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
This application filed 07/24/2024 is a National Stage entry of PCT/US2023/061975 , International Filing Date: 02/03/2023, PCT/US2023/061975 Claims Priority from Provisional Application 63306978 , filed 02/04/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/01/2024 complies with the
provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the
examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 6-13, 22-24, 20, 26, 28, 29 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 1 recites the broad recitation ‘wherein the oligopeptide comprises’ (line 4), i.e. any N/C terminal additions; and the claim also recites ‘oligopeptide consisting of the amino acid’ (lines 1-4), with ‘X’ defined by a specific range, i.e. sequence lengths, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Dependent claims are rejected under 35 U.S.C. 112(b), as these claims incorporate by dependency the indefiniteness of claim 1.
Claim Rejections - 35 USC § 112
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.
Claims 3, 6 and 7 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 it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 3, the instant claim recites the limitation ‘comprising the amino acid sequence’, which is not further limiting of claim 1, which recites ‘an isolated oligopeptide consisting of the amino acid sequence’. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Regarding claim 6, the instant claim recites ‘comprising the amino acid sequence’ which does not further limit the ‘isolated oligopeptide consisting of’ as recited in independent claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Regarding claim 7, the instant claim recites ‘comprising the amino acid sequence’ which does not further limit the ‘isolated oligopeptide consisting of’ as recited in independent claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-13, 20, 22-24, 26, 28, 29 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. This is a written description rejection.
Claim 1 is directed to an oligopeptide consisting of the amino acid sequence of Xm(R/D)EES(G/D)(E/K)Xn, wherein ‘X’, ‘m’ and ‘n’ are variables. Applicant reduces to practice SEQ ID NO: 1-8 (see page 19, Table 5-1). Applicant does not reduce to practice all possibilities of sequences generated by the variables, noting that each ‘X’ is any amino acid, and the integers ‘m’ and ‘n’ include a range of sequence lengths. Additionally, in the instant claim, Examiner interprets ‘comprising’ as open-ended and inclusive of any N/C terminal additions. Therefore, ‘comprises the amino acid sequence of..’ (lines 4-5), accordingly, fails to find support in the Applicant’s disclosure for reasons noted above.
Claim 2 is directed to sequence XjREESDKPXk, in which ‘j’ and ‘k’ are integers and each ‘X’ if present is any amino acid. Here, Applicant reduces to practice SEQ ID NO: 1-8 (see page 19, Table 5-1) but does not reduce to practice the sequence as claimed.
Claims 3-7 are directed to sequences ‘comprising’, which is interpreted as open-ended or inclusive. Applicant does not reduce to practice all possibilities of sequence lengths and sequence composition, that encompass the N/C terminal extensions flanking the recited sequences.
Claims 20, 22, 26, 28, 29 are directed to a method, comprising administering the oligopeptide of claim 7. Applicant does not reduce to practice a method of administering oligopeptides of all possible sequence lengths and composition as recited.
The written description requirement for “a peptide” may be satisfied through sufficient
description of a representative number of species of peptide, by actual reduction to practice, reduction
to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that the Applicant
was in possession of the claimed genus of peptides. A “representative number of species” means that
the species that are adequately described are representative of the entire genus. See MPEP 2163. The
peptide SEQ ID NO: 1 to SEQ ID NO: 8 described in the specification, is not representative of the full
variation of peptides comprising different sequence lengths, sequence composition, or of alternate
residues located in the variable positions. A skilled artisan is unable to predict the peptides that would
collectively present a core structure sufficient to represent an isolated peptide and practice a method, as claimed. Thus, the specification fails to satisfy the written description requirement of 35
USC 112 (a) with respect to claims 1-13, 20, 22-24, 26, 28, 29.
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.
Claims 1, 6, 7 and 8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon (natural product) without significantly more.
Regarding claim 6, the claim(s) recite(s) the judicial exception of ‘comprising the amino acid sequence of SEQ ID NO: 8’. This judicial exception is not integrated into a practical application because the claims are drafted such that there is no difference in substance from the sequence claim to a naturally occurring sequence in Chinese chestnut (see below). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional claim elements do not integrate the judicial exception into something more.
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See the following analysis:
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, the claim is directed to a composition of matter.
Step 2A: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or
abstract idea?
Prong One: Does the claim recite an abstract idea, law of nature or natural phenomenon? Yes,
the claim recites an amino acid sequence. Under the broadest reasonable interpretation, the claimed sequence comprising SEQ ID NO: 8, is the sequence in the Chinese chestnut protein that is naturally occurring.
Prong Two: Does the claim recite additional elements that integrate the judicial exception into a
practical application? No, the additional elements in the claim do not integrate the judicial exceptions into a practical application. The claim is directed only to the amino acid sequence and to the function incorporated by the sequence.
