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 .
Status of the claims
Currently, claims 1-20 are pending and under examination.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The use of the term QuickPlex (e.g. para 0053), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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 Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 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 claims are directed to a naturally occurring correlation between the levels of the recited biomarkers in an infant subject with atopic dermatitis or atopic disease compared to a control sample.
Step 2A, Prong 2
The additional elements of obtaining a skin sample from a subject and determining the recited biomarker levels and making a comparison to that of a control does not 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 “wherein an elevated level of IL13 and/or TSLP…….”. The “wherein” 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 correlated with atopic disease/dermatitis. No active method steps are invoked or clearly required; the “wherein” 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.
Also, with respect to the “administering an immune modifier, a skin barrier enforcing emollient and combinations thereof to the infant” as recited in claim 7. Although the claim invokes administering a treatment to the subject the claim as currently recited does not specifically required the identification in the subject and thus allows for a scenario wherein a decreased level of IL13 or TSLP or an increase of the ceramides or sphingomyelins may be determined and therefore no treatment would be administered. Therefore, the claims as currently recited do not recite something significantly more than the judicial exception.
ELIGIBILITY STEP 2B: WHETHER THE ADDITIONAL ELEMENTS CONTRIBUTE AN "INVENTIVE CONCEPT"
Further, the additional elements of the claims are recited with a high level of generality and do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. (the active method steps/limitations recited in addition to the judicial exceptions themselves) and do not add significantly more to the judicial exception(s).
As shown by the art below it is well known routine and conventional in the art to obtain a skin sample from a subject and to determine the recited biomarkers expression levels and make an identification based on a comparison.
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 § 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.
Written Description
Claims 14-20 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are directed to a method to prevent and/or decrease the severity of an atopic disease in a human infant.
The specification in paragraph 0006 discloses that another embodiment is a method to prevent and/or decrease the severity of an atopic disease in a human infant. The specification in paragraph 0021 discloses that the strategy is believed to be able to prevent the development of early-life AD. However, the specification does not provide any data, graphs, examples, experiments to show the prevention of any and all atopic diseases in a human infant or even the prevention of early-life AD. The term “prevent” (recited in claim 14) is interpreted as implying an absolute and complete prevention of the appearance/onset of atopic diseases, i.e., not any overt symptom or pre-symptomatic marker or damage may be present at any level. The specification fails to reasonably provide written description for prophylaxis (prevention) of atopic diseases. It is recommended to delete the term from the claims.
Scope of enablement
Claims 14-20 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 decrease the severity of atopic dermatitis in a human infant at risk of developing atopic dermatitis, does not reasonably provide enablement for a method to identify risk and decrease severity of all other atopic diseases such as allergic rhinitis, allergic asthma, food allergies and allergic conjunctivitis to name a few. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention without undue or unreasonable experimentation. Regarding undue experimentation, In re Wands, 8 USPQ2d 1400, at 1404 (Fed. Cir. 1988) states:
Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. (Citations omitted).
These factors are considered for the determination of whether a disclosure satisfies the enablement requirement and whether any necessary experimentation is "undue." The claimed invention must be enabled so that any person skilled in the art can make and use the invention without undue experimentation.
Regarding the nature of the invention and the state of the prior art, the instant claims require identifying a subject at risk of developing an atopic disease. Claim 14 as currently recited allows for any and all types of atopic dieases. However, the allergic diseases of food allergy, asthma, and allergic rhinitis have different pathologies and etiologies from the pathology and etiology of atopic dermatitis and eczema. Moreover, there is no clear link between these diseases. These different pathologies/etiologies and lack of link between these allergic diseases are evidenced by Belgrave (Curr. Derm. Rep. 2015. 4: 221-227). Belgrave discusses the aetiology and progression of atopic dermatitis and respiratory allergy (abstract). Belgrave noted that there is no evidence that targeting children with atopic dermatitis with an intervention designed to modify the progression towards asthma is effective (page 222, first paragraph). Furthermore, studies conducted investigating genetic and other biological markers of atopic dermatitis and other allergic diseases have raised the question as to whether atopic dermatitis is a cause of the subsequent development of asthma and allergic rhinitis (page 222, left column, second paragraph). In reviewing the literature concerning this subject matter, Belgrave concluded that the current evidence suggests that the developmental profiles of atopic dermatitis, asthma, and rhinitis are heterogeneous (page 225, right column, second-to-last paragraph). The distinct nature of atopic diseases also demonstrates that breadth of the claims.
