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 of Group 1 (claims 31-47) and the following species:
A lipid carrier that is GM1-Gb3 and further comprises a ceramide moiety composed of an alcohol and/or a fatty acid, which has the non-lipid portion is a first carbohydrate moiety and the first sugar is glucose, the lipid portion is an amino alcohol moiety. The election also includes the second peptide of an antibody.
A bacteria.
in the reply filed on 30 Sep 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Status
The amended claim set filed 30 Sep 2025 is acknowledged. Claims 31-50 are currently pending. Of those, claims 31, 43-45, 48 are currently amended, claims 31-48 have been amended relative to the original filed claims, and no claims are new. Claims 34 and 48-50 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species of lipid portion and a nonelected invention, respectively, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 30 Sep 2025. Claims 1-30 are cancelled. Claims 31-33 and 35-47 will be examined on the merits herein.
Priority
This application claims priority to provisional application 62/914,912 (filed 14 Oct 2019) and is a 371 of PCT/EP2020/069910 (filed 14 Jul 2020). The instant claimed subject matter lacks support in the provisional application for at least the following reasons:
For claim 31 (and its dependent claims), the instant claim reads “a lipid portion, …, wherein said lipid portion comprises one or both a ceramide-like glycolipid moiety and a fatty acid moiety”, but ‘912 only supports lipid portions “wherein said lipid portion comprises a fatty acid moiety;” (claim 1) and optionally also comprises a ceramide moiety (claim 6). ‘912 claims and specification do not support ceramide-like moieties (term not used in the provisional application), or lipid portions with only ceramide-like moieties and no fatty acid moieties.
For claim 32, (c) reads “said non-lipid portion comprising a first carbohydrate moiety, a lipopeptide moiety, a linker, a chemical compound, and a first peptide moiety;” (i.e. must comprise all of these options). The provisional application does not support a non-lipid portion comprising all options.
For claim 36, DPBS is not disclosed in the provisional application.
For claim 39, human milk oligosaccharides are not disclosed in the provisional application.
Therefore, the effective filing date that was used for searching the art for all claims is 14 Jul 2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11 Apr 2022 were both filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner. Signed copies of these statements are attached with this action.
Drawings
The drawings are objected to because Figures 2 and 6-9 cannot be interpreted in their current black-and white form. The colors and symbols are visually the same, so the data presented cannot be matched with the key. For example, see Examiner’s view of Figure 8 following this section.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Also, the drawings are objected to because Figures 8 and 12c contains a typographical error. Figure 8 should read “rate” instead of “trate” and Figure 12 should read “thaw” or “thawed”, not “taugth”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Examiner’s view of Figure 8
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Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code at [0053]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Also, the disclosure is objected to because of the following informalities: typographical errors. At [0193] “weigth” should read “weight”, and at [0205] “freeze and taught” should read “freeze and thaw” or “thawed”. Appropriate correction is required. The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Also, the abstract is objected to because it is too long (208 words). Applicant is reminded of the proper content of an abstract of the disclosure:
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Additionally, applicant is made aware of the following situation, which is not grounds for an objection. At many locations, the specification references other patents, patent applications, and NPL documents. These references are not an incorporation by reference. The attempt to incorporate subject matter into this application by reference to the documents is ineffective because the root words “incorporate” and/or “reference” have been omitted, see 37 CFR 1.57(c)(1). As stated in 37 CFR 1.57(h)(1): “A correction to comply with paragraph (c)(1) of this section is permitted only if the application as filed clearly conveys an intent to incorporate the material by reference. A mere reference to material does not convey an intent to incorporate the material by reference.”
The incorporation by reference will not be effective until correction is made to comply with 37 CFR 1.57(c), (d), or (e). If the incorporated material is relied upon to meet any outstanding objection, rejection, or other requirement imposed by the Office, the correction must be made within any time period set by the Office for responding to the objection, rejection, or other requirement for the incorporation to be effective. Compliance will not be held in abeyance with respect to responding to the objection, rejection, or other requirement for the incorporation to be effective. In no case may the correction be made later than the close of prosecution as defined in 37 CFR 1.114(b), or abandonment of the application, whichever occurs earlier.
