DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
2. Applicant’s Appeal Brief submitted June 23, 2025 has been considered. The finality of the rejection of the last Office action mailed January 30, 2025 is withdrawn.
3. Claims 102, 104-107, 116 and 118-120 are pending.
Claims 102, 104-107, 116 and 118-120 are examined on the merits.
Claim Interpretation
4. The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
5. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
6. Claims 102 and 104 recite “…a first means for binding a non-glycosylated from of claudin-18A2 protein,” and in parts (b) and (c) of both claims, it is stated, “…a second means for binding a non-glycosylated from of claudin-18A2 protein,”.
Claim 116 cites “administering a means for binding a non-glycosylated form of clauidin-18A protein”, see line 3.
Arguments addressing this interpretation are set forth in the pending 112 rejections herein.
This language invokes 135 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The specification does not cite the means, but rather cites “…two or more antibodies binding to said two or more different tumor-associated antigens…”; “agents, in particular antibodies”; and “…substances such as polypeptides which bind to tumor-associated antigens”, see page 16, lines 3-15; last sentence on page 17; page 25, 1st paragraph and lines 18-30; page 51, 2nd paragraph; page 52, lines 13-29; page 57, lines 5-10; page 107, first paragraph; and paragraph spanning pages 108 and 109.
These citations make clear the first means cited in section (b) of claims 102 and 104 are regarded as utilizing antibodies for the in vitro binding of a non-glycosylated form of claudin-18A2, particularly mAB1 and mAB2 antibodies that are specific for the A2 variant, see Specification, page 108, lines 32-36; and Figure 44.
However, “…administering to the patient a second means for binding the non-glycosylated form of claudin-18A2 protein …” cited in section (c) of claims 102 and 104, as well as “administering a means for binding a non-glycosylated form of claudin-18A2 protein” cited in claim 116 are remiss of clear interpretation as there is no definition within the Specification for these “means”. There is no disclosure for the second means and there is no demonstration that mAB1 and mAB2 antibodies are implemented for in vivo treatment. The Specification is silent with respect to any structural elements and corresponding structure.
New and Maintained Grounds of Rejection
Claim Rejections - 35 USC § 112
7. 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.
8. The rejection of claims 102, 104-107, 116 and 118-120 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 is maintained.
Applicant asserts “despite the Examiner’s acknowledgement that at least claims 102 and 104 [as well as claim 116] invoke pre-AIA 35 U.S.C. § 112, sixth paragraph, the Examiner appears to apply standard written description analysis”, see page 9, 1st paragraph (para.) with the Brief on Appeal under 37 C.F.R. § 41.37, further referenced as the Brief. Applicant “…submits that the present specification and claims clearly meet the standards under §112, pre-AIA 6th paragraph” and proclaim they have met “the two part test outlined by the Federal Circuit with regard to satisfying the written description requirement for such claims has been met”, see para. bridging pages 9 and 10 of the Brief; and segment E bridging pages 11-13.
Applicant concludes “…a means-for-binding element was adequately described, the Appeals Review Panel (ARP) of the Patent Trial and Appeal Board recently concluded that identification of “two specific antibodies ... is the corresponding structure” for a “means for binding.” Ex parte Chamberlain, Appeal No. 2022-001944 (May 21, 2024) at 28-29. The ARP went on to conclude that “it is not necessary for the Specification to describe equivalents.” Id.”, see page 11, 1st complete para.
“[T]he specification identifies two antibodies — referred to as mAB1 and mAB2 — that are “specific for the A2 variant and do not bind to the A1 variant” and bind to claudin-18A2 on the cell surface. Id. at page 108, lines 32-36.”, see page 13, 2nd paragraph (para.) within the Brief on Appeal under 37 C.F.R § 41.37 submitted June 23, 2025.
Applicant submits that a proper written description analysis for the pending means-plus- function claims lead to a conclusion that the statutory requirements have been met; therefore, the rejections should be reversed.
Applicant’s arguments and points of view have been carefully considered, but fail to persuade.
