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 .
Information Disclosure Statement
The IDS filed 9/21/22 has been considered and an initialed copy of the PTO-1449 is enclosed.
Specification
In the amended claim set filed 9/21/22, applicant amended claim 9. In view of this, the specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The claimed subject matter in claims 9-12 is not found in the specification as originally filed. Specifically, claim 9 is directed to a “method for the treatment or the prevention of an autoimmune disease comprising the administration of anti-citrullinated protein autoantibodies”. The specification, as originally filed, does not have support for “comprising the administration of anti-citrullinated protein autoantibodies”. The specification, as originally, filed states treatment or prevention of autoimmune diseases “with anti-citrullinated protein autoantibodies” (page 8, lines 27-28). Treatment of autoimmune diseases “with anti-citrullinated protein autoantibodies” means that the autoimmune diseases are caused by the anti-citrullinated protein autoantibodies. This is supported by Serre et al US 8207299 (PTO-892) col. 1, lines 25-35 which states that patients suffering from rheumatoid arthritis contain autoantibodies”. This is not the same as administering the autoantibodies.
It is noted that applicant filed the amendments to the claims at the same time as the application, therefore the amended claim set is part of the disclosure and applicant is allowed to insert the language of claim 9 into the specification without the insertion being considered new matter.
Applicant has two options to overcome this objection: (1) applicant can insert the amended language of claim 9 into the specification or (2) applicant can delete the claim language.
If applicant amends the specification to insert the language of claim 9 into the specification, then the instant application would be a continuation-in-part of PCT/EP2021/057849. Therefore, applicant must (a) file a supplemental ADS reflecting the new continuity data and (b) amend the first line of specification to reflect the new relationships of the applications.
Priority
In view of the above, claims 9-12 have a priority date of 9/21/22. Claims 1-8 and 13 have a priority date of 3/26/2020.
Specification
The abstract of the disclosure is objected to because the abstract contains over 150 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Interpretation
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: :means of one or more intermediate compounds” in claim 6.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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.
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 5 and 8-9 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.
In claim 5 the term “optionally” renders the claims vague and indefinite because it leads to confusion over the intended scope of a claim. It is not clear whether the claimed peptide is a limitation. MPEP 2173.05(d).
In claim 5, there is improper antecedent basis for “the alpha501-515Cit peptide”.
The overuse of “and/or” in claim 5 renders the claim confusing.
Claim 8 is confusing because it refers to the “composition as defined in claim 1” yet claim 1 is directed to an apheresis column and not a composition. Additionally, the column in claim 1 already has the peptides linked to it.
Claim 9 is confusing because, as amended, the claim states “A method for the treatment or the prevention of an autoimmune disease; comprising the administration of anti-citrullinated protein autoantibodies according to claim 1, wherein the peptide or the peptides of the composition are immobilised on a solid support.” It is not clear how the wherein clause fits into the rest of the claim. For the purposes of this action, claim 9 is interpreted as “a method for the treatment or the prevention of an autoimmune disease; comprising the administration of anti-citrullinated protein autoantibodies according to claim 1.”
The terminology “the administration of anti-citrullinated protein autoantibodies according to claim 1” renders claim 9 confusing because claim 1 does not mention autoantibodies.
Claims 9-12 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. This is an enablement rejection.
Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, have been described in In Re Colianni, 195 USPQ 150 (CCPA 1977) and have been adopted by the Board of Patent Appeals and Interferences in Ex Parte Forman, 230 USPQ 546 (BPAI 1986). Among these factors are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or lack thereof in the art,
4. the breath of the claims,
5. the amount of direction or guidance present, and
6. the presence or absence of working examples.
The following is an analysis of these factors in relationship to this application.
As stated above, for the purposes of this action, claim 9 is interpreted as “a method for the treatment or the prevention of an autoimmune disease; comprising the administration of anti-citrullinated protein autoantibodies according to claim 1.”
