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 .
Priority
This application claims benefit of priority to the Italian Republic Application No. IT102020000018901 filed on 07/31/2020. This application is also a 371 of PCT/IB2021/056913 filed on 07/29/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. However, an English translation of the foreign application was not provided. Therefore, the effective filing date, for the purposes of applying prior art, of the instant application is 07/29/2021.
Amendment and Claim Status
In the reply filed on 08/25/2025, Applicant amended claims 1 and 7. Claims 2, 11 and 17 were previously canceled by Applicant. Claims 10, 12 and 14-16 remain withdrawn by the Examiner as not being encompassed by the elected group.
Claims 1, 3-10, 12-16 and 18-20 are currently pending.
Claims 10, 12 and 14-16 are withdrawn by the Examiner.
Claims 1, 3-9, 13, and 18-20 are under examination.
Withdrawn Rejections
The 35 USC § 112(b) rejection over previously examined claims 1, 3-9, 13 and 18-20 is withdrawn due to Applicants amendment to instant claim 1.
The 35 USC § 112(d) rejection over previously examined claim 7 is withdrawn due to Applicants amendment to instant claim 7.
Maintained Rejections (with modifications to address claim amendments)
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, 3-8 and 13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the claims are directed to a product of nature.
Claims 1, 3-8 and 13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a non-eligible natural product as supported below.
STEP 1: Is the claim to a process, machine, manufacture or composition of matter?
With regard to Step 1, the composition as claimed in claims 1, 3-8 and 13 is a composition of matter.
Answer to Step 1: Yes, claim 1 is directed toward a product of nature.
STEP 2: Is the claim directed to a law of nature, a natural phenomenon or an abstract idea (judicially recognized exceptions)?
Step 2 comprises two, respective steps: Step 2A Prong 1 and Step 2A Prong 2. Both steps together, provide the analysis for determining whether the claim recites a Judicial Exception (JE).
Step 2A, Prong 1: Is the claim ‘directed to’ an abstract idea, law of nature or natural phenomenon?
A claim product is ‘directed to’ a natural phenomenon/natural product if the product of the claim is not ‘markedly different’ when compared to its closest-occurring natural counterpart.
With regard to Step 2A, Prong 1:
Claim 1 is directed to three microorganisms comprising Lactobacillus plantarum PBS067, Lactobacillus rhamnosus LRH020 and Lactobacillus reuteri PBS072. Thus, claim 1 is generally directed to microorganisms. It is noted L. plantarum PBS0fil67 was isolated from the feces of healthy humans as evidenced by Giani et al. (AMB Express, 2019) and L. reuteri PBS072 was isolated from the stool of a healthy infant as evidenced by Vicariotto et al. (Nutrients, 08/09/2023). While it is unclear exactly where L. rhamnosus LRH020 was isolated from, it is well known L. rhamnosus strains can be found abundantly in nature, for example in the human intestinal tract, vaginal cavity or oral cavity, as well as in cheese as evidenced by Douillard et al. (PLoS Genetics, 08/15/2013). Thus, each of the claimed Lactobacillus strains are natural strains that have been isolated from their natural habitat.
Since there is no evidence that all of the claimed bacteria are found ‘together’ in nature, the ‘closest-occurring natural counterpart’ to the claimed invention appears to be each, individual microorganism as they exist in nature.
It is noted that isolating a natural microorganism, and then placing the microorganism in a non-natural environment does not alter the structure or function of the claimed microorganism. The combination of three, naturally occurring Lactobacillus strains does not provide for any marked effect compared to the closest, naturally-occurring counterpart. Again, all three Lactobacillus species of the instant invention are present naturally as discussed above. Therefore, the mixture of the three Lactobacillus strains as claimed is naturally occurring and there is no evidence set forth within the Instant Specification demonstrating combining the claimed, naturally-occurring bacteria into one, single composition changes the intrinsic function of each bacteria how each is present in nature and does not change the structure of any of the claimed, naturally-occurring bacteria. Thus, when combined, the respective bacteria do not differ in any respect; genetically, functionally or phenotypically from its naturally occurring counterpart.
