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 .
Priority
The present application claims status as a 371 (National Stage) of PCT/IB2022/058039 filed 08/27/2022, and claims priority under 119(a)-(d) to Indian Application No. IN202121039213 filed on 08/30/2021.
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d) for Indian Application No. IN202121039213, which papers have been placed of record in the file.
Claim Status
Claims 1-17 were originally filed and amended on 02/15/2024; the amendment cancelled claims 2-3, and amended claims 1, 4-6, 9-14 and 16.
Information Disclosure Statement
The IDS filed on 04/15/2024 has been considered by the Examiner.
Drawings
The drawings are objected to because Fig. 1 is illegible. The percent change in body weight of the analyzed groups cannot be differentiated from each other because the different lines appear faded. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. In the instant case, the disclosure includes executable code at pg. 10, line 33 and at pg. 11, lines 8. Applicants’ cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1 and 14 are objected to because of the following informalities: Grammar. The claim recites “inflammation caused due to”. The phrase “cause due to” is repetitive because it combines two overlapping causal prepositions caused by and due to. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: Grammar. The claim recites “comprises of the amino acid”. The preposition “of” is not needed. Appropriate correction is required.
Claims 4, 9, 15-16 are objected to because of the following informalities: Grammar. The claims recite “wherein the protein”. The adjective “recombinant” should be included before “the protein” for improved clarity. Appropriate correction is required.
Claims 9-13 are objected to because of the following informalities: Grammar. The claim recites “composition comprises of”. The preposition “of” is not needed because the term “comprises” describes the relationship between a whole an its parts, therefore “of” makes the term redundant. Appropriate correction is required.
Claim Interpretation
The scope of “a recombinant lectin protein” is interpreted as having at least 70% homology to SEQ ID NO: 1. Since SEQ ID NO: 1 is 141 amino acids in length, a recombinant protein having at least 70% homology to SEQ ID NO: 1 would encompass up to 42 modifications including any insertions, substitutions, deletions, etc.
Per MPEP 2111.03(IV), the transitional phrase “having”, is being interpreted in light of the instant specification as open claim language. Therefore, a recombinant lectin protein having at least 70% homology to SEQ ID NO: 1 allows the inclusion of other components in addition to those recited. Thus allowing for the inclusion of any N-/-C terminal additions.
Additionally, the term “homology” is being interpreted as recited in the instant specification at pg. 10, lines 22-24 (i.e., Areas, regions or domains of homology or identity refer to a portion of two or more referenced entities that share homology or are the same). Thus, it is understood that the term "homology" is used interchangeably with the term "sequence identity" (see instant specification, pg. 11, lines 10-11).
The term “an amino acid sequence” is being interpreted as any amino acid sequence with at least two amino acids (i.e., dipeptide) that is within SEQ ID NO: 2 or SEQ ID NO: 3 or SEQ ID NO: 4.
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.
1. Claim 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 depends from claim 1, which is drawn to a recombinant lectin protein having at least 70% homology to SEQ ID NO: 1. Therefore the scope of parent claim 1 encompasses a recombinant lectin protein having 70% homology or more to SEQ ID NO: 1. The limitations recited in parent claim 1, carry over to claim 5. Thus, claim 5 is indefinite because it has not been clearly established whether:
a) the protein of claim 1, further comprises the amino acid sequence of SEQ ID NO: 2, SEQ ID NO: 3 or SEQ ID NO: 4, as in a protein complex; or
b) the recombinant lectin protein of claim 1 comprises additional non-essential amino acids present in SEQ ID NOs: 2 or 3 or 4, but absent in the amino acid sequence represented by SEQ ID NO: 1. Furthermore, it is noted that SEQ ID NOs: 2, 3 and 4 have more than 90% homology with SEQ ID NO: 1 (see instant specification, pg. 13, lines 31-32). Therefore, the recombinant lectin protein of claim 1, cannot further comprise the amino acid sequence of SEQ ID NO: 2, SEQ ID NO: 3 or SEQ ID NO: 4 because a recombinant lectin protein having at least 70% homology to SEQ ID NO: 1 encompasses recombinant proteins that are 91%, 96%, or 98% homologous to SEQ ID NO: 4, SEQ ID NO: 3 or SEQ ID NO: 2, respectively.
2. Claim 9 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 depends from claim 6, which is drawn to a composition comprising recombinant lectin protein having the amino acid sequence of SEQ ID NO: 1 or a recombinant lectin protein having at least 70% homology to SEQ ID NO: 1. Therefore the scope of parent claim 6 encompasses a recombinant lectin having the amino acid sequence of SEQ ID NO: 1, or a recombinant lectin protein having 70% homology or more to SEQ ID NO: 1. The limitations recited in parent claim 6, carry over to claim 9. Thus, claim 9 is indefinite because it has not been clearly established whether:
a) the recombinant lectin protein of claim 6, further comprises the amino acid sequence of SEQ ID NO: 2, SEQ ID NO: 3 or SEQ ID NO: 4, as in a protein complex; or
b) the recombinant lectin protein of claim 6 comprises additional non-essential amino acids present in SEQ ID NOs: 2 or 3 or 4, but absent in the amino acid sequence represented by SEQ ID NO: 1; and if so, it is noted that SEQ ID NOs: 2, 3 and 4 have more than 90% homology with SEQ ID NO: 1 (see instant specification, pg. 13, lines 31-32). Therefore, the recombinant lectin protein of claim 6, cannot further comprise the amino acid sequence of SEQ ID NO: 2, SEQ ID NO: 3 or SEQ ID NO: 4 because a recombinant lectin protein having at least 70% homology to SEQ ID NO: 1 encompasses recombinant proteins that are 91%, 96%, or 98% homologous to SEQ ID NO: 4, SEQ ID NO: 3 or SEQ ID NO: 2, respectively.
