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 .
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.
DETAILED ACTION
Election/Restrictions
This action is in response to claim amendments filed 8/27/25. Claims 13-23 are pending.
Applicant’s election without traverse of Group II and the species of a detection agent for CD34, CD106 is not expressed at a normal level, the gene is not expressed at a normal level, CD34 is the additional gene or protein, the suppressing agent is an HDAC inhibiting agent, and neuropathy is the disease, disorder, or symptom, in the reply filed on 8/27/25 is acknowledged.
Claims 13 and 15-21 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claim 22 is withdrawn as being drawn to a non-elected species. Election was made without traverse in the reply filed on 8/27/25.
Claims 14 and 23 are under examination.
Drawings
The drawings are objected to because:
In figures 1-3, the labels on both the x and y axis for the four graphs on the left are illegible.
In figure 6, the labeling on the x and y axis for the Hoechst graphs are illegible.
In figures 7A-7D, the labeling on the x and y axis for the top row is illegible.
Figure 11 is described in the brief description of the drawings as showing blue, green, and red. However, no color drawings have been submitted. Thus, the submitted drawing fails to show the details set forth in the description.
In figures 12-13, the labels on both the x and y axis for the four graphs on the left are illegible.
In figure 14, the lines cannot be distinguished. In the legend of the top graph, it appears that “no treatment” might be a square and “CD106” might be a diamond, yet the graph appears to use circles for both. The bottom graph appears to use circles for both groups on the graph and in the legend. The color for the groups and lines in both appears to be the same shade of grey and so cannot be distinguished.
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.
Claim Objections
Claim 14 is objected to because of the following informalities:
The claim recites several options for diagnosis –
Diabetes mellitus OR
Diabetes mellitus and/OR
A disease, disorder, and/or symptom associated with diabetes mellitus OR
A risk [of a disease, disorder, and/or symptom associated with diabetes mellitus]
As evident from the above, the claim lists diagnosing “diabetes mellitus” twice, i.e., “diabetes mellitus or diabetes mellitus or”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
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) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(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) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a detection agent for CD34” in claim 23.
The first step of the analysis is to determine that, even without an explicit “means for”, if the claim uses a generic placeholder. These terms are non-structural terms that have no specific structural meaning. “Agent” does not imply any particular or specific structure. A person of ordinary skill in the art would understand that an agent would include a small molecule, chemical, protein, peptide, antibody, siRNA, mRNA, or any number of other potential molecules. No specific structure would be required for such a term and thus, “agent for” is equivalent to “means for”.
The second step is that the generic placeholder term is modified by functional language. While typically this functional language comes after the “for”, this is not a requirement. In this case, the “agent” is modified by “detection” and “for CD34”. Taken together, the agent is modified by the functional language of for detection of CD34.
The third step is evaluating any additional structure, material, or acts that modify the placeholder. In this case, no such additional language exists in the claim.
As such, the phrase “a detection agent for CD34” is interpreted under a “means for” analysis in accordance with 35 USC §112(f).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/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 this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth 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 14 and 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.
Claim 14, in the preamble, states that the method is “for” a series of alternatives. This list includes four uses of “or” and two uses of “and”. This makes the list unclear as to which elements modify the other elements. For example, “or a risk thereof” is currently being interpreted as “a risk [of a disease, disorder, and/or symptom associated with diabetes mellitus]”. However, this is not the only reasonable interpretation. This risk “thereof” may only be modifying the most recent preceding element of the list, e.g., a risk [of a symptom associated with diabetes mellitus]. It may also modify every element, such as including a risk [of diabetes mellitus]. The use of multiple conjunctions in the same list makes multiple interpretations both possible and reasonable, leading to indefiniteness in the claim scope.
