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 Status
The amendments and remarks filed 10/27/2025 and 10/29/2025 are acknowledged.
Claims 4-26 and 29-34 are pending.
Claims 1-3 and 27-28 are canceled.
Claims 4-23 are amended.
Claims 30-34 are new.
Applicant’s election of the following species in the reply filed on 10/27/2025 is acknowledged: an antibody fragment with a molecular weight of 5 to 70 kDa and a human subject. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 15-19, 22, 24-26, and 29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species there being no allowable generic or linking claim. Election was made in the reply filed on 10/27/2025.
Therefore, claims 4-14, 20-21, 23, and 30-34 are under examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 02/13/2023 and 03/15/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Notably, the disclosure statement filed lists a Search Report. The listing of the references cited in a Search Report itself is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, "the list ... must be submitted on a separate paper." Therefore, the references cited in the Search Report have not been considered. Applicant is advised that the date of submission of any item of information or any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the IDS, including all "statement" requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Note: If copies of the individual references cited on the Search Report are also cited separately on the IDS (and these references have not been lined-through) they have been considered.
Claim Rejections - 35 USC § 112(b)
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 4-14, 20-21, 23, and 30-34 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.
Claim 4 recites the limitation “wherein extravasation of the biological therapeutic molecule is assisted.” There is insufficient antecedent basis for this limitation in the claim. The lack of antecedent basis arises from claim 4’s dependence on claim 20 where “extravasation” is not mentioned. Further, extravasation is not a form of administration and is the unintentional leakage of fluids into surrounding tissues, which can cause serious damage to a patient. Since extravasation is the unintentional leakage, it is unclear how this could also be assisted. Therefore, the scope of this claim is indefinite.
Claims 11, 14, 18, and 32-34 recite the limitation “about”. Applicant has not provided an explicit definition for “about”. Therefore, the metes and bounds for “about” are dependent on the interpretation of others for determining what is an acceptable variation of the value or parameter. Given a single value, one person of ordinary skill in the art could determine that the value is acceptable. Yet, another person of ordinary skill in the art could determine that it is unacceptable, leading to two different interpretations on if the claim infringes with “about.” Therefore, the scope of these claims are indefinite.
Claim 20 recites “A method for administering a biological therapeutic molecule to a subject in need thereof, wherein said biological therapeutic molecule is co-administered with an insulin and glucose.” However, the claim does not include any method steps and so, the language of a method “for” administering makes it unclear if the method is a particular route of administration, a procedure, or merely a method of administering a biological therapeutic molecule by co-administering with insulin and glucose. Further, it is unclear what is encompassed by “a subject in need thereof” without knowing what the biological therapeutic molecule is or what is to be treated in the subject. Therefore, the scope of this claim is indefinite.
Claims 4-14, 21, 23, and 30-34, which depend from claim 20, are therefore indefinite for the same reasons set forth above.
Claim 31 recites the limitation “wherein the insulin is administered to a human subject at a rate from 2 to 4 I.U./kg body weight/day or 3 I.U./kg body weight/day.” A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 31 recites the broad recitation 2 to 4 I.U./kg body weight/day, and the claim also recites 3 I.U./kg body weight/day which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 34 recites the limitation “wherein the acceptable glucose level is from about 70 mg/dl to about 130 mg/dl for a human subject.” There is insufficient antecedent basis for this limitation in the claim. The lack of antecedent basis arises from claim 34’s dependence on claim 20 where “a glucose level” is not mentioned. Therefore, the scope of this claim is indefinite.
The Examiner recommends amending claim 34 to depend from instant claim 9 to overcome this rejection.
Claim Rejections - 35 USC § 112(a)
Enablement
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 4-14, 20-21, 23, and 30-34 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 method of administering glucose, potassium, and insulin to treat hyperglycemia in a subject in need thereof, and for a method of administering a digoxin-specific Fab in combination with glucose and insulin to treat hyperkalemia in a subject in need thereof, does not reasonably provide enablement for a method of administering any biological therapeutic molecule in combination with an insulin and a glucose to a subject in need thereof without any requirement for what the molecule is or what is to be treated in the subject. 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.
