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 .
Detailed Action
Summary
This is the Final Office Action based on application 17/760249 response filed 12/26/2025.
Claims 1-5, 9, 14, & 16-22 have been elected, and fully considered.
Claims 10-13 are withdrawn from consideration.
Claims 6-8 & 15 are cancelled.
Claims 21-22 have been newly added.
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 ofmatter, or any new and useful improvement thereof, may obtain a patent therefor, subject to theconditions and requirements of this title.
The claimed invention of Claims 1-5, 9, 14, & 16-22 are directed to non-statutory subject matter.
The invention of instant claims for independent claims 1 & 14 are drawn towards a method treating a disease or medical conditions. However, as instantly considered as a whole the claim is drawn towards the judicial exceptions which are a combination of a natural correlation and abstract idea without significantly more to make the claims move past these judicial exceptions.
Through 101, inquiry:
Inquiry: Are the claims directed to a statutory category of invention?
Yes, independent Claims 1 & 14 and all claims depending therefrom are drawn towards a statutory category (a method).
Step 2A, Prong 1: Do the claims involve a Judicial Exception?
Yes, independent Claims 1 & 14 and those that depend therefrom though are drawn towards “treating,” involve the judicial exception of lipid biomarker in sebum correlation to if patient has a disease or medical condition or not. The claimed diagnosing (even if that word is not used), it is implicitly there, on the basis of level of biomarker compared to a normal level of biomarker is a natural correlation. This is a law of nature judicial exception. See USPTO subject matter eligibility example 29. This is particularly the case, since the claimed treatment is not particular or specific.
Further, instant independent Claims 1 & 14 contain the step “identifying,” which through broadest reasonable interpretation is a mental process/abstract idea. This is another type of judicial exception of an abstract idea
See MPEP 2106.03 & 2106.04.
Claim 14 had an additional amendment on 12/26/2025 that the “identifying,” is that the lipids are elevated or reduced in comparison to a reference. This “identifying,” based on comparison to a reference is a mental comparison which is an abstract idea and the correlation of levels = disease is part of the natural correlation which is another judicial exception so this is part of the judicial exceptions themselves.
Step 2A, Prong 2: Has the natural correlation or abstract idea been integrated into a particular practical application?
In Claim 1, there is no particular integration into a practical application.
In addition to the claimed judicial exceptions, the additional steps are required for Claims 1 & 14:
Performing either ambient ionization, ion mobility, and/or liquid chromatography mass spectrometry;
Treating the subject if found to have disease or condition with “effective amount,” of treatment.
For the specific types of detection claimed, especially at the level of generality claimed—these are just used as data pulls/mere data gathering to accomplish the judicial exceptions so is insignificant extra-solution activity MPEP 2106.05 (g) for insignificant extra-solution activity.
For the claimed treating of the subject, as claimed not particular treatment is claimed and the claimed treatment is very general. Therefore, this is not particular or specific, but instead is akin to claiming, “administering a suitable medication,” even when claimed as administering a therapeutically effective amount since no specific treatment is claimed for the disease, and also since the claims are left open to no treatment occuring. Therefore, this does not practically apply the judicial exceptions. See MPEP 2016.04 (d)(2):
“Consider a claim that recites the same abstract idea and “administering a suitable medication to a patient.” This administration step is not particular, and is instead merely instructions to “apply” the exception in a generic way.”
Further, it was added in amendments dated 12/26/2025 to both independent Claims 1 & 14 that the method also comprises, “collecting a sebum sample from the subject, wherein collecting the sebum sample comprises swabbing the back of the subject with a medical gauze, absorbent paper or cotton wool, or scraping the back of the subject with a rigid implement.” This also is not integration into a practical application from the standpoint of patent eligible subject matter.
Collecting sample by swab, absorbent paper, or rigid implement is data collecting and in combination with the claimed mass spectrometry remains mere data gathering used to perform the judicial exception. Data gathering has been shown to be insignificant extra-solution activity so is not a particular practical application. See MPEP 2106.05 (g).
Claim 14 had an additional amendment on 12/26/2025 that the “identifying,” is that the lipids are elevated or reduced in comparison to a reference. This “identifying,” based on comparison to a reference is a mental comparison which is an abstract idea and the correlation of levels = disease is part of the natural correlation which is another judicial exception so therefore as this is part of the judicial exceptions themselves, does nothing to practically apply.
