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 .
Response to Amendment
The preliminary amendment filed on April 19, 2024 is acknowledged. The application will be examined accordingly.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 19, 2024 is being considered by the examiner.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it contains the legal terminology “means”.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Interpretation
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 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) 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):
(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). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) 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). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) 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) 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) except as otherwise indicated in an Office action.
Consequently, the “means” recited in claims 1, 13, 16 and 18 are subject to interpretation under 35 U.S.C. 112(f). However, the “means” in claims 9 and 17 is not subject to 35 U.S.C. 112(f) interpretation because the means is further modified by sufficient material/acts for performing the claimed function.
In addition, this application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) because the claim limitations use generic placeholders that are coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholders are not preceded by a structural modifier.
Such claim limitations are: “input unit”, “analytical measurement unit”, “data processing unit” and “output unit” in claim 18.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f), they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If Applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f), Applicant may:
(1) amend the claim limitations to avoid them being interpreted under 35 U.S.C. 112(f) (e.g., by reciting sufficient structure to perform the claimed function); or
(2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f).
Claim Objections
Claims 12-16 and 18 are objected to because of the following informalities:
Claims 12-16 recite verbs in passive voice (e.g. “are provided”; “is treated”) instead of active voice (e.g. “providing”; “treating”). Because the claimed invention is directed to a method, steps that are intended to be part of the method should be recited in active voice. Otherwise, the steps may be construed as conveying intent. For examination purposes, the passive voice limitations will be subject to their broadest reasonable interpretations.
In claim 12, the limitation “are provided” should be changed to “is provided”.
In claim 18, the limitation “an determination value” should be changed to “a determination value”.
Appropriate corrections are required.
Claim Rejections - 35 USC § 112
In the event the determination of the status of the application as subject to AIA (or as subject to pre-AIA ) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the rationale supporting the rejection would be the same under either status.
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.
Claims 1-17 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 is indefinite because the scope of the claim cannot be ascertained. According to the preamble of claim 1, the claimed invention is directed to a “method for providing information”. A method is defined by its step(s). However, the claim does not recite any limitation that can be construed as a method step (i.e. an act), let alone an act that is directed to “providing information”. While claim 1 recites a step of “using an indicator”, the limitation “using” is considered indefinite due to its abstract nature. See MPEP 2173.05(q). Consequently, the metes and bounds of the claimed invention is unclear. The rejected dependent claims fail to remedy the indefinite nature of claim 1. While claims 12-17 recite discernible acts (e.g. comparing, adjusting the amount of D-amino acid), said acts are not deemed to be directed to “providing information”. Consequently, the scope of the limitation “providing information” remains unclear in claims 12-17.
In claim 17, it is unclear how treating a biological sample taken from a cancerous subject constitutes a cancer treatment. According to the claim, it’s not the subject that is treated, but rather a sample taken from the subject. Further clarification regarding the scope of the claim is requested.
Claims not explicitly rejected are rejected due to dependency.
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 1-16 and 18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea and/or laws of nature without significantly more.
Regarding claims 1-15, as discussed above, the scope of the limitation “providing information” is unclear. That said, assuming that the limitations refers to steps of “converting” the claimed indicator into the claimed information and “conveying” the information to the subject, the claims recite a judicial exception in the form of a mental process (e.g. converting a value to a cancer diagnosis/classification/prognosis/treatment) that is dictated by laws of nature (there is a natural correlation between amount of D-amino acid in a subject and presence of cancer and stage/prognosis of cancer). This judicial exception is not integrated into a practical application because the claims consist of the judicial exception (i.e. the entire subject matter of the claims is directed to the judicial exception). Naturally, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Regarding claim 16, because it is a dependent claim, it encompasses the judicial exception identified above. While the claim also recites a step of treating cancer, the treatment step does not constitute a practical application of the judicial exception because it is not “particular”. See MPEP 2106.04(d)(2). Consequently, claim 16 fails to remedy the deficiency of claim 1.
Claim 17, on the other hand, is not rejected under 35 U.S.C. 101 because it recites performance of a particular cancer treatment, which constitutes a practical application of the judicial exception identified above.
