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 .
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 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.
DETAILED ACTION
This action is in response to claim amendments filed 7/28/23. Claims 8-9, 11-12, 22, 29, 31, 37, 38, 43, 46, and 48-55 are pending and under examination.
Drawings
The drawings are objected to because:
Figure 7: the sequences must be identified by a SEQ ID NO.
Figure 8: the sequences must be identified by a SEQ ID NO.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 46 is objected to because of the following informalities: the claim begins “method”. A claim must begin with a capital letter and generally begins with an article such as “A” or “The”. Appropriate correction is required.
Claim 29 is objected to because of the following informalities: two elements are marked as “xxiv”. The last element should likely be identified as “xxix”. Appropriate correction is required.
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 37 and 54 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 determining the range encompassed by the term "about", one must consider the context of the term as it is used in the specification and claims of the application. Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir. 2007). In this case, the claim uses “about” in the phrase “at least about 80%”. The term “about” is defined in the specification—when it modifies a number, such as it does here—as “extending the boundaries above and below the numerical values set forth” (paragraph 47). Thus, the broadest interpretation of this definition is that “about 85%” encompasses 0% to 100%, as these are maximum values that are “above and below” the numerical value. The first part of the definition—where it is not limited to numerical values—is that “about” is “approximately, roughly, around, or in the regions of”. It is unclear if this first part of the definition also applies to numerical values or if this definition is solely when “about” is not used in conjunction with a numerical range, where the second definition takes priority.
Further, guidance that “about” should be “roughly” or one of the other similar terms does not provide any clear guidance regarding the metes and bounds of “about”. The specification notes that “about” can modify a numerical value “above and below the stated value by a variance”; however, while 10% is provided as an example, this is not a limiting value. Thus, based on the guidance in the specification, one is not clearly made aware of the limits of this “variance”.
Finally, combining “about” with “at least” further blurs the lines of what is sought to be claimed. A sequence might be 84% identical; while this is not “at least 85%”, it may or may not be “at least about 85%”. Such a sequence could be 80% or 65% identical and there is no clear guidance on whether or not these sequences would be “at least about 85%”.
MPEP § 2173.02 (II) states that one of the purposes of examination under 35 USC § 112, second paragraph is to determine whether the claim apprises one of ordinary skill in the art of its scope and, therefore, serves the notice function required by 35 U.S.C. 112, second paragraph, by providing clear warning to others as to what constitutes infringement of the patent. See, e.g., Solomon v. Kimberly-Clark Corp., 216 F.3d 1372, 1379, 55 USPQ2d 1279, 1283 (Fed. Cir. 2000). See also In re Larsen, No. 01-1092 (Fed. Cir. May 9, 2001) (unpublished). If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112, second paragraph, would be appropriate. See Morton Int’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993). In this case, provided with a sequence that is less than 85% identical, the skilled artisan would be uninformed as to whether or not such a sequence was infringing because they would be unable to ascertain how far from 85% the term “about” encompasses.
Therefore, claims 37 and 54 are indefinite.
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 8, 9, 11, 12, 22, 37, 38, 43, 46, and 48-55 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 8, 11, and 51 are directed to any FAM19A antagonist. As such, the claim is directed to a compound defined entirely by function (antagonist). See MPEP §2163(I)(A) which states:
"The claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art recognized correlation or relationship between the structure of the invention and its function. A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.”
Claiming a genus by function alone is possible when “the art has established a correlation between structure and function” (Ariad 598 F.3d 1336,1350; In re Wallach 378 F.3d 1330,1335; Amgen 872 F.3d 1367,1378). However, there is no such structure/function relationship established. To the contrary, the classes of molecules, e.g., antibodies, siRNA, aptamer, PNA, all vary greatly in structure. An antibody is a polypeptide which binds directly to a target, usually a protein, whereas siRNA is made of nucleic acids and downregulates the expression of genes.
