DETAILED ACTION
Examiner acknowledges receipt of applicant’s reply filed 12/01/2025, in response to the non-final office action mailed 7/29/2025.
Examiner acknowledges receipt of the Schwaneberg declaration filed 12/01/2025.
Claims 1 and 3-21 are pending. Claim 2 has been cancelled. Claims 10-12, 17-19, and 21 are withdrawn for the reasons made of record.
Claims 1, 3-9, 13-16, and 20 are being examined on the merits in this office action.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Declaration under 37 CFR 1.132
The Declaration under 37 CFR 1.132 filed 12/041/2025 is insufficient to overcome the 102(a)(1)/103(a) rejections of claims 1, 3-9 and 14-16 over Rübsam et al (Polymer 116: 124-132 (online March 2017)- previously cited); OR
over Meurer et al (Angew. Chem. Int. Ed. 56:7380 –7386 (online May 2017- previously cited), as evidenced by Supporting Information accessed at URL onlinelibrary.wiley.com/action/downloadSupplement?doi=10.1002%2Fanie.201701620&file=anie201701620-sup-0001-misc_information.pdf, 7 pages- previously cited), as set forth in the last Office action because:
Applicant asserts that the claimed bi- or multifunctional peptide/protein constructs comprising anchor peptide that adheres to plastic particles [micro- and nanoplastic particles] and that the anchor peptide selectively binds to the surface of plastic enabling fast detection and quantification of micro- and nano plastics the signaling unit that generates a fluorescent signal (declaration at para 4). Applicant asserts a “significant analytical gap at the time of the invention” because deleting Michael plastic particles in the environment and food was highly challenging (referencing Alexy et al; para. 6). Applicant asserts that Rübsam relates to macroscopic polypropylene surfaces with anchor peptides construct LCI-eGFP for functionalization. Applicant further asserts that the “goal” of Rübsam was to provide anchor peptide constructs improved binding to macroscopic plastic surfaces, not plastic particles with an average diameter of 5 mm as claimed (declaration at paras. 9-11). With regard to Meurer, applicant asserts that the reference teaches coding of macroscopic plant leaf surfaces with anchor peptides-eGFP-hydrogel constructs for functionalization of the plant leaf surfaces with nutrient containers. Applicant asserts that the “goal” of Meurer was to provide anchor peptide constructs that improved binding to macroscopic plant leaf surfaces, not plastic particles with an average diameter of 5 mm as claimed (declaration at paras. 12 -15).
The declaration further provides data relating to anchor peptide-eGFP fusion proteins wherein the anchor peptide was LCI, tachystatin A2, Macaque histatin, thanatin, or CgDef. The anchor peptide fusion proteins were identified as binding to polystyrene particles having a diameter of 500 nm (paras. 17-18; Figs 1-2).
Applicant’s arguments have been fully considered but not found persuasive.
Examiner notes the declaration confirms that inventor Schwaneberg was a co-author on each of the cited references.
Rübsam et al teach fusion proteins comprising anchor peptides (e.g. cecropin A or LCI), a spacer unit, and eEGF adhered to polypropylene (e.g., methods, methods, pp. 125, 128-131).
Meurer et al teach anchor-peptide-based fusion proteins composed of enhanced green fluorescent protein (EGFP) and anchor peptides. Ten structurally different potential anchor peptides (BM Moricin, Carnocylcin A, Cecropin A, EBA, LCI, hDermcidin, Macaque histatin, Plantaricin A, Spinigerin, Stomoxyn) were selected and genetically fused to the reporter protein eGFP (enhanced green fluorescent protein) (pp. 7383-7384; Supporting information at Tables S2 and S3; pp. S2-S5). The fusion proteins further included a spacer unit helix (17 amino acids) between the anchor peptide and the eGFP [signaling unit that generates a fluorescent signal].
Examiner directs Applicant to MPEP 2112, which discusses when claimed properties are presumed to be inherent:" Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established." (In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)).
Regarding applicant’s assertions of surprising results, evidence of secondary considerations, such as unexpected results or commercial success, is irrelevant to 35 U.S.C. 102 rejections and thus cannot overcome a rejection so based. In re Wiggins, 488 F.2d 538, 543, 179 USPQ 421, 425 (CCPA 1973). See M.P.E.P. § 2131.04.
Additionally, applicant’s arguments as relating to the “goals” of Rübsam and Meurer are irrelevant to the structural composition of the claimed constructs. Applicant ‘s arguments relating to microscopic versus macroscopic are merely intended uses of the claimed compositions. Examiner reiterates that the anchor peptide-eGFP fusion proteins of the cited prior art is applicant’s own work.
In view of the foregoing, when all of the evidence is considered, applicants arguments, declaration, and post-filing data are insufficient to overcome the art rejections presented herein.
Examiner Comment
Parent application No, 17/253291 (now abandoned) referred to a bi- or multifunctional fusion protein, not a bi- or multifunctional construct. Examiner reiterates from the indefinite rejection in the non-final office action mailed 7/29/2025, the claim term “bi- or multifunctional construct” is not expressly defined in the specification.
Application states on page 10 of the reply filed 12/01/2025:
The term "construct" in the preamble of the claim is expressly defined by the body of the claims. Furthermore, as is well known in the art, a 'construct' is a designed or engineered combination of molecular components that are joined together to perform one or more intended functions. The term is commonly used in US patents and in the art generally. (citing issued patents)
Emphasis added.
