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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 7, 2025 has been entered.
Response to Amendment
Claims 1 and 8 are pending in the application. Claims 2-7 are cancelled. Claim 1 has been amended. Claim 8 is newly added. Claims 1 and 8 are rejected.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 8 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 has been amended to recite in relevant part “wherein the dome shape of the half shell remains unchanged between the open configuration and the closed configuration, completely enclosing the breast prosthesis therein” in lines 23-25 of the claim. There is insufficient support for this limitation in the specification. Neither the drawings nor the written description support the limitation “ the dome shape of the half shell remains unchanged between the open and closed configurations.” The written description states the container body is flexible and made from ECM. (See paragraphs [0074] and [0076]).
It is clear from the drawings that the half shell has a hollow dome shape in both the open and closed configurations (See Figs. 2A, 3, and 4), however there is not sufficient support for a limitation that the shape remains unchanged between the open and closed configurations.
For the purposes of examination, this limitation is being interpreted as “the half shell has a hollow dome shape in both the open and closed configurations.”
Claim 1 has also been amended to recite “a breast prosthesis having upper and lower portions, the lower portion having a greater lateral cross-sectional thickness than the upper portion” in lines 4-5. There is insufficient support for this limitation in the specification. Neither the drawings nor the written description support the limitation “the lower portion having a greater lateral cross-sectional thickness than the upper portion”. The specification does not define the upper or lower portion of the breast prosthesis, nor any associated thicknesses.
For the purposes of examination, this limitation is being interpreted as “a breast prosthesis having a curved upper surface and a flat lower, bottom surface”.
Claim 1 has also been amended to recite “wherein the perimeter of the flat appendage is greater than the perimeter of the base of the half shell” in lines 21-23. There is insufficient support for this limitation in the specification. Neither the drawings nor the written description support the limitation of the perimeter of the flat appendage being greater than the perimeter of the base of the half shell.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bertoli (US PG Pub 2016/0250016).
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Regarding claim 1, Bertoli teaches a medical device (1), made in bio-material (see paragraph [0064]), for breast reconstruction (See paragraph [0064]; Figs. 6-7), containing a breast prothesis (8), said device comprising:
a breast prosthesis (8) having upper and lower portions, the lower portion having a greater lateral cross-sectional thickness than the upper portion (See Figs. 2-3);
a two-part container body (See Fig. 2, note the container has two general parts, the flat back (19) made from pieces 14a & b and the hollow front portion (20) made of portions 3) comprising:
a half shell (20) having a hollow dome shape (See Fig. 2), having an internal surface shaped to correspond to an external surface of the breast prothesis to be contained therein (See Figs. 3-5; paragraphs [0066] and [0070]), and
a flat appendage (19) in the form of a flat sheet having a circular or oval shape (See annotated Figs. 1 & 2, note the rear part (19) is oval shaped),
wherein the hollow dome-shaped half shell (20) is connected to the flat appendage (19) along a partial portion of a base of said half shell corresponding to a lower portion of the breast prosthesis (See Figs. 1 and 2) and corresponding lower portion of the half shell, wherein in an open configuration (Fig. 2) the flat appendage (19) extends outwardly from the base of said dome-shaped half shell (20) and is coplanar1 to said partial portion of the base of said half shell (See Fig. 3), wherein in a closed configuration (See Figs. 4-5), a perimeter of the flat appendage is sutured to a lower border of the half shell (See Fig. 5, note suture stiches 7), constituting the perimeter of the base of the half shell to form the container body (See Figs. 4 & 5), wherein the perimeter of the flat appendage is greater than the perimeter of the base of the half shell (See Figs. 5 and 6, note the flat appendage 19 extends beyond the perimeter of the dome section 20), and wherein the dome shape of the half shell remains unchanged between the open configuration (Fig. 2) and the closed configuration (Fig. 5), completely enclosing the breast prosthesis therein (See Figs. 2-6; paragraphs [0064]-[0072]).
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) 8 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Bertoli (US PG Pub 2016/0250016).
