DETAILED ACTION
. Acknowledgment and entry of the Amendment submitted on 6/10/26 is made.
Claims 1, 3-5, 7-13 and 15-20 are currently pending.
Applicants previously elected without traverse of Group 1 and the Species: antibody panel comprising BVU_0562 and SP_1992, in the reply filed on 11/10/25.
Claims 1, 4 and 5 encompass the elected Species. Claims 3 and 7 are drawn solely to non-elected species.
Claims 3, 7-13 and 15 -20 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claims 1, 4 and 5 are currently under examination.
Claim Rejections - 35 USC § 112-2nd paragraph
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 4 and 5 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.
Claims 1, 4 and 5 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
The species (different antibodies) are independent or distinct because they have different profile panels which recognize different antigens. The antibodies do not have a common structure or functionality. In addition, these species are not obvious variants of each other based on the current record. Different combinations are different inventions, recognizing different immunogenic profiles.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim 1, 4 and 5 are vague and indefinite because it the mere recitation of a name, i.e., BVU_652 or SP_1992, to describe the invention is not sufficient to satisfy the Statute's requirement of adequately describing and setting forth the inventive concept. The claim should provide any structural properties, such as the amino acid sequence of the antibody or the sequence which encodes it, which would allow for one to identify the antigens without ambiguity. The mere recitation of a name does not adequately define the claimed antigens or antibodies in the panel. Additionally, BVU_0562 does not appear to be a well-known antigen in the prior art. It was not identified in the prior art and Applicants identify it as “an “uncharacterized protein” from Bacteroidetes vulgatus. The structure is not provided and no other identifying properties are recited in the specification. Appropriate clarification and/or correction is required.
Response to Applicant’s arguments:
Applicants argue:
With respect to the question of whether the antigen names recited in claims 1, 2, 4 and 5 are sufficiently descriptive, Applicant respectfully submits that these names do provide a person of ordinary skill in the art the structure properties of the amino acid sequence of these antigens. The antigens specified in claim 1 have entries with the Kyoto Encyclopedia of Genes and Genomes (KEGG) that provide nucleic acid and amino acid sequence information. Exhibits E and F contain the KEGG entries for BVU_0652 and SP_1992 respectively. Though Exhibit E shows that BVU_0652 is from Phocaeicola vulgatus, this the new name for B. vulgatus (see Exhibit G). Accordingly, the names of antigens used in claims 1, 2, 4, and 5, clearly identifies the antigens to a person having ordinary skill in art.
These arguments have been fully and carefully considered but are not deemed persuasive. It is unclear what Exhibits Applicant is referring to as they are not part of the response and cannot be found in the original specification. These are not designations generally known to one skilled in the art and the nucleic acid and amino acid sequence information is neither in the original specification, the drawings or the claims. There are no sequences/sequence listing filed in the instant application. The claim should provide any structural properties, such as the amino acid sequence of the antibody or the sequence which encodes it, which would allow for one to identify the antigens without ambiguity. The mere recitation of a name does not adequately define the claimed antigens or antibodies in the panel. Accordingly, one viewing the application and claims would have no description of these antigens. While the specification can be used to provide definitive support, the claims are not read in a vacuum. Rather, the claim must be definite and complete in and of itself. Limitations from the specification will not be read into the claims. The claims as they stand are incomplete and fail to provide adequate structural properties to enable one to identify what is being claimed.
