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 .
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 6, 9 and 10 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 6 contains the trademark/trade name Montanide ISA. 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 proprietary adjuvant that is a water-in-oil emulsion and, accordingly, the identification/description is indefinite.
Regarding claims 9 and 10, the word "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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, and 5 rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claim(s) recite(s) a fragment of the polynucleotide that codes for an arginase 1 enzyme. This judicial exception is not integrated into a practical application because the claims provide for a naturally occurring sequence.
Claim 1of the instant invention provides for a polynucleotide sequence, wherein the provided sequence codes for a fragment of an arginase 1 enzyme. Claim 5 provides for the claimed sequence, along with diluents and carriers, which can include water and saline. These claims will be analyzed under the guidance provided in MPEP 2106, particularly the flow chart provided in section III. Step 1 of the flow chart asks if the claims are drawn to a statutory category. Since the claims are drawn to a composition, the answer is “yes.” Step 2A asks if the claims are drawn to a product of nature. Based upon the prior art, and confirmed by the instant specification, the claimed polynucleotide is a coding sequence for a fragment of the naturally occurring human form of arginase 1. See Howe, et al (US Pat. 8,871,999), SEQ ID NO. 95. Since the claimed enzyme occurs in nature, its polypeptide coding sequence must also occur in nature. Therefore, the answer to step 2A is “yes.” The final step asks if the claim provides for significantly more than the judicial exception. Since claim 1 describes only the polynucleotide, and nothing more, the claimed composition must be a product of nature; this assessment is confirmed by the Office guidance regarding Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 106 USPQ2d 1972 (2013), wherein a composition drawn to a BRCA1 polynucleotide sequence was considered a product of nature. See MPEP 2106.04(b) and 2106.04(c). Since claim 5 provides for compounds like water, or saline, there does not appear to be significantly more than the judicial exception.
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, and 4-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,194,081. Although the claims at issue are not identical, they are not patentably distinct from each other because although the claims are not identical, the elements of the pending patent would be obvious to the ordinary artisan, based upon the claims provided in the ‘081 patent.
The patent provides for a fragment of the human arginase 1 polypeptide, as well as methods of using the polypeptide. Although the patent never claims the polynucleotide that codes for the polypeptide of the patent, the coding sequence for the polypeptide would be obvious to the ordinary artisan. That is to say, the ordinary artisan can look at an amino acid and know which nucleotide codon would represent it. Since it has been established that the claimed polypeptide sequence is known, any polynucleotide sequence would have also been known, and as such, obvious: “Differences may be considered patentably insufficient when they are de minimis or obvious to a designer of ordinary skill in the art.” See MPEP 1504.06(II). Additionally, since the method of the instant invention overlaps with the method of the patent, treating cancer, the claimed methods overlap.
Allowable Subject Matter
Claims 7-10 and 13-15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The method of claims 7-10 is not rejected as being statutory double patenting with the abovementioned patent because these provide for a method of treating cancer with a polynucleotide, not the polypeptide of the patent; as such, the methods are fundamentally different, since the method of the instant claim-set requires the recipient to produce the fragment, in vivo, whereas the cited patent directly administers the polypeptide.
Claims 13-15 are not considered non-statutory double patenting since it would not necessary be obvious to the ordinary artisan to take the polynucleotide sequence that codes for the polypeptide sequence of the patent, and provide it with a vector.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651
Prosecution Insights