Thus, per Applicant’s arguments – a construct is a designed or engineered combination of “molecular components”. Given the broadest reasonable claim interpretation- a construct is construed as encompassing molecular components of any chemical/structural composition. For instance, a bi- or multifunctional construct could be a claimed anchor peptide and a lipid, polysaccharide, DNA, inorganic compounds, polymer, etc. This is deemed to be broader in scope than the parent application, which recited a “bi- or multifunctional fusion protein”.
In contrast, a bi- or multifunctional fusion protein, encompassed by the parent applications, would be construed as being limited to amino acids.
Denial of Priority- New
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original no provisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of the first paragraph of 35 U.S.C. 112. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
Upon review of Applicant’s arguments filed 12/01/2025, the instant specification, parent Appl. No 17/253931, the PCT application, and foreign priority EP 18178726.8, it is noted that subject matter relating to the instant claims “bi- or multifunctional construct”, was not taught in the prior applications.
The prior applications all referred to a “bi- or multifunctional fusion protein”, not a “bi- or multifunctional construct”.
The claim term “bi- or multifunctional construct” first appeared in the instant application in a claim set filed 11/26/2023. This is the filing date of the instant application. It is expressly noted that there is no new matter rejection because the claims filed 11/26/2023 were submitted the same day as the instant application was filed.
The instant application and claims are not entitled to the benefit of the earliest filing date. Thus, priority to foreign application EP 18178726.8 (filed 6/20/2018) is denied.
The earliest filing date for the instant application is deemed to be the filing date of the instant application, filed 11/26/2023.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification- withdrawn
The objection to the specification is withdrawn in view of the amendment filed 12/01/2025.
The objection to the specification for trademarks is withdrawn in view of the amendment filed 12/01/2025.
Claim Objections- withdrawn
The objection of claims 1, 3-7, 14, and 20 is withdrawn in view of the amendment filed 12/01/2025.
Claim Rejections - 35 USC § 112- withdrawn, in part
The rejection of claims 6, 7, 14-16, and 20 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is withdrawn in view of the amendment filed 12/01/2025.
Claim Rejections - 35 USC § 102- withdrawn
The rejection of claims 1 and 4-9 under 35 U.S.C. 102(a)(1) as being anticipated by Rübsam et al (Polymer 116: 124-132 (online March 2017)- cited in IDS filed 11/26/2023), is withdrawn in view the amendment filed 12/01/2025.
Response to Arguments
Applicant's amendment, arguments, and Schwaneberg declaration filed 12/01/2025, with respect to the above objections and rejections have been fully considered and are persuasive. objections and rejections have been withdrawn.
Applicant's arguments filed 12/01/2025 have been fully considered but they are not persuasive with respect to the maintained rejections.
Upon further consideration, a new ground(s) of objection and rejection made in view of the amendment filed 12/01/2025. An action on the merits is set forth herein.
An action on the merits is presented herein.
Specification
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Sequence Interpretation/Claim Interpretation
The Office interprets claims comprising SEQ ID NOs: in the following manner: “comprising an amino acid sequence of SEQ ID NO: 1” requires only a dipeptide or more within SEQ ID NO: 1, “comprising the amino acid sequence of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 with or without additional amino acids at any N-/C-terminal ends or additional nucleotides at 5' /3' ends, “consisting of an amino acid sequence of SEQ ID NO: 1” would encompass any sequence of two or more consecutive amino acids (dipeptide or more) fully contained within SEQ ID NO: 1, and “consisting of the amino acid sequence of SEQ ID NO: 1” would be limited to the sequence of the amino acids as specified by SEQ ID NO: 1, and nothing more or less; "an amino acid selected from the group consisting of SEQ ID NOs: 1, 2 and 3” is any sequence of two or more consecutive amino acids (dipeptide or more) fully contained within SEQ ID NO: 1, 2 or 3; and “the amino acid selected from the group consisting of SEQ ID NOs: 1, 2, and 3” requires the full-length sequence with 100% identity to SEQ ID NOs: 1, 2, or 3 and the same length as SEQ ID NOs: 1, 2, or 3.
Please note that claims 13 and 21 recite “comprising an amino acid sequence of SEQ ID NO:1”.
Maintained Rejections
Claim Rejections - 35 USC § 112 - maintained
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 1, 3-5, 8, 9, and 13 remain/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. This rejection is maintained from the office action mailed 7/29/2025, but has been amended to reflect claims filed 12/01/2025.
Regarding claim 1, the claim term “anchor peptide” is not expressly defined in the specification. The term “anchor peptide” is deemed to be a relative term which renders the claim indefinite. The skilled artisan is not reasonably apprised of peptides that fall within and those that fall outside of the claim scope of the invention. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus (or composition) must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997). It is unclear as to what peptides fall within and outside of the independent claim scope. This claim term is not expressly defined in the specification.
Because claims 3-5, 8, 9, and 13 depend from indefinite claim 1 and do not clarify the point of confusion, they must also be rejected under 35 U.S.C. 112, second paragraph.
