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 .
DETAILED ACTION
The amended claims filed on December 8, 2025, have been acknowledged. Claims 1-5 were amended. Claims 6-7 are new. Claims 1-7 are pending and examined on the merits.
Response to Arguments
Applicant's arguments filed December 8, 2025, are acknowledged.
Applicant argues that SEQ ID NOs: 48-49 should not be considered new matter as these sequences would have been inherently present disclosed in the present specification (page 5, paragraphs 1-3).
Applicant’s arguments are considered persuasive.
Examiner has reviewed the prior art to assess whether the wildtype sequences of SEQ ID NOs: 48-49 are the consensus sequences for wildtype. After careful review, SEQ ID NOs: 48-49 are the consensus sequences for the human wildtype BMPR2 amino acid and nucleic acid sequences. Furthermore, Applicant’s specification cites to MIM # 600799 which provides a link to the wildtype sequence that corresponds to SEQ ID NOs: 48-49. Therefore, SEQ ID NOs: 48-49are not considered new matter.
there is no motivation to combine Moreau and Koch, and there would be no reasonable expectation of success in combining an invariant chain fused to an antigenic peptide, together with IL-10 (p.12-15 of Remarks). Specifically, Applicant argues that a skilled person would expect the co-expression of IL-10 and Ii-autoantigen constructs to lead to a dampening of the HLA-class II-autoantigen epitope expression on the cell surface. This dampening would inhibit the desired autoantigen presentation to CD4+ T cells in the presence of IL-10. The skilled person would not have expected a combination of the invariant chain construct including autoantigen epitopes and IL-10 to result in DC that acquire the ability to present the encoded epitope to CD4+ T cells.
Applicant's arguments and the cited prior art have been fully considered but they are not persuasive.
Priority
Acknowledgment is made of Applicant’s claim for foreign priority under 35 U.S.C. 119(a)-(d).The applicant claims foreign priority from KR10-2020-0075323 filed on June 19, 2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55, received December 19, 2022. While a certified copy of the foreign patent application KR10-2020-0075323 is provided with the instant application, a certified English translation of said foreign patent application has not been provided.
Information Disclosure Statement
The information disclosure statement (IDS) filed on December 8, 2025, has been considered.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825. This application contains a “Sequence Listing” as a PDF file (37 CFR 1.821(c)(2)) or as physical sheets of paper (37 CFR 1.821(c)(3)). A copy of the "Sequence Listing" in computer readable form (CRF) has been submitted; however, the content of the CRF does not comply with one or more of the requirements of 37 CFR 1.822 through 1.824, as indicated in the "Error Report" that indicates the "Sequence Listing" could not be accepted. Refer to attachment or document "Computer Readable Form (CRF) for Sequence Listing – Defective" dated December 8, 2025.
Specifically, the “Sequence Listing” filed December 8, 2025, could not be accepted because there were 49 sequences counted in this sequence listing but numeric identifier <160> indicates that there are 47 sequences, SEQ ID NO: 4 contains additional information (120 is repeated) that needs to be removed, and multiple sequences include additional white spaces between the last nucleotide and the number enumerating that line and need to be removed.
Required response – Applicant must provide:
A replacement "Sequence Listing" part of the disclosure, as described above in item 1); together with
An amendment specifically directing its entry into the application in accordance with 37 CFR 1.825(b)(2);
A statement that the "Sequence Listing" includes no new matter as required by 37 CFR 1.825(b)(5); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4).
If the replacement "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter and
An amendment to the specification to remove the “Sequence Listing previously submitted as a PDF file (37 CFR 1.821(c)(2)) or as physical sheets of paper (37 CFR 1.821(c)(3))
If the replacement "Sequence Listing" part of the disclosure is submitted according to item 1) c) or d) above, Applicant must also provide:
A CRF in accordance with 1.821(e)(1) or 1.821(e)(2) as required by 37 CFR 1.825(b)(6)(ii); and
Statement according to item 2) a) or b) above.
Specific deficiency - This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 - 1.825.