3. Claims 11-13 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.
Claims 11-13 further limit the composition of claim 6, wherein the composition comprises “0.01% to 2.5% of the recombinant lectin protein”. Claim 6 recites that the composition comprises a recombinant lectin protein having the amino acid sequence of SEQ ID NO: 1 or a recombinant lectin protein having at least 70% homology to SEQ ID NO: 1. However, it has not been clearly established whether the limitation “0.01% to 2.5% of the recombinant lectin protein” recited in instant claims 11-13, further limits the recombinant protein having the amino acid sequence of SEQ ID NO: 1 or whether the limitation further limits the recombinant protein having at least 70% homology to SEQ ID NO: 1. As such, an ordinary skilled artisan would not be able to ascertain the metes and bounds of the claimed composition, because claims 11-13 fail to particularly point out and distinctly claim the subject matter which the inventor(s) regard as the invention.
3. Claim 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 15 is dependent upon claim 14, which is drawn to a method of prophylactic and/or therapeutic treatment of inflammation caused due to chemotherapy and/or radiotherapy in a subject undergoing cancer treatment. However, claim 15 includes the phrase "more preferably to oral mucosa", which renders the claim indefinite because it is unclear whether the preferred limitation (i.e., the oral mucosa) is a required element of the method recited in parent claim 14, or just an optional suggestion.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
4. Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The recitation “further comprises the amino acid sequence of SEQ ID NO: 2, SEQ ID NO: 3, or SEQ ID NO: 4” fails to further limit parent claim 1, because a recombinant lectin protein that has at least 70% homology to SEQ ID NO: 1 encompasses sequences that have 70% or more percent homology with SEQ ID NO: 1. Since SEQ ID NO: 2 has 98% homology with SEQ ID NO: 1; SEQ ID NO: 3 has 96% homology with SEQ ID NO: 1; and SEQ ID NO: 4 has 91% homology with SEQ ID NO: 1. These sequences are encompassed by the scope of the recombinant lectin protein of claim 1. Claim 5, does not further limit parent claim 1, because an embodiment of claim 1 encompasses a recombinant lectin protein having at least 70% or more homology with SEQ ID NO: 1.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
5. Claim 9 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The recitation “further comprises the amino acid sequence of SEQ ID NO: 2, SEQ ID NO: 3, or SEQ ID NO: 4” fails to further limit parent claim 6, because a recombinant lectin protein that has at least 70% homology with SEQ ID NO: 1 encompasses sequences that have 70% or more percent homology with SEQ ID NO: 1. Since SEQ ID NO: 2 has 98% homology with SEQ ID NO: 1; SEQ ID NO: 3 has 96% homology with SEQ ID NO: 1; and SEQ ID NO: 4 has 91% homology with SEQ ID NO: 1. These sequences are encompassed by the scope of the recombinant lectin protein of claim 6. Claim 9, does not further limit parent claim 6 because an embodiment of claim 6 encompasses a recombinant lectin protein having at least 70% or more homology with SEQ ID NO: 1.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
6. Claims 11-13 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which they depend, or for failing to include all the limitations of the claim upon which it depends.
Claims 11-13 depend upon claim 6, which is drawn to a composition for topical application comprising a recombinant lectin protein having the amino acid sequence of SEQ ID NO: 1 or a recombinant lectin protein having at least 70% homology to SEQ ID NO: 1.
Dependent claims 11-13 fail to specify a further limitation of the subject matter claimed in parent claim 6. Stated differently, claims 11-13 recite: “0.01% to 2.5% of the recombinant lectin protein”. However, it has not been clearly established whether the limitation applies to recombinant lectin protein having the amino acid sequence of SEQ ID NO: 1 or to a recombinant lectin protein having at least 70% homology to SEQ ID NO: 1.
Additionally, claims 11-13 include details pertaining to pharmaceutically acceptable excipients and/or diluents, which are not included in parent claim 6; therefore claims 11-13 broaden the scope of parent claim 6. Applicants could amend the claims to specify the recombinant lectin protein (i.e., recombinant lectin having SEQ ID NO: 1 , or recombinant lectin having 70% homology to SEQ ID NO: 1), and change the claim dependency to claim 10; thus claims 11-13 would be drawn to “The composition of claim 10,” instead of to “The composition of claim 6”.
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.
7. Claims 1, 4, 6-8, and 10-17 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. Claims 5 and 9 are not part of this rejection because these claims require the amino acid sequence of SEQ ID NO:2, SEQ ID NO: 3, or SEQ ID NO: 4.
MPEP § 2163 states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus.
Independent claim 1 is drawn to a recombinant lectin protein having at least 70% homology to SEQ ID NO: 1 for use in the prophylactic and/or therapeutic treatment of inflammation caused by oral mucositis caused due to chemotherapy and/or radiotherapy in a subject undergoing cancer treatment. As such, the scope of the claimed “recombinant lectin protein” encompasses any sequence that has at least 70% or more homology to SEQ ID NO: 1. Therefore, the scope of claims 4, 6-8, 10-17 encompass a vast array of recombinant lectin proteins that have homology to SEQ ID NO: 1.
Applicants are in possession of SEQ ID NOs: 1, 2, 3 and 4, however Applicants only reduced to practice SEQ ID NO: 2, as shown in Examples 1-6 (see instant specification, pp. 25-42). Thereby, the specification is void of any data which demonstrates possession of a variant of SEQ ID NO: 1 having at least 70% homology to SEQ ID NO: 1. In other words, the specification is void of data pertaining to recombinant lectin proteins having 70% or more homology to instant SEQ ID NO: 1.
An invention described solely in terms of a method of making and/or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function. MPEP 2163 (I)(A). As recited in the instant spec, the recombinant lectin protein reduced to practice (i.e., SEQ ID NO: 2) has 98% homology with SEQ ID NO: 1 (see pg. 13, line 31). Thus, a recombinant protein comprising an amino acid sequence (.e., SEQ ID NO: 2) having 98% homology to SEQ ID NO: 1, does not constitute a representative number of species of recombinant lectin proteins that have at least 70% homology to SEQ ID NO: 1. Therefore, it would be difficult for a skilled artisan to envision the correlation between structure and function for the whole genus and/or to predict what would be covered by the functionally claimed genus because Applicants have failed to provide a representative number of species to support the scope of the whole genus.
