DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-3 & 10, and the species elections of DSG4 in claims 1, 3, & 10 and of androgenic alopecia in claim 1 in the reply filed on 01/12/2026 is acknowledged. Group II, claims 4, 5, 8, & 9, and Group III, claims 6 & 7, are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
A first office action on the merits of claims 1-3 & 10 is set forth herein and claims 4-9 are withdrawn from consideration.
Information Disclosure Statement
Only the abstract of the reference in the IDS submitted on 04/25/2023 that is lined through, under the foreign patent documents section, was considered because an English copy of the full documents was not provided.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3 & 10 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.
Regarding claim 1, the claim recites the limitation “the expression level” in line 2 of the claim and there is insufficient antecedent basis for this limitation in the claim. In addition, the recitation of “seasonal alopecia, age-related alopecia and micro-inflammatory alopecia” in lines 10-11 of the claim is unclear if age-related alopecia and micro-inflammatory alopecia are meant to refer to the same type of common alopecic state, or if this is the result of a typographical error and should read “seasonal alopecia, age-related alopecia, and micro-inflammatory alopecia”.
Regarding claim 2, the claim recites the limitation “comparing the level” in line 2 of the claim and there is insufficient antecedent basis for this limitation in the claim and it is unclear if “the level” is meant to refer back to “the expression level” in claim 1, from which claim 2 depends from.
Claims 3 & 10 are rejected due to their dependence on claim 1.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3 & 10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural correlation/law of nature and an abstract idea without significantly more. This judicial exception is not integrated into a practical application and the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below.
35 U.S.C. § 101 requires that to be patent-eligible, an invention (1) must be directed to one of the four statutory categories, and (2) must not be wholly directed to subject matter encompassing a judicially recognized exception. M.P.E.P. § 2106. Regarding judicial exceptions, “[p]henomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U.S. 63, 67 (1972); see also M.P.E.P. § 2106. The unpatentability of abstract ideas was confirmed by the U.S. Supreme court in Bilski v. Kappos, 561 U.S. 593, 601 (June 28, 2010) and Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014). See also Myriad v Ambry, CAFC 2014-1361, -1366, December 17, 2014. The unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66, 71 (2012). “[L]aws of nature, natural phenomena, and abstract ideas” are not patentable. Dia-mond v. Diehr, 450 U. S. 175, 185 (1981); see also Bilski v. Kappos, 561 U. S. at 601 (2010).
Claims Analysis:
As set forth in MPEP 2106, the claims have been analyzed to determine whether they are directed to one of the four statutory categories (STEP 1).
The instant claims are directed to methods and therefore are directed to one of the four statutory categories of invention.
The claims are then analyzed to determine if they recite a judicial exception (JE) (STEP 2A, prong 1) [Mayo Collaborative Services v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012), Alice Corp. Pry. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014)].
The claimed invention recites a method for in vitro prognosis and/or diagnosis of a common alopecic state of a scalp in a subject comprising measuring the level of at least one gene selected from a group and comparing with a control. This recitation is a natural correlation between expression level of at least one gene and prognosis and/or diagnosis of a common alopecic state. With regard to the natural correlation, as in Mayo, the relationship is itself a natural process that exists apart from any human action. The claimed invention also recites “comparing the level of at least one gene measuring in step a) with a control” and “determining whether the scalp of said subject exhibits a common alopecic state” which is a recitation of an abstract idea because it encompasses conclusions and determinations which can occur entirely within the mind. It is therefore determined that the claims are directed to judicial exceptions.
The claims are then analyzed to determine whether they recite an element or step that integrates the JE into a practical application (STEP 2A, prong 2) [Vanda Pharmaceuticals Inc., v. West-Ward Pharmaceuticals, 887 F.3d 1117 (Fed. Cir. 2018)].
The claims recite steps of measuring the expression level of at least one gene selected from a group, comparing the level with a control, and determining whether the scalp of said subject exhibits a common alopecic state, however this does not integrate the JE into a practical application because it is a mere data gathering step to use the correlation and does not add a meaningful limitation to the method.
In the absence of steps or elements that integrate the JE into a practical application, the additional elements/steps are considered to determine whether they add significantly more to the JE either individually or as an ordered combination, to “’transform the nature of the claim’ into a patent eligible application” [Mayo Collaborative Services v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012), Alice Corp. Pry. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014)] (STEP 2B).