Any correction inserting material by amendment that was previously incorporated by reference must be accompanied by a statement that the material being inserted is the material incorporated by reference and the amendment contains no new matter. 37 CFR 1.57(g).
Claim Interpretation
Regarding claim 31, part (ii)(b) reads “said microorganism is capable of one or both locating and displaying said non-lipid portion or fragment thereof onto the exterior surface of said cell”. The specification does not define any difference between locating and displaying, and the distinction between the two options is also not apparent in the art. The broadest reasonable interpretation is that these two options have the same scope.
Regarding claim 32 part (d), the claims read “said modified microorganism further comprises a heterologous steroid moiety selected from the group consisting of cholesterol, a cholesterol derivative and a cholesterol analog”, but the specification does not define the terms “derivative” or “analog”. As many different enzymes are known to the art that are capable of performing a wide range of molecular transformations, the broadest reasonable interpretation of the claim is that any “heterologous steroid moiety” could be a cholesterol derivative or analog because it could be produced from cholesterol by a series of reactions.
Regarding claims 37, parts (xv) and (xvi) state that the lipid carrier further comprises a glycolipid and a lipopeptide, respectively. However, parts (iii) and (iv) stated that the lipid carrier can further comprise a carbohydrate or a polypeptide, respectively. Since the heterologous lipid carrier was defined in claim 31 as having a lipid portion, it appears that any carbohydrate or polypeptide would become a glycolipid or a lipopeptide. Applicant is invited to clarify if this interpretation is incorrect. However, the broadest reasonable interpretation of the claim does not depend on the interpretation of parts (xv) and (xvi) because these either the same as or narrower than parts (iii) and (iv).
Claim Objections
Regarding claim 31, 37, 39, 41, 43, and 45, the claims are objected to because they include reference characters which are not enclosed within parentheses. Reference characters corresponding to elements recited in the detailed description of the drawings and used in conjunction with the recitation of the same element or group of elements in the claims should be enclosed within parentheses so as to avoid confusion with other numbers or characters which may appear in the claims. See MPEP § 608.01(m).
Regarding claims 31 and 45, part (ii)(a) has a grammatical error; it should read “one or both of a ceramide-like…”
Regarding claim 32, part (c) has a grammatical error; it should read “comprises” instead of “comprising”.
Regarding claim 37, part (vi) has a grammatical error; it should read “one or both of a recombinant polypeptide”. Also, part (x) has the same error; it should also read “one or both of”.
Regarding claim 38, for clarity of the claims, each option (a)-(p) should be presented on its own line. Also, part (j) has a grammatical error; it should read “comprises” instead of “comprising”.
Regarding claim 39, the specification (including the abstract and claims), and any amendments for applications, except as provided for in 37 CFR 1.821 through 1.825, must have text written plainly and legibly either by a typewriter or machine printer in a nonscript type font (e.g., Arial, Times Roman, or Courier, preferably a font size of 12) lettering style having capital letters which should be at least 0.3175 cm. (0.125 inch) high, but may be no smaller than 0.21 cm. (0.08 inch) high (e.g., a font size of 6) in portrait orientation and presented in a form having sufficient clarity and contrast between the paper and the writing thereon to permit the direct reproduction of readily legible copies in any number by use of photographic, electrostatic, photo-offset, and microfilming processes and electronic capture by use of digital imaging and optical character recognition; and only a single column of text. See 37 CFR 1.52(a) and (b).
The application papers are objected to because the chemical structures in parts (i) and (ii) are too faint to be legible (see Examiner’s view of structure below where the non-carbon atoms cannot be distinguished). 37 C.F.R. 1.52(a)(iv) requires the use of dark ink, which has not been used for this chemical structure. A legible substitute specification (specifically a claim set) in compliance with 37 CFR 1.52(a) and (b) and 1.125 is required.
Examiner’s view of chemical structure in claim 39(ii).
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Also regarding claim 39, redundant listings should be removed for clarity. For example, the options of part (vi) are also in the table of (vii), Sialyl Lewis x is listed twice in part (iv), etc. Also, an “and” or “or” should be placed before the final object listed in parts (iv) and (vi), and part (v) has a typographical error and should read “and” instead of “und”.
Regarding claim 42, for clarity of the claims, each option (a)-(d) should be presented on its own line.