Applicant is reminded each case is independent, examined and decided
upon on its own individual limitations and merits. Moreover, the cited Patent Trial
and Appeal Board decision is not precedential and the Examiner will continue
to follow the statutes and rules set forth in the Manual of Patent Examining
Procedure. Accordingly, the rejection is maintained based on the analysis set
forth herein.
While Applicant states they have a working example of preparing specific antibodies that bind to claudin-18A2 by immunization with peptides, as well as two antibodies, “…mAB1 and mAB2-that are “specific for the A2 variant and do not bind to the A1 variant” and bind to claudin-18A2 on the cell surface”, none of this can be extrapolated as evidence of possession of the antibodies instrumental to the claimed invention, see page 13 of the Brief. The claims do not cite them, as well as the claims continue to read on a host of binding molecules not adequately defined by both, structure and function. The claims read on a broad class of binding agents not defined by structure, but exclusively by function and binding site(s), residue at noted positions of SEQ ID NO: 16.
There continues to be an absence of written description support for the broad genus of means for binding a non-glycosylated form of claudin-18A, as well as administering means for binding the non-glycosylated form of claudin-18A2 protein. The Specification does not mention administering a means for binding the non-glycosylated form of claudin-18A2 for the in vivo treatment of any condition, particularly gastric or pancreatic cancer. At the most, the Specification notes utilizing “…claudin-18A2-specific antibodies (extracellular domain)” as detection agents, see page 33, line 9- page 34, line 4; page 35; and pages 105, 106. These pages do not limit the breadth of the means to facilitate treatment of a patient with cancer. There is no demonstration of the means to do such characterized by structure and function alone does not suffice.
"Generally, a genus can be sufficiently disclosed by either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize' the members of the genus." Id. (citation omitted). "For genus claims using functional language, ... the written description 'must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus."' Id. (quoting Ariad Pharms., 598 F.3d at 1349).
A "representative number of species" means any such number of species that adequately describes 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. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300 (Fed. Cir. 2014). Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the inventor was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. See generally MPEP § 2163 (9th ed. rev. 07-2022 Feb. 2023).
Applicant’s claimed invention reads on methods of detecting, treating and administering with therapeutic antibodies that are essential to the claimed invention. The claims present the same deficiency as the claims in Amgen. Applicants attempt to describe the means for binding by describing something that is not the invention: viz., the antigens to which the first and second means for binding non-glycosylated residues of SEQ ID NO: 16. Applicants have not pointed to anything else in the disclosure that describes the means for binding as required by the test set forth in Ariad. While the Federal Circuit has recognized that “the written description requirement can in some cases be satisfied by functional description,” it has made clear that “such functional description can be sufficient only if there is also a structure-function relationship known to those of ordinary skill in the art.” In re Wallach, 378 F.3d 1330, 1335 (Fed. Cir. 2004); see also, Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 964 (Fed. Cir. 2002) (holding that the written description requirement would be satisfied “if the functional characteristic of preferential binding . . . were coupled with a disclosed correlation between that function and a structure that is sufficiently known or disclosed”); Amgen Inc. v. Sanofi, 782 F.3d 1367, 1378 (Fed. Cir. 2017) (holding that an “adequate written description must contain enough information about the actual makeup of the claimed products”). Here, Applicants provide a functional description of the means for binding within the claimed methods — i.e., selectively binding the non-glycosylated form of claudin-18A2 protein comprising non-glycosylated residue(s) at stated positions within SEQ ID NO: 16. Applicants do not identify any disclosure of a correlation between the asserted function and the structure of the means for binding that perform the function. The Examiner recognizes the different inventions at issue amongst the herein referenced court decisions and the instant claims under examination, the basic problem remains that the description at issue must allow one of skill in the art to “visualize or recognize” the means for binding or binding agents at issue. Applicants point to nothing in the Specification where the complete or partial structure of the said antibodies or other properties other than its binding targets are disclosed. Absent such a disclosure, the written description requirement is not met. Hence, the rejection is maintained.
