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 with traverse of Group I in the reply filed on 8-17-2026 is acknowledged. The traversal is on the ground(s) that claim 8 is drawn to a vaccine composition comprising the polypeptide of SEQ ID NO:1 and incorporates all the limitations of claim 1. Further the International Search Report and Written Opinion considered them to be in the same group. This is not found persuasive because claim 8 is drawn to multiple combination vaccines whereas claim 1 is limited to a single immunogen. Moreover, the USPTO is not bound by the findings of the EPO. As set forth in the restriction requirement there is no unifying special technical feature unifying the instant claims that makes a contribution over the art.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-4 and 8-12 are pending. Claims 8-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-4 are currently under examination.
Information Disclosure Statement
The Information Disclosure Statement filed on 5-22-25 has been considered. An initialed copy is attached hereto.
It should be noted that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claim 1 objected to for utilizing the acronym “NEAT2” without defining it upon its first recitation.
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 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
Laws of nature or natural phenomena include naturally occurring principles/ relations that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature (MPEP2106.04(b)).
“The law of nature and natural phenomenon exceptions reflect the Supreme Court's view that the basic tools of scientific and technological work are not patentable, because the "manifestations of laws of nature" are "part of the storehouse of knowledge," "free to all men and reserved exclusively to none." Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948). Thus, "a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter" under Section 101. Diamond v. Chakrabarty, 447 U.S. 303, 309, 206 USPQ 193, 197 (1980). "Likewise, Einstein could not patent his celebrated law that E=mc2; nor could Newton have patented the law of gravity." Id. Nor can one patent "a novel and useful mathematical formula," Parker v. Flook, 437 U.S. 584, 585, 198 USPQ 193, 195 (1978); electromagnetism or steam power, O’Reilly v. Morse, 56 U.S. (15 How.) 62, 113-114 (1853); or "[t]he qualities of ... bacteria, ... the heat of the sun, electricity, or the qualities of metals," Funk, 333 U.S. at 130, 76 USPQ at 281; see also Le Roy v. Tatham, 55 U.S. (14 How.) 156, 175 (1853).”
Products of nature are analyzed under 35 USC 101 through the “markedly different characteristics analysis”. MPEP 2106.04(c) as a part of step 2A prong one of the analysis.
“If the claim includes a nature-based product that has markedly different characteristics, then the claim does not recite a product of nature exception and is eligible (Step 2A: NO) at Pathway B unless the claim recites another exception (such as a law of nature or abstract idea, or a different natural phenomenon). For claims where the entire claim is a single nature-based product (e.g., a claim to "NEAT2 polypeptides"), once a markedly different characteristic in that product is shown, no further analysis would be necessary for eligibility because no product of nature exception is recited (i.e., Step 2B is not necessary because the answer to Step 2A is NO). For claims including limitations in addition to the nature-based product, further eligibility analysis is required.
If the claim includes a nature-based product that does not exhibit markedly different characteristics from its naturally occurring counterpart in its natural state, then the claim recites a "product of nature" exception and requires further analysis in Step 2A Prong Two to determine whether the claim as a whole integrates the exception into a practical application.
Claims 1-4 recite the following natural product: An “NEAT2 polypeptide comprising an amino acid sequence of SEQ ID NO:1”.
MPEP2106.04(C) II sets forth:
Appropriate characteristics can be expressed as the nature-based product’s structure, function, and/or other properties, and are evaluated on a case-by-case basis. Non-limiting examples of the types of characteristics considered by the courts when determining whether there is a marked difference include:
• Biological or pharmacological functions or activities;
• Chemical and physical properties;
• Phenotype, including functional and structural characteristics; and
• Structure and form, whether chemical, genetic or physical.
“To show a marked difference, a characteristic must be changed as compared to nature and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75. Thus, in order to be markedly different, applicant must have caused the claimed product to possess at least one characteristic that is different from that of the counterpart.” (MPEP2106.04 (c)II. C).
Comparing the relevant characteristics between the products of claims 1-4 and its naturally occurring counterpart, the examiner finds no markedly difference characteristics between the characteristics of the two.
If there are no markedly different characteristics between the product of the claim and the naturally occurring counterpart, the claim is probed for the presence of additional limitations. The claimed additional elements are analyzed alone or in combination to determine if the natural product is sufficiently different than is integrated into a practical application (MPEP 2106.04(d).I.; MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the natural product, the claim fails to integrate the natural product into a practical application (MPEP 2106.04(d).III).
There are no additional limitations to the natural products in claim 1-4.
The recitation of the phrase “vaccine composition” is not considered an additional limitation as it constitutes an intended use and conveys no structural limitations.
The recitation of the phrase “pharmaceutical carrier” is not considered an additional limitation as it conveys no structural limitations.
Considering the additional limitations in addition to the natural product together as a whole, the additional elements do not rise to the level of significantly more than the natural product.
In combination, the lack of additional limitations, acted upon by the judicial exception (or natural law, or natural product), fail to rise to the level of significantly more. No additional limitation has clearly been identified.
