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 .
DETAILED ACTION
Claim Status
1. The Amendment filed 5/13/26 is acknowledged. Claims 1-35, 37, 39-65, 67-80, 82, 84-101, and 103-105 have been canceled without prejudice or disclaimer. Claims 36, 66, 81, and 106 have been modified. While new claims 111-116 have been added. Currently claims 36, 38, 66, 81, 83, 102, and 106-116 are pending.
Election/Restrictions
2. Applicant’s election without traverse of species (antibody binding constructs comprising the combination of sequence identification numbers 11, 12, 13, 16, 7, and 18) and (SAS1B as the target for the antibody binding construct) in the reply filed on 5/13/26 is acknowledged.
3. The Restriction requirement is still deemed proper and is therefore made FINAL.
4. Claims 81, 83, 102, 106-111, 113-114, and 116 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. The withdrawn claims are directed to different sequence identification numbers that are not indicated as obvious variants of the elected species. Election was made without traverse in the reply filed on 5/13/26.
5. Claims 36, 38, 66, 112, and 115 are under consideration.
Priority
6. The priority date for the instant application is December 19, 2019. This application is a 371 of PCT/US20/66333 filed 12/21/2020 and PRO (provisional application) No. 62/950,706 filed 12/19/2019.
Information Disclosure Statement
7. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609 A(1) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the Examiner on form PTO-892 or Applicant on PTO-1449 cited the references they have not been considered.
8. The information disclosure statement filed 7/6/26 has been considered as to the merits before First Action.
Specification
9. The disclosure is objected to because of the following informalities: The first line of the specification should list “371 of PCT/US20/66333 filed 12/21/2020 and PRO (provisional application) No. 62/950,706 filed 12/19/2019”. Appropriate correction is required.
If applicant desires to claim the benefit of a prior-filed application under 35 U.S.C. 119(e), 120, 121, 365(c) or 386(c), the instant application must contain, or be amended to contain, a specific reference to the prior-filed application in compliance with 37 CFR 1.78.
10. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. For example, see sections 0003, 0300, and 0304.
11. The use of the term “TRITON”, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. See sections 0387, 0389, and 0391.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112
12. 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.
13. Claim 36 (and dependent claims 38, 66, 112, and 115) is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A. Claim 36 is vague and indefinite because it is not clear as to what is intended in the contact step. As recited the claim necessitates “contacting said cancer cell with an effective amount of an antibody or antigen-binding portion thereof or antibody-drug conjugate comprising”. The wording is ambiguous as it is not clear if the cell will be contacted with the antibody or some other reagent (antibody-drug conjugate, antigen-binding portion). Additionally it is not known what the components that are included with the antibody will entail. In other words what drug and what binding portion. As recited the metes and bounds of the claim cannot be determined. It is suggested that the actual reagent is listed in the clams in order to obviate the rejection.
B. Claim 36 line 13 recites the limitation "antigen binding fragment thereof" in the claim. There is insufficient antecedent basis for this limitation in the claim. It is suggested that consistent language is utilized in the claims in order to obviate the rejection. Please clarify.
C. Claims 36, 66, and 115 recite the phrase "antigen binding portion or antigen-binding fragment thereof”, however it is unclear how to define fragments, portions, and/or partial peptides that are considered to relate to the recited antibodies and further being operable in the instantly claimed method of binding to SAS1B+ cancer cells to inhibit proliferation or kill said cell.
The specification does not teach examples of the required components of the recited "fragments and/or portions” that contain conserved regions allowing for the claimed detection procedures.
Therefore, the phrase "fragment thereof and binding portion” are vague and indefinite because the characteristics needed to determine whether an unknown could be considered immunologically detectable while being a "fragment, fragment thereof, or binding portion” is unknown. Accordingly, the claims are unclear. It is suggested that the actual sequence identification number of the fragments, fragments thereof, and binding portions are included in the claims in order to obviate the rejection. Appropriate correction is required.
D. Claim 38 recites the limitation "said cancer" in claim 36. There is insufficient antecedent basis for this limitation in the claim. Claim 36 is drawn to binding a cancer cell and is not directed to the disease. It is not clear if Applicant means to specify the type of cell (i.e. carcinoma cell). Appropriate correction is required.
