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 .
Response to Amendment
Applicant’s response filed 01 June 2026 has been received and entered. Claims 15 and 20 have been amended, claims 1-14, 16 and 23 have been canceled and claims 24-26 have been newly added. Claims 15, 17-22 and 24-26 are currently pending and under consideration in the instant Office action.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Any objection or rejection of record which is not expressly repeated in this action
has been overcome by Applicant’s response and withdrawn.
Applicant’s arguments filed 01 June 2026 have been fully considered but are not found to be persuasive.
NOTE: Many of Applicant’s arguments refer to paragraph numbers. However, the instant specification does not contain paragraph numbers. Applicant is reminded that all references to the specification should be made to the instantly filed specification in the instant application and not to paragraph numbers which correspond to the PGPub.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 29 January 2026 has been considered by the examiner.
Drawings
The replacement drawings filed 01 June 2026 are still objected to because they do not comply with 37 CFR 1.84 (a)(1) which requires that black and white drawings use India ink, or its equivalent that secures solid black lines and 37 CFR 1.84 (l) which requires that all drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black, sufficiently dense and dark, and uniformly thick and well-defined. The weight of all lines and letters must be heavy enough to permit adequate reproduction. All of the Figures fail to meet the standards of 37 CFR 1.84(a)(1) and/or 37 CFR 1.84(l).
Several of the figures do not have solid black lines and several of the figures do not have lines, numbers and letters which are black, sufficiently dense and dark and uniformly thick and well-defined. Additionally, because these requirements are not met, the lines/letters do not permit adequate reproduction. See example below:
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The Figures have the exact same issues as noted in the previous Office actions.
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 22 is objected to because of the following informalities: the claim recites “SEQ ID NO:11 RVS”. However, SEQ ID NO:11 is a skipped sequence in the sequence listing and therefore, there is no associated amino acid sequence with SEQ ID NO:11. The recitation of “SEQ ID NO:11” should be removed from the claim. Appropriate correction is required.
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.
Claim 26 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 26 is directed to a method of treatment which administers an antibody which comprises “a light chain variable region comprising CDR1, CDR2, and CDR3, wherein the CDR1 comprises SEQ ID NO: 10, the CDR2 comprises sequence RVS, and the CDR3 comprises SEQ ID NO: 11” (emphasis added). First, SEQ ID NO:11 is a skipped sequence and in the CRF, this means that there is no amino acid sequence associated with SEQ ID NO:11. Secondly, SEQ ID NO:11 was previously used to denote the light chain CDR2. The instant specification fails to disclose an antibody with a light chain CDR3 which has the amino acid sequence of SEQ ID NO:11, therefore, this is new matter.
Claims 15,17-19, 25 and 26 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.
Claim 15 is directed to a method of treatment comprising administering an antibody (or anti-adrenomedullin antibody fragment to a subject, wherein said subject has a level of mature adrenomedullin below a predetermined threshold level (or based on a ratio of mature adrenomedullin to other forms of adrenomedullin). Claim 15 defines the antibody/fragment as “produced by a process” wherein the process includes generation of an antibody by immunizing a mammal with mature ADM or screening for antibodies against adrenomedullin from an antibody gene library.
Claim 26 15 is directed to a method of treatment comprising administering an antibody or antibody fragment generated against the N-terminal part of ADM that competitively inhibits the binding of a reference antibody or antibody fragment to ADM.
The instant specification fails to provide an adequate written description for an antibody or antibody fragment obtained by the recited processes as well as failing to describe an antibody or antibody fragment which is generated against the N-terminal part of ADM that competitively inhibits the binding of a reference antibody or antibody fragment to ADM.
While the art before the effective filing date of the claimed invention teaches some antibodies which bind mature adrenomedullin, the prior art is lacking with regard to antibodies which bind “to the N-terminal part (aa 1-21) of adrenomedullin” as recited in claim 15. Claim 15 does not provide any structure or amino acid sequence what so ever for the antibody/fragment in the claimed method. Neither the prior art nor the instant specification teach a representative number of species falling within the scope of the recited genus and neither the prior art nor the instant specification provides any structure/function correlation with regard to antibody structure and ability to bind the N-terminal part of adrenomedullin. With regard to claim 26, the instant specification fails to describe the epitope to which the reference antibody binds which would be necessary for generating an antibody that competitively inhibits binding of a given antibody.
Vas-Cath Inc. V. Mahurkar, 19 USPQ2d 1111, states that Applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention, for purposes of the written description inquiry, is whatever is now claimed (see page 1117). A review of the language of the claims indicate that these claims are drawn to methods which administer anti-adrenomedullin (ADM) antibodies or anti-adrenomedullin antibody fragments.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing 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.
