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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 21, 2026 has been entered.
Claims 2-4, 10-24, 26, 28 and 30 have been cancelled.
New claims 34-39 have been added.
Claims 1, 5-9, 25, 27, 29 and 31-39 are pending in this application.
Applicant elected Invention 1 (claims 1-9 and 23-31, now claims 1, 5-9, 25, 27, 29 and 31-39) and brain cells as the species of a type of cell, SEQ ID NO: 1 as the species of a fully defined LRP/LR sequence, non-parenteral, oral administration as the species of administration, daily as the species of first time period, SEQ ID NO: 6 as the species of nucleotide sequence for down regulation, and human as the species for patient population in the reply filed on February 18, 2025. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election had been treated as an election without traverse (see MPEP 818.01(a)). Restriction was deemed to be proper and was made FINAL in the previous office action. Claims 1, 5-9, 25, 27, 29 and 31-39 are examined on the merits in this office action.
Withdrawn Objections and Rejections
Objection to claim 1 is hereby withdrawn in view of Applicant’s amendment to the claims.
Rejection of claim 9 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is hereby withdrawn in view of Applicant’s amendment to the claim.
Rejection of claims 1, 5-9, 25, 27, 29 and 31-39 remain/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), is hereby withdrawn in view of Applicant’s persuasive arguments. However, due to Applicant’s response/arguments, a new rejections under 35 U.S.C. 112(f) and 35 U.S.C. 112(a) are set forth below.
Rejection of claims 2-4, 23-24 and 30 under 35 U.S.C. 112(d), is hereby withdrawn in view of Applicant cancelling the claims.
Objections
The specification is objected for the following minor informality: The specification at paragraph [0129] appears to have grammatical error. The specification recites, “It is to be understood that…and/or homologs of the fragments may also utilized in order to exercise…” The term “be” needs to be inserted in between the term “also” and “utilized”. Applicant is required to correct this error.
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
New Rejections
35 U.S.C. 112(f)
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.
Claims 1, 5-9, 25, 27, 29 and 32-39 recite, “a/the step for “ in the claims.
Additionally, claim 32 and new claim 36 recite, “…means for causing overexpression ...”
Applicant’s Comments/Response to 35 U.S.C. 112(b) rejection
Applicant argues that “Each of claims 1 and 6 contains a “step-plus-function” recitation that invokes the provisions of 35 USC(f). 35 USC 112(f) specifies:
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. In view of the specific language in the statute, any requirement for claim 1 to be amended to recite a component/material for performing the specified function of increasing the expression of LRP/LR, or for claim 6 to be amended to recite a component/material for downregulating LRP/LR, is inconsistent with the admonition in 35 USC 112(f) that the claim must not comprise such structure or material.”
35 U.S.C. 112(a)
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, 5-9, 25, 27, 29 and 31-39 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.
The courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP 2163.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co., the court stated:
“A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials. Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284-85 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus. . . ."). Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitute a sufficient number of representative, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gostelli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d at 1012, 10 USPQ2d at 1618.
In the instant case, the claims are drawn to a method of decreasing concentration of tau (t) protein and/or phosphorylated tau (t) protein in a target cell of a human or animal subject having Alzheimer’s Disease (AD), the method comprising a step for increasing expression of laminin receptor precursor/high affinity laminin receptor (LRP/LR) in the target cell so as to result in decreasing concentration of tau (t) protein and/or phosphorylated tau (t) protein in the target cell, wherein the target cell is a brain cell of the human or animal subject. Claims 32 and 36 further recite, “…comprises transfecting the target cell with means for causing overexpression of the LRP/LR in the target cell” (claim 32) and “…wherein the means for causing oversecpression comprises pCIneo-moLRP::FLAG plasmid” (claim 36). The generic statements “a step for increasing expression of laminin receptor precursor/high affinity laminin receptor (LRP/LR), “a means for causing overexpression of the LRP/LR in the target cell,” and “the means for causing overexpression comprises pCIneo-moLRP::FLAG plasmid” do not provide ample written description for the compounds since the claims do not describe a single structural feature. The specification does not clearly define or provide examples of what qualify as compounds of the claimed invention.
