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 2/09/26. Claims 1-12 and 14-19 are pending. Claims 14 is withdrawn. Claims 1-12 and 15-19 are considered on the merits.
Response to Restriction
Applicant's response, with traverse, to the Restriction/Election requirement filed on 2/9/26 is acknowledged. The applicant elected Group I which includes claims 1-12 and 16-17 as well as new claims 18 and 19. Amended claim 15 is included since it is more appropriate in Group I than former Group II.
The Applicant Yu et al. teach using a cell-free fat extract to promote angiogenesis which differs than the method of claim 1. However the composition made in claim 13 is completely disclosed by Yu et al. (See Fig 1). This composition is the special technical feature that unites these groups. Since the technical features is taught by Yu et al, then unity is broken.
Therefore, the Restriction/Election requirement is therefore made FINAL and the elected species and the claims they include will now be examined on the merits.
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 1-12 and 15-19 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 has three issues that make the claim confusing:
Issue #1: the parenthetical phrase “(e.g., with physiological saline)” appears to be an optional limitation and it is unclear how it limits step 1. Specifically it is unclear if physiological saline is required for this step.
Issue #2: the parenthetical phrase “(that is, the fat layer containing cells)” appears to be an optional limitation and it is unclear how it limits step 3. Specifically it is unclear if this phrase is further describing the intermediate layer, or a different layer.
Issue #3: : the parenthetical phrase “(also called nano-fat)” appears to be a synonym for “emulsified fat mixture”. However it is unclear if the term adds additional limitations to this fat mixture or if it is an optional limitation.
Claim 15 is simply confusing. In its clean form it reads:
The method according to claim 1, wherein the composition or preparation comprising (a) the cell-free fat extract and (b) pharmaceutically, food, nutraceutical, or dietary acceptable carriers or excipients.
This claim does not add an additional step to the method and it is unclear where it is integrated into the method since part (b) is absent in claim 1. It is unclear which of the steps in claim 1 is further limited by this claim or if this claim is an additional step.
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 1-12 and 15-19 are 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 factors to be considered in determining whether undue experimentation is required are summarized in In re Wands, 858 F.2d 731, 737, 8 USPQd 1400, 1404 (Fed. Cir. 1988). These factors include, but are not limited to:
The breadth of the claims; (B) The nature of the invention;
The claims are drawn to preventing arthritis and/or pain with a cell-free fat extract prepared according to steps in the method.
(C) The state of the prior art; (D) The level of one of ordinary skill;
(E) The level of predictability in the art;
The prior art does not teach preventing arthritis or pain with the claimed cell-free fat extract. However one of ordinary skill understands that to prevent a disease, the subject must have some means to predict the risk of getting this disease before acting to prevent it. Also, the disease must have a mechanism that the fat extract can interrupt to accomplish prevention. Neither of these are disclosed in the prior art or in the Specification.
(F) The amount of direction provided by the inventor;
The Specification defines prevent as “a method of preventing the onset of a
disease and/or its accompanying symptoms or protecting a subject from developing a disease…also includes delaying the onset of a disease and/or its accompanying symptoms and reducing the risk of illness in a subject” (Specification, pg. 10, lines 1-10). The Specification does not provide any guidance what identifies a subject as likely to have pain or arthritis so that it can be prevented. Nor does it provide a mechanism that the fat extract is shown to inhibit or eliminate that will prevent pain/arthritis.
(G) The existence of working examples; and
No working examples are provided that show the prevention of arthritis and pain in an individual.
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
One of ordinary skill would have to determine their own guidance on how to predict the subject will have pain/arthritis and when to apply the cell-free fat extract to prevent these conditions.
In the instant case several of these factors are missing and do not provide assurance that the disclosure is enable and that undue experimentation would be needed to make and use this invention.
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) 1-12 and 15-19 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).
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) that cause a movement disorder due to the hindlimb impairment. 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 later 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 primary fat extract is 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).
The only active treatment step for all the conditions listed in the claims is administering the FE. Since this is accomplished when treating a subject with hindlimb ischemia, then they also inherently prevent arthritis and pain in that subject since the same active step appears to treat those issues without any additional modification to the method. This also includes preventing osteoarthritis and preventing conditions listed in claims 3-5 and 16 since they are prevented as the result of the steps taking in claim 1. Also claims 11 and 17 appears 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.
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