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 .
Claims 14-20 and 23-33 remain pending and examined on the merits.
Applicant’s affidavit is noted and has been reviewed.
Previous Interview Summary noted (relevant aspects retained for continuity below).
The examiner reached out to applicant’s representative but was unable connect ahead of departing out of town on unexpected family matters, but requests interview hereafter to address the below (re: outstanding issues; possession at the time of filing, including what falls inside/outside the scope of “permutations” of VPGVG at positions 1 and 4 of the pentapeptide, e.g. breadth of amino acid substitutions/additions/deletions). This is requested to advance prosecution on the merits, aiming to reach agreement on the scope supported by the test data and bringing the claim scope in line therewith.
Previous New Rejection: Maintained As previously noted, a new rejection had been applied below under 35 USC 112(a) written description as to what peptide/molecule applicant was in possession of as the only tested embodiment and potentially the only support for that claimed – but which the structure thereof cannot be determined based on the Example and review of the specification for further definition and/or support that was undertaken by the examiner and applicant’s representative (neither the examiner nor applicant’s representative were previously aware of this issue). As applicant’s representative indicated applicant was not able to provide such at this time via Declaration and/or other evidence, the Office action is processed (per internal timelines) which will give applicant time to acquire such.
Inventive Concept Search Based on Supported Species Thereto Not Currently Possible Reasonably (Especially if Sequence Compliance Issues are Invoked): A search of the prior art as to the tested peptide/molecule (Elastin-like recombinamers (ELRs) functionalized with azide (HRGD6) and cyclooctyne (HE5); see instant PGPUB para 87 below) provides some evidence of what ‘may’ be elements of that tested but not provide sufficient guidance to confirm the complete structure and ratio (see below). Further, what was uncovered shows that what was tested there is a much larger molecule (which may invoke Sequence Compliance issues, another issue raised here) which is very different than the present claim scope only directed to pentapeptides of SEQ ID NO: 1 or 2. Thus, until the above be resolved as to what actual peptide/molecule applicant tested and had possession of as the only representative species assertedly carrying out the invention scope claimed, an updated search of the prior art cannot be undertaken thereto.
Claim Rejections - 35 USC § 112(a)(i)/(pre-AIA ) – Written Description, Maintained,
As Necessitated Post-Interview (3/20/25)
The following is a quotation 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.
Claims 14-20 and 23-33 remain 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
To provide evidence of possession of a structural molecule, the specification must provide sufficient distinguishing/identifying characteristics. 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 this case, the following and only peptide/molecule tested cannot be determined structurally and until such be fully identified there is a lack of possession as to this solo tested peptide/molecule and that for which it assertedly does (treat MI) until that structure bw identified via some other support (Declaration with original lab notes and/or other evidence) as to:
Only Test: Peptide/Molecule (Unnamed ELR(s) Functionalized) & @ A Ratio of 1.79:1
[0087] Elastin-like recombinamers (ELRs) functionalised with azide (HRGD6) and cyclooctyne (HE5) groups for crosslinking were weighed under sterile conditions. ELRs were resuspended to maintain the HE5-cycloctyne to HRGD6-azide ratio at 1.79:1. ELRs were stored at 4° C. until the day before they were required for injection. Therefore, each ELR was dissolved in 750 μl of sterile molecular grade water overnight at 4° C. Once the solutions were totally clear, 250 μl of HRGD6-azide was placed in a sterile eppendorf tube, where 250 μl of HE5-cycloctyne was added to initiate crosslinking of the recombinamers and hydrogel formation. Cold sterile tips were used to carry out this procedure and the eppendorf tube containing the mixed ELRs was kept on ice for exactly 10 minutes before injection. The feasibility of the ELRs hydrogel epicardial injection and its physical integration in the myocardial tissue was tested ex vivo in a lamb heart collected from the abattoir (FIG. 1 and FIG. 2).
