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 .
Applicant’s submission filed on May 21, 2026 has been entered and considered. Rejections and/or objections not reiterated from the previous action mailed February 24, 2026 are hereby withdrawn. The following rejections and/or objections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Election/Restrictions
Applicant’s election without traverse of Group 1, claims 1, 6-9, 12, 14-15, 20-21, and 25-28; and Applicant’s species election of the method of claim 1(a) and the Cytor agonist of claim 1(i) in the reply filed on January 16, 2026 is acknowledged.
Claims 32-33 and 37-40 were previously withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Claims 9, 15, 20-21, and 26-28 were previously withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species. Claim 9 which is drawn to the RNA or nucleic acid molecule of claim 1, item (ii), and claims 15 and 21 which depend from claim 9, 20 are withdrawn based on Applicant’s election of the Cytor agonist of claim 1, item (i). Claims 20 and 26-28 are also withdrawn based on Applicant’s election of the Cytor agonist of claim 1, item (i).
Claims 1, 14, and 25 have been amended to correct matters of clarity. Claim 1 has been amended to recite the Cytor agonist comprises RNA “comprising the full length of any one of SEQ ID NOs: 1-15 or…a sequence with at least 80% sequence identity for a full length sequence of any one of SEQ ID NOs: 1-15”. Claim 12 has been canceled. Claims 1, 6-8, 14, and 25 are examined on the merits.
Priority
The instant application is a 35 U.S.C 371 national stage filing of the International Application No. PCT/EP22/53229 filed on February 10, 2022. The instant application claims foreign priority under 35 U.S.C 119(a)-(d) to British Patent Applications GB2101932.8, filed on February 11, 2021. Receipt is acknowledged of a certified copy of the foreign patent application as required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 10, 2032 is in compliance with the provisions of 37 CFR 1.97 and is being considered by the examiner.
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.
Withdrawn Objections to the Specification
In light of Applicant’s amendments to the Specification to capitalize the trademarks and include generic terminology on Pgs. 83 and 84, these objections to the specification have been withdrawn.
Withdrawn Claim Objections
With regard to claim 1, in light of Applicant’s amendment to correct the misspelling of hybridizing on pg. 4, item (iii), line 6 and to remove the word “or” following part (e) and prior to “by administering the subject a Cytor agonist…”, the objections have been withdrawn.
Withdrawn 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, 6-8, 12, 14, and 25 were 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.
With regard to claim 1, in light of Applicant’s amendment to claim 1 to remove repeated use of the phrase "for example" (“e.g.”), the rejection has been withdrawn.
With regard to claim 12, claim 12 has been canceled rendering the rejections moot.
With regard to claim 14, in light of the Applicant’s amendment to claim 14 to recite “the Cytor agonist”, the rejection has been withdrawn.
With regard to claim 25, in light of the Applicant’s amendment to claim 25 to recite “the Cytor agonist”, the rejection has been withdrawn.
Maintained Claim Rejections - 35 USC § 103
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 1, 7-8, 14, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (2020, LncRNA CYTOR attenuates sepsis‐induced myocardial injury via regulating miR‐24/XIAP. Cell Biochem. and Funct., 38(7), 976-985, found in IDS, hereafter “Chen”) in view of Mammalian Gene Collection (MGC) Program Team (2002, Generation and initial analysis of more than 15,000 full-length human and mouse cDNA sequences. PNAS, 99(26), 16899-16903, hereafter “MGC Program Team”) and as evidenced by National Library of Medicine entry, SNP 7436072 (NIH National Library of Medicine, SNP 74360724, https://www.ncbi.nlm.nih.gov/snp/?term=74360724, retrieved February 19, 2026).
With regard to claims 1 and 14, Chen teaches that upregulation of the long noncoding RNA Cytor via administration of a Cytor overexpression plasmid (Pg. 977, left col., 4th para.), i.e. a Cytor agonist, is protective against sepsis-induced myocardial injury in human cardiomyocytes (Pg. 979, Section 3.2) and in systemic administration (Pg. 977, Section 2.1) in a rat model (Pg. 981, Section 3.6). Thus, Chen provides support for treatment of a subject having sepsis with systemic administration of a Cytor agonist. Chen is silent as to Cytor RNA promoting myogenesis in skeletal muscle, however, promotion of myogenesis in skeletal muscle appears to be an inherent property of Cytor RNA.
