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 .
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.
Claims 1-5, 8, 13-15, 18-19, 23, 28-33, 36 & 39 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 the administration of an effective amount of L. rhamnosus HN001 or derivative thereof, does not reasonably provide enablement for the administration of an effective amount of a component of L. rhamnosus HN001. 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 process of the invention commensurate in scope with these claims.
The breadth of the claim is very broad, as defined by the applicant in the specification of the instant application a component of L. rhamnosus HN001 is one of the following: “a cell wall fragment, cell supernatant, cell lysate, intracellular metabolite, secreted metabolite, enzyme, protein, short chain fatty acid, vitamin, phenol, amino acid, bacteriocin, extracellular vesicle, and exopolysaccharide”. The nature of the invention is the administration of a known strain of L. rhamnosus, HN001, to a subject for the purpose of increasing happiness in that subject.
The prior art teaches administration of L. rhamnosus HN001 to subjects for the purpose of treating depression and anxiety, in both probiotic and postbiotic form (Mitchell et. al. and Mousset et. al.) It is well understood that postbiotics contain all the elements describes as “components” by applicant, but the prior art does not appear to provide evidence which particular “component” is responsible for successfully treating anxiety and depression. Nor does the prior art provide evidence of a single “component” demonstrating efficacy in treating anxiety or depression in isolation.
The level of ordinary skill in the art is high. An ordinary artisan in the area of probiotic type microbiology with a focus on the gut brain axis would have experience isolating, cultivating and characterizing novel probiotic strains. An ordinary artisan also needs to have an in depth understanding of the gut microbiome and human psychology/neurobiology, and be able to design, execute, analyze and interpret experiments to determine the effects of changes to the gut microbiome on the human psychology. The ordinary artisan needs to be able to not only identify effects at the level of human psychology, but be able to design, conduct and interpret data from mechanistic experiments to determine the underlying cause of the relationship between a specific microbe (or a component thereof) and the psychological phenotype.
The level of predictability in the art is low, this is due to the immense complexity of the human gut microbiome as well as the immense complexity of the human brain/social factors of psychology and the high level of variance in both areas, from person to person. The gut brain axis is a relatively new field of interest and is under intense research with indicative studies but few mechanistic and repeatable high-powered trials (Ou et. al., Methodological recommendations for human microbiota-gut-brain axis research, Microbiome Research Reports, 17OCT23).
The amount of direction provided by inventor and existence of working examples is not sufficient to encompass the breadth of the claim to each of the individual “components” of L. rhamnosus HN001 as defined by applicant. The specification of the instant application recites embodiments of the claimed invention with each of the defined elements of HN001 that comprise a “component”, but does not provide any evidence of any one of those elements in isolation being administered to a subject with the effect of increasing happiness. Specifically, the instant application only provides evidence of administration of live HN001 cells with the effect of increasing happiness though the prior art provides evidence that inactivated cells can provide the same benefit (Mousset et. al.). The amount of experimentation required would not be reasonable since it would require designing, conducting and interpreting experiments to determine the efficacy of each one of the 15 elements comprising “component” as defined by the applicant. Some of the elements (metabolites, enzymes, proteins…) comprise thousands of individual compounds in and of themselves, each of which would require the development of isolation protocols, before being able to start the process of experimentation to determine efficacy at increasing happiness.
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.
Claims 1, 2, 5, 8, 14, 15, 23, 28-33, 36 & 39 are rejected under 35 U.S.C. 102 (a)(1) as being clearly anticipated by Mitchell et. al (WO 2018/220429 Al, hereafter “Mitchell”).