Step 2B: Do the claims recite any elements which are significantly more than the natural correlation or abstract idea?
In addition to the claimed judicial exceptions, the additional steps are required for Claims 1 & 14:
Performing either ambient ionization, ion mobility, and/or liquid chromatography mass spectrometry;
Treating the subject if found to have disease or condition with “effective amount,” of treatment
With respect to both of the above steps, especially at the level of generality claimed- all these things, are well understood, routine and conventional (WURC) in the art. There is nothing claimed which requires the claimed biomarkers to be derivatized or processed in any way which is not WURC, and further no unconventional way of performing a comparison nor a particular or specific, unconventional treatment is claimed. Therefore, this is standard laboratory technique and is not sufficient to show an improvement in technology or add significantly more. See MPEP 2106.05 (a) & MPEP 2106.05 (d).
Further, it was added in amendments dated 12/26/2025 to both independent Claims 1 & 14 that the method also comprises, “collecting a sebum sample from the subject, wherein collecting the sebum sample comprises swabbing the back of the subject with a medical gauze, absorbent paper or cotton wool, or scraping the back of the subject with a rigid implement.” This also is not integration into a practical application from the standpoint of patent eligible subject matter.
Collecting sebum samples, and particularly collecting the samples by swab, absorbent paper, or rigid implement is well understood, and routine and conventionally (WURC) done in the art. This is a standard laboratory practice and is not sufficient to show an improvement in technology or add significantly more. See MPEP 2106.05 (a) & MPEP 2106.05 (d).
Claim 14 had an additional amendment on 12/26/2025 that the “identifying,” is that the lipids are elevated or reduced in comparison to a reference. This “identifying,” based on comparison to a reference is a mental comparison which is an abstract idea and the correlation of levels = disease is part of the natural correlation which is another judicial exception so therefore as this is part of the judicial exceptions themselves, does nothing to add significantly more.
The dependent claims are reviewed for additional limitations dependent on the independent claim above.
Claim 2 adds that paper spray ionization mass spectrometry is used. Again, especially at the level of generality claimed, this is used for mere data gathering to accomplish the judicial exception so does not add practical application at step 2A/2. Also- at the level of generality claimed, this technique is WURC so does not add significantly more at step 2B.
Claims 3-5 & 17-19 claim what the molecular mass of the lipids measured are. This molecule being detected is part of the judicial exception itself, and the molecular weight is just a material property. Therefore- this does not change the analysis given already above.
Claims 9 & 16 specify the disease or conditions which are identified or detected. The disease or condition is part of the judicial exception itself, so this does not change the analysis given already above.
Claim 20, adds that when the disease is Parkinson’s, the therapeutically effective treatment is a neuroprotective agent. Though this is slightly more specific given the claiming of a neuroprotective agent, this is still not considered a particular and specific treatment since it seemingly can be administered when the measured level of any lipid is above or below a control/reference, so it is seemingly administered all the time for any lipid detected in a Parkinson’s patient. Further things like antioxidants (found in things like orange juice) can be considered neuroprotective. Many people drink orange juice on a daily basis. Therefore, this is not considered particular or specific treatment at step 2 A/2 and also it can be considered WURC at step 2B.
Claim 21 specifies what the lipids are. The lipids are part of the claimed judicial exception/natural correlation itself. Therefore, this does nothing to practically apply nor does it add significantly more to the claimed judicial exceptions.
Claim 2s specifies what the lipids are. The lipids are part of the claimed judicial exception/natural correlation itself. Therefore, this does nothing to practically apply nor does it add significantly more to the claimed judicial exceptions.
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.
Claim 1-5, 9, 14, & 16-22 which depend from Claim 1 and 14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for certain types of diseases or conditions and treatments, does not reasonably provide enablement for the realm of what can be encompassed by these terms. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
This decision was made in taking into consideration all of the Wand’s factors including:
(A) The breadth of the claims: It is noted that these claim terms encompass a broader scope than what is actually described in the instant specification. The specification focuses on diagnosis and treatment of Parkinson’s disease, and mentions other conditions like cancer (though presumably not all types of cancers, since this method would not work for ALL cancers, and tuberculosis). The specification also gives examples for the method working for COVID (paragraph 0182) and ischaemic heart disease (paragraph 0205-0206), and hypertension (paragraphs 0085-0086). This also applies to the claimed treatments and effective treatments as treatment with neuroprotective agents are disclosed, and treatments with things like lipid lowering agents and statins (paragraph 0204, 0017), but again not all treatments for all diseases are disclosed.
