DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/14/2026 has been entered.
Claim Status
Currently, claims 2-10 and 13 are pending in the instant application. Claims 1, 11-12, and 14 have been canceled. Claims 7-10 are withdrawn. This action is written in response to applicant' s correspondence submitted 01/14/2026. All the amendments and arguments have been thoroughly reviewed but were found insufficient to place the instantly examined claims in condition for allowance. The following rejections are either newly presented, as necessitated by amendment, or are reiterated from the previous office action. Any rejections not reiterated in this action have been withdrawn as necessitated by applicant' s amendments to the claims. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. This action is FINAL.
Claims 2-6 and 13 are under examination.
Withdrawn Rejections
The rejection of claims 2-6 under 35 USC 101 has been withdrawn due to the amendment to the claims. Specifically the later steps following step (c) of the claim requires that this step is not conditional and step (e) applies a practical application to the recited judicial exceptions of the claim.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
The specification on page 8 lists 5 sequences that do not have sequence identifiers, specification in line 1 and 15-17. The recitation of “comprised in SEQ ID NO 584” and “all comprised in SEQ ID NO 333” is not a sequence identifier for the sequences because the sequence of SEQ ID NO 133 is 174 amino acids and the sequences in lines 15-17 are 20 amino acids long. Additionally the sequence of SEQ ID NO 584 is 21 amino acid long whereas the sequence recited in line 1 of page 28 is 20 amino acid longs.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
New Grounds of Rejection
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.
Claims 2-6 and 13 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.
Claim 2 recites a method of preparing a subject-specific immunogenic composition by identifying an identical string of at least 10 consecutive amino acids to thereby identify a tumor-specific neoantigen in step (c) and preparing a subject-specific immunogenic composition comprising at least one tumor-specific neoantigen identified in step (c), wherein the neoantigen is greater than 30 amino acids in length. It is unclear if the neoantigen in step (c) is the same neoantigen identified in step (c) and if this is the same neoantigen is it unclear how only 10 amino acids are identified in step (c) but the composition comprises a neoantigen that is greater than 30 amino acids in length. It is unclear if the neoantigen in step (e) is the same neoantigen identified in step (c) or if the neoantigen in step (e) is different from the neoantigen identified in step (c) and how the neoantigen that is 30 amino acids in length in different in structure from that identified by the database. It is unclear what is encompassed by the immunogenic composition of the claims and therefore the metes and bounds of the claim are indefinite and one of ordinary skill in the art would not be reasonably apprised of the scope of the claims.
Claim 13 recites a method of preparing a subject-specific immunogenic composition by identifying an identical string of at least 10 consecutive amino acids to thereby identify a tumor-specific neoantigen in step (b) and preparing a subject-specific immunogenic composition comprising at least one tumor-specific neoantigen identified in step (c), wherein the neoantigen is greater than 30 amino acids in length. It is unclear if the neoantigen in step (c) is the same neoantigen identified in step (c) and if this is the same neoantigen is it unclear how only 10 amino acids are identified in step (b) but the composition comprises a neoantigen that is greater than 30 amino acids in length. It is unclear if the neoantigen in step (c) is the same neoantigen identified in step (b) or if the neoantigen in step (c) is different from the neoantigen identified in step (b) and how the neoantigen that is 30 amino acids in length in different in structure from that identified by the database. It is unclear what is encompassed by the immunogenic composition of the claims and therefore the metes and bounds of the claim are indefinite and one of ordinary skill in the art would not be reasonably apprised of the scope of the claims.
Claims 3-6 depend from claim 2 and are indefinite for the reasons applied to claim 2.
Claim Rejections - 35 USC § 112
Claim 2-6 and 13 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. This rejection was previously presented for claim 14 and has been rewritten to address the amendment to the claims.
The claims are drawn to a method of preparing a subject specific immunogenic composition comprising at least one tumor specific neoantigen that is identified by identifying a match between a sequence and a sequence in a database when they have in common a string of at 10 amino acids to thereby identify a tumor specific neoantigen encoded by a tumor specific frameshift mutation in genes of a subject having cancer. The claims require that the neoantigen comprises 30 amino acids of the neoantigen identified the database. Thus the claims require identifying a tumor specific neoantigen and preparing a specific immunogenic compositions comprising the tumor specific neoantigen.
