Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of Group I, claims 16-23, hyaluronic acid for species A and atopic dermatitis for species B in the reply filed on January 13, 2026 is acknowledged. The traversal is on the ground(s) that the technical feature of a bacterial cell wall or fragment thereof linked with a mucopolysaccharide wherein the bacterial strain is gram-positive and is Cutibacterium acnes is not obvious based on the teachings of Melis et al (Taylor & Francis, (Year: 2018), vol. 34, no. 10, pp. 880-883) in view of Longo et al (U.S. Pub. No. US 2017/0173163 A1). This is not found persuasive because as demonstrated below, the references cited by Melis et al and Longo et al demonstrates a lack of unity between the claimed inventions because they teach the linking technical feature of a combination of a bacterium linked to a mucopolysaccharidic fraction [(e.g. hyaluronic acid)] (paragraph 0016), therefore, the lack of unity principle is used properly with obviousness. Thus, applicant’s argument is not persuasive.
The requirement is still deemed proper and is therefore made FINAL.
Claims 24-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 16-23 are examined on the merits in regards to the elected species.
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 16-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Since the microorganism Cutibacterium acnes under accession number DSM 28251 is recited in the claims, it is essential to the invention recited in those claims. It must therefore be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the microorganism is not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the microorganism.
Since a deposit has been made under the terms of the Budapest Treaty, then an affidavit or declaration by Applicants or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney or record over his/her signature, and registration number, stating that the specific strain has been deposited under the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirements. See 37 C.F.R. § 1.808.
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 16-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 is indefinite because it is unclear what the applicant means by “is gram-positive and is Cutibacterium acnes”. Since Cutibacterium acnes is a gram-positive bacterium, it is unclear if “gram-positive” is referring to another type of bacterium and also Cutibacterium acnes at the same time.
Claim 17 is indefinite because the phrase “and chitosan and physiologically salt thereof” is unclear. It is unclear if the salts are only chitosan salts or if salts of all the listed ingredients that can be used. In addition, “acceptable” appears to be missing between “physiologically” and “salt”.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 18 recites the broad recitation of the grouping of mucopolysaccharides, and the claim also recites “preferably is hyaluronic acid” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 21 is indefinite because is states that it is drawn to “the bacterial cell wall…or lysate thereof associated with a mucopolysaccharide or claim 16.” There is a lack of antecedent basis for “the lysate” and “associated”. Claim 16 does not contain a lysate. In addition, claim 16 requires that the bacterial cell wall or fraction is “linked” to the mucopolysaccharide rather than “associated” with the mucopolysaccharide. “Associated” could encompass a simple mixture rather than a linked composition.
Claim 22 is indefinite because it is unclear what “effective amount” constitutes. It is unclear what amount is needed in order for it to be considered an effective amount because the claim does not state what the desired effect is.
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 16-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a naturally occurring Cutibacterium acnes linked to a hyaluronic acid (HA) without significantly more.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claims are directed to a product; thus, the answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites to a product of nature. In this case, applicant’s claims recite Cutibacterium acnes deposited with accession number DSM 28251. Cutibacterium acnes is a naturally occurring bacteria. Hyaluronic acid (HA) is naturally occurring within various tissues of the human body. Thus, the claims do recite products of nature. MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”.
In this case, applicant specification states that the fragment or lysate of the bacterial cell wall of the strain Cutibacterium acnes DSM 28251 may be obtained by delipidation of the bacterial cell wall and subsequent crushing of the strain (page 6, lines 7-9) and HA is obtained through oxidation on the hydroxyl of carbon six of the N-acetylglucosamine moiety of the mucopolysaccharide such as HA (page 6, lines 14-16). Selection of a particular species of a naturally occurring organism does not create a markedly distinct organism. The selected microorganism would be the same as the identical microorganism because selection only occurs from what exists. In addition, selection of a particular compound, such as HA, which is a glycosaminoglycan (GAG), would be the same as the identical GAG because selection only occurs from what exists. There is no indication that linking the bacterial cell wall with the hyaluronic acid as commensurate in scope with the stated claims changes the structure, function, or other properties of the two ingredients in any marked way in comparison with the closest naturally occurring counterpart. The closest naturally occurring counterpart for each ingredient is the ingredient itself. While the linking is not described as naturally occurring, there is no evidence that the linking produces a markedly distinct characteristic. Thus, the claimed composition as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, applicant’s claims are directed to a composition with an intended use as a medicament. MPEP § 2106.04(d)(2) specifically states that a claim is only directed to “an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the ‘treatment or prophylaxis’ consideration.” Therefore, applicant’s intended use is not sufficient to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, the additional element in the claims is the addition of a physiologically acceptable carrier (e.g. water). However, MPEP § 2106.05(d) states that well-understood, routine, and conventional activities are not sufficient to show that the claims amount to significantly more than the judicial exception. Mixing specific compounds and carriers does not amount to significantly more than the judicial exception. Mixing specific compounds and carriers does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field. Thus, mixing the ingredients together does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field.
