DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Applicant’s election of Group I, claims 1-13 and 16 in the reply filed on 16 December 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 15 and 17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 16 December 2025.
Claim Rejections - 35 USC § 112(b) – Indefiniteness
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.
Claim 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites a polyethylene glycol/silane copolymer, preferably a mSilane-PEG 2kDa. Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph should be made. See MPEP 2173.05(d) as well as MPEP 2173.05(c)(I). In this case, it is unclear whether claim 6 is drawn to the broader limitation of a polyethylene glycol/silane copolymer or the narrower limitation of a mSilane-PEG 2kDa.
For the purposes of examination under prior art, the examiner understands the broader claim limitation to be limiting.
Claim Interpretation
Various claims such as claim 5 recite a polyethylene glycol/silane copolymer. This phrase does not appear to have been redefined by the instant specification. The examiner has included the following text to clarify how this term is interpreted.
The examiner clarifies that the term “silane” is often used to refer to small molecules containing silica. The term “silane” itself refers to SiH4, which is a silicon atom bound to four hydrogen atoms and is therefore the silicon analog of methane.
With that being said, derivatives of the term “silane” is often used for chemical compounds in which one of the hydrogen atoms bound to the silicon has been replaced by a different functional group. For example, tetraethoxysilane is a term that can be used to refer to Si(OCH2CH3)4 (which is also known as tetraethyl orthosilicate). Similarly, 3-aminopropyltriethoxysilane refers to a silicon substituted by three ethoxy groups and 1 aminopropoxy group. These silanes are small molecules rather than copolymers, and are often used to form silica by methods involving hydrolysis and condensation, which is also referred to as sol-gel chemistry.
For the purposes of examination under prior art, the examiner understands silica that has been formed by hydrolysis and condensation of silanes to be a silane copolymer. Therefore, a particle comprising sol-gel silica that is covalently grafted to polyethylene glycol is understood to read on the required polyethylene glycol/silane copolymer.
Regarding claim 8, the examiner understands “antibody” and “immunoglobulin” to be synonyms.
Claim 12 recites that the functional constituent is not embedded by the protective layer. The examiner will interpret this limitation as reading on a case where the functional constituent is partially embedded by the protective layer and partially not embedded by the protective layer.
Claim Rejections - 35 USC § 103 – Obviousness
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 9 and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shahgaldian et al. (US 2016/0168559 A1).
Shahgaldian et al. (hereafter referred to as Shahgaldian) is drawn to a biocatalytical composition, as of Shahgaldian, title and abstract. Specifically, the teachings of Shahgaldian appear to read on the claimed requirements in the following manner:
Claimed Requirement from Claim 1
Teaching in Shahgaldian Prior Art
Solid Carrier
5th line in abstract
Enzyme or fragment thereof
Abstract, 4th to last line and 3rd to last line
Enzyme is immobilized on the surface
Abstract, 3rd to last line
Enzyme is embedded
Paragraph [0059]
Functional constituent immobilized
At least paragraph [0048]
As such, Shahgaldian appears to teach all of the requirements of claim 1. With that being said, as best understood by the examiner, the relevant features appear to have been taught in separate parts of the reference. As such, while the prior art teaches all of the claimed components, the prior art is not anticipatory insofar as these components must be selected from various lists/locations in the prior art reference. It would have been prima facie obvious; however, to have selected the recited components from various lists/locations in the prior art reference and to have combined them together. This is because such a modification would have represented nothing more than the predictable use of prior art components according to their established functions. Combining separate prior art components (from a single prior art reference) according to known methods to yield predictable results is prima facie obvious. See MPEP 2143, Exemplary Rationale A.
As to claim 2, Shahgaldian cites a reference published prior to Shahgaldian in which PEG was attached to the surface, as of Shahgaldian, paragraph 0042. As such, the skilled artisan would have been motivated to have modified the composition of Shahgaldian with PEG. The skilled artisan would have been aware that PEG would have increased circulation time and would have rendered phagocytosis less likely. The examiner also notes that Shahgaldian teaches the term “target” at multiple locations in the reference including paragraph 0054.