Response to Arguments
Applicant traverses the rejection at pp. 9-10 of the reply filed 12/01/2025. Applicant asserts that the “specification explains that the first and second anchor peptides (anchor peptide I and anchor peptide II) are “adhesion promoting peptides” (referencing specification at p. 9, ll. 8-15).
Examiner has reviewed and considered applicants arguments but is not persuaded.
The following is a full excerpt from the specification as identified by applicant above.
Herein, the anchor peptide I is an adhesion promoting protein and/or adhesion promoting peptide, which binds, preferably which selectively binds, to one or more of a first target surface, preferably of a first polymer target surface, and is providing for a target binding function, preferably for a selective target binding function
Herein, the anchor peptide II is an adhesion promoting protein and/or adhesion promoting peptide, which binds, preferably which selectively binds, to one or more of a second carrier surface, preferably of a second polymer or non-polymer carrier surface, and is providing for a carrier binding function, preferably for a selective target binding function.
Examiner first notes that the claim term “anchor peptide” is not expressly defined in the specification. The claim refers to “adhesion promoting peptide” which is also not expressly defined in the specification. The terms “anchor peptide I” and “anchor peptide II” were claim terms in the parent application, Appl. No. 17/253291, now abandoned. The claim terms “anchor peptide I” and “anchor peptide II” related to a fusion protein with anchor peptides I and II each having different binding properties.
As underscored in the specification, the “anchor peptides” binds to the variable and undefined compounds. The term “anchor peptide” provides no probative value to the actual chemical and structural composition of the peptide. The term “anchor peptide” is deemed to be a relative term. The skilled artisan is not apprised of compounds that fall within and those that fall outside of the scope of “anchor peptides”.
While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus (or composition) must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997).
The rejection is maintained for at least these reasons and those previously made of record.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-9, and 14-16 remain/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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This rejection is maintained from the office action mailed 7/29/2025, but has been amended to reflect claims filed 12/01/2025.
The courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP 2163.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co., the court stated:
“A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials. Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284-85 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus. . . ."). Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitute a sufficient number of representative, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gostelli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d at 1012, 10 USPQ2d at 1618.
In the instant case, the claim 1 is drawn to a bi- or multifunctional construct comprising:(i) an anchor peptide that adheres to plastic particles having an average diameter of 5 mm or less; (ii) a signaling unit that generates a fluorescent signal; (iii) optionally, a spacer unit that connects the signaling unit with the anchor peptide.
Claim 14 is drawn to a bi- or multifunctional construct comprising:(i) an anchor peptide that adheres to plastic particles having an average diameter of 5 mm or less, wherein the anchor peptide is selected from androctonin (ANR), antifungal protein 1, cecropin A, Cg-defensin (Cg-Def), dermaseptin S1 (DS1), human dermcidin (hDerm), liquid chromatography peak 1 (LCI), macaque histatin, methicillin-binding protein 1 (MBP-1), plantaricin A, pteromalus puparum 102 (PP102), psoriasin, tachystatin A2 (TA2), thanatin (THA), or any combination thereof, and the plastic particles are comprised of a plastic selected from polyethylene (PE), polypropylene (PP), polyurethane (PU), polystyrene (PS), polyvinyl chloride (PVC), polycarbonate (PC), polyamide (PA), polyoxymethylene (POM), polymethyl methacrylate (PMMA), polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polytetrafluoroethylene (PTFE), polyhydroxyalkanoate (PHA), polyhydroxybutyrate (PHB), polyimide (PI), polylactide (PLA), polyvinylidene fluoride (PVDF), polyetherketone (PEK), or any combination thereof (ii) a signaling unit that generates a fluorescent signal; and (iii) optionally, a spacer unit that connects the signaling unit with the anchor peptide
The specification does not explicitly define the terms “anchor peptide”. It is noted that the “spacer unit” can be anything from a peptide, protein, nucleic acid, lipid, saccharide, or combination thereof, etc. Claim 13 recites that the spacer unit is a domain Z staphylococcal protein A, a helix comprising an amino acid sequence of SEQ ID NO:1, or “an inactivated enzyme” - not limited to a specific length, or amino acid composition (and associated chemical/physical properties). The claim term signaling unit is not expressly defined by the specification. The signaling unit can also arise from a direct change and/or be a an indirect response requiring an in vitro assay, e.g., sandwich ELISA assay. The specification does not clearly define or provide examples of what qualify as compounds of the claimed invention.
As stated earlier, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable claims 1, 3-9, and 13 are broad generics with respect to all possible compounds encompassed by the claims. There are numerous proteins and peptides that can fall within the category of “anchor peptide” but there is no guidance as to what specific proteins/peptides functionally interact with specific materials, e.g., “plastic particles”. A given protein may fall within the category of an “anchor peptide” but could be limited to specific materials/particles for which it can bind/interact with.
It must not be forgotten that the MPEP states that if a peptide is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. Here, though the claims may recite some functional characteristics [e.g., anchor peptide], the claims lack written description because there is no disclosure of a correlation between function and structure of the compounds beyond compounds disclosed in the examples in the specification. Moreover, the specification lacks sufficient variety of species to reflect this variance in the genus.