E. The term “at least about” in claim 66 is a relative term which renders the claim indefinite. The term “at least about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear as to what limitations are meant by “at least about”. Will any Molar parameter acceptable, 10-1, 10-6, 10-50, etc. It is suggested that the phrase is removed in order to obviate the rejection. Please correct.
F. Claim 115 is vague and indefinite in not including sequence identification numbers in the claim. Additionally, a transitional phrase of “comprising” or “consisting of” is not included to indicate the scope of the claimed sequence. 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.
14. Claims 36, 38, 66, 112, and 115 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 contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventors, at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
Claims 36, 38, 66, 112, and 115 are drawn to methods involving antibody constructs, wherein the claims read on "fragments thereof and/or antigen-binding portion”. The written description in this case does not set forth the utility of any and all "fragments thereof or binding portions”. Therefore the written description does not reasonably convey the claimed subject matter to one of ordinary skill in the art. Neither the specification nor the claims exemplify every "fragment thereof or antigen-binding portion”, in all antibody compositions being measurable in samples with differential expression for mere detection or in disease samples as compared to normal samples SAS1B positive cancer cells.
There is no guidance as to what portions of the "fragment thereof or antigen-binding portion” are or how much modification can occur while maintaining product characteristics with respect to the instant invention.
There is no guidance as to what "fragment thereof or antigen-binding portion”, if any can be produced and utilized for the intended purpose. Thus, the resulting "fragment thereof or antigen-binding portion”, having specified binding characteristics could result in any number of complexes not taught and enabled by the specification.
Vas-Cath Inc. V. Mahurkar, 19 USPQ2d 1111, clearly 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 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).
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 USC 112 is severable from its enablement provision (see page 115).
Without a sequence or examples of "fragments thereof and antigen-binding portions”, the skilled artisan cannot envision the detailed structure of the partial peptides as claimed, thus conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of production and or isolation. An adequate description requires more than a mere statement that it is part of the invention and a reference to a potential method of isolating it.
The court indicated that while Applicants are not required to disclose every species encompassed by a genus, the description of a genus is achieved by the recitation of a representative number of molecules falling within the scope of the claimed genus. Therefore the full breadth of the claims, reading on the claimed "fragment thereof and antigen-binding portions”, does not meet the written description provision of 35 USC 112, first paragraph.
15. Claims 36, 38, 66, 112, and 115 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are directed to a method that binds SAS1B+ cancer cells via an antibody, antigen binding portion thereof, antibody-drug conjugate, or antigen-binding fragment thereof to thereby inhibit proliferation or kill said SAS1B+ cancer cells.
The antibody, antigen binding portion thereof, antibody-drug conjugate, or antigen-binding fragment thereof comprising a heavy chain variable region (CDRs) comprising the amino acid sequences: HCDR1 - SEQ ID NO: 11, HCDR2 - SEQ ID NO: 12, HCDR3 – SEQ ID NO:13 and a light chain variable region (CDRs) comprising the amino acid sequences: LCDR1 - SEQ ID NO: 16, LCDR2 - SEQ ID NO: 7, LCDR3 – SEQ ID NO:18.
However, Applicant appears to have made a single antibody designated OV119 (see figure 20). Specification sections 0040-0049, 0362, and 03721. Applicant has made one OV119 antibody construct. But states that a skilled artisan can make other antibodies with the claimed CDRs which retain binding to the antigen. However, the prior art does not appear to recognize that the framework regions and constant regions were generally known at the time the application was filed. Additionally, the claimed antibody or antigen binding fragment does not appear to be deposited.
The prior art has demonstrated that an antibody structure is highly variable in the CDR regions. Lloyd et al. (2009, Protein Eng Des Sel., 22(3):159-168.) found that on average, about 120 different antibodies in a library can bind to a given antigen. Additionally, Coleman et al. (Research in Immunology, 1994; 145(1): 33-36) teach single amino acid changes in an antigen can effectively abolish antibody antigen binding.
Recently, the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) decided Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017), which concerned adequate written description for claims drawn to antibodies.
