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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I, claims 3, 5-6, 8-9, 11-13, 15, 17, and 19-23 and species: 100 mg to about 2000 mg of antibody, once every four weeks (Q4W), subcutaneous administration, formulation of claim 22, and the single pharmaceutical dosage unit of about 100 mg to about 2000 mg in the reply filed 10/21/2025 is acknowledged.
Claims 23-24, 26-28, 31 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and species, there being no allowable generic or linking claims. Election was made in the reply filed 10/21/2025.
Claims 3, 5-6, 8-9, 11-13, 15, 17, 19-22, and new claims 32-35 are now under consideration in the instant Office Action.
Withdrawn Objections
Objections to the disclosure because it contains an embedded hyperlink and/or other form of browser-executable code are hereby withdrawn in view of the submission of a substitute specification on 02/27/2026.
Objections to the drawings because some of captions for the figures are upside down and out of alignment with the figure legends are hereby withdrawn in view of corrections to the drawings filed on 02/27/2026.
Objections to claim 15 due to minor informalities are hereby withdrawn in view of amendments to the claims that correct the issue.
Withdrawn Rejections
Rejections of claims 3 and 9 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paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter are hereby withdrawn due to the amendments to the claims.
Rejections of claims 3, 5-6, 8-9, 11-13, 15, 17, and 19-22 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 treating a cholesterol-related disease using the claimed antibody, does not reasonably provide enablement for a method for preventing a cholesterol-related disease using the claimed antibody are hereby withdrawn due to amendments to the claims to remove the “preventing” language.
Rejections of claims 3, 5-6, 8-9, 11-13, 15, 17, and 19-21 under 35 U.S.C. 102(a)(2) as being anticipated by Tsun et al. are hereby withdrawn due to the amendments to the claims, which now outline a varied scope than was originally presented. As such, the prior art no longer anticipates the instant invention.
New Rejections Necessitated by Amendment
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 3, 5-6, 8-9, 11, 12-13, 15, 17, 19-23, and new claims 32-35 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.
Instant claims 3, 5-6, 8-9, 11, 12-13, 15, 17, 19-23, and 32-35 recite the CDRs and heavy and light chain variable region sequences of the claimed antibody as “… an amino acid sequence set forth in…” It is unclear what is meant by “an amino acid sequence set forth in” as the use of “an amino acid” broadens the scope of the claim as it does not explicitly define all embodiments of the sequence. For example, this terminology of “an amino acid” can be interpreted as a subset of amino acids contained within the listed sequence identity number. Applicant is encouraged to amend the claim language to read as “…comprising SEQ ID NO:…” or “…comprising the amino acid sequence of SEQ ID NO:…” at every iteration to obviate this rejection.
Instant claims 5 and 6 recite both transitional phrases “comprises” and “consists of” in the claims to encompass the sequences for the antibody. The scope of the claim is unclear because both of the terms denote different scopes and cannot be used interchangeably. Applicant is encouraged to select one of the terms and adjust the language claiming the amino acid sequences accordingly.
Instant claim 23 recites a list of components that are encompassed within the antibody formulation, but does so in a disorganized fashion. As such, the claim limitations are unclear and do not describe the limitations of the claims in a manner which properly denotes the scope of the invention. Applicant is encouraged to amend the claim formatting to improve the clarity.
The term “about” in claims 3, 8, 22, and 35 and dependent claims 5-6, 9, 11, 12-13, 15, 17, 19-21, 23, 32-34 is a relative term which renders the claim indefinite. The term “about” 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.
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 3, 5-6, 8-9, 11, 12-13, 15, 17, 19-23, and 32-35 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.
Instant claims 3, 5-6, 8-9, 11, 12-13, 15, 17, 19-23, and 32-35 recite the heavy and light chain CDRs and variable region sequences of the antibody that binds to PCSK9 with the terminology “an amino acid sequence set forth in”. There is no limitation or exclusion in the claim language that prevents the modifications from occurring within the CDR region due to the claim language of “an amino acid sequences set forth in”, which widens the scope of the claim to encompass an immense number of unknown molecules that share some identity to the claimed sequences and can bind to the claimed receptor. Applicant has not demonstrated that they are in possession of all the molecules that fall within the immense scope of the claim that are able to achieve the claimed function.
