DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
The instant application was filed 09/03/2024 and is a continuation of 17929958 , filed 09/06/2022, which is a continuation of 16987070 , filed 08/06/2020, which is a continuation of 15896027, which is a continuation of 15176950 , filed 06/08/2016, which is a continuation of 13628541, filed 09/27/2012 which is a continuation of 11679657 , filed 02/27/200, which claims priority from provisional application 60776970, filed 02/27/2006.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/23/2024 is being considered by the examiner.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, 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 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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 statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - The incorporation by reference paragraph required by 37 CFR 1.834(c)(1), 1.835(a)(2), or 1.835(b)(2) is missing, defective or incomplete. The paragraph provides size in KB not bytes.
Required response - Applicant must:
• 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.
Claim Objections
Claims 1-3 are objected to because of the following informalities:
The application fails to comply with CFR 1.821(d), which states:
(d)Where the description or claims of a patent application discuss a sequence that is set forth in the “Sequence Listing” in accordance with paragraph (c) of this section, reference must be made to the sequence by use of the sequence identifier, preceded by “SEQ ID NO:” in the text of the description or claims, even if the sequence is also embedded in the text of the description or claims of the patent application.
However, the Claims recite, “SEQ ID No.” or “SEQ ID. No.” .
Appropriate correction is required.
Claim Rejections - 35 USC § 101
Claims 1-3 are not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claim(s) 1-3 do not recite something significantly different than a judicial exception. The rationale for this determination is explained below:
The claims are directed to a multimer therapeutic agent comprising different isolated amino acid sequence selected from the group consisting of SEQ ID NO: 21-SEQ ID NO: 24.
Applicants specification (page 12) sets forth that SEQ ID NO: 21, SEQ ID NO: 23, and SEQ ID NO: 24 are all obtained from the CEACAM1 protein.
Muchova et al (Biomedical Chromatography Vol. 15, pp 418-422, 2001) disclose of isolating CEACAM1 from hepatic bile. (See pages 418-419).
Accordingly, the CEACAM1 polypeptide isolated from bile inherently contains each of SEQ ID NO: 21, SEQ ID NO: 23, and SEQ ID NO: 24, as it is the same protein from which each of these peptides were obtained.
The claims are drawn to naturally occurring polypeptides are not patent eligible merely because they have been isolated.
Applicants are respectfully directed to the nature based product examples published by the USPTO. Example 3 is drawn to a claim of purified amazonic acid. Although Applicant has discovered that amazonic acid naturally occurs in the leaves of the Amazonian cherry tree, this discovery does not, by itself, render amazonic acid patent eligible. Association for Molecular Pathology v. Myriad Genetics, Inc. 569 U.S.__, 133 S. Ct. 2107, 2117 (2013). Instead the claim is analyzed to determine if separating the acid from its surrounding material in the leaf has resulted in the purified amazonic acid having markedly different characteristics from its naturally occurring counterpart.
Based on the limited background information, there is no indication that the isolated polypeptide has any characteristics (structural, functional, or otherwise) that are different from naturally occurring polypeptides. Because there is no difference between the claimed and naturally occurring polypeptide, the claimed polypeptide does not have markedly different characteristics from what occurs in nature, and this is a product of nature exception.
http://www.uspto.gov/patents/law/exam/mdc_examples_nature-based_products.pdf
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-3 are rejected under pre-AIA 35 U.S.C. 102b as being anticipated by Muchova et al (Biomedical Chromatography Vol. 15, pp 418-422, 2001).
Applicants specification (page 12) sets forth that SEQ ID NO: 21, SEQ ID NO: 23, and SEQ ID NO: 24 are all obtained from the CEACAM1 protein.
Muchova et al (Biomedical Chromatography Vol. 15, pp 418-422, 2001) disclose of isolating CEACAM1 from hepatic bile. (See pages 418-419).
Claim(s) 1 and 3 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Stanners (WO99/41370).
Stanners teaches SEQ ID NO 21 and SEQ ID NO 24 in Figure 9. Thus the claim anticipates the claims.
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 1-2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2of U.S. Patent No. 8,298,544. Although the claims at issue are not identical, they are not patentably distinct from each other because They are coextensive in scope.
Instant claims are drawn to a multimer therapeutic agent comprising different isolated amino acid sequences selected from the group consisting of SEQ ID No. 21 – SEQ ID No. 24.
The claims of 544 are drawn to a foodstuff having a multimer antipathogen agent comprising different isolated amino acid sequences selected from the group consisting of SEQ ID No.21-SEQ ID No.23, wherein said foodstuff is a milk remedy for use with children.
