Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of Claims
2. Applicant's preliminary amendment of the instant application, which was originally submitted on 06/22/2023 and later amended on 01/02/2024, is acknowledged by the Examiner. The cancellation of claims 1 pursuant to the amendment on 01/04/2024 is acknowledged. Claims 1 are pending and under review.
Priority
3. The instant application is a National Stage Entry of International Patent Application No. PCT/EP2021/079199 filed on 10/21/2021. Additionally, the instant application claims priority to International Patent Application No. PCT/EP2021/059643 filed on 04/14/2021 and European Patent Application No. 20216717.7 filed on 12/22/2020, wherein United States Patent Application No. 17/918,679 filed on 10/13/2022 is a National Stage Entry of PCT/EP2021/059643 that claims priority to United States Provisional Application No. 63/010,423 filed on 04/15/2020.
4. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 112(a):
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 nonprovisional 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 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, United States Provisional Application No. 63/010,423, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The provisional application fails to provide support for a method which increases the binding of virus neutralizing antibodies to a virus in a subject, or to provide any suggestion that this is the case. The provisional application also fails to teach the composition further comprising any of chitosan lactate, chitosan acetate, chitosan hydrochloride, and any combination thereof; any of galactose, mannose, caffeine, and any combination thereof; a particle comprising chitosan or a salt thereof or a co-agglomerate of different particles comprising chitosan or a salt thereof; and degree of deacetylation of the chitosan or salt thereof. Accordingly, claims 124 – 143 are not entitled to the benefit of the provisional application and receive the filing date of the PCT/EP2021/059643, i.e., 12/22/2020.
Information Disclosure Statement
5. The information disclosure statement (IDS) submitted on 06/22/2023 has been considered by the Examiner. Notably, 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 of the specification have been cited by the examiner on form PTO-892, they have not been considered. Applicant is also reminded of the duty to disclose information to the Office which is material to patentability as defined in 37 CFR 1.56. This includes a list of all patents, publications, or other information that should be considered by the Office pursuant to 37 CFR 1.98(b). See MPEP § 609. All references submitted on the IDS were considered.
Specification
6. The use of the terms Monolith™ on pages 4 – 6 and 104; Tween® on pages 4 – 6; NanoTemper™ on pages 4, 104, and 105; SNAP-tag® on pages 4 – 9, 104, and 105; Proteintech® on page 106, and possibly others in the specification, which are trade names or a marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore, the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, ℠, or ® following the terms. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Applicant is required to properly annotate all trade names and/or marks that are present in the specification.
7. The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Drawings
8. The drawings are objected to because the degree of color in the 96-well plates for the ELISA, as shown in Figure 1, is difficult to quantitate. Greyscale does not provide a sufficient means to determine the degree of color, which would correlate with the concentration. Additionally, a figure legend is missing for the solid white bars in Figure 2C.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Applicant should note that color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Objections
9. Claims 126–128, 130, 133, and 143 are objected to because of the following informalities:
Claim 126 recites the limitation “body fluid” in line 1. There is insufficient antecedent basis for this limitation in the claim. There is no recitation of “body fluid” in claim 125, upon which claim 126 depends. However, there is a recitation of “bodily fluid” in line 1 of claim 125. “Body fluid” and “bodily fluid” are similar limitations and encompass the same subject matter. It is recommended that claim 126 be amended to read “bodily fluid” to be in agreement with the limitation set forth in claim 125 and the specification;
In claim 127, line 3, there is a bracket around the RSV abbreviation, i.e., “[RSV]”, that should be a parenthesis;
In claim 128, line 2, the acronym “SARS-CoV-2” is recited, but not defined in the claim. An acronym should be defined the first time it appears in an independent claim or in the group of claims under an independent claim. For the purposes of examination, “SARS-CoV-2” is interpreted to mean “severe acute respiratory syndrome coronavirus 2”, as defined in the specifications;
In claim 128, line 2, the acronym “MERS-CoV” is recited, but not defined in the claim. An acronym should be defined the first time it appears in an independent claim or in the group of claims under an independent claim. For the purposes of examination, “MERS-CoV” is interpreted to mean “Middle East respiratory syndrome coronavirus”, as defined in the specifications;
In claim 128, line 3, the acronym “SARS-CoV-1” is recited, but not defined in the claim. An acronym should be defined the first time it appears in an independent claim or in the group of claims under an independent claim. For the purposes of examination, “SARS-CoV-1” is interpreted to mean “severe acute respiratory syndrome coronavirus 1”, as defined in the specifications;
In claim 130, line 1, the acronym “RBD” is recited, but not defined in the claim. An acronym should be defined the first time it appears in an independent claim or in the group of claims under an independent claim. For the purposes of examination, “RBD” is interpreted to mean the “receptor binding domain of the spike protein of SARS-CoV-2”, as defined in the specifications;
There is a typographical error in claim 133, line 2. There should be an “is” between “compound selected” such that the phrase reads “compound is selected”;
The phrase “of from” in claim 143, line 2 is grammatically incorrect. The “from” should be removed so the phrase reads “of 40 to 50%”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
35 USC § 112(b)
10. 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.