The written description requirement may be met by provided a representative number of species of the genus and/or in light of the state of the art. With regard to the state of the art, Peppa et al. (Molecules 2015, 20, 1848-10865) created two recombinant variants of SRL (Sclerotium rolfsii lectin), SSR1 and SSR2. "[D]eliberate replacement of the amino acid is incorporated between SRL and SSR1 at 14th, 113th and 123rd positions, where the amino acids Asn, Glu and Glu residues were replaced by Asp, Gln and Gln, respectively. In case of SSR2 amino acids at the 1st, 14th, 34th, 113th and 123rd were replaced with Val, Asp, Ser, Gln and Gln, respectively" (pg. 10851 col. 2, Figure 2). Peppa et al. also published SRL protein structures highlighting the modified amino acids (Figure 2).
Furthermore, WO 2020/044296 A2 (cited in the IDS filed on 04/15/2024) teach SEQ ID NOs: 1-4, which are 100% identical to instant SEQ ID NOs: 1-4 (see pp. 44-45, summary of sequences). Additionally, Tables 1-6 6 depicts a summary of clone variants derived from the disclosed sequences (i.e., SEQ ID NOs: 1-4). Therefore, Peppa’s and WO2020/044296 A2 teachings present compelling evidence stablishing the structure and function of recombinant lectin proteins having at least 70% homology to SEQ ID NO: 1.
Alternatively, the written description requirement may be met by providing a representative number of species of the genus. In the instant case, the specification teaches Examples 1-6, which pertain to SEQ ID NO: 2. (see instant specification, pp. 25-42). However, the specification is void of any data pertaining to recombinant lectin proteins having at least 70% homology to SEQ ID NO: 1. Thus, evidence of a handful of positive integrant and replicative experiments of only one recombinant lectin protein that does not have at least 70% homology to SEQ ID NO: 1 is not sufficient for the skilled artisan to envisage what constitutes a necessary core structure and/or sequence that would constitute a representative number of species of the claimed genus. As such, Applicants are not in possession of the claimed invention.
Accordingly, claims 1, 4, 6-8, and 10-17 do not meet the written description requirement.
8. Claims 1, 4, 6-8, and 10-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a recombinant lectin protein comprising the amino acid sequence of SEQ ID NO: 2 for reducing inflammation caused by oral mucositis caused due to chemotherapy and/or radiotherapy in a subject undergoing cancer treatment; does not reasonably provide enablement for a recombinant lectin protein having at least 70% homology to SEQ ID NO: 1 for use in the prophylactic treatment and/or therapeutic treatment of inflammation caused by oral mucositis caused due to chemotherapy and/or radiation therapy in a subject undergoing cancer treatment.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected to make and/or use the invention. In particular, the method claims are drawn to prophylactic and/or therapeutic treatment of inflammation. The instant specification teaches that the term “treatment” comprises substantially curing (i.e., eliminating) the inflammation of an underlying chronic inflammatory disease (see pg. 5, lines 25-26). It is noted that the embodiments of the instant invention may comprise preventing the onset of the inflammation, the disease and/or the symptoms (“prophylactic treatment”) (see instant specification, pg. 5, lines 25-31). The specification also emphasizes that the term “prevention” may comprise preventing the onset of the inflammation or preventing or slowing the progression of the inflammation of an underlying chronic inflammatory disease (see instant specification, pg. 5, lines 32-34). It is also noted that the specification fails to provide a definition for the term “therapeutic treatment”. As such, the instant specification, as best understood discloses that the terms curing (i.e., eliminating) and prevention (i.e., as in 100% prevention from happening or occurring) are nested within the terms “prophylactic treatment” and “therapeutic treatment”. Therefore, the scope of the claims encompass: curing (i.e. eliminating) the inflammation or an underlying chronic inflammatory disease; and preventing the onset of the inflammation, the disease, and/or the symptoms.
To address whether sufficient evidence supports the determination that the disclosure does not satisfy the enablement requirement and whether undue experimentation might be needed, the below factors are considered:
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The breadth of the claims: The claims are drawn to a recombinant lectin protein having at least 70% homology to SEQ ID NO: 1; and to a method of prophylactic and/or therapeutic treatment of inflammation caused by oral mucositis caused due to chemotherapy and/or radiotherapy. Details disclosed in the specification do not show that a recombinant lectin protein having at least 70% homology to SEQ ID NO:1 can be used in the prophylactic and/or therapeutic treatment of inflammation caused by oral mucositis caused due to chemotherapy and/or radiotherapy. Accordingly claims 1, 4, 6-8, and 10-17 are unduly broad with respect to a recombinant lectin protein having at least 70% homology to SEQ ID NO: 1 for use in the prophylactic and/or therapeutic treatment of inflammation caused by oral mucositis caused due to chemotherapy and/or radiotherapy in a subject undergoing cancer treatment.
The nature of the invention: The invention pertains to a recombinant lectin protein having at least 70% homology to SEQ ID NO: 1 and to a method of prophylactic and/or therapeutic treatment of inflammation caused by oral mucositis caused due to chemotherapy and/or radiotherapy in a subject undergoing cancer treatment.
