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 (IDS) submitted on 12/05/2025 is being considered by the examiner. The signed IDS form is attached with the instant office action.
Response to Amendment
Applicant's amendment and argument filed 12/05/2025, in response to the non-final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1-8, 10-11 and 13 are being examined on the merits.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-8, 10-11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Graham Vesey (From IDS, US20110293577A1) and Yunfie (CN109876189A), with supporting evidence from Ziyou Yu et. al. (Fat extract promotes angiogenesis in a murine model of limb ischemia: a novel cell-free therapeutic strategy, Stem Cell Research and Therapy, 9, 294, 08-Nov-2018). This rejection is maintained with slight modifications due to the amendments filed on 12/05/2025.
Regarding claims 1-3 and 6, Vesy discloses “a method of treating an inflammatory disorder or a cartilage or bone disorder, or alleviating pain associated with an inflammatory disorder in a subject, comprising administering to the subject a pharmaceutical composition which comprises: (i) an adipose tissue-derived cell suspension which comprises adipocytes; or (ii) a cell-free extract which is prepared from an adipose tissue-derived cell suspension,” (see abstract).
Vesy discloses “In certain embodiments the cartilage or bone disorder is a cartilage or bone fracture, for instance a non-union bone fracture, or osteoporosis” (see 0016) and wherein the composition is administered for a cartilage or bone disorder which may include a loss of bone or cartilage volume and strength (see 00825).
Regarding claim 10, Vesy teaches the composition to have a pharmaceutically acceptable carrier (see 0083).
Regarding claim 11, Vesy discloses topical administration and subcutaneous injection (see 0070).
Vesy does not teach the instantly disclosed method for obtaining the cell-free fat extract.
Yunfei also teaches the instantly claimed methods for obtaining a fat extract. Yunfei teaches providing a fat source adipose tissue and wherein the S1. adipose tissue is centrifuged to 1~8 min under the conditions of 1000~12000rpm, if being divided into three layers after centrifugation, is respectively pushed up Layer grease, middle layer mixture and bottom Tumescent fluid, then discard bottom Tumescent fluid, and filtering removal top layer grease simultaneously takes filtrate. S2. filtrate obtained by S1 non-contact ultrasonic is carried out to be crushed, the ultrasonication condition be 600~1190W, 5~ 55min, 20~38 DEG C. This process of ultrasonication would mechanically emulsify the fat mixture as claimed. S3. 3 will be centrifuged under the conditions of 1000~10000 rpm through the broken fat blend of S2 non-contact ultrasonic~ 10min, and centrifugation is discarded, collects the light-yellow floccule in upper layer to get the cell epimatrix material of cell factor is rich in (see claim 1). Yunfei also teaches rinsing the tissue with saline (see S5 and S6 of claim 1).
Yunfei teaches that this method recycles high speed centrifugation to remove the cell component and ECM, and cell factor loss is low (see abstract).
Regarding claims 6-8, the same extraction process would inherently bring about the same components in the extract as claimed. As additional evidence Yu, discloses these same extracted components.
Yu’s disclosure is relied upon to show that a fat tissue extract would contain the same components as claimed.
Yu teaches “In the current study, we aimed to produce a cell-free extract directly from human fat tissue and evaluate its potential therapeutic efficacy” (see abstract).
Yu teaches “the detailed procedures for isolating FE are shown in Fig. 1. The lipoaspirate was first rinsed with saline to remove red blood cells and then centrifuged at 1200 × for 3 min. After the first spin, the superior oily and inferior fluid layers were discarded, and the middle fat layer was g collected and mechanically emulsified. The emulsification was achieved via 30 passes of shifting the fat between two 10-cm syringes 3 connected by a female-to-female Luer-Lok connector (B. Braun Medical Inc., Melsungen, Germany). The emulsified fat was then frozen at − 80 °C and thawed at 37 °C for further disruption of the fat tissue. After one cycle of the freeze/thaw process, the fat was again centrifuged at 1200 × for 5 min. After a second spin, the fat was separated into four layers. The upper layer of oil was discarded; the second layer of g unbroken fat and the fourth layer of debris was discarded; and the third aqueous layer, namely the FE, was carefully aspirated without contamination of the bottom pellet. The final extract was produced by passing it through a 0.22-μm filter (Corning Glass Works, Corning, NY, USA) for sterilization and removal of cell debris” (see page 8 2nd para.). Here Yu teaches the same intermediate fat components as being claimed.
