Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
The amended claim set filed 27 April 2026 is acknowledged. Claims 31-42 and 44-50 are currently pending. Of those, claims 31-39, 42, 44-46, and 48 are currently amended, 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 Claims 34 and 48-50 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species of lipid portion and a nonelected invention, respectively, there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 and 43 are cancelled. Claims 31-33 and 35-47 will be examined on the merits herein.
The claim status marker for claim 34 is incorrect and should be corrected in future claim sets.
The claim amendments do not comply with 37 C.F.R. 1.121 (c)(2), which states “The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters.” The deletions in the table in claim 39 use brackets to show long deletions of more than five characters. The claim amendments do not comply with 37 C.F.R. 1.121 (c)(2), which states “The text of any added subject matter must be shown by underlining the added text.” The text in claim 39 “Thomsen-Friedenreich -antigen (TF)[[TF]]” should have been presented as “Thomsen-Friedenreich -antigen (TF)[[TF]]” with the added subject matter underlined. The claims are nevertheless being examined in this action, but may be returned as a non-compliant amendment if future claim sets are not compliant.
Response to Arguments
The Applicants’ arguments filed 27 April 2026 are acknowledged. For clarity, in this action, said arguments will be referred to as “Remarks” and the Non-Final Office Action mailed 9 Dec 2025 will be referred to as “NFOA.”
Priority
The priority determination from the NFOA (par. 4-9) was not disputed in the Remarks. Therefore, the effective filing date that was used for searching the art for all claims is 14 Jul 2020.
Claim Interpretation
Regarding the species election, applicant’s arguments stated “Please note that the election of GM1-Gb3 as the preferred lipid carrier is correct. Further, GM1-Gb3 comprises a lipid portion, which is a ceramide moiety comprising an amino alcohol (sphingosine) and a fatty acid; and a non-lipid portion (carbohydrate moieties) with a first sugar, namely glucose, being attached to the lipid portion, as correctly outlined by the Examiner.” (Remarks pg. 25). The lipid portion of the lipid carrier is not defined in the structure of GM1-Gb3 found in the claims at claim 39(ii), but is interpreted more narrowly in view of applicant’s explicit statement that the lipid portion of GM1-Gb3 is a ceramide moiety. Also, the species election is interpreted as being limited to GM1-Gb3 chimera instead of “a globotriaosylceramide (Gb3) that is a GM1-Gb3 chimera” (NFOA par. 82) in view of the amendment to claim 39 indicating that Gb3 and GM1-Gb3 chimera are two different structures.
Regarding claim 42, as amended, parts (b) and (c) are redundant given the recitation of part (a) because all microbiota from a digestive system, urogenital system, etc. (part (b)) are also from an animal vertebral organism (part (a)) and all microbiota from a human (part (c)) are also from an animal vertebral organism (part (a)). No change to the claim is required. Parts (b) and (c) are examined as non-limiting, optional limitations, see MPEP 2173.05(h).
Objection(s) and Rejection(s) Withdrawn
The objections to Figure 12 (NFOA par. 14) and to the specification and abstract (NFOA par. 17-18) are withdrawn in view of the new drawings, specification, and abstract.
The objection to claim 43 (NFOA par. 25) is withdrawn because the claim has been cancelled.
The objections to claims 31 and 45 (NFOA par. 26), claim 32 (NFOA par. 27), claim 37 (NFOA par. 28), claim 38 (NFOA par. 29), claim 39 in part (NFOA par. 32), claim 42 (NFOA par. 33), and claim 44 (NFOA par. 34) are withdrawn in view of the claim amendments; but see other maintained parts of the objection below.
The rejection of claims 32 under 35 U.S.C. 112(d) (NFOA par. 36-37), the part of the rejection of claim 37 parts (vi) and (x) and parts (iv) and (ix) (NFOA par. 38), claim 38 parts (e, k, j, and o-p) (NFOA par. 40-41, and 43), claim 39 parts (xi) and (xii) (NFOA par. 46), and claim 43 (NFOA par. 47) is withdrawn in view of the claim amendments; but see the other maintained parts of the 35 U.S.C. 112(d) rejection below.
