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 .
Election/Restrictions
Applicant's election with traverse of Group I, Sub-Species I(d), and Sub-Species II(a) in the reply filed on 03/25/2026 is acknowledged. The traversal is on the ground(s) that the restriction requirement should have been made after a non-final, since the claims reading on the elected groups/species are generic. As such, Applicant believes the requirement for restriction is not timely, so there is no serious burden on the Examiner. Applicant cites MPEP 811 for support. This is not found persuasive because MPEP 811 reads on the U.S. restriction practice, not on a unity of invention restriction.
Additionally, a serious burden is not the standard for determining if a restriction is proper when there is lack of unity in a national stage application filed under 35 U.S.C. 371. The appropriate question is whether or not the claims are linked to form a single general inventive concept under PCT Rule 13.1. As shown in the Requirement for Restriction, and again below, the indicated species do not form a single general inventive concept because the linking technical features of the species are not special technical features. The Examiner notes that the Applicant has not made any arguments against this assertion.
The requirement is still deemed proper and is therefore made FINAL.
Claims 17-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 03/25/2026.
Claim Objections
Claim 14 is objected to because of the following informalities.
Claim 14 should read --The method of claim 1, wherein the at least one medication is an angiotensin receptor blocker and a neprilysin-inhibitor, and wherein the neprilysin-inhibitor is sacubitril.--
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are as follows,
“flow diverting apparatus” in Claim 1, where the generic placeholder is “apparatus”, the functional language is “flow diverting”, “such that blood pressure to the kidneys and/or brain of the patient is increased”, or “to partially occlude blood flow through the vessel when implanted to thereby increase blood pressure upstream the implanted flow diverting apparatus”, and sufficient modifying structure is not provided; instant application Paragraph 0009 describes the flow diverting apparatus as “an inflatable member, a stent, or a stent-graft”, providing sufficient modifying structure
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-16 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.
As to Claim 1, the limitation “implanting a flow diverting apparatus…relative to a vessel of the patient”, in Lines 4-5, is indefinite. The phrase “relative to” is a relative term which renders the claim indefinite. The phrase “relative to” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Instant application Paragraph 0055 provides examples of what may be considered relative. However, these examples do not provide any boundaries for how to interpret the phrase “relative to”, so do not provide the necessary standard for ascertaining the requisite degree of the phrase, rendering the claim indefinite. For the purpose of examination, the limitation will be interpreted as broadly within a patient, where the implantation must also be able to meet the claimed function regarding blood flow.
The limitation “the flow diverting apparatus is configured to partially occlude blood flow through the vessel when implanted to thereby increase blood pressure upstream the implanted flow diverting apparatus”, in Lines 6-8, should read --the flow diverting apparatus is configured to partially occlude blood flow through the vessel when implanted to thereby increase blood pressure upstream of the implanted flow diverting apparatus.
The term “an angiotensin receptor enzyme (ACE) inhibitor”, first used in Lines 11-12, but used multiple times thereafter, including in dependent claims, is indefinite. Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “an angiotensin receptor enzyme inhibitor” is used by the claim to mean “ACE inhibitor” while the accepted meaning is “angiotensin converting enzyme inhibitor”. The term is indefinite because the specification does not clearly redefine the term.
Additionally, the Acronym for “angiotensin receptor enzyme” would be “ARE”, not “ACE”. As such, it is not clear if Applicant intended for the claimed ACE inhibitor to be an angiotensin receptor enzyme, or if the claimed term is a typo. If the claimed term is not a typo, it is not clear what an angiotensin receptor enzyme is or does.
For the purpose of examination, the term “angiotensin receptor enzyme (ACE) inhibitor” will be interpreted as “angiotensin converting enzyme (ACE) inhibitor”, which is the known interpretation of an ACE inhibitor.
As to Claim 5, the limitation “the respective dosage of the one or more of the at least one medication is increased one or more times until a hemodynamic status of the patient is stable”, is indefinite. It is not clear if the increase in dosage in Claim 5 is the same increase in dosage defined in Claim 1, or if the increase in dosage in Claim 5 is in addition to the increase in dosage in Claim 1, rendering the claim indefinite. For the purpose of examination, the increase in dosage in Claim 5 will be interpreted as further limiting the increase in dosage of Claim 1.