The following reference provides potential guidance as to one of the para 87 acronym molecules listed (HRGD6) but not sufficient guidance to confirm the actual structure tested and functionalized without more (see Gonzalez de Torre et al. section 2.1 reciting a peptide molecule labeled HRGD6 as the “amino-acid sequences of [this polymer is]: MESLLP VG VPGVG [VPGKG(VPGVG)5]23 VPGKG VPGVG VPGVG VPGVG VPGV for VKVx24; MGSSHHHHHHSSGLVPRGSHMESLLP [(VPGIG)2(VPGKG)(VPGIG)2]2AVTGRGDSPASS[(VPGIG)2(VPGKG)(VPGIG)2]2
(Gonzalez de Torre et al. Elastin-like recombinamer-covered stents: Towards a fully biocompatible and non-thrombogenic device for cardiovascular diseases. Acta Biomaterialia. Volume 12, 15 January 2015, Pages 146-155. https://www.sciencedirect.com/science/article/pii/S1742706114004802).
How the above is functionalized/associated with the other acronym molecule tested in para 87 labeled HE5 and a ratio with HRGD6, is a further issue. As well as the ratio of both and whether this is critical/essential to function or optimizable?
Thus, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of that claimed.
Administration Day/Time Support Based on Example Above
[0089] Myocardial infarction was induced in five months old male sheep (weight 30 kg) by transmural suture ligation at intervals parallel to and along the left anterior descending artery. This novel concept was developed to mimic as closely as possible, the real-life type of myocardial infarction seen in clinical practice, unlike previous models of simple LAD ligation. Cardiothoracic surgeon (Mark Da Costa) and the veterinary team ensured that the surgical procedure was performed according to current European animal laboratory guidelines and practice. One week [7 DAYS] after MI induction the animal was re-operated and the hydrogel solution was injected into the pen-infarct zone by the repeated administration of 500 μl of ELR solution by epicardial injection. A sterile syringe having a maximum capacity of 1 ml and a 25G needle was used to perform each epicardial injection through the wall of the heart. Three hydrogels of 500 μl volume each were injected per sheep through the peri-infarct zone, which is the edge of the region between the site where ischemia was induced by coronary ligation and the healthy zone of the myocardial walls. The needle was carefully retracted after each injection to avoid backflow of the hydrogel solution. Echocardiography measurements were performed before surgery and at day 28 days post MI induction and 21 days post injection of the hydrogel.
Further, while the instantly claimed invention has been amended to treating post-MI with the peptides claimed anytime before/up to Day 10 (akin to para 8 below), the only support above in para 89 is that a currently structurally un-identified peptide/molecule was administered Day 7 – which would seem to reasonably support that administration anytime up to or before Day 7 would stand to yield the same or similar results, but after that would be unknown depending on the effects of MI on heart tissue (e.g. scarring, healing).
Background/Summary
[0008] The present invention addresses the need for a treatment of myocardial infarction that induces repair of cardiac muscle damaged by the infarct. The Applicant has discovered that delivery of an elastin hydrogel, and preferably a crosslinked elastin-like recombinamer (ELR) hydrogel, into the coronary muscle damaged by an acute myocardial infarction can modulate the response of the damaged coronary muscle, for example by limiting scarring, inducing positive remodelling of the damaged muscle, and/or restores cardiac muscle function to a clinically significant extent after infarction. The treatment generally involves administration of the hydrogel at two days, and preferably at least three, four, five, six, or seven days after the myocardial infarction, for example at least two to four days, and preferably at last five to seven days, after the myocardial infarction, as the delayed administration has been found to lead to better functional recovery and remodelling of the affected cardiac muscle. An injectable ELR is described herein, which is suitable for minimally invasive delivery by epicardial injection, and forms part of the invention.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111; clearly states that "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 claimed." (See Vas-Cath at page 1116).
Without more, the above un-identified peptide/molecule tested above - the skilled artisan cannot envision the detailed chemical structure or equivalents thereof to provide support for that claimed AND what was in possession of carrying out the claimed invention. 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, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
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).