The rejection of all claims under 35 U.S.C. 112(b) related to the species election (NFOA par. 49-53) is withdrawn in part in view of the clear statement that “Please note that the election of GM1-Gb3 as the preferred lipid carrier is correct.” (Remarks pg. 25) and the amendment to claim 39(ii) to add “or” between “Globotriaosylceramide (Gb3), or a GM1-Gb3 chimera”; but see the other maintained parts of the 35 U.S.C. 112(b) rejection below.
The following rejections under 35 U.S.C. 112(b) are withdrawn in view of the claim amendments:
the rejection of claim 32 related to the language of part (a) (NFOA par. 54),
claim 33 (NFOA par. 55),
claim 35 (NFOA par. 56-57),
claim 36 (NFOA par. 58),
claim 37 related to parts (ii) and (vi) (NFOA par. 59-60),
claim 37-38 in part (NFOA par. 61, see maintained rejection part below),
claim 38 (NFOA par. 62-63),
claim 39 related to part (vi) “H” (NFOA par. 64), related to parenthetical statements in part (vii) (NFOA par. 65), related to the cell without a structure (NFOA par. 66), related to the Man3 structure (NFOA par. 67), related to “human milk oligosaccharide” (NFOA par. 68-70), related to the broader and narrower language “R is or R comprises” (NFOA par. 71), related to “TF” (NFOA par. 72), and related to part (xii) (NFOA par. 73),
claim 42 (NFOA par. 74-75)
claim 44 related to the grouping of Gram-positive bacteria in (b) (NFOA par. 76), and related to the broader and narrower groupings of fungi (NFOA par. 78), rejection also partially withdrawn in view of arguments pointing out the fungal groupings from Remarks pg. 30
The rejection of claim 44 relating to the fungi limiting “said non-pathogenic bacterium or opportunistic pathogen” and having insufficient antecedent basis in view of that claim construction (NFOA par. 77) is withdrawn in view of the amendments to claim 44 so that the limitation to “said fungus” is no longer part (c) and instead is separate from the limitation of “said non-pathogenic bacterium or opportunistic pathogen”. Now, “said fungus” properly claims antecedent basis to claim 31.
claim 46 (NFOA par. 79)
The rejection of claims 31-33 and 35-47 under 35 U.S.C. 112(a) (NFOA par. 80-88) is withdrawn because the rejection was based on an interpretation of the elected species of lipid carrier that is moot in view of the claim amendments and arguments. See the claim interpretation section above for the interpretation of the elected species of lipid carrier.
Drawings
The drawings filed 27 April 2026 are objected to because Figures 2, 6B, 7B, 8, and 9B 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. Also, the drawings are objected to because Figure 8B and 9B contains a typographical error. The y-axis should read “rate” instead of “trate”. For example, see the annotated version of Figure 8B below.
Annotated Examiner’s view of Figure 8B.
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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.
Response to Arguments
Applicants argue (Remarks pg. 21) that the replacement drawings address the objection. This argument has been carefully considered but is not persuasive. The new drawings have the problems identified above. For example, see the annotated Figure 8B from the new drawings copied above.
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.
Response to Arguments
Applicants argue (Remarks pg. 22) that the replacement specification addresses the objection. This argument has been carefully considered but is not persuasive. The new specification still contains hyperlinks. Please remove the http or https to comply with the Office’s rules but leave the rest of the website name.
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The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: in part (vii) on pg. 16, the claim has been amended to recite “Thomsen-Friedenreich -antigen (TF)” in place of “TF”. This name is not found in the specification as filed.
Claim Objections
Regarding claim 31, 37, 39, 41, and 45, the claims remain 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).
