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 .
Status of Claims
The claim set filed 9/4/26 is under consideration.
Claims 1-3 are pending and under consideration.
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 1-3 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claims 1 do not recite something significantly different than a judicial exception. The rationale for this determination is explained below and is based on the analysis presented in the USPTO’s 2019 Revised Patent subject matter Eligibility Guidance (referred to as 2019 PEG) published January 2019 and the “PEG update” in October 2019.
Claim Interpretation
Claims 1-3 are drawn to a non-recombinant IGFBP-3 stock calibration solution for automated immunoassay equipment, wherein the non-recombinant human IGFBP-3 is disposed in an aqueous buffered medium, such as borate, phosphate, TRIS…wherein the aqueous buffered medium has a pH in the range of about 7-9 and the calibration solution has an nr-IGFBP-3 concentration ranging from about 16-40 µg/ml and wherein the calibration solution contains no recombinant IGFBP-3.
Subject Matter Eligibility Test for Products and Processes
Step 1: Is the claim to a process, machine, manufacture, or composition of matter (see, e.g., 79 FR 74621)?
Yes, the instant claims are directed to a statutory patent-eligible subject matter category, namely a composition of matter.
Step 2A (1): Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea (see, e.g., 79 FR 74621)?
Yes, the claims are directed to a natural phenomenon. Specifically, the claims are drawn to a naturally occurring human IGFBP-3 in a composition with a buffer. As evidenced by the instant claims, IGFBP-3 is a naturally occurring hormone [0003]. The limitation “calibration stock solution for automated immunoassay equipment” is regarded as the “intended use” of the composition and does not further limit the claims draw to the composition or product.
Accordingly, the pending claims are directed to a naturally occurring product.
Step 2A (2): Does the Claim recite additional Elements that integrate the judicial Exception into a Practical Application?
No, the claim does not recite additional elements that integrate the judicial exception into a practical application.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception (see, e.g., 79 FR 74621)?
No, the claims do not recite additional elements that amount to significantly more than the judicial exception. The concentration, pH and different aqueous buffers do not make the naturally occurring protein significantly different. The nr-IGFBP-3 in a phosphate buffer (pH=7.4) does not render the nr-IGFBP-3 markedly different that what naturally occurs.
Factors for determining if the claim directed to a product of nature, as a whole, recites something significantly more than the judicial exception, are provided in the Guidance (74623; see esp. 79 FR 74623 at §I.A.3.b). see also, 79 FR.
In sum, when the relevant considerations are analyzed, they weigh against a significant difference. Accordingly, claims 1-3 do not qualify as eligible subject matter.
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 1-3 are 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.
Regarding claim 1, the limitation “i.e.” in parenthesis renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention.
Claims 2-3 are rejected for depending from the rejected claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Clark et al. (USPN 5,187,151 cited on the IDS) as evidenced by Sigma Aldrich (<https://www.sigmaaldrich.com/catalog/product/sigma/1805?lang=en®ion=US&gclid=EAIaIQobChMI7aa9jerF6wIVQQiICR1IEw7VEAAYAyAAEgK-YfD_BwE> accessed 9/16/26).
Clark et al. teach solutions comprising IGFBP-3 (Abstract, col. 10,Exp 1-2).
With respect to the limitation in the preamble “...protein stock calibration solution for automated immunoassay equipment”, please note that MPEP 2111.02 II states "a preamble generally is not limiting when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention." In the instant case, the claim body describes a structurally complete invention. The preamble in this case recites a statement of purpose or use, and therefore was not treated as a claim limitation. Furthermore, the limitation “for automated immunoassay equipment”, please note that it is regarded that "intended use" of a composition or product will not further limit claims drawn to a composition or product. See, e.g., Ex parte Masham, 2 USPQ2d 1647 (1987) and In Re Hack 114, USPQ 161. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitation.
With respect to the limitation “non-recombinant human IGFBP-3” , Clark et al. teach the IGFBP-3 may be from humans and includes any source, whether natural, synthetic or recombinant (col. 6, lines 28-35 and claim 5). Clark et al. are suggestive of using natural IGFBP-3. Importantly, Clark et al. teach:
As used herein, "IGFBP-3' is defined as described above and in WO 89/09268 published Oct. 5, 1989 and Wood et al., Molecular Endocrinology, supra, but includes animal equivalents to human IGFBP-3 as well as human IGFBP-3, for example , the bovine, ovine, porcine and equine species (col. 6, lines 28-37).
