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 .
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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/24/2025 has been entered.
Response to Amendment
The amendment filed 11/24/2025 has been entered. Claims 1 and 3-13 remain pending in the application.
Response to Arguments
Applicant’s arguments, see Applicant Arguments/Remarks Made in an Amendment, filed 07/17/2025, with respect to the rejections of Claims 1-8 and 11-13 rejected under 35 U.S.C. 103 as being unpatentable over US 20210093469 A1 (hereafter --Halley--), in view of US 20140309750 A1 (hereafter --Kelley--) have been fully considered and are moot in light of the newly applied rejection.
As discussed in the interview, it is agreed upon that Kelley does not disclose the thermal fibers being thin, spaced apart, elongated continuous, and unbroken thermal fibers. However, upon further consideration, the Instant Application does not disclose the thermal fibers being thin, spaced apart, elongated continuous, unbroken thermal fibers solving any problem or is for any particular purpose, nor does it place criticality on the limitation. It appears that Halley as modified’s thermal conductors would perform equally and function as intended if the thermal fibers were thin, spaced apart, elongated continuous, unbroken thermal fibers, as both configurations would result in the heat being transferred out from the user. Therefore, it would have been obvious to one having ordinary skill in the art to make the thermal fibers be thin, spaced apart, elongated continuous, unbroken thermal fibers, as an obvious matter of design choice within the skill of the art. The shape of the thermal conductors in the secondary reference are different from those in the Instant Application, but they still perform the same function, and would extend from the inner to outer wall if they are dispersed within the entire implant as they are in the secondary reference implant (see paragraph [0075]).
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, 3-8, and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over US 20210093469 A1 (hereafter --Halley--), in view of US 20140309750 A1 (hereafter --Kelley--).
Regarding Claim 1, Halley discloses an external breast prosthesis comprising a main body (510) made from a polymer (see paragraph [0038] denoting the main body 510 is made from silicone, see also main body 510 in Figure 5A below), the body having an inner surface for coinciding with an outer chest surface of a person wearing the breast prosthesis and an opposing outer surface (see annotated inner and outer surfaces in Figure 5A below).
Halley fails to disclose the main body including multiple elongated thermal conductors that extend from a position adjacent the inner surface of the breast prosthesis to a position adjacent the outer surface of the breast prosthesis.
Kelley discloses a liner for a socket prosthesis (see paragraphs [0016], [0017], and [0018], see also Figure 2 below). Kelley teaches wherein the liner for the socket prosthesis includes multiple elongated thermal conductors made from polymeric fibers (see paragraphs [0074] and [0076]) extending throughout the entire structure that extend from a position adjacent the inner surface of the liner to a position adjacent the outer surface of the liner, as the thermal conductors are dispersed through the entire material from which the liner is made (see paragraphs [0027], [0076], and [0109]).
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Therefore, it would have been obvious to one of ordinary skill of the art before the effective filing date of the invention to have the main body of the Halley prosthesis to include multiple elongated thermal conductors made from polymeric fibers extending throughout the entire structure that extend from a position adjacent the inner surface of the main body to a position adjacent the outer surface of the main body, as taught by Kelley, as by doing so would optimize the transfer of heat away from the surface from which the prosthesis is on and to provide for the enhanced absorption of heat emitted by the surface (see paragraph [0027]).
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Halley as modified fails to disclose that the thermal fibers are thin, spaced apart, elongated continuous, unbroken thermal fibers. The Instant Application does not disclose the thermal fibers being thin, spaced apart, elongated continuous, unbroken thermal fibers solving any problem or is for any particular purpose, nor does it place criticality on the limitation. It appears that Halley as modified’s thermal conductors would perform equally and function as intended if the thermal fibers were thin, spaced apart, elongated continuous, unbroken thermal fibers, as both configurations would result in the heat being transferred out from the user. Therefore, it would have been obvious to one having ordinary skill in the art to make the thermal fibers be thin, spaced apart, elongated continuous, unbroken thermal fibers, as an obvious matter of design choice within the skill of the art.
Regarding Claim 3, Halley as modified discloses an external breast prosthesis according to claim 1, wherein the elongated thermal fibers are polymer fibers (see claim 1 rejection above).
