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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 24 January 2026 has been entered.
DETAILED OFFICE ACTION
This Office Action is in response to the papers filed on 24 January 2026.
PRIORITY
The Applicant claims priority to CN201810911038.2 filed on 10 August 2018.
CLAIMS UNDER EXAMINATION
Claims 14-17, 21 and 23-35 have been examined on their merits.
WITHDRAWN REJECTION
The previous rejections have been withdrawn.
NEW REJECTIONS
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.
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.
Claims 14-15, 21, 23-24, 27-29 and 32-35 and 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 amniotic fluid obtained from embryos of rodents. As evidenced by Brittanica, rodents are any mammal characterized by upper and lower pairs of ever-growing rootless incisor teeth. Therefore the claim encompasses amniotic fluid from any mammal with these characteristics. As evidenced by Brittanica,
rodents constitute half of the 4,660 known mammalian species. Rodents include, but are not limited to, beavers, agouti, chinchilla, capybara, guinea pigs, porcupines, squirrels, ground hogs, and prairie dogs. While the claims encompass all rodents, the specification only demonstrates amniotic fluid from mice ([0065]).
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 methods. All dependent claims are included in this rejection.
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, 21 and 23-35 are rejected under 35 U.S.C. 103 as being unpatentable over Werber et al. (Method of treatment utilizing an acellular amnion derived therapeutic composition. US20160199417) in view of Bertin et al. (First steps to define murine amniotic fluid stem cell microenvironment. Sci Rep. 2016 Nov 15;6:37080) and Reboucas et al. (Cardiac Regeneration using Growth Factors: Advances and Challenges. Arq Bras Cardiol. 2016 Sep;107(3):271–275) as evidenced by Jeltsch et al. (previously cited; Michael’s Domain, Development-Carnegie Stage Comparison. 2006 pages 1-2).
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]). The therapeutic composition can be administered “to treat heart disease or disorders including, but not limited to, coronary artery disease, abnormal heart rhythms, congenital heart disease, cardiomyopathies, pericarditis and arterial fibrillation” ([0055]). A patient with these conditions is interpreted to be in need of cardiac function improvement.
The composition can be administered intravenously, including a patent’s cardiac system ([0050]). Werber teaches areas for injection associated with the circulatory system include, but are not limited to, heart or any portion thereof, arteries, veins, capillaries ([0048]).
The composition comprises growth factors and/or cytokines ([0007]). Werber teaches amniotic fluid contains proteins including basic fibroblast growth factors (bFGF), bone morphogenetic protein 2 (bmp-2), bone morphogenic protein 4 (bmp4), bone morphogenetic protein 7 (bmp-7), bone morphogenic protein 9 (bmp-9), epidermal growth factor (EGF), insulin-like growth factor 1 (IGF-1), platelet-derived growth factor AA (PDGF-AA), platelet growth factor BB (PDGF-BB), platelet growth factor AB (PDG AB), transforming growth factor beta one (TGF-b1), and vascular endothelial growth factor (VEGF) ([0026]).
The amniotic fluid can be obtained from any mammal ([0041]).
Werber does not teach amniotic fluid derived from a rodent at a gestational age of 8-20 days.
Bertin et al. disclose murine (rodent) amniotic fluid from E11.5 to E17.5 (page 2, fourth and fifth paragraphs). Bertin analyzes the cytokines present during the course of gestation between E11.5 to E17.5. Bertin detects cytokines including HGF, IGF and VEGF (Fig. 2E).
Reboucas teaches novel strategies targeting at regenerating the injured myocardium have been investigated, including the use of growth factors. Growth factors induce myocardial repair and regeneration. See Abstract. Table 1 discloses the mechanism for growth factor regeneration. Reboucas teaches VEGF induces cardiac regeneration by promoting angiogenesis (Table 1). HGF induces cardiac regeneration through antiapoptosis. IGF-1 promotes angiogenesis through stem cell and progenitor cell viability and differentiation (Table 1). Reboucas teaches mechanisms promote myocardial repair and improvement of the cardiac function (Abstract).