The use of “an amino acid sequence set forth in” can be interpreted as comprising the whole sequence or only comprising some of the amino acids contained within the sequence. As currently recited, the language of “an amino acid sequence” reads on less than the amino acids listed in the sequence identity number that are capable of binding to any isolated antigen. The minimum requirement of any sequence that would meet the limitations of the claim as written only requires a few amino acids in common with the claimed sequence. There is a lack of support for all of the potential amino acid sequence as claimed that is capable of binding to any antigen as written. Applicant is encouraged to amend the claim language to “… region comprising the amino acid sequence of SEQ ID NO: … ” in the instant claims to obviate this rejection.
Modified Rejections Necessitated by Amendment
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 3, 5-6, 8-9, 11-13, 15, 17, 19-22, and new claims 32-35 are rejected under 35 U.S.C. 103 as being unpatentable over Tsun et al. (US 2020087416 A1, in IDS filed 05/18/2022), in view of Sitlani et al. 2009 (in PTO-892 filed 11/28/2025).
Tsun et al. teaches “an antibody that specifically binds to proprotein convertase subtilisin/kexin type 9 (PCSK9), an antigen-binding fragment of the antibody, and a composition comprising the antibody”, see Abstract, wherein the “antibodies or antibody fragments against PCSK9 of the invention may be administered prophylactically to prevent or alleviate the onset of hypercholesterolemia, hyperlipidemia, cardiovascular diseases, and/or the onset of any of the cholesterol-related diseases”, see paragraph 0167. Tsun et al. specifies that the methods are used for “lowering the level of cholesterol in a subject, the method comprises administering an effective amount of any of the anti-PCSK9 antibodies or fragments thereof described herein to the subject. In one embodiment, the cholesterol is LDL-cholesterol, preferably serum cholesterol”, see paragraph 0074. Tsun et al. also teaches that anti-PSCK9 monoclonal antibodies that shown remarkable efficacy in various types of primary hypercholesterolemia and in familial hypercholesterolemia (including heterozygous and homozygous familial hypercholesteremia, see paragraph 0014.
Tsun et al. discloses the structure for an antibody referred to as “ADI-10087” which shares 100% sequence identity to the instantly claimed antibody also referred to as “ADI-10087”. The sequence matches from Table B of the reference are as follows:
Instant SEQ ID NO: 4 is a 100% match for the reference’s SEQ ID NO: 10
Instant SEQ ID NO: 5 is a 100% match for the reference’s SEQ ID NO: 17
Instant SEQ ID NO: 6 is a 100% match for the reference’s SEQ ID NO: 19
Instant SEQ ID NO: 1 is a 100% match for the reference’s SEQ ID NO: 4
Instant SEQ ID NO: 2 is a 100% match for the reference’s SEQ ID NO: 5
Instant SEQ ID NO: 3 is a 100% match for the reference’s SEQ ID NO: 6
Instant SEQ ID NO: 8 is a 100% match for the reference’s SEQ ID NO: 30
Instant SEQ ID NO: 7 is a 100% match for the reference’s SEQ ID NO: 24
Instant SEQ ID NO: 10 is a 100% match for the reference’s SEQ ID NO: 41
Instant SEQ ID NO: 9 is a 100% match for the reference’s SEQ ID NO: 35.
Tsun et al. also teaches that the “administration of an anti-PCSK9 antibody of the invention may occur prior to, simultaneously as and/or after the administration of the additional therapeutic agents/adjuvant”, see paragraph 0169. Tsun et al. teaches “an antibody of the invention (and any additional therapeutic agent) can be administered by any suitable means, including parenteral, intrapulmonary, and intranasal, and, if desired for local treatment, intralesional administration. Parenteral infusions include intramuscular, intravenous, intraarterial, intraperitoneal, or subcutaneous administration”, see paragraph 0170, and that the “pharmaceutical compositions or formulations of the present invention may also contain more than one active ingredient which is required for a particular indication to be treated, preferably those active ingredients which do not adversely affect each other's complementary activities”, see paragraph 0163.