Regarding Claim 4, Halley as modified discloses an external breast prosthesis according to claim 3, wherein the elongated thermal fibers are polymer fibers of an oriented strand polymer (see claim 1 rejection). The phrase “oriented strand polymer” is being given its broadest interpretation, in that all chemical strands of polymers are oriented a certain way.
Regarding Claim 5, Halley as modified discloses an external breast prothesis according to claim 1, wherein the main body consists essentially of a thermoplastic elastomer (see paragraph [0043]).
Regarding Claim 6, Halley as modified discloses an external breast prosthesis according to claim 5, wherein the main body is a reticulated solid foam (see paragraphs [0006], [0011], [0038], [0042] denoting the “cushion” attached to the prosthesis, in this case the main body 510, is made of foam).
Regarding Claims 7 and 8, Halley as modified discloses an external breast prosthesis according to claim 6, wherein the porosity of the reticulated solid foam is between 45 and 75% (see paragraph [0043]), a range that overlaps with the claimed range of 50 and 95% or 60 and 85%, in order to allow multiple routes for air flow (see paragraph [0043]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the porosity of the reticulated solid foam of Halley as modified be between 45% and 75%. Doing so would enable multiple routes of air flow while still giving a sturdy structure to hold its shape under typical wearing conditions, as taught by Halley (see paragraph [0043]). Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the porosity of the reticulated solid foam of Halley as modified from between 45% and 75% to between 50 and 95% or 60% and 85% as claimed, since in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see page 10 indicating the porosity “may” be varied significantly, typically from 5 to 95%).
Regarding Claim 11, Halley as modified discloses external breast prothesis according to claim 1.
The claimed phrase “wherein the thermoplastic elastomer is deposited in the form of multiple separate droplets that are fused together” is being treated as a product by process limitation; that is the thermoplastic elastomer is made by fusing together multiple separate deposited droplets. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Thus, even though Halley as modified is silent as to the process used to make thermoplastic elastomer, it appears that the thermoplastic elastomer would be the same as that claimed.
Regarding Claim 12, Halley as modified discloses external breast prothesis according to claim 11.
The claimed phrase “wherein the droplets are deposited via a 3D printing process” is being treated as a product by process limitation; that is the droplets are deposited via a 3D printing process. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Thus, even though Halley as modified is silent as to the process used to make thermoplastic elastomer, it appears that the thermoplastic elastomer would be the same as that claimed.
Regarding Claim 13, Halley as modified discloses external breast prothesis according to claim 12.
The claimed phrase “wherein the droplets are deposited via an ink droplet deposition process” is being treated as a product by process limitation; that is the droplets are deposited via an ink droplet deposition process. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Thus, even though Halley as modified is silent as to the process used to make thermoplastic elastomer, it appears that the thermoplastic elastomer would be the same as that claimed.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over US 20210093469 A1 (hereafter --Halley--), in view of US 20140309750 A1 (hereafter --Kelley--), as applied to claim 5 above, in further view of US 20070055371 A1 (hereafter --Laghi--).
Regarding Claim 9, Halley as modified discloses an external breast prosthesis according to claim 5.
Halley as modified fails to disclose wherein the thermoplastic elastomer is a styrene block copolymer.
Laghi discloses an external breast prosthesis (see Abstract) comprising a main body made from a polymer (see paragraph [0054], see also annotated main body in Figure 2 below), the body having an inner surface for coinciding with an outer chest surface of a person wearing the breast prosthesis and an opposing outer surface (see annotated inner and outer surfaces in Figure 2 below). Laghi teaches wherein the external breast prosthesis comprises of a styrene block copolymer, an option being a styrene-ethylene-butylene-styrene copolymer (see paragraphs [0012] and [0032]).
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Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the thermoplastic elastomer be a styrene block copolymer, specifically a styrene-ethylene-butylene-styrene copolymer, since 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. In re Leshin, 125 USPQ 416.
Regarding Claim 10, Halley as modified discloses an external breast prosthesis according to claim 9, wherein the thermoplastic elastomer is a styrene-ethylene-butylene-styrene copolymer (see claim 9 rejection above).
Conclusion
THIS ACTION IS MADE FINAL. 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 PARIS MARIE BLASS whose telephone number is (703)756-5375. The examiner can normally be reached Monday - Thursday 9 a.m. - 7 p.m. ET.
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, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774