The state of the prior art: The art teaches the inventive concept of recombinant lectin proteins and induced mechanisms of immunological and inflammatory responses (see Coelho et al. Evid Based Complement Alternat Med. 2017 Mar 7; 2017:1594074). For instance, lectin from seaweed has demonstrated to lower the expression levels of IL-1ß and TNFα compared with a nontreated lectin group; thus being a probable way for antinociception and anti-inflammation effects lectin induced (see pg. 3, left column, last paragraph). As it will be further discussed in the obviousness rejection below; the art also teaches recombinant lectins derived from Sclerotium rolfsii that have at least 70% homology to instant SEQ ID NO: 1; in addition to having close resemblances with native lectin with respect to their binding properties towards cancer tissues, in vitro cultured cells, and their apoptotic activity to cultured cells (see WO2010/095143, pg. 4, lines 17-22). Accordingly, the state of the prior art demonstrates that the scope of the claims would require undue experimentation given that to date recombinant lectin proteins having at least 70% homology to SEQ ID NO: 1 have not been demonstrated to cure (i.e., eliminate) the inflammation or an underlying chronic inflammation disease; nor prevent the onset of the inflammation, the disease and/or the symptoms caused by oral mucositis caused due to chemotherapy and/or radiotherapy in a subject undergoing cancer treatment.
The level of one of ordinary skill: Practitioners in this art (medical clinicians, pharmacists, doctors and/or pharmaceutical chemists) would presumably be highly skilled in the art of recombinant lectin protein for use in the prophylactic and/or therapeutic treatment of inflammation.
5. The level of predictability in the art: The instant claimed invention is highly unpredictable. If one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains (i.e., recombinant lectin protein having at least 70% homology to SEQ ID NO: 1 for use in the prophylactic and/or therapeutic treatment of inflammation caused by oral mucositis caused due to chemotherapy and/or radiotherapy in a subject undergoing cancer treatment), then there is a lack of predictability in the art. Moreover, it is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. The court has indicated that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. (See In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970)). This is because it is not obvious from the disclosure of one species, what other species will work. In the instant case, Applicants do not demonstrate that a recombinant lectin protein having at least 70% homology to SEQ ID NO: 1 has use in the prophylactic and/or therapeutic treatment of inflammation caused by oral mucositis due to chemotherapy and/or radiotherapy in a subject undergoing cancer treatment. 6. The amount of direction provided by the inventor: The specification does not enable any person skilled in the art to which it pertains to use the invention commensurate in scope with the claims. There is a lack of adequate guidance from the specification with regard to the actual recombinant lectin protein having at least 70% homology to SEQ ID NO: 1 for use in the prophylactic and/or therapeutic treatment of inflammation caused by oral mucositis caused due to chemotherapy and/or radiotherapy in a subject undergoing cancer treatment. Applicants fail to provide the guidance and information required to ascertain whether the claimed recombinant lectin protein of claim 1, for use in the prophylactic and/or therapeutic treatment of inflammation can treat inflammation due to oral mucositis caused due to chemotherapy and/or radiotherapy in a subject undergoing cancer treatment. The disclosure is not sufficient to justify the scope of the claimed invention because the data provided only pertains to SEQ ID NO: 2 (see Examples 1-7, instant specification, pp. 25-44). With respect to the functional properties of SEQ ID NO: 2 in relation to inflammation caused by oral mucositis caused due to chemotherapy and/or radiotherapy; Table 9 (see instant specification, pg. 35) and Table 10 (see instant specification, pg. 35), depict percentage inhibition of inflammatory markers expressed in Oral (buccal) mucosa cell line (TR146) do to chemotherapy and radiotherapy, respectively. Thereby demonstrating the downregulation of cytokines (IL-12/IL-23p40, IL-6, IL-1-ß, TNF-a), VEGF, MMP-3 and NF-kB against chemotherapy induced levels (see instant specification, pg. 34, lines 22-23); and the downregulation of TNF-α, MMP-3, CCL-2, MMP-8, RAGE and VEGF against radiation induced levels (see instant specification, pg. 35, lines 10-11). In summation, the effect of SEQ ID NO: 2 on TNF-α and IL-1ß levels in relation to the mucositis severity is depicted in Tables 13-14 and Figures 2-3 (see instant specification, pg. 38-39). Accordingly, Applicants' limited disclosure is noted but is not sufficient to justify claiming prophylactic treatment and/or therapeutic treatment of inflammation caused by oral mucositis caused due to chemotherapy and/or radiotherapy in a subject undergoing cancer treatment with a recombinant lectin protein having at least 70% homology to SEQ ID NO: 1. 7. The existence of working examples: The specification does not articulate the use of a recombinant lectin protein having at least 70% homology to SEQ ID NO: 1 for use in the prophylactic and/or therapeutic treatment of inflammation caused by oral mucositis caused due to chemotherapy and/or radiotherapy in a subject undergoing cancer treatment . Instead, the working examples pertain to the use of SEQ ID NO: 2 and its effects on TNF-α and IL-1ß levels (see instant specification, pg. 39). It is also noted that the working examples only include data obtained with SEQ ID NO: 2, and lack evidence of prophylactic and/or therapeutic treatment of inflammation wherein the prophylaxis and the treatment encompass 100% prevention of inflammation caused by oral mucositis due to chemotherapy and/or radiation therapy in a subject undergoing cancer treatment. With respect to the correlation between TNF-α and IL-1ß levels and SEQ ID NO: 2; the specification teaches that the subjects such as hamsters suffering from oral mucositis (OM) due to 5-FU and radiation, exhibited reduction in mucositis score, histology score and also reduction in the levels of cytokines such as IL-1ß and TNF-α when treated with the composition of recombinant lectin protein of SEQ ID NO: 2, as compared to untreated subjects (instant specification, pg. 22, lines 33-34 to pg. 23, lines 5-6). Thereby it is understood that SEQ ID NO: 2 downregulates cytokines (i.e., TNF-α and IL-1ß) that promote inflammation.8. The quantity of experimentation needed to make or use the invention based on the content of the disclosure: Due to the breadth of the claim, prophylactic and/or therapeutic treatment of inflammation caused by oral mucositis caused due to chemotherapy and/or radiotherapy in a subject undergoing cancer treatment, would require substantive experimentation, given that the claimed recombinant protein has at least 70% homology to SEQ ID NO: 1, and given that the prophylactic and/or therapeutic treatment encompasses inflammation of the oral mucosa due to chemotherapy and/or radiotherapy would also require substantive experimentation.