Applicant claims a method for the treatment or the prevention of an autoimmune disease; comprising the administration of anti-citrullinated protein autoantibodies.
First, there is no disclosure of the administration of anti-citrullinated protein autoantibodies. Thus, applicant has not provided any direction or guidance or working examples to support the claimed invention.
Second, the state of the art discloses that anti-citrullinated protein autoantibodies are the cause of rheumatoid arthritis, an autoimmune disease. Serre et al US 8207299 (PTO-892) col. 1, lines 25-35 that the serum of patients suffering from rheumatoid arthritis contain autoantibodies and that these are markers for the disease.
Third, applicant is claiming the treatment or prevention of all autoimmune diseases. This includes, but is not limited to, multiple sclerosis, rheumatoid arthritis, lupus, Crohn’s Disease and ulcerative colitis. These are a wide range of disease with different etiologies. Li et al, Frontiers in Pharmacology, vol. 8, Article 480 12 pages (2017) (PTO-892) disclose a variety of different drugs used in the treatment of autoimmune inflammatory diseases. On page 2, first column, second full paragraph, the reference states “Anti-TNF biologics (such as infliximab, adalimumab, etanercept, golimumab, and certolizumab pepol) have markedly improved the outcome of the management of autoimmune inflammatory diseases… However, a considerable proportion of patients do not respond to anti-TNF treatment”. Thus, in view of this, one of skill in art would not expect a single compound to treat all types of autoimmune diseases because patients may not respond to a compound.
In view of the lack of any direction or guidance or working examples and in view of the state of the art, it is the Examiner's position that one skilled in the art could not make and/or use the invention without undue experimentation.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 7 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Serre et al US 8207299 (PTO-892).
Serre et al discloses citrullinated peptides of X1PAPPPISGGGYX2AX3 (SEQ ID NO. 1) wherein X1 and X2 and X3 each represent a citrullyl residue and wherein the citrullyl reside can be functionalized with a carboxamide (summary, claim 3, col. 4, lines 54-55 and entire reference). This is applicant’s SEQ ID NO 15 wherein X1 and X2 each represent a citrullyl residue and X3 represents a citrullyl derivative with a carboxamide group in place of the carboxyl group.
The reference also discloses GPX1VVEX2HQSACKDS (SEQ ID NO: 2) wherein X1 and X2 each represent a citrullyl residue (summary and entire reference). This reads on applicant’s GPX1VVEX2HQSACKDS (SEQ ID NO: 5) wherein X1 and X2 each represent a citrullyl residue.
The reference also discloses VDIDIKIX1SCX2GSCS (SEQ ID NO: 4) wherein X1 and X2 each represent a citrullyl residue (summary and entire reference) and this reads on applicant’s VDIDIKIX1SCX2GSCS (SEQ ID NO: 8) wherein X1 and X2 each represent a citrullyl residue.
The reference also discloses X1GHAKSX2PVX3GIHTS (SEQ ID NO: 12) wherein X1, X2 and X3 each represent a citrullyl residue (summary and entire reference) which is the same as applicant’s X1GHAKSX2PVX3GIHTS (SEQ ID NO: 12) wherein X1, X2 and X3 each represent a citrullyl residue.
The reference discloses that these citrullinated peptides, and compositions thereof, can be used alone or in combination with each other (col. 5, lines 32-35 and lines 45-51). Thus, the reference discloses a composition comprising at least two peptides from the aforementioned peptides. The reference specifically discloses antigenic compositions comprising SEQ ID NO. 1 and 2 (col. 5, lines 53-56).
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.
Claim(s) 1-6, 8 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Serre et al US 8207299 (PTO-892) in view of Winqvist et al WO 2012/172339 (PTO-892).