Applicants further argue:
As to the allegation that claim 1 comprises an improper Markush grouping of alternatives because the species are distinct, Applicant respectfully submit that amended claim 1, which lists different groups of antigens that can form the antibody panel for diagnosing a subject with inflammatory bowel disease do form a proper Markush grouping. As stated in MPEP 2117.II.B, "[w]here a Markush grouping describes alternatives [that] do not belong to a recognized class..., the members of the Markush grouping may still be considered to be proper where the alternatives share a substantial structural feature that is essential to a common use." Here, the recited antigens are unified by a common use, namely their use in combination as targets for antibody-based diagnosis of inflammatory bowel disease. Each antigen is selected based on their binding to antibodies that form an antibody signature of IBD. As claimed, the antigens are not interchangeable arbitrarily but are functionally related members of a defined diagnostic class, namely, to detect an anti-microbial antibody signatures of IBD. The claims are not directed to the antigens in isolation, but to a combination of antigens used in conjunction for diagnosing IBD. The inventive concept lies in the selection and combination of these antigens to improve detect the presence of an anti-microbial antibody signature indicative of IBD. Each member of the Markush group contributes to the same diagnostic purpose and operates according to the same technical principle. This shared diagnostic function provides the requisite unity for proper Markush grouping.
These arguments have been fully and carefully considered but are not deemed persuasive. The members in a Markush Group must contain both a single structural similarity and a common use. Antibody panels that comprise different antigens will have different diagnostic results. They will bind to different antibody profiles. The antigens themselves will be made up of different amino acid sequences. Hence, they are different products.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 4 and 5 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter because the claims are drawn to antigens which exist in nature. The claimed antigens are not markedly different from what naturally exists in nature. Even though isolation structurally changes a polypeptide or antibody from its natural state, the resultant difference is no enough to render the isolated product markedly different because the genetic structure and amino acid sequence has not been altered. The recitation of “an antibody panel for diagnosing a subject with inflammatory bowel disease” is an intended use only. The claim only requires SP_1992 or BVU_0562 as the product and the antigen(s) are the only components claimed. There is no other structure recited in the body of the claim. According to the instant specification these are naturally occurring products. It is noted that claims 1 and 2 only require “at least one” antigen. For claim 4, there is no indication that these components would cause any changes to the structure of either component. The two antigens would be expected to have the same functional properties. See Myriad, 133 S.Ct. at 2166-18.
Response to Applicant’s arguments:
Applicants argue that the antigens are assembled into a defined panel for diagnostic use and that although the individual antigens may be derived from microbial source, nature does not provide a panel comprising these antigens in combination.
These arguments have been fully and carefully considered but are not deemed persuasive. . The recitation of “an antibody panel for diagnosing a subject with inflammatory bowel disease” is an intended use only. The claim only requires SP_1992 or BVU_0562 as the product and the antigen(s) are the only components claimed. There is no other structure, e.g., solid support, etc., recited in the body of the claim. The species (different antibodies) are independent or distinct because they have different profile panels which recognize different antigens. The antigens on the panel do not have a common structure and functionality. In addition, these species are not obvious variants of each other based on the current record. Different combinations are different inventions, recognizing different immunogenic profiles.
Claim Rejections - 35 USC § 112-Written Description
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 and 5 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.
Instant claim 1, with the elected species, recites:
(Original) An antibody panel for diagnosing a subject with inflammatory bowel disease, the antibody panel comprising at least one antigen selected from the group consisting of: HP 0115, CK LafA, CK LafA.1, VC flaD, VC flaB, VC flaE, and VC flaA; BVU 0562, SP 1992, PMI RS06815, and SF Lpp; HP 0115, BVU 0562, CK LafA, CK LafA. 1, A4-Fla2, PMI RS06815, VC_flaD, VC flaB, VC flaE, VC flaA, SF Lpp, SP 1992, and BILF2; and CK flgG, A4-Fla2, BVRF2, and UL139
with
BVU_0562 and SP_1992 as the Elected species.
The specification fails to provide adequate written description for the claims which describe the antibodies/antigens by name alone. Additionally, BVU_0562 does not appear to be a well-known antigen in the prior art. It was not identified in the prior art and Applicants recite it as “an “uncharacterized protein” from Bacteroidetes vulgatus. The structure is not provided and no other identifying properties are recited.
