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 Arguments
Applicant's arguments filed 8/12/2026 have been fully considered but they are not persuasive.
Applicant argues that Shippert discloses an applicator for releasing a synthetic “absorptive foam pad 40” or a synthetic breast implant which do not constitute living biological cellular “organic tissue”. However, claim analysis is highly fact-dependent. A claim is only limited by positively recited elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935). In this case, “organic tissue” is the material or article worked upon by claimed device.
Applicant argues that Shippert’s housing (24) is not a hollow tubular structure; however, chamber 32 in housing (24) is a hollow tubular base element.
Applicant argues that Shippert does not feature a distal-end opening configured to let out tissue through distal axial pushing. However, Shippert teaches the base element (24) further comprising a first opening (at the distal end), which is arranged in a distal zone (DZ) towards the first end and is configured to let out and position the organic tissue in the target tissue through the action of the pushing element (via the combined action of using the panel 78 and pusher made of 56 and 68).
Applicant’s arguments, see pages 8-9, filed 8/12/2026, with respect to the rejection(s) of claims 1-2, 4, 7, 12-13, 17-18 and 21 under U.S.C. 102(a)(1) and claims 10-11 under 35 U.S.C. 103 based on Innocenti and claim 5 under 35 U.S.C. 103 based on Innocenti or Shippert in view of Berget have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Japanese Patent Publication No. 2013-526300 A (hereinafter “JP ‘300”).
Claim Rejections - 35 USC § 102
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.
Claims 1-2, 4, 6-7, 12-13, 15, 17-18 and 20-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent No. 5,507,807 (Shippert).
Regarding claim 1, Shippert discloses a device (see figures 5 and 7 when used for breast treatments; figure 8; col. 5, line 63 – col. 6, line 32) for the placement of organic tissue comprising:
a hollow tubular base element (chamber 32 in housing 24 in figure 8), comprising, on the inside thereof, a primary duct (the volume inside the housing 24) configured to house, in a seat (the foot or substance contact wedge 64 is considered such a "seat"), at least one portion of the organic tissue to be positioned; the base element (24) comprising a first end (see at distal end) and a second end (see at proximal end) opposite the first end relative to the primary duct;
a pushing element (shaft 56) configured for insertion on the inside of the base element (24) coupled to the base element (24) in a sliding manner;
the base element (24) is configured to at least partially penetrate a target tissue (see figure 5 or 7: the base element is shown in a state penetrated in a target tissue (breast));
the base element (24) further comprises a first opening (at the distal end), which is arranged in a distal zone (DZ) towards the first end and is configured to let out and position the organic tissue in the target tissue through the action of the pushing element (via the combined action of using the panel 78 and pusher made of 56 and 68).
Regarding claim 2, Shippert discloses a protection element (panel member 78) for the organic tissue which is configured to protect the organic tissue while the base element (24) penetrates towards the target tissue (see fig. 5, 7-8).
Regarding claim 4, Shippert discloses the pushing element comprises a pushing member (shaft 56) provided with a piston (64), which at least partially longitudinally goes through the base element (24) and is configured to push the organic tissue through at least the first opening following a relative movement between the piston (64) and the base element (24) (see fig. 8).
Regarding claim 6, Shippert discloses the first opening is arranged along a side wall of the base element (24) so as to let out the organic tissue crosswise to a longitudinal axis (A) of the base element (24) (see the opening along a side wall in fig. 8).
Regarding claim 7, Shippert discloses that the first opening is arranged in the area of the first end (at distal end) so as to let out the organic tissue crosswise or parallel to a longitudinal axis (A) of the base element (24) (see fig. 8).
Regarding claim 12, Shippert discloses the substance holding assembly 76 which can be said to be a retractable element that is disposed in the region of the first opening (the opening defined by the housing 24 and the substance holding assembly 76) and is configured to close the chamber 32 during penetration toward the target tissue and then retract into the respective seats (see col. 4, lines 19-48).
Regarding claim 13, Shippert discloses that the seat portion can be loaded with the substance 40 by the operator (see Fig. 2).
Regarding claim 15, Shippert discloses an apparatus for the placement of organic tissue comprising a device according to claim 1 described above and a portion of organic tissue housed in the seat (64) (see figure 8).
Regarding claim 17, Shippert discloses that the protection element (78) is configured to assume at least a closed configuration, in which it partially or totally obstructs the positioning of the organic tissue in the target tissue (see figure 8).
Regarding claim 18, Shippert discloses that the protection element (78) in the closed configuration at least partially closes the first opening (at the end of extension 124 / panel member 78) at the distal end; and, in an open configuration, the protection element (78) allows the organic tissue to come out and be positioned in the target tissue (see figure 8).
Regarding claim 20, Shippert discloses that the first opening (at the end of extension 124 / panel member 78) is parallel to a longitudinal axis (see figure 8).
Regarding claim 21, Shippert discloses that the first opening (at the end of extension 124 / panel member 78) at distal end is defined as a continuation of the primary duct (inside housing 24) (see fig. 8).
Claims 1-3, 5, 7-8, 10-11, 13-18 and 20-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by of Japanese Patent Publication No. 2013-526300 A (hereinafter “JP ‘300”).