11. Claims 124 – 143 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.
12. Claim 124 is vague and unclear, which renders the claim indefinite. This rejection affects all claims that are dependent on claim 124, i.e., claims 125 – 143. Claim 124 recites “[A] method of increasing the binding of virus neutralizing antibodies…comprising contacting a fluid that contains a virus and virus neutralizing antibodies, wherein the virus neutralizing antibodies bind to said virus, with a compound…” in lines 1 – 3. A similar reiteration occurs in lines 1 and 2 of claim 133, wherein claim 133 fails to further limit from claim 124, as discussed below in paragraph 15. Claim 129 also recites “…the compound increases binding of SARS-CoV-2 neutralizing antibodies to the spike protein of SARS-CoV-2…” in lines 1 and 2. It is not clear if the virus neutralizing antibodies bind to the virus, then have increased binding to the virus or the compound, have increased binding to the virus as a result of contacting the compound, or strictly bind to the compound. Moreover, it is not clear whether increasing means inducing a stronger binding between the virus neutralizing antibody and virus, i.e., a higher binding affinity, or rather inducing a more efficient binding in terms of overall amount of binding. The presence of multiple very different interpretations of the same claim language renders the claim indefinite. In the interest of compact prosecution and in view of the instant specification, it will be inferred that the presence of the compound results in an increased binding affinity of the virus neutralizing antibodies for the virus. However, an appropriate amendment is required.
13. Claim 130 recites the limitation "RBD domain" in line 1. There is insufficient antecedent basis for this limitation in the claim. There is no recitation of “the RBD domain” in claims 124 and 127 – 129, upon which claim 130 depends. It has been inferred from the specification that “the RBD domain” is intended to mean the receptor binding domain (RBD) of the spike protein from SARS-CoV-2, as outlined in the claim objections above. In turn, the recitation of “the RBD domain” is repetitive as the RBD is already defined as being a domain as part of the abbreviation. Thus, the claim lacks sufficient antecedent basis and is thus rendered indefinite.
14. It is noted that any interpretation of the claims set forth above does not relieve Applicant of the responsibility of responding to this Office Action. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejection(s) and art may be applied in a subsequent Office Action.
35 USC § 112(d)
15. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS. —Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
16. Claims 133 – 141 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 133 requires that “the fluid contains the virus and virus neutralizing antibodies is contacted with a composition that contains the compound is selected from the group consisting of chitosan or a salt thereof, galactose, mannose, caffeine, and any combination thereof.” Claim 124, which claim 133 is dependent upon, recites “contacting a fluid that contains a virus and virus neutralizing antibodies, wherein the virus neutralizing antibodies bind to said virus, with a compound selected from the group consisting of chitosan or a salt thereof, galactose, mannose, caffeine, and any combination thereof.” There are no additional limitations in claim 133 that are not recited in claim 124. Thus, claim 133 fails to further limit the subject matter of claim 124. This rejection affects all claims that are dependent upon claim 133, i.e., claims 134 – 141. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
17. 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.
18. Claims 124 – 127, 131 – 137, and 139 are rejected under 35 U.S.C. 103 as being unpatentable over Chen, A. X. (US 8470346 B2; Published 06/25/2013), hereby Chen, in further view of Pilgaonkar, P. S., et. al. (US 20120093738 A1; Published 04/19/2012), hereby Pilgaonkar, and Muralidharan, A., et. al. (2019). Chitosan alters inactivated respiratory syncytial virus vaccine elicited immune responses without affecting lung histopathology in mice. Vaccine, 37(30), 4031–4039, (Published 07/09/2019), hereby Muralidharan.
