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 .
Claims 1-15 are still at issue and are present for examination.
Applicants attention is directed to the proper method of amending the claims as per MPEP 714, 37 CFR 1.121 Manner of making amendments in application. Applicants attention is directed to the claims 7-15 which applicants list as “(Withdrawn)” but show no text for the claims.
37 CFR 1.121 Manner of making amendments in applications
(3) When claim text in clean version is required. The text of all pending claims not being currently amended shall be presented in the claim listing in clean version, i.e., without any markings in the presentation of text. The presentation of a clean version of any claim having the status of "original," "withdrawn" or "previously presented" will constitute an assertion that it has not been changed relative to the immediate prior version, except to omit markings that may have been present in the immediate prior version of the claims of the status of "withdrawn" or "previously presented." Any claim added by amendment must be indicated with the status of "new" and presented in clean version, i.e., without any underlining.
(4) When claim text shall not be presented; canceling a claim.
(i) No claim text shall be presented for any claim in the claim listing with the status of "canceled" or "not entered."
(ii) Cancellation of a claim shall be effected by an instruction to cancel a particular claim number. Identifying the status of a claim in the claim listing as "canceled" will constitute an instruction to cancel the claim.
As per the above, the status of claims 7-15 as withdrawn is recognized, however, the text of the withdrawn claims should be present in applicants claim list.
Please use proper markings in all future amendments. This is required to clarify the record and prosecution and avoid issues that result from a lack of clarity of the record and prosecution.
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.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609 A(1) states, "the list may not be incorporated into the specification but must be submitted in a separate paper."
Currently there are no information disclosure statements in the application file.
Specification
The disclosure is objected to because of the following informalities:
The use of the terms: Tween (page 14, line 4) which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
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 1-6 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.
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 1-6 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 1-6 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.
As such, the claims recite patent ineligible subject matter for the reasons stated.
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.
Claims 1-6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a pharmaceutical composition comprising a therapeutically-effective amount of a polypeptide of SEQ ID NO: 2, wherein the therapeutically effective amount is sufficient to lower blood glucose level in a subject to less than 200 mg/dL thereof does not reasonably provide enablement for any pharmaceutical composition comprising a therapeutically effective amount of a polypeptide according to SEQ ID No. 2. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Claims 1-6 are so broad as to encompass any polypeptide having 80% identity to any of SEQ ID NO:2 and fragments and compositions thereof. The scope of the claims is not commensurate with the enablement provided by the disclosure with regard to the extremely large number of polypeptides/compositions broadly encompassed by the claims. Since the amino acid sequence of a protein determines its structural and functional properties, predictability of which changes can be tolerated in a protein's amino acid sequence and obtain the desired activity requires a knowledge of and guidance with regard to which amino acids in the protein's sequence, if any, are tolerant of modification and which are conserved (i.e. expectedly intolerant to modification), and detailed knowledge of the ways in which the proteins' structure relates to its function. However, in this case the disclosure is limited to a showing that the polypeptide of SEQ ID NO:1 is capable of reducing fasting blood glucose levels, reducing hepatic glucose production, reducing cholesterol levels, reducing glucagon levels, and reducing blood pressure when administered to a diabetic subject. It is noted that the specification includes no showing that a polypeptide having a mere 80% sequence identity to the polypeptide of SEQ ID NOS:2 have the same activity as that of SEQ ID NO:1. While Figure 17 shows that the polypeptide of SEQ ID NO:2 is capable of increasing the growth of human dermal microvascular endothelial cells in a similar fashion to SEQ ID NO:1, the specification does not provide sufficient correlation of this activity to those of reducing fasting blood glucose levels, reducing hepatic glucose production, reducing cholesterol levels, reducing glucagon levels, and reducing blood pressure when administered to a diabetic subject nor provide any teaching of a use of polypeptides exhibiting the capability of increasing the growth of human dermal microvascular endothelial cells such the specification includes limited showing that any of the peptides of SEQ ID NOS:2 can be used as taught for the polypeptide of SEQ ID NO:1.
While recombinant and mutagenesis techniques are known, it is not routine in the art to screen for multiple substitutions or multiple modifications, as encompassed by the instant claims, and the positions within a protein's sequence where amino acid modifications can be made with a reasonable expectation of success in obtaining the desired activity/utility are limited in any protein and the result of such modifications is unpredictable. In addition, one skilled in the art would expect any tolerance to modification for a given protein to diminish with each further and additional modification, e.g. multiple substitutions.
The specification does not support the broad scope of the claims which encompass any polypeptide having 80% identity to any of SEQ ID NO:2 and fragments and compositions thereof because the specification does not establish: (A) regions of the protein structure which may be modified without effecting activity to reduce fasting blood glucose levels, reduce hepatic glucose production, reduce cholesterol levels, reduce glucagon levels, and/or reduce blood pressure when administered to a diabetic subject; (B) the general tolerance of 40S ribosomal protein S2 to modification and extent of such tolerance; (C) a rational and predictable scheme for modifying any amino acid residues with an expectation of obtaining the desired biological function; and (D) the specification provides insufficient guidance as to which of the essentially infinite possible choices is likely to be successful.
Thus, applicants have not provided sufficient guidance to enable one of ordinary skill in the art to make and use the claimed invention in a manner reasonably correlated with the scope of the claims broadly including any polypeptide having 80% identity to any of SEQ ID NO:2and fragments and compositions thereof. The scope of the claims must bear a reasonable correlation with the scope of enablement (In re Fisher, 166 USPQ 19 24 (CCPA 1970)). Without sufficient guidance, determination of polypeptides/compositions having the desired biological characteristics is unpredictable and the experimentation left to those skilled in the art is unnecessarily, and improperly, extensive and undue. See In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988).
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.
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).
Guo et al. teach the preparation of recombinant human 40s ribosomal protein S2 (i.e., SEQ ID NO:1, 100% identical to instant SEQ ID NO:2) in PBS buffer, a pharmaceutically acceptable carrier, diluent and excipient (see page 2287). It is noted that said composition would be suitable for oral, parenteral, or topical application and thus this composition anticipates all of claims 3-6. Furthermore although Guo et al. do not teach or suggest that the disclosed composition of human 40s ribosomal protein S2 has an activity selected from reducing hepatic glucose production, reducing insulin resistance, reducing cholesterol levels, reducing glucagon levels, and 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 Guo et al. anticipates claims 3-6 also.
Thus, 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).
Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stearns et al. (US 2010/0221753).
Stearns et al. teach the PCADM-1 polypeptide (SEQ ID NO:2 of Stearns et al.) which has 99% 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 3-6 also.
Thus, claims 1-6 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 1-6 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 1-7 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--6 drawn to a pharmaceutical composition comprising a therapeutically effective amount of a polypeptide according to SEQ ID No. 2.
Claims 1-6 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--6 drawn to a pharmaceutical composition comprising a therapeutically effective amount of a polypeptide according to SEQ ID No. 2.
Remarks
No claim is allowed.
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
4/3/2026
/RICHARD G HUTSON/Primary Examiner, Art Unit 1652