In regards to the dosage, Tsun et al. recommends that “effective amount” refers to an amount or dose of an antibody or fragment of the invention that produces the desired effect in a patient to be treated, when administered to the patient in single or multiple doses. An effective amount can be readily determined by the attending physician as a person skilled in the art by considering various factors such as the species of the mammal; its size, age and general health; the particular disease involved; the extent or severity of the disease; the response of an individual patient; the specific antibody to be administered; mode of administration; bioavailability characteristics of the formulation to be administered; selected dosing regimen; and use of any concomitant therapy, see paragraph 0107.
Tsun et al. explicitly recites “for the prevention or treatment of diseases, the appropriate dosage of an antibody of the invention (when used alone or in combination with one or more other additional therapeutic agents) will depend on the type of disease to be treated, the type of antibody, the severity and course of the disease, whether the antibody is administered for preventive or therapeutic purposes, previous therapy, the patient's clinical history and response to the antibody, and the discretion of the attending physician. The antibody is suitably administered to the patient at one time or over a series of treatments. Exemplary dosage range for the antibody includes 3-30 mg/kg”, see paragraph 0171. Tsun et al. also recommends that the treatment with ADI-10087 at 3-30 mg/kg dosing be carried out until there is a significant decrease in the levels of serum LDL-C and HDL-C for 3-28 days after administration, see paragraph 0268.
While Tsun et al. does not explicitly teach that the dosage of antibody administered results in a certain percentage reduction of LDL-cholesterol levels, certain serum free PCSK-9 levels, certain reductions in cholesterol levels such as apolipoprotein B or non-high-density-lipoprotein, it is clear that the taught dosages using the same antibody as claimed would have the same characteristics and would respond to the same treatment as the instantly claimed methods since there is no evidence to the contrary. The antibodies when administered will produce the same results as the instantly claimed method since one is practicing the active steps, administering the same antibody to the same patient population. Note that rejections for anticipation are appropriate when the prior art discloses a method (or product) that appears to be identical except that the art is silent as to an inherent property; see MPEP §2112(III).
MPEP § 2112 (II), states, "there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003)." In such situations, the burden is on applicant to provide evidence that the prior art product (or method) is not the same or an obvious variant; see MPEP § 2112(V). Furthermore, Integra Life Sciences I Ltd. v. Merck KGaA, 50 USPQ2d 1846 (DC SCalif, 1999) makes clear that a reference teaching a process may anticipate claims drawn to a method comprising the same process steps, despite the recitation of a different intended use in the preamble or the later discovery of a particular property of one of the starting materials or end products.
See also MPEP 2145(II) states: “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.” Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985)” (“The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.”).
However, Tsun et al. does not teach a stable formulation for the antibody. Sitlani et al. remedies this deficiency.
Sitlani et al. teaches antagonistic antibodies for human proprotein convertase subtilisin-kexin type 9 or “PCSK9”, see Abstract. Sitlani et al. also teaches compositions for the administration of the PCSK-9 specific antagonistic antibody comprising the following, see claims 9 and 10:
about 50 mg/mL to about 200 mg/mL of a PCSK9-specific antagonist;
a polyhydroxy hydrocarbon (including but not limited to sorbitol, mannitol, glycerol and dulcitol) and/or a disaccharide (including but not limited to sucrose, lactose, maltose and trehalose); the total of said polyhydroxy hydrocarbon and/or disaccharide being about 1% to about 6% w/v of the formulation;
about 5 mM to about 200 mM of histidine, imidazole, phosphate or 35 acetic acid;
about 5 mM to about 200 mM of arginine, proline, phenylalanine, alanine, glycine, lysine, glutamic acid, aspartic acid or methionine;
about 0.01 M to about 0.1 M of hydrochloric acid ("HCl") in an amount sufficient to achieve a pH in the range of about 5.5 to about 7.5;
a liquid carrier including but not limited to sterile water, petroleum, animal oil, vegetable oil, mineral oil, synthetic oil, physiological saline solution, dextrose or other saccharide solution or glycols, such as ethylene glycol, propylene glycol or polyethylene glycol; wherein said pharmaceutical composition has a pH in the range of about 5.5 to 10 about 7.5;
about 0.01% to about 1% w/v of the formulation of a non-ionic surfactant (including but not limited to Polysorbate-80 (Tween 80™), Polysorbate-60 (Tween 60™), Polysorbate-40 (Tween 40™), and Polysorbate-20 (Tween 20™), polyoxyethylene alkyl ethers, including but not limited to Brij 58™, Brij35™, as well as others such as Triton X-100™, Triton X-1 14™, NP40™ Span 15 85 and the Pluronic series of non-ionic surfactants (e.g., Pluronic 121)).