Example 1 teaches a bi-functional protein comprising N-terminal dermasepstin S1 (DS1) which binds stainless steel, and C-terminal liquid chromatography peak 1 (LCI) which binds polycaprolactone (PCL). Example 2 purports to disclose bi-functional proteins there were prepared with a separator protein (domain Z). It is unclear from Example 2 is the actual identity of the two distinct proteins that were used in the bifunctional proteins. Instead, Ex. 2 discloses proteins in which the fluorescence marker eGFP was fused to specific proteins and binding was assessed. See Fig 2. In comparison, example 1 discloses a DS1-LCI bifunctional fusion protein. Example 2 discloses that LCI, Tachystatin A2 (TA2), and Thanatin (THA) show strong binding affinity to tested polymers (polypropylene/polystyrene) as well as to the leaf surfaces of plants. DS1 was tested in both orientations, both N-terminal anchor and C-terminal anchor in the eGFP fusion protein. Example 3 discloses bifunctional proteins comprising N-terminal DS1 fused to C-terminal LCI, TA1 or THA. The peptides were separated by a linker, domain Z. Example 4 discloses production of PCL particles. However, the exact components that make up the PCL particles is unclear from the example/specification. Example 5 discloses PCL particles on stainless steel. The specific bifunctional protein was DS1-DZ-LCI (N-terminal DS1- linker domain Z- C-terminal LCI). Examiner reiterates that the exact components that make up the PCL particles is unclear from the example/specification. Example 6 discloses eGFP-anchor proteins that were assessed. Specifically, LCI, TA2, and THA were assessed as anchor proteins. Example 6 discloses that cecropin A binds to a triblock polymer, TA2 and LCI bind to polystyrene and polypropylene. Ex 6 discloses that DS1 can bind stainless steel. Example 6 teaches bifunctional proteins of DS1-DZ-LCI, DS1-DZ-TA2, and DS1-DZ-THA. Example 7 discloses detection of polymers of microparticles (micro plastics). eGFP was fused to cecropin A, liquid chromatography peak 1 (LCI), or tachystatin A2 (TA2). See Figs 5-6. For comparison, see Example 1 which specifically discloses a DS1-LCI bifunctional protein. See also examples 3 and 6.
The specification appears to be limited to combinations of 5 proteins: Cercopin A, DS1, TA2, LCI, and THA. A single separator unit, domain Z, was used in the bifunctional proteins. The target materials were also limited: DS1/stainless steel; TA2 and LCI/ polystyrene and polypropylene; and LCI/polycaprolactone.
Claim 3 recite average diameters of plastic particle sizes (1 micron or less). However, this fails to provide any probative guidance as to the identity of “anchor peptides” that would bind to such plastic particles. Signaling units include numerous compositions of varying chemical and physical structures. It is further noted that the spacers/linkers are not limited to any particular chemical composition. Spacer units can include, but are not limited to, peptides, saccharides, lipids, and combinations thereof. With regard to spacers, the properties of conjugates are sensitive to the linker moiety [see section 6 in He et al, Molecules 24:1855, 1-34 (2019); see abstract and conclusion in Lu et al, Int J Mol Sci 17:561, 1-22 (2016)]. The art also recognizes that the choice of a spacer has great impacts on biological activity, expression yield, and pharmacokinetic properties of a fusion partner (see Chen et al. (Adv. Drug Deliv. Rev. 65:1357-1369 (2013)).
The specification does not disclose any anchor peptides that specifically bound to the elected species of polyurethane. There are no examples of the elected species of anchor peptide histatin that were reduced to practice.
There is not a sufficient amount of examples provided to encompass the numerous characteristics of the entire genus claimed.
Examiner further notes that merely listing components in the specification is not sufficient to extrapolate to all combinations of “anchor peptides”, signaling units, and spacer units that are not only capable of being fused together but further retain their functional binding/targeting to “plastic particles”, e.g. polystyrene, polyurethane, etc.
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate"). Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Response to Arguments
Applicant traverses the rejection at pp. 11-12 of the reply filed 12/01/2025. Applicant asserts that claim 2 was incorporated in the claim 1 (plastic particles having an average diameter of 5 mm or less). Applicant asserts that the specification provides written description support for the claimed bi- or multifunctional construct (reply at p. 11). Applicant asserts that the figures, embodiments, and peptides (including DS1, LCI, Tachystatin A2, Cg-defenseman, and others) teach “the precise construct architecture required by the claim: an anchor peptide that binds plastic particles, signaling unit that generates a fluorescent signal, and an optional spacer connecting these functional domains”. Id. Applicant alleges that the disclosure satisfies the written description requirements. Id.
Applicant asserts that the Schwaneberg declaration cooperates the inventors possession of the claimed constructs by providing additional representative species (post-filing data) were prepared and experimentally shown to hereto plastic particles of less than 500 nm. Figures 1 and 2 of the declaration show binding to polystyrene and poly(methyl methacrylate) microparticles and indicate that the few signaling units generate the required fluorescent signal (reply at p. 12). Applicant asserts the working embodiments “collectively spent range of anchor peptides and plastic particle types”. Id. Applicant asserts the anchor peptides in the application belong to “well-characterized classes of material binding peptides with predictable and conserved interactions” (reply at p. 12). Applicant asserts that the construct descriptions and representative working examples provide sufficient structure/function correlation. Id.
Examiner has reviewed and considered applicants arguments, but is not persuaded.
