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
Election/Restrictions
Applicant’s election of species with traverse in the reply filed on 06/19/2026 is acknowledged. Applicant provisionally elects with traverse E6 for the species 1 with corresponding CDR1, CDR2, and CDR3 set forth is SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, respectively (Claims 1-4 and 8-10 read on the elected species). Additionally, applicants provisionally elect cervical cancer for Species 2 with traverse (claim 11 reads on the elected species).
Applicant contends: As discussed in the 37 C.F.R. § 1.141(a), an application may claim a reasonable number of species within a claimed genus as long as at least one genus claim encompassing all of the species is patentable. The Examiner has separately indicated that a specific HPV protein and cancer must be elected. Applicants assert that the election is an appropriate application of the 37 C.F.R. § 1.141, which is aimed at situations where there are unreasonable numbers of species claimed. Applicants respectfully assert that the present genus of two (2) HPV proteins (E6 or E7) and five (5) cancers represents a finite number of species and thus Applicants should not be required in the present application to elect a species when applicants have not claimed an unreasonable number of species.
Office Response: Applicant's election with traverse of species in the reply filed on 06/19/2026 is acknowledged. The traversal is on the ground(s) that the present genus of two (2) HPV proteins (E6 or E7) and five (5) cancers represents a finite number of species and thus Applicants should not be required in the present application to elect a species when applicants have not claimed an unreasonable number of species.
This is not found persuasive because according to the 371 National Stage filing, the standard for restriction in the instant case is a lack of unity one rather than any kind of search burden one. As indicated on page 4 of the Restriction Action issued 2/19/2026, the species are not so linked as to form a single general inventive concept under PCT Rule 13.1 for the reasons as indicated therein.
The requirement is still deemed proper and is therefore made FINAL.
Claims 5-7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/19/2026.
Claims 1-4, 8-11 are under consideration.
Priority
This application is a 371 National Stage entry from PCT/US2022/025906 (04/22/2022). PCT PCT/US2022/025906 claims benefit of provisional application 63/178,188 (04/21/2021).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/23/2023 and 10/24/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on page 29. 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.
The use of the term which is a trade name or a mark used in commerce, has been noted in this application on pages 21-23, 37, and 45-49. An example is ProteinChip® array (p. 37).
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.
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 Objections
Claims 1, 3, 4, 9 are objected to because of the following informalities:
Claim 1 and 9: For improved consistency with terms in the art, change “human papilloma virus (HPV)” to “human papillomavirus (HPV)”.
Claims 1, 3, 4: For improved consistency with terms in the art, add a hyphen between “complementarity” and “determining regions”. For example, “complementarity-determining regions”.
Claim 4: Use all commas or semicolons when separating out the CDR set SEQ ID NOs:. As written, there is a semicolon after “1-3;”, a period after “7-9.”, and commas after “10-12,” etc.
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.
Claims 1-4, 9-11 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.
See claims 1-4, 9-11 as submitted 10/23/2023.
The claims have been described above. Each of the claims is drawn to a binding molecule comprising a variable domain comprising 3 complementarity-determining regions (CDR1, CDR2, CDR3) as set forth in SEQ ID NO: 7-8, respectively. Thus, the claims are drawn to compositions comprising a genus of binding molecules. The Specification (p. 9) provides the following examples, in name alone, not experimentally, for the broad term, “binding molecules”: a chimeric antigen receptor (CAR) T cell, CAR NK cell, CAR Macrophage (CARMA), immunotoxin, bispecific antibody, diabody, triabody, Bispecific T cell engager (BiTE), antibody (including, but not limited to polyclonal or monoclonal antibodies), or antibody fragments (including, but not limited to scFV, Fab'2 or a nanobody) comprising a variable domain.
The following quotation from section 2163 of the Manual of Patent Examination
Procedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirement for a generic claim covering several distinct inventions:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice..., reduction to drawings..., or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus... See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. 'A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed.