Regarding claim 44, for clarity of the claims, each option (a)-(c) should be presented on its own line. Also, “Gram” should be capitalized in “Gram positive” and “Gram negative” as it is a person’s name. Also, the list of Gram positive bacteria in (b) has a grammatical error and should have “and” before the second to last option (L. paracasei) instead of in the middle of the list.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 32, 37-39, and 43 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Regarding claim 32, part (a) reads “said exterior surface of said cell comprises: a cell wall and/or a cell membrane and/or an outer cell membrane and/or a polysaccharide;” This appears to encompass all possible options, as evidenced by Bruslind (2019; PTO-892) that teaches that most bacteria have a cell wall, wall-less bacteria have an outer cell membrane, and fungi also have a cell wall. Therefore, all modified microorganisms will meet this limitation and claim 32 does not further limit parent claim 31.
Also, part (e) reads “wherein said mycomembrane is located in the exterior surface of said cell of said modified microorganism”, but this has antecedent basis in the negative limitation of parent claim 31 that “said cell does not comprise a mycomembrane”. If part (e) recites an inherent feature shared by all mycomembranes, then all modified microorganisms will meet this limitation and claim 32 does not further limit parent claim 31. If part (e) recites a narrower limitation of the mycomembrane, then claim 32 is broader because the excluded subject matter has been narrowed, and the claim does not include all limitations from the parent claim.
Regarding claim 37, parts (iv) and (ix), parts (vi) and (x), parts (vii) and (viii), and parts (xii) and (xiii) are each opposite limitations. One part states that the modified microorganism has a characteristic, and the other states that the modified microorganism does not have the same characteristic (comprises one or more second polypeptides, comprise one or both a recombinant polypeptide and a fusion polypeptide, expressed or synthetized by said microorganism, immunogenic to a mammalian host, respectively). As the modified microorganism must necessarily either have or not have the property, claiming both limitations in a single claim means that claim 37 does not limit the parent claim 31.
Regarding claim 38, part (c) reads “said ceramide moiety is composed of an amino alcohol and/or a fatty acid” and part (d) reads “said lipid portion of said lipid carrier comprises said ceramide moiety”. However, a ceramide is by definition a lipid (rather than a non-lipid) that is modified from sphingosine to comprise a fatty acid (as evidenced by Invitrogen Handbook Figure 13.3.1 pg. 566; 2010; PTO-892). Therefore, parts (c)-(d) do not limit the parent claim 37 because they must necessarily occur.
Also, part (e) reads “said non-lipid portion of said lipid carrier comprises said second carbohydrate moiety;” part (j) reads “said non-lipid portion comprising said one or more second polypeptides”. However, a carbohydrate and a polypeptide are by definition non-lipids rather than lipids. Therefore, parts (e) and (j) do not limit the parent claim 37 parts (iii) and (iv), respectively, because they must necessarily be in the non-lipid portion of the lipid carrier.
Also, part (k) states that “said one or more second polypeptides is selected from the group consisting of …, a fragment and a derivative thereof”. The broadest reasonable interpretation of a fragment is as few as two amino acids and given the range of other proteins listed this would include all possible arrangements of two amino acids, and the broadest reasonable interpretation of a derivative would include any polypeptide, because it could be derived from the other claimed polypeptides by treating it with peptidases and using the amino acids to make a new protein. Therefore, these options do not further limit the second polypeptide.
Also, part (m) limits the recombinant protein from the negative limitation claim 37 (vi), and must either not limit the parent claim (if the limitation is inherent) or broaden the parent claim (if the scope is narrower). Also, part (k) would have the same reason for rejection, if it limits the negative limitation claim 37 (ix) instead of the positive limitation claim 37 (iv).
Also, parts (o) and (p) are opposite limitations. One part states that the modified microorganism has a characteristic, and the other states that the modified microorganism does not have the same characteristic (immunogenic to a human). As the modified microorganism must necessarily either have or not have the property, claiming both limitations in a single claim means that claim 38 does not limit the parent claim 37.
Also, this claim is rejected as not limiting the parent claim 31 for the same reasons as claim 37 above, because claim 38 does not limit claim 37.