As to claim 3, Shahgaldian teaches a silane at various locations in the reference including paragraphs 0100 and 0108. To the extent that Shahgaldian teaches organosilane monomers, the skilled artisan would have expected said monomers to have formed polymers during normal operation.
As to claim 4, Shahgaldian teaches covalent bonding at the surface, as of at least paragraph 0066.
As to claim 9, Shahgaldian teaches a hydrolase as of at least paragraph 0298.
As to claim 11, Shahgaldian teaches that the solid carrier [is] embedded in a protective material, as of the abstract, which is understood to meet the claim limitation.
As to claim 12, Shahgaldian teaches the following in paragraph 0048, reproduced below.
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A case wherein the functional constituent is partially embedded and partially not embedded is understood by the examiner to read on the claim requirements. See the section above entitled “Claim Interpretation.”
Claim(s) 5-6, 8 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shahgaldian et al. (US 2016/0168559 A1) in view of Trogler et al. (US 2015/0273061 A1).
Shahgaldian is drawn to a biocatalytical composition involving an encapsulated protein or enzyme, as of Shahgaldian, title and abstract. See the rejection above over Shahgaldian by itself. The composition of Shahgaldian is in the form of a particle, as of Shahgaldian, figure 1. The composition of Shahgaldian is made from silica and comprises an amino-modified silica surface, as of paragraph 0075. Shahgaldian teaches administration of the composition, alone or in combination with other drugs, as of Shahgaldian, paragraph 0157 – this appears to teach administration to the body or an organism including but not limited to a human.
Shahgaldian does not teach a polyethylene glycol/silane copolymer.
Trogler et al. (hereafter referred to as Trogler) is drawn to degradable silica nanoshells, as of Trogler, title and abstract. Trogler teaches a PEGylated silica shell, as of Trogler, figure in abstract, reproduced below.
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PEGylation extends circulation lifetime, as of Trogler, paragraph 0134.
It would have been prima facie obvious for one of ordinary skill in the art to have modified the composition of Shahgaldian with the PEGylated silica taught by Trogler. Shahgaldian is drawn to a composition that may be administered to the body of a living organism, as of Shahgaldian, paragraph 0157. Trogler teaches that modifying a mesoporous silica particle with PEG extends the circulation lifetime and thereby increase therapeutic effectiveness. As such, the skilled artisan would have been motivated to have modified the composition of Shahgaldian in the manner taught by Trogler in order to have predictably increased circulation lifetime and improved therapeutic effectiveness with a reasonable expectation of success.
The examiner further notes that Shahgaldian appears to be drawn to delivery of a protein compound, as of the title of Shahgaldian. Trogler is drawn to administration for ultrasonic imaging, as of Trogler, title. However, elsewhere in the document, Trogler teaches drug delivery more generically as of paragraphs 0002 and 0059, and teaches a protein therapeutic in paragraph 0021. As such, Trogler appears to suggest the delivery of proteins. As such, both Trogler and Shahgaldian appear to be drawn to the same field of endeavor of administration of proteins.
As to claims 5-6, the structure in the above-reproduced figure from Trogler is understood to read on the required polyethylene glycol/silane copolymer. The examiner notes that the phrase “polyethylene glycol/silane copolymer” is further defined by the section of the office action above entitled “Claim Interpretation.”
As to claim 8, Trogler teaches an antibody in paragraph 0059; the examiner understands this to read on the required immunoglobulin.
As to claim 16, Trogler is drawn to an imaging agent, and an imaging agent is used in a method of measuring the distribution of a composition in a subject.
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shahgaldian et al. (US 2016/0168559 A1) in view of Santos et al. (Microporous and Mesoporous Materials, Vol. 251, 2017, pages 181-189).
