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
This action is in response to the papers filed March 28, 2024.
Amendments
Applicant's response and amendments, filed March 28, 2024, is acknowledged. Applicant has cancelled Claims 1-67, and added new claims, Claims 68-85.
Claims 68-85 are pending and under consideration.
Priority
This application is a continuation of application 17/099,942 filed on November 17, 2020, now U.S. Patent 11,910,787, which is a division of application 16/052,700, filed August 2, 2018, now U.S. Patent 10,863,729, which is a continuation of application 15/442,857, filed February 27, 2017, now U.S. Patent 10,070,632. Applicant’s claim for the benefit of a prior-filed application provisional application 62/301,023 filed on February 29, 2016 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
The Examiner also acknowledges application 15/624,774 filed on June 16, 2017, now U.S. Patent 10,070,631, which is also a continuation of application 15/442,857, filed February 27, 2017, now U.S. Patent 10,070,632.
Information Disclosure Statement
Applicant has filed Information Disclosure Statements on January 16, 2024 that have been considered.
The information disclosure statement filed January 16, 2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because 37 CFR 1.98(b) requires that each item of information in an IDS be identified properly. Each publication must be identified by publisher, author (if any), title, relevant pages of the publication, and date and place of publication. The date of publication supplied must include at least the month and year of publication, except that the year of publication (without the month) will be accepted if the applicant points out in the information disclosure statement that the year of publication is sufficiently earlier than the effective U.S. filing date and any foreign priority date so that the particular month of publication is not in issue.
See also MPEP 707.05(e) for electronic documents, including, but not limited to:
(D) reference to the unique Digital Object Identifier (DOI) number, or other unique identification number, if known.
A plurality of Patent Document citations have been lined through for being defective of one or more requirements.
NPL 49-50 have an embedded hyperlink that should be removed.
The signed and initialed PTO Forms 1449 are mailed with this action.
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.
1. Claim 81 is 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 81 recites the limitation “TMPRSS4” in reference to Claim 80. There is insufficient antecedent basis for this limitation in the claim because Claim 80 is directed to TMPRSS11D.
Claim 81 appears to have suffered a typographical error, reciting TMPRSS4, not TMPRSS11D.
Appropriate correction is required.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
2. Claims 74-85 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,910,787, since the claims, if allowed, would improperly extend the “right to exclude” already granted in the patent. The subject matter claimed in the instant application is fully disclosed in the patent and is covered by the patent since the patent and the application are claiming common subject matter.
‘787 claims a rodent ES cells whose genome comprises a heterologous nucleic acid encoding…. Tmprss4 (claims 1-15) or Tmprss11D (claims 16-21),
wherein the humanized Tmprss4 gene encodes a humanized Tmprss4 protein that comprises (i) an ectodomain of the human TMPRSS4 protein encoded by the human TMPRSS4 gene, and (ii) a cytoplasmic and transmembrane portion encoded by the endogenous rodent Tmprss4 gene; and
wherein the humanized Tmprss11D gene encodes a humanized Tmprss4 protein that comprises (i) an ectodomain of the human TMPRSS11D protein encoded by the human TMPRSS11D gene, and (ii) a cytoplasmic and transmembrane portion encoded by the endogenous rodent Tmprss11D gene.
Those of ordinary skill in the art immediately recognize that the heterologous nucleic acid introduced into the ES cells in order to achieve the genomic recombination is provided in the form of a vector.
Thus, instant claims are anticipated by and/or obvious variants of the ‘787 patented claims.
Furthermore, there is no apparent reason why applicant was prevented from presenting claims corresponding to those of the instant application during prosecution of the application which matured into a patent. See In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968). See also MPEP § 804.
See, for example, originally presented claim 47 filed May 15, 2017, “a vector…”, and amended claim 47 filed March 19, 2018, “a vector…”, in 15/442,857.
3. Claims 68-73 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,863,729, since the claims, if allowed, would improperly extend the “right to exclude” already granted in the patent. The subject matter claimed in the instant application is fully disclosed in the patent and is covered by the patent since the patent and the application are claiming common subject matter.
‘729 claims a rodent ES cells whose genome comprises a heterologous nucleic acid encoding…. Tmprss2 (claims 1-15),
wherein the humanized Tmprss2 gene encodes a humanized Tmprss2 protein that comprises (i) an ectodomain of the human TMPRSS2 protein encoded by the human TMPRSS2 gene, and (ii) a cytoplasmic and transmembrane portion encoded by the endogenous rodent Tmprss2 gene.
Those of ordinary skill in the art immediately recognize that the heterologous nucleic acid introduced into the ES cells in order to achieve the genomic recombination is provided in the form of a vector.
Thus, instant claims are anticipated by and/or obvious variants of the ‘729 patented claims.