In the present case, the specification provides examples of a nanobody clone in its Figures 1-7 and the nanobodies ability to bind to E6 (Figure 3) and interacting with E6 intracellularly (Figure 4). Nanobodies only require 3 CDRs as evidenced by Bathula in Figure 1 B. who teaches “the nanobody (VHH) is the antigen binding region of a heavy-chain (camelid) antibody with three CDRs” (p. 110). However, the application does not expand on any of the other binding molecule examples, e.g., a chimeric antigen receptor (CAR) T cell, CAR NK cell, CAR Macrophage (CARMA), immunotoxin, bispecific antibody, diabody, triabody, Bispecific T cell engager (BiTE), antibody (including, but not limited to polyclonal or monoclonal antibodies), or antibody fragments (including, but not limited to scFV, Fab'2). In the case of antibodies, for example, six CDRs are required for full binding complementarity as also evidenced by Bathula in Figure 1 A. (p. 110).
The state of the prior art is such that it is well established in the art that the formation of an intact antigen-binding site of antibodies generally requires the association of the complete heavy and light chain variable regions of a given antibody, each of which consists of three CDRs or hypervariable regions, which provide the majority of the contact residues for the binding of the antibody to its target epitope (Paul et al.)(Paul)(See PTO-892 Notice of References Cited). The amino acid sequences and conformations of each of the heavy and light chain CDRs are critical in maintaining the antigen binding specificity and affinity, which is characteristic of the immunoglobulin. It is expected that all of the heavy and light chain CDRs in their proper order and in the context of framework sequences which maintain their required conformation, are required in order to produce a protein having antigen-binding function and that proper association of heavy and light chain variable regions is required in order to form functional antigen binding sites (Paul, p. 293).
Additionally, Bendig et al. (Bendig)(See PTO-892 Notice of References Cited) reviews that the general strategy for “humanizing” antibodies involves the substitution of all six CDRs from a rodent antibody that binds an antigen of interest, and that all six CDRs are involved in antigen binding (see entire document, but especially Figures 1-3). It is noted that Bendig used Kabat CDRs in their humanization process (Pg. 86, Column 2, Paragraph, second). Similarly, the skilled artisan recognized a “chimeric” antibody to be an antibody in which both the heavy chain variable region (which comprises the three heavy chain CDRs) and the light chain variable region (which comprises the three light chain CDRs) of a rodent antibody are recombined with constant region sequences from a human antibody of a desired isotype (see entire document, but especially Figures 1-3).
Thus, the state of the art recognized that it would be highly unpredictable that a specific antibody comprising less than all six parental CDRs would have antigen binding function. The minimal structure which the skilled artisan would consider predictive of the function of binding the antigen of a murine or humanized antibody includes six CDRs (three from the heavy chain variable region and three from the light chain variable region) in the context of framework sequences which maintain their correct spatial orientation and have the requisite binding function. One of skill in the art would neither expect nor predict the appropriate functioning of the antibody fragments and mutated antibodies of the instant claims as broadly as claimed. In the instant claims only 3 CDRs are provided and no distinction is made as to whether they are light or heavy chain. Further, the instant claims broadly read on a or “any” “binding molecule”.
In the case of antibodies, it is especially important to disclose which residues are permissive to mutation. Even minor changes in the amino acid sequences of the heavy and light variable regions, particularly in the CDRs, may dramatically affect antigen-binding function as evidenced by Rudikoff et al. (Rudikoff)(See PTO-892 Notice of References Cited). Rudikoff teach that the alteration of a single amino acid in the CDR of a phosphocholine-binding myeloma protein resulted in the loss of antigen-binding function.
In view of the fact that the examples provided do not demonstrate possession of a sufficient amount of “binding molecule comprising a variable domain”, and that the application has not identified a sufficient amount “binding molecules comprising a variable domain”, only named examples without detailed description, there is insufficient written description support for the indicated genus of “binding molecule comprising a variable domain”.
Thus, the application does not identify species clearly within the claimed genus.