Serre et al discloses citrullinated peptides of:
X1PAPPPISGGGYX2AX3 (SEQ ID NO. 1) wherein X1 and X2 and X3 each represent a citrullyl residue and wherein the citrullyl reside can be functionalized with a carboxamide (summary, claim 3, col. 4, lines 54-55 and entire reference). This is applicant’s SEQ ID NO 15 wherein X1 and X2 each represent a citrullyl residue and X3 represents a citrullyl derivative with a carboxamide group in place of the carboxyl group,
GPX1VVEX2HQSACKDS (SEQ ID NO: 2) wherein X1 and X2 each represent a citrullyl residue (summary and entire reference). This reads on applicant’s GPX1VVEX2HQSACKDS (SEQ ID NO: 5) wherein X1 and X2 each represent a citrullyl residue,
VDIDIKIX1SCX2GSCS (SEQ ID NO: 4) wherein X1 and X2 each represent a citrullyl residue (summary and entire reference) and this reads on applicant’s VDIDIKIX1SCX2GSCS (SEQ ID NO: 8) wherein X1 and X2 each represent a citrullyl residue,
X1GHAKSX2PVX3GIHTS (SEQ ID NO: 12) wherein X1, X2 and X3 each represent a citrullyl residue (summary and entire reference) which is the same as applicant’s X1GHAKSX2PVX3GIHTS (SEQ ID NO: 12) wherein X1, X2 and X3 each represent a citrullyl residue and
SGIGTLDGFXIHX2HPD (SEQ ID NO: 3) wherein X1 and X2 each represent a citrullyl residue (summary and entire reference) and this is the same as applicant’s SGIGTLDGFXIHX2HPD (SEQ ID NO: 10) wherein X1 and X2 each represent a citrullyl residue.
The reference also discloses that these citrullinated peptides, and compositions thereof, can be used alone or in combination with each other (col. 5, lines 32-35 and lines 45-51). Thus, the reference discloses a composition comprising at least two peptides from the aforementioned peptides. The reference specifically discloses antigenic compositions comprising SEQ ID NO. 1 and 2 and compositions comprising SEQ ID NO. 3 with SEQ ID NO. 4 or 12 (col. 5, lines 53-62). These citrullinated peptides are used in in vitro detection assays which detect anti-citrullinated protein autoantibodies (ACPA) in biological samples and can be linked to solid substrates, such as beads, particle, strips etc (summary, col, 6, lines 15-27 and entire reference). In col. 1, lines 25-35, the reference discloses that the serum of patients suffering from rheumatoid arthritis contain autoantibodies and that these are markers for the disease.
The only difference between the reference and the instant invention is the peptides linked directly or indirectly (thru intermediate compounds) to a solid support and the formation of an apheresis column.
Winqvist et al discloses that patients suffering from rheumatoid arthritis have an increased frequency of chemokine receptor expressing cells in the peripheral blood and that these can be removed using suitable binding reagents (page 2, lines 1-15). The reference discloses methods of treating the arthritis comprising applying the peripheral blood from a patient to an apheresis column loaded with a solid support comprising one or more binding peptides that bind chemokine receptors and the use of this column to remove one or more chemokine receptors from the peripherial blood of the patient and then returning the peripheral blood to the patient (abstract, page 2, lines 25+ and entire reference). The reference discloses the formation of the apheresis column by immobilizing and linking the binding agent, either directly or indirectly using avidin/biotin technology (reads on applicant’s intermediate compounds of claim 8), to the solid support (page 22, line 20 to page 26, line 14).