As stated earlier, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable claims 1, 5-9, 25, 27, 29 and 31-39 are broad generics with respect all possible compounds encompassed by the claims. The possible structural variations are limitless to any class of compounds that has a “function” for increasing expression of laminin receptor precursor/high affinity laminin receptor (LRP/LR). It must not be forgotten that the MPEP states that if a peptide is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. Here, though the claims may recite some functional characteristics, the claims lack written description because there is no disclosure of a correlation between function and structure of the compounds beyond compounds disclosed in the examples in the specification. Moreover, the specification lack sufficient variety of species to reflect this variance in the genus since the specification does not provide any examples other than the disclosed compounds.
The specification discloses “a transfecting agent for the expression of LRP/LR” (see for example, abstract). The specification discloses that “The step of transfecting the cell may upregulate LRP/LR to cause overexpression of LRP/LR” (see paragraphs [0022] and [0094] of instant specification US 2023/0212250). The specification discloses “a transfecting agent for the expression of LRP/LR, in the manufacture of a pharmaceutical composition for use…37 kDa/67 kDa laminin receptor precursor/high affinity laminin receptor (LRP/LR) and/or a fragment thereof, or a transfecting agent for the expression of LRP/LR (see paragraph [0116] of instant specification). The specification further discloses the following: It is to be understood that LRP/LR is highly conserved and homologs or fragments of SEQ ID NO: 1 and SEQ ID NO: 2, and/or homologs of the fragments may also utilized in order to exercise the disclosure described…” (see paragraph [0129] of instant specification). The specification is limited to instant SEQ ID NOs: 1-7. Instant SEQ ID NOs: 1-5 are protein/peptide sequences; instant SEQ ID NOs: 6-7 are nucleotide sequences (see sequence listing). Instant SEQ ID Nos: 1-2 are full length sequences having 295 residues. Instant SEQ ID NO: 3 is a 8 residue peptide sequence. Instant SEQ ID NOs: 4-5 are protein sequence both having 194 residues. The fragments of instant SEQ ID NOs: 4-5 are recited as being fragments of instant SEQ ID NO:1 and 2, respectively. A fragment of a protein/peptide can be any peptide with at least 2 amino acids (dipeptide) and up, within the defined protein sequence. For example, a fragment of instant SEQ ID NO: 1 can be any peptide sequence having two residues up to 294 residues. Instant specification discloses that a fragment of the peptide/protein sequence as exemplified as SEQ ID NO: 4, corresponding to a fragment of SEQ ID NO: 1 from 102 to 295 and/or SEQ ID ON: 5 corresponding to a fragment of SEQ ID NO: 2 from 102 to 295 (see paragraph [0023]). Additionally, the specification does not define what residues and structural characteristics are required for fragment of antibody and what nucleotide residues are required to maintain function of “decreasing concentration of tau protein and/or phosphorylated tau protein in a target cell.” Furthermore, a peptide/protein sequence having at least 80% homology to SEQ ID NO: 1 or SEQ ID NO:2 is not clearly defined in the specification. Kanduc reference (Journal of Peptide Science, June 14, 2012, 18: 487-494, cited in the previous office action) teaches that “homology is a concept of quality. The word asserts a type of relationship between two or more things. Thus, amino acid or nucleotide sequences are either homologous or they are not. They cannot exhibit a particular “level of homology” or “percent homology”. Instead, two sequences possess a certain level of similarity.” (see p. 487, left column, Introduction). Kanduc reference further teaches that “Homology indicates an ancient common origin and temporal evolution and refers to structural characteristics…homology retains the original meaning of “having a common evolutionary origin” (see p. 488, left column, first paragraph under “What are Homology, Similarity, and Identity, and How Do We Measure Them?”). Kanduc reference further teaches “It is important to note that homologous structures do not imply sequence similarity as a necessary condition” (see p. 488, left column, first paragraph under “What are Homology, Similarity, and Identity, and How Do We Measure Them?”). Kanduc reference teaches that “Similarity is quantitative property…there are two ways to measure sequence similarity: (1) percent identity and (2) percent similarity” (see p. 488, left column, 1st and 2nd paragraphs under “Similarity and Identity: Definition and Measurement Based on Quantification”). Therefore, Applicant was not in possession of LRP/LR fragment thereof, and ALL agents that have transfecting activity of instant SEQ ID NOs: 1-2 and 4-5, for example. There is not sufficient amount of examples provided to encompass the numerous characteristics of the whole genus claimed. Thus, Applicant was not in possession of ALL agents that can be used in a “step for increasing expression of laminin receptor precursor/high affinity laminin receptor (LRP/LR) in the target cell so as to result in decreasing concentration of tau protein and/or phosphorylated tau protein in the target cell.
