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 .
Election/Restrictions
Applicant’s election without traverse of Group II (method for creating a multilayer vascular construct) in the reply filed on 06/01/2026 is acknowledged.
Claims 1-5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/01/2026.
Status of Claims
This office action is responsive to the amendment filed on 06/01/2026. As directed by the amendment: claims 16-20 have been cancelled, new claims 21-25 have been added, and claims 1-5 are withdrawn from further consideration as being drawn to a nonelected invention. Thus, claims 6-15 and 21-25 are presently examined in the current Office Action.
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.
Claim 23 is 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 23 depends from claim 22, which sets forth that the plurality of collagen membranes being independently seeded with cells, and claim 23 further sets forth that “the cells are seeded at a concentration between 2.5 million/mL to 30 million/mL”; however, this parameter was never disclosed in the originally filed disclosure. Specifically, the originally filed specification never mentions that the plurality of collagen membranes are independently seeded with cells at a concentration between 2.5 million/mL to 30 million/mL.
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 8-11, 23 and 25 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 8, which sets forth the parameter of “at least one of the two pieces of elastomeric material has a positive feature” (emphasis added); however, this parameter is found to be confusing since it is not clear what exactly, structurally, is meant by the term “positive feature”. Specifically, it is unclear what exact structure would be needed in order to meet the limitation of the elastomeric material having a “positive feature”; and the originally filed disclosure dose not aid in defining, clarifying, and/or illustrating such a parameter/term.
Regarding claim 9, which recites the term “positive feature”, which is found to be indefinite, as detailed above with regard to claim 8; additionally, claim 9 recites the term “vascular diameter”, which is also found to be confusing. Specifically, it is unclear what exactly is meant, structurally by a “vascular diameter”; is this just a term for a generic diameter, or is it specifically a diameter of a specific vasculature, and if so, which/what vasculature, or is it something else completely different.
Regarding claim 11, which sets forth the parameter of “at least one of the two pieces of elastomeric material has a negative feature” (emphasis added); however, this parameter is found to be confusing since it is not clear what exactly, structurally, is meant by the term “negative feature”. Specifically, it is unclear what exact structure would be needed in order to meet the limitation of the elastomeric material having a “negative feature”; and the originally filed disclosure dose not aid in defining, clarifying, and/or illustrating such a parameter/term.
Regarding claim 23, which depends from claim 22, which sets forth that the plurality of collagen membranes being independently seeded with cells, and claim 23 further sets forth that “the cells are seeded at a concentration between 2.5 million/mL to 30 million/mL”; however, this parameter is found to be confusing since it is not clear if the above mentioned concentration applies to each independently seeded collagen membrane, or if it is the concentration for the whole perfusable collagen construct, i.e. all of the plurality of membranes together. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 25, which recites the limitation “the vascularized construct”; there is insufficient antecedent basis for this limitation in the claim. In order to overcome this rejection, and keep claim terminology consistent, it is suggested the word “multilayer” be added between the words “the” and “vascularized”.
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 6-15, 22 and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rylander et al. (US PG Pub. 2020/0115667), hereinafter Rylander.
Regarding claims 6-10, 12-15 and 22, Rylander discloses a method for creating a multilayer vascularized construct comprising preparing a first collagen mixture and injecting it into a mold to form top and bottom pieces; gelling a second collagen mixture, which is seeded with endothelial cells, between two pieces of elastomeric material, specifically polydimethylsiloxane (PDMS), to form a collagen membrane, wherein at least one of the two pieces of elastomeric material has a vascular diameter of 10 mm to 500 mm; sandwiching a plurality of collagen membranes between the top piece and the bottom piece to form a perfusable collagen construct, wherein the plurality of collagen membranes are independently seeded with same/different/combination types of cells and manufactured in parallel; and culturing the perfusable collagen construct with growth medium such that the plurality of collagen membranes of the perfusable collagen construct integrate into a cohesive construct ([0047]; [0121] & [0128] – [0134]).
Regarding claim 11, Rylander discloses the method of claim 7, wherein at least one of the two pieces of elastomeric material has a negative feature ([0131] – to clarify, it is stated the PDMS elastomeric material has a channel pattern; thus, the space between the channels are formed by negative features on the PDMS material).
Regarding claim 23, Rylander discloses the method of claim 22, wherein the cells are seeded at a concentration between 2.5 million/mL to 30 million/mL ([0132], Last 6 Lines).
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.
Claims 21, 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Rylander.
Regarding claim 21, Rylander discloses the method of claim 6, wherein a bottom of a first collagen membrane of the plurality of collagen membrane is in face sharing contact with a top of a second collagen membrane of the plurality of collagen membrane ([0121] & [0131]); and though it is not specifically disclosed that the bottom of the first collagen membrane is complementary in shape to the top of the second collagen membrane, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine appropriate design channel patterns for the plurality of collagen membranes, including a top and a bottom of adjacent membranes having complementary shapes, since doing so amounts to a mere change in shape/form of the design channel patterns; and a change in shape/form is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see MPEP 2144.04). Furthermore, it is to be noted that neither the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of the bottom of the first collagen membrane being complementary in shape to the top of the second collagen membrane, as opposed to the plurality of collagen membranes having any other type of form/pattern.
Regarding claim 24, Rylander discloses the method of claim 6, and though it is not specifically disclosed that the plurality of collagen membranes comprises 4 to 20 layers of collagen membrane, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate number of layers of collagen membrane, including 4-20 layers, based on intended use/parameters needed for a specific vascularized construct; and 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 (see MPEP 2144.05). Furthermore, it is to be noted that neither the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of the plurality of collagen membranes comprises 4 to 20 layers of collagen membrane, as opposed to having any other number of layers.
Regarding claim 25, Rylander discloses the method of claim 6, and though it is not specifically disclosed that the vascularized construct is 2 mm thick, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate thickness for the vascularized construct, including having a 2 mm thickness, based on intended use/parameters needed for a specific vascularized construct; and such a modification would have involved a mere change in the size of a component, which is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04). Furthermore, it is to be noted that neither the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of the vascularized construct being 2 mm thick, as opposed to having any other thickness.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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/DINAH BARIA/Primary Examiner, Art Unit 3774 06/27/2026
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