Regarding claims 1, 2, 8, 14, 33, 36 & 39: administering an effective amount of L. rhamnosus HN001 or a derivative or a component thereof to a subject, to increase happiness, treat unhappiness or increase mental well-being, and wherein increasing happiness does not comprise changes in salivary cortisol, is anticipated by Mitchell (Claims section, pages 40-42 and page 30 lines 6-7). Mitchell teaches the administration of the exact same strain of bacteria for the purpose of treating or preventing post-natal depression or anxiety in adult female humans, without measuring any salivary cortisol levels (as in claim 14). Increasing happiness and treating unhappiness are encompassed by treating depression and anxiety, because a person who is experiencing the negative emotional states of depression or anxiety, who is then effectively treated for those conditions is inherently in a more positive/happier emotional state or a state of increased mental well-being. The AscI restriction enzyme digest profile of L. rhamnosus HN001 is an inherent feature of the strain, since the locations of the AscI restriction sites are features of the bacteria’s genome, and thus the digest profile will always be the same if the genome is the same. A bacterial strain is the progeny from a single isolated parent cell and thus all subsequent daughter cells carry the same genome as the original mother. Mitchell specifically teaches that their use of the term “derivative” (Page 11, lines 5-30) encompasses both derivative and component thereof of as the terms are defined in the instant application.
Regarding claims 5 & 15: orally administering 6x109 to 1x1010 CFU of HN001 on a daily basis. Mitchell teaches the exact dose of 6 x 109 CFUs (page 20, lines 18 & 19), via daily oral administration (page 30, lines 14-20) for a duration of between 11-13 months (this is an approximation because the dates were based on gestational weeks and postpartum months) for the purpose of treating or preventing post-natal depression or post-natal anxiety, and increasing happiness is encompassed by treating depression and anxiety because a person who is experiencing the negative emotional states of depression or anxiety, who is then effectively treated for those conditions is in a more positive/happier emotional state. Thus, their happiness or mental well-being was increased.
Regarding claims 23, 28-32: the administration of HN001, with prebiotics, in various forms such as tablets, capsules…, a supplement or a food, such as a dairy product, such as milk, yoghurt…, or a formula such as infant, growing up…, for the purpose of increasing happiness. Mitchell (page 24, lines 27-30) teaches the inclusion of prebiotics to include: galacto-oligosaccharides (GOS), short chain GOS, long chain GOS, fructo-oligosaccharides (FOS), human milk oligosaccharides (HMO), short chain FOS, long chain FOS, inulin, galactans, fructans, lactulose. Mitchell (Claims section pages 40-42 & Compositions section pages 13-16) also teaches the incorporation of HN001 or a derivative or a component thereof into a tablet, capsule, syrup, nutritional supplements and food products. Mitchell also specifically teaches dairy products including milk, yoghurt, butter, cream, ice-cream and cheese, as well as maternal supplements, infant formulas, follow on formula, growing up formula, maternal formula, and other dietetic products (specialized meal replacement products) which encompasses adult and elderly nutritional formulations (especially since maternity can occur in both the adult and elderly populations). Mitchell teaches all of those combinations and formulations for the purpose of treating or preventing post-natal depression or post-natal anxiety. Increasing happiness is encompassed by treating depression and anxiety because a person who is experiencing the negative emotional states of depression or anxiety, who is then effectively treated for those conditions is in a more positive/happier emotional state. Thus, their happiness was increased. Therefore, the claims are anticipated.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
The 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). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that "just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel." Id. See also MPEP § 2112.01 with regard to inherency and product-by-process claims and MPEP § 2141.02 with regard to inherency and rejections under 35 U.S.C. 103.
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Mitchell as applied to claims 1, 2, 5, 8, 14, 15, 23, 28-33, 36 & 39 above, and further in view of Mousset et. al. (US 2022/0249591 Al, hereafter “Mousset”).
Mitchell teaches a method of increasing happiness in a subject, the method comprising administering an effective amount of L.rhamnosus HN001 to a subject. Mitchell further teaches the combination of L. rhamnosus HN001 with other probiotic agents, including: “Lactobacillus rhamnosus GG, Lactobacillus acidophilus (for example, Lactobacillus acidophilus (LA VRI-Al), Lactobacillus reuteri (for example Lactobacillus reuteri ATCC 55730) or Bifidobacteria lactis (for example, Bifidobacteria lactis strain HN019 or Bifidobacteria lactis strain BB 12)”.