Claim 20 is drawn to a method for administering a biological therapeutic molecule to a subject in need thereof, wherein said biological therapeutic molecule is co-administered with an insulin and a glucose. Claim 12 further limits claim 20 to wherein the biological therapeutic molecule is a polypeptide, which is an antibody, an antibody derivative, an antibody fragment, an immunoglobulin fusion protein, an interferon, an interleukin or a cytokine and claim 13 further limits claim 20 to wherein the biological therapeutic molecule is a monoclonal antibody fragment. Applicant elected the species of an antibody fragment for the biological therapeutic molecule in the reply filed on 10/27/2025.
Factors to be considered in determining whether undue experimentation is
required, are set forth in In re Wands 8 USPQ2d 1400. They include (1) the quantity of
experimentation necessary, (2) the amount of direction or guidance presented, (3) the
presence or absence of working examples, (4) the nature of the invention, (5) the state
of the prior art, (6) the relative skill of those in the art, (7) the predictability or
unpredictability of the art and (8) the breadth of the claims.
(4) The nature of the invention and (8) The breadth of the claims:
The nature of the invention is a chemical case, where there is natural unpredictability in performance of certain species or sub-combinations other than those specifically enumerated; see MPEP 2163. Accordingly, it is the Office’s position that undue experimentation would be required to use the claimed product, with a reasonable expectation of success, because it would not be predictable from the disclosure of any one particular species what other species may or may not work; see MPEP 2164.03. The claims broadly encompass any biological therapeutic molecule, specifically an antibody fragment as elected, administered to a subject in need thereof. Thus the claims are broad in that they encompass any biological therapeutic molecule, specifically any antibody fragment, and without any requirement for what the molecule is treating in the subject in need thereof.
(6) The amount of direction or guidance provided by the inventor; (7) The
existence of working examples:
Regarding the election of “an antibody fragment” for the biological therapeutic molecule, the specification does not specially define “an antibody fragment”, and therefore, “an antibody fragment” encompasses the hinge region, the framework region, or even a single amino acid of any said antibody. Further, the specification does not provide examples of any antibody fragment that is also a biological therapeutic molecule. Additionally, without knowing what is to be treated in “the subject in need thereof” with the biological therapeutic molecule, one could not determine what molecule, let alone what antibody fragment, would be therapeutic. Thus, support is not provided for the breadth of the claims.
(5) The state of the prior art and (7) The predictability or unpredictability of the art:
The art teaches administering a glucose, potassium, and insulin (GKI) infusion to stroke patients with mild to moderate hyperglycemia (see Scott et al., 1999 (instant PTO-892)). The art also teaches administering dextrose (glucose) mixed with insulin by infusion to treat hyperkalemia (see PSA, 2017 (instant PTO-892)) and administering digoxin-specific Fabs to treat hyperkalemia (see Wenger et al., 1985 (instant PTO-892)). However, the art does not teach administering any biological therapeutic molecule to treat any condition in a subject in combination with insulin and glucose.
Regarding the election of “an antibody fragment” for the biological therapeutic molecule, there is no known therapeutic function of the hinge region, framework regions, or a single amino acid of any said antibody, all of which are encompassed in “an antibody fragment.” The functional characteristics of antibodies (including binding specificity) are dictated on their structure. Amino acid sequence and conformation of each of the heavy and light chain CDRs are critical in maintaining the antigen binding specificity and affinity which is characteristic of the parent immunoglobulin. For example, Vajdos et al., 2002 (instant PTO-892) teaches that even within the Fv, antigen binding is primarily mediated by the complementarity determining regions (CDRs), six hypervariable loops (three each in the heavy and light chains) which together present a large contiguous surface for potential antigen binding. Aside from the CDRs, the Fv also contains more highly conserved framework segments which connect the CDRs and are mainly involved in supporting the CDR loop conformations, although in some cases, framework residues also contact antigen. As an important step to understanding how a particular antibody functions, it would be very useful to assess the contributions of each CDR side-chain to antigen binding, and in so doing, to produce a functional map of the antigen-binding site [page 426, left column, second paragraph-right column, first paragraph]. The art shows an unpredictable effect when making single versus multiple changes to any given CDR. For example, Brown et al., 1996 (instant PTO-892), describes how the VH CDR2 of a particular antibody was generally tolerant of single amino acid changes, however the antibody lost binding upon introduction of two amino changes in the same region [see Abstract].