MPEP 2112.01(II) states:
“’Products of identical chemical composition can not have mutually exclusive properties.’ In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
MPEP 2112(I) states:
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
As Chen teaches Cytor RNA overexpression for use in sepsis-induced myocardial injury in both rats and human cardiomyocytes, the Cytor RNA as taught by Chen and the instantly claimed Cytor RNA appear to be the same composition. Thus, the ability of Cytor RNA to promote myogenesis in skeletal muscle is considered to be an previously unknown inherent property of Cytor RNA.
Chen is silent as to the sequence of Cytor RNA in the Cytor overexpression plasmid.
MGC Program Team teaches characterization of an RNA sequence for human non-protein coding RNA 152 and entry of that sequence into the Mammalian Gene Collection program (Abstract). The RNA sequence for human non-protein coding RNA 152 as taught by MGC Program Team has 88% sequence identity to instantly claimed SEQ ID NO: 1 (see sequence search 02/04/2026, SEQ ID NO:1, .rge file, result 4). It was well known that human Cytor is also known as non-protein coding RNA 152 (see Pg. 8 of Applicant’s specification), thus a skilled artisan would have recognized that non-protein coding RNA 152 and Cytor were alternate names for the same molecule.
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to choose the RNA sequence encoding non-protein coding RNA 152 (i.e., Cytor) as taught by MGC Program Team for use in the method of treating a subject having sepsis by systemic administration of Cytor RNA as taught by Chen with a reasonable expectation of success. A skilled artisan would have been motivated to choose the RNA sequence encoding non-protein coding RNA 152 (i.e., Cytor) as taught by MGC Program Team for use in the method of treatment as taught by Chen as it was a known characterized sequence freely available in the Mammalian Gene Collection database and was known to encode the same molecule as taught by Chen.
With regard to claim 7, Chen is silent as to a subject being heterozygous or homozygous for the G allele of cis-eQTL rs74360724. However, the National Library of Medicine entry for SNP 74360724 evidences that, in most populations, the G allele is the major allele and would be present in greater than 50% of the population. In particular, since Chen’s group studying sepsis-induced myocardial injury in the Intensive Care Unit at a hospital in China and the National Library of Medicine entry for SNP 74360724 evidences that in other Asiatic populations, the G allele is present in upwards of 80% of the population (see entry for TOMMO, Korea4K, and KOREAN), a skilled artisan interested in treatment of sepsis-induced myocardial injury would have a much larger chance of patients being heterozygous or homozygous for the G allele of cis-eQTL rs74360724. Therefore, a skilled artisan would realize that being heterozygous or homozygous for the G allele of cis-eQTL rs74360724 would be an inherent property the majority of human subjects. Thus, it is more likely than not that any given sepsis-induced cardiomyopathy patient treated by upregulating Cytor RNA would be heterozygous or homozygous for the G allele of cis-eQTL rs74360724.
With regard to claim 8, Chen teaches that rats having sepsis-induced cardiomyopathy exhibit decreased activity, slow movement, and decreased response to stimuli (Pg. 977, section 2.1), which is considered to reasonably read on subjects who are inactive.
With regard to claim 25, as detailed above, Chen teaches upregulation of Cytor RNA expression via systemic administration of a Cytor overexpression plasmid, i.e. a Cytor agonist. Although Chen is silent as to inhibition of degradation of endogenous Cytor, one having ordinary skill in the art would recognize that increasing the amount of exogenous Cytor RNA would increase the amount of Cytor RNA substrate present in the degradation pathway and therefore would naturally result in the inhibition of the degradation of endogenous Cytor RNA.
Claims 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Chen and MGC Program Team as applied to claim 1 above, and in further view of Schefold et al. (2010, Intensive care unit-acquired weakness (ICUAW) and muscle wasting in critically ill patients with severe sepsis and septic shock. J. of Cachexia, Sarcopenia and Muscle, 1(2), 147-157, hereafter “Schefold”).
With regard to claims 6 and 8, as detailed above the combination of Chen and MGC Program Team teaches use of Cytor RNA having a sequence with over 80% sequence identity to instantly claimed SEQ ID NO: 1 for use in treating sepsis-induced myocardial injury both in human cardiomyocytes and in a rat model of sepsis.
Although Chen teaches that rats having sepsis-induced cardiomyopathy exhibit decreased activity, slow movement, and decreased response to stimuli (Pg. 977, section 2.1), Chen is silent as to subjects having or being at risk of skeletal muscle atrophy or subjects who are inactive or immobile.
Schefold teaches that sepsis is associated with muscle wasting which involves atrophy of skeletal muscle fibers and is accompanied by prolonged immobilization (Section 2.1), which is considered to reasonably read on subjects having or being at risk of skeletal muscle atrophy and subjects who are immobile.