Response to Arguments
Applicants argue (Remarks pg. 22) that there are no reference characters and the Examiner is requested to clarify. This argument has been carefully considered but is not persuasive. The reference characters are shown in boxes. The following is an example only; the error should be corrected for all claims and reference characters.
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Regarding claim 39, the claims remain objected to because the chemical structures in part (i) remain too faint to be legible (see Examiner’s view of structure below where the non-carbon atoms cannot be distinguished). A legible substitute specification (specifically a claim set) in compliance with 37 CFR 1.52(a) and (b) and 1.125 is required.
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Also, 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.
Response to Arguments
Applicants argue (Remarks pg. 23) that claim 39 has been amended as suggested. This argument has been carefully considered but is not persuasive because only the chemical structures from part (ii) were amended but the prior objection also pointed out part (i) and because the duplicate listings are still present in the claim. Some examples are provided but the claim should be checked to remove all issues of this type.
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Rejection(s) Maintained
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 112(d)
Claims 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 37, 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 (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 lipid portion of said lipid carrier comprises said ceramide moiety comprising an amino alcohol and a fatty acid;”. 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 mailed 9 Dec 2025). Therefore, part (c) does not limit the parent claim 37 (ii) because they must necessarily occur.
Also, part (j) 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 (h) has the same reason for rejection when it limits the negative limitation claim 37 (ix) instead of the positive limitation claim 37 (iv).
Also, claim 38 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.
Response to Arguments
Applicants argue (Remarks pg. 23) that Applicant amends Claim 37 by introducing the nonce phrase "provided however that ...". This argument has been carefully considered but is not persuasive because adding this phrase does not change that the claim recites choosing from a list that includes both having and not having properties. The arguments do not point out any errors in the rejection or explain how the amendment overcomes the rejection. The examiner’s opinion remains that the rejections apply despite the claim amendments.
Applicants argue (Remarks pg. 23-24) that the limitations in claim 38(c), (d), claim 37(vi) and (m) were amended. This argument has been carefully considered but is not persuasive because the arguments do not point out any errors in the rejections or explain how the amendment overcomes the rejection. The examiner’s opinion remains that the rejections apply despite the claim amendments.
Applicants argue (Remarks pg. 24) that “Applicant amends Claim 39 to state that the lipid carrier comprises a moiety from the list. Accordingly, the lipid carrier can have a lipid portion (and a non-lipid portion) and the options listed in claim 39 that only have a sugar do not offend the non-lipid portion of claim 31.” This argument has been carefully considered but is not persuasive because this claim amendment was omitted from the claim set submitted (copied below in part). For example, note that the claim states that the lipid carrier can consist essentially of sugars in (vi) that do not have a lipid group.
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Claim Rejections - 35 USC § 112(b)
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. 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 mailed 9 Dec 2025) (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 polypeptide, referencing the language in claim 38 part (h). The election Remarks filed 27 March 2026 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 3/27/26 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 32-33 and 35-47 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 affirmed in the current Remarks pg. 25 will be taken to be controlling and the structure from claim 39 part (ii) was searched. See the claim interpretation section above.
Response to Arguments
Applicant argues (Remarks pg. 25) that “GM1-Gb3 comprises a lipid portion, which is a ceramide moiety comprising an amino alcohol (sphingosine) and a fatty acid”
Applicant argues (Remarks pg. 27) that “The Examiner does not state to which claim this comment [relating to the amino alcohol moiety] relates. ... The Examiner is respectfully requested to state to which claim point 52 comment relates.”
This argument has been carefully considered but is not found persuasive. The section began in the NFOA at par. 49 and with the statement “Regarding the elected species that is examined in claims 31, 45, and dependent claims” and concluded at par. 53 with the statement “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.” The species election is an election of an invention for examination (see Restriction mailed 9 April 2025), so it relates to all claims under examination.
