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 . Claims 1-11 are pending and examined below.
Response to Arguments
Applicant's arguments filed 07/01/2026 have been fully considered but they are not persuasive. Applicant argues that the amendments to the independent claim overcome the rejections of record (pages 6-9) and that the dependent claims rise and fall with the same arguments (pages 6-9).
Applicant argues that Pashos in view of Edwards do not disclose or suggest a nipple-areola complex having an intact anatomic structure as claimed (pg. 7). The examiner respectfully disagree. Pashos teaches obtaining a donor nipple, an areola, or a nipple attached to an areola (¶0013, Pashos) and the nipple and areola are removed together (¶0029, Pashos) therefore this would read on the intact anatomic structure. Pashos teaches intact structures of human tissue consisting of a nipple areola complex belonging to humans, which is a type of animal, and Edwards teaches the pig, cattle, or goat animal source. Furthermore, Pashos discloses decellularizing the nipple-areola complex (¶0013, Pashos) and recellularization for human use (Fig. 8, Pashos).
Applicant argues that the skilled person would be discouraged from substituting animal tissue into the process of Pashos would be unsuitable because of immunogenicity (pg. 9, Pashos). However, Pashos discloses as persons of skill will understand, a tissue can be decellularized and then repopulated or recellularized (¶0044, Pashos) which would be obvious to do a certain decellularization process as this is a known process in the art, depending on the type of animal tissue that is being used.
Therefore, the applicant’s argument is not sufficient to overcome the rejection of record and the claims remain rejected.
Claim Objections
The claims are objected to because they include reference characters which are not enclosed within parentheses.
Reference characters corresponding to elements recited in the detailed description of the drawings and used in conjunction with the recitation of the same element or group of elements in the claims should be enclosed within parentheses so as to avoid confusion with other numbers or characters which may appear in the claims. See MPEP § 608.01(m).
Claims 5, 7 & 8 have reference characters that are not within parentheses.
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 1-11 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.
Claim 1 recites the limitation “treated for implantation in a human” in line 4. It is unclear if this “treated for implantation in a human” means the treatment is occurring in a human or if it is treated for implantation to use in a human.
All dependent claims are likewise rejected.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pashos et al. (US 20180015204 A1) hereinafter, Pashos, in view of Edwards (US 20210052774 A1).
Regarding claim 1, Pashos teaches a biological prosthesis (10) consisting wholly or partly of a nipple-areola complex (NAC (nipple-areolar complex) graft, Fig. 8, Pashos), said nipple-areola complex having been harvested with an intact anatomic structure (a donor nipple, an areola, or a nipple attached to an areola, ¶0013 & the nipple and areola are removed together, ¶0029, Pashos) and treated for implantation in a human (Fig. 8, Pashos).
Pashos does not teach the biological prosthesis belonging to a family of pigs, cattle or goats. However, Edwards teaches tissue products produced from a combination of three-dimensional biologic scaffolds and acellular tissue matrices (abstract, Edwards)
belonging to a family of pigs, cattle or goats (¶0039, Edwards).
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 teachings of Pashos by incorporating the teaching above as taught by Edwards in order to create acellular tissue matrices used to form various moldable tissue matrix products and compositions (¶0038, Edwards).
Regarding claim 2, Pashos teaches
wherein it comprises a planar or substantially planar section (18), and a projecting section (16) (see annotated Figs. 4 & 8 below, Pashos).
Regarding claim 3, Pashos teaches wherein the projecting section (16) is arranged in the center or substantially in a center of section (18) (Figs. 4 & 8, Pashos).
Regarding claim 4, Pashos teaches wherein section (18) is circular or oval, or substantially circular or substantially oval, in shape (Figs. 4 & 8, Pashos).
Regarding claim 5, Pashos teaches wherein a thickness e of section (18) is between 0.5 and 4 mm (although the thickness is not specifically disclosed, Pashos discloses a thickness excised to the depth of the epidermis, dermis or hypodermis of the surrounding tissue and those are known measurements in the art, Figs. 4 & 8, ¶0029, Pashos).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the thickness e of section (18) since these are result effective variables that contribute to the successful use of the biological prosthesis, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art and modifying Pashos as suggested would allow for the placement of the biological prosthesis. MPEP 2144.05.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the prosthesis would perform equally well with either designs, these modifications are a matter of design choice. Absent a teaching as to criticality, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. MPEP 2144.05.
Regarding claim 6, Pashos teaches wherein the projecting section (16) has a height h of between 0.5 and 20 mm (although the height is not specifically disclosed, Pashos discloses the NAC is taken from a human cadaver or the own patient therefore, the height of the projecting section would fall in between the given range, Figs. 4 & 8, ¶0020, Pashos).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the projecting section (16) since these are result effective variables that contribute to the successful use of the biological prosthesis, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art and modifying Pashos as suggested would allow for the ideal size of the biological prosthesis. MPEP 2144.05.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the prosthesis would perform equally well with either designs, these modifications are a matter of design choice. Absent a teaching as to criticality, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. MPEP 2144.05.
Regarding claim 7, Pashos teaches wherein a mean diameter D of section (18) is between 10 and 60 mm (although the diameter is not specifically disclosed, Pashos discloses the NAC is taken from a human cadaver or the own patient therefore, the diameter of the NAC would fall in between the given range, Figs. 4 & 8, ¶0020, Pashos).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the mean diameter D of section (18) since these are result effective variables that contribute to the successful use of the biological prosthesis, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art and modifying Pashos as suggested would allow for the ideal size of the biological prosthesis. MPEP 2144.05.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the prosthesis would perform equally well with either designs, these modifications are a matter of design choice. Absent a teaching as to criticality, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. MPEP 2144.05
Regarding claim 8, Pashos teaches wherein a mean diameter d of section (16) is between 5 and 15 mm (although the diameter is not specifically disclosed, Pashos discloses the NAC is taken from a human cadaver or the own patient therefore, the diameter of the NAC would fall in between the given range, Figs. 4 & 8, ¶0020, Pashos).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the mean diameter d of section (16) since these are result effective variables that contribute to the successful use of the biological prosthesis, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art and modifying Pashos as suggested would allow for the ideal size of the biological prosthesis. MPEP 2144.05.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the prosthesis would perform equally well with either designs, these modifications are a matter of design choice. Absent a teaching as to criticality, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. MPEP 2144.05.
Regarding claim 9, Pashos teaches wherein the biological prosthesis (10) is decellularized, deantigenized, treated for virus inactivation, or any combination thereof (Figs. 4 & 8, ¶0030, Pashos).
Regarding claim 10, Pashos teaches wherein it is freeze-dried (¶0074, Pashos).
Regarding claim 11, Pashos teaches wherein it is a breast biological prosthesis for humans (Figs. 4 & 8, Pashos).
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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 KIA XIONG WHITE whose telephone number is (703)756-4773. The examiner can normally be reached 0830-1630 EST.
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, Jerrah 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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/K.X.W./Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
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