The claims have all been examined to identify the presence of a naturally occurring product or natural phenomena. Each additional limitation in the claims has been addressed, alone and in combination, to determine whether the additional limitations integrate the judicial exception into a practical application. Each additional limitation in the claims has been addressed, alone and in combination, to determine whether those additional limitations provide an inventive concept which provides significantly more than those exceptions. Individually, the limitations of the claims and the claims as a whole have been found lacking.
For these reasons, the claims, when the limitations are considered individually, and as a whole, are rejected under 35 USC § 101 as being directed to non-statutory subject matter.
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 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.
The claimed invention is directed to vaccines against an unnamed pathogen comprising a polypeptide (NEAT2) with an amino acid sequence of SEQ ID NO:1 and variants and fragments thereof.
The claims are drawn to a vast genus of “vaccines” that may contain a sequence of SEQ ID NO:1, but are not limited any particular amino acid sequence. It should be noted that the instant claims merely require that the vaccine contain “an” sequence of SEQ ID NO:1 meaning that they encompass any polypeptide that has 2 contiguous amino acids in common with the sequence of SEQ ID NO:1.
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. To adequately describe the genus of vaccines, Applicant must adequately describe the immunoepitopes within a given “NEAT2” polypeptide that induce a protective immune response against a given pathogen. The specification, however, does not disclose distinguishing and identifying features of a representative number of members of the genus of antibodies to which the claims are drawn, such as a correlation between the structure of the claimed polypeptide and its recited function (inducing a protective immune response against any and all pathogens), so that the skilled artisan could immediately envision, or recognize at least a substantial number of members of the claimed genus of vaccines. Moreover, the specification fails to disclose which amino acid residues in said domain are essential for antibody binding, or which amino acids might be added, replaced or deleted so that the resultant domain peptide retains the binding specificity of its parent, or by which other amino acids the essential amino acids might be replaced so that the resultant peptide retains the binding specificity of its parent. Therefore, the specification fails to adequately describe at least a substantial number of members of the genus of polypeptides to which the claims refer; and accordingly, the specification fails to adequately describe at least a substantial number of members of the claimed genus of vaccines. The term “vaccinate” is defined as the use of a specific antigen to induce protective immunity to infection or disease induction. The specification does not provide substantive evidence that the claimed vaccines are capable of inducing protective immunity. This demonstration is required for the skilled artisan to be able to use the claimed vaccines for their intended purpose of preventing infections. Without this demonstration, the skilled artisan would not be able to reasonably predict the outcome of the administration of the claimed vaccines, i.e. would not be able to accurately predict if protective immunity has been induced. The ability to reasonably predict the capacity of a single bacterial immunogen to induce protective immunity from in vitro antibody reactivity studies is problematic. Ellis (Vaccines, W.B. Saunders Company, Chapter 29, 1988, pages 568-574) exemplifies this problem in the recitation that "the key to the problem (of vaccine development) is the identification of the protein component of a virus or microbial pathogen that itself can elicit the production of protective antibodies"(page 572, second full paragraph). Unfortunately, the art is replete with instances where even well characterized antigens that induce an in vitro neutralizing antibody response fail to elicit in vivo protective immunity. See Boslego et al (Vaccines and Immunotherapy, 1991, Chapter 17), wherein a single gonococcal pillin protein fails to elicit protective immunity even though a high level of serum antibody response is induced (page 212, bottom of column 2). Accordingly, the art indicates that it would require empirical testing to formulate and use a successful vaccine without the prior demonstration of vaccine efficacy.
MPEP § 2163.02 states, “[a]n 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' ”. The courts have decided:
The purpose of the “written description” requirement is broader than to merely explain how to “make and use”; the 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 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 from its enablement provision; and adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
MPEP 2163.02 further states, “[p]ossession 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” See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"). 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. 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.
Additionally, MPEP 2163 states:
"A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004)”
And:
For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." Such correlations may be established "by the inventor as described in the specification," or they may be "known in the art at the time of the filing date." See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014) (Holding that claims to all human antibodies that bind IL-12 with a particular binding affinity rate constant (i.e., koff) were not adequately supported by a specification describing only a single type of human antibody having the claimed features because the disclosed antibody was not representative of other types of antibodies in the claimed genus, as demonstrated by the fact that other disclosed antibodies had different types of heavy and light chains, and shared only a 50% sequence similarity in their variable regions with the disclosed antibodies.).
As evidenced by the teachings of Skolnick et al. the art is unpredictable. Skolnick et al. (Trends in Biotechnology 18: 34-39, 2000) discloses the skilled artisan is well aware that assigning functional activities for any particular protein or protein family based upon sequence homology is inaccurate, in part because of the multifunctional nature of proteins (see, e.g., the abstract; and page 34, Sequence-based approaches to function prediction). Even in situations where there is some confidence of a similar overall structure between two proteins, only experimental research can confirm the artisan's best guess as to the function of the structurally related protein (see, in particular, the abstract and Box 2). Thus, one skilled in the art would not accept the assertion, which is based only upon an observed similarity in amino acid sequence that a variant of a given polypeptide would necessarily have a given immunological property. The instant specification has failed to teach or disclose vaccine compositions comprising the claimed variant of SEQ ID NO:1 against any pathogen. Additionally, there is no disclosure of subjects that have been immunized with the claimed vaccines nor is there a disclosure of challenge studies that have been conducted to establish the claimed vaccines ability to provide protection against any pathogenic infection. Consequently, there is no correlation between structure and function as required by the Written Description requirement.