Regarding claim 39, the claim recites that the lipid carrier is selected from the options, and the lipid carrier is defined in claim 31 as having both a lipid and a non-lipid component. However, many of the options defined in claim 39 only have a sugar (i.e. non-lipid component) and do not comprise a lipid component. For example, see the table of (vii), which also defines the options from part (vi), that lists sugar residues attached to an R group, but then states that the R group may be a lipid but is not required to be a lipid. Therefore, claim 39 is rejected as failing to include all limitations from parent claim 31 because it broadens the definition of a lipid carrier.
Also, parts (xi) and (xiii) recite that the lipid carrier can be “derivatives and analogs of any of (i)-(xii).” As many different enzymes are known to the art that are capable of performing a wide range of molecular transformations, the broadest reasonable interpretation of the claim is that any heterologous lipid carrier could be a derivative or analog of one of the listed options because it could be produced from the listed lipid carrier by a series of reactions.
Regarding claim 43, the claim reads the microorganism can be selected from “(i) a non-pathogenic bacterium and (ii) a fungus”, which has antecedent basis in claim 31 as “wherein said microorganism is i) a non-pathogenic bacterium or an opportunistic pathogen; or ii) a fungus”. However, the specification at [0057] reads “Non-pathogenic microorganisms further preferably include but are not limited to lactic acid bacteria or bifidobacteria. They may also include opportunistic pathogenic microorganisms.” Claim 43 does not limit parent claim 31 when it recites only non-pathogenic (and not opportunistic) bacteria because the specification has specifically defined non-pathogenic bacteria as including opportunistic pathogens, so the claim scope is the same whether or not opportunistic pathogens are specifically mentioned.
Claim Rejections - 35 USC § 112(b)
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 31-33 and 35-47 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding the elected species that is examined in claims 31, 45, and dependent claims, the elected species of heterologous lipid carrier cannot be interpreted. Applicant is reminded that they were asked to elect a single lipid carrier structure, and they were required to either elect that the structure was present or state that none of the claimed options are elected (Restriction mailed 9 Apr 2025 pg. 3). The Remarks pg. 18 state: “Applicant notes that GM1-Gb3 as per claim 39 ii) does not comprise any peptide and is a carbohydrate moiety which can be conjugated directly to the carrier, but can also be conjugated to the carrier through the second peptide (i.e., in which Applicant herein elects is an antibody) i.e., the carrier can further comprise a second peptide as per claim 37 iv).” Applicant’s argument that GM1-Gb3 “is a carbohydrate moiety” raises a question of indefiniteness because claim 39 requires that GM1-Gb3 is the lipid carrier (which must have a lipid and non-lipid portion), and also because this argument is inconsistent with the structure displayed at part 39(ii) which also requires that GM1-Gb3 have a lipid portion (labeled “lipid”). Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “GM1-Gb3” in claim 39 is used by the claim to mean “a lipid carrier,” while arguments state that the term is used to refer to “a carbohydrate moiety”. The arguments also state that GM1-Gb3 is conjugated to the carrier, but the claims state that GM1-Gb3 is the carrier, and it is unclear what it means for the structure to be conjugated to itself. The term, and the elected species, is indefinite because the arguments raise a question about the definition of the term “GM1-Gb3”.
Claim 39 part (ii) recites “Globotriaosylceramide (Gb3), a GM1-Gb3 chimera”, but it is unclear how the Gb3 structure can be defined as a chimera that incorporates Gb3 itself. 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 39(ii) recites the broad recitation Gb3, and the claim also recites a GM1-Gb3 chimera which is the narrower statement of the range/limitation because it requires that GM1 also be present or used in some manner. 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.
The “globotriaosylceramide (Gb3), a GM1-Gb3 chimera” structure in claim 39 part (ii), where the letters are not fully legible, is nevertheless clearly not the same as the art-recognized globotriaosylceramide (Gb3) structure (see comparison below). Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “globotriaosylceramide (Gb3)” in claim 39 is used by the claim to mean “a GM1-Gb3 chimera having the right structure” while the accepted meaning is “a different chemical structure with a defined lipid component and a differently shaped sugar component.” The term is indefinite because the specification does not clearly redefine the term.
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Image of globotriaosylceramide from PubChem (left; PTO-892) and claim structure (right).