After applying the Wands factors and analysis to claims 1, 4, 6-8, and 10-17, in view of the Applicant' s entire disclosure, and considering the In re Wright, In re Fisher and Genentech decisions discussed above, it is concluded that the practice of the invention as claimed in claims 1, 4, 6-8, and 10-17 would not be enabled by the written disclosure for a recombinant lectin protein having at least 70% homology to SEQ ID NO: 1, nor to a method of prophylactic and/or therapeutic treatment of inflammation caused by oral mucositis caused due to chemotherapy and/or radiotherapy in a subject undergoing cancer treatment. Therefore, claims 1, 4, 6-8, and 10-17 are rejected under 35 U.S.C. §112(a) for failing to disclose sufficient information to enable a person of skill in the art to use the recombinant lectin protein of claim 1 in the prophylactic and/or therapeutic treatment of inflammation of the oral mucosa (i.e., oral mucositis).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
9. Claims 1 and 4-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product (a judicial exception) without significantly more. The claims are drawn to a recombinant lectin protein having at least 70% homology to SEQ ID NO: 1. Based upon an analysis with respect to the claims as a whole, claims 1 and 4-9 do not recite something significantly different than a judicial exception, a product of nature, which is not markedly different from its closest-occurring naturally-occurring counterpart and does not present “significantly more” than the judicial exception. The rationale for this determination is explained below and in the MPEP § 2106.
Claims 1 and 4-5 are drawn to a recombinant lectin protein, and claims 6-9 are drawn to a composition comprising the recombinant lectin protein. Claim 8 recites that the composition comprises one or more pharmaceutically acceptable excipients and/or diluents selected from buffer, viscosity enhancer, stabilizer, and humectant. Since the inclusion of one of the pharmaceutically acceptable excipients is an alternative between excipients or diluents or viscosity enhancer or stabilizer or humectant; the a pharmaceutically acceptable excipient can be a natural product such as water.
Furthermore, MPEP § 2106.04 (c) states that when the judicial exception is a natural product, the markedly different characteristics analysis is used to identify product of nature exceptions. For example, Chakrabarty relied on a comparison of the claimed bacterium to naturally occurring bacteria when determining that the claimed bacterium was not a product of nature because it had "markedly different characteristics from any found in nature". Diamond v. Chakrabarty, 447 U.S. 303, 310, 206 USPQ 193, 197 (1980). Similarly, Roslin relied on a comparison of the claimed sheep to naturally occurring sheep when determining that the claimed sheep was a product of nature because it "does not possess ‘markedly different characteristics from any [farm animals] found in nature.’" In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1337, 110 USPQ2d 1668, 1671-72 (Fed. Cir. 2014) (quoting Chakrabarty, 447 U.S. at 310, 206 USPQ at 197 (alterations in original)).
In the instant case, the closest-occurring natural counterpart to the claimed invention is naturally occurring S. rolfsii lectin amino acid sequence represented by SEQ ID NO: 1 (see instant specification, pg. 12, line 10). Claim 1 limits the lectin protein to be recombinant and to have at least 70% homology to SEQ ID NO: 1. In light of the term “at least” the recombinant lectin protein can have 70% or more (e.g., 100%) homology to SEQ ID NO: 1. Therefore, expression of a S. rolfsii lectin amino acid sequence through genetic engineering techniques in a host organism does not make exclude the native S. rolfsii lectin amino acid sequence from being a natural product (judicial exception).
Thus, native S. rolfsii lectin amino acid sequence is the closest-occurring natural counterpart to the claimed invention and the one pharmaceutically acceptable excipient which can be a natural product such as water. Therefore, all of the components appear to be identical to the components as they occur in nature. Hence, the composition claims would not appear to be markedly different from their nature-based counterparts.
This judicial exception is not integrated into a practical application because there is nothing in the original disclosure which would suggest that the combination of natural products in claims 6-9 would change the structure or function of the natural products; hence, the judicial exception is not integrated into a practical application because the claims, directed to a composition, recite nothing in addition to the natural products. Furthermore, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims only recite combinations of natural products which do not appear to change the structure or function of the natural products.
Accordingly, claims 1 and 4-9 are rejected under 35 USC 101 as directed to patent ineligible subject matter.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
10. Claims 1, 4-7, 9 and 16-17, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2010/095143 published on August 26, 2010 (herein after “Swamy”), as evidenced by GenCore Sequence Alignment of instant SEQ ID NO: 1 versus Swamy’s SEQ ID NOs: 2 and 3.
Swamy discloses SEQ ID NO: 1, which represents the amino acid sequence of lectin protein isolated from S. rolfsii (see pg. 6, line 3 and Fig. 3). In addition to SEQ ID NO: 2 and SEQ ID NO: 3, which represent recombinant lectin proteins (see Fig. 3, and pg. 6). Upon comparing instant SEQ ID NO: 1 to Swamy’s SEQ ID NO: 2 and SEQ ID NO: 3, the percent homology (identity) is 98.6% and 97.4%, respectively (see GenCore SEQ alignment, pp. 1-2). Thereby Swamy’s SEQ ID NO: 2 and SEQ ID NO: 3 correspond to a recombinant lectin protein having at least 70% homology to SEQ ID NO: 1.
Although Swamy does teach that the recombinant lectin proteins can be used in the prophylactic and/or therapeutic treatment of inflammation caused by oral mucositis caused due to chemotherapy and/or radiotherapy in a subject undergoing cancer treatment. Applicants are respectfully reminded that the use of a descriptive clause, i.e. “for use” or “for topical application” or “for the manufacture of", when referring to the contemplated use (i.e. “intended use”) of a claimed compound is proper, it is not a limitation and thus of no significance in determining the patentability thereof over the prior art.