In view of the Amgen decision, adequate written description of a newly characterized antigen alone should not be considered adequate written description of a claimed antibody to that newly characterized antigen, even when preparation of such an antibody is routine and conventional.
In this case, the specification lacks complete deposit information for the deposit of hybridoma cell lines and antibodies comprised in accordance with 37 CFR1.801-1.809.
While the specification provides enough information for one ordinary skill in the art to produce hybridoma cell lines and antibodies with the same or similar properties of and antibodies produced by the same (OV119) reproduction of identical cell lines and antibodies is an extremely unpredictable event. Because it does not appear that the antibodies and their corresponding hybridoma cell lines, are known and publicly available or can be reproducibly isolated from nature without undue experimentation, a suitable deposit of the hybridoma cell lines and antibodies for patent purposes is required.
If the deposits have not been made under the provisions of the Budapest Treaty, then in order to certify that the deposits comply with the criteria set forth in 37 CFR § § 1.801-1.809, assurances regarding availability and permanency of deposits are required.
Such assurance may be in the form of an affidavit or declaration by applicants, assignees or a statement by an attorney of record over his or her signature and registration number stating that the deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty, that all restrictions upon public access to the deposit will be irrevocably removed upon the grantof a patent on this application and that the deposit will be replaced if viable samples cannot be dispensed by the depository is required. This requirement is necessary when a deposit is made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State
Amendment of the specification to recite the current practice requiring that a statement concerning all restrictions upon public access to the deposit will be irrevocably removed upon the grant of a patent on this Application and that the deposit will be replaced if viable samples cannot be dispensed by the depository made in the instant Application.
Without such a statement, it would be impossible for the skilled artisan to practice the invention of claims 36, 38, 66, 112, and 115 because the specific deposits cannot be placed into the hands of the artisan because other clones made from the source material have no predictable reasonable expectation of success of being identical to the single clone deposited.
Furthermore, unless the deposit was made at or before the time of filing, a declaration filed under 37 C.F.R. 1.132 is necessary to construct a chain of custody.
The declaration, executed by a person in a position to know should identify the deposited hybridomas and monoclonal antibodies by its depository accession number, establishes that the deposited hybridomas and antibodies are the same as that described in the specification, and establish that the deposited hybridomas and antibodies were in applicants’ possession at the time of filing.
Applicant's attention is directed to In re Lundak, 773 F.2d. 1216, 27 USPQ 90 (CAFC1985) and 37 CRF §§ 1.801-1.809 for further information concerning deposit practice.
Vas-Cath Inc. V. Mahurkar, 19 USPQ2d 1111, clearly 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 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). Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 USC 112 is severable from its enablement provision (see page 115).
Without a deposit and removal of public restrictions, the skilled artisan cannot envision the detailed structure of the claimed antibody compositions, thus conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of production and or isolation.
An adequate description requires more than a mere statement that it is part of the invention and a reference to a potential method of isolating it.
The court indicated that while Applicants are not required to disclose every species encompassed by a genus, the description of a genus is achieved by the recitation of a representative number of molecules falling within the scope of the claimed genus.
Therefore the full breadth of the claims, reading on the claimed antibody, antigen binding portion thereof, antibody-drug conjugate, or antigen-binding fragment thereof comprising a heavy chain variable region (CDRs) comprising amino acid sequences: HCDR1 - SEQ ID NO: 11, HCDR2 - SEQ ID NO: 12, HCDR3 – SEQ ID NO:13 and a light chain variable region (CDRs) comprising the amino acid sequences: LCDR1 - SEQ ID NO: 16, LCDR2 - SEQ ID NO: 7, LCDR3 – SEQ ID NO:18 having utility in binding SAS1B+ cancer cells do not meet the written description provision of 35 USC 112, first paragraph.
16. Claims 36, 38, 66, 112, and 115 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.
Enablement requires that the specification teach those in the art to make and use the invention without undue experimentation. Factors to be considered in determining, whether a disclosure would require undue experimentation include 1) the nature of the invention, 2) the state of the prior art, 3) the predictability or lack thereof in the art, 4) the amount of direction or guidance present, 5) the presence or absence of working examples, 6) the quantity of experimentation necessary, 7) the relative skill of those in the art, and 8) the breadth of the claims.
