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 .
Applicant’s cancellation of claims 2, 3, amendment of claim 1, in the paper of 7/9/2026, is acknowledged. Applicants' arguments filed on 7/9/2026, have been fully considered and are deemed to be persuasive to overcome some of the rejections previously applied. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. Claims 1, 4-15 are still at issue and are present for examination.
Election/Restrictions
Applicant's election without traverse of the Group I, to a pharmaceutical composition comprising SEQ ID NO:2, claims 1-6, in the paper of 3/17/2026, is acknowledged.
Claims 7-15 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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, 4-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-9, 11-14, and 17 are directed to a law of nature or a natural phenomenon. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons stated below.
This rejection was stated in the previous office action as it applied to previous claims 1-6. In response to the rejection applicants have minorly amended the claims and traverse the rejection as it applies to the amended claims.
The “2014 Interim Guidance on Patent Subject Matter Eligibility” 79 FR 74618 (Dec. 16, 2014) directs that claims drawn to 1) a composition of matter, 2) a law of nature or a natural phenomenon and 3) lacking recitation of additional elements that make the claims directed to significantly more than a judicial exception are ineligible for patenting under 35 U.S.C. 101. See, 79 FR, page 74621 (flow chart). Nature-based compositions of matter are not directed to significantly more than a judicial exception when the claimed "naturally occurring products and some man-made products ... are essentially no different from a naturally occurring product ... that fall under the laws of nature or natural phenomena exception.” 79 FR, page 74623, left column. That is, a patent-eligible composition of matter must be "markedly different" in terms of the "product's structure, function, and/or other properties." 79 FR, page 74623, center column. Further, processes directly to isolating nature-based compositions of matter have also been found to be directed to nothing more than a judicial exception when only routine purification techniques are employed. 79 FR, page 74622, center column (e.g. isolating DNA or other nature-based products).
Here, the protein of SEQ ID NO:2 is a naturally occurring polypeptide (Guo et al. (Mol. BioSyst. Vol 7, pp 2286-2295, 2011). The features of claims 1, 4-6 are met by the protein of SEQ ID NO:2 or a solution thereof in water. Since the features of the claims are met by the structure of a naturally occurring protein or composition, the claims do not recite additional features or elements that amount to significantly more than the judicial exception, since the structure recited in claims 1. 4-6 is "essentially no different from a naturally occurring product” such that there is no marked difference in the "product's structure, function, and/or other properties." Furthermore, while claims 5 additionally recite a pharmaceutically acceptable carrier, and/or one or more of a pharmaceutically acceptable diluent, and one or more of a pharmaceutically acceptable excipient does not amount to significantly more than the judicial exception as the addition of a buffer, or particularly phosphate buffered saline to a protein is routine and conventional in the art as proteins are well known to be pH sensitive.
Applicants Response
Applicants submit that the premise is factually incorrect. Applicants submit that as described in the specification [at p. 18, paragraph 2], SEQ ID NO:2 is a 159-amino-acid polypeptide corresponding to a fragment produced by cleavage of the full-length, 293-amino-acid protein (SEQ ID NO:1). Applicants submit that the naturally occurring molecule is the full-length 293-residue protein; the 159-residue polypeptide of SEQ ID NO:2 does not occur in nature as a discrete molecule.
Applicants submit that as amended, claim 1 recites a composition comprising a polypeptide “consisting essentially of the amino acid sequence of SEQ ID NO:2.”. Applicants submit that the claimed polypeptide is markedly different from its closest naturally occurring counterpart in both structure and function. Applicants submit that structurally, it lacks 134 of the 293 residues of the natural protein and functionally, the full-length 40S ribosomal protein S2 participates in ribosome assembly and translation, whereas the claimed polypeptide, in a therapeutically effective amount, lowers blood glucose to less than 200 mg/dL which is an activity not attributed to the natural protein in its native form located in the ribosome. Under Association for Molecular Pathology v. Myriad Genetics, Inc. and the Office’s Subject Matter Eligibility Guidance, a product that is structurally and functionally markedly different from any naturally occurring product is patent-eligible.
Applicants amendment of the claims and applicants complete argument is acknowledged and has been carefully considered, however, is not found persuasive for the reasons previously made of record and for those reasons repeated herein.
