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 .
This is a second non-final office action because a new non-statutory double patenting rejection is being made over an application that as filed after the previous office action.
Election/Restrictions
Applicant’s election without traverse of Group I, claimed in claims 44-57 in the reply filed on 10/1/25 was previously acknowledged. Election was made without traverse in the reply filed on a peptide comprising GGL (CNTF compound), the sequence YLGA (FAS inhibitor) and the FAS inhibitor and CNTF compound are covalently bonded.
Claims 54 and 58-63 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.
In the reply filed 5/4/26, Applicants amended claims 44, 46, 49-51, 53 and 55 were amended. Claims 47 and 48 were canceled.
Claims 44-46, 49-55 and 58-63 are pending.
Claims 44-46, 49-53 and 55 read on the elected Group I and species and are under consideration.
IDS
The information disclosure statement filed 5/4/26 fails to comply with the provisions of 37 CFR 1.97(a) because it lacks the appropriate size fee set forth in 37 CFR 1.17(v). It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
Claim Objections-Withdrawn
The objection of claims 46 and 48-50 is withdrawn due to amendment of the claims.
Claim Rejections-Withdrawn
The rejection of claims 46, 53, 56 and 57 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn due to amendment of the claims.
The rejection of claims 44-46, 48, 50-53 and 55-56 under 35 U.S.C. 103 as being unpatentable over Mossler et al. (US2011/0160141) and Zarnegar et al. (US2007/0184522) is withdrawn due to amendment of the claims and Applicants arguments.
The rejection of claims 44-46, 48-53 and 55-56 under 35 U.S.C. 103 as being unpatentable over Mossler et al. (US2011/0160141) and Zarnegar et al. (US2007/0184522) in view of Jiang et al. (Journal of Neuroinflammation (2015) Vol. 12 article number 179) is withdrawn due to amendment of the claims and Applicants arguments.
Response to Arguments
Applicant’s arguments with respect to the rejections above have been considered but are moot because the rejections have been withdrawn.
Claim Rejections - 35 USC § 112-Maintained
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.
The rejection of claims 44-46, 49-53 and 55 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 is maintained. 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This rejection has been modified due to amendment of the claims.
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 applicant was in possession of the claimed genus. A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Scope of the claimed genus
Claim 44 is drawn to a drug delivery system comprising 1) a peptide that contains part of the CNTF amino acid sequence and that has neurotrophic activity or a salt thereof, 2) a FAS or FASL inhibitor, wherein the FAS or FASL inhibitor is a peptide comprising the amino acid sequence YLGA (SEQ ID NO: 5) or a salt thereof and 3) a sustained delivery component that forms a hydrogel, wherein the CTNF peptide and FAS or FASL inhibitor are covalently bonded to the sustained delivery component. The USPTO provides claim terms with broadest reasonable interpretation in light of the specification. With respect to the “part of the CNTF amino acid sequence”, the instant specification states [0007]: With respect to a subject drug delivery system, a neurotrophic agent can include a CNTF compound or another neurotrophic agent, a CNTF compound includes any compound having a structure or activity similar to ciliary neurotrophic factor (CNTF), including CNTF, protein derivatives of CNTF, or a CNTF peptide. Examples include CNTF, a peptide containing part of the CNTF sequence, such as a neurotrophic peptide containing the sequence DGGL (SEQ ID NO: 18), e.g. Peptide 6 (P6; Ac-VGDGGLFEKKL-NH2 (SEQ ID NO: 1)) and Peptide 21 (P21; Ac-DGGLAG-NH2 (SEQ ID NO: 2)), recombinant CNTF (rhCNTF), or a neurotrophic peptide identified in U.S. Pat. No. 8,592,374, which is incorporated herein by reference for its disclosure related to neurotrophic peptides, including neurotrophic peptides having an adamantly group at the C- and/or N-terminal end, or any other peptide having similar biological activity to CNTF. Other neurotrophic agents include nerve growth factor (NGF), Brain-derived neurotrophic factor (BDNF), glial cell-derived neurotrophic factor (GDNF), etc.