Written description may also be met by providing a “representative number” of species within the genus. In this case, Applicant has not provided even a single member of: antisense oligonucleotide, siRNA, shRNA, miRNA, dsRNA, aptamer, or PNA that specifically targets FAM19A5. Moreover, the Examiner’s search of the art did not discover evidence that molecules within this class rise to the level of “well known and conventional”. Where a class of molecule is ubiquitously known throughout the art, guidance to that class of molecule may be enough to meet the written description requirement. “Information which is well known in the art need not be described in detail in the specification. However, sufficient information must be provided to show that the inventor had possession of the invention as claimed” (MPEP §2163, citations omitted). The Examiner does not contest that the classes of “antibody” or “shRNA” are well known in the art as are generic methods of making such molecules. However, the claims are not simply to any antibody or PNA, but must specifically be FAM19A5 antagonists. The other members (e.g., siRNA, aptamer) need not even specifically target FAM19A5 so long as, by some unclaimed and undisclosed mechanism, they act as antagonists of FAM19A5. There is no art of record nor evidence in the specification that oligonucleotides which are FAM19A5 antagonists even exist, much less that they are well known in the art. A search for anti-FAM19A5 antibodies discovered 28 such antibodies (Biocompare; form 892). However, while these antibodies bind FAM19A5, it is not clear that any of them are antagonists as required. Further, not all of them were available at the time of filing, as some are first cited after the instant priority date and therefore cannot serve to establish what was well known at the time of filing, which is the date at which the written description requirement must be met.
Even within the classes, Applicant nor the art of record establishes a known structure/function correlation. As antibodies are the only molecule for which the specification provides an example, antibodies will be discussed as exemplary of the issues. Antibodies generally share certain characteristics such as Fc regions or hinge regions. However, these structures are not correlated with the binding function of the antibody. The hyper variable regions (HVRs), i.e., complementarity determining regions (CDRs) of an antibody, are well established in the art as the portion of the binding region which imparts the specificity of an antibody. However, there is no way to a priori look at an antigen sequence (FAM19A5) and envisage the combination of six CDRs that will bind that antigen. First, even highly related CDRs may not bind the same target. See for example Kussie (cited on form 892) who demonstrates that a single amino acid change in the heavy chain of an antibody which binds p-axophenylarsonate (Ars) completely abrogates the ability of the antibody to bind Ars but adds the functionality of binding the structurally related p-azophenylsulfonate (e.g., abstract). Second, even when provided with several related antibodies that bind the desired target, this does not represent the astronomical and potentially unknowable breadth of all possible amino acid sequences which will result in the desired binding properties. This is exemplified by the Court decision in Abbvie (Abbvie v Janssen 759 F.3d 1285 (Fed. Cir. 2014)), where Abbvie developed over 200 antibodies that shared 99.5% identity in the variable regions (p.7) and which bound the target, but in no way allowed one to envisage the unique structure of Centocor’s antibodies which bound the same target but shared only 50% sequence similarity (see table on page 11).
Thus, the art recognizes that the CDRs define the binding properties of an antibody and that even single amino acid changes to this region can completely abrogate the binding specificity of an antibody. As a further example, see Chen (cited on form 892) which demonstrates single amino acid changes in the VH CDR2 sequence can increase binding, decrease binding, destroy binding, or have no effect on binding when compared to the wild-type antibody.
Thus, making changes to the CDR sequence of an antibody is a highly unpredictable process and the skilled artisan could not a priori make any predictions regarding such mutations with any reasonable expectation of success nor envisage the breadth of structurally unrelated CDR combinations that would still possess the required functions.
The specification discloses 29 antibodies (claim 29). However, as discussed above, without any way to determine the breadth of the genus of such antibodies, there is no way to determine if these antibodies represent the full breadth of what is claimed. The disclosure of these specific antibodies would not convey to the artisan that Applicant was in possession of the full genus of all antibodies which possess the required functions nor does it allow the skilled artisan to envisage the specific structure of such antibodies. This rationale is extended to the more generic claims: if the specification as filed does not convey possession of the genus of FAM19A5 antagonist antibodies, then the specification as filed cannot convey possession of the genus of all possible FAM19A antagonists, particularly as it is unclear if molecules within the other classes existed at the time of filing.
