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 .
Claim status
Claims 1-10 are pending
Claims 1-10 are under examination
Claim objection
Claim 4 recites the term “of” twice, please correct.
Claim Rejections - 35 USC § 112(b)
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 2, 4 and 6-10 are 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. Claims 7-10 are included in the rejection, because they are dependent on the indefinite claim 6 which renders the
Regarding claim 2, claim recites that the composition of claim 1 is treated at a stage of otic placode formation. The claim is drawn to a composition and not a method claim. However the claim recites steps in a method form. Thus, the meaning of the claim cannot be discerned. Therefore, the claim is indefinite.
Regarding claim 4, claim recites that the composition of claim 1 is treated on day 12 to 18 from a start date of cell differentiation. The claim is drawn to a composition and not a method claim. However the claim recites steps in a method form. Thus, the meaning of the claim cannot be discerned. Therefore, the claim is indefinite.
Regarding claim 6, “true endoderm” is not defined in the specification. It is not clear how the “true” endoderm is different from the endoderm in general. There for the claim is indefinite for failing to distinctly point out the subject matter.
Regarding claim 10, the term “large amount” in claim 10 is a relative term which renders the claim indefinite. The term “large amount of hair cells” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the claim is indefinite.
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Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-5 and 9- 10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to product of nature without significantly more..
According to the 2019 Revised Patent Subject Matter Eligibility Guidelines (2019PEG), the claim is first analyzed to determine if it is directed to one of the acceptable statutory categories (i.e. process, machine, manufacture, or composition of matter). Claims 1-5 are drawn to a composition of matter comprising ‘retinoic acid’. Claims 9 and 10 are drawn to an “inner ear organoid”. Therefore, claims 1-5 and 9-10 recite composition of matter. Thus, claims 1-5 and 9- 10 meet the requirements for step 1 of the analysis.
Second, the claims are assessed to determine if they are directed to a judicial exception under step 2A. Under 2019PEG, “directed to” is determined via a two-prong inquiry: (1) Does the claim recite a law of nature, a product of nature, a natural phenomenon, or an abstract idea; and (2) Does the claim recite additional element(s) that integrate the judicial exception into a practical application. The phrase, “integration of a practical application”, requires the presence of an additional claim element(s) or a combination thereof to apply, rely on or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception, such that the claim does not monopolize the judicial exception. (See MPEP § 2106.05 for examples of integration of practical application).
Regarding the first prong (1), claims 1-5 recite the composition “retinoic acid “ which is a molecule found in in vivo. Therefore, claims 1-5 recite a judicial exception, a product of nature.
Claims 9-10 recite “inner ear organoid”. Given the definition of organoid, “is also called a pseudo-organ, and cells separated from stem cells or organs are re-aggregated/recombined through three-dimensional culture to achieve tissue formation similar to actual organs and reproduction of the functions of living organs such that it may be used as a model for various studies such as development and diseases”, disclosed in the specification (specification page 4, paragraph 20) inner ear organoids have the same composition of a sample of structure from the inner ear. Thus, claims 9-10 recite a judicial exception, a product of nature.
Regarding the second prong (2), claims 1-5 do not recite additional elements that further limit the structure of the judicial exception. i.e., retinoic acid.
Claims 9-10 recite additional elements that the inner ear organoid recited in each claim is “produced” by the preparation method according to claims 6. The term “produced” further describes means by which the inner organoid is produced. (limitations after wherein clause of claim 10 is not given patentable weight, see USC 103 rejection). Thus, the additional elements do not further limit the structure of the inner ear organoid recited in claims 9-10.Therefore, claims 9-10 do not recite any additional elements or a combination thereof that integrate the judicial exception identified in prong 1 into a practical application.
Further since the claims 1-5 and 9-10 are not meaningfully limited to any particular practical application, the generic nature of the claim appears to monopolize the claimed composition in claims 1-5 and the method in claims 9-10. Thus, claims 1-5 and 9-10 meet the requirement of step 2A as being directed to a judicial exception.
Third, if a judicial exception is present in the claim, it is further assessed to determine if the claim recites any additional elements or steps that are sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception. As discussed above, the claims 1-5 do not recite additional elements that limit the structure of the retinoic acid.
Claims 9-10 recite the structural element “produced”. It is noted that “produced” does impart a structural distinction to the claimed inner ear organoid in claims 9-10 because in nature compositions comprising inner ear organoids are not produced but rather are found within the ear. However, the claimed produced inner ear organoid is structurally indistinguishable from a sample of the inner ear, because they are naïve or unaltered having the same structural and functional features of what occurs in vivo.
Thus, as a whole, claims 1-5 and 9-10 do not impart any structural or functional distinctions to the claimed composition retinoic acid in claims 1-5, and the inner ear organoid in claims 9-10 that would distinguish it from the said compositions found in nature. As such, claims 1-5 and 9-10 do not meet the requirements of step 2B of the 2019PEG.
In conclusion, claims 1-5 and 9-10 meet all the requirements of the 2019PEG and therefore deemed patent ineligible.
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 1-5 are rejected under 35 U.S.C. 102(1) as being anticipated by Saeki, et al., Regenerative Therapy 20 (2022): 165-186. (Year: 2022).
Regarding claim 1, Saeki teaches a composition comprising retinoic acid (RA) (Materials and methods, differentiation of otic placodal cells, page 166)
Regarding claim 3, Saeki teaches a composition comprising 2000nM (i.e., 2µM ) RA (fig.3, page 172).
Regarding claims 2 and 4, Saeki teaches a composition comprising RA (Materials and methods, differentiation of otic placodal cells, page 166). The intended uses of the claimed composition to treat at a stage of otic placode formation recited in claim 2, and to treat on day 12-18 recited in claim 4, do not further limit the structure of the claimed composition. Therefore, the intended uses are not given patentable weight.
Regarding claim 5, Saeki teaches the requisite composition. Therefore, promoting the differentiation of hair cells of the inner ear organoid is anticipated by the reference.
Therefore, the reference anticipates the claimed composition.
Claims 9-10 are rejected under 35 U.S.C. 102(1) as being anticipated by Koehler et al., Nat Bitechnol 35, (2017).
Regarding claims 9 and 10, these claims are “product by process claims”, and the process steps that describe the means of producing the inner ear organoid are not given patentable weight. Koehler teaches inner ear organoid containing hair -cells (fig 2, page 586, fig.4, page 588).
Therefore, the reference anticipates the claimed composition.
Conclusion
No claim is allowed.Any inquiry concerning this communication or earlier communications from the examiner should be directed to HASHANTHI ABEYRATNE-PERERA whose telephone number is (571)272-6562. The examiner can normally be reached Monday-Friday 7:30 am- 5:00pm.
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/HASHANTHI KOMITIGE ABEYRATNE-PERERA/ Examiner, Art Unit 1632
/MARCIA S NOBLE/ Primary Examiner, Art Unit 1632
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