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/Restriction
Claims 1, 3, 5, 7-8, 11, 15-16, 22-23, 56-58, 64-65, 78-80, and 93-94 are pending.
Applicant’s election without traverse of Group I, claims 1, 3, 5, 7-8, 11, 15-16, 22-23, and 93-94 in the reply filed on 08/03/2026 is acknowledged.
Claim 56-58, 64-65, and 78-80 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/03/2026
Claims 1, 3, 5, 7-8, 11, 15-16, 22-23, and 93-94 have been examined on their merits.
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, 3, 5, 7-8, 11, 15-16, and 22-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural phenomenon (natural product) without significantly more.
Applicant is directed to the subject matter eligibility test for products processes (MPEP 2106; specifically, MPEP 2106(III) flowchart).
Briefly summarized here, the new guidance cites a two part test: is the claimed invention directed to a statutory class of invention (Step 1), if so then is the claimed invention as a whole directed to a law of nature, natural phenomena, or an abstract idea (i.e. set forth or described in the claim) (Step 2A, prong one), if so then is the claimed invention recite additional elements that integrate the judicial exception into a practical application (Step 2A, prong two), if not then does the claim as a whole amount to significantly more than the judicial exception (Step 2B).
In regards to Step 1, the claimed invention is directed to a non-human animal cell (a composition) which is a statutory class of invention (Step 1: YES).
In regards to Step 2A, Prong One, independent claim 1 is drawn to a non-human animal cell wherein the non-human animal cell comprises a nucleic acid sequences encoding a heterologous Calcium Voltage-Gated Channe; Auxiliary Subunit Gamma 1 (CACNG1) or a portion there.
While the claim recites that the nucleic acid sequences encodes a “heterologous” CACNG1 (which is defined in the specification to mean “that the nucleic acid or protein comprises at least two portions that do not naturally occur together in the same molecule” (paragraph [0058]), the claim is more broadly limited to any “portion thereof”, which reads on at least any pair of nucleotides (which would be a sequence) and does not require two portions that do not naturally occur together. Therefore, the claim is indistinguishable from and overlaps with a portion of a nucleic acid sequence encoding a CACNG1 protein found in nature.
For example, claim 3 specifically allows for a portion of exon 1 of the human CACNG1 gene. However, as shown in the instant specification, mouse and human CACNG1 nucleic acids overlap at least with sequences GTGACCCTCT (sequences 31-40, SEQ IDS: 1 and 3, respectively).
Claim 5 allows the sequence part to be in the endogenous Cacng1 locus which is naturally occurring.
Claim 7 allows the sequence part to be in the endogenous Cacng1 locus which is naturally occurring. While the claim states that the portion thereof is orthologous (meaning genes from different species), as above, mouse and human genomic DNA portions indistinguishable.
Claim 8 allows for any portion of human amino acid sequence. However, as demonstrated by instant Fig. 4, sequence portions of human and mouse CACNG1 amino acids overlap (e.g., MSQTK, etc.) and therefore, are indistinguishable in multiple portions thereof.
Claim 11 allows for the cell to be a mammalian cell which is naturally occurring.
Claim 15 allows for the cell to be a skeletal muscle cell. It is well-known in the art that CACNG1 is naturally occurring skeletal muscle protein.
Claim 16 requires that the cell does not express CACNG1 gene portions on a cell’s surface. It is well known in the art that natural germ cells comprise the CACNG1 gene but do not express them on their surfaces.
Claim 22 requires a portion of SEQ ID NO: 6. However, SEQ ID NO: 6 comprises sequence portions AT which as above are naturally occurring.
Claim 23 requires a non-human animal comprising the CACNG1 nucleotide portion. However, as above, mice are naturally occurring.
Claim 93 is limited to a heterologous protein specifically, which is non-naturally occurring and therefore, is not rejected under 35 USC 101. Claim 94 depends on claim 93 and therefore, also specifically requires a heterologous protein.
Therefore, the claimed cells are indistinguishable from naturally occurring cells, which are a product of nature.
Accordingly, the claim is directed to a judicial exception (Step 2A, prong one: YES).
In regard to Step 2A, prong two, the instant claim is directed a non-human animal cell.
With respect to Step 2A, prong two, limitations that may be enough to qualify as additional elements that integrate the judicial exception into a practical application include:
Improvements to another technology or technical field.
Improvements to the functioning of the computer itself.
Applying the judicial exception with, or by use of, a particular machine.
Effecting a transformation or reduction of a particular article to a different state or thing
Adding a specific limitation other than what is well-understood, routine and conventional in the field, or adding unconventional steps that confine the claim to a particular useful application.
Other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment.
With respect to Step 2A, prong two, limitations that were found not to be enough to qualify as additional elements that integrate the judicial exception into a practical application include:
Adding the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer
Simply appending well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well understood, routine and conventional activities previously known to the industry
Adding insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea
Generally linking the use of the judicial exception to a particular technological environment or field of use.
In regards to Step 2A, prong 2, the instant claim does not recite additional elements or a combination of elements in the claims other than the natural product itself (the non-human animal cells) (therefore, Step 2A, prong one: NO).
In regards to Step 2B, the claim does not the claim recite additional elements that amount to significantly more than the judicial exception. In instant case, as above, the instant claim does not additional elements or a combination of elements in the claims other than the natural product itself (the non-human animal cells) (therefore, Step 2B: NO).