Thus, the cited references demonstrate the importance of a specific combination of CDRs for an antibody to be therapeutic and that making changes to the CDR regions in the heavy chain and light chain sequences of an antibody is highly unpredictable. Additionally, the cited references demonstrate that antibody function is dependent upon the antigen it binds, and without knowing what is to be treated in “the subject in need thereof” with the biological therapeutic molecule, specifically an antibody fragment, one could not determine what would be therapeutic. Therefore, administering any antibody fragment to a “subject in need thereof” with the intent of the antibody fragment being therapeutic is highly unpredictable.
Therefore, given the lack given the lack of guidance provided, lack of working examples commensurate in scope to the claimed invention, and teachings of the art, the specification, as filed, does not provide enablement for the biological therapeutic molecule, or an antibody fragment as elected.
Applying the above test to the facts of record, it is determined that 1) no
declaration under 37 C.F.R. 1.132 or other relevant evidence has been made of record
establishing the amount of experimentation necessary, 2) insufficient direction or
guidance is presented in the specification with respect to broadly encompassing any biological therapeutic molecule, let alone any antibody fragment, with the intent of it being therapeutic without knowing what is to be treated in a subject in need thereof, 3) the relative skill of those in the art is commonly recognized as quite high (post-doctoral level). One of skill in the art would require guidance, in order to make the claimed fragments in a manner reasonable in correlation with the scope of the claims. Without proper guidance, the experimentation to is undue.
The Applicant has not provided sufficient guidance to enable one of skill in the art
to make and use the claimed invention in a manner reasonably correlated with the
scope of the claims. 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 such
guidance, determining a function other than on-target activity is unpredictable and the
experimentation left those skilled in the art is unnecessarily and improperly, extensive
and undue. See Amgen Inc v Chugai Pharmaceutical Co Ltd. 927 F 2d 1200, 18
USPQ2d 1016 (Fed. Cir. 1991) at 18 USPQ2d 1026-1027 and Exparte Forman, 230
U.S.P.Q. 546(Bd. Pat=. App & int. 1986).
In view of all of the above, one of skill in the art would be forced into undue
experimentation to practice the claimed invention, and thus, the claimed invention does
not satisfy the requirements of 35 U.S.C. 112 first paragraph.
Claims 4-14, 21, 23, and 30-34, are therefore deficient for the same reasons above and do not meet the enablement requirement.
Written Description
Claims 4-14, 20-21, 23, and 30-34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 20 is drawn to a method for administering a biological therapeutic molecule to a subject in need thereof, wherein said biological therapeutic molecule is co-administered with an insulin and a glucose. Claim 12 further limits claim 20 to wherein the biological therapeutic molecule is a polypeptide, which is an antibody, an antibody derivative, an antibody fragment, an immunoglobulin fusion protein, an interferon, an interleukin or a cytokine and claim 13 further limits claim 20 to wherein the biological therapeutic molecule is a monoclonal antibody fragment. Applicant elected the species of an antibody fragment for the biological therapeutic molecule in the reply filed on 10/27/2025.
The election of “an antibody fragment” encompasses any portion of said antibody such as the hinge region, the framework region, or even a single amino acid of any said antibody. Thus, a single amino acid would suffice to meet the limitations of the claims. Because function of any protein, including an antibody, is dependent on the presence of each specific amino acid residue, and with the possibility of added, deleted, or substituted amino acids, a wide variety of antibodies is encompassed by the instant claim. The phrase “an antibody fragment” allows any fragment, including any amino acid in said antibody sequence, to be encompassed in the instant claim. This would in theory encompass any possible antibody on earth. These antibodies have no correlation between their structure and function.
The specification does not teach examples of any antibody fragment that is also a biological therapeutic molecule. Additionally, the specification does not teach what is to be treated in “the subject in need thereof” with the biological therapeutic molecule, i.e. the antibody fragment, and therefore, it can also not be determined what molecule, let alone what antibody fragment, would be therapeutic.
