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 .
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). The amino acid sequences in claim 1 linker parts (j), (k), and (l) require sequence identifiers every time they appear in the claims and specification.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Election/Restrictions
Applicant’s election without traverse of the species wherein
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in the reply filed on July 29, 2026, is acknowledged.
Claim 9 is 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.
The elected species was searched and prior art was found. Therefore, the search was not extended in accordance with MPEP § 803.02.
Claim Rejection – Improper Markush Grouping
Claims 1-4 and 10-22 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush groupings of independent claims 1 and 15 are improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: independent claims 1 and 15 recite a compound containing three components: 1) a TBM, 2) a LRP1BM, and a 3) a linker, which joins the TBM and LRP1BM.
TBM (target binding motif) includes options a)-g), which span pages 2-7 of claim 1. T
LRP1BM (low density lipoprotein receptor related protein 1 binding motif ) includes SEQ ID NOs: 1-22.
The alternatives for TBM do not share a substantial structural feature and a common use that flows from the substantial structural feature. There is no single structural element common to all of the options for TBM from which the function of target binding flows.
The alternatives for LRP1BM do not share a substantial structural feature and a common use that flows from the substantial structural feature. Although the alternatives for LRP1BM are peptides, SEQ ID NOs: 1-22, the peptides do not share a common amino acid sequence from which LRP1 binding flows.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Dependent claims 2-4 and 16-22 fail to remedy all of these issues and are likewise rejected.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4 and 10-22 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 treating ALS with the elected species, does not reasonably provide enablement for treating any other condition with the elected species or for using the full scope of the claimed compounds. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
To comply with the enablement requirements of 35 U.S.C. §112, first paragraph, a specification must adequately teach how to make and how to use a claimed invention throughout its scope, without undue experimentation. Plant Genetic Systems N.V. v. DeKalb Genetics Corp., 315 F.3d 1335, 1339, 65 USPQ2d 1452, 1455 (Fed. Cir. 2003). There are a variety of factors which may be considered in determining whether a disclosure would require undue experimentation. These factors include (In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)):
The Nature of the Invention
The invention is in the pharmaceutical field, specifically the field of peptide drug conjugates.
The breadth of the claims
Claims 1-4 and 13-22 recite a compound containing three components: 1) a TBM, 2) a LRP1BM, and a 3) a linker, which joins the TBM and LRP1BM.
TBM (target binding motif) is very broad and includes options a)-g), which span pages 2-7 of the claims. TBM includes the elected species riluzole.
LRP1BM (low density lipoprotein receptor related protein 1 binding motif) is also very broad and includes SEQ ID NOs: 1-22, peptides that do not share any common structure but allegedly share the function of binding a low density lipoprotein receptor related protein 1 (LRP1). LRP1BM includes he elected species SEQ ID NO: 1, a peptide derived from angiopep-2.
Linker is very broad and includes options which span pages 8-12 of the claims.
Claims 10-12 limit the LRP1BM to SEQ ID NO: 1 but do not limit the TBM or linker.
Claims 13-14 recite pharmaceutical compositions and claims 15-22 recite method of treating or ameliorating a disease or disorder, wherein the compound of claim 1 is the active agent. Claims 16-17 are limited to neurological diseases or disorders. Claim 18 is limited to Alzheimer’s disease.
The State of the Prior Art
BELIVEAU teaches a conjugate comprising a drug and a peptide analogue of aprotinin that is capable of transporting the drug across the blood brain barrier (BBB) to treat a neurological disease ([0009]-[0011], [0067]-[0088]). BELIVEAU teaches that the peptide may be SEQ ID NO: 74, which is identical to instant SEQ ID NO: 1 ([0046]).
MILLER teaches that amyotrophic lateral sclerosis (ALS) is a fatal, progressive degenerative motor neuron disease that leads to death within three to four years after symptom onset for approximately half of all patients. ALS is characterized by weakness in limb and bulbar muscles with atrophy, spasticity, weight loss and ultimately respiratory failure. MILLER teaches that the only approved therapy, riluzole, slows disease progression but does not stabilize or improve the underlying disorder (p 5, col 1). MND teaches that a review of 15 clinical studies in 2020 revealed that riluzole treatment increases survival between 6 and 19 months, which is substantially longer than survival times found in the original trials of the drug but confirms that it is the only approved therapy for ALS (p 2). CHO teaches that an additional drug, edavarone, which operates by a different mechanism was recently approved for ALS (abstract).
The Predictability or Unpredictability of the Art
The prior art pertaining to the treatment of neurological diseases is highly unpredictable. Despite extensive research, MILLER and MND teach that for many years riluzole was the only approved therapy for ALS. Furthermore, MOHAMMED teaches that the blood–brain barrier (BBB) is an impediment for treatment of central nervous system (CNS) diseases, including ALS. MOHAMMED teaches that progressive resistance to CNS penetration develops during ALS therapy with riluzole (abstract). The prior art does not teach that rilazole can be used to treat any other neurological disease besides ALS, including Alzheimer’s disease.