Thus, instant claims do not amount to significantly more than the judicial exception itself and do not qualify as patent eligible subject matter under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 3, 5, 7-8, 11, 15-16, and 22-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Freise et al. (The Journal of Biological Chemistry, 2000).
Regarding claims 1 and 3, Freise discloses mouse cells comprising nucleic acid sequences encoding CACNG1 (Results, p14478; Fig. 1, p14478, referring to any of the γ1+/+, γ1+/-, or γ1-/- cells). As discussed above, the claim does not require a heterologous CACNG1 protein. Since as discussed above, portions mouse and human CACNG1 nucleic acids are indistinguishable (e.g., sequences GTGACCCTCT (sequences 31-40, SEQ IDS: 1 and 3, referring to human and mouse, respectively, and which appear to be in Exon 1), it reads on a “portion thereof” of a nucleic acid sequence encoding a heterologous CACNG1 protein as claimed.
Regarding claim 5, Freise discloses that this is the endogenous Cacng1 locus (Results, p14478; Fig. 1, p14478).
Regarding claim 7, mouse and human CACNG1 sequences are orthologs. As above, the claimed portions between mouse and human are indistinguishable and therefore, reads on a “portion thereof” as clamed.
Regarding claim 8, as above, as demonstrated in instant Fig. 4, sequence portions of human and mouse CACNG1 amino acids overlap (e.g., MSQTK, etc.) and therefore, are indistinguishable in multiple portions thereof. Therefore, a “portion thereof” of an amino sequence as claimed.
Regarding claim 11, Freise discloses that the animal cells are mouse cells (Abstract, p14476; Results, p14478; Fig. 1, p14478).
Regarding claim 15, CAGNG1 is a well known skeletal muscle surface protein.
Regarding claim 16, a person of ordinary skill in the art would have recognized that germ cells comprise portions of the CACNG1 gene but do not express them on their surface.
Regarding claim 22, both mouse and SEQ ID NO: 6 comprise ATG sequences (sequences 1-3) and therefore, reads on a “portion thereof” of a nucleic acid sequence encoding a heterologous CACNG1 protein as claimed.
Regarding claim 23, Freise discloses a mouse comprising a portion of the CACNG1 gene (Results, p14478; Fig. 1, p14478).
Therefore, Freise anticipates the invention as claimed.
Claims 1, 3, 8, 11, 15, and 22-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Okada et al., (Scientific Reports, 04/28/20221, previously cited).
Regarding claims 1 and 11, Okada discloses a mouse cell comprising a CACNG1 heterologous protein (Cacng1 induces a decrease in muscle fiber size in vitro and in vivo, p9; Fig. 5, p10).
Regarding claim 3, as above, the claim does not require a heterologous CACNG1 protein. Since as discussed above, portions mouse and human CACNG1 nucleic acids are indistinguishable (e.g., sequences GTGACCCTCT (sequences 31-40, SEQ IDS: 1 and 3, referring to human and mouse, respectively, and which appear to be in Exon 1), it reads on a “portion thereof” of a nucleic acid sequence encoding a heterologous CACNG1 protein as claimed.
Regarding claim 8, as above, as demonstrated in instant Fig. 4, sequence portions of human and mouse CACNG1 amino acids overlap (e.g., MSQTK, etc.) and therefore, are indistinguishable in multiple portions thereof. Therefore, a “portion thereof” of an amino sequence as claimed.
Regarding claim 15, CAGNG1 is a well known skeletal muscle surface protein.
Regarding claim 22, both mouse and SEQ ID NO: 6 comprise ATG sequences (sequences 1-3) and therefore, reads on a “portion thereof” of a nucleic acid sequence encoding a heterologous CACNG1 protein as claimed.
Regarding claim 23, Okada discloses a mouse comprising a CACNG1 heterologous protein (Cacng1 induces a decrease in muscle fiber size in vitro and in vivo, p9; Fig. 5, p10).
Therefore, Okada anticipates the invention as claimed.
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.
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.
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 93 and 94 are rejected under 35 U.S.C. 103 as being unpatentable over Okada et al., (Scientific Reports, 04/28/20221, previously cited) in view of Murata et al. (Journal of Electron Microscopy, 2010).
Regarding claims 93 and 94, the mouse expresses the heterologous CACNG1 protein (Cacng1 induces a decrease in muscle fiber size in vitro and in vivo, p9; Fig. 5, p10). While Okada does not explicitly teach an antigen-binding protein that binds the heterologous CACNG1, a person of ordinary skill in the art would have been motivated to employ an antigen-binding protein (i.e., antibody) in order to visualize receptors as taught by Murata (Title, Abstract, p215). Furthermore, because Murata demonstrates targeting CACNG1 with antibodies (Materials, p216) and because targeting proteins with antibodies for visualization assays is routine in the art, it could have been done with predictable results and a reasonable expectation of success.
Therefore, Okada and Murata render the invention unpatentable as claimed.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH (PAUL) MIANO whose telephone number is (571)272-0341. The examiner can normally be reached Mon-Fri from 8:30am to 5:30pm.
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/JOSEPH PAUL MIANO/Examiner, Art Unit 1631
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