The sequence disclosures are located Figures 2 and 4 refer to sequences 48-55 that have been removed in the new sequence listing. Furthermore, the new sequence listing identifies different sequences that do not correspond to the sequences identified as SEQ ID NOs: 48-49 in Figure 2a.
Required response – Applicant must provide:
A "Sequence Listing" part of the disclosure, as described above in item 1); as well as
An amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application in accordance with 1.825(b)(2);
A statement that the "Sequence Listing" includes no new matter in accordance with 1.825(b)(5); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter;
If the "Sequence Listing" part of the disclosure is submitted according to item 1) b), c), or d) above, Applicant must also provide:
A replacement CRF in accordance with 1.825(b)(6); and
Statement according to item 2) a) or b) above.
Drawings
Sequence Compliance
As stated supra, Figures 2 and 4 refer to sequences 48-55 that have been removed in the new sequence listing. Furthermore, the new sequence listing identifies different sequences that do not correspond to the sequences identified as SEQ ID NOs: 48-49 in Figure 2a.
The applicant is reminded that the specification must be amended in order to comply with regulations cited above. All references to sequences in claims and specification should be referred to as “SEQ ID NO:1”, for example. To avoid all doubts of the examiner and to ensure correct interpretation of the claims and specification, the identification of sequences with proper sequence identifiers is required.
Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance
Withdrawn Claim Rejections - 35 USC § 112a
The prior rejection of claim 3 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in light of Applicant’s amendment to claim 3 to remove the language wherein the mutant is characterized by causing a phenotype of Fibrodysplasia ossificans progressiva (FOP).
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.
Claim 4 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This rejection is substantially similar to a previous rejection made in response to Applicant’s amendments to claims 1 and 4. Applicant’s traversal has been considered but is considered unpersuasive as the amendments do not overcome the rejection.
Claim 4 recites the generic functional limitations “wherein the mutant is characterized by being used to treat bone disease through osteogenic differentiation” but does not describe specific structures, per se, capable of performing these functions. Vas-cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states that Applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.'' (See page 1117) The specification should “clearly allow persons of ordinary skill in the art to recognize that (he or she) invented what is claimed.'' (See Vas-cath at page 1116).
In analyzing whether the written description requirement is met for genus claims, it is first determined whether a representative number of species have been described by their complete structure. To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. The disclosure of a single species is rarely, if ever, sufficient to describe a broad genus, particularly when the specification fails to describe the features of that genus, even in passing. (see In re Shokal 113USPQ283(CCPA1957); Purdue Pharma L.P. vs Faulding Inc. 56 USPQ2nd 1481 (CAFC 2000).
The specification discloses two BMPR2-E376K mutant receptors. In the first instance, the mutant receptor was examined in patient derived dermal fibroblast cells (page 34 of the instant specification). In the second instance, the specification discloses that they ectopically expressed human BMPR2-E376K variant in several different cell types (human HEK293T cells, mouse MSCs, and mouse C2C12 cells) by modifying the cDNA of wild type human BMPR2 from addgene with a C.1126G>A point mutation that encodes a BMPR2-E376K mutant receptor. The specification discloses that BMPR2-E376K mutant receptors expressed in patient derived cells, mouse MSCs, and mouse C2C12 cells recapitulated markers of FOP pathogenesis, such as ALP staining (page 20-21 and page 35, paragraph 3-page 39, paragraph 1 of the instant specification).
Applicant does not provide any examples of using BMPR2-E376K mutant receptors to treat bone disease.
Although the applicant provides two examples of human BMPR2-E376K mutant receptors that recapitulate markers of FOP pathogenesis in three different cell types, the applicant has not provided any description or reduction to practice of for any other human BMPR2 sequences. Furthermore, Applicant does not provide any examples of using BMPR2-E376K mutant receptors to treat bone disease. Based on the applicant's specification, the skilled artisan cannot envision the detailed method encompassed by the claims.