The arguments appear to be defining sphingosine as a type of ceramide, but this argument is not persuasive because it is inconsistent with the use of the terms in the field as referencing different molecules, as cited in the rejection above. See MPEP 2173.01: “An applicant may not add a special definition or disavowal after the filing date of the application. However, an applicant may point out or explain in remarks where the specification as filed contains a special definition or disavowal.” Applicant may also provide evidence that the reference cited by the examiner does not reflect the plain meaning of the term in the art at the time of filing. The argument is not persuasive because it does not point out a special definition from the specification and it does not dispute the definition of the terms provided in the prior rejection.
Applicant argues (Remarks pg. 25) that “Applicant respectfully submits that the Examiner's statement that "GM1-Gb3 as per claim 39 ii) does not comprise any peptide" is incorrect.”
Applicant argues (Remarks pg. 27) that “Applicant has amended claim 37 limitations (iv) and (ix) and claim 38 limitation (k). The Examiner's summary is no longer accurate and the rejection is moot.”
This argument has been carefully considered but is not found persuasive. The rejection has been updated to reflect the claim amendments. Applicant’s argument that the examiner’s statement is incorrect is not persuasive because it does not explain why the prior statement was incorrect. The definition of the structure of GM1-Gb3 as per claim 39 (ii) is copied below. Applicant is invited to point out where the peptide is located within the structure from the claim; Examiner cannot find a peptide within this structure even with additional search and consideration.
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Regarding claims 37-38, these claims are indefinite because the limitations contradict each other. Claim 37 part (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 part (i) 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.
Response to Arguments
Applicant argues (Remarks pg. 29) that claims 37 and 38 were amended. The argument has been carefully considered but is not persuasive because there were no amendments to the text of claim 37 part (v) or claim 38 part (i, formerly l).
New Rejection(s)
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 37-38 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 37, parts (ix) and (x) have been amended to state “ix) provided however that said lipid portion of lipid carrier does not comprise one or more polypeptides; x) provided however that said lipid portion of lipid carrier does not comprise one or both of a transmembrane polypeptide and a polypeptide membrane anchor domain;”. The lipid portion is defined by being a lipid, so it does not comprise polypeptides by definition. The polypeptides (if present) must be part of the non-lipid portion of the lipid carrier by definition. So, the limitations do not limit the lipid carrier of parent claim 31 because they recite a universal feature of the parent lipid carrier.
Regarding claim 38, part (j) recites “said recombinant polypeptide and/or fusion polypeptide is obtained by the means of artificial genetic manipulation” but parent claim 37(vi) was amended to recite “vi) provided however that said non-lipid portion of lipid carrier does not comprise one or both of a recombinant polypeptide obtained by the means of artificial genetic manipulation and a fusion polypeptide obtained by the means of artificial genetic manipulation;”. Claim 38 does not limit the parent claim because the limitation is now recited in the parent claim.
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 37-39 and 44 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 claim 37, it has been amended to state “iii) said lipid portion of lipid carrier further comprises a carbohydrate moiety” (emphasis added). But the lipid portion is lipid by definition, and carbohydrates are not lipids. 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 “lipid” in claim 37(iii) is used by the claim to include carbohydrates and potentially other non-lipid components, while the accepted meaning is “lipids but not non-lipids.” Alternately, the term “carbohydrate” in claim 37(iii) is used to mean a lipid rather than the accepted meaning of a carbohydrate. The term is indefinite because the specification does not clearly redefine the term(s). Dependent claim 38 is also rejected because it does not obviate this grounds of rejection and also claim 38 parts (e-g) reference back to the indefinite “said carbohydrate moiety”.
Regarding claim 38, part (c) has been amended to recite “said lipid portion of said lipid carrier comprises said ceramide moiety comprising an amino alcohol and a fatty acid” (emphasis added). 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 mailed 9 Dec 2025) (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.
Regarding claim 39, part (ii) recites an amended chemical formula in which the letter “R” is visible, but the meaning of this term is not defined in part (ii). Therefore, one of ordinary skill in the art would not be appraised of the scope of structure(s) claimed in part(ii) because the “R” group is not defined for this structure.