Applicants have also elected that the lipid portion both is an amino alcohol moiety (i.e. the lipid portion comprises both an amino -NH2 and alcohol -OH group) and that the lipid portion is a ceramide moiety composed of an amino alcohol and/or a fatty acid. However, the art at the time of filing shows that ceramide does not have an amino -NH2 group; only sphingosine is an amino alcohol moiety (Invitrogen Handbook, Figure 13.3.1 on pg. 566; 2010; PTO-892) (reproduced below). Therefore, at least one term from “ceramide” and “amino alcohol” must be used differently than the art in order for the lipid portion to be described in both ways, and the contradictory elections render the scope of the terms used unclear. Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The terms “amino alcohol” and “ceramide” are indefinite because the election uses them in ways where at least one term must differ from its typical meaning, but the specification does not clearly redefine the term(s).
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Partial reproduction of Figure 13.3.1 on pg. 566 of Invitrogen Handbook. Note sphingosine but not ceramide has both amino and alcohol groups.
Applicants have also elected an antibody as the one or more second polypeptide, referencing the language in claim 38 part (k). However, parent claim 37 requires that the second polypeptide is both present (part (iv)) and absent (part (ix)). The election Remarks also do not clarify the election because they state that GM1-Gb3 does not comprise any peptide (i.e. no antibody) but that it can also be conjugated to the carrier (i.e. itself) through the second peptide antibody (i.e. antibody present, Remarks pg. 18). Therefore, the elected species is indefinite because it is unclear whether the elected species of lipid carrier must comprise or must exclude this structure. Applicant is reminded that they were required to elect “a specific lipid carrier” (Restriction mailed 9 Apr 2025 pg. 3), not multiple optional lipid carriers. Therefore, claim 31 is rejected as indefinite because the heterologous lipid species carrier species election is indefinite, and dependent claims 32-47 are also rejected because they also include this indefinite heterologous lipid species carrier species election. In the interest of compact prosecution, applicant’s election that “a lipid carrier is a GM1-Gb3” (Remarks pg. 17) will be taken to be controlling, and the search will be limited to the text “globotriaosylceramide”, “Gb3” and “GM1-Gb3” based on claim 39 part (ii).
Regarding claim 32, part (a) reads “said exterior surface of said cell comprises: … a cell membrane and/or an outer cell membrane…” 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 32 recites the broad recitation “cell membrane”, and the claim also recites “outer cell membrane” 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. One of ordinary skill in the art would not be able to clearly determine what differentiates an outer cell membrane from the broader recitation of an exterior surface that is a cell membrane (if anything) and would not be able to clearly determine whether these additional features are a required feature or are only a non-required exemplary statement.
Regarding claim 33, the claim recites “(b) the first carbohydrate of said non-lipid portion contains a sialic acid residue.” There is insufficient antecedent basis for the limitation “the first carbohydrate” in claim 33 or parent claim 31. Inherent components of elements recited have antecedent basis in the recitation of the elements themselves, see MPEP 2173.05(e), but said non-lipid portion does not inherently contain a carbohydrate. Also, the term “first carbohydrate” is a relative term which renders the claim indefinite. The term “first” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. One of ordinary skill in the art would not be able to determine which carbohydrate is the first one without a reference point of where to count carbohydrates from.
Regarding claim 35, the claim recites “the association of the heterologous lipid carrier with said exterior surface of said cell one or both of (a) resists treatment with 0.3 % bile salts, and (b) remains associated after treatment with 0.3 % bile salts.” The terms “resists treatment” and “remains associated in claim 35 are a relative terms which renders the claim indefinite. The terms “resists” and “remains associated” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Must the heterologous lipid carrier fully resist treatment, or is partial resistance included in the claims? One of ordinary skill in the art would not be able to determine how much of the heterologous lipid carrier must remain associated or resist treatment in order to be encompassed by the claim.
Also, one of ordinary skill in the art would not be able to determine claim scope because it is unclear how resisting treatment (part (a)) is different from remaining associated with the cell (part (b)). The specification does not define the term “resisting” as being different from remaining associated with the cell and “resisting treatment” does not have a well-recognized definition in the art in this context. Due to the lack of a definition, one of ordinary skill would not be able to determine whether these two limitations are redundant or whether “resisting treatment” is a broader limitation. Recitation of both a broader and a narrower limitation can also be indefinite, see MPEP § 2173.05(c). Recitation of redundant limitations would be objected to in order to increase clarity of the claims.