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.
Applicants broadly claim methods of detecting a tumor-associated antigen and treating comprising contacting a patient’s biological sample with a first means for binding a non-glycosylated form of claudin-18A2 protein in order to determine a glycosylation pattern of claudin-18A2 protein and a second means for binding the non-glycosylated form of claudin-18A2 protein when the presence of the non-glycosylated form of claudin-18A2 is detected.
The specification describes a claudin-18A2 variant antibody that binds SEQ ID NO: 16, antibodies that specifically bind forms of claudin-18A, which are and are not glycosylated, as well as antibodies that “[do] not bind or [do] not essentially bind to the variant…”, see page 24, last paragraph-page 26, line 6; pages 33-36; and page 108, line 18-page 110, line 8. The specification also cites “…two or more antibodies binding to said two or more different tumor-associated antigens…”; “agents, in particular antibodies”; and “…substances such as polypeptides which bind to tumor-associated antigens”, see page 16, lines 3-15; last sentence on page 17; page 25, 1st paragraph and lines 18-30; page 51, 2nd paragraph; page 52, lines 13-29; and page 57, lines 5-10; page 107, first paragraph; paragraph spanning pages 108 and 109.
The specification also identifies mAB1 and mAB2 that recognize specifically claudin-18A2, see page 39, Fig. 44 caption. Moreover, the specification teaches methods for making A2-specific antibodies, see paragraph bridging pages 24 and 25; and page 105, lines 4-page 107, line 25. These descriptions and methods of making antibodies do not read on possession of the actual means for binding. The ability to make the antibodies essential to the claimed methods does not place the skilled artisan in possession of the relevant identifying characteristics of a genus of molecules commensurate in scope with the claimed invention.
Applicants are not entitled to all therapeutic anti-claudin-18A2 binding agents that may or may not be capable of specifically binding the glycosylated form of claudin-18A2 protein or the claudin-18A2 protein independent of glycosylation. There is a plethora of binding agents, which are not adequately identified in the claims or defined by structure. As the claims read the means for binding or an agent encompasses many different and distinct compounds. Applicants are not permitted to claim all means for binding that are encompassed by the claims, hence not entitled to the wide breadth of the claims at issue.
The written description is not commensurate in scope with the plethora of binding agents, antibodies and means for binding the non-glycosylated form of claudin-18A2. The instant application does not provide sufficient guidance as to the nexus or correlation between the structure and function of the means for binding that bind the different forms of the claudin-18A2 protein comprising glycosylated and non-glycosylated residues.
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 U.S.C. 112 is severable from its enablement provision (see page 115).
The skilled artisan cannot envision the detailed structure of all the anti-claudin-18A2 means for binding to different forms of claudin-18A2 protein, therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation.
Adequate written 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 polypeptide itself 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.
Furthermore, In The Reagents 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 a genus is achieved by the recitation of a representative number of DNA molecules, usually defined by a nucleotide sequence, falling within the scope of the claimed genus. At section B(1), the court states that "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".
There is insufficient written description of the required kind of structure-identifying information about the corresponding makeup of the antibodies essential to the claimed invention to demonstrate possession that fulfill the requirements of a structure-function relationships of written description. Also, see Amgen Inc. v. Sanofi, 124 USPQ2d 1354 (Fed. Cir. 2017).
“When a patent claims a genus using functional language to define a desired result, the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.” See Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005).
In Amgen Inc. v. Sanofi, 124 USPQ2d 1354 (Fed. Cir. 2017), relying upon Ariad Pharms.,Inc. v. Eli Lily & Co., 94 USPQ2d 1161 (Fed Cir. 2010), the following is noted. To show invention, a patentee must convey in its disclosure that is “had possession of the claimed subject matter as of the filing date. Demonstrating possession “requires a precise definition” of the invention. To provide this precise definition” for a claim to a genus, a patentee must disclose “a representative number of species within the scope of the genus of structural features common to the members of the genus so that one of skill in the art can visualize or recognize the member of the genus” (see Amgen at page 1358).