The instant specification does not specifically define “part of the CNTF amino acid sequence”. The instant specification provided a few examples, however the part of CNTF is not limited to those specific examples. The specification does not require the claimed peptide contain a particular number of CNTF residues. Therefore, the broadest reasonable interpretation of “a peptide that contains part of the CNTF amino acid” includes any CNTF fragment. The fragment is not limited to a particular domain or to a particular length.
Assessment of whether species are support in the original specification
The complete structure of the following species was disclosed: SEQ ID NOs: 1, and 18 as examples of “part of CNTF” compounds.
There was no disclosure of other peptide sequences that are part of the CTNF amino acid sequence.
In summary, for these reasons, the skilled artisan would reasonably conclude that the inventor(s), at the time the application was filed, had possession of SEQ ID NO: 1, 2 and 18 at the time the invention was filed.
Assessment of whether disclosed species are representative of the claimed genus
MPEP § 2163 states that a “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
In the instant case, the disclosure of SEQ ID NOs: 1, 2 and 18 are not representative of the genus. The disclosure of the sequences and compounds are not representative of the entire genus encompassed by part of the CNTF amino acid sequence. The broadest reasonable interpretation of the claim is any portion or fragment of CNTF and examples of peptides containing the DGGL sequence is not representative of the genus. The genus includes any portion of CNTF and the three examples is not representative of that.
Identifying characteristics and structure/function correlation
In the absence of a reduction to practice of a representative number of species, the written description requirement for a claimed genus may be satisfied 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 applicant was in possession of the claimed genus. To meet this requirement in the instant case, the specification must describe the structural, physical and/or chemical properties of part of the CNTF amino acid that has the claimed function. The data do not suggest the physical basis for the claimed activity and therefore do not describe which substitutions, deletions or additions could be made while preserving function. This is an issue of written description. The specification does not make clear which compounds are in the genus and which are not because it does not describe the physical basis for the claimed activity. Aside from the three specific peptides, the specification does not disclose additional peptides comprising other portions of CNTF nor does it describe any structural features or identifying characteristics that would demonstrate possession of the broad genus.
In conclusion, for the reasons presented above, the skilled artisan would reasonably conclude that the inventors, at the time the application was filed had full possession SEQ ID NOs: 1, 2 and 18 as examples of CNTF compounds.
Response to Arguments
Applicant's arguments filed 5/4/26 have been fully considered but they are not persuasive. Applicants argue that one of ordinary skill in the art would reasonably conclude that the inventors had full possession of more than just SEQ ID NO: 1-22. Applicants argue that claim 1 has been amended to recite a peptide that contains part of the CNTF amino acid that has neurotrophic activity. Applicants argue that the specific amino acid sequence of CTNF and the activity of neurotrophic factors and peptides were well known in the art at the time of filing. Applicants argue that CNTF is relatively short (200 amino acids) and association of parts with neurotrophic activity were known in the art. therefore, the structure/functional correlation were known in the art.
These arguments were considered but are not persuasive for the reasons presented in the WD above. Although CNTF peptide is relatively short in length, the broadest reasonable interpretation of “part of” includes and portion of it. The instant specification does not specifically define the part of the protein that is neurotrophic. The specification does provide a few examples, but a few examples is not representative of the huge genus of “part of”. Although the specification discloses the peptides containing the sequence DGGL as having neurotrophic activity, the specification does not identify the structural characteristics that distinguish neurotrophic peptide from inactive peptides. While the specification provides examples of certain active peptides, it does not establish a structure function correlation that would allow a person of ordinary skill in the art to recognize which portions of CNTF confers neurotrophic activity or to conclude that the inventors were in full possession of the peptides broadly defines as containing part of the CNTF amino acid sequence and having neurotrophic activity. For the reasons presented above, the rejection is maintained.
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 44-46, 51 and 55 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. This is a NEW rejection necessitated by amendment of the claims.
Claim 44 recites the limitation "the CNTF peptide" in line 2nd to last line of claim There is insufficient antecedent basis for this limitation in the claim because claim 44 does not specifically recite “a CNTF peptide”. The claim recites “the CNTF amino acid sequence”.