The two human sequences used to encode the BMPR2-E376K mutant receptors are not representative of the genera because the genera are highly variant. OMIM (600799: BONE MORPHOGENETIC PROTEIN RECEPTOR, TYPE II;BMPR2, 2019) evidences that there are at least 28 allelic variants of BMPR2 with clinical relevance with a multitude altering the function of the BMPR2 receptor (pages 5-9). As many of these identified allelic variants are either in highly conserved regions or result in large truncations, it is not clear that they would be capable of treating bone disease through osteogenic differentiation. Furthermore, NCBI (bone morphogenetic protein receptor type-2 precursor) evidences there is also a precursor protein (whole documents). Considering the above, the ordinary artisan would have to perform a trail-and-error assessment of different allelic variants with unpredictable results. Furthermore, Applicant does not provide any examples of using BMPR2-E376K mutant receptors to treat bone disease. As such, the ordinary artisan would have to perform a trail-and-error assessment to determine whether this was possible with any mutant BMPR2-E376K receptor with unpredictable results.
Thus, for the reasons outlined above, it is concluded that the claims do not meet the requirements for written description under 35 U.S.C. 112, first paragraph.
Applicant is reminded that MPEP 2163 - 35 U.S.C. 112(a) and the first paragraph of pre-AIA 35 U.S.C. 112 require that the “specification shall contain a written description of the invention ....” This requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc).
The court explained that “reading a claim in light of the specification, to thereby interpret limitations explicitly recited in the claim, is a quite different thing from ‘reading limitations of the specification into a claim,’ to thereby narrow the scope of the claim by implicitly adding disclosed limitations which have no express basis in the claim.” The court found that applicant was advocating the latter, i.e., the impermissible importation of subject matter from the specification into the claim.). See also In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997).
Claims 1-7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This rejection is substantially similar to a previous rejection made in response to Applicant’s amendments to claims 1 and 4. Applicant’s traversal has been considered but is considered unpersuasive as the amendments do not overcome the rejection.
Claim 1 recites the following claim language, “An isolated complementary DNA (cDNA) encoding a BMPR2-E376K mutant in which an amino acid 376 of a human bone morphogenetic protein type 2 receptor (BMPR2) (SEQ ID No. 48) is mutated from glutamic acid (E) to lysine (K).” Regarding the BMPR2-E376K mutant receptor, the broadest reasonable interpretation is that the BMPR2-E376K mutant can be the any variant of the human wildtype BMPR2 gene as long as it also has the E376K mutation.
Under the written description guidelines (see MPEP 2163) the Examiner is directed to determine whether one skilled in the art would recognize that the Applicant was in possession of the claimed invention as a whole at the time of filing. The following considerations are critical to this determination.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. "Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement." Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
Accordingly, to satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.
Actual Reduction to Practice
In regard to claim 1 encompassing a genus of BMPR2-E376K mutant receptors, the specification discloses two BMPR2-E376K mutant receptors. In the first instance, the mutant receptor was examined in patient derived dermal fibroblast cells (page 34 of the instant specification). In the second instance, the specification discloses that they ectopically expressed human BMPR2-E376K variant in several different cell types (human HEK293T cells, mouse MSCs, and mouse C2C12 cells) by modifying the cDNA of wild type human BMPR2 from addgene to with a C.1126G>A point mutation that encodes a BMPR2-E376K mutant receptor. The specification discloses that BMPR2-E376K mutant receptors expressed in patient derived cells, mouse MSCs, and mouse C2C12 cells recapitulated markers of FOP pathogenesis, such as ALP staining (page 20-21 and page 35, paragraph 3-page 39, paragraph 1).
Accordingly, although Applicant did demonstrate a reduction to practice of a human BMPR2-E376K mutant isolated from a patient and through modifying a cDNA with a single point mutation (C.1126G>A), Applicant has not disclosed any other BMPR2-E376K mutant receptors for other allelic variants of the human BMPR2, nor did Applicant adequately set forth in terms of distinguishing identifying characteristics as evidenced by other descriptions of the invention that are sufficiently detailed to show that Applicant was in possession of the claimed genus of BMPR2-E376K mutant receptors.
