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/Restriction Requirement
Applicant’s election of Group II, claims 32-41 in the reply filed on 3/5/26 is acknowledged. Claims 31, 42, 43, 46-48 and 50 are withdrawn. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Response to Applicant’s Arguments and Amendments
In the response submitted by the Applicant the following 35 U.S.C § 103 (a) rejections are withdrawn:
Claim(s) 31 and 42, 43, 46-48 and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bosley et al. (US 2011/0020418, in IDS 2/21/24) in view of Badylak et al. (US 2008/0260831, in IDS 2/21/24) and Firestone (US 2008/0279939, in IDS 2/21/24). These claims are now withdrawn in light of the latest restriction requirement.
The following 35 U.S.C. 112 rejections are withdrawn:
Claims 48 and 50 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. These claims are now withdrawn in light of the latest restriction requirement.
All arguments drawn to these rejections are now considered moot.
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.
Claim(s) 32-41 remain rejected under 35 U.S.C. 103 as being unpatentable over Bosley et al. (US 2011/0020418, in IDS 2/21/24) in view of Badylak et al. (US 2008/0260831, in IDS 2/21/24) and Firestone (US 2008/0279939, in IDS 2/21/24). This rejection has been modified to address the claim amendments.
Bosley et al. teach a composition of two extracellular matrix particles (ECM), each from different sources, at a 1:1 ratio (50:50 ratio) (Bosley, [0050] and [0069]). This ECM particle mixture can be suspended into a gel carrier for injection into the tissue site of a patient (Bosley, [0063]). Bosley et al. teach that their ECM particles can be obtained from allogenic, autogenic, or xenogeneic native tissue sources including submucosa, dermis, epithelial basement membrane, aponeurosis, tendons, and ligaments (Bosley, [0056]) including SIS (small intestinal submucosa), LBM (liver basement membrane), and UBM (urinary bladder membrane) (Bosley 0061). Bosley et al. does not expressly teach that the ECM is from the spleen and lungs.
It would be obvious to use ECM from spleen in view of Badylak et al. who teach a gelled ECM composition (Badylak, [0041]). This gel can be formulated into an injectable graft to implant into a patient (Badylak [0042-0043]). They teach that several sources of ECM are suitable for their injectable gel, including urinary bladder, small intestine, and spleen. It would be obvious for one of ordinary skill in the art to include spleen ECM into the composition of Bosley et al. since Badylak et al. teaches that ECM from the urinary bladder, small intestine, and spleen are all suitable for injectable gels and it is obvious to substitute equivalents for the same purpose (MPEP 2144.06).
While Badylak et al. does not teach their spleen ECM comprises 6.6 ± 0.5 to 8.7 ± 1.2 ng/mg of native VEGF, this appears to be an inherent property of spleen ECM when considering Applicant’s Specification. Table 1 shows the amount of growth factors in micronized ECM (Specification, 0030). This includes VEGF that ranges from 8.7 ± 1.2 and 6.6± 0.4 ng/mg (Table 1, Specification 0030, see note 5). The ECM is micronized by grinding, crushing, or milling (Specification, 0039), which are the same techniques used to make the particulate ECM of Bosley (0068), concluding that the micronized ECM of the current application is equivalent to the particulate ECM of Bosley. Since Bosley and Badylak render obvious using ECM particles (e.g. micronized ECM) from the spleen, it would appear this ECM would have the same properties as well, including the amount of native VEGF from 8.7 ± 1.2 and 6.6 ± 0.4 ng/mg.
It would be obvious to use ECM from lungs in view of Firestone who also teach a gelled ECM composition (Firestone, [0008-0009]). This gel can be formulated into an injectable graft for defects in the heart, pancreas, liver, lungs, reproductive tissues, and kidneys (Firestone, [0009] and [0035]). They teach that several sources of ECM are suitable for their injectable gel, SIS, LBM, UBS, and lung (Firestone [0017] and [0011]). It would be obvious for one of ordinary skill in the art to include lung ECM into the composition of Bosley et al. since Firestone teaches that ECM from the SIS, LBM, UBS, and lung are all suitable for injectable gels and it is obvious to substitute equivalents for the same purpose (MPEP 2144.06).
In summary, Bosley et al. in combination with Badylak et al. and Firestone render obvious a composition of a 50:50 mix of particulate ECM from spleen and lung in the form of a gel for injection to a target site in a patient.