The Level of Guidance in the Specification
The guidance provided in the specification with respect to administration and dosage is generic.
The level of guidance in the specification is insufficient to determine which of the countless species encompassed by the claim can be used in the claimed method of treating a disease or disorder, including neurological disorders such as Alzheimer’s disease.
The specification does not describe a general correlation between structure and function for the claimed genus. The role of the amino acids in each of the LRP1BM peptides in the binding site, binding site formation, binding site environment and overall fold, stability and dynamics of the peptide are not described. Furthermore, the role of the amino acids in each of the LRP1BM peptides in the ability of the peptides to deliver a drug across the BBB are not described. Furthermore, a structure-function correlation is not presented for rilazole that could be used by POSITA to predict how the drug could be used to treat any other disease besides ALS.
The Presence or Absence of Working Examples
The specification fails to provide a single working example demonstrating that the elected species can be used to treat a disease.
The Quantity of Experimentation Necessary
Considering the factors above, the skilled artisan would be burdened with undue experimentation in determining if one of the claimed compounds would be effective at treating any disease or disorder, including the highly unpredictable disease ALS and Alzheimer’s disease. The experimentation required represents years of inventive effort. When the above factors are weighed, it is the examiner's position that one skilled in the art could not practice the invention without undue experimentation.
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.
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 1-4, 10-13, 15-17, and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Beliveau et al. (US 2006/0189515 A1; hereafter “BELIVEAU”) in view of Miller et al. (Riluzole for amyotrophic lateral sclerosis (ALS)/motor neuron disease (MND). Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD001447; hereafter “MILLER”), MND Research Blog (Review of evidence suggest Riluzole treatment may lead to extended survival, published 28 July 2020, retrieved from https://mndresearch.blog/2020/07/28/review-of-evidence-suggests-riluzole-treatment-may-lead-to-extended-survival/; hereafter “MND”), Mohamed et al. (Blood-Brain Barrier Driven Pharmacoresistance in Amyotrophic Lateral Sclerosis and Challenges for Effective Drug Therapies. AAPS J 19, 1600-1614 (2017); hereafter “MOHAMED”), and Alas et al. (Peptide-Drug Conjugates with Different Linkers for Cancer Therapy. J. Med. Chem. 2021, 64, 216-232; Epub 2020 Dec 31; hereafter “ALAS”).
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Determining the scope and contents of the prior art.
BELIVEAU teaches a conjugate comprising a drug and a peptide analogue of aprotinin that is capable of transporting the drug across the blood brain barrier (BBB) to treat a neurological disease ([0009]-[0011], [0067]-[0088]). BELIVEAU teaches that the peptide may be SEQ ID NO: 74, which is identical to instant SEQ ID NO: 1 ([0046]). BELIVEAU teaches that the drug and peptide are connected via an optional linker ([0081], [0133]).
Ascertaining the differences between the prior art and the claims at issue.
BELIVEAU does not teach that the conjugate comprises the drug riluzole or the elected species of linker, a PEG-containing linker.
Resolving the level of ordinary skill in the pertinent art.
MILLER teaches that amyotrophic lateral sclerosis (ALS) is a fatal, progressive degenerative motor neuron disease that leads to death within three to four years after symptom onset for approximately half of all patients. ALS is characterized by weakness in limb and bulbar muscles with atrophy, spasticity, weight loss and ultimately respiratory failure. MILLER teaches that the only approved therapy, riluzole, only slows disease progression and does not stabilize or improve the underlying disorder (p 5, col 1). MND teaches that a review of 15 clinical studies in 2020 revealed that riluzole treatment increases survival between 6 and 19 months, which is substantially longer than survival times found in the original trials (p 2).
MOHAMMED teaches that the blood–brain barrier (BBB) is an impediment for treatment of central nervous system (CNS) diseases, including ALS. MOHAMMED teaches that progressive resistance to CNS penetration develops during ALS therapy with riluzole (abstract).
ALAS reviews linker technology for peptide-drug conjugates (abstract; Figure 1), which include PEG-containing linkers containing four or seven PEG residues (Figure 12; p 227, col 2; p 228, col 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the drug in the conjugate taught by BELIVEAU with the riluzole taught by MILLER, MND, and MOHAMMED, and to connect the two elements via a linker taught by ALAS. The rationale for obviousness is simple substitution of one known element for another to obtain predictable results (MPEP § 2143.01(B)). The relevant findings for this rationale are as follows.
