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 .
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 1-3, 7, and 9-23 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.
Independent claims 1, 18, and 19, recites “wherein the patient is suspected of having or has stage I endometriosis according to revised Americal Society for Reproductive Medicine (rASRM) staging or stage II endometriosis according to rASRM staging”.
Some of the claims dependent on these independent claims also refer to the “revised American Society for Reproductive Medicine (rASRM) stagin or stage II endometriosis according to rASRM staging”.
It is not clear as to what comprises the “revised Americal Society for Reproductive Medicine (rASRM) staging or stage II endometriosis according to rASRM staging”.
Applicant’s specification states: “The term "rASRM stage" or "rASRM staging" refers to the revised classification system established by the American Society for Reproductive Medicine (ASRM) describing the severity of endometriosis based on the findings at surgery (laparoscopy).” This classification system appears to be incorporated into Applicant’s claim 1. However, what this revised system comprises is not clear. Moreover, a classification system can or may have been revised at different times, and it is not clear as to which revised classification system is being referred. Also, a “revised” system appears to be subject to change, which further renders the claim vague and indefinite.
Moreover, claim 2 recites in the preamble a “method of selecting a patient for drug-based therapy or surgical therapy (laparoscopy) of endometriosis”, but claim 2 does not include such a step in the body of the claim. Therefore, it is not clear whether or not claim 2 requires selecting a patient for drug-based therapy or surgical therapy (laparoscopy) of endometriosis. Clarification in the claim is required. For examination purposes, claim 2 is interpreted to require this limitation.
Also, claim 3 recites in the preamble “monitoring a patient suffering from endometriosis” but the body of claim 3 does not include such a step. Therefor, it is not clear whether or not claim 3 requires monitoring a patient suffering from endometriosis. Clarification in the claim is required. For examination purpose, claim 3 is interpreted to require this limitation.
Claim 13 recites “wherein the patient has dysmenorrhea according to the visual Analog Scale (VAS) scale”. It is not clear as to what the VAS scale encompasses.
Moreover, claim 20 recites in the preamble “assessing whether the patient has endometriosis or is at risk of developing endometriosis” but does not recite this limitation in the body of claim 20 (nor its dependent claims). Therefore it is not clear whether or not a step of assessing whether the patient has endometriosis or is at risk of developing endometriosis is required in claim 20 or its dependent claims.
Clarification in the claim is required. For examination purpose, claim 20 is interpreted to require this limitation.
The remaining claims are rejected because they depend on one of the claims above without remedying the lack of clarity.
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 1-3, 7, and 9-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a law of nature or an abstract idea without significantly more.
Independent claim 1 recites “wherein the patient is suspected of having or has stage I endometriosis according to revised Americal Society for Reproductive Medicine (rASRM) staging or stage II endometriosis according to rASRM staging”.
Claim 1 also recites “comparing the measuring amount or concentration to reference”.
Examiner notes that “the patient is suspected of having….endometriosis” is directed to an abstract idea, or a mental step.
Examiner notes that “comparing” is a mental step and thus an abstract idea, which is a judicial exception.
Examiner also notes that a comparing step or assessment is implied in the following limitations, since it is required in order to meet the limitations: “wherein the patient is suspected of having or has stage I endometriosis according to revised Americal Society for Reproductive Medicine (rASRM) staging or stage II endometriosis according to rASRM staging”. Such comparing is an abstract idea, i.e., a judicial exception. Moreover, such an assessment is also an abstract idea (a judicial exception) and is also based on a correlation that is a natural law, which is also a judicial exception.
In other words, these limitations require a comparison between i) a measurement or observation of the individual and ii) the standard recited (the revised American Society for Reproductive Medicine (rASRM) staging or stage II endometriosis according to rASRM staging.) Such a comparison is an abstract idea. The limitations also require an assessment that “the patient is suspected of having or has stage I endometriosis according to revised Americal Society for Reproductive Medicine (rASRM) staging or stage II endometriosis according to rASRM staging”. Such an assessment is also an abstract idea, which is a judicial exception. Examiner also notes that such an assessment is based on a correlation between a measurement or observation and the state of having stage I endometriosis. Such correlation is a natural law, which is a judicial exception.
These judicial exceptions are not integrated into a practical application because the combination of additional elements fail to integrate the judicial exception into a practical application. The data gathering step of measuring the amount or concentration of S100A12, in a sample that is blood, serum, or plasma, do not add a meaningful limitation to the method as it is an insignificant extra-solution activity.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the following reasons. Regarding claim 1, there are no further limitations in addition to the data gathering step, and the judicial exception of comparing and assessing.