Regarding claim 8, Bertoli teaches the medical device required by claim 1 as set forth above and further teaches between 3 and 4 suture stiches are used to secure the half shell (20) to the flat appendage (19) See Figs. 5-7 which show two suture stiches on one side connecting the half shell (20) to the appendage (19). Since the device is symmetrical (See Fig. 1), it is presumed there are also two stiches on the opposing side making four total stitches.
Alternatively, as disclosed, the number of sutures connecting the hollow dome half shell to the flat appendage is disclosed to be a result effective variable which assists with reducing operating time on the patient. Further it appears one of ordinary skill in the art would have a reasonable expectation of success in modifying Bertoli to have three to four stitches to connect the half shell to the base, as it only involves adjusting the dimension of a component already disclosed to be adjustable. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the number of suture stitches as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 223, 235 (CCPA 1955). See also MPEP §2144.05
It is further noted, neither the claim, nor the originally filed specification give any reason for or criticality to the parameter of using between 3 and 4 suture stiches to secure the half shell to the flat appendage.
Claim(s) 1 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over applicant cited Peres et al (US PG Pub 2021/0260245) in view of Bertoli (US PG Pub 2016/0250016) and Richter et al (US PG Pub 2011/0022171).
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Regarding claim 1, Peres teaches a medical device (See Figs. 9 & 10) for breast reconstruction for2 containing a breast prothesis (2) (See Fig. 9), comprising:
a breast prosthesis (2) having upper (21) (curved upper surface) and lower (20) (flat bottom surface) portions, the lower portion having a greater lateral cross-sectional thickness than the upper portion (See Fig. 9);
a two-part container body (1) which is comprised by a half shell3 (5) having a hollow dome shape4, (See Fig. 9 &10) having an internal surface shaped to correspond to an external surface of the breast prothesis5 (See annotated Fig. 9 above) to be contained therein (See also paragraph [0075] which states the device (1) “perfectly fits the covered prosthesis”), and
a flat appendage (11) in the form of a flat sheet having a circular or oval shape (See Figs. 9 and 10; paragraphs [0074] and [0075]),
wherein the hollow dome-shaped half shell (5, upper portion as seen in Fig. 10) is connected to the flat appendage (11) (note connection at 14) along a partial portion of a base (bottom connected portion 14 – See Fig. 10) of the half shell (See Fig. 10) corresponding to a lower portion of the breast prosthesis and corresponding to a lower portion of the half shell (See Figs. 6, 9, and 10),
wherein in an open configuration the flat appendage (11) extends outwardly from the base (bottom connected portion 14) of said dome-shaped half shell (5) (See Fig. 10) and is coplanar to said partial portion of the base of the half shell,
wherein in a closed configuration (See Fig. 9) a perimeter of the appendage (11) is sutured6 to a lower boarder of the half shell, constituting the perimeter (note border of half shell 5 as seen in Fig. 10) of the base of the half shell (5) to form the container body (1) completely enclosing the breast prosthesis therein (See Fig. 9; paragraph [0071]).
Peres does not explicitly teach the perimeter of the flat appendage is greater than the perimeter of the half shell or that the dome shape of the half shell remains unchanged between the open configuration and the closed configuration.
Bertoli teaches an analogous medical device for breast reconstruction featuring a breast prosthesis (8) contained in a two part container body featuring a half shell (20) and a flat appendage (19) where the perimeter of the flat appendage is greater than the perimeter of the half shell. (See Figs. 5-7 and paragraphs [0064]-[0074]) Bertoli teaches this arrangement ensures continuing stability over time of the anatomical shape even when subjected to the force of gravity. (See paragraph [0074]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the teachings of Bertoli into the device as taught by Peres since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, F.2d 459, 105 USPQ 237 (CCPA 1955). Additionally, In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See also MPEP §2144.04(IV)(A). Additionally, MPEP §2144.05(II)(A) states: “It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions." In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929).