Regarding claim 7, the claim(s) recite(s) the judicial exception of ‘comprising the amino acid sequence of SEQ ID NO: 2’. This judicial exception is not integrated into a practical application because the claims are drafted such that there is no difference in substance from the sequence claim to a naturally occurring sequence in cysteine proteinase 2 (see below). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional claim elements do not integrate the judicial exception into something more.
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See the following analysis:
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, the claim is directed to a composition of matter.
Step 2A: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or
abstract idea?
Prong One: Does the claim recite an abstract idea, law of nature or natural phenomenon? Yes,
the claim recites an amino acid sequence. Under the broadest reasonable interpretation, the claimed sequence comprising SEQ ID NO: 2, is the sequence in the cysteine proteinase 2 protein that is naturally occurring.
Prong Two: Does the claim recite additional elements that integrate the judicial exception into a
practical application? No, the additional elements in the claim do not integrate the judicial exceptions into a practical application. The claim is directed only to the amino acid sequence and to the function incorporated by the sequence.
Regarding claim 8, the claim(s) recite(s) the judicial exception of ‘comprising the amino acid sequence of SEQ ID NO: 2’ (i.e. oligopeptide of claim 7). This judicial exception is not integrated into a practical application because the claims are drafted such that there is no difference in substance from the sequence claim to a naturally occurring sequence in cysteine proteinase 2. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional claim elements do not integrate the judicial exception into something more.
See the following analysis:
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, the claim is directed to a composition of matter.
Step 2A: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or
abstract idea?
Prong One: Does the claim recite an abstract idea, law of nature or natural phenomenon? Yes,
the claim recites an amino acid sequence. Under the broadest reasonable interpretation, the claimed sequence comprising SEQ ID NO: 2, is the sequence in the cysteine proteinase 2 protein that is naturally occurring.
Prong Two: Does the claim recite additional elements that integrate the judicial exception into a
practical application? No, the additional elements in the claim do not integrate the judicial exceptions into a practical application. The claim is directed only to the amino acid sequence and to the function incorporated by the sequence i.e., increasing expression of FTHI mRNA.
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.
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.
Claim(s) 1, 3-13, 20, 22, 23, 24, 26, 28, 29 are rejected under 35 U.S.C. 103 as being unpatentable over James M. Olson et al., hereinafter Olsen (James M. Olsen et al., US11548923B2, EFD: Jan 18, 2017).
Regarding claim 1, as noted in the rejection under 35 U.S.C 112(b), the claim scope is indefinite. For prior art purpose, Examiner interprets the claim to be directed to comprising SEQ ID NO: 2 or SEQ ID NO: 8. Here, ‘wherein the oligopeptide comprises the amino acid sequence’ (line 4) is inclusive or open-ended (MPEP§ 2111.03 (I)), therefore, SEQ ID NO: 2 or SEQ ID NO: 8 as recited, is with any N/C terminal additions. Olsen teaches SEQ ID NO: 1 and site saturation mutagenesis (see Example 8), generating a total of 612 variants of SEQ ID NO: 1, wherein all possible single amino acid substitutions of SEQ ID NO: 1 is cloned, except for the cysteine residues. SEQ ID NO: 1 in Olsen is shown below (see Col 109). The boxed region in SEQ ID NO: 1 corresponds to SEQ ID NO: 2 or SEQ ID NO: 8 in instant, which can achieve 100 % sequence identity with site saturation mutagenesis.
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Obviousness can be established by combining or modifying the teachings of the prior art to
produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re
Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the
motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
Consequently, 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 the teaching in Olsen, to generate the claimed oligopeptide. One motivated to do so would have a reasonable expectation of success as specific peptide variants are created in Olsen that match the instantly claimed sequences. Thus, one would have recognized that applying the teaching of Olsen, would have yielded predictable results in generating the oligopeptide as claimed (See MPEP § 2143 l(A)(D)).
Regarding claims 3-7, the obviousness rationale has been set forth above.
Regarding claim 8, ‘wherein the oligopeptide…mRNA’ is interpreted as function, incorporated by the claimed sequence, i.e. SEQ ID NO: 2. Olsen teaches a peptide that is substantially identical to the peptide as instantly claimed. Therefore, the claimed properties or functions are presumed to be inherent 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. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). (See MPEP § 2112.01 (I)).
Regarding claim 9, Olsen teaches pharmaceutically acceptable carrier (i.e. excipient) (Col 6, lines 28-29).
Regarding claim 10, Olsen teaches that the pharmaceutical composition is formulated for oral administration (Col 6, line 32).
Regarding claim 11, Olsen teaches fatty acid (Col 56, line 61), tyrosine kinase inhibitor (i.e. enzyme inhibitor; Col 58, line 1), PEG (Col 56, lines 55-56), polymer (Col 56, lines 55-56), cell penetrating peptide (Col 31, line 13).