The instant clams define the antibody panel by name alone, yet BVU_0562 is not a well-known protein in the prior art and the structure is not provided. The antigen is “uncharacterized” with no sequence or identifying characteristics provided in the instant specification. Accordingly, the claim lacks written description. There is also no description of structure for an antibody binding SP_1992. Shome et al World Journal of Gastroenterology. August 14, 2022 (after effective filing date; Applicants’ work; 28(30): 4089-4101) describes BVU_0562 as an “uncharacterized protein” from B. vulgatus. SP_1992 is described as a “cell wall surface anchor: from S.pneumoniae. See Table 2 on page 4095.
As with other subject matter, in order to meet the written description requirement, a patent application claiming antibodies must disclose the invention in such detail that a person of ordinary skill in the art would understand that the inventors had possession of the claimed invention at the time of filing the patent application. See Ariad Pharms., Inc. v. Eli Lilly and Co., 598 F.3d 1336 (Fed. Cir. 2010). One approach to show possession of an antibody genus involves drafting patents that disclose either a representative number of species or common structural features of antibodies. See Id. at 1350 (stating “functional claim language can meet the written description requirement when the art has established a correlation between structure and function.” emphasis added). No structure has been provided in the instant specification for the antibody or for the antigen to which it binds.
To fulfill the written description requirements set forth under 35 USC § 112, first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession the claimed invention. Applicants have not described the antigens/antibodies such that the specification might reasonably convey to the skilled artisan that Applicants had possession of the claimed invention at the time the application was filed.
To fulfill the written description requirements set forth under 35 USC § 112, first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession the claimed invention. Applicants have not described the genus of claimed antigens in the antibody panel such that the specification might reasonably convey to the skilled artisan that Applicants had possession of the claimed invention at the time the application was filed.
The purpose of the "written description" requirement is broader than tomerely explain how to "make and use"; the applicant must convey with reasonableclarity to those skilled in the art that, as of the filing date sought, he or she was inpossession of the invention. The invention is, for purposes of the "writtendescription" inquiry, whatever is now claimed. See Vas-Cath, Inc. v. Mahurkar,935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991).Furthermore, the written description provision of 35 USC § 112 is severable fromits enablement provision; and adequate written description requires more than amere statement that it is part of the invention and reference to a potential methodfor isolating it. The nucleic acid [product] itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was 'ready for patenting' such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention" (Id. at 1104). Moreover, because the claims encompass a genus of variant species, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). To satisfy the written description requirement, an 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, and that the invention, in that context, is whatever is now claimed. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991) and MPEP 2163.02.
However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was "ready for patenting" by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus'" (Id. at 1106); accordingly, it follows that an adequate written description of a genus cannot be achieved in the absence of a disclosure of at least one species within the genus. The scope of the claim includes numerous structural variants, and the genus is highly variant because a significant number of structural differences between genus members is permitted.
One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus, and thus, that the applicant was not in possession of the claimed genus. The claimed subject matter is not supported by an adequate written description because a representative number of species has not been described.
The scope of the claim is highly variant because a significant number of structural differences between genus members is permitted. The specification does not describe any members of the claimed genus by complete structure. One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus, and thus, that the applicant was not in possession of the claimed genus. The claimed subject matter is not supported by an adequate written description because a representative number of species has not been described.
There are no drawings or structural formulas or sequence disclosure for any of these antigens. The level of skill and knowledge in the art is such that one of ordinary skill would not be able to identify without further testing which of those peptides would have the required functional activities. Based on the lack of knowledge and predictability in the art, those of ordinary skill in the art would not conclude that the applicant was in possession of the claimed genus of antigens.
While the specification recites that novel antibodies were generated against the antigens of Bacteroidetes vulgatus (BVU_0562) and Streptococcus pneumoniae (SP_1992) showing higher prevalence in CD patients relative to healthy controls, the specification fails to recite any structure or identifying properties of these “novel antibodies.” Biomarker panels were built with the antibodies, yet the antibodies and antigens are undefined and identified by name alone.
