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.
ELECTION/RESTRICTION
Applicant timely traversed the restriction (election) requirement in the reply filed on 06/25/2026. The restriction arguments filed on 06/25/2026 are persuasive and the restriction under lack of unity is withdrawn.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because it is not on a separate sheet, apart from any other text. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
Paragraph [108], line 5, “Allergen” should read “Allergan”
Appropriate correction is required.
The use of the term PHASIX, PERFIX, GalaFLEX, TIGR Matrix, SERI Surgical Scaffold, BIO-A, ULTRAPRO, and Arista AH, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 35 is objected to because of the following informalities:
Line 1, “wherein step (b)” should read “wherein act (b)”
Appropriate correction is required.
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.
Claim 32 is 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 32 recites the limitation "body segment" in lines 2, and 3. There is insufficient antecedent basis for this limitation in the claim.
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 1-9, 11-20, 22-36, 59, and 60 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rehnke (US 2020/0268503).
Regarding claim 1, Rehnke discloses an implantable prosthesis (see [0009]) comprising:
a tissue infiltratable body of biocompatible material (see [0009] disclosing a scaffold made of porous absorbable material providing a biological scaffold matrix, thereby making this biocompatible), the body including a proximal end and a distal end spaced from the proximal end (see [0035] disclosing the implant scaffold having a wide base or proximal portion (24) and a narrower apex or distal portion (26), to which are spaced apart), the body being configured to augment and/or reconstruct an anatomical shape of a human breast (see [0035] disclosing the tissue engineering device (20) which includes the scaffold (22) and its use in breast reconstruction or augmentation), the body including:
a plurality of body components circumferentially arranged about a longitudinal axis of the body extending from the proximal end to the distal end (see [0035] disclosing the proximal portion (24) and the distal portion (26) spaced from the proximal portion, a hollow central core (32) extending between the portions, and a plurality of partially open tissue engineering chambers (30), to which are circumferentially/radially arranged about a longitudinal axis around the central core)), each of the plurality of body components including an outer layer defining a cavity (see [0036] disclosing the chambers (30) formed of pleated sheets of absorbable material to form a bottom with opposing panels extending from the bottom to form interior walls, thereby defining the outer surface and the cavities), the outer layer having a conical shape (see [0036] disclosing the frustoconical configuration).
Regarding claim 2, Rehnke discloses wherein the prosthesis includes a base attached to the proximal end of prosthesis body (see [0035] disclosing the base or proximal portion (24) having a disc-like end surface (42) disposed at the base of the scaffold).
Regarding claim 3, Rehnke discloses wherein each of the plurality of body components is attached to the base and/or to one another (see [0035] disclosing the plurality of tissue engineering chambers (30) formed by sheets of absorbable material that extend upward from the base or proximal portion (24) of the scaffold; Fig. 1 illustrating this arrangement).
Regarding claims 4, and 5, Rehnke discloses wherein the outer layer of one or more of the plurality of body components is pleated (see [0036] disclosing the scaffold made of one or more pleated sheets connects with the adjacent tissue engineering chambers (30) to create a contiguous outer surface); and wherein the outer layer of at least two of the plurality of body components is pleated (see [0036] disclosing the scaffold made of one or more pleated sheets connects with the adjacent tissue engineering chambers (30) to create a contiguous outer surface)
Regarding claim 6, Rehnke discloses wherein one or more of the plurality of body components includes a filler material within the cavity (see [0037] disclosing inserting autologous tissue, normally fat, into the tissue engineering chambers (30), as well as filing the chambers with a loose felt cellulose matrix prior to inserting fat).
Regarding claim 7, Rehnke discloses wherein the filler material includes at least one filler layer (see [0039] disclosing a layer of cellulose matrix (66) disposed on a surface of the scaffold where fat is injected into the layer).
Regarding claim 8, Rehnke discloses wherein the at least one filler layer includes a plurality of pleats and/or has a conical shape (see [0037] disclosing the steps of filling the tissue engineering chambers (30), which possess the pleated, conical scaffold structure, with a loose felt cellulose matrix prior to inserting fat).
Regarding claim 9, Rehnke discloses wherein the at least one filler layer has a shape which corresponds with a shape of the outer layer of the body component (see [0040] disclosing applying the loose felt of a cellulose matrix directly to the mesh absorbable material forming the tissue engineering chambers (30) of the scaffold, thereby allowing the filler material to conform to the contours and shape of the chambers).