In particular, claims 36, 38, 66, 112, and 115 are directed a method that binds SAS1B+ cancer cells via an antibody, antigen binding portion thereof, antibody-drug conjugate, or antigen-binding fragment thereof to thereby inhibit proliferation or kill said SAS1B+ cancer cells.
The antibody, antigen binding portion thereof, antibody-drug conjugate, or antigen-binding fragment thereof comprising a heavy chain variable region (CDRs) comprising the amino acid sequences: HCDR1 - SEQ ID NO: 11, HCDR2 - SEQ ID NO: 12, HCDR3 – SEQ ID NO:13 and a light chain variable region (CDRs) comprising the amino acid sequences: LCDR1 - SEQ ID NO: 16, LCDR2 - SEQ ID NO: 7, LCDR3 – SEQ ID NO:18.
Applicant appears to have made a single antibody designated OV119 (see figure 20). Specification sections 0040-0049, 0362, and 03721. Applicant has made one OV119 antibody construct. But states that a skilled artisan can make other antibodies with the claimed CDRs which retain binding to the antigen.
However, the prior art does not appear to recognize that the framework regions and constant regions were generally known at the time the application was filed.
Additionally, the claimed antibody or antigen binding fragment does not appear to be deposited. Antibody OV119 is the only antibody taught by the disclosure as having the required capture antibody specificity (particular sequence id combination claimed). Please see figure 20. Yet, antibody OV119 is not deposited.
The specification does not state the identity to a deposited antibody, amino acid sequence, or any structural characteristics of antibodies that has the claimed characteristics.
One of skill in the art cannot extrapolate the teachings of the specification to the enablement of the claims because the claims require the antigen binding site to comprise the CDR regions (comprising a heavy chain variable region (CDRs) comprising the amino acid sequences: HCDR1 - SEQ ID NO: 11, HCDR2 - SEQ ID NO: 12, HCDR3 – SEQ ID NO:13 and a light chain variable region (CDRs) comprising the amino acid sequences: LCDR1 - SEQ ID NO: 16, LCDR2 - SEQ ID NO: 7, LCDR3 – SEQ ID NO:18), thus one of skill in the art could not predictably make and use the antibody constructs, without undue experimentation.
Further, the specification demonstrates binding of the OV119 to human SAS1B, in particular the peptide region upstream of the cleavage site of human SAS1B such as amino acid residues 34-53 (GTSFPDGLTPEGTQASGDK) and 64-86 (LEETPESSFLIEGDIIRPSPFRL). Yet, the specification does not teach the OV119 in the inhibition of proliferation or cell killing. See section 0189, for example.
The specification provides insufficient guidance with regard to these issues and provides no working examples which would provide guidance to one skilled in the art and no evidence has been provided which would allow one of skill in the art to predict that the invention will function as claimed with a reasonable expectation of success.
For the above reasons, it appears that undue experimentation would be required to practice the claimed invention.
In view of the lack of evidence, it is apparent that Applicants were not in possession of the claimed OV119 antibody comprising CDRs (SEQ ID Nos: 11, 12, 13, 16, 7, and 18) that will bind SBS1B+ cancer cells and inhibit proliferation or kill said cells, at the time of filing the instant application. It is not clear that Applicant has identified a single antibody protein configuration that meets the claimed limitation.
The skilled artisan cannot envision the detailed structure of the infinite possible antibodies or amino acid sequences, thus conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. An adequate description requires more than a mere statement that it is part of the invention. The antibody structure is required. See Fiers v. Revel, 25 USPQ 2d 1601 at 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Lts., 18 USPQ2d 1016.
A skilled artisan cannot envision all the contemplated recognition sequence sites by the detailed chemical structure of the claimed antibody, therefore conception cannot be achieved until reduction to practice has occurred. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention.
In fact, very different structures may be found on antibodies with the same specificity. For example, very different VH chains can combine with the same VL chain to produce antibody binding sites with nearly the same size, shape, antigen specificity, and affinity. A similar phenomenon can also occur when different VH sequences combine with different VL sequences to produce antibodies with very similar properties.