Shahgaldian is drawn to a biocatalytical composition involving an encapsulated protein or enzyme, as of Shahgaldian, title and abstract. See the rejection above over Shahgaldian by itself. The composition of Shahgaldian is in the form of a particle, as of Shahgaldian, figure 1. The composition of Shahgaldian is made from silica, as of paragraph 0075. Shahgaldian teaches administration of the composition, alone or in combination with other drugs, as of Shahgaldian, paragraph 0157 – this appears to teach administration to the body or an organism including but not limited to a human.
Shahgaldian does not teach serum albumin.
Santos et al. (hereafter referred to as Santos) is drawn to a mesoporous silica nanoparticle comprising human albumin, as of Santos, page 181, title and abstract. Said albumin would appear to help avoid clearance of the particles by the mononuclear phagocyte system, as of Santos, page 181, title and abstract, as well as to reduce uptake by liver and spleen, as of Santos, page 186, left column, middle paragraph.
It would have been prima facie obvious for one of ordinary skill in the art to have modified the composition of Shahgaldian with the albumin of Santos. Shahgaldian is drawn to a composition that may be administered to the body of a living organism, as of Shahgaldian, paragraph 0157. Santos teaches that modifying a mesoporous silica particle with albumin extends the circulation lifetime and can result in increased therapeutic effectiveness. As such, the skilled artisan would have been motivated to have modified the composition of Shahgaldian in the manner taught by Santos in order to have predictably increased circulation lifetime and improved therapeutic effectiveness with a reasonable expectation of success.
As to claim 7, Santos teaches human serum albumin, as of page 188, left column, top paragraph.
As to claim 8, the albumin of Santos is understood to read on the required peptide.
Claim(s) 10 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shahgaldian et al. (US 2016/0168559 A1) in view of Kishimoto (US 2014/0328924 A1).
Shahgaldian is drawn to a biocatalytical composition involving an encapsulated protein or enzyme, as of Shahgaldian, title and abstract. See the rejection above over Shahgaldian by itself. Shahgaldian appears to be drawn to delivery of a wide variety of enzymes, including hydrolases, lyases, isomerases, and other types of enzymes, as of paragraphs 0147 and 0298 of Shahgaldian.
Shahgaldian does not teach an asparaginase.
Kishimoto is drawn primarily to delivery of immunosuppressants, as of Kishimoto, title and abstract. However, Kishimoto also teaches delivery of therapeutic enzymes, which may include hydrolases, lyases, isomerases, and asparaginases, as of Kishimoto, paragraphs 0150-0151.
It would have been prima facie obvious for one of ordinary skill in the art to have used the composition of Shahgaldian to have delivered the asparaginase of Kishimoto. Shahgaldian is drawn to delivery of a wide variety of enzymes, including hydrolases, lyases, and isomerases. Kishimoto teaches that asparaginases are a type of enzyme, in addition to other types of enzymes such as hydrolases, lyases, or isomerases. As such, the skilled artisan would have been motivated to have used the composition of Shahgaldian to have predictably delivered other types of enzymes such as isomerases with a reasonable expectation of success.
As to claim 13, Kishimoto teaches EDTA (i.e. ethylene diamine tetraacetic acid) as a preservative, as of Kishimoto, paragraph 0172. As such, the skilled artisan would have been motivated to have used the EDTA of Kishimoto with the composition of Shahgaldian to have predictably preserved the composition of Shahgaldian. The skilled artisan would have understood EDTA to have read on the required chelating agent because EDTA is known to chelate with hard metal ions.
Non-Statutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-13 and 16 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 17/997,724 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a composition comprising a solid carrier, an enzyme or fragment thereof, and a functional constituent.
The copending claims are drawn to a method of producing a composition. This method entails the use of a solid carrier, as of copending claim 1 step (a), a functional constituent, as of copending claim 1 step (c), and an enzyme, as of copending claim 5.
The instant and copending claims differ because the copending claims are drawn to a method of making a composition, whereas the instant claims are drawn to a composition. Nevertheless, the subject matter made by the method of copending claim 5 would appear to comprise all of the ingredients required by instant claim 1. As such, the subject matter of the copending claims appears to effectively anticipate the subject matter recited by instant claim 1, resulting in a prima facie case of anticipatory-type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-13 and 16 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/221,195 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a composition comprising a solid carrier, an enzyme or fragment thereof, a protective layer and a functional constituent.
