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 I, claims 1, 4-11, 18-26 (as amended) in the reply filed on June 23, 2026 is acknowledged.
Claims 2, 12-17, 27-41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 June 23, 2026.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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, 4-11, 18-26 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.
Claim 1 recites "PLA" in line 3. The first use of an acronym or initialism should write out the full meaning of the abbreviated words, followed by the abbreviation in parentheses. As currently written, the meaning of "PLA" is unclear, rendering the claim indefinite. Claims 4-11, 18-26 depend from claim 1, incorporate all of its limitations, and are therefore also indefinite. Applicant may overcome this rejection by amending claim 1 to define the abbreviation "PLA".
Claim 8 recites "(commonly denoted PLA)" in line 2. The phrase which is "commonly denoted PLA" is unclear, rendering the claim indefinite. Applicant may overcome this rejection by defining "PLA" the first time it is used and removing the parenthetical statement from claim 8.
Regarding claim 20, the phrase "such as" and “e.g.” in the clause “such as tissue-derived cells (e.g. cells derived from epithelial, connective, muscular and/or nervous tissue), pluripotent stem cells (e.g. bone-marrow derived mesenchymal stromal cells, adipose-tissue derived stem cells), embryonic stem cells or induced pluripotent stem cells” (emphasis added) renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Appropriate correction or clarification is required.
Claims 18-26 recite a preamble of “A sterilized PLA-collagen scaffold” according to claim 1, however claim 1 recites “a loaded scaffold”. It is unclear as to whether claim 18 incorporates all the limitations of the loaded scaffold of claim 1 since the preamble recites a sterilized PLA-collagen scaffold instead of a loaded scaffold. Appropriate correction to claims 18-26 to correspond to the preamble of claim 1 is recommended.
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, 7-11, 18-22, 25, 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Muhonen, et al, WO 2016/042211 (“Muhonen”).
Regarding claims 1 and 21, Muhonen discloses a loaded scaffold (3D hybrid scaffold), which is a sterilized PLA-collagen scaffold (PLA fibers, page 9, lines 1-15; and collagen, page 10, lines 5-15; mesh gamma sterilized at 25kGy, page 16, lines 24-35) loaded with cells that are chondrocytes (bovine chondrocytes, page 13, lines 30-35), wherein the cells are pre-proliferated (chondrocytes that have been previously grown or proliferated, page 12, lines 1-25 and page 13, lines 15-35).
Regarding claim 7, Muhonen discloses a loaded scaffold according to claim 1, wherein the PLA is a polylactide polymer or copolymer (page 9, lines 5-15).
Regarding claim 8, Muhonen discloses a loaded scaffold according to claim 1, wherein the PLA is in the form of a fiber mesh containing fibers of polylactide polymer or copolymer (commonly denoted PLA, page 9, lines 5-25; fiber mesh of PLA).
Regarding claims 9 and 25, Muhonen discloses a loaded scaffold according to claim 1, wherein collagen is recombinant collagen, tissue derived collagen, animal collagen or animal derived collagen or combinations thereof (page 10, lines 5-30).
Regarding claim 10, Muhonen discloses a loaded scaffold according to claim 1, wherein the collagen has been loaded to the scaffold before sterilization (mesh gamma sterilized at 25kGy, page 16, lines 24-35 done after collagen/PLA mesh formed).
Regarding claims 11 and 26, Muhonen discloses a loaded scaffold according to claim 1, further comprising an agent selected from anti-inflammatory agent, an anti-infectious agent, an analgesic agent, an anti-catabolic agent, a pro-anabolic agent, and mixtures thereof (materials or agents, see page 11, lines 20-30).
Regarding claim 18, Muhonen discloses a sterilized PLA-collagen scaffold according to claim 1, wherein the cells are pre-proliferated in vitro prior to loading to the scaffold (page 13, lines 15-25; differentiation of stem cells or chondrocytes in vitro).
Regarding claim 19, Muhonen discloses a sterilized PLA-collagen scaffold according to claim 18, wherein the pre-proliferation of the cells in vitro is performed as 2D expansion in a culture medium. The phrase “performed as 2D expansion in a culture medium” is being treated as a product by process limitation; that is cells can be prepared in culture medium with 2D expansion. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113. In the instant case, Muhonen teaches that the cells can be grown in vitro and cultured in a medium, which would result in the same type of cells as those in a 2D expansion culture medium (see page 18, lines 5-20 and also page 13, lines 30-35).
Regarding claim 20, Muhonen discloses a sterilized PLA-collagen scaffold according to claim 1, wherein the cells are selected from somatic cells such as tissue-derived cells (e.g. cells derived from epithelial, connective, muscular and/or nervous tissue), pluripotent stem cells (e.g. bone-marrow derived mesenchymal stromal cells, adipose-tissue derived stem cells), embryonic stem cells or induced pluripotent stem cells (page 12, lines 3-30).
Regarding claim 22, Muhonen discloses a sterilized PLA-collagen scaffold according to claim 21, wherein the chondrocytes are obtained from articular cartilage (page 13, lines 25-30).
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 4-6, 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Muhonen, et al, WO 2016/042211 in view of Xiangchen Qiao et al. (J. Funct. Biomater. 2015, 6, 667., hereafter referred to as Qiao).