Chen teaches that sepsis-induced cardiomyopathy is a common complication during sepsis which occurs in about 40% of patients and that treatment of sepsis-induced cardiomyopathy reduces patient mortality (Pg. 976, left col., 1st para.). Therefore, one having ordinary skill in the art would have recognized that a sizable population of patients experiencing sepsis also would experience sepsis-induced myocardial injury and would be expected to exhibit a prolonged recovery, putting them at risk of longer term hospitalization and thereby skeletal muscle atrophy and immobilization. Therefore, it would have been obvious before the effective filing date of the claimed invention, to choose the population of subjects experiencing a prolonged recovery from sepsis-induced myocardial injury who are at risk of skeletal muscle atrophy and would be likely to be immobile as taught by Schefold for use in the method of treating sepsis-induced myocardial injury via upregulation of Cytor RNA as taught by Chen with a reasonable expectation of success. One having ordinary skill in the art would have been motivated to make this combination since Chen teaches that timely and effective treatment of sepsis-induced myocardial injury, a common complication of sepsis, is important for reduction of patient mortality.
Response to Arguments
Applicant's arguments filed May 21, 2026 have been fully considered but they are not persuasive.
Claims 1, 7-8, 12, 14, and 25 were rejected under 35 U.S.C. 103 as being unpatentable over Chen, in view of MGC Program Team and as evidenced by National Library of Medicine entry SNP 74360724. Claims 6 and 8 were rejected under 35 U.S.C. 103 as being unpatentable over Chen, in view of MGC Program Team and in further view of Schefold. Claim 12 has been canceled rendering any arguments regarding the rejection of claim 12 moot.
First, Applicant traverses on Pgs. 12-13, Section 1 that Office’s assertion that promotion of myogenesis in skeletal muscle is a previously unknown inherent property of a known compound Cytor RNA does not provide a basis in fact or technical reasoning to support the determination of an inherent characteristic of the Cytor RNA known in the prior art. Applicant asserts that the prior art of Chen which teaches Cytor upregulation in cardiomyocytes/cardiac tissue is a tissue distinct from skeletal muscle and that promoting myogenesis in skeletal muscle occurs by a process distinct from processes found in cardiac tissue. Applicant asserts that the functional behavior of noncoding RNA is tissue specific and that any effects of Cytor RNA on skeletal muscle do not necessarily flow from Chen’s disclosure.
Second, Applicant traverses on Pgs. 13-14, Section 2, regarding the rejection of claim 1, that the cited references do not teach or suggest all of the features of the claims. Applicant asserts that claim 1 requires use of the claimed Cytor agonist comprising “RNA comprising the nucleotide sequences in any one of SEQ ID NOs: 1-15…wherein the RNA promotes myogenesis in skeletal muscle” and that the recited functional feature of promotion myogenesis is skeletal muscle is critical to the instantly claimed invention. Applicant asserts that a skilled artisan would not have had a reasonable expectation of success that the effects of upregulation of Cytor as it related to cardiac tissue would translate to promotion of myogenesis in skeletal muscle as cardiac tissue and skeletal muscle are distinct tissue types. Applicant asserts that the instant specification demonstrates that Cytor mRNA levels were upregulated in rat vastus lateralis and soleus muscle after exercise but not in the left ventricle of the heart indicating that exercise induced induction of Cytor is skeletal muscle specific. Applicant asserts that this finding indicates Cytor’s effects in skeletal muscle is distinct from cardiac tissue. Applicant further traverses that addition of a human Cytor RNA sequence as taught by MGC Program Team does not cure the deficiency of Chen as it relates to the functional language reciting promotion of myogenesis in skeletal muscle. Regarding the rejection of claim 7, Applicant traverses that the Office’s assertion that subjects being heterozygous or homozygous for the G allele of cis-eQTL rs74360724 is an inherent property of the majority of human subjects does not establish obviousness. Applicant asserts that the inventors have identified a genetic marker associated with increased risk of developing sarcopenia which is a novel discovery not disclosed or suggested by Chen.
Third, Applicant traverses on Pg. 15, Section 3 that the Office has relied on improper hindsight reasoning. Applicant asserts that a skilled artisan would not have arrived at the instantly disclosed method without the benefit of Applicant’s disclosure. Applicant asserts that the Office’s assertion that promotion of myogenesis is an inherent property of the Cytor RNA known in the prior art could only be reached via use of Applicant’s disclosure. Applicant traverses that the prior art of Chen is related to treatment of myocardial injury in sepsis via use of upregulation of Cytor and that nothing in Chen suggests a connection to skeletal muscle myogenesis. Applicant asserts that without the instant disclosure, there would have been no reason for a skilled artisan to look to Chen for solutions to skeletal muscle atrophy.
