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 .
Election/Restrictions
Applicant’s election of Group II and the species Complement Cir subcomponent protein (C1RL, platelet glycoprotein 1b alpha chanin (GP1BA, vtironectin (VTNC) and beta-2-glycoprotein 1 (APOH) in the reply filed on 11/09/25 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 4, 5, 7, 9, 10, 12, 13, 19, 20, 22, 23, 24, 28, 47, 48, 49, and 50 have been amended. Claims 1-3, 6, 11, 14-18, 25-27, 29-46, and 51-75 have been canceled. Claim 5 is withdrawn as being directed to a non-elected invention. Accordingly, claims 4, 7-10, 12-13, 19-24, 28 and 47-50 are under examination.
Drawings
The drawings are objected to because Figure 6 is blurry and the biomarkers disclosed cannot be read Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (e.g. page 50, para 0133). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 10 is objected to because of the following informalities: Claim 10 the recitation “the group consisting of a protease inhibitor, a soluble complement regulator, an anti-complement antibody, and a complement component inhibitor, a receptor agonist” should be -- the group consisting of a protease inhibitor, a soluble complement regulator, an anti-complement antibody, a complement component inhibitor, and a receptor agonist-- . Appropriate correction is required.
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 4, 7-10, 12-13, 19-24, 28 and 47-50 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 claims are directed to a method of treating a subtype of preeclampsia in a pregnant subject based on the measure of one or more of any and all coagulation-related biomarkers and/or any and all complement activity-related biomarkers. Thus, the current claims allow for only a single coagulation-related biomarker or a single complement activity-related biomarker for differentiating coagulation-associated preeclampisa from complement activity-type preeclampsia and specifically treating the subtype. Also, the limitation ‘coagulation-related biomarkers’ represents a genus and encompasses prothrombin fragment 1+2, thrombin-antithrombin complex (TAT), fibrinopeptide A, fibrin monomers, activated protein C-protein C inhibitor (APC-PCI), D-dimer, Factor X and fibrinogen to name a few. The limitation ‘complement activity-related biomarkers’ represents a genus and encompasses C3, C4, C5b-9, Ba, CFH, C3d, C3d and C5a to name a few. The claim as currently recited also allows for any and all measures of the biomarkers and encompasses increases, decreases, presence absence and even equal amounts. However, there is inadequate written description in the instant specification for a method of such broad scope as claimed currently.
In order to fulfill the written description requirements set forth under 35 U.S.C § 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, each member correlated with the requisite function, 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 Applicants have possession the claimed invention. Applicants have not described and established structure-function correlation for a representative number of species within the broad genus of at least the recited ‘coagulation-related biomarkers’, and ‘complement activity-related biomarkers’, nor has the applicant described that a single marker is differential and that any and all increases, decrease etc provide for differentiation of subtypes of preeclampsia such that the specification might reasonably convey to the skilled artisan that Applicants had possession of the full scope of the claimed invention at the time the application was filed.
The purpose of the written description requirement is ‘to ensure that the inventor had possession, as of the filing date of the application relied on, of the specific subject matter later claimed by him.’ In re Edwards, 568 F.2d 1349, 1351-52, 196 USPQ 465, 467 (CCPA 1978). 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. A ‘representative number of species’ means that the species which are adequately described are representative of the entire genus. When there is substantial structural variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
A review of the instant specification indicates the following. The specification on page 11 discloses two clusters of proteins identified as being predictive for coagulation-associated preeclampsia and a cluster of proteins identified as being predictive for complement-associated preeclampsia. The specification on page 27 discloses that the first cluster was characterized by increased concentration of the proteins in volved in promoting blood coagulation and the second cluster was characterized by an increased concentration of proteins involved in complement activation. The specification on page 37, paragraph 0105 discloses 4 biomarkers C1RL, GP1BA, VTNC and ZA2G and a second set with APHO, ZA2G, C1RL and VTNC. Page 37 discloses that cluster 1 had 7 biomarkers and cluster 2 had 16. Table 4 on pages 38-39 discloses the 22 associated proteins for differential expression in one of the two clusters. The specification on page 42 discloses a set of proteins obtained between 10-12 weeks gestation that are able to stratify women at risk for preeclampsia and that the 4 proteins C1RL, GP1BA, VTNC, ZA2G return useful information for the prediction of preeclampsia. Page 43 of the specification discloses a few of the biomarkers in cluster 1 and cluster 2.