With respect to the limitation “aqueous buffered medium” and “pH in a range from about 7.0 to about 9.0” , Clark et al. teach the formulation are prepared with liquid carriers (col. 8, lines 42-44) and carriers include buffers such as phosphate, citrate… (col. 8, lines 54-55). Clark et al. teach the IGFBPs are typically formulated at pH of about 4.5 to 8 (col. 9, lines 3-4). Moreover, as evidenced by Sigma-Aldrich (<https://www.sigmaaldrich.com/catalog/product/sigma/1805?lang=en®ion=US&gclid=EAIaIQobChMI7aa9jerF6wIVQQiICR1IEw7VEAAYAyAAEgK-YfD_BwE> accessed 8/31/2020) phosphate buffer has a pH of 7.6-7.8. Please note that MPEP 2131.01 states: that an extra reference or evidence can be used to show an inherent characteristic of the thing taught by the primary reference. In the instant case, the evidentiary reference is relied upon only to establish that the phosphate buffer of Clark et al. is characterized with the property of a pH within the claimed pH range. The MPEP 2144.05 (Obviousness of Ranges) states: “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976)
With respect to the limitation “concentration ranging from 16-40 µg/ml” (claim 1) and “within a range of about 20-30 µg/ml” (claim 2), Clarke et al. teach IGFBP-3 solutions comprising various concentrations of IGFBP-3, including 50, 100 and 200 µg/ml (Exp. 1, col. 10).Clark et al. teach that co-injected with IGF-1, so that 25, 50 and 100 µg were injected (Ex. 1, col. 10). Clarke et al. also teach a composition comprising 15 µg of IGF-1 and 40 µg of IGFBP-3 (top of col. 12). The concentration of the active agent in a composition is a result-effective variable and the determination of the optimum or workable ranges of said variable may be characterized by routine experimentation (Please see MPEP 2144 II-Optimization of Ranges). In the instant case, Clarke et al. teach solutions comprising 50, 100 and 200 µg/ml of IGFBP-3. It would have been obvious and routine experimentation to a person of ordinary skill in the art with a reasonable expectation of success to optimize the concentration of IGFBP-3, to arrive at the dose ranges of claims 1 and 2.
With respect to the limitation” wherein the calibration solution contains no recombinant IGFBP-3”, the solution of Clarke et al. is not listed as containing a recombinant IGF binding proteins.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Clark et al. (USPN 5,187,151 cited on the IDS) as evidenced by Sigma Aldrich (<https://www.sigmaaldrich.com/catalog/product/sigma/1805?lang=en®ion=US&gclid=EAIaIQobChMI7aa9jerF6wIVQQiICR1IEw7VEAAYAyAAEgK-YfD_BwE> accessed 9/16/26) as applied to claims 1-2 above, and further in view of Sigma-Aldrich (<https://www.sigmaaldrich.com/life-science/core-bioreagents/biological-buffers/learning-center/buffer-reference-center.html> available 10/26/2008).
The teachings of Clark et al. is presented above in detail. The reference does not teach the nrIGFBP-3 in PBS. The teachings of Sigma-Aldrich cure this deficiency.
Sigma-Aldrich teaches that you will want to choose a buffer based on your pH requirement and pKa. Sigma-Aldrich discloses tables to help navigate the many common buffer solutions. Sigma-Aldrich lists buffers such as PIPES, MOPS, HEPES, Bicine and Tris.
It would have been obvious to a person of ordinary skill in the art to optimize the buffer in Clark et al. to arrive at PBS or Tris as claimed in claim 3. A person would have been motivated to optimize the aqueous buffer because Clark et al. teach the formulation are prepared with liquid carriers and the carriers include buffers such as phosphate, citrate etc. Moreover, Sigma-Aldrich teaches tables of commonly used buffers that are commercially available, which includes TRIS buffer. There is a reasonable expectation of success given that it is common in the art to optimize the buffers. Moreover, buffers such as TRIS and PBS are commonly used in the art and commercially available.
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 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,167,255. Although the claims at issue are not identical, they are not patentably distinct from each other because the USPN claims IGFBP-3 stock calibration solution for automated immunoassay equipment, wherein the calibration solution comprises a nr human IGFBP-3 and an aqueous buffered medium comprising borate, phosphate…,wherein the aqueous buffered medium has a pH of 7 to 9 and the calibration solution has a concentration ranging from 16-40µg/ml and does not contain recombinant IGFBP-3. Therefore, the USPN anticipates the instant claims.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TARA L MARTINEZ whose telephone number is (571)270-1470. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/TARA L MARTINEZ/Primary Examiner, Art Unit 1654
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