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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 1/17/2025 has been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as "configured to" or "so that"; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “at least one element” in claim 67.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 67-85 are objected to because of the following informalities:
In claim 67 (and thereby dependent claims 68-85), there are apparent typographical errors in line 11 and line 12 at “polymer component”, respectively (wherein an amendment such as “polymeric component” will moot this minor objection);
In claim 69, there is an instance of rough grammar in line 1 at “comprising a two or more assemblies” (wherein an amendment such as “comprising [[a]] two or more assemblies” will moot this minor objection);
In claim 69, there is an apparent typographical error in lines 2-3 at “a polymer component” (wherein an amendment such as “[[a]] said at least one polymeric component” will moot this minor objection);
In claim 70, a plurality of words are provided in italic font for no apparent reason and create unnecessary ambiguity and/or uncertainty (wherein an amendment removing the italic font will moot this minor objection);
In claim 71, there is an apparent typographical error in line 1 at “the polymer component” (wherein an amendment such as “the at least one polymeric component” will moot this minor objection);
In claim 72, a plurality of words are provided in italic font for no apparent reason and create unnecessary ambiguity and/or uncertainty (wherein an amendment removing the italic font will moot this minor objection);
In claim 73, there are apparent typographical errors in line 2 at “at least one polymer component” (wherein an amendment such as “at least one first polymeric component” will moot this minor objection), and in line 3 at “at least one second polymer component” (wherein an amendment such as “at least one second polymeric component” will moot this minor objection); and
In claim 75, a plurality of words are provided in italic font for no apparent reason and create unnecessary ambiguity and/or uncertainty (wherein an amendment removing the italic font will moot this minor objection).
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.
Claims 76-82 and 84 are 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.
Regarding claim 76 (and thereby dependent claims 77-82), the phrase "at least one decellularized tissue" in line 3 renders the claim(s) indefinite because at least one decellularized tissue was already introduced in line 1 of claim 67 (from which claim 76 depends), thereby rendering the scope of the claim(s) unascertainable. It is unclear whether applicant intended to refer back to the at least one decellularized tissue of claim 67 or introduce a new, additional at least one decellularized tissue. To move prosecution forward, the examiner assumed applicant intended to refer back to the at least one decellularized tissue originally introduced in claim 67. Appropriate correction is required.
Regarding claim 76 (and thereby dependent claims 77-82), the phrase "at least one polymer" in lines 3-4, lines 5-6, line 8 and line 9 renders the claim(s) indefinite because at least one polymeric component was already introduced in line 2 of claim 67 (from which claim 76 depends), thereby rendering the scope of the claim(s) unascertainable. It is unclear whether applicant intended to refer back to the at least one polymeric component of claim 67 or introduce a new, additional at least one polymer. To move prosecution forward, the examiner assumed applicant intended to refer back to the at least one polymeric component originally introduced in claim 67. It is noted that “the polymer” is further used in claims 77-82 and all may need correction to align with the “at least one polymeric component” of claim 67. Appropriate correction is required.
Regarding claim 76 (and thereby dependent claims 77-82), the phrase "at least one metal element" in line 5 renders the claim(s) indefinite because at least one element was already introduced in lines 1-2 of claim 67 (from which claim 76 depends), thereby rendering the scope of the claim(s) unascertainable. It is unclear whether applicant intended to refer back to the at least one element of claim 67 or introduce a new, additional at least one metal element. To move prosecution forward, the examiner assumed applicant intended to refer back to the at least one element originally introduced in claim 67. Appropriate correction is required.
Regarding claim 81, the phrase "at least one decellularized tissue" in line 2 renders the claim(s) indefinite because at least one decellularized tissue was already introduced in line 1 of claim 67 (from which claim 76 depends), thereby rendering the scope of the claim(s) unascertainable. It is unclear whether applicant intended to refer back to the at least one decellularized tissue of claim 67 or introduce a new, additional at least one decellularized tissue. To move prosecution forward, the examiner assumed applicant intended to refer back to the at least one decellularized tissue originally introduced in claim 67. Appropriate correction is required.
Regarding claim 81, the phrase "at least one polymer" in line 3 renders the claim(s) indefinite because at least one polymer was already introduced in lines 3-4 of claim 76 (which itself is subject to a 112 rejection in view of the conflicting “at least one polymeric component” of claim 67 from which claim 76 depends), thereby rendering the scope of the claim(s) unascertainable. It is unclear whether applicant intended to refer back to the at least one polymer of claim 76 (or the “at least one polymeric component” of claim 67) or introduce a new, additional at least one polymer. To move prosecution forward, the examiner assumed applicant intended to refer back to the at least one polymer of claim 76. Appropriate correction is required.