The specification does not provide for any and all “coagulation-related biomarkers” and any and all “complement activity-related biomarkers” nor does it provide a correlation of any and all increases, decreases etc. The specification fails to provide any examples of single biomarkers as differential. Denny et al (Journal of Reproductive Immunology, 97, 2013, pages 211-216) teaches that a single biomarker such as C5a alone is unlikely to serve as a reliable biological marker to predict pregnancy outcomes.
The only example utilized in the specification appears to the biomarkers disclosed in clusters 1 and 2 and to be detected in panels for the differentiation of subtypes of preeclampsia. The specification does not disclose that any and all biomarkers of coagulation or complement activity is correlated with preeclampsia and provides for the differentiation of subtypes of preeclampsia. The specification appears to be limited to measuring panels of the biomarkers disclosed in cluster 1 and cluster 2 and detecting increased concentrations of the markers for determining risk of preeclampsia and to differentiate the subtypes of preeclampsia.
The purpose of the ‘written description; requirement is broader than to merely explain how to ‘make and use’, 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.
It must be noted that "[t]he applicant must . . . convey to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention." Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir.1991). The invention, is for purposes of the ‘written description’ inquiry, whatever is now claimed.” See page 1117. The specification does not describe the claimed embodiments in sufficient detail to convey to a person skilled in the art that Applicants were in possession of the full scope of the claimed invention at the time of filing. The Written Description Guidelines state: There is an inverse correlation between the level of predictability in the art and the amount of disclosure necessary to satisfy the written description requirement. For example, if there is a well-established correlation between the structure and function in the art, one skilled in the art will be able to reasonably predict the complete structure of the claimed invention from its function. Furthermore, the written description provision of 35 U.S.C § 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. The Guidelines for Examination of Patent Applications Under the 35 U.S.C. 112, paragraph 1, ‘Written Description’ Requirement (66 FIR 1099-1111, January 5,2001) state, ‘[p]ossession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was 'ready for patenting' such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the Applicant was in possession of the claimed invention’ (Id. at 1104). Moreover, because the claims encompass a genus of variant species, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. Factual evidence of an actual reduction to practice has not been disclosed in the instant specification, nor has Applicant shown the invention was ‘ready for patenting’. The Guidelines further state, ‘[f]or inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus' (Id. at 1106). For inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession. Instant claims are viewed as not meeting the written description provision of 35 U.S.C § 112, first paragraph.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4, 7-10, 12-13, 19-24, 28 and 47-50 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 7 is vague and indefinite because the current claim allows for alternative scenarios in reciting “or” and the claim currently recites that “one” or more coagulation-related biomarkers or “one” or more complement activity-related biomarkers. As is known in the art Vitronectin is a protein that links cell adhesion, coagulation, and the complement system. Vitronectin regulates coagulation by binding to platelets and inhibits the complement system by blocking Membrane Attack Complex formation. Therefore, Vitronectin is involved in both coagulation and complement activity and thus is associated with both coagulation and complement activity. As paragraph 0028 discloses Coagulation associated preeclampsia is characterized by altered expression of proteins that are involved in blood coagulation and complement-associated preeclampsia is characterized by altered expression of proteins that are involved in complement activity. Therefore, it is unclear how one can determine a specific subtype such as required in claim 7 if only vitronectin is assessed. Applicant is reminded that although the claims are read in light of the specification limitations from the specification are not read into the claims. Also, coagulation is encompassed by complement and thus appears to be synonymous in scope. The claim as currently recited does not appear to recite biomarkers that are specific to only one of the subtypes. Thus, how can one differentiate one subtype from another if the biomarker is known to be in both coagulation and complement activity. The claim appears to be lacking essentially elements for a clear understanding of differentiating subtypes based on coagulation and/or complement activity. Applicant is reminded that although the claims are read in light of the specification limitations from the specification are not read into the claims.