As to Claim 11, the portion “the respective dosage of [the claimed drug] is increased to a dosage within a range of …” in each limitation, is indefinite. It is not clear if the increase in dosage of each drug is the same increase in dosage from Claim 1, or if the increase in dosage for each drug is in addition to the dosage increase of Claim 1. For the purpose of examination, the increase in dosage of each drug within Claim 11 will be interpreted as the same increase in dosage of Claim 1.
As to Claim 13, the portion “the respective dosage of [the claimed drug] is increased to a dosage within a range of …” in each limitation, is indefinite. It is not clear if the increase in dosage of each drug is the same increase in dosage from Claim 1, or if the increase in dosage for each drug is in addition to the dosage increase of Claim 1. For the purpose of examination, the increase in dosage of each drug within Claim 13 will be interpreted as the same increase in dosage of Claim 1.
As to Claim 16, the portion “the respective dosage of [the claimed drug] is increased to a dosage within a range of …” in each limitation, is indefinite. It is not clear if the increase in dosage of each drug is the same increase in dosage from Claim 1, or if the increase in dosage for each drug is in addition to the dosage increase of Claim 1. For the purpose of examination, the increase in dosage of each drug within Claim 16 will be interpreted as the same increase in dosage of Claim 1.
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.
Claims 1-5, 8-10, 12 & 14 are rejected under 35 U.S.C. 103 as being unpatentable over Keren (U.S. Patent 7,780,628), in view of Clark (see Applicant provided NPL, Change in renal function associated with drug treatment in heart failure: national guidance).
As to Claim 1, Keren teaches a method for administering at least one medication (the drug described in Column 15, Lines 3-16) comprising:
administering a respective dosage (Column 15, Lines 3-16; at t0, as shown in Figure 20) of each of the at least one medication (the drug described in Column 15, Lines 3-16) to a patient (the patient described in Column 15, Lines 3-16) at a respective baseline dosage (the initial dosage at t0 described in Column 15, Lines 3-16, and shown in Figure 20);
implanting (Column 14, Lines 26-27) a flow diverting apparatus (the balloon 316 described in Column 15, Lines 3-16) in the patient (the patient described in Column 15, Lines 3-16) receiving the respective baseline dosage of each of the at least one medication (the initial dosage at t0 described in Column 15, Lines 3-16, and shown in Figure 20), relative to (as shown in Figure 16) a vessel (310; Column 4, Lines 1-3; Column 14, Lines 26-27) of the patient (the patient described in Column 15, Lines 3-16), such that blood pressure to the kidneys (Column 2, Lines 52-55, where one of ordinary skill in the art would conclude an increase in blood flow would result in an increase in blood pressure, since the kidney size would not change) and/or brain (since the first option is taught, the second option is not required) of the patient (the patient described in Column 15, Lines 3-16) is increased (Column 2, Lines 52-55), wherein the flow diverting apparatus (316) is configured to partially occlude blood flow through (Column 14, Lines 62-65) the vessel (310; Column 4, Lines 1-3; Column 14, Lines 26-27) when implanted (Column 14, Lines 26-27) to thereby increase blood pressure upstream (one of ordinary skill in the art would conclude the blood pressure upstream of balloon 316 would increase, since the respective volume of the vessel 310 has decreased) the implanted flow diverting apparatus (316); and
changing the respective dosage of one or more of the at least one medication (Column 15, Lines 11-13) subsequent to (as shown in Figure 20) implanting (Column 14, Lines 26-27) the flow diverting apparatus (316).
Keren does not teach increasing the respective dosage of one or more of the at least one medication above the respective baseline dosage subsequent to implanting the flow diverting apparatus.
Additionally, Keren is silent on the type of drug administered, so does not explicitly teach the at least one medication is: (i) an angiotensin-receptor blocker, (ii) an angiotensin receptor enzyme (ACE) inhibitor, (iii) a chymase inhibitor, (iv) an angiotensin receptor enzyme (ACE) inhibitor and an angiotensin-receptor blocker, (v) an angiotensin receptor blocker and a neprilysin-inhibitor, or (vi) a beta-blocker and an angiotensin receptor enzyme (ACE) inhibitor, an angiotensin-receptor blocker, or a neprilysin inhibitor.
