DETAILED ACTION
Applicants’ arguments, filed 17 July 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Office Action is NON-FINAL
The examiner notes that the current office action includes an obviousness rejection over Shahgaldian et al. (US 2016/0168559 A1). The instant claims were previously rejected as obvious over Shahgaldian et al. (US 2016/0168559 A1) in the prior office action mailed on 18 February 2026. Nevertheless, the currently applied rejection cites the structure in paragraph 0097 and 0175 of the prior art, which was not cited in the rejection in the prior office action.
As such, the examiner understands that the current rejection cites new structure that was not cited in the rejection in the prior office action. This is considered by the examiner to be sufficient to render the applied rejection to be a new ground of rejection. See MPEP 1207.03(a)(I), factual situation #4. As such, the applied rejections are understood to be new grounds of rejection not necessitated by amendment. Therefore, this office action has been made NON-FINAL.
Claim Interpretation
The examiner notes that, in accordance with the examiner’s understanding of applicant’s response on 17 July 2026, various terms appear in both the instant application and prior art reference Shahgaldian et al. (US 2016/0168559 A1), but have different meanings in the instantly claimed invention and the prior art. One such term is “functional constituent” – this has a different meaning in the claimed invention and in the prior art. The examiner takes the position that this difference in meaning of the phrase “functional constituent” was not understood by the examiner when the examiner drafted the office action mailed on 18 February 2026. As such, the claim interpretation of the phrase “functional constituent” that is applied in this office action differs from that which was applied in the prior office action mailed on 18 February 2026.
Regarding the term “surface”, the examiner notes that instant claim 1 recites both
the surface of the solid carrier; and
the surface of the protective layer.
These are different locations in the particle. The examiner has reproduced below an annotated version of figure 1 to clarify this difference.
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The examiner notes that this interpretation of claim 1 is different from the interpretation of claim 1 relied upon in the previous office action.
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) 1-3, 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. Shahgaldian teaches the following as of figure 1A of Shahgaldian, wherein the final product of this figure is reproduced below with annotation by the examiner as to how the components of this figure are understood to read on the required claimed elements.
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As such, the example of claim 1 appears to teach all of the requirements of instant claim 1 with the exception of the required functional constituent immobilized on the surface of the protective layer. Nevertheless, Shahgaldian teaches the following as of paragraph 0097, which is reproduced below.
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The examiner best understands the additional functionalities discussed above to read on the required functional constituent. See also paragraph 0175 of Shahgaldian, which provides a similar teaching. Shahgaldian also teaches polyethylene glycol (i.e. PEG) modification in 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, with the material reading on the required functional constituent in a paragraph in the broad disclosure of Shahgaldian but not in an embodiment of Shahgaldian. 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.
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 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, the skilled artisan would have expected that the material taught by paragraph 0097 of Shahgaldian would not have been embedded in order to have served the function taught by paragraph 0097 of Shahgaldian.
Claim(s) 4-6, 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 claim 4, the PEG in the above-reproduced figure from Trogler appears to be covalently bound.
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 10, the asaparaginase of Kishimoto is understood to read on the additional requirement of the claim.
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.
Response to Arguments Regarding Obviousness Rejections
Applicant has presented arguments regarding the previously applied obviousness rejections, as of applicant’s response on 17 July 2026 (hereafter referred to as applicant’s response). These arguments are addressed below.
Applicant makes the following argument regarding claim 1, wherein relevant text is reproduced below.
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The examiner does not dispute the position taken here. Nevertheless, the examiner has further reviewed Shahgaldian and now takes the position that the subject matter taught by paragraphs 0097 and 0175 would appear to read on the required functional constituent. The examiner has reproduced below paragraph 0097 of Shahgaldian below.
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The above-indicated further modification at the outer surface is understood by the examiner to read on the required functional constituent.
The examiner notes here that the examiner pointing to paragraphs 0097 and 0175 is newly cited in this office action. These newly cited paragraphs change the basic thrust of the rejection. These newly cited paragraphs also point to new structure. As such, the applied rejection is regarded by the examiner as a new ground of rejection not necessitated by amendment. Therefore, this office action has been made NON-FINAL.
Regarding claim 2, applicant makes the following argument, as of page 6 of applicant’s response.