Claim 7 the recitation “complement activity-type preeclampsia” is vague and indefinite. The specification does not provide a definition for the term and the term is not well known in the art. Please clarify.
Claim 13 the recitations “an up-regulated biomarker” and “a down-regulated biomarker” is vague and indefinite because it is unclear if the applicant is referring to the biomarkers recited in claim 7 or another biomarker. Further, it is unclear if the applicant is referring to coagulation-related biomarker or the complement activity-related biomarker. Please clarify.
Claim 24, the phrase "e.g.," renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 50, the phrase "e.g.," renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). See deficiencies throughout the claim.
Claim 50, the recitation “(e.g., multiple linear regression (MLR), partial least squares (PLS) regression, principal components regression (PCR))” is vague and indefinite because it is unclear if the recitation contained within the parenthesis () are a part of the claim or not. See deficiencies throughout the claim.
Claim 50, line 4 the recitation “such as” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4-5 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The currently recited claims do not refer to a preceding claim (see MPEP 608.01(n)) and therefore fail to further limit the subject matter of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 4, 7-10, 12-13, 19-24, 28 and 47-50 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas and/or to laws of nature/natural phenomena without significantly more.
The U.S. Patent and Trademark Office recently revised the MPEP with regard to § 101 (see the MPEP at 2106). Regarding the MPEP at 2106, in determining what concept the claim is “directed to,” we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an “‘inventive concept’ sufficient to ‘transform’” the claimed judicial exception into a patent-eligible application of the judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82). In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field (see MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
See MPEP 2106.
ELIGIBILITY STEP 2A: WHETHER A CLAIM IS DIRECTED TO A JUDICIAL EXCEPTION
Step 2A, Prong 1
The is directed to a naturally occurring correlation between the levels of the recited biomarkers in subjects with coagulation-associated preeclampsia and/or complement activity-type preeclampsia.
Step 2A, Prong 2
There are no additional element steps that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception.
Also, with respect to the recitation “determining whether the subject is at increased risk of coagulation- associated preeclampsia or complement activity-type preeclampsia, wherein determining comprises associating a measure of one or more coagulation--related biomarkers and/or one or more complement activity-related biomarkers with coagulation-associated preeclampsia or complement activity-type preeclampsia;”. The “determining” and “associating a measure” statements at best articulates the judicial exception, amounting only to a general instruction to apply or use the judicial exception. This could read on mental activity being performed solely in a practitioner’ head, e.g. A mental appreciation of the recited biomarkers being with coagulation-associated preeclampsia or complement activity-type preeclampsia. No active method steps are invoked or clearly required; the “determining” and “associating” statements do not include any activity that would constitute a practical application, i.e. steps that apply, rely on or use the natural principle in a manner such that the claims amount to significantly more that the natural principal itself.
With respect to the “treating the subject” as recited in claim 7. Although the claim invokes administering a therapeutic intervention the claim, the claim currently recited “if the subject is determined to be at increased risk of coagulation-associated preeclampsia” and “if the subject is determined to be at increased risk of complement activity-type preeclampsia”. The recitation of “if” allows for the scenario when the subject is not at risk and thus allows for an embodiment wherein intervention will occur. Therefore, this scenario does not recite something significantly more than the judicial exception. Also, the currently recited claims allow for any and all generic therapeutic interventions including the “planning” or “strategy” of a treatment which would also be interpreted as a mental step and thus would not recite something significantly more than the judicial exception.
ELIGIBILITY STEP 2B: WHETHER THE ADDITIONAL ELEMENTS CONTRIBUTE AN "INVENTIVE CONCEPT"
Further, as stated supra there are not additional elements of the claims which apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception.
As shown by both below it is well known routine and conventional in the art to assess the values of the recited biomarkers.
It does not appear to be the case that the active steps recited, which are performed in order to gather the data or perform the assay, are steps recited or performed in an unconventional or non-routine way, such to provide an inventive concept under step 2B.
The claimed limitations as currently presented fail to recite limitations that add a feature that is more than well understood, conventional or routine in the field of diagnostics and biochemical assay methodologies.