Chen teaches an antiviral composition that reduces the number of viral particles in an infected subject and/or the likelihood a subject exposed to potentially infective viral particles will contract a viral disease, wherein administration of the composition inhibits or reduces contact between the viral particles and the subject and/or the replication or emission of the viral particles (column 6, lines 10 – 24; claim 11), as recited in instant claims 124, 131, and 133. Column 16, lines 2 and 3 go on to teach that the effectiveness of the antiviral composition at treating a subject may be determined using in vivo models and/or patients, as required in instant claim 131. It is further taught that the virus is a respiratory virus, which includes influenza virus, rhinovirus, coronavirus, and RSV (column 1, lines 22 – 28; column 2, lines 39 and 40; column 5, lines 6 – 9; column 15, lines 44 – 52; claims 1, 11, and 12), as recited in instant claim 127. Chen also teaches that the composition can be administered to a subject locally to a mucosal secretion, including the nasal mucous membrane and oral mucous membrane (column 15, lines 1 – 14), as required in instant claims 125 and 126. It is further taught that the antiviral composition itself is comprised of chitosan, wherein the chitosan is chitosan hydrochloride, and has anti-viral activity (column 4, line 9; column 16, lines 23 – 26; column 17, lines 28 – 48), as disclosed in instant claims 124, 132, and 133. Chen continues to teach that the compositions may be in any form suitable for local administration to the oral or nasal membrane, wherein that may be in the form of a solution, paste, gel, suspension, lotion, cream, ointment, aerosol/spray, including nasal ointments, nasal drops, nasal washes, nasal packings, and nasal sprays (column 5, lines 13 – 15; column 15, lines 15 – 25 and 36 – 44; claims 8 and 9), as defined in instant claims 134, 136, and 139.
While Chen does not explicitly teach the usage of galactose, mannose, or caffeine in the composition, as defined in instant claims 124 and 133, it does teach that pharmaceutically acceptable excipients are added, including an osmotic agent, flavor, sweetener, colorant, preservative, and adhesive (column 4, lines 34 – 38; column 11, lines 6 – 10; claim 6). However, Pilgaonkar teaches that the bitter taste of influenza antivirals, which can include chitosan, can be masked with taste-masking agents, wherein sugar and sugar alcohols, including mannose and galactose, are often added (page 2, paragraph 0011; page 6, paragraphs 0050 and 0054), as disclosed in instant claims 124 and 133. It is further taught that other active agents may be combined with the antiviral, including caffeine (page 8, paragraph 0086; claim 8), as required in instant claims 124 and 133. Page 5, paragraph 0045; page 7, paragraph 0061; and claim 22 go on to teach that the antiviral can be in the formulation of a chewing gum, as recited in instant claim 135. The instant specification discloses that the sustained delivery system includes a chewing gum and gel (page 55, lines 20 – 28). Thus, the composition forms taught by both Chen and Pilgaonkar encompass the sustained delivery system required in instant claim 137.
Chen and Pilgaonkar are considered to be analogous to the claimed invention because all are drawn to influenza neutralization with chitosan. It would have been obvious to a person having ordinary skill in the art to include the galactose, mannose, and caffeine in the chewing gum taught by Pilgaonkar to administer viral treatment at the locations taught by Chen. This obviousness is mainly owed to both references teaching antiviral formulations against influenza. Therefore, it would have been obvious to a person having ordinary skill in the art to have combined the teachings of Chen and Pilgaonkar before the effective filing date of the claimed invention with a reasonable expectation of success to mask the taste of the antiviral compound (Pilgaonkar; abstract). All the claimed elements were known in the prior art. Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415–421, 82 USPQ2d 1385, 1395–97 (2007) and MPEP §§ 2143F and 2143.02.
Neither Chen nor Pilgaonkar teaches that contacting the bodily fluid with the antiviral compound results in increased binding of the virus neutralizing antibodies to the virus, as required in instant claims 124 and 133. However, Muralidharan teaches that administration of chitosan against RSV enhances antigen-specific immune responses (page 4031, abstract and introduction). It is further taught that chitosan increases levels of neutralizing antibody in a subject that were originally induced by an inactivated RSV vaccine (pages 4034 and 4035, results sections 3.3 and 3.4), as recited in instant claims 124 and 133.