In the instant situation, the steps of detecting the expression level of at least one gene, comparing the level with a control, and determining whether the scalp of said subject exhibits a common alopecic state, are generally recited and do not provide any particular reagents that might be considered elements that transform the nature of the claims into a patent eligible application because no specific elements/steps are recited. This step is not only a mere data gathering step, but the general recitation of detection of known nucleic acids is well understood, routine, and conventional activity (See MPEP 2106.05(d)(II)). Applicant is reminded that in Mayo, the Court found that “[i]f a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself." Further "conventional or obvious" "[pre]solution activity" is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law”. Flook, 437 U. S., at 590; see also Bilski, 561 U. S., at ___ (slip op., at 14) (“[T]he prohibition against patenting abstract ideas ‘cannot be circumvented by’ . . . adding ‘insignificant post-solution activity’” (quoting Diehr, supra, at 191–192)). The Court also summarized their holding by stating “[t]o put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.” Therefore these limitations/steps do not “‘transform the nature of the claim’ into a patent-eligible application.’” Alice, 134 S. Ct. at 2355 (quoting Mayo, 132 S. Ct. at 1297).
When viewed as an ordered combination, the claimed limitations are directed to nothing more than the determination that a natural correlation/phenomena exists. Any additional element consists of using well understood, routine and conventional activity, and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.
Accordingly, it is determined that the instant claims are not directed to patent eligible subject matter.
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) 1-3 & 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Owens (Owens et al.; Developmental Biology, Vol. 322, pages 156-166, July 2008).
Regarding claim 1, Owens teaches examining the expression levels of key molecules associated with hair follicle differentiation in progressive alopecia (common alopecic state), comprising measuring the expression of DSG4 in samples that develop into progressive alopecia (common alopecic state) compared to control (measuring expression level in at least one gene comprising DSG4 from a biological sample from an area suspected of being an alopecic area or of becoming an alopecic area in said subject) (abstract lines 1-6; pg. 157 column 2 1st full paragraph lines 1-11; pg. 157 column 2 2nd full paragraph lines 11-14; pg. 162 column 1 1st full paragraph lines 21-33; pg. 162-163 paragraph bridging pg. 162 & 163 lines 1-6; Fig. 4).
Regarding claim 2, Owens teaches comparing the expression of DSG4 to a control in determining samples that develop into progressive alopecia (common alopecic state) (comparing level of DSG4 with a control and on the basis of the comparison determining whether the scalp exhibits a common alopecic state) (abstract lines 1-6; pg. 157 column 2 1st full paragraph lines 1-11; pg. 157 column 2 2nd full paragraph lines 11-14; pg. 162 column 1 1st full paragraph lines 21-33; pg. 162 column 2 1st full paragraph lines 1-26; pg. 162-163 paragraph bridging pg. 162 & 163 lines 1-6; Fig. 3; Fig. 4).
Regarding claim 3, Owens teaches examining the expression levels of key molecules associated with hair follicle differentiation in progressive alopecia (common alopecic state) in which DSG4 is downregulated (decreased) in samples that develop progressive alopecia (common alopecic state) compared to control (confirming a scalp exhibits a common alopecic state when the expression level of DSG4 is decreased compared to a control level) (abstract lines 1-6; pg. 157 column 2 1st full paragraph lines 1-11; pg. 157 column 2 2nd full paragraph lines 11-14; pg. 162 column 1 1st full paragraph lines 21-33; pg. 162-163 paragraph bridging pg. 162 & 163 lines 1-6; Fig. 4).
Regarding claim 10, Owens teaches examining the expression levels of key molecules associated with hair follicle differentiation in progressive alopecia (common alopecic state) in which DSG4 is downregulated (decreased) in samples that develop progressive alopecia (common alopecic state) compared to control (confirming a scalp exhibits a common alopecic state when the expression level of DSG4 is decreased compared to a control level) (abstract lines 1-6; pg. 157 column 2 1st full paragraph lines 1-11; pg. 157 column 2 2nd full paragraph lines 11-14; pg. 162 column 1 1st full paragraph lines 21-33; pg. 162-163 paragraph bridging pg. 162 & 163 lines 1-6; Fig. 4).
Claim(s) 1 & 2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Christiano (WO 2013/149194 A1, October 2013), as recited in the IDS dated 04/25/2023.