Fourth, regarding the rejection of claims 6 and 8, Applicant traverses that Schefold only discloses that sepsis is associated with loss of muscle mass and ICU-acquired weakness but does not disclose use of Cytor agonists to treat these conditions and therefore that the combination of Chen, MGC Program Team, and Schefold does not teach nor suggest, nor provide motivation to use Cytor for treating of skeletal muscle atrophy.
Applicant’s traversal has been fully considered but is not persuasive.
Responses to Applicant’s arguments in sections 1 and 2 are addressed together. Applicant’s traversal is based on the assertion that the wherein clause of claim 1(i), reciting “wherein the RNA promotes myogenesis in skeletal muscle” is a critical functional feature of the instant invention which should not be considered an inherent property of the Cytor agonist of the prior art as promoting myogenesis does not “necessarily flow” from the teachings of the prior art and which a skilled artisan would not reasonably expect based on the teachings of the prior art.
Firstly, Applicant’s instant invention is a method of treatment of a subject comprising administration of a Cytor agonist which comprises RNA comprising one of the nucleotide sequences as recited in SEQ ID NOs: 1-15 or a sequence having 80% homology to SEQ ID NOs: 15 “wherein the RNA promotes myogenesis in skeletal muscle”. Applicant is directed to MPEP 2111.04(I) which states “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure” and a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” The wherein clause of the instant claim does not limit the structure of the claimed Cytor agonist nor does it affect the method of treatment. Further, “wherein the RNA promotes myogenesis in skeletal muscle” does not recite any additional active method steps but simply states a characterization or conclusion of the results of a process step positively recited (e.g. administering a Cytor agonist). Therefore, the "wherein" clause is not considered to further limit the method defined by the claim and is not given weight in construing the claims. See Texas Instruments, Inc. v. International Trade Comm., 988 F.2d 1165, 1171,26 USPQ2d 1018, 1023 (Fed Cir. 1993) ("A 'whereby' clause that merely states the result of the limitations in the claim adds nothing to the patentability or substance of the claim."). See also Minton v. National Assoc. of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003) ("A whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited."). The prior art of Chen teaches administration of a Cytor agonist for the treatment of sepsis-induced myocardial injury and MGC Program team teaches a human sequence of Cytor RNA which is considered to reasonably read on the limitations of the claims as instantly recited.
Secondly, in response to Applicant’s traversal related to inherent properties, if the wherein clause reciting “wherein the RNA promotes myogenesis in skeletal muscle” were to be given weight in construing the claims, issues of inherency still exist. Although Applicant asserts that the Office has not provided a basis in fact and/or technical reasoning to support the determination that the inherent characteristic “necessarily flows” from the teachings of the prior art, the instantly claimed Cytor agonist which is RNA comprising a nucleotide sequence with at least 80% sequence identity to any one of SEQ ID NOs: 1-15 would reasonably be understood by a skilled artisan to be the same composition as the Cytor agonist as taught by the combination of Chen and MGC Program Team, which shares greater than 80% sequence identity to instantly claimed SEQ ID NO: 1. MPEP 2112.01 states
“Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).”; "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990); and “The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978)”.
Therefore, it would be reasonable for one of ordinary skill in the art to expect that the instantly claimed Cytor RNA and the Cytor RNA as taught by the prior art, which appear to be structurally identical, would also have the same effects and properties. Although Applicant asserts that the cardiac tissue as recited in the prior art and the skeletal muscle as instantly claimed are different types of tissue, that function of noncoding RNA is tissue specific, and that the mechanism by which Cytor mRNA affects cardiac tissue is distinct from promoting myogenesis in skeletal muscle as instantly claimed, arguments presented by Applicant cannot take the place of factually supported objective evidence (See MPEP 2145). Applicant has provided no objective evidence that the prior art products as taught by the combination of Chen and MGC Program Team do not possess the instantly claimed characteristics and would have different effects on skeletal muscle if skeletal muscle had been examined by Chen (See MPEP 2112(V)).