The claims encompass any neoantigen that comprises 10 consecutive amino acids of SEQ ID NO 1-1989 that encodes a tumor specific frameshift mutation and comprises the sequence or a portion of sequence of SEQ ID NO 1-1989. The claims require that the tumor specific neoantigen is immunogenic as the claim recites an immunogenic composition comprising the neoantigen.
The specification shows 5 peptides of SEQ ID NO 333 and one peptide of SEQ ID NO 584. The specification asserts that the vaccine contains these peptides, are personalized based on the patient’s tumor genome. The specification teaches the peptides are shipped for vaccination (sese pg. 28). The instant specification does not provide adequate written description of the claimed genus of immunogenic compositions comprising tumor specific neoantigens. The legal standard for sufficiency of a patent’s written description is whether that description "reasonably conveys to the artisan that the inventor had possession at that time of the claimed subject matter", Vas-Cath, Inc. V. Mahurkar, 19 USPQ2d 1111 (Fed. Cir. 1991). In the instant case, the specification does not convey to the artisan that the Applicant had possession at the time of invention the genus of subject specific immunogenic compositions comprising at least one tumor specific neoantigen.
The specification provides no description of any immunogenic composition comprises a tumor-specific neoantigen that is at least 10 amino acids in identity to SEQ ID NO 1-1989 that comprises at least 30 amino acids in length. The specification does not describe any neoantigen that comprises a frameshift that is an immunogenic composition.
The post filing date art demonstrates the lack of effective immunogenic compositions based on predicted neoantigens. Liu (Signal Transduction and Targeted Therapy, (2024) 9: 175, pp 1-42) teaches certain types of cancer lack effect neoantigens. Liu teaches discovery and validation of neoantigens is time consuming and expression of antigens varies among individuals (see pg. 10). Liu further teaches only a few bioinformatically predicted neoantigens/peptides are recognized by T cells leading to controversy regarding the reliability of the predictions (see neoantigen identification and validation, pg. 18). As Liu demonstrates predicted neoantigens need to be screened and validated to be used for immunogenic compositions. Liu further demonstrates that due to individual variability of antigens and the interferences of the immune microenvironment, the efficacy of cancer vaccines targeting neoantigens exhibits inconsistencies (see pg. 22). Here the specification does not provide any assay to determine which of the predicted neoantigens would be a successful immunogenic composition. The specification does not describe a representative number of immunogenic compositions or describe as assay to predictably determine which of the predicted neoantigens would be a reliable immune compositions.
The guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, § 1 "Written Description" Requirement make clear that if a claimed genus does not show actual reduction to practice for a representative number of species, then the Requirement may be alternatively met by reduction to drawings, or by disclosure of relevant, identifying characteristics, 1.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 genus.
The specification does not provide adequate written description of the claimed invention. The legal standard for sufficiency of a patent's (or a specification's) written description is whether that description "reasonably conveys to the artisan that the inventor had possession at that time of the. . .claimed subject matter", Vas-Cath, Inc. V. Mahurkar, 19 USPQ2d 1111 (Fed. Cir. 1991). In the instant case, the specification does not convey to the artisan that the Applicant had possession at the time of invention of the claimed invention, the genus of subject specific immunogenic compositions comprising at least one tumor specific neoantigen comprising a frameshift mutation in genes by identifying a match with a database consisting SEQ ID NO 1-1989,
The Federal Circuit addressed the application of the written description requirement to DNA-related inventions in University of California v. Eli Lilly and Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997). The court stated that “[a] written description of an invention involving a chemical genus, like a description of a chemical species, requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials.” Id. At 1567, 43 USPQ2d at 1405. The court concluded that “naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material.” Id.