Chen, Pilgaonkar, and Muralidharan are considered to be analogous to the claimed invention because all are drawn to viral neutralization with chitosan. Based on the prior art teachings, it would have been obvious to a person having ordinary skill in the art to anticipate that the antiviral formulation with chitosan taught by both Chen and Pilgaonkar would result in increased antibody binding to the virus, as disclosed by Muralidharan. This obviousness is mainly owed to the references teaching chitosan to treat viruses. Therefore, it would have been obvious to a person having ordinary skill in the art to have combined the teachings of Chen, Pilgaonkar, and Muralidharan before the effective filing date of the claimed invention with a reasonable expectation of success to augment antigen-specific immune responses (Muralidharan; page 4031, introduction). All the claimed elements were known in the prior art. It would have been obvious to a person having ordinary skill in the art to have combined the elements as claimed by known methods with no change in their respective functions. The combination would have yielded nothing more than predictable results to one having ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415–421, 82 USPQ2d 1385, 1395–97 (2007) and MPEP §§ 2143A and 2143.02.
19. Claims 128 – 130 are rejected under 35 U.S.C. 103 as being unpatentable over Chen, Pilgaonkar, and Muralidharan as applied to claims 124 – 127, 131 – 137, and 139 above, and further in view of Quinlan, B. D., et. al., (2020), The SARS-CoV-2 Receptor-Binding Domain Elicits a Potent Neutralizing Response Without Antibody-Dependent Enhancement, bioRxiv, 1 – 24, (Published 04/14/2020), hereby Quinlan.
While Chen does not explicitly teach that the virus is a human pathogenic coronavirus, including SARS-CoV-2, MERS-CoV, and SARS-CoV-1, as recited in instant claims 128 and 129, it teaches that the disclosed formulation may be employed to prevent the spread of severe acute respiratory syndrome (SARS). However, Quinlan teaches that at least seven coronaviruses infect humans, including SARS-CoV-2, MERS-CoV, and SARS-CoV-1, wherein SARS-CoV-1 is the causative agent of SARS and closely related to SARS-CoV-2 with 79% nucleotide identity (introduction, page 3, first paragraph). It is further taught that antibodies to the RBD of SARS-CoV-1 have potent neutralization of the virus and that the presence of anti-RBD antibodies correlates with neutralization of SARS-CoV-2 in previous studies of sera (summary, page 1; results, page 7, first paragraph). Quinlan goes on to teach the evaluation of whether the SARS-CoV-2 RBD could raise efficient neutralizing antibodies (introduction, page 5, second paragraph). It is further taught that the SARS-CoV-2 spike protein used was NCBI Reference Sequence: YP_009724390.1 (submitted 01/05/2020), which has been reproduced below, wherein the SARS-CoV-2 RBD is located from amino acid residues 319 – 519 and is moderately conserved with the RBD of SARS-CoV-1 (results, page 5, second paragraph; see also figure 1d as reproduced below). Results, pages 5 – 7 continue to teach that antibodies against this sequence were elicited and resulted in robust neutralization
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of SARS-CoV-2. A sequence alignment shows that instant SEQ ID NO: 1 has 100% local similarity to the SARS-CoV-2 RBD sequence taught by Quinlan, as reproduced below and disclosed in instant claim 130.
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Chen, Pilgaonkar, Muralidharan, and Quinlan are considered to be analogous to the claimed invention because all are drawn to viral neutralization with chitosan. Based on the prior art teachings, it would have been obvious to a person having ordinary skill in the art to treat SARS-CoV-2 by targeting any portion of the spike protein that encodes for the RBD with neutralizing antibodies, as set forth by Quinlan, by administering the antiviral compound containing chitosan at the location and in the form taught by Chen and Pilgaonkar to increase the antibody binding as taught by Muralidharan. This obviousness is mainly owed to Chen teaching the treatment can be applied to SARS, wherein Quinlan teaches that SARS-CoV-1 is the causative agent of SARS and is structurally similar to SARS-CoV-2. Therefore, it would have been obvious to a person having ordinary skill in the art to have combined the teachings of Chen, Pilgaonkar, Muralidharan, and Quinlan before the effective filing date of the claimed invention with a reasonable expectation of success to prevent the virus, i.e., SARS-CoV-2, from spreading (Chen; column 15, lines 54 – 64). All the claimed elements were known in the prior art. Known work in one field of endeavor, i.e., SARS-CoV-1, may prompt variations of it for use in either the same field, i.e., SARS-CoV-2, or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415–421, 82 USPQ2d 1385, 1395–97 (2007) and MPEP §§ 2143F and 2143.02.