Thirdly, in response to Applicant’s traversal related to reasonable expectation of success, if the wherein clause reciting “wherein the RNA promotes myogenesis in skeletal muscle” were to be given weight in construing the claims, a skilled artisan would still reasonably expect that systemic administration of a Cytor agonist which upregulates Cytor mRNA in cardiac tissue would also upregulate Cytor mRNA in skeletal muscle and result in promotion of myogenesis as instantly claimed. Applicant asserts that cardiac tissue and skeletal muscle are distinct tissue types and there is no expectation that Cytor’s effects in cardiac tissue would translate to myogenesis in skeletal muscle. As detailed above, the Cytor agonist which can be RNA having greater than 80% sequence identity to SEQ ID NO: 1 as taught by the prior art is considered to be the same Cytor agonist as instantly claimed. Although Chen is silent as to any effects of upregulation of Cytor mRNA in skeletal muscle, Chen teaches systemic administration of a Cytor agonist via tail vein injection (Pg. 977, Section 2.1) which results in upregulation of Cytor mRNA. A skilled artisan would expect that systemic administration of a Cytor agonist would result in widespread delivery of the Cytor agonist to all tissue types. Chen teaches that the Cytor agonist was delivered via an adenovirus. Both the cardiomyocytes of Chen and myotubes of skeletal muscle are known to posses the necessary receptors (CARs) in order for adenoviruses to bind and infect cells. Therefore, there is a reasonable expectation of success that systemic administration of the Cytor agonist in Chen would inherently result in upregulation of Cytor in skeletal muscle as well as cardiac tissue, despite the tissue types being distinct. In fact, Applicant’s instant specification teaches use of AAVs to deliver gene editing components to skeletal muscle tissue (See Example 3). Additionally, Applicant’s specification indicates that Cytor mRNA was upregulated in specific muscles (i.e., vastus lateralis and soleus) after exercise but not in the left ventricle of the heart and Applicant asserts this fact demonstrates that Cytor’s effects in skeletal muscle are distinct from those in cardiac tissue. However, a skilled artisan would be likely to interpret this finding as indicative of differential effects of exercise on Cytor mRNA expression in different tissue types, not adenoviral overexpression, which is also the conclusion of Applicant on Pg. 69, line 14. Applicant’s specification indicates that administration of Cytor agonists which increase Cytor expression in skeletal muscle promotes myogenesis, although it is noted that this effect appears to be limited to myogenesis of Type II muscle (See Example 2). Therefore, it is reasonable to expect that systemic administration of a Cytor agonist which increases Cytor expression in cardiac tissue as taught by Chen, would also increase Cytor expression in skeletal muscle, and would be likely to promote skeletal muscle myogenesis.
In response to Applicant’s traversal regarding nonobviouness of claim 7, it is noted that Applicant’s assertion appears to be limited to use of presence of the G allele of cis-eQTL rs74360724 for identification of subjects having an increased risk of developing sarcopenia, which is not commensurate in scope with the instant claims. Applicant’s instant claims include methods of treating subjects having sepsis, which is disclosed by the prior art of Chen. As stated above, as Chen is drawn to treatment of sepsis-induced complications in subjects in China. According to the National Library of Medicine entry for SNP 74360724, the G allele is present in more than 80% of Asian populations. Therefore, it is more likely than not that the subjects treated for sepsis-induced complications in the prior art of Chen would be heterozygous or homozygous for the G allele of cis-eQTL rs74360724.
In response to applicant's traversal that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). It is noted that Applicant’s elected method of claim 1(a) recites “a method of treating a subject having or being at risk of developing skeletal muscle atrophy, starvation, sarcopenia, cachexia, sepsis, diabetes, muscular dystrophy,…”. As Applicant has not limited the claimed method of treatment to only treatment of skeletal muscle atrophy and the scope of Applicant’s instant claims include methods of treating sepsis, a skilled artisan could have easily looked to the teachings of Chen for solutions to complications of sepsis and would have been able to envision treatment of sepsis using a Cytor agonist.
In response to Applicant’s traversal regarding the rejection of claims 6 and 8, claim 6 recites “wherein the subject has or is at risk of skeletal muscle atrophy” and claim 8 recites “wherein the subject… (ii) in inactive or immobile”. As has been noted above, Applicant has not limited the instantly claimed method to treatment of skeletal muscle atrophy as relied upon in Applicant’s traversal. As detailed in the rejections above, Schefold teaches that sepsis is associated with muscle wasting which involves atrophy of skeletal muscle fibers and is accompanied by prolonged immobilization (Section 2.1). Since Applicant’s instantly claimed method encompasses treatment of sepsis, Chen teaches treatment of sepsis-induced complications via upregulation of Cytor RNA. MCG Program Team is relied upon for the sequence of Cytor RNA and Schefold is relied upon for teachings that the population of patients as taught by Chen would have or be at risk of atrophy of skeletal muscles and be immobile.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 ERIN V PAULUS whose telephone number is (571)272-6301. The examiner can normally be reached Mon-Fri 8 AM-5 PM.
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/ERIN V PAULUS/Examiner, Art Unit 1631
/ARTHUR S LEONARD/Examiner, Art Unit 1631
Prosecution Insights