Disclosure of structure
Although the Applicant has disclosed that the amino acid sequence of the mutant receptor must have a E376K mutation and the Applicant disclosed the BMPR2-E376K mutant receptor was based on a modified human WT cDNA from addgene or isolated from a human patient derived fibroblasts that express the mutant receptor. However, Applicant does not provide the full sequence of the WT cDNA from addgene or the patient derived mutant receptor
Sufficient relevant identifying characteristics
The breadth of the claims encompass a genus of BMPR2-E376K mutant receptors, yet the present specification only provides guidance and description of a human BMPR2-E376K mutant isolated from a patient and through modifying a cDNA with a single point mutation (C.1126G>A), but not BMPR2 mutants with any other allelic variants, therefore the skilled artisan would not know what rational approach to take to make the genus of BMPR2-E376K mutant receptors. Therefore, it is incumbent on the applicant to provide this nexus between structure and function, in order to be given credit for possession of the claimed genus of mutant receptors.
The specification discloses two BMPR2-E376K mutant receptors. In the first instance, the mutant receptor was examined in patient derived dermal fibroblast cells (page 34 of the instant specification). In the second instance, the specification discloses that they ectopically expressed human BMPR2-E376K variant in several different cell types (human HEK293T cells, mouse MSCs, and mouse C2C12 cells) by modifying the cDNA of wild type human BMPR2 from addgene to with a C.1126G>A point mutation that encodes a BMPR2-E376K mutant receptor. The specification discloses that BMPR2-E376K mutant receptors expressed in patient derived cells, mouse MSCs, and mouse C2C12 cells recapitulated markers of FOP pathogenesis, such as ALP staining (page 20-21 and page 35, paragraph 3-page 39, paragraph 1 of the instant specification).
An applicant may show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. Enzo Biochem, 323 F.3d at 964, 63 USPQ2d at 1613.
STATE OF THE ART & QUANTITY OF EXPERIMENTATION
The claimed BMPR2-E376K mutant receptor is not well established in the art. Although BMPR2 mutants were known in the state of the art, BMPR2-E376K mutants were not.
Furthermore, the art identifies that there are a multitude of BMPR2 varaints and differences between species. For example, OMIM (600799: BONE MORPHOGENETIC PROTEIN RECEPTOR, TYPE II;BMPR2, 2019) evidences that there are at least 28 allelic variants of BMPR2 with clinical relevance with a multitude altering the function of the BMPR2 receptor (pages 5-9). As many of these identified allelic variants result in large truncations, it is not clear that they would produce a BMPR2-E376K mutant receptor. Furthermore, NCBI (bone morphogenetic protein receptor type-2 precursor) evidences there is also a precursor protein (whole documents). Considering the above, the ordinary artisan would have to perform a trail-and-error assessment of different allelic variants with unpredictable results.
Applicant has claimed a genus of BMPR2-E376K mutant receptors, yet the specification has not disclosed a limited number of human BMPR2-E376K mutant receptors, but has not set forth in terms of distinguishing identifying characteristics as evidenced by other descriptions of the invention that are sufficiently detailed to show that Applicant was in possession of the claimed genus of BMPR2-E376K mutant receptors. However, the claims are much broader to these, and one of skill in the art would neither expect nor predict the producing BMPR2-E376K mutant receptors for every variant of those sequences beyond those described by the Applicant.
CONCLUSION
Therefore, the Examiner concludes that there is insufficient written description of the instantly claimed genus ofBMPR2-E376K mutant receptors. Specifically, there is limited description of the structure-function relationship between the claimed genus of BMPR2-E376K mutant receptors, and the Examiner further concludes a skilled artisan would find the specification inadequately describes the claimed genus of BMPR2-E376K mutant receptors.
Withdrawn Claim Rejections - 35 USC § 112b
The prior rejection of claims 1-5 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 is withdrawn in light of Applicant’s amendments to claim 1 to a specify that the mutation is in the amino acid sequence.