Pursuant under MPEP 2111.02(II): In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962) (statement of intended use in an apparatus claim did not distinguish over the prior art apparatus). To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997) (anticipation rejection affirmed based on Board’s factual finding that the reference dispenser (a spout disclosed as useful for purposes such as dispensing oil from an oil can) would be capable of dispensing popcorn in the manner set forth in appellant’s claim 1 (a dispensing top for dispensing popcorn in a specified manner)) and cases cited therein. (emphasis added).
As such, a recombinant lectin protein having at least 70% homology to SEQ ID NO: 1 is intended to be used for the prophylactic and/or therapeutic treatment of inflammation caused by oral mucositis caused due to chemotherapy and/or radiotherapy in a subject undergoing cancer treatment. Thus, the use in the prophylactic and/or therapeutic treatment of inflammation is the intended use of the claimed recombinant lectin protein. Although Swamy does not teach the claimed intended use, Swamy’s recombinant lectin proteins (i.e., SEQ ID NOs: 2 and 3) are capable of performing the claimed intended use, i.e., for use in the prophylactic and/or therapeutic treatment of inflammation caused by oral mucositis caused due to chemotherapy and/or radiotherapy in a subject undergoing cancer treatment.
Furthermore, MPEP 2112.01 states that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. Since Swamy teaches recombinant lectin proteins that have 98.6% and 97.4% homology/identity to instant SEQ ID NO: 1, then the properties applicant discloses and/or claims are necessarily present in a composition comprising the recombinant lectin protein.
Thus, the teachings of Swamy satisfy the claim limitations as recited in instant claims 1, 4-7, 9 and 16-17.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
103 - KSR Examples of 'Rationales' Supporting a Conclusion of Obviousness
(Consistent with the "Functional Approach" of Graham)
Further regarding 35 USC 103(a) rejections, the Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) (KSR) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
Also, a reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976).
11. Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over WO 99/11278 published on March 11, 1999 (cited in the IDS field on 04/15/2024) (herein after “Pusztai”) in view of WO2010/095143 published on August 26, 2010 (herein after “Swamy”); and Hunter et al. Bone Marrow Transplant 43, 563–569 (2009) (cited in the IDS filed on 04/15/2024) (herein after “Hunter”).
Regarding claim 14, Pusztai’s invention pertains to the use of Robinia pseudoacacia lectin for use in medicine, wherein the use is for the control of mucosal cell proliferation; for the reduction and/or treatment of damage caused by a cell-damaging agent; and wherein the use in medicine is for the control or reduction and/or treatment of mucositis (see pg. 27, claims 1-3). Pusztai emphasizes that the term “reduction” means any effect which mitigates any damage or any medical disorder, to any extent, and includes prevention (prophylactic use) (see pg. 5, lines 27-29). Likewise, the term “treatment” means any amelioration of disorder, disease, syndrome, condition, pain or a combination of two or more thereof (see pg. 5, lines 29-31). The treatments and compositions taught by Pusztai may be carried out during an additional “treatment”, such as chemotherapy and/or radiotherapy (see pg. 5, lines 31-33). Furthermore, Pusztai teaches that the use of Robinia pseudoacacia lectin in relation to the control of mucosal cell proliferation includes the nature and/or density of gastrointestinal-cell expressed surface glycoproteins (see pg. 8, lines 12 and 15-16). Thus the teachings of Pusztai read on a method of prophylactic and/or therapeutic treatment of inflammation caused due to chemotherapy and/or radiotherapy in a subject undergoing cancer treatment.
Pusztai also teaches that the Robinia pseudoacacia lectin may be naturally occurring, chemically synthesized, or produced by recombinant technology (see pg. 9, lines 20-22). Pusztai’s method also comprises administering to an individual an effective amount of Robinia pseudoacacia lectin (see pg. 29, claim 23). Thereby corresponding to administering an effective amount of recombinant lectin protein as recited in instant claim 14.
However, Pusztai does not expressly teach that the recombinant lectin protein has the amino acid sequence of SEQ ID NO: 1 or a recombinant lectin protein having at least 70% homology to SEQ ID NO: 1 or (ii) a pharmaceutical composition comprising effective amount of recombinant lectin protein having the amino acid sequence of SEQ ID NO: 1 or a recombinant lectin protein having at least 70% homology to SEQ ID NO: 1.
As previously discussed, Swamy teaches SEQ ID NO: 1, which represents the amino acid sequence of lectin protein isolated from S. rolfsii (see pg. 6, line 3 and Fig. 3). In addition to SEQ ID NO: 2 and SEQ ID NO: 3, which represent recombinant lectin proteins (see Fig. 3, and pg. 6). Upon comparing instant SEQ ID NO: 1 to Swamy’s SEQ ID NO: 2 and SEQ ID NO: 3, the percent homology (identity) is 98.6% and 97.4%, respectively (see GenCore SEQ alignment, pp. 1-2). Thereby Swamy’s SEQ ID NO: 2 and SEQ ID NO: 3 correspond to a recombinant lectin protein having at least 70% homology to SEQ ID NO: 1. Swamy adds that the recombinant lectins have better stability and solubility properties compared to native lectin, making them ideal for various applications (see pg. 6, lines 34-35). For instance, the recombinant lectins exhibit substrate specificity towards cancer associated cell surface carbohydrate such as desialylated TF antigen, they can have application as affinity matrices for the purification of glycoproteins and glycoconjugates of physiological and biochemical significance that bind to these recombinant lectins (see pg. 7, lines 12-15). As such, the teachings of Pusztai when combined with the teachings of Swamy are suggestive of the claim limitations recited in instant claim 14.