One means of providing adequate written description and evidence of possession of a claimed genus is through providing sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In this case, there is no disclosure for a biological therapeutic molecule that is an antibody fragment that can be administered to a subject in need thereof for any purpose since it is not disclosed what is to be treated in the subject. One of skill in the art could not envisage such a structure.
The art recognizes that a complete set of six CDRs comprise the binding region of an antibody (see Sela-Culang et al., 2013 (instant PTO-892)), and that even a single amino acid change to these regions can completely abrogate the binding specificity of an antibody (see Kussie et al., 1994 (instant PTO-892)). Thus, making changes to the CDR sequence of an antibody is a highly unpredictable process and the skilled artisan could not a priori make any predictions regarding such changes with any reasonable expectation of success nor envisage the breadth of structurally unrelated CDR combinations that would still possess the required functions. Further, regarding instant claim 33 which requires the biological therapeutic molecule to have a weight of about 6kDa to about 10kDa, there is no known antibody fragment within the weight range of 6-10kDa that would be a “biological therapeutic molecule.” Xenaki et al., 2017 (instant PTO-892) teaches that the smallest naturally occurring antigen-binding fragment, is a nanobody consisting of only the variable domain of the heavy-chain (VHH), which has a molecule weight of about 15 kDa [page 2, left column, first paragraph].
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404. 1405 held
that:
...To fulfill the written description requirement, a patent specification must
describe an invention and does so in sufficient detail that one skilled in the art can
clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines Inc. , 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re
Gosteli , 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the
inventor] invented what is claimed."). Thus, an applicant complies with the written
description requirement "by describing the invention, with all its claimed limitations, not
that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention."
Lockwood, 107 F.3d at 1572, 41 USPQ2d 1966.
A "representative number of species" means that the species, which are
adequately described, are representative of the entire genus. Thus, when there is
substantial variation within the genus, one must describe a sufficient variety of species
to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if
the disclosure "indicates that the patentee has invented species sufficient to constitute
the gen[us]. "See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v.
Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir.
2004) "[A] patentee of a biotechnological invention cannot necessarily claim a genus
after only describing a limited number of species because there may be unpredictability
in the results obtained from species other than those specifically enumerated."). "A
patentee will not be deemed to have invented species sufficient to constitute the genus
by virtue of having disclosed a single species when ... the evidence indicates ordinary
artisans could not predict the operability in the invention of any species other than the
one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir.
2004).
Thus, based on the teachings of the instant specification and the art, Applicant has failed to meet the written description requirement. Therefore, one of skill in the art would not conclude that Applicant was in possession of the claimed invention.
Claims 4-14, 21, 23, and 30-34, are therefore deficient for the same reasons above and do not meet the written description requirement.
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 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.
Claims 6, 8-10, and 20-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Scott et al., 1999 (instant PTO-892).
Regarding claims 20 (independent claim) 6, 8, 10, and 21, Scott teaches administering a glucose, potassium (biological therapeutic molecule; polypeptide), and insulin (GKI) infusion to stroke (human) patients with mild to moderate hyperglycemia [see Abstract].
Regarding claim 9, Scott teaches that the GKI infusion effectively lowers plasma glucose level to within the normal range (physiologically acceptable glucose level) [page 798, left column, last paragraph - right column, first paragraph].
Claim Rejections - 35 USC § 103
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 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5-6, 8-14, 20-21, 30, 32, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over PSA, 2017 (instant PTO-892) and Wenger et al., 1985 (instant PTO-892).
Regarding claims 20 (independent claim), 6, 8, 10, 12-13, and 21, PSA teaches administering dextrose (glucose) mixed with insulin by infusion to treat hyperkalemia [page 2, third paragraph].
However, PSA does not teach that co-administering a monoclonal antibody fragment (biological therapeutic molecule) with the insulin and glucose.
Wenger teaches that treatment with digoxin-specific Fabs reversed hyperkalemia [see Abstract].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the insulin and glucose of PSA and co-administered both with the Fab of Wenger to treat hyperkalemia. This follows the logic of MPEP 2144.06 which states “it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Therefore, it would have been obvious to combine the separate, known compositions for the same purpose of treating hyperkalemia.