Examiner first notes that the specification is assessed based on possession of the claimed subject matter as of the filing date, not post-filing data. It is further noted that essential matter cannot be incorporated by reference to non-patent literature.
An application for a patent when filed may incorporate "essential material" by reference to (1) a U.S. patent, >or< (2) a U.S. patent application publication, **>which patent or patent application publication does not itself incorporate such essential material by reference "Essential material" is defined in >37CFR1.57(c)< as that which is necessary to (1) **>provide a written description of the claimed 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 set forth the best mode contemplated by the inventor of carrying out the invention as required by the first paragraph of 35 U.S.C. 112, (2) describe the claimed invention in terms that particularly point out and distinctly claim the invention as required by the second paragraph of 35 U.S.C. 112..." (see MPEP 608.01(p).
As indicated above, the claim term “anchor peptide” is not expressly defined in the specification. The skilled artisan is not apprised of chemical compositions (e.g., amino acid composition) or physical structure (e.g., secondary or tertiary structure) of an “anchor peptide” that would render a given peptides sufficient to qualify as a “anchor peptide” much less what specific chemical/physical properties of a given peptides give rise to yield the functional ability to “adhere to plastic particles having an average diameter of 5 mm or less”. The “anchor peptides” that were reduced to practice do not have any common core structure or attributes. Additionally, there is no guidance as to whether or not a peptide could bind to a plastic generally, or specifically target to plastic particles less than 5 mm or less. Contrary to applicant’s assertions, the “anchor peptides” and bi- or multifunctional constructs reduced to practice lack sufficient structure/function correlation and written description to support the breadth of infinite combinations of anchor peptides/plastic particles/signaling units/spacers that fall within the instant claim scope.
The rejection is maintained for at least these reasons, and those previously made of record.
Claim Rejections - 35 USC § 102/103- maintained
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1, 3-9 and 14-16 remain/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103(a) as obvious over Rübsam et al (Polymer 116: 124-132 (online March 2017)- previously cited). Rübsam et al has inventors Jakob and Schwaneberg as co-authors. This rejection is maintained from the office action mailed 7/29/2026, but has been amended to reflect claims filed 12/01/2025.
Rübsam et al teach that polypropylene is one of the widest spread commodity polymers in plastic industry with an estimated global consumption of 62.4 million tons in 2020. Modification of polypropylene is challenging due to absent functional surface groups. An anchor-peptide-based toolbox for green and versatile polypropylene functionalization was developed. Fusion proteins composed of enhanced green fluorescent protein (EGFP) and anchor peptides (e.g. cecropin A or LCI) were designed and applied to polypropylene surfaces. Resulting protein coatings of EGFP-LCI were characterized by fluorescence and scanning force microscopy. The fusion protein EGFP-LCI formed densely packed monolayers of 4.1 ± 0.2 nm thickness (abstract, pp. 126-128). A spacer sequence including 10 x alanine and a TEV-protease cleavage site sterically separates EGFP from the anchor peptide (p. 125). The fusion proteins comprising anchor peptides (e.g. cecropin A or LCI), a spacer unit, and eEGF adhered to polypropylene (e.g., pp. 128-131).
With respect to instant claims 1 and 14, - adheres to plastic particles having an average diameter of 5mm or less- and claim 2, -average diameter of 1 µm or less- MPEP § 2212-2112.02 states that when the reference discloses all the limitations of a claim except a property or function, and the examiner cannot determine whether or not the reference inherently possesses properties which anticipate or render obvious the claimed invention, the examiner has a basis for shifting the burden of proof to applicant as in In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980). Rübsam et al teach the claimed fusion proteins comprising anchor peptides (e.g. cecropin A or LCI), a spacer unit, and eEGF which adhered to polypropylene (e.g., pp. 128-131).
M.P.E.P. § 2112 recites, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (holding that who discovered the properties of a composition is immaterial to the composition’s patentability, since the composition was the same and, therefore, has necessarily always possessed all of its inherent properties). The fact that the fusion proteins taught by Rübsam et al satisfy all other claim limitations, is grounds for shifting the burden to Applicant to prove that fusion proteins taught by Rübsam et al do not anticipate or render obvious the invention of instant claims 1, 3-7, and 14.
Regarding claims 8, 9, 15, and 16, Rübsam et al teach fusion proteins comprising eGFP as the reporter protein.
Response to Arguments
Applicant traverses the rejection at pages 13-15 of the reply filed 12/01/2025. Applicant asserts that the claimed fusion constructs bind directly to plastic particles (not merely flat surfaces); e.g., “sub-micron plastic particles across multiple polymer types and generate robust fluorescent signals” (p. 13). Applicant further states: This allows for efficient identification and quantification micro plastic contamination and liquid environments. Id.
Applicant asserts that the cited references do not teach or suggest the claimed constructs bind to plastic particles, especially micro- or nanoparticles, “nor does it provide a reasonable expectation of success” (reply at p. 13).
Applicant asserts that Rübsam and Meurer describe fusion proteins “immobilized on planar surfaces such as flat films and plant leaves”. Applicant asserts that the cited references “do not suggest binding to plastic particles, nor do they address the challenges associated with detecting or immobilizing micro-nanoplastics”. Id. Applicant asserts that the “constructs of Rübsam and Meurer have different purposes, design, and functional architecture.