Regarding claim 1, JP ‘300 teaches a device (1500) for placement of organic tissue (micrograft 120), particularly endocrine tissue (see paragraph [0121]), comprising:
a hollow tubular base element (needle 1520 or hollow tube 1010) comprising, on the inside thereof, a primary duct configured to house, in a seat (hollow tube 1010 or a distal portion of hollow tube 1010), at least one portion of the organic tissue (120) to be positioned; and the base element (1520, 1010) comprising a first end and a second end opposite the first end relative to the primary duct;
a pushing element (1040), configured for insertion on the inside of the base element (1520, 1010) and coupled to the base element in a sliding manner;
wherein the base element (1520, 1010) is configured to at least partially penetrate a target tissue (1510); and
wherein the base element (1520, 1010) further comprising a first opening, which is arranged in a distal zone (DZ) towards the first end and is configured to let out and position the organic tissue (120) in the target tissue (1510) through the action of the pushing element (1040)
(see paragraphs [0116] - [0121], Figs. 15A-15E).
Regarding claim 2, JP ‘300 teaches a protection element (the needle 1520 or the hollow tube 1010) for the organic tissue (120), which is configured to protect the organic tissue (120) while the base element (1520, 1010) penetrates towards the target tissue (1510)(see paragraph [0121]).
Regarding claim 3, JP ‘300 teaches at least one injection device which is configured to inject into the target tissue (1520) a culture liquid, which is configured to enhance the activity of the organic tissue (120) in the target tissue (1510)(see paragraphs [0125] - [0126]).
Regarding claim 5, JP ‘300 teaches that the pushing element (1040) is a culture liquid, which at least partly longitudinally flows through the primary duct and is configured to push the organic tissue (120) through at least the first opening following a relative movement between the culture liquid and the base element (1520, 1010) (see Figs. 15A-15D; paragraph [0124]).
Regarding claim 7, JP ‘300 teaches that the first opening is arranged in the area of the first end so as to let out the organic tissue (120) crosswise or parallel to a longitudinal axis (A) of the base element (1520, 1010) (see Figs. 15A-15E; paragraphs [0116]-[0121]).
Regarding claim 8, JP ‘300 teaches that the base element (1520, 1010) defines an outer shell (needle 1520); wherein the protection element for the organic tissue (120) is at least partially defined by a hollow tubular inner shell (hollow tube 1010), which is arranged inside the outer shell (1520) in a concentric manner and is configured to house the at least one portion of the organic tissue (120) to be positioned and the pushing element (1040); the inner shell (1010) comprising a second opening, which is available in the distal zone (DZ) and is configured to let out the organic tissue (120) towards the first opening; the inner shell (1010) being capable of at least partially translating along and/or rotating around a longitudinal axis (A) so as to cause the first opening and the second opening to become complementary to one another, thus determining a connection between the inside of the inner shell (1010) and the outside of the outer shell (1520) in the target tissue (1510) (see Figs. 15A-15E; paragraphs [0116]-[0121]).
Regarding claims 10-11, JP ‘300 teaches that the primary duct and the base element (520, 1010) has an outer diameter of about 0.51 mm and an inner diameter of about 0.31 mm which is smaller than or equal to 3 mm (see paragraph [0095]).
Regarding claim 13, JP ‘300 teaches that the seat is adapted to be loaded by an operator with the organic tissue (120)(see Figs. 15A-15E).
Regarding claim 14, JP ‘300 teaches that the first end of the base element (1520) comprises a cutting profile (1525) for at least partially piercing the target tissue (1510) (see paragraph [0116]-[0121], Figs. 15A-15E).
Regarding claim 15, JP ‘300 teaches an apparatus for the placement of organic tissue (120) comprising a device (1500) and a portion of organic tissue (120) housed in the seat (hollow tube 1010 or a distal portion of hollow tube 1010)(see paragraph [0116]-[0121], Figs. 15A-15E).
Regarding claim 16, JP ‘300 teaches an injection system for a culture liquid, which is configured to inject said culture liquid from the second opening, through the primary duct and the first opening, towards the target tissue (1510) (see Figs. 15A-15E; paragraphs [0125] - [0126]).
Regarding claim 17, JP ‘300 teaches that the protection element (1525) is configured to assume at least a closed configuration, in which it partially or totally obstructs the positioning of the organic tissue (120) in the target tissue (1510)(see Figs. 15A-15E).
Regarding claim 18, JP ‘300 teaches that the protection element (1525) in the closed configuration at least partially closes the first opening at the distal end; and, in an open configuration, the protection element (1525) allows the organic tissue to come out and be positioned in the target tissue (see Figs. 15A-15E).
Regarding claim 20, JP ‘300 teaches that the first opening is parallel to a longitudinal axis (see Figs. 15A-15E).
Regarding claim 21, JP ‘300 teaches that the first opening at distal end is defined as a continuation of the primary duct (inside housing 1010) (see Figs. 15A-15E).
Allowable Subject Matter
Claims 9 and 19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 6/25/2026 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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 JOHN KIM whose telephone number is (571)272-1142. The examiner can normally be reached Maxi Flex.
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, INSUK BULLOCK can be reached at 571-272-5954. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/John Kim/Primary Examiner, Art Unit 1772
JK
9/20/26
Prosecution Insights