Keren continues to teach, the sustained respective dosage amount is a result-effective variable which determines renal perfusion (Column 15, Lines 11-13). See MPEP 2144.05(II)(B)).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to increase the respective dosage of one or more of the at least one medication above the respective baseline dosage subsequent to implanting the flow diverting apparatus, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. (1955)
Clark describes describes a liquid pump used for the forced lubrication of manual transmissions, and teaches the at least one medication is: (i) an angiotensin-receptor blocker (Page 904, “Background” section), (ii) an angiotensin receptor enzyme (ACE) inhibitor (Page 904, “Background” section), (iii) a chymase inhibitor, (iv) an angiotensin receptor enzyme (ACE) inhibitor and an angiotensin-receptor blocker (Page 904, “Background” section), (v) an angiotensin receptor blocker and a neprilysin-inhibitor, or (vi) a beta-blocker and an angiotensin receptor enzyme (ACE) inhibitor (Page 904, “Background” section), an angiotensin-receptor blocker (Page 904, “Background” section), or a neprilysin inhibitor.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to make the at least one medication, as taught by Keren, one or more of the medications listed in the Clark “Background” section, due to the increased life expectancy of patients when used (Page 904, “Background” section).
As to Claim 2, Keren, as modified, teaches all the limitations of Claim 1, and continues to teach the flow diverting apparatus (Keren 316) includes an inflatable member (Keren 316 is described as balloon which is inflated in Keren Column 14, Lines 45-46), a stent, or a stent-graft. Since Keren teaches the first option, the remaining options do not need to be taught.
As to Claim 3, Keren, as modified, teaches all the limitations of Claim 1, and continues to teach the vessel (Keren 310) is the infrarenal aorta (Column 4, Lines 1-3; Column 14, Lines 26-27) or a vessel downstream the infrarenal aorta. Since Keren teaches the first option, the remaining options do not need to be taught.
As to Claim 4, Keren, as modified, teaches all the limitations of Claim 1, and continues to teach prior to implanting (Column 14, Lines 26-27) the flow diverting apparatus (316) into the patient (the patient described in Column 15, Lines 3-16), a respective dosage of the at least one medication (the dosage of any of the medication described in Clark Page 904, “Background” section) above (Keren describes using smaller than normal doses in Column 2, Lines 41-44, which one of ordinary skill in the art would conclude is lower than a baseline dosage) the respective baseline dosage (the Keren initial dosage at t0 described in Keren Column 15, Lines 3-16, and shown in Keren Figure 20) causes the patient to experience negative side effects of the at least one medication (Clark Page 904, “Background” section).
As to Claim 5, Keren, as modified, teaches all the limitations of Claim 1, and continues to teach the respective dosage (Keren Column 15, Lines 3-16; at t0, as shown in Keren Figure 20) of the one or more of the at least one medication (one or more of the medications listed in the Clark “Background” section) is increased (as described in the Claim 1 rejection above, where increasing the dosage is considered optimization) one or more times (Keren Column 15, Lines 11-13; as shown in Keren Figure 20) until a hemodynamic status of the patient is stable (Keren Column 15, Lines 11-13, where “renal perfusion” is broadly interpreted as a hemodynamic status, and Keren teaches renal perfusion is “sustained”, i.e., stable).
As to Claim 8, Keren, as modified, teaches all the limitations of Claim 1, and continues to teach increasing the respective increased dosage (the third drug infusion duration shown in Keren Figure 20; as described in the Claim 1 rejection above, where increasing the dosage is considered optimization) of the one or more of the at least one medication (one or more of the medications listed in the Clark “Background” section) after (as shown in Keren Figure 20) a period of maintaining (the second drug infusion duration shown in Keren Figure 20) the respective increased dosage (as described in the Claim 1 rejection above, where increasing the dosage is considered optimization).
As to Claim 9, Keren, as modified, teaches all the limitations of Claims 1 & 8, but does not teach the period is greater than or equal to one week and less than or equal to two weeks.