A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. Regents of the University of California v. Eli Lilly & Co., 119 F3d 1559, 1569, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). In Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that, while applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. At section B(1), the court states, “An adequate written description of a DNA ... requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention.”
The specification, beginning at page 31, generically describes antibodies. The disclosure (beginning at page 38) teaches an embodiment of anti-ADM antibody with a defined CDR structure (the portions of the antibody which are responsible for binding antigen).
The specification discloses the reduction to practice of antibodies which comprise the following CDRs:
heavy chain CDRs:
SEQ ID NO: 7 (GYTFSRYW),
SEQ ID NO: 8 (ILPGSGST),
SEQ ID NO: 9 (TEGYEYDGFDY);
and light chain CDRs:
SEQ ID NO: 10 (QSIVYSNGNTY),
RVS,
SEQ ID NO: 12 (FQGSHIPYT).
However, the claims encompass many more binding structures which are not further described.
Thus, given the level of skill and knowledge and predictability in the art, those of skill in the art would not conclude that the applicant was in possession of the genera of ADM-binding proteins recited in the claimed methods based on disclosures set forth above. Claim 15 does not provide any guidance on the structure of the antibody/fragment that must be present in order for antigen binding and claim 26 does not provide any guidance on the structure of the antibody/fragment that must be present for an antibody to competitively inhibit the binding of the reference antibody to ADM.
"A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when ... the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004).
For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly.
Further, it is not sufficient to define the genus solely by its principal biological property, because an alleged conception having no more specificity than that is simply a wish to know the identity of any material with that biological property. Per the Enzo court's example, (Enzo Biochem, Inc. v. Gen-Probe Inc., 63 USPQ2d 1609 (CA FC 2002) at 1616) of a description of an anti-inflammatory steroid, i.e., a steroid (a generic structural term) couched "in terms of its function of lessening inflammation of tissues" which, the court stated, "fails to distinguish any steroid from others having the same activity or function" and the expression "an antibiotic penicillin" fails to distinguish a particular penicillin molecule from others possessing the same activity and which therefore, fails to satisfy the written description requirement. Similarly, the function of the variant as claimed does not distinguish a particular variant from others having the same activity or function and as such, fails to satisfy the written-description requirement. Applicant has not disclosed any relevant, identifying characteristics, such as structure or other physical and/or chemical properties, sufficient to show possession of the claimed genus. Mere idea or function is insufficient for written description; isolation and characterization at a minimum are required. A description of what a material does, rather than what it is, usually does not suffice. (Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406).
In the absence of sufficient recitation of distinguishing characteristics, the specification does not provide adequate written description of the genus of molecules being administered in the claims, which are “anti-adrenomedullin (ADM) antibodies and anti-adrenomedullin antibody fragments”. One of skill in the art would not recognize from the disclosure that the applicant was in possession of the genus recited in the instant method claims. 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).
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. 112 is severable from its enablement provision (see page 1115).
Response to Arguments
Applicant asserts at page 8 of the response that the administration of an anti-ADM antibody which binds the N-terminus of ADM increases bio-ADM in subjects, that the specification discloses CDR sequences for the ADM antibody and method of generating antibodies and that the specification provides binding data and epitope mapping for antibodies recognizing the N-terminal region.
Applicant’s arguments have been fully considered, but are not found persuasive. The disclosure applicant refers to regarding methods for generating antibodies, including phage display and hybridoma technology is not supportive of a written description of the anti-ADM antibodies which are utilized in the claimed method for the reasons provided above. Applicant’s assert that the specification provides “binding data and epitope mapping” are not supported by the portions of the specification that Applicant cites (page 36 of the specification, filed 01 December 2023). These paragraphs refer to preferred embodiments for the anti-ADM antibody and does not relate to binding data or epitope mapping.
Applicant argues at page 9 of the response that the case law cited in the Office action is directed to products and not products by process and that product by process claims are created as an alternative to structural claiming. Applicant asserts at page 10 of the response that the current application is presented as the product of a claimed process and therefore, no structural support is required.
Applicant’s argument has been fully considered, but is not found persuasive. The process which is recited does not result in a specific product. The process may result in a number of products which then must be screened to identify a potential product. The portion of the claim directed to “using” a gene library is not a process for making anything, but rather, merely a screening method for products in a library.
Applicant argues at page 10 of the response that MPEP § 2163(II)(A)(3)(a)(ii) does not discuss product by process claims at all and that Applicant has no control over how the MPEP is arranged.
Applicant's argument has been fully considered, but is not found persuasive.