In response to applicants submission that as described in the specification SEQ ID NO:2 is a 159-amino-acid polypeptide corresponding to a fragment produced by cleavage of the full-length, 293-amino-acid protein (SEQ ID NO:1), this is acknowledged, however applicants claim language continues to read on the full-length 293 residue protein.. In response to applicants submission that the naturally occurring molecule is the full-length 293-residue protein and the 159-residue polypeptide of SEQ ID NO:2 does not occur in nature as a discrete molecule., while this is acknowledged, applicants claimed language continues to read on the full length naturally occurring 293 residue molecule.
In response to applicants submission that structurally, it lacks 134 of the 293 residues of the natural protein and functionally, the full-length 40S ribosomal protein S2 participates in ribosome assembly and translation, whereas the claimed polypeptide, in a therapeutically effective amount, lowers blood glucose to less than 200 mg/dL which is an activity not attributed to the natural protein in its native form located in the ribosome this is not found persuasive for the reasons previously stated and repeated above. It continues that “consisting essentially of the amino acid sequence of SEQ ID NO:2.” continues to read on the 293 residue naturally occurring polypeptide of SEQ ID NO:1. Use of the phrase “consisting essentially of” allows for additional components or sequence as long as they do not materially change the basis and novel characteristics of the invention.
In response to applicants submission that claim 1 relates to a pharmaceutical composition, which is substantially different from any composition found in nature, as stated previously and repeated above, a pharmaceutically acceptable carrier, and/or one or more of a pharmaceutically acceptable diluent, and one or more of a pharmaceutically acceptable excipient does not amount to significantly more than the judicial exception as the addition of a buffer, or particularly phosphate buffered saline to a protein is routine and conventional in the art as proteins are well known to be pH sensitive.
In response to applicants submission that an RPS2 fragment (identified herein as SEQ ID NO:2) is substantially different than the full RPS2 structural protein bound to the 40S ribosomal subunit found in cells, while the difference between a RPS2 fragment such as SEQ ID NO:2 and the full length ROS2 structural protein bound to the 40S ribosomal subunit found in cells, is appreciated, as stated above applicants claims are not drawn to a polypeptide consisting of the fragment of SEQ ID NO: but rather “consisting essentially of the amino acid sequence of SEQ ID NO:2”.
In response to applicants submission that claim 1 is substantially different from a natural composition insofar that the pharmaceutical compositions require a “therapeutically effective amount” of the polypeptide consisting essentially of the amino acid sequence of SEQ ID NO:2, this is not found persuasive on the basis that applicants claims have not defined what amount is considered to be a “therapeutically effective amount” and as such any amount even as small as that cited by applicant in their rebuttal is considered to be a “therapeutically effective amount”, especially since the intended purpose of the “therapeutically effective amount” has not been defined.
As such, the claims recite patent ineligible subject matter for the reasons stated.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The rejection of claim(s) 1-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Guo et al. (Mol. BioSyst. Vol 7, pp 2286-2295, 2011) is withdrawn based upon applicants amendment of the claims and applicants arguments presented in the paper of 7/9/2026. Guo et al. does not teach a pharmaceutical composition comprising a therapeutically effective amount of a polypeptide consisting essentially of the amino acid sequence of SEQ ID No. 2, wherein the therapeutically effective amount is an amount sufficient to lower blood glucose level in a subject to less than 200 mg/dL.
Claims 1, 4-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stearns et al. (US 2010/0221753).
This rejection was stated in the previous office action as it applied to previous claims 1-6. In response applicants traverse the rejection as it applies to newly amended claims 1, 4-6, however, applicants traversal is found non-persuasive for the reasons previously made of record and for those reasons repeated herein.
Stearns et al. teach the PCADM-1 polypeptide (SEQ ID NO:2 of Stearns et al.) which has 100% identity to SEQ ID NO:2. Stearns et al. further teach pharmaceutical compositions of said polypeptide [0094] and teach that said compositions can be prepared in formulations suitable for oral parenteral and topical administration [0443] can be solid formulation [0444], can comprise pharmaceutically acceptable carriers, diluents [0441] or excipients [0458] or buffer [0485]and that pharmaceutically acceptable carriers include salt solutions of phosphates [0440]. Furthermore although Stearns et al. do not teach or suggest that the disclosed composition of PCADM-1 has an activity of reducing blood pressure when administered to a subject, the recitation of an intended use of a composition has no patentable weight as intended use does not limit the composition itself and thus Stearns et al. anticipates claims 4-6 also.