The copending claims are drawn to a composition comprising a solid careri, a functional constituent, an enzyme, and a protective layer, as of copending claim 1.
The instant and copending claims differ because the copending claims recite various ingredients from which the protective layer is made, which is not recited by the instant claims. Nevertheless, the subject matter of the copending claims appears to recite all of the required elements of the instant claims because a specific example or narrower scope of a protective layer in the copending claims effectively anticipates the broader range; see MPEP 2131.03(I). As such, the subject matter of the copending claims appears to effectively anticipate that of the instant claims, thereby resulting in a prima facie case of anticipatory-type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-13 and 16 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 18/729,752 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a composition comprising a solid carrier, an enzyme or fragment thereof, a protective layer and a functional constituent.
Copending claim 1 is drawn to a solid carrier, a protein or fragment thereof immobilized thereon, a functional constituent, and a protective layer. Copending claim 8 recites an enzyme. Copending claim 16 recites various enzymes which may be used as the protein.
The instant and copending claims differ because the copending claims recite various limitations regarding the protective layer such that the protective layer must have repeat units comprising an amino group or thiol group. This is not recited by the instant claims. Nevertheless, the subject matter of the copending claims appears to recite all of the required elements of the instant claims because a specific example or narrower scope of a protective layer in the copending claims effectively anticipates the broader range; see MPEP 2131.03(I). As such, the subject matter of the copending claims appears to effectively anticipate that of the instant claims, thereby resulting in a prima facie case of anticipatory-type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-13 and 16 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 19/113,222 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a composition comprising a solid carrier, an enzyme or fragment thereof, a protective layer and a functional constituent.
Copending claim 1 recites a composition comprising a solid carrier, an enzyme or fragment thereof, a protective layer and a functional constituent.
The instant and copending claims differ because the copending claims recite a particular particle size in copending claim 1. This is not recited by the instant claims. Nevertheless, the subject matter of the copending claims appears to recite all of the required elements of the instant claims because a specific example or narrower scope of a particle size in the copending claims effectively anticipates the broader range; see MPEP 2131.03(I). As such, the subject matter of the copending claims appears to effectively anticipate that of the instant claims, thereby resulting in a prima facie case of anticipatory-type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-8, 11-13 and 16 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. 19/498,076 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a composition comprising a solid carrier, an enzyme or fragment thereof, a protective layer and a functional constituent.
The copending claims recite a solid carrier, a lipase or fragment thereof, an agent which interacts with the lipase, and a protective layer, as of copending claim 1.
The instant and copending claims differ because the copending claims recite a lipase, as of copending claim 1. While the instant claims do not specify a lipase, this is understood to read on the required enzyme. Additionally, the copending claims recite an agent that interacts with the lid domain of the lipase; the examiner understands this to read on the required functional constituent since it affects the function of the lipase. Nevertheless, the subject matter of the copending claims appears to recite all of the required elements of the instant claims because a specific example or narrower scope of an enzyme and functional constituent in the copending claims effectively anticipates the broader range recited by the instant claims; see MPEP 2131.03(I). As such, the subject matter of the copending claims appears to effectively anticipate that of the instant claims, thereby resulting in a prima facie case of anticipatory-type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
This rejection does not apply to instant claims 9-10 because the type of enzyme recited in claims 9-10 differs from the lipase recited by the copending claims.
Claims 1-13 and 16 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 18/282,361 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a composition comprising a solid carrier, an enzyme or fragment thereof, a protective layer and a functional constituent.
Copending claim 1 recites a composition comprising a solid carrier, a functional protein, and a first and second protective layer, among other ingredients. Copending claim 2 recites that the functional protein is an enzyme. Copending claim 16 recites an antibody.