Mitchell does not explicitly teach the incorporation of those other probiotic agents as postbiotics.
However, Mousset teaches the incorporation of a list of L. rhamnosus strains (which includes L. rhamnosus HN001) as well as the incorporation of all their probiotics as live or inactivated forms (postbiotics) (page 4 paragraph 0073).
Regarding claims 18 & 19: the inclusion of other probiotics or postbiotics in the composition recited in claim 1, are obvious over Mitchell further in view of Mousset. Where, Mitchell teaches the inclusion of other probiotic strains in its composition with L. rhamnosus HN001 (page 26 lines 25-30) but not that the strains would be inactivated (postbiotics) but Mousset teaches that probiotic refers to live or inactivated bacteria (postbiotics) (page 4 paragraph 0073) and the inclusion of additional strains of microorganisms chosen from the group consisting of Bacillus, Bacteroides, Bifidobacterium, Enterobacteriaceae, Enterococcus, Faecalibacterium, Fusobacterium, Kluyveromyces, Lactobacillus, Odoribacter, Parabacteroides, Pediococcus, Ruminococcus, Streptococcus and/or Saccharomyces (page 9 paragraph 0162). This suggests that a person of ordinary skill in the art would understand that including both live and dead forms of probiotic strains of bacteria are beneficial to human health, and thus would consider the inclusion of both live or dead bacteria in their probiotic compositions. One would have been motivated to do so, since inactivated bacteria are more stable for the purposes of a product’s shelf life, since the bacteria do not need to remain viable.
Claims 3, 4 & 13 are rejected under 35 U.S.C. 103 as being unpatentable over Mitchell as applied to claims 1, 2, 5, 8, 14, 15, 18, 19, 23, 28-33, 36 & 39 above, and further in view of Michalos et. al. (Alex C. Michalos (editor), Encyclopedia of Quality of Life and Well-Being Research, first edition, Springer Dordrecht, 04MAR14, hereafter “Michalos”).
Mitchell further teaches the assessment of the emotional state of adult female human subjects using the “Edinburgh Postnatal Depression Scale (EPDS): The EPDS is a 10 item screening questionnaire widely used to assess maternal mood” and the “State Trait Anxiety Inventory 6 item version (STAI6): The STAI6 is a short 6 item scale validated as an anxiety screening questionnaire based on the longer State Trait Anxiety Inventory”. Mitchell also teaches the assessment of both male and female infant human subjects for infant colic.
Mitchell does not teach the use of assessments directed specifically towards assessing happiness per se, or measuring salivary cortisol and thus does not teach the limitations of claims 3, 4 or 13.
However, Michalos teaches the Oxford Happiness Questionnaire, Subjective Happiness Scale, Satisfaction with Life Scale, Panas Scale, Authentic Happiness Inventory, Psychological Wellbeing Scale, the Fordyce Emotions Questionnaire and the testing of salivary cortisol.