Regarding claims 4-6, 23-24, Muhonen discloses a loaded scaffold according to claim 1, but is silent as to wherein the sterilized PLA-collagen scaffold comprises collagen in a concentration from 5% to 25% w/w and PLA in a concentration from 75% to 95% w/w, the concentrations being based on the total weight of PLA and collagen; or concentrations being based on the total weight of the sterilized scaffold; or wherein the concentration of collagen in the sterilized scaffold is from 5% to 20% w/w and the concentration of PLA in the sterilized scaffold is from 80% to 95% w/w, or the concentration of collagen in the sterilized scaffold is from 5% to 15% w/w and the concentration of PLA in the sterilized scaffold is from 85% to 95% w/w; and wherein the scaffold contains from 5 to 25% w/w collagen, the percentage being based on the total weight of PLA and collagen; or percentage being based on the total weight of the scaffold.
However, Qiao, in the same field of art, namely PLA/collage scaffolds, teaches scaffolds for use in biological environments made from a blend of poly-dl-lactic acid (PDLLA), which is interpreted as equivalent to the elected poly(L/D)lactide, and type I collagen (Abstract). Collagen and PDLLA are taught to be biocompatible materials useful for bone tissue engineering (pg. 668, Introduction, para. 1-3). Qiao investigated the suitability of PDLLA to stabilize collagen in a scaffold for in vitro delivery of human bone marrow stromal cells (HBMSCs) and compared it to scaffolds made from PDLLA and gelatin (pg. 669, para. 4). In one embodiment, the ratio of PDLLA to collagen in the dried scaffold is taught to be 80/20, which is equivalent to 80% w/w PDLLA and 20% w/w collagen and falls within the ranges recited in claims 4-6, 23-24 (Abstract, Table 1, and pg. 680, 3.2. Preparation of PDLLA/Collagen Scaffolds). HBMSCs loaded on the PDLLA/Collagen scaffolds were found to be viable 4 weeks after loading, with varying levels of proliferation and differentiation based upon the ratio of PDLLA:Collagen (pg. 673-674, 2.2. Cell Culture on PDLLA/Collagen Scaffolds). Qiao teaches that all scaffolds were sterilized using UV irradiation prior to cell seeding (pg. 681, 3.4. Biological Characterisation of Electrospun PDLLA/Collagen Scaffolds).
With respect to claimed ranges which "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). These guidelines apply to the quantities of animal collagen and PDLLA - Qiao teaches discrete quantities that fall within the ranges recited in instant claims 4-6, 23-24 rendering them prima facie obvious. See guidelines on the obviousness of similar and overlapping ranges, amounts, and proportions are provided in MPEP § 2144.05.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the scaffold of Muhonen with the PLA/collagen percentages as taught by Qiao in order to provide the stated advantages of selection of an optimum PLA/collagen scaffold composition to balance the need to provide a highly water-stable construction with the need for fibre surface hydration (page 678, 2.4.2, lines 14-15).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 4-11, 19-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 12-14, 35 of copending Application No. 18/705,154 (reference application) in view of Muhonen et al, WO 2016/042211 (“Muhonen”). The ‘154 reference application recites all the same claim elements as the instant application claims 1, 4-11, 19-26 except for the scaffold loaded with cells, wherein the cells are pre-proliferated. However, Muhonen, in the same field of art, teaches a loaded scaffold (3D hybrid scaffold), which is a sterilized PLA-collagen scaffold (PLA fibers, page 9, lines 1-15; and collagen, page 10, lines 5-15; mesh gamma sterilized at 25kGy, page 16, lines 24-35) loaded with cells that are chondrocytes (bovine chondrocytes, page 13, lines 30-35), wherein the cells are pre-proliferated (chondrocytes that have been previously grown or proliferated, page 12, lines 1-25 and page 13, lines 15-35).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the scaffold of the ‘154 application with pre-proliferated cells as taught by Muhonen in order to provide the stated advantages of providing an optimal environment for cell migration and viability, nutrition exchange and promote integration into the transplantation area and improve the biomechanical properties of the scaffold (Muhonen, page 13, lines 5-30).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4-7, 8, 23-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-28 of copending Application No. 18/904,227 (reference application) in view of Muhonen. The ‘154 reference application recites all the same claim elements as the instant application claims 1, 4-11, 19-26 except for the scaffold loaded with cells, wherein the cells are pre-proliferated. However, Muhonen, in the same field of art, teaches a loaded scaffold (3D hybrid scaffold), which is a sterilized PLA-collagen scaffold (PLA fibers, page 9, lines 1-15; and collagen, page 10, lines 5-15; mesh gamma sterilized at 25kGy, page 16, lines 24-35) loaded with cells that are chondrocytes (bovine chondrocytes, page 13, lines 30-35), wherein the cells are pre-proliferated (chondrocytes that have been previously grown or proliferated, page 12, lines 1-25 and page 13, lines 15-35).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the scaffold of the ‘154 application with pre-proliferated cells as taught by Muhonen in order to provide the stated advantages of providing an optimal environment for cell migration and viability, nutrition exchange and promote integration into the transplantation area and improve the biomechanical properties of the scaffold (Muhonen, page 13, lines 5-30).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for scaffolds containing polymers, collagen and/or cells.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATRINA M STRANSKY whose telephone number is (571)270-3843. The examiner can normally be reached Monday-Friday 8:30 am-5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at (571)272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
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