Since Serre et al discloses the same citrullinated peptides as applicant and that these are used in in vitro detection assays to detect anti-citrullinated protein autoantibodies (ACPA) in biological samples, it is the Examiner’s position that this reads on pulling the ACPA from the biological sample which results in removal of the ACPA from the serum. Since Serre et al discloses that these ACPA are found in the serum of patients suffering from rheumatoid arthritis contain autoantibodies and that these are markers for the disease and since Serre et al reads on pulling the ACPA from the biological sample which results in removal of the ACPA from the serum and since Winqvist et al discloses methods of treating the arthritis comprising applying the peripheral blood from a patient to an apheresis column loaded with a solid support comprising one or more binding peptides that bind chemokine receptors and the use of this column to remove one or more chemokine receptors from the peripherial blood of the patient and then returning the peripheral blood to the patient, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the methodology of Winqvist et al to Serre et al with the expected benefit of removing the ACPA from the blood serum. Specifically, Winqvist et al discloses rheumatoid arthritis patients have an increased frequency of chemokine receptor expressing cells in the peripheral blood and that these can be removed using suitable binding reagents loaded onto an apheresis column. Similarly, Serre et al discloses that ACPA are found in the serum of rheumatoid arthritis patients and that the citrullinated peptides, when bound on a solid support, detect the ACPA and this reads on removing the ACPA from the serum. Thus, applying the same methodology of Winqvist et al to Serre et al, it would have been obvious for one of ordinary skill in the art to make an apheresis column loaded with the citrullinated peptides of Serre et al with the expected benefit of removing the ACPA from the serum.
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, 5-6 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 8207299 (PTO-892) in view of Winqvist et al WO 2012/172339 (PTO-892).
The patent claims are directed to citrullinated peptides of X1PAPPPISGGGYX2AX3 (SEQ ID NO. 1) wherein X1 and X2 and X3 each represent a citrullyl residue and wherein the citrullyl reside can be functionalized with a carboxamide (summary, claim 3, col. 4, lines 54-55 and entire reference). This is applicant’s SEQ ID NO 15 wherein X1 and X2 each represent a citrullyl residue and X3 represents a citrullyl derivative with a carboxamide group in place of the carboxyl group. The claims states that this peptide is recognized by anti-citrullinated protein autoantibodies (ACPA) in patients suffering from rheumatoid arthritis.
The only difference between the reference and the instant invention is the peptides linked directly or indirectly (thru intermediate compounds) to a solid support and the formation of an apheresis column.
Winqvist et al discloses that patients suffering from rheumatoid arthritis have an increased frequency of chemokine receptor expressing cells in the peripheral blood and that these can be removed using suitable binding reagents (page 2, lines 1-15). The reference discloses methods of treating the arthritis comprising applying the peripheral blood from a patient to an apheresis column loaded with a solid support comprising one or more binding peptides that bind chemokine receptors and the use of this column to remove one or more chemokine receptors from the peripherial blood of the patient and then returning the peripheral blood to the patient (abstract, page 2, lines 25+ and entire reference). The reference discloses the formation of the apheresis column by immobilizing and linking the binding agent, either directly or indirectly using avidin/biotin technology (reads on applicant’s intermediate compounds of claim 8), to the solid support (page 22, line 20 to page 26, line 14).
Since the patent claims are directed to the same citrullinated peptides as applicant and that the citrullinated peptides recognize ACPA in patients suffering from rheumatoid arthritis and since Winqvist et al discloses methods of treating the arthritis comprising applying the peripheral blood from a patient to an apheresis column loaded with a solid support comprising one or more binding peptides that bind chemokine receptors and the use of this column to remove one or more chemokine receptors from the peripherial blood of the patient and then returning the peripheral blood to the patient, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the methodology of Winqvist et al to the patent claims with the expected benefit of removing the ACPA from the blood serum. Specifically, Winqvist et al discloses rheumatoid arthritis patients have an increased frequency of chemokine receptor expressing cells in the peripheral blood and that these can be removed using suitable binding reagents loaded onto an apheresis column.
Similarly, the patent claims are directed to the same citrullinated peptides as applicant and that the citrullinated peptides recognize ACPA in patients suffering from rheumatoid arthritis. Thus, applying the same methodology of Winqvist et al to the patent claims, it would have been obvious for one of ordinary skill in the art to make an apheresis column loaded with the citrullinated peptides of the patent claims with the expected benefit of removing the ACPA from the serum.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHEELA J HUFF whose telephone number is (571)272-0834. The examiner can normally be reached M-Th 6:30am to 4pm Eastern Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Sheela J. Huff/ Primary Examiner, Art Unit 1643
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