offer softness (¶ [0057], Nelson).
Regarding claim 18, Dehlin fails to disclose the fastener is a hook and loop fastener. However, Nelson further discloses the fastener is a hook and loop fastener (108, hook, 110, loop, fig. 1A). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Dehlin to include the fastener is a hook and loop fastener as taught by Nelson in order for the materials to be taught and give shape yet offer softness (¶ [0057], Nelson).
Regarding claims 12 and 19, Dehlin further discloses the filler is Alpaca fiber (it would have been obvious to one having ordinary skill in the art at the time the invention was filed to use alpaca fiber, since it has been held to be within 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) in a spun form (col 1, lines 7-30).
Dehlin fails to teach the inner felt layer of the shell comprises felted Alpaca fiber. However, Nelson further discloses felted Alpaca fiber (¶ [0069]), wherein the contacting of the Alpaca fiber in loose or spun form with the felted Alpaca fiber causes friction fit within the artificial breast to keep filler in position when worn (It would have been obvious to try since there are only two layers, the inner felted layer and the filling, in direct contact with each other. Further the phrase “wherein the contacting of the Alpaca fiber . . . to keep filler in position when worn” is a functional recitation that is not given full patentable weight. The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case the device of Dehlin and Nelson discloses the claimed structural features and is considered to be capable of creating a friction fit within the artificial breast.). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Dehlin to include felted Alpaca fiber by Nelson in order for the materials to be taught and give shape yet offer softness (¶ [0057], Nelson).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dehlin (US 3,706,104 A) in view of Nelson (US 2021/0113352 A1) as applied to claim 1 above, and further in view of Silverman (US 4,071,914 A).
Regarding claim 3, Dehlin and Nelson fail to teach an inner cloth layer. However, Silverman discloses an external breast prothesis that includes an inner layer (73, outer panel, fig. 24) comprising Alpaca fiber, hemp fiber, wool fiber, cotton fiber, bamboo fiber, silk fiber, rayon fiber, or a combination thereof (It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use alpaca fiber, since it has been held to be within 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). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Dehlin and Nelson to include an inner cloth layer as taught by Silverman in order to aid in creating a seamless implant by reducing wrinkles and malformations of the filler.
Claim(s) 8-10, 13 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dehlin (US 3,706,104 A) in view of Nelson (US 2021/0113352 A1) as applied to claims 1 and 17 above, and further in view of Creamer (US 2,867,818 A).
Regarding claims 8 and 20, Dehlin further discloses the distal side of the shell is formed as a horizontally approximately oblong shape (fig. 1, Dehlin) comprising an upper portion configured as a semi-oblong (2, top front portion of the casing, figs. 1-2).
Dehlin and Nelson fail to teach two lower oblong quadrants. However, Creamer discloses a bust pad that includes two lower oblong quadrants (11, 12, areas, fig. 1) forming the lower portion of the oblong shape with an approximately central vertical seam between the quadrants to define the contours of the bra cup (18, seam, fig. 3). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Dehlin and Nelson to include two lower oblong quadrants as taught by Creamer in order to give the appearance of a normal breast (col 1, lines 15-19, Creamer).
Regarding claim 9, Dehlin further discloses the upper portion of the oblong shape of the distal side of the shell is configured to the wearer’s desired shape and volume of bra cup (col 2, lines 48-61).
Regarding claim 10, Dehlin further discloses the upper portion and the two lower portions of the oblong shape of the distal side of the shell are each configured to the wearer’s desired shape and volume of bra cup (col 2, lines 48-61).
Regarding claim 13, Dehlin further discloses the filler is Alpaca fiber (it would have been obvious to one having ordinary skill in the art at the time the invention was filed to use alpaca fiber, since it has been held to be within 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) in a spun form (col 1, lines 7-30).
Dehlin fails to teach the inner felt layer of the shell comprises felted Alpaca fiber. However, Nelson further discloses felted Alpaca fiber (¶ [0069]), wherein the contacting of the Alpaca fiber in loose or spun form with the felted Alpaca fiber causes friction fit within the artificial breast to keep filler in position when worn (It would have been obvious to try since there are only two layers, the inner felted layer and the filling, in direct contact with each other. Further the phrase “wherein the contacting of the Alpaca fiber . . . to keep filler in position when worn” is a functional recitation that is not given full patentable weight. The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case the device of Dehlin and Nelson discloses the claimed structural features and is considered to be capable of creating a friction fit within the artificial breast.). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Dehlin to include felted Alpaca fiber by Nelson in order for the materials to be taught and give shape yet offer softness (¶ [0057], Nelson).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dehlin (US 3,706,104 A) in view of Nelson (US 2021/0113352 A1) as applied to claim 14 above, and further in view of official notice.
Regarding claim 15, Dehlin and Nelson fail to teach the weight is a porous rock. However, examiner takes official notice at porous rocks are known to be used as weights. It would have been obvious to use a porous rock as a weight in a breast prosthesis because doing so merely involves a simple substitution of one known element for another to obtain predictable results. Courts have been found to support a conclusion of obviousness in MPEP 2143(I)(B) when one of ordinary skill in the art could have substituted one known element for another and the results of the substitution would have been predictable.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JERRAH C EDWARDS can be reached at (408)918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.M.D./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774