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 .
Priority
This application is a 371 of PCT/DE2021/100902 (11/11/2021)
and claims foreign priority to GERMANY 10 2020 131 547.3 (11/27/2020).
Applicant has filed a certified copy of the foreign priority document – however the Examiner requires a certified English translation as per 37 C.F.R. 1.55 to perfect the priority claim. See MPEP 706.02.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 23-47 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 23 is to “[a] method for detecting and influencing an uptake and/or release of bioactive substances from a hydrogel material comprising,” but does not recite any clear active method steps and only characterizes the hydrogel material properties. Claim 23 has the language: “said hydrogel material configured for affinity of bioactive substances by parameters defining the anionically charged building blocks,” which is unclear with respect to how the language limits the claim. The “parameters” are not defined and one of ordinary skill in the art would find the claim language confusing and ambiguous such that they could not understand the metes and bounds of the claim. Claim 23 has the language “the anionic charge of the hydrogel material” which lacks antecedent basis. Claim 23 has the language “its affinity” which has an unclear antecedent basis as to what “it” is. Claim 23 has the following language in a wherein clause of the method:
affinity for bioactive substances is changed by the electrically conductive component by influencing an electric potential such that bringing the hydrogel material into contact with a biofluid, a change in electrical resistance and/or a change in charge storage capacity of the hydrogel material is detected and an uptake of bioactive substances into the hydrogel material or a release of bioactive substances from the hydrogel material into the biofluid occurs and is determined by the detected change in electrical resistance and/or the detected change in charge storage capacity, and wherein a concentration of bioactive substances in the biofluid and a concentration of bioactive substances in the hydrogel material is being influenced by an electrical potential acting on the hydrogel material.
where the language is unclear as to how the language is limiting with respect to the anionic charge or whether the language is specifying additional method steps or structure of the hydrogel material.
Claim 25 uses “P0, P1, P2, P3” which apparently have some value, but does not provide clear indication of how the parameters limit the scope of the claims. Claims 26-28 include wherein clauses that do not clearly limit the structure of the claim with respect to a particular method step or the structure of the hydrogel.
Claim 29 is to a “[a]n electrically conductive hydrogel material comprising” which is “configurable on the basis of … ” “parameters P0, P1, P2, P3” which parameters apparently have a value but none is recited in the claim, and the claim does not provide clear indication of how the parameters limit the scope of the claims or the structure of the claimed product.
Claim 33 has the phrase “II-conjugated” which is not defined and does not have an art-accepted meaning such that one of skill in the art would understand how the phrase limits the claim.
Claim 39 uses the language of “wherein parameter … is preset” in a manner which would be confusing to one of skill in the art as to when the parameter is set or preset and how it would impact the structure of the resulting product.
Claim 41 is to “[a] method of using an electrically conductive hydrogel material according to claim 29, comprising, managing an in vivo factor …” which lacks a clear active method step such that one of skill in the art could determine the metes and bounds of the claim. For example, the claim nor the specification describes what “managing” entails.
Claim 42 is a “use” claim which is indefinite. See MPEP 2173.05(q).
Claim 43 is to “[a] method of using an electrically conductive hydrogel material according to claim 29, comprising, managing an in vivo factor …” which lacks a clear active method step such that one of skill in the art could determine the metes and bounds of the claim. For example, the claim nor the specification describes what “managing” entails.
Claim 44 is to “[a] method of using an electrically conductive hydrogel material according to claim 29, comprising for in vitro cell culture …” which lacks a clear active method step such that one of skill in the art could determine the metes and bounds of the claim.
Claim 47 uses the language “the parameter configuration” which lacks antecedent basis.
In addition, the claims that depend from the above claims are also rejected as indefinite for incorporating all of the limitations of the claim it depends from.
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.
Claim 45 is 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 45 depends from claim 27 but has a broader scope of electrical potential such that the claim fails to further limit the claim it depends from. 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
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.
Claims 23-47 are rejected under 35 U.S.C. 103 as being unpatentable over Jou et al. (ACS Biomater. Sci. Eng. 2020, 6, p. 6228−6240, published 2020-10-08) in view of Zare et al. (US20120238943), Kelber et al. (Adv. Healthcare Mater. 2019, 8, 1801488, 11 pages), and Schirmer et al. (WO2018162009, citations to English language equivalent US20200040147).
Jou teaches “electrochemically active hydrogel, which has been prepared by gelling a mixture of poly(3,4-ethylenedioxythiophene): polystyrene sulfonate (PEDOT:PSS) and alginate (Alg), has been loaded with curcumin (CUR), a hydrophobic drug with a wide spectrum of clinical applications” (Abstract).
Jou does not teach the particular combination of hydrogel material.
Zare teaches a conductive hydrogel for drug delivery by applying an electric field (claims 1-22; Examples 1-3: “hydrogel (PLGA-PEG-PLGA”, “drug release from the conductive nanoparticles is controlled by the application of a weak, external DC electric field. This approach represents a novel interactive drug delivery system”, “PEDOT”, [0049]-[0109]).
Kleber teaches drug delivery hydrogels from “conducting polymer hydrogel made from a hydrogel precursor poly(dimethylacrylamideco-4-methacryloyloxy benzophenone (5%)-co-4-styrenesulfonate (2.5%)) (PDMAAp) and the conducting polymer poly(3,4-ethylenedioxythiophene) (PEDOT)” wherein a drug “is actively released through application of an electrical trigger signal” (Abstract).
Schirmer teaches a controlled release hydrogel comprising uncharged building blocks (UGB) and charged building blocks (GB) comprising polymers including poly (4-styrenesulfonic acid-co-maleic acid) (claim 59) and polyethylene glycols (PEG) (claim 58) and conjugated with enzymatically cleavable peptides having lysine as reactive amino acid (claim 60), cleavable by MMPs (claim 61), having a bioactive molecule with an amino group bound via lysine formed by Michael-type addition. Schirmer teaches the hydrogels comprise agents for treating asthma and rheumatoid arthritis (claim 70) and for cultures of iPS cells (claim 74).
One of ordinary skill in the art following the teaching of Jou would have reasonably considered using other known hydrogels for same purpose as Jou with hydrogels such as disclosed by Zare, Kleber, and Schirmer. Each of the references are in the same field of endeavor of controlled delivery of agents and would have had a reasonable expectation of success in their combination to arrive at the claimed invention.
With each of the claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed before the effective filing date with a reasonable expectation of success.
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.
Claim 23-47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 25-48 of copending Application No. 18039183 (reference application) in view of Jou et al. (ACS Biomater. Sci. Eng. 2020, 6, p. 6228−6240, published 2020-10-08), Zare et al. (US20120238943), Kelber et al. (Adv. Healthcare Mater. 2019, 8, 1801488, 11 pages), and Schirmer et al. (WO2018162009, citations to English language equivalent US20200040147). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims the same type of hydrogel and as detailed in the 35 USC 103 rejection supra would have been an obvious combination.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626