The Federal Circuit clarified that a molecule can be adequately described without disclosing its complete structure. See Enzo Biochem, Inc. V. Gen-Probe Inc., 296 F.3d 1316, 63 USPQ2d 1609 (Fed. Cir. 2002). The Enzo court adopted the standard that the written description requirement can be met by “show[ing] that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics ....i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. “ Id. At 1324, 63 USPQ2d at 1613. Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895. The court in In re Alonso (Fed. Cir. 2008) citing In re Enzo, Enzo, 323 F.3d at 969 stated that For purposes of satisfying the written description requirement, it is not enough merely to disclose a method of making and identifying compounds capable of being used to practice the claimed invention.
It is noted that AbbVie v. Janssen Biotech and Centocor Biologics (Fed. Cir. 2014) confirms a strong Post-Ariad Written Description requirement - especially with regard to genus- species claim situations. In the decision, Judge Lourie focuses particularly on the alleged infringing antibodies and notes that: [While] AbbVie patents need not describe the allegedly infringing [compound] in exact terms . . . [t]he patents must at least describe some species representative of antibodies that are structurally similar to [the accused compound]. Because the patent document lacked any such structural description, the court confirmed that the corresponding claims were invalid under 112(a). In discussing the case, Judge Lourie was clear that one problem here is that the invention was described in terms of its function rather than its structure. Lourie writes: Functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description support, especially in technology fields that are highly unpredictable, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed 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 or through disclosure of a functional characteristic of the claimed genus coupled with a known or disclosed non-functional characteristic (structure) that correlates to the function.
In this case, the specification does not describe the genus of subject specific immunogenic compositions comprising tumor specific neoantigens identified by sequence comparison to a database consisting of SEQ ID NO 1-1989 that satisfies either the Lilly or Enzo standards. The specification does not provide a number of examples sufficient so to describe the entire scope of the claims, the predictability of the scope of the claims. The specification merely identifies how to identify compound capable of neoantigen. The specification provides an example of 6 peptides however there is no indication that these 6 peptides are immunogenic compositions. The specification does not provide a description on how to prepare these compositions. Thus, the specification does not provide an adequate written description of the genus. The instant disclosure does not adequately describe the scope of the claimed genus, which encompasses a substantial variety of subgenera. Since the disclosure fails to provide sufficient relevant identifying characteristics, and because the genus is highly variant, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus as broadly claimed.
Response to Arguments
The response traverses the rejection on pages 5-7 of the remarks mailed 01/14/2026. The response asserts that the set of 1989 sequences are known immunogenic sequences found to occur in human cancer. The response asserts that the database sequences only require at least 10 and the database established frameshift mutations in actual tumors producing neoantigens can be used as the basis for immunogenic compositions. The response asserts there is a 100% chance that a match has been found within the database and further asserts that the method only requires that any match is found within the database because any match yields a neoantigen sequence suitable for the making an immunogenic composition to have some value in stimulating the immune system of a particular patient to fight cancer. This response has been reviewed but not found persuasive. It is unclear if the traversal is asserted that the claim requires there is a 100% chance that a match is found within the database or that the method only requires that any match is found within the database. Even arguendo the claim requires that there is 100% chance of a match found or if the method only requires any match is found, the claim requires preparing an immunogenic composition and therefore requires that the neoantigen has immunogenic properties. The specification does not describe a representative number of neoantigens that comprise immunogenic properties. While neoantigens are mutated proteins found on cancer cells this does not necessarily result in immunogenic properties. Many mutant peptides fail to naturally elicit a T cell response and Liu demonstrates the unpredictability of using bioinformatic neoantigen sequences to predict immunogenic properties. As such the art demonstrates that not all neoantigens will have immunogenic properties and given the lack of description with regard to which neoantigens in the claimed database will possess immunogenic properties, the claims are not described for preparing immunogenic compositions.