In addition, applicant’s intended uses are not considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A), “Generally linking the use of the judicial exception to a particular technological environment or field of use” is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional elements are not considered to amount to significantly more. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
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.
Claim(s) 16-23 are rejected under 35 U.S.C. 103 as being unpatentable over Melis et al (Taylor & Francis, (Year: 2018), vol. 34, no. 10, pp. 880-883) in view of Longo et al (U.S. Pub. No. US 2017/0173163 A1).
Melis et al teaches Propionibacterium acnes (P. acnes) is an insoluble particulate fraction obtained from the bacterial cell wall (page 880). Melis et al teaches [the] fraction of P. acnes, the P40 (page 880). Melis et al teaches that the parietal fraction from P. acnes associates to hyaluronic acid (page 881). Melis et al teaches these bacterial fractions can be
obtained by the mechanical or chemical crushing of bacterial walls (page 880). Melis et al teaches the composition can be in the form of a vaginal gel (abstract). Melis et al teaches the composition of the P. acnes fraction is represented by cell wall peptidoglycan linked to a glycoprotein (page 880).
The Melis et al reference does not teach the bacterial cell wall or fragment thereof linked to a mucopolysaccharide.
Longo et al teaches the covalent P40-mucopolysaccharidic fraction (paragraph 0018). Longo et al teaches P40-physiologically acceptable covalent conjugate carrier is provided, wherein the physiologically acceptable carrier comprises a physiologically acceptable mucopolysaccharide or mucopolysaccharidic fraction (paragraph 0028). Longo et al teaches the mucopolysaccharides or mucopolysaccharidic fractions contained in the conjugate of the invention are selected from the group comprising hyaluronic acid (HA) (paragraph 0047).
Given the teachings above, one of ordinary skill would make the combination of the two references – Melis et al with Longo et al to create a bacterial cell wall or fragment thereof linked to a mucopolysaccharide in which that bacterium is Cutibacterium acnes (e.g. formally known as Propionibacterium acnes or P. acnes). The motivation to combine the two references stems from the fact that Melis et al teaches a fraction of P. acnes (also referenced as P40 on page 880) linked to a glycoprotein and Longo et al also teaches a P40 fraction that is linked to a mucopolysaccharide. Although Melis et al teaches the fraction linked to a glycoprotein, one of ordinary skill in the art would reasonably expect the use of a mucopolysaccharide in lieu of a glycoprotein off the premise that the combination of P40 with a mucopolysaccharidic fraction would determine a synergistic effect (paragraph 0018) as taught by Longo et al. Regardless of the fact that Longo et al teaches the use of the Corynebactrium species attached to a mucopolysaccharidic fraction, that does not negate the fact that the Melis et al reference teaches the bacterium, P. acnes in association with a glycoprotein is not vastly different than Longo et al, which has the bacterium, Corynebacterium in association with HA (a mucopolysaccharidic fraction). Therefore, one would reasonably expect to create a bacterial cell wall or fragment thereof of P. acnes bacterium linked to a mucopolysaccharide using the Corynebacterium species mucopolysaccharidic fraction to achieve the composition as stated within the claims of the present invention.
The Melis et al reference does not specifically teach that the Cutibacterium acnes is Cutibacterium acnes DSM 28251. However, the reference teaches a Cutibacterium acnes which is useful as a bacterial cell wall or fragment thereof. The Melis et al reference teaches a microorganism which appears to be identical to the presently claimed microorganism, based on the fact that the both the reference microorganism and the claimed microorganism are from the same genus and species and have overlapping pharmaceutical properties.
However, even if the reference microorganism and the claimed microorganism are not one and the same, the reference microorganism would, nevertheless, have rendered the claimed microorganism obvious to one of ordinary skill in the art at the time the claimed invention was made in view of the clearly close relationship between the microorganism as evidenced by their shared taxonomical classification and pharmaceutical characteristics. The selection of a specific strain of a known type of microorganism is considered to be prima facie obvious in the absence of sufficient, clear, and convincing evidence to the contrary.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nashara L Moreau whose telephone number is (571)272-5804. The examiner can normally be reached Monday - Thursday, 8 AM - 4 PM ET.
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NASHARA L MOREAUExaminer, Art Unit 1655
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655