Claims 5 and 30 are included in this rejection because PSA teaches that rapid-acting insulin analogs are used for treating hyperkalemia [page 2, second paragraph]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have specifically used rapid-acting insulin, as taught by PSA. One of skill in the art would have been motivated to use rapid-acting insulin instead of regular insulin because PSA teaches that the use of rapid-acting insulin may decrease the incidence of hypoglycemia because it has a shorter half-life.
Claims 9 and 34 are included in this rejection because PSA teaches that dextrose (glucose) is given to prevent hypoglycemia [page 2, second paragraph], and hypoglycemia is a blood glucose of less than 70 mg/dL [page 5, last paragraph], thereby indicating that the glucose is administered to keep the glucose within normal range (i.e. physiologically acceptable level; above 70 mg/dL). MPEP 2144.05 (I) states “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facia case of obviousness exists.”
Claims 11, 14, and 32 are included in this rejection because the Fab of Wenger is necessarily about 50 kDa, as evidenced by Xenaki et al., 2017 (instant PTO-892) who teaches that the molecular weight of Fab fragments is about 50 kDa [page 2, left column, first paragraph]. MPEP 2144.05 (I) states “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facia case of obviousness exists.”
Claims 5-14, 20-21, 30-32, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over PSA, 2017 (instant PTO-892) and Wenger et al., 1985 (instant PTO-892), as applied to claims 5-6, 8-14, 20-21, 30, 32, and 34 above, and further in view of ANMF, 2019 (instant PTO-892).
The teachings of PSA and Wenger are above.
However, PSA and Wenger do not specifically teach that the insulin is administered at a rate of 1.5 to 6 I.U. kg body weight/day, as set forth in instant claim 7, or that the insulin is administered at a rate of 2 to 4 I.U./kg body weight/day, as set forth in instant claim 31.
Regarding claims 7 and 31, ANMF teaches that treatment for hyperkalemia with insulin and glucose should have insulin at a dosage of 0.1 unit/kg/hour for the starting dose and 0.05 to 0.2 unit/kg/hour for the dose range [see page 1, Dosage/Interval section].
0.1 unit/kg/hour is equivalent to 2.4 unit/kg/hour and 0.05 to 0.2 is equivalent to 1.2 to 4.8 unit/kg/hour.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have specifically administered the insulin of PSA at a dose of 2 to 4 I.U./kg body weight/day, as taught by ANMF, for the treatment of hyperkalemia. One would have been motivated to administer the insulin of PSA at a dosage of 2 to 4 I.U./kg body weight/day because ANMF teaches that this is an acceptable dose range for insulin in the treatment of hyperkalemia. MPEP 2144.05 (I) states “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facia case of obviousness exists.” Further, it would have been obvious to one of ordinary skill in the art because the insulin dosage is recognized as a variable in the art and therefore would engage in routine optimization.
Claims 5-6, 8-14, 20-21, 30, 32, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over PSA, 2017 (instant PTO-892) and Wenger et al., 1985 (instant PTO-892), as applied to claims 5-6, 8-14, 20-21, 30, 32, and 34 above, and further in view of Analox Instruments, 2019 (instant PTO-892).
The teachings of PSA and Wenger are above.
However, PSA and Wenger do not specifically teach that the insulin and glucose are administered as an insulin-glucose clamp.
Regarding claim 23, Analox Instruments teaches that clamps work by varying an infusion of glucose or insulin so that blood glucose concentration is maintained (clamped) at a specific level [page 1, second paragraph].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have specifically administered the insulin and glucose of PSA as an insulin-glucose clamp, as taught by Analox Instruments. One would have been motivated to administer the insulin and glucose as an insulin-glucose clamp because Analox Instruments teaches that clamps work by varying an infusion of glucose or insulin so that blood glucose concentration is maintained (clamped) at a specific level, and therefore, the blood glucose could be monitored and maintained at a normal level to prevent hypoglycemia or hyperglycemia.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brittney E Donoghue whose telephone number is (571)272-9883. The examiner can normally be reached Mon - Fri 7:30 - 3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571) 272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B.E.D./Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675