For all of these reasons, the claims fail to include additional elements that are sufficient to either integrate the judicial exception(s) into practical application(s) thereof, or amount to significantly more than the judicial exception(s).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 4, 7-8, 12-13, 19-24, 28 and 47-50 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rosenblatt et al (WO 2019/152741) (submitted in the IDS filed 09/22/23).
Rosenblatt et al discloses a method for determining the risk of preeclampsia in a pregnant subject comprising assessing the measure of one or more biomarkers such as C1RL, GP1BA, VTNC, ZA2G and APOH (same markers as currently recited in claim 4) in a sample from the pregnant subject (e.g. para’s 0016). Rosenblatt et al discloses that the sample can be taken during the first or second trimester and can be taken during weeks 10-12 of gestation (e.g. para 0016). Rosenblatt et al discloses that the pregnant subject can have a singleton or multiple pregnancy (e.g. para 0016). Rosenblatt et al discloses that the pregnant subject can be primigravida (e.g. para 0016). Rosenblatt et al discloses that the subject can be asymptomatic (e.g. para’s 0016, 0027). Rosenblatt et al discloses the assessing can be by classification rule or ROC curve (e.g. abstract, para’s 0016, 0023). Rosenblatt et al also discloses the class rule classifying includes maternal age (e.g. para 0016). Rosenblatt et al discloses that the classification rule can employ cut-off, liner regression (e.g. para 0016). Rosenblatt et al discloses Rosenblatt et al discloses that the biomarkers may be involved with key physiological and developmental process such as coagulation and the complement system (e.g. para 0107). Rosenblatt et al discloses treating the subjects at increased risk of preeclampsia with targeted inhibitors of complement activation (e.g. para 0085).
With respect to “determining if the subject is at increased risk of complement activity-type preeclampsia” as currently recited. Rosenblatt et al discloses detecting and measuring the same biomarkers as currently recited and specifically teaches that one or more of the biomarkers can be complement C1 r subcomponent (complement biomarker). Thus, Rosenblatt et al is teaching a complement activity biomarker and teaching determining the subject of risk of preeclampsia wherein a known complement biomarker is associated with preeclampsia. Rosenblatt et al then teaches treating the subject with targeted inhibitors of complement activation. Therefore, Rosenblatt et al has determined a complement activity-type preeclampsia. Further, the specification does not provide a specific definition for “complement activity-type preeclampsia”. Also, it is unclear how the subtypes are differentiated and specifically diagnosed (see 112(b) supra. Thus, for the reasons stated above Rosenblatt et al reads on the instantly recited claims.
NOTE: It is noted that the Rosenblatt et al WO’ reference and the current application have inventors in common. However, there is no evidence explaining the involvement of Brian D. Brohman and Robert C. Doss and therefore the 102(a)(1) rejection has been made.
Claims 4, 7-8, 12-13, 19-24, 28 and 47-50 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Rosenblatt et al (US 2021/0050112) (submitted in the IDS filed 09/22/23).
Rosenblatt et al discloses a method for determining the risk of preeclampsia in a pregnant subject comprising assessing the measure of one or more biomarkers such as C1RL, GP1BA, VTNC, ZA2G and APOH (same markers as currently recited in claim 4) in a sample from the pregnant subject (e.g. para’s 0016). Rosenblatt et al discloses that the sample can be taken during the first or second trimester and can be taken during weeks 10-12 of gestation (e.g. para 0016). Rosenblatt et al discloses that the pregnant subject can have a singleton or multiple pregnancy (e.g. para 0016). Rosenblatt et al discloses that the pregnant subject can be primigravida (e.g. para 0016). Rosenblatt et al discloses that the subject can be asymptomatic (e.g. para’s 0016, 0027). Rosenblatt et al discloses the assessing can be by classification rule or ROC curve (e.g. abstract, para’s 0016, 0023). Rosenblatt et al also discloses the class rule classifying includes maternal age (e.g. para 0016). Rosenblatt et al discloses that the classification rule can employ cut-off, liner regression (e.g. para 0016). Rosenblatt et al discloses that the biomarkers may be involved with key physiological and developmental process such as coagulation and the complement system (e.g. para 0106). Rosenblatt et al discloses treating the subjects at increased risk of preeclampsia with targeted inhibitors of complement activation (e.g. para 0085).