Thus it is prima facie obvious to one of ordinary skill in the art at the time of filing the claims of 544 are a species that anticipates the rejected claims.
Claims 1 and 2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 9,694, 046. Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope
Instant claims are drawn to a multimer therapeutic agent comprising different isolated amino acid sequences selected from the group consisting of SEQ ID No. 21 – SEQ ID No. 24.
The claims of 046 are drawn to A multimer therapeutic agent consisting of the isolated peptide SEQ ID No. 24 and at least two additional isolated peptides selected from the group consisting of SEQ ID No. 21-SEQ ID No. 23, and A multimer therapeutic agent consisting of the isolated peptide SEQ ID No. 24 and at least two additional isolated peptides selected from sequence NRQIV (SEQ ID No. 21) and QNDTG (SEQ ID No. 23).
Thus it is prima facie obvious to one of ordinary skill in the art at the time of filing the claims of 046 are a species that anticipates the rejected claims.
Claims 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 10,765,719. Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope
Instant claims are drawn to a multimer therapeutic agent comprising different isolated amino acid sequences selected from the group consisting of SEQ ID No. 21 – SEQ ID No. 24.
The claims of 719 are drawn to A multimer therapeutic agent consisting of two different isolated peptides selected from the group consisting of SEQ ID No. 21 SEQ ID No. 24.2. A multimer therapeutic agent consisting of the isolated peptides NRQIV (SEQ ID No. 21) and QNDTG (SEQ ID No. 23).3. A multimer therapeutic agent consisting of the isolated peptides NRQIV (SEQ ID No. 21) and GYSWYK (SEQ ID. No. 24).
Thus it is prima facie obvious to one of ordinary skill in the art at the time of filing the claims of 719 are a species that anticipates the rejected claims.
Claims 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11,433,113. Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope
Instant claims are drawn to a multimer therapeutic agent comprising different isolated amino acid sequences selected from the group consisting of SEQ ID No. 21 – SEQ ID No. 24.
The claims of 113 are drawn to A multimer therapeutic agent consisting of two or more different isolated peptides selected from the group consisting of SEQ ID No. 21-SEQ ID No. 24. 2. A multimer therapeutic agent consisting of the isolated peptides NRQIV (SEQ ID No. 21), NRQII (SEQ ID No. 22), and QNDTG (SEQ ID No. 23). 3. A multimer therapeutic agent consisting of the isolated peptides NRQIV (SEQ ID No. 21), NRQII (SEQ ID No. 22), and GYSWYK (SEQ ID. No. 24).
Thus it is prima facie obvious to one of ordinary skill in the art at the time of filing the claims of 113 are a species that anticipates the rejected claims.
Claims 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 12,076,365. Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope
Instant claims are drawn to a multimer therapeutic agent comprising different isolated amino acid sequences selected from the group consisting of SEQ ID No. 21 – SEQ ID No. 24.
The claims of 365 are drawn to A multimer therapeutic agent consisting of two or more different isolated peptides selected from the group consisting of SEQ ID No. 21-SEQ ID No. 24, wherein the therapeutic agent is an antipathogen agent. 2. A multimer therapeutic agent consisting of the isolated peptides NRQIV (SEQ ID No. 21), NRQII (SEQ ID No. 22), QNDTG (SEQ ID No. 23), and GYSWYK (SEQ ID. No. 24), wherein the therapeutic agent is an antipathogen agent.3. A multimer therapeutic agent consisting of the isolated peptides NRQII (SEQ ID No. 22), QNDTG (SEQ ID No. 23), and GYSWYK (SEQ ID. No. 24), wherein the therapeutic agent is an antipathogen agent.
Thus it is prima facie obvious to one of ordinary skill in the art at the time of filing the claims of 365 are a species that anticipates the rejected claims.
Claims 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. 9,889,175. Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope
Instant claims are drawn to a multimer therapeutic agent comprising different isolated amino acid sequences selected from the group consisting of SEQ ID No. 21 – SEQ ID No. 24.
The claims of 175 are drawn to A multimer therapeutic agent consisting of at least two isolated proteins selected from the group consisting of SEQ ID No. 1-SEQ ID No. 5.
SEQ ID NO 1-5 are full length CEACAMs. SEQ ID NO 1-5 comprise SEQ ID NO 21-24.
Thus it is prima facie obvious to one of ordinary skill in the art at the time the invention was made the instant claims are a obvious as they encompass the claims.
Summary
No Claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN C POHNERT PhD whose telephone number is (571)272-3803. The examiner can normally be reached Monday- Friday about 6:00 AM-5:00 PM, every second Friday off.
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/Steven Pohnert/Primary Examiner, Art Unit 1683