MPEP § 2163(II)(A)(3)(a)(i) is directed to “claim drawn to a single embodiment or species”. The instant claims encompass a genus of antibodies/fragments. Furthermore, the methods which are recited do not result in a specified antibody/fragment as the processes result in a host of antibodies which then must be screened for their ability to bind the specified target. Therefore, the recitation of the processes in claim 15 do not actually appear to produce a specific species/product but rather a genus of compounds which then would require further screening and selection to arrive at a potential compound to be used in the claimed method. The MPEP at the section cited by Applicant goes on to state that “the requirement may not be satisfied where it is not clear that the acts set forth in the specification can be performed, or that the product is produced by that process’.
Applicant argues:
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Applicant’s argument is unclear. However, a “product by process” claim makes a singular “product”.
Applicant asserts that “it seems that the USPTO is taking the position that structural support for a representative number of species must be present the specification even when the claimed subject matter is as a product by process” and asks at page 12 under Issue 3 if the USPTO has a “special rule which only applies to antibodies”. In response, the answer is that there is no special rule which only applies to antibodies. The issue of “representative species” is relevant to claims which are directed to a genus (see MPEP § 2163(II)(A)(3)(a)(ii)).
Claims 15, 17-22 and 24-26 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.
Claims 15, 20 and 26 are directed to a method of treating dementia in a subject suffering from dementia or Alzheimer’s disease by administering an antibody (or fragment) to said, wherein said subject has a level of mature adrenomedullin below a predetermined threshold level (or based on a ratio of mature adrenomedullin to other forms of adrenomedullin). Dependent claims recite threshold levels and define a sample.
The instant specification fails to teach any methods of treatment which comprise administration of an antibody or antibody fragment to adrenomedullin in which the subject has a level of adrenomedullin below a predetermined threshold or below 15 pg/ml (claims 17 and 21). The specification speculates that administration of N-terminal anti-ADM antibodies “may help to repair the leaky or damaged blood brain barrier” in subjects with dementia (see page 13 of the specification at lines 15-19). However, the instant specification provides no evidence that administration of anti-ADM antibodies which bind to the N-terminal part of adrenomedullin to any subject or to a subject who has a level of adrenomedullin below 15 pg/ml and any therapeutic benefit at all that relates to a “treatment” in a subject with dementia or Alzheimer’s disease.
The prior art of Letizia et al. (1998, Blood Pressure, 7:1, 19-23, DOI: 10.1080/080370598437529) states that normal levels of plasma adrenomedullin are 13.2 +/- 6.2 pg/ml. The prior art of Lupo et al. (Investigative Ophthalmology & Visual Science May 2004, Vol. 45, 5113) states that in the average population, adrenomedullin plasma concentration ranges between 13.7 +/- 6.1 pg/ml. The claimed method requires “treatment” of a patient the level of adrenomedullin is below 15 pg/ml. However, based on the prior art, patients with levels of adrenomedullin below 15 pg/ml would be considered normal subjects. One of ordinary skill in the art would not consider administration of an antibody/fragment to a subject to be a “treatment” when the subjects which are encompassed by the claims with levels of adrenomedullin below 15 pg/ml have adrenomedullin levels which would be considered normal and therefore, not in need of treatment. Additionally, the claims fail to specify what condition is being treated. The claims are not enabled for treating a subject who has a plasma adrenomedullin level that is considered to be normal according to the prior art because such subjects would not be in need of treatment. A normal subject is not one that is in need of treatment.
While limitations are not read into the claims, the claims are to be read in the light of the specification. Based on the disclosure of the specification, it would be fair to assume that the instant claims are intended to be methods of treating dementia and/or Alzheimer’s disease. However, the instant specification fails to provide any evidence that administration of antibodies which bind to N-terminal adrenomedullin would result in any therapeutic benefit for dementia or Alzheimer’s disease. As pointed out above, the “threshold” value which is recited in the claims is considered by the prior art to encompass normal levels of adrenomedullin in the population. While the specification asserts that low levels of adrenomedullin may be an indicator of dementia, the instant specification fails to establish that adrenomedullin is causative for the condition of dementia or is involved in the disease’s development and progression such that administration of antibodies which bind adrenomedullin would provide a treatment. While a protein may be a marker for a given condition, the association of a marker with a given condition does not establish that the marker is causative or implicated in progression of the condition and therefore, a therapeutic target for a given condition. In so far as the claims encompass a treatment for dementia, the state of the prior art is clearly unpredictable as there is no known cure for dementia although there are some treatments that can help with symptoms such as cholinesterase inhibitors. However, there are no current medications that stop, slow down or reverse dementia and there are clearly no antibody therapies for such. In light of the fact that at the time of the effective filing date of the claimed invention actual treatments for dementia were lacking, one of ordinary skill in the art would find it unpredictable that administration of an antibody which binds to the N-terminal part of adrenomedullin would result in the treatment of dementia or Alzheimer’s disease, absent evidence to the contrary.