Regarding claim 11, Rehnke discloses wherein the body includes one or more tiers of body components (see [0036] disclosing the tissue engineering chambers (30) and sub-segments are arranged in rings around the central core (32), and the plurality of rings can be arranged in tiers), the one or more tiers being stacked along the longitudinal axis of the prosthesis (see Fig. 1 illustrating the plurality of rings formed by the chambers (30) are arranged with decreasing diameters stacked along the longitudinal axis of the central core (32)).
Regarding claim 12, Rehnke discloses wherein each of the plurality of body components includes an open end with one or more voids facing an outward radial direction away from the longitudinal axis (see [0035] disclosing the plurality of partially open tissue engineering chambers (30), to which the partial opening create voids, and the chambers extend radially outward from the central core (32) away from its longitudinal axis; Fig. 1 illustrating this configuration), the one or more voids configured to allow fat and/or tissue to fill and pass through the body and fill-out the implantable prosthesis (see [0013] disclosing the scaffold permits lipoaspirate fatty tissue to be injected directly into the tissue engineering chambers (30), thereby allowing the fat to fill out the prosthesis body while being held in place by the absorbable mesh material).
Regarding claim 13, Rehnke discloses wherein each of the plurality of body components includes a closed end opposite the open end (see [0035] disclosing the scaffold featuring a hollow central core (32) and a sidewall (28) formed by a plurality of partially open tissue engineering chambers (30) arranged around the core, thereby establishing a closed inner boundary at the core and an open outer perimeter).
Regarding claim 14, Rehnke discloses wherein the plurality of body components are compressible and/or collapsible (see [0036] disclosing the pleated sheets that form the tissue engineering chambers (30) creates a contiguous outer surface for the scaffold and stabilizes the compression and tension forces exerted on the scaffold by body tissue, thereby allowing the structure to adapt, compress, and flex within the tissue bed).
Regarding claim 15, Rehnke discloses wherein the plurality of body components are pre-formed (see [0017] disclosing the methods of fabricating tissue engineering scaffolds and its components).
Regarding claim 16, Rehnke discloses wherein the body includes a hollow core (see [0036] disclosing the hollow central core (32)), the plurality of body components being arranged about the hollow core (see Fig. 1 illustrating the plurality of tissue engineering chambers (30) around the hollow central core (32)).
Regarding claim 17, Rehnke discloses wherein the hollow core is attached to a base attached to a lower end of the body (see [0035] disclosing the scaffold having a wide base or proximal portion (24) and a hollow inner region formed by a central core (32) extending between the base portion and the apex or distal portion (26)), the base having an opening therethrough which is aligned with a first end of the hollow core to permit access to the hollow core through the base (see [0036] disclosing the base or proximal portion (24) of the scaffold has a disc like end surface (42) with an opening (46, 48) therein that is aligned with the hollow central core (32))
Regarding claim 18, Rehnke discloses wherein the longitudinal axis defines a central axis of the prosthesis (see Fig. 1 illustrating the hollow region formed by a central core (32) extending longitudinally between the proximal base portion (24) and the distal apex portion (26) with the central core defined by the hollow inner region creates the central axis).
Regarding claim 19, Rehnke discloses an implantable prosthesis (see [0009]) comprising:
a tissue infiltratable body of biocompatible material (see [0009] disclosing a scaffold made of porous absorbable material providing a biological scaffold matrix, thereby making this biocompatible), the body having a proximal end and a distal end spaced from the proximal end (see [0035] disclosing the implant scaffold having a wide base or proximal portion (24) and a narrower apex or distal portion (26), to which are spaced apart), the body being configured to augment and/or reconstruct an anatomical shape of a human breast(see [0035] disclosing the tissue engineering device (20) which includes the scaffold (22) and its use in breast reconstruction or augmentation), the body including:
a plurality of body components arranged about a longitudinal axis of the body extending from the proximal end to the distal end (see [0035] disclosing the proximal portion (24) and the distal portion (26) spaced from the proximal portion, a hollow central core (32) extending between the portions, and a plurality of partially open tissue engineering chambers (30), to which are circumferentially/radially arranged about a longitudinal axis around the central core)), wherein each of the body components includes an outer layer defining a cavity (see [0036] disclosing the chambers (30) formed of pleated sheets of absorbable material to form a bottom with opposing panels extending from the bottom to form interior walls, thereby defining the outer surface and the cavities), the outer layer being pleated (see [0035] disclosing the sidewall (28) formed by a plurality of partially open engineering chambers (30) to which the sidewall has a rugose configuration formed by pleats or folds of one or more sheets); and
a base attached to the body (see [0035] disclosing a wide base or proximal portion (24) and a tapering sidewall (28) extending from the base portion of the tissue engineering device (20); Fig. 1 illustrating this configuration).
