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 .
Claims 1-7,10,12-23 are under examination.
Claim Objections
Claim 23 is objected to because of the following informalities: Claim 23 recites “HLA-A,B,C+” which should instead be –HLA-A, HLA-B, HLA-C+--. Claim 23 recites “HLA-DP, DQ,DR-“ which should instead be –HLA-DP, HLA-DQ, HLA-DR- --. Appropriate correction is required.
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 1-4,6-7,10,12-23 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 a method for treating a subject having SARS-CoV-2 related acute respiratory failure (COVID-19) comprising intravenously administering to the subject a composition comprising CD10+, CD34-, CD105+, CD200+ placental stem cells, does not reasonably provide enablement for a method of treating a subject having SARS-CoV-2 related acute respiratory failure (COVID-19), comprising administering to the subject a composition comprising CD10+, CD34-, CD105+, CD200+ placental stem cells. 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 test of enablement is whether one skilled in the art could make and use the claimed invention from the disclosures in the application coupled with information known in the art without undue experimentation (United States v. Telectronics, Inc. 8 USPQD2d 1217 (Fed. Cir. 1988). Whether undue experimentation is required is a conclusion reached by weighing several factors. These factors were outlined in Ex parte Forman, 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and again in In re Wands, 8 USPQQ2d 1400 (Fed. Cir. 1988).
While determining whether a specification is enabling, one considers whether the claimed invention provides sufficient guidance to make and use the claimed invention, if not, whether an artisan would require undue experimentation to make and use the claimed invention and whether working examples have been provided. When determining whether a specification meets the enablement requirements, some of the factors that need to be analyzed are: the breadth of the claims, the nature of the invention, the state of the prior art, the level of one of ordinary skill, the level of predictability in the art, the amount of direction provided by the inventor, the existence of working examples, and whether the quantity of any necessary experiment to make and use the invention based on the content of the disclosure is undue.
Nature of the Invention:
The invention encompasses treating SARS-CoV-2 acute respiratory failure by administering to a subject adherent placental stem cells that are positive for (CD10+, CD34-, CD105+, CD200+).
Breadth of the Claims:
The claims, with the exception of claim 5, are so broad that they encompass any method of administration.
Teachings from the Prior Art:
Yanay (US 20210283189) discloses that placental adherent cells (CD10+, CD34-, CD105+, CD200+) can be administered intravenously, subcutaneously, intraperitoneally, intramuscularly, intratracheally, by inhalation, or intranasally. Oral and topical methods of administration are not disclosed.
Applicants Specification/Guidance/Working Examples:
Applicants’ specification and claims recite intravenous administration.
Conclusion
Applicants specification discloses intravenous administration. Yanay (a prior art reference) discloses only a few methods of administration. Applicant is not disclosing other methods of administration such as topically applying the cells to feet or oral administration. There is no prior art available that teaches that topical or oral administration of placental stem cells to treat COVID-19 ARD would be successfully. Thus, not all methods of administration are enabled. Because there is no support for all methods of administering placental stem cells, applicants are limited to the intravenous administration method taught in applicants’ specification.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7,10,12-23 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Yanay (US 20210283189)
Yanay (US 20210283189) discloses a method of treating a subject having SARS-CoV-2 related acute respiratory failure (COVID-19) (Paragraphs 257 and 242), comprising administering to the subject a composition comprising CD10+, CD34-, CD105+, CD200+ placental adherent stem cells (Paragraph 114, 120,123,132-133, 242, and 257) as in instant Claim 1. Yanay discloses wherein the subject has Acute Respiratory Disease Syndrome (ARDS) (Paragraph 242) as in instant Claim 2. Yanay discloses treating moderate ARD symptoms (Paragraph 39-43,46---many of these symptoms/characteristics listed would be considered a more moderate version of ARDS) as in instant Claim 3. Yanay discloses wherein the subject has severe ARDS (Paragraph 242) as in instant Claim 4. Yanay discloses wherein the composition comprising placental stem cells is administered intravenously (Paragraph 171) as in instant Claim 5. Yanay discloses that the treatment composition contains between 100 to 600 million cells (Paragraph 181) as in instant Claim 6-7,10. Yanay discloses the same method of administering the same cell types as taught by applicant (Paragraph 114, 120,123,132-133, 242, and 257). Therefore, it would be expected that administering those placental stem cells would result in the following: an increase in oxygenation, stable oxygenation with a decrease in oxygen utilization, improvement in the need for oxygen supplementation, a decrease in progression to mechanical ventilation or extracorporeal membrane oxygenation (ECMO), decrease in duration of mechanical ventilation or extracorporeal membrane oxygenation (ECMO), decrease in duration of stay in the intensive care unit, decrease in duration of hospital stay, or decrease in mortality as in instant claims 12-19. Yanay teaches wherein the placental stem cells are CD45- and CD90+ (Paragraph 122 of Yanay) as in instant Claims 20-22. Yanay teaches that the placental stem cells are HLA-DR- (Paragraph 120 of Yanay) as in instant Claim 23.
Conclusion
All claims stand rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN K VAN BUREN whose telephone number is (571)270-1025. The examiner can normally be reached M-F:9:30am-5:40pm; 9:00-10:00pm.
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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638