(B) The nature of the invention: The nature of this invention is such that any and every disease and or treatment which could be encompassed by these terms would not actual be able to be detected or used to treat the patient.
(C) The state of the prior art: There are so many diseases present and treatments available in the art one would not be able to just guess diseases or treatments that fit within the overly broad ones claimed that would work.
(D) The level of one of ordinary skill: The level of ordinary skill in this art is high, though even given that is the case, one would not be able to just guess diseases and or treatments that fit within the overly broad ones claimed that would work.
(E) The level of predictability in the art: The level of predictability of what might work and what wouldn’t is not high when considering any and every disease and any and every treatment possible.
(F) The amount of direction provided by the inventor: The inventor does provide some amount of direction for the diseases/conditions and treatments shown above, but again does not provide enough direction to show how one would be able to effectively treat or effectively detection diseases in any and every possibility encompassed by these terms.
(G) The existence of working examples: The inventor does provide working examples (for the diseases and treatments as shown above), but again there is not direction enough that would support effective use or detection of any and every disease and/or treatment which could be encompassed by these terms.
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure: There are so many treatments which could be encompassed by these terms, and so many diseases, that the quantity of experimentation would be high and consequential for someone to determine if any and every treatment and disease encompassed by these terms would work.
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 1-5, 9, 14, & 16-22 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.
The term “back” in claims 1 & 14 is a relative term which renders the claim indefinite. The term “back” 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. Back is relative since what is considered the “back,” of a patient can be different dependent on how the patient is positioned and also dependent on which body part is sampled. Further a patient can be moving so the “back,” can change.
Claims 2-5, 9, & 16-22 are rejected by virtue of being dependent on Claims 1 & 14.
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 non-obviousness.
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, 16-19 & 22 is/are rejected under 35 U.S.C. 103 as being unpatentable by SPETZLER in US 20130178383 in view of SPETZLER2 in AU 2011291599 (PCT/US2011/048327).
With respect to Claim 14, SPETZLER teaches of a method for assessing biomarkers for diagnostic, therapy-related or prognostic methods to identify phenotypes, such as a condition or disease, or the stage or progression of a disease. Circulating biomarkers from a bodily fluid can be used in profiling of physiological states or determining phenotypes. These include nucleic acids, protein, and circulating structures such as vesicles. Biomarkers can be used for theranostic purposes to select candidate treatment regimens for diseases, conditions, disease stages, and stages of a condition, and can also be used to determine treatment efficacy (abstract).
SPETZLER further teaches that the body sample/ bodily fluid can be sebum (paragraph 0010, 0159, Table 1), and also that the biomarkers in the sample can be lipids (paragraph 0002, 0015, 0180).
SPETZLER further teaches that the biomarkers go through a filtration module and that the filtration module retains molecules greater than about 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 250, 300, 400, or 500 kiloDaltons (kDa) (paragraph 0205).
SPETZLER teaches of analyzing the sample by mass spectrometry (paragraph 0264, 0293, 0749), comparing them to see if they are increased or decreased in comparison to a reference or control sample (paragraph 0169) and then also determining and administering effective treatment (administering therapeutically effective treatment if patient has a disease) (paragraph 0335, 0907, 0929, 0008, 0332, 0364). SPETZLER further teaches of analyzing by liquid chromatography mass spectrometry (paragraph 0779, 1025-1026).
SPETZLER does not specifically teach of the swabbing taking a sample from the neck.
SPETZLER2 is used to remedy this. SPETZLER2 further teaches of a method for assessing biomarkers for disease (abstract), wherein sebum is the sample (paragraph 0010) and further wherein the sebum sample can be collected from the neck of the patient (Table 1), and wherein the sample is collected by using a swab (paragraph 0184).