Regarding claim 18, recitation of a computer that performs the judicial exception fails to obviate a rejection under 35 U.S.C. 101. See MPEP 2106.04(d)(I). Consequently, claim 18, which recites the judicial exception identified above, is rejected under 35 U.S.C. 101.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of co-pending Application 18/598,428 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 2 of the reference application anticipates claim 1 of the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 102
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 1-15 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hamase et al. (“Hamase”) (US 2019/0339281 A1).
With respect to claim 1, Hamase discloses a method for providing information associated with cancer in a subject using an indicator (numerical value) representative of the amount of a D-amino acid in a biological sample (e.g. urine, blood) of the subject (see abstract and [0154]), wherein the information is cancer diagnosis (see [0154] and [0167]).
With respect to claim 2 and 3, the indicator is a value obtained by correcting the amount of the D-amino acid with an in vivo L-amino acid in the subject (see [0383]).
With respect to claims 4 and 5, the indicator is a value obtained by correcting the amount of the D-amino acid with a kidney function marker (see [0383]), specifically protein (L-alanine containing proteins) in urine of the subject (see abstract disclosing that the sample is urine, meaning the L-alanine by which the concentration of D-amino acid is corrected is found in urine).
With respect to claim 6, the D-amino acid is D-serine, D- alanine or D-asparagine (see [0154]).
With respect to claims 7 and 8, the cancer is gastrointestinal cancer, specifically cancer in the large intestine (see [0383]), which includes colon and rectum.
With respect to claims 9-11 and 13-15, the subject matter of the claims is directed to alternative embodiments (e.g. classification of cancer progression for the subject) that is not addressed by the rejection of claim 1. Consequently, prior art need not teach the subject matter of the claims to reject them.
With respect to claim 12, the diagnosis is determined by comparing the indicator with the amount of D-amino acids in biological samples from subjects having cancer (see [0383]).
For claims 12-15, it should also be noted that the claims recite verbs in passive voice, as discussed above (see objections to the claims), meaning it is unclear whether the claims intend the verbs to convey method steps. Moreover, the claimed invention is directed to a method of “providing information”, not a method of determining/deriving information. Consequently, claims 12-15, which are directed to manners in which the various claimed information is determined/derived, does not further limit the claimed invention. The claims are rejected if the claimed information (e.g. cancer diagnosis based on D-amino acid concentration) is provided, regardless of how the information is derived.
With respect to claim 18, Hamase discloses a data processing unit for conducting the method disclosed above (see [0001]), the data processing unit comprising a memory unit, an input unit, an analytical measurement unit, a data processing unit and an output unit (see [0029] and [0169]).
The memory unit stores therein concentrations of various D-amino acids associated with cancer diagnosis (see [0029]), the analytical measurement unit separates and quantifies the D-amino acids in a biological sample of the subject (see [0029]), the data processing unit compares the quantified D-amino acids with the concentration values stored in the memory unit (see [0029]), and the output unit outputs the information (see [0031]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Hamase.
Hamase does not explicitly disclose a step of treating a cancer patient once the patient is diagnosed with cancer. However, it is well-known in the art to treat a cancer patient (e.g. via chemotherapy, radiation therapy, gene therapy) after cancer diagnosis. That said, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have treated the subject based on the information provided by the method of claim 1 (i.e. treat the subject after cancer diagnosis).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Hamase as applied to claim 16 above, and further in view of Livant (US 2012/0077755 A1).
With respect to claim 17, while it would have been obvious to treat the subject (see rejection of claim 16 above), Hamase does not disclose treating cancer using by adjusting the amount of the D-amino acid in the subject.
Livant discloses a method of treating a cancerous patient by administering D-amino acids (e.g. D-histidine, see claim 1, which is the same D-amino acid used as a biomarker for cancer in Hamase, see [0158]) to the patient so that the amount of the D-amino acid in the patient is within or near a prescribed range (see abstract). According to Livant, the treatment inhibits the ability of cancer cells to invade tissues and cause metastases (see [0001]). In light of the disclosure of Livant, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have administered D-histidine to the subject after diagnosing the subject with cancer.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL S HYUN whose telephone number is (571)272-8559. The examiner can normally be reached M-F 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan Van can be reached at 571-272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL S HYUN/Primary Examiner, Art Unit 1796
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