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This argument does not appear to address the full scope of the positions taken by the examiner in regard to claim 2 in the prior office action mailed on 18 February 2026. This is because in the prior office action, the examiner addressed the issue of polyethylene glycol (PEG) modification. See Shahgaldian, paragraph 0048 and page 7 of the prior office action. This is not addressed in the above-reproduced paragraph. The arguments in the above-reproduced paragraph regarding targeting ligands are not applicable to polyethylene glycol because polyethylene glycol is not a targeting ligand. As such, applicant’s response fails to address all of the issues relevant to claim 2 and is therefore not persuasive.
Additionally, applicant’s argument that Shahgaldian solves the problem of chemical transformation whereas the instant invention solves the problem of biological delivery is also not persuasive. This is because Shahgaldian provides substantial teachings regarding biological delivery. See e.g. Shahgaldian, paragraph 0163, in which Shahgaldian teaches various modes of administration including intravenous administration.
Applicant makes the following arguments regarding claim 3, as of the bottom of page 6 of applicant’s response, relevant text reproduced below.
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The examiner best understands this argument as a statement that in the prior art, Shahgaldian adds silanes only once; namely, to form the protective layer. In contrast, applicant argues that in the claimed invention of claim 2 regarding the silanes, it is the case that the silanes are added twice; first as the protective layer and then as the functional constituent. Even if, purely en arguendo, this is accurate, it is not sufficient to overcome the applied rejection. This is because the applied rejection is drawn to a composition claim rather than a method claim. That the prior art has one steps of adding silanes whereas the instant invention has two steps of adding silanes is a difference in the method by which the prior art was made as compared with the method by which the material of the instant invention is made. It is not a difference in the composition. As such, applicant’s arguments are not commensurate in scope with claim 3, which is a composition claim rather than a method claim.
Additionally, the different intended use of the silane in the prior art as compared with the instant invention is insufficient to overcome the applied rejection. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See MPEP 2144(IV).
Applicant makes the following argument regarding claim 4, as of applicant’s response, page 7, relevant text reproduced below.
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In view of this, claim 4 is no longer rejected as obvious over Shahgaldian by itself. In contrast, claim 4 is rejected over the combination of Shahgaldian in view of Trogler. Trogler teaches covalent bonding of polyethylene glycol to the surface in at least the figure in the abstract, which was reproduced on page 9 of the office action mailed on 18 February 2026. The newly applied rejection of claim 4 over the combination of Shahgaldian with Trogler is understood by the examiner to be a new ground of rejection not necessitated by amendment.
Regarding claim 9, applicant makes the following argument on page 7 of applicant’s response.
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This is not persuasive. The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain. See MPEP 2123(I).
Applicant also makes the following arguments on page 7 regarding claim 9.
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This is not persuasive because Shahgaldian teaches treating cancer in paragraph 0156, which is an oncology application.
Applicant then provides the following argument regarding claim 11, as of applicant’s response, page 7, bottom paragraph, relevant text reproduced below.
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This is not persuasive. The skilled artisan would not have been motivated to have embedded the material suggested by paragraphs 0097 and 0175 of Shahgaldian.
In applicant’s argument on page 8, applicant makes the following argument regarding claim 12.
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This appears to be essentially the same argument made in regard to claim 1. As such, claim 12 has been rejected for essentially the same reason that claim 1 has been rejected.
Applicant then makes the following argument at the bottom of page 8 of applicant’s response.
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This is not persuasive. The prior art’s teaching of PEGylation, e.g. as of the figure in the abstract of Trogler, is understood to be sufficient to render PEGylation prima facie obvious. See MPEP 2123, especially MPEP 2123(I).
Applicant makes the following argument at the top of page 9, relevant text reproduced below.
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This is not persuasive. The PEG taught by Trogler is not embedded. As such, Trogler does appear to teach the required layered architecture. Regarding the issue of successful integration, this is not persuasive. Obviousness requires a reasonable expectation of success, not absolute predictability. See MPEP 2143.02(II). The examiner notes that applicant may provide evidence showing lack of a reasonable expectation of success in order to support a conclusion of non-obviousness; however, the assertion that integration would not have been successful in the above-reproduced paragraph is not evidence. Argument does not replace evidence where evidence is necessary; see MPEP 2145(I).
Applicant then makes the following arguments on the first full paragraph of page 9 of applicant’s response.
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This is not persuasive. Shahgaldian teaches intravenous administration as of paragraph 0163. As such, there would have been a reasonable expectation that the composition of Shahgaldian would have been successful for intravenous administration.