Keren continues to teach, the sustained respective dosage period/time is a result-effective variable which determines renal perfusion (Column 15, Lines 11-13). See MPEP 2144.05(II)(B)).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the period greater than or equal to one week and less than or equal to two weeks, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. (1955)
As to Claim 10, Keren, as modified, teaches all the limitations of Claim 1, and continues to teach the at least one medication (one or more of the medications listed in the Clark “Background” section) is one of the angiotensin-receptor blockers in the group consisting of valsartan (the valsartan medication listed in the Clark “Background” section), losartan, candesartan, eprosartan, telmisartan, and irbesartan.
As to Claim 12, Keren, as modified, teaches all the limitations of Claim 1, and continues to teach the at least one medication (one or more of the medications listed in the Clark “Background” section) is one of the angiotensin receptor enzyme (ACE) inhibitors in the group consisting of enalapril (the enalapril medication listed in the Clark “Background” section), lisinopril, trandolapril, ramipril, captopril, quinapril, and cilazapril.
As to Claim 14, Keren, as modified, teaches all the limitations of Claim 1, and continues to teach the at least one medication (one or more of the medications listed in the Clark “Background” section) is an angiotensin receptor blocker and a neprilysin-inhibitor, and wherein the neprilysin-inhibitor is sacubitril (as described in the Clark “Background” section).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Keren, in view of Clark, further in view of Sica (see attached Combination Angiotensin‐Converting Enzyme Inhibitor and Angiotensin Receptor Blocker Therapy_ Its Role in Clinical Practice – PMC pdf from pmc.ncbi.nlm.nih.gov/articles/PMC8099326/).
As to Claim 6, Keren, as modified, teaches all the limitations of Claim 1, and continues to teach the at least one medication (one or more of the medications listed in the Clark “Background” section) is a first medication (one or more of the medications listed in the Clark “Background” section).
Keren, as modified, does not teach the method further comprising administering a dosage of a second medication to the patient subsequent to implanting the flow diverting apparatus.
Sica describes using ACE inhibitors and ARBs together (see “Conclusions” section).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to use a second medication, as taught by Sica, in addition to a first medication, as taught by Keren, as modified, since “these agents are complementary in their actions (“Abstract” section).”
Modifying Sica into Keren, as modified, results in the method further comprising administering a dosage (as shown in Keren Figure 20) of a second medication (Sica ARBs) to the patient (the Keren patient described in Keren Column 15, Lines 3-16) subsequent to (as shown in Keren Figure 20) implanting (Keren Column 14, Lines 26-27) the flow diverting apparatus (Keren 316). Since the first and second medications are administered together, the second medication is also administered after implanting the Keren flow diverting apparatus Keren 316.
As to Claim 7, Keren, as modified, teaches all the limitations of Claims 1 & 6, and continues to teach the second medication (Sica ARBs) is an angiotensin receptor enzyme (ACE) inhibitor, an angiotensin receptor blocker (Sica ARBs), or a neprilysin-inhibitor.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Keren, in view of Clark, further in view of drugs.com (see attached Valsartan Dosage Guide with Precautions - Drugs.com pdf from web.archive.org/web/20190403172757/https://www.drugs.com/dosage/valsartan.html from 2019).
As to Claim 11, Keren, as modified, teaches all the limitations of Claims 1 & 10, but does not teach if the at least one medication is valsartan, the respective dosage of valsartan is increased to a dosage within a range of greater than or equal to 40 and less than or equal to 320 mg/day;
if the at least one medication is losartan, the respective dosage of losartan is increased to a dosage within a range of greater than or equal to 25 and less than or equal to 150 mg/day;
if the at least one medication is candesartan, the respective dosage of candesartan is increased to a dosage within a range of greater than or equal to 8 and less than or equal to 32 mg/day;
if the at least one medication is eprosartan, the respective dosage of eprosartan is increased to a dosage is within a range of greater than or equal to 500 and less than or equal to 800 mg/day;
if the at least one medication is telmisartan, the respective dosage of telmisartan is increased to a dosage within a range of greater than or equal to 40 and less than or equal to 80 mg/day; and
if the at least one medication is irbesartan, the respective dosage of irbesartan is increased to a dosage within a range of greater than or equal to 150 and less than or equal to 300 mg/day.
