DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election of Group I and the election of species of claims 1-5, 7, 8, 13 and 14 in the reply filed on 10/9/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Therefore, claims 9-12 are withdrawn from further consideration by the Examiner as being drawn to non-elected subject matter.
Thus, the restriction/election of species is hereby made FINAL.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5, 7, 8, 13 and 14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to an ionic therapeutic contact lenses containing Aloe vera extract and being permeable to eye drops such that the ionic therapeutic contact lenses are adapted for use as an ocular bandage and simultaneously for the administration of eye drops through the lenses, without the need of removing the lenses from the eyes, wherein the lenses are made of a material consisting of a copolymer of 2- hydroxyethylmethacrylate and methacrylic acid crosslinked with ethylene glycol dimethacrylate plus an initiator (claim 2).
Thus, the claims are drawn to a genus of compounds (and a genus of their use) that is defined only by their function. Since it is clearly NOT clear on the record what the “initiator” is, the claims lack written description.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In the instant case, the only factor present in the claims is drawn to wherein the lenses are made of a material consisting of a copolymer of 2- hydroxyethylmethacrylate and methacrylic acid crosslinked with ethylene glycol dimethacrylate plus an initiator. The specification appears to disclose wherein the lenses are made of a material consisting of a copolymer of 2- hydroxyethylmethacrylate and methacrylic acid crosslinked with ethylene glycol dimethacrylate plus an initiator.
The specification fails to describe the structure of even one compound of this type of initiator. Accordingly, in the absence of sufficient recitation of distinguishing characteristics, the specification does not provide adequate written description of the the lenses wherein they are made of a material consisting of a copolymer of 2- hydroxyethylmethacrylate and methacrylic acid crosslinked with ethylene glycol dimethacrylate plus an initiator or knowing what the final product of the reaction occurring from the composition claimed is.
.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed (See page 1117). The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is now is claimed.” (See Vas-Cath at page 1116). As discussed above, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus of inhibitors, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation or identification. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v.Revel, 25USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF’s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence.
Therefore, without knowing what the “initiator” is and without knowing what the final product of the reaction occurring from the composition claimed is, the full breadth of the claims DO NOT meet the written description provision of 35 U.S.C. 112, first paragraph. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. 112 is severable from its enablement provision (see page 1115).
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5, 7, 8, 13 and 14 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 1 is confusing since it is not clear what, “being permeable to eye drops such that the ionic therapeutic contact lenses are adapted for use as an ocular bandage and simultaneously for the administration of eye drops through the lenses, without the need of removing the lenses from the eyes” actually means. What does this mean? The metes and bounds of this claim are not clearly defined.
Claim 2 is confusing since it is not clear what material the contact lenses are actually made of since claim 2 defines the material that the contact lenses are made of in terms of a chemical reaction which is undefinable especially without knowing what the “initiator” actually is. Claim 2 is unsearchable. Even when combining the terms in a search query, the search comes up with nothing.
The other claims are rejected since they are dependent on claims 1 and/or 2.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 5, 7, 8, 13 and 14 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Pulliero et al. (cited by Applicants).
Pulliero teaches a contact lens with an aloe vera extract, see abstract. The composition of the therapeutic lenses is disclosed in “Section 2.1” on page 2. The aloe vera extract was taught as containing what was claimed in claims 4 and 14. It is inherent that the contact lenses of Pulliero would be permeable to eye drops such that the ionic therapeutic contact lenses are adapted for use as an ocular bandage and simultaneously for the administration of eye drops through the lenses, without the need of removing the lenses from the eyes since the same contact lenses containing aloe vera was used. It is also inherent that the lenses are permeable to anti-inflammatory and/or antibiotic eye drops such that the lenses are adapted for use with the administration of anti-inflammatory and/or antibiotic eye drops. It is also inherent that the lenses are permeable to antibiotic eye drops containing chloramphenicol such that the lenses are adapted for use with the administration of antibiotic eye drops containing chloramphenicol. It is also inherent that the lenses are adapted for post-surgical therapeutic indications. It further is inherent that the lenses have a water content of about 72% and a refractive index of 1.384.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1, 5, 7, 8, 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Pulliero et al. (cited by Applicants).
Pulliero teaches a contact lens with an aloe vera extract, see abstract. The composition of the therapeutic lenses is disclosed in “Section 2.1” on page 2. The aloe vera extract was taught as containing what was claimed in claims 4 and 14. It is inherent that the contact lenses of Pulliero would be permeable to eye drops such that the ionic therapeutic contact lenses are adapted for use as an ocular bandage and simultaneously for the administration of eye drops through the lenses, without the need of removing the lenses from the eyes since the same contact lenses containing aloe vera was used. It is also inherent that the lenses are permeable to anti-inflammatory and/or antibiotic eye drops such that the lenses are adapted for use with the administration of anti-inflammatory and/or antibiotic eye drops. It is also inherent that the lenses are permeable to antibiotic eye drops containing chloramphenicol such that the lenses are adapted for use with the administration of antibiotic eye drops containing chloramphenicol. It is also inherent that the lenses are adapted for post-surgical therapeutic indications. It further is inherent that the lenses have a water content of about 72% and a refractive index of 1.384.
MPEP 2144.05, subsection II.
II. ROUTINE OPTIMIZATION
A. Optimization Within Prior Art Conditions or Through Routine Experimentation
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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The 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."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.").
B. There Must Be an Articulated Rationale Supporting the Rejection
In order to properly support a rejection on the basis that an invention is the result of "routine optimization", the examiner must make findings of relevant facts, and present the underpinning reasoning in sufficient detail. The articulated rationale must include an explanation of why it would have been routine optimization to arrive at the claimed invention and why a person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range. See In re Stepan, 868 F.3d 1342, 1346, 123 USPQ2d 1838, 1841 (Fed. Cir. 2017). See also In re Van Os, 844 F.3d 1359,1361,121 USPQ2d 1209, 1211 (Fed. Cir. 2017 ("Absent some articulated rationale, a finding that a combination of prior art would have been ‘common sense’ or ‘intuitive’ is no different than merely stating the combination ‘would have been obvious.’"); Arendi S.A.R.L. v. Apple Inc., 832 F.3d 1355, 1362, 119 USPQ2d 1822 (Fed. Cir. 2016) ("[R]eferences to ‘common sense’ … cannot be used as a wholesale substitute for reasoned analysis and evidentiary support … .").
The Supreme Court has clarified that an "obvious to try" line of reasoning may properly support an obviousness rejection. In In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977), the CCPA held that a particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation, because "obvious to try" is not a valid rationale for an obviousness finding. However, in KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court held that "obvious to try" was a valid rationale for an obviousness finding, for example, when there is a "design need" or "market demand" and there are a "finite number" of solutions. 550 U.S. at 421 ("The same constricted analysis led the Court of Appeals to conclude, in error, that a patent claim cannot be proved obvious merely by showing that the combination of elements was ‘[o]bvious to try.’ ... When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under §103."). Thus, after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.
In the event it is seen that the contact lenses of Pulliero would not inherently have the above noted properties (which is NOT being admitted) then it would have been obvious for one having ordinary skill in the art through routine optimization to use the lenses with the claimed concentrations and properties of the claimed contact lenses since clearly the contact lenses and the substance in them are result effective variables.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL V MELLER whose telephone number is (571)272-0967. The examiner can normally be reached M-F 9 am-5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Terry McKelvey can be reached at 571-272-0995. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MICHAEL V. MELLER
Primary Examiner
Art Unit 1655
/MICHAEL V MELLER/Primary Examiner, Art Unit 1655