Claim 14 also recites “diabetes mellitus and/or a disease, disorder, and/or symptom associated with diabetes mellitus”. Where this is either “and” or “or”, it is reasonable that this represents a separate element in the list as described above. However, it is also possible that this is “diabetes mellitus and/or a disease, disorder, and/or symptom associated with diabetes mellitus”. Where this is “and”, one reasonable interpretation is that the subject is one that has both diabetes mellitus (DM) AND a disease, disorder, or symptom associated with diabetes mellitus. This would justify the inclusion of “diabetes mellitus” as both the first and second element in the claim list since the first is having just the disease, while the second is having the disease AND an associated disease/symptom. However, this interpretation is undermined by the use of “and/or”, clearly indicating the subject need not have diabetes mellitus at all, but only a disease or symptom associated with DM (“diabetes mellitus” OR “a disease, disorder…associated with [DM]”). This renders the term “associated” indefinite. Where a subject has DM, the associated conditions, e.g., neuropathy, Alzheimer’s disease, skin symptoms, or cancer, are caused by the comorbid DM; see p.25 for a list of examples of associated conditions. When the claim makes clear that the subject does not have DM, by using “or”, then these symptoms clearly cannot be caused by a comorbid DM in which case the broadest, reasonable interpretation is that these diseases, conditions, and symptoms are known to be associated with DM—as in, subjects with DM are known to have a higher incidence of these conditions than those without DM—but include these conditions even where they are not caused by DM. For example, p.25 of the specification lists “leg cramp” as an associated symptom. The BRI of the claim would therefore include diagnosing leg cramp—which is a symptom associated with DM—in subjects that do not have DM but instead have leg cramps caused by exercise or electrolyte imbalances (Young; form 892). The instant specification does not explicitly redefine the claimed phrase but notes that the phrase “associated” can include any such condition “associated”. In other words, the specification does not clarify if “associated” means DM must be comorbid/causative or if the condition merely needs to be known to have some association with DM irrespective of why a particular subject has the condition.
The term “risk” in claim 14 is a relative term which renders the claim indefinite. The term “risk” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Throughout the specification, the word “risk” is not defined nor is any particular example provided of someone “at risk” of DM or a symptom associated with DM. The broadest, reasonable interpretation is that this term encompasses any subject who might in some way develop DM or an associated symptom. For example, all humans have a non-zero risk of developing diabetes mellitus at some point in their lives. In the same way, all humans are at risk of a leg cramp. In another interpretation, there is some level of increased risk when compared to a general population. This is supported when disclosing the levels of certain biomarkers, such as the level of CD106 in a KSL cell population when comparing NOD mice to ICR mice (p.75; example 2). However, under this interpretation, it remains indefinite as to what this “threshold” is to establish a subject is “at risk” and that threshold will be dependent on what is being measured and what groups are being compared. The claim requires detecting abnormal HSC, but there are multiple ways in which HSC might be abnormal; see specification p.2 L23-27 where the cell is abnormal by not expressing CD106 at a “normal” level and p.3 L3-7 where the cell is abnormal by not expressing the CD34 gene or TNFα protein at a “normal” level. It is unclear what meets the limitations of “at risk” and so the claim scope is indefinite.
The same logic applies to the term “abnormal”. The claim recites detecting “an abnormal hematopoietic stem cell (HSC) in the subject” but does not define the term “abnormal”. As above, an HSC may be abnormal in different ways and it is unclear if the cell must be abnormal in some specific way, if being abnormal in any particular aspect is sufficient, or if the cell must be abnormal in a combination of aspects disclosed by the specification. Where an HSC does not express “normal” levels of CD106 but expresses “normal” levels of TNFα, the cell is both normal and abnormal depending on what is being evaluated, leading to confusion over the scope of the claims.
The preamble itself also introduces indefiniteness. When reading the preamble in the context of the entire claim, it is unclear if the recitation “a method for diagnosing” is limiting. In one case, the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. The claim provides a single active method step (detecting) where the claim may be complete after said detection. The use of “for” may be only an intended use which does not modify the steps of the method itself. In that case, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
On the other hand, “a method for diagnosing” may be similar to “a method of diagnosing”. In that case, rather than just an intended use, it describes a necessary outcome: after detection, a diagnosis must be provided. Supporting this interpretation is the use of “diagnosing” in the preamble and the general disclosure including embodiments where a diagnosis is provided. Weighing against this interpretation is that there is no actual diagnostic step required and detection without ultimate diagnosis is also disclosed. Taking the evidence as a whole, it is unclear if this is 1) a method of diagnosing or 2) a method of detection “for” diagnosing.
Claim 23 recites the limitation "the abnormal HSC detection agent". There is insufficient antecedent basis for this limitation in the claim. The claim depends from claim 14. Claim 14 recites “detecting” abnormal HSC but does not recite an “agent” nor does the claim require detecting with an “agent”. Thus, there is insufficient antecedent basis for “the…agent”.
Regarding the phrase “detection agent for CD34”, when interpreting the phrase under §112(f), the necessary description must be disclosed in the specification in a way that one skilled in the art will understand what structure will perform the recited function (MPEP §2181(II)(A)). The MPEP is explicit that if there is no disclosure of structure, material or acts for performing the recited function, the claim fails to satisfy the requirements of 35 U.S.C. 112(b). The specification discloses that CD34 was detected but does not describe the structure or materials required to do so. The MPEP also states that such disclosure may be implicit if it would have been clear to those skilled in the art what structure (or material or acts) corresponds to the means- (or step-) plus-function claim limitation. See id. at 1380, 53 USPQ2d at 1229; In re Dossel, 115 F.3d 942, 946-47, 42 USPQ2d 1881, 1885 (Fed. Cir. 1997). However, “[a] bare statement that known techniques or methods can be used does not disclose structure” in the context of a means plus function limitation. Biomedino, LLC v. Waters Technology Corp., 490 F.3d 946, 952, 83 USPQ2d 1118, 1123 (Fed. Cir. 2007).
