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 .
Election/Restrictions
Applicant’s election of Group I, claims 1-6, in the reply filed on 03/20/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 7-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/20/2026.
Drawings
The specification contains a description of color referring to Fig. 1, in Example 1 (pg. 25, para 4). Fig. 1 also contains reference to the color green within the figure.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
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.
Claim 6 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. Based upon an analysis with respect to the claim as a whole, the claims do not recite something significantly different than a judicial exception. The rationale for this determination is explained below.
The claims are directed to:
An alveolar organoid
There are no limitations in the claim that require the composition differ from alveolar cells in tissue found in nature.
The claims are directed to a composition of only a nature-based product, i.e., alveolar cells, this nature-based product is analyzed to determine whether it has markedly different characteristics from any naturally occurring counterpart(s) in their natural state. In this regard, the disclosed alveolar cells exist entirely in nature (e.g., same genotype and phenotype potential and structure).
The art, Brandt et al (NCBI Bookshelf, last updated 08/28/2023), teaches that alveolar cells make up the most distal portion of the respiratory tract (pg. 1, section titled “Structure” Para 1).
The claims thus encompass alveolar cells that are identical (no difference in characteristics) to naturally occurring alveolar cells. Since there is no difference between the alveolar cells claimed and naturally occurring alveolar cells, the alveolar cells do not have markedly different characteristics, and thus are a “product of nature” exception. In re Roslin Institute (Edinburgh), 750 F.3d
1333, 1338-39 (Fed. Cir. 2014). Accordingly, the claimed invention is directed to an exception. Because
the claimed invention does not include any additional features that could add significantly more to the
exception, the claimed culture does not qualify as eligible subject matter, and should be rejected under
35 U.S.C. § 101.
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Step 2A has recently been revised to include two prongs (Federal Register / Vol. 84, No. 4 / Monday, January 7, 2019):
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An examination of Step 2A in the revised 101 guidance, with respect to the claimed invention, the answer is yes since the claimed invention comprises naturally occurring products (judicial exceptions), in the instant case these naturally occurring products are alveolar cells. When examining the claimed invention with regards to Step 2A prong 1, the answer is yes since the claimed invention encompasses naturally occurring products. When examining the claimed invention with regards to Step 2A prong 2, the answer is no since the claimed invention does not recite additional elements that integrate the judicial exception, in the instant case alveolar cells, into a practical application.
It is only the recited limitations in the claims that are examined under 101 and not aspects such as what the alveolar cells are capable of treating or used for (i.e. alveolar cells for testing). In this case only alveolar cells are examined with respect to its status as a judicial exception. It is again emphasized that the claimed invention is a composition and not a method.
An examination of Step 2B, the answer is no with respect to the claimed invention. There are no other additional elements recited in the claim that would amount to significantly more than the judicial exceptions. The alveolar cells as claimed encompasses a composition that is indistinguishable from those that exist in nature and there are no limitations that add any additional elements to the claimed alveolar cells. The alveolar cells have the same function as they do in nature and the fact that they may exist in an isolated system does not change the alveolar cells in a significant or meaningful way to amount to more than the judicial exception.
The only factors which can be examined under 101 in the claimed composition are those that are recited in the claim i.e. alveolar cells. How the alveolar cells were obtained and the knowledge of using them is not considered with respect to a composition claim, it is only the judicial exceptions themselves that are analyzed under 101 and in this case all of the components in the claimed composition are naturally-occurring products and thus qualifies as a judicial exception.
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.
Claims 1-6 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.
Claim 1 contains the preamble “a method of manufacturing an alveolar organoid” however the method of claim 1 does not clearly result in the formation of an alveolar organoid. Claim 1 recites “d) culturing the alveolar progenitor cells of step c) in an alveolar medium (AM)” but does not state whether this step results in the differentiation of the alveolar progenitor cells into alveolar cells and additionally does not state whether this step results in the formation of organoids. Applicant is encouraged to include the resultant cells (alveolar cells) and cell structure (organoid) of step d), or include additional steps to describe if necessary/desired.
Claims 3 and 4 contains the trademark/trade name B27 supplement™. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a serum-free neuronal supplement and, accordingly, the identification/description is indefinite.
Claims 3 contains the trademark/trade name Glutamax™. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a L-alanyl-L-glutamine and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Seibold et al (WO 2021/202898) in view of Kim et al (US 2021/0030811).
With regards to claim 1, Seibiold teaches a method of forming an alveolar organoid comprising the steps of:
a) culturing induced pluripotent stem cells (iPSCs) in a medium to induce the iPSCs to differentiate into endoderm cells (pg. 9, last para spanning pg. 10)
b) inducing the differentiation of the endoderm cells into anterior foregut endoderm cells in an anterior foregut endoderm medium (AFM) (pg. 10, last para spanning pg. 11)
c) inducing the differentiation of the anterior foregut endoderm cells of step b) into an alveolar progenitor in an alveolar progenitor differentiation medium (pg. 11, para 1-2)
d) culturing the alveolar progenitor of step c) in an alveolar medium (AM) (pg. 11, para 1-2).
Regarding claim 3, Seibold teaches that the AFM comprises Ham’s F12, ascorbic acid, a B27 supplement, an N2 supplement and BSA (pg. 10, last para spanning pg. 11).
Regarding claim 4, Seibold teaches that the AM comprises cAMP, IBMX, FGF-10, and dexamethasone.
Regarding claim 5, Seibold teaches that the method of steps b) through d) can be performed using 3D culture (pg. 34, para 3).
Regarding claim 6, Seibold teaches the formation of organoids (pg. 11, para 2).
Seibold does not teach that the iPSCs are specifically derived from alveolar cells as required by claim 1. Seibold does not teach that the alveolar cells used to derive the iPSCs are alveolar type 2 cells as required by claim 2.
However, Kim teaches a similar method of making alveolar organoids. Specifically, Kim teaches a method of making alveolar organoids which can successfully engraft into lung tissue ([0003]).
Regarding claim 1, Kim teaches that iPSCs can be derived from the subject to which an alveolar organoid would be administered. Specifically, Kim describes obtaining somatic cells from a subject and inducing them into iPSCs for further differentiation into a lunch/alveolar organoid ([0168]), and that the somatic cells can be taken from patient lungs ([0175]).
Regarding claim 2, Kim teaches that the lung cells can comprise either alveolar type I or II cells ([0179]/[0182]).
One of ordinary skill in the art would find it obvious at the effective filling date of the instant invention to combine the method of making alveolar organoids taught by Seibold with the method of making alveolar organoids employing alveolar cell-derived iPSCs taught by Kim to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because , Kim teaches a method of making alveolar organoids which can successfully engraft into lung tissue ([0003]). One of ordinary skill in the art would have a reasonable expectation of success when combining Seibold with Kim because both teach the necessary information to make and use alveolar organoids.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONSTANTINA E STAVROU whose telephone number is (571)272-9899. The examiner can normally be reached M-F 8:00-5:00.
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CONSTANTINA E. STAVROU
Examiner
Art Unit 1632
/ANOOP K SINGH/Primary Examiner, Art Unit 1632