Bosley et al. teach that their composition is made with the following steps:
commuting two different ECM sheets (Bosley, Fig 3, #20 and #22) into particles A and B (Bosley Fig 3 #14 and #16);
A mixture of these particles is then made (Bosley, Fig 3 #24); and
These particles are then suspended into a gel (Bosley, 0009, 0063, and 0093).
This ECM particle mixture can be placed into a gel carrier for injection into the tissue site of a patient to treat damage (Bosley, [0063]) including the synovium, joint capsule, intraarticular ligaments, cartilage, intervertebral disks (spinal disc), organs, and skin (Bosley, 0095).
Table 1 of the Applicant’s Specification appears to confirm that ECM particles (e.g. micronized ECM) contains from 8.7 ± 1.2 and 6.6± 0.4 ng/mg native VEGF.
The ECM sheets are lyophilized and milled into particles by comminuting, grinding, blending, pulverizing, or mincing (Bosley, [0012-0013]). These particles can range in size from 50-750 microns (Bosley, 0062, 0096). It would be obvious that the ECM sources can be from lung and spleen since Badylak et al. and Firestone teach that these are suitable ECM sources for injectable gel formulations of Bosley et al.
The ECM particles naturally contain growth factors (Bosley [0064]) . These growth factors include epidermal growth factor (EGF), vascular endothelial growth factor (VEGF), insulin-like growth factor (IGF), platelet derived growth factor (PDGF) and fibroblast growth factor (FGF) (Bosley [0064-0065]). Also it is noted that the Applicant’s Specification confirms that both spleen and lung ECM contain native VEGF, FGF, PDGF, IGF, EGF, (Specification, Table 1) as well as elastin (Specification, [0075]). The Specification confirms that spleen ECM contains 5.2 ng/mg of EGF while lung ECM contains 5.0 ng/mg. Therefore the ECM disclosed by Bosley, Badylak, and Firestone appear to read on a composition with lung tissue that retains its native elastin as well as the growth factors previously listed.
The gel can be an ECM gel material including UBM gel, SIS gel (Bosley, 0080). Badylak et al. teach that ECM gels can be made from SIS and other sources and then solubilized with acid protease including pepsin or trypsin to form a gel (Badylak [0014]). It would be obvious to sue the SIS gel made by Badylak et al. in the method of Bosley who expressly desires a SIS gel.
Firestone teaches that the ECM composition can be applied to not only defects, cuts or scars, but burns as well (Firestone, 0030). Therefore it would be obvious to inject the composition into a burned tissue site to expedite healing. Since Bosley et al. teach injecting the composition into the synovium and joint capsule, this would also read on injecting into the target site for arthritis since this is where the symptoms of that disease appear. Also since Applicant provides no target site for injection for a patient with amyotrophic lateral sclerosis disease (ALS) or multiple sclerosis (MS), then simply injecting the ECM composition into the skin reads claim 50 since all subjects with ALS and MS have skin.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response To Applicant’s Arguments
Applicant's arguments have been fully considered but they are not persuasive. The Applicant argues Bosley et al. combined with Badylak et al. and Firestone would not have provided one of ordinary skill to retain native growth factors, especially at the concentrations now limited in the claims. As addressed in the modified rejection, it appears that both Bosley et al. and the current claims obtain their ECM particulates by comminuting (e.g. grinding, pulverizing, etc.) or micronizing the ECM material. This seems to be the only action performed on the ECM to obtain the growth factors cited in Table 1 of the Specification. No additional steps appear to be taken to modify the concentration of growth factors retained by the ECM. This leads one of ordinary skill to believe that ECM particles will naturally contain the growth factor concentrations in Table 1 which includes a native VEGF in spleen ECM from 8.7 ± 1.2 and 6.6 ± 0.4 ng/mg and the different concentrations of EGF in spleen vs. lung ECM. MPEP 2112 I and II state i) something that is old does not become patentable when discovery a new property and ii) inherency does not need to be recognized at a relevant time.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
In response to this office action the applicant should specifically point out the support for any amendments made to the disclosure, including the claims (MPEP 714.02 and 2163.06).
CONTACT INFORMATION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THANE E UNDERDAHL whose telephone number is (303) 297-4299. The examiner can normally be reached Monday through Thursday, M-F 8-5 MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311.The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THANE UNDERDAHL/Primary Examiner, Art Unit 1699
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