It would have been obvious to one of ordinary skill in the art to use a neck swab sample as is done in SPETZLER2 in the method of the SPETZLER due to the advantage this has shown in being an illustrative biological sample for many conditions and diseases (SPETZLER2, Table 1).
With respect to Claim 16, SPETZLER teaches that the disease which is assessed being hypertensions (paragraph 0943).
With respect to Claim 17, SPETZLER teaches that the body sample/ bodily fluid can be sebum (paragraph 0010, 0159, Table 1), and also that the biomarkers in the sample can be lipids that are detected/analyzed (paragraph 0002, 0015, 0180). SPETZLER further teaches of collecting the microvesicles/biomarkers that are retained in the device (Claim 1), and that the filtration module retains molecules greater than about 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 250, 300, 400, or 500 kiloDaltons (kDa) (paragraph 0205). Therefore- on the low end, SPETZLER teaches of retaining and detecting molecules which are 50,000 da, which reads on the claimed > or = 700 da.
With respect to Claim 18, SPETZLER teaches that the body sample/ bodily fluid can be sebum (paragraph 0010, 0159, Table 1), and also that the biomarkers in the sample can be lipids that are detected/analyzed (paragraph 0002, 0015, 0180). SPETZLER further teaches of collecting the microvesicles/biomarkers that are retained in the device (Claim 1), and that the filtration module retains molecules greater than about 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 250, 300, 400, or 500 kiloDaltons (kDa) (paragraph 0205). Therefore- on the low end, SPETZLER teaches of retaining and detecting molecules which are 50,000 da, which reads on the claimed > or = 1000 da.
With respect to Claim 19, SPETZLER teaches that the body sample/ bodily fluid can be sebum (paragraph 0010, 0159, Table 1), and also that the biomarkers in the sample can be lipids that are detected/analyzed (paragraph 0002, 0015, 0180). SPETZLER further teaches of collecting the microvesicles/biomarkers that are retained in the device (Claim 1), and that the filtration module retains molecules greater than about 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 250, 300, 400, or 500 kiloDaltons (kDa) (paragraph 0205). Therefore- on the low end, SPETZLER teaches of retaining and detecting molecules which are 50,000 da, which reads on the claimed > or = 1200 da.
With respect to Claim 22, SPETZLER teaches that the biomarkers in the sample can be lipids (paragraph 0002, 0015, 0180) and more specifically that the lipid can be ceramides, phosphatidylcholines (Table 2,9) or lipopolysaccharides (which are glycolipids) (paragraph 0986).
Claims 1-5, 9, & 2-21 are rejected under 35 U.S.C. 103 as being unpatentable by SPETZLER in US 20130178383 in view of SPETZLER2 in PCT/US2011/048327 and further in view of PRINGLE in US 20180103935.
With respect to Claim 1, SPETZLER teaches of a method for assessing biomarkers for diagnostic, therapy-related or prognostic methods to identify phenotypes, such as a condition or disease, or the stage or progression of a disease. Circulating biomarkers from a bodily fluid can be used in profiling of physiological states or determining phenotypes. These include nucleic acids, protein, and circulating structures such as vesicles. Biomarkers can be used for theranostic purposes to select candidate treatment regimens for diseases, conditions, disease stages, and stages of a condition, and can also be used to determine treatment efficacy (abstract).
SPETZLER further teaches that the body sample/ bodily fluid can be sebum (paragraph 0010, 0159, Table 1), and also that the biomarkers in the sample can be lipids (paragraph 0002, 0015, 0180).
SPETZLER further teaches that the biomarkers go through a filtration module and that the filtration module retains molecules greater than about 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 250, 300, 400, or 500 kiloDaltons (kDa) (paragraph 0205).
SPETZLER teaches of analyzing the sample by mass spectrometry (paragraph 0264, 0293, 0749), comparing them to see if they are increased or decreased in comparison to a reference or control sample (paragraph 0169) and then also determining effective treatment (administering therapeutically effective treatment if the patient has the disease). (paragraph 0335, 0907, 0929, 0008, 0332, 0364). SPETZLER further teaches of analyzing by liquid chromatography mass spectrometry (paragraph 0779, 1025-1026).
SPETZLER does not specifically teach of the swabbing taking a sample from the neck.