Regarding the existence of working examples, it is noted that the examples in the specification are drawn to the diagnosis of atopic dermatitis. However, there are no examples to support that the levels of the recited biomarkers of a skin sample as recited in claim 14 are used to identify the subject at risk of developing any other atopic disease.
Given the nature of the invention, the state of the prior art, the breadth of the claims, and the absence of working examples for allergic diseases other than atopic dermatitis and eczema, it is clear that undue experimentation would be required to perform the full scope of the claimed invention.
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 1-20 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 1, step (b) is indefinite in reciting “determining from the skin sample an expression level of a cytokine….” because the term “determining” appears to intend a mental step; hence, it is unclear if applicant actually intends a positive active method step in the claim. It is suggested but not required to delete the term “determining” and replace it with --detecting--.
Claim 7, step (b) is indefinite in reciting “determining from the skin sample an expression level of a cytokine….” because the term “determining” appears to intend a mental step; hence, it is unclear if applicant actually intends a positive active method step in the claim. It is suggested but not required to delete the term “determining” and replace it with --detecting--.
Claim 14, line 2 the recitation “AD” is vague and indefinite because the claims previously indicated AD to stand for atopic dermatitis (e.g. Claim 1). Claim 14 recites “atopic disease” in line 1 but does not designate the AD to the atopic disease. Therefore, it is unclear if the applicant intends AD represent atopic disease, atopic dermatitis or something else. Please clarify.
Claim 14, step (b) is indefinite in reciting “determining from the skin sample an expression level of a cytokine….” because the term “determining” appears to intend a mental step; hence, it is unclear if applicant actually intends a positive active method step in the claim. It is suggested but not required to delete the term “determining” and replace it with --detecting--.
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.
Claims 1, 5, 7, 11, 13-14, 18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leung et al (US 10,852,307).
Leung et al discloses a method of identifying a subject that is at risk for developing atopic dermatitis and treating the subject (e.g. col 12). Leung et al discloses that the subject can be a human infant (e.g. col 3, lines 40-41; col 4, lines 12-16; col 12). Leung et al discloses the method comprises obtaining a non-lesional skin sample from the infant and determining the expression level of TSLP in the sample and comparing the level to a control sample and determining an elevated level to identify the subject as at risk of developing atopic dermatitis (e.g. col 12, lines 7-24). Leung et al discloses that the skin sample is obtained by a skin tape stripping method (e.g. col 12, lines 7-12). Leung et al discloses administering humanized antibodies (immune modifier that neutralizes TSLP action and/or a moisturizer for treating the atopic dermatitis (e.g. col 12, lines 19-24).
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.
Claims 2-3, 8-9 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Leung et al in view of Imokawa et al (The Journal of Investigative Dermatology, Vol 96, No. 4, April 1991).
See above for the teachings of Leung et al.
Leung et al differ from the instant invention in failing to teach the detection of one or more ceramides.
Imokawa et al teaches the association of decreased levels of ceramides in skin such as Ceramide I, Ceramide 5 (comprise alpha hydroxy fatty acids) and Ceramide 6 (comprise alpha hydroxy fatty acids) in subjects that have atopic dermatitis (e.g. abstract, page 614). Imokawa et al teaches that the levels are decreased compared to that of a healthy subject (e.g. pgs 523, 525-526, Table 1).
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to incorporate determining the level of ceramides such as taught by Imokawa et al into the method of Leung et al because Imokawa et al teaches that ceramide levels are decreased in subjects having atopic dermatitis and one of ordinary skill in the art would understand that additional tests and assessments known to be correlated with atopic dermatitis would provide a more confident assessment of atopic dermatitis. It has long been held that it is obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose. In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Therefore, one of ordinary skill in the art would have a reasonable expectation of success incorporating the determination of ceramides such as taught by Imokawa et al in the method of Leung et al for the determination of atopic dermatitis.
With respect to the ceramides being protein bound as recited in the claims. The combination of Leung et al and Imokawa et al disclose the same skin sample with the same ceramides and therefore absent evidence to the contrary it is deemed that the ceramides in the modified method of Leung et al are protein bound.
Claims 4, 10 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Leung et al in view of Berdyshev et al (JCI insight, Feb. 2018 (4), pages 1-15) (submitted in the IDS filed 08/20/24).
See above for the teachings of Leung et al.
Leung et al differ from the instant invention in failing to teach the detection ofone or more shpingomyelins comprising unsaturated fatty acids.