Applicant then makes arguments regarding particle size, as of applicant’s response, page 9, relevant text reproduced below.
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This is not persuasive. As an initial matter, this does not appear to be relevant to the claimed invention because the instant claims do not actually require a particular particle size. Arguments related to unclaimed limitations are not persuasive. See MPEP 2145(VI).
Additionally, Shahgaldian teaches particle sizes from 20 nm to 1000 nm, as of Shahgaldian, paragraph 0294. This would appear to overlap with the particle size disclosed in the instant specification on page 9 lines 10-16, which discloses particles sized from between 1 nm and 1000 nm.
Regarding claims 7-8, applicant makes the following arguments, as of the last paragraph of page 9 of applicant’s response.
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As an initial matter, applicant appears to have acknowledged that Santos teaches albumin to reduce clearance. As such, this would have provided motivation for the skilled artisan to have added albumin, with a reasonable expectation of success. This is sufficient to result in a prima facie case of obviousness for the reasons set forth above.
Applicant makes the following arguments regarding claims 10 and 13, which have been reproduced below from page 10 of applicant’s response.
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This is not persuasive. When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. See MPEP 2121(I). Mere assertions that the teachings of the prior art are generic are insufficient to meet applicant’s burden to rebut the presumption of operability.
Regarding the issue of comparative testing and alleged unexpected results, applicant makes the following arguments on page 11, relevant text reproduced below.
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In response, the examiner notes that expected beneficial results are evidence of obviousness. See MPEP 716.02(c)(II). In this case, that polyethylene glycol coating increases circulation time would have been an expected beneficial result. See e.g. Immordino et al. (International Journal of Nanomedicine, Vol. 1(3), 2006, pages 297-315), in which polyethylene glycol increasing circulation time is discussed in the abstract on page 297 as well as elsewhere in the document. See also Ashley et al. (US 2015/0272885 A1), which teaches in paragraphs 0011 and 0235 that modification of a lipid coated silica nanoparticle with PEG extends circulation times. The examiner clarifies that the newly cited references Immordino and Ashley are not part of the statement of rejection, and have been cited by the examiner only to address applicant’s arguments.
Applicant then cites Example 11, as of applicant’s response, pages 11-12, relevant text reproduced below.
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Example 11 is discussed in the instant specification on pages 38-39 of the instant specification, which have been reproduced below.
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In order to overcome a prior art rejection based upon unexpected results, applicant must compare the claimed invention to the closest prior art. See MPEP 716.02(e). In this case, the free asparaginase would not appear to be as close to the claimed invention as the composition of Shahgaldian. As such, Example 11 does not appear to represent a comparison to the closest subject matter to actually exist in the prior art and is therefore not probative of non-obviousness.
Applicant then makes the following arguments regarding Example 12, as of applicant’s response, page 12, relevant text reproduced below.
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In response, the examiner has reproduced Example 12 below from page 39 of the instant specification.
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Applicant’s results appear to indicate that PEG coating results in a reduction of immune response.
In response, the examiner notes that expected beneficial results are evidence of obviousness. See MPEP 716.02(c)(II). In this case, that polyethylene glycol coating increases circulation time would have been an expected beneficial result. See e.g. Immordino et al. (International Journal of Nanomedicine, Vol. 1(3), 2006, pages 297-315), in which polyethylene glycol having low immunogenicity is discussed at least on page 303, left column. See also Ashley et al. (US 2015/0272885 A1), which teaches that PEG coating extends circulation times in paragraphs 0011 and 0235. As such, that polyethylene glycol coating would have resulted in less immunogenicity would appear to be an expected beneficial result.
Applicant then makes the following argument as of page 12 of applicant’s response.
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This is not persuasive at least because Shahgaldian teaches particles sized in the range of 20 nm to 1000 nm, as of Shahgaldian, paragraph 0294. As best understood by the examiner, particles in this size range would not have inherently been clinically unsafe; this determination is made in view of the fact that that these are the same particle sizes disclosed in the instant specification on page 9 lines 10-16. Shahgaldian also teaches various modes of administration in paragraph 0163 including intravenous administration. As such, the above-reproduced text is sufficient to establish that there would have been a reasonable expectation that the composition of Shahgaldian would have been successful clinically and would have been safe to have been administered clinically. See MPEP 2143.02 regarding the issue of a reasonable expectation of success.