Regarding claim 20, Rehnke discloses wherein one or more of the plurality of body components includes a first filler layer in the cavity (see [0037] disclosing inserting autologous tissue, normally fat, into the tissue engineering chambers (30), as well as filing the chambers with a loose felt cellulose matrix prior to inserting fat, to which the matrix functions as the first filing layer).
Regarding claim 22, Rehnke discloses wherein the first filler layer is substantially conically shaped and/or is pleated (see [0036] disclosing the scaffold and sidewall (28) configuration as having a truncated, frustoconical, or pyramidal shape formed by a plurality of pleated tissue engineering chambers that is later filled with a loose felt cellulose matrix before fat is inserted).
Regarding claim 23, Rehnke discloses wherein the first filler layer and the outer layer of the one or more of the plurality of body components are the same shape (see [0040] disclosing the loose felt of a cellulose matrix, effectively functioning as the first filing layer, is applied directly to the mesh absorbable material forming the tissue engineering chambers (30) of the scaffold, thereby causing the filling layer to match and conform to the shape and contours of the chambers, making them the same shape).
Regarding claim 24, Rehnke discloses wherein the body includes one or more tiers of body components (see [0036] disclosing the tissue engineering chambers (30) and sub-segments are arranged in rings around the central core (32), and the plurality of rings can be arranged in tiers), the one or more tiers being stacked along the longitudinal axis (see Fig. 1 illustrating the plurality of rings formed by the chambers (30) are arranged with decreasing diameters stacked along the longitudinal axis of the central core (32)).
Regarding claim 25, Rehnke discloses wherein each of the plurality of body components includes an open end with one or more voids facing in an outward radial direction away from the longitudinal axis (see [0035] disclosing the plurality of partially open tissue engineering chambers (30), to which the partial opening create voids, and the chambers extend radially outward from the central core (32) away from its longitudinal axis; Fig. 1 illustrating this configuration), the one or more voids arranged to allow fat and/or tissue to fill and pass through the body and fill-out the implantable prosthesis (see [0013] disclosing the scaffold permits lipoaspirate fatty tissue to be injected directly into the tissue engineering chambers (30), thereby allowing the fat to fill out the prosthesis body while being held in place by the absorbable mesh material).
Regarding claim 26, Rehnke discloses wherein each of the plurality of body component includes a closed end opposite the open end (see [0035] disclosing the scaffold featuring a hollow central core (32) and a sidewall (28) formed by a plurality of partially open tissue engineering chambers (30) arranged around the core, thereby establishing a closed inner boundary at the core and an open outer perimeter).
Regarding claim 27, Rehnke discloses wherein the plurality of body components are compressible and/or collapsible (see [0036] disclosing the pleated sheets that form the tissue engineering chambers (30) creates a contiguous outer surface for the scaffold and stabilizes the compression and tension forces exerted on the scaffold by body tissue, thereby allowing the structure to adapt, compress, and flex within the tissue bed).
Regarding claim 28, Rehnke discloses wherein the plurality of body components are pre-formed (see [0017] disclosing the methods of fabricating tissue engineering scaffolds and its components).
Regarding claim 29, Rehnke discloses wherein the outer layer of one or more of the plurality of body components is conical in shape (see [0036] disclosing the frustoconical configuration).
Regarding claim 30, Rehnke discloses wherein the longitudinal axis defines a central axis of the prosthesis (see Fig. 1 illustrating the hollow region formed by a central core (32) extending longitudinally between the proximal base portion (24) and the distal apex portion (26)).
Regarding claim 31, Rehnke discloses a method of fabricating an implantable prosthesis (see [0017]), the method comprising acts of:
(a) providing a plurality of body components (see [0035] disclosing a plurality of partially open, tissue engineering chambers (30)), each of the plurality of body components including an outer layer defining a cavity (see [0036] disclosing the chambers (30) formed of pleated sheets of absorbable material to form a bottom with opposing panels extending from the bottom to form interior walls, thereby defining the outer surface and the cavities), wherein:
the outer layer has a conical shape (see [0036] disclosing the frustoconical configuration); and/or
the outer layer is pleated (see [0035] disclosing the sidewall (28) formed by a plurality of partially open engineering chambers (30) to which the sidewall has a rugose configuration formed by pleats or folds of one or more sheets);
(b) arranging the plurality of body components circumferentially about a longitudinal axis of the prosthesis and in an outward radial direction end (see [0035] disclosing the proximal portion (24) and the distal portion (26) spaced from the proximal portion, a hollow central core (32) extending between the portions, and a plurality of partially open tissue engineering chambers (30), to which are circumferentially/radially arranged about a longitudinal axis around the central core) to form a body configured to augment and/or reconstruct an anatomical shape of a human breast (see [0035] disclosing the tissue engineering device (20) which includes the scaffold (22) and its use in breast reconstruction or augmentation); and
(c) securing the plurality of body components together (see [0014] disclosing the joining together of the tissue engineering chambers, to which are defined as a plurality).