SPETZLER2 is used to remedy this. SPETZLER2 further teaches of a method for assessing biomarkers for disease (abstract), wherein sebum is the sample (paragraph 0010) and further wherein the sebum sample can be collected from the neck of the patient (Table 1), and wherein the sample is collected by using a swab (paragraph 0184).
It would have been obvious to one of ordinary skill in the art to use a neck swab sample as is done in SPETZLER2 in the method of the SPETZLER due to the advantage this has shown in being an illustrative biological sample for many conditions and diseases (SPETZLER2 Table 1).
SPETZLER and SPETZLER2 does not teach of using specifically ambient ionization mass spectrometry and ion mobility mass spectrometry.
PRINGLE is used to remedy this and further teaches of a method of using ion mobility and or mass spectrometry, in which the method used may be an ambient ionization method (abstract). PRINGLE further teaches of using these methods to detect lipid samples (paragraph 0034, 0076, 0148, 0175-0176).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use ambient ionization and ion mobility as is done in PRINGLE in the method of SPETZLER due to the advantages these techniques offer for real time rapid and direct analysis (paragraph 0072, 0100) and due to the advantage mixing with ion mobility allows for determination of properties in real time (PRINGLE, paragraph 0103).
With respect to Claim 2, SPETZLER teaches of the above, but does not teach of using paper spray ionization. PRINGLE is used to remedy this and teaches of paper spray (paragraph 0108, 0115).
It would have been obvious to one of ordinary skill in the art at the time of the invention to use ionization and ion mobility as is done in PRINGLE in the method of SPETZLER due to the advantages these techniques offer for real time rapid and direct analysis (paragraph 0072, 0100) and due to the advantage mixing with ion mobility allows for determination of properties in real time (PRINGLE, paragraph 0103).
With respect to Claim 3, SPETZLER teaches that the body sample/ bodily fluid can be sebum (paragraph 0010, 0159, Table 1), and also that the biomarkers in the sample can be lipids that are detected/analyzed (paragraph 0002, 0015, 0180). SPETZLER further teaches of collecting the microvesicles/biomarkers that are retained in the device (Claim 1), and that the filtration module retains molecules greater than about 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 250, 300, 400, or 500 kiloDaltons (kDa) (paragraph 0205). Therefore- on the low end, SPETZLER teaches of retaining and detecting molecules which are 50,000 da, which reads on the claimed > or = 700 da.
With respect to Claim 4, SPETZLER teaches that the body sample/ bodily fluid can be sebum (paragraph 0010, 0159, Table 1), and also that the biomarkers in the sample can be lipids that are detected/analyzed (paragraph 0002, 0015, 0180). SPETZLER further teaches of collecting the microvesicles/biomarkers that are retained in the device (Claim 1), and that the filtration module retains molecules greater than about 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 250, 300, 400, or 500 kiloDaltons (kDa) (paragraph 0205). Therefore- on the low end, SPETZLER teaches of retaining and detecting molecules which are 50,000 da, which reads on the claimed > or = 1000 da.
With respect to Claim 5, SPETZLER teaches that the body sample/ bodily fluid can be sebum (paragraph 0010, 0159, Table 1), and also that the biomarkers in the sample can be lipids that are detected/analyzed (paragraph 0002, 0015, 0180). SPETZLER further teaches of collecting the microvesicles/biomarkers that are retained in the device (Claim 1), and that the filtration module retains molecules greater than about 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 250, 300, 400, or 500 kiloDaltons (kDa) (paragraph 0205). Therefore- on the low end, SPETZLER teaches of retaining and detecting molecules which are 50,000 da, which reads on the claimed > or = 1200 da.
With respect to Claim 9, SPETZLER teaches of the disease which is assessed or diagnosed being Parkinson’s (paragraph 0030).
With respect to Claim 20, SPETZLER teaches of the disease which is assessed or diagnosed being Parkinson’s (paragraph 0030). SPTEZLER further teaches of the treatment being with neuroprostane (Table 5), which is a neuroprotective agent.
With respect to Claim 21, SPETZLER teaches that the biomarkers in the sample can be lipids (paragraph 0002, 0015, 0180) and more specifically that the lipid can be ceramides, phosphatidylcholines (Table 2,9) or lipopolysaccharides (which are glycolipids)(paragraph 0986).