In this case, there must have been some agent used to detect CD34. Thus, implicitly, there was a structure; however, depending on what agent was used, that structure could have varied significantly such that the skilled artisan could not envisage the particular structure required across the whole of the genus claimed. Essentially, the disclosure is generic to the level of claiming “known agents” in the context of the means-plus-function limitation. Thus, under a §112(f) analysis, the claims are indefinite because there is insufficient description of a structure—either explicit or implicit—in the disclosure to understand the structure required to perform the claimed function.
Therefore, claims 14 and 23 are indefinite.
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 14 and 23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (observation of a natural phenomenon) without significantly more.
Step 1: It must first be determined if the claim is to a statutory category and, if so, proceed to step 2A prong 1. Claims 14 and 23 are methods and fall within the statutory category of a process.
Step 2A, prong 1: Prong 1 requires the Examiner to evaluate whether the claim recites a judicial exception and, if so, proceed to prong 2. In this case, the claim recites “diagnosing diabetes” comprising “detecting an abnormal…HSC in the subject”. A preamble is given weight where it breaths life and meaning into the claim. As set forth in the §112(b) rejection above, it is unclear if the preamble recites an implicit step of diagnosing. Under the interpretation where this claim is more than just a detection method, the claim must require diagnosis correlated to the detection of abnormal HSCs and so recites a judicial exception.
Step 2A, prong 2: Prong 2 requires the Examiner to evaluate whether the claim recites additional elements that integrate the exception into a practical application of that exception and, if not, proceed to step 2B. In order to integrate the recited judicial exception into a practical application, the claim will apply, rely on, or use the judicial exception that imposes a meaningful limit such that the claim is more than a drafting effort to monopolize the judicial exception. Examiners evaluate integration by identifying additional elements in the claim beyond the judicial exception and evaluating those elements individually and in combination to determine whether they integrate the exception in to a practical application. Examples that have been found by the Courts in which the exception was not integrated into a practical application include:
Mere instructions to implement an abstract idea on a computer
Adding generic instructions that the judicial exception should be used ("apply it")
Adding insignificant extrasolution activity to the exception ("mere data gathering")
Generally linking the use of the exception to a particular technological environment or field of use
In this case, there are no steps after the “diagnosis” and so no application of the judicial exception. The observation of the judicial exception—the detection—is part of the judicial exception. However, even if considering the detection is additional to the JE, the detection is recited at such a high level of generality—detection using any possible means—the step is no more than insignificant extrasolution activity, e.g., “mere data gathering” or gathering the required information to observe the natural phenomenon.
For claim 23, detection is performed using a “detection agent” for CD34. Thus, the judicial exception is the level of CD34 on abnormal HSCs and the diagnosis. The agent is additional to the JE but is generic and directed to the necessary data gathering, i.e., is insignificant extrasolution activity.
Step 2B: Where a claim does not integrate the exception, a claim may nevertheless be patent eligible, for example where additional elements are “significantly more” than the exception such that the additional elements were unconventional in combination. Considerations include whether or not the claim adds a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present; or simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present. In this case, the only potential element which is more than the JE is the detection using a detection agent. However, the claims do encompass all known means of detecting the HSCs and all known agents for detecting CD34. It would have been routine and conventional at the time of filing to “detect CD34” with a “detecting agent of CD34” as the latter encompasses, by definition, every possible agent and method for doing so. This is also similar to “determining the level of a biomarker in blood by any means”, which is an enumerated fact pattern which is well-understood, routine, and conventional as recognized by the Courts (MPEP §2106.05(d)(II)).
Therefore, claims 14 and 23 are patent ineligible. Note the above rejection does not apply under the interpretation where the claimed method only requires the detection step. If no diagnosis is performed, i.e., the preamble is only an intend use and not a required outcome, then there is no judicial exception recited by the claim.
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.
Claim(s) 14 and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ferraro (form 892).