Regarding claim 32, Rehnke discloses wherein act (c) includes attaching one or more portions of each body segment to one or more portions of an adjacent body segment (see [0036] disclosing the adjacent sheets or panels of absorbable material forming the chambers (30) can be fixed of connected (such as via welding to attach points of contact) to form sub-segment tissue engineering chambers (30’, 30”) and create a contiguous outer surface).
Regarding claim 33, Rehnke discloses wherein act (a) includes pleating the outer layer of one or more of the plurality of body components (see [0035] disclosing the sidewall (28) forms the tissue engineering chambers (30) which has a rugose configuration created by pleats or folds of one or more sheets of absorbable material).
Regarding claim 34, Rehnke discloses further comprising an act (d) of attaching one or more of the plurality of body components to a base (see [0035] disclosing a wide base or proximal portion (24) and a tapering sidewall (28) extending from the base portion of the tissue engineering device (20); Fig. 1 illustrating this configuration).
Regarding claim 35, Rehnke discloses wherein step (b) includes:
arranging a first plurality of body components about the longitudinal axis to form a first tier (see [0036] disclosing the tissue engineering chambers (30) and sub-segments (30’, 30”) are arranged in a ring round the core (32), to which the rings form tiers defined by its outer, intermediate, and inner rings, with the outer ring effectively functioning as the first tier about the longitudinal axis, located at the outermost perimeter of the scaffold; Fig 1. Illustrating this configuration along the longitudinal axis); and
arranging a second plurality of body components about the longitudinal axis to form a second tier wherein the second tier is stacked on the first tier along the longitudinal axis (see [0036] disclosing the tissue engineering chambers (30) and sub-segments (30’, 30”) are arranged in a ring round the core (32), to which the rings form tiers defined by its outer, intermediate, and inner rings, with the intermediate and inner rings effectively functioning as the second tier about the longitudinal axis; Fig 1. Illustrating this configuration along the longitudinal axis).
Regarding claim 36, Rehnke discloses wherein the longitudinal axis defines a central axis of the prosthesis (see Fig. 1 illustrating the hollow region formed by a central core (32) extending longitudinally between the proximal base portion (24) and the distal apex portion (26), with the central core defined by the hollow inner region creates the central axis).
Regarding claims 59, and 60, Rehnke discloses wherein each body component of at least a portion of the plurality of body components includes an open end oriented radially away from the longitudinal axis (see [0035] disclosing the plurality of partially open tissue engineering chambers (30) extending radially outward from the central core (32) away from its longitudinal axis; Fig. 1 illustrating this configuration).
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 10, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Rehnke (US 2020/0268503) in view of Rehnke (US 2018/0206978).
Rehnke discloses at least one filler layer (see [0039] disclosing a layer of cellulose matrix (66) disposed on a surface of the scaffold where fat is injected into the layer); and a first filler layer (see [0037] disclosing a loose felt cellulose matrix applied to the mesh absorbable material of the scaffold, to which it is designed to match and conform to the pleated and conical configuration of the tissue engineering chambers (30), thereby defining the first fill layer prior to inserting fat).
Rehnke fails to disclose wherein the at least one filler layer includes a plurality of petals; and wherein the first filler layer includes a plurality of petals.
Rehnke also discloses an internal absorbable matrix and tissue engineering scaffold for breast reconstruction, including compartments (see [0022]). Rehnke teaches wherein the at least one filler layer includes a plurality of petals (see [0052] disclosing the compartments formed in the cup member produce a scaffold having folded chambers arranged around a central core similar to petals of a lotus flower); and wherein the first filler layer includes a plurality of petals (see [0052] disclosing the compartments formed in the cup member produce a scaffold having folded chambers arranged around a central core similar to petals of a lotus flower).
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 provided Rehnke’s tissue engineering device comprised of a scaffold with a hollow core, wherein the at least one filler layer includes a plurality of petals; and wherein the first filler layer includes a plurality of petals, as further taught by Rehnke. Doing so would provide a means to configure the filler layer of an implantable breast prosthesis to include a plurality of petals, in order to subdivide the cavity volume into smaller subunit spaces that maximize surface area for neovascularization, tissue ingrowth, and autologous fat graft retention (see [0052]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEFAN BRADLEY CAMPBELL whose telephone number is (571)272-3498. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
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.
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.
/STEFAN BRADLEY CAMPBELL/Examiner, Art Unit 3774
/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
