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 OFFICE ACTION
This Office Action is in response to the papers filed on 08 June 2026.
PRIORITY
The Applicant claims priority to CN201810911038.2 filed on 10 August 2018.
CLAIMS UNDER EXAMINATION
Claims 14-17, 23-26, 28-31 and 33-35 have been examined on their merits.
WITHDRAWN REJECTION
The rejection of claims 14-15, 21, 23-24, 27-29 and 32-35 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, has been withdrawn due to claim amendment.
The rejections made under 35 U.S.C. 103 have been withdrawn due to claim amendment.
NEW REJECTIONS
New grounds of rejection have been necessitated by claim amendment.
Claim Rejections - 35 USC § 112
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.
Claims 14-17, 23-26, 28-31 and 33-35 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 14, 23 and 28 recite an extract of an amniotic fluid. As evidenced by Silva et al. (submitted in IDS; The Unique Features of Proteins Depicting the Chicken Amniotic Fluid. Poultry Science. Volume 96, Issue 8. 2017 2931-2941) at least 91 nonredundant proteins are present in chicken amniotic fluid (see Abstract). As evidenced by Silva, chicken amniotic fluid also contains water and mineral elements such as chloride, sodium, potassium, phosphorus, magnesium calcium, iron and sulfur (page S175 right column). The instant specification does not provide an explicit definition for “extract”. An extract is defined as “a substance removed from another substance to” (Cambridge Dictionary). A single component (e.g., a protein) removed from amniotic fluid would read on an extract. The claims encompass any known or unknown component (growth factors, hormones, amino acids, enzymes, proteins, etc.) present in any chicken, duck or goose amniotic fluid.
The specification discloses fractionation of amniotic fluid to obtain “active ingredients” with a molecular weight of 500-1200 Daltons (page 10, lines 22-23). The effect of fractions 3-1 to 3-6 (eluted fractions 1-6) on AC16 (cardiomyocyte) cell proliferation is analyzed (Figure 15; see page 6, lines 22-21). Figure 15 demonstrates different eluted/unbound fractions with the claimed molecular weight have different effects on viability. For example: fraction 3-2 has an OD value of about 0.15, while fraction 3-3 has an OD value of about 1.0.
Claim 14 encompasses any unbound 500-1200 dalton component, but the specification demonstrates different extracts have different effects. While the specification discloses “biologically active growth factor groups” (page 26, lines 19-20), they are not identified. The specification lacks written description because it does not disclose what extract specifically from amniotic fluid has the claimed effect of treating myocardial ischemia necrosis or improving cardiac function..
A consideration of the four corners of the specification does not reflect that applicants have actually invented the claimed invention, since the specification does not permit the skilled artisan to visualize or recognize all of the members of the genus being utilized in the claimed method.
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 14-17, 23-26, 28-31 and 33-35 are rejected under 35 U.S.C. 103 as being unpatentable over Werber et al. (previously cited; Method of treatment utilizing an acellular amnion derived therapeutic composition. US20160199417) in view of Hertzog et al. (Laminine YTE: The Ultimate Gift To Health. 2016 pages 1-37) as evidenced by Da Silva et al. (cited in IDS, The Unique Features of Proteins Depicting the Chicken Amniotic Fluid. Poultry Science. Volume 96, Issue 8. 2017 2931-2941).
Werber teaches a therapeutic composition comprising amniotic fluid (Abstract; [0007], claim 1). The composition can treat cardiac related conditions including, myocardial infarction, atrial fibrillation, congestive heart failure, endocarditis and cardiomyopathy ([0050]). A patient with these conditions is interpreted to be in need of cardiac function improvement. The composition can be administered intravenously ([0050]). The amniotic fluid can be obtained from any mammal ([0041]). The composition can include proteins derived from amniotic fluid (hence, an extract of amniotic fluid; [0007]).
Werber does not teach amniotic fluid derived from chicken, duck or goose eggs at the claimed gestational stage.
Hertzog teaches Laminine Young Tissue Extract (YTE) is produced by taking an incubated fertilized avian egg at the critical day 9 stage or up to day 11, and freeze drying the protein extract at its peak level of potency (see page 7, first paragraph). The composition also helps to alleviate heart disease (page 7, last paragraph). Hertzog teaches the fertilized egg extract can be converted into an injectable form (page 19, section below diagram).
Claim 14 recites the amniotic fluid or extract thereof is from chicken eggs at an embryo stage of 5-12 days. The claimed extract is undefined. Although Werber teaches an amniotic fluid extract, the reference does not teach the day it was extracted. It is unclear if the day the fluid/extract is obtained makes a structurally different product and this limitation appears to be a product by process. Absent evidence that the day obtaining the extract provides a structurally different product, Werber renders it obvious. However, for compact prosecution, Hertzog teaches the chick amniotic fluid extract contains glycoproteins which enhance health in the human body (same cited section). As evidenced by Da Silva, chick amniotic fluid contains mucins (glycoproteins; page S187, right column, first paragraph).