The response further asserts that the present invention is not analogous to describing the structure of antibody where the structure has to possess a requisite function. The response asserts the claimed invention results in identification of one or more suitable neoepitopes that form neoantigen that in turn forms active component of immunogenic composition to stimulate patient’s immune system. The response asserts that the database is guaranteed to contain one neoantigen that are identical to neoantigen known to be expressed in human cancer. The response further asserts there is no need to demonstrate by working examples that the database contains one or more matching sequences. The response asserts the size of the database increased the functionality. The response asserts that the database is expected to include over 30% cancer neoantigens encounter in human cancer patients and the structure ensures that every immunogenic composition produced is based on a match with one or more neoepitope sequences found int eh database. This response has been thoroughly reviewed but not found persuasive. The claims are not limited to identification of neoepitopes nor are the claims limited to preparing a composition comprising a neoantigen, the claims require a method of preperaring an immunogenic composition and therefore the claims require that the composition comprising the neoantigen has immunogenic properities. The present invention is analogous to describing an antibody that has a possessed request function. The claim require preparing an immunogenic composition, therefore the neoantigen should possess the function of immunogenic. In the instant case there is no assay or description of any of the neoantigens of the claimed database that will function as an immunogenic composition. A mere statement that they include over 30% cancer neoantigens does not necessarily result in an immunogenic composition. The prior art demonstrates the unpredictability of using bioinformatically predicted neoantigens to generate immunogenic compositions (see Liu, pg. 18). As addressed previously, the art demonstrates the lack of effective immunogenic compositions based on predicted neoantigens. In the instant case the database disclosed in the instant specific comprise predicted neoantigens, the response confirms that the database is expected to include over 30% cancer antigens, thus demonstrating that the database comprises predicted neoantigens and Liu demonstrates the lack of effective immunogenic compositions based on predicted neoantigens. The specification does not describe any neoantigens that are immunogenic compositions, the specification only discloses neoantigen sequences but does not disclose which of these sequences will be immunogenic compositions.
For these reasons and reasons of record this rejection is maintained.
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.
Claim 13 is rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more. The claims are directed to abstract idea and law of nature. This judicial exception is not integrated into a practical application. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The following inquiries are used to determine whether a claim is drawn to patent-eligible subject matter. This rejection was previously presented and has been rewritten to address the amendment to the claims.
Step 1. Is the claim directed to a process, machine, manufacture, or composition of matter? Yes, all of the claims are directed to a process and a system.
Step 2A. Is the claim directed to a law of nature, a natural phenomenon or an abstract idea (judicially recognized exception) and does the claim recite additional elements that integrate the judicial exception into a practical application?
Yes, the claims are directed to law of nature/natural phenomenon. Claim 13 recites identifying at least one neoantigen and step (b) recites to thereby identify a tumor specific neoantigen encoded by a tumor-specific frameshift mutation. The relationship of the neoantigen being tumor specific and the frameshift mutation being tumor specific is a natural phenomenon. The recited relationship is a natural phenomenon that exists apart from any human action. This type of correlation is a consequence of natural processes.
The claims also recite the judicial exception of an abstract idea that is a mental process. Claim 13 recite “identifying at least one neoantigen”, “determining” the presence of absence of a match between a set of sequences…”identifies a tumor specific neoantigen encoded by a tumor specific frameshift mutation”. Neither the specification or the claims set forth limiting definition for determining or identifying and the claims do not set forth how determining is accomplished. The broadest reasonable interpretation of the determining. comparing and identifying step is a step that can be accomplished mentally by evaluating data and critical thinking process wherein one mentally reads information in a database then draws a mental conclusion. Such “determining”, “comparing” and “identifying “thereby encompasses process that may be performed mentally and this is an abstract idea.
The recitation of database does not negate the mental nature of the limitations because the claim merely uses the database as a tool to perform the mental process.
Having determined that the claims recite a judicial exception, it is then determined whether the claims recite additional elements that integrate the judicial exception into a practical application.
The claims do not recite additional steps or elements that integrate the recited judicial exceptions into a practical application of the exception(s). For example, the claims do not practically apply the judicial exception by including one or more additional elements that the courts have stated integrate the exception into a practical application:
An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
An additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
An additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
An additional element effects a transformation or reduction of a particular article to a different state or thing; and
An additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological
environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
As mentioned above, a claim limitation can integrate a judicial exception by applying or using the judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. When evaluating this consideration one must the following:
(i) the particularity or generality of the treatment or prophylaxis limitation;
(ii) whether the limitations have more than a nominal or insignificant relationship to the exception; and
(iii) whether the limitations are merely extra solution activity or field of use.