Regarding claim 36, the claim recites the limitation "said treatment". There is insufficient antecedent basis for this limitation in the claim because one of ordinary skill in the art would not be able to determine whether “said” refers back to the treatment recited in claim 35 part (a) or the treatment recited in claim 35 part (b).
Regarding claim 37, in part (ii) the term “second carbohydrate” is a relative term which renders the claim indefinite. The term “second” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. One of ordinary skill in the art would not be able to determine which carbohydrate is the second one without a reference point of where to count carbohydrates from.
Also, part (vi) recites the limitation “vi) said lipid carrier does not comprise … a recombinant polypeptide…” The term “recombinant polypeptide” is not defined in the claims or specification, and the term is used in the art more narrowly to refer to a polypeptides that are not native to the modified microorganism and is also used more broadly to refer to all proteins produced recombinantly via a method of producing proteins in a non-native cell (regardless of whether the protein produced is originally native to the modified microorganism). 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). The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language (specifically, that the protein be non-native to the modified cell, rather than merely produced in any non-native cell) is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claims 37-38, these claims are indefinite because the limitations are contradict each other. Claim 37 parts (i), (ii), (iii), (iv), (v) defines that the lipid carrier further comprises certain objects, so that the object is in addition to the previously-defined lipid and non-lipid portions of claim 31. However, claim 38 parts (b), (d), (e), (j), (l) defines the same object as being part of either the lipid or non-lipid portion of the lipid carrier. The claims are indefinite because it is unclear what lipid carrier structure is claimed because the compositions cannot be both in addition to and also examples of the lipid and non-lipid portions of claim 31.
Regarding claim 38, part (i) reads “a first sugar of the said second carbohydrate is…” The term “first sugar” is a relative term which renders the claim indefinite. The term “first” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. One of ordinary skill would not be able to determine what reference point is used to begin counting sugars.
Also, part (c) reads “said ceramide moiety is composed of an amino alcohol and/or a fatty acid”. The scope of the claim is unclear because one of ordinary skill in the art would not be able to clearly determine whether “composed of” is an open (i.e. like “comprising”) or closed (i.e. like “consisting of”) limitation.
Regarding claim 39, part (vi) recites a list of gangliosides that includes “H”, which is located on line 3 of this part between “Lewis x” and “Sialyl lewis x”. Ganglioside H is was not found by a search of the art, and the specification does not define the structure of this compound. The unknown chemical appears to be only claimed by the laboratory designation “H”. The use of laboratory designations only to identify a particular molecule renders the claims indefinite because different laboratories may use the same laboratory designations to define completely distinct molecules.
Also, part (vii) many of the names have a parenthetical statement after the name. For example, “Blood Group A Type 1 (difucosyl)” and many of the compounds that start with G such as “GD1a: (IV3Neu5AcII3Neu5AcGg4Cer)”. The claim is indefinite because the purpose of the parenthetical is unclear. Especially for the compounds that start with G, it is noted that the same names were previously used without the parenthetical (GD1a in part (iii)), so the parenthetical phrase appears to be functioning as an example or a narrower version of the name. The phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). 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). 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. Therefore, the claim is indefinite because it is unclear what the name is of the compounds and if the parenthetical phrases have any weight.
Also, part (vii) is indefinite because the top of pg. 8 has a compound “4GlacNAc” with no structure defined. This may be an error with the spacing of the previous cell of the table- please ensure that the full cell is in a single page to ensure that the names and structures claimed are unambiguous.
Also, part (vii) is indefinite because on pg. 12 the compound “Man3” has a structure that ends in a ?, but the claim does not define what the question mark refers to as a structure and a question mark does not have a well-characterized definition in the field as part of a chemical structure.
Also, part (vii) on pg. 12 defines the structure of “human milk oligosaccharide” as “see WO 2012/092153, WO 2010/120682, WO 2005/055944, US 5 945 314”. The claim is indefinite because neither the claim nor the specification describes the structure required by the claims, and one of ordinary skill in the art would not be able to determine what part(s) of the several references disclosed in the claims should be reviewed in order to find the claimed structure.