Regarding claim 12, Olsen teaches nanoparticle and liposome (Col 58 line 4-5).
Regarding claim 13, Olsen teaches various expression vector (i.e. nucleic acid)/host systems, for recombinant expression of peptides (Col 74, lines 49-50).
Regarding claim 20, Examiner interprets ‘for increasing…concentration’ and ‘and/or increase serum….concentration’ as intended use. Olsen teaches administering peptide composition to a subject (see Example 14). As the teachings in Olsen of the peptide is 100 % identical to the claimed peptide, it would be capable of the same intended use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children's Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (see MPEP §2111. 02 (II)). As previously noted, 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. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). (See MPEP § 2112.01 (I)).
Regarding claim 22, Olsen teaches a method for treating or preventing a mammalian subject comprising administering the formulation of claim 9 (see Example 14 (Col 93), Example 15 (Col 94)). Olsen teaches that the method of administration of the peptide to a subject can also be adapted to treat diabetes (Col 94, lines 21-22).
Regarding claim 23, Olsen teaches that treatment with the peptide can be used in a method of treating cancer, anemia (i.e. iron deficiency) (Col 79, 2nd paragraph, line 10), etc.
Regarding claim 24, Olsen teaches anemia as noted above.
Regarding claim 26, Olsen teaches oral administration (Col 6, line 32; Example 15, Col 94, line 9).
Regarding claim 28, Olsen teaches sublingual administration (Col 79, line 23).
Regarding claim 29, Olsen teaches that the method of administration of the peptide to a subject can also be adapted to treat diabetes (Col 94, lines 21-22) (i.e. not cancer).
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, 7-13, 20, 22-24, 26, 28, 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 3, 4, 5, 22, 28, 29 of copending Application No. 18/832,867 (reference application) in view of James M. Olson et al., hereinafter Olsen (James M. Olsen et al., US11548923B2, EFD: Jan 18, 2017).
Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The teachings of Olsen have been set forth above.
Regarding claim 1, reference application ‘867 teaches SEQ ID NO: 10, which meets the limitations of the instant claim. See claims 2-5.
Regarding claim 7, reference application ‘867 teaches SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO: 2. (see claims 2, 3, 4)
Regarding claim 8, reference application teaches the oligopeptide of claim 7 as noted above.
Regarding claim 9, reference application ‘867 does not teach excipient.
Olsen teaches pharmaceutical carrier(Col 6, lines 28-29).
Obviousness can be established by combining or modifying the teachings of the prior art to
produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re
Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the
motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
Consequently, 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 the teaching in the reference application ‘867, to generate the claimed oligopeptide comprising an excipient. One motivated to do so would have a reasonable expectation of success as Olsen and the reference application ‘867 teach the specific oligopeptide sequence that match the instantly claimed sequences. Thus, one would have recognized that applying the teaching of Olsen, would have yielded predictable results in generating the oligopeptide as claimed (See MPEP § 2143 l(A)(D)).
Regarding claim 10, Olsen teaches that the pharmaceutical composition is formulated for oral administration (Col 6, line 32).
Regarding claim 11, Olsen teaches fatty acid (Col 56, line 61), tyrosine kinase inhibitor (i.e. enzyme inhibitor; Col 58, line 1), PEG (Col 56, lines 55-56), polymer (Col 56, lines 55-56), cell penetrating peptide (Col 31, line 13).
Regarding claim 12, Olsen teaches nanoparticle and liposome (Col 58 line 4-5).
Regarding claim 13, Olsen teaches various expression vector (i.e. nucleic acid)/host systems, for recombinant expression of peptides (Col 74, lines 49-50).
Regarding claim 20, reference application teaches administering to the subject an effective amount of peptide composition. See claim 2.
Regarding claim 22, reference application teaches a method of treating comprising administering oligopeptide. See claim 22.
Regarding claim 23, reference application ‘867 does not teach iron deficiency. Olsen teaches that treatment with the peptide can be used in a method of treating cancer, anemia (i.e. iron deficiency) (Col 79, 2nd paragraph, line 10), etc.
Regarding claim 24, reference application ‘867 does not teach anemia. Olsen teaches anemia as noted above.
Regarding claim 26, reference application ‘867 does not teach oral administration. Olsen teaches oral administration (Col 6, line 32; Example 15, Col 94, line 9).
Regarding claim 28, reference application ‘867 does not teach sublingual administration. Olsen teaches sublingual administration (Col 79, line 23).
Regarding claim 29, reference application ‘867 does not teach a method, wherein the subject population does not have cancer. Olsen teaches that the method of administration of the peptide to a subject can also be adapted to treat diabetes (Col 94, lines 21-22) (i.e. not cancer).
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARCHANA VARADARAJ whose telephone number is (571)272-2366. The examiner can normally be reached Monday-Friday 10:00am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 5712707430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARCHANA VARADARAJ/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
Prosecution Insights