Further note the decision in Amgen v. Sanofi 2017, where the Court supported previous decisions (Centocor 2011; Abbvie 2014) that defining an antibody solely by what it binds does not satisfy the written description requirement, stating that this would allow patentees to “claim antibodies by describing something that is not the invention, i.e., the antigen”. This decision has precipitated the removal of the “newly characterized antigen test” (indicating a well-characterized antigen is sufficient to satisfy written description for antibodies which bind that antigen).
It is appreciated that certain claims do include at least some degree of structure, e.g., claim 22 defines the choices for each CDR, allowing any of the CDRs of the disclosed antibodies to be intermixed with CDRs of the other antibodies and only requiring a single CDR (“and/or”). Claims such as claim 37 requires a partial structure when compared to certain other sequences. However, as above, arbitrarily altering any amino acid in the CDR of an antibody is unpredictable and the specification does not convey possession of any CDRs or CDR combinations other than those of the disclosed antibodies. Further, it is well-known in the art that specificity of an antibody stems from the interaction of six CDRs and CDRs are not generally recognized as interchangeable, such that using one CDR from one antibody would not be reasonably expected to confer the same binding properties or even the same binding target when combined with two to five CDRs from other antibodies. For example, WO 2008068048 (cited on form 892) discloses an antibody with a heavy chain comprising three CDRs (SEQ ID NO: 2) that binds secreted aspartyl protease from Candida sp. US 20170355756 (form 892) describes the same three CDRs in the heavy chain (C10-VH3) combined with a different light chain that binds human TDP-43. It is also reiterated that the art discussed above establishes that even a single amino acid change in a single CDR—where the other five remain the same—can alter the binding target of the antibody. There is no evidence in the instant specification that a single CDR placed in the context of two to five other CDRS, even if those CDRs come from other FAM19A5 binding antibodies, would result in the required function, whereas claims that only require a percent identity allow for all such mutations to occur in the CDRs, which would be unpredictable as above. As such, the specification fails to set forth a structure-function correlation sufficient to claim all possible antibodies defined by function and one-three CDRs or alterations thereof nor does the specification provide a representative number of antibodies.
One could not envisage which portions of the CDRs are necessary to impart the claimed binding properties or which could be mutated without affecting such properties, nor does the instant specification provide guidance to this effect. As such, the disclosure of the instant antibody sequences does not convey possession of other antibodies with the same binding properties; possession of the precisely defined sequence of six CDRs is required. This deficiency is only amplified when considering claims to any “antagonist”, where no examples of, e.g., PNAs or aptamers are provided.
It is further noted that the instant definition of antibody includes, e.g., single-domain antibodies or camelized antibodies. Such antibodies are rare and there is no evidence of the existence of any sdAb which also acts as a FAM19A5 antagonist.
Regarding claim 43, these claims are directed to human antibodies. According to the specification, the disclosed antibodies were raised in chickens (paragraph 234). As such, the specification does not convey any examples of a human antibody nor does a chicken CDR sequence inform the skilled artisan of the structure of a human hypervariable region. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
The Examiner does not contest that the methods of making, e.g., antibodies or siRNA in general are well known; however, the ability to eventually discover these molecules with the desired function is insufficient to meet the written description requirement.
Amgen makes clear that there is no special written description requirement for a particular class of compounds and the same written description requirement applies, while the Court in Ariad (598 F.3d 1336,1350) and Rochester (358 F.3d 916) clearly noted that decisions in composition of matter cases apply to methods. The case in Rochester was concerned with a method of treatment, as is the instant case, and the Court indicated that “the claimed method depends upon finding a compound that selectively inhibits PGHS-2 activity. Without such a compound, it is impossible to practice the claimed method of treatment”. Replacing “inhibits PGHS-2 activity” with “inhibits FAM19A5 activity” (an antagonist), leads to the same conclusion: the compounds are required to practice the method and so the specification must meet the written description requirement of such compounds. While the specification provides certain antibodies with this function, the breadth of the claims is of such breadth that there is no structure/function correlation and where the vast majority of “potential” species within the genus simply do not exist. In that same case:
“Pfizer points out that the district court found that the '850 patent does not disclose the structure or physical properties of any of the compounds required to practice the claimed methods, and that the structure of such compounds cannot be deduced from any known structure-function correlation. Pfizer agrees with the district court that the '850 patent discloses nothing more than a hoped-for function for an as-yet-to-be-discovered compound, and a research plan for trying to find it.”