The website drugs.com describes recommended medication doses, and teaches if the at least one medication is valsartan (the valsartan medication listed in the Clark “Background” section), the respective dosage of valsartan is increased to a dosage within a range of greater than or equal to 40 and less than or equal to 320 mg/day (“Usual Adult Dose for Congestive Heart Failure” section);
if the at least one medication is losartan, the respective dosage of losartan is increased to a dosage within a range of greater than or equal to 25 and less than or equal to 150 mg/day;
if the at least one medication is candesartan, the respective dosage of candesartan is increased to a dosage within a range of greater than or equal to 8 and less than or equal to 32 mg/day;
if the at least one medication is eprosartan, the respective dosage of eprosartan is increased to a dosage is within a range of greater than or equal to 500 and less than or equal to 800 mg/day;
if the at least one medication is telmisartan, the respective dosage of telmisartan is increased to a dosage within a range of greater than or equal to 40 and less than or equal to 80 mg/day; and
if the at least one medication is irbesartan, the respective dosage of irbesartan is increased to a dosage within a range of greater than or equal to 150 and less than or equal to 300 mg/day.
Note – since the valsartan option was taught, the remainder of the medication options do not need to be taught.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to make the increased valsartan dosage, as taught by Keren, as modified, in a range of greater than or equal to 40 and less than or equal to 320 mg/day, as taught by drugs.com, since this dosage is a well-known dosage which yields predictable results, i.e., effectively treats known diseases.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Keren, in view of Clark, further in view of drugs.com (see attached Enalapril Dosage Guide with Precautions - Drugs.com pdf from web.archive.org/web/20190921113448/https://www.drugs.com/dosage/enalapril.html from 2019).
As to Claim 13, Keren, as modified, teaches all the limitations of Claims 1 & 12, but does not teach if the at least one medication is enalapril, the respective dosage of enalapril is increased to a dosage within a range of greater than or equal to 5 and less than or equal to 40 mg/day;
if the at least one medication is lisinopril, the respective dosage of lisinopril is increased to a dosage within a range of greater than or equal to 5 and less than or equal to 40 mg/day;
if the at least one medication is trandolapril, the respective dosage of trandolapril is increased to a dosage within a range of greater than or equal to 2 and less than or equal to 4 mg/day;
if the at least one medication is ramipril, the respective dosage of ramipril is increased to a dosage within a range of greater than or equal to 2.5 and less than or equal to 10 mg/day;
if the at least one medication is captopril, the respective dosage of captopril is increased to a dosage within a range of greater than or equal to 37.5 and less than or equal to 450 mg/day;
if the at least one medication is quinapril, the respective dosage of quinapril is increased to a dosage within a range of greater than or equal to 10 and less than or equal to 40 mg/day; and
if the at least one medication is cilazapril, the respective dosage of cilazapril is increased to a dosage within a range of greater than or equal to 1 and less than or equal to 5 mg/day.
The website drugs.com describes recommended medication doses, and teaches if the at least one medication is enalapril (the enalapril medication listed in the Clark “Background” section), the respective dosage of enalapril is increased to a dosage within a range of greater than or equal to 5 and less than or equal to 40 mg/day (“Usual Adult Dose for Congestive Heart Failure” section);
if the at least one medication is lisinopril, the respective dosage of lisinopril is increased to a dosage within a range of greater than or equal to 5 and less than or equal to 40 mg/day;
if the at least one medication is trandolapril, the respective dosage of trandolapril is increased to a dosage within a range of greater than or equal to 2 and less than or equal to 4 mg/day;
if the at least one medication is ramipril, the respective dosage of ramipril is increased to a dosage within a range of greater than or equal to 2.5 and less than or equal to 10 mg/day;
if the at least one medication is captopril, the respective dosage of captopril is increased to a dosage within a range of greater than or equal to 37.5 and less than or equal to 450 mg/day;
if the at least one medication is quinapril, the respective dosage of quinapril is increased to a dosage within a range of greater than or equal to 10 and less than or equal to 40 mg/day; and
if the at least one medication is cilazapril, the respective dosage of cilazapril is increased to a dosage within a range of greater than or equal to 1 and less than or equal to 5 mg/day.