Claims 45 and 46 recite the limitation "the CNTF compound". There is insufficient antecedent basis for this limitation in the claim because claim 44 does not recite a “CNTF compound”.
Claims 51 and 55 recites the limitation "the CNTF peptide". There is insufficient antecedent basis for this limitation in the claim because claim 44 does not specifically recite “a CNTF peptide”. The claim recites “the CNTF amino acid sequence”.
Double Patenting-Maintained
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.
The rejection of claims 44-46, 49-53 and 55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,147,855 Although the claims at issue are not identical, they are not patentably distinct from each other because the USPN anticipates the instant claims.
The USPN claims a method of treating glaucoma or ocular hypertension comprising prostaglandin, wherein the drug delivery system further comprises peptide 6, 221 or contains the sequence YLGA, wherein the drug delivery further comprises MET4-8. Therefore, the drug delivery system of the USPN comprises a CNTF compound and FAS or FASL inhibitor. With respect to the limitation “a sustained delivery component that forms a hydrogel”, the USPN state that the sustained delivery component includes a silica hydrogel and also states that the components of the sustained delivery system may be covalently boned to the a molecule that is part of the sustained delivery system (col. 38). MPEP 804 states “The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999) (“[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning.”); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) (“Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings.”). “The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ ” Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364, 70 USPQ2d 1827, 1830 (Fed. Cir. 2004); see also MPEP § 2111.01. Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970).” Therefore, the copending application meets the limitations of the instant claims.
The rejection of claims 44-46, 49-53 and 55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,128,104 Although the claims at issue are not identical, they are not patentably distinct from each other because the USPN anticipates the instant claims.
The USPN claims a drug delivery system comprising a CNTF compound and FAS/FASL inhibitor covalently linked. The USPN claims the claimed range of components (claims 2-3). The instant specification teaches the FAS/FASL inhibitor is Met12 and the CNTF compound is peptide 6 and 21. The MPEP states: The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In the instant case, the specification was used to properly construe FAS/FASL inhibitor and CNTF compound. . With respect to the limitation “a sustained delivery component that forms a hydrogel”, the USPN state that the sustained delivery component includes a silica hydrogel and also states that the components of the sustained delivery system may be covalently boned to the a molecule that is part of the sustained delivery system (col. 38). MPEP 804 states” The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999) (“[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning.”); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) (“Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings.”). “The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ ” Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364, 70 USPQ2d 1827, 1830 (Fed. Cir. 2004); see also MPEP § 2111.01. Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970).” Therefore, the copending application meets the limitations of the instant claims.
Claims 44-46, 49-53 and 55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/893,848 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending Application anticipates the claims. The copending application claims a drug delivery system comprising FAS/FASL inhibitor and TNFalpha/TNFR inhibitor, wherein they are covalently bonded. The copending application also claims the claimed concentration. The instant specification teaches the FAS/FASL inhibitor is Met12 and the CNTF compound is peptide 6 and 21. The MPEP states: The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In the instant case, the specification was used to properly construe FAS/FASL inhibitor and CNTF compound. . With respect to the limitation “a sustained delivery component that forms a hydrogel”, the USPN state that the sustained delivery component includes a silica hydrogel and also states that the components of the sustained delivery system may be covalently boned to the a molecule that is part of the sustained delivery system [PGPUB0055-0059]. MPEP 804 states “The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999) (“[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning.”); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) (“Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings.”). “The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ ” Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364, 70 USPQ2d 1827, 1830 (Fed. Cir. 2004); see also MPEP § 2111.01. Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970).” Therefore, the copending application meets the limitations of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 44-46, 49-53 and 55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 19/274,423 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending Application anticipates the claims. The copending application claims a drug delivery system comprising prostaglandin, peptide 21 (CNTF compound) and a FAS/FASL inhibitor (claims 1-4), wherein the FAS/FASL inhibitor is MetA, or MET5-8. The CNTF and FAS/FASL meets the limitations of instantly claimed CNTF compound and FAS/FASL inhibitor. The copending application claim the sustained delivery component is a hydrogel. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 44-46, 49-53 and 55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/238,317 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending Application anticipates the claims. The copending application claims a drug delivery system comprising a CNTF compound and FAS/FASL inhibitor, wherein they are covalently bonded. The copending Application claim the same concentration of compounds. The CNTF compound meets the limitation of the CNTF compound instantly claimed. With respect to the limitation “a sustained delivery component that forms a hydrogel”, the USPN state that the sustained delivery component includes a silica hydrogel and also states that the components of the sustained delivery system may be covalently boned to the a molecule that is part of the sustained delivery system [0056-0060]. MPEP 804 states: ”The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999) (“[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning.”); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) (“Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings.”). “The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ ” Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364, 70 USPQ2d 1827, 1830 (Fed. Cir. 2004); see also MPEP § 2111.01. Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970).” Therefore, the copending application meets the limitations of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 44-46, 49-53 and 55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of copending Application No. 17/843,796 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending Application anticipates the claims. The copending application claims a drug delivery system comprising prostaglandin and CNTF compound and FAS/FASL inhibitor, wherein they are covalently bonded. The CNTF and FAS/FASL inhibitor are claimed as peptide 6, 21 and SEQ ID NO: 5, which meet the limitation of the CNTF compound and FAS/FASL inhibitor instantly claimed. With respect to the limitation “a sustained delivery component that forms a hydrogel”, the USPN state that the sustained delivery component includes a silica hydrogel and also states that the components of the sustained delivery system may be covalently boned to the a molecule that is part of the sustained delivery system [0096-0099]. MPEP 804 states: ”The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999) (“[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning.”); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) (“Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings.”). “The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ ” Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364, 70 USPQ2d 1827, 1830 (Fed. Cir. 2004); see also MPEP § 2111.01. Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970).” Therefore, the copending application meets the limitations of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 5/4/26 have been fully considered but they are not persuasive. Applicants argue that the Office has required restriction of the instant application and claims 44-46, 48-53 and 55 are composition claims. Applicants argue that the double patenting rejections over the method claims of USPN 11,147,855 and 12,128,104, copending applications 18/893,848; 19/238,317 and 17/843,796 should be withdrawn. Applicants further argue that the patents and copending applications do not recites in their claims a sustained delivery component is a hydrogel, the CNTF is a compound covalently bound to the sustained release component, that the Fas inhibitor is covalently bound to the sustained delivery components and/or the drug delivery system contains part of the CNTF amino acid sequence.
These arguments were considered but are not persuasive. The USPN’s or copending applications applied in the double patenting rejections are not divisional of the instant claims. Furthermore, the methods recited in the USPNs or copending applications are using the claimed composition and a double patenting rejection is appropriate. With respect to the arguments regarding the hydrogel or other limitations, the Examiner has addressed them in the rejections above. For the reasons presented above, the rejection is maintained.
Double Patenting-NEW
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 44-46, 49-53 and 55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/682,398 (reference application). This is a NEW rejection. The Application was filed after mailing of the NF rejection. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending Application anticipates the claims. The copending application claims a drug delivery system comprising CNTF compound and FAS/FASL inhibitor, wherein they are covalently bonded. The CNTF compound is claimed as peptide comprising DGGL, which meets the limitation of the CNTF compound instantly claimed. With respect to the limitation “a sustained delivery component that forms a hydrogel”, the USPN state that the sustained delivery component includes a silica hydrogel and also states that the components of the sustained delivery system may be covalently boned to the a molecule that is part of the sustained delivery system [top of p. 35]. MPEP 804 states: ”The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999) (“[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning.”); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) (“Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings.”). “The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ ” Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364, 70 USPQ2d 1827, 1830 (Fed. Cir. 2004); see also MPEP § 2111.01. Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970).” Therefore, the copending application meets the limitations of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TARA L MARTINEZ whose telephone number is (571)270-1470. The examiner can normally be reached Mon-Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached at (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TARA L MARTINEZ/Primary Examiner, Art Unit 1654
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