There is no indication mixing the claimed bacteria provides for some function that does not naturally and inherently occur within each bacteria naturally. Therefore, each bacteria, as claimed, upon mixing together, will perform the same functions each, individual bacteria perform in nature, and thus, the mixture of bacteria as a whole does not display any markedly different characteristics compared to the naturally occurring counterparts and “serves the ends nature originally provided, and acts quite independently of any effort of the patentee” (Funk Brothers Seed Co. v. Kalo Inoculant Co., Id.).
Claims directed toward particular CFUs, or ratios regarding the CFUs, of bacteria also are solely directed toward a mixture of naturally-occurring bacteria and the amounts of bacteria as-claimed are not demonstrated as providing a markedly different effect compared to the same amount of individual bacteria as found in nature.
Regarding claim 7, replacing a natural product with another natural product, L. acidophilus, does not render the composition non-natural. L. acidophilus is a bacteria typically found in the human gut as evidenced by Filippis et al. (FEMS Microbiology Reviews, 06/18/2020). Replacing one of the natural products, the claimed Lactobacillus strains, with another Lactobacillus strain that is abundantly found in nature, does not provide any markedly different characteristic compared to the naturally occurring counterpart.
Pertaining to claims which recite particular percentages, or ratios regarding the percentage, of bacteria: Again, the instant Specification does not provide any indication that altering the percentage of any one or more bacteria in the claimed mixture provides for any result that would not be expected from each, individual bacteria in nature.
Answer to Step 2A, Prong 1: Yes, the claim is ‘directed to’ an abstract idea, law of nature or natural phenomenon.
Step 2A, Prong 2: Does the claim recite additional elements that integrate the natural product into a practical application?
‘Integration into a practical application’ according to the most recent PEG guidance:
Requires an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception.
Uses the considerations laid out by the Supreme Court and the Federal Circuit to evaluate whether the judicial exception is integrated into a practical application.
With regard to Step 2A, Prong 2:
Claim 1 contains one ‘additional element’ (an element in addition to the natural product) which is the mixture of bacteria; i.e., manually admixing the bacteria together to form one, single product. However, this additional element does not integrate the natural product into a practical application because there is no demonstration within the instant Specification that admixing these naturally-occurring bacteria provides for any new manifestation that was not intrinsically present in the naturally-occurring bacteria as they exist in nature.
Pertaining to claims reciting particular percentage ranges of one or more bacteria: The addition of percentages is considered an ‘additional element,’ however, there is no showing of an improvement, the claims do not apply the product of nature to a particular treatment nor do the claims effect a transformation or reduction to a different state or thing. Therefore, the claims directed toward certain percentages of bacteria are directed to a natural product and nothing more.
Claims directed toward particular CFUs of bacteria also are solely directed toward a mixture of naturally-occurring bacteria and the amounts of bacteria as-claimed are not demonstrated as adding any meaningful element to these claims which would provide for any effect in-addition to what the same amount of each, individual bacteria in nature would provide.
Regarding claim 7, the addition of a Lactobacillus acidophilus strain is considered an ‘additional element,’ however, L. acidophilus is also a natural product and there is no evidence this naturally occurring bacteria provides for any new manifestation that was not intrinsically present in the naturally-occurring bacteria as it existed in nature. As such, the claim is directed to a natural product and nothing more.
The addition of ‘in oral or topical form’ as recited by claims 8 and 13 does not meaningfully limit the claimed natural product because ‘in oral or topical form’ requires nothing more than the natural products themselves. For example, one could form these bacteria into a form that could easily be used orally or topically as there are no particular ingredients which are required with claims 8 and 13. Therefore, the ‘additional component’ fails to practically apply the natural product.
As such, there is no additional element within the claims that applies or uses the judicial exception in some meaningful way beyond generally linking the use of the judicial exception to the natural microorganisms, Lactobacillus plantarum PBS067, Lactobacillus rhamnosus LRH020 and Lactobacillus reuteri PBS072, such that the claims as a whole are more than a drafting effort designed to monopolize the exception.
Thus, there is no showing of an improvement, the claim does not apply the product of nature to a particular treatment nor does the claim effect a transformation or reduction to a different state or thing.
The claim is directed toward a natural product and nothing more. The claim is also not directed to a method for treating or applying the natural product.
Answer to Step 2A, Prong 2: No, the claim does not recite additional elements that integrate the Judicial Exception into a practical application.
Answer to Step 2A: Yes, the claim is directed to a Judicial Exception.