Withdrawn Double Patenting Rejections
The instantly claimed application was previously rejected on the grounds of provisional non-statutory double patenting over the claims of application 17/997,724 and 18/221,195. These rejections been withdrawn. This is because the claims of the ‘724 and ‘195 applications do not appear to recite a material that reads on the required functional constituent.
The examiner notes that the claims of the ‘724 and ‘195 applications do recite the phrase “functional constituent.” However, this phrase appears to have a different meaning in the claims of the ‘724 and ‘195 applications as compared with the instant claims. The examiner has annotated figure 1A of the instant application to best explain this issue.
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As such, the above-reproduced annotated diagram shows why the phrase “functional constituent”, as recited by the claims of the ‘724 and ‘195 applications, does not read on the claimed functional constituent.
The examiner takes the position that this rationale for withdrawal of non-statutory double patenting rejections applies only to the ‘724 and ‘195 applications, and not to the other applications over which the claims were rejected on the grounds of non-statutory double patenting, which are maintained below.
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 are 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 1-19 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.
Response to Arguments Regarding Double Patenting Rejections
As an initial matter, applicant’s arguments regarding the previously presented provisional non-statutory double patenting rejections over applications 17/997,724 and 18/221,195 are understood to be moot in view of the withdrawal of these rejections. Arguments related to these rejections have therefore not been addressed substantively by the examiner.
Applicant has made the following argument regarding the applied provisional non-statutory double patenting rejection over application 18/729,752, as of applicant’s response, page 13, relevant text reproduced below.
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Applicant does not appear to dispute that the claims of the ‘752 application have a material immobilized on the surface of the protective layer. However, applicant’s argument appears to be that the claims of the ’752 application define this material more narrowly than the instant claims by requiring that it comprises at least one amino group and at least one thiol group, which is not recited by the instant claims.
This is not persuasive. Even if, purely en arguendo, the above-reproduced text from applicant’s response represents an accurate summary of the fact pattern, it is insufficient to overcome the applied rejection. This is because the more narrowly defined material immobilized on the surface of the protective layer in the copending claims is understood to read on the required functional constituent. That the material of the copending claims is more narrowly defined than that of the instant claims is not sufficient to rebut this determination. This is because a species will anticipate a claim to a genus. See MPEP 2131.02(I). In this case, the copending claims recite the species and the instant claims recite the genus, at least with regard to the instantly claimed functional constituent. As such, the subject matter of the copending claims of the ‘752 application reads on that of the instant claims, resulting in a prima facie case of non-statutory double patenting.
The examiner notes that the applied rejection requires a one-way test for double patenting; namely, it is required that the instant claims be anticipated by or obvious over the claims of the copending application. There is no requirement that the copending claims be anticipated by or obvious over the instant claims. The examiner notes that if, purely en arguendo, it was required that there be a two-way test for distinctness, then applicant would indeed be correct that the applied double patenting rejection over the ‘752 application should be withdrawn for the reasons indicated in applicant’s response. However, applicant did not argue that a two-way test should for distinctness be required and there is no indication that a two-way test for distinctness should be required. As such, it is the examiner’s understanding that a one-way test for distinctness is appropriate. See MPEP 804(II)(B)(4).
Applicant’s arguments regarding the copending claims in applications 19/113222 and 18/282361, which were presented on page 14 of applicant’s response, have similarities to the arguments regarding the ‘752 application. Namely, applicant has pointed to a feature in the claims of the ‘222 and ‘361 application that is not recited by the instant claims. Even if, purely en arguendo, applicant is correct that the claims of the ‘222 and ‘361 applications require a feature that is not required by the instant claims, this is insufficient to overcome the previously applied double patenting rejections. That the material of the copending claims is more narrowly defined than that of the instant claims is not sufficient to rebut the determination of non-statutory double patenting. A species will anticipate a claim to a genus. See MPEP 2131.02(I).
With regard the non-statutory double patenting rejection over copending applications 19/498076, 19/498069, 19/498070, and 19/498073, applicant points out that the composition of the copending claims was made by a different method than that of the instant claims. Even if, purely en arguendo, this is true, it is not sufficient to overcome the previously applied rejections because the pending claims are drawn to products, not processes. Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing a nonobvious difference between the claimed product and the prior art product. See MPEP 2113(II). Applicant’s mere statement that the instantly claimed product was made by a different process than that of the copending claims is insufficient to meet this burden.
Conclusion
No claim is allowed.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612
Prosecution Insights