The attempt to incorporate subject matter into this application by reference to the documents WO 2012/092153, WO 2010/120682, WO 2005/055944, US 5 945 314 is ineffective because the root words “incorporate” and/or “reference” have been omitted, see 37 CFR 1.57(c)(1). As stated in 37 CFR 1.57(h)(1): “A correction to comply with paragraph (c)(1) of this section is permitted only if the application as filed clearly conveys an intent to incorporate the material by reference. A mere reference to material does not convey an intent to incorporate the material by reference.”
Also, 37 CFR 1.57(d) states that “"Essential material" may be incorporated by reference, but only by way of an incorporation by reference to a U.S. patent or U.S. patent application publication, which patent or patent application publication does not itself incorporate such essential material by reference. "Essential material" is material that is necessary to:… (2) Describe the claimed invention in terms that particularly point out and distinctly claim the invention as required by 35 U.S.C. 112(b);…” The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
Also, part (vii) on pg. 12 has redundant language “wherein R is… or R comprises…”, but “R comprises” encompasses a broader claimed scope and “R is” is a narrower version of this broader scope. 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 39(vii) recites the broad recitation R comprises one or more of the options, and the claim also recites R is one or more of the options 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. One of ordinary skill in the art would not be able to determine why “R is” was included if it is only exemplary and has no function in the claim.
Also, part (vii) recites the abbreviation “TF” which is not defined in the specification and is not a well-known, unambiguous abbreviation in the art at the time of filing. The abbreviation appears to be a private laboratory designation for an unknown structure. The use of laboratory designations only to identify a particular molecule renders the claims indefinite because different laboratories may use the same laboratory designations to define completely distinct molecules.
Also, part (xii) reads “derivatives and analogs of any of (i)-(xii)”, but the term “analog” is not defined in the specification. The term “analog” in claim 39 is a relative term which renders the claim indefinite. The term “analog” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. One of ordinary skill in the art would not be able to determine in what way(s) the lipid carrier must be analogous to the structures of (i)-(xii). Also, it is noted that part (xii) requires that the claim requires that the lipid carrier be both derivative and analog.
Regarding claim 42, the claim recites both “microflora” and “microbiota” at many locations. There is insufficient antecedent basis for these terms. First, the grouping in claim 42 is “selected from the group consisting of microflora of…”, but then options (a)-(d) state that the microflora can be of/from a microbiota. In these situations, the term “microbiota” has insufficient antecedent basis in the earlier recitation of “microflora.” Second, in parent claim 41, only options (i)-(ii), animal and plant, include an option of microflora, and options (iii) and (iv), plants and food, recite microbiotas alone. However, claim 42 option (d) states that the grouping of microflora includes plant samples. In this situation, the term “microflora” at the beginning of the grouping has insufficient antecedent basis in the earlier recitation of “microbiota” in claim 41 (iii). The specification does not define the difference (if any) between a microflora and a microbiota and there is not a well-understood difference in the art, so one of ordinary skill in the art would not be able to determine what the difference is (if any) between the two terms. If the two terms are interchangeable, it is suggested that only one term be used consistently in order to avoid antecedent basis issues and to improve the clarity of the claims.
Also, claim 42 concludes with “where said naturally- occurring microorganism is obtained from a sample selected from the group consisting of gut, feces, oral cavity, nasal cavity, vagina, lung, sputum, mucus source, and urine of said vertebral organism.” First, the claim is indefinite because the organization of the claim makes it unclear whether this is part of part (d) and only applies if that option is chosen, or whether it applies to all microflora options (a)-(d). Second, the claim is indefinite because it this limitation conflicts with the earlier part (d) of the claim which states that the naturally- occurring microorganism does not need to be obtained from a vertebral organism and the earlier parts (a)-(c) which recite broader scopes for vertebral organism sources. 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 42 recites the broad recitations in parts (a)-(d), and the claim also recites the wherein clause 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.
Regarding claim 44, the claim recites “said gram-positive bacteria is selected from the genera consisting of Lactobacillus … Lactobacillus paracasei, Lactobacillus reuteri;”, but L. paracasei and L. reuteri are species of Gram positive bacteria instead of genera. The usage contrary to the accepted definition raises questions about the meaning of the term “genera” in the claim, but the specification does not provide a special definition that is different from the accepted meaning. Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “genera” in claim 44 is use