Furthermore, there is no apparent reason why applicant was prevented from presenting claims corresponding to those of the instant application during prosecution of the application which matured into a patent. See In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968). See also MPEP § 804.
See, for example, originally presented claim 47 filed May 15, 2017, “a vector…”, and amended claim 47 filed March 19, 2018, “a vector…”, in 15/442,857.
4. Claims 68-85 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 10,070,631, since the claims, if allowed, would improperly extend the “right to exclude” already granted in the patent. The subject matter claimed in the instant application is fully disclosed in the patent and is covered by the patent since the patent and the application are claiming common subject matter.
‘631 claims a rodent whose genome comprises a heterologous nucleic acid encoding…. Tmprss2 (claims 1-7), Tmprss4 (claims 8-13), or Tmprss11D (claims 14-22),
wherein the humanized Tmprss2 gene encodes a humanized Tmprss2 protein that comprises (i) an ectodomain of the human TMPRSS2 protein encoded by the human TMPRSS2 gene, and (ii) a cytoplasmic and transmembrane portion encoded by the endogenous rodent Tmprss2 gene;
wherein the humanized Tmprss4 gene encodes a humanized Tmprss4 protein that comprises (i) an ectodomain of the human TMPRSS4 protein encoded by the human TMPRSS4 gene, and (ii) a cytoplasmic and transmembrane portion encoded by the endogenous rodent Tmprss4 gene; and
wherein the humanized Tmprss11D gene encodes a humanized Tmprss4 protein that comprises (i) an ectodomain of the human TMPRSS11D protein encoded by the human TMPRSS11D gene, and (ii) a cytoplasmic and transmembrane portion encoded by the endogenous rodent Tmprss11D gene.
Those of ordinary skill in the art immediately recognize that the heterologous nucleic acid introduced into the ES cells in order to achieve the genomic recombination, thereby yielding the transgenic rodent, is provided in the form of a vector.
Thus, instant claims are anticipated by and/or obvious variants of the ‘631 patented claims.
Furthermore, there is no apparent reason why applicant was prevented from presenting claims corresponding to those of the instant application during prosecution of the application which matured into a patent. See In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968). See also MPEP § 804.
See, for example, originally presented claim 47 filed May 15, 2017, “a vector…”, and amended claim 47 filed March 19, 2018, “a vector…”, in 15/442,857.
5. Claims 68-85 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 10,070,632, since the claims, if allowed, would improperly extend the “right to exclude” already granted in the patent. The subject matter claimed in the instant application is fully disclosed in the patent and is covered by the patent since the patent and the application are claiming common subject matter.
‘632 claims a rodent whose genome comprises a heterologous nucleic acid encoding…. Tmprss.
wherein the humanized Tmprss2 gene encodes a humanized Tmprss protein that comprises (i) an ectodomain of the human TMPRSS protein encoded by the human TMPRSS gene, and (ii) a cytoplasmic and transmembrane portion encoded by the endogenous rodent Tmprss gene.
The disclosure of ‘632 defines and provides written description of the claimed cognate human Tmprss2, Tmprss4, and Tmprss11D ectodomains to be encoded by the heterologous nucleic acid, thereby generating the transgenic rodents.
The disclosure of '632 defines and provides written description of the claimed cognate human Tmprss2 ectodomain to be encoded by the nucleotide sequences of coding exon 4 through the stop codon in coding exon 13 of the human TMPRSS2 gene (e.g. Abstract; Figures 1b and 1c; col. 3, lines 33-39; Example 1) and exons 1-2 of the endogenous rodent Tmprss2 (e.g. col. 3, lines 50-60).
The disclosure of '632 defines and provides written description of the claimed cognate human Tmprss4 ectodomain to be encoded by the nucleotide sequences of coding exon 4 through the stop codon in coding exon 13 of the human TMPRSS4 gene (e.g. Abstract; Figures 2b and 2c; col. 4, lines 48-51; Example 2). and exons 1-3 of the endogenous rodent Tmprss4 (e.g. col. 4, lines 43-51).
The disclosure of '632 defines and provides written description of the claimed cognate human Tmprss11d ectodomain to comprise coding exon 3 through the stop codon in coding exon 10 of the human TMPRSS11d gene (e.g. Abstract; Figures 3b-3c; col. 5, lines 16-36; Example 3). and exons 1-2 of the endogenous rodent Tmprss11d (e.g. col. 5, lines 30-40).
Those of ordinary skill in the art immediately recognize that the heterologous nucleic acid introduced into the ES cells in order to achieve the genomic recombination, thereby yielding the transgenic rodent, is provided in the form of a vector, as per claim 8.
Thus, instant claims are anticipated by and/or obvious variants of the ‘632 patented claims.
Furthermore, there is no apparent reason why applicant was prevented from presenting claims corresponding to those of the instant application during prosecution of the application which matured into a patent. See In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968). See also MPEP § 804.