From the teachings of the references, the Examiner recognizes that it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pusztai’s method by substituting Robinia pseudoacacia lectin with Swamy’s recombinant lectin, in order to arrive at the claimed method. One of ordinary skill in the art would have been motivated to do so because it was known that Robinia pseudoacacia lectin helps control mucosal cell proliferation and the density of cell express surface glycoproteins when the cells are undergoing damage due chemotherapy and/or radiotherapy as taught by Pusztai. One of ordinary skill in the art would have been motivated to do so given that recombinant lectin proteins such as the ones taught by Swamy exhibit substrate specificity towards cancer associated cell surface carbohydrate such as desialylated TF antigen; and have better stability and solubility properties compared to native lectin as taught by Swamy. Therefore, substituting Robinia pseudoacacia lectin for Swamy’s recombinant lectin would support the instantly claimed method by constituting some teaching, suggesting, or motivation in the prior art that would have let one of ordinary kill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention pursuant to KSR.
Regarding claim 15, Pusztai teaches that the medicament manufactured according to any aspect of the invention is preferably administered by mouth (orally), nasally (for example via a nasal spray) or rectally (for ease of route to one or more parts of the alimentary canal) although parenteral or intravenous administration of the medicament may also be used (see pg. 16, lines 18-21).
However, Pusztai does not expressly teach wherein the protein or composition is administered topically, more preferably to oral mucosa, as recited in instant claim 15.
Hunter teaches treatment of oral mucositis after peripheral blood SCT with ALT-104 mouthwash (see pg. 563, Title). In particular, ATL-104 is a recombinant tetrameric form of PHA-L, a plant lectin derived from the kidney bean Phaseolus vulgaris (see pg. 563, right column, last paragraph). Hunter’s results show that ALT-104, administered as a once-daily mouthwash, substantially reduced both the duration of severe mucositis and the overall severity and duration of mucositis compared with placebo (see pg. 567, right column, Discussion). As such, the combined teachings of Pusztai and Hunter are suggestive of a composition administered topically, more preferably to oral mucosa.
An ordinary skilled artisan would have been motivated with reasonable expectation of success to incorporate Hunter’s composition as part of a method of control or reduction and/or treatment of mucositis in order to arrive at the claimed method wherein the protein or composition is administered topically, more preferably to oral mucosa. One of ordinary skill in the art would have done so because it was known that mouthwash comprising a recombinant tetrameric form of a plant lectin substantially reduced the duration and severity of oral mucositis in subjects who underwent peripheral blood stem cell transplant (PBSCT). Therefore, incorporating Hunter’s mouthwash as part of Pusztai’s method would support the instantly claimed method by constituting some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention, pursuant to KSR.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the above claims would have been obvious to one of ordinary skill in the art within the meaning of 35 U.S.C 103. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references discussed above.
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.
12. Claims 1, 4-5 and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-3 of copending Application No. 18/290,404 (reference application) PG Pub US20240398899A1.
Regarding instant claims 1, 4-5 and 9, copending Application No. 18/290,404 claims:
The recombinant lectin protein as claimed inclaim1,wherein the recombinant lectin protein is selected from SEQ ID NO.1, SEQ ID NO. 2, SEQ ID NO. 3 or amino acid sequence having at least 70% homology to SEQ ID NO. 4 (see claim 2 in copending Application No. 18/290,404, claim set 1 of 2, filed 01/16/2024).
The recombinant lectin protein as claimed in claim 2, wherein the amino acid sequence has at least 75%, 80%, 90%, 95%, 96%, 97%, 98% or 99% homology to SEQ ID NO. 4 (see claim 3 in copending Application No. 18/290,404, claim set 1 of 2, filed 01/16/2024).
Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)).
This is pertinent because in Copending App No. 18/290,404:
SEQ ID NO: 1 represents a variant of the S. rolfsii lectin amino acid sequence (reported as Rec-2 in WO2010/095143) and has the following sequence: TYKITVRVYQTNPDAFFHPVEKTVWKYANGGTWTITDDQHVLTMGGSGTSGTLRFHADNGESFTATFGVHNYKRWCDIVTNLAADETGMVINQQYYSQKNREEARERQLSNYQVKNAKGRNFQIVYTEAEGNDLHANLIIG (see specification, pg. 16, lines 23-28).
SEQ ID NO. 2: represents a variant of the S. rolfsii lectin amino acid sequence (reported as Rec-3 in WO 2010/095143) has the following sequence: VYKITVRVYQTNPDAFFHPVEKTVWKYANGGTWSITDDQHVLTMGGSGTSGTLRFHADNGESFTATFGVHNYKRWCDIVTNLAADETGMVINQQYYSQKNREEARERQLSNYQVKNAKGRNFQIVYTEAEGNDLHANLIIG (see specification, pg. 17, lines 1-5).
SEQ ID NO. 3: represents a variant of the S. rolfsii lectin amino acid sequence (reported in WO 2014/203261) has the following sequence: VYKITVRVYQTNPDAFFHPVEKTVWKYADGGTWSITDDQHVLTMGGSGTSGTLRFHADNGESFTATFGVHDYKRWCDIVTDLAADETGMVINQEYYSEKDREEARERQNSNYEVKDAKGRNFEIVYTEAEGNDLHADLIIG (see specification, pg. 17, lines 6-10).
SEQ ID NO 4: represents the native S. rolfsii lectin amino acid sequence (reported as SEQ ID NO:1 in WO2010/095143), has the following sequence: TYKITVRVYQTNPNAFFHPVEKTVWKYANGGTWTITDDQHVLTMGGSGTSGTLRFHADNGESFTATFGVHNYKRWCDIVTNLAADETGMVINQQYYSQKNREEARERQLSNYEVKNAKGRNFEIVYTEAEGNDLHANLIIG (see specification, pg. 16, lines 18-22).
Upon comparing these sequences to instant SEQ ID NO: 1, it was found that the percent homology is 98.6% (SEQ ID NO: 1), 97.4% (SEQ ID NO: 2), 92.5% (SEQ ID NO: 3) and 100% (SEQ ID NO: 4).