With respect to “determining if the subject is at increased risk of complement activity-type preeclampsia” as currently recited. Rosenblatt et al discloses detecting and measuring the same biomarkers as currently recited and specifically teaches that one or more of the biomarkers can be complement C1 r subcomponent (complement biomarker). Thus, Rosenblatt et al is teaching a complement activity biomarker and teaching determining the subject of risk of preeclampsia wherein a known complement biomarker is associated with preeclampsia. Rosenblatt et al then teaches treating the subject with targeted inhibitors of complement activation. Therefore, Rosenblatt et al has determined a complement activity-type preeclampsia. Further, the specification does not provide a specific definition for “complement activity-type preeclampsia”. Also, it is unclear how the subtypes are differentiated and specifically diagnosed (see 112(b) supra. Thus, for the reasons stated above Rosenblatt et al reads on the instantly recited claims.
Claim Rejections - 35 USC § 103
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 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 9 is rejected under 35 U.S.C. 103 as being unpatentable over Rosenblatt et al (WO 2019/152741) or Rosenblatt et al (US 2021/0050112) in view of Rolnik et al (N Eng J Med, Vol. 77, No. 7, August 17, 2017, pages 613-622).
See above for the teachings of Rosenblatt et al (WO 2019/152741) and Rosenblatt et al (US 2021/0050112).
Rosenblatt et al (WO 2019/152741) and Rosenblatt et al (US 2021/0050112) differ from the instant invention in failing to teach treating with aspirin.
Rolnik et al teaches that it is known and conventional in the art to administer aspirin to a subject determined to be at risk of preeclampsia (p. 613). Rolnik et al teaches that treatment with low-dose aspirin in women at high risk for preeclampsia resulted in a lower incidence of this diagnosis (p. 613).
It would have been obvious before the effective filing date of the clamed invention to a person having ordinary skill in the art to incorporate the administration of aspirin such as taught by Rolnik et al into the method of Rosenblatt et al (WO 2019/152741) or Rosenblatt et al (US 2021/0050112) because Rolnik et al teaches that treatment with low-dose aspirin in women at high risk for preeclampsia resulted in a lower incidence of this diagnosis. Further, both Rosenblatt’s teach that the biomarkers may be involved with key physiological and developmental process such as coagulation and one of ordinary would administer a treatment such as aspirin which helps with the coagulation system. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating the administration of aspirin such as taught by Rolnik et al into the method of Rosenblatt et al (WO 2019/152741) or Rosenblatt et al (US 2021/0050112).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Rosenblatt et al (WO 2019/152741) or Rosenblatt et al (US 2021/0050112) in view of Feinberg (US 2007/029421).
See above for the teachings of Rosenblatt et al (WO 2019/152741) and Rosenblatt et al (US 2021/0050112).
Rosenblatt et al (WO 2019/152741) and Rosenblatt et al (US 2021/0050112) differ from the instant invention in failing to teach treating with aspirin.
Feinberg teaches that it is known and conventional in the art to treat subjects at risk of preeclampsia with an anti-complement antibody, a complement component inhibitor such as eculizumab (e.g. para’s 0020, 0037, 0066, 0101). Feinberg teaches that these antibodies are safe and efficient and office a protective/preventive role in averting the inflammatory symptoms of subjects at risk for preeclampsia (e.g. para 0020).
It would have been obvious before the effective filing date of the clamed invention to a person having ordinary skill in the art to incorporate the administration of eculizumab such as taught by Feinberg into the method of Rosenblatt et al (WO 2019/152741) and Rosenblatt et al (US 2021/0050112) because Feinberg teaches that these antibodies are safe and efficient and office a protective/preventive role in averting the inflammatory symptoms of subjects at risk for preeclampsia. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating the administration of eculizumab such as taught by Feinberg into the method of Rosenblatt et al (WO 2019/152741) and Rosenblatt et al (US 2021/0050112).
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Alrahmani et al (Current Hypertension Reports, 2018, 20:40, pages 1-8) teaches diagnostic approaches and treatment strategies for disorders of the complement alternative pathway (CAP) as related to preeclampsia.
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/GARY COUNTS/ Primary Examiner, Art Unit 1678