Regarding claims 3, 4 & 13, the measurement of the increased happiness of claim 1 via several different tests, are obvious over Mitchell further in view of Michalos. Mitchell does not teach the use of psychological tests oriented towards testing happiness per se, nor does it teach the assessment of emotional state via salivary cortisol levels. However, Michalos is a standard reference in the field of quality of life and well-being research, and as such provides artisans of ordinary skill in the art the information required to understand and select the appropriate tests to measure the emotional state of happiness in a subject. Specifically, Michalos teaches the Oxford Happiness Questionnaire (page 4551), Subjective Happiness Scale (6420), Satisfaction with Life Scale (page 5660), Panas Scale (page 4918), Authentic Happiness Inventory (pages 4933-8), Psychological Wellbeing Scale (page 5172), the Fordyce Emotions Questionnaire/Happiness Measure (pages 6452) and the testing of salivary cortisol (7101). This suggests that an ordinary artisan in the field would be able to select from any of the tests found within its chapters. One would be motivated to do so because including multiple tests of happiness (as in claim 3) would increase the scientific rigor of any assertions of increased happiness as well as provide flexibility in experimental design. According to Michalos (page 4551 last paragraph) one would also be motivated to use the Oxford Happiness Questionnaire specifically (as in claim 4) because “Greater professionalism has been shown in the development of the OHQ in terms of item selection, the inclusion of reverse-coded items, and the proper publication of psychometric properties. When time is short as well as space, the short 7-item form of the OHQ provides a reasonable approximation of the larger 29-item form”. One would also be motivated to use a test of salivary cortisol levels (as in claim 13) as opposed to the previously mentioned questionnaires because this is an objective measurement and is more rigorous than subjective measurements. Thus, providing stronger evidence of the positive effects of the composition recited in claim 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 1-2, 5, 8, 13-15, 18-19, 23, 28-33, 36 & 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 5-6 & 20-25 of U.S. Patent Application No. 18/832,675.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 3 (and its dependent claims 4-7, 9-11, 13, 16-18 & 21-25) of 18/832,675 recites the use of L. rhamnosus HN001 for “reducing or preventing stress, optionally chronic stress; (ii) reducing or preventing anxiety; (iii) reducing or preventing one or more symptoms of depression; (iv) decreasing or reversing certain changes caused by stress, anxiety or depression; (v) improving mood; (vi) increasing relaxation; (vii) increasing energy”. While ‘675 does not teach the increase in happiness or mental well-being of instant application; this claim recites an obvious variant of increasing happiness/mental wellbeing in a subject by administering L. rhamnosus HN001 (as in the independent claims 1, 36, & 39 and claim 1’s dependent claims, 2-5, 8, 13-15, 18-19, 23, & 28-33) since a subject who has been effectively treated for the reduction of depression, anxiety or both is by definition in a more positive/happier emotional state or otherwise in a state of increased mental wellbeing.
Regarding claims 1-2, 5, 8, 14-15, 18-19, 33, 36 & 39: the administration of 6x109 to 1x1010 CFUs of HN001 in viable form, derivatives or components thereof and other probiotic or postbiotic microorganisms for the purpose of increasing happiness, mental well-being or treating unhappiness, wherein increasing happiness does not comprise changes in salivary cortisol levels, are anticipated by claims 3, 5, 20, & 25 of ‘675. Claim 3 of ‘675 recites the administration of HN001 and/or B. lactis HN019 or derivatives thereof for reducing or preventing anxiety, one or more symptoms of depression or improving mood amongst other conditions. Claim 20 of ‘675 recites the composition of HN001 and or HN019 as reproductively viable, killed, lysed, fractionated or attenuated forms. Claim 3 of ‘675 teaches the administration of the exact same strain, HN001, plus another probiotic strain from the list found in claim 19 of instant application, for the purpose of treating anxiety and depression which are obvious variants of increasing happiness or treating unhappiness or increasing mental well-being since a subject that has been successfully treated for anxiety or symptoms of depression is inherently in a more positive/ happier state or a state of increased mental well-being. Neither claim comprises changes to salivary cortisol levels. The AscI restriction enzyme digest profile of L. rhamnosus HN001 is an inherent feature of the strain, since the locations of the AscI restriction sites are features of the bacteria’s genome, and thus the digest profile will always be the same if the genome is the same. A bacterial strain is the progeny from a single isolated parent cell and thus all subsequent daughter cells carry the same genome as the original mother. The lysed or fractionated cells of claim 20 of ‘675 encompasses the “components thereof” of the instant application since the fractions of the cells of ‘675 could include any or all of the components of the cell defined in the specification of instant application. A subject in need thereof from claim 3 of ‘675 encompasses the “is selected from an/a: infant, child, adolescent, adult and elderly adult” of claim 8 of the instant application. Claim 5: oral administration of the composition recited in the method of claim 1; is anticipated by claim 5 of ‘675 which also recites the oral administration of HN001 or derivatives thereof. Claim 15 of instant application is anticipated by claim 25 of ‘675 which recites administering a dose of at least 1.9x109 CFUs, which reasonably includes 6x109 CFUs.