Step 2B: Does the claim recite additional elements that amount to significantly more than the Judicial Exception?
With regard to Step 2B, claim 1 one contains one ‘additional element’ (an element in addition to the natural product) which is the mixture of bacteria; i.e., manually admixing the bacteria together to form one, single product, in addition to the Lactobacillus plantarum PBS067, Lactobacillus rhamnosus LRH020 and Lactobacillus reuteri PBS072. However, the element, mixing the bacteria, does not add significantly more because it is routine in the probiotic art to admix probiotic bacteria to produce probiotic compositions comprising a variation of bacteria to improve gut flora.
With regard to dependent claims 3-8 and 13, it is noted these claims only recite elements that further characterize the natural product, or further natural components that can be included with the composition.
With regard to dependent claims 3-6, the recitation of the percent of each claimed microbe does not alter any functional or structural characteristic of any claimed, naturally-occurring component nor does it create a different use for each component or for the combination of components different from what is found in nature in order to demonstrate significantly more than the JE.
With regard to claim 7, the replacement of one Lactobacillus strain for L. acidophilus is simply a further natural component that can be included with the composition. This addition does not create a different use or change the structure of the naturally-occurring microbe.
With regard to claims which recite particular percentage ranges or CFUs of bacteria: these claims are not found to offer significantly more than the bacteria themselves because modifying the amount and/or percentage of bacteria in a bacterial mixture is well-understood, routine, conventional practice in the art; particularly within the food/bacterial supplement art.
With regard to dependent claim 8 and 13, the bacteria being in oral or topical form is not deemed to render the composition non-natural as the composition itself can be an oral or topical form as discussed above. There are no particular components nor shape the claim requires and it is well-understood, routine and conventional to offer bacterial products in various forms with the art.
Answer to Step 2B: No, the claims do not recite any additional elements that amount to significantly more than the judicial exception.
For the foregoing reasons, the claims are not deemed to encompass patent eligible subject matter under 35 USC § 101.
35 USC § 101 – Response to Arguments
In the reply filed on 08/25/2025, Applicant presented multiple arguments which will be discussed below.
Applicant argued the Office Action mailed on 05/23/2025 stated “Claim 1 is directed toward a product of nature” and then concedes that there is no evidence that the bacteria recited in claim 1 are found together in nature (Page 8, Last 2 Paragraphs), the Examiner agrees with this assessment.
Step 1 of the 35 U.S.C. 101 analysis determines if the claims are directed to an acceptable statutory category. In the instant case, the answer is “Yes,” as the claims are directed to a product. If the answer to Step 1 was “No,” the claims are not directed an acceptable statutory category, the analysis would stop there and the claims would be deemed ineligible. Since the answer to Step 1 was “yes,” Step 2 was addressed, which is where the ‘closest-occurring natural counterpart’ comes into the equation, and where the Examiner stated “since there is no evidence that all of the claimed bacteria are found ‘together’ in nature, the ‘closest-occurring natural counterpart’ to the claimed invention appears to be each, individual microorganism as they exist in nature.” This statement was referring to Step 2, not Step 1. Additionally, the claimed strains not being found together in nature has no impact on Step 2, Prong 1. Thus, there is nothing ‘fundamentally flawed’ about that examination, that is the proper examination when following the steps in the 35 USC § 101 analysis.
Applicant further argued the Office Action asserts the combination of the three bacteria does not provide for any marked effect compared to the closest-occurring natural counterpart but does not offer any evidence in support of that assertion (Page 9, Paragraph 1).
Applicants arguments have been fully considered. However, it is not incumbent upon the Examiner to provide evidence supporting the assertion that combination of bacteria does not provide a marked effect compared to the closest-occurring natural counterpart. The burden of showing the composition does have a marked effect when compared to the closest-occurring natural counterpart lies with the Applicant. The courts have emphasized that to show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75. Thus, in order to be markedly different, the inventor must have caused the claimed product to possess at least one characteristic that is different from that of the counterpart. See MPEP 2106.04(c).
Applicants go on to argue the Office Action asserts “the mixture of the three Lactobacillus strains as claimed is naturally occurring” which contradicts “there is no evidence that all of the claimed bacteria are found ‘together’ in nature” (Page 9, Paragraph 2).