Response to Arguments
Applicant argues at page 13 of the response that the claims have been amended to explicitly indicate what condition/disease is being treated. Applicant’s amendment has been considered and the portion of the rejection which was directed to a failure to recite what condition was being treated has been removed.
Applicant argues at page 13 of the response that the act of administering the antibody or antibody fragment to adrenomedullin to the subject is well within the skill of one skilled in the art. Applicant’s argument has been fully considered, but is not found persuasive. The rejection did not take issue with the ability of a person of ordinary skill in the art being able to determine a level of adrenomedullin and then administer an antibody to adrenomedullin if said level was below a particular threshold. The rejection which was made is based on the fact that the instant specification fails to teach any methods of treatment which comprise administration of an antibody to adrenomedullin.
Applicant argues at the bottom of page 13 of the response that the “specification also teaches that subjects with bio-ADM levels below 15 pg/ml are at increased risk of developing dementia, particular Alzheimer’s disease. To increase the bio-ADM level in blood, NT-ADM antibodies can be administered, as demonstrated in the example where Adrecizumab was administered to healthy subjects.”
First, the instant specification does not disclose administration of Adrecizumab as alleged by Applicant. The specification, in Example 7, merely states that NT-H antibody was administered. Next, there is no teaching in the instant specification that asserts that NT-ADM antibodies should be administered for the treatment of dementia. Lastly, the instant specification provides no evidence administration of an antibody to adrenomedullin has any therapeutic effects on dementia.
Applicant at page 14 of the response asserts that an application must be taken as in compliance with the enablement requirement of §112(a) unless there is reason to doubt the objective truth of the statements contained therein. However, such reasons have been provided in the rejection of record including the fact that the state of the prior art is such that there are no current medications that stop, slow down or reverse dementia and there are clearly no antibody therapies for such and therefore, one of ordinary skill in the art would find it unpredictive that administration of an antibody which binds to the N-terminal part of adrenomedullin would result in the treatment of dementia. Additionally, the art does not agree with Applicant’s finding that plasma levels of Adrenomedullin are decreased in subjects with dementia as evidenced by Marcucci et al. (Exploratory Research and Hypothesis in Medicine. 6(4): 164-176, 2021) which found that adrenomedullin was elevated in plasma in patients with Alzheimer’s disease (see Table 1).
Briefly, the specification provides no methods of treatment which administer an antibody and the specification merely speculates that N-terminal anti-ADM antibody may help to repair leaky/damaged blood brain barrier. The specification did not administer an N-terminal anti-ADM antibody to any subject to arrive at any therapeutic outcome which would be suggestive of a treatment in subjects suffering from dementia/Alzheimer’s disease.
There is no teaching or suggestion in the prior art that would lead one of ordinary skill in the art before the effective filing date of the claimed invention that increasing the amount of adrenomedullin in a subject by administration of an antibody which binds the N-terminus of adrenomedullin would provide a therapeutic benefit for subjects with any type of dementia, including Alzheimer’s disease. In fact, the prior art contemplates that elevated levels of adrenomedullin in the brain contribute to the pathogenesis of Alzheimer’s disease. Ferrero et al. (Mol. Neurobiol. (2018) 55:5177-5183) conclude “from our present observations in AD postmortem tissue, it might be inferred that therapeutical approaches aimed at reducing AM/PAMP levels may constitute a novel path to prevent/delay AD neurodegeneration” and that “ADM gene products might represent novel pathological features contributing to perturbations of neuronal maintenance and synaptic function in AD, and their pharmacological inhibition may constitute a novel approach to the treatment of AD” (see page 5182). The instant specification fails to provide any evidence that administration of an antibody which binds to the N-terminus of adrenomedullin would provide any therapeutic effect for the treatment of Alzheimer’s disease or any other form of dementia Furthermore, the prior art teaches that adrenomedullin levels are elevated in the brain of subjects with Alzheimer’s disease and suggests that inhibition of adrenomedullin may provide a treatment for Alzheimer’s disease. Additionally, the state of the prior art was determined to be unpredictable in view of the lack of treatments available at the time of the instant invention. Therefore, the required burden was met.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christine J Saoud whose telephone number is (571)272-0891. The examiner can normally be reached M-F, 6am-2:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Z Wu can be reached on 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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/Christine J Saoud/Primary Examiner, Art Unit 1645
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