Response to Arguments/Affidavit (No Amendments)
Applicant’s response (arguments/affidavit, no amendments) is acknowledged, but not yet found persuasive. The claim scope remains drawn to treating myocardial infarction (MI) employing the pentapeptide VPGVG (SEQ ID NO: 1), or “permutations” thereof having an [ANY] amino acid change at 2 of the 5 peptide positions: 1 and 4, leaving only 3 of the 5 peptide positions retained – while only testing a single peptide per the test data of record. It is noted that the rejection is maintained alone relevant to ‘an’ amino acid change at positions 2 and 5, as there is no definition as to what falls inside or outside the scope of “permutations” of VPGVG – even as to positions 1 and 5, which could entail inserting more than one amino acid therein OR even deletion, absent further evidence. The specification contains but a single reference to “permutations” (see PGPUB para 63):
[0063] As used herein, the term “elastin-like recombinamer” or “ELR” means a biocompatible recombinant protein-based polymer comprising a repeat sequence found in the mammalian elastic protein elastin, or a modification thereof. The most well-known members within the ELR family are based on the pentapeptide VPGVG (or its permutations), and a wide variety of polymers with the general formula (VPGXG), where X represents any natural amino acid except proline. ELR's are described in the following references: [0064] Rodriguez-Cabello et al (Polymer, Volume 50, Issue 22, 20 October 2009, Pages 5159-5169; [0065] Girotti et al (Macromolecules, 37 (9) (2004) Page 3396-3400; [0066] Martina et al (macromolecular Bioscience, 2 (7) (2002, Pages 319-328; [0067] Miao et al (Journal of Biological Chemistry, 278 (49) (2003), Pages 48553-48562; [0068] Zio et al (Macromolecules, 36 (5) (2003) Pages 1553-1558; [0069] Urry et al (Journal of Bioactive and Compatible Polymers, 6 (3) (1991) Pages 263-282; [0070] Mayer et al (Biomacromolecules, 3 (2) (2002) Pages 357-367; [0071] Spanish Patent Application No: ES2012030474; and [0072] European Patent Application No: 2397150.
Without more and/or a definition of “permutations” – the affidavit does not address – possession at the time of filing cannot be determined as to what actually falls inside or outside of a “permutation” comprising an amino acid change at position 1 and 5 – which could under the broadest reasonable interpretation be any amino acid substitution (including even more than one amino acid added) OR deletion entirely, the scope of what falls inside or outside the claim scope as to “permutations” thereof cannot be known, without a specific definition thereof.
Even if the actual peptide tested can be determined and the scope limited thereto:
Only Test: Peptide/Molecule (Unnamed ELR(s) Functionalized) & @ A Ratio of 1.79:1
[0087] Elastin-like recombinamers (ELRs) functionalised with azide (HRGD6) and cyclooctyne (HE5) groups for crosslinking were weighed under sterile conditions. ELRs were resuspended to maintain the HE5-cycloctyne to HRGD6-azide ratio at 1.79:1. ELRs were stored at 4° C. until the day before they were required for injection. Therefore, each ELR was dissolved in 750 μl of sterile molecular grade water overnight at 4° C. Once the solutions were totally clear, 250 μl of HRGD6-azide was placed in a sterile eppendorf tube, where 250 μl of HE5-cycloctyne was added to initiate crosslinking of the recombinamers and hydrogel formation. Cold sterile tips were used to carry out this procedure and the eppendorf tube containing the mixed ELRs was kept on ice for exactly 10 minutes before injection. The feasibility of the ELRs hydrogel epicardial injection and its physical integration in the myocardial tissue was tested ex vivo in a lamb heart collected from the abattoir (FIG. 1 and FIG. 2).
. . . what falls inside or outside the scope of VPGVG or “permutations” thereof” cannot be determined and fails the possession inquiry under written description.
Thus, as there remains numerous questions as to what was molecule/peptide was even tested let alone how much further the scope thereof can be stretched as broadly claimed (“permutations”), the rejection is maintained, at a minimum on these grounds, as the scope of which has not been persuasively addressed by either the arguments and/or affidavit (no amendments filed).
*A follow-up interview is requested, as noted above in the outset, to discuss these outstanding scope issues.
Claim Rejections - 35 USC § 103 – Disposition Held in Abeyance Until the 35 USC 112(a) Written Description ‘Possession’ Issue is Resolved as to What Peptide/Molecule was Tested; In Order to Determine the Scope of the Inventive Concept to be Searched
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 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.
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.