It would be obvious at the time of the instant invention to use the antibody and dosage regimen taught by Tsun et al., which is an effective treatment that results in the reduction of serum cholesterol levels as a result of hypercholesterolemia, with the formulation taught by Sitlani et al. which keeps the proteins of the antibody stable and able to retain its physical or chemical stability, conformational integrity, its ability to exhibit less denaturation, protein clipping, aggregation, fragmentation, acidic variant formation or loss of biological activity compared with a control sample at a temperature in the range of 4-37 degrees Celsius for at least about 30 days until 12 months. One would be motivated to combine the antibody and the dosage regimen with the composition for the same genus of antibody with the expectation of maintaining a stable antibody formula safe for effective administration whilst treating cholesterol-related diseases.
Therefore, claims 3, 5-6, 8-9, 11-13, 15, 17, 19-22, and new claims 32-35 are rejected as obvious over Tsun et al. and Sitlani et al.
Response to Arguments
Applicant's arguments filed 02/27/2026 have been fully considered but they are not persuasive.
Applicant argues “Tsun fails to disclose the anti-PCSK9 antibody or antigen-binding fragment thereof is administered once at an interval equal to or greater than every two weeks (Q2W)” and that “Tsun teaches a single administration, or administering once every week”. This is not found persuasive.
As discussed in the rejection above, Tsun et al. explicitly recites “for the prevention or treatment of diseases, the appropriate dosage of an antibody of the invention (when used alone or in combination with one or more other additional therapeutic agents) will depend on the type of disease to be treated, the type of antibody, the severity and course of the disease, whether the antibody is administered for preventive or therapeutic purposes, previous therapy, the patient's clinical history and response to the antibody, and the discretion of the attending physician. The antibody is suitably administered to the patient at one time or over a series of treatments. Exemplary dosage range for the antibody includes 3-30 mg/kg”, see paragraph 0171. Tsun et al. also recommends that the treatment with ADI-10087 at 3-30 mg/kg dosing be carried out until there is a significant decrease in the levels of serum LDL-C and HDL-C for 3-28 days after administration, see paragraph 0268, when treating hypercholesterolemia, hyperlipidemia, cardiovascular diseases, and/or the onset of any of the cholesterol-related diseases. Given this disclosure, one of ordinary skill in the art would be able to arrive at a dosage, such as every two weeks or a dose of about 100 mg to about 1000 mg, based on a treatment plan designed to treat or prevent hypercholesterolemia, hyperlipidemia, cardiovascular diseases, and/or the onset of any of the cholesterol-related diseases by targeting a decrease in the levels of LDL-C and HDL-C in the blood.
Applicant states that this particular dosage schedule is not taught in the prior art, but this argument is not persuasive because optimization of a dosage from within a broader range is considered routine in the art. The limitations recited in the instant claims are predictable because the art teaches the rationale behind each dosage of the antibody, which a skilled artisan can adjust depending upon the desired end goal or disease state, such as targeting a decrease in the levels of LDL-C and HDL-C in the blood. The prior art disclosures themselves speak to the fact that drug administration standards are not static and depend on multiple factors to achieve the desired end goals in an individual subject. As such, achieving certain endpoints, such as protein levels in the blood based on drug administration schedules, could be routinely experimented for and determined based on the existing guidance within the prior art.
See also MPEP 2145(II) states: “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.” Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985)” (“The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.”).
Applicant argues “unexpected results” arise from the administration dosage of every two weeks or a dose of about 100 mg to about 1000 mg. This is not found persuasive.