Note – since the enalapril option was taught, the remainder of the medication options do not need to be taught.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to make the increased enalapril dosage, as taught by Keren, as modified, in a range of greater than or equal to 5 and less than or equal to 40 mg/day, as taught by drugs.com, since this dosage is a well-known dosage which yields predictable results, i.e., effectively treats known diseases.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Keren, in view of Clark, further in view of drugs.com (see attached List of Cardioselective beta blockers - Drugs.com pdf from web.archive.org/web/20190418043031/https://www.drugs.com/drug-class/cardioselective-beta-blockers.html from 2019).
As to Claim 15, Keren, as modified, teaches all the limitations of Claim 1, and continues to teach the at least one medication (one or more of the medications listed in the Clark “Background” section) is (1) a beta-blocker (as described in the Clark “Background” section) and (2) an ACE-inhibitor (as described in the Clark “Background” section), an angiotensin-receptor blocker (as described in the Clark “Background” section), or a neprilysin inhibitor.
Keren, as modified, does not teach the beta-blocker is one of the medications in the group consisting of bisoprolol, carvedilol, and metoprolol.
The website drugs.com describes drugs for various diseases, and teaches the beta-blocker is one of the medications in the group consisting of bisoprolol, carvedilol, and metoprolol (“List of Cardioselective beta blockers:” section).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to make the beta blocker, as taught by Keren, as modified, metoprolol, as taught by drugs.com, since this drug is a well-known drug which yields predictable results, i.e., effectively treats known diseases.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Keren, in view of Clark, further in view of drugs.com (see attached List of Cardioselective beta blockers - Drugs.com pdf from web.archive.org/web/20190418043031/https://www.drugs.com/drug-class/cardioselective-beta-blockers.html from 2019), further in view of drugs.com (see attached Metoprolol Dosage Guide with Precautions - Drugs.com pdf from web.archive.org/web/20190427105609/https://www.drugs.com/dosage/metoprolol.html from 2019).
As to Claim 16, Keren, as modified, teaches all the limitations of Claims 1 & 15, but does not teach if the beta-blocker is bisoprolol, the respective dosage of bisoprolol is increased to a dosage within a range of greater than or equal to 2.5 and less than or equal to 20 mg per day until the patient's hemodynamic status is stable;
if the beta-blocker is carvedilol, the respective dosage of carvedilol is increased to a dosage within a range of greater than or equal to 6.25 and less than or equal to 100 mg per day until the patient's hemodynamic status is stable; and
if the beta-blocker is metoprolol, the respective dosage of metoprolol is increased to a dosage within a range of greater than or equal to 25 and less than or equal to 200 mg per day until the patient's hemodynamic status is stable.
The website drugs.com describes recommended medication doses, and teaches if the beta-blocker is bisoprolol, the respective dosage of bisoprolol is increased to a dosage within a range of greater than or equal to 2.5 and less than or equal to 20 mg per day until the patient's hemodynamic status is stable;
if the beta-blocker is carvedilol, the respective dosage of carvedilol is increased to a dosage within a range of greater than or equal to 6.25 and less than or equal to 100 mg per day until the patient's hemodynamic status is stable; and
if the beta-blocker is metoprolol, the respective dosage of metoprolol is increased to a dosage within a range of greater than or equal to 25 and less than or equal to 200 mg per day (“Usual Adult Dose for Congestive Heart Failure” section).
Note – since the metoprolol option was taught, the remainder of the medication options do not need to be taught.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to make the increased metoprolol dosage, as taught by Keren, as modified, in a range of greater than or equal to 25 and less than or equal to 200 mg per day, as taught by drugs.com, since this dosage is a well-known dosage which yields predictable results, i.e., effectively treats known diseases.
Modifying drugs.com into Keren, as modified, results in if the beta-blocker is metoprolol, the respective dosage of metoprolol is increased to a dosage within a range of greater than or equal to 25 and less than or equal to 200 mg per day (“Usual Adult Dose for Congestive Heart Failure” section) until the patient's hemodynamic status is stable (Keren Column 15, Lines 11-13, where “renal perfusion” is broadly interpreted as a hemodynamic status, and Keren teaches renal perfusion is “sustained”, i.e., stable).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Llanos (2005/0004663) and Sulaimon (2012/0239131) describe similar methods.
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/DAVID N BRANDT/ Primary Examiner, Art Unit 3783
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