Claims 14-20 and 23-33, until the above be resolved, remain rejected under the previous 35 U.S.C. 103 as being unpatentable over Gagner et al. (Designing protein-based biomaterials for medical applications. Acta Biomaterialia. Volume 10, Issue 4, April 2014, Pages 1542-155. https://doi.org/10.1016/j.actbio.2013.10.001) in view of Andrews et al. (U.S. Patent Application No. 2019001543) and Soederstroem et al. (U.S. Patent Publication No. 20140161802) and now further in view of Chaikoff et al. (U.S. Patent Publication No. 20040110439).
Gagner teach protein-based biomaterials for medical use (title), including methods of treating myocardial infarction (MI; page 1547, left column section 4.1, 1st full paragraph, last line), where the focus from the outset (see page 1542, abstract and Introduction) is on uses of the specific biomaterial of elastin-like recombinamers (ELR; e.g. elastin-like polypeptides (ELP) as labeled in Gagner, which are made recombinantly), especially those comprising the pentapeptide VPGVG (page 1543, left column). [Note: The latter is the same preferred ELR instantly described though not claimed in para [0063], 2nd sentence: “The most well-known members within the ELR family are based on the pentapeptide VPGVG (or its permutations), and a wide variety of polymers with the general formula (VPGXG), where X represents any natural amino acid except proline.”). Gagner’s passage on page 1543, left and right column, under section 4.1 Targeting strategies, teach that PEG-PE conjugates accumulated in the injured myocardial infarction (MI) site, similar to results seen in tumor necrotic areas, based on what the art recognizes as the EPR effect:
“Biomaterials for drug delivery must enable the enhanced accumulation of therapeutics in targeted areas. This can be accomplished through a passive targeting system known as the ‘‘enhanced permeability and retention’’ (EPR) effect, in which drugs and particles are accumulated in the target site due simply to changes in physiology associated with the pathology.”
Gagner then by extension, teaches the use of ELP/ELR nanoparticles for treating tumors via the EPR effect; and by extension back to the previous paragraph, teach and/or suggest that ELP’s/ELR’s are equally open to the same employment for treating myocardial infarction where such will accumulate there just like PEG-PE based on the EPR effect.
However, “in this passage” Gagner does not teach that the ELP/ELR is comprised within a “hydrogel” as instantly claimed. Notwithstanding, Gagner recites employment of the term hydrogel 13 times based on a KWIC search thereof, including the 1st recitation on page 1545 reciting ELPs/ELRs in hydrogels and/or nanoparticles, and the advantageous properties of these ELPs/ELRs. From there, whether via nanoparticle or hydrogel, Gagner page 1551 section 6.1 teach and/or suggest the delivery of any desired therapeutic agents, such as peptides and proteins vie the carrier ELP/ELR comprising the peptide VPAPG. Thus, Gagner it would have been prima facie obvious to employ (either nanoparticles and/or) hydrogels (via simple substitution) comprising ELP’s/ELR’s, either alone for treating myocardial infarction or as a carrier for other therapeutic agents for treating myocardial infarction. This therapeutic benefit is based on Gagner’s overview of the EPR effect which generates the accumulation of therapeutic agents (ELP’s/ELR’s such as peptide VPAPG or the therapeutic cargo being carried) specifically at the site of injury resulting from the myocardial infarction.
Further in claim 1, Gagner teach the treatment of myocardial infarction with ELPs/ELRs, Gagner necessarily teaches “some” therapeutic amount thereof, which necessary would equally be “an amount sufficient to modulate the response of cardiac muscle damaged by the [myocardial] infarct” as applicant has neither claimed nor described that there is any cutoff of amount that is ‘not’ sufficient to treat myocardial infarction, and by extension ‘some’ modulation of the cardiac muscle damaged by the infarct. (See MPEP 2144.05, overlap of amounts, where Gagner relies on a reference that administered “some” amount).
Claims 15 and 16 are directed to the timing of administration being at least 3 days after MI or about 2 to 7 days after (where “about” is not defined and is thus given its broadest reasonably interpretation of even same day as or one day after MI), where PHOSITA would understand based on Gagner and the EPR effect discussed therein that any injury such as that by MI would benefit from immediate administration up to days later – until such injury is shown fully treated.