Although the claims at issue are not identical, they are not patentably distinct from each other because the sequences in the copending Application fall within the scope of the instantly claimed recombinant lectin protein, thereby SEQ ID NOs: 1-4 represent species of the instantly claimed recombinant lectin protein.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
13. Claims 1, 4-5 and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of copending Application No. 18/718,862 (reference application) PG Pub US20250041380A1.
Regarding instant claims 1, 4-5 and 9, copending Application No. 18/718,862 claims:
A recombinant Sclerotium rolfsii lectin protein of SEQ ID NO. 1 or an amino acid sequence having at least 70% homology to SEQ ID NO. 1; for use in the treatment or prevention of an infectious disease in a subject caused by Coronaviridae or a mutant thereof (see claim 1 in copending Application No. 18/718,862, claim set filed 06/12/2024).
The recombinant Sclerotium rolfsii lectin protein of claim 1, wherein the amino acid sequence has at least 75%, 80%, 90%, 95%, 96%, 97%, 98% or 99% homology to SEQ ID NO. 1 (see claim 2 in copending Application No. 18/718,862, claim set filed 06/12/2024).
The recombinant Sclerotium rolfsii lectin protein of claim 1, wherein the lectin protein is selected from the group consisting of SEQ ID NO. 2, SEQ ID NO. 3 and SEQ ID NO. 4 (see claim 3 in copending Application No. 18/718,862, claim set filed 06/12/2024).
Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)).
This is pertinent because in Copending App No. 18/718,862:
SEQ ID NO: 1 represents the native S. rolfsii lectin amino acid sequence TYKITVRVYQTNPNAFFHPVEKTVWKYANGGTWTITDDQHVLTMGGSGTSGTLRFHADNGESFTATFGVHNYKRWCDIVTNLAADETGMVINQQYYSQKNREEARERQLSNYEVKNAKGRNFEIVYTEAEGNDLHANLIIG (see specification, pg. 10).
SEQ ID NO: 2 represents a variant of S. rolfsii lectin amino acid sequence (reported as Rec-2 in WO2010/095143) TYKITVRVYQTNPDAFFHPVEKTVWKYANGGTWTITDDQHVLTMGGSGTSGTLRFHADNGESFTATFGVHNYKRWCDIVTNLAADETGMVINQQYYSQKNREEARERQLSNYQVKNAKGRNFQIVYTEAEGNDLHANLIIG (see specification, pg. 10).
SEQ ID NO: 3 represents a variant of S. rolfsii lectin amino acid sequence (reported as Rec-3 in WO2010/095143) VYKITVRVYQTNPDAFFHPVEKTVWKYANGGTWSITDDQHVLTMGGSGTSGTLRFHADNGESFTATFGVHNYKRWCDIVTNLAADETGMVINQQYYSQKNREEARERQLSNYQVKNAKGRNFQIVYTEAEGNDLHANLIIG (see specification, pg. 10).
SEQ ID NO: 4 represents a variant of S. rolfsii lectin amino acid sequence (reported in WO 2014/203261) VYKITVRVYQTNPDAFFHPVEKTVWKYADGGTWSITDDQHVLTMGGSGTSGTLRFHADNGESFTATFGVHDYKRWCDIVTDLAADETGMVINQEYYSEKDREEARERQNSNYEVKDAKGRNFEIVYTEAEGNDLHADLIIG (see specification, pg. 10).
Upon comparing these sequences to instant SEQ ID NO: 1, it was found that the percent homology is 100% (SEQ ID NO: 1), 98.6% (SEQ ID NO: 2), 97.4% (SEQ ID NO: 3) and 92.5% (SEQ ID NO: 4).
Although the claims at issue are not identical, they are not patentably distinct from each other because the sequences in the copending Application fall within the scope of the instantly claimed recombinant lectin protein, thereby SEQ ID NOs: 1-4 represent species of the instantly claimed recombinant lectin protein.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
14. Claims 1, 4-5 and 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-3 of U.S. Patent No. US 11,965,003 B2.
Regarding instant claims 1, 4-5 and 8-9, U.S. Patent No. US 11,965,003 B2 claims:
1. A modified lectin protein, wherein the modified lectin protein comprises an amino acid sequence selected from the group consisting of SEQ ID NOs: 5 and 14.
2. A pharmaceutical composition comprising a modified lectin protein as claimed in claim 1 and a pharmaceutically acceptable diluent or excipient and optionally a further therapeutic ingredient.
3. A medicine comprising the pharmaceutical composition according to claim 2.
Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)).
This is pertinent because in U.S. Patent No. US 11,965,003 B2:
The amino acid sequence SYKITVRVYQTNPNAFFHPVEKTVWKYANGGTWTITDDQHVLTMGGSGTSGTLRFHADNGESFTATFGVHNYKRWCDIVTNLAADETGMVINQQYYSQKNREEARERQLSNYEVKNAKGRNFEIVYTEAEGNDLHANLIIG is represented by SEQ ID NO: 5.
Likewise, the amino acid sequence GYKITVRVYQTNPNAFFHPVEKTVWKYANGGTWTITDDQHVLTMGGSGTSGTLRFHADNGESFTATFGVHNYKRWCDIVTNLAADETGMVINQQYYSQKNREEARERQLSNYEVKNAKGRNFEIVYTEAEGNDLHANLIIG is represented by SEQ ID NO: 14.
Upon comparing these sequences to instant SEQ ID NO: 1, it was found that the percent homology is 99.5 % (SEQ ID NO: 1) and 99.3% (SEQ ID NO: 14). Although the claims at issue are not identical, they are not patentably distinct from each other because the sequences in the copending Application fall within the scope of the instantly claimed recombinant lectin protein, thereby SEQ ID NOs: 5 and 14 represent species of the instantly claimed recombinant lectin protein.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CLAUDIA E ESPINOSA whose telephone number is (703)756-4550. The examiner can normally be reached Monday-Friday 9:30-5:30 EST.
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/CLAUDIA ESPINOSA/Patent Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
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