Regarding clam 1, Christiano taches a method of detecting differentially expressed genes in skin from human subject with alopecia areata (measuring expression level in at least one gene from a biological sample from an area suspected of being an alopecic area or of becoming an alopecic area in said subject) in which the differential expression of DSG4 (at least one gene chosen from DSG4) was measured in skin from human alopecia areata versus skin from control individuals (paragraph [80286 lines 1-4; Table 4).
Regarding clam 2, Christiano taches detecting differentially expressed genes in skin from human subject with alopecia areata compared to skin from control individuals (comparing with a control) in which differential expression in DSG4 was measured (measuring expression level in at least one gene from a biological sample from an area suspected of being an alopecic area or of becoming an alopecic area in said subject and on the basis on comparison determining whether the scalp of said subject exhibits a common alopecic state) (paragraph [80286 lines 1-4; Table 4).
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.
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) 3 & 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Christiano (WO 2013/149194 A1, October 2013), as recited in the IDS dated 04/25/2023, in view of Owens (Owens et al.; Developmental Biology, Vol. 322, pages 156-166, July 2008).
The teachings of Christiano with respect to claim 1 & 2 are discussed above and incorporated herein.
Regarding claim 3, Christiano does not teach that the scalp is confirmed as exhibiting a common alopecic state when the expression level of at least one gene of DSG4 is decreased compared to a control level.
Owens teaches examining the expression levels of key molecules associated with hair follicle differentiation in progressive alopecia (common alopecic state) in which DSG4 is downregulated (decreased) in samples that develop progressive alopecia (common alopecic state) compared to control (confirming a scalp exhibits a common alopecic state when the expression level of DSG4 is decreased compared to a control level) (abstract lines 1-6; pg. 157 column 2 1st full paragraph lines 1-11; pg. 157 column 2 2nd full paragraph lines 11-14; pg. 162 column 1 1st full paragraph lines 21-33; pg. 162-163 paragraph bridging pg. 162 & 163 lines 1-6; Fig. 4). Owens also teaches that this methods indicates the importance of identifying functional Smad transcriptional targets, comprising DSG4, in different developmental stages to identify targets in hair differentiation leading to progressive alopecia (pg. 162 column 1 1st full paragraph lines 21-33; pg. 165 column 1 1st full paragraph lines 1-8; pg. 165 column 2 1st full paragraph lines 1-14).
Christiano and Owens are considered to be analogous to the claimed invention because they are all in the same field of measuring expression of genes in common alopecic states. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of differential expression of DSG4 in samples from a human subject with alopecia areata in Christiano to incorporate the confirming a scalp exhibits a common alopecic state when the expression level of DSG4 is decreased compared to a control level as taught in Owens because Owens teaches that doing so would provide a method of identifying functional Smad transcriptional targets, comprising DSG4, in different developmental stages to identify targets in hair differentiation leading to progressive alopecia.
Regarding claim 10, Christiano Owens teaches examining the expression levels of key molecules associated with hair follicle differentiation in progressive alopecia (common alopecic state) in which DSG4 is downregulated (decreased) in samples that develop progressive alopecia (common alopecic state) compared to control (confirming a scalp exhibits a common alopecic state when the expression level of DSG4 is decreased compared to a control level) (abstract lines 1-6; pg. 157 column 2 1st full paragraph lines 1-11; pg. 157 column 2 2nd full paragraph lines 11-14; pg. 162 column 1 1st full paragraph lines 21-33; pg. 162-163 paragraph bridging pg. 162 & 163 lines 1-6; Fig. 4). Owens also teaches that this methods indicates the importance of identifying functional Smad transcriptional targets, comprising DSG4, in different developmental stages to identify targets in hair differentiation leading to progressive alopecia (pg. 162 column 1 1st full paragraph lines 21-33; pg. 165 column 1 1st full paragraph lines 1-8; pg. 165 column 2 1st full paragraph lines 1-14).
Conclusion
Claims 1-3 & 10 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAILEY C BUCHANAN whose telephone number is (703)756-1315. The examiner can normally be reached Monday-Friday 8:00am-5:00pm ET.
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/BAILEY BUCHANAN/Examiner, Art Unit 1682
/JEHANNE S SITTON/ Primary Examiner, Art Unit 1682
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