Yu also teaches “To verify the underlying mechanism of FE treatment, the angiogenic factors within FE were then measured in six samples using ELISA. High levels of growth factors, including BDNF, GDNF, TGF-β, HGF, bFGF, VEGF, PDGF, EGF, NT-3, and G-CSF, were detected in the FE (Fig. 4). The mean level and variation of each factor in the six samples are presented in Table 1” (see page 3). These appear to be within ranges of what is instantly claimed as can be appreciated from the values of those components in Yu’s Figure 4.
Therefore it is obvious that the same cell types would have the same markers as being claimed and it would be inherent to the extract itself especially if there was nothing done to optimize those said components. It would be expected that the same fat extract would have the same biomarkers present and within similar amounts as this appears to be inherent to the fat extract itself.
It would have been obvious to persons having ordinary skill in the art to adopt Yungfei’s or Yu’s methods in mechanically separating adipose tissue by first providing fat tissue and crushing the tissue as opposed to using blunt force as this is considered gentler to the cells. Centrifuging and rinsing the cut tissues would assist in eliminating any source in contamination. One can look to Yunfei or Yu to appreciate the order of operations and to see which layers need to be held and discarded (top and bottom layers). Yunfei and Yu both also teach to emulsify and centrifuging after separation, and it would have been obvious to persons skilled in the art to filter and de-bacterizing the fat extract in order to not administer a sample containing bacteria. Also Yu teaches sterilizing which would be the same as de-bacterizing.
Persons having skill in the art would look to Yu or Yunfei for an improved method of obtaining a cell-free fat extract for the composition taught by Vesy, because as Yunfei teaches it can recycle high speed centrifugation to remove the cell component and cell factor loss is low.
The method for obtaining the cell-free fat extract is known in the art and the use of the cell-free fat extract for treating osteoporosis has also been taught, thus using this extract for disuse osteoporosis or for a bone which is selected from the list of bones in instant claim 4, would have been prima facie obvious given the prior art.
There would have been a reasonable expectation of success in arriving at the instant invention given that the prior art already teaches and makes obvious each element of the invention.
Response to Arguments
Applicant's arguments filed 12/05/2025 have been fully considered but they are not persuasive. The applicant argues that the prior art does not disclose every limitation because the prior art is directed to osteoporosis which stems particularly from inflammation. The prior art makes obvious and teaches each component of the invention, that is the same patient population being administered the same effective amount of a cell-free adipose extract. The prior art also teaches the same fat extraction process. The only thing the prior art is silent on is wherein the method would necessarily increase bone volume fraction, increase trabecular bone number or junction density, increase mineral density, increases trabecular thickness; and/or decreasing trabecular separation. These effects would have been inherent to the administration of the cell-free fat extract as described in the art because they are the same extracts administered to the same patient population.
As discussed in the MPEP “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003) (rejecting the contention that inherent anticipation requires recognition by a person of ordinary skill in the art before the critical date and allowing expert testimony with respect to post-critical date clinical trials to show inherency); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) ("[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention."); Abbott Labs v. Geneva Pharms., Inc., 182 F.3d 1315, 1319, 51 USPQ2d 1307, 1310 (Fed.Cir.1999) ("If a product that is offered for sale inherently possesses each of the limitations of the claims, then the invention is on sale, whether or not the parties to the transaction recognize that the product possesses the claimed characteristics.")”. See also MPEP 2112.02 (at Ex Parte Novitski, and Dart cited therein) which establishes in a method of treating with a biological material that the properties need not be expressly taught in the prior art such that even reference-silent properties are inherently present, including those properties appreciated and evidenced as present only by Applicant’s own disclosure.
Furthermore, It is well established that “[m]ere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention.” In re Baxter Travenol Labs, 21 USPQ2d 1281, 1285 (Fed. Cir. 1991). In Baxter, the court held that even when the prior art did not expressly disclose hemolysis-suppression feature or property of a blood bag plasticizer, such unrecognized feature or property is insufficient for rebutting a prima facie case of obviousness over a prior art blood bag that utilized the same plasticizer. Id. See also Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Int. 1985) (“The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious’).
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). In this case the composition is the cell-free fat extract obtainable by known methods which has already been taught to be able to treat osteoporosis. The applicant may have discovered mechanisms in which that method would treat the disease however that does not make it patentably distinct from the prior art, because the art already teaches that it indeed is useful in treating the same disease.
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 1-8 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8, 11-16 of copending Application No. 18/295,945 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the both sets of claims are drawn to method of using a cell-free extract for treatment of osteoporosis comprising of the same fat extract which also comprises of the same cellular components. The method of obtaining the extract is the same and thus it appears that both inventions are substantially the same.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Currently no claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655