Also, regarding part (vii), the table comprises cells where only one of the two columns have been filled out, rendering the scope of the table and the lipid carriers claimed indefinite. 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.
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Regarding claim 44, the claim reads “wherein said non-pathogenic bacterium or opportunistic pathogen is: (a) a Gram-positive bacteria, or a Gram-negative bacteria; (b) said Gram-positive bacteria is selected from the group consisting of Lactobacillus selected from the group consisting of Lactobacillus paracasei and Lactobacillus reuteri, Bifidobacterium, Clostridium, Enterococcus, Pediococcus and Streptococcus;”. The claim does not have “and” or “or” between the two limitations, so one of ordinary skill in the art would not be able to determine whether the part (b) is a required limitation (a and b) or whether it is an optional limitation (a or b). Therefore, the claim scope is indefinite.
Claim Rejections - 35 USC § 112(a)
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 37-39 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Regarding claim 37, parts (i) and (ii) have been amended to require that “said lipid portion of lipid carrier further comprises a” glyceride or ceramide moiety, respectively (emphasis added). This is in addition to the limitation in parent claim 31 that “said lipid portion comprises one or both of a ceramide-like glycolipid moiety and a fatty acid moiety”. Applicant has not pointed out where the amended claim is supported (Remarks only point out support for claims 35 and 42 on pg. 21), nor does there appear to be a written description of the claim limitation of a lipid portion that comprises a glyceride /ceramide in addition to the other components from claim 31 in the application as filed. A search for glyceride and ceramide do not show apparent support for a lipid carrier that comprises these lipids in addition to another lipid. See MPEP 2163 and Hyatt v. Dudas, 492 F.3d 1365, 1370, 83 USPQ2d 1373, 1376 (Fed. Cir. 2007).
Regarding claim 38, part (h) has been amended to recite “a fragment that generates a pharmaceutically active compound and a derivative thereof that generates a pharmaceutically active compound”, with new functional limitations for the fragments and derivatives. Therefore, the specification must describe structure(s) correlated with the function and/or a representative number of species within the genus of fragments and derivatives claimed (see MPEP 2163). A search for the term “generate” in the specification did not yield any relevant results. Applicant has not pointed out where the amended claim is supported (Remarks only point out support for claims 35 and 42 on pg. 21), nor does there appear to be a written description of the functional claim limitation in the application as filed. See MPEP 2163 and Hyatt v. Dudas, 492 F.3d 1365, 1370, 83 USPQ2d 1373, 1376 (Fed. Cir. 2007).
Regarding claim 39, the lipid carriers have been broadened to a group “consisting essentially of” the listed options. Applicant has not pointed out where the amended claim is supported (Remarks only point out support for claims 35 and 42 on pg. 21), nor does there appear to be a written description of the functional claim limitation in the application as filed. The phrase “consisting essentially of” is not found in the specification as filed. See MPEP 2163 and Hyatt v. Dudas, 492 F.3d 1365, 1370, 83 USPQ2d 1373, 1376 (Fed. Cir. 2007).
Also, in part (vii) on pg. 16, the claim has been amended to change the structure of Man3 to have a “R” in place of part of the prior “?”. Applicant has not pointed out where the amended claim is supported (Remarks only point out support for claims 35 and 42 on pg. 21), nor does there appear to be a written description of the functional claim limitation in the application as filed. All recitations of Man3 in the specification as filed are defined as including a “?” and no recitations have the “R” that was added by the amendments. See MPEP 2163 and Hyatt v. Dudas, 492 F.3d 1365, 1370, 83 USPQ2d 1373, 1376 (Fed. Cir. 2007).
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIA N DICKENS whose telephone number is (571)272-0381. The examiner can normally be reached M-F 8:30-4:30 (EDT/EST).
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/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
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