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 .
Priority
Applicant’s claim for the benefit of a prior-filed application provisional application 63014499 ,filed on 04/23/2020 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/02/2024 was filed before the
mailing date of the non-final first action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. Page 1 of the specification contains hyperlink. Appropriate correction is required.
The use of the term “MultiStem”, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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.
Claim 12 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.
Regarding claim 12, the phrase "Including" renders the claim indefinite because it is unclear from the claim wording if the treatment of ARDS caused by coronavirus infection would encompass all coronavirus stains or only the three strains recited in line 2 (i.e. SARS-CoV, MERS-CoV, SARS-CoV2). As a result, the metes and bounds of the claim are indefinite.
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.
(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 1-14 are rejected under 35 U.S.C. 102 (a)(1)as being anticipated by Healios K.K. clinical trial with a government ID# NCT03807804 ( a public disclosure of 01/17/2019).
It should be noted that the disclosure by Healios K.K. ( Applicant) is prior to the effective filing date and is considered relevant prior art for having taught the applicability of using MultiStem to treat patients with COVID-19 (i.e. SARS-CoV-2).
Regarding claims 1-5, 7-8, 10-12, and 13, It is noted that in page 3 ( 1st paragraph of “Detailed description”) of instant specification that the administered Cells (I) are presumed to be Multipotent Adult progenitor cells (MAPC). Instant specification also refer to this MAPC as MultiStem (See page 15- 3rd paragraph of instant specification). The clinical trial sponsored by Healios K.K. discloses a multicenter phase 2 study to evaluate the efficacy and safety of administering HLCM051(MultiStem) in patients with ARDS caused by pneumonitis/COVID19 (i.e. SARS-CoV-2 infection). (See page 6-7).It is noted that Healios K.K. teach administering MultiStem, which are presumed to be the same cells as in the instant application. Thus, the properties of the claimed cells are considered to be inherently present in the cells taught by Healios K.K. Furthermore, the disclosure by Healios K.K.is a phase 2 clinical trial. It is well known in the art that phase 2 studies are specifically designed to evaluate safety, efficacy, and appropriate dosage of the administered martials. Therefore, the claimed teachings of administering the cells in amounts sufficient for a time sufficient, and by a route effective to treat ARDS are also presumed to be inherent in the teachings of Healios K.K., absent evidence to the contrary.
Regarding claim 6 and 9, Healios K.K teaches that the MultiStem are derived from adult adhesive stem cells that are isolated from bone marrow of healthy unrelated donors (i.e. allogenic).(See page 7).
Regarding claim 14, Healios K.K also teaches that the MultiStem are administered intravenously. (See “Study arms” in page 7).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Anthony et al (US 2011/0305638 A1) in view of Healios K.K. clinical trial with a government ID# NCT03807804 ( with a public disclosure of 01/17/2019).
Regarding claims 1-4, and 10-12, Anthony et al teach cell-based therapy to treat any disease involving inflammation, such as ARDS. (See [0052]. Anthony’s method involves administering Multipotent adult stem cells (MAPC) (trade marketed as MultiStem) to a subject in need of therapy. Anthony et al suggest that the cells to be administered in a therapeutically effective amount and for a sufficient time to treat inflammation. Anthony et al disclose that the cells of the invention (i.e. MultiStem) are non-embryonic stem, non-germ cells that have undergone at least 10-40 cell doublings in culture, and wherein the cell further express telomerase and/or oct4,not transformed, not tumorigenic, and have a normal karyotype. ( See claim 15, and paragraphs [0015]-[0019], and [0025]). Anthony et al also disclose that the cells can differentiate into at least one cell type of at least two of the endodermal, ectodermal, and mesodermal embryonic lineages.(See paragraph [0020]).
Anthony et al do not teach administering MultiStem cells to treat ARDS caused by viral infection.
The teachings of Healios K.K. are set forth above.
Healios K.K. discloses the applicability of using MultiStem cells to treat ARDS caused by viral infection, such as SARS-Cov-2. Therefore, it would have been prima facie obvious for one with ordinary skill in the art at the time the invention was filed to combine the teachings of Anthony and Healios K.K to use cell-based therapy to treat ARDS caused by viral infection. Anthony et al teach cell-based therapy to treat any disease involving inflammation, such as ARDS. Healios K.K. discloses a clinical trial to evaluate the efficacy and safety of administering MultiStem to patients suffering from ARDS caused by viral infections. Thus, one would have been motivated to use cell-based therapy, as disclosed by Anthony, for the treatment of ARDS caused by viral infection, as taught by Healios K.K. because there would be a reasonable expectation of success, as prior art suggested the applicability of administering cell-based therapy to treat ARDS caused by different factors, including viral infection. Some Teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. See MPEP 2143 (I)(G).
Regarding to claims 5-6, Anthony et al also disclose that the cells of the invention are human and can be derived from bone marrow. (See paragraph [0129] and [0083]).
Regarding to claims 7-9, Anthony et al teach administering cells that have undergone for example, 10-20, 20-30, 30-40, 40-50 or more cell doublings. (See paragraph [0148]).
Regarding to claims 13-14, Anthony et al disclose that the cells of the invention can be used to treat humans, and the route of administration may include intravenous-administration. (See claim 24, and paragraph [0156]).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FATIMAH KHALAF MATALKAH whose telephone number is (703)756-5652. The examiner can normally be reached Monday-Friday,7:30 am-4:30 pm EST.
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/FATIMAH KHALAF MATALKAH/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638