The instant disclosure, including the claims fails to disclose a representative number of species falling with the scope of the genus and/or structural common to the members of the genus so the one of skill in the art can visualize or recognize the member of the genus of binding agents.
Also, it is not enough for the specification to show how to make and use the invention, i.e., to enable it (see Amgen at page 1361).
An adequate written description must contain enough information about the actual makeup of the claimed products – “a precise definition, such as structure, formula, chemic name, physical properties of other properties, of species falling with the genus sufficient to distinguish the gene from other materials”, which may be present in “functional terminology when the art has established a correlation between structure and function” (Amgen page 1361).
A skilled artisan cannot, as one can do with a fully described genus, visualize or recognize the identity of the members of the genus that exhibit this functional property.
At the time the application was filed Applicants does not have possession of the breadth of means for binding. The specification does not evidence the possession of all these said means for binding that are undefined and uncharacterized falling within the potentially large genus to establish possession. There is insufficient to support the generic claims as provided by Memo on the Clarification of Written Description Guidance For Claims Drawn to Antibodies and Status of 2008 Training Materials, 02/22/2018. See https://www.uspto.gov/sites/default/files/documents/amgen_22feb2018.pdf.
The specification does not evidence the possession of all binding molecules falling under the purview of “…means for binding the non-glycosylated form of claudin-18A2 protein…” and in particular, a second means and administering a means to provide therapeutic treatment that are undefined and uncharacterized falling within the potentially large genus to establish possession. The disclosure is inadequate to demonstrate possession of a method of treating any cancerous condition with “a second means” or “administering a means”.
Consequently, Applicant was not in possession of the instant claimed invention. See University of California v. Eli Lilly and Co. 43 U5PQ2d 1398.
The full breadth of the claims do not meet the written description provision of 35 U.S.C. 112, first paragraph.
9. Claims 102, 104-107 and 116-120 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. THIS IS A NEW MATTER REJECTION. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 102 and 104 recite “administering to the patient a second means for binding the non-glycosylated form of claudin-18A2 protein” and claim 116 recites “administering a means for binding the non-glycosylated form of claudin-18A2 protein”. The Specification does not provide any experimental design or disclosure for this second means to be administered as a therapeutic to treat a patient suspected of containing cancerous cells or cancerous tissue. There is no disclosure of any therapeutic antibodies that read on these means capable of treating pancreatic cancer or gastric cancer.
Applicant is requested to delete the new matter or note specifically where in the Specification (i.e. page, paragraph, sentence) there is disclosure for the second means or means that are administered for treatment.
10. Claims 102, 104-107, 116 and 118-120 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, because the claims purports to invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, but fail to recite a combination of elements as required by that statutory provision and thus cannot rely on the specification to provide the structure, material or acts to support the claimed function. As such, the claims recite a function that has no limits and covers every conceivable means for achieving the stated function, while the specification discloses at most only those means known to the inventor. Accordingly, the disclosure is not commensurate with the scope of the claims.
11. Claims 102, 104-107, 116 and 118-120 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.
Applicant’s claims read on treating patients with cancerous cells, cancerous tissues and also pancreatic cancer or gastric cancer comprising administering a means for binding non-glycosylated form of claudin-18A2 protein, wherein the non-glycosylated form of claudin-18A2 protein comprises a non-glycosylated reside at position 37, 38, 45, 116, 141, 146 or 205 of SEQ ID NO: 16. However, the Specification does not evidence treatment of any cancer cells, cancerous tissue and in particular, pancreatic cancer or gastric cancer with this second means. At the earliest filing date of the instant application, 2005, treatment options for both, pancreatic cancer and gastric cancer were limited and evolving. Lockhart cites bevacizumab, antibodies to epidermal growth factor receptor (EGFR; HER-1) and anti-vascular endothelial growth factor (VEGF) were at the forefront of treatment for pancreatic cancer and chemoradiation for gastric cancer, see Lockhart et al. (Gastroenterology 128: 1642-1654, 2005.)