Applicants arguments have been fully considered but are not persuasive. The Examiner specifically states “Again, all three Lactobacillus species of the instant invention are present naturally as discussed above. Therefore, the mixture of the three Lactobacillus strains as claimed is naturally occurring …”. Respectfully, Applicant has misconstrued what the Examiner is saying. That statement is referring to the earlier sentence, hence the use of “again” and “as discussed above,” where the Examiner states “since there is no evidence that all of the claimed bacteria are found ‘together’ in nature, the ‘closest-occurring natural counterpart’ to the claimed invention appears to be each, individual microorganism as they exist in nature.” Thus, each bacterial strain individually is naturally occurring.
Applicant further argued the combination of bacteria, the instantly claimed composition, works for treating inflammatory skin disorders and therefore provides a marked effect compared to the closest naturally-occurring counterpart
Applicants arguments have been fully considered but are not persuasive. As stated above, the Applicant must provide evidence of a marked effect. The Examiner has thoroughly reviewed the instant Disclosure and there is no showing by Applicant that the bacteria that have been combined into the instant composition do not have the same effects individually. Moreover, showing the combination has these effects does not mean the individual strains do not also have these effects. Therefore, the are no marked effects when compared to its closest naturally-occurring counterpart.
It is noted Applicants state multiple times throughout the arguments that the composition is an ‘admittedly novel combination.’ This is an inaccurate representation of what the Examiner stated as the Examiner never stated the composition was a novel combination.
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.
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, 3-9, 13 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Mezzasalma et al. (BioMed Research International, 08/09/2016).
Regarding claim 1, Mezzasalma et al. disclose probiotic compositions for treating irritable bowel syndrome (Abstract). They disclose two probiotic compositions, composition 1 comprising L. acidophilus and L. reuteri, and composition 2 comprising L. plantarum and L. rhamnosus (Page 2, Right Column, Paragraph 3). Mezzasalma et al. further disclose the probiotic strains used were Lactobacillus rhamnosus LRH020 with deposit number DSM 25568, Lactobacillus plantarum PBS067 with deposit number DSM 24937, Lactobacillus acidophilus PBS066 with deposit number DSM 24936 and Lactobacillus reuteri PBS072 with deposit number DSM 25175 (Table 1).
Mezzasalma et al. do not disclose a single composition comprising L. plantarum PBS067, L. rhamnosus LRH020 and L. reuteri PBS072.
However, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose.” See MPEP 2144.06. 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 combined the strains of the two probiotic compositions disclosed by Mezzasalma et al. as they are both know and effective probiotic compounds for treating irritable bowel syndrome as taught by Mezzasalma et al. as it amounts to combining two compositions useful for the same purpose.
Regarding claim 3, Mezzasalma et al. disclose composition 2 contained 5 x 109 CFU L. plantarum (Page 2, Right Column, Paragraph 3).
Mezzasalma et al. does not disclose the L. plantarum strain being present in a percentage from 10% to 30% of the total weight or from 0.5 to 2.5 billion CFU.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). See also, In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine all operable and optimal concentrations of the claimed component (i.e., L. plantarum) because the claimed component is an art-recognized result-effective variable having pharmacological ability as disclosed by the prior art above. Therefore, the claimed component would have been routinely and predictably optimized in the pharmaceutical art. The differences between the instant claim and that suggest by the prior art appear minor in nature. Although the prior art does not teach the amount or percent claimed, since the claimed component is known to have a pharmacological effect as discussed by the prior art above, it would have been conventional and within the skill level of an ordinary artisan to identify and modify the percentages and amounts of the claimed component motivated by the desire to create an effective probiotic composition.
Regarding claim 4, Mezzasalma et al. disclose composition 2 contained 5 x 109 CFU L. rhamnosus (Page 2, Right Column, Paragraph 3).
Mezzasalma et al. does not disclose the L. rhamnosus strain being present in a percentage from 25% to 45% of the total weight or from 0.5 to 2.5 billion CFU.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). See also, In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine all operable and optimal concentrations of the claimed component (i.e., L. rhamnosus) because the claimed component is an art-recognized result-effective variable having pharmacological ability as disclosed by the prior art above. Therefore, the claimed component would have been routinely and predictably optimized in the pharmaceutical art. The differences between the instant claim and that suggest by the prior art appear minor in nature. Although the prior art does not teach the amount or percent claimed, since the claimed component is known to have a pharmacological effect as discussed by the prior art above, it would have been conventional and within the skill level of an ordinary artisan to identify and modify the percentages and amounts of the claimed component motivated by the desire to create an effective probiotic composition.