Regarding claims dependent on claim 1, they either recite limitations that are details of the judicial exception (such as the particular type of endometriosis), and/or they do not recite a practical application or additional limitations that are not well-known, conventional, and routine in the art. Therefore when considered separately and in combination, any additional recitations in the remaining claims do not add significantly more (also known as an “inventive concept”) to the exception.
Similarly, independent claims 2 and 3 each recite “comparing the measured amount or concentration to a reference”, “wherein the patient is suspected of having or has stage I endometriosis according to rASRM staging or stage II endometriosis according to rASRM staging.”
As mentioned further above, such comparing is an abstract idea, i.e., a judicial exception. Moreover, such an assessment is also an abstract idea (a judicial exception) and is also based on a correlation that is a natural law, which is also a judicial exception. Also, the limitation reciting “the patient is suspected of having….endometriosis” is directed to an abstract idea, or a mental step.
These judicial exceptions are not integrated into a practical application because the combination of additional elements fail to integrate the judicial exception into a practical application. The data gathering step of measuring the amount or concentration of S100A12 in blood, serum or plasma do not add a meaningful limitation to the method as it is an insignificant extra-solution activity.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the following reasons. Regarding claim 1, there are no further limitations in addition to the data gathering step recited at a high level of generality, and the judicial exceptions mentioned above.
Likewise, claim 18 recites “wherein the patient is suspected of having or has stage I endometriosis according to rASRM staging or stage II endometriosis according to rASR staging.” The limitations of “the patient is suspected of having….endometriosis” is directed to an abstract idea, or a mental step. Moreover, the above limitations imply a comparing step or assessment, which are judicial exceptions (abstract idea and natural law), for the same reasons as mentioned above.
These judicial exceptions are not integrated into a practical application because the combination of additional elements fail to integrate the judicial exception into a practical application. The data gathering step of detecting the elevated amount or concentration of S100A12, and contacting the sample, that is blood, serum, or plasma, with an antibody that bind to S100A12, do not add a meaningful limitation to the method as it is an insignificant extra-solution activity.
Moreover, claim 18 does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. For example, the step of contacting the sample with an agent that is an antibody that binds S100A12 is well-known, conventional, and routine in the art, as exemplified by US 20120171694 (Mansfield), which discloses methods for predicting the presence of ovarian cancer (see abstract), by detecting biomarkers that includes…. EN-RAGE…….and CA-125 (see para. 0032) (Examiner notes that EN-RAGE is the same as S100A12), through performing immunoassays, such as enzyme-linked immunosorbent assays and multiplexed immunoassays (para. 0031) using antibodies as binding molecules to measure the biomarkers (para. 0034).
Similarly, independent claim 19 recites “wherein the patient is suspected of having or has stage I endometriosis according to rASRM staging or stage II endometriosis according to rASR staging.” Such limitations imply a comparing step or assessment, which are judicial exceptions (abstract idea and natural law), for the same reasons as mentioned above. Again, the limitation of “the patient is suspected of having….endometriosis” is directed to an abstract idea, or a mental step.
These judicial exceptions are not integrated into a practical application because the combination of additional elements fail to integrate the judicial exception into a practical application. The data gathering step of measuring the amount of S100A12, and contacting the sample, that is blood, serum, or plasma, with an antibody that bind to S100A12, do not add a meaningful limitation to the method as it is an insignificant extra-solution activity.
Moreover, claim 19 does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. For example, the step of contacting the sample with an agent that is an antibody that binds S100A12 is well-known, conventional, and routine in the art, as exemplified by US 20120171694 (Mansfield), which discloses methods for predicting the presence of ovarian cancer (see abstract), by detecting biomarkers that includes…. EN-RAGE…….and CA-125 (see para. 0032) (Examiner notes that EN-RAGE is the same as S100A12), through performing immunoassays, such as enzyme-linked immunosorbent assays and multiplexed immunoassays (para. 0031) using antibodies as binding molecules to measure the biomarkers (para. 0034).
Similarly, independent claim 20 recites:
“comparing the measure amount or concentration to a reference”, and
“assessing whether the patient has endometriosis or is at risk of developing endometriosis”.
For the same reasons as discussed above regarding claim 1, such comparing is an abstract idea, i.e., a judicial exception. Moreover, such an assessment is also an abstract idea (a judicial exception) and is also based on a correlation that is a natural law, which is also a judicial exception (as discussed above, regarding claim 1).