The same is true of the instant case. The disclosure of some newly developed antibodies does not convey to the skilled artisan that Applicant was in possession of all such antibodies—or more broadly all such compounds—sufficient to practice the claimed method. Since the antibodies/antagonists are needed to perform the method, failure to be in possession of the antibodies/antagonists supports a conclusion that the method itself was not adequately described and is not rectified by the disclosure of a “research plan” for finding more.
Therefore, claims 8, 9, 11, 12, 22, 37, 38, 43, 46, and 48-55 do not meet the written description requirement. Note that claims 29 and 31 are not included in this rejection. Claim 29 requires the combination of six specific CDRs from the disclosed antibodies that, in that specific combination, was demonstrated to function. The VH and VL of claim 31 include those CDRs and meet the written description requirement for the same reason.
Claims 8-9, 11-12, 22, 29, 31, 37, 38, 43, 46, and 48-55 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.
Independent claim 8 requires administering an antagonist to increase a threshold or latency to an external stimulus “in a subject in need thereof”. However, the specification as filed fails to adequately describe this group such that it does not convey to the skilled artisan the identity of the group being treated.
Independent claim 11 requires administering an antagonist to increase a sensory nerve conduction velocity “in a subject in need thereof”. However, the specification as filed fails to adequately describe this group such that it does not convey to the skilled artisan the identity of the group being treated.
One means of providing adequate written description and evidence of possession of a claimed genus is through providing sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In this case, there is no identification of any particular characteristic or identifying feature that would identify the population “in need” of these results. The name of the group—people in need of increased threshold or people in need of increase nerve conduction—cannot itself serve as the identifying feature as a mere statement that they are part of the invention does not serve to identify the members of that group; see Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
In a second way, the specification might provide a representative number of species for the claimed genus that would convey to the artisan possession of the whole genus. However, in this case, the species disclosed do not represent the full breadth of all possible members of the genus. For claim 8, hyperalgesia is disclosed as a subject in need of an increased threshold or latency to an external stimuli (paragraph 32). However, the specification conveys to the skilled artisan that this hyperalgesia is a symptom of neuropathic pain, as the specification teaches hyperalgesia is one symptom of neuropathic pain and, when testing efficacy in increasing the threshold, compares this value to a subject with neuropathic pain that did not receive the treatment, e.g., paragraph 133. Thus, the specification only discloses that those with neuropathic pain are “in need” of an increased threshold or latency to an external stimulus. However, the claim is not limited to those with neuropathic pain and so there must be other groups “in need” of such a treatment, yet the specification as filed provides no guidance as to who these others might be.
Claim 11 is similarly deficient. The specification does not explicitly identify any members—other than possibly those with neuropathic pain—which are in need of increase nerve conduction velocity. The specification does teach that increased velocity is the sign of a healthy nerve (paragraph 135). Thus, the guidance in the specification is that faster nerve conduction is better. Under this guidance, it is possible that everything with nerves is “in need” of increased sensory nerve conduction velocity, as this increase is taught as beneficial. As with the increased latency, the only population clearly set forth are those with neuropathic pain (paragraph 135). It does not identify nor provide guidance as to any other members of the group “in need” of the results of claim 11 and thus does not convey to the skilled artisan that Applicant was in possession of the method as broadly as claimed.
For claim 51, the deficiencies are similar to those for claim 11. The phrase “in need thereof” would imply that there are subjects that do not need increased motor function. However, the specification as filed discloses testing on CCI-induced rated, which is a “good indicator of any pain or muscle weakness in the lower limbs, resulting from the CCI induction”. Other than CCI-rats, the specification does not disclose those “in need” of the claimed treatment. While CCI may be extendable to neuropathic pain, the disclosures does not allow the skilled artisan to envisage any other members of this genus.
