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 .
Detailed Action
This Office Action is in response to the Applicant’s reply received 6/7/26. Claims 1-12, 14-20 are pending. Claims 14 are withdrawn. Claims 1-12 and 15-20 are considered on the merits.
Response to Applicant’s Arguments and Amendments
In the response submitted by the Applicant the following 35 U.S.C § 102 rejections are withdrawn:
Claim(s) 2-6, 15 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yu et al. (Stem Cell Research & Therapy 2018, in IDS 5/9/23).
The following 35 U.S.C. 112 rejections are withdrawn:
Claims 1-12 and 15-19 were 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 1-12 and 15-19 were rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating arthritis, pain, and movement disorder, does not reasonably provide enablement for preventing arthritis or pain. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The Applicant’s amendments removing the language of “preventing” the claimed ailments necessitated the above withdrawals. All arguments drawn to these rejections are now considered moot.
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.
Claim(s) 1, 6-12 and 17-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yu et al. (Stem Cell Research & Therapy 2018, in IDS 5/9/23). This rejection has been modified to address the claim amendments
Yu et al. teach treating an injury caused by hindlimb ischemia with an injection of human tissue fat extract (FE) to prevent necrosis and cyanosis of the toes (see Abstract and Fig 2 D) which cause a movement disorder due to the hindlimb impairment or even amputation of the toes or limb. Yu et al. teach the following method (Fig 1 and pg. 14, col 1):
Fat tissue raw material was obtained from human subjects. The fat was harvested using a cannula to suction and shred the fat into a lipoaspirate which was then rinsed with saline to remove red blood cells;
The lipoaspirate was centrifuged at 1200 g for 3 mins at 4°C to obtain a 3-layer mixture of a) an oily upper layer, b) an intermediate layer, c) a lower fluid layer;
The a) oily upper layer and c) lower fluid layer are discarded and the b) intermediate layer is collected;
Layer b) is emulsified to produce an emulsified fat layer which is freeze-thawed to remove lipid (oil) droplets (pg. 12, col 2, lines 5-8);
The emulsified fat layer of 4) is then centrifuged a 2nd time at 1200 g for 5 mins at 4°C to obtain a 4-layer mixture where i) the top layer is an oil layer, ii) the 2nd layer is a residual fat layer, iii) the 3rd layer is a liquid layer, and iv) cell/tissue debris;
The liquid layer iii) is recovered and passed through a 0.22 μm filter to obtain the cell-free human tissue fat extract (FE) without adding ingredients that is formulated into an injectable preparation used to treat hindlimb ischemia (pg. 5, col 2, 1st full paragraph).
Claims 11 and 17 appear to be inherently met since it only lists the properties of the FE obtained by claim 1 and does not add an active step that would change the structure of that FE. Since Yu et al. teaches all the limitations of claim 1 to obtain the FE, then they also inherently teach the properties of that FE. MPEP 2112.01 II state “If the composition is physically the same, it must have the same properties”.
Yu et al. teach the FE has the following growth factor concentrations (see Fig 4 and Table 1):
BDNF at 1,000-2,500 pg/mL
GDNF at 1,000-2,500 pg/mL
TGF-β at 400-2,500 pg/mL
HGF at 400-1,500 pg/mL
bFGF at 200-350 pg/mL
VEGF at ~200 pg/mL and
PDGF at 150-200 pg/mL.
These ranges provide several ratios of growth factors reading on claim 8. For example using the average values of Table 1:
175.26 pg/mL PDGF to 197.27 pg/mL VEGF is a ratio of 0.9:1;
1860.99 pg/mL BDNF to 197.27 pg/mL VEGF is a ratio of 9.4:1; and
229.26 pg/mL bFGF to 197.27 pg/mL VEGF is a ratio of 1.2:1.
Therefore the invention as a whole is anticipated by the reference.
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) 1, 6-12 and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al. (Stem Cell Research & Therapy 2018, in IDS 5/9/23) in view of .