Claims 19 and 20 are all standard sites and/or routines open for selection as to injection of therapeutic administration of treatment of MI’s (see MPEP 2144.03, Official Notice taken of standard art-recognized injection sites for MI, no reference needed).
As for claim 17, whatever would work for a full MI as implied by Gagner, would equally be reasonably expected by PHOSITA to work for “partial” MI as instantly claimed.
As for claim 18, treatment of MI would be reasonably expected by PHOSITA based on Gagner to lead to some degree of achieving any one or all claimed end results.
As for claims 21-22, concentration of an agent for treatment is standard routine optimization (MPEP 2144.05 II. “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)).
As for claim 23, whether the hydrogel is administered chilled, at room temperature, or heated (or something in between) is all merely at the desire of the administrating physician or other health-care professional’s discretion based on what he’s found is best tolerated in his respective MI patients based on their history, condition, and other factors for consideration.
As for claim 24, Gagner page 1545 left column teach crosslinking of hydrogels.
As for claim 25, Gagner page 1549, last sentence into page 1550 teach functionalizing an ELP/ELR via an azide linker to an active agent.
As for claim 26, Gagner in view of Andrews and Soederstroem finds Andrews teaching that ELPs/ELRs are known has “half-life extending moieties” (para 51) and that glycans may be attached as part of the peptide comprising such (para 55) and Sodeerstroem extend that glycans themselves like ELPs/ELRs are “half-life extending moieties” (para 146) providing the motivation to attached glycans even to ELPs/ELRs to extend their half-life further if desired.
As for new claim 27, adding that the hydrogel is acellular, which the previous prior art combination did not expressly teach. Chaikoff fills this gap by teaching not only hydrogels with acellular properties, but also use of the pentapeptide VPGVG – which by extension may be used in such hydrogels (e.g. for repairing damaged cardiac tissue after heart attck/myocardial infarction) – see e.g. abstract, para’s 46, 70. Regarding para 70, Chaikoff teach that: Collagen may be used in hydrogels . . . “As a biomaterial, collagen has been predominantly used after processing into a dry powder or slurry, a hydrogel after solution phase [crosslinking] . . .” and equally in “fiber networks constitute the principle structural elements of a variety of acellular bioprosthetic tissue substitutes, such as porcine heart valves and bovine artery heterografts, as well as other tissue derived matrices . . .”. Thus, Chaikoff teach that collagen is routinely used in hydrogels, and by extension that such may be acellular (like tissue substitutes used in cardiac repair, e.g. after a heart attack/myocardial infarction).
As for new claims 28-29, such is taught by the primary reference Gagner teach that at least V at position 4 may be substituted with amino acids other than the wild-type amino acid thereof at either/both position.
Thus, claims 14-27 and new claim 28-29 remain/are found prima facie obvious over the combination of references relied upon.
Response to Amendments/Arguments
Applicant’s amendment and arguments have been fully considered but are not yet found persuasive. The prior art ‘combination’ of the 4 recited references remains applied over all claims, including new claims 28-29, as providing the motivation as to why PHOSITA would administer VPGVG or at least modified position 4 thereof as hydrogels to treat post-MI cardiac muscle damage. In response to applicant’s arguments over the ‘individual references’ as well as the ‘combination’:
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant's argument that the examiner has combined an excessive number of references, reliance on a large number of references in a rejection does not, without more, weigh against the obviousness of the claimed invention. See In re Gorman, 933 F.2d 982, 18 USPQ2d 1885 (Fed. Cir. 1991).
The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Arguments as to Unexpected Results: Claim Scope Not Commensurate with Assertion(s)
As to applicant’s arguments of potential unexpected results, the claim scope has not been amended commensurate in scope with the assertion(s). Namely, as to the “amounts sufficient” is ‘any’ amount equally capable of reducing fibrosis and/or increasing muscle volume as claimed? What minimum amount is required to achieve either or both as claimed? Such is not clear on the record nor deemed merely a matter of routine experimentation without further evidence; e.g. a graph illustrating such might be a consideration.
Thus, the claimed invention remains/is prima facie obvious over the prior art combination applied.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURY AUDET whose telephone number is (571)272-0960. The examiner can normally be reached on M-Th. 7AM-5:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAURY A AUDET/Primary Examiner, Art Unit 1654
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