It would have been obvious to try using E11.5 to E17.5 rodent amniotic fluid
in the method taught by Werber. Werber teaches a mammalian amniotic fluid containing cytokines and growth factors and Bertin teaches E11.5 to E17.5 rodent amniotic fluid comprises growth factors. One would have been motivated to use amniotic fluid from E11.5 to E17.5 since Bertin teaches the fluid contains VEGF, HGF and IGF and Reboucas teaches these growth factors can regenerate cardiac tissue. One would have had a reasonable expectation of success since Werber teaches any mammalian amniotic fluid can be used. One would have expected similar results since the cited references are directed to components of amniotic fluid. Therefore claim 14 is rendered obvious.
Bertin teaches rodent E11.5, E12.5 and E13.5 rodent amniotic fluid (see Figure 2E). Therefore claims 15 and 21 are included in this rejection.
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 teach amniotic fluid derived from a rodent at a gestational age of 8-20 days.
The teachings of Bertin and Reboucas are reiterated.
It would have been obvious to try using E11.5 to E17.5 rodent amniotic fluid
in the method taught by Werber. Werber teaches a mammalian amniotic fluid containing cytokines and growth factors and Bertin teaches E11.5 to E17.5 rodent amniotic fluid comprises growth factors. One would have been motivated to use amniotic fluid from E11.5 to E17.5 since Bertin teaches the fluid contains VEGF, HGF and IGF and Reboucas teaches these growth factors can regenerate cardiac tissue. One would have had a reasonable expectation of success since Werber teaches any mammalian amniotic fluid can be used. One would have expected similar results since the cited references are directed to components of amniotic fluid. Therefore claim 23 is rendered obvious.
Bertin teaches rodent E11.5, E12.5 and E13.5 rodent amniotic fluid (see Figure 2E). Therefore claim 24 and 27 are included in this rejection.
Regarding independent claim 28: The preamble recites treating heart failure.
The teachings of Werber are reiterated. Werber teaches treating myocardial infarction (supra). Werber does not teach amniotic fluid derived from a rodent at a gestational age of 8-20 days.
The teachings of Bertin and Reboucas are reiterated.
It would have been obvious to try using E11.5 to E17.5 rodent amniotic fluid
in the method taught by Werber. Werber teaches a mammalian amniotic fluid containing cytokines and growth factors and Bertin teaches E11.5 to E17.5 rodent amniotic fluid comprises growth factors. One would have been motivated to use amniotic fluid from E11.5 to E17.5 since Bertin teaches the fluid contains VEGF, HGF and IGF and Reboucas teaches these growth factors can regenerate cardiac tissue. One would have had a reasonable expectation of success since Werber teaches any mammalian amniotic fluid can be used. One would have expected similar results since the cited references are directed to components of amniotic fluid. Therefore claim 28 is rendered obvious.
Bertin teaches rodent E11.5, E12.5 and E13.5 rodent amniotic fluid (see Figure 2E). Therefore claim 29 and 32 are included in this rejection
Bertin teaches intravenous and heart injection (supra). Therefore claims 33-35 are included in this rejection.
Regarding dependent claims 16-17, 25-26 and 30-31: The claims recite an amniotic fluid “derived from” a chicken egg embryo age 7-9 days, or 7-8 days. This is a product by process limitation that does not distinguish the claimed amniotic fluid from that taught by Bertin. MPEP 2113 indicates that “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. Bertin teaches amniotic fluid from an E14.5 rodent. As evidenced by Jeltsch et al., a E14.5 mouse (rodent) embryo corresponds to a day 7.25 day chick embryo (see “Data For Carnegie Stages Comparison Graph on page 1”). Therefore they are functional equivalents. Even arguendo Jeltsch did not, as evidenced by the specification, a day 7-8 chicken embryo corresponds to a 8-20 day rodent embryo. The amniotic fluid taught by Bertin contains growth factors (supra). The specification discloses amniotic fluid from a day 7 chick embryo contains biologically active growth factors (see Example 7). Therefore the amniotic fluids appear to be the same. Any slight variation rendered by the process is considered obvious evidence to the contrary. The examiner concludes the burden has been shifted to the applicant to show an unobvious difference between the claimed product and the prior art product.Therefore claims 16-17, 25-26 and 30-31 are included in this rejection.
Therefore Applicant’s Invention is rendered obvious as claimed.
APPLICANT’S ARGUMENTS
The arguments made in the response filed on 24 February 2026 are acknowledged. New grounds of rejection have been set forth above to address the amended claims.
Conclusion
No claims are allowed.
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) 270-8439.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NATALIE M MOSS/ Examiner, Art Unit 1653