Richter teaches an analogous medical device for breast reconstruction featuring a breast prosthesis (21) contained in a biomaterial graft container which is “ready-to-use, off-the-shelf graft material” which is “designed to conform to breast implants of various specifications” and “specifically sized and shaped to conform to a portion of a surface of a breast implant” (See paragraphs [0033] and [0035]). Richter teaches this is advantageous to reduce the amount of graft material that is wasted due to inaccurate estimates and reduce the need to perform trimming and resizing which in turn reduces the duration of the surgery which is beneficial to the health of the patient and for reducing costs of surgery (See paragraph [0035])
It would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the teachings of Richter into the device of modified Peres such that the dome shape of the half shell remains unchanged between the open and closed configurations since having the graft material be specifically sized and shaped to conform to the surface of the breast implant reduces the need for trimming which in turn reduces the duration of surgery which is known to lead to better patient outcomes.
Regarding claim 8, modified Peres teaches the medical device required by claim 1 as set forth above but is silent as to the number of suture stitches used to secure the half shell to the flat appendage. As disclosed, the number of sutures connecting the hollow dome half shell to the flat appendage is disclosed to be a result effective variable which assists with reducing operating time on the patient. Further it appears one of ordinary skill in the art would have a reasonable expectation of success in modifying Bertoli to have three to four stitches to connect the half shell to the base, as it only involves adjusting the dimension of a component already disclosed to be adjustable. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the number of suture stitches as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 223, 235 (CCPA 1955). See also MPEP §2144.05
It is further noted, neither the claim, nor the originally filed specification give any reason for or criticality to the parameter of using between 3 and 4 suture stiches to secure the half shell to the flat appendage.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 8 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL S. HIGHLAND whose telephone number is (571)270-3254. The examiner can normally be reached on Monday through Thursday between 9:30am and 2:30pm .
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/R.S.H/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
1 See Fig. 3 which shows the flat appendage (19) lies coplanar to the portion of the base of the half shell. It is further noted that the instant claims are drawn to an apparatus, and “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).” A claim containing 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" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP §2114(II). In the instant case, the flat appendage (19) as taught by Bertoli is capable of being co-planar with the portion of the base of the half shell and thus meets the claim.
2 It is noted that this is a recitation of intended use in the preamble and not given full patentable weight, in that the prior art is not required to disclose this function/method of use. Since the body of the claim in the instant case fully and intrinsically sets forth all the limitations of the claimed invention, the preamble recitation of intended use is not considered a claim limitation. Additionally, MPEP 2111.02(II) states: “If a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997)” In the instant case, the devices of both Peres and Cronin explicitly teach containers for a breast implant.
3 See paragraph [0075] which states the device (1) “is elongate and in the form of two ovoid or shell-shaped parts” (emphasis added)
4 MPEP §2111 requires claim limitations be given their “broadest reasonable interpretation in light of the specification”. Additionally, claim terms are given their “plain meaning” unless applicant has provided a special definition. However, it is improper to import claim limitations from the specification into the claims. As seen in Fig. 9, when fully assembled, the front of the device has a hollow dome shape. It is noted that the claims do not presently require the half shell to always have a hollow dome shape or to have the hollow dome shape in any particular condition. As long as the half shell has the dome shape at some point (or during some phase or configuration) then it meets the limitation as currently claimed.
5 It is noted that the breast prosthesis is a recitation of intended use in the preamble and not given full patentable weight, in that the prior art is not required to disclose this function/method of use. Since the body of the claim in the instant case fully and intrinsically sets forth all the limitations of the claimed invention, the preamble recitation of intended use is not considered a claim limitation. Additionally, MPEP 2111.02(II) states: “If a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997)”. It is noted that the breast prothesis is functionally recited and not positively required by the claim.
6 It is noted that this is a product-by-process limitation, and as such only the product will be examined. As noted by the court in Thorpe. “[e]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. 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 (Fed. Cir. 1985) (citations omitted). The court further stated in Brown. “[w]e are therefore of the opinion that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product by process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 173 USPQ 685, 688 (CCPA 1972) (See also MPEP §2113). In the instant case, Peres explicitly states the two halves of the device are sewn together to form a closed pocket which keeps the prosthesis in place (See paragraph [0071])