These judicial exceptions are not integrated into a practical application because the combination of additional elements fail to integrate the judicial exception into a practical application. The data gathering step of measuring the amount of S100A12, and incubating the sample, that is blood, serum, or plasma, with an antibody that bind to S100A12, and quantifying the complex do not add a meaningful limitation to the method as it is an insignificant extra-solution activity.
Moreover, claim 20 does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. For example, the step of incubating the sample with an agent that is an antibody that binds S100A12 and quantifying the complex are well-known, conventional, and routine in the art, as exemplified by US 20120171694 (Mansfield), which discloses methods for predicting the presence of ovarian cancer (see abstract), by detecting biomarkers that includes…. EN-RAGE…….and CA-125 (see para. 0032) (Examiner notes that EN-RAGE is the same as S100A12), through performing immunoassays, such as enzyme-linked immunosorbent assays and multiplexed immunoassays (para. 0031) using antibodies as binding molecules to measure the biomarkers (para. 0034).
Regarding claims dependent on claim 20, they do not recite a practical application or additional limitations that are not well-known, conventional, and routine in the art. Therefore when considered separately and in combination, any additional recitations in the remaining claims do not add significantly more (also known as an “inventive concept”) to the exception.
Examiner further notes that, regarding amended claim 2, which recites “selecting the patient for drug-based therapy or surgical therapy (laparoscopy) based on the comparison” is not considered to be a practical application as it is not sufficiently specific enough to be tailored to the judicial exception.
Similarly, regarding amended claim 3, which recites “monitoring the patient suffering from endometriosis or being treated for endometriosis based on the comparison” is not a specific or tailored practical application.
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 17-23 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 claims contain 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 pre-AIA the inventors, at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The claims require an agent that binds to S100A12, wherein the agent is an antibody. The specification does not describe which amino acid residues, nucleic acid residues or other molecular components are responsible for the functions claimed. The specification fails to disclose the structures common to all members of the genus encompassed by the broad definition provided by applicant. The specification does not disclose the structure of all of the claimed variant agents and fails to disclose which regions of the agents are responsible for the functions claimed. In the absence of a known or disclosed correlation between structure and function, claims which encompass variants defined by their function are generally not considered described.
Applicant is directed to MPEP § 2163 for guidelines on compliance with the written description requirement. Here, applicant has not described a reasonable number of members of the genus of agents or antibodies that bind to S100A12, i.e. the required starting materials for the claims, but rather has presented the public with an idea of how to perform an assay that might identify some peptides that fall within the scope of the claim. Of course, depending on what agents are used in the screening assay, it may well identify none. The Court of Appeals for the Federal Circuit addressed claims of this sort in great detail in University of Rochester v. G.D. Searle and Co. (69 USPQ 2nd 1886, CAFC 2004). In Rochester, the Federal Circuit upheld the district court's ruling that patent claims which recited administration of compounds not disclosed, but rather to be identified in a screening assay, were invalid on their face.
Regarding the scope of the claims that includes antibodies that bind to S100A12, the specification does not describe the structure of the full genus of antibodies responsible for each of the functions claimed. The Federal Circuit has clarified Written Description as it applies to antibodies in the recent decision Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017). The Federal Circuit explained in Amgen that when an antibody is claimed, 35 U.S.C. 112(a) (or pre-AIA first paragraph) requires adequate written description of the antibody itself. Amgen, 872 F.3d at 1378-79. The Amgen court expressly stated that the so-called “newly characterized antigen” test, which had been based on an example in USPTO-issued training materials and was noted in dicta in several earlier Federal Circuit decisions, should not be used in determining whether there is adequate written description under 35 U.S.C. 112(a) for a claim drawn to an antibody. Citing its decision in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., the court also stressed that the “newly characterized antigen” test could not stand because it contradicted the quid pro quo of the patent system whereby one must describe an invention in order to obtain a patent. Amgen, 872 F.3d at 1378-79, quoting Ariad, 598 F.3d 1336, 1345 (Fed. Cir. 2010). In view of the Amgen decision, adequate written description of an antigen alone is not considered adequate written description of a claimed antibody to that antigen, even when preparation of such an antibody is routine and conventional. Id.
While generically the structure of antibodies is known, the structure of the presently recited antibodies can vary substantially within the above given claimed recitations. As noted in Amgen, knowledge that an antibody binds to a particular epitope on an antigen tells one nothing at all about the structure of the antibody, wherein “instead of analogizing the antibody-antigen relationship to a ‘key in a lock,’ it [is] more apt to analogize it to a lock and ‘a ring with a million keys on it.” (Internal citations omitted). The relevant antibody art confirms this quandary, indicating that “knowledge of an epitope or antigen used to generate a monoclonal antibody is insufficient for making the original antibody available, even if suitable in vitro test systems for screening are used.” See p. 8, lines 3-5 of WO 2009/033743 A1. Therefore, those of skill in the art would not accept that the inventor had been in possession of the full genus of antibodies presently claimed.