For the reasons above, the application has not provided sufficient written description support for “binding molecule comprising a variable domain”, other than the aforementioned “nanobodies”.
Claim 9 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the Specification, while being enabling for the administration of the HPV binding molecule, it does not reasonably provide enablement for the therapeutically effective treatment of a human papillomavirus (HPV) infection in a human subject. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
See claim 9 as submitted 10/23/2023.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
Here, the instant claim 9 recites a method of treating a human papillomavirus (HPV) infection in a subject comprising administering to the subject a therapeutically effective amount of the HPV binding molecule of claim 1.
The level of skill in the art is high and would include, e.g., Ph.D. level scientists, immunologists, oncologists, and physicians.
State of the art and the unpredictability of the art:
With respect to experimental mice, Li et al (Li) (2010) demonstrated that HPV16 full-length E6 and E7 protein vaccination can induce protective immunity in mice against TC-1 tumor growth (p. 1323, Abstract). The mice used in this study included female C57BL/6 mice aged 6-8 weeks and TC-1 mouse models (p. 1323).
With respect to humans, Meites et al. (Meites)(See PTO-892 Notice of References Cited), as part of the 2019 Advisory Committee on Immunization Practices, reported that “Three prophylactic HPV vaccines are licensed for use in the United States: 9-valent (9vHPV, Gardasil 9, Merck), quadrivalent (4vHPV, Gardasil, Merck), and bivalent (2vHPV, Cervarix, GlaxoSmithKline)...As of late 2016, only 9vHPV is distributed in the United States. The majority of HPV-associated cancers are caused by oncogenic HPV 16 or 18, types targeted by all three vaccines. In addition, 4vHPV and 9vHPV target HPV 6 and 11, types that cause anogenital warts. 9vHPV also protects against five additional high-risk types: HPV 31, 33, 45, 52, and 58”(p. 698). Meites also reminded the public that “HPV vaccines are prophylactic (i.e., they prevent new HPV infections). They do not prevent progression of HPV infection to disease, decrease time to clearance of HPV infection, or treat HPV-related disease.
In their review, Huber et al. (Huber)(See PTO-892 Notice of References Cited) reported that the three aforementioned licensed vaccines are recombinant vaccines consisting of purified virus-like particles of the major capsid (L1) protein of different HPV types (p. 1, Abstract) and that a HPV16/18 L1 VLP vaccine, Cecolin, was also approved in China (p. 3). With respect to L2-based broad-spectrum vaccine candidates, Huber stated that “different scaffolds have been investigated for the improved and more immunogenic presentation of promising HPV16 L2 cross-neutralization epitopes which include presentation by HPV L1-VLP, non-HPV VLP, or the generation of nanoparticles of concatemeric peptides, filterable aggregates, or fusions to immunostimulatory agents” as evidenced in their Table 1. Several candidates combine L2 with E6 or E7 and have either initiated Phase 1 trials (CRTE6E7L2) or completed Phase II (TA-CIN) or completed Phase I-IIb (TA-GW)(p. 7).
The specification does not, however, address the method in potential subjects identified, to include humans.
There are four human vaccines that appear to provide protection against select HPV strains. However, they do not prevent progression of HPV infection to disease, decrease time to clearance of HPV infection, or treat HPV-related disease. Additionally, other vaccine candidates are being explored that include HPV L2, with some in combination with E6 or E7, in humans and these vaccine candidates are in various stages of experimentation.
The amount of direction and the working examples provided:
The disclosure does provide some examples of in vitro experiments with nanobodies, particularly demonstrating that the E6 nanobodies induce late-stage apoptosis (Figure 6) and decrease colony formation (Figure 7). However, it is unclear what is meant by colony formation.
Animal studies and human clinical trials are not featured in the specification nor are efficacy and safety data nor are sufficient descriptions of experimental oversight such as through Institutional Review Boards (IRBs) or data and safety monitoring boards (DSMBs).