Yu et al. teach treating an injury caused by hindlimb ischemia with an injection of human tissue fat extract (FE) to prevent necrosis and cyanosis of the toes (see Abstract and Fig 2 D) which cause a movement disorder due to the hindlimb impairment or even amputation of the toes or limb. Yu et al. teach the following method (Fig 1 and pg. 14, col 1):
Fat tissue raw material was obtained from human subjects. The fat was harvested using a cannula to suction and shred the fat into a lipoaspirate which was then rinsed with saline to remove red blood cells;
The lipoaspirate was centrifuged at 1200 g for 3 mins at 4°C to obtain a 3-layer mixture of a) an oily upper layer, b) an intermediate layer, c) a lower fluid layer;
The a) oily upper layer and c) lower fluid layer are discarded and the b) intermediate layer is collected;
Layer b) is emulsified to produce an emulsified fat layer which is freeze-thawed to remove lipid (oil) droplets (pg. 12, col 2, lines 5-8);
The emulsified fat layer of 4) is then centrifuged a 2nd time at 1200 g for 5 mins at 4°C to obtain a 4-layer mixture where i) the top layer is an oil layer, ii) the 2nd layer is a residual fat layer, iii) the 3rd layer is a liquid layer, and iv) cell/tissue debris;
The liquid layer iii) is recovered and passed through a 0.22 μm filter to obtain the cell-free human tissue fat extract (FE) without adding ingredients that is formulated into an injectable preparation used to treat hindlimb ischemia (pg. 5, col 2, 1st full paragraph).
Claims 11 and 17 appear to be inherently met since it only lists the properties of the FE obtained by claim 1 and does not add an active step that would change the structure of that FE. Since Yu et al. teaches all the limitations of claim 1 to obtain the FE, then they also inherently teach the properties of that FE. MPEP 2112.01 II state “If the composition is physically the same, it must have the same properties”.
Yu et al. teach the FE has the following growth factor concentrations (see Fig 4 and Table 1):
BDNF at 1,000-2,500 pg/mL
GDNF at 1,000-2,500 pg/mL
TGF-β at 400-2,500 pg/mL
HGF at 400-1,500 pg/mL
bFGF at 200-350 pg/mL
VEGF at ~200 pg/mL and
PDGF at 150-200 pg/mL.
These ranges provide several ratios of growth factors reading on claim 8. For example using the average values of Table 1:
175.26 pg/mL PDGF to 197.27 pg/mL VEGF is a ratio of 0.9:1;
1860.99 pg/mL BDNF to 197.27 pg/mL VEGF is a ratio of 9.4:1; and
229.26 pg/mL bFGF to 197.27 pg/mL VEGF is a ratio of 1.2:1.
While Yu et al. teach injecting their FE composition to treat hindlimb ischemia that causes a movement disorder due to the hindlimb impairment, they do not teach treating arthritis. However this would be obvious in view of Cronstein et al. who teach injecting compositions comprising recombinant BDNF (called proBDNF) to treat arthritis (Cronstein 0019, 0037-0038). They teach that these compositions can be injected intravenously, intramuscularly, intra-articularly or intra-synovially with suitable excipients and carriers (Cronstein, 0120). While Cronstein et al. does not expressly teach the arthritis was osteoarthritis, this would be obvious to one of ordinary skill in the art since Cronstein et al. also mentions osteoarthritis as one of the possible conditions treated by their invention (Cronstein, 0099) and it treats arthritis when injected directly into the joint (intrasynovially or intraarticularly).
The FE composition of Yu et al. comprises a significant amount of BDNF it would be obvious to use this composition in the method of Cronstein et al. since this is taught as an active ingredient to treat arthritis. One of ordinary skill would recognize that the FE composition of Yu et al. is suitable substitute for the BDNF composition of Cronstein et al. to treat arthritis since they both contain BDNF (MPEP 2141 III (B and D).
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.
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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