Additionally, Sarnataro et al (Scientific Reports, 13 April 2016, pp. 1-13) teach the following:
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(see abtract). Sarnataro et al teach:
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(see p. 2, 4th paragraph).
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(see p. 2, paragraphs 6-8). Sarnataro et al teach examining PrPc and 37/67 kDa LR expression and intracellular localization in both neuronal and non-neuronal cells (see p. 2, “results”). Sarnataro et al teach that “the finding that 37/67 kDa LR may play a role in Alzheimer’s disease (AD) and that modulation of 37/67 kDa LR could affect Ab cytotoxicity and its release from cells, highlights the importance of NSC47924 inhibitor to modulate 37/67 kDa LR trafficking and degradation, and the consequences that this inhibitor could have on other neurodegenerative disorders” (see p. 10, 4th paragraph). Sarnataro et al teach that the inhibiting to modulate the 37/67 kDa LR trafficking and degradation lead to treatment of Alzheimer’s disease.
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate"). Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention. Applicant was not in possession of ALL compounds that increases expression of laminin receptor precursor/high affinity laminin receptor (LRP/LR) in a target cell.
Closest Art of Interest
Pinnock et al (J. of Alzheimer’s Disease, 2016, 49(3): 645-657) teach LRP/LR antibody mediated rescuing of amyloid-beta-induced cytotoxicity is dependent on PrPc in Alzheimer’s Disease (see Title). Pinnock et al teach that PrPc overexpression significantly enhanced Ab42 cytotoxicity in vitro, while PrP-/- cells were more resistant to the cytotoxic effect of Ab42 and exhibited significantly less cell death than PrPc expressing N2a cells (see abstract). Pinnock et al do not teach increasing expression (overexpressing) of LRP/LR in the target cell.
Sarnataro et al (Scientific Reports, 13 April 2016, pp. 1-13) teach the following:
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(see abtract). Sarnataro et al teach:
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(see p. 2, 4th paragraph).
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(see p. 2, paragraphs 6-8). Sarnataro et al teach examining PrPc and 37/67 kDa LR expression and intracellular localization in both neuronal and non-neuronal cells (see p. 2, “results”). Sarnataro et al teach that “the finding that 37/67 kDa LR may play a role in Alzheimer’s disease (AD) and that modulation of 37/67 kDa LR could affect Ab cytotoxicity and its release from cells, highlights the importance of NSC47924 inhibitor to modulate 37/67 kDa LR trafficking and degradation, and the consequences that this inhibitor could have on other neurodegenerative disorders” (see p. 10, 4th paragraph). Sarnataro et al teach that the inhibiting to modulate the 37/67 kDa LR trafficking and degradation lead to treatment of Alzheimer’s disease.
CONCLUSION
No claim is allowed.
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/JULIE HA/Primary Examiner, Art Unit 1654
6/2/2026
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