These observations indicate that divergent variable region sequences, both in and out of complementarily determining regions, can be folded to form similar binding site contours, which result in similar immunochemical characteristics. Conversely, similar structure may be found on antibodies having different specificities.
In the court decision of Noelle v. Lederman, 355 F.3d 1343 (Fed. Cir. 2004), claims which recite a genus of antibodies that bound to a mouse antigen were found to be unpatentable, because the corresponding human antigen had not been adequately characterized. This is the same issue currently at hand. The art indicates that it would require undue experimentation to formulate and use a successful antibody binding composition without prior demonstration of utility and/or efficacy.
The nature of the invention- the invention is directed to a method that binds SAS1B+ cancer cells via an antibody, antigen binding portion thereof, antibody-drug conjugate, or antigen-binding fragment thereof to thereby inhibit proliferation or kill said SAS1B+ cancer cells.
The antibody, antigen binding portion thereof, antibody-drug conjugate, or antigen-binding fragment thereof comprising a heavy chain variable region (CDRs) comprising the amino acid sequences: HCDR1 - SEQ ID NO: 11, HCDR2 - SEQ ID NO: 12, HCDR3 – SEQ ID NO:13 and a light chain variable region (CDRs) comprising the amino acid sequences: LCDR1 - SEQ ID NO: 16, LCDR2 - SEQ ID NO: 7, LCDR3 – SEQ ID NO:18.
The state of the prior art- the prior art of record fails to disclose the particular antibody meeting the claimed limitations.
The predictability or lack thereof in the art- there is no predictability based on the instant specification that the antibody and its structure can be readily identified.
The amount of direction or guidance present- appropriate guidance is not provided by the specification for the OV119 antibodies in the claimed method.
The presence or absence of working examples- working examples are not provided in the specification that identify and/or exemplify the OV119 antibodies in the claimed methods.
The quantity of experimentation necessary- it would require undue amount of experimentation for the skilled artisan to make and use the antibodies as claimed.
The relative skill of those in the art-the level of skill in the art is high.
The breadth of the claims- as recited, the instant claims are directed to a single OV119 antibody comprising SEQ ID Nos: 11, 12, 13, 16, 7, and 18 having the ability to inhibit cell proliferation or kill the cell.
While it is not necessary to show working examples for every possible embodiment, there should be sufficient teachings in the specification that would suggest to the skilled artisan that the breadth of the claimed antibody is enabled. This is not the case in the instant specification.
In view of the teachings of In re Wands, 8 USPQ2d 1400, it has been determined that the level of experimentation required to enable the breadth of the claims is undue.
Patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may not be workable. See Brenner v. Manson, 383 U.S. 519, 536, 148 USPQ 689, 696 (1966). While every aspect of a generic claim does not have to be carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention.
Genetech Inc. v. Novo Nordisk A/S (CAFC) 42 USPQ2d 1001. That requirement has not been met in this specification with respect to an OV119 antibody antibody, antigen binding portion thereof, antibody-drug conjugate, or antigen-binding fragment thereof comprising a heavy chain variable region (CDRs) comprising the amino acid sequences: HCDR1 - SEQ ID NO: 11, HCDR2 - SEQ ID NO: 12, HCDR3 – SEQ ID NO:13 and a light chain variable region (CDRs) comprising the amino acid sequences: LCDR1 - SEQ ID NO: 16, LCDR2 - SEQ ID NO: 7, LCDR3 – SEQ ID NO:18.
Therefore, in view of the insufficient guidance in the specification, extensive experimentation would be required to enable the claims and to practice the invention as claimed.
17. Conclusion: No claim is allowed.
18. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lisa Cook whose telephone number is 571-272-0816. The examiner works a flexible Part-Time schedule but can normally be reached on Monday, Thursday, and Friday from 9am to 5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu, can be reached at telephone number 571-270-3505. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only.
For more information about the PAIR system, see http://portal.uspto.gov/external/portal. Should you have questions about access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
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.
Lisa V. Cook
Patent Examiner
Art Unit 1641
Remsen
571-272-0816
7/25/26
/LISA V COOK/Primary Examiner, Art Unit 1641
Prosecution Insights