Regarding claim 5, Mezzasalma et al. disclose composition 2 contained 5 x 109 CFU L. reuteri (Page 2, Right Column, Paragraph 3).
Mezzasalma et al. does not disclose the L. reuteri strain being present in a percentage from 35% to 55% of the total weight or from 0.5 to 2.5 billion CFU.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). See also, In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine all operable and optimal concentrations of the claimed component (i.e., L. reuteri) because the claimed component is an art-recognized result-effective variable having pharmacological ability as disclosed by the prior art above. Therefore, the claimed component would have been routinely and predictably optimized in the pharmaceutical art. The differences between the instant claim and that suggest by the prior art appear minor in nature. Although the prior art does not teach the amount or percent claimed, since the claimed component is known to have a pharmacological effect as discussed by the prior art above, it would have been conventional and within the skill level of an ordinary artisan to identify and modify the percentages and amounts of the claimed component motivated by the desire to create an effective probiotic composition
Regarding claim 6, Mezzasalma et al. disclose composition 1 contained 5 x 109 CFU L. reuteri and composition 2 contained 5 x 109 CFU L. plantarum and 5 x 109 CFU L. rhamnosus (Page 2, Right Column, Paragraph 3). The disclosed amount in CFU reads on the probiotic composition being equal to 1:1:1 if expressed in CFU.
Regarding claim 7, as stated above with regard to instant claim 1, Mezzasalma et al. disclose composition 1 comprising L. acidophilus and L. reuteri (Page 2, Right Column, Paragraph 3).
Mezzasalma et al. do not disclose wherein one strain of the composition is replaced with a strain of Lactobacillus acidophilus.
However, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose.” See MPEP 2144.06. 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 replaced one strain of the composition with a strain of L. acidophilus as it was disclosed as a known and effective component of a probiotic composition for treating IBS as taught by Mezzasalma et al. as it amounts to combining two compositions useful for the same purpose.
Regarding claims 8 and 13, Mezzasalma et al. disclose each group received a daily oral administration of probiotic mixtures (Abstract).
Regarding claims 9, 13 and 18-20, Mezzasalma et al. disclose treatment with two multispecies probiotic formulates on subjects diagnosed with IBS-C (Abstract), reading on a medicament.
35 USC § 103 – Response to Arguments
In the reply filed on 08/25/2025, Applicant argued the Examiner took the position that “it would have been prima facie obvious to combine any of the strains disclosed by Mezzasalma, in any combination, which of course finds no basis in the disclosure of the reference or in the factual record” (Page 10, Last Paragraph – Page 11, First Paragraph).
Applicants arguments have been fully considered, and the Examiner agrees the position taken was any combination of the strains disclosed by Mezzasalma et al. in any combination would have been prima facie obvious. The Examiner maintains this position. As discussed above, Mezzasalma et al. disclose two probiotic compositions for treating irritable bowel syndrome, with composition 1 comprising L. acidophilus and L. reuteri, and composition 2 comprising L. plantarum and L. rhamnosus (Page 2, Right Column, Paragraph 3). The basis for this rejection is not within the disclosure, the basis for this rejection is MPEP 2144.06(I), which states “it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Thus, it would have been obvious to combine any of the strains disclosed by Mezzasalma et al. in any combination because the compositions are taught by the prior art to be useful for the same purpose.
Applicant further argued they have convincingly shown the composition works for its intended purpose, being the treatment of inflammatory diseases of the skin, while there is nowhere in the prior art that even hints toward the specific combination of Lactobacillus strains for the treatment of inflammatory diseases of the skin (Page 11, Paragraphs 2-3).
Applicants arguments have been fully considered but are not persuasive. The composition of the instant applicant was not examined for a method of treating inflammatory diseases of the skin. The claims directed to a method of treating inflammatory disease of the skin were withdrawn and they are not encompassed by the elected group. Thus, this argument is not directed to the elected invention and the rejection properly does not address these limitations.
Conclusion
Claims 1, 3-9, 13, and 18-20 are rejected.
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/A.T.W./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653