Applicants’ specification provides no evidence establishing means able to exert any form of treatment to the cancerous cells, cancerous tissue, pancreatic cancers or gastric cancers. The specification teaches “[d]etection of the tumor cells with antibodies may be carried out here on a sample isolated from the patient or as imaging intravenously administered antibodies. In addition to diagnostic usability, splice variants having new or altered epitopes are attractive targets for immunotherapy. The epitopes of the invention may be utilized for targeting therapeutically active monoclonal antibodies or T lymphocytes.”, see paragraph (para.) bridging pages 8 and 9. The specification does speak here and there on the administration of different pharmaceutical compositions, however none of this evidence the treatment as described in claims 102, 104 and 116, see para. bridging pages 14 and 15; page 15, 1st para.; para. bridging pages 18 and 19; para. bridging 59 and 60; para. bridging pages 60 and 61; para. bridging pages 63 and 64; para. bridging pages 64 and 65; page 67, 2nd para.; page 68, last full para.; para. bridging pages 68 and 69; page 70, 1st para.; and page 70, 2nd para.
It appears that undue experimentation would be required of one skilled in the art to practice the instant claimed invention using the teachings of the specification. See Ex parte Forman, 230 USPQ 546 BPAI, 1986. Granted the Office does not require that experiments under the scope of the claims produce positive and astonishing results, the experiments must be within the scope of the Forman factors (see Ex parte Forman, 230 USPQ 546, BPAI, 1986). There would also need to be some valid amount of direction or guidance, as well as presence or absence of working examples presented in the specification that would enable one skilled in the art to perform the method as presented in the recited claims.
In absence of guidance and/or working examples, one skilled in the art would not reasonably conclude that means could be administered to a patient for the effective treatment of the broadly termed “cancerous cells” and “cancerous tissue” and the specification has not taught effective therapeutics directed to cancers of the pancreas or gastrointestinal system.
It is well known in the art of cancer treatment that tumors of differing cell types respond differently to a given therapeutic approach, and that a treatment modality that is effective against of a tumor of one given cell type would not necessarily be expected to be effective against tumors of differing histological origin. Cancers differ in histopathobiologies, as well as etiologic origin. Those of skill in the art do not expect neoplasms of all cell types to respond in a similar fashion to the administration of a given class of molecules. Therefore, one of skill in the art would conclude that a prophylactic regimen would not only be unpredictable. There are no reasons why one of skill in the art would expect the claimed method would be capable of treating different cancer types given the unpredictable nature of treating cancer. The specification fails to provide sufficient guidance to enable one of ordinary skill in the art to use the variant botulinum serotypes in a manner reasonably correlated with the broad scope of the claimed method.
Thus, undue experimentation would be required to implement the instantly claimed method for the broad treatment of cancer with means for binding a non-glycosylated form of claudin-18A2 protein. The scope of the claims must bear a reasonable correlation with the scope of enablement. One skilled in the art would be forced into undue experimentation in order to practice the broadly claimed invention.
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. Claims 102, 104-107, 116 and 118-120 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
a. Claims 102, 104 and 116 have no clear structural definition for “…a first means for binding a non-glycosylated form or claudin-182 protein”, “…a second means for binding the non-glycosylated form of claudin-18A2 protein”, and “administering a means for binding a non-glycosylated form of cauding-18A2 protein”. For the purpose of expedited prosecution, the recitation, “means for” is interpreted to be an antibody or structural variance thereof that is capable of performing the corresponding function. However, the metes and bounds cannot be determined given the indefiniteness of the recitations.
Conclusion
14. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ALANA HARRIS DENT whose telephone number is (571)272-0831. The Examiner works a flexible schedule, however she can generally be reached 8AM-8PM, Monday through Friday and occasionally Saturday evening.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Julie Wu can be reached 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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ALANA HARRIS DENT
Primary Examiner
Art Unit 1643
11 October 2025
/Alana Harris Dent/Primary Examiner, Art Unit 1643