Regarding claim 14, Ferraro teaches Hematopoietic stem/progenitor cells (HSPC; abstract), which meets the limitations of the instantly claimed HSCs. The instant specification defines “hematopoietic stem cell” as “a stem cell capable of differentiating into a blood cell” (specification p.27 L33), which is a capability of HPCs. The instant specification also uses the terms interchangeably; see e.g., p.90 L14-19, describing the “effect of eliminating an abnormal hematopoietic stem cell” by quantifying “bone marrow progenitor cells”. Ferraro uses the term “hematopoietic stem/progenitor cells”, suggesting that “stem” and “progenitor” are synonyms or at least that the discussion of HSPC is a description of the characteristics of both “stem” and “progenitor” cells. Similar to the instant specification, Ferraro also uses the terms seemingly interchangeably; see e.g., the abstract describing “HSPC mobilization defects” and the introduction describing the same phenomenon as “impairs HSC mobilization”.
Ferraro teaches using flow cytometry to collect blood from mice (p.3). The blood was assessed and poor HSPC mobilization was detected. This meets the limitations of “detecting an abnormal [HSC] in the subject” because poor HSPC mobilization meets the limitation of “abnormal” HSC and these cells/abnormalities were detected. The blood came from mice, which meets the limitation of “in the subject”.
In one interpretation, this meets all of the limitations of the claim, i.e., where diagnosis is not actually a required step. However, Ferraro teaches diabetes—specifically diabetes mellitus—impairs HSC mobilization (p.2 Introduction, Results) and so a determination that HSCs have impaired mobilization meets the limitations of “diagnosing a symptom associated with diabetes mellitus”.
Regarding claim 23, Ferraro teaches using a CD34 detection agent; p.9 “for detection we used lineage-streptavidin conjugated with…PeCy5 (CD34)”. See also p.2 describing the “amount of CD34+ cells/kg was lower in diabetic”, indicating that CD34 status was detected and that this detection was of abnormal (lower amount) HSCs.
Therefore, claims 14 and 23 are anticipated.
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(s) 14 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ferraro.
The above rejection sets forth why Ferraro is deemed to anticipate the claims. However, Ferraro uses subjects with a known diabetes status and does not explicitly diagnose diabetes. However, the instant claim for diagnosing diabetes would have been obvious. The teachings and rationale above are incorporated herein. Further, Ferraro directly attributes the abnormal HSC mobilization and CD34+ HSCs to diabetes mellitus, e.g., p.2 Results. Throughout the document, Ferraro directly correlates poor HSC mobilization to DM and detects the abnormal HSCs through CD34, e.g., figure 1, abstract (“diabetes correlated with lower CD34+ cell mobilization”; “we found impaired HSPC egress from…diabetic animals”; “HSPC aberrantly localized within…diabetic animals”; “HSPC mobilization defects in diabetic patients).
Taken as a whole, Ferraro clearly teaches the correlation between diabetes and abnormal CD34+ HSCs. While Ferraro starts with known diabetic status, it would have been obvious to utilize the same method to diagnose diabetes with a reasonable expectation of success as the abnormal CD34+ HSCs are clearly correlated to/indicative of diabetes mellitus as taught by Ferraro.
Therefore, claims 14 and 23 would have been obvious.
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.
Claims 14 and 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-3, 5-6, 8-12, 20-21, 23-30, and 32 of copending Application No. 18548023 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claim 14 is a method of diagnosing diabetes mellitus comprising detecting an abnormal HSC in the subject. Reference claim 21 is the same method with the addition that the detecting step is “based on” an HDAC gene or protein expression. Thus, reference claim 21 anticipates instant claim 14.
Instant claim 23 requires the abnormal HSC detection step is performed using a detection agent for CD34. Reference claim 21 is also directed to detecting abnormal HSCs. While the abnormality is “based on” HDAC gene/protein expression, the claim does not explicitly claim the means by which the HSCs are detected, motivating one of ordinary skill in the art to use known methods of detecting HSCs. Lemos teaches “quantification of CD34+ cells by flow cytometry is widely used in the clinical practice as an indirect indicator of hematopoietic progenitor cells” (p.214 C1) and teaches detection with a monoclonal antibody (p.214 C2). Thus, it would have been obvious to use the antibody of Lemos, which meets the limitations of a CD34 detection agent, to detect CD34 and thereby quantify the HSCs. One would have been motivated to do this because the method of the reference claim requires detection of gene expression in HSCs and CD34 detection is a widely accepted way of identifying HSCs in order to then proceed to such gene analysis.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
While currently non-elected, the instant application still has claims 13 and 15-21 pending. These claims appear patentably indistinct from claims 17, 19-21, and 24-28 of Application No. 17/769710, though they have not been examined. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
No double patenting rejection was made over application 17/769710 because the elected invention is a diagnostic method with no treatment step while the reference claims are a treatment method with no diagnostic step. As such, they are considered patentably distinct.
Conclusion
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/Adam Weidner/ Primary Examiner, Art Unit 1675