Rübsam discloses eGFP-LCI fusion proteins wherein the “purposes surface functionalization of macroscopic polypropylene surfaces, not detection” (reply at p. 14). Meurer discloses “anchor peptide-EGFP-hydrogel constructs” for the purpose is functionalizing plainly structures with hydrogel nutrient carriers, not used for particle detection. Id.
Applicant refers to the Schwaneberg declaration for the assertion of challenges associated with binding small plastic particles. The declaration asserts that available methods often lacked the sensitivity and specificity required for small particles, as well as absence of standardized protocols and analytical techniques, leading to differences in the detection of macroscopic plastic and micro plastics (reply at p. 14, referencing para. 6 of the declaration).
Applicant asserts that the binding of peptides to flat surfaces including plant leaves does not predict the ability to bind three dimensional particulate substrates, especially at the nanoscale, where curvature, service energy, and polymer mobility differ fundamentally (reply at p. 14). Applicant asserts that Rübsam discloses LCI-eGFP for functionalization, with the goal to provide improved binding to macroscopic plastic surfaces. Id.
Applicant asserts that Meurer discloses anchor peptide-eGFP-hydrogel constructs for functionalization of the plant leaf surfaces with nutrient containers, with the goal to provide improved binding to macroscopic plant leaf surfaces (reply at p. 15). Applicant states “According to Dr. Schwaneberg, a person of ordinary skill in the art ‘looking for solution to the analytically challenging detection of microplastics,’ would not look to these references for guidance” (referring to declaration at paras 11 and 15; reply at p. 15).
Applicant further alleges surprising data in that the claimed constructs selectively binds and detects plastic particles, as small as 500 nm (see Figs 1 and 2 of declaration: anchor peptide-eGFP constructs LCI, TA2, Thanatin, Cg-defensin, and Macaque histatin). The claimed constructs bind and fluorescently label 500 nm polystyrene and PMMA particles in suspension, producing clear, particulate fluorescence (reply at p. 15). Applicant alleges this behavior was not predictable from the planar-surface binding systems of Rübsam or Meurer.
Applicant’s arguments and the Schwaneberg declaration have been reviewed and considered but are not persuasive.
Examiner directs Applicant to MPEP 2112, which discusses when claimed properties are presumed to be inherent:" Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established." (In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)).
Regarding applicant’s assertions of surprising results, evidence of secondary considerations, such as unexpected results or commercial success, is irrelevant to 35 U.S.C. 102 rejections and thus cannot overcome a rejection so based. In re Wiggins, 488 F.2d 538, 543, 179 USPQ 421, 425 (CCPA 1973). See M.P.E.P. § 2131.04.
Additionally, applicant’s arguments as relating to the “goals” of Rübsam and Meurer are irrelevant to the structural composition of the claimed constructs. Rübsam and Meurer, respectively, teach fusion proteins [reads on bi- or multifunctional constructs] comprising an anchor peptide [e.g., liquid chromatography peak 1 (LCI),cecropin A], and a signaling unit that generates a fluorescent signal [e.g., eGFP].
See Rübsam teaching EGFP-CecA and EGFP-LCI; Meurer teaching e.g., eGFP-BM Moricin, eGFP-Carnocylcin A, eGFP-EBA, eGFP-LCI, eGFP-hDermcidin, eGFP-Macaque histatin, eGFP-Plantaricin A, eGFP-Spinigerin, and eGFP-Stomoxyn. See respective rejections further relating to spacer units.
The rejection is maintained for at least these reasons and those previously made of record.
Claims 1, 3-9 and 14-16 remain/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103(a) as obvious over Meurer et al (Angew. Chem. Int. Ed. 56:7380 –7386 (online May 2017- previously cited), as evidenced by Supporting Information accessed at URL onlinelibrary.wiley.com/action/downloadSupplement?doi=10.1002%2Fanie.201701620&file=anie201701620-sup-0001-misc_information.pdf, 7 pages- previously cited). This rejection is maintained from the office action mailed 7/29/2026, but has been amended to reflect claims filed 12/01/2025.
Meurer et al has inventors Jakob and Schwaneberg as co-authors.
Meurer et al teach anchor-peptide-based fusion proteins composed of enhanced green fluorescent protein (EGFP) and anchor peptides. Ten structurally different potential anchor peptides (BM Moricin, Carnocylcin A, Cecropin A, EBA, LCI, hDermcidin, Macaque histatin, Plantaricin A, Spinigerin, Stomoxyn) were selected and genetically fused to the reporter protein eGFP (enhanced green fluorescent protein) (pp. 7383-7384; Supporting information at Tables S2 and S3; pp. S2-S5). The fusion proteins further included a spacer unit helix (17 amino acids) between the anchor peptide and the eGFP [signaling unit that generates a fluorescent signal]. S3 of the supporting information states: Production of eGFP-Anchor-Peptide Fusion Proteins. Protein production of nine generated fusion proteins (eGFP-BM Moricin, eGFP-Carnocylcin A, eGFP-EBA, eGFP-LCI, eGFP-hDermcidin, eGFP-Macaque histatin, eGFP-Plantaricin A, eGFP-Spinigerin, eGFP-Stomoxyn).