It would have been obvious to combine the teachings of Werber and Hertzog and administer the day 9 chicken egg extract taught by Hertzog in a method of improving cardiac function. Werber teaches administering an amniotic extract to treat the heart and Hertzog teaches a chicken egg extract can be used to alleviate heart disease. One would have been motivated to use a day 9 extract since Hertzog teaches this stage contains glycopeptides that enhance health. One would have had a reasonable expectation of success since Hertzog teaches the extract can be administered to treat the heart and can be formulated for injection. One would have expected similar results since both references are directed to method of using embryonic fluids. Therefore claim 14 is rendered obvious.
Regarding independent claim 23: The preamble recites treating heart failure.
The teachings of Werber are reiterated. Werber teaches treating congestive heart failure (supra). Werber does not each an extract of day 9-11 chicken egg embryo.
The teachings of Hertzog are reiterated.
It would have been obvious to combine the teachings of Werber and Hertzog and administer the day 9 chicken egg extract taught by Hertzog in a method of treating heart failure. Weber teaches administering an amniotic extract to treat heart failure and Hertzog teaches a chicken egg extract can be used to a heart condition. One would have been motivated to use an extract from day 9 since Hertzog teaches this stage contains glycopeptides that enhance health. One would have had a reasonable expectation of success since Hertzog teaches the extract can be administered to treat the heart and can be formulated for injection. One would have expected similar results since both references are directed to method of using embryonic fluids. Therefore claim 23 is rendered obvious.
Regarding independent claim 28: The preamble recites treating cardiac insufficiency (heart failure). Claim 28 is rejected on the same grounds as claim 23.
The day 9 extract taught by Hertzog reads on claims 15-16, 24-25 and 29-30.
Regarding claims 17, 26 and 31: The claims recite the amniotic fluid or extract thereof is of chicken eggs at an embryo age of 7-8 days. The claimed extract is undefined. Although Werber teaches an amniotic fluid extract, the reference does not teach the day it was extracted. It is unclear if the day the fluid/extract is obtained makes a structurally different product and this limitation appears to be a product by process. Absent evidence that the day obtaining the extract provides a structurally different product, Werber renders it obvious. However, for compact prosecution, Hertzog teaches the chick extract contains glycoproteins which enhance health in the human body (same cited section). As evidenced by Da Silva, ED8 (day 8) chick amniotic fluid contains mucins (glycoproteins; page S187, right column, first paragraph).
It would have been obvious to combine the teachings of the prior art and administer the extract taught by Hertzog in a method of improving cardiac function. Werber teaches administering an amniotic extract to treat the heart and Hertzog teaches a chicken egg extract can be used to alleviate heart disease. One would have been motivated to use the extract since Hertzog teaches this stage contains glycopeptides that enhance health. One would have had a reasonable expectation of success since Hertzog teaches the extract can be administered to treat the heart and can be formulated for injection. One would have expected similar results since both references are directed to method of using embryonic fluids Claims 17, 26 and 31 are included in this rejection.
Werber teaches the composition can be administered intravenously ([0050]). Claims 33-35 are rejected.
Therefore Applicant’s Invention is rendered obvious as claimed.
APPLICANT’S ARGUMENTS
The arguments made in the response filed on 08 June 2026 are acknowledged. The claims have been amended to exclude an amniotic fluid from mice.
Argument 1: The Applicant argues Weber does not teach obtaining amniotic fluid of an extract of chicken, duck or goose eggs.
Response: New ground of rejection have been necessitated by claim amendment. The claims are directed to an undefined product. Absent evidence to the contrary, the day 9 extract taught by Hertzog is interpreted to be the same as the claimed product.
Argument 2: The Applicant argues Weber teaches the composition comprises particles of amniotic membrane at [0096] and may comprise membrane or collagen ([0010]). The Applicant argues the claims require amniotic fluid as the sole active ingredient.
Response: Werber teaches an “acellular” “amniotic fluid” can be used (Abstract; [0007]). The art teaches the composition can include components derived from the amniotic fluid, including growth factors and cytokines ([0007]). While Weber teaches the amniotic fluid may be combined with other therapies (e.g., platelet rich plasma [0014]) and may comprise micronized particles, these embodiments are not required thus reading on the consisting language since other additives are taught in separate embodiment.
The instant claims have been amended to include an extract from amniotic fluid. The extract is undefined. As set forth above, it is unclear if the day the fluid/extract is obtained makes a structurally different product and this limitation appears to be a product by process. Absent evidence that the day obtaining the extract provides a structurally different product, Werber renders it obvious. However, for compact prosecution, Hertzog teaches the chick extract contains amino acids, oligopeptides and glycoproteins which enhance health in the human body (same cited section). As evidenced by Da Silva, ED8 (day 8) chick amniotic fluid contains mucins (glycoproteins; supra).
It would have been obvious to combine the teachings of Werber and Hertzog and administer the extract taught by Hertzog to treat cardiac dysfunction. One would have been motivated to use the extract since Hertzog teaches this stage contains glycopeptides that enhance health. One would have had a reasonable expectation of success since Hertzog teaches the extract can be administered to treat the heart and can be formulated for injection.
CONCLUSION
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE MOSS whose telephone number is (571) 270-7439. The examiner can normally be reached on Monday-Friday, 8am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached on (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/NATALIE M MOSS/ Examiner, Art Unit 1653
/SHARMILA G LANDAU/ Supervisory Patent Examiner, Art Unit 1653
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