Regarding claim 84, the phrase "a decellularized tissue" in line 4 renders the claim(s) indefinite because at least one decellularized tissue was already introduced in line 1 of claim 67 (from which claim 84 depends), thereby rendering the scope of the claim(s) unascertainable. It is unclear whether applicant intended to refer back to the at least one decellularized tissue of claim 67 or introduce a new, additional decellularized tissue (i.e., the at least one decellularized tissue comprising at least a first decellularized tissue and potentially a second decellularized tissue, as shown in Figs. 14A-16C). To move prosecution forward, the examiner assumed applicant intended to refer back to the at least one decellularized tissue originally introduced in claim 67. Appropriate correction is required.
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) 67-68, 70-72, 74-75 and 85 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Matheny (US 2014/0148897).
Matheny discloses (see Figs. 12A-12C) an ECM construct comprising the following claim limitations:
(claim 67) A construct (50a) comprising at least one decellularized tissue (58a) ([0145]), at least one element ([0068]; [0163]-[0164]; the inventive ECM and scaffold layers expressly be incorporated onto stents, prosthetic heart valves and other cardiovascular prostheses), and at least one polymeric component (52) (see claim 9; [0019]; [0102]-[0103]; [0145]; support scaffold 52 expressly disclosed as a polymeric material); said at least one polymeric component (52) is in physical contact with at least a portion of at least one surface region of the at least one decellularized tissue (58a) (as expressly shown in Figs. 12A-12C), wherein the polymeric component (52) is fully anchored into the tissue (58a) to completely penetrate the tissue (58a), from one face of the tissue to the other (as shown in Figs. 12A-12C; microneedles 56 completely penetrate tissue 58a), whereby the anchoring is through a single anchoring point, or through two or more anchoring points (two or more anchoring points expressly shown in Figs. 12A-12C); and said at least one polymeric component (52) at least partially coating a surface region of the element (as shown in Figs. 12A-12C; [0068]; [0163]-[0164]; ECM and scaffold layers expressly may be used on a surface of stents, covered stents, prosthetic heart valves, etc.); wherein said at least one surface region of the decellularized tissue (58a) being in physical contact with said polymer component (52) comes into contact with the at least one surface region of the element (i.e., stent, covered stent, prosthetic heart valve, etc.) coated by said polymer component (52) (as expressly shown in Figs. 12A-12C, ECM and scaffold layers expressly may be used on a surface of stents, covered stents, prosthetic heart valves, etc.);
(claim 68) wherein said at least one element is selected from a group consisting of a metal element, or a polymeric material ([0068]; [0163]-[0164]; the inventive ECM and scaffold layers expressly be incorporated onto stents, covered stents, and prosthetic heart valves and other cardiovascular prostheses);
(claim 70) wherein the decellularized tissue (58a) is a tissue selected from oral mucosa, small intestinal submucosa and bladder-decellularized matrixes, pericardium, omentum or small intestine mucosa, bovine pericardium, swine pericardium and any combination thereof (see claim 5; [0015]);
(claim 71) wherein the polymer component (52) is or comprises a blend, an IPN, or a semi-IPN ([0102]-[0103]);
(claim 72) wherein said metal element is selected from stents, metallic stents, vascular grafts, heart valves, membrane, sealing devices, suture or staple lines, hernia meshes or hernia repair devices, pelvic floor reconstruction devices, wound or burn dressings, dural closures and cardiac patches ([0068]; [0163]-[0164]; the inventive ECM and scaffold layers expressly be incorporated onto stents, covered stents, prosthetic heart valves and other cardiovascular prostheses);
(claim 74) An implant comprising a construct (50a) according to claim 67 (as shown in Fig. 16; [0068]; [0163]-[0164]);
(claim 75) selected from stents, metallic stents, vascular grafts, heart valves, membrane, sealing devices, suture or staple lines, hernia meshes or hernia repair devices, pelvic floor reconstruction devices, wound or burn dressings, dural closures and cardiac patches (as shown in Fig. 16; [0068]; [0163]-[0164]; usage in stents and prosthetic valves is expressly disclosed); and
(claim 85) wherein the polymeric component (52) is a polymeric sheet having one or more tissue-penetrating features (30) and the decellularized tissue (58a) is decorated with one or more holes through which the features (30) protrude (as shown in Figs. 12A-12B), the tissue-penetrating features (30) being composed of the material of the polymeric sheet (52) (as shown in Fig. 12B).
Allowable Subject Matter
Claims 69, 73 and 76-84 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. It is noted that claims 69, 73 and 76-84 each remains subject to at least one of claim objections and/or 112 rejections, as set forth above, which must be resolved before any of these claims can be rewritten in independent form for allowance.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: see Ward et al. (US 2020/0188077), see at least Figs. 1-2B.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ROBERT A LYNCH/Primary Examiner, Art Unit 3771
Prosecution Insights