Thus, the instant disclosure does not provide guidance or direction to use the claimed method of treating a human papillomavirus (HPV) infection in a subject.
Quantity of experimentation necessary:
As discussed above undue experimentation would be required to practice the claimed invention commensurate with the scope of the claims if one skilled in the art were to use the invention with subjects. Reasonable correlation must exist between the scope of the claims and scope of enablement set forth. In view of the quantity of experimentation necessary, the limited working examples, the unpredictability of the art, the lack of sufficient guidance in specification, it would take undue trials and errors to practice the claimed invention.
Thus, the specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with this claim.
Claims 10 and 11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the Specification, while being enabling for the administration of the HPV binding molecule, it does not reasonably provide enablement for treating a cancer, e.g., cervical cancer, caused by a human papillomavirus (HPV) infection in a subject. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
See claims 10 and 11 as submitted 10/23/2023.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
Here, the instant claim 10 recites a method of treating a cancer caused by an HPV infection comprising administering to the subject a therapeutically effective amount of the HPV binding molecule of claim 1. Instant claim 11, dependent on instant claim 10, recites wherein the cancer comprises cervical cancer. Thus, the claims encompass a method of treating cervical cancer caused by an HPV infection comprising administering to the subject a therapeutically effective amount of the HPV binding molecule of claim 1.
The level of skill in the art is high and would include, e.g., Ph.D. level scientists, immunologists, oncologists, and physicians.
State of the art and the unpredictability of the art:
With respect to experimental mice, Li et al (Li)(2010) demonstrated that HPV16 full-length E6 and E7 protein vaccination can induce protective immunity in mice against TC-1 tumor growth (p. 1323, Abstract). The mice used in this study included female C57BL/6 mice aged 6-8 weeks and TC-1 mouse models (p. 1323).
With respect to humans, Meites et al. (Meites)(See PTO-892 Notice of References Cited), as part of the 2019 Advisory Committee on Immunization Practices, reported that “Three prophylactic HPV vaccines are licensed for use in the United States: 9-valent (9vHPV, Gardasil 9, Merck), quadrivalent (4vHPV, Gardasil, Merck), and bivalent (2vHPV, Cervarix, GlaxoSmithKline)...As of late 2016, only 9vHPV is distributed in the United States. The majority of HPV-associated cancers are caused by oncogenic HPV 16 or 18, types targeted by all three vaccines. In addition, 4vHPV and 9vHPV target HPV 6 and 11, types that cause anogenital warts. 9vHPV also protects against five additional high-risk types: HPV 31, 33, 45, 52, and 58”(p. 698). Meites also reminded the public that “HPV vaccines are prophylactic (i.e., they prevent new HPV infections). They do not prevent progression of HPV infection to disease, decrease time to clearance of HPV infection, or treat HPV-related disease.
In their review, Huber et al. (Huber) (See PTO-892 Notice of References Cited) reported that the three aforementioned licensed vaccines are recombinant vaccines consisting of purified virus-like particles of the major capsid (L1) protein of different HPV types (p. 1, Abstract) and that a HPV16/18 L1 VLP vaccine, Cecolin, was also approved in China (p. 3). With respect to L2-based broad-spectrum vaccine candidates, Huber stated that “different scaffolds have been investigated for the improved and more immunogenic presentation of promising HPV16 L2 cross-neutralization epitopes which include presentation by HPV L1-VLP, non-HPV VLP, or the generation of nanoparticles of concatemeric peptides, filterable aggregates, or fusions to immunostimulatory agents” as evidenced in their Table 1. Several candidates combine L2 with E6 or E7 and have either initiated Phase 1 trials (CRTE6E7L2) or completed Phase II (TA-CIN) or completed Phase I-IIb (TA-GW)(p. 7).