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. Abbvie Deutschland GMBH & Co. v. Janssen Biotech, Inc. (759 F.3d 1285 (Fed. Cir. 2014). “When a patent claims a genus using functional language to define a desired result, the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus." Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005).
Consequently, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus of binding agents (including antibodies) nor guidance as to which of the myriad of molecules encompassed by the binding agents would meet the limitations of the claims. Further, given the well-known high level of polymorphism of immunoglobulins and antibodies, the skilled artisan would not have recognized that applicant was in possession of the vast repertoire of antibodies encompassed by the claimed invention.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111 (Fed. Cir. 1991), clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117). The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116).
The skilled artisan cannot envision the detailed chemical structure of the genus of binding agents, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of identification. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016 (Fed. Cir. 1991). Therefore, the instant claims do not meet the written description provision of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph.
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.
Claim(s) 1-3, 7, 9-12, and 18-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over EP 3961217 (hereinafter “Kobayashi”).
Kobayashi discloses a method of diagnosing endometriosis, comprising measuring S100-A12. See claim 1 and paras. 0001 and 0011 and 0018-0021. The marker S100A12 is found to be highest in plasma of endometriosis patients, and lowest in health individuals (para. 01116). Kobayahishi also discloses monitoring patients diagnosed with or affected by endometriosis (para. 0094).
Thus Applicant’s claims 1-3, 7, 9, 10, 11, and 18-22 is rendered obvious given these disclosures by Kobayashi. As the limitations regarding the patient being “suspected of having or has stage I endometriosis according to revised American Society for Reproductive Medicine (rASRM) staging or stage II endometriosis according to rASRM staging” is indefinite as mentioned above, the disclosures by Kobayashi renders obvious monitoring patients diagnosed with or affected by endometriosis by medical professionals, thus meeting Applicant’s claim, as it remains indefinite for the reasons set forth above.
As to claim 2, selecting a patient for drug-based therapy or surgical therapy based on the comparison would have been obvious to one skilled in the art as it would have been predictable that therapy would be desirable in the case of diagnosis of endometriosis. Kobayashi also shows that treatments are known, and that a delay in diagnosis would lead to a delay in the start of treatment of endometriosis (para. 0003).
Regarding claims 11-12, Kobayashi discloses diagnosing endometriosis, and does not exclude any particular endometriosis, and thus Kobayashi’s teaching provides a prima face case of obviousness regarding specific types of endometriosis.
As to claims 20-21, use of a second antibody that is labeled is well known in the art, and such is also disclosed by Kobayashi (see for example para. 0011).
Claim(s) 13 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over EP 3961217 (Kobayashi) in view of Ameade et al. “Menstrual Pain Assessment: Comparing Verbal Rating Scale (VRS) with Numerical Rating Scales (NRS) as Pain Measurement Tools” Int J Womens Health Wellness 2016, 2:017, Vol. 2, Issue 1.
Kobayashi has been discussed above.
However, regarding claim 13, Kobayashi is silent as to the disclosed method further comprising an assessment of dysmenorrhea according to a VAS scale.
Regarding claim 15, Kobayashi is silent as calculating a ratio of the amount or concentration of S100A12 and dysmenorrhea.
The Kobayashi disclosure as mentioned above encompasses monitoring or diagnosing patients with endometriosis (paras. 0001 and 0011 and 0018-002 and 0094), thus rendering claim 13 obvious as it would have been obvious that such patients suspected of having endometriosis symptoms should be tested for endometriosis.
Moreover, assessment of dysmenorrhea according to a VAS scale is known in the art, as shown by Armeade, (see first page under “Introduction”) and providing such an assessment in addition to assessing whether the patient has endometriosis (as discussed regarding claim 1 above) requires ordinary skills in the art since it merely adds a second assessment that is known in the art, shown by Armeade, as may be desirable for a more comprehensive assessment of a woman’s health, and in particular reproductive health.
Claim(s) 14 and 16 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over EP 3961217 (Kobayashi) in view of Irungu et al. “Discovery of non-invasive biomarkers for the diagnsosis of endometriosis”, Clinical Proteomics, Vol. 16, no. 1, 6 April 2019, pages 1-16.
Kobayahsi has been discussed above regarding claim 1.
Regarding claim 14, Kobayashi is silent as to the method further comprising determining the amount of CA-125.