Applicants Response
Applicants submit that the office acknowledges the Stearns PCADM-1 polypeptide has “99% identity to SEQ ID NO:2” (Office Action, p. 10)—that is, PCADM-1 is not identical to SEQ ID NO:2. Applicants submit that anticipation requires identity, not similarity. Applicants submit that because Stearns discloses a 99%-identical variant rather than the amino acid sequence of SEQ ID NO:2 itself, Stearns does not disclose a polypeptide consisting essentially of SEQ ID NO:2 and cannot anticipate the claims. Stearns’s additional disclosures regarding formulation, carriers, and buffers do not cure this deficiency.
Applicants submit that as with Guo, Stearns also does not disclose the recited therapeutically effective amount sufficient to lower blood glucose to less than 200 mg/dL. The § 102 rejection over Stearns is respectfully traversed.
Applicants amendment of the claims and applicants complete argument is acknowledged and has been carefully considered, however, is found no-persuasive for the reasons previously made of record and for those reasons repeated herein.
In response to applicants submission that the office acknowledges the Stearns PCADM-1 polypeptide has “99% identity to SEQ ID NO:2” (Office Action, p. 10)—that is, PCADM-1 is not identical to SEQ ID NO:2, this is not accurate, as SEQ ID NO:2 of Stearns is 100% identical to instant SEQ ID NO:2. (It is noted that the previous reference to 99% identity was based upon applicants previous sequences in the parent cases as well as what was the previous claims were limited to). In response to applicants submission that that because Stearns discloses a 99%-identical variant rather than the amino acid sequence of SEQ ID NO:2 itself, Stearns does not disclose a polypeptide consisting essentially of SEQ ID NO:2 and cannot anticipate the claims, is not found persuasive as Sterns discloses a polypeptide which is 100% identical to instant SEQ ID NO:2 and thus discloses a polypeptide consisting essentially of the amino acid sequence of SEQ ID NO:2.
Thus, claims 1, 4-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stearns et al. (US 2010/0221753).
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.
Claims 1, 4-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10,548,941. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-5 of U.S. Patent No. 10,548,941 drawn a pharmaceutical composition comprising a therapeutically-effective amount of a polypeptide of SEQ ID NO: 1, wherein the therapeutically effective amount is sufficient to lower blood glucose level in a subject to less than 200 mq/dL anticipates claims 1, 4-6 drawn to a pharmaceutical composition comprising a therapeutically effective amount of a polypeptide according to SEQ ID No. 2.
In response to this rejection applicants have stated that they are submitting herewith a Terminal Disclaimer under 37 CFR 1.321(c) with respect to U.S. Patent No. 10,548,941, however no such Terminal Disclaimer has been received or is found in the application file.
Claims 1, 4-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10,751,384. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-13 of U.S. Patent No. 10,751,384 drawn method for treating at least one of diabetes, hyperglycemia, hypercholesterolemia, and hypertension in a subject, comprising: administering to the subject a pharmaceutical formulation comprising a therapeutically effective amount of a polypeptide having at least 95% identity to SEQ ID NO:1 and able to reduce blood glucose levels to less than 200 mg/dl, reduce cholesterol levels to less than 200 mg/dl, and/or lower blood pressure to less than 140/90 mmHg when administered to a diabetic subject make obvious claims 1, 4-6 drawn to a pharmaceutical composition comprising a therapeutically effective amount of a polypeptide according to SEQ ID No. 2.
In response to this rejection applicants have stated that they are submitting herewith a Terminal Disclaimer under 37 CFR 1.321(c) with respect to U.S. Patent No. 10,548,941, however no such Terminal Disclaimer has been received or is found in the application file.
Remarks
No claim is allowed.
Conclusion
THIS ACTION IS MADE FINAL. 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 RICHARD G HUTSON whose telephone number is (571)272-0930. The examiner can normally be reached 6-3 EST Mon-Fri.
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rgh
8/25/2026
/RICHARD G HUTSON/Primary Examiner, Art Unit 1652
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