The steps of “identifying” a neoantigen for preparing a subject specific immunogenic composition is not particular i.e., specifically identified so that it does not encompass all applications of the judicial exception. The step of “preparing” a neoantigen is not specific, there is no specific immunogenic composition that is claimed and encompasses all application of the judicial exception. In other words the claims broadly encompass any and all immunogenic compositions and further does not require administering the therapy to the subject. The recitation of a database is a general link between the abstract idea and generic computer. The database can be any kind of file and storing information in files is what every computer does and there is not any additional elements that use the judicial exception with a particular machine. Here the recitation of a database that consists of sequences and use of a computer is generic. The recitation of a database consisting of SEQ ID NO 1-147 is no more than mere instructions to apply the judicial exception on a computer. These limitations can be viewed as nothing more than an attempt to generally link the use of the judicial exception to a technological environment of a computer.
While 13 recite a step of preparing a subject-specific immunogenic composition, this step is only performed if the presence of match is step (b) in claim 13 is determined. Claim 13 recites determining presence or absence of a match, if there is no match determined in step (b) of claim 13 then step (c) of preparing a composition is not performed. As such the step of preparing an immunogenic composition does not integrate the judicial exception.
Step 2B - Does the claim recite additional elements that amount to significantly more than the judicial exception? No.
Herein the claims as a whole are not considered to recite any additional steps or elements that amount to significantly more than well-understood, routine, and conventional activities in the art and do not add something “significantly more” so as to render the claims patent-eligible. The step of preparing a subject specific immunogenic composition is conditional and the step of performing sequencing merely instructs a scientist to use well established, routine and conventional methods to prepare a composition. As address in the instant specification methods of sequence analysis including preparing immunogenic compositions is well known in the art (see pg. 24).
The step of performing complete, targeted, or partial genome, exome, or transcriptome sequence of at least one tumor sample obtained from a subject constitutes a data gathering step required to apply the law of nature/natural phenomenon and abstract idea. The sequences to be detected are part of the judicial exception and thereby the naming of the sequences does not add something “significantly more” to the recited judicial exceptions.
The additional steps and elements are recited at a high degree of generality and are all routine, well understood and conventional in the prior art. The recited steps and elements do not provide inventive concept necessary to render the claims patient eligible. There is no combination of elements in these steps that distinguishes it from well-understood, routine and conventional data gathering activity engaged in by scientists prior to applicant’s invention and at the time the application was filed. Many cited prior art references in this record demonstrate that these techniques were conventional at the time of the invention. The dependent claims further limit the abstract idea and do not provide significantly more to the claims outside of the judicial exception.
Response to Amendment
The response traverses the rejection on page 7-8 of the remarks mailed 01/14/2026. The response asserts the claims have been amended and the step of preparing an immunogenic composition is not conditional and is required to complete the object of the claim set out of the preamble. The response asserts that if no match between the patient sequence and at least one sequence database as required by the claims then no immunogenic composition is prepared and the claim does not read on the process. It is noted that the examiner agrees if no match between the sequence and the database is identified then no immunogenic composition is prepared and therefore the claim does not include a step that is a practical application of the recited judicial exception in claim 13.
The response asserts that the collection of a patient sample and obtaining sequence information cannot be regarded as mere data gathering because the data obtained are part of specific, real world method for preparing immunogenic compositions designed for a specific patient which is not an abstract concept or mere calculated results. This response has been reviewed but not fund persuasive. The step of obtaining sequence information is a data gathering step that is required to perform the method and the judicial exceptions of the claim. While this is a real world method, this is also a data gathering step. The response asserts that the process of obtaining sequence of patient cancer is an integral part of preparing the immunological compositions. While obtaining sequence of patient is part of preparing immunological composition, the step of obtaining a sequence is a data gathering step, required to compared the identity of the sequence, the abstract idea of the claim and therefore is a data gathering step to perform the abstract idea of the claim. It is noted that this rejection could be overcome by removing the phrase “or absence” in step (b) of claim 13. For these reasons and reasons of record the rejection is maintained.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAE L BAUSCH whose telephone number is (571)272-2912. The examiner can normally be reached M-F 9a-4p.
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/SARAE L BAUSCH/Primary Examiner, Art Unit 1699