With respect to monoclonal antibodies, Jiang et al. (Jiang) (See PTO-892 Notice of References Cited) teach “Nearly all cases of cervical cancer are initiated by persistent infection with high-risk strains of human papillomavirus (hr-HPV). When hr-HPV integrates into the host genome, the constitutive expression of oncogenic HPV proteins E6 and E7 function to disrupt p53 and retinoblastoma regulation of cell cycle, respectively, to favor malignant transformation. HPV E6 and E7 are oncogenes found in over 99% of cervical cancer, they are also expressed in pre-neoplastic stages making these viral oncoproteins attractive therapeutic targets. Monoclonal antibodies (mAbs) represent a novel potential approach against the actions of hr-HPV E6 and E7 oncoproteins” (p. 1289). Jiang also teaches “Despite significant advances in understanding the mechanism of HPV-infection and the causative role in cervical cancer, …there are no HPV-specific therapies utilized in clinical practice outside of a clinical trial” (p. 1292). Jiang further teaches “Mostly molecular targets in clinical usage have been tested in cervical cancer non-specifically and target drugs evaluated for therapeutic potential without knowledge of driver mutations. In clinical trials, small inhibitory RNA (siRNA) based therapies in clinical trials since 2004 however currently there are no FDA approved usages of this approach in clinical practice” (p 1292-1293). Finally, Jiang teaches “As our results point out, the E6 and E7 targeting antibodies cause complement deposition that appears to be triggered by the antibodies concentrations below the ones used in our work. The overall effect on the tumor reflects the contribution of specific complement deposition and non-specific immunoglobulin effect, probably, via macrophage polarization. Here we show that C1P5 and TVG701Y monoclonal antibody treatment can significantly inhibit the tumor progression. Although combination treatment of C1P5 and TVG701Y was equally effective as independent C1P5 and TVG701Y treatment, combinatorial dosing regimens or intratumoral injections did not enhance therapeutic efficacy” (p. 1293-1294).
In summary, there are four human vaccines that appear to provide protection against select HPV strains. However, they do not prevent progression of HPV infection to disease, decrease time to clearance of HPV infection, or treat HPV-related disease. Additionally, other vaccine candidates are being explored that include HPV L2, with some in combination with E6 or E7, in humans or as in the case of Jiang et al, monoclonal antibodies, and these vaccine candidates are still in various stages of experimentation.
The amount of direction and the working examples provided:
The disclosure does provide some examples of in vitro experiments with nanobodies, particularly demonstrating that the E6 nanobodies induce late-stage apoptosis (Figure 6) and decrease colony formation (Figure 7). However, it is unclear what is meant by colony formation and the significance of this result..
Human clinical trials are not featured in the specification nor are efficacy and safety data nor are sufficient descriptions of experimental oversight such as through Institutional Review Boards (IRBs) or data and safety monitoring boards (DSMBs).
Thus, the instant disclosure does not provide guidance or direction to use the claimed method of treating a cancer caused by an HPV infection in a subject.
Quantity of experimentation necessary:
As discussed above undue experimentation would be required to practice the claimed invention commensurate with the scope of the claims if one skilled in the art were to use the invention with subjects such as humans. Reasonable correlation must exist between the scope of the claims and scope of enablement set forth. In view of the quantity of experimentation necessary, the limited working examples, the unpredictability of the art, the lack of sufficient guidance in specification, it would take undue trials and errors to practice the claimed invention.
Thus, the specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with this claim.
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.
Claim 8 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.
See claim 8 as submitted 10/23/2023.
Claim 8: Claim 8 contains the trademark/trade name “nanobody” as evidenced by Roobrouck et al. (WO2015044386A1)(See PTO-892 Notice of References Cited) who notes “that the terms Nanobody or Nanobodies are registered trademarks of Ablynx N.V. and thus may also be referred to as Nanobody® or Nanobodies®, respectively” (p. 17).
Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe “nanobody” and, accordingly, the identification/description is indefinite.
Conclusion
SEQ ID NOs: 7-9 are free of the prior art of record.
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Claire Cornelius whose telephone number is (571) 272-0860. The examiner can normally be reached M-F, 0930-1700.
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/C.C./Examiner, Art Unit 1672
/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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