20. Claims 138 and 140 – 143 are rejected under 35 U.S.C. 103 as being unpatentable over Chen, Pilgaonkar, and Muralidharan as applied to claims 124 – 127, 131 – 137, and 139 above, and further in view of Li, X., et. al. (WO 2020131890 A1; Published 06/25/2020), hereby Li.
Chen, Pilgaonkar, and Muralidharan do not teach that the sustained delivery system is a drug delivery implant, as stated in instant claim 138; that the composition is made of either particles comprising chitosan or a co-agglomerate of different particles comprising chitosan in a liquid or semi-solid composition, as required in instant claim 140; that the particles or co-agglomerate of particles be suspended in a composition, as disclosed in instant claim 141; or that the chitosan or the salt thereof has a degree of deacetylation of 80% or more, as recited in instant claim 142, or 40 to 50%, as defined in instant claim 143. However, Li teaches microcapsule compositions that have different formulation states, wherein the microcapsules are homogenously dispersed in an aqueous phase or in a solid form, including a unit dose tablet or capsule, chewing gum, shower gel, shave gel, cream, soap, lotion, chewable candy, hard candy, denture adhesive, and a health care device, among others (pages 3 and 4, paragraph 0016; page 7, paragraph 0030; claim 14), as required in instant claims 140 and 141. The instant specification teaches that the drug delivery system is an implant, including a prosthesis fixation glue material, i.e., a dental adhesive (page 69, lines 28 – 33; page 99, lines 29 – 31). Thus, the dental adhesive taught by Li encompasses the drug delivery system required in instant claim 138. Moreover, Li teaches that the microcapsule is a particle with a size range of 0.1 to 1000 microns that has a wall comprised of chitosan (page 2, paragraph 0011; page 7, paragraph 0029), as stated in instant claim 140. It is further taught that the microcapsule composition contains one or more additional microcapsules, wherein the microcapsules are different from each other in terms of size, degree of polymerization, degree of crosslinking, encapsulating polymer, thickness or the wall, active material, ratio between the wall material and active material, rupture force, or fracture strength (page 24, paragraphs 0092 and 0093), as required in instant claim 140. Page 8, paragraph 0032 goes on to teach that the chitosan has a degree of deacetylation of 50 to 100%, as required in instant claims 142 and 143. Additionally, the degree of deacetylation is clearly a result effective parameter that a person having ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient, i.e., the degree of deacetylation, needed to achieve the desired results. The principle of law states from MPEP §§ 2144.05: "[T]he normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages," (see In re Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," (See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)). In light of this case law, Muralidharan teaches that the chitosan employed has a degree of deacetylation of ≥75% (page 4032, materials and methods section 2.2). Thus, the degree of deacetylation of the chitosan is clearly a result effective parameter that one having skill in the art would routinely optimize.
Chen, Pilgaonkar, Muralidharan, and Li are considered to be analogous to the claimed invention because all are drawn to formulations of microcapsules/particles with chitosan. Based on the prior art teachings, it would have been obvious to a person having ordinary skill in the art to have the different microcapsules containing chitosan with different degrees of deacetylation, as set forth by Li, with the formulations taught by Chen, Pilgaonkar, and Muralidharan. This obviousness is owed to all references teaching compositions of pharmaceutical capsules. Therefore, it would have been obvious to a person having ordinary skill in the art to have combined the teachings of Chen, Pilgaonkar, Muralidharan, and Li before the effective filing date of the claimed invention with a reasonable expectation of success to develop environment friendly microcapsules that are high performing, stable, and compatible with consumer products (Li; page 1, paragraph 0006). All the claimed elements were known in the prior art. Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415–421, 82 USPQ2d 1385, 1395–97 (2007) and MPEP §§ 2143F and 2143.02.
Conclusion
21. Claims 124 – 143 are rejected. No claims are allowed.
22. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Hallie N. Pennington, Ph.D. whose telephone number is (571)272-6781. The examiner can normally be reached M-Th 7:30-5:30 ET.
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/HALLIE N. PENNINGTON, PH.D./Examiner, Art Unit 1671
/Shanon A. Foley/Primary Examiner, Art Unit 1671