(1) The prior art contained a product which differed from the claimed device by the substitution of some elements with other elements. In the instant case, the primary reference BELIVEAU teaches a conjugate comprising a drug and a peptide analogue of aprotinin that is capable of transporting the drug across the BBB ([0009]-[0011], [0067]-[0088]) via an optional linker ([0081], [0133]). BELIVEAU teaches that the peptide may be SEQ ID NO: 74, which is identical to instant SEQ ID NO: 1 ([0046]). This conjugate, which is designed to improve delivery of the drug across the BBB, differs from the claimed conjugate by the substitution of riluzole for the drug and by the substitution of a PEG-containing linker for the linker. Therefore, prior art contained a product which differed from the claimed device by the substitution of some elements with other elements.
(2) The substituted elements and their functions were known in the art. The primary reference BELIVEAU teaches a conjugate comprising a drug for a neurological disease and a peptide analogue of aprotinin that is capable of transporting the drug across the BBB ([0009]-[0011], [0067]-[0088]). Therefore, the drug for treating a neurological disease that must cross the BBB is the substituted component. The function of riluzole is known in the art because MILLER, MND, and MOHAMMED teach that it is approved for ALS, a neurological disease. In addition, MOHAMMED teaches riluzole must cross the BBB during ALS treatment (abstract). Likewise, PEG-containing linkers are known in the prior art to connect peptide carriers and drugs, as shown by ALAS. Therefore, the substituted components and their functions were known in the art.
(3) One of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable. One of ordinary skill in the art would expect that the peptide analogue of aprotinin SEQ ID NO: 74, which is identical to instant SEQ ID NO: 1, would perform the function of delivering the drug across the BBB in the combination with riluzole because BELIVEAU teaches that it performs this function when conjugated with other CNS drugs ([0009]-[0011], [0067]-[0088]). One of ordinary skill in the art would expect that riluzole would perform the function of treating ALS in the combination with SEQ ID NO: 1 because MILLER, MND, and MOHAMMED teach that it is approved for ALS. One of ordinary skill in the art would expect that the PEG-based linker would perform the function of connecting a peptide carrier and a drug in the combination because ALAS teach that it performs this function in other peptide-drug conjugates. Therefore, one of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable.
(4) Whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness. The specification does not include a reduction to practice of the elected species.
The rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art. Therefore, a conjugate comprising
TBM is riluzole,
LRP1BM is SEQ ID NO: 1,
Linker is a PEG-containing linker with, for example, four or seven PEG residues, and
m, n, and o are 1
is obvious over the cited art, satisfying claims 1-4 and 10.
Regarding claim 11, BELIVEAU teaches that the peptide may be SEQ ID NO: 70, which is identical to instant SEQ ID NO: 1 wherein the C-terminal cysteine residue is absent ([0046]).
Regarding claim 12, BELIVEAU teaches that the peptide may be attached to the drug via a linker through an amino group on the peptide (Figure 2), which POSITA would understand to mean the N-terminal amino group or an amino group in a side chain of lysine.
Regarding claims 13, 15-17, and 20-22, it would have been obvious to formulate the conjugate in a pharmaceutical composition with a suitable carrier and to administer it to treat ALS in a human given that MILLER, MND, and MOHAMMED teach that riluzole is approved for ALS, a neurological disease.
Claims 14 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over BELIVEAU in view of MILLER, MND, MOHAMED, and ALAS, as applied to claims 1-4, 10-13, 15-17, and 20-22 above, in further view of Cho et al. (Role of Edaravone as a Treatment Option for Patients with Amyotrophic Lateral Sclerosis. Pharmaceuticals (Basel). 2020 Dec 31;14(1):29; hereafter “CHO”).
CHO teaches that edaravone is a newly approved antioxidant drug for ALS that halts the progression of ALS in the early stages through its cytoprotective effect and protects the nerves by reducing ROS (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the drug in the conjugate taught by BELIVEAU with the riluzole taught by MILLER, MND, and MOHAMMED, and to connect the two elements via a linker taught by ALAS, for the reasons presented above, and to further combine the conjugate with edavarone taught by CHO. Doing so would satisfy all of the limitations of claims 14 and 19. The rationale for obviousness is that both drugs, riluzole and edaravone, are approved for ALS.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4 and 10-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 18/547,289 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims.
The only difference in scope between the sets of claims is that the reference claims allow embodiments wherein m, n, and o can be 0. Otherwise the claims are the same and therefore anticipate the instant claims. Claims 1-4 and 10-22 correspond to reference claims 1-4 and 10-22, respectively.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA M MARCHETTI BRADLEY whose telephone number is (571)272-9044. The examiner can normally be reached Monday-Friday, 8:30 am - 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G Garyu can be reached at (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTINA M MARCHETTI BRADLEY
Primary Examiner
Art Unit 1654
/CHRISTINA M MARCHETTI BRADLEY/Primary Examiner, Art Unit 1654
Prosecution Insights