Regarding claims 23, 28-32: the administration of HN001, with prebiotics, in various forms such as tablets, capsules…, a supplement or a food, such as a dairy product, such as milk, yoghurt…, or a formula such as infant, growing up…, for the purpose of increasing happiness. These claims are anticipated by claims 21-24 of ‘675 which recite the inclusion of HN001 (for the purpose of reducing or preventing anxiety or depression…) with prebiotics in a food product or supplement to include: cultured milk, yoghurt, cheese milk drink and milk powder as well as a maternal supplement, a dietetic product, and infant formula a follow-on formula and a growing up formula. Claim 23 of ‘675 anticipates claim 28 of the instant application in that a milk drink is a liquid and a milk powder is a powder form of HN001. Reducing or preventing anxiety and depression are obvious variants of increasing happiness or treating unhappiness or increasing mental well-being since a subject that has been successfully treated for anxiety or symptoms of depression is inherently in a more positive/ happier state or a state of increased mental well-being.
Regarding claim 13: wherein increasing happiness comprises changes in salivary cortisol levels, is anticipated by claim 6 of ‘675 which recites the administration of HN001 (for the purpose of reducing or preventing anxiety or depression…) reducing cortisol levels. Reducing or preventing anxiety and depression are obvious variants of increasing happiness or treating unhappiness or increasing mental well-being since a subject that has been successfully treated for anxiety or symptoms of depression is inherently in a more positive/ happier state or a state of increased mental well-being.
Claims 3 & 4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent Application No. 18/832,675 further in view of Michalos.
Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious over claim 3 of ‘675 (administration of the exact same strain, HN001, for the purpose of treating anxiety and depression) further in view of Michalos, which teaches all the tests for happiness described in claims 3 & 4 of instant application. Specifically, Michalos teaches the Oxford Happiness Questionnaire (page 4551), Subjective Happiness Scale (6420), Satisfaction with Life Scale (page 5660), Panas Scale (page 4918), Authentic Happiness Inventory (pages 4933-8), Psychological Wellbeing Scale (page 5172), the Fordyce Emotions Questionnaire/Happiness Measure (pages 6452) and the testing of salivary cortisol (7101). This suggests that an ordinary artisan in the field would be able to select from any of the tests found within its chapters. One would be motivated to do so because including multiple tests of happiness (as in claim 3) would increase the scientific rigor of any assertions of increased happiness as well as provide flexibility in experimental design. According to Michalos (page 4551 last paragraph) one would also be motivated to use the Oxford Happiness Questionnaire specifically (as in claim 4) because “Greater professionalism has been shown in the development of the OHQ in terms of item selection, the inclusion of reverse-coded items, and the proper publication of psychometric properties. When time is short as well as space, the short 7-item form of the OHQ provides a reasonable approximation of the larger 29-item form”.
Conclusion
Claims 1-5, 8, 13-15, 18-19, 23, 28-33, 36 & 39 are rejected under 35 U.S.C. 112(a) for scope of enablement for “components thereof”.
Claims 1, 2, 5, 8, 14, 15, 23, 28-33, 36 & 39 are rejected under 35 U.S.C. 102 (a)(1) as being clearly anticipated by Mitchell.
Claims 3, 4, 13 & 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Mitchell, Mousset and Michalos.
Claims 1-5, 8, 13-15, 18-19, 23, 28-33, 36 & 39 rejected on the ground of nonstatutory double patenting as being unpatentable over 18/832,675.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GREGORY WILLKEEN whose telephone number is (571)272-6184. The examiner can normally be reached 9:00-5:00 Mon-Fri.
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/G.A.W./Examiner, Art Unit 1651
/MELENIE L GORDON/ Supervisory Patent Examiner, Art Unit 1651