Further, claims 8, 11, and 51 differ only in the subjects being treated; the same therapeutic is administered. It is presumed that these are not merely duplicates, which implies there is some difference in scope between those in need of increased motor function, increased sensory nerve conduction velocity, and increased threshold/latency to an external stimulus. However, these three categories are all supported by the same condition: neuropathic pain. Reading the specification, those of skill in the art could not envisage the other members of these genera nor the distinction between them.
Dependent claims do not provide sufficient additional identifying features of the subjects to be treated and are deficient for the same reasons.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117). The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). As discussed above, the artisan cannot envision the identity of the subjects to be treated and therefore the specification has failed to convey to the skilled artisan possession of the method as broadly as it is claimed.
Therefore, claims 8-9, 11-12, 22, 29, 31, 37, 38, 43, 46, and 48-55 do not meet the written description requirement.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 11 and 48 is/are rejected under 35 U.S.C. 102(a)(1-2) as being anticipated by Seong (US 20150118230; form 892).
Regarding claim 11, Seong teaches a method of treating a degenerative brain disease in animals by administering a FAM19A5 inhibitor (paragraph 17). An animal meets the instant limitations of a subject. The instant specification provides guidance that those with nerve dysfunction are subjects “in need” of this treatment (paragraph 135) and Seong teaches these subjects have degenerative brain disease or central nervous system disease, i.e., have dysfunctional nerves. Thus, the population being treated by Seong is “in need” of increased sensory nerve conduction velocity. Seong does not teach this method increases a sensory nerve conduction velocity. However, as evidenced by the instant specification, this is an inherent result in administering the FAM19A5 antagonist. The method of Seong and the instant method practice identical methods, where the only therapeutic being administered is a FAM19A5 antagonist. While the instant claims also recite a result of practicing this method (increased conduction velocity), those subjects treated in Seong would nevertheless have also had their nerve conduction velocity increased as this result flows from the administration of the compound itself. Applicant's attention is directed to MPEP § 2112 (II), which states, "there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003)." Furthermore, Integra Life Sciences I Ltd. v. Merck KGaA, 50 USPQ2d 1846 (DC SCalif, 1999) makes clear that a reference teaching a process may anticipate claims drawn to a method comprising the same process steps, despite the recitation of a different intended use in the preamble or the later discovery of a particular property of one of the starting materials or end products.
Regarding claim 48, Seong teaches the antagonist is an antibody (paragraph 63).
Therefore, claims 11 and 48 are anticipated.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
It is noted that Applicant has numerous filed applications and issued patents regarding FAM19A5 antibodies and related compositions as well as methods of treatment using those antibodies. In many cases, those antibodies are the same as instantly claimed, though often are mixed amongst many other antibodies. While the examiner made efforts to identify patents and co-pending applications that claim the same antibodies by the same sequences as instantly claimed, Applicant is in the best position to identify such documents. Where a patent or co-pending application claims the same six CDRs as one of the instant combinations or the same VH/VL combinations as one of the instant combinations, assistance in identifying this is appreciated. Note that, as set forth in the reasons for allowance, where the reference document does not claim the exact same sequence combinations, no double patenting rejection is generally necessary as even a single amino acid difference in a CDR is considered a non-obvious, patentably distinct invention.
Claims 8-9, 11-12, 22, 29, 31, 37, 38, 43, 46, and 48-55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11332521. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are directed to an identical antibody as one instantly claimed; compare reference SEQ ID NOs: 7-12 to instant SEQ ID NOs: 17-19 and 29-31, respectively. The reference claims also include the antibody being humanized (claim 13). The reference claims include the antibody being a Fab (claim 18). The reference claims are directed to a composition of matter and so the utility of this antibody must be examined in order to determine what is and is not an obvious variation. See the decisions in Sun Pharmaceuticals v Eli Lily Fed Cir July 28, 2010; Geneva v GlaxoSmithKline 349, F.3d 1373; and Pfizer v Teva 518 F3d 1353 supporting the Office’s use of disclosed utilities of compositions when applying double patenting rejections to method claims. In this case, the reference discloses treating neuropathic pain (paragraphs 65 and 68). This is the example provided in the instant specification of someone “in need” of increased threshold latency, increased sensory nerve velocity, and increased motor function. As the instant claims are directed to results of administering the antibody, these results must necessarily follow from the same active step (administer the antibody) performed on the same subject (one with neuropathic pain). In support of enabling such a method, the reference discloses, e.g., oral administration (embodiment 47).