Berdyshev et al teaches the association of increased levels of sphingomyelins such as 24:1 SM in skin (as disclosed by Applicant in paragraph 0062 of the current specification 24:1 is unsaturated) in subjects that have atopic dermatitis (e.g. page 3, Fig. 1 B). Imokawa et al teaches that the levels are increased compared to that of a normal control (e.g. Fig. 1B).
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to incorporate determining the level of sphingomyelins such as taught by Berdyshev et al into the method of Leung et al because Berdyshev et al teaches that 24:1 SM is increased in subjects having atopic dermatitis and one of ordinary skill in the art would understand that additional tests and assessments known to be correlated with atopic dermatitis would provide a more confident assessment of atopic dermatitis. It has long been held that it is obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose. In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Therefore, one of ordinary skill in the art would have a reasonable expectation of success incorporating the determination of 24:1 SM such as taught by Berdyshev et al in the method of Leung et al for the determination of atopic dermatitis.
Claims 6, 12 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Leung et al (hereafter Leung 1) in view of Leung et al (US 2020/0113508) (hereafter Leung 2).
See above for the teachings of Leung 1.
Leung 1 differs from the instant invention in failing to teach the skin tape stripping method comprises extracting the epidermal sample comprising the cells adhering to the adhesive tape with a cell scraper comprising thermoplastic elastomer material in a solvent of about 5% to about 30% alcohol in water.
Leung 2 teaches that it is known and conventional in the art to obtain a skin sample from a subject by performing a skin tape stripping method comprising applying an adhesive tape to target area of the skin of the subject in a manner sufficient to isolate an epidermal sample comprising cells from the stratum corneum of the subject , and wherein the tape comprises a rubber adhesive; and extracting the epidermal sample adhering to the adhesive tape with cell scraper comprising thermoplastic elastomer material in a solvent of about 5% to about 30% alcohol in water.
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to incorporate a skin tape method such as taught by Leung 2 for the skin taping method of Leung 1 because Leung 2 shows that it is known and conventional in the art and thus would be an obvious substitution. Therefore, one of ordinary skill in the art would have a reasonable expectation of success incorporating a skin tape method such as taught by Leung 2 for the skin taping method of Leung 1.
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 1, 5, 7, 11, 14, 18 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-35 of copending Application No. 19/046,303 in view of Leung et al (US 10,852.307). US Application 19/046,303 is directed a method to identify and treat a subject at risk of developing atopic dermatitis comprising determining the level of TSLP in a non-lesional skin sample from the subject wherein the sample has been obtained by a skin tape stripping method and comparing the level to that of a control sample wherein an increased level in the subjects sample identified the subject as at risk of developing atopic dermatitis and administering a pharmaceutical composition comprising a TSLP inhibiting agent. US 19/046,303 differs from the instant invention in failing to teach the subject is an infant. Leung et al (US 10,852.307) shows that it is known to test an infant subject for atopic dermatitis by detecting the level of TSLP. Therefore, it would have been obvious to one of ordinary skill in the art to incorporate infant subjects for the subjects of US 19/046,303. This is a provisional nonstatutory double patenting rejection.
Claims 6, 12 and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-35 of copending Application No. 19/046,303 in view of Leung et al (US 10,852,307) and further in view of Leung et al (US 2020/0113508) (hereafter Leung 2). 19/046,303 and Leung (US 10,852.307) (see above for the teachings of US 19/046,303 and Leung (US 10,852.307). US 19/046,303 and Leung (10,852,307) differs from the instant invention in failing to teach the specifics of the skin tape stripping method. US Leung 2 teaches that it is known and conventional in the art to obtain a skin sample from a subject by performing a skin tape stripping method comprising applying an adhesive tape to target area of the skin of the subject in a manner sufficient to isolate an epidermal sample comprising cells from the stratum corneum of the subject , and wherein the tape comprises a rubber adhesive; and extracting the epidermal sample adhering to the adhesive tape with cell scraper comprising thermoplastic elastomer material in a solvent of about 5% to about 30% alcohol in water. Therefore, it would have been obvious to one of ordinary skill in the art to incorporate a skin tape stripping method such as taught by Leung 2 into the method of US 19/046,303.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Toncic et al (International Journal of Molecular Sciences, 2020, 21, pages 1-14) shows that ceramides 5 and 6 comprise a-hydroxy fatty acids (e.g. page 2).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY W COUNTS whose telephone number is (571)272-0817. The examiner can normally be reached M-F 7:00-4:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Emch can be reached at 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GARY COUNTS/ Primary Examiner, Art Unit 1678
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