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 1-7 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 1 recites the broad recitation a human BMPR2, and the claim also recites SEQ ID NO: 48 which is the narrower statement of the range/limitation.
In the present instance, claim 2 recites the broad recitation a human BMPR2 gene, and the claim also recites SEQ ID NO: 49 which is the narrower statement of the range/limitation.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 2-7 are also rejected because of their dependency on claim 1. Claim 6 is also rejected because of its dependency on claim 2.
Claims 1-2 use parentheses to identify example SEQ ID NOs. However, this renders the claim indefinite because it is unclear whether the limitations within the parentheses are part of the claimed invention.
Claims 2-7 are also rejected because of their dependency on claim 1. Claim 6 is also rejected because of its dependency on claim 2.
Withdrawn Claim Rejections - 35 USC § 101
The prior rejection of claims 1-4 under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more is withdrawn in light of Applicant’s amendment to claims 1-4 to recite that the mutant is encoded by isolated cDNA. MPEP 2106.04(c). In Myriad, the Supreme Court identified a claimed full-length complementary DNA (cDNA) of the BRCA1 gene as a nature-based product having markedly different characteristics. This claimed cDNA had the same functional characteristics (i.e., it encoded the same protein) as the naturally occurring gene, but had a changed structural characteristic, i.e., a different nucleotide sequence containing only exons, as compared to the naturally occurring sequence containing both exons and introns. The Supreme Court concluded that the "cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, [this] cDNA is not a ‘product of nature’" and is eligible. Myriad, 569 U.S. at 595, 106 USPQ2d at 1981.
The prior rejection of claim 5 under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more is withdrawn in light of Applicant’s amendment to claim 5 to recite that the cell line includes the isolated cDNA. MPEP 2106.04(c). In Myriad, the Supreme Court identified a claimed full-length complementary DNA (cDNA) of the BRCA1 gene as a nature-based product having markedly different characteristics. This claimed cDNA had the same functional characteristics (i.e., it encoded the same protein) as the naturally occurring gene, but had a changed structural characteristic, i.e., a different nucleotide sequence containing only exons, as compared to the naturally occurring sequence containing both exons and introns. The Supreme Court concluded that the "cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, [this] cDNA is not a ‘product of nature’" and is eligible. Myriad, 569 U.S. at 595, 106 USPQ2d at 1981.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 18/011,419 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a new rejection made in response to Applicant’s amendments. Applicant’s traversal has been fully considered but is moot in response to the new rejection.
‘419 claims a mutant BMPR2-E376K receptor as part of a mutation complex with ACVR1-R206K. ‘419 teaches that the E376K mutation is characterized by having a point mutation of guanine (G) to adenine (A) at nucleotide 1126. ‘419 claims the mutation complex is characterized by being used to treat bone disease through osteogenic differentiation. ‘419 claims the mutant is included within a cell line (claims 1-9).
Although ‘419 does not identify that the BMPR2-E376K mutant receptor is encoded by isolated cDNA, it was well understood in the art that cDNA encoding only the exons can be used to generate proteins. As ‘419 identifies that the mutation is characterized by having a point mutation of guanine (G) to adenine (A) at nucleotide 1126, there would be a nucleic acid encoding the protein complex of ‘419 and this could be based on isolated cDNA of the BMPR2 gene. As such, one of ordinary skill in the art would readily envision the possibility of using cDNA to encode the protein complex.
Although ‘419 does not identify that a vector encoding the protein complex is used, it was well understood in the art that cDNA can be incorporated into plasmids (a type of vector) for expressing proteins of interest in a cell, as claimed by ‘419. As such, it would have been obvious to one of ordinary skill in the art that the cDNA encoding the BMPR2 mutant complex can be placed in a plasmid for expression in a cell line.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEENAN A BATES whose telephone number is (571)270-0727. The examiner can normally be reached M-F 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Doug Schultz can be reached at (571) 272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KEENAN A BATES/Examiner, Art Unit 1631
/JAMES D SCHULTZ/Supervisory Patent Examiner, Art Unit 1631