Claims 8-9, 11-12, 22, 29, 31, 37, 38, 43, 46, and 48-55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12202889. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are directed to a nucleic acid that encodes an identical antibody as one instantly claimed; compare reference SEQ ID NOs: 7-12 to instant SEQ ID NOs: 17-19 and 29-31, respectively. A nucleic acid encoding an antibody renders obvious the antibody the nucleic acid encodes because this is the primary function of such nucleic acids and the correlation between nucleic acids and the proteins they encode are well-established. The reference claims also include the antibody being humanized (claim 7-8). The reference claims include the antibody being a Fab (claim 9-10). The reference claims are directed to a composition of matter and so the utility of this antibody must be examined in order to determine what is and is not an obvious variation. See the decisions in Sun Pharmaceuticals v Eli Lily Fed Cir July 28, 2010; Geneva v GlaxoSmithKline 349, F.3d 1373; and Pfizer v Teva 518 F3d 1353 supporting the Office’s use of disclosed utilities of compositions when applying double patenting rejections to method claims. In this case, the reference discloses treating neuropathic pain (paragraphs 65 and 68). This is the example provided in the instant specification of someone “in need” of increased threshold latency, increased sensory nerve velocity, and increased motor function. As the instant claims are directed to results of administering the antibody, these results must necessarily follow from the same active step (administer the antibody) performed on the same subject (one with neuropathic pain). In support of enabling such a method, the reference discloses, e.g., oral administration (embodiment 47).
Claims 8-9, 11-12, 22, 29, 31, 37, 38, 43, 46, and 48-55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of copending Application No. 18982077 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are directed to a nucleic acid that encodes an identical antibody as one instantly claimed; compare reference SEQ ID NOs: 7-12 (claim 6) to instant SEQ ID NOs: 17-19 and 29-31, respectively. The reference claims also include the antibody being humanized (claim 9). In determining the definition of “antibody binding portion thereof” in claim 1, the specification includes the antibody being a Fab (embodiment 25). The reference claims are directed to treating all diseases and conditions, so the specification may be inspected to determine what is covered by this claimed phrase.
“The specification can be used as a dictionary to learn the meaning of a term in the patent 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.’). See also MPEP § 2111.01. Further, those portions of the specification which provide support for the patent 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 patent. In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized ‘that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,’ but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent which provides support for the patent claim. According to the court, one must first ‘determine how much of the patent disclosure pertains to the invention claimed in the patent’ because only ‘[t]his portion of the specification supports the patent claims and may be considered.’ The court pointed out that ‘this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined.’’’ MPEP §804(II)(B)(1)
In this case, the reference discloses treating neuropathic pain (embodiment 46). This is the example provided in the instant specification of someone “in need” of increased threshold latency, increased sensory nerve velocity, and increased motor function. As the instant claims are directed to results of administering the antibody, these results must necessarily follow from the same active step (administer the antibody) performed on the same subject (one with neuropathic pain). In support of enabling such a method, the reference discloses, e.g., oral administration (embodiment 47).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 8, 9, 11, 12, 22, 37, 38, 43, 46, and 48-55 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 33, 35-39, 41, 43-54 of copending Application No. 18987829 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are also directed to a FAM19A5 antibody. The reference claims also include the antibody being a Fab (claim 53). The reference claims treating neuropathic pain (claim 37), increasing a latency to an external stimulus (claim 39), and oral administration (claim 41). Further, a subject with neuropathic pain is the example provided in the instant specification of someone “in need” of increased threshold latency, increased sensory nerve velocity, and increased motor function. As the instant claims are directed to results of administering the antibody, these results must necessarily follow from the same active step (administer the antibody) performed on the same subject (one with neuropathic pain).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 8-9, 11-12, 22, 29, 31, 37, 38, 43, 46, and 48-55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11970532. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are also directed to a FAM19A5 antibody. The reference claims also include the antibody being a Fab (claim 5) and humanized (claim 4). The reference claims treating various diseases including fibrosis, neurodegenerative diseases, stroke, and neuropathic pain (claim 14). These are considered subjects in need of the instantly claimed results. Further, a subject with neuropathic pain is the example provided in the instant specification of someone “in need” of increased threshold latency, increased sensory nerve velocity, and increased motor function. As the instant claims are directed to results of administering the antibody, these results must necessarily follow from the same active step (administer the antibody) performed on the same subject (one with neuropathic pain). Under the definition of “administering”, the reference patent discloses “orally”.