The instant and copending claims are different because, while the copending claims recite all of the required ingredients, these appear to be in separate claims. For example, while the solid carrier and protective layer is recited by copending claim 1, the enzyme is recited by copending claim 2 and the antibody (which reads on the required functional constituent) is recited by copending claim 16. Nevertheless, the skilled artisan would have been motivated to have combined these features recited in disparate copending claims. The result of this combination would have been expected to have rendered the instantly claimed invention prima facie obvious, thereby resulting in a prima facie case of obviousness-type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-8, 11-13 and 16 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/498,069 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a composition comprising a solid carrier, an enzyme or fragment thereof, a protective layer and a functional constituent.
The copending claims recite a solid carrier, a disaccharidase or fragment thereof, an agent which interacts with the disaccharidase, a protective layer, and a functional constituent, as of copending claim 1.
The instant and copending claims differ because the copending claims recite a disaccharidase, as of copending claim 1. While the instant claims do not specify a disaccharidase, this is understood to read on the required enzyme. Nevertheless, the subject matter of the copending claims appears to recite all of the required elements of the instant claims because a specific example or narrower scope of an enzyme and functional constituent in the copending claims effectively anticipates the broader range recited by the instant claims; see MPEP 2131.03(I). As such, the subject matter of the copending claims appears to effectively anticipate that of the instant claims, thereby resulting in a prima facie case of anticipatory-type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
This rejection does not apply to instant claims 9-10 because the type of enzyme recited in instant claims 9-10 differs from the disaccharidase recited by the copending claims.
Claims 1-8, 11-13 and 16 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 19/498,070 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a composition comprising a solid carrier, an enzyme or fragment thereof, a protective layer and a functional constituent.
The copending claims recite a solid carrier, a phenylalanine ammonia lyase or fragment thereof, an agent which interacts with the phenylalanine ammonia lyase, a protective layer, and a functional constituent, as of copending claim 1.
The instant and copending claims differ because the copending claims recite a phenylalanine ammonia lyase, as of copending claim 1. While the instant claims do not specify a phenylalanine ammonia lyase, this is understood to read on the required enzyme. Nevertheless, the subject matter of the copending claims appears to recite all of the required elements of the instant claims because a specific example or narrower scope of an enzyme and functional constituent in the copending claims effectively anticipates the broader range recited by the instant claims; see MPEP 2131.03(I). As such, the subject matter of the copending claims appears to effectively anticipate that of the instant claims, thereby resulting in a prima facie case of anticipatory-type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
This rejection does not apply to instant claims 9-10 because the type of enzyme recited in instant claims 9-10 differs from the phenylalanine ammonia lyase recited by the copending claims.
Claims 1-8, 11-13 and 16 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of copending Application No. 19/498,073 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a composition comprising a solid carrier, an enzyme or fragment thereof, a protective layer and a functional constituent.
The copending claims recite a solid carrier, multiple enzymes including a lipase, protease, amylase, or a fragment thereof or fragment thereof, an agent which interacts with the phenylalanine ammonia lyase, a protective layer, and a functional constituent, as of copending claim 1.
The instant and copending claims differ because the copending claims recite a specific mixture of enzymes, as of copending claim 1. While the instant claims do not specify the mixture of enzymes recited by the copending claims, it is nevertheless the case that the mixture of enzymes required by the copending claims reads on the claimed mixture of enzymes. As such, the subject matter of the copending claims appears to recite all of the required elements of the instant claims because a specific example or narrower scope of an enzyme and functional constituent in the copending claims effectively anticipates the broader range recited by the instant claims; see MPEP 2131.03(I). As such, the subject matter of the copending claims appears to effectively anticipate that of the instant claims, thereby resulting in a prima facie case of anticipatory-type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
This rejection does not apply to instant claims 9-10 because the type of enzyme recited in instant claims 9-10 differs from the types of enzymes recited by the copending claims.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISAAC SHOMER whose telephone number is (571)270-7671. The examiner can normally be reached 7:30 AM to 5:00 PM Monday Through Friday.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612