See, for example, originally presented claim 47 filed May 15, 2017, “a vector…”, and amended claim 47 filed March 19, 2018, “a vector…”, in 15/442,857.
6. Claims 68-85 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 10,070,632, in view of de Aberasturi et al (British J. Cancer 112: 4-8, doi.10.1038/bjc.2014.403, 2015; available online September 9, 2014; of record in IDS), NCBI NG_047085.1 (human TMPRSS2, 2017; of record), NCBI NB_011858 (human TMPRSS4, 2014; of record in IDS), and NCBI NP_004253.1 (human TMPRSS11D, March 15, 2015; of record in IDS).
The disclosure of '632 defines and provides written description of the claimed cognate human Tmprss2 ectodomain to be encoded by the nucleotide sequences of coding exon 4 through the stop codon in coding exon 13 of the human TMPRSS2 gene (e.g. Abstract; Figures 1b and 1c; col. 3, lines 33-39; Example 1) and exons 1-2 of the endogenous rodent Tmprss2 (e.g. col. 3, lines 50-60).
The disclosure of '632 defines and provides written description of the claimed cognate human Tmprss4 ectodomain to be encoded by the nucleotide sequences of coding exon 4 through the stop codon in coding exon 13 of the human TMPRSS4 gene (e.g. Abstract; Figures 2b and 2c; col. 4, lines 48-51; Example 2). and exons 1-3 of the endogenous rodent Tmprss4 (e.g. col. 4, lines 43-51).
The disclosure of '632 defines and provides written description of the claimed cognate human Tmprss11d ectodomain to comprise coding exon 3 through the stop codon in coding exon 10 of the human TMPRSS11d gene (e.g. Abstract; Figures 3b-3c; col. 5, lines 16-36; Example 3). and exons 1-2 of the endogenous rodent Tmprss11d (e.g. col. 5, lines 30-40).
The claims, if allowed, would improperly extend the “right to exclude” already granted in the patent. The subject matter claimed in the instant application is fully disclosed in the patent and is covered by the patent since the patent and the application are claiming common subject matter.
With respect to Claim 69, wherein the TMPRSS2 ectodomain comprises amino acid residues W106 to G492 of SEQ ID NO:4, the disclosure of ‘632 defines and provides written description of the claimed human ectodomain to comprise amino acid residues W106 to G492 of SEQ ID NO:4 (Figure 1d; col. 3, lines 15-16; col. 9, line 64, “Ectodomain begins at W106”).
Furthermore, NCBI NG_047085.1 (2017; of record) evidences that the human TMPRSS2 ectodomain was previously recognized to naturally comprise amino acid residues W106 to G492 of SEQ ID NO: 4.
With respect to Claim 75, wherein the ectodomain comprises amino acid residues K54-L437 of SEQ ID NO: 11, the disclosure of ‘632 defines and provides written description of the claimed human ectodomain to comprise amino acid residues K54-L437 of SEQ ID NO: 11 (Figure 2d; col. 4, lines 20-22; col. 10, line 12, “Ectodomain begins at K54”).
Furthermore, Aberasturi et al evidences that the human TMPRSS4 ectodomain was previously recognized to naturally comprise amino acid residues K54-L437 of SEQ ID NO: 4 (pg 5, Figure 1).
With respect to Claim 81, wherein the TMPRSS11d ectodomain comprises amino acid residues A42 to I418 of SEQ ID NO: 18, the disclosure of ‘632 defines and provides written description of the claimed human ectodomain to comprise amino acid residues A42 to I418 of SEQ ID NO: 18 (Figure 3d; col. 5, lines 3-4; col. 10, line 65, “Ectodomain begins at A42”).
Furthermore, NCBI NP_004253.1 (2015; of record) evidences that the human TMPRSS11d ectodomain was previously recognized to naturally comprise amino acid residues A42 to I418 of SEQ ID NO: 18.
With respect to Claims 73, 79, and 85, ‘632 claims (claims 2, 6-7, and 12-20) wherein the rodent ES cell is a mouse ES cell or a rat ES cell.
Those of ordinary skill in the art immediately recognize that transgenic rodents, as per ‘632 claims 1, 7, 9-10, and 12-20) are naturally derived from, and develop from, the corresponding transgenic ES cells.
Thus, the instant claims are considered obvious variants of the patented claims.
Furthermore, there is no apparent reason why applicant was prevented from presenting claims corresponding to those of the instant application during prosecution of the application which matured into a patent. See In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968). See also MPEP § 804.
See, for example, originally presented claims 18-46 filed February 27, 2017 in 15/442,857.
Conclusion
7. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN K. HILL whose telephone number is (571)272-8036. The examiner can normally be reached 12pm-8pm EST.
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KEVIN K. HILL
Examiner
Art Unit 1638
/KEVIN K HILL/Primary Examiner, Art Unit 1638
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