Claims 8-9, 11-12, 22, 29, 31, 37, 38, 43, 46, and 48-55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11634484. Although the claims at issue are not identical, they are not patentably distinct from each other because reference claim 1 claims the same antibodies as instantly claimed. Further, the reference claims the antibodies in a method of treating neuropathic pain. A subject with neuropathic pain is the example provided in the instant specification of someone “in need” of increased threshold latency, increased sensory nerve velocity, and increased motor function and so the reference claim anticipates the instant claims. The reference claims also explicitly claim the effect on threshold (claims 6-7), that the antibody is a Fab (claim 9), humanized (claim 10), and provided orally (claim 11).
Note that Applicant has voluntarily filed the instant application as a divisional of parent application 17/050056 (now US 11634484). As there was no restriction set forth in the parent application, there is no safe harbor protection available under 35 USC 121 (see MPEP §804.01).
Allowable Subject Matter
The effects of FAM19A4 (TAFA4) in neuropathic pain were known at the time of filing. Moqrich (US 20160113996; form 892) teaches such a method, whereby administering TAFA4 or an agonist treats neuropathic pain (claim 17).
Thus, even though TAFA4 and TAFA5 are in the same protein family, the prior art teaches more (agonist) TAFA4 treats neuropathic pain, while the instant method is one of allowing less (antagonist) TAFA5. Further, one would not have expected that a TAFA5 agonist would be beneficial, as Moqrich explicitly notes that these effects on neuropathic pain were specific to TAFA4, “as addition of recombinant TAFA5…could not elicit this low threshold outward current from TAFA5-null neurons” (paragraph 201). In other words, TAFA4 is required to maintain a normal pain threshold (paragraph 199), but the mechanisms by which TAFA4 accomplishes this are separate from TAFA5. Adding exogenous TAFA4 reduced neuropathic pain while these results were not replicated by TAFA5.
Seong (US 20150118230) is discussed above. The Examiner had articulated the reasoning as to why claims directed at increasing a sensory nerve conduction velocity is inherent to the method of Seong. Briefly, all subjects inherently have a “conduction velocity” and administering the subjects an identical compound will necessarily have the same effects on these internal mechanisms. However, Seong does not teach the specific CDR sequences of claims 29 and 31. Moreover, an increased conduction velocity, i.e., nerve conduction is faster, would not reasonably be considered to increase latency to a stimulus, i.e., slow the response time. While the results of administering a therapeutic to the same population are inherent, there is contradictory reasoning available to suggest that this specific result would not have occurred with the method of Seong. Moreover, Seong teaches treatment of degenerative brain disease, which is a condition of the central nervous system. While it is unclear what defines a subject “in need of” increased motor function, the instant specification as a whole implies that person has some particular condition or dysfunction of motor function to begin with. In other words, the instant claims do not cover “everyone”. Since there is no evidence that those with the brain disease of Seong are in need of increased motor function, Seong was not applied to that claim.
Note that double patenting was considered for pending application 17/418681. However, that application—at the time of writing—has claims solely to treating atherosclerosis. This is considered a non-obvious variation from the instant methods as there is no clear evidence that such a subject is “in need” of increased velocity, latency, or motor function.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM M WEIDNER whose telephone number is (571)272-3045. The examiner can normally be reached M-F 9-16.
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/Adam Weidner/Primary Examiner, Art Unit 1675