With respect to instant claims 1, 3-9 and 14-16, MPEP § 2112-2112.02 states that when the reference discloses all the limitations of a claim except a property or function, and the examiner cannot determine whether or not the reference inherently possesses properties which anticipate or render obvious the claimed invention, the examiner has a basis for shifting the burden of proof to applicant as in In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980). Meurer et al teach the claimed fusion proteins comprising anchor peptides (e.g., cecropin A, Macaque histatin, or LCI), a spacer unit, and eEGF [reporter protein] (e.g., pp. 7383-7384; Supporting information at Tables S2 and S3; pp. S2-S5).
M.P.E.P. § 2112 recites, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (holding that who discovered the properties of a composition is immaterial to the composition’s patentability, since the composition was the same and, therefore, has necessarily always possessed all of its inherent properties). The fact that the fusion proteins taught by Meurer et al satisfy all other claim limitations, is grounds for shifting the burden to Applicant to prove that fusion proteins taught by Meurer et al do not anticipate or render obvious the invention of instant claims 1, 3-9 and 14-16.
Response to arguments
The aforementioned arguments by applicant are set forth with respect to the instant rejection. The office’s rebuttal of these arguments remains the same and is incorporated herein by reference. After full consideration of applicants arguments, the rejection is maintained.
New Objections and Rejections
Specification- Sequence Compliance
This is a new objection necessitated by the amendment filed 12/01/2025.
This application is objected to because the peptide sequence on p. 49, l. 7 is not associated with a sequence identifier (a SEQ ID NO). All sequences longer than ten nucleotides or four amino acids referenced in the specification must include a SEQ ID NO and must be included in the Sequence Listing. See MPEP § 2421-2422. Applicant must amend the specification in response to this office action and must confirm that all peptide sequences of the specification are included in the sequence listing. Examiner requests that the Applicants review the specification to confirm that all of the peptides, as required, comply with MPEP § 2421-2422.
Claim Rejections - 35 USC § 103- New
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.
Claim(s) 1, 3-9, 13-16, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rübsam et al (Polymer 116: 124-132 (online March 2017)- previously cited), as applied to claims 1, 3-9 and 14-16 above, and further in view of Arai et al (Prot Eng 14(8): 529-532 (2001)). This is a new rejection necessitated by the amendment filed 12/01/2025.
Rübsam et al teach that polypropylene is one of the widest spread commodity polymers in plastic industry with an estimated global consumption of 62.4 million tons in 2020. Modification of polypropylene is challenging due to absent functional surface groups. An anchor-peptide-based toolbox for green and versatile polypropylene functionalization was developed. Fusion proteins composed of enhanced green fluorescent protein (EGFP) and anchor peptides (e.g. cecropin A or LCI) were designed and applied to polypropylene surfaces. Resulting protein coatings of EGFP-LCI were characterized by fluorescence and scanning force microscopy. The fusion proteins comprising anchor peptides (e.g. cecropin A or LCI), a spacer unit, and eEGF adhered to polypropylene (e.g., pp. 128-131).
With respect to the instant claims, MPEP § 2212-2112.02 states that when the reference discloses all the limitations of a claim except a property or function, and the examiner cannot determine whether or not the reference inherently possesses properties which anticipate or render obvious the claimed invention, the examiner has a basis for shifting the burden of proof to applicant as in In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980). Rübsam et al teach the claimed fusion proteins comprising anchor peptides (e.g. cecropin A or LCI), a spacer unit, and eEGF which adhered to polypropylene (e.g., pp. 128-131).
M.P.E.P. § 2112 recites, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (holding that who discovered the properties of a composition is immaterial to the composition’s patentability, since the composition was the same and, therefore, has necessarily always possessed all of its inherent properties). The fact that the fusion proteins taught by Rübsam et al satisfy all other claim limitations, is grounds for shifting the burden to Applicant to prove that fusion proteins taught by Rübsam et al do not anticipate or render obvious the claimed invention.
Although Rübsam et al teach a spacer sequence including 10 x alanine and a TEV-protease cleavage site sterically separates EGFP from the anchor peptide (p. 125), the reference does not explicitly teach a spacer unit of claims 13 or 20.
Arai et al teach the design of linkers which effectively separate domains of a bifunctional fusion protein. Arai et al disclose helix-forming peptide linkers A(EAAAK)nA (n = 2-5) (abstract). The reference discloses the ability of the helical linkers to control the distance and reduce the interference between the domains. Arai et al disclose linkers including AEAAAKEAAAKEAAAKA (instant SEQ ID NO:1).
It would have been obvious before the effective filing date of the claimed invention to prepare Rübsam’s EGFP-anchor peptide (cecropin A or LCI) fusion protein with a spacer unit of instant SEQ ID NO:1, as taught by Arai et al. One of ordinary skill in the art would have been motivated to do so given Arai et al taught linkers that effectively separate domains of a bifunctional fusion protein, e.g. eGFP-anchor peptide fusion proteins. Arai et al explicitly taught peptide linkers that form an alpha helix. The distance between the domains can be controlled by changing repetitions of the EAAAK motif (p. 531). A person of ordinary skill in the art would have had a reasonable expectation of success in substituting the linker of Rübsam with the linker/spacer unit of Arai et al because the art explicitly taught them as being useful spacer units separating functional domains of the fusion protein. Therefore, these compositions are functional equivalents in the art, and substituting one for the other would have been obvious at the time of the invention. “When a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious.” See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) at 1395-1396, quoting Sakraida v. AG Pro, Inc., 425 U.S. 273 (1976) and In re Fout, 675 F.2d 297, 301 (CCPA 1982) (“Express suggestion to substitute one equivalent for another need not be present to render such substitution obvious”).