Regarding claims 16 and 23, Kobayashi is silent as to calculating a ratio of the amount of [S100A12] and the amount of CA-125.
Determining the amount of S100A12 is disclosed by Kobayashi as discussed above regarding claim 1.
Moreover, CA-125 is a known biomarker of endometriosis, as shown by Irungu (see “Abstract” on the first page, under the subheading “Methods”.) Determining the amount of S100A12 and the amount of CA-125 in a patient to have been obvious given that these two biomarkers are known markers of endometriosis. Thus determining the ratio of the amount of these two biomarkers appear to be prima facie obvious, as it merely provides data to the clinician or doctor as may be desirable in assessing endometriosis or comparing assessments of endometriosis of a patient compared to other patients or compared to the same patient over time, for study in general or for the medical care of the patient.
Response to Arguments
The following arguments made by Applicant have been fully considered but they are not persuasive.
Regarding the rejections under 35 USC 112(b) for indefiniteness, Applicant submits Exhibit E3 which is a copy of the American Society for Reproductive Medicine, “Revised American Society for Reproductive Medicine Classification of Endometriosis: 1996” Fertility and Sterility, vol. 67, no. 5, pp. 817-821. Applicant states that the term “rASRM staging” unambiguously identifies the 1997 publication as the operative version. Applicant also asserts that Applicant’s specification further provides explicit morphological criteria for all four stages: rASRM stages I and II (minimal to mild endometriosis) “are defined by superficial peritoneal endometriosis, possible presence of small deep lesions, absence of endometrioma and/or mild filmy adhesion” and rASRM stages III and IV (moderate to severe endometriosis) “are defined by the presence of superficial peritoneal endometriosis, deep infiltrating endometriosis with moderate to extensive adhesions between the uterus and bowels and/or endometrioma cysts with moderate to extensive adhesions involving the ovaries and tubes”.
This is not found to be persuasive. Nowhere is it clear that the term “rASRM staging” identifies the 1997 publication as the operative version. In any case, neither Applicant’s specification nor other publications are not read into the claims. It remains unclear as to the meaning of “wherein the patient is suspected of having or has stage I endometriosis according to revised American Society for Reproductive Medicine (rASRM) staging or stage II endometriosis according to rASRM staging.”
As mentioned in the grounds for rejection, what this revised system comprises is not clear. Moreover, a classification system can or may have been revised at different times, and it is not clear as to which revised classification system is being referred. Also, a “revised” system appears to be subject to change, which further renders the claim vague and indefinite.
Regarding the rejections under 35 USC 101, Applicant argues that the limitation of “wherein the patient is suspected of having or has stage I endometriosis according to rASRM staging or stage II endometriosis according to rASRM staging” defines the patient population from which the sample is obtained and it does not recite, require, or imply any natural correlation or mental step of comparison. This is not found to be persuasive since the limitation “the patient is suspected of having….endometriosis” (emphasis added) is a requirement in the claimed alternative and is directed to an abstract idea, or a mental step.
Applicant also argues that it is irreconcilable that the Office finds that detecting S100A12 in blood from stage I or II endometrios patients is not taught or suggested by the prior art due to unpredictability, and at the same time find under Section 101 that the same detection steps are well-understood, routine, and conventional. This is not found to be persuasive since Examiner is asserting that the detection steps, i.e., the data gathering step, recited at a high level of generality, is well-understood, routine, and conventional (i.e., are not significantly more than the judicial exception). The correlation between detecting specifically S100A12 and assessing whether a patient has endometriosis is the judicial exception itself, and that correlation cannot be used to support that the claimed invention recites limitations that are significantly more than the judicial exception.
Applicant also argues that the measuring limitations are specific manipulation steps (incubating, generating a complex, quantifying, and sandwich complex formation with a detectably labeled antibody) further integrate any judicial exception into a practical application. This is not found to be persuasive since these are mere data gathering steps, i.e., extra-solution activity.
Regarding the written description rejection, Applicant argues that the claims are directed to diagnostic methods in which antibodies serve as detection reagents, and they are not directed to antibody compositions as products. This is not persuasive since the claims nevertheless recite the antibody products as a requirement for the method.
Applicant further argues that the disclosures identify specific structural and functional characteristics of the antibodies, their binding specificity, format of use, conjugation chemistry, and detection modality. This argument is not persuasive for the reasons set forth above in the written description rejection. See above in the rejection, for example: adequate written description of an antigen alone is not considered adequate written description of a claimed antibody to that antigen, even when preparation of such an antibody is routine and conventional.
Conclusion
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/Ann Montgomery/Primary Examiner, Art Unit 1678