The dosage range claimed by Applicant as achieving unexpected results has been taught by the references in the obviousness rejection supra. Applicant argues that the specific range is not explicitly called out in the prior art; however, that fact does not avoid a finding of prima facie obviousness in light of the overlap of the claimed range. “Selecting a narrow range from within a somewhat broader range disclosed in a prior art reference is no less obvious than identifying a range that simply overlaps a disclosed range.” In re Peterson, 315 F.3d at 1329—30.
Because a skilled person in the art would attempt to identify the optimal treatment dose amount and dosing schedule for an antibody when used a therapeutic and would adjust the dose accordingly to achieve a particular disease state, the method of the instant claims are obvious over the teaching of Tsun et al. and Sitlani et al. “(W)here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” In re Aller, 220F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
See MPEP 2144.05.III.A, which states that applicants can rebut a prima facie case of obviousness by showing the criticality of the range. "The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. . . . In such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range." In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Thus, the burden is on the applicant to demonstrate that the new dose of administering the antibody formulation every two weeks or at a dose of about 100 mg to about 1000 mg shows unexpected results. Types of unexpected results include greater than expected results, superiority of a property shared with the prior art, presence of an unexpected property, or absence of an expected property (see MPEP 716.02(a)I. There is no evidence that administering the drug every two weeks or at a dose of about 100 mg to about 1000 mg shows unexpected results when compared to the same dosage range taught by Tsun et al. and Sitlani et al.
Therefore, the rejection is maintained.
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 3, 5-6, 8-9, 11-13, 15, 17, 19-22, and new claims 32-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 11, 14, 16-17, 24-26, 28, 32-34, 36, and 38-39 of copending Application No. 17/050,179, in view of Sitlani et al. (see reference in the rejection above). Although the claims at issue are not identical, they are not patentably distinct from each other because they recite the same antibody, methods of use, and composition.
‘179’s claims are drawn to a method of lowering the cholesterol level in a subject and a method for treating a cholesterol-related disease in a subject comprising administering a composition. The composition of ‘179 comprises the same concentration for a histidine buffer, the same weight by volume concentration for a viscosity inhibitor such as sorbitol or arginine, the same antibody as the instantly claimed sequences and antibody concentration of 50 mg/ml to about 200 mg/mL, the same concentration of surfactants such as polysorbate 20 and polysorbate 80, the same pH range, and the same route of administration of the composition (subcutaneous) as recited by the instant claims and taught in view of Sitlani et al. The sequence identity matches to the instantly recited sequences are as follows:
Instant SEQ ID NO: 4 is a 100% match for the reference’s SEQ ID NO: 10
Instant SEQ ID NO: 5 is a 100% match for the reference’s SEQ ID NO: 17
Instant SEQ ID NO: 6 is a 100% match for the reference’s SEQ ID NO: 19
Instant SEQ ID NO: 1 is a 100% match for the reference’s SEQ ID NO: 4
Instant SEQ ID NO: 2 is a 100% match for the reference’s SEQ ID NO: 5
Instant SEQ ID NO: 3 is a 100% match for the reference’s SEQ ID NO: 6
Instant SEQ ID NO: 8 is a 100% match for the reference’s SEQ ID NO: 30
Instant SEQ ID NO: 7 is a 100% match for the reference’s SEQ ID NO: 24
Instant SEQ ID NO: 10 is a 100% match for the reference’s SEQ ID NO: 41
Instant SEQ ID NO: 9 is a 100% match for the reference’s SEQ ID NO: 35.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 02/27/2026 have been fully considered but they are not persuasive.
Applicant argues that “the amended claims are not made obvious by the reference application claims”. This is not found persuasive.
The copending claims in the ‘179 application still render the instant claims unpatentable because they continue to teach the same antibody used in an identical method to treat the same disease state(s). The amendments to the instant claims have not changed the scope sufficiently to render the copending claims as no longer reading on the instant claims.
As such, the rejection is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SELAM BERHANE whose telephone number is (571)272-6138. The examiner can normally be reached Monday - Friday, 9-5.
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/SELAM BERHANE/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
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