Applicant is referred to the revised guidelines concerning compliance with the written description requirement of U.S.C. 112, first paragraph, published in the Official Gazette and also available at www.uspto.gov.
Response to Applicants’ arguments:
Applicant respectfully submits that the specification fully satisfies the written description requirement with respect to the antibody panel claims of the present application. As explained above in response to the indefiniteness rejection, the antigen names recited in the claims correspond to known amino acid sequences and nucleic acid sequences that are publicly available and readily identifiable by a person of ordinary skill in the art. Identification of antigens by their accepted names is therefore sufficient to convey possession of the claimed subject matter. Moreover, the Examples of the present application demonstrate that the specified antigens help identify the presence of anti-microbial antibody signatures associated with IBD, thereby evidencing Applicant's possession of the claimed invention.
These arguments have been fully and carefully considered but are not deemed persuasive. These antigens were not well known in the art. The specification provides no structure for these antigens. There is no sequence listing, so there is no structure or written support for these amino acid sequences and/or nucleic acid sequences. In order to meet the written description requirement, a patent application claiming antibodies/antigens must disclose the invention in such detail that a person of ordinary skill in the art would understand that the inventors had possession of the claimed invention at the time of filing the patent application. See Ariad Pharms., Inc. v. Eli Lilly and Co., 598 F.3d 1336 (Fed. Cir. 2010). One approach to show possession of an antibody genus involves drafting patents that disclose either a representative number of species or common structural features of antibodies. See Id. at 1350 (stating “functional claim language can meet the written description requirement when the art has established a correlation between structure and function.” emphasis added). No structure has been provided in the instant specification for the antibody or for the antigen to which it binds. For example, as stated in the rejection above, BVU_0562 is not a well-known protein in the prior art and the structure is not provided. The antigen is “uncharacterized” with no sequence or identifying characteristics provided in the instant specification. Accordingly, the claim lacks written description. There is also no description of structure for an antibody binding SP_1992. Shome et al World Journal of Gastroenterology. August 14, 2022 (after effective filing date; Applicants’ work; 28(30): 4089-4101) describes BVU_0562 as an “uncharacterized protein” from B. vulgatus. SP_1992 is described as a “cell wall surface anchor: from S.pneumoniae. See Table 2 on page 4095.
Rejection withdrawn
The rejection of Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Meinke et al (US 2006/0263846 A1; published 11/23/2006) is withdrawn pursuant to the amendment to the claims.
Meinke et al teach SP1992 cell wall surface 6-12 antigen. See paragraph 0401. SP1992 cell wall surface anchor family 50 4/197 80 is also disclosed at paragraph 0403. Meinke describes hyperimmune serum reactive antigens or fragments thereof from S. pneumoniae, numerous different antigens and antibodies. Meinke does not teach the groups set forth in the amended claim. Note: applicants recite:
As amended, claim 1 recite an antibody comprising a specific group of antigens, which is limited to just SP_1992. Amended claim 1 is not limited to SP_1992.
Prior art, not presently relied upon:
Covacci, A (US 20070184443 A1; published 8/9/2007).
[0167] TABLE-US-00003 TABLE 3 Genes for which knockout does not affect in vitro growth characteristics of SP_1992.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence regarding this application should be directed to Group Art Unit 1645. Papers related to this application may be submitted to Group 1600 by facsimile transmission. Papers should be faxed to Group 1600 via the PTO Fax Center located in Remsen. The faxing of such papers must conform with the notice published in the Official Gazette, 1096 OG 30 (November 15,1989). The Group 1645 Fax number is 571-273-8300 which is able to receive transmissions 24 hours/day, 7 days/week.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer E. Graser whose telephone number is (571) 272-0858. The examiner can normally be reached on Monday-Friday from 8:00 AM-4 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Thomas Visone, can be reached on (571) 270-0684.
Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-0500.
/JENNIFER E GRASER/Primary Examiner, Art Unit 1645 8/24/26
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