Therefore, because the art is unpredictable, in accordance with the MPEP and current case law, the description of claimed vaccines is not deemed representative of the genus of NEAT2 polypeptides based on SEQ ID NO:1 to which the claims refer.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Malley et al. (U.S. Patent Application Publication US 2021/0008192 – IDS filed on 5-22-2025).
Malley et al. disclose polypeptides with comprising the amino acid sequence of SEQ ID NO:1 (see SEQ ID NO:12 and the alignment below). Malley et al. further disclose that said sequence correlates to the IsdB protein from Staphylococcus and encompass not only the wild type protein but variants that elicit an immune response to Staphylococcus bacteria IsdB proteins (see paragraph [0193] and [0196] for example) and can be divided into domain fragments (see paragraph [0269]). Finally, Malley et al. disclose that said proteins can be used in vaccine compositions and said compositions can further comprise a pharmaceutically acceptable carrier (see paragraph [0388] for example). Consequently, Malley et al. anticipates all the limitations of the rejected claims.
US-16-498-856-12
Sequence 12, US/16498856
Patent No. 11305001
GENERAL INFORMATION
APPLICANT: CHILDREN'S MEDICAL CENTER CORPORATION
TITLE OF INVENTION: A MULTIPLE ANTIGEN PRESENTING SYSTEM (MAPS)-BASED STAPHYLOCOCCUS
TITLE OF INVENTION: AUREUS VACCINE, IMMUNOGENIC COMPOSITION, AND USES THEREOF
FILE REFERENCE: 701039-088361-PCT
CURRENT APPLICATION NUMBER: US/16/498,856
CURRENT FILING DATE: 2019-09-27
PRIOR APPLICATION NUMBER: PCT/US2018/024810
PRIOR FILING DATE: 2018-03-28
PRIOR APPLICATION NUMBER: 62/477,618
PRIOR FILING DATE: 2017-03-28
NUMBER OF SEQ ID NOS: 58
SEQ ID NO 12
LENGTH: 605
TYPE: PRT
ORGANISM: Staphylococcus aureus
Query Match 100.0%; Score 1920; Length 605;
Best Local Similarity 100.0%;
Matches 377; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 TEEDYKAEKLLAPYKKAKTLERQVYELNKIQDKLPEKLKAEYKKKLEDTKKALDEQVKSA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 229 TEEDYKAEKLLAPYKKAKTLERQVYELNKIQDKLPEKLKAEYKKKLEDTKKALDEQVKSA 288
Qy 61 ITEFQNVQPTNEKMTDLQDTKYVVYESVENNESMMDTFVKHPIKTGMLNGKKYMVMETTN 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 289 ITEFQNVQPTNEKMTDLQDTKYVVYESVENNESMMDTFVKHPIKTGMLNGKKYMVMETTN 348
Qy 121 DDYWKDFMVEGQRVRTISKDAKNNTRTIIFPYVEGKTLYDAIVKVHVKTIDYDGQYHVRI 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 349 DDYWKDFMVEGQRVRTISKDAKNNTRTIIFPYVEGKTLYDAIVKVHVKTIDYDGQYHVRI 408
Qy 181 VDKEAFTKANTDKSNKKEQQDNSAKKEATPATPSKPTPSPVEKESQKQDSQKDDNKQLPS 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 409 VDKEAFTKANTDKSNKKEQQDNSAKKEATPATPSKPTPSPVEKESQKQDSQKDDNKQLPS 468
Qy 241 VEKENDASSESGKDKTPATKPTKGEVESSSTTPTKVVSTTQNVAKPTTASSKTTKDVVQT 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 469 VEKENDASSESGKDKTPATKPTKGEVESSSTTPTKVVSTTQNVAKPTTASSKTTKDVVQT 528
Qy 301 SAGSSEAKDSAPLQKANIKNTNDGHTQSQNNKNTQENKAKSLPQTGEESNKDMTLPLMAL 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 529 SAGSSEAKDSAPLQKANIKNTNDGHTQSQNNKNTQENKAKSLPQTGEESNKDMTLPLMAL 588
Qy 361 LALSSIVAFVLPRKRKN 377
|||||||||||||||||
Db 589 LALSSIVAFVLPRKRKN 605
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT A ZEMAN whose telephone number is (571)272-0866. The examiner can normally be reached Monday thru Friday; 6:30 am - 3pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached at 571-272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT A ZEMAN/Primary Examiner, Art Unit 1645 September 1, 2026
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