Response to Arguments
Applicant's arguments filed 12/26/2025 have been fully considered but they are not persuasive.
With respect to the 101 rejection, it is maintained and further explained for the claims which were significantly amended 12/26/2025 as shown in the rejection above.
With respect to the 101 rejection, applicant argues that there is a general prejudice against using sebum samples, as claimed, in the art due to the non-sterile environment of the skin and due to potential contaminants such as soaps. Because of this, applicant argues that since applicant uses sebum samples in the claims, the use of sebum samples is not WURC and particularly not WURC for lipid analysis in the art and therefore eligible under 101. The examiner disagrees. Collecting skin samples, especially by swabbing in commonly done. For example—this is done in doctors offices and further in biology laboratories in schools. Further—both SPETZLER and SPETZLER2 teach of using sebum samples. The examiner maintains the 101 rejection and maintains that collecting sebum samples by swab for analysis is WURC.
Applicant further argues that both independent claims 1 & 14 require “administering a therapeutically effective amount of treatment thereto,” and that this makes the claims eligible. The examiner again disagrees and the reasoning for this is found in the rejection above.
With respect to the enablement rejection, applicant argues again that their amendment to the claims that a sebum sample is used and collected by swabbing that this enables the instant claims for the detection of any disease or condition and any treatment. The examiner strongly disagrees.
The addition that a sebum sample is used has no affect on what diseases or treatments are encompassed by the claims.
Applicant argues that the specification has support for the diagnosis and treatment of Parkinson’s disease, coronavirus, hypertension, type 2 diabetes mellitus, high cholesterol and ischemic heart disease. The examiner notes that however, none of these diseases are claimed and particularly they are not claimed in the independent claims. Therefore the claims as written are not enabled for oh lets say ALS or Alzheimer’s or a bazillion other types of diseases which are included in the scope of the word “disease,” as instantly claimed. Further, the examiner maintains that applicant also still not shown where/ if there is any support for actual specific treatments in the instant specification and that the claimed general “administering a therapeutically effective amount of treatment,” is not supported for the broad scope which this could encompass.
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on the combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues that the SPETZLER and PRINGLE references do not teach of using one of the claimed media/tools to collect the sebum sample. The examiner notes that SPETZLER2 is newly used to remedy this, for the claims amended 12/26/2025.
Applicant argues that the use of swab or similar collection of sebum samples is advantageous for the collected of samples for diagnosis of Parkinson’s and coronavirus diseases. With respect to this, this is not convincing, but the examiner further points outs that this is also not commensurate in scope with the instant claims since neither Parkinson’s nor coronavirus is claimed.
Applicant further argues that sebum samples offer and additional advantage that it can be stored under ambient conditions and that there is a general prejudice against using sebum samples in the art. The examiner again maintains that this is not commensurate in scope with the instant claims as this is not claimed. Further--- the examiner notes that both SPETZLER and SPETZLER2 teach of using sebum samples, so the use of sebum is still taught by the prior art and would has the same “advantage,” as applicant is arguing, though the examiner maintains that this is not a surprising or unexpected result. Therefore, whether there is prejudice against using it or not, sebum samples are taught by the prior art and therefore make the instant claims obvious.
Applicant further argues that the use of ambient ionization and ion mobility mass spec is advantageous. Though the examiner does not disagree---ambient ionization and ion mobility mass spectrometry is taught by the prior art as shown above. Applicant has made not arguments with respect to the prior art with respect to the ambient ionization.
Applicant further argues that the SPETZLER reference does not teach that “the biomarker for any specific disease may be a lipid.” With respect to this--- the examiner again notes that applicant does not claim, a “specific disease,” so this argument is not commensurate in scope with the claims. Further, SPETZLER teaches that the body sample/ bodily fluid can be sebum (paragraph 0010, 0159, Table 1), and also that the biomarkers in the sample can be lipids (paragraph 0002, 0015, 0180).
Applicant further argues that the PRINGLE prior art does not teach of swabbing the “back of the subject.” The examiner notes that this subject matter was newly amended 12/26/2025. Further—there is a 112 rejection made with respect to this as “back,” is a relative term on a moving subject.
All claims remain rejected.
IDS filed 12/26/2025 has been considered.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 9:30-4:30 MT Monday-Friday.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758