Accordingly, claims 13 and 20 are rendered obvious
Accordingly, claims 1, 3-9, 13-16, and 20 are rendered obvious in view the teachings of the cited references.
Claim(s) 1, 3-9, 13-16, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meurer et al (Angew. Chem. Int. Ed. 56:7380 –7386 (online May 2017- previously cited), as evidenced by Supporting Information accessed at URL onlinelibrary.wiley.com/action/downloadSupplement?doi=10.1002%2Fanie.201701620&file=anie201701620-sup-0001-misc_information.pdf, 7 pages- previously cited), as applied to claims 1, 3-9 and 14-16 above, and further in view of Arai et al (Prot Eng 14(8): 529-532 (2001)). This is a new rejection necessitated by the amendment filed 12/01/2025.
Meurer et al teach anchor-peptide-based fusion proteins composed of enhanced green fluorescent protein (EGFP) and anchor peptides. Ten structurally different potential anchor peptides (BM Moricin, Carnocylcin A, Cecropin A, EBA, LCI, hDermcidin, Macaque histatin, Plantaricin A, Spinigerin, Stomoxyn) were selected and genetically fused to the reporter protein eGFP (enhanced green fluorescent protein) (pp. 7383-7384; Supporting information at Tables S2 and S3; pp. S2-S5). The fusion proteins further included a spacer unit helix (17 amino acids) between the anchor peptide and the eGFP [signaling unit that generates a fluorescent signal].
With respect to the instant claims, MPEP § 2212-2112.02 states that when the reference discloses all the limitations of a claim except a property or function, and the examiner cannot determine whether or not the reference inherently possesses properties which anticipate or render obvious the claimed invention, the examiner has a basis for shifting the burden of proof to applicant as in In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980). Meurer et al teach the claimed fusion proteins comprising anchor peptides (e.g., cecropin A, Macaque histatin, or LCI), a spacer unit, and eEGF [reporter protein] (e.g., pp. 7383-7384; Supporting information at Tables S2 and S3; pp. S2-S5).
M.P.E.P. § 2112 recites, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (holding that who discovered the properties of a composition is immaterial to the composition’s patentability, since the composition was the same and, therefore, has necessarily always possessed all of its inherent properties). The fact that the fusion proteins taught by Meurer et al satisfy all other claim limitations, is grounds for shifting the burden to Applicant to prove that fusion proteins taught by Meurer et al do not anticipate or render obvious the claimed invention.
Although Meurer et al teach a spacer unit helix (17 amino acids) between the anchor peptide and the eGFP (p. 7383), the reference does not explicitly teach the amino acid sequence of the spacer.
Arai et al teach the design of linkers which effectively separate domains of a bifunctional fusion protein. Arai et al disclose helix-forming peptide linkers A(EAAAK)nA (n = 2-5) (abstract). The reference discloses the ability of the helical linkers to control the distance and reduce the interference between the domains. Arai et al disclose linkers, including AEAAAKEAAAKEAAAKA (instant SEQ ID NO:1).
It would have been obvious before the effective filing date of the claimed invention to prepare Meurer’s EGFP-anchor peptide (e.g., LCI or macaque histatin) fusion protein with a spacer unit of instant SEQ ID NO:1, as taught by Arai et al. One of ordinary skill in the art would have been motivated to do so given Arai et al taught linkers that effectively separate domains of a bifunctional fusion protein, e.g. eGFP-anchor peptide fusion proteins. Arai et al explicitly taught peptide linkers that form an alpha helix. The distance between the domains can be controlled by changing repetitions of the EAAAK motif (p. 531). A person of ordinary skill in the art would have had a reasonable expectation of success in substituting the linker of Meurer with the linker/spacer unit of Arai et al because the art explicitly taught them as being useful spacer units separating functional domains of the fusion protein. Therefore, these compositions are functional equivalents in the art, and substituting one for the other would have been obvious at the time of the invention. “When a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious.” See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) at 1395-1396, quoting Sakraida v. AG Pro, Inc., 425 U.S. 273 (1976) and In re Fout, 675 F.2d 297, 301 (CCPA 1982) (“Express suggestion to substitute one equivalent for another need not be present to render such substitution obvious”).
Accordingly, claims 13 and 20 are rendered obvious
Accordingly, claims 1, 3-9, 13-16, and 20 are rendered obvious in view the teachings of the cited references.
Conclusion
No claims allowed.
Claims 1 and 3-21 are pending. Claims 10-12, 17-19, and 21 are withdrawn.
Claim 1, 3-9, 13-16, and 20 are rejected.
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 KRISTINA M HELLMAN whose telephone number is (571)272-2836. The examiner can normally be reached M-F 9:00 am-5:30 pm.
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/